Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness, Tremor
Clinical narrative: Feeling dizzy and bad; Thought her blood sugar was dropping; Lips started tingling; Started sweating; Felt weak; Felt pressure on chest; Muscles started twitching/legs started twitching; Had difficulty breathing; Anaphylaxis Shock; When the Benadryl wears off I start shaking; When the Benadryl wears off I have shallow breathing; When the Benadryl wears off throat starts tightening; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Feeling dizzy and bad), BLOOD GLUCOSE DECREASED (Thought her blood sugar was dropping), PARAESTHESIA ORAL (Lips started tingling), HYPERHIDROSIS (Started sweating), ASTHENIA (Felt weak), CHEST DISCOMFORT (Felt pressure on chest), MUSCLE TWITCHING (Muscles started twitching/legs started twitching), DYSPNOEA (Had difficulty breathing) and ANAPHYLACTIC SHOCK (Anaphylaxis Shock) in a 40-year-old female patient who received mRNA-1273 (batch no. 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fruit allergy.    On 15-Apr-2021, the patient received first dose of mRNA-1273  (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced DIZZINESS (Feeling dizzy and bad) (seriousness criteria hospitalization and life threatening), BLOOD GLUCOSE DECREASED (Thought her blood sugar was dropping) (seriousness criteria hospitalization and life threatening), PARAESTHESIA ORAL (Lips started tingling) (seriousness criteria hospitalization and life threatening), HYPERHIDROSIS (Started sweating) (seriousness criteria hospitalization and life threatening), ASTHENIA (Felt weak) (seriousness criteria hospitalization and life threatening), CHEST DISCOMFORT (Felt pressure on chest) (seriousness criteria hospitalization and life threatening), MUSCLE TWITCHING (Muscles started twitching/legs started twitching) (seriousness criteria hospitalization and life threatening), DYSPNOEA (Had difficulty breathing) (seriousness criteria hospitalization and life threatening), ANAPHYLACTIC SHOCK (Anaphylaxis Shock) (seriousness criteria hospitalization, medically significant and life threatening), TREMOR (When the Benadryl wears off I start shaking), HYPOPNOEA (When the Benadryl wears off I have shallow breathing) and THROAT TIGHTNESS (When the Benadryl wears off throat starts tightening). The patient was hospitalized from 15-Apr-2021 to 15-Apr-2021 due to ANAPHYLACTIC SHOCK, ASTHENIA, BLOOD GLUCOSE DECREASED, CHEST DISCOMFORT, DIZZINESS, DYSPNOEA, HYPERHIDROSIS, MUSCLE TWITCHING and PARAESTHESIA ORAL. On 15-Apr-2021, DIZZINESS (Feeling dizzy and bad), BLOOD GLUCOSE DECREASED (Thought her blood sugar was dropping), HYPERHIDROSIS (Started sweating), ASTHENIA (Felt weak), CHEST DISCOMFORT (Felt pressure on chest), DYSPNOEA (Had difficulty breathing) and ANAPHYLACTIC SHOCK (Anaphylaxis Shock) had resolved, MUSCLE TWITCHING (Muscles started twitching/legs started twitching) had not resolved. At the time of the report, PARAESTHESIA ORAL (Lips started tingling) had not resolved and TREMOR (When the Benadryl wears off I start shaking), HYPOPNOEA (When the Benadryl wears off I have shallow breathing) and THROAT TIGHTNESS (When the Benadryl wears off throat starts tightening) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Intramuscular) was unknown.       The patient was treated at the closest hospital with epinephrine (epi pen), IV diphenhydramine, and IV Famotidine. The patient was having anaphylaxis shock (confirmed by Emergency Department). She stated epinephrine made her heart beat so fast that it was going to collapse. She was discharged 3 hours later from the hospital with epi pen (emergency use), diphenhydramine(as needed), Famotidine (as needed). Consumer stated that when the Benadryl weaned off she felt tingling of lips, starts shaking, muscles start twitching, throat tightening, and has shallow breathing.  Company comment: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, excluding other etiologies causal relationship cannot be excluded. Anaphylaxis is consistent with the product known safety profile.; Sender's Comments: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, excluding other etiologies causal relationship cannot be excluded. Anaphylaxis is consistent with the product known safety profile.