Moderna

Patient received vaccine that she should not have. she was questioned again at the check in station that she goes on calls and interacts with people on the call. She answered yes to both and said she was sent by her Chief. The borough supervisor was called that same day and told no one but first responders dealing with the public were to be sent to the clinic, he called back and said he had e-mailed the police and fire departments and they had given a revised count that eliminated all of those not eligible. When her shot was entered in the PA-siis data system. The correct birthday was changed on the online form and she was denied for any further vaccinations. She then clarified that she was 14 and thought she had to get it because her Chief sent out an email indicating that active fire fighters were to get vaccinated if they wanted and she thought she should. I then instructed her to bring her parents or guardians into the clinic. Her grandfather; her guardian spoke to us and said he thought she was supposed to get it. I had her sit for 30 minutes with no problems. I followed up the next morning and she indicated feeling fine, I then reviewed all the symptoms that could occur and asked them to call me on my cell or if severe seek medical attention. I have followed up daily she has reported sore arm and a headache at work that lasted 30 minutes on1/26/2021, A mild itch at the injection sight 1/27/2021 but gone in the morning. We will continue to follow up daily with the vaccine

Provider administering vaccines accidentally administered Moderna instead of Pfizer. Within 6 hours of the administration the individual developed headache, nausea and swelling. Symtpoms lasted approximately 36 hours and returned to normal.

Fainting episode; Dehydration; Received 1st Moderna dose at age 14; This spontaneous case was reported by a pharmacist and describes the occurrence of SYNCOPE (Fainting episode) in a 14-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received 1st Moderna dose at age 14). On an unknown date, the patient experienced SYNCOPE (Fainting episode) (seriousness criterion medically significant) and DEHYDRATION (Dehydration). On 25-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received 1st Moderna dose at age 14) had resolved. At the time of the report, SYNCOPE (Fainting episode) and DEHYDRATION (Dehydration) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered SYNCOPE (Fainting episode) to be not related. No further causality assessments were provided for PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received 1st Moderna dose at age 14) and DEHYDRATION (Dehydration). No concomitant medications were provided. No treatment medications were provided. Company Comment: This report refers to a case of product administered to patient of inappropriate age (14- year old) for mRNA-1273 (lot number 016C21A) with associated AEs reported as syncope and dehydration. Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Follow-up received on 10 June 2021.Follow-up letter uploaded. New information included added events, including serious event of fainting. On 11-Jun-2021: Follow-up received on 11 June 2021.General tab information was updated (like information regarding the person completing form). In patient tab patient's height and weight was added.In product tab anatomical location was added.Events like syncope and dehydration were added in events tab.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (14- year old) for mRNA-1273 (lot number 016C21A) with associated AEs reported as syncope and dehydration.

Patient received Moderna vaccine on 6/25/2021 at age 14. She should have received Pfizer. The patient developed a high fever after vaccination.

The patient was given Modern instead of Pfizer for their second dose. 4 hours after injection (6pm), patient complained of and was admitted to a hospital ICU floor with high fever, rapid heart rate, and arrhythmia.