chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Fatigue, Pain, Panic attack, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Apr2021 10:45 (Lot number: EW0153) at the age of 37 years as dose 1, single for Covid-19 immunisation. Patient received bnt162b2 Dose 2 (Lot number: EW0153) in arm left on administration date 30Apr2021. Relevant medical history included: "Known Allergies: Sulfa" (unspecified if ongoing) and other medical history was none. The patient's concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant) with onset 09Apr2021, outcome "not recovered", described as "Blood Clogs"; ANXIETY (non-serious) with onset 09Apr2021, outcome "not recovered", described as "Anxiety"; PANIC ATTACK (non-serious) with onset 09Apr2021, outcome "not recovered", described as "Panic Attacks"; FATIGUE (non-serious) with onset 09Apr2021, outcome "not recovered", described as "Tiredness"; PAIN (non-serious) with onset 09Apr2021, outcome "not recovered", described as "Body Pain". The events "blood clogs", "anxiety", "panic attacks", "tiredness" and "body pain" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (28Dec2021) negative, notes: Nasal Swab; (04Jan2022) positive, notes: Nasal Swab; (12Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of thrombosis, anxiety, panic attack, fatigue, pain. Patient had not received any other vaccine in four weeks. Patient had not received any other medications in two weeks. Patient did not experienced Covid prior vaccination. Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug 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.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Apr2021 10:45 (Lot number: EW0153) at the age of 37 years as dose 1, single for Covid-19 immunisation. Patient received bnt162b2 Dose 2 (Lot number: EW0153) in arm left on administration date 30Apr2021. Relevant medical history included: "Known Allergies: Sulfa" (unspecified if ongoing) and other medical history was none. The patient's concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant) with onset 09Apr2021, outcome "not recovered", described as "Blood Clogs"; ANXIETY (non-serious) with onset 09Apr2021, outcome "not recovered", described as "Anxiety"; PANIC ATTACK (non-serious) with onset 09Apr2021, outcome "not recovered", described as "Panic Attacks"; FATIGUE (non-serious) with onset 09Apr2021, outcome "not recovered", described as "Tiredness"; PAIN (non-serious) with onset 09Apr2021, outcome "not recovered", described as "Body Pain". The events "blood clogs", "anxiety", "panic attacks", "tiredness" and "body pain" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (28Dec2021) negative, notes: Nasal Swab; (04Jan2022) positive, notes: Nasal Swab; (12Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of thrombosis, anxiety, panic attack, fatigue, pain. Patient had not received any other vaccine in four weeks. Patient had not received any other medications in two weeks. Patient did not experienced Covid prior vaccination. Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug 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.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Optic ischaemic neuropathy
Clinical narrative: This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient. A 74 year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 28Oct2021 (Batch/Lot number: unknown) at the age of 73 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Psoriasis" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Open heart surgery" (unspecified if ongoing). Family history included: "Hypertension" (unspecified if ongoing), notes: mother. Concomitant medications included: Allopurinol; Nexium [Esomeprazole Magnesium]; Metoprolol; Valsartan; Atorvastatin; Folic Acid; Methotrexate; Baby Aspirin; Remicade. Past drug history included: Brimonidine. Vaccination history included: COVID-19 vaccine (Primary Immunization series unknown; unknown manufacturer), for COVID-19 Immunization. The following information was reported: OPTIC ISCHAEMIC NEUROPATHY (medically significant), outcome "unknown", described as "I had a micro stroke in my left eye and it is called NAION". Additional information: Consumer stated, "I am calling to report a possible side effect from, I guess it would be the booster, I have only had the third booster (Pfizer COVID-19 booster shot) not the fourth (further not clarified) but about 6 weeks ago (further not clarified) I had a micro stroke in my left eye and it is called NAION that is the name of the problem and my husband is just 'proof of it' (further not clarified), because my pulmonologist told me he knows of someone who after a booster went blind in her eye (further clarification unknown) and we googled it and there does seem to be a connection between the mRNA vaccines and after that problem (further clarification unknown)." Consumer stated, "The Lot# is it looks like PR the way they wrote it 2012  it looks like, I cannot tell it is FS or FP, 2588."