Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pain assessment, Product dose omission issue, Respiratory rate, Vaccination complication
Clinical narrative: Second dose not given; it was like if periaureal area felt some numbness; there was no visual swelling just the feeling of swelling and numbness; Flushed; Sweaty; possible allergic reaction; Allergic reaction with angioedema secondary to IM drug and Covid-19 vaccine; the top of her lip was numb; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of ANGIOEDEMA (Allergic reaction with angioedema secondary to IM drug and Covid-19 vaccine) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to vaccine (Allergy to Hepatitis B vaccine.), Psoriasis, Chest pain and Sinus disorder NOS. Concomitant products included VITAMINS NOS for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced HYPOAESTHESIA ORAL (the top of her lip was numb). On 04-Feb-2021, the patient experienced ANGIOEDEMA (Allergic reaction with angioedema secondary to IM drug and Covid-19 vaccine) (seriousness criterion medically significant), HYPOAESTHESIA ORAL (it was like if periaureal area felt some numbness), VACCINATION COMPLICATION (there was no visual swelling just the feeling of swelling and numbness), FLUSHING (Flushed), HYPERHIDROSIS (Sweaty) and HYPERSENSITIVITY (possible allergic reaction). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second dose not given). On 04-Feb-2021, HYPOAESTHESIA ORAL (it was like if periaureal area felt some numbness) and VACCINATION COMPLICATION (there was no visual swelling just the feeling of swelling and numbness) had resolved. At the time of the report, ANGIOEDEMA (Allergic reaction with angioedema secondary to IM drug and Covid-19 vaccine) and PRODUCT DOSE OMISSION ISSUE (Second dose not given) outcome was unknown and FLUSHING (Flushed), HYPERHIDROSIS (Sweaty), HYPERSENSITIVITY (possible allergic reaction) and HYPOAESTHESIA ORAL (the top of her lip was numb) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Blood pressure measurement: 198/80 193/80 at 14:38 144/66 at 15:58. On 04-Feb-2021, Body temperature: 97.4 97.4 at 14:48 97.6 at 15:58. On 04-Feb-2021, Heart rate: 77 77 at 14:38 71 at 15:58. On 04-Feb-2021, Mean arterial pressure: 117 117 at 14:38 92 at 15:58. On 04-Feb-2021, Oxygen saturation: 98 percent 98 percent at 14:38 99 percent at 15:58. On 04-Feb-2021, Pain assessment: 4 pain level 4/10. On 04-Feb-2021, Respiratory rate: 18 18 at 14:38 20 at 15:58.     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.   Follow up received on 13-May-2021 was significant and included the completed VAERS form. The new events of missed second dose of covid-19 vaccine, angioedema, allergic reaction, flushing, sweaty, numbness top lip were added and medical history was updated.  On 04-Feb-2021, it was reported that the patient developed perioral swelling and numbness that came on approximately fifteen minutes after receiving her first covid-19 vaccine. The patient was taken to the emergency department, and was kept under observation for two hours with no worsening of her condition. Treatment medication included 50 milligram of Benadryl (diphenhydramine). The patient was given a prescription for diphenhydramine and asked to follow-up with her primary care physician/ emergency department if symptoms worsened.  Company comment This case concerns a 79-year-old female with a serious unexpected event of angioedema and nonserious hypersensitivity, hypoaesthesia oral, flushing, hyperhidrosis, vaccination complication, and product dose omission issue. Latency within 1 day after mRNA-1273 dose. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow up received included the completed VAER form and medical records from the emergency department. Additional information included medical history, patient demographics, age of patient, patient contact details, concomitant medication, new events with outcome of events, missed second dose.; Sender's Comments: This case concerns a 79-year-old female with a serious unexpected event of angioedema and nonserious hypersensitivity, hypoaesthesia oral, flushing, hyperhidrosis, vaccination complication, and product dose omission issue. Latency within 1 day after mRNA-1273 dose. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.