Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Blood pressure measurement, Dizziness, Dysphonia, Dyspnoea
Clinical narrative: Anaphylactic reaction; Head itch; Light headed / I got dizzy; could not swallow / Difficulty swallowing / Sensation of throat closing; mouth, chin, neck, numb / Numbness; voice hoarse / Hoarseness; Swelling of upper airway (lips, tongue, throat, uvula, or larynx); Redness/erythema; Difficulty breathing; Flushing; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy, Diabetes since 2005, Heart disorder since 17-Dec-2017, Asthma, Seafood allergy (Anaphylaxis) since 2000, Food allergy (Anaphylaxis), Allergy to antibiotic (Anaphylaxis) since 2012, Drug allergy (Anaphylaxis) since 1990 and Cholesterol. Concomitant products included ATORVASTATIN from 20-Dec-2017 to an unknown date for Cholesterol, DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FARXIGA) from 01-Jan-2020 to 01-Apr-2021 and GLIMEPIRIDE from 20-Dec-2017 to an unknown date for Diabetes, TICAGRELOR (BRILINTA) from 20-Dec-2017 to an unknown date and AMLODIPINE from 20-Dec-2017 to an unknown date for Heart disorder.    On 05-Mar-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PRURITUS (Head itch), DIZZINESS (Light headed / I got dizzy), ODYNOPHAGIA (could not swallow / Difficulty swallowing / Sensation of throat closing) and DYSPHONIA (voice hoarse / Hoarseness). 05-Mar-2021, the patient experienced HYPOAESTHESIA (mouth, chin, neck, numb / Numbness), SWELLING (Swelling of upper airway (lips, tongue, throat, uvula, or larynx)), ERYTHEMA (Redness/erythema), DYSPNOEA (Difficulty breathing) and FLUSHING (Flushing). On 05-Mar-2021 at 1:10 PM, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion medically significant). The patient was treated with PREDNISONE (intravenous) 05-Mar-2021 for Adverse event, at a dose of 1 dosage form; EPINEPHRINE (EPIPEN) 05-Mar-2021 for Adverse event, at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (intravenous) 05-Mar-2021 for Adverse event, at a dose of 1 dosage form. On 05-Mar-2021, PRURITUS (Head itch), DIZZINESS (Light headed / I got dizzy), ODYNOPHAGIA (could not swallow / Difficulty swallowing / Sensation of throat closing), HYPOAESTHESIA (mouth, chin, neck, numb / Numbness), DYSPHONIA (voice hoarse / Hoarseness), SWELLING (Swelling of upper airway (lips, tongue, throat, uvula, or larynx)), ERYTHEMA (Redness/erythema), DYSPNOEA (Difficulty breathing) and FLUSHING (Flushing) had resolved. On 05-Mar-2021 at 5:00 PM, ANAPHYLACTIC REACTION (Anaphylactic reaction) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Blood pressure measurement: blood pressure increased (High, kept going up).     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.   The reporter stated that the EMT was called. The doctor at the facility started a IV with Benadryl and steroid. She was then given epi-pen and was taken to the ER by ambulance (arrived around 2:45pm). After being at ER for about 2 hours, patient left against medical advice. The ER doctor wanted to give her more prednisone and she did not react well with it. She received a ride back to location site and drove home herself. The doctor at vaccine location told her not to get second dose while the ER doctor told her she could as long as pre-medicated and was monitored. She wanted to know if we could arrange this appointment.   Treatment medication included oxygen.  Company Comment Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, the medical history of Asthma and Anaphylaxis could be a contributory factor.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow-up information received on 07-Jul-2021 contains added relevant history, lab data, concomitants drug, event outcome was added. On 07-Jul-2021: Upon internal review on 16-SEP-2022 non significant corrections performed to update case received from field.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, the medical history of Asthma and Anaphylaxis could be a contributory factor.