Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac discomfort, Expired product administered, Hyperhidrosis, Loss of consciousness
Clinical narrative: passed out for 1-2 minute; Patient was sweating; heart was palliating; Dose Expire on 24-Mar-2021, which administered by patient on 22-Dec-2021; This spontaneous case was reported by a pharmacist and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out for 1-2 minute), HYPERHIDROSIS (Patient was sweating), CARDIAC DISCOMFORT (heart was palliating) and EXPIRED PRODUCT ADMINISTERED (Dose Expire on 24-Mar-2021, which administered by patient on 22-Dec-2021) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032H21A) for COVID-19 vaccination.     Concomitant products included INFLUENZA VACCINE (INFLUENZA VACCIN) for an unknown indication.    On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 22-Dec-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out for 1-2 minute), HYPERHIDROSIS (Patient was sweating), CARDIAC DISCOMFORT (heart was palliating) and EXPIRED PRODUCT ADMINISTERED (Dose Expire on 24-Mar-2021, which administered by patient on 22-Dec-2021). On 22-Dec-2021, LOSS OF CONSCIOUSNESS (passed out for 1-2 minute) and EXPIRED PRODUCT ADMINISTERED (Dose Expire on 24-Mar-2021, which administered by patient on 22-Dec-2021) had resolved. At the time of the report, HYPERHIDROSIS (Patient was sweating) and CARDIAC DISCOMFORT (heart was palliating) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was given Coca-Cola since the patient did not eat anything prior to vaccine. However, when the 911 arrived at the pharmacy, patient was alert and oriented and walked out with the emergency service. The vaccine was administered on the patient on their left arm on deltoid muscle. No treatment medication reported. Company comment: This Spontaneous case concerns a 29-year-old, male patient, with no reported medical history, who experienced the unexpected, non-serious events of loss of consciousness and hyperhidrosis, among others. Expired product administered is also reported. The patient passed out for 1-2 minutes after receiving a dose of mRNA-1273 vaccine, considered as booster dose. He was also sweating and heart was palliating. He was given Coca-Cola since the patient did not eat anything prior to vaccine and recovered. It was reported that at the same time he received the Influenza vaccine. Rechallenge was not applicable. Concomitant administration of Influenza vaccine remains as a confounder. The benefit -risk relationship of mRNA -1273 Vaccine is not affected by this report. Event loss of consciousness was upgraded per IME list, however, based on medical judgement and available information, it was kept as non-serious.; Sender's Comments: This Spontaneous case concerns a 29-year-old, male patient, with no reported medical history, who experienced the unexpected, non-serious events of loss of consciousness and hyperhidrosis, among others. Expired product administered is also reported. The patient passed out for 1-2 minutes after receiving a dose of mRNA-1273 vaccine, considered as booster dose. He was also sweating and heart was palliating. He was given Coca-Cola since the patient did not eat anything prior to vaccine and recovered. It was reported that at the same time he received the Influenza vaccine. Rechallenge was not applicable. Concomitant administration of Influenza vaccine remains as a confounder. The benefit -risk relationship of mRNA -1273 Vaccine is not affected by this report. Event loss of consciousness was upgraded per IME list, however, based on medical judgement and available information, it was kept as non-serious.