Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue, Wrong technique in product usage process
Clinical narrative: I have no balance walking with cane; foggy brain can not make clear sentences; foggy brain can not make clear sentences; Neck and back pain; Neck and back pain; he was given a vaccine that did not follow protocol; It was suppose to be given in 15 days instead it was given in 21 days.; It was suppose to be given in 15 days instead it was given in 21 days.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 48 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 13Oct2021 11:00 (Lot number: FF8839) at the age of 48 years as dose 1, single and administered in arm left, administration date 04Nov2021 12:22 (Lot number: FH8020) as dose 2 single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, administration date 04Nov2021. The following information was reported: BALANCE DISORDER (disability) with onset 14Oct2021 10:00, outcome "not recovered", described as "I have no balance walking with cane"; FEELING ABNORMAL (disability), DISTURBANCE IN ATTENTION (disability) all with onset 14Oct2021 10:00, outcome "not recovered" and all described as "foggy brain can not make clear sentences"; NECK PAIN (disability), BACK PAIN (disability) all with onset 14Oct2021 10:00, outcome "not recovered" and all described as "Neck and back pain"; WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (non-serious) with onset 13Oct2021, outcome "unknown", described as "he was given a vaccine that did not follow protocol"; PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious) all with onset 13Oct2021, outcome "unknown" and all described as "It was suppose to be given in 15 days instead it was given in 21 days.". The events "i have no balance walking with cane", "foggy brain can not make clear sentences", "foggy brain can not make clear sentences", "neck and back pain", "neck and back pain", "he was given a vaccine that did not follow protocol", "it was suppose to be given in 15 days instead it was given in 21 days." and "it was suppose to be given in 15 days instead it was given in 21 days." were evaluated at the physician office visit. Therapeutic measures were not taken as a result of balance disorder, feeling abnormal, disturbance in attention, neck pain, back pain, wrong technique in product usage process, product temperature excursion issue, poor quality product administered. He got a call and was told they did the wrong protocol and it was one of the Pfizer covid shot doses that he got. The reporter does not know which Pfizer COVID shot it was. He also had a flu vaccine on 04Nov2021 administered to his right arm. Covid shot was given on 13Oct21 and second shot on 04Nov21. On 07Nov21 got phone call from pharmacy house where patient received Covid shot from. Pharmacy person informed patient that protocol was broken. The shot was taken out of freezer to refrigeration to shelf and then given to patient. Instead it went from freezer to be injected into patient arm. Then later patient was told it was out of date. It was suppose to be given in 15 days instead it was given in 21 days. patient was told that Pfizer was notified by e-mail that Pfizer said "They would not stand by the shot". Because it was given out of protocol and out of date. Medication not given per protocol by pharmacy manager house and expired. Affected patient not had balance walking with cane and foggy brain can not make clear sentences. Neck and back pain. Dispensing, preparation and administration was all wrong as described in number "1". It was reported that put patient life in danger was how he feel. No follow-up attempts are possible. No further information is expected.  Follow-up(20Dec2021):This is a follow up-spontaneous report from same contactable consumer. This consumer (patient) reported in response to consumer letter sent via follow-up letter which included that: Updated information: Vaccination time updated and new Events added.  Follow-up attempts are completed. No further information is expected.