Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Injection site swelling, Oropharyngeal spasm, Pallor, Pulmonary congestion
Clinical narrative: I felt very tired, I  was exhausted; White as a ghost; itching at the injection site; Injection site was hard/hard in the middle/injection site hardness would come and go; Arm was red at the injection site 4x4 inches/injection site redness would come and go; injection site swollen; Headache; Lungs started feeling congested; Felt like my throat spasmed and felt like it wanted to close up; A spontaneous report was received from a licensed nursing assistant concerning a 48-year old, female patient who received Moderna's COVID-19 vaccine and experienced throat spasms, lung congestion, headache, injection site itching, injection site redness, injection site hardness, injection site swelling, fatigue, and pallor.   The patient's medical history, as provided by the reporter, included asthma, eczema, and penicillin allergy.  No relevant concomitant medications were reported.   On 22 Dec 2020, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 22 Dec 2020, the patient experienced throat spasms about 8 minutes after administration of the vaccine. The patient described the feeling as "feeling like it wanted to close up". She was given water. After 19 minutes, her throat relaxed. That evening, her lungs felt congested, and she had a headache. Treatment included ibuprofen.   On 23 Dec 2020, upon awakening, the congestion and headache were better.   On 28 Dec 2020, the injection site began itching, was hard in the middle, and red (approximately 4x4 inch area and increasing in size by the end of the day). She was checked in to emergency room and given prednisone for injection site symptoms.  Her blood pressure reading was 150/90 which, according to the patient, was a little higher than normal.   On 29 Dec 2020, the patient woke up feeling very tired and exhausted. Her nurses said she looked "white as a ghost". She was given orange juice and crackers and felt like she had more energy. She returned to work. The injection site redness and hardness would come and go.   On 01 Jan 2021, the patient described the injection site as looking "like a tick bite". The site was still hard and red. On 02 Jan 2021, treatment included clindamycin.   On 04 Jan 2021, the redness went away.   On 08 Jan 2021, she completed the antibiotic and all events were resolved.   Action taken with mRNA-1273 in response to the events was not reported.   The event, throat spasms, was considered recovered/resolved on 22 Dec 2020. The events, lung congestion and headache, were considered recovered/resolved on 23 Dec 2020.  The event, injection site redness, was considered resolved on 04 Jan 2021. The events, injection site itching, injection site hardness, injection site swelling, fatigue, and pallor, were considered recovered/resolved on 08 Jan 2021.; Reporter's Comments: This case concerns a 48 year old female patient with medical history asthma, penicillin allergy among others.  The patient was administered the first and only dose of the mRNA-1273 (lot # 039K20A) (expiration date unknown) and experienced serious unexpected event of pulmonary congestion on the same day after administration and non-serious events of headache occurred on the same day mRNA-1273 administration, oropharyngeal spasm occurred  8 minutes after mRNA-1273 administration , injection site hardness, injection site pruritus', injection site redness, injection site swelling  and fatigue occurred 7 days after mRNA-1273 administration and pallor occurred 8 days after mRNA-1273 administration,.De-challenge and re-challenge. Based on temporal association between the use of the product and the start date of the event of pulmonary congestion and laryngospasm, and on the known safety profile for mRNA-1273 for the other reported r non-serious events, a causal relationship cannot be excluded. Hence events are assessed as possibly related to the administration of mRNA-1273 vaccine