Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Fatigue, Off label use, Overdose, Vaccination site pain
Clinical narrative: off label use; pain in the arm where she received the injection on Monday; fatigue; The caller reports patient having received 5 doses of the Pfizer COVID-19 Vaccines; The caller reports patient having received 5 doses of the Pfizer COVID-19 Vaccines; This is a spontaneous report from a contactable consumer. A 86-years-old female patient received fifth dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on 16Aug2021 as a single dose for COVID-19 immunization. The patient had received fourth dose bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on 12Jul2021 as a single dose for COVID-19 immunization. Medical history included amnesia from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took first dose was administered on 18Apr2021; the 2nd was given on 20May2021. the patient received a 3rd dose of the vaccine 26May2021.On an unknown date 2021, the patient experienced pain in the arm where she received the injection on Monday, fatigue. It was reported that Caller is the caretaker of an 86-year-old female patient whose birthday was yesterday 24Aug2021. The caller reports patient having received 5 doses of the Pfizer COVID-19 Vaccines. The caller was unaware that she had received this additional vaccines prior to her logging into her "My Chart" account. She states that she took the patient to get her 1st 2 doses of the vaccines. The first dose was administered on 18Apr2021, the 2nd was given on 20May2021. Those were the only ones the caller was aware the patient had received. Then she has now found out that the patient received a 3rd dose of the vaccine 26May2021, then a forth dose on 12Jul2021 and then another dose on 16Aug2021. Due to having received these vaccines, in excess in such a short period of time, the caller is concerned and wants to know what she should be watching or looking out for. The patient already suffers from short term memory loss and thus is causing this confusion. The caller reports that the patient will wander off "in the neighborhood" and go to places like a possible (Withheld) and ask to get a vaccine and they are just giving it to her with no clarification on past vaccinations. The caller reports the patient complaining of pain in the arm where she received the injection on Monday. She has also had fatigue where she wanted to just lie down and this is not like her. Safety report was filed with DSU. Adverse Reactions Adverse Reactions in Clinical Trials Adverse reactions following the Pfizer-BioNTech COVID-19 Vaccine that have been reported in clinical trials include injection site pain, fatigue, headache, muscle pain, chills, joint pain, fever, injection site swelling, injection site redness, nausea, malaise, and lymphadenopathy (see Full EUA Prescribing Information).Adverse Reactions in Post Authorization Experience Severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions (e.g., rash, pruritus, urticaria, angioedema), diarrhea, vomiting, and pain in extremity (arm) have been reported following administration of the Pfizer-BioNTech COVID-19 Vaccine outside of clinical trials. Myocarditis and pericarditis have been reported following administration of the Pfizer-BioNTech COVID-19 Vaccine outside of clinical trials. LAB-1450-12.0 Revised: 23Aug2021.Caller, who is a caretaker of the patient, wants to know if there is any way that we can "flag the system" so that the patient does not receive any more COVID vaccinations since she has inadvertently received a total of 5 currently. The patient has short term memory loss and will go into facilities and ask for a vaccination she states. The caller does think that one of the times the patient may have thought she was going for her flu shot but inadvertently got the COVID vaccine again. Caller wants to know why "all this information" is given when you go and get your vaccine if we are unable to stop her from getting another one. She states that people are able to go and get their 2nd shots and booster doses but this system is failing for her. The caller is not aware other than (withheld) where she may have received the other doses at and states she will have to do some searching but was hoping that Pfizer would be able to flag "the system. Advised the caller that there is no information available or a way that we can do this through Pfizer MI, however we would recommend that she reach out to her vaccination sites where the patient is able to access these vaccines and ensure they are aware and maybe it is something in their system they can do. The system, if pulled up by her demographic information, should show that she has been vaccinated in the registry.The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.