Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue, Tinnitus, Urine analysis
Clinical narrative: tongue swelled up twice the normal size; Fibromyalgia flare up; Ear ringing; soreness; they are like clock work and her cycle is 7 days late; 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 40-year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm left, administration date 27Sep2021 15:00 (Lot number: FF2587, Expiration Date: 31Mar2022) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: BUSPAR taken for anxiety (ongoing); GABAPENTIN taken for fibromyalgia (ongoing).  The following information was reported: OLIGOMENORRHOEA (non-serious) with onset 2021, outcome "unknown", described as "they are like clock work and her cycle is 7 days late"; FIBROMYALGIA (non-serious) with onset 27Sep2021, outcome "recovering", described as "Fibromyalgia flare up"; TINNITUS (non-serious) with onset 27Sep2021, outcome "not recovered", described as "Ear ringing"; SWOLLEN TONGUE (non-serious) with onset 28Sep2021, outcome "recovering", described as "tongue swelled up twice the normal size"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "soreness". The events "fibromyalgia flare up" and "tongue swelled up twice the normal size" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of fibromyalgia, swollen tongue, pain.  Additional information: 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) was None. all vaccines administered on same date with the Pfizer vaccine considered as suspect was None. any other vaccinations within four weeks prior to the first administration date of the suspect vaccine was None. AE(s) following prior vaccinations was none. Family Medical History Relevant to AE(s) was none. Covid 19 vaccine manufacturer and NDC number was unknown. Vaccine administered at hospital facility. Vaccines administered on same date with the Pfizer vaccine and prior vaccinations within 4 weeks was none. Adverse events following prior vaccinations was none. Family Medical History relevant to AE was not reported. The patient reported that her menstrual cycles were like clockwork, she knows when she was supposed to get it. She had been trying to get pregnant at home. Her and her husband had been trying for a baby. She did not go to the emergency room, but she went to physician office for adverse events. She did go to her HCP because she had a fibromyalgia flare up and her tongue swelled up twice the normal size. She started having pain about 2 hours after getting the vaccine but didn't think much about it. She woke up at 2am the next morning in severe pain with a bad flare. Her HCP did give her pain medication to help, and she could take it every 6 hours, but she was still having break through pain so it was not helping. Caller clarified that the pain medication helps for a couple of hours, but once it started wearing off the pain came right back. She was prescribed Percocet 10/325mg, take one every 6 hours as needed. No Lot/NDC on pharmacy bottle, Expiry: 1Oct2022 and product strength and count size dispensed: 10/325mg.She also stated that her ears started ringing almost immediately after getting the vaccine. Her tongue swelled up the day after getting the vaccine. It was still a little swollen but not as bad. Her HCP gave her a mouth wash to use for the soreness because she wasn't able to eat. She was prescribed Modified Mouthwash, use every 6 hours as needed; but caller stated that she only used it about twice a day. Reporter seriousness for menstrual cycle is 7 days late, fibromyalgia flare up, ear ringing, and tongue swelled up were unspecified. Her HCP did blood work and a urinalysis to make sure that everything was okay, and everything came back normal. Stated that she has been doing the pregnancy tests at home. Her and her husband have been trying for a baby, and every pregnant test she has taken at home is saying negative. Relevant Tests: Her HCP did blood work and a urinalysis to make sure that everything was okay, and everything came back normal. Home pregnancy tests are negative. The case was assessed as non-serious.  No follow-up attempts possible. No further information is expected.