Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Tongue discomfort
Clinical narrative: pain in chest from sneezing; headache; severe running of eyes; sneezing; left side of tongue burned intensely more then normal, then returned to normal burning sensation; "I feel stuffy" congestion; Sore Arm; joint pain in legs and arms/sore arm; Body ached; low grade fever; skin was very hot and felt "hot as fire"; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (skin was very hot and felt "hot as fire"), LACRIMATION INCREASED (severe running of eyes), SNEEZING (sneezing), TONGUE DISCOMFORT (left side of tongue burned intensely more then normal, then returned to normal burning sensation) and NASAL CONGESTION ("I feel stuffy" congestion) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Oral carcinoma (had oral cancer 5 years ago and has damage to left tongue that normally burns). Concurrent medical conditions included Allergy and Diabetic neuropathy. Concomitant products included LABETALOL for an unknown indication.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced FEELING HOT (skin was very hot and felt "hot as fire"), TONGUE DISCOMFORT (left side of tongue burned intensely more then normal, then returned to normal burning sensation), NASAL CONGESTION ("I feel stuffy" congestion), PAIN IN EXTREMITY (Sore Arm), ARTHRALGIA (joint pain in legs and arms/sore arm), MYALGIA (Body ached) and PYREXIA (low grade fever). On 30-Mar-2021, the patient experienced LACRIMATION INCREASED (severe running of eyes), SNEEZING (sneezing) and HEADACHE (headache). On 31-Mar-2021, the patient experienced CHEST PAIN (pain in chest from sneezing). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 30-Mar-2021, FEELING HOT (skin was very hot and felt "hot as fire"), LACRIMATION INCREASED (severe running of eyes), SNEEZING (sneezing), TONGUE DISCOMFORT (left side of tongue burned intensely more then normal, then returned to normal burning sensation), PAIN IN EXTREMITY (Sore Arm), HEADACHE (headache), ARTHRALGIA (joint pain in legs and arms/sore arm), MYALGIA (Body ached) and PYREXIA (low grade fever) had resolved. At the time of the report, NASAL CONGESTION ("I feel stuffy" congestion) and CHEST PAIN (pain in chest from sneezing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Additional information received on 13-May-2021 contain no new information. On 12-Jul-2021: Followup contains no new information. On 01-Aug-2021: Additional information received on 01-Aug-2021 contain no new information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.