Age: 74.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: COVID-19, Coronavirus test, Feeling cold
Clinical narrative: Got boosted 2 times and both times it felt like a cold. He didn't think he had it. Had to test and it came back positive; Boosted 2 times and both times it felt like a cold; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Got boosted 2 times and both times it felt like a cold. He didn't think he had it. Had to test and it came back positive) and FEELING COLD (Boosted 2 times and both times it felt like a cold) in a 74-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLUZONE [INFLUENZA VACCINE]) for an unknown indication.    The patient's past medical history included COVID-19 (His first attack was a year ago.). Concurrent medical conditions included Pituitary adenoma. Concomitant products included SOMATROPIN (GENOTROPIN) for Pituitary adenoma, LEVOTHYROXINE and DEXAMETHASONE for an unknown indication.   On 11-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (FLUZONE [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Got boosted 2 times and both times it felt like a cold. He didn't think he had it. Had to test and it came back positive) and FEELING COLD (Boosted 2 times and both times it felt like a cold). At the time of the report, COVID-19 (Got boosted 2 times and both times it felt like a cold. He didn't think he had it. Had to test and it came back positive) and FEELING COLD (Boosted 2 times and both times it felt like a cold) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Coronavirus test: Positive.         The patient started taking Genotropin about 10 years ago. Started at .5, then .6, and now .7. pen was 5 years old. Pen had some numbers and lines for a dead battery. Pen showed F9.  Cartridge -1. proceeded to put in a cartridge and that came out. It had not moved and he pushed on the plunger and all of a sudden it just kept going and everything came out. Clarified he was holding it up. It really did not register the dosage so he turned it and no dosage came up. He was pushing the plunger down to put it back in the box and call us but it kept going through the vial and all the medication came out. There was about 0.4 left and he injected that even though his dose supposed to be 0.7. Had to move to better light to see NDC, lot and expiry. Product strength and count size dispensed: 1 pen. The sample of the product available to be returned. Packaging sealed and intact. The patient had bloodwork a month ago because it seemed like medication was not working so his doctor determined that Levothyroxine and Dexamethasone doses need to be adjusted so his Genotropin could work better and changed the time of day he took it. The patient experienced first attack was a year ago. Then he got boosted 2 times and both times it felt like a cold. The patient had a booster the year before also. Batch number for Genotropin Pen 5 included as: H107.  The patient had another prior to that and had the Mini quicks, they were quick and easy. No treatment medication was reported.   This case was linked to MOD-2023-705955 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-Jan-2023: Follow-up received and added new event of feeling cold, added quality complaint number into reference.