Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Throat irritation, Throat tightness
Clinical narrative: Eyes are teary; Can't tolerate light; Pain in her eyes; Her throat is irritated; Can't move much; Started to feel her feet very cold; Very very weak; Feels her throat closes; Her breathing gets a little heavy; Pain in all her body / When she goes to sleep is like laying on a bed of nails; Very dizzy/a lot of dizziness; Stomach ache that expanded, it was very strange/very bad stomach ache on 05 Oct/pain in her stomach; Diarrhea; Arthritis in one shoulder and this made it worse; Bad nausea/a lot of nausea; A lot of joint pain/pain in her joints on 04 Oct 2021; headache/pain in her head; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (Her throat is irritated), HYPOKINESIA (Can't move much), PERIPHERAL COLDNESS (Started to feel her feet very cold), ASTHENIA (Very very weak) and THROAT TIGHTNESS (Feels her throat closes) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 06-Aug-2021. Concurrent medical conditions included Arthritis.    On 01-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Oct-2021, the patient experienced ARTHRALGIA (A lot of joint pain/pain in her joints on 04 Oct 2021) and HEADACHE (headache/pain in her head). On 04-Oct-2021, the patient experienced PERIPHERAL COLDNESS (Started to feel her feet very cold), ASTHENIA (Very very weak), THROAT TIGHTNESS (Feels her throat closes), DYSPNOEA (Her breathing gets a little heavy), DIZZINESS (Very dizzy/a lot of dizziness), ABDOMINAL PAIN UPPER (Stomach ache that expanded, it was very strange/very bad stomach ache on 05 Oct/pain in her stomach), DIARRHOEA (Diarrhea), CONDITION AGGRAVATED (Arthritis in one shoulder and this made it worse), NAUSEA (Bad nausea/a lot of nausea) and MYALGIA (Pain in all her body / When she goes to sleep is like laying on a bed of nails). On 05-Oct-2021, the patient experienced THROAT IRRITATION (Her throat is irritated) and HYPOKINESIA (Can't move much). On an unknown date, the patient experienced LACRIMATION INCREASED (Eyes are teary), PHOTOPHOBIA (Can't tolerate light) and EYE PAIN (Pain in her eyes). At the time of the report, THROAT IRRITATION (Her throat is irritated), HYPOKINESIA (Can't move much), PERIPHERAL COLDNESS (Started to feel her feet very cold), ASTHENIA (Very very weak), THROAT TIGHTNESS (Feels her throat closes), DYSPNOEA (Her breathing gets a little heavy), LACRIMATION INCREASED (Eyes are teary), PHOTOPHOBIA (Can't tolerate light), EYE PAIN (Pain in her eyes), DIZZINESS (Very dizzy/a lot of dizziness), ABDOMINAL PAIN UPPER (Stomach ache that expanded, it was very strange/very bad stomach ache on 05 Oct/pain in her stomach), DIARRHOEA (Diarrhea), CONDITION AGGRAVATED (Arthritis in one shoulder and this made it worse), NAUSEA (Bad nausea/a lot of nausea), ARTHRALGIA (A lot of joint pain/pain in her joints on 04 Oct 2021), HEADACHE (headache/pain in her head) and MYALGIA (Pain in all her body / When she goes to sleep is like laying on a bed of nails) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.  Company comment: This case concerns a 51-year-old female patient with no relevant medical history, who experienced the expected event of Arthralgia. The event occurred one day after receiving the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the first dose was disclosed. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 07-Oct-2021: Follow-up received on 08 Oct 2021 contains no new information.; Sender's Comments: This case concerns a 51-year-old female patient with no relevant medical history, who experienced the expected event of Arthralgia. The event occurred one day after receiving the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the first dose was disclosed. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.