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Moderna Vaccine, Ottumwa, IA, USA

March 22, 2021 6:46 PM

Ottumwa, 52501 Iowa, United States

I have now had both shots of the Moderna vaccine and I have not experienced any side effects. Nothing! I feel great and I am now waiting two weeks to be fully protected.

Reported By SafelyHQ.com User

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Got my Janssen on Thursday, 04/08, Batavia, IL, USA

Symptoms: Fever Headache Chills Joint Pain Muscle Pain Swelling
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Covid-19 OSHA Complaint, American Home Finding Association, 217 5th Street East, OTTUMWA, IA, 52501, USA

American Home Finding Association, 217 5th Street East, OTTUMWA, IA, 52501, USA

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Johnson & Johnson Covid-19 Vaccine, Webster City, IA, USA

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O'Reilly Auto Parts, 2927 Southeast 14th Street, DES MOINES, IA, 50320, USA

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Pfizer - 1st can, Fort Dodge, IA, USA

Symptoms: Fatigue Soreness
Fort Dodge, IA, USA

April 1, 2021 4:56 PM

“- First shot
- Pfizer
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- Mild side affects included soreness in deltoid and fatigue See Less
Reported By SafelyHQ.com User

March 29, 2021 12:00 PM

“A power outage occurred on March 26 in the area of Scott County that impacted more than 1,000 customers.

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Covid-19 OSHA Complaint, Harley-Davidson of Siouxland, Inc., 1930 N. Lewis Blvd., SIOUX CITY, IA, 51105, USA

Harley-Davidson of Siouxland, Inc., 1930 N. Lewis Blvd., SIOUX CITY, IA, 51105, USA

March 24, 2021 12:00 PM

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Recent Interesting Reports

April 6, 2021 5:00 PM

“Company name: Yolo Studio
Brand name: PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500
Product recalled: Dietary Supplement for male sexual enhancement
Reason of the recall: Undeclared Tadalafil
FDA Recall date: April 06, 2021
Recall details: Company Announcement Cli... See Moreffside Park, NJ, Yolo Studio is voluntarily recalling all lots of PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500 to the consumer level. FDA analysis has found the product to contain undeclared tadalafil. Tadalafil is ingredient known as a phosphodiesterase (PDE-5) inhibitor found in FDA approved products for the treatment of male erectile dysfunction. The presence of tadalafil in PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500 makes these unapproved new drugs for which the safety and efficacy have not been established and, therefore subject to recall.

Consumers with underlying medical issues who take PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500 with undeclared tadalafil may experience serious health risks. For example, PDE- 5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels that may be life-threatening. Consumers with diabetes, high blood pressure, or heart disease often take nitrates. To date, Yolo Studio has not received any reports of adverse events related to this recall. These tainted products are marketed as dietary supplements for male sexual enhancement and are packaged in cardboard blisters containing one pill per card.

The affected lot numbers of PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500 include all lots. PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500 were distributed via internet and fulfilled by amazon at www.amazon.com nationwide in the USA. On December 17, 2020, FDA issued a press release that warned consumers to avoid certain products found on Amazon, eBay and other retailers due to hidden and potentially dangerous drug ingredients. It also encouraged online marketplaces to ensure these products are not sold on their platforms.

Yolo Studio is notifying its customers by this press announcement and via e-mail of this recall. Consumers that have PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500 which are being recalled should stop using and destroy them. Consumers with questions regarding this recall can contact Yolo Studio by phone at (201) 233-3521 Monday through Friday from 9am to 5pm eastern time zone or e-mail yolostudiodamazon@gmail.com.

