Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 78 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 31Aug2021 (Lot number: FA6780) at the age of 78 years as dose 2, single and administered in arm right, administration date 03Aug2021 (Lot number: FA6780) as dose 1, single for Covid-19 immunisation. Relevant medical history included: "Arthritis" (ongoing), notes: Arthritis, diagnosed 20 years ago, runs in the family; "Bell's Palsy", start date: 1976 (unspecified if ongoing), notes: she had the beginnings of Guillain Barre Syndrome and Bell's Palsy; "Guillain Barre Syndrome" (unspecified if ongoing), notes: she had the beginnings of Guillain Barre Syndrome and Bell's Palsy; "Campylobacter" (unspecified if ongoing); "GERD" (unspecified if ongoing), notes: She has GERD, reflux, mild controlled with diet; "reflux" (unspecified if ongoing); "Irritable bowel syndrome" (unspecified if ongoing), notes: she lost weight on a special diet for irritable bowel; "scarlet fever" (unspecified if ongoing), notes: heart valve damage is because she had scarlet fever as a teenager, her heart doesn't rest like it should between beats; "Allergic to dust" (unspecified if ongoing); "Allergic to mold" (unspecified if ongoing); "eczema" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Tetanus, reaction(s): "allergic to Tetanus", notes: She is semi allergic to Tetanus. Vaccination history included: Flu vaccine (she has had allergic reactions to other vaccines, like the flu vaccine, she has had tingling and numbness in legs after last flu vaccine), reaction(s): "allergic reactions"; Flu vaccine (she has had tingling and numbness in legs after last flu vaccine, luckily the tingling and numbness went away., Occurred in 2009, legs tingling), reaction(s): "tingling"; Flu vaccine (she has had tingling and numbness in legs after last flu vaccine, luckily the tingling and numbness went away.), reaction(s): "numbness". The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant) with onset 04Feb2022, outcome "unknown" and all described as "had Covid after receiving the Covid-19 vaccine / tested positive for Covid on 07Feb2022". The event "had Covid after receiving the Covid-19 vaccine / tested positive for Covid on 07Feb2022" and "had Covid after receiving the Covid-19 vaccine / tested positive for Covid on 07Feb2022" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (07Feb2022) positive, notes: Result: positive; Unit: Not Provided. Clinical Course: Caller has gotten two of the Pfizer shots, she had to wait until last August, wanted to wait because she has had allergic reactions to other vaccines, like the flu vaccine, she had the beginnings of Guillain Barre Syndrome and Bell's Palsy. Her doctor said not to get any more of flu shots. She has a science background, does some investigating for her doctor, she came across that Moderna is coming out with a shot that has things like the corona viruses and flu shots. She talked to her doctor, she knows what her problem is, she cannot have the flu vaccine or any vaccine like how flu shot is made, she wants to know if Pfizer will keep some plan shots? Her husband brought home Covid although he was vaccinated, she can get booster at the end of April. Doctor said he doesn't know what she would do if she had to do a shot that also includes a flu vaccine, she has had tingling and numbness in legs after last flu vaccine, luckily the tingling and numbness went away. She can't get Johnson and Johnson either, she has had good luck with the Pfizer shot. She had two shots but not able to the booster last August, she had to wait to get the booster, she had Covid, ringing in her ears and swollen ankles. Her husband's brother and his wife also got Covid after being boosted. No further details, she doesn't know if they would want to report. Declines to complete a report for her husband's bother and his wife. Her doctor had her stay unvaccinated until August because of some of her medical allergies, once it got to be August, he said Delta plus and Omicron are here and she should take the risk and take the shot. He watched her for a good hour, hour and half, she has a weak heart, so he had an EpiPen ready. She felt safe to receive the Covid-19 vaccine, she didn't have an reaction to the shot itself. HCP: no further detail, she doesn't know if he would want to be contacted. She got her last vaccine on 31Aug2021, she got Covid symptoms earlier, 04Feb2022, and then tested positive for Covid on 07Feb 2022. She had a horrible sore throat, upper respiratory, rough days, could have been worse. She was over everything in about six or seven days. Three or four weeks later, she got swelling in ankles and feet. From her toes up to ankle, like ventricles, gradually the swelling went away. Swelling persists in the large ankle bones, rash to feet went away, she was over everything and then this came along later. She doesn't know why some people get the swelling and some the swelling stays longer. Her swelling is nearly gone, outer ankles are where there's still some swelling. Before having Covid she already had ankle swelling from being older, her doctor said it was normal and nothing to be concerned about. Strange, after all that time, other wise doing good. Ringing in her ears got worse, she had had ringing for decades, hearing damage, the ringing is a brain problem not a hearing problem, after receiving the Covid shot she had some ringing, after having Covid virus ringing was worse. She read an article from a Doctor who works for in one of the Covid departments, he had ringing too and the ringing is like having a screaming microphone in the ear. She went to ENT doctor for her throat, which was fire engine red, could be Covid or could be from her sinuses, ears, could have been either one. The doctor considered doxycycline but said only if the redness was not Covid, he called back and said it was Covid so not to take the doxycycline, she did not take doxycycline, she is allergic to almost every antibiotic out there, the only one she has left is Clindamycin, which has terrible side effects, she knew that doxycycline would be hard on her digestion. Longer she lives live the more problems that develop. The reason she has heart valve damage is because she had scarlet fever as a teenager, her heart doesn't rest like it should between beats. No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s): US-PFIZER INC-202200469081 same reporter/drug/AE, different patient; US-PFIZER INC-202200470008 same reporter/drug/AE, different patient.