Sex: F
Vaccine: COVID19-2, COVID19-2, COVID19
Symptoms: Feeling abnormal, Insomnia, Malaise, Pain in extremity
Clinical narrative: I always get a sore arm where I get the shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hip replacement" (unspecified if ongoing). Concomitant medication(s) included: AMOXICILLIN taken for hip arthroplasty. Vaccination history included: Bnt162b2 (Dose 1,Single), for Covid-19 immunization, reaction(s): "I always get a sore arm where I get the shot"; Bnt162b2 (Dose 2, Single), for Covid-19 immunization, reaction(s): "I always get a sore arm where I get the shot"; Bnt162b2 (Dose 3 (Booster), Single), for Covid-19 immunization, reaction(s): "I always get a sore arm where I get the shot"; Bnt162b2 (Dose 4 (Booster), Single), for Covid-19 immunization, reaction(s): "I always get a sore arm where I get the shot". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "I always get a sore arm where I get the shot".  Additional information: She states she had to go to her dentist and had to take amoxicillin due to history of a hip replacement. She mentioned, at the time, she always get a sore arm where she got the shot. She did share information about friends that came down with Covid a few weeks (approximately 2 weeks) after receiving their Pfizer newest booster dose. The patient states she is being bombarded with multiple (8 packs) of mailed packages about the this information.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Serious: No, Patient characteristics,,Patient: Privacy, Sex: Female,Reaction(s)/Event(s); MedDRA version for reaction/event term LLT: N/A; Reaction/event in MedDRA terminology (LLT): Medical Information Potential AE. Drug(s) Information; Characterization of drug role: Suspect Proprietary medicinal product name: Comirnaty, Pfizer-BioNTech COVID-19 Vaccine [Monovalent] and/or Biv. Identification of the country where the drug was obtained: private. Country of authorization/application: private. Active Substance Information: COVID-19 Vaccine, mRNA [Monovalent and/or Bivalent]      Narrative case summary and further information: Originating AE Request: REQ-997387. Attachments:1  Reporter Subtype: Patient, PQC Present: No, AE Present: Yes. PQC Details: Request- Name: REQ-997387  Product: Comirnaty, Pfizer-BioNTech COVID-19 Vaccine [Monovalent] and/or Bivalent. Dose/Dosage Form: Gray cap,Original/Omicron BA.4/BA.5 (Bivalent), less than equal to 12 years-15/15 mcg per dos. Question: Caller states she called Pfizer a few weeks ago she informed the PMI agent that she had received the most newest booster. She states she had to go to her dentist and had to take amoxicillin due to history of a hip replacement. She mentioned, at the time, I always get a sore arm where I get the shot. I did share information about friends that came down with Covid a few weeks (approximately 2 weeks) after receiving their Pfizer newest booster dose. The patient states she is being bombarded with multiple (8 packs) of mailed packages about the this information. She stated Please do not send anymore questionaires to me. They are about 10 pages long and want more information about her experience. She would like this mail to STOP now.  E-transmitting duplicate AE to agent: Please do not send anymore mailed packages to this caller. Its too much   The information on the batch/lot number for [BNT162B2, BNT162B2 OMI BA.4-5] has been requested and will be submitted if and when received.