Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lupus myositis, Nausea, Sinusitis
Clinical narrative: She states she did take something before the last one, and it's usually a combination of Tylenol and Naproxen; Malaise; This is a spontaneous report from a contactable consumer or other non-HCP (patient himself).  A 48-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6206, Expiry Date: Unknown) via an unspecified route of administration on 07Mar2021 at 15:49 (at the age of 48 years-old) as dose 1, single for COVID-19 immunization, naproxen (NAPROXEN, batch/lot number: Unknown) via unspecified route of administration on an unspecified start and stop date and dose were not reported taken for an unspecified indication and paracetamol (TYLENOL, batch/lot number: Unknown) via unspecified route of administration on an unspecified start and stop date, and dose were not reported and taken for an unspecified indication. Patient medical history and concurrent conditions included depression, headaches, nausea, ongoing systemic lupus erythematosus (Verbatim: lupus), She states she had a reaction (hypersensitivity) to contrast dye, throat closed. The concomitant medications included hydroxychloroquine (HYDROXYCHLOROQUINE) taken for systemic lupus erythematosus started taking it from 3.5 years ago and ongoing, colecalciferol (VITAMIN D 3) taken as a dose of 50000 units once a week for an unspecified indication, start and stop date were not reported. The patient previously took flu and experienced hypersensitivity, and she had a reaction to the flu shot, got depressed and not feeling well. No additional vaccines administered on same date of the pfizer suspect and vaccine was not administered at military facility. No prior vaccinations (within 4 weeks) and adverse events following prior vaccinations. Patient medical history (including any illness at time of vaccination) reported as no. No family medical history relevant to adverse events. The patient experienced malaise on 08Mar2021 and she states she did take something before the last one, and it's usually a combination of tylenol and naproxen on an unspecified date. The duration of the malaise was reported as 5 days. Additional Information for Concomitant Products Vitamin D and she states her vitamin D last lab was insanely off the charts, and she suffers from depression. She states she was diagnosed a few years ago, well the titer showed up in her blood 5 years ago, but she didn't have enough elements for a diagnosis. She stated that the doctor is an idiot. She says it's slow, so they state you have a connective tissue disease. She had a rash, then her hand started to be paralyzed. They were fish-netting to figure out what it was. She is with a new rheumatologist, and they said lupus, no way diseases evolve, the more they can step back and look at them the better. It was reported that She was scheduled to get part two of the vaccine she states that at the beginning of March she got sick, and it had nothing to do with the vaccine. She states she is supposed to go today to get the vaccine, but her doctor said she needs to hold off. States she has been having really bad migraines and nausea. Adds it has nothing to do with COVID it is just my cycle that happens in my body. Adds it is hard for her to exist without taking Naproxen and Tylenol. She is asking what's the real harm; she states that she won't take anything before if my trade-off is getting there. She states that she has been hearing conflicting things, oh it's totally fine to take medication before the vaccine and then reading online, no you shouldn't do it. She states that because of her Lupus she was afraid it would knock her off her terrain. No events result in emergency and physician office visit. No investigation assessment and relevant tests are performed. The action taken in response to the events for naproxen was unknown, for paracetamol was unknown. Therapeutic measures were taken as a result of malaise. The clinical outcome of the event malaise recovered on 13Mar2021  No follow-up attempts are possible. No further information is expected.