Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Altered state of consciousness, Anaphylactic reaction, Dizziness, Dyspnoea, Feeding disorder
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ALTERED STATE OF CONSCIOUSNESS (felt out of it) and ANAPHYLACTIC REACTION (anaphylactic reaction) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C27A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Smoker and Detergent sensitivity (Thirteen years ago, contact allergies with Woolite and Tide laundry detergent) since 2008. Concomitant products included AMFETAMINE ASPARTATE, AMPHETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication. On 30-Apr-2021 at 11:12 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced ALTERED STATE OF CONSCIOUSNESS (felt out of it) (seriousness criteria medically significant), ANAPHYLACTIC REACTION (anaphylactic reaction) (seriousness criterion medically significant), DIZZINESS (felt dizzy), FEEDING DISORDER (unable to eat until 4pm) and DYSPNOEA (hard time breathing). On 30-Apr-2021 at 1:00 PM, the patient experienced OROPHARYNGEAL DISCOMFORT (throat started to clamp up). On 01-May-2021, the patient experienced PHARYNGEAL SWELLING (throat started to get a little swollen), THROAT IRRITATION (throat started to get a little itchy) and OROPHARYNGEAL PAIN (Sore throat). On 30-Apr-2021 at 4:00 PM, FEEDING DISORDER (unable to eat until 4pm) had resolved. At the time of the report, ALTERED STATE OF CONSCIOUSNESS (felt out of it), ANAPHYLACTIC REACTION (anaphylactic reaction), DIZZINESS (felt dizzy) and OROPHARYNGEAL DISCOMFORT (throat started to clamp up) was resolving and DYSPNOEA (hard time breathing), PHARYNGEAL SWELLING (throat started to get a little swollen), THROAT IRRITATION (throat started to get a little itchy) and OROPHARYNGEAL PAIN (Sore throat) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient has never had a reaction to vaccines or latex.  After waiting in the vaccinating provider's observation area, she felt fine. On the drive home she felt dizzy and a little out of it. Her Epi-Pen had expired. She took Claritin and laid down to see if the reaction would get better or worse. The symptoms got better 2.5-3 hours (3:30-4pm) later. Things were better and she felt fine. She took Claritin for a total of 4 days following the injection. She did contact her healthcare professional, who referred her to an allergist and her appointment with the allergist is pending. Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Anaphylactic reaction is consistent with the product safety profile; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Anaphylactic reaction is consistent with the product safety profile.