Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Body temperature, Loss of personal independence in daily activities, Pyrexia, Tremor
Clinical narrative: 8 hours after her second dose, she started with a terrible reaction; felt shaken; in the bed for a week/he couldn't get up to get anything to drink; she has not been able to taste since she got her second shot and had whatever that was.; temp 104 for 3 days; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (8 hours after her second dose, she started with a terrible reaction), TREMOR (felt shaken), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (in the bed for a week/he couldn't get up to get anything to drink), AGEUSIA (she has not been able to taste since she got her second shot and had whatever that was.) and PYREXIA (temp 104 for 3 days) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History Information was reported.  Concomitant products included CALCIUM, VITAMIN D NOS, ASPIRIN [ACETYLSALICYLIC ACID], ATORVASTATIN CALCIUM (LIPITOR), CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]), ESCITALOPRAM OXALATE (LEXAPRO), FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), LORATADINE (CLARITIN [LORATADINE]), MONTELUKAST SODIUM (SINGULAIR), OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) and DENOSUMAB (PROLIA) for an unknown indication.    On 27-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (8 hours after her second dose, she started with a terrible reaction), TREMOR (felt shaken), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (in the bed for a week/he couldn't get up to get anything to drink), AGEUSIA (she has not been able to taste since she got her second shot and had whatever that was.) and PYREXIA (temp 104 for 3 days). At the time of the report, VACCINATION COMPLICATION (8 hours after her second dose, she started with a terrible reaction), TREMOR (felt shaken), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (in the bed for a week/he couldn't get up to get anything to drink), AGEUSIA (she has not been able to taste since she got her second shot and had whatever that was.) and PYREXIA (temp 104 for 3 days) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104 degree (High) 104 degree for 3 days.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Symptoms: It was reported that the patient stated that her primary thought that she had COVID-19 before she got the second dose of vaccine, patient wanted to know if those were the reaction to COVID, after second dose of vaccine she had terrible reaction, and was not able to taste since vaccination.  No treatment medications were reported.   This case was linked to MOD-2021-341235 (Patient Link).; Sender's Comments: This case concerns a 67 year old female, with no relevant medical history reported, who experienced the unexpected event  of vaccination  reaction which occurred 8 hours post vaccination with the 2nd dose of  mRNA-1273 (Moderna) . Other unexpected events of  tremors, loss of personal independence in daily activities  and Ageusia occurred on an unknown time onset after the 2nd dose. Expected event of fever was experienced which occurred 8 hours post vaccination with the 2nd dose. The rechallenge is not applicable. The benefit-risk relationship of mRNA-1273 is not affected by this report.