Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) as Dose 1, single on 26Jan2021 in the afternoon, 13:00 or 13:30 (doesn't remember) and Dose 2, single on 16Feb2021 in the afternoon, 13:00 or 13:30 (doesn't remember), both at the age of 74-year-old, via an unspecified route of administration, administered in left upper arm (Left arm), for covid-19 immunization. Medical history included granuloma annulare (had this condition for years and years), rash (had the rash for 25 years); and obesity (she was obese prior to receiving the Pfizer Covid 19 Vaccines and has always been heavy). No history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). Additional vaccines administered on same date of the pfizer suspect was none. No other vaccinations within four weeks prior to the first administration date of the suspect vaccines. AE(s) following prior vaccinations were none. Patient's illness at time of vaccination was none and family medical history relevant to AE(s) was none. The patient's concomitant medications were not reported. The consumer who reported that she and her daughter (53y/o female) had both been fully vaccinated with the Pfizer-Biontech Covid19 vaccine. The caller reported that she tested positive for Covid illness about a week ago, and she then passed it on to her daughter. She indicated they had been following CDC recommendations that stated fully vaccinated patients could be around each other and not wear a mask. She was asking for how many people in the population who were fully vaccinated have tested positive for Covid19; what were the percentages; and what percent of the cases were the new delta variant. The patient had been fully vaccinated with the Pfizer-Biontech Covid19 vaccine. She would like to know how she could determine which variant had caused her case of Covid illness to which she was directed to HCP office for possible additional lab work to determine variant. She stated that she received her first dose Pfizer Covid 19 Vaccine in Jan and her second dose Pfizer Covid 19 Vaccine in Feb and on an unspecified date in 2021, she had an awful reaction after receiving the second dose Pfizer Covid 19 Vaccine. The caller stated that she had two months of problems and contacted doctors and finally got over that. Right now, the caller was quarantined at home, because after two Pfizer Covid 19 Vaccinations, the caller had come down from break through case with Covid. That was self-alarming. On 17FEeb2021, broke out in a rash: Immediately, the day after the caller received the second dose Pfizer Covid 19 Vaccine, received on 16Feb2021, the caller remembered because her sister-in-law also got her vaccine the same date and the caller called it our time, family time. The caller states she has had the rash for 25 years was saw a dermatologist less than a month before this and did not have this rash. The caller stated that she got skin checks every 6 months and did not have this rash. The caller stated she has had this condition for years and years. The caller stated the condition was either called Annulare Granuloma or Granuloma Annulare. It was a benign skin condition. The caller states she did not really know what causes it or why people got the skin condition. The caller stated that the rash went away wans clarified it is called Granuloma Annulare. She mentioned that she got it everywhere except the trunk of her body; had the rash on her arms, legs, thighs. Never in her life, she had the rash on her knuckles, on her fingers and on her wrists. The caller stated that the rash was everywhere. Further added that, the rash did not go away completely and had a little bit of signs; The rash did not go away until May. The caller treated the rash with medication. The caller called the dermatologist and the dermatologist said she was not surprised because the dermatologist had done a seminar before and knew the Vaccines were going to be coming out and the rash was one thing that had come up as a possible side effect. Why this happened to her so badly, she did not know. On an unspecified date in Feb2021 (week after the caller received the second dose Pfizer Covid Vaccine), the caller stated that she did get a pinched nerve; osteoarthritis, had sigmoid colitis that acted up; got HR (Hidradenitis suppurativa) on top of that; and had Terrible body aches and Joint aches. She stated that she had HR since she was in her 20's and usually got one a year or maybe the caller got one every two years. The caller might get two HR, but the caller came down with four of these. They were like boils and stated that that was a shock. The caller was going to go see a Rheumatologist but then the caller came down with Covid. The caller wanted to tell the Rheumatologist and she figured out, "oh my God, this is related. Didn't in the caller's whole life think of this as related until came down with all of them." She had sigmoid colitis and that acted up: The caller has sigmoid colitis and that acted up. The caller states the sigmoid colitis did not act up long. The doctor put the caller on medicine, the gastrointestinal doctor. The sigmoid colitis calmed down. Right now, the sigmoid colitis was going away. The caller states everything went away by May. Everything calmed down and went away by May. The caller was thrilled with two months of on and off problems. She had osteoarthritis and that acted up worse than ever: The caller has osteoarthritis and that acted up worse than ever. The caller had terrible body aches, joint aches. The caller stated that she always had osteoarthritis, but it became worse. It was not as bad, and caller's shoulder was killing her at the moment. The caller stated that the osteoarthritis did not go away, but it calmed down. It had improved and it was persistent right now, but the caller did not know if that was because the caller got Covid. She further added that she had a nerve block before all of this happened, like three weeks ago, and the pinched nerve was better now. The patient underwent lab tests and procedures which included sars-cov-2 test positive: positive on 29Jun2021. Other relevant tests were none, and no investigation assessment was seen. The outcome of events rash, Hidradenitis suppurativa, and colitis were resolved on an unspecified date in May2021, Pinched nerve was resolving; osteoarthritis aggravated, Terrible body aches and Joint aches was not resolved, while for other events was unknown. The reporter assessed case as non-serious.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported vaccination failure and COVID-19 cannot be ruled out. Efficacy of bnt162b2 on variants of SARS-COV-2 virus is yet to be known.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.