Consumers should contact their physicians or healthcare provider if they have experienced any problems that may be related to taking or using these drug products. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

- Complete and submit the report Online.
- Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

April 1, 2021 12:02 PM

“Company name: NANA Collection LLC
Brand name: PremierZen Platinum 5000, Triple SupremeZen Gold 3500
Product recalled: Dietary Supplement for male sexual enhancement
Reason of the recall: Undeclared Sildenafil and Tadalafil
FDA Recall date: April 01, 2021
Recall details: NANA Collection LLC is v... See Moreoluntarily recalling all lots of PremierZen Platinum 5000 and Triple SupremeZen Gold 3500 to the consumer level. FDA analysis has found the PremierZen Platinum 5000 to contain undeclared Tadalafil and Triple SupremeZen 3500 to contain undeclared Tadalafil and Sildenafil. Sildenafil and Tadalafil are ingredients known as phosphodiesterase (PDE-5) inhibitors found in FDA approved products for the treatment of male erectile dysfunction.

The presence of Tadalafil and Sildenafil in PremierZen Platinum 5000 & Triple SupremeZen Gold 3500  renders them unapproved drugs for which safety and efficacy have not been established and, therefore, subject to recall. Consumers with underlying medical issues who take PremierZen Platinum 5000 with Tadalafil and Triple SupremeZen Gold 3500 with undeclared Tadalafil and Sildenafil may experience serious health risks. For example, PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels that may be life-threatening.

Consumers with diabetes, high blood pressure, or heart disease often take nitrates. To date, NANA Collection LLC has not received any reports of adverse events related to this recall. This tainted PremierZen Platinum 5000 and Triple SupremeZen Gold 3500 are marketed as dietary supplements for male sexual enhancement and are packaged in paper packaging with a pill blister, 1 capsule per package.  The affected PremierZen Platinum 5000 and Triple SupremeZen Gold 3500 lots include all lot numbers to include GATCO 01671, GATCO 1805 with expiration date 12/30/2024. The product can be identified by the word ZEN stamped on the capsule along with PremierZen and Triple SurpremeZen written on the packaging.

PremierZen Platinum 5000 and Triple SupremeZen Gold 3500 were distributed via internet and fulfilled by amazon at www.amazon.com nationwide in the USA. On December 17, 2020, FDA issued a press release that warned consumers to avoid certain products found on Amazon, eBay and other retailers due to hidden and potentially dangerous drug ingredients. It also encouraged online marketplaces to ensure these products are not sold on their platforms. NANA Collection LLC is notifying its customers by this press announcement and via email of this recall.


Consumers that have PremierZen Platinum 5000 and Triple SupremeZen Gold 3500 which are being recalled should discard the product. Consumers with questions regarding this recall can contact NANA Collection LLC by 201-773-8545 or nanastyle2014@gmail.com on Monday through Friday from 9am to 5pm, eastern time. 

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online by regular mail or by fax. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

Moderna vaccine first shot, Sayville, NY, USA

Symptoms: Numbness Fatigue Soreness
Sayville, NY, USA

April 6, 2021 9:13 PM

“Got my first shot yesterday afternoon at Walgreens. Felt fine most of the evening. Woke up at 1am and my left arm (I had the shot in my left arm) was numb along with the left side of my face. I started to panic thinking great it’s a stroke but I read about temporary Bell’s palsy and calmed down and... See Morewent to sleep. Woke up at 8:30. My arm was very sore which got worse as the day went on, I was very fatigued and had a low fever which Tylenol got rid of. Aches and pains came and went all day. My top lip on my left side of my mouth is still numb and parts of my face feels numb still but I look fine and feel fine otherwise. 30 hours later i would say the worst is the arm pain, I can’t really use my arm. I suggest getting it in your non dominant arm/hand which was suggested to me. Overall the numbness was scary but I think the vaccine is worth it. See Less
Reported By SafelyHQ.com User
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Pfizer First Dose Vaccine, Parkland Hospital, Harry Hines Boulevard, Dallas, TX, USA

Symptoms: Headache Fatigue Soreness
Parkland Hospital, Harry Hines Boulevard, Dallas, TX, USA