(Further clarification unknown). Consumer was informed about the role of Pfizer Drug Safety department. Other medical condition: Consumer stated, "A lot of them. I just recently had open heart surgery (further clarification unknown), I have hypertension/blood pressure. I have psoriasis, I have 'Gals' (further not clarified), I have asthma, and there is a bunch". The patient had no lab test. The patient had no prior vaccination. The patient had family medical history (Blood pressure or hypertension) on her mother. Time of vaccination: around 10-10:30 (AM). The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 62 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 18Feb2022 11:15 (Lot number: FK9894) at the age of 62 years as dose 4 (booster), single for Covid-19 immunisation. Relevant medical history included: "Lupus" (unspecified if ongoing); "High Blood pressure" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Dose=3, Manufacturer name unknown.), for Covid-19 immunization; Covid-19 vaccine (Primary immunization series completed, Manufacturer name unknown), for Covid-19 immunization. The following information was reported: BELL'S PALSY (medically significant) with onset 27Feb2022 17:00, outcome "recovering", described as "9 days after my #4 vaccine I got Bell's Palsy on the right side of my face. My mouth was opened more to the right side, my right eye didn't blink automatically, my right eye brow didn't move". The event "9 days after my 4 vaccine I got Bell's palsy on the right side of my face, my mouth was opened more to the right side, my right eye didn't blink automatically. my right eye brow didn't move", was evaluated at the emergency room visit. Therapeutic measures were taken as a result of Bell's palsy. The patient had no other vaccine in four weeks. The patient had no Covid prior vaccination not tested post vaccination. The patient was treated with Prednisone for 11 days. Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Swelling, Tinnitus
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 58-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 25Aug2021 (Lot number: FC3181) at the age of 59 years as dose 3 (booster), single, administered in arm left, administration date 28Apr2021 (Lot number: EW-0162) as dose 2, single and administered in arm right, administration date 07Apr2021 (Lot number: EW-0150) as dose 1, single for Covid-19 immunisation. Relevant medical history included: "Ankylosing Spondylitis" (unspecified if ongoing); "Type II Diabetic" (unspecified if ongoing). Concomitant medication(s) included: HUMULIN REGULAR; NPH INSULIN. The following information was reported: SWELLING (disability) with onset 07Apr2021, outcome "not recovered", described as "First Pfizer Covid-19 Vaccine swelling in neck behind ear down under arm in the lymph nods, face and the rest of my body swelled up so much I had no wrinkles left. After 7 days days the swelling went"; TINNITUS (disability) with onset 07Apr2021, outcome "not recovered", described as "I also had Tinnitus started with in a few hours of the vaccine that has not gone down or away it is here 24/7 everyday". The events "first Pfizer Covid-19 vaccine swelling in neck behind ear down under arm in the lymph nods, face and the rest of my body swelled up so much I had no wrinkles left. After 7 days days the swelling went" and "I also had tinnitus started with in a few hours of the vaccine that has not gone down or away it is here 24/7 everyday" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (28Oct2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of swelling, tinnitus. Clinical course: First Pfizer Covid 19 Vaccine swelling in neck behind ear down under arm in the lymph nods, face and the rest of my body swelled up so much I had no wrinkles left. After 7 days the swelling went down. She also had Tinnitus started within a few hours of the vaccine that has not gone down or away it is here 24/7 everyday. 2nd Vaccine same swelling, same went down after 7 days, 3rd Vaccine same swelling, 7 days later swelling just from the stomach down to my toes, BUT this time it has not gone down. She have iron leaking out of my capillaries in her feet, looks like red dots all over her feet. Adverse event resulted in doctor or other healthcare professional office/clinic visit, Disability or permanent damage. The treatment included steroid dose packs, Lasix, Bumetanide, no results. Patient takes a lot more concomitant meds. Facility type vaccine was pharmacy or Drug Store. She had not taken any other vaccine in four weeks. Covid prior vaccination was unknown. She had tested Covid post-vaccination by Nasal Swab (BinaxNOW). She had known allergies. No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Multiple sclerosis
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number Unknown, Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: MULTIPLE SCLEROSIS (medically significant), outcome "unknown", described as "Multiple Sclerosis". Clinical course: The neurologist said he had another patient with multiple sclerosis after the COVID booster shot. The lot number for bnt162b2 was not provided and will be requested during follow up. Sender's Comments: Linked Report(s): US-PFIZER INC-202200500520 Same product/event, different patient.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Hypoaesthesia, Neuropathy peripheral
