Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pruritus, Pyrexia, Rash, Tremor
Clinical narrative: Big welt and itchy as hell right around the injection site; Big welt and itchy right around the injection site; Felt like drinking all night; Woke up middle of night room spinning and lightheaded; Shaking uncontrollably; Hives; Itchy; Rash; Fever; Chills; Nausea; Headache; Aches and Pains; Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt like drinking all night), DIZZINESS (Woke up middle of night room spinning and lightheaded), TREMOR (Shaking uncontrollably), URTICARIA (Hives) and PRURITUS (Itchy) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Factor V Leiden thrombophilia and Neutropenia. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for Factor V Leiden thrombophilia.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site). On 06-Mar-2021, the patient experienced TREMOR (Shaking uncontrollably), URTICARIA (Hives), PRURITUS (Itchy), RASH (Rash), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea), HEADACHE (Headache) and MYALGIA (Aches and Pains). On 11-Mar-2021, the patient experienced FEELING ABNORMAL (Felt like drinking all night) and DIZZINESS (Woke up middle of night room spinning and lightheaded). On 15-Mar-2021, the patient experienced VACCINATION SITE URTICARIA (Big welt and itchy right around the injection site) and VACCINATION SITE PRURITUS (Big welt and itchy as hell right around the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 07-Mar-2021, URTICARIA (Hives), PRURITUS (Itchy) and RASH (Rash) had resolved. On 08-Mar-2021, TREMOR (Shaking uncontrollably), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea), HEADACHE (Headache) and MYALGIA (Aches and Pains) had resolved. At the time of the report, FEELING ABNORMAL (Felt like drinking all night), VACCINATION SITE URTICARIA (Big welt and itchy right around the injection site), VACCINATION SITE PRURITUS (Big welt and itchy right around the injection site) and VACCINATION SITE PAIN (Pain at injection site) outcome was unknown and DIZZINESS (Woke up middle of night room spinning and lightheaded) had resolved.            No events after dose 2 were reported.   Most recent FOLLOW-UP information incorporated above includes: On 05-Jun-2021: Added Reporter address, Patient demographics ( race, height, ethnic group, weight, medical history). Added second dose of the drug and updated the Action Taken from unknown to not applicable. Added the events and updated the outcome of the event (Dizziness) from unknown to recovered.