Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging head abnormal, Magnetic resonance imaging spinal, Mean cell volume increased, Nausea, Pyrexia
Clinical narrative: After first dose she had an "adverse reaction" and a fever the next day; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 21Dec2020 (Lot number: EK5730) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "migraines" (unspecified if ongoing); "episode of anemia" (unspecified if ongoing). There were no concomitant medications. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "After first dose she had an "adverse reaction" and a fever the next day". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Caller was for both a registered nurse and a consumer.  She had her first dose of Pfizer Covid 19 vaccine in was Dec2020 and second dose 11Jan2021. Caller reports that she has a history of migraines since she was a teenager.  After first dose she had an "adverse reaction" and a fever the next day. Following the second dose it was about two to three weeks later she continued to get really sick.  She has seen several specialists to rule out diseases/infections. Caller feels that up to know her body has had an immune response that continues to make her sick. She has continued to experience horrible headaches/migraines, severe nausea requiring phenergan. With recurring fevers consumer has had a lumbar puncture for CSF sample, her provider was concerned CSF pressure was elevated and it tested positive for positive gamma oligoclonal bands in June. She has been evaluated by a Rheumatologist to rule out Lupus. She explained that her sedimentation rate has tripled and her C-Reactive protein level was high (In Apr it was 37). These constellation of symptoms and illness has caused her to miss work for a week at a time including this week. She has had an MRI with and without contrast of her brain with non-specific changes that she reveals are related to her history of migraines. Her hematologist has run additional labs and noted her ferratin levels have dropped. Consumer mentioned episode of anemia last year. She has received medrol dose pack for inflammatory response. Her occupational health department at work did not notify VAERS and consumer explains she waited this long to report these events as she was seeing specialist to rule out other disorders.  She had a follow up today with a provider and will have another follow up soon. The following adverse reactions have been identified during post authorization use of Pfizer-BioNTech COVID-19 Vaccine. Because these reactions are reported voluntarily, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. Side effects that have been reported with the Pfizer-BioNTech COVID-19 Vaccine which included headache, fever, nausea, feeling unwell, vomiting. Age at time of onset of reaction/event was 49 years. Fever on 18Feb2021, loss of appetite was resolving/ongoing, lost weight, nausea, history of migraines before but not this bad, inflammatory markers SED rate and c-reactive proteins are high, inflammation in her body. Results of tests and procedures for investigation of the patient: 23Jun202 lumbar puncture. Drug result was related. Investigation Assessment was yes. Caller is calling about the Covid vaccine. She got the covid vaccine, the first one back in December. She did have an adverse reaction and had a fever the next day. She had the second vaccine on 11Jan2021 and then three weeks later she got really sick. She has a history of migraines and was having low grade fevers. She has, on her own has gone to all of these specialists who ruled out diseases and disorders. It was ruled out with a rheumatologist. She also saw a hematologist and neurologist. She just got her lab results today and it triggered her to contact to see if this should be reported. She is at a lost of what to do next. Jan she first got sick and has a history of migraines but she did not check her temperature. The first documented on fever was on 18Feb2021. The last fever was 03Aug2021 but she cannot predict if it was going reoccur, improved. She was on the generic, Butalb-acetaminophen-caffeine 50/300/40 dose with Tylenol in it for migraines. She was not sure if that affected the fevers. Treatment - She saw her primary care provider in Feb and he did a rapid everything and it was negative. She has had a loss of appetite and migraine headaches. In Feb she got her appetite back and then she regressed. She lost weight and then gained it back. Treatment - She saw her primary care provider. She has been to the ER twice for loss of appetite and nausea. Tons of lab testing and procedures and diagnostic testing. Lumbar Puncture: well defined gamma restrictive bands that were not present in serum but present in cerebral spinal fluid, oligoclonal bands. She had labs drawn back in Feb and she had a rapid covid, strep and flu. Caller clarified she had the history of migraines before but not this bad and usually she only misses two days of work and now she is missing a week of work. No additional vaccines administered on same date of the Pfizer suspect. Emergency room and physician office: yes. Both times were nausea and she was incoherent and her blood sugar was 48 she was sure it was not relevant to the vaccine. No prior vaccinations (within 4 weeks). What prompted her to call is she has been seeing all of these specialists and no one can pin-point. The hematologist and the rheumatologist ruled out lupus. She saw a neurologist, and she has white matter changes in her brain and she is relating it to long term history of migraines. What is concerning to her is that her inflammatory markers SED rate and c-reactive proteins are high and it started back in march when the PCP checked it and the rheumatologist checked it in Mar when she was feeling better. She called the CDC first. Her hematologist wanted her to repeat some labs when she was feeling better, her SED rate tripled and her c-reactive protein is still high. She has all of this inflammation in her body and she is missing a lot of work. She can't pinpoint what is causing inflammation.  No follow-up attempts are possible. No further information is expected. Follow-up attempts are completed.