Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, FLUX, TDAP, COVID19, FLUA4, TDAP
Symptoms: Feeling hot, Headache, Injection site pain
Clinical narrative: Her forehead feels a little warm; Soreness on her arm at the injection site/Soreness at injection/tenderness in the arm at the injection site; A little bit of a headache; Fatigue; Covid-19 vaccine and Fluad Quadrivalent administarted in the same arm at the same day; Pain on her left arm/it was still sore, but she can put weight on her arm/If she touched or pressed down, it was a little tender; This spontaneous case was retrieved on 07-Nov-2023 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 2691508-1), reported by other non-healthcare professional (consumer) and concerned a 66-year-old, female patient.  The patient's concurrent conditions included tonsillar disorder, gastro issues, as reported, appendix disorder, migraine, fibromyalgia, dry eyes and gastrointestinal infection. The patient's concomitant medications were not reported. The patient's historical vaccines included four doses of BNT162b2 (tozinameran), the first dose was received on 05-Apr-2021 (batch number: EW0150, expiry date: 31-Jul-2021, the second dose on 31-Aug-2021 (batch number: EW0169, expiry date: 31-Aug-2021, third dose was received on 01-Nov-2021 (batch number: FH8028, expiry date: 31-May-2022) and fourth dose was received on 24-Sep-2022 (batch number: GH9703, expiry date: 30-Jun-2023), all received in left arm and all used for Covid-19 immunization, after each dose the patient developed tenderness in the arm at the injection site, forehead felt a little warm, headache and fatigue. The patient's historical vaccine also included Pfizer Covid vaccine received on 09-Apr-2022 (batch number: FX9895 or FK9895, as reported) used for unreported indication. As reported, with all her vaccination a little over five hours after vaccination the soreness and fatigue and little mild headache started. She had no nausea or vomiting or dizziness, nothing like that. She thought the reason she didn't have anything like that was because of the quality of the drug. As reported, dry eyes, fibromyalgia, gastrointestinal infection, and migraine were not affected by the vaccinations. The patient had never got flu shot and never got the flu, as reported. The patient personally thought that the reason she did not get the flu had a lot to do with clearly genetic code and possibly her blood type (0 positive).  On 28-Sep-2023, between 1PM and 4PM (post meridiem), the patient was vaccinated with non-company, co-suspect Covid-19 vaccine (reported as bnt162b2 omi xbb.1.5 Comirnaty (formula 2023-2024); dose reported as '5 (booster)', anatomical location: left arm, route of administration: not reported) for Covid-19 immunisation. The batch number reported was HG4629.  It was reported that on 28-Sep-2023, the patient was vaccinated with influenza vaccine (brand not specified; dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm) for immunisation. The batch number reported was 370266 and expiry date 19-Apr-2024. The reported batch number was identified by Seqirus to be linked to suspect product Fluad Quadrivalent (influenza vaccine inact sag 4v) instead of reported suspect product influenza vaccine. Based on the reported batch number, the suspect product was changed to Fluad Quadrivalent (explicitly coded as 'Product administration error'). As reported, the only reason the patient started getting the flu shot was because of Covid and they were saying to get both, so she has done it.  On the same day, the patient was also vaccinated with non-company, co-suspect Boostrix (diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid; route of administration: intramuscular, anatomical location: right arm, dose: not reported) for immunisation. The batch number reported was 54CP2 and expiry date 11-Jan-2026.  On the same day, five to four hours after receiving Fluad Quadrivalent and non-company co-suspects Covid-19 vaccine and Boostrix vaccines, the patient experienced soreness on her arm at the injection site. The patient also had a little bit of a headache.  On the same day, late 28-Sep-2023, the patient's forehead felt a little warm, however the rest of her body didn't feel warm. By the evening around eight or nine, she started feeling fatigue and a little bit of a headache. The patient knew the difference between a little bit of a headache and a migraine. This was not a migraine. The patient was kind of back to normal.   On 29-Sep-2023, as reported when the patient woke up at 7AM (after meridiem), she still felt it. The patient only took Motrin (ibuprofen). She had light breakfast and has been lying down, resting. The patient reported that 20% of the headache was left. It was very mild and not throbbing. The warmth she never felt like a full-blown fever, only on her forehead. Usually when she got that she had low grade headache or low-grade fever and just her forehead felt warm. The warmth on the forehead was still there. Neither the headache nor the warmth on the forehead have been anything that would have caused her to go to the hospital. The soreness at injection has subsided. Overnight she could roll over and get out of bed, but she could feel the pain on her left arm. All she did was take one Motrin at 1AM and went to sleep again. By the time she woke up again at 7AM, it was still sore, but she could put weight on her arm. If she touched or pressed down, it was a little tender. Therapeutic measures were taken as a result of vaccination site pain and headache. As reported, the events did not require a visit to emergency room, physician office and intensive care unit. As reported, even once she got Covid vaccination and flu shot she still did not get the flu. The patient didn't think her not getting the flu has anything to do with the flu vaccine, but her immune system is very strong against the flu and cold.  At the time of initial reporting, the patient had not recovered from the event 'localized feeling of warmth' and the patient was recovering from the events of vaccination site pain, headache and 'painful L arm'.  The outcome of the event fatigue was unknown.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: On the same day, five to four hours after receiving Fluad Quadrivalent and non-company co-suspects Covid-19 vaccine and Boostrix vaccines, the patient experienced vaccination site pain, headache, localized feeling of warmth, pain in arm and fatigue. Although confounded by co-suspect vaccines, causal role of the vaccine is assessed as possibly related, due chronological plausibility. Fluad Quadrivalent and Covid-19 vaccine were given on the same day, in the same arm. Product administration error is assessed as unrelated per company conventions.; Sender's Comments: On the same day, five to four hours after receiving Fluad Quadrivalent and non-company co-suspects Covid-19 vaccine and Boostrix vaccines, the patient experienced vaccination site pain, headache, localized feeling of warmth, pain in arm and fatigue. Although confounded by co-suspect vaccines, causal role of the vaccine is assessed as possibly related, due chronological plausibility. Fluad Quadrivalent and Covid-19 vaccine were given on the same day, in the same arm. Product administration error is assessed as unrelated per company conventions.