Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Peripheral swelling, Swelling, Syncope, Vomiting
Clinical narrative: hallucination; fainting; confusion; swollen lymph nodes in various body parts; brain fog for 2 weeks; Armpit swollen; arms swollen; joint pains; nausea; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (hallucination) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anaphylaxis (idiopathic anaphylaxis), Chronic idiopathic urticaria and Erythromelalgia. Concurrent medical conditions included Psoriatic arthritis and Bipolar disorder. Concomitant products included DEXAMETHASONE, FEXOFENADINE HYDROCHLORIDE (ALLEGRA), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), HYDROXYZINE (ATARAX [HYDROXYZINE]), HYDROXYZINE, CYCLOBENZAPRINE, DICLOFENAC, LAMOTRIGINE, CHLORHEXIDINE GLUCONATE (CORSODYL), ELDERBERRY [SAMBUCUS NIGRA], LINUM USITATISSIMUM OIL (FLAXSEED OIL [LINUM USITATISSIMUM OIL]), MAGNESIUM, ZINC, ASCORBIC ACID (VIT C) and VIT D [VITAMIN D NOS] for an unknown indication.   On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Aug-2021, the patient experienced HALLUCINATION (hallucination) (seriousness criterion medically significant), SYNCOPE (fainting), CONFUSIONAL STATE (confusion), LYMPHADENOPATHY (swollen lymph nodes in various body parts), FEELING ABNORMAL (brain fog for 2 weeks), SWELLING (Armpit swollen), PERIPHERAL SWELLING (arms swollen), ARTHRALGIA (joint pains), NAUSEA (nausea) and VOMITING (vomiting). At the time of the report, HALLUCINATION (hallucination), SYNCOPE (fainting), CONFUSIONAL STATE (confusion), LYMPHADENOPATHY (swollen lymph nodes in various body parts), FEELING ABNORMAL (brain fog for 2 weeks), SWELLING (Armpit swollen), PERIPHERAL SWELLING (arms swollen), ARTHRALGIA (joint pains), NAUSEA (nausea) and VOMITING (vomiting) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On an unknown date patient had mammogram test and results was not given.  Concomitant medications included fisher oil for unknown indication.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.  Treatment information was not provided.  Company comment: This case concerns a 48 year-old, female subject with a history bipolar disorder, who experienced the unexpected events of HALLUCINATION and SYNCOPE. The events occurred on the same day than the second dose of Spikevax. The rechallenge was negative. The medical history bipolar disorder and negative rechallenge remain confounders. The benefit-risk relationship of Spikevax is not affected by this report. Events of hallucination and syncope were automatically upgraded as serious events. However, based on information available and as per medical criteria, they were classified as Non-serious. Further information is expected for assessment.; Sender's Comments: This case concerns a 48 year-old, female subject with a history bipolar disorder, who experienced the unexpected events of HALLUCINATION and SYNCOPE. The events occurred on the same day than the second dose of Spikevax. The rechallenge was negative. The medical history bipolar disorder and negative rechallenge remain confounders. The benefit-risk relationship of Spikevax is not affected by this report. Events of hallucination and syncope were automatically upgraded as serious events. However, based on information available and as per medical criteria, they were classified as Non-serious. Further information is expected for assessment.