Clinical narrative: I couldn't breathe; my left side of my arm and leg gos numb here and there; nerves in my feet are messed up and really sensitive to socks and shoes.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20May2021 14:45 (Lot number: ER8727) at the age of 34 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (prev dose brand= Pfizer, prev dose brand unknown: False, prev dose dose number:1, other vaccine same date lot number: ER8727,, prev dose vaccine  location: Left arm ), administration date: 29Apr2021, when the patient was 34 years old, for Covid-19 immunization. The following information was reported: DYSPNOEA (disability), outcome "not recovered", described as "I couldn't breathe"; HYPOAESTHESIA (disability), outcome "not recovered", described as "my left side of my arm and leg gos numb here and there"; NEUROPATHY PERIPHERAL (disability), outcome "not recovered", described as "nerves in my feet are messed up and really sensitive to socks and shoes.". The events "i couldn't breathe", "my left side of my arm and leg gos numb here and there" and "nerves in my feet are messed up and really sensitive to socks and shoes." were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of dyspnoea, hypoaesthesia, neuropathy peripheral.  Clinical course: As reported no other vaccine was give to the patient prior to four week of vaccination, and after 2 week of vaccination. The things got even worse, he couldn't breathe, and his left side of my arm and leg goes numb here and there, he can't wear any shoes because the nerves in his feet was messed up and really sensitive to socks and shoes. Ae resulted in disability. For adverse event treatment he was put on medication. He was not tested post covid vaccination. He had prior covid vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200500526 Same patient and drug, different event separated in time.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program. A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The patient who was fully vaccinated with Pfizer's vaccine and got treated with Paxlovid for COVID-19 4 weeks ago. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "got treated with Paxlovid for COVID-19 4 weeks ago". Therapeutic measures were taken as a result of Covid-19. Caller would like to know if there's any interval (waiting time) between the end of Paxlovid treatment and the second booster. Pharmacist stating that she has a patient that already took 3 booster shots and wants to get the 4th booster shot and also mentioned that the patient took the Paxlovid pill 4 weeks ago. Caller wants to confirm if the Patient can get the 4th booster shot today or should they still wait. The lot number for bnt162b2 was not provided and will be requested during follow up. Sender's Comments: Based on available information a contributory role of BNT162B2 to the reported events Covid-19 and Drug ineffective cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of Covid-19 and drug ineffective is: expected. The case will be reassessed further upon receipt of additional information.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Papillary thyroid cancer, SARS-CoV-2 test
Clinical narrative: Papillary Thyroid Carcinoma; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Jan2022 12:00 (Lot number: FJ6369) at the age of 36 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "HTN" (unspecified if ongoing); "Known allergies: sulfa drugs" (unspecified if ongoing); "COVID-19" (unspecified if ongoing). Concomitant medication(s) included: OLMESARTAN. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot No: EL9261, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 04Feb2021, when the patient was 35 years old, for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE, Lot No: EL9261, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 21Feb2021, when the patient was 35 years old, for COVID-19 immunization, reaction(s): "Inappropriate schedule of vaccine administered".  The following information was reported: PAPILLARY THYROID CANCER (medically significant) with onset 14Feb2022, outcome "not recovered", described as "Papillary Thyroid Carcinoma". The event "papillary thyroid carcinoma" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: Nasal Swab. Therapeutic measures were taken as a result of papillary thyroid cancer. with Total thyroidectomy and RAI.  Clinical course: The patient did not received other vaccine in four weeks, and was treated with Total thyroidectomy and RAI. The patient had covid prior to vaccination and was tested for covid post vaccination.  No follow-up attempts are possible. No further information is expected; Sender's Comments: Based on limited information in the case , a possible causal association between   the reported  event papillary thyroid carcinoma and the suspect drug BNT162B2 cannot be 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
