Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Extra dose administered, Off label use, Pain in extremity
Clinical narrative: , yesterday 15Sep2021, but was inadvertently given a third dose of the Pfizer-Biontech Covid19 vaccine; , yesterday 15Sep2021, but was inadvertently given a third dose of the Pfizer-Biontech Covid19 vaccine; She also reports having a covid infection in Aug2021; She also reports having a covid infection in Aug2021; Leg aches; This is a spontaneous report from a contactable consumer (patient). A 32 years old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 16May2021 (at age of 31 years old) (Lot Number: EW0176) administered to the right arm around 6:50pm as single dose, second dose via an unspecified route of administration on 06Jun2021 (at age of 31 years old) (lot number: EW0196) as single dose for covid-19 immunisation. Medical history was not provided. Concomitant medications included amfetamine aspartate/ amfetamine sulfate/ dexamfetamine saccharate/ dexamfetamine sulfate (ADDERALL) and ongoing. The caller (patient) presented to her pharmacy to receive her flu shot, yesterday 15Sep2021, but was inadvertently given a third dose of the Pfizer-Biontech Covid19 vaccine. Caller received her original series on 16May2021 and 06Jun2021. She also reported having a covid infection in Aug2021. Caller inadvertently received a 3rd dose of the Pfizer-Biontech Covid19 vaccine when she presented for her flu shot on 15Sep2021. She reported having had a covid infection in Aug2021, and was worried that she received the third dose close to this infection. As of 16Sep2021, the patient reported that had Covid about 25 days ago, from Aug2021. The patient tested negative for Covid on 22Aug2021. Caller reported she got the first Covid shot 16May2021 and the second 06Jun2021. She just had Covid about 25 days ago (based on 16Sep2021) and just tested negative for Covid. The patient received the first Covid vaccine 16May2021. Unable to provide the NDC, expiry or dose, but provides a lot number of EW0176. Received the second dose on 06Jun2021. Unable to provide the NDC, expiry or dose, but provides a lot number of EW0196. Yesterday (based on 16Sep2021) she was supposed to receive the Flu shot, but they gave her another Pfizer Covid vaccine. Unable to provide the NDC, Lot, or expiry stating they printed it out and it's on like a prescription sheet with the name, Rx number on it. She stated she also complained about that. She was supposed to get the Flu shot for nursing school and had to get it by the 15Sep2021. She got the first 2 Covid vaccines because she knew it was required for a cruise she wanted to go on and she ended up with the Covid virus anyway. Stated no other vaccines given the same day or 4 weeks prior the third dose yesterday. She did get a Hepatitis B shot back on 01Jul2021 and provided the lot number of T035865, expiry of 04Nov2021. Later provided she had no side effects with the first Covid shot other than the arm hurt and the second time (shot) had leg aches (from Jun2021), but felt fine. Stated she was supposed to go on a cruise and that was cancelled because she got Covid. On 11Aug2021 her son was exposed to Covid and so she tested on 16Aug and every day after up until the 21st positive for covid and didn't test negative until the 22Aug2021. Her mother gave her home tests and that was what they used everyday. No require a visit to Emergency Room or Physician Office. No vaccinations within four weeks prior to the first administration date of the suspect vaccine. Relevant Tests included At home Covid testing 16Aug through 21Aug2021, result positive. 22Aug2021 negative. Event outcome was recovering. As of 17Sep2021, Product Quality Complaint Group providing investigation results: Conclusion of Previously Completed Investigation provided as "The final scope was determined to be the reported finished goods lot EW0176, fill lot EP8727, and the bulk formulated drug product lot EP8608. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  Follow-Up (21Sep2021): Follow-up attempts are completed. No further information is expected.