Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: had incorrectly been given injections of expired Moderna vaccine; general malaise; headaches for several days; injection site soreness; injection site soreness and swelling; administered vaccine that was "not stored properly"/"room temperature since Monday"/in syringes that were kept in non-sterile conditions without temperature or other controls; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT STORAGE ERROR (administered vaccine that was "not stored properly"/"room temperature since Monday"/in syringes that were kept in non-sterile conditions without temperature or other controls), EXPIRED PRODUCT ADMINISTERED (had incorrectly been given injections of expired Moderna vaccine), MALAISE (general malaise), HEADACHE (headaches for several days) and VACCINATION SITE PAIN (injection site soreness) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was provided.  Concomitant products included CELECOXIB (CELEBREX) from 01-Jan-2010 to an unknown date for an unknown indication.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced PRODUCT STORAGE ERROR (administered vaccine that was "not stored properly"/"room temperature since Monday"/in syringes that were kept in non-sterile conditions without temperature or other controls). On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (had incorrectly been given injections of expired Moderna vaccine), MALAISE (general malaise), HEADACHE (headaches for several days), VACCINATION SITE PAIN (injection site soreness) and VACCINATION SITE SWELLING (injection site soreness and swelling). On 29-Apr-2021, PRODUCT STORAGE ERROR (administered vaccine that was "not stored properly"/"room temperature since Monday"/in syringes that were kept in non-sterile conditions without temperature or other controls) had resolved. At the time of the report, EXPIRED PRODUCT ADMINISTERED (had incorrectly been given injections of expired Moderna vaccine), MALAISE (general malaise), HEADACHE (headaches for several days), VACCINATION SITE PAIN (injection site soreness) and VACCINATION SITE SWELLING (injection site soreness and swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported patient was getting Johnson and Johnson vaccine The Owner at the vaccination facility called and stated the vaccine that was given was supposed to be destroyed on Monday (26-Apr-2021), and that it was "not stored properly", "room temperature since Monday".   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Follow up information received on 1-jun-2021, patient demographic details updated, new events and  dose information of concomitant medication updated.