Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Beta 2 microglobulin, Blood immunoglobulin A, Blood immunoglobulin G, Blood immunoglobulin M, Electrophoresis protein
Clinical narrative: she is scared to death of COVID; she has received both the Moderna Covid 19 vaccine and Pfizer Covid 19 vaccine series.; This is a spontaneous report from a contactable from nurse (patient, both a retired nurse and a consumer) received via a Pfizer sponsored program Pfizer Patient Assistance and Savings Program for Lyrica and Lyrica CR.  A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown) on 12May2021 and the second dose of BNT162B2 (lot number: unknown) on 02Jun2021, at the age of 66 years old, in right arm at single dose for COVID-19 immunisation. Medical history included ongoing diabetes (Type 2) from 1995, ongoing high cholesterol from 1995, ongoing terrible neuropathy (Initially stated it began in 2004 but is not sure. Clarified it began early 2000s.Stated neuropathy used to just be in her feet. Now is in her hands as well. Began feeling neuropathy in her hands four years ago) and getting crippled (because she is out of Lyrica. Had real trouble getting the refill going this time because doctor had not written it right). The patient was not sick at time of vaccinations. The family medical history relevant to events was none. Concomitant medications included pregabalin (LYRICA, NDC: 00071101968, strength: 225 mg, formulation: capsule, lot number: CM6475, expiration date: 30Jun2022) taken for terrible neuropathy (Lyrica was her lifesaver. Would be crippled without Lyrica. The patient stated Lyrica was a wonderful medication). The patient was not taking antipyretic use around the dates of vaccination. The patient previously took rituximab (RITUXAN) for chemotherapy and rituximab wiped her B-cells out (had no NDC/LOT/EXP for rituximab). The patient previously received the first dose of Moderna COVID-19 vaccine (lot number: unknown) on 02Mar2021 and the second dose of Moderna COVID-19 vaccine (lot number: unknown) on 30Mar2021, at the age of 66 years old, in right arm at single dose for COVID-19 immunisation and experienced no adverse event. The events following prior vaccinations was none. The patient had received both the Moderna COVID 19 vaccine and BNT162B2 series. The patient received Moderna COVID-19 vaccines at 11:00 (unspecified) and BNT162B2 at 14:00 (unspecified). The patient clarified she had both doses of Moderna COVID-19 Vaccines the first time. She lied her way through and received both doses of BNT162B2. Because the first one did not work. The patient was desperate trying to see if the second one would. The patient was also on chemotherapy prior and explained that it wiped out her B cells, since she had no B cells the vaccine did not have anything to "hook on to" and replicate. Vaccine did not take as she had no B-cells because she was taking rituximab for chemo. The patient requested monoclonal antibody therapy primitively from her oncologist. However, the patient explained this had not happened due to the cost for three weeks. Despite being vaccinated she was still concerned given the ongoing pandemic. She continuously expressed the desire to receive monoclonal antibodies. The patient confirmed the details provided by the transfer agent. The patient clarified she had not had rituximab at time of vaccinations. The patient had not had rituximab since Sep2020. Rituximab wiped her B-cells out, she did not have anything. She would like to know if there was a study, she could enroll in. She would go across the country. The patient received both BNT162B2 and Moderna COVID-19 Vaccines all in her right arm. If it got sore, since she was right handed, this would lessen the effect of the soreness. The patient never had even a sore arm for all of the COVID-19 vaccines she received. The patient had nothing. The patient did not go to emergency room or physician office. The patient stated she was already at her oncologist when this was figured out. She did not go to her oncologist because of this. Would check medically significant and a life-threatening situation because she was scared to death of COVID. The patient underwent lab tests and procedures which included SARS-CoV-2 IgG antibody blood test: negative (there were no monoclonal antibodies detected, performed after both doses of Moderna COVID-19 Vaccines were received) on 28Apr2021, SARS-CoV-2 IgG antibody blood test: negative (there were no monoclonal antibodies detected, performed after both doses of BNT162B2 were received)  on 23Jun2021, soluble serum transferum: unknown results, protein electrophoresis: unknown results, cappa serum: unknown results, free lambda serum: unknown results, IgG: unknown results, IgM: unknown results, IgA: unknown results, beta 2 microglobulin: unknown results. The causality of Moderna COVID-19 vaccine/BNT162B2 and events was unrelated. The patient thought it was due to the rituximab. The patient was sure the vaccine would have taken if not for the rituximab. The outcome of events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: The association between the event "scared to death of COVID" with BNT162b2 can not be completely 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.