Reporte zur Charge 044B21A & 026C2

Symptomtext

sweating; potential invalid Moderna COVID-19 doses given; body aches; a little bit of fever; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPERHIDROSIS (sweating), PRODUCT PREPARATION ERROR (potential invalid Moderna COVID-19 doses given), MYALGIA (body aches) and PYREXIA (a little bit of fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A & 026C21A) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (sweating), PRODUCT PREPARATION ERROR (potential invalid Moderna COVID-19 doses given), MYALGIA (body aches) and PYREXIA (a little bit of fever). At the time of the report, HYPERHIDROSIS (sweating), MYALGIA (body aches) and PYREXIA (a little bit of fever) outcome was unknown and PRODUCT PREPARATION ERROR (potential invalid Moderna COVID-19 doses given) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was reported by the reporter. No treatment was reported by the reporter. Moderna vaccine was transported from one clinic to the other in a trip that lasted 5 hours tops. vials were surrounded with icepacks. Temperature was not checked. Two of this conveyances took place. First one on 15Sep2021 (lot #044B21A) while second one on 15Sep2021 (lot #026C21A). HCP said that the conditions were the same for both transportations. Most of the vials were still frozen or starting to thaw (with only a small portion in liquid state). Frozen vials were placed in the freezer while partially thawed were put in the fridge. All doses from carton with lot #044B21A (expired on 21Oct2021) were given; but only 6 vials from carton with lot #026C21A (expires on 06Dec2021) were administered. The remaining 4 vials were confiscated in an audit. Both cartons contained 15-dose vials. Vaccines given included 1st doses, 2nd doses and booster doses.