Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: tongue was swelling; Couldn't breathe; Throat was swelling; Had anaphylaxis; Some chest pains; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (tongue was swelling), DYSPNOEA (Couldn't breathe), PHARYNGEAL SWELLING (Throat was swelling), CHEST PAIN (Some chest pains) and ANAPHYLACTIC REACTION (Had anaphylaxis) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 045A21A) for COVID-19 vaccination.     Concomitant products included TERAZOSIN HYDROCHLORIDE (TERAZIN) for an unknown indication.   On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SWOLLEN TONGUE (tongue was swelling) (seriousness criteria hospitalization and medically significant), DYSPNOEA (Couldn't breathe) (seriousness criteria hospitalization and medically significant), PHARYNGEAL SWELLING (Throat was swelling) (seriousness criteria hospitalization and medically significant) and ANAPHYLACTIC REACTION (Had anaphylaxis) (seriousness criteria hospitalization and medically significant). In May 2021, the patient experienced CHEST PAIN (Some chest pains) (seriousness criteria hospitalization and medically significant). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and EPINEPHRINE (EPIPEN) at an unspecified dose and frequency. At the time of the report, SWOLLEN TONGUE (tongue was swelling), DYSPNOEA (Couldn't breathe), PHARYNGEAL SWELLING (Throat was swelling), CHEST PAIN (Some chest pains) and ANAPHYLACTIC REACTION (Had anaphylaxis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-May-2021, Blood pressure measurement: 180/110 (High) Increased.         Patient reported two minutes after second dose, tongue was swelling and had anaphylaxis where she could not breathe, blood pressure was through the roof, throat was swelling. Pharmacist gave her Benadryl and another allergy pill. Went to urgent care after and received steroid injection. Blood pressure was 180/110. Blood pressure was up a little before that, but it seemed to stay higher after. Stayed on allergy medication for two weeks and got an Epi Pen just in case. Blood pressure went down after steroid injection. Given prescription for steroid just in case it was needed.  This case concerns a 52-year-old female patient with no relevant medical history, who experienced the serious expected AESI event of Anaphylactic reaction  along with serious events of Swollen tongue, Dyspnoea, Pharyngeal swelling  and Chest pain. The events of Anaphylactic reaction, Swollen tongue, Dyspnoea, Pharyngeal swelling occurred 2 min after the second dose of mRNA-1273 vaccine administration, and the event of Chest pain occurred on unknown day in May 2021. The events were considered as related, per temporal association with the product administration. The rechallenge was not applicable as no events were reported after the first vaccination dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-409809 (Patient Link).; Sender's Comments: This case concerns a 52-year-old female patient with no relevant medical history, who experienced the serious expected AESI event of Anaphylactic reaction  along with serious events of Swollen tongue, Dyspnoea, Pharyngeal swelling  and Chest pain. The events of Anaphylactic reaction, Swollen tongue, Dyspnoea, Pharyngeal swelling occurred 2 min after the second dose of mRNA-1273 vaccine administration, and the event of Chest pain occurred on unknown day in May 2021. The events were considered as related, per temporal association with the product administration. The rechallenge was not applicable as no events were reported after the first vaccination dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.