Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Somnolence, Vaccination site pain
Clinical narrative: persistent arthralgia/joint pain; severe myalgia/muscle pain; nausea; headache; severe sweating; chill; Fatigue extreme/tiredness; fever; severe flu like symptoms; didn't feel well; migraine; fell asleep; no appetitie and could not eat; vaccination site pain; This spontaneous case was reported by a physician and describes the occurrence of HYPERHIDROSIS (severe sweating), VACCINATION SITE PAIN (vaccination site pain), INFLUENZA LIKE ILLNESS (severe flu like symptoms), MALAISE (didn't feel well) and MIGRAINE (migraine) in a 73-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.     No medical history was provided.  Previously administered products included for an unreported indication: VARICELLA VACC. (90716) on 01-Jan-2000, TD ((7 years and up) 90718) on 01-Jan-2005, HEPATITIS B VACCINE on 06-Oct-2011, HEPATITIS A VACCINE on 06-Oct-2011, TDAP ((7 years and up) 90715) on 20-Oct-2011, INFLUENZA (Influenza quadrivalent preservative free (90686)) on 21-Oct-2011, HEPATITIS A VACCINE on 10-Nov-2011, HEPATITIS B VACCINE on 10-Nov-2011, PNEUMOCOCCAL VACCINES ((2 years and up) 90732) on 16-Nov-2011, MMR on 30-Nov-2011, HEPATITIS A VACCINE on 19-Apr-2012, HEPATITIS B VACCINE on 19-Apr-2012, INFLUENZA (Influenza quadrivalent preservative free (90656)) on 03-Nov-2012, INFLUENZA (Influenza quadrivalent preservative free (90656)) on 10-Oct-2013, IPV on 04-Jun-2014, PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) ((2 years and up) 90732) on 01-Oct-2014, ZOSTER (Shingles (90736)) on 28-Oct-2014, INFLUENZA (Influenza quadrivalent preservative free (90686)) on 28-Oct-2014, INFLUENZA (Influenza quadrivalent preservative free (90656)) on 16-Sep-2015, INFLUENZA (Influenza quadrivalent preservative free (90656)) in September 2016, INFLUENZA (Influenza quadrivalent preservative free (90686)) on 15-Sep-2016 and INFLUENZA (Influenza quadrivalent preservative free (90686)) on 01-Jan-2019. Concurrent medical conditions included Drug allergy (Acyclovir), Allergy (Blue dye), Drug allergy, Drug allergy (pristiq), Drug allergy (Tegretol) and Drug allergy (prolensa). Concomitant products included MACROGOL 3350 (MIRALAX) for Dysuria, GABAPENTIN for Herpes esophagitis, ESTRADIOL from 28-Apr-2021 to an unknown date for Hormone replacement therapy, GABAPENTIN (NEURONTIN) for Post herpetic neuralgia, CLONAZEPAM from 17-Mar-2021 to an unknown date, DICLOFENAC SODIUM, EPINEPHRINE (EPIPEN 2-PAK), FAMCICLOVIR, CLARITHROMYCIN (MACROBID [CLARITHROMYCIN]), ONDANSETRON, SUMATRIPTAN from 28-Apr-2021 to an unknown date, SUMATRIPTAN SUCCINATE, VALACICLOVIR HYDROCHLORIDE (VALTREX) from 16-Nov-2020 to an unknown date, CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) from 28-Apr-2021 to an unknown date, VITAMIN D3, VORICONAZOLE from 23-Nov-2020 to an unknown date, CETIRIZINE HYDROCHLORIDE (ZYTREC) and ESTRADIOL from 28-Apr-2021 to an unknown date for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced HYPERHIDROSIS (severe sweating), INFLUENZA LIKE ILLNESS (severe flu like symptoms), MALAISE (didn't feel well), MIGRAINE (migraine), SOMNOLENCE (fell asleep), DECREASED APPETITE (no appetitie and could not eat), CHILLS (chill), FATIGUE (Fatigue extreme/tiredness), PYREXIA (fever), NAUSEA (nausea) and HEADACHE (headache). In March 2021, the patient experienced VACCINATION SITE PAIN (vaccination site pain). On 01-Apr-2021, the patient experienced ARTHRALGIA (persistent arthralgia/joint pain) and MYALGIA (severe myalgia/muscle pain). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (severe sweating), VACCINATION SITE PAIN (vaccination site pain), INFLUENZA LIKE ILLNESS (severe flu like symptoms), MALAISE (didn't feel well), MIGRAINE (migraine), SOMNOLENCE (fell asleep), DECREASED APPETITE (no appetitie and could not eat), ARTHRALGIA (persistent arthralgia/joint pain), CHILLS (chill), MYALGIA (severe myalgia/muscle pain) and HEADACHE (headache) outcome was unknown and FATIGUE (Fatigue extreme/tiredness), PYREXIA (fever) and NAUSEA (nausea) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient was treated with opioids, ibuprofen, and Tylenol.   This case was linked to MOD-2021-081675 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Significant follow up appended. Added additional information for 2nd dose and events after 2nd dose; Sender's Comments:  MOD-2021-081675:1st dose of vaccine