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Blood test, Computerised tomogram, Electrocardiogram, Magnetic resonance imaging
Clinical narrative: Had TIA and recently diagnosed with A-Fib; Had TIA and recently diagnosed with A-Fib; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Oct2021 (Lot number: FF2590) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "mild copd" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Left), administration date: 28Mar2021, when the patient was 58 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6199), administration date: 03Mar2021, when the patient was 58 years old, for COVID-19 Immunization. The following information was reported: ATRIAL FIBRILLATION (medically significant), TRANSIENT ISCHAEMIC ATTACK (medically significant) all with onset Nov2021, outcome "not recovered" and all described as "Had TIA and recently diagnosed with A-Fib". The event "had tia and recently diagnosed with a-fib" and "had tia and recently diagnosed with a-fib" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood test: unknown results; computerised tomogram: unknown results; electrocardiogram: unknown results; magnetic resonance imaging: unknown results. Therapeutic measures were taken as a result of atrial fibrillation, transient ischaemic attack.  Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Transient ischaemic attack
Clinical narrative: Had TIA and recently diagnosed with A-Fib; Had TIA and recently diagnosed with A-Fib; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Oct2021 (Lot number: FF2590) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "mild copd" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Left), administration date: 28Mar2021, when the patient was 58 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6199), administration date: 03Mar2021, when the patient was 58 years old, for COVID-19 Immunization. The following information was reported: ATRIAL FIBRILLATION (medically significant), TRANSIENT ISCHAEMIC ATTACK (medically significant) all with onset Nov2021, outcome "not recovered" and all described as "Had TIA and recently diagnosed with A-Fib". The event "had tia and recently diagnosed with a-fib" and "had tia and recently diagnosed with a-fib" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood test: unknown results; computerised tomogram: unknown results; electrocardiogram: unknown results; magnetic resonance imaging: unknown results. Therapeutic measures were taken as a result of atrial fibrillation, transient ischaemic attack.  Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: his is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Apr2021 (Lot number: EW0153) at the age of 37 years as dose 2, single and administered in arm left, administration date 09Apr2021 10:45 (Lot number: EW0153) as dose 1, single for Covid-19 immunisation. Relevant medical history included: "allergies: SULFA" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 04Jan2022, outcome "unknown" and all described as "Test Nasal Swab: Result Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (28Dec2021) negative; (04Jan2022) positive; (12Jan2022) positive. Facility type vaccine was reported as other. No other vaccine in four weeks and no other medications in two weeks were reported. No follow-up attempts are needed. No further information is expected. Sender's Comments: The reported COVID-19 positive after both the doses of COVID-19 immunization is considered as vaccination failure of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 33-year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for Covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: Z-PAK; ZYRTEC ALLERGY. Past drug history included: Biaxin, reaction(s): "Known allergies: Biaxin". Vaccination history included: Covid-19 vaccine (Dose 2 single, unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 1 single, unknown manufacturer), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Clinical course: Anti-viral details: Product- COVID 19 Treatment. If treatment ae: No. Adverse event: Metallic taste in mouth. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 71 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 12Feb2022, outcome "unknown" and all described as "tested positive for Covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (12Feb2022) positive. Therapeutic measures were taken as a result of suspected Covid-19. Additional information: Tested positive for Covid on 12Feb2022 and subsequently received Paxlovid. She received both initial doses of the Pfizer BioNTech Covid-19 vaccine as well as the booster prior. Confirmed all three were the Pfizer BioNTech Covid-19 vaccine. She is scheduled to receive her second booster today at Pharmacy, is there any recommended interval between Paxlovid treatment and receiving the second booster shot. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Hepatic enzyme, Hepatic enzyme increased, Hepatitis C
