Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Periarthritis, Pyrexia, Vaccination site pain
Clinical narrative: Chills; Hallucinating; Sick; Frozen shoulder; Being able to sleep only one to two hours; Soaking wet whit sweet; no appetite; Pain in the arm; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (Hallucinating), ILLNESS (Sick), PERIARTHRITIS (Frozen shoulder), INSOMNIA (Being able to sleep only one to two hours) and HYPERHIDROSIS (Soaking wet whit sweet) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 077C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroiditis, Blood pressure and Cholesterol. Concomitant products included VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Nov-2021, the patient experienced HALLUCINATION (Hallucinating), ILLNESS (Sick), PERIARTHRITIS (Frozen shoulder), INSOMNIA (Being able to sleep only one to two hours), HYPERHIDROSIS (Soaking wet whit sweet), DECREASED APPETITE (no appetite), VACCINATION SITE PAIN (Pain in the arm) and PYREXIA (Fever). On an unknown date, the patient experienced CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Pain, at an unspecified dose and frequency. At the time of the report, HALLUCINATION (Hallucinating), ILLNESS (Sick), PERIARTHRITIS (Frozen shoulder), INSOMNIA (Being able to sleep only one to two hours), HYPERHIDROSIS (Soaking wet whit sweet), DECREASED APPETITE (no appetite), VACCINATION SITE PAIN (Pain in the arm), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.            Concomitant product use was not provided by the reporter.   Additional treatment medication include were thyroid condition, a blood pressure condition and doctor recommended to stop using ice packs in the arm that is in pain, and start using hot Packs.  Company's comment:This case concerns am 86-year-old, female patient, with no relevant medical history, who experienced the non-serious, unexpected event of hallucination. The event occurred  on the same day after booster dose of mRNA 1273 vaccine. The patient had frozen shoulder, arm pain, unable to sleep, had no appetite and was hallucinating from the pain, chills and fever after the booster dose. The rechallenge is not applicable as no additional dose is expected. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns am 86-year-old, female patient, with no relevant medical history, who experienced the non-serious, unexpected event of hallucination. The event occurred  on the same day after booster dose of mRNA 1273 vaccine. The patient had frozen shoulder, arm pain, unable to sleep, had no appetite and was hallucinating from the pain, chills and fever after the booster dose. The rechallenge is not applicable as no additional dose is expected. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.