Sex: M
Vaccine: COVID19
Symptoms: Paralysis
Clinical narrative: third shot gave him a significant temporary muscle paralysis; This spontaneous case was reported by a patient and describes the occurrence of PARALYSIS (third shot gave him a significant temporary muscle paralysis) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PARALYSIS (third shot gave him a significant temporary muscle paralysis) (seriousness criterion medically significant). At the time of the report, PARALYSIS (third shot gave him a significant temporary muscle paralysis) was resolving.            No Concomitant medications were provided.  It was reported that caller, who decided to remain anonymous, mentioned he had never received a dose from the Pfizer COVID-19 Vaccine, but that he actually got 3 doses from the Moderna COVID-19 Vaccine, but that the third shot gave a significant temporary muscle paralysis and a nurse told that it was similar to a Guillian-Barre syndrome. Patient felt fine a couple of days later, but that he hopes not to go through that again.    No treatment medications were provided. Company comment-This spontaneous case concerns a male patient of unspecified age with no medical history reported, who experienced the unexpected, serious (medically significant) event of Paralysis on unknown date after third dose of Spikevax Bivalent .222 (Original/Omicron BA.4/5) vaccination. Latency cannot be assessed since exact vaccination date and event onset date were not disclosed.  Patient reported that he got 3 doses from the Moderna COVID-19 Vaccine, but the third shot gave a significant temporary muscle paralysis and a nurse told that it was similar to a Guillian-Barre syndrome. Patient felt fine a couple of days later. No further information on risk factors, clinical course, investigations, treatment of the event, details of previous doses was available in the report. Outcome of the event was resolving at the time of report. The benefit-risk relationship of Spikevax Bivalent .222 (Original/Omicron BA.4/5) vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a male patient of unspecified age with no medical history reported, who experienced the unexpected, serious (medically significant) event of Paralysis on unknown date after third dose of Spikevax Bivalent .222 (Original/Omicron BA.4/5) vaccination. Latency cannot be assessed since exact vaccination date and event onset date were not disclosed.  Patient reported that he got 3 doses from the Moderna COVID-19 Vaccine, but the third shot gave a significant temporary muscle paralysis and a nurse told that it was similar to a Guillian-Barre syndrome. Patient felt fine a couple of days later. No further information on risk factors, clinical course, investigations, treatment of the event, details of previous doses was available in the report. Outcome of the event was resolving at the time of report. The benefit-risk relationship of Spikevax Bivalent .222 (Original/Omicron BA.4/5) vaccine is not affected by this report.