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient. A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 20Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single, administration date 09Apr2021 (Batch/Lot number: unknown) as dose 2, single and administration date 17Mar2021 (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEPATITIS C (medically significant), outcome "unknown", described as "Hep C"; HEPATIC ENZYME INCREASED (non-serious) with onset 2021, outcome "unknown", described as "No history of elevated liver levels enzymes etc. until after two vaccinations and the booster". The patient underwent the following laboratory tests and procedures: hepatic enzyme: (2021) elevated. Therapeutic measures were taken as a result of hepatitis C. Clinical course: The patient asked Where can find copies of liver impact studies related to the Pfizer Vaccine. The patient do not fall into any of the categories related to risk for Hep C infection. Any guidance you can provide as to current clinical trials or studies would be appreciated. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Hepatitis C
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient. A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 20Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single, administration date 09Apr2021 (Batch/Lot number: unknown) as dose 2, single and administration date 17Mar2021 (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEPATITIS C (medically significant), outcome "unknown", described as "Hep C"; HEPATIC ENZYME INCREASED (non-serious) with onset 2021, outcome "unknown", described as "No history of elevated liver levels enzymes etc. until after two vaccinations and the booster". The patient underwent the following laboratory tests and procedures: hepatic enzyme: (2021) elevated. Therapeutic measures were taken as a result of hepatitis C. Clinical course: The patient asked Where can find copies of liver impact studies related to the Pfizer Vaccine. The patient do not fall into any of the categories related to risk for Hep C infection. Any guidance you can provide as to current clinical trials or studies would be appreciated. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Tinnitus
Clinical narrative: Tinnitus; Gestational period: 30; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Jul2021 (Lot number: ER8736) at the age of 32 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient was 30 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 05Oct2021. Concomitant medication(s) included: ENALAPRIL MALEATE; LEXAPRO in two week. Past drug history included: Known allergies: calcium channel blocker, reaction(s): "Known allergies: Calcium channel blocker". No other vaccine taken in four weeks. No covid prior to vaccination and no covid tested post vaccination. The following information was reported: TINNITUS (disability) with onset 31Jul2021, outcome "not recovered", described as "Tinnitus"; MATERNAL EXPOSURE DURING PREGNANCY (non-serious), outcome "unknown", described as "Gestational period: 30". The event "tinnitus" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of tinnitus. Clinical course: Last menstrual date: 25Dec2021 (as reported). Facility type vaccine was Pharmacy or Drug Store. Dose 2 administered in left arm, administration date was 20Aug2021 with lot no. FD8448 and Vaccine location for dose 3 on left arm, administration date was 17Feb2022.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Muscle disorder, Pain
Clinical narrative: 65yr old) had pain in his whole body after Pfizer Covid19 vaccine 2nd dose, his muscles shut down, he couldn't move, they put him in hospital; 65yr old) had pain in his whole body after Pfizer Covid19 vaccine 2nd dose, his muscles shut down, he couldn't move, they put him in hospital; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  A 65 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Unknown manufacturer, Primary Immunization completed, Dose 1), for COVID-19 immunization. The following information was reported: MUSCLE DISORDER (hospitalization), PAIN (hospitalization) all with onset 25Mar2021, outcome "not recovered" and all described as "65yr old) had pain in his whole body after Pfizer Covid19 vaccine 2nd dose, his muscles shut down, he couldn't move, they put him in hospital".   Clinical course: Given dose at 10:30 that should have been discarded at 04:30.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Electrocardiogram ST segment abnormal, Fatigue, Illness, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Other HCP), Nurse from product quality group. A 47-year-old male patient received bnt162b2 (BNT162B2), administration date 12Oct2021 (Lot number: FF2589) at the age of 46 years as dose 3 (booster), single, administration date 18Mar2021 (Lot number: EL3247) as dose 2, single and administration date 23Feb2021 (Lot number: EL3247) as dose 1, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30Mar2022, outcome "unknown" and all described as "PCR was positive"; ILLNESS (non-serious) with onset 29Mar2022, outcome "unknown", described as "Sick"; ELECTROCARDIOGRAM ST SEGMENT ABNORMAL (non-serious) with onset 01Apr2022, outcome "unknown", described as "mild ST"; FATIGUE (non-serious) with onset 01Apr2022, outcome "unknown", described as "Fatigue". