Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Product contamination, Swollen tongue, Throat tightness, Vaccination site pruritus, Wheezing
Clinical narrative: Wheezing; Sensation of throat closing; Hoarseness; Red eyes; Face numbness/Lips felt numb; Feeling hot; Allergy to vaccine; Angioedema; Chills; The dose from may have been contaminated with latex; Swelling of lips; Swelling of tongue; Itchy injection site; This spontaneous case was reported by a nurse and describes the occurrence of ANGIOEDEMA (Angioedema) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.  The patient's past medical history included Head injury in 2000 and Angioedema (Due to latex). Concurrent medical conditions included Latex allergy (Latex and chemicals that cross react to latex. When exposed lip swelling, tongue swelling, numbness of face, shortness of breath and flushed face occurs.) since 1994, Cystitis interstitial since 1992, Hyperactive airway disease since 1994, Allergy to chemicals (Multiple chemical sensitivity.) since 1994 and Gastritis since 1992.    On 07-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jun-2021, the patient experienced LIP SWELLING (Swelling of lips), SWOLLEN TONGUE (Swelling of tongue) and VACCINATION SITE PRURITUS (Itchy injection site). On an unknown date, the patient experienced ANGIOEDEMA (Angioedema) (seriousness criterion medically significant), WHEEZING (Wheezing), THROAT TIGHTNESS (Sensation of throat closing), DYSPHONIA (Hoarseness), OCULAR HYPERAEMIA (Red eyes), HYPOAESTHESIA (Face numbness/Lips felt numb), FEELING HOT (Feeling hot), ALLERGY TO VACCINE (Allergy to vaccine), CHILLS (Chills) and PRODUCT CONTAMINATION (The dose from may have been contaminated with latex). The patient was treated with EPINEPHRINE (EPIPEN) for Adverse event, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) from 04-Jun-2021 to 01-Jul-2021 for Adverse event, at a dose of 25 mg three times a day; BENZONATATE from 04-Jun-2021 to 01-Jul-2021 for Adverse event, at a dose of UNK, prn and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, ANGIOEDEMA (Angioedema), LIP SWELLING (Swelling of lips), SWOLLEN TONGUE (Swelling of tongue), WHEEZING (Wheezing), THROAT TIGHTNESS (Sensation of throat closing), DYSPHONIA (Hoarseness), OCULAR HYPERAEMIA (Red eyes), HYPOAESTHESIA (Face numbness/Lips felt numb), FEELING HOT (Feeling hot), ALLERGY TO VACCINE (Allergy to vaccine), VACCINATION SITE PRURITUS (Itchy injection site) and CHILLS (Chills) was resolving and PRODUCT CONTAMINATION (The dose from may have been contaminated with latex) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jun-2021, Body temperature: 100.2 (High) 100.2 F when got home. On 07-Jun-2021, Heart rate: 70-82 (normal) 70-80 beats per minute. On 08-Jun-2021, Heart rate: 68 (normal) 68 Beats per minute at resting. On 28-Jun-2021, Body temperature: high (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Patient was pre administered an Epipen as well as Benadryl and Benzonatate prior to receiving the vaccine.  The patient had a reaction on 07-June-2021 that continued for weeks afterwards. The patient had this latex allergy for almost 30 years and the reaction was very much like a latex reaction. The patient had her first dose but not easy still need a second dose. The patient would like to try to take the second dose in a month or so, to give more time for the allergy reaction to abate more fully and planned to be discussed with her doctor ahead of time.  Company comment: 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 14-Aug-2021: Follow up document was  received and the significant information. Added demographic details, medical history, laboratory investigations, treatment information , events(angioedema, chills, wheezing, sensation of throat closing, hoarseness, red eyes, face numbness, feeling hot). On 26-Aug-2021: Follow-up was received on 26 August 2021 and had non significant information. On 27-Aug-2021: Additional information received included relevant history details.; 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.