Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Malaise, Pain in extremity, Pyrexia
Clinical narrative: Reddened ring well below injection site; felt warm to the touch; generally unwell; Painful; Felt like chills; felt feverish; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-May-2021 and was forwarded to Moderna on 07-May-2021.    This spontaneous case was reported by a nurse and describes the occurrence of RASH ERYTHEMATOUS (Reddened ring well below injection site), FEELING HOT (felt warm to the touch), MALAISE (generally unwell), PAIN IN EXTREMITY (Painful) and CHILLS (Felt like chills) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 10A21A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient had no history of anaphylaxis, hypersensitivity reactions (prior vaccines, medications, foods and environmental conditions), hives/urticaria, asthma and hay fever,.  Previously administered products included for an unreported indication: SHINGRIX (Moderna vaccine was less painful). Concurrent medical conditions included GERD and Hypothyroidism. Concomitant products included ALUMINIUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETICONE (PEPSID) for GERD, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced RASH ERYTHEMATOUS (Reddened ring well below injection site), FEELING HOT (felt warm to the touch), MALAISE (generally unwell), PAIN IN EXTREMITY (Painful), CHILLS (Felt like chills) and PYREXIA (felt feverish). On 18-Mar-2021, PYREXIA (felt feverish) had resolved. On 20-Mar-2021, RASH ERYTHEMATOUS (Reddened ring well below injection site), FEELING HOT (felt warm to the touch), MALAISE (generally unwell) and PAIN IN EXTREMITY (Painful) had resolved. At the time of the report, CHILLS (Felt like chills) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered RASH ERYTHEMATOUS (Reddened ring well below injection site), FEELING HOT (felt warm to the touch), MALAISE (generally unwell), PAIN IN EXTREMITY (Painful), CHILLS (Felt like chills) and PYREXIA (felt feverish) to be possibly related.    It was reported that within less than 24 hours of receiving vaccine the patient developed a reddened ring well below the injection site on right arm. The ring was about 3/4 of the way around her arm in bicep area. The patient stated that the reddened area was more painful than the injection site. It was reported that patient felt feverish but did not have fever. The patient went to seek urgent medical care at doctor's office however no laboratory tests or vital signs measurements were taken. No treatment was received for the adverse events. It was reported that there were no other potential causes for the reactions.   This case was linked to MOD-2021-114894 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: ADR form added