Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Vaccination site pain
Clinical narrative: feeling like passing out; paleness; injection site pain; she felt tired, exhausted; headache; feeling like a golf ball is under the skin; inability to move her arm above her heart because the pain was so severe. Patient reports inability to use her arm and intense pain when changing clothes; feeling horrible; she couldn't function; she couldn't or eat; wanting to sleep; This spontaneous case was reported by a consumer and describes the occurrence of NEAR DEATH EXPERIENCE (feeling like passing out) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in April 2021, Narcolepsy, Depression, Anxiety, Loss of smell on 02-Apr-2021 and Loss of taste on 02-Apr-2021. Concurrent medical conditions included Drug allergy (Biaxin) and Drug allergy (Adderall generics-anaphylaxis related to an unidentified inactive ingredient in certain). Concomitant products included PARACETAMOL (TYLENOL), VITAMIN C [ASCORBIC ACID], COLECALCIFEROL (VITAMIN D3), FISH OIL and ZINC for an unknown indication.    On 25-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced SWELLING (feeling like a golf ball is under the skin), MOBILITY DECREASED (inability to move her arm above her heart because the pain was so severe. Patient reports inability to use her arm and intense pain when changing clothes), FEELING ABNORMAL (feeling horrible), MOVEMENT DISORDER (she couldn't function), EATING DISORDER (she couldn't or eat), SOMNOLENCE (wanting to sleep), VACCINATION SITE PAIN (injection site pain), FATIGUE (she felt tired, exhausted) and HEADACHE (headache). On 26-Apr-2021, the patient experienced NEAR DEATH EXPERIENCE (feeling like passing out) (seriousness criterion medically significant) and PALLOR (paleness). The patient was treated with CHLORPHENAMINE MALEATE, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (TYLENOL COLD MEDICATION) from 25-Apr-2021 to 30-Apr-2021 at a dose of 1 dosage form. On 26-Apr-2021, NEAR DEATH EXPERIENCE (feeling like passing out) and PALLOR (paleness) had resolved. On 02-May-2021, SWELLING (feeling like a golf ball is under the skin), MOBILITY DECREASED (inability to move her arm above her heart because the pain was so severe. Patient reports inability to use her arm and intense pain when changing clothes) and VACCINATION SITE PAIN (injection site pain) had resolved. On 06-May-2021, FEELING ABNORMAL (feeling horrible), MOVEMENT DISORDER (she couldn't function), EATING DISORDER (she couldn't or eat), SOMNOLENCE (wanting to sleep), FATIGUE (she felt tired, exhausted) and HEADACHE (headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, SARS-CoV-2 test: positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient administered two Tylenol tablets per day from 25Apr2021 to 30Apr2021 to treat her symptoms. Patient reports these symptoms [unrelated to injected site] lasted 10-11 days. Patient reports no previous reactions to any past vaccinations.   Patient reports loss of sense of smell and taste on 2Apr2021, which prompted her to get a rapid COVID-19 test, that initially resulted in a negative result. Patient reports receiving a phone call on 5Apr2021 notifying her that upon further laboratory testing of her sample, she was COVID-19 positive. Patient reports quarantining until 11Apr2021. Patient reports she was symptom free by 11Apr2021 when she discontinued isolation.  Company comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.