Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Presyncope, Tremor
Clinical narrative: stomach cramps; brain foggy; Body aches/pains; Did not sleep last night I had only 2 hours, because around 4 AM; sweating/and broke out in a sweat everywhere; Sore arm/ arm was sore; nausea; Felt quiet tired; mild headache; I felt like I was going to Faint or lose consciousness.; Weird chills/a wave of chills/I had chills; Shaking; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (I felt like I was going to Faint or lose consciousness.), ABDOMINAL PAIN UPPER (stomach cramps), BRAIN FOG (brain foggy), PAIN (Body aches/pains) and INSOMNIA (Did not sleep last night I had only 2 hours, because around 4 AM) in a 71-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030335) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: FLU VACCINE VII and Pfizer (All prior doses were 6 Pfizer doses). Past adverse reactions to the above products included No adverse effect with FLU VACCINE VII and Pfizer.    On 26-Sep-2023, the patient received seventh dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 27-Sep-2023, the patient experienced TREMOR (Shaking) and CHILLS (Weird chills/a wave of chills/I had chills). On 28-Sep-2023, the patient experienced PRESYNCOPE (I felt like I was going to Faint or lose consciousness.). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (stomach cramps), BRAIN FOG (brain foggy), PAIN (Body aches/pains), INSOMNIA (Did not sleep last night I had only 2 hours, because around 4 AM), HYPERHIDROSIS (sweating/and broke out in a sweat everywhere), PAIN IN EXTREMITY (Sore arm/ arm was sore), NAUSEA (nausea), FATIGUE (Felt quiet tired) and HEADACHE (mild headache). At the time of the report, PRESYNCOPE (I felt like I was going to Faint or lose consciousness.), ABDOMINAL PAIN UPPER (stomach cramps), BRAIN FOG (brain foggy), PAIN (Body aches/pains), INSOMNIA (Did not sleep last night I had only 2 hours, because around 4 AM), TREMOR (Shaking), HYPERHIDROSIS (sweating/and broke out in a sweat everywhere), PAIN IN EXTREMITY (Sore arm/ arm was sore), CHILLS (Weird chills/a wave of chills/I had chills), NAUSEA (nausea), FATIGUE (Felt quiet tired) and HEADACHE (mild headache) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Patient received 7th dose from Moderna. About 3-4 hours after, patient reported, she was very active, but felt quite tired, brain foggy and overnight into Wednesday sore arm, body aches and pains. But on the night of 27Sep2023, around 8:30 PM, she had weird chills, shaking, a wave of chills, did not sleep last night. She had only 2 hours around 4 AM. Patient had chills, stomach cramps, mild headache, arm was sore, sweating nausea, and broke out in sweat everywhere. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-742748 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-742748:Daughter case