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (30Mar2022) positive, notes: COVID test name post vaccination: PCR. Clinical Course: There were no Seriousness criteria that Resulted in death, Congenital anomaly/birth defect and Disabling/Incapacitating. There were no seriousness criteria that was Life threatening and that Caused/prolonged hospitalization. It was unknown whether patient receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. COVID test type post vaccination was Unknown. Device Date was 01Apr2022. No follow-up attempts are possible. No further information is expected. Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events of COVID-19 and Vaccination failure due to temporal relationship.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Other HCP), Nurse from product quality group. A 47-year-old male patient received bnt162b2 (BNT162B2), administration date 12Oct2021 (Lot number: FF2589) at the age of 46 years as dose 3 (booster), single, administration date 18Mar2021 (Lot number: EL3247) as dose 2, single and administration date 23Feb2021 (Lot number: EL3247) as dose 1, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30Mar2022, outcome "unknown" and all described as "PCR was positive"; ILLNESS (non-serious) with onset 29Mar2022, outcome "unknown", described as "Sick"; ELECTROCARDIOGRAM ST SEGMENT ABNORMAL (non-serious) with onset 01Apr2022, outcome "unknown", described as "mild ST"; FATIGUE (non-serious) with onset 01Apr2022, outcome "unknown", described as "Fatigue". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (30Mar2022) positive, notes: COVID test name post vaccination: PCR. Clinical Course: There were no Seriousness criteria that Resulted in death, Congenital anomaly/birth defect and Disabling/Incapacitating. There were no seriousness criteria that was Life threatening and that Caused/prolonged hospitalization. It was unknown whether patient receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. COVID test type post vaccination was Unknown. Device Date was 01Apr2022. No follow-up attempts are possible. No further information is expected. Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events of COVID-19 and Vaccination failure due to temporal relationship.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from product quality group. The reporter is the patient. A 16-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 21Aug2021 (Lot number: FC3182) at the age of 16 years as dose 2, single and administration date 21Jun2021 (Lot number: Ew0186) as dose 1, single for Covid-19 immunisation. Relevant medical history included: "If Covid prior vaccination: Yes" (unspecified if ongoing), notes: If Covid prior vaccination: Yes; "Known allergies: Tree nuts" (unspecified if ongoing), notes: Known allergies: Tree nuts. The patient took concomitant medications. The following information was reported: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Covid diagnosed between 2nd vaccine and booster". Clinical Course: Facility type vaccine was Pharmacy or Drug Store. There was no other vaccine in four weeks. There was other medications in two weeks. Covid was not tested post vaccination.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Investigation, Malaise, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the parent. A 17 year-old male patient received bnt162b2 (BNT162B2), administration date 10Apr2021 (Lot number: EP6955, Expiration Date: 30Jun2021) at the age of 16 years as dose 2, single and administration date 20Mar2021 (Lot number: EP6955, Expiration Date: 30Jun2021) as dose 1, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03Apr2022, outcome "unknown" and all described as "tested positive for COVID-19"; OROPHARYNGEAL PAIN (non-serious) with onset 31Mar2022, outcome "unknown", described as "a severe sore throat"; MALAISE (non-serious), outcome "unknown", described as "generally not feeling well". The patient underwent the following laboratory tests and procedures: investigation: (31Mar2022) positive; sars-cov-2 test: (03Apr2022) positive, notes: on a home test; (31Mar2022) negative, notes: (rapid and PCR). No follow-up attempts are possible. No further information is expected.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the parent. A 17 year-old male patient received bnt162b2 (BNT162B2), administration date 10Apr2021 (Lot number: EP6955, Expiration Date: 30Jun2021) at the age of 16 years as dose 2, single and administration date 20Mar2021 (Lot number: EP6955, Expiration Date: 30Jun2021) as dose 1, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03Apr2022, outcome "unknown" and all described as "tested positive for COVID-19"; OROPHARYNGEAL PAIN (non-serious) with onset 31Mar2022, outcome "unknown", described as "a severe sore throat"; MALAISE (non-serious), outcome "unknown", described as "generally not feeling well". The patient underwent the following laboratory tests and procedures: investigation: (31Mar2022) positive; sars-cov-2 test: (03Apr2022) positive, notes: on a home test; (31Mar2022) negative, notes: (rapid and PCR). No follow-up attempts are possible. No further information is expected.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Type 1 diabetes mellitus
