Sex: F
Vaccine: COVID19, FLUX
Symptoms: Allergy to vaccine, COVID-19, Chills, Drug ineffective, Headache
Clinical narrative: did get COVID even after having a vaccine; did get COVID even after having a vaccine; allergic to Covid vaccine; sick; fever; chills; ached; Muscles aches all over my body; headache; The initial case was missing the following minimum criteria: unspecified suspect drug. Upon receipt of follow-up information on 15Jan2025, this case now contains all required information to be considered valid.  This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A 75-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), as dose number unknown, single) for immunisation. The patient's relevant medical history included: "cancer", start date: 2019 (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "Surgery" (unspecified if ongoing); "radiation therapy" (unspecified if ongoing). Concomitant medication(s) included: XANAX; WELLBUTRIN. Vaccination history included: Bnt162b2, bnt162b2 omi ba.4-5 (DOSE 1, SINGLE; left arm), administration date: Oct2022, for COVID-19 Immunization, reaction(s): "chills", "bad headache", "sick", "muscles aches all over my body", "ached", "fever". The following information was reported: MYALGIA (non-serious) with onset Oct2023, 6 hrs after the suspect product(s) administration, outcome "recovered", described as "Muscles aches all over my body"; PAIN (non-serious) with onset Oct2023, 6 hrs after the suspect product(s) administration, outcome "recovered", described as "ached"; CHILLS (non-serious) with onset Oct2023, 6 hrs after the suspect product(s) administration, outcome "recovered"; PYREXIA (non-serious) with onset Oct2023, 6 hrs after the suspect product(s) administration, outcome "recovered", described as "fever"; HEADACHE (non-serious) with onset Oct2023, 6 hrs after the suspect product(s) administration, outcome "recovered"; ILLNESS (non-serious) with onset Oct2023, 6 hrs after the suspect product(s) administration, outcome "recovered", described as "sick"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "did get COVID even after having a vaccine"; ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "allergic to Covid vaccine". The patient underwent the following laboratory tests and procedures: Radiotherapy: (Aug2024) Unknown results. Therapeutic measures were taken as a result of illness, pyrexia, chills, pain, myalgia, headache.  Clinical course: The patient reported that she had a reaction to the Pfizer COVID-19 vaccine in Oct2022 and 2023. She said, she got those and got really sick, and she said that she ran a fever, chills and she ached, and this occurred 4 to 6 hours after the vaccine, and real bad headache. Both times and they were all Pfizer. Treated herself with Tylenol. The patient also mentioned that she had cancer in 2019 and then had surgery for it and then in 2024 she had radiation therapy in Aug. The patient would like to get another Covid vaccine, but now is afraid of them.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.