Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Pain in extremity, Underdose
Clinical narrative: This is a spontaneous report from a contactable other-HCP (patient). A 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9262), via an unspecified route to administration in right arm on 23Jan2021 at approximately 08:35 to 8:40 AM for covid-19 immunization. The patient medical history included Hashimoto's disease diagnosed in 2020. Family history included immunocompromised mother. The patient was not using other products. Concomitant medications were not reported. The patient called to inform that she received her first Pfizer COVID-19 vaccine 4 hours away from her home via her employer. She was scheduled to receive the second dose on 12Feb2021. When she received the first dose, she reported having a stream of liquid running down her arm so much that she had to take a tissue to wipe it up. She was advised by a physician at the Health Department who said she spoke to Pfizer and the CDC and that "they think she received enough of the first dose" and that she could receive the second dose. The patient did not believe this information to be accurate. The patient stated that her mother was immunocompromised and she was concerned that the first dose was not enough and that she might contract COVID-19 and pass it on to her mother. The patient reported soreness in her arm the following day (on 24Jan2021). She had seen video on the news of vaccines being given and liquid dripping down recipient's arms. Endocrinologist recently told her she had Hashimoto's. She had heard of leakage between the syringe and needles during administrations. She wanted to know whether she had received an adequate amount of the first dose and whether she should get the second dose or whether she needed to repeat the first dose or could she repeat the first dose or receive three doses of the Pfizer vaccine. The patient was given disclaimers and was responded from the attached document: Select Fact Sheet for Vaccination Providers Administering Vaccine Literature Search, Advisory Committee on Immunization Practices (ACIP) and Centres for Disease Control and Prevention (CDC)-Administration, Immunization Action Coalition- regarding a similar incident with a child who wiggled when they were injecting a dose of vaccine, and approximately halt the dose was lost. The fact sheet included inquiry of whether the child should have been revaccination and when. The patient was referred to her HCP or vaccination provider and informed the patient that the Health Department was managing the administration of the vaccine and was setting up the appointments. The patient was informed that there was no information of who the physician from the health department may have spoken to at Pfizer or what information she may have been given. The patient was emailed the document as it was not possible to offer the survey to the patient as disconnected the call. The patient called again and inquired that whether she could undergo a blood test to check, or could her PCP order a test to check if correct dose has been administered to her. The patient was responded with disclaimers and was advised from the attached document: With regards to the interpretation of SARS-CoV-2 test results in vaccinated persons, the following is mentioned: Prior receipt of an mRNA COVID-19 vaccine will not affect the results of SARS-CoV-2 viral tests (nucleic acid amplification or antigen tests). Currently available antibody tests for SARS-CoV-2 assess IgM and/or IgG to one of two viral proteins: spike or nucleocapsid. Because both the Pfizer-BioNTech and Moderna COVID-19 vaccines contain mRNA that encodes the spike protein, a positive test for spike protein IgM/IgG could indicate either prior infection or vaccination. To evaluate for evidence of prior infection in an individual with a history of mRNA COVID-19 vaccination, a test specifically evaluating IgM/IgG to the nucleocapsid protein [(i.e., N-binding antibody assay)] should be used. Antibody testing is not currently recommended to assess for immunity to COVID-19 following mRNA COVID-19 vaccination or to assess the need for vaccination in an unvaccinated person. The patient was informed that Pfizer does not have information on who can order an antibody test for her. She was again emailed the documents. The patient inquired about the efficacy of the Pfizer vaccine after one dose. The patient was given reply from the following press release: The cumulative incidence of COVID-19 cases over time among placebo and vaccine recipients began to diverge by 12 days after the first dose, and 52.4% vaccine efficacy (95% confidence interval: 29.5, 68.4) was observed between dose 1 and dose 2, indicating the early onset of a partially protective effect of immunization. Two doses of vaccine provide the maximum protection observed. Ten cases of severe COVID-19 were observed with onset after the first dose. Nine cases occurred among placebo recipients and one among BNT162B2 recipients. The patient was emailed the attached document. Then the patient inquired whether she should take the moderna vaccine. The patient was given response with a disclaimer and was informed based on the attached document: Recommendations- "The Pfizer-BioNTech COVID-19 vaccine is not interchangeable with other COVID-19 vaccine products and the safety and efficacy of a mixed-product series have not been evaluated. Persons initiating vaccination with Pfizer-BioNTech COVID-19 vaccine should complete the series with this product. If two doses of different mRNA COVID-19 vaccine products are inadvertently administered, no additional doses of either product are recommended at this time. Recommendations may be updated as further information becomes available or other vaccine types (e.g., viral vector, protein subunit vaccines) are authorized." The patient was informed that the vaccines were similar but not the same. The patient was emailed the documents. The patient