Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lethargy, Off label use, Overdose, Wrong product administered
Clinical narrative: administered 1.0 mL of the Pfizer Covid-19 vaccine. He reports the vaccine was diluted, but received more than the recommended 0.3mL of vaccine; administration error/inadvertently received the Pfizer COVID 19 vaccine; administration error/inadvertently received the Pfizer COVID 19 vaccine; feeling more lethargic and fatigued; feeling more lethargic and fatigued; This is a spontaneous report from a contactable pharmacist reported for a patient. A 50-years-old female patient received an unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered in unknown arm on 22Jun2021 at 14:50 pm (age at vaccination was 50 years) as unknown, single for COVID-19 immunization. The patient received second dose of COVID-19 vaccine MRNA (MRNA 1273) (MODERNA COVID-19 VACCINE, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 02Jun2021 (age at vaccination was 50 years) as 2nd dose, single for COVID-19 immunization. Medical history included existing ectopic dermatitis due to poison ivy exposure and had long-standing rheumatoid arthritis (longstanding stable condition). The patient had no known vaccine allergies. The patient's concomitant medications were not reported. The patient previously received first dose of COVID-19 vaccine MRNA (MRNA 1273) (MODERNA COVID-19 VACCINE, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 30Jan2021 (age at vaccination was 50 years) as 1st dose, single for COVID-19 immunization and no reaction was reported. The patient previously received Adacel administered on an unknown date in Jan2020. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines were administered on same date of the Pfizer suspect. The caller was a Pharmacist and Medication Safety Officer inquiring about additional information regarding inadvertent administration of the Pfizer COVID-19 vaccine. Called in regard to a patient who inadvertently received the Pfizer COVID 19 vaccine on 22Jun2021 and already received both doses of the Moderna COVID 19 vaccine, first dose 30Jan2021 and second dose 2Jun2021. Caller reported that a patient was being seen yesterday (22Jun2021) in the ambulatory clinic for another condition and was supposed to receive a steroid, but there was an administration error and the nurse administered 1.0 mL of the Pfizer COVID-19 vaccine. He reported that the vaccine was diluted, but received more than the recommended 0.3mL of vaccine. Caller stated "roughly 3 doses of the vaccine". Caller reported that the patient had previously received both doses of the Moderna COVID-19 vaccine (first dose 30Jan2021, second dose 02Jun2021). This patient was being seen for something else. Patient was given one ml instead of 0.3ml of product which was diluted correctly. Caller corrected information provided by the agent stating the notes said that the patient received 0.9ml but that was close to one CC. Clarified the patient received the Pfizer COVID 19 vaccine 22Jun2021 at about 14:50 pm in unknown arm. When ask to provide information for the Moderna COVID 19 vaccine caller stated he did not have any information and cannot provide NDC, lot or expiration date. Caller reported that the patient was seen in the emergency room last night, but was having no apparent side effects. Caller reported the patient was feeling more lethargic and fatigued today. Mentioned the usual dose was 0.3ml but the patient was not even supposed to get that. That was a medication error. His question was regarding advice to give to the provider and patient and asked whether there would be additional side effects and what were the main side effects to advise. He received the response which confirmed Pfizer Covid-19 vaccine. Provided disclaimers and spoke from the attached document from page 3 and 4 under Inadvertent administration of the whole multi-dose vial of vaccine instead of the recommended Dose. Stated they are considering this an event with harm. Stated it was medically significant. Adds the only side effect the patient has had is fatigue and lethargy which was persisting. Patient was being seen for Ectopic dermatitis due to poison ivy exposure. The event inadvertently administered the Pfizer COVID 19 vaccine required a visit to emergency room. Caller reported that the patient was just observed in the emergency room and not admitted to the hospital. No relevant tests were done. The events were reported as medically significant. The causality was reported as unrelated to the product. The outcome of the event feeling more lethargic and fatigued was not resolved.  Follow-up#01 (23Jun2021): New information received from a contactable consumer reported for a patient included: Updated the relevant medical history, historical vaccine, seriousness criteria and causality of the events and details of the medication error.   Follow-up attempts are needed. Information on Lot/Batch number can be requested.; Sender's Comments: Considering a plausible temporal relationship, a possible contributory role of suspect product  bnt162b2  to the reported event of Lethargy ,Fatigue  and AT risk events cannot be excluded 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.