Age: 82.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Migraine, Pain, Tremor
Clinical narrative: started to feel aching/I've never had that kind of a headache and aching; a headache like I've never experienced before/searing headache through the night on and off/I've never had that kind of a headache and aching / I had a headache like I never had before / it was shots of pain in my head; couldn't sleep on Saturday night; almost felt like a migraine; I think my blood pressure went up; it aggravated my essential tremors; I'm still feeling a little strange; he has some residual effects lingering maybe there are residual effects; This spontaneous case was reported by a patient and describes the occurrence of PAIN (started to feel aching/I've never had that kind of a headache and aching), HEADACHE (a headache like I've never experienced before/searing headache through the night on and off/I've never had that kind of a headache and aching / I had a headache like I never had before / it was shots of pain in my head), INSOMNIA (couldn't sleep on Saturday night), MIGRAINE (almost felt like a migraine) and BLOOD PRESSURE INCREASED (I think my blood pressure went up) in an 84-year-old male patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. AS7140C, 07622A, 012F21A, 001A21A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Essential tremor. Previously administered products included for Drug use for unknown indication: Flu shot on 29-Aug-2022. Past adverse reactions to the above products included No adverse event with Flu shot. Concurrent medical conditions included Penicillin allergy, Allergy and Dust allergy.   On 04-Feb-2021, the patient received first dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 05-Mar-2021, received second dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to .5 milliliter. On 22-Oct-2021, received third dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2022, received fourth dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 03-Sep-2022 at 7:00 AM, received dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 03-Sep-2022, the patient experienced PAIN (started to feel aching/I've never had that kind of a headache and aching), HEADACHE (a headache like I've never experienced before/searing headache through the night on and off/I've never had that kind of a headache and aching / I had a headache like I never had before / it was shots of pain in my head), INSOMNIA (couldn't sleep on Saturday night), MIGRAINE (almost felt like a migraine), BLOOD PRESSURE INCREASED (I think my blood pressure went up), TREMOR (it aggravated my essential tremors), FEELING ABNORMAL (I'm still feeling a little strange) and IMMUNISATION REACTION (he has some residual effects lingering maybe there are residual effects). At the time of the report, PAIN (started to feel aching/I've never had that kind of a headache and aching), INSOMNIA (couldn't sleep on Saturday night), MIGRAINE (almost felt like a migraine), BLOOD PRESSURE INCREASED (I think my blood pressure went up), TREMOR (it aggravated my essential tremors), FEELING ABNORMAL (I'm still feeling a little strange) and IMMUNISATION REACTION (he has some residual effects lingering maybe there are residual effects) was resolving and HEADACHE (a headache like I've never experienced before/searing headache through the night on and off/I've never had that kind of a headache and aching / I had a headache like I never had before / it was shots of pain in my head) had resolved.        For mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.  It was reported that patient almost went to the emergency room for symptoms. Patient could not sleep on Saturday night after receiving the vaccine. It was like stabbing pains in patient's brain which would be shooting every so often. Patient message his doctor about this experience. Patient did not take any medications for symptoms and by Sunday morning, patient felt better. Patient still does feel a little strange as it has some residual effects lingering. Patient does not feel totally relaxed still.  No treatment medication was reported.   This case was linked to MOD-2022-640746.   Most recent FOLLOW-UP information incorporated above includes: On 06-Sep-2022: Live follow up received included significant information, secondary reporter, patient's demographics, relevant medical history, product details and event were added. Narrative was updated.