Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Pain, Pain in extremity, Pyrexia, SARS-CoV-2 test
Clinical narrative: viscous headache; Fever of 100.4; hot/cold; Tired; run-down achey; her arm hurts; she was hot and was running temperatures/some parts of her body were 102 last night; could not lift her arm; a few days prior to getting her first dose on 10Feb2021 at 8:22AM, she had a migraine, states she takes diclofenac and it is an NSAID; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 72-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EL9264), via intramuscular route of administration, administered in arm left on 10Feb2021 at 08:22 AM (at the age of 72-year-old) as dose 1, single for COVID-19 immunization. The patient medical history included migraine (a long time ago, over 10 years). The patient concomitant medications included botulinum toxin type A (BOTOX) taken for migraines, start and stop date were not reported; liothyronine sodium (CYTOMEL) at a dose of 10 ug, once a day taken for hashimoto from an unspecified start date and ongoing; diclofenac at a dose of 50 mg, as needed (1 pill, 2 days prior) taken for migraines from an unspecified start date and ongoing; levothyroxine sodium (SYNTHROID) at a dose of 50 ug, once a day taken for hashimoto from an unspecified start date and ongoing. The patient did not receive any other vaccine within 4 weeks prior vaccinations. The patient experienced a few days prior to getting her first dose on 10feb2021 at 8:22am, she had a migraine, states she takes diclofenac and it is an NSAID on an unspecified date in 2021; could not lift her arm on an unspecified date in Feb2021; she was hot and was running temperatures/some parts of her body were 102 last night on 10Feb2021; viscous headache, fever of 100.4, hot/cold, tired, run-down achey, her arm hurts on 11Feb2021 17:00 (05:00 PM). Stated she had NSAIDs a few days before her first dose of the vaccine. Patient stated she was doing okay until her neighborhood social media that people are keeping in touch for the vaccine posted to do not take any NSAIDs prior to getting vaccine. Stated she is coming up due for her second dose. Patient stated that she is worried because a few days prior to getting her first dose on 10Feb2021 at 8:22AM, she had a migraine, states she takes diclofenac and it is an NSAID, states that medication is specifically targeted for the migraines, and she also gets Botox for her migraines. Stated she called previously to ask about taking diclofenac and botox after the vaccine but not before. Patient wants to know if taking the NSAIDs prior to the first dose of the vaccine will invalidate the vaccine. Stated she will be really upset. Stated the doctor told her it would be fine to get Botox between the doses. Patient stated yesterday she had the vaccine, Pfizer Covid vaccine, stated she is not calling to complain, states typically when she gets a vaccine the next day, her arm hurts and she is tired. Stated last night she was hot and was running temperatures, but her head was warm and she went and got something cool, did everything to not have to take medication, stated today she has a viscous headache, stated she typically gets Botox for migraines and that she is due for some soon. Stated she typically takes Diclofenac, did not want to take anything without permission. Can patient take diclofenac after having the vaccine, did not want to take it until she got the okay from someone. Stated she has one of those thermal thermometers and that some parts of her body were 102 last night. Stated she also could not lift her arm, stated that is typical for her after she gets shots, that it has been that way since she was a child. Stated she wants to get next vaccine, doesn't want someone to tell her she cannot get it. Response: After reviewing call recording, Yes, diclofenac in the additional context is the same product listed in the concomitant product field. On 11Feb2021 at 05:00 PM, Pertinent Details: fever of 100.4, hot/cold, tired, headache, run-down achey. Stop date: until 4 days after. The patient underwent lab tests and procedures which included temperatures was 102 on 10Feb2021, temperatures was 100.4 on 11Feb2021, SARS-CoV-2 rapid ag COVID-19 was negative on 05Mar2021. Therapeutic measures were taken as a result of she was hot and was running temperatures/some parts of her body were 102 last night. The events were considered as non-serious. Outcome of the events she was hot and was running temperatures/some parts of her body were 102 last night, could not lift her arm was unknown; outcome of remaining events viscous headache, fever of 100.4, hot/cold, tired, run-down achey, her arm hurts was recovered on 15Feb2021.  No follow-up attempts are possible. No further information is expected.