Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Malaise, Mania, Memory impairment, Nasal congestion
Clinical narrative: wheezing; urinary tract infection; tongue felt swollen; trouble breathing, coughing, reactionary asthma attack; second dose administered at day 38; she didn't feel well; spacy; got confused; arm was sore/arm became sore; face was swollen; face was bright red; lip got swollen; lips got tingly; felt hyper manic(hyper)felt hypermanic; she had the munchies; arm become sore; memory issues; She had nasal congestion/sounded congested; Tired; dry patches on her skin at her ankle and side of her head; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (urinary tract infection), SWOLLEN TONGUE (tongue felt swollen), ASTHMA (trouble breathing, coughing, reactionary asthma attack), WHEEZING (wheezing) and INTENTIONAL PRODUCT USE ISSUE (second dose administered at day 38) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21-2A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cancer (NOS) (cancer in her 20's), Bone injury (broken neck, shoulder and head injury) and COVID-19 (reported in Feb 2020). Concurrent medical conditions included Penicillin allergy, Food allergy (Tomato), Asthmatic attack (reactionary asthma attacks), Rosacea and Guillain Barre syndrome. Concomitant products included EPINEPHRINE (EPIPEN), CALCIUM LEVOMEFOLATE (METHYL FOLATE) and SALBUTAMOL (ALBUTEROL HFA) for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced MANIA (felt hyper manic(hyper)felt hypermanic), HUNGER (she had the munchies), PAIN IN EXTREMITY (arm become sore), MEMORY IMPAIRMENT (memory issues), NASAL CONGESTION (She had nasal congestion/sounded congested), FATIGUE (Tired), FEELING ABNORMAL (spacy), CONFUSIONAL STATE (got confused), INJECTION SITE PAIN (arm was sore/arm became sore), SWELLING FACE (face was swollen), ERYTHEMA (face was bright red), LIP SWELLING (lip got swollen) and PARAESTHESIA ORAL (lips got tingly). On 12-Feb-2021, the patient experienced MALAISE (she didn't feel well). In February 2021, the patient experienced DRY SKIN (dry patches on her skin at her ankle and side of her head). On 19-Mar-2021, the patient experienced SWOLLEN TONGUE (tongue felt swollen), ASTHMA (trouble breathing, coughing, reactionary asthma attack) and INTENTIONAL PRODUCT USE ISSUE (second dose administered at day 38). On 24-Mar-2021, the patient experienced URINARY TRACT INFECTION (urinary tract infection). On 02-Apr-2021, the patient experienced WHEEZING (wheezing). On 11-Feb-2021, FEELING ABNORMAL (spacy), CONFUSIONAL STATE (got confused), SWELLING FACE (face was swollen), ERYTHEMA (face was bright red), LIP SWELLING (lip got swollen) and PARAESTHESIA ORAL (lips got tingly) had resolved. On 23-Feb-2021, NASAL CONGESTION (She had nasal congestion/sounded congested) had resolved. On 12-Mar-2021, MALAISE (she didn't feel well) had resolved. On 19-Mar-2021, SWOLLEN TONGUE (tongue felt swollen), INTENTIONAL PRODUCT USE ISSUE (second dose administered at day 38), MANIA (felt hyper manic(hyper)felt hypermanic) and HUNGER (she had the munchies) had resolved. On 19-Apr-2021, FATIGUE (Tired) had resolved. At the time of the report, URINARY TRACT INFECTION (urinary tract infection), ASTHMA (trouble breathing, coughing, reactionary asthma attack), WHEEZING (wheezing), PAIN IN EXTREMITY (arm become sore), MEMORY IMPAIRMENT (memory issues), DRY SKIN (dry patches on her skin at her ankle and side of her head) and INJECTION SITE PAIN (arm was sore/arm became sore) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Chest X-ray: inconclusive (Inconclusive) it was clear.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 in response to the event was not applicable.   She has called the CDC to report the reactions.    Consent given to contact by phone.   Consent given to contact HCP.    12May2021   This case was linked to MOD21-089812, MOD21-089813 (E2B Linked Report). This case was linked to MOD-2021-123397 (Patient Link).; Sender's Comments:  MOD21-089812:Same reporter MOD21-089813:Same reporter