Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dizziness, Headache, Myalgia, Tinnitus
Clinical narrative: dizziness; ears ringing; flesh feels like they are hurting; stomach upset; severe headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), TINNITUS (ears ringing), MYALGIA (flesh feels like they are hurting), ABDOMINAL DISCOMFORT (stomach upset) and HEADACHE (severe headache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939904, 017821A and 048A21A) for COVID-19 vaccination.     The patient's past medical history included Heart attack in 2020. Concomitant products included ACETYLSALICYLIC ACID (ASAPRIN), METOPROLOL, ATORVASTATIN and OLMESARTAN for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In November 2021, the patient experienced DIZZINESS (dizziness), TINNITUS (ears ringing), MYALGIA (flesh feels like they are hurting), ABDOMINAL DISCOMFORT (stomach upset) and HEADACHE (severe headache). At the time of the report, DIZZINESS (dizziness), TINNITUS (ears ringing), MYALGIA (flesh feels like they are hurting), ABDOMINAL DISCOMFORT (stomach upset) and HEADACHE (severe headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered DIZZINESS (dizziness), TINNITUS (ears ringing), MYALGIA (flesh feels like they are hurting), ABDOMINAL DISCOMFORT (stomach upset) and HEADACHE (severe headache) to be possibly related.    This spontaneous case concerns a 62-year-old, female patient with relevant history of concomitant intake of aspirin, anti-hypertensive drugs (metoprolol and olmesartan) and atorvastatin, who experienced the expected, non-serious event of severe headache and other associated unexpected and expected, non-serious events. The events occurred on an unspecified date in Nov2021 following administration of the booster dose of the Moderna mRNA-1273. The rechallenge was not applicable as no additional dosing will be given. The medical history of aspirin intake, which may cause stomach irritation; anti-hypertensive drug and atorvastatin intake, which may cause dizziness and headache, remain as confounders. The benefit-risk relationship of the Moderna mRNA-1273 is not affected by this report. Further information has been requested.   This case was linked to MOD-2021-382303, MOD-2021-382288 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2021: Follow up received on 12-NOV-2021 includes non-Significant  information contains Email updated; Sender's Comments: This spontaneous case concerns a 62-year-old, female patient with relevant history of concomitant intake of aspirin, anti-hypertensive drugs (metoprolol and olmesartan) and atorvastatin, who experienced the expected, non-serious event of severe headache and other associated unexpected and expected, non-serious events. The events occurred on an unspecified date in Nov2021 following administration of the booster dose of the Moderna mRNA-1273. The rechallenge was not applicable as no additional dosing will be given. The medical history of aspirin intake, which may cause stomach irritation; anti-hypertensive drug and atorvastatin intake, which may cause dizziness and headache, remain as confounders. The benefit-risk relationship of the Moderna mRNA-1273 is not affected by this report. Further information has been requested.