Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Product preparation error
Clinical narrative: body aches; tiredness; trouble swallowing; soreness in left arm to the point that she can barely lift it up; soreness in left arm to the point that she can barely lift it up; she receive entire undiluted vial of vaccine in her left arm; she receive entire undiluted vial of vaccine in her left arm; This is a spontaneous report from a contactable pharmacist. A 15-years-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Formulation: solution for injection, Lot Number: EW0191, Expiration date: 30Sep2021 [Provided date, 30Sep2021 on the actual vaccine but stated that there is a certain time frame that may be sooner. She does not have the exact date.]), via an unspecified route of adminitartion in the Arm Left on 29Jun2021 as dose 2, single for covid-19 immunisation (Covid protection, prevention; Her mom wanted her to take it). Time the Vaccination was given was unknown. The Patient Medical History (including any illness at time of vaccination) was Unknown. Family Medical History Relevant to AE(s) was unknown The Patient concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. AE(s) following prior vaccinations: Unknown. The patient had earlier received first dose of BNT162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, Lot Number: EW0186), via an unspecified route of administration in the Arm Left on 08Jun2021 at 0.3 mL dose 1, single in the left arm for covid-19 immunisation.   Reporter reports that the patient received second dose of Pfizer COVID-19 vaccine on 29Jun2021, (21 days from the first dose) but she receive entire undiluted vial of vaccine in her left arm (received more than the normal dose). Since receiving second dose the patient was experiencing body aches, tiredness, trouble swallowing and soreness in left arm to the point that she can barely lift it up. Reporter reports patient had been to Emergency Room (ER) twice, to Physician Office its unknown. Caller reports patient has been to ER and healthcare professional (HCP) and they are telling her the same information she is telling her. They are looking for recommendations, the patients mother was not satisfied while in the ER she was told to just watch it. Stated that it had not gotten any worse but had not gotten any better. Response was given and Referred to HCP. The reported asked what is recommended, as the patient's mother, who is unsatisfied because they were just told to watch these symptoms. The reported inquired whether there was a time frame where there is going to be relief. Queried if there were long term side effects that patients have had when given a high dose. The patient underwent lab tests and procedures which included Chest X-ray was normal. Test results: Mother stated that in the ER, they only did a chest X-ray which showed nothing. There was no blood work. The events was assessed as serious (medically significant) for all events. The outcome of the events had not recovered. Causality: Yes, that is what her mother is stating. She is not too sure. She is not a regular patient and does not know what medications she usually takes. (as reported).; Sender's Comments: Based on the information in the case report, a possible causal relationship between the events Overdose, Pain in extremity, Pain, Dysphagia, Fatigue and Product preparation error and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.