Age: 72.0
Sex: F
Vaccine: COVID19, FLUX, RVX
Symptoms: Hyperacusis, Injection site erythema, Injection site warmth, Limb discomfort, Migraine
Clinical narrative: sore; Light, sound and smell bothered her; Light, sound and smell bothered her; Light, sound and smell bothered her; She also had "all over body nausea", she never threw up but she had the feeling that she will throw all her guts out.; red or warm around the injection site; her right arm (where the Spikevax was injected) also felt like she was carrying a lead weight from her elbow up, like a piece of iron; migraine headache; This spontaneous case was reported by a patient and describes the occurrence of MIGRAINE (migraine headache), PAIN (sore), PHOTOPHOBIA (Light, sound and smell bothered her), HYPERACUSIS (Light, sound and smell bothered her) and PAROSMIA (Light, sound and smell bothered her) in a 72-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 203F23A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication and RSV VACCINE for an unknown indication.    She had 50 million things going but these are the more serious ones.  Concurrent medical conditions included Drug allergy, Asthma, Chronic bronchitis, Atrial fibrillation, Blood pressure high, Dust allergy (allergies to stuff in the air), Arthritis (Arthritis - different kinds) and Urinary tract infection. Concomitant products included NITROFURANTOIN for Urinary tract infection.   On 12-Oct-2023, the patient received seventh dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form, dose of INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) 1 dosage form and dose of RSV VACCINE (unknown route) 1 dosage form. On 12-Oct-2023, the patient experienced MIGRAINE (migraine headache). On an unknown date, the patient experienced PAIN (sore), PHOTOPHOBIA (Light, sound and smell bothered her), HYPERACUSIS (Light, sound and smell bothered her), PAROSMIA (Light, sound and smell bothered her), NAUSEA (She also had "all over body nausea", she never threw up but she had the feeling that she will throw all her guts out.), INJECTION SITE ERYTHEMA (red or warm around the injection site) and VACCINATION SITE PAIN (her right arm (where the Spikevax was injected) also felt like she was carrying a lead weight from her elbow up, like a piece of iron). At the time of the report, MIGRAINE (migraine headache) had resolved and PAIN (sore), PHOTOPHOBIA (Light, sound and smell bothered her), HYPERACUSIS (Light, sound and smell bothered her), PAROSMIA (Light, sound and smell bothered her), NAUSEA (She also had "all over body nausea", she never threw up but she had the feeling that she will throw all her guts out.), INJECTION SITE ERYTHEMA (red or warm around the injection site) and VACCINATION SITE PAIN (her right arm (where the Spikevax was injected) also felt like she was carrying a lead weight from her elbow up, like a piece of iron) outcome was unknown.            Patient received first Moderna dose - 04 Mar 2021, lot number 029A21A, second dose - 02 Apr 2021, lot number 017B21A, third dose- 03 Dec 2021, lot number 033F21A fourth dose - 15 Apr 2022, lot number 056M21A, fifth dose - 06 Oct 2022, bivalent lot number 055F22B sixth dose -01 May 2023, bivalent lot number 069H22A.   Treatment medication not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-746027, US-MODERNATX, INC.-MOD-2023-746069, US-MODERNATX, INC.-MOD-2023-746070 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-746027:Reporter's case US-MODERNATX, INC.-MOD-2023-746069:Monovalent case US-MODERNATX, INC.-MOD-2023-746070:Bivalent Dose