Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Swelling, Swelling face, Swollen tongue
Clinical narrative: cry all day long; hard to breath, air is not entering; severe cough at night; generated fear; dizziness; rash on her body\rash on her hands and leg; nausea; started to swell, felt strong to her body; swelling on her eyes; redness on face; tongue heaviness; dry cough; feeling like drawing and throat itching; feeling like drawing and throat itching; weakness; accelerated chest; nasal congestion; itching; affected emotionally; Asthma/severe asthma; lips face tongue eyes swelling; lips face tongue eyes swelling; lips face tongue eyes swelling; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (started to swell, felt strong to her body), EYE SWELLING (swelling on her eyes), ERYTHEMA (redness on face), TONGUE DISCOMFORT (tongue heaviness) and COUGH (dry cough) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045j21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 vaccination: J and J COVID 19 vaccine (1st dose and Lot number 1805020) on 13-Mar-2021. Past adverse reactions to the above products included No adverse event with J and J COVID 19 vaccine. Concurrent medical conditions included Allergy to vaccine (Allergy to the vaccine only.).    On 11-Jan-2022 at 5:30 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2022, the patient experienced SWELLING (started to swell, felt strong to her body), EYE SWELLING (swelling on her eyes), ERYTHEMA (redness on face), TONGUE DISCOMFORT (tongue heaviness), COUGH (dry cough), OROPHARYNGEAL DISCOMFORT (feeling like drawing and throat itching), THROAT IRRITATION (feeling like drawing and throat itching), ASTHENIA (weakness), CHEST DISCOMFORT (accelerated chest), NASAL CONGESTION (nasal congestion), PRURITUS (itching), EMOTIONAL DISORDER (affected emotionally), ASTHMA (Asthma/severe asthma), LIP SWELLING (lips face tongue eyes swelling), SWOLLEN TONGUE (lips face tongue eyes swelling), SWELLING FACE (lips face tongue eyes swelling), COUGH (severe cough at night), FEAR (generated fear), DIZZINESS (dizziness), RASH (rash on her body\rash on her hands and leg) and NAUSEA (nausea). On an unknown date, the patient experienced CRYING (cry all day long) and DYSPNOEA (hard to breath, air is not entering). The patient was treated with BENZONATATE (TESSALON) at an unspecified dose and frequency; IPRATROPIUM BROMIDE, SALBUTAMOL SULFATE (IPRATROPIUM/ALBUTEROL) at an unspecified dose and frequency; PREDNISONE (DELTASONE [PREDNISONE]) at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency; EPINEPHRINE (EPIPEN) at an unspecified dose and frequency; MONTELUKAST SODIUM (SINGULAIR) at an unspecified dose and frequency; PREDNISONE at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching, at an unspecified dose and frequency; FAMOTIDINE for Nausea, at an unspecified dose and frequency; AZELASTINE at a dose of spray decongestive nasal and EPINEPHRINE at an unspecified dose and frequency. At the time of the report, SWELLING (started to swell, felt strong to her body), EYE SWELLING (swelling on her eyes), ERYTHEMA (redness on face), TONGUE DISCOMFORT (tongue heaviness), COUGH (dry cough), OROPHARYNGEAL DISCOMFORT (feeling like drawing and throat itching), THROAT IRRITATION (feeling like drawing and throat itching), ASTHENIA (weakness), CHEST DISCOMFORT (accelerated chest), NASAL CONGESTION (nasal congestion), PRURITUS (itching), EMOTIONAL DISORDER (affected emotionally), ASTHMA (Asthma/severe asthma), LIP SWELLING (lips face tongue eyes swelling), SWOLLEN TONGUE (lips face tongue eyes swelling), SWELLING FACE (lips face tongue eyes swelling), COUGH (severe cough at night), FEAR (generated fear), DIZZINESS (dizziness), RASH (rash on her body\rash on her hands and leg) and NAUSEA (nausea) had not resolved and CRYING (cry all day long) and DYSPNOEA (hard to breath, air is not entering) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EMOTIONAL DISORDER (affected emotionally), CRYING (cry all day long) and DYSPNOEA (hard to breath, air is not entering) to be related. No further causality assessments were provided for SWELLING (started to swell, felt strong to her body), EYE SWELLING (swelling on her eyes), ERYTHEMA (redness on face), TONGUE DISCOMFORT (tongue heaviness), COUGH (dry cough), OROPHARYNGEAL DISCOMFORT (feeling like drawing and throat itching), THROAT IRRITATION (feeling like drawing and throat itching), ASTHENIA (weakness), CHEST DISCOMFORT (accelerated chest), NASAL CONGESTION (nasal congestion), PRURITUS (itching), ASTHMA (Asthma/severe asthma), LIP SWELLING (lips face tongue eyes swelling), SWOLLEN TONGUE (lips face tongue eyes swelling), SWELLING FACE (lips face tongue eyes swelling), COUGH (severe cough at night), FEAR (generated fear), DIZZINESS (dizziness), RASH (rash on her body\rash on her hands and leg) and NAUSEA (nausea).    Patient reported that she was not able to work. Patient's health care professional stated that the events were related to Moderna COVID-19 vaccine. Patient stated that the symptoms started at night on 11-Jan-2022. Patient reported that the event emotional disorder, crying and dyspnea were because of the situation and due to the medicines she was taking for the treatment. Patient stated that she never been diagnosed or tested positive for COVID-19. It was reported that other vaccines were not been taken one month prior to Moderna COVID-19 vaccine. Patient stated that the Adverse events caused her to seek medical care and she had visited the hospital 4 times, had went near an allergy specialist and primary physician. Patient stated that they gave her treatment. No similar event was experienced by the patient in the past. It was reported that the symptoms were worsened.  No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-Feb-2022: Reporter details added, events crying and dyspnea added and I-narrative updated.