chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Off label use, Product use issue, Pruritus, Rash
Clinical narrative: states that she is also postpartum and nursing; states that she is also postpartum and nursing; rash on her legs and arms that has turned into severe itching/rash on the torso; severely itchy rash, afraid it will get infected; rash was kind of like hives in the arms and legs.; rash on her legs and arms that has turned into severe itching; bruising on her legs/big bruise on her leg that is now on both arms and legs; This is a spontaneous report from a contactable pharmacist reported information for both mother and fetus/baby. This is the maternal case. Only this case is serious. A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 intramuscular, administered in left arm on 18Aug2021 (Batch/Lot Number: FC3182) as dose 2, 0.3 ml single (at the age of 32 years old) for COVID-19 immunisation.  Medical history included allergies: seasonal allergy and postpartum disorder from 20Jul2021 to an unknown date. There were no concomitant medications.  The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 intramuscular, administered in left arm on 28Jul2021 around 2:00 or 3:00pm (Batch/Lot Number: FA7485) for COVID-19 immunisationThe patient experienced two weeks later she developed a rash on her legs and arms that has turned into severe itching. She is also experiencing bruising on her legs on 04Sep2021.  Severely itchy rash, afraid it will get infected, rash on the torso. The rash was kind of like hives in the arms and legs. Treatment: She took Claritin for allergies and a topical steroid cream, Fluticasone. The patient stated that she is also postpartum (20Jul2021) and nursing. The events worsened and the reported as medically significant. The outcome of rash was kind of like hives in the arms and legs was unknown and other events was not recovered. The reaction was assessed by the primary reporter and global instrospection as related to the vaccine.; Sender's Comments: Based on the information currently available, The casual association between the reported events and suspected vaccine BNT162B2 cannot 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.,Linked Report(s) : US-PFIZER INC-202101208347 baby case
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Urticaria
Clinical narrative: states that she is also postpartum and nursing; states that she is also postpartum and nursing; rash on her legs and arms that has turned into severe itching/rash on the torso; severely itchy rash, afraid it will get infected; rash was kind of like hives in the arms and legs.; rash on her legs and arms that has turned into severe itching; bruising on her legs/big bruise on her leg that is now on both arms and legs; This is a spontaneous report from a contactable pharmacist reported information for both mother and fetus/baby. This is the maternal case. Only this case is serious. A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 intramuscular, administered in left arm on 18Aug2021 (Batch/Lot Number: FC3182) as dose 2, 0.3 ml single (at the age of 32 years old) for COVID-19 immunisation.  Medical history included allergies: seasonal allergy and postpartum disorder from 20Jul2021 to an unknown date. There were no concomitant medications.  The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 intramuscular, administered in left arm on 28Jul2021 around 2:00 or 3:00pm (Batch/Lot Number: FA7485) for COVID-19 immunisationThe patient experienced two weeks later she developed a rash on her legs and arms that has turned into severe itching. She is also experiencing bruising on her legs on 04Sep2021.  Severely itchy rash, afraid it will get infected, rash on the torso. The rash was kind of like hives in the arms and legs. Treatment: She took Claritin for allergies and a topical steroid cream, Fluticasone. The patient stated that she is also postpartum (20Jul2021) and nursing. The events worsened and the reported as medically significant. The outcome of rash was kind of like hives in the arms and legs was unknown and other events was not recovered. The reaction was assessed by the primary reporter and global instrospection as related to the vaccine.; Sender's Comments: Based on the information currently available, The casual association between the reported events and suspected vaccine BNT162B2 cannot 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.,Linked Report(s) : US-PFIZER INC-202101208347 baby case
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headaches almost daily; This is a spontaneous report from a contactable other healthcare professional (patient). A non-pregnant 36-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly in the right arm on 19Jan2021 at 13:15 (at the age of 35-years-old) at dose 2, single for COVID-19 immunisation. Medical history included endometriosis. The patient had not COVID prior vaccination and no COVID tested post vaccination. Concomitant medications were reported as none. The patient did not receive other vaccine in four weeks and other medications in two weeks. The patient received the first dose of BNT162b2 intramuscularly, in the right arm, in Dec2020 at 13:15, at the age of 35-years-old, for COVID-19 immunization. The patient would very rarely get a headache before taking the COVID vaccine. A few months after taking vaccine, since 18Feb2021, she had headaches almost daily. At times had to miss work due to the severeness of headache which was not like her to do at all. No treatment was received for the event. The patient had not recovered from the event.   The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the limited information in the case, a possible retalitionship between BNT162B2 and the event headache cannot be completely ruled out. 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: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Loss of consciousness, Pain, Pyrexia
Clinical narrative: Passed out; Body pains; Very dizzy; High fever for over 24 hrs; This is a spontaneous report from a non-contactable consumer (patient). A 23-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: Unknown, Expiration date: Not reported), via an unspecified route of administration in left arm on 13Sep2021 at 13:00 (at the age of 23-years-old) as dose 2, single for COVID-19 immunization in a pharmacy or drug Store. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported), via an unspecified route of administration, on an unspecified date as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. No other vaccines within 4 weeks prior to COVID vaccination. Prior vaccination, the patient was not diagnosed with COVID-19 and post vaccination, the patient was not tested for COVID-19. The patient was passed out, felt very dizzy, had body pains and high fever for over 24 hrs on 13Sep2021 at 15:45. It was unknown if the patient received treatment for these events. The outcome of the events was not recovered at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis, Thrombosis
Clinical narrative: I also spit up blood clots; Nose bleed; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 24Feb2021 12:00 (at the age of 62-year-old) (Lot number and expiration date was not reported) as dose 1, single for COVID-19 immunization. The vaccine was administered in a hospital. Medical history included diabetic and hypertension. The patient did not have any known allergies. The patient took other medications (unspecified) in two weeks prior to COVID vaccination. The patient did not receive any other vaccine within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient experienced severe nose bleed on 08Mar2021 20:00 which lasted over 20 minutes. The patient was transported to nearby hospital for examination. The patient spat up blood clots during transport and at hospital. The patient received anti-blood clot treatment for the events. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Hypotension
Clinical narrative: Hypotension (extreme drop of blood pressure); Dizziness; This is a spontaneous report from a Pfizer-sponsored program from a contactable physician.    A 66-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date, at single dose, for COVID-19 immunization. Relevant medical history and concomitant medications were unknown. The patient previously, on an unspecified date, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose, for COVID-19 immunization. On an unspecified date, in Feb2021, the patient experienced hypotension (extreme drop of blood pressure) and dizziness. She had episodes of hypotension to approximately 60-70 systolic over 40, dizziness and extreme drop of blood pressure that lasted for about an hour that was not associated with chest pain or shortness of breath. These hypotensive episodes never happened to her before. Clinical outcome of the adverse events was unknown at time of this report.    The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Hypotension and BNT162B2.  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: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Menstruation irregular, Thrombosis
Clinical narrative: with blood clotting; I had a late menstrual cycle that lasted almost 2 weeks; very painful; very heavy; This is a spontaneous report from a contactable consumer (patient). A 38-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in the left arm on 15May2021 (Batch/Lot Number: ER8736) as dose 2, single (at the age of 38-years-old), for Covid-19 immunisation. Medical history included hyperthyroidism, known allergies: shellfish and COVID-19 from an unknown date and unknown if ongoing. Concomitant medication included methimazole (METHIMAZOLE) 5mg/daily taken for an unspecified indication, start and stop date were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in the left arm on 24Apr2021 (Batch/Lot Number: EW0169) as dose 1, single (at the age of 37-years-old) for Covid-19 immunisation. The patient had no other vaccine in four weeks. It was reported that less than 2 weeks after her second dose on 15May2021, on 28May2021, she had a late menstrual cycle that lasted almost 2 weeks, very painful, very heavy with blood clotting and not normal for her. She historically has very easy, short (3 days), non-painful cycles. After she had that cycle in late May, she has not had a cycle since then. It is nonexistent. She is not pregnant; she recently took a test with her physician in their office. The patient had not tested for Covid post vaccination. No treatment was administered for the events. The patient had not recovered from the events at the time of the report. The events resulted in Physician Office Visit.   No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Cardiac failure congestive, Dyspnoea, Peripheral swelling, Polyuria
Clinical narrative: either going into congestive heart failure or acute renal failure; either going into congestive heart failure or acute renal failure; Gained weight; difficulty breathing; significant swelling of feet and lower extremities; continuing large diureses; This is a spontaneous report from a contactable physician (patient). A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ek1283), via an unspecified route of administration in left arm on 06Jan2021 (at the age of 59-years-old) as dose 2, single for COVID-19 immunization. Medical history included asthma, psoriatic arthritis, hereditary pressure point neuropathy, Sulfa allergy, latex allergy, and penicillin allergy. Concomitant medications included omeprazole (PRILOSEC); trazodone hydrochloride (TRAZODON) and ASA. The patient previously took NEURONTIN and experienced drug allergy. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ek2730), via an unspecified route of administration in right arm on an unspecified date in Dec2020 (at the age of 59-years-old) as dose 1, single for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19 and did not receive any vaccines within four weeks. The patient experienced either going into congestive heart failure or acute renal failure, gained weight, difficulty breathing, significant swelling of feet and lower extremities and continuing large diuresis on 19Jan2021. It was reported that starting 4 days after inoculation, patient was either going into congestive heart failure or acute renal failure. From symptoms it was probably congestive heart failure. Gained weight despite fluid restriction and Lasix, difficulty breathing and significant swelling of feet and lower extremities. Starting just before two weeks after onset of symptoms, patient experienced a continuing large diuresis and felt much better but have not returned to base line. Patient was treated with Lasix and fluid restriction. Since the vaccination, patient has not been tested for COVID-19. Outcome of events was resolved with sequel.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Weight increased
Clinical narrative: either going into congestive heart failure or acute renal failure; either going into congestive heart failure or acute renal failure; Gained weight; difficulty breathing; significant swelling of feet and lower extremities; continuing large diureses; This is a spontaneous report from a contactable physician (patient). A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ek1283), via an unspecified route of administration in left arm on 06Jan2021 (at the age of 59-years-old) as dose 2, single for COVID-19 immunization. Medical history included asthma, psoriatic arthritis, hereditary pressure point neuropathy, Sulfa allergy, latex allergy, and penicillin allergy. Concomitant medications included omeprazole (PRILOSEC); trazodone hydrochloride (TRAZODON) and ASA. The patient previously took NEURONTIN and experienced drug allergy. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ek2730), via an unspecified route of administration in right arm on an unspecified date in Dec2020 (at the age of 59-years-old) as dose 1, single for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19 and did not receive any vaccines within four weeks. The patient experienced either going into congestive heart failure or acute renal failure, gained weight, difficulty breathing, significant swelling of feet and lower extremities and continuing large diuresis on 19Jan2021. It was reported that starting 4 days after inoculation, patient was either going into congestive heart failure or acute renal failure. From symptoms it was probably congestive heart failure. Gained weight despite fluid restriction and Lasix, difficulty breathing and significant swelling of feet and lower extremities. Starting just before two weeks after onset of symptoms, patient experienced a continuing large diuresis and felt much better but have not returned to base line. Patient was treated with Lasix and fluid restriction. Since the vaccination, patient has not been tested for COVID-19. Outcome of events was resolved with sequel.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Cardiac monitoring, Dyspnoea, SARS-CoV-2 test
Clinical narrative: a few heart flutter episodes; After the first vaccine a few heart flutter episodes and shortness of breath each day of the first week; This is a spontaneous report from a contactable consumer (patient). A 34-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 1 at vaccination age of 34-year-old via an unspecified route of administration in the left arm on 02Aug2021 at 15:00 (Lot Number: EV00181) as dose 1, single for covid-19 immunisation. Medical history included supraventricular tachycardia (SVT) in 2004 and catheter ablation was performed. The patient was patient diagnosed with COVID-19 prior to vaccination. The patient has no known allergies. Concomitant medications included valacyclovir [valaciclovir] (VALACYCLOVIR); fish oil; and ascorbic acid, betacarotene, biotin, calcium amino acid chelate, calcium pantothenate, chromium amino acid chelate, copper amino acid chelate, cyanocobalamin, equisetum arvense stem, ferrous fumarate, folic acid, laminaria digitata powder, magnesium oxide, manganese amino acid chelate, nicotinamide, oenothera biennis oil, potassium amino acid chelate, pyridoxine hydrochloride, riboflavin, selenium amino acid chelate, thiamine mononitrate, zinc amino acid chelate (reported as OLLY WOMEN'S MULTI); all indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 02Aug2021 at 19:30 after the first vaccine, the patient experienced a few heart flutter episodes and shortness of breath each day of the first week. It was further reported that after the first vaccine, a few heart flutter episodes and shortness of breath each day of the first week but then she wore a heart monitor the week before the second dose. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient considered as the adverse events as non-serious. The events did not result in hospitalization. The patient has been tested for COVID-19 since vaccination. She had Pixel nasal swab on 02Sep2021 and on 07Sep2021 with both having the results of negative. The patient did not received treatment for the adverse events. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blindness
Clinical narrative: Losing vision in right eye; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19  VACCINE, Solution for injection; lot number