Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Inappropriate schedule of product administration, Pain, Pain in extremity
Clinical narrative: had no energy; body aches; arm was sore; mild headache; she inadvertently received her second dose on 14OCT2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 59 year-old female patient received bnt162b2 (BNT162B2), administration date 14Oct2021 (Lot number: FH8027) at the age of 59 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1st, Lot Number: FF2589), administration date: 30Sep2021, when the patient was 59 years old, for Covid-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 14Oct2021, outcome "unknown", described as "she inadvertently received her second dose on 14OCT2021"; ASTHENIA (non-serious), outcome "unknown", described as "had no energy"; PAIN (non-serious), outcome "unknown", described as "body aches"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm was sore"; HEADACHE (non-serious), outcome "unknown", described as "mild headache".  Additional information: Reporter was stated she received her first dose of Comirnaty on 30Sep2021. Caller states she inadvertently received her second dose on 14Oct2021, thinking the second dose should have been two weeks after the first dose. Caller states she just received a notification on her phone that her second dose is coming up on 21Oct2021. From this caller realized that she got her second dose one week too early. Caller states she is "afraid for her life" and wants to know if Pfizer has any additional information on the timing of the second dose of Comirnaty. The initial primary vaccination series of Comirnaty (COVID-19 Vaccine, mRNA) and the Pfizer BioNTech COVID-19 Vaccine are to be administered as a 2-dose series, 3 weeks apart. In the Pfizer-BioNTech COVID-19 Vaccine clinical study, the second dose was allowed to be given 19-23 days after the first dose. Initial primary series of Pfizer-BioNTech COVID-19 Vaccine consists of 2 doses given 3 weeks (21 days) apart. The second dose of Pfizer-BioNTech vaccine should be given as close to the recommended interval (3 weeks after the first dose) as possible, but not earlier than 3 weeks.  However, individuals who receive the second dose up to 4 days before or at any time after the recommended date can be considered fully vaccinated. Advised caller that she does not fall into this timeframe. Informed caller that no additional untoward side effects should be expected other than those listed in the Fact Sheet for Recipients and Caregivers. Advised caller that this timing is more related to vaccine efficacy. Advised caller to notify her vaccination provider of what has occurred and have the vaccination provider contact Pfizer or the CDC for guidance moving forward on whether or not she will need revaccination. Provided caller with Case Number. Sending attached document via email fulfillment for patient to review with vaccination provider. Advised caller to contact her HCP if she experiences any side effects that bother her or do not go away. Transfer agent has a consumer on the line who had the 1st dose of the Pfizer COVID vaccine on 30Sep2021 and the 2nd dose 14Oct2021, so the caller did get the 2nd dose a week early and the caller is specifically asking if she has any medical liability for that early dose. Caller asks, so she is the only person in the whole world that this has happened to? She has been overdosed, or at least she feels like she has been and she is trying not to cry. She doesn't understand the question but she has taken her thyroid medication daily. Reworded question and caller states that she had the normal side effects to the COVID vaccine. She had her vaccine on Thursday and then on Friday she had no energy, she had body aches, her arm was sore and she had a mild headache so to the question, no, not at this time. She is unsure about the future though and what was going to happen to her.  Follow-up attempts are completed. No further information is expected.