Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: After the second dose the patient felt fine for 4 days but then started getting headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (After the second dose the patient felt fine for 4 days but then started getting headaches) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A, 039K20A and 939906) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced HEADACHE (After the second dose the patient felt fine for 4 days but then started getting headaches) (seriousness criterion medically significant). At the time of the report, HEADACHE (After the second dose the patient felt fine for 4 days but then started getting headaches) had resolved.            No concomitant meds reported. Patient had three doses of mRNA-1273 vaccine on his left arm (dose 1 - 26/2/2021; dose 2 - 26/3/2021; dose 3 12/11/2021). No adverse reactions reported after dose 1 and 3 with mRNA1273 vaccine. 4 days after dose 2 of mRNA-1273, patient started getting headaches. On 13/4/2021, ER consult done due to headaches where he received a shot of steroids that took his headache away.   Company Comment: This spontaneous case concerns a 75-year-old, male patient, with no reported medical history, who experienced an unexpected, medically significant serious event of Headache 4 days after receiving his second dose of mRNA-1273 COVID-19 vaccine. Persistence of headaches prompted emergency care consult 2 weeks after initial onset of said event. At the ER, administration of a shot of steroids relieved the patient's headaches. Event outcome of headache was reported as recovered, but information on the clinical course, diagnostics, and further treatment details was not provided for medical review. The patient's elderly age could be a predisposing risk factor to the event Headache. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed per the primary source.; Sender's Comments: This spontaneous case concerns a 75-year-old, male patient, with no reported medical history, who experienced an unexpected, medically significant serious event of Headache 4 days after receiving his second dose of mRNA-1273 COVID-19 vaccine. Persistence of headaches prompted emergency care consult 2 weeks after initial onset of said event. At the ER, administration of a shot of steroids relieved the patient's headaches. Event outcome of headache was reported as recovered, but information on the clinical course, diagnostics, and further treatment details was not provided for medical review. The patient's elderly age could be a predisposing risk factor to the event Headache. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed per the primary source.