Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Anaphylactic reaction, Diarrhoea, Pruritus, Urticaria
Clinical narrative: I am allergic to Moderna COVID-19 Vaccine; itching; hives; diarrhea; Anaphylactic reaction; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. D38B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Interstitial lung disease (interstitial lung disease and pulmonary emphysema) in April 2018, Emphysema pulmonary (interstitial lung disease and pulmonary emphysema) in April 2018 and Obstructive sleep apnea syndrome on 22-Oct-2018. Previously administered products included for Product used for unknown indication: Premarin (hives and itching) on 02-Sep-2009, Premarin (hives and itching) on 02-Sep-2009 and ACTEMRA on 08-Oct-2018. Past adverse reactions to the above products included Anaphylaxis with ACTEMRA; Hives with Premarin; and Itching with Premarin. Concurrent medical conditions included Seasonal allergy (sneezing, itching, watery eyes, runny nose.) since 10-Aug-2009, Seropositive rheumatoid arthritis since 13-Dec-2016, Hypothyroidism since 25-Sep-2009, Type 2 diabetes mellitus on 24-Sep-2019, Joint stiffness, Pain and Inflammation. Concomitant products included LEVOTHYROXINE SODIUM (LEVOTHYROXIN) for Hypothyroidism, METHYLPREDNISOLONE (MEDROL [METHYLPREDNISOLONE]) for Inflammation, CHLORZOXAZONE for Joint stiffness, IBUPROFEN for Pain, TOFACITINIB CITRATE (XELJANZ XR) for Rheumatoid arthritis.    On 07-Apr-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion medically significant), PRURITUS (itching), URTICARIA (hives) and DIARRHOEA (diarrhea). On an unknown date, the patient experienced ALLERGY TO VACCINE (I am allergic to Moderna COVID-19 Vaccine). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) (oral) from 12-Apr-2021 to 20-Apr-2021 at a dose of UNK, qd. On 15-Apr-2021, ANAPHYLACTIC REACTION (Anaphylactic reaction) had resolved. At the time of the report, ALLERGY TO VACCINE (I am allergic to Moderna COVID-19 Vaccine), PRURITUS (itching), URTICARIA (hives) and DIARRHOEA (diarrhea) had resolved.        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.   Patient stated hives were visible on 09Apr2021 became severe on 11Apr2021.  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.   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: Follow-up received on 31-May-2021: Added medical history, concomitant medications and events. Upgraded the case as serious due to IME event anaphylaxis. Updated the outcome of the events as recovered.; 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.