Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Chills, Contusion, Diarrhoea, Heart rate
Clinical narrative: throat pain; hives still keeps coming back; could feel heart pounding  for 24  hours; diarrhea; pain on swallowing food and on drinking water; chills,; upon standing, soles of her feet were hurting which lasted 24 hours; had bruises on her palms of her hands.; developed  angioedema  on her upper lip, forehead, right eyelid and on her left arm; whole body itched; fever; This spontaneous case was reported by a consumer and describes the occurrence of ANGIOEDEMA (developed  angioedema  on her upper lip, forehead, right eyelid and on her left arm) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced PYREXIA (fever). On 15-Mar-2021, the patient experienced ANGIOEDEMA (developed  angioedema  on her upper lip, forehead, right eyelid and on her left arm) (seriousness criterion medically significant) and PRURITUS (whole body itched). On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (upon standing, soles of her feet were hurting which lasted 24 hours) and CONTUSION (had bruises on her palms of her hands.). On 17-Mar-2021, the patient experienced DIARRHOEA (diarrhea), ODYNOPHAGIA (pain on swallowing food and on drinking water) and CHILLS (chills,). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (throat pain), URTICARIA (hives still keeps coming back) and PALPITATIONS (could feel heart pounding  for 24  hours). The patient was treated with PREDNISONE at a dose of 1 dosage form; CETIRIZINE HYDROCHLORIDE (ZYRTEC HIVES RELIEF) at a dose of 1 dosage form and FAMOTIDINE at a dose of 1 dosage form. At the time of the report, ANGIOEDEMA (developed  angioedema  on her upper lip, forehead, right eyelid and on her left arm) and OROPHARYNGEAL PAIN (throat pain) had resolved and DIARRHOEA (diarrhea), PRURITUS (whole body itched), ODYNOPHAGIA (pain on swallowing food and on drinking water), URTICARIA (hives still keeps coming back), PALPITATIONS (could feel heart pounding  for 24  hours), PAIN IN EXTREMITY (upon standing, soles of her feet were hurting which lasted 24 hours), CONTUSION (had bruises on her palms of her hands.), CHILLS (chills,) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: increased (High) Heart Rate was 130 to 135. On an unknown date, White blood cell count: high (High) Increased.         Patient was not on any concomitant medications.  Patient's whole body itched, and she developed angioedema on her upper lip, forehead, right eyelid and on her left arm. Patient stated that she went to see allergy specialist and got lab test done which came normal. Patient said, her doctor. Patient mentioned that her angioedema and pain in her throat went away after 3 to 4 days of starting prednisone, but her hives still keeps coming back. Patient stated that on her recent visit to a Immuno- Allergy specialist, her doctor said, "this was a possible an allergic reaction to the vaccine." Patient's Lab result had high WBC count, but doctor said that it is because of steroid that she was on. As per patient, she was still taking a half tablet of Zyrtec to get relief from the reoccurring hives and doctor do not have any answer for her condition.  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.   This case was linked to MOD-2021-270283 (Patient Link).; 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.