Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Oropharyngeal pain, Pain in extremity
Clinical narrative: sore throat; feeling very distress; unable to sleep; arm hurt; headache; tiredness; Expiration: 29-Apr-2024 / Patient received vaccine on: 30-Apr-2024; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), FEELING ABNORMAL (feeling very distress), INSOMNIA (unable to sleep), PAIN IN EXTREMITY (arm hurt) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. AU3916D) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Shingrix vaccine on 15-Aug-2023, Flu vaccine on 05-Oct-2023 and Shingles vaccine on 22-Nov-2023. Past adverse reactions to the above products included No adverse event with Flu vaccine, Shingles vaccine and Shingrix vaccine.    On 30-Apr-2024, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 30-Apr-2024, the patient experienced OROPHARYNGEAL PAIN (sore throat), FEELING ABNORMAL (feeling very distress), INSOMNIA (unable to sleep), PAIN IN EXTREMITY (arm hurt), HEADACHE (headache), FATIGUE (tiredness) and EXPIRED PRODUCT ADMINISTERED (Expiration: 29-Apr-2024 / Patient received vaccine on: 30-Apr-2024). At the time of the report, OROPHARYNGEAL PAIN (sore throat), FEELING ABNORMAL (feeling very distress), INSOMNIA (unable to sleep), PAIN IN EXTREMITY (arm hurt) and HEADACHE (headache) was resolving, FATIGUE (tiredness) had resolved and EXPIRED PRODUCT ADMINISTERED (Expiration: 29-Apr-2024 / Patient received vaccine on: 30-Apr-2024) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: temperature go up to 99.6 briefly.         Patient had no relevant medical history or conditions, allergy, concomitant diseases and risk factor.  Patient received other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  Patient had a headache, her arm hurt, she think actually a little more than usual. Maybe, maybe not. She did not know, her arm hurt, of course. She had a headache. She did notice her temperature go up to 99.6 briefly, but not for very long. She was really upset that these people, not just that they made the mistake but that they were so cavalier about. She would say one more side effect that she had this time was and she had not noticed this before, but immediately after being administered the vaccine, She felt a tiredness, like her body feeling heavy and she felt that tiredness throughout the day. She would say she did not recall that specifically in the past, but she would say fatigue was something in a more general kind of way for a couple of days. Sore throat, feeling very distress and unable to sleep due to being very concerned about receiving an expired vaccine.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2024-766921 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-766921:Same patient different dose