Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Pharyngeal swelling, Throat tightness
Clinical narrative: throat swelling; dizziness; throat started to tighten; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 80 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 07Jan2021 (Lot number: EL9262) at the age of 79 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "first degree AV block" (ongoing), notes: had it for over 30 years; "gout" (unspecified if ongoing), notes: takes Allopurinol for gout and he has been taking that for several years,; "low heart rate" (unspecified if ongoing), notes: takes low dose aspirin as a preventative he guesses because he had very low heart rate; "cholesterol" (unspecified if ongoing), notes: on atorvastatin, 10 mg, for cholesterol and started on that over 10 years ago. Concomitant medication(s) included: LEVOFLOXACIN; ALLOPURINOL (100 mg, 1x/day) taken for gout (ongoing); ATORVASTATIN (10 mg)  taken for blood cholesterol (ongoing); ASPIRIN [ACETYLSALICYLIC ACID] (81 mg) taken for heart rate decreased (ongoing). Vaccination history included: Horse serum tetanus (he was small, 11 to 12 years old, he had a severe reaction to the horse serum tetanus.), for Immunization, reaction(s): "had a severe reaction". The following information was reported: PHARYNGEAL SWELLING (medically significant) with onset 07Jan2021, outcome "unknown", described as "throat swelling"; DIZZINESS (medically significant) with onset 07Jan2021, outcome "recovered" (2021), described as "dizziness"; THROAT TIGHTNESS (medically significant) with onset Jan2021, outcome "recovered" (2021), described as "throat started to tighten". The events "throat swelling", "dizziness" and "throat started to tighten" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of pharyngeal swelling, dizziness, throat tightness. When the patient had the first dose, he had side effects and he was advised that he can no longer get the COVID 19 vaccine. He stated that he was told that once he had reactions that he was probably 70% protected and then delta came, and he was told that he was about 30% protected and now with the new variants he was not sure if he was protected at all. At the time that he had the first shot he was on an antibiotic called levofloxacin and he had read some place that being on an antibiotic could trigger a reaction to the vaccine. When he stood up after the vaccine, he had some dizziness and his throat started to tighten. This was within 10 minutes of having the vaccine. He got it in the hospital, so they took him right to the emergency room and they gave him an epi pen and ibuprofen, wait that's wrong, it was Benadryl. They gave him an epi pen and Benadryl. He was in the emergency room for probably 4 to 5 hours and then they put him on a steroid. Since he previously had difficulty with Benadryl, they put him on 2 Zyrtec a day for 5 days. He stated he thought that this was on 07Jan2021, but he would not swear to that, he confirmed sometime in the first part of Jan2021. The dizziness didn't last very long, and he was not sure about how long the tightness lasted. After he had finished the steroids and Zyrtec, that was on a Tuesday, and early Wednesday morning he started to have the symptom of his throat tightening again and he went back to the emergency room and this time all they did was tests and stuff. They didn't really give him an epi pen or anything like that. The side effects went away within several hours, but he doesn't know if that was related back to his original vaccine or not. On his card there was the date of 28Jan2021, but he thought that was the date for the second shot, when he was supposed to get the second dose. 3 weeks prior to that would have been 07Jan2021 so he thought that was when his first dose was. When he was small, 11 to 12 years old, he had a severe reaction to the horse serum tetanus. That was the only thing that he can remember where he had an adverse reaction to a vaccination or shot that he received. 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). No additional vaccines administered on same date of the Pfizer suspect. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine was administered. He had no family medical history relevant to adverse event.  No relevant test was performed.