Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: a little tired; sore arm; This is a spontaneous report from a contactable consumer or other non hcp. A 71-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on an unspecified date (Batch/Lot Number: EL3247) as 1ST DOSE, SINGLE for Covid-19 immunization. Medical history included dry eye, multiple allergies, food allergy to eggs. Concomitant medication included krill oil (KRILL OIL) taken for an unspecified indication, vitamin D nos (VITAMIN D NOS) taken for an unspecified indication, salmo salar oil (OMEGA-3 [SALMO SALAR OIL]) taken for an unspecified indication. The patient previously took Amoxil for pruritus and experienced drug hypersensitivity. The patient experienced a little tired, sore arm on an unspecified date with outcome of unknown. Therapeutic measures were taken because of sore arm (pain in extremity).  Question: Attention DSU - Possible duplicate Caller is reporting that she received her second dose of Pfizer-BioNTech Covid19 vaccine on day 33 instead of the scheduled day 21. Vaccination was delayed due to medical reasons from 15Feb2021 to 27Feb2021. Also, caller states that the only AE she experienced was a sore arm for 24hours. She is concerned that due to delaying the dose, it may not be as effective, especially since the 2nd dose has a reputation of worse AEs than the first, and she's had increased energy and no reaction besides soreness.  Follow-up (02Mar2021): This is a follow-up spontaneous report from a contactable consumer. This consumer (patient) reported that: Additional Context: Consumer says she is calling with concern about second Pfizer COVID-19 vaccine shot, who says she received it pretty late, it was delayed due to weather and she was supposed to have her second dose on 15Feb and she had it on 27Feb. She says it has been 72 hours, and she hasn't had any reaction, other than the sore arm for 24 hours, and nothing else, her energy level has been high. She says her question is was it effective since the second dose has the reputation of having a more powerful reaction.   Email Address: Documented as provided. Provider Information: Caller declines to provide provider information. Pfizer COVID-19 vaccination NDC/EXP: Caller says that her vaccine card is a preprinted card created by CDC, and she wrote a number on there that she added that started with W44 that was on an email she got in scheduling email from the health department. She says neither dose of the vaccine had an EXP or NDC provided for it on the vaccine card. She says that the first dose LOT was EL3247, and the second dose LOT was EL9266, and both doses were given in her left arm. Caller offered but did not provide date of first dose injection.  AE: Sore arm: Caller says after both doses were given she had a sore arm that started probably about 4 hours later, and she took Acetaminophen, that was that. She says that there was little to none for both soreness after about 24 hours, maybe a little bit more that, with taking the Acetaminophen. Caller says she doesn't take meds often normally, she took two doses, each time as a dose two tablets 8 hours apart. She says actually she never took the second dose of Acetaminophen on her second dose of the vaccine. She says that the Acetaminophen tablets were 650mg each. UPC/LOT/EXP: not provided.  Caller says after her first vaccine dose she woke up second day a little tired, and continued to feel a little tired through the day, which didn't cause her to go to bed or anything, she just did everything slower. She says this time after the second dose she cleaned closets and her garage and had no lack of energy.   Concomitant Medications: Caller says she is not on meds at all, she only takes something for dry eye recommended by her optometrist, which is over the counter Preservision AREDs. She says she also takes krill oil, Omega-3, Vitamin D one 2000 IU a day, which seemed to be important, though none were new meds, they seemed important for COVID, she started some of the vitamins 6 months ago, and some she has been taking for three years. No further details provided about any of these medications.   Other Medical Conditions: Caller says she has hay fever allergies, she is allergic to Amoxil. Amoxil NDC/LOT/EXP: Unknown, caller doesn't thinks she ever had that information. Caller says that they discovered her allergy to Amoxil because she had severe itching when she took it back in 1984. She says that they didn't test everything for every allergy back then. She says that she has a food allergy to eggs, which wasn't diagnosed, it started with her childhood doctor who basically said that if she gets a rash each time she is eating eggs, to stop eating eggs.   Is there a Product Complaint: Yes  Description of Product Complaint: Description of complaint: Consumer says she is calling with concern about second Pfizer COVID-19 vaccine shot, who says she received it pretty late, it was delayed due to weather and she was supposed to have her second dose on 15Feb and she had it on 27Feb. She says it has been 72 hours, and she hasn't had any reaction, other than the sore arm for 24 hours, and nothing else, her energy level has been high. She says her question is was it effective since the second dose has the reputation of having a more powerful reaction. Pfizer COVID-19 vaccination NDC/EXP: Caller says that her vaccine card is a preprinted card created by CDC, and she wrote a number on there that she added that started with W44 that was on an email she got in scheduling email from the health department. She says neither dose of the vaccine had an EXP or NDC provided for it on the vaccine card. She says that the first dose LOT was EL3247, and the second dose LOT was EL9266, and both doses were given in her left arm. Caller offered but did not provide date of first dose injection. Product strength and count size dispensed: two doses. Is a sample of the product available to be returned, if requested (Y/N): not provided. Packaging sealed and intact? not provided.  No follow up attempts are possible. No further information is expected.