Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoacusis, Swollen tongue
Clinical narrative: Highly anemic; A little headache; Allergic; Hard of hearing; Bladder infection; Tongue swelled up; This is a spontaneous report from a contactable consumer. This contactable 62-year-old male consumer (patient) reported for himself that: A 62-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EP6955), via an unspecified route of administration, injected in arm left on 26Mar2021 at around 15:00 (at the age of 62-year-old) as dose 2, single for covid-19 immunization. Medical history included diabetes was diagnosed probably 15 years ago, triple bypass in 2011, his arms were crushed in 2015, when he was diagnosed with anxiety and depression in 2015, gout was diagnosed 20 years ago, he had an allergic reaction to Bactrim as well in Feb2021 which he was taking for a bladder infection, he also reports having allergies to Morphine and Hydrocodone but did not describe his reaction to these medications. He states that his kidneys are so bad he may have to be seen by a specialist according to his doctor. Patient didn't receive any other vaccination the same day or four weeks prior to getting Pfizer COVID-19 doses. He didn't start any new medication. Concomitant medications included dulaglutide (TRULICITY) 1.5-0.5 injection (NDC/LOT/EXP: box was covered with a pharmacy label), once a week for diabetes and he has never had an allergic reaction to it; gabapentin for pain, one capsule by mouth three times a day, NDC/LOT/EXP: Unknown, he gets it from Optum RX and they don't put anything on that bottle pharmacy label and allopurinol for his gout, it was dispensed in a pharmacy bottle thru Optum RX, so it doesn't have NDC/LOT/EXP on it either. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: ENS203), via an unspecified route of administration, it was unknown on which arm he got it injected on 05Mar2021 (at the age of 62-year-old) as dose 1, single for covid-19 immunization. Patient received vaccines at 3-week interval between first and second dose. He got both shots and had some side effects on it. On an unspecified date, patient was diagnosed as anemic one day last week, which he has never been in his life, he was kind of hard of hearing and has a slight headache, which he hadn't had one lately in a little while. He says his side effects were not immediately after, it was the second time he got the shot that he had to go to the doctor. On an unspecified date, he said that he got allergy due to Bactrum and had to go get a shot because his tongue swelled up. On Mar2021, patient experienced tongue swelled up. On Apr2021, he has had a bladder infection for 3 weeks, that he cannot get rid of, which he has never had one of those before. He was seen by his doctor because his tongue started to swell, on 01Apr2021. Patient stated that he felt like it was important for him to report this information and wanted to know if anything like this has happened to other people (swelling of the tongue multiple days after receiving the second dose of the vaccine). He says that the doses are dated wrong on the card, it says he got his first dose the 05Mar and it said his second dose was 26Mar. He has also got 4-5 members of his family who took it at the same time, one week apart, and now he has been hearing it should have been two weeks apart. He says he doesn't know if it should be one week or two weeks apart between doses. He was not sure of the doses of the vaccine being given one or two weeks apart, he knows that they all took it the same day, it was two weeks. Finally, he confirmed when the card told them to come back, so the dates 05Mar2021 and 26Mar fort the doses are correct and confirms that those dates are 21 days apart or would be three weeks apart. The patient did not receive any other recent vaccines on same day or within four weeks prior to the vaccination. His doctor stated that she was not sure whether the swelling in his tongue was an allergic reaction caused by the COVID-19 vaccine or not, however, she prescribed an Epi-pen for him to carry in the event that it happens again. He has a lot of meds he took for years that he was allergic to now, now he was only taking Penicillin 500 mg twice daily by mouth, for the bladder infection, he thinks he started taking it 01Apr2021 when he filled it, which after three weeks was still not cleared up, NDC/LOT/EXP: Unknown, product was dispensed in a prescription bottle/pharmacy bottle that has a RX number and says it was filled 01April2021, and says refill by 16Mar2022, discard after 01Apr2022, quantity 21 pills. Patient stated that the manufacturer name was not provided on the pharmacy label. He says his provider said if it does not clear up, he will have to go to a specialist. He says his tongue swelled up when he was on Bactrim, the antibiotic generic. He said that the week before that he got up at 04:00 AM with his tongue swelling, and he decided to try to make it until 08:00 AM before he called his provider and she said to come straight to her, and she gave him a shot and told him to get off that medication, and then she put him on the Penicillin. Bactrim, later clarified to being Bactrim SMZ TMP DS 800mg: NDC/LOT/EXP: Unknown and was dispensed in a pharmacy bottle; he does not see those details on the pharmacy label. He says the pharmacy label says it was substituted for Bactrim. He says it does not say who it was manufactured by. He says he thinks after his tongue swelled up, he had to get shot of a steroid maybe, he guesses, and then he had to go back, and they put him on Penicillin for the bladder infection. He says he has never had one in his life. Patient's wife provides unknown number from Bactrim pharmacy label of 10-0364. Magnesium oxide 400mg and also on another one, he takes two of them a day are prescribed for his anemia. The patient underwent lab tests and procedures which included he was having really bad anemic, she has his lab results, but he does not know what they were. The outcome of the events was reported as unknown.   No follow-up attempts are needed. No further information is expected.