Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Gout, Peripheral swelling
Clinical narrative: Gout; red, swollen, and very ugly, but it wasn't her big toe; This is a spontaneous report from a contactable consumer (patient). This is report 1 of 2. A female patient of 73-year-old age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was EN 6701, Expiration date- Jun2021), second dose on right arm via an intramuscular route of administration on 24Feb2021, 11:15 as single dose for COVID-19 immunization. Medical history was none. She is allergic to aspirin, the antibiotic penicillin, and a medication she can't remember the name of , but it was a pill for an upset stomach that sent her to the hospital in anaphylactic shock- she confirms this anaphylactic reaction was more than 17 years ago. She confirms she has no name for this medication and has no NDC, Lot number or expiry date for any of these products, it's been more than 10 years for all 3 of these medications. She states she didn't use to be allergic to aspirin but it happened about 20 years ago. No concomitant medication reported. The caller explains she takes her regular prescribed medications, nothing new or added within the 2 weeks leading up to the gout. Previously she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was EL 9265, Expiration date-May2022), via Intramuscular injection route of administration in left arm on 03Feb2021 for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no AE prior vaccination. She got her shots in February, both of them. Then, she got gout really bad at the end of May. She has never had gout before. She states she spoke to two people last week who said they had never had gout before the vaccine and had it after, and she was told to call to let Pfizer know. Caller confirms the gout happened on a Thursday. She clarifies the gout was starting up her leg. She later clarifies she didn't start feeling the gout until about 4pm in the afternoon on Thursday, 27May2021. It was red, swollen, and very ugly, but it wasn't her big toe. Everybody she knows had gout in their big toe. the caller states its still red but its much better. The foot doctor said it will take a while until the redness goes away. She mentions she will see the Rheumatologist again in August. The caller states the Tuesday, she was prescribed something, but doesn't know what it was. By Thursday, it was in her veins. She clarifies the gout was starting up her leg. She clarifies further her blood vessels were highlighted with red like she had an infection. She called got in and got into see the foot doctor that Friday morning and had to go to the surgical center to treat by draining it. She states she was told she had Tophi which is a part of the gout and an infection. A week and a half later she was at the Rheumatologist. Patient visited Physician Office for AE. She should have gone to emergency room but she didn't. Caller states she believes the Lot number is EN6701, she thinks the fourth digit is a 7, but it could be a 2, but she doubts it. She confirms she believes the Lot number reads EN6701. The outcome of event was recovering.  Follow-up attempts are needed. Further information is requested.