stated that it was an absolute nightmare and that she was concerned that Pfizer and the CDC wouldn't know if she had got enough of the dose since they weren't there to see it. The patient said that it was terrible that no one could tell her how to make a decision. She started that she wondered why Pfizer was even talking to doctors then if Pfizer couldn't provide any recommendations- for her to say that she had called the CDC and Pfizer and had spoken to both obviously and they could only provide the documents that they had. The patient stated that it was crazy that in a clinical trial not a single dose was given to check the difference between giving single dose and two doses. She said it blew her mind that such issue was not addressed in clinical trial. The patient stated that it hung over her head that as a first responder, she didn't get it because a person administered it improperly and now, she had to go through all of this just because of an improper injection. She said that it was terrible and awful that she had spent hours and days on the phone and hadn't gotten any sleep and understood that it was not the call responder's issue, but that it was extremely frustrating and now she had to call back or get her primary care physician and try to get a zoom meeting with her as she thought of not wasting driving nine hours in a car. She said it was discouraging. The patient called again to report the same instance that after the first dose of Pfizer vaccine, fluid was dripping down her arm after the shot. The patient stated that she had a thyroid condition, which her endocrinologist said was Hashimoto's, which was diagnosed in Apr2020 or May2020. The patient did not undergo any investigation assessment. The patient stated that it had been a nightmare, and she just got off the phone recently with a doctor form the Department of Health due to a concern with how her first dose was administered. She said it literally took the person who administered the vaccine a half a second, then there was fluid dripping down her arm. She said she was supposed to go back 13Feb2021 for her second dose, and she had been calling to escalate her concern to upper management since last Friday, and they said they would call back, and called back today. The patient said that the doctor said that they spoke with Pfizer and the CDC, and they said that they assumed she had received enough of it to be ok to go back for a second dose. The patient said she did not know if that doctor had filed a safety report and said that she had not done one yet herself. Thus, she filed an initial report. The patient said that the doctor she spoke with shared a similar case that was not reported by the patient but by the person administering the vaccination where they realized there was not a great connection between the needle and the syringe and fluid came out there. The patient said that the doctor said that person was also looking into it. The patient said that she had no further details to provide about this provider or patient and the scenario, she wouldn't have any more details as for them to be provided would have been a HIPAA violation. She says that she had never received a vaccination where she had anything other than a drop of blood that was there afterwards, and this time there was enough to wipe with a tissue and it be wet. She said after her injection she then finished the 9 hours round trip to get the shot then went home and went to work a 12-hour shift. She said that the Department of Health, CDC, and Pfizer were assuming some dose got in, but she was worried that this was misguided, and was extremely worried if management agreed for her to get the second dose if the first dose didn't go in, that then it would not be 95 percent effective. The patient said she got her first dose of Pfizer covid vaccine on 23Jan2021 in her right arm at approximately 08:35 to 8:40 AM, and they had her stay 15 minutes until 08:55 when she could leave. The patient stated she couldn't see NDC number in the picture she took of her vaccine care. She said she had no lab tests done, though she knew there was an antibody test, she thought this would be reserved for research purposes and if there was a test, she would have gone for it because she had decent health insurance. The patient clarified that she believed that the vaccine syringe needle went in, though she didn't feel or see it go in. She said her boyfriend, who was also a first responder was there as well and watched, and the person who gave the vaccine was also a first responder. She said that when the person gave her the injection, she looked away because she did not like needles. The patient said right when he gave her the vaccine, she felt it going down her arm. She said it was like the other scenario that the doctor told her about, where the person administering the vaccine reported that as they gave the injection, the medication came out where the needle connects to the syringe, there were different types of syringes that were used, and one was a block syringe, so it depended on which was being used. She said that the syringe that was used for her dose was pre-packaged in a whole pile of them, and the person who administered her vaccine opened the plastic bag, took the vaccination out, which she saw had a pink cap on it, then the vaccine took less than a second to give it. She said she had talked to others who said they could or could not feel the needle when they got the vaccine. No further details were provided about these other people. The patient said that she thought that there should have been no fluid on her arm. She said that different syringes could be used, and if the needle went in and she felt fluid on her arm, and she felt that it didn't go thought the needle. The patient did not provide a sample of the product available for return and did not provide information about whether packaging was sealed and intact. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.