Clinical narrative: Type 1 Diabetes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 10 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Dec2021 10:15 (Batch/Lot number: unknown) at the age of 10 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. No known allergies. No covid prior vaccination. No covid tested post vaccination. Vaccination history included: Bnt162b2 (Prev dose administration time: 02:00 PM, Prev dose dose number: 1, Prev dose vaccine location: Left arm), administration date: 22Nov2021, when the patient was 10 years old, for Covid-19 immunization. The following information was reported: TYPE 1 DIABETES MELLITUS (hospitalization, disability, life threatening) with onset Dec2021, outcome "recovered with sequelae", described as "Type 1 Diabetes". The patient was hospitalized for type 1 diabetes mellitus (hospitalization duration: 3 day(s)). The event "type 1 diabetes" was evaluated at the physician office visit. Therapeutic measures were taken as a result of type 1 diabetes mellitus including Insulin treatment. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Inflammation, Lymphadenitis, Lymphadenopathy, Neoplasm malignant
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 77 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number: Unknown, Manufacturer: Unknown), for Covid-19 immunization. The following information was reported: NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "cancer"; SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant), outcome "unknown", described as "Inactive lupus"; INFLAMMATION (non-serious), outcome "not recovered", described as "inflammation in the body"; LYMPHADENOPATHY (non-serious), outcome "not recovered", described as "the size of the lymph nodes was related to the vaccine/enlargement and inflammation of the lymph glands"; LYMPHADENITIS (non-serious), outcome "not recovered", described as "inflammation of the lymph glands". It was reported that she has had some reactions in relation to the fact that she had some inflammation in the body, enough to go to rheumatologist who said she has lupus and that's when the information on the papers stopped. Caller states since that time, the rheumatologist said she has inactive lupus. Caller states the size of the lymph nodes was related to the vaccine, but probably not the cancer. Caller states her oncologist said it was unusual problem but recommended her to contact Pfizer. Caller was asking have you had other people with activated lupus after receiving the Pfizer Covid-19 vaccine. The patient underwent the following laboratory tests and procedures: biopsy: cancer, notes: Caller states she spoke with an oncologist regarding the enlargement and inflammation of the lymph glands that happened after the booster that have not gone away, therefore they did a biopsy and as a result found cancer. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Follow-up (07Apr2022): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Systemic lupus erythematosus
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 77 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number: Unknown, Manufacturer: Unknown), for Covid-19 immunization. The following information was reported: NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "cancer"; SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant), outcome "unknown", described as "Inactive lupus"; INFLAMMATION (non-serious), outcome "not recovered", described as "inflammation in the body"; LYMPHADENOPATHY (non-serious), outcome "not recovered", described as "the size of the lymph nodes was related to the vaccine/enlargement and inflammation of the lymph glands"; LYMPHADENITIS (non-serious), outcome "not recovered", described as "inflammation of the lymph glands". It was reported that she has had some reactions in relation to the fact that she had some inflammation in the body, enough to go to rheumatologist who said she has lupus and that's when the information on the papers stopped. Caller states since that time, the rheumatologist said she has inactive lupus. Caller states the size of the lymph nodes was related to the vaccine, but probably not the cancer. Caller states her oncologist said it was unusual problem but recommended her to contact Pfizer. Caller was asking have you had other people with activated lupus after receiving the Pfizer Covid-19 vaccine. The patient underwent the following laboratory tests and procedures: biopsy: cancer, notes: Caller states she spoke with an oncologist regarding the enlargement and inflammation of the lymph glands that happened after the booster that have not gone away, therefore they did a biopsy and as a result found cancer. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Follow-up (07Apr2022): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.