Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, COVID-19 immunisation, Headache, Inappropriate schedule of product administration
Clinical narrative: (aches and pains) in hand and Knee; (aches and pains) in back; pains/aches/ (aches and pains) specially where I have arthritis; first 2 shots of Pfizer, got the Moderna booster; pretty bad headache/headache was much stronger; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA ((aches and pains) in hand and Knee), BACK PAIN ((aches and pains) in back), MYALGIA (pains/aches/ (aches and pains) specially where I have arthritis), COVID-19 IMMUNISATION (first 2 shots of Pfizer, got the Moderna booster) and HEADACHE (pretty bad headache/headache was much stronger) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 vaccination: first two shots of Pfizer (First shot on 17Mar2021, given in left non-dominant arm. Lot number EP7534. Second shot on 07Apr2021 and given in left non-dominant arm. Lot number ER8735.) from 17-Mar-2021 to 07-Apr-2021. Past adverse reactions to the above products included No adverse event with first two shots of Pfizer. Concurrent medical conditions included Arthritis (back, knee and hand). Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication.    On 16-Nov-2021 at 3:45 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced ARTHRALGIA ((aches and pains) in hand and Knee), BACK PAIN ((aches and pains) in back), MYALGIA (pains/aches/ (aches and pains) specially where I have arthritis), COVID-19 IMMUNISATION (first 2 shots of Pfizer, got the Moderna booster), HEADACHE (pretty bad headache/headache was much stronger) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. On 16-Nov-2021, COVID-19 IMMUNISATION (first 2 shots of Pfizer, got the Moderna booster) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, ARTHRALGIA ((aches and pains) in hand and Knee), BACK PAIN ((aches and pains) in back), MYALGIA (pains/aches/ (aches and pains) specially where I have arthritis) and HEADACHE (pretty bad headache/headache was much stronger) was resolving.            Reporter stated that on 16-Nov-2021 before she went to bed, symptoms were just minor and around 5 AM next day, the headache was much stronger and experienced a pretty bad headache and aches and pains, specially where she had arthritis (back, knee and hand).  Company comment contains This is a case of Covid-19 immunization (Revaccination with different Covid 19 vaccine) concerning a 61-year-old, female patient, with medical history of arthritis, who experienced the non-serious, unexpected event of back pain and non-serious expected events of myalgia, arthralgia and headache. The events occurred  1 day after a dose of mRNA 1273 vaccine. The patient received primary series of Pfizer vaccine and had a Moderna booster. Patient felt headache, and aches and pains in the back, knee and hand. The rechallenge is not applicable as there is no additional dose expected. The patient's arthritis remains as confounder to events arthralgia, back pain and myalgia. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This is a case of Covid-19 immunization (Revaccination with different Covid 19 vaccine) concerning a 61-year-old, female patient, with medical history of arthritis, who experienced the non-serious, unexpected event of back pain and non-serious expected events of myalgia, arthralgia and headache. The events occurred  1 day after a dose of mRNA 1273 vaccine. The patient received primary series of Pfizer vaccine and had a Moderna booster. Patient felt headache, and aches and pains in the back, knee and hand. The rechallenge is not applicable as there is no additional dose expected. The patient's arthritis remains as confounder to events arthralgia, back pain and myalgia. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.