Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Could not sleep; Agitated; Itching at injection site; Redness at the injection site; Swelling at the injection site; Auditory hallucinations; felt irritable; Angry; felt confused like i was having some kind of cognitive thing; I experience fear along with paranoia; I experience fear along with paranoia; underlying diplopia increased; felt uncharacteristically emotional; joint pain in both hips; episode of hard sneezing; tinnitus/ increased and spiked throughout the day; Became fatigued; temperature rose to 102DF; Mild headache/ headache soreness; Sore arm; Increased sinus congestion; brain fog; Imbalance/ Imbalance worse; urinary incontinence x 3 episodes; felt weak; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION, AUDITORY (Auditory hallucinations) in a female patient of an unknown age who received mRNA-1273  (batch no. 019b21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Mast cell activation syndrome and Diplopia.    On 31-Mar-2021, the patient received second dose of mRNA-1273  (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), SINUS CONGESTION (Increased sinus congestion), FEELING ABNORMAL (brain fog), BALANCE DISORDER (Imbalance/ Imbalance worse), URINARY INCONTINENCE (urinary incontinence x 3 episodes), ASTHENIA (felt weak), FATIGUE (Became fatigued), PYREXIA (temperature rose to 102DF) and HEADACHE (Mild headache/ headache soreness). On 02-Apr-2021, the patient experienced SNEEZING (episode of hard sneezing), TINNITUS (tinnitus/ increased and spiked throughout the day) and ARTHRALGIA (joint pain in both hips). On 03-Apr-2021, the patient experienced HALLUCINATION, AUDITORY (Auditory hallucinations) (seriousness criterion medically significant), IRRITABILITY (felt irritable), ANGER (Angry), CONFUSIONAL STATE (felt confused like i was having some kind of cognitive thing), FEAR (I experience fear along with paranoia), PARANOIA (I experience fear along with paranoia), DIPLOPIA (underlying diplopia increased), EMOTIONAL DISTRESS (felt uncharacteristically emotional), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE SWELLING (Swelling at the injection site). On 04-Apr-2021, the patient experienced INSOMNIA (Could not sleep) and AGITATION (Agitated). On 02-Apr-2021, URINARY INCONTINENCE (urinary incontinence x 3 episodes), ASTHENIA (felt weak), SNEEZING (episode of hard sneezing) and HEADACHE (Mild headache/ headache soreness) had resolved. On 04-Apr-2021, TINNITUS (tinnitus/ increased and spiked throughout the day), IRRITABILITY (felt irritable), ANGER (Angry), CONFUSIONAL STATE (felt confused like i was having some kind of cognitive thing), FEAR (I experience fear along with paranoia), PARANOIA (I experience fear along with paranoia), DIPLOPIA (underlying diplopia increased), ARTHRALGIA (joint pain in both hips), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE SWELLING (Swelling at the injection site) had resolved. At the time of the report, HALLUCINATION, AUDITORY (Auditory hallucinations), PAIN IN EXTREMITY (Sore arm), SINUS CONGESTION (Increased sinus congestion), FEELING ABNORMAL (brain fog), BALANCE DISORDER (Imbalance/ Imbalance worse), AGITATION (Agitated), FATIGUE (Became fatigued) and PYREXIA (temperature rose to 102DF) outcome was unknown and EMOTIONAL DISTRESS (felt uncharacteristically emotional) and INSOMNIA (Could not sleep) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Body temperature: 102 (High) 102. On 01-Apr-2021, Heart rate: 74 (Inconclusive) 74. On 02-Apr-2021, Body temperature: 99.4 (Inconclusive) 99.4. On 02-Apr-2021, Heart rate: 64 (Inconclusive) 64.         Treatment information for the events were not provided.  Company Comment  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.