April 2, 2021 7:33 PM

“The vaccine process went relatively smooth. Waited the recommended 15 minutes for any allergic reactions. Had none. My side effects have been mild. Headache, run down feeling, head fogginess, sore arm from where the vaccine was injected, alittle fatigued, and have noticed my heart rate being alittle... See Moretoo high for comfort. See Less
Reported By SafelyHQ.com User

Pfizer vaccine first dose, Fort Collins, CO, USA

Symptoms: Soreness
Fort Collins, CO, USA

April 13, 2021 11:07 PM

“I just received my first dose today. The shot was completely painless. I did not have any soreness in my arm until a few hours later. No side effects so far. I have been feeling good after the shot. My next one is in 21 days. See Less
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March 29, 2021 8:00 PM

“Company name: Antoto-K
Brand name: Thumbs Up 7
Product recalled: Dietary Supplement for male sexual enhancement
Reason of the recall: Undeclared Sildenafil and Tadalafil
FDA Recall date: March 29, 2021
Recall details: Manassas, VA, Antoto-K is voluntarily recalling all lots of Thumbs Up 7 Red 7... See More0K, 10 capsules to consumer level. FDA analysis has found the product to contain undeclared Sildenafil and Tadalafil. Sildenafil and Tadalafil are ingredients known as phosphodiesterase (PDE-5) inhibitors found in FDA approved products for the treatment of male erectile dysfunction.

The presence of Sildenafil and Tadalafil in Thumbs Up 7 Red 70K, 10 capsules makes them unapproved new drugs for which the safety and efficacy have not been established and, therefore subject to recall. Consumers with underlying medical issues who take Thumbs Up 7 Red 70K, 10 capsules with undeclared Sildenafil and Tadalafil may experience serious health risks. For example, PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels that may be life-threatening. Consumers with diabetes, high blood pressure, or heart disease often take nitrates.

To date, Antoto-K has not received any reports of adverse events related to this recall. This tainted product is marketed as a dietary supplement for male sexual enhancement and is packaged in foil sheet and a box containing 10 capsules. The affected lot numbers of Thumbs Up 7 Red 70K includes all lots. Thumbs Up 7 Red 70K was distributed via internet and fulfilled by amazon at www.amazon.com nationwide in the USA.

On December 17, 2020, FDA issued a press release that warned consumers to avoid certain products found on Amazon, eBay and other retailers due to hidden and potentially dangerous drug ingredients. It also encouraged online marketplaces to ensure these products are not sold on their platforms. Antoto-K is notifying its customers by this press announcement and via e-mail of this recall. Consumers that have Thumbs Up 7 Red 70K which is being recalled should stop using and destroy them.

Consumers with questions regarding this recall can contact Antoto-K by email at ngtbtr.k17@gmail.com. Consumers should contact their physicians or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

March 30, 2021 10:00 AM

“Company name: Bit & Bet LLC
Brand name: Thumbs Up 7
Product recalled: Blue 69K Dietary Supplement for male sexual enhancement
Reason of the recall: Undeclared Sildenafil and Tadalafil
FDA Recall date: March 30, 2021
Recall details: Bit & Bet LLC is voluntarily recalling all lots of Thumbs Up 7... See MoreBlue 69K capsules to consumer level. FDA analysis has found the product to contain undeclared sildenafil and tadalafil. Sildenafil and tadalafil are ingredients known as phosphodiesterase (PDE-5) inhibitors found in FDA approved products for the treatment of male erectile dysfunction.

The presence of sildenafil and tadalafil in Thumbs Up 7 Blue 69K capsules make them unapproved new drugs for which the safety and efficacy have not been established and, therefore subject to recall. Consumers with underlying medical issues who take Thumbs Up 7 Blue 69K capsules with undeclared sildenafil and tadalafil may experience serious health risks. For example, PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels that may be life-threatening. Consumers with diabetes, high blood pressure, or heart disease often take nitrates.

