Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Malaise, Nausea
Clinical narrative: I had a significant side effects/serious side effects; Felt very ill/I was in bed for a day and a half; "I had terrible chills"; "All my joints hurt"; Felt nauseous; Have headaches that came and go; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I had a significant side effects/serious side effects), MALAISE (Felt very ill/I was in bed for a day and a half), CHILLS ("I had terrible chills"), ARTHRALGIA ("All my joints hurt") and NAUSEA (Felt nauseous) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F21A, 013L20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included DULOXETINE HYDROCHLORIDE (DULOXETINE HCL) for Anxiety, MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, the patient experienced MALAISE (Felt very ill/I was in bed for a day and a half), CHILLS ("I had terrible chills"), ARTHRALGIA ("All my joints hurt"), NAUSEA (Felt nauseous) and HEADACHE (Have headaches that came and go). On an unknown date, the patient experienced VACCINATION COMPLICATION (I had a significant side effects/serious side effects). On 10-Nov-2021, MALAISE (Felt very ill/I was in bed for a day and a half) had resolved. On 11-Nov-2021, CHILLS ("I had terrible chills"), ARTHRALGIA ("All my joints hurt") and NAUSEA (Felt nauseous) had resolved. At the time of the report, VACCINATION COMPLICATION (I had a significant side effects/serious side effects) and HEADACHE (Have headaches that came and go) was resolving.            Treatment information were not provided by reporter. Patient reported that she had moderate to severe illness. Patient had Joint pain which was terrible to the point she though she was developing rheumatoid arthritis.  Company comment: This case concerns a 79-year-old, female patient, with no disclosed medical history, who experienced the non-serious, unexpected events of malaise and vaccination complication  and non-serious expected events of chills, arthralgia, nausea, and headache. The events occurred  on the same day after the booster dose of mRNA 1273 vaccine. The patient felt very ill, was in bed a day and a half, had nausea, headache and severe joint pains, patient did not mention any treatment medication she took. and says she is feeling better. The rechallenge is not applicable as there is no additional dose expected. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2021: Follow up received contains Reporter details, Patient details, Dosage information and New events.; Sender's Comments: This case concerns a 79-year-old, female patient, with no disclosed medical history, who experienced the non-serious, unexpected events of malaise and vaccination complication  and non-serious expected events of chills, arthralgia, nausea, and headache. The events occurred  on the same day after the booster dose of mRNA 1273 vaccine. The patient felt very ill, was in bed a day and a half, had nausea, headache and severe joint pains, patient did not mention any treatment medication she took. and says she is feeling better. The rechallenge is not applicable as there is no additional dose expected. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.