Age: 86.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arrhythmia, Atrial fibrillation, Blood test, Deep vein thrombosis, Gait inability
Clinical narrative: A-FiB; Arrhythmia; Deep vein thrombosis; She then got sciatica in her leg and couldn't walk; blood clot/ blood clot left (L) calf; Sciatica; charley horse in the lower leg; soreness in arm/pain in her foot/lower leg/calf still hurt; This is a spontaneous report from a contactable nurse (patient). This 86-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EN6203, Expiration date: unknown) intramuscular, administered in left deltoid on 04Mar2021 at 13:15 pm (age at vaccination was 86 years) as dose 2, single for COVID-19 immunization. The patient's medical history included atrial fibrillation (A-FiB) (heart disease) from 2008 and ongoing, hypothyroid from 1976 and ongoing, hypertension and hypolipidemia. The patient was not a smoker/former smoker. The patient received some years ago an unspecified pneumonia vaccine and an unspecified tetanus vaccine and after both experienced headache, swollen arm and rash, the patient was taking concomitant medications routinely prior to the event being reported. She didn't react to the flu vaccine. Her body didn't want any more vaccine. No other vaccines were administered on the same date and within four weeks. The patient did not receive any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination. The patient did not have any pre-existing diseases worsened during the SARS-CoV2 infection. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EN6201, Expiration date: unknown) intramuscular, administered in left deltoid on 11Feb2021 at 18:15 pm (age at vaccination was 86 years) as dose 1, single. On an unspecified date in Mar2021, maybe a week or two after the second vaccination, early to mid-afternoon, the patient had what felt like a charley horse in her lower leg while walking, but didn't pay any attention to it, just put ice on the leg. She then got sciatica in her leg on 24Apr2021 and couldn't walk; that was what sent her to the hospital as it was getting worse, and she went to the hospital because of the pain. She just ignored it for at least a week, but she was still having pain after the second week and could hardly walk due to the sciatica in that leg. At the hospital they found she had a blood clot in the calf of her leg on 28Apr2021. She was hospitalized from 28Apr2021 to 02May2021. The patient was not admitted to an Intensive Care Unit. The doctors in the hospital recommended that she should report her experience even though they didn't know if it was due to the COVID vaccine due to the proximity. The hospital doctors took care of her but her primary care provider knew that she had been in the hospital. The doctors gave her medications in the hospital that helped the pain in her foot and the sciatica but her lower leg/calf still hurt so they decided to do an ultrasound and found a blood clot. The patient still had to give herself injections in the belly for blood thinner to treat the blood clot. The patient also experienced soreness in arm on an unspecified date in 2021. Sciatica required ER visit. Additionally, the patient experienced positive (pos) COVID-19 test (nasal swab came back positive for covid-19) on 28Apr2021 and A-FiB on an unspecified date both required emergency room (ER) visit and reported as serious with hospitalization criterion and duration of stays from 28Apr2021 to 02May2021. No treatment was received due to positive COVID-19 test while diltiazem 120 mg was given due to A-FiB. It was also reported that patient experienced blood clot left (L) calf and sciatica treated with enoxaparin. The patient did not display clinical signs at rest indicative of severe systemic illness. The patient did not require supplemental oxygen (including high flow or ECMO) or receive mechanical ventilation. The event did not require the initiation of new medication or other treatment or procedure. It was unknown whether the patient had SARS-CoV2 antibodies at diagnosis and SARS-CoV2 antibodies at hospital discharge. The doctor said that there was a possibility that the blood clot could be related to the COVID vaccine, but it may not be related at all. The hypoxemia, arrhythmia, hematological, acute respiratory distress syndrome (ARDS) and dermatological was unknown, COVID-pneumonia, respiratory failure, cardiovascular, gastrointestinal/Hepatic, renal and neurological was no and deep vein thrombosis was yes. The patient underwent lab tests and procedure which included blood test with unknown results, ultrasound showed blood clot in calf and COVID-19 RT-PCR test (positive) (nasal swab came back positive for COVID-19), imaging for thrombo-embolic events (e.g., doppler or CT) on 28Apr2021: DVT 75mm occlusive thrombus (Range: Us Doppler lower venous left) on 28Apr2021. There was no multiorgan involvement, no respiratory, no dyspnoea, no tachypnea, no hypoxemia, no COVID-pneumonia, no respiratory failure, no acute respiratory distress syndrome (ARDS), no cardiovascular, no heart failure, no cardiogenic shock, no acute myocardial infarction, no myocarditis, no gastrointestinal, no vomiting, no diarrhoea, no abdominal pain, no jaundice, no acute liver failure, no vascular, no renal, no acute kidney injury, no renal failure, no neurological, no altered consciousness, no convulsions/seizures, no encephalopathy, no meningitis, no cerebrovascular accident, no dermatological, no chilblains and no erythema multiforme. The outcome of the events blood clot/ blood clot left (L) calf and sciatica was recovering. The patient did not receive any additional therapies for COVID-19. The outcome of the events A-FiB was recovered on an unspecified date in 2021. The outcome of the other events was unknown.  Follow-up (07Jun2021): New information received from the same contactable nurse (patient) included: new events ("Pos covid 19 test" and "A-FiB"), clinical details, patient's medical history, lab data and suspect drug details (route of administration) were added, outcome of the events ("blood clot/ blood clot left (L) calf"and "sciatica") and suspect drug details (site and time of administration) were updated.  Follow-up (24Jun2021): New information received from a contactable other Healthcare professional reported for the patient in response to HCP letter via follow-up letter included: Updated the date of positive (pos) COVID-19 test (28Apr2021) and outcome as resolved, updated drug ineffective to vaccination failure as SARS Cov-2 test was positive on 28Apr2021, medical history, details of multiorgan involvement and clinical course.  Follow-up (06Aug2021): New information was received via contactable consumer (receptionist) in response to HCP letter sent to physician via telephonic follow-up activity which included: Added new reporter: consumer (receptionist).  Follow up (07Sep2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation of a query. The response included: It is cancelled status in CITI.   Follow-up (08Nov2021): This is a follow-up spontaneous report received from a contactable physician. This physician reported in response to HCP letter sent that included unknown concomitant medication, lab test and clinical information in narrative.  Follow-up attempts are completed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previous information: Split case created for the events reported only after second dose of vaccine.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events Sciatia, thrombosis, Atrial Fibrillation, Deep Vein thrombosis and Gait inability which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available. 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.