To date, Bit & Bet has not received any reports of adverse events related to this recall. To date, Bit & Bet has not received any reports of adverse events related to this recall This tainted product is marketed as a dietary supplement for male sexual enhancement and is packaged in blister foil sheets in a box labeled with UPC 6 17135 89467 3. Each box contains 10 capsules. The affected lot numbers of Thumbs Up 7 Blue 69K includes all lots. Thumbs Up 7 Blue 69K was distributed via internet and fulfilled by amazon at www.amazon.com nationwide in the USA.

On December 17, 2020, FDA issued a press release that warned consumers to avoid certain products found on Amazon, e Bay and other retailers due to hidden and potentially dangerous drug ingredients. It also encouraged online marketplaces to ensure these products are not sold on their platforms. Bit & Bet LLC is notifying its customers by this press announcement and via email of this recall. Consumers that have Thumbs up 7 Blue 69K, which is being recalled should stop using and descard them.

Consumers with questions regarding this recall can contact Bit & Bet LLC by phone at (201) 208-2836 Monday to Friday from 9AM to 5PM or e-mail thumbsup7blue@gmail.com. For more information, please visit www.thumbsup7blue.com. Consumers should contact their physicians or healthcare provider if they have experienced any problems that may be related to takin or using this drug product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

I am reporting Pfizer vaccine, Lecompte, LA 71346, USA

Symptoms: Other Headache
Lecompte, LA 71346, USA

March 22, 2021 7:48 PM

“In February I received my 1st dose of Pfizer vaccine and I did get a headache.. yet it was the second dose on March 3 that made me go to the doctor and found that that vaccine has cause me to have high high blood pressure! My numbers doubled and I have not recovered. Now on high blood pressure me... See Moreds. The doctor says I have fluid built up around my heart and palpitations that are driving me to unhappy days.
Letting you know. .
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Reported By SafelyHQ.com User

March 25, 2021 9:01 AM

“Company name: Sanit Technologies LLC d/b/a Durisan
Brand name: Durisan
Product recalled: Antimicrobial Hand Sanitizer
Reason of the recall: Due to microbial contamination
FDA Recall date: March 24, 2021
Recall details: Sanit Technologies LLC d/b/a Durisan announces a voluntary recall of the lot... See Mores listed in the table below of Durisan Antimicrobial Hand Sanitizer, Non-Alcohol products in various sizes listed. The products are being recalled due to microbial contamination. Specifically, out of specification results for bacterial count for Burkholderia cepacia complex and Ralstonia pickettii. The issue was discovered during a routine audit focused on production scale-up during the height of the pandemic.

Check the link below for the full list of Durisan Antimicrobial Solutions Hand Sanitizer Sizes and Lot Numbers. To date, no reports of adverse reactions or customer complaints have been reported related to this recall.

The product was packaged in sizes ranging from 18mL credit cards, to bottles sized in 118, 236, 300 and 550 mL and 1000mL wall mounted dispenser refills. Pictures are available in the attached related file.

Use of a hand sanitizer contaminated with Burkholderia cepacia complex and Ralstonia pickettii, can range from no reaction to serious infections in a person with a hand wound or scrapes because the bacteria could enter the bloodstream, especially in patients with compromised immune systems. Health care professionals who use this contaminated hand sanitizer and tend to an at-risk patient, such as one with cystic fibrosis, could lead to adverse events ranging from a localized infection to lung or bloodstream infections, which could require patient hospitalization.

The product is intended to be applied topically to help reduce bacteria on the skin that could cause diseases when soap and water are not available. The product can be identified by examples of the product labels below. The product was manufactured from Feb. 1, 2020 until June 30, 2020, and distributed to selected retailers nationwide in the United States.

Durisan has provided written notification to its distributors and retailers and is alerting customers via this voluntary recall. Consumers that have the product which is being recalled are advised to destroy it immediately.

