Age: 58.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Dizziness, Electrocardiogram, Heart rate, Heart rate irregular, Hypertension
Clinical narrative: Lip swelling; Tongue Swelling; Chest tightness; dizziness; irregular heat rate; Not received second dose; anaphylaytic reaction; Within 15 minutes blood pressure went up to 200/120; Diastolic went down to 95; Super racy heart / pulse was really high/ heart was beating through her chest; Super super sensitive; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (anaphylaytic reaction) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ATENOLOL for an unknown indication.    Previously administered products included for an unreported indication: INFLUENZA VACCINE in 2014 and MUCINEX. Concurrent medical conditions included Hypersensitivity (Sensitivity to petroleum type products), Drug allergy (atenolol) on 25-Aug-2021 and Egg allergy. Concomitant products included FISH OIL, VITAMIN D NOS and PROBIOTICS NOS for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, the patient started ATENOLOL (unknown route) Low dose. On 04-Mar-2021, the patient experienced ANAPHYLACTIC REACTION (anaphylaytic reaction) (seriousness criterion medically significant), HYPERTENSION (Within 15 minutes blood pressure went up to 200/120), BLOOD PRESSURE DIASTOLIC DECREASED (Diastolic went down to 95), TACHYCARDIA (Super racy heart / pulse was really high/ heart was beating through her chest), ALLERGY TO VACCINE (Super super sensitive), HEART RATE IRREGULAR (irregular heat rate) and PRODUCT DOSE OMISSION ISSUE (Not received second dose). On an unknown date, the patient experienced LIP SWELLING (Lip swelling), SWOLLEN TONGUE (Tongue Swelling), CHEST DISCOMFORT (Chest tightness) and DIZZINESS (dizziness). On 07-Mar-2021, HYPERTENSION (Within 15 minutes blood pressure went up to 200/120), BLOOD PRESSURE DIASTOLIC DECREASED (Diastolic went down to 95), DIZZINESS (dizziness) and HEART RATE IRREGULAR (irregular heat rate) had resolved. At the time of the report, ANAPHYLACTIC REACTION (anaphylaytic reaction), TACHYCARDIA (Super racy heart / pulse was really high/ heart was beating through her chest), ALLERGY TO VACCINE (Super super sensitive), LIP SWELLING (Lip swelling), SWOLLEN TONGUE (Tongue Swelling) and CHEST DISCOMFORT (Chest tightness) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Not received second dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Blood pressure measurement: 200/120 mmhg (High) Blood pressure went up to 200/120. On 04-Mar-2021, Electrocardiogram: normal (normal) Heart was strong. On 04-Mar-2021, Heart rate: high (High) High.     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.   Patient reported having an allergy to PEG ingredient in the Moderna vaccine. No treatment medications were provided.  Company comment: This case concerns a 58-year-old female with a serious expected event of anaphylactic reaction, and non-serious tachycardia, allergy to vaccine, lip swelling, swollen tongue, chest discomfort, and product dose omission issue. Event latency within 15 minutes after first dose mRNA-1273. Events resolved. Based on 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.   This case was linked to MODERNATX, INC.-MOD-2021-296548 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Significant Follow-up received on 01-SEP-21, updating new historical drug, historical conditions and allergy, event added and event outcome was changed; Sender's Comments: This case concerns a 58-year-old female with a serious expected event of anaphylactic reaction, and non-serious tachycardia, allergy to vaccine, lip swelling, swollen tongue, chest discomfort, and product dose omission issue. Event latency within 15 minutes after first dose mRNA-1273. Events resolved. Based on 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. MODERNATX, INC.-MOD-2021-296548:Cross linked case