Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Weight increased
Clinical narrative: weight gain /gained 20lbs; A month later I was diagnosed with hypothyroidism; Two months later I developed severe polyarthritis/6 weeks post his second shot he got this sudden polyarthritis in hands, wrists, and ankles.; flu symptoms; he had achiness and chills after both shots; chills for 24 hours after each injection/achiness and chills after both shots.; This spontaneous case was reported by a consumer and describes the occurrence of POLYARTHRITIS (Two months later I developed severe polyarthritis/6 weeks post his second shot he got this sudden polyarthritis in hands, wrists, and ankles.), HYPOTHYROIDISM (A month later I was diagnosed with hypothyroidism), WEIGHT INCREASED (weight gain /gained 20lbs), INFLUENZA LIKE ILLNESS (flu symptoms) and PAIN (he had achiness and chills after both shots) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 37K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (one year ago) in 2020. Concomitant products included LOSARTAN, BISOPROLOL FUMARATE, SILODOSIN (RAPAFLO), ROSUVASTATIN, LEVOTHYROXINE and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu symptoms), PAIN (he had achiness and chills after both shots) and CHILLS (chills for 24 hours after each injection/achiness and chills after both shots.). In April 2021, the patient experienced POLYARTHRITIS (Two months later I developed severe polyarthritis/6 weeks post his second shot he got this sudden polyarthritis in hands, wrists, and ankles.). In May 2021, the patient experienced HYPOTHYROIDISM (A month later I was diagnosed with hypothyroidism). On an unknown date, the patient experienced WEIGHT INCREASED (weight gain /gained 20lbs). The patient was treated with DICLOFENAC for Pain ankle, at a dose of 75 mg twice a day. At the time of the report, POLYARTHRITIS (Two months later I developed severe polyarthritis/6 weeks post his second shot he got this sudden polyarthritis in hands, wrists, and ankles.), HYPOTHYROIDISM (A month later I was diagnosed with hypothyroidism), WEIGHT INCREASED (weight gain /gained 20lbs), INFLUENZA LIKE ILLNESS (flu symptoms), PAIN (he had achiness and chills after both shots) and CHILLS (chills for 24 hours after each injection/achiness and chills after both shots.) outcome was unknown.            Company comment:  This spontaneous case concerns a 73-year-old male patient, with no relevant medical history reported, who experienced the non-serious unexpected AESI of polyarthritis. The event occurred approximately 6 weeks after receiving a second dose of mRNA-1273. The rechallenge is not applicable since no information about further dosing is provided. Patient has taken diclofenac for pain associated with event. No other clinical information has been provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-405267 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Dec-2021: follow up received on 7 December 2021 with Reporter details updated, Patient initials updated, Product details updated, concomitant drugs added, New event added, event Onset date updated; Sender's Comments: This spontaneous case concerns a 73-year-old male patient, with no relevant medical history reported, who experienced the non-serious unexpected AESI of polyarthritis. The event occurred approximately 6 weeks after receiving a second dose of mRNA-1273. The rechallenge is not applicable since no information about further dosing is provided. Patient has taken diclofenac for pain associated with event. No other clinical information has been provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.