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IMPORTANT - YOUR REPORT IS QUEUED - IT MAY TAKE UP TO 12 HOURS FOR YOUR REPORT TO SHOW ON OUR HOME PAGE (IF NOT OPTED AS PRIVATE)

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Pfizer first and second dose, Berkeley, CA, USA

March 29, 2021 6:33 PM

Berkeley, California, United States

Symptoms: Fever Headache Blurry vision Chills Fatigue Sweating Body Ache Soreness

I was given Pfizer.
First dose: fatigue, very mild chills, mild backache
Second dose: fatigue, intense body wracking chills, body aches, fever, splitting headache, blurry vision, sweating, arm pain at injection site. Got the vaccine at 1pm, symptoms started at 12:30 am that night, had a fever all day the next day, and was feeling completely better the following morning. It was a rough day, but I'm glad I did it and would do it again.

Reported By SafelyHQ.com User

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McDonald's, 1998 Shattuck Avenue, BERKELEY, CA, 94704, USA

April 7, 2021 12:00 PM

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April 7, 2021 12:00 PM

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April 1, 2021 12:00 PM

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Reaction to Moderna vax, Berkeley, CA, USA

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March 8, 2021 11:00 PM

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Johnson and Johnson Vaccine Review, Perth Amboy, NJ, USA

Symptoms: Soreness
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April 6, 2021 10:19 PM

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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

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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.

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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

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Reported By SafelyHQ.com User

Pfizer Vaccine, Lafayette, CO, USA

Symptoms: Soreness
Lafayette, CO, USA

April 12, 2021 11:56 PM

“I have had previous allergic reactions to nuts, but am happy to report I did not experience an allergic reaction as a result of having the Pfizer vaccine. I had it at about 4-5PM, and no immediate side effects. By the late evening my arm hurt and I didn’t want to lift it. By the next morning, the pa... See Morein had decreased, and by that evening it was completely gone. I have never had Covid before :^) See Less
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2nd Dose Pfizer Vaccine, Parkland Hospital, Harry Hines Boulevard, Dallas, TX, USA

Symptoms: Nausea Headache Dizziness Fatigue Body Ache Soreness
Parkland Hospital, Harry Hines Boulevard, Dallas, TX, USA

April 21, 2021 6:01 PM

“Day 1 after vaccination my symptoms were a headache, nausea, medicine head, dizzy spells and alittle fatigue. Day 2 after my second dose. My symptoms include the following, sore painful arm, nausea, slight headache, medicine head, body & muscle aches, lymph nodes appeared to be inflamed which caused... See Moremy ears to hurt. Felt like I had a mild case of the flu. Been miserable and missing 2 days of work because of this. See Less
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J&J one shot vaccine, Valencia, Santa Clarita, CA, USA

Symptoms: Nausea Fever Headache Chills Soreness
Valencia, Santa Clarita, CA, USA

April 5, 2021 7:15 PM

“Recieved my shot on 4/1/21 @ 2pm. By 10pm had a headache. Middle of the night low grade fever, chills, and nausea. Lasted 48 hours. Now 5 days out and still redess, soreness, and lump at injection site. See Less
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After first Moderna shot, Sebastopol, CA, USA

Symptoms: Other Body Ache Soreness
Sebastopol, CA, USA

March 26, 2021 5:51 PM

“Sore arm first night, much like a flu shot. In subsequent days had achy lymph nodes in armpit, neck and upper chest. No big deal, just rather odd. 9 days after shot I woke with first Atrial fib in almost 6 weeks (had second Cardiac ablation last summer that we hoped would "fix" it). I had Afib episo... See Moredes next two nights, decreasing in intensity, but certainly requiring meds and monitoring. Since been diagnosed with Afib bit over 2 years ago had never had it multiple days in a row before.
Since then, every days it's less problematic. Now just an hour of feeling a tad funky in the afternoons.Asked my cardiologist if he'd had other patients with similar reactions and he said "yes", but mostly after second vaccination. Seems as if the inflammation that's triggered by vaccine as body responds and creates antibodies to virus, triggers "twitchy" susceptible heart into freaking out (my language, not his!) Makes me rather dread how I"m going to feel next week after second shot, But will certainly not deter me to get fully covered.
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Reported By SafelyHQ.com User

March 26, 2021 7:00 PM

“Company name: Namoo Enterprise LLC
Brand name: PremierZen
Product recalled: Dietary Supplement for male sexual enhancement
Reason of the recall: Undeclared Sildenafil and Tadalafil
FDA Recall date: March 26, 2021
Recall details: Little Ferry, NJ, Namoo Enterprise LLC is voluntarily recalling al... See Morel lots within expiry of PremierZen Black 5000 capsules to the consumer level. FDA analysis has found the product to contain undeclared sildenafil and tadalafil. Sildenafil and tadalafil, known as phosphodiesterase (PDE-5) inhibitors, are found in FDA approved products for the treatment of male erectile dysfunction.

The presence of sildenafil and tadalafil in PremierZen Black 5000 products makes them unapproved new drugs for which the safety and efficacy have not been established and therefore subject to recall. Risk Statement: Consumers with underlying medical issues who take PremierZen Black 5000 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, Namoo Enterprise LLC has not received any reports of adverse events related to this recall. The tainted product is marketed as a dietary supplement for male sexual enhancement and is packaged in card form with one capsule per card and is aware of at least one lot with an expiration date of December 2023. Each pack is black with gold, blue, white and red text. The capsule appears black and is enclosed within clear plastic on the package. The affected lots of PremierZen Black 5000 includes all lots. PremierZen Black 5000 was sold nationwide in the USA via the internet and fulfilled by ebay at www.ebay.com and also fulfilled by amazon at www.amazon.com.

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. Namoo Enterprise LLC is notifying its customers by this press announcement and by mailing recall letters. Consumers that have PremierZen Black 5000 should stop using and destroy them. Consumers with questions regarding this recall can contact Namoo Enterprise LLC by phone at 201-267-0539, Monday to Friday, 9 A.M. to 5 P.M. EST or email at namooenterprise@gmail.com from Monday to Friday.

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