Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling abnormal, Headache, Nausea
Clinical narrative: white noise/ white noise in her head; threw up; neck hurt; headache/ wicked headache; Nausea; scared; chills; tremors; shaking; high fever continued fever went up and down Saturday night; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6207 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 12Mar2021 (age at vaccination: 60 years), as a single dose for COVID-19 immunization at Clinic. The patient taking Covid vaccine due to build up her immunity for covid. Vaccine was not administered at Military Facility. The patient's medical history included kidney transplant. Concomitant medications included mycophenolate mofetil (MYCOPHENOLATE), tacrolimus (PROGRAF), sirolimus, famotidine, metoprolol succinate, rosuvastatin calcium, sulfamethoxazole, trimethoprim, furosemide, and acetylsalicylic acid (BABY ASPIRIN). The patient did not receive any vaccine prior vaccinations within 4 weeks. The patient reported that she was immunosuppressed because she had a kidney transplant. She had a severe reaction which scared her on 13Mar2021; not sure she wanted to get the 2nd one and asked was it a normal reaction. She received the shot on Friday morning around 10:30 and not much happened. Probably about 1pm on Saturday, she started feeling a little off, nothing major, just off. When she got home from work around 3 she ate and went to bed, slept for 3 or 4 hours. On 13Mar2021, by 7pm Saturday night she had chills/tremors/ shaking thing for a while went into a high fever continued fever went up and down Saturday night. Sunday morning on 14Mar2021, she had threw up a little bit, tremors again really bad. Her fitbit recorded it as a bicycle ride. Tremors stopped then fever again. She was good early Sunday afternoon and fever again Sunday night until 11:00-12:00. Monday when she woke up the fever was gone, but had a headache and white noise, weird in her head. Tuesday morning, she still had a slight headache. Going through it; it was scary. There was no report related to a study or programme. She thinks on Saturday, her temperature was just over 100 degrees and then when that stopped, she fell asleep and woke back up with another fever. She stated then when she woke up Sunday morning, she felt a little nauseous, not awful nausea, but a little nausea and she had a wicked headache. She could tell the fever was back but was not as high. She got up, took a Tylenol, and immediately threw that up, so she laid down a little bit longer and she could tell her fever was going up so did get up and took another Tylenol which stayed down and it was fine. About 7:00ish, she started getting tremors again but this time she didn't hold herself really tight, and her arms were flopping, her head, her whole body was flopping around. Then, after that, she got a fever again that went up to 102 and that lasted for a while and then she came off of that. At that point, she was okay, her head still hurt and neck hurt but she thought it was done. About 5pm, she got hungry and had something to eat, and she was fine. She went back to bed and then probably around 10:00pm that night, she started getting the fever again and this lasted until 1-2 and again it was pretty high so she took Tylenol again and iced herself. The next morning when she woke up the fever was gone and the shakes were gone, but her head was really weird and her neck hurt, she had a headache. She also had a white noise in her head all day long, which was kind of weird. Tuesday when she woke up, she still just had a slight headache, she took a Tylenol and then it was gone, and that was the end of it. She clarified on Sunday, the tremors lasted for at least 15 minutes. She stated she did have the tremors on both days in two sessions, and the fever also. The patient mentioned with the nausea, she had a little bit later on Saturday, but it was more on Sunday. The nausea ended about mid-day 14Mar2021. The adverse events did not require a visit to emergency room and physician office. There was a Product Complaint and description of Product Complaint included Tylenol: Caller was reporting adverse events with COVID vaccine. While providing information, caller stated she felt a little nauseous, she had a wicked headache and she could tell the fever was back but was not as high. She got up, took a Tylenol, she immediately threw that up, laid down, could tell her fever was going up and took another one. She states she got a fever again, that went up to 102 and that lasted for a while and then she came off of that. Caller stated she went back to bed and then 10:00pm that night she started getting the fever again and lasted until 1-2am and again it was pretty high and took Tylenol again. Tylenol: She clarified it is not Tylenol, it was the cheaper brand, Equate, she thinks that was the(Name) brand. LOT: P118837 EXP: Jan2022, Product strength and count size dispensed: 250mg tablets. Caller states she probably took just one on Saturday and she took two on Sunday. Additional lot numbers: N/A, Is a sample of the product available to be returned, if requested (Y/N)? Not provided Packaging sealed and intact? Not provided. Sulfamethoxazole TMP DS: Caller states she takes it every other day. She stated it was some kind of antibiotic, something that normal people have that she does not have. She states it was a single dose, no mg listed, so she has no idea the dose. NDC, Lot number and expiry date not provided. The patient underwent lab test and procedure included fever with 100 and 102 on an unspecified date. Outcome of the event neck hurt was resolved on 15Mar2021, high fever continued fever went up and down Saturday night, headache/ wicked headache, white noise/ white noise in her head was resolved on 16Mar2021, and for all other events, it was resolved on 14Mar2021.  No follow-up attempts are possible. No further information is expected.