Age: 66.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Respiratory rate, White blood cell count
Clinical narrative: Severe intractable headache; nausea; myalgias; fatigue; Low grade fever / temperature: 36.4 degrees Celsius,; This spontaneous case was reported by a physician and describes the occurrence of HEADACHE (Severe intractable headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product RALINEPAG for Pulmonary arterial hypertension.    The patient's past medical history included Diastolic dysfunction, Acne (took tetracycline for acne) in 1969, Diverticulitis in 2004, Hiatus hernia in 2004, Cough, Tonsillectomy in 1964, Laparoscopy in 1994, Female sterilisation in 1995, Colonoscopy on 08-Jul-2016 and Oesophagogastroduodenoscopy on 08-Jul-2016. Family history included Migraine (family history of migraine (mother, maternal grandmother, sister and son)) since 1970, Osteoarthritis (Mother, maternal grandmother, maternal grandfeather) since 2015 and Caffeine consumption (Rarely) since an unknown date. Concurrent medical conditions included Depression since 1996, Gastrooesophageal reflux disease since 2004, Shortness of breath since 2018, Headache (had an onset in May 2021 and on 22 Jul 2021) since May 2021, Drug allergy (Rituxan (rituximab) allergy led to angioedema, chills, joints pain, shortness of breath and headache), Drug allergy (nitrate analogues.), Alcohol use (2 glass of wine (2 standard drink or equivalent) per week), Basedow's disease since 1994, Sjogren's syndrome since 1994, Raynaud's phenomenon since 2008, Systemic scleroderma (Progressive or Diffuse) since 2010, Menopausal symptoms since 2006, Osteopenia since 2006, Supraventricular extrasystoles since 2013, Rhinitis allergic since 2015, Intervertebral disc degeneration since 2015, Diastolic dysfunction since 2016, Radiculopathy since 18-Apr-2016, Interstitial lung disease since 2018, Pulmonary arterial hypertension (WHO 1 PAH associated with systemic sclerosis (scleroderma) since 27-Nov-2018, Constipation and Scleroderma since 12-Mar-2019. Concomitant products included PARACETAMOL (TYLENOL) for Adverse event, CICLOSPORIN (RESTASIS), FISH OIL (FISH OIL OMEGA 3), CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM CARBONATE AND VITAMIN D), DICLOFENAC SODIUM (VOLTAREN [DICLOFENAC SODIUM]), FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), LIDOCAINE (LIDODERM), MYCOPHENOLATE MOFETIL (CELLCEPT [MYCOPHENOLATE MOFETIL]), METOPROLOL TARTRATE (LOPRESSOR) from 27-Aug-2018 to an unknown date, AZELASTINE HYDROCHLORIDE (ASTELIN [AZELASTINE HYDROCHLORIDE]) from 14-Oct-2019 to an unknown date, DENOSUMAB (PROLIA) from 11-Apr-2021 to an unknown date, FAMOTIDINE (PEPCID [FAMOTIDINE]) from 23-Sep-2021 to an unknown date, BOSWELLIA SERRATA RESIN, CURCUMA LONGA ROOT, GLUCOSAMINE HYDROCHLORIDE (OSTEO BI-FLEX JOINT HEALTH TRIPLE STRENGTH + TURMERIC), LISINOPRIL from 18-Jul-2021 to 16-Aug-2021, MACROGOL 3350 (MIRALAX) from 20-Jan-2020 to an unknown date, SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]) from 24-Jun-2021 to an unknown date, AZITHROMYCIN (ZITHROMAX) from 22-Jul-2021 to an unknown date, DEXLANSOPRAZOLE (DEXILANT) from 24-Jun-2021 to an unknown date, FUROSEMIDE (LASIX [FUROSEMIDE]) from 03-Aug-2021 to an unknown date, GABAPENTIN (NEURONTIN) from 08-Mar-2021 to an unknown date, LOPERAMIDE HYDROCHLORIDE (IMODIUM A-D) from 09-Aug-2021 to an unknown date, MACITENTAN (OPSUMIT) from 07-May-2021 to an unknown date, MULTIVITAMIN WITH MINERALS from 16-Jan-2021 to an unknown date, TADALAFIL (ADCIRCA) from 05-May-2021 to an unknown date, TRAMADOL from 20-Aug-2021 to an unknown date, CELECOXIB (CELEBREX) and NINTEDANIB for an unknown indication.   On 11-Aug-2021, the patient started RALINEPAG (unknown route) at an unspecified dose. On 30-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2021, the patient experienced HEADACHE (Severe intractable headache) (seriousness criterion hospitalization), NAUSEA (nausea), MYALGIA (myalgias), FATIGUE (fatigue) and PYREXIA (Low grade fever / temperature: 36.4 degrees Celsius,). The patient was hospitalized from 03-Sep-2021 to 03-Sep-2021 due to HEADACHE. The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) ongoing since an unknown date at a dose of 4 milligram; ONDANSETRON (ZOFRAN [ONDANSETRON]) at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 02-Sep-2021 for Adverse event, at an unspecified dose and frequency; OXYCODONE on 03-Sep-2021 for Adverse event, at an unspecified dose and frequency; TRAMADOL HYDROCHLORIDE (ULTRAM [TRAMADOL HYDROCHLORIDE]) on 02-Sep-2021 for Adverse event, at an unspecified dose and frequency; MAGNESIUM SULFATE (intravenous) on 02-Sep-2021 for Adverse event, at an unspecified dose and frequency; DROPERIDOL on 02-Sep-2021 for Adverse event, at an unspecified dose and frequency; PROCHLORPERAZINE MALEATE (COMPAZINE [PROCHLORPERAZINE MALEATE]) (intravenous) on 