Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site pain, Vaccination site swelling
Clinical narrative: Malaise; Had a runny nose; Could hardly move /Could hardly move her body; Arm hurt tremendously, hit her like a brick; Arm  was swollen; Arm was hard; Fatigue; Body aches from feet to neck/muscles hurt so bad; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Malaise), RHINORRHOEA (Had a runny nose), MOBILITY DECREASED (Could hardly move /Could hardly move her body), VACCINATION SITE PAIN (Arm hurt tremendously, hit her like a brick) and VACCINATION SITE SWELLING (Arm  was swollen) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Previously administered products included for Product used for unknown indication: FLU in September 2021.Past adverse reactions to the above products included No adverse event with FLU. In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose.In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced MALAISE (Malaise), RHINORRHOEA (Had a runny nose), MOBILITY DECREASED (Could hardly move /Could hardly move her body), VACCINATION SITE PAIN (Arm hurt tremendously, hit her like a brick), VACCINATION SITE SWELLING (Arm  was swollen), VACCINATION SITE INDURATION (Arm was hard), FATIGUE (Fatigue) and MYALGIA (Body aches from feet to neck/muscles hurt so bad). In November 2021, VACCINATION SITE PAIN (Arm hurt tremendously, hit her like a brick), VACCINATION SITE SWELLING (Arm  was swollen) and VACCINATION SITE INDURATION (Arm was hard) had resolved. At the time of the report, MALAISE (Malaise), RHINORRHOEA (Had a runny nose), MOBILITY DECREASED (Could hardly move /Could hardly move her body), FATIGUE (Fatigue) and MYALGIA (Body aches from feet to neck/muscles hurt so bad) outcome was unknown. Concomitant information was not provided. It was reported that the patient experienced body aches all from feet to neck and could hardly move for 3 days. Rheumatologist thought may be it could be arthritis. She were also not able to get out of bed for days. Patient completed the primary series of Moderna COVID-19 vaccine in April 2021 and she had no issue with that. Patient stated that he had never gotten the flu, never gotten a cold, never really been sick.Treatment information was not provided. Company Comment: This is a Spontaneous case concerning a 74-year-old, female patient with unknown medical history,  who experienced the non serious events of mobility decreased, fatigue, myalgia, malaise, rhinorrhea and vaccination site pain, swelling and induration. The events occurred after the third dose of mRNA 1273 vaccine. Patient received previous primary schedule with no adverse event related.   The rechallenge is not applicable. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 01-Dec-2021: Follow up received includes no new information.; Sender's Comments: This is a Spontaneous case concerning a 74-year-old, female patient with unknown medical history,  who experienced the non serious events of mobility decreased, fatigue, myalgia, malaise, rhinorrhea and vaccination site pain, swelling and induration. The events occurred after the third dose of mRNA 1273 vaccine. Patient received previous primary schedule with no adverse event related.   The rechallenge is not applicable. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.