Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain in extremity, Pyrexia
Clinical narrative: chills; headache; feel like fever but its normal 98.6F; arm hurts; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD22-015117 (Moderna).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: ET7534), on 12Apr2021 as dose 2, single (Lot number: EW0151) and on 01Dec2021 as dose 3 (booster), single (Lot number: 300308D), all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "COVID-19", start date: Jul2020 (unspecified if ongoing), notes: Has patient ever had COVID + test or diagnosis? If yes, provide date.: Yes, July2020. The patient's concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "recovered"; HEADACHE (non-serious), outcome "recovered"; PYREXIA (non-serious), outcome "recovered", described as "feel like fever but its normal 98.6F"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "arm hurts". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Patient wants to know if its okay if she got another first booster (twice). Response: Spoke from FAQS-Reactive Talking Points for Questions on the Emergency Use Authorization of 2.5mL vial for booster and 2nd booster authorization and refer to HCP. 06Jun2022. Title: FAQS-Reactive Talking Points for Questions on the Emergency use Authorization of 2.5mL vial for booster and 2nd booster authorization. General Adverse Event script - please use for any AE/Safety events experienced with EUA/Marketed products. Patient information: Height. Past Medical History Allergies (medications, food and other products): No Has patient ever had COVID + test or diagnosis, If yes, provide date: Yes, Jul2020. Medical Hx: Hx relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination: no. Recent change in status such as improvement or worsening: N/A. Other vaccines given within 1 month prior to Moderna COVID-19 vaccine (type, brand, lot, route, dose #): N/A. Manufacturer and dose of all COVID-19 vaccinations received. First dose on ET7534 22Mar2021 (Pfizer), Second dose on EW0151 on 12Apr2021 (Pfizer), Booster (Pfizer) 300308D on 1Dec2021, Second booster (Moderna) 054A22A 5Jun2022. Adverse Event Verbatim term: Second booster (Moderna) gave chills, headache, feel like fever but its normal 98.6F, arm hurts where got the vaccine left arm. No AE cause patient to seek medical care (office visit, Urgent care, ER, hospitalized). Has the patient experienced a similar event in the past, Yes for one day after the Pfizer vaccine. No AE Outcome (recovered, residual effects, ongoing, unknown). No cause of death and was autopsy done. symptoms Not worsening, shoulder hurts. Transfer to safety 06Jun2022. Batch Number: ET7534, Dose Form Injection, Route Intramuscular, Frequency Drug Start Date 22Mar2021, Drug Stop Date Indication COVID-19 vaccine. There is no concomitant list.  No follow-up attempts are possible, No further information is expected.