02-Sep-2021 for Adverse event, at an unspecified dose and frequency; ENOXAPARIN on 03-Sep-2021 for Adverse event, at an unspecified dose and frequency and FUROSEMIDE on 03-Sep-2021 for Adverse event, at an unspecified dose and frequency. On 03-Sep-2021, HEADACHE (Severe intractable headache) had resolved. At the time of the report, NAUSEA (nausea) had not resolved and MYALGIA (myalgias), FATIGUE (fatigue) and PYREXIA (Low grade fever / temperature: 36.4 degrees Celsius,) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Sep-2021, Blood potassium: 4.2 (normal) 4.2. On 02-Sep-2021, Blood pressure measurement: 138/70 mmhg. (abnormal) 138/70 mmHg. On 02-Sep-2021, Blood sodium: 138 (normal) 138. On 02-Sep-2021, Body temperature: 36.4 degrees celsius (normal) 36.4 degrees Celsius. On 02-Sep-2021, Computerised tomogram head: normal (normal) no definite acute intracranial mass or hemorrhage. On 02-Sep-2021, Haemoglobin: 12.1 (normal) 12.1. On 02-Sep-2021, Heart rate: 77/min (normal) 77/min. On 02-Sep-2021, Pain assessment: 10/10 headache (abnormal) 10/10 headache. On 02-Sep-2021, Physical examination: abnormal (abnormal) positive for headache and nausea and negative for abdominal pain, diarrhea and vomiting. The subject was positive for Reynaud's and had slight kyphosis and consolidated lung sound. On 02-Sep-2021, Respiratory rate: 18/min (normal) 18/min. On 02-Sep-2021, White blood cell count: 4.9 (normal) 4.9. On 03-Sep-2021, Blood pressure measurement: 129/60 mmhg (abnormal) 129/60 mmHg. On 03-Sep-2021, Body temperature: 36.6 degrees celsius (normal) 36.6 degrees Celsius. On 03-Sep-2021, Heart rate: 64 /min (normal) 64 /min. On 03-Sep-2021, Oxygen saturation: 96 percent (normal) 96 percent. On 03-Sep-2021, Physical examination: normocephalic, atraumatic and tachycardiac (abnormal) normocephalic, atraumatic and tachycardiac.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered HEADACHE (Severe intractable headache) to be possibly related. No further causality assessments were provided for NAUSEA (nausea), MYALGIA (myalgias), FATIGUE (fatigue) and PYREXIA (Low grade fever / temperature: 36.4 degrees Celsius,).    On 02-Sep-2021, the patient went to the emergency room (ER) and various evaluations were performed. On 03-Sep-2021, the patient was admitted for further observation and was treated. On the same day, the patient was discharged from the hospital with normal functional and mental status. The patient  was completely free from headache.  Company comment: This report concerns a 66 year old female subject with relevant medical history of pulmonary arterial hypertension, headaches and migraines who experienced a serious unexpected event of headache and was hospitalized. The event occurred one day after vaccination with the booster dose (third dose) of mRNA-1273. The headache was associated with nausea and the subject additionally experienced non-serious events of pyrexia, fatigue and myalgia. The diagnostic evaluation for the event headache was found to be normal.  The re-challenge was assessed as not applicable as the events happened after the third dose. Further, the event is reported to have recovered. The subject is reported to have experienced similar events after the second dose of the vaccine. The event headache was considered related to the product per the reporter's assessment. The medical history of migraines and headache remains a confounder. The events headache, nausea, myalgia, fatigue and pyrexia are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report. The report also states that the subject was concurrently on a blinded study medication for pulmonary arterial hypertension.   This case was linked to MOD-2021-328380.; Sender's Comments: This report concerns a 66 year old female subject with relevant medical history of pulmonary arterial hypertension, headaches and migraines who experienced a serious unexpected event of headache and was hospitalized. The event occurred one day after vaccination with the booster dose (third dose) of mRNA-1273. The headache was associated with nausea and the subject additionally experienced non-serious events of pyrexia, fatigue and myalgia. The diagnostic evaluation for the event headache was found to be normal.  The re-challenge was assessed as not applicable as the events happened after the third dose. Further, the event is reported to have recovered. The subject is reported to have experienced similar events after the second dose of the vaccine. The event headache was considered related to the product per the reporter's assessment. The medical history of migraines and headache remains a confounder. The events headache, nausea, myalgia, fatigue and pyrexia are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report. The report also states that the subject was concurrently on a blinded study medication for pulmonary arterial hypertension.