Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Influenza, Malaise, Nasal congestion
Clinical narrative: diagnosed with COVID virus yesterday; diagnosed with COVID virus yesterday; couldn't taste anything/lost her taste; lost her taste and smell; she was not feeling good; feeling crummy sunday/feeling bad before that; feeling a scratchy throat/throat felt off, not sore, but a little irritated; sore all over; so tired; nostrils would get worse; cold; flu multi-symptoms; She wakes up with a cough; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A female patient of an unspecified age received bnt162b2, via an unspecified route of administration, administered in Arm Right on 01May2021 (Lot Number: EW0164; Expiration Date: 31Aug2021) as dose 2, single and via an unspecified route of administration, administered in Arm Right on 10Apr2021 (Lot Number: ER8732; Expiration Date: Jul2021) as dose 1, single for COVID-19 immunisation. Medical history included ongoing hearing disability on an unknown date. There were no concomitant medications. The patient experienced she wakes up with a cough in 2021; vaccination failure and diagnosed with covid virus yesterday on 20Sep2021; feeling crummy sunday/feeling bad before that, feeling a scratchy throat/throat felt off, not sore, but a little irritated, sore all over, so tired, nostrils would get worse, cold, flu multi-symptoms and she was not feeling good in Sep2021; couldn't taste anything/lost her taste and lost her taste and smell n 16Sep2021. The clinical course was reported as follows: Patient called in regards to Pfizer COVID vaccine. She got both doses of the vaccine and just diagnosed with COVID virus yesterday. She wanted to call and reported. She was diagnosed yesterday, 20Sep2021. Her fiance just went to get tested today and he is fully vaccinated too. She was not sure who got who sick. She started feeling crummy Sunday. He started feeling bad before that. She was out doing yard work. It was pollenated a lot in (withheld) right now. She was just feeling a scratchy throat, but she had been out in the weeds. She went to bed and had to work the next morning. When she woke up she felt like she had been hit by a bus, sore all over. She felt like she had done an extreme workout. Then her throat felt off, not sore, but a little irritated. She has never had a fever this whole time. She has been normal. Normally she is 97.5. She may have gone up to 98. She has had no fever like you hear about in the news and mainstream media. She went to work. She was so tired. She could have fell asleep on her job. She went to bed and slept for 12 hours from Monday night into Tuesday. She wasn't feel any worse. It would get worse at night. The nostrils would get worse. She would prop up and take a decongestant. She clarified the decongestant as Diphenhydramine. Her fiance pushed for her to Zicam Swab and Emergen-C. She hates the way Emergen-C taste. She can't taste now, but the fizz is awkward. She also did cold and flu Multi-Symptoms Equate. She couldn't taste anything on Wednesday, 15Sep2021. Her fiance said he couldn't taste anything on Monday and Tuesday. They have not been quarantining because they thought they had a cold. She has a daughter and her son has asthma. That was scary. She clarified that she lost her taste and smell on 16Sep2021 and hasn't got it back yet. She clarified all the thing she has tried for treatment were Diphenhydramine (lot number: P122068, expiry: Sep2023, strength: 25mg manufacturer: Wal-dryl. It says compared to Benadryl ultra tabs); Equate Combo Pack: She didn't take the nighttime. She only took the daytime non-drowsy. Lot number: WJ43038. Expiry: Jun2022. Strength: Acetaminophen 325mg, Dextromethorphan 10mg, Phenylephrine 5mg; Zicam Swabs lot number: 24354. Expiry: Jun2023. Strength: four times Galphimia Glauca, four times Luffa, four times Sabadilla. Manufacturer: Xycam Cold Remedy, Zinc free. Medicated nasal swabss with cooling menthol and eucalyptus. Honestly she wouldn't know because she can't smell; Emergen-C It is immune plus super orange. Lot number: EJ55881431. Expiry: Jan2023. Manufacturer: Wellmune WGP Biothera; and Sinex Severe: moisturizing mist. It is supposed to be 12 hours with vapor. Lot Number: 1119028830. Expiry: Mar2023. It is made by the same people that makes Vicks. She stated that she hasn't done steroids. She called the doctor this morning because she found after hours that she had COVID. She just took last pill of Azithromycin 250mg today. Lot: KY2666. Expiry: Sep2022. She took it for 5 days. Azithromycin was prescribed prior to finding out she had COVID. It came in a really junky popsicle thing. She is usually a hard worker and she was not feeling good. She thought if she had sinus congestion she didn't want to go the weekend without help. She told the doctor that she went and got tested and she is fully vaccinated. She was just explaining to the doctor and the doctor gave her Azithromycin. It helped a little, but she was still congested. She has a hearing disability and it was not healing or helping her ears. From her neck up is what was troublesome. She wakes up with a cough. When she was getting up and moving she will cough. Sometimes the cough will wake her up. Once she sits up and was moving around she won't cough. She clarified that she only coughs in the morning. The doctor prescribed a steroid, but she has not taken it. The doctor said if she wasn't getting better and felt she needed the steroid she could take it. She clarified that the hearing disability was prior to the vaccine. The events did not require Emergency Room and Physician Office. There were no prior Vaccinations (within 4 weeks). The patient underwent lab tests and procedures which included body temperature: 97.5 on Sep2021 and 98 on Sep2021, COVID virus/SARS COVID 2 RT PCR test: positive on 20Sep2021. Therapeutic measures were taken as a result of feeling crummy sunday/feeling bad before that, feeling a scratchy throat/throat felt off, not sore, but a little irritated, sore all over, so tired, nostrils would get worse, cold, flu multi-symptoms, couldn't taste anything/lost her taste, lost her taste and smell and she was not feeling good. The outcome of the events 'so tired', 'couldn't taste anything/lost her taste' and 'lost her taste and smell' was not recovered and outcome of the other events was unknown.  Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE INJECTABLE lot EW0164 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of complaint history 5985244 5984117 for the reported lot. The final scope was determined to be the reported finished goods lot EW0164, fill lot EP8696, and the formulated drug product lot EP8593. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot ER8732 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot and product type. The final scope included the 6164660 6163790 reported finished goods lot ER8732, fill lot EP8684, and bulk formulation lot EP8571. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.