Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Inappropriate schedule of product administration, Off label use, Pain in extremity
Clinical narrative: severe headache; she took the first dose on 21Jan2021 and then she got the second dose Friday 29Jan2021; she took the first dose on 21Jan2021 and then she got the second dose Friday 29Jan2021; sore arm; This is a spontaneous report from a contactable consumer (patient) via Medical information Team. A 66-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9265; Expiration Date: May2021), via an unspecified route of administration on 29Jan2021 as SINGLE DOSE for COVID-19 immunisation.  Medical history included type 2 diabetes mellitus, hospitalisation (because of her type 2 diabetes and she has had 2 hospitalizations). Historical vaccine included BNT162B2 for COVID-19 immunisation and experienced sore arm (she took the first dose on 21Jan2021). The patient's concomitant medications were not reported. The patient experienced sore arm (non-serious) on an unspecified date in 2021, severe headache (non-serious) on 30Jan2021, she took the first dose on 21Jan2021 and then she got the second dose Friday 29Jan2021 (non-serious) on 29Jan2021.  Therapeutic measures were taken as a result of severe headache (headache). Caller mentioned she came from another call; Caller mentioned she received the Pfizer-BioNTech COVID-19 Vaccine Dose 1 and reported to have had a sore arm. She got the second dose and reported having sore arm and severe headache. She took ibuprofen (2 capsules at 4:30AM, 2PM and 3PM after the shot) and eventually the headache resolved. Caller was asking if it was okay to take ibuprofen or would this have compromised the vaccine. Can she used antipyretics before or after vaccination with the Pfizer-BioNTech COVID-19 vaccine. Caller was calling about Pfizer COVID 19 vaccine. She says she took the first dose on 21Jan2021 and then she got the second dose Friday 29Jan2021 then that day around 3:30 she got a headache which was not the issue but the thing was she took ibuprofen so she woke up, it was actually about 4:30 it woke her up and she took Ibuprofen and she took some Saturday morning at around 10:30 and then again at around 3 that afternoon. She hasn't had a headache since but she has heard she is not suppose to take anything after she got the vaccine and she was wondering if she compromised the vaccine. She said no one said anything when she got it about not taking anything. She said she also had type 2 diabetes. She said she got the first dose 21Jan2021 and then she got the second dose 29Jan2021. No further information provided. She was totally fine right now. It has recovered completely it was gone late that same afternoon. She said they were in a hurricane area so they have an adjuster coming, she said her husband is going to handle all that. Product details: She saw Pfizer BioNtech. The first dose lot number said E13246 or maybe the second character is an L because the other lot number says EL9265. She thought the lot number for the first dose actually was EL3246 and the expiration for the first dose is Apr2021. Lot number for the second dose is EL9265 She does not see an NDC number. Indication: because of her type 2 diabetes and she has had 2 hospitalizations earlier this year so she is concerned with that. She confirms she was hospitalized prior to receiving the Pfizer COVID 19 vaccines. For event, sore arm, outcome was recovered on 30Jan2021, for severe headache, outcome was recovered on an unspecified date in 2021 and for remaining, outcome was unknown.