Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Sore arm; This case has been considered invalid as other-Info not qualifying for AE reporting - Medical Information since patient experienced no adverse effect under suspect BNT162B2, BNT162B2 OMI BA.4-5. The initial case was missing the following minimum criteria: (other-Info not qualifying for AE reporting - Medical Information). Upon receipt of follow-up information on 28Dec2022 this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team, Program ID:  The reporter is the patient.  A 61-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Nov2022 as dose 5 (booster), single (Lot number: GJ6796) at the age of 61 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, lot number: EJ1685), administration date: 22Dec2020, when the patient was 59-year-old, for COVID-19 immunization, reaction(s): "Caller did not get swollen lymph nodes with 5th dose like caller did with the prior 4 doses"; BNT162b2 (DOSE 2, SINGLE, lot number: EK4176), administration date: 12Jan2021, when the patient was 59-year-old, for COVID-19 immunization, reaction(s): "Caller did not get swollen lymph nodes with 5th dose like caller did with the prior 4 doses"; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Lot number: Assuming FH8020), administration date: 10Oct2021, when the patient was 59-year-old, for COVID-19 Immunization, reaction(s): "Caller did not get swollen lymph nodes with 5th dose like caller did with the prior 4 doses"; BNT162b2 (DOSE 4 (BOOSTER), SINGLE,, Lot number: FM9992), administration date: 12May2022, when the patient was 60-year-old, for COVID-19 Immunization, reaction(s): "Caller did not get swollen lymph nodes with 5th dose like caller did with the prior 4 doses". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Nov2022, outcome "not recovered", described as "Sore arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was inquired of wondering if patinet's last COVID vaccine was an older version. She was expecting one that it would provide protection against the most recent strains. She has had 5 vaccinations since 22Dec2020 and has just tested positive for COVID for the first time (24Dec2022 and still positive on 26Dec2022.) This was very disappointing, her last vaccine was 12Nov2022 from: GJ6796, Comirnaty, Pfizer-BioNTech COVID-19 Vaccine [Monovalent] and/or Bivalent, gray cap, original/omicron BA.4/BA.5 (Bivalent), above 12 years -15/15 mcg per dose. Caller performed a call back with regards to INT. Upon confirming details submitted in previous INT, caller stated that she has avoided covid all of this time with receiving 5 COVID vaccines. Caller stated that she reacted pretty severely, however this time she did not, but thought maybe her body was becoming used to the vaccines. Caller stated that she had been tested for COVID multiple times over the years and this was her first time that she had tested positive. Caller has had 5 vaccinations, confirmed all five vaccinations were the Pfizer COVID vaccine, since 22Dec2020 and caller just tested positive for COVID for the first time on 24Dec2022 and was still positive on 26Dec2022. Her last vaccine was on 12Nov2022, the lot number for the last dose was GJ6796. She usually reacts pretty severely however this time with the last vaccine caller did not. Upon transfer caller confirmed event details provided by transfer agent. Was just surprised that she came down with COVID, was careful, had a immunosuppressed daughter and grandkids. She has had many tests before which were negative. Originally called to make sure caller got the most recent vaccine that was available, which was verified with the agent that she got the most recent vaccine. She thought it would be interesting for Pfizer to know that she got COVID. Event details included that she did not get swollen lymph nodes with fifth dose like she did with the prior four doses. Just got the sore arm with the fifth dose. Sore arm started pretty much right away that evening, last dose was on 12Nov2022, so sore arm started maybe within 8 hours. Stop date: there was still some strange stuff going on with arm, does not know if related, something bugging arm going down into elbow, more like a nerve kind of thing. Event details included that she does not think there are any new events to report, thought caller reported all of this information on the Pfizer website. Just has a couple of questions and wanted to relay concerns to call handler first. She was surprised, caller had COVID after five vaccines and had not had COVID at all for two years, usually got pretty severe reactions to the prior four doses of the Pfizer COVID vaccine, this one, the fifth dose of the Pfizer COIVD vaccine, she did not get a severe reaction just pretty mild, just had a sore arm. So that was why she called in to see if caller had protection against the newest strain. Then clarified and confirmed that caller does not believe caller reported the sore arm on the Pfizer website. Reference number:  took picture of form completed online but does not think there was any other reference number. Initially reported of having had 5 vaccinations of the Pfizer COVID vaccine and just tested positive for COVID. Fifth dose: Lot number: assuming first letter, handwritten on vaccination card so could not read, provided lot number as GJ6796.  Product strength and count size dispensed were not provided. Additional lot numbers included: EJ1685; EK4176; FH8020; FM9992.  Follow-up (28Dec2022): The initial case was missing the following minimum criteria: (other-Info not qualifying for AE reporting - Medical Information). Upon receipt of follow-up information on 28Dec2022 this case now contains all required information to be considered valid. This is a spontaneous follow-up report from a contactable Nurse. This 61-year-old female Nurse (Patient) reported for herself with updated information which included: Reporter title and occupation updated as Nurse. Reporter suffix added. Patient age and age at vaccination added. Age at vaccination, reaction and lot number added for dose 1 and Dose 2 in historical vaccine. Historical vaccine recoded to BNT162B2 for Dose 3 and Dose 4, vaccination date, reaction and lot number added as per SD. Lab test coded for COVID with Positive result as per VT: tested positive for COVID for the first time on 24Dec2022 and was still positive on 26Dec2022. Event onset date conservatively captured as Nov2022. As per VT: stop date of adverse event: There is still some strange stuff going on with arm, outcome of event conservatively captured as not recovered/not resolved.   Additional information was updated. No new information provided.; Sender's Comments: Linked Report(s) :PFIZER INC-2021010707 same reporter/patient, different dose/events;