Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Feeling cold, Headache, Hypersomnia
Clinical narrative: Slept a lot; sick; within an hour, was cold; within an hour, had chills; headache for 6 days; anaphylactic symptoms; pain at the injection site; swelling of the lymph nodes under the right arm; redness; fatigue; muscle pain; joint pain; nausea; puked for 3 days; fever of 102 degrees F; very swollen mouth/swollen mouth got worse/today is first day she can eat; roof of her mouth was swollen from throat to back of teeth couldn't feel teeth; armpit was swollen on the same side of the vaccine; mouth sores/As swelling went down, very sensitive; 10 minutes after receiving the vaccine, very dizzy; Gagged within 30 seconds; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (anaphylactic symptoms) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  The patient's past medical history included COVID-19 (Had COVID for 10 days in August) in August 2021.    On 08-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Nov-2021, the patient experienced ANAPHYLACTIC REACTION (anaphylactic symptoms) (seriousness criterion medically significant), VACCINATION SITE PAIN (pain at the injection site), VACCINATION SITE LYMPHADENOPATHY (swelling of the lymph nodes under the right arm), ERYTHEMA (redness), FATIGUE (fatigue), MYALGIA (muscle pain), ARTHRALGIA (joint pain), NAUSEA (nausea), VOMITING (puked for 3 days), PYREXIA (fever of 102 degrees F), MOUTH SWELLING (very swollen mouth/swollen mouth got worse/today is first day she can eat), DENTAL DISCOMFORT (roof of her mouth was swollen from throat to back of teeth couldn't feel teeth), VACCINATION SITE SWELLING (armpit was swollen on the same side of the vaccine), STOMATITIS (mouth sores/As swelling went down, very sensitive), DIZZINESS (10 minutes after receiving the vaccine, very dizzy), RETCHING (Gagged within 30 seconds), FEELING COLD (within an hour, was cold), CHILLS (within an hour, had chills) and HEADACHE (headache for 6 days). On an unknown date, the patient experienced HYPERSOMNIA (Slept a lot) and ILLNESS (sick). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. On 14-Nov-2021, ILLNESS (sick), FEELING COLD (within an hour, was cold), CHILLS (within an hour, had chills) and HEADACHE (headache for 6 days) had resolved. At the time of the report, ANAPHYLACTIC REACTION (anaphylactic symptoms), VACCINATION SITE PAIN (pain at the injection site), VACCINATION SITE LYMPHADENOPATHY (swelling of the lymph nodes under the right arm), ERYTHEMA (redness), FATIGUE (fatigue), MYALGIA (muscle pain), ARTHRALGIA (joint pain), NAUSEA (nausea), VOMITING (puked for 3 days), PYREXIA (fever of 102 degrees F), MOUTH SWELLING (very swollen mouth/swollen mouth got worse/today is first day she can eat), DENTAL DISCOMFORT (roof of her mouth was swollen from throat to back of teeth couldn't feel teeth), VACCINATION SITE SWELLING (armpit was swollen on the same side of the vaccine), STOMATITIS (mouth sores/As swelling went down, very sensitive), DIZZINESS (10 minutes after receiving the vaccine, very dizzy), RETCHING (Gagged within 30 seconds) and HYPERSOMNIA (Slept a lot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Nov-2021, Pyrexia: high degree (plane angle) (High) 102 degrees F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were not reported.  Company Comment 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.; 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.