Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Oral pain, Pharyngeal swelling, Pyrexia, Retching, Tongue disorder
Clinical narrative: Sweaty; tongue feel raw and sore; feels feverish; Anaphylactic reaction; Heart rate more than 100 beats per min; Blood pressure which was 188/143.; Systolic blood pressure <90 mmHg; throat started to swell; Abdominal cramping; Feeling hot; her face became red and than blue; Started to gag/gagging sensation; Flushing; nausea; tongue felt huge; couldn't breathe; Mouth pain; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 045B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: DIPHTHERIA TETANUS PERTUSSIS VACCINE on 29-Jan-2021. Concurrent medical conditions included Sulfonamide allergy (FACE SWELLING   HALF OF TONGUE SWELLED  WHEEZING HARD TIME BREATHING) since 2016 and Blood pressure high on 30-Jun-2020. Concomitant products included LISINOPRIL from 30-Jun-2021 to an unknown date for Blood pressure, ATORVASTATIN from 01-Feb-2021 to an unknown date for Cholesterol, GABAPENTIN from 04-Feb-2021 to an unknown date for Nerve pain, DULOXETINE, MELOXICAM and VITAMIN D NOS for an unknown indication.   On 22-Apr-2021 at 2:22 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021 at 5:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-May-2021, the patient experienced HEART RATE INCREASED (Heart rate more than 100 beats per min), BLOOD PRESSURE INCREASED (Blood pressure which was 188/143.), BLOOD PRESSURE SYSTOLIC DECREASED (Systolic blood pressure <90 mmHg), PHARYNGEAL SWELLING (throat started to swell), ABDOMINAL PAIN (Abdominal cramping), FEELING HOT (Feeling hot), ERYTHEMA (her face became red and than blue), RETCHING (Started to gag/gagging sensation), FLUSHING (Flushing), TONGUE DISORDER (tongue felt huge), DYSPNOEA (couldn't breathe), ORAL PAIN (Mouth pain), VOMITING (vomiting) and NAUSEA (nausea). On 20-May-2021 at 5:00 PM, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion medically significant). On 21-May-2021, the patient experienced HYPERHIDROSIS (Sweaty), GLOSSODYNIA (tongue feel raw and sore) and PYREXIA (feels feverish). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; EPINEPHRINE (EPIPEN) at an unspecified dose and frequency; ALUMINIUM HYDROXIDE, DIMETICONE, MAGNESIUM HYDROXIDE (ANTACID [ALUMINIUM HYDROXIDE;DIMETICONE;MAGNESIUM HYDROXIDE]) at an unspecified dose and frequency and DULOXETINE HYDROCHLORIDE (CYMBALTA) ongoing from 29-Jan-2021 for Pain, at a dose of 60 mg twice a day. On 20-May-2021, BLOOD PRESSURE SYSTOLIC DECREASED (Systolic blood pressure <90 mmHg) had resolved. On 20-May-2021 at 8:00 PM, ANAPHYLACTIC REACTION (Anaphylactic reaction) had resolved. On 21-May-2021, GLOSSODYNIA (tongue feel raw and sore) and ORAL PAIN (Mouth pain) had resolved with sequelae. At the time of the report, HEART RATE INCREASED (Heart rate more than 100 beats per min), BLOOD PRESSURE INCREASED (Blood pressure which was 188/143.), PHARYNGEAL SWELLING (throat started to swell), ABDOMINAL PAIN (Abdominal cramping), FEELING HOT (Feeling hot), FLUSHING (Flushing), DYSPNOEA (couldn't breathe), VOMITING (vomiting) and NAUSEA (nausea) had resolved and ERYTHEMA (her face became red and than blue), RETCHING (Started to gag/gagging sensation), TONGUE DISORDER (tongue felt huge), HYPERHIDROSIS (Sweaty) and PYREXIA (feels feverish) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-May-2021, Blood pressure measurement: 188/143 (High) high. On 20-May-2021, Blood pressure systolic: less than 90 mmhg (abnormal) abnormal. On 20-May-2021, Heart rate: 100 breaths per minute (High) high.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ANAPHYLACTIC REACTION (Anaphylactic reaction) to be possibly related. No further causality assessments were provided for HEART RATE INCREASED (Heart rate more than 100 beats per min), BLOOD PRESSURE INCREASED (Blood pressure which was 188/143.), BLOOD PRESSURE SYSTOLIC DECREASED (Systolic blood pressure <90 mmHg), PHARYNGEAL SWELLING (throat started to swell), ABDOMINAL PAIN (Abdominal cramping), FEELING HOT (Feeling hot), ERYTHEMA (her face became red and than blue), RETCHING (Started to gag/gagging sensation), FLUSHING (Flushing), TONGUE DISORDER (tongue felt huge), HYPERHIDROSIS (Sweaty), GLOSSODYNIA (tongue feel raw and sore), DYSPNOEA (couldn't breathe), ORAL PAIN (Mouth pain), VOMITING (vomiting), PYREXIA (feels feverish) and NAUSEA (nausea).    It was reported that patient called in after receiving her 2nd dose of the Moderna covid vaccine on 20-May-2021. After receiving her vaccine approximately within 2 minutes, she started to gag, throat started to swell, and she was told by the staff members that her face became red and than blue. The pharmacist immediately administered an epi-pen and she slowly was able to stop gagging. The pharmacy dialed 9-1-1 and the EMS came. They took her blood pressure which was 188/143. They took her to the hospital and about 10 minutes in the ambulance she experienced the gagging sensation  and her tongue felt huge. They administered the epi-pen again along with Benadryl and an antacid. She was monitored at the hospital for four hours and discharged. While at the hospital she had the gagging experience again and tongue felt huge. They administered the epi-pen again and she remained on IV which she believes contained Benadryl and an antacid. She is contacting the hospital to find out exactly what she was prescribed there. Today, 21may2021 she has to clear her throat a lot, feels feverish, sweaty, tongue feel raw and sore. She is highly allergic to sulfa. She wanted to know if these symptoms have been reported before and if the medications, she was administered at the hospital are going to effect the vaccine efficiency. She was wondering if Moderna could provide any compensation for her medical costs.  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 24-Jun-2021: Follow up information received on 24-Jun-2021 and included New reporter details were added, Suspect vaccine dosing details were updated, Patient demographics (race) was updated, new medical history was added, concomitant drugs indications, dosing and start dates were added, new concomitant drug Cymbalta was added, New historical vaccine was added, New serious event anaphylactic event was added, New non serious events were added, New lab tests were added. Suspect vaccine Batch number was added.; 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.