Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Lethargy, Muscle swelling, Myalgia, Off label use
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. A 74 year-old female patient received bnt162b2 (BNT162B2), administration date 23Mar2022 (Batch/Lot number: unknown) as dose 4 (booster), single for Covid-19 immunisation. Relevant medical history included: "cancer survivor" (unspecified if ongoing), notes: She is a cancer survivor, COPD, AFib, and is on a cancer medication (but did not state what it was); "COPD" (unspecified if ongoing), notes: She is a cancer survivor, COPD, AFib, and is on a cancer medication (but did not state what it was).; "AFib" (unspecified if ongoing), notes: She is a cancer survivor, COPD, AFib, and is on a cancer medication (but did not state what it was). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer. Dose 1, They did not experience these with the first 3 shots, just a little arm soreness and tiredness), for COVID-19 Immunization, reaction(s): "tiredness", "arm soreness"; Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer, Dose 2. They did not experience these with the first 3 shots, just a little arm soreness and tiredness), for COVID-19 Immunization, reaction(s): "tiredness", "arm soreness"; Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer, Dose 3. They did not experience these with the first 3 shots, just a little arm soreness and tiredness), for COVID-19 Immunization, reaction(s): "tiredness", "arm soreness". The following information was reported: OFF LABEL USE (non-serious), IMMUNISATION (non-serious) all with onset 23Mar2022, outcome "unknown" and all described as "On 23Mar2022 they both received the 4th booster shot"; PYREXIA (non-serious), outcome "recovered", described as "fever"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "swollen arm"; MUSCLE SWELLING (non-serious), outcome "unknown", described as "swollen arm and muscle"; INJECTION SITE MASS (non-serious), outcome "unknown", described as "lump below the injection site"; DIZZINESS (non-serious), outcome "unknown", described as "dizziness/she does feel very dizzy"; FATIGUE (non-serious), outcome "unknown", described as "extremely tired/major concern is the tiredness"; ASTHENIA (non-serious), outcome "unknown", described as "loss of energy"; MYALGIA (non-serious), BACK PAIN (non-serious), outcome "unknown" and all described as "muscle and lower back pain"; LETHARGY (non-serious), outcome "unknown", described as "really feel totally lethargic". Additional information: The caller was calling about himself and his wife (agent stated but name was not spelled out). They are 74 years old and he was calling about the Pfizer BioNTech Covid-19 vaccine. Symptoms have improved some but are still there. They did not experience these with the first 3 shots, just a little arm soreness and tiredness. The extreme tiredness where they were in bed for 3-4 days and the fever they did not have before (with previous shots). They are both immunocompromised. The caller stated the internist is in on Tuesday and Thursdays and if they are not better Thursday they will get an appointment. The caller wanted to know if it is normal to experience these and if we had any further recommendations for them. The lot number for bnt162b2 was not provided and will be requested during follow up.