Consumers with questions regarding this recall can contact Durisan at 941-351-9114 [Call: 941-351-9114] , 8:30 am - 4:30 pm Eastern time, Monday through Friday or by e-mail at customerservice@durisan.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

March 31, 2021 8:00 PM

“Company name: Apotex Corp.
Brand name: Apotex Corp.
Product recalled: Guanfacine Extended-Release Tablets 2mg
Reason of the recall: Trace amounts of Quetiapine Fumarate
FDA Recall date: March 31, 2021
Recall details: Weston, Florida, Apotex Corp is voluntarily recalling three (3) lots of Guanfa... See Morecine Extended-Release Tablets 2mg to the consumer level due to trace amounts of Quetiapine Fumarate in one lot RX1663. Out of an abundance of caution, lots RX1662 and RX1664 are also included in the scope of this voluntary recall, as they were manufactured in the same campaign as lot RX1663.

Risk Statement: Administration of Guanfacine Extended-Release Tablets containing trace amounts of Quetiapine Fumarate to a patient can result in the possibility of hypersensitivity reaction and may potentially have additive effects in lowering blood pressure, sleepiness/sedation, and dizziness. Pediatric patients, pregnant patients and older adults may be more likely to experience low blood pressure and dizziness if exposed to the defective product.

To date, Apotex Corp has not received any reports of adverse events related to this recall. Guanfacine is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and can be used with other stimulant medications. Quetiapine is indicated for the treatment of Schizophrenia and other serious mental disorders such as Bipolar disorder manic episodes, Bipolar disorder, and depressive episodes.

The affected Guanfacine Extended-Release Tablets can be identified by NDC numbers stated on label of the product. The lot number and Expiration date are located to the left side of the product description on the label besides the 2D barcode. The affected lots were distributed in the USA between December 22, 2020 to March 19, 2021.

- Guanfacine Extended-Release Tablets. Pack Size: 100 Tablets. Strength: 2 mg. NDC Number: 60505-3928-1. UPC Code: 3 60505 39281 0. Lot Number / Expiry Date: RX1662 / Nov-22 | RX1663 / Nov-22 | RX1664 / Nov-22

The three (3) affected lots of Guanfacine extended-release tablets were distributed by Apotex nationwide in the USA to Wholesalers, Distributors, Warehousing Chains, Independent Retail Pharmacy and Retail Buying Group. Apotex Corp is currently notifying its affected direct account Wholesalers, Distributors, Warehousing Chains, Independent Retail Pharmacy and Retail Buying Group, via mail (FedEx Standard Overnight) and is arranging for return of all recalled product.

Patients who have received either of the three impacted lots of Guanfacine Extended-Release Tablets or have questions regarding this recall should contact their pharmacy. Individuals should not interrupt their therapy due to this notice. They should immediately contact their health care provider for medical advice and return the impacted product to Inmar Rx Solutions by contacting at the numbers provided in this press release.

Wholesalers, Distributors, Warehousing Chains, Independent Retail Pharmacy and Retail Buying Group should return the recalled product to the place of purchase. Anyone with an existing inventory of the recalled product should quarantine the recalled lots immediately. Customers who purchased the impacted product directly from Apotex can call Inmar Rx Solutions at 1-855-697-4722 (9:00am – 5:00-pm, EST Monday thru Friday), to arrange for their return.

Consumers with the affected units of Guanfacine Extended-Release Tablets, can contact Inmar Rx Solutions (“Inmar”) at 1-855-697-4722, to receive a recall/return packet including the Recall Stock Response Form, or you may obtain this form clsnetlink.comExternal Link Disclaimer

Consumers with questions regarding this recall can contact Apotex Corp. by phone at 1-800-706-5575 (8:30am –5:00pm, EST Monday thru Friday) or email address UScustomerservice@Apotex.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Check the full recall details on fda.gov

Source: FDA
See Less
Reported By SafelyHQ.com User