Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: 1st 2nd and 3rd Vision headache episode after first dose; Sore arm after first vaccine dose; I have been having off and on, uncharacteristically strange dreams; Causes anxiety; Wakes me up in the middle of the night / keeps me up; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ABNORMAL DREAMS (I have been having off and on, uncharacteristically strange dreams), ANXIETY (Causes anxiety), INSOMNIA (Wakes me up in the middle of the night / keeps me up), HEADACHE (1st 2nd and 3rd Vision headache episode after first dose) and VACCINATION SITE PAIN (Sore arm after first vaccine dose) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043L20A and 001A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and VITAMINS NOS for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced ABNORMAL DREAMS (I have been having off and on, uncharacteristically strange dreams), ANXIETY (Causes anxiety) and INSOMNIA (Wakes me up in the middle of the night / keeps me up). On an unknown date, the patient experienced HEADACHE (1st 2nd and 3rd Vision headache episode after first dose) and VACCINATION SITE PAIN (Sore arm after first vaccine dose). At the time of the report, ABNORMAL DREAMS (I have been having off and on, uncharacteristically strange dreams), ANXIETY (Causes anxiety), INSOMNIA (Wakes me up in the middle of the night / keeps me up), HEADACHE (1st 2nd and 3rd Vision headache episode after last dose) and VACCINATION SITE PAIN (Sore arm after first vaccine dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Magnetic resonance imaging: normal (normal) normal.         Patient started with sore arm, 3 vision headache episodes. These headache episodes occurred 3 times over the 2 weeks period after the first dose. She had second vaccine dose on 27Feb2021 on her left arm, and for about 4.5 weeks had no headache but then had 4 episodes of vision headaches. Patient had 7 total headache episodes, then she went to see her Doctor. Patient had 7 total headache episodes, then she went to see her Doctor, and brain MRI was performed but nothing was found to be related to this situation.  Treatment information was not provided.   This case was linked to MOD-2021-093357  (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Follow-up received on 21-APR-2021.Added new AE(Sore arm, 1st,2nd,3rd Vision headache episode after first dose) and dose 2.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.