Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Extra dose administered, Feeling hot, Illness, Malaise
Clinical narrative: unspecified reaction to the first and second shot/wife had the 3rd Moderna COVID-19 vaccine shot and had a reaction; fainted; increasing weakness/very weak; felt sick; received 3rd shot and is not immunocompromised; muscle pain; arm pain pretty same immediate after vaccination; rash; seems to be very hot; not feeling fine; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (fainted) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Oct-2021, the patient experienced EXTRA DOSE ADMINISTERED (received 3rd shot and is not immunocompromised), MYALGIA (muscle pain) and VACCINATION SITE PAIN (arm pain pretty same immediate after vaccination). On 13-Oct-2021, the patient experienced ILLNESS (felt sick). On 14-Oct-2021, the patient experienced SYNCOPE (fainted) (seriousness criterion medically significant) and ASTHENIA (increasing weakness/very weak). In October 2021, the patient experienced FEELING HOT (seems to be very hot), MALAISE (not feeling fine) and RASH (rash). On an unknown date, the patient experienced VACCINATION COMPLICATION (unspecified reaction to the first and second shot/wife had the 3rd Moderna COVID-19 vaccine shot and had a reaction). On 12-Oct-2021, EXTRA DOSE ADMINISTERED (received 3rd shot and is not immunocompromised) had resolved. At the time of the report, SYNCOPE (fainted), ILLNESS (felt sick), ASTHENIA (increasing weakness/very weak), FEELING HOT (seems to be very hot), MALAISE (not feeling fine), VACCINATION COMPLICATION (unspecified reaction to the first and second shot/wife had the 3rd Moderna COVID-19 vaccine shot and had a reaction), MYALGIA (muscle pain) and RASH (rash) outcome was unknown and VACCINATION SITE PAIN (arm pain pretty same immediate after vaccination) had not resolved.            No concomitant medications information was reported. No treatment medications were provided.  The patients husband reported that his wife had the 3rd Moderna COVID-19 vaccine shot and had a reaction. She felt sick after the shot, by the following day. She had arm pain pretty immediate, the same day. She had increasing weakness and seemed to be very hot, he did not knew if it was fever or not. Early morning on 14 Oct 2021 at 4am his wife got up to get a drink of ginger ale and in the process of taking that out of the fridge she fainted on the floor and she had been very weak all day. There was no such reaction to the first shots. She had muscle pain pretty soon after and that continued and wa still not feeling fine. He had the same side effects as with the first two shots (which he had in February), the same they all had at the moment. When asked if immunocompromised he said he did not know and they assumed the 3rd dose included people over 65 years old as well. The side effects were so much different than the previous doses. She also had a rash, and had that every time she had a bad cold or something like that.  This is an spontaneous case concerning a 75 year-old, female patient with unknown clinical history who experienced the unexpected serious event of SYNCOPE and other non-serious events. The event occurs approximately 3 days after the third dose of a COVID-19 vaccine (we do not have information if the first two doses were Spikevax or not). The rechallenge is unknown as per no information is available at the time of the report. The benefit-risk relationship of Spikevax is not affected by this report.  Most recent FOLLOW-UP information incorporated above includes: On 15-Oct-2021: Follow up document received wherein batch number updated.; Sender's Comments: This is an spontaneous case concerning a 75 year-old, female patient with unknown clinical history who experienced the unexpected serious event of SYNCOPE and other non-serious events. The event occurs approximately 3 days after the third dose of a COVID-19 vaccine (we do not have information if the first two doses were Spikevax or not). The rechallenge is unknown as per no information is available at the time of the report. The benefit-risk relationship of Spikevax is not affected by this report.