Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Cervical spinal stenosis, Chest pain, Fibromyalgia
Clinical narrative: cervical spinal stenosis; Fibromyalgia/muscular pain/feel extremely muscular, ribs , chest aches.; had terrible chest pains, doesn't feel like it's their heart, feel extremely muscular, ribs , chest ache; This spontaneous case was reported by a consumer and describes the occurrence of CERVICAL SPINAL STENOSIS (cervical spinal stenosis) in a 54-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS716881) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient was very healthy, ate organic, did not have on any heart or blood pressure medications.  The patient's past medical history included Anemia, Vaccination adverse reaction and COVID-19. Previously administered products included for Product used for unknown indication: IRON, VACCINE, HERPES SIMPLEX 1, AZITHROMYCIN, ZINC and PREDNISONE. Past adverse reactions to the above products included No adverse event with AZITHROMYCIN, IRON, PREDNISONE, VACCINE, HERPES SIMPLEX 1 and ZINC. Concomitant products included IBUPROFEN (ADVIL [IBUPROFEN]), HYDROCODONE and INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    On 08-Jan-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 08-Jan-2023, the patient experienced CHEST PAIN (had terrible chest pains, doesn't feel like it's their heart, feel extremely muscular, ribs , chest ache). On an unknown date, the patient experienced CERVICAL SPINAL STENOSIS (cervical spinal stenosis) (seriousness criterion medically significant) and FIBROMYALGIA (Fibromyalgia/muscular pain/feel extremely muscular, ribs , chest aches.). At the time of the report, CERVICAL SPINAL STENOSIS (cervical spinal stenosis), FIBROMYALGIA (Fibromyalgia/muscular pain/feel extremely muscular, ribs , chest aches.) and CHEST PAIN (had terrible chest pains, doesn't feel like it's their heart, feel extremely muscular, ribs , chest ache) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No treatment medication were reported.  Company comment-This spontaneous case concerns a female patient aged 54 years with no relevant medical history reported, who experienced the unexpected, serious (medically significant) event of Cervical spinal stenosis, unexpected, non-serious AESI event of Fibromyalgia which occurred on unknown dates in the context of fifth dose of mRNA-1273.222 vaccination. Patient also experienced non serious event of Chest pain. Patient had received initial four doses with mRNA-1273. It was reported that after 5th dose, she had severe chest pains, muscular pain, treated with Advil. She is on hydrocodone with Advil for cervical spinal stenosis and fibromyalgia. No further information on clinical course, investigations, other treatment details were available in the report. Outcome of the events was not resolved at the time of report. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.   This case was linked to MOD-2023-696164 (Patient Link).