Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral coldness, Tremor
Clinical narrative: Pins/needles in upper armslders; Trembling; Freezing feet; Sore back; Sore ribs; Bloated stomach; Sore shoulders; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Pins/needles in upper armslders), TREMOR (Trembling), PERIPHERAL COLDNESS (Freezing feet), BACK PAIN (Sore back), MUSCULOSKELETAL CHEST PAIN (Sore ribs), ABDOMINAL DISTENSION (Bloated stomach) and ARTHRALGIA (Sore shoulders) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Neck injury NOS (Vehicle accident broke neck), Rib fracture (Vehicle accident broke left rib), Fracture of spine (Vehicle accident broke spine in 3 places) and Hysterectomy (had hysterectomy). Concurrent medical conditions included Uterine cancer, Angioedema, Allergy (Allergic to bees) and Allergy to NSAIDs (Naproxen).    On 30-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Other) 1 dosage form. On 30-Nov-2021, the patient experienced PARAESTHESIA (Pins/needles in upper armslders) (seriousness criterion medically significant), TREMOR (Trembling) (seriousness criterion medically significant), PERIPHERAL COLDNESS (Freezing feet) (seriousness criterion medically significant), BACK PAIN (Sore back) (seriousness criterion medically significant), MUSCULOSKELETAL CHEST PAIN (Sore ribs) (seriousness criterion medically significant), ABDOMINAL DISTENSION (Bloated stomach) (seriousness criterion medically significant) and ARTHRALGIA (Sore shoulders) (seriousness criterion medically significant). At the time of the report, PARAESTHESIA (Pins/needles in upper armslders), TREMOR (Trembling), PERIPHERAL COLDNESS (Freezing feet), BACK PAIN (Sore back), MUSCULOSKELETAL CHEST PAIN (Sore ribs), ABDOMINAL DISTENSION (Bloated stomach) and ARTHRALGIA (Sore shoulders) had not resolved.            No concomitant medications were reported. The patient had not undergone any treatment yet but reported that she would call doctor the next day. The patient was not known whether an additional dose will be administered. The medical history reported included that the vehicle accident broke neck, left rib, spine in 3 places and lacerated spleen.  Company comment: This spontaneous case concerns a 71-year-old female patient with a relevant medical history of Rib fracture and Fracture of spine, who experienced the unexpected serious (medically significant) events of Paraesthesia, Tremor, Peripheral coldness, Back pain, Rib pain, Abdominal distension and Arthralgia after mRNA- 1273 vaccine. The onset of the events occurred on the day after the third dose of mRNA- 1273 vaccine. Very limited information is available regarding clinical course of the events, which were assessed as serious by the reporter. Arthralgia is consistent with the known safety profile of the vaccine, but since it was reported with a seriousness criteria it is considered unexpected. Previous history of Fracture of spine and Rib fracture could have contributed to Back pain and Rib pain. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 71-year-old female patient with a relevant medical history of Rib fracture and Fracture of spine, who experienced the unexpected serious (medically significant) events of Paraesthesia, Tremor, Peripheral coldness, Back pain, Rib pain, Abdominal distension and Arthralgia after mRNA- 1273 vaccine. The onset of the events occurred on the day after the third dose of mRNA- 1273 vaccine. Very limited information is available regarding clinical course of the events, which were assessed as serious by the reporter. Arthralgia is consistent with the known safety profile of the vaccine, but since it was reported with a seriousness criteria it is considered unexpected. Previous history of Fracture of spine and Rib fracture could have contributed to Back pain and Rib pain. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.