Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Wheezing
Clinical narrative: Any movement gave her shortness of breath/All of her breath was gone/The shortness of breath went on for 2 weeks and would happen whenever she walks,does/she has shortness of breath/can not exercise without experiencing shortness of breath; Chest congestion; wheezing at night; worsening chest congestion; Headache; Worsening cough/coughing; she could not get warm even with an electric heat pad,; chills for three days; she believes she had anaphylactic reaction to the vaccine; runny nose; her face is swollen; She thought she was going to die/ her forehead was killing her; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Any movement gave her shortness of breath/All of her breath was gone/The shortness of breath went on for 2 weeks and would happen whenever she walks,does/she has shortness of breath/can not exercise without experiencing shortness of breath), PULMONARY CONGESTION (Chest congestion), CONDITION AGGRAVATED (worsening chest congestion) and ALLERGY TO VACCINE (she believes she had anaphylactic reaction to the vaccine) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 025B21) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Congestion pulmonary and Exercise regular. Concomitant products included DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced DYSPNOEA (Any movement gave her shortness of breath/All of her breath was gone/The shortness of breath went on for 2 weeks and would happen whenever she walks,does/she has shortness of breath/can not exercise without experiencing shortness of breath) (seriousness criterion hospitalization), ALLERGY TO VACCINE (she believes she had anaphylactic reaction to the vaccine) (seriousness criterion medically significant), FEELING COLD (she could not get warm even with an electric heat pad,), RHINORRHOEA (runny nose), SWELLING FACE (her face is swollen), FEELING ABNORMAL (She thought she was going to die/ her forehead was killing her) and CHILLS (chills for three days). On 03-Apr-2021, the patient experienced COUGH (Worsening cough/coughing). On 05-Apr-2021, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced PULMONARY CONGESTION (Chest congestion) (seriousness criterion medically significant), CONDITION AGGRAVATED (worsening chest congestion) (seriousness criterion medically significant) and WHEEZING (wheezing at night). At the time of the report, DYSPNOEA (Any movement gave her shortness of breath/All of her breath was gone/The shortness of breath went on for 2 weeks and would happen whenever she walks,does/she has shortness of breath/can not exercise without experiencing shortness of breath), PULMONARY CONGESTION (Chest congestion), CONDITION AGGRAVATED (worsening chest congestion), ALLERGY TO VACCINE (she believes she had anaphylactic reaction to the vaccine), FEELING COLD (she could not get warm even with an electric heat pad,), WHEEZING (wheezing at night), RHINORRHOEA (runny nose), SWELLING FACE (her face is swollen) and FEELING ABNORMAL (She thought she was going to die/ her forehead was killing her) outcome was unknown, COUGH (Worsening cough/coughing) had not resolved and HEADACHE (Headache) and CHILLS (chills for three days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not applicable. Steroids were used as one of the concomitant medications for wheezing and shortness of breath. 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. The fact that the patient experiences shortness  of breath before both doses of vaccination could be a possible confounder and could suggest a prior relevant medical condition.   This case was linked to US-MODERNATX, INC.-MOD-2021-089474 (E2B Linked Report). This case was linked to MOD-2021-089474 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Additional information was received on 26 May 2021 which includes the following new information: New events added, dosage details updated, action taken updated and reporter details updated.; 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. The fact that the patient experiences shortness  of breath before both doses of vaccination could be a possible confounder and could suggest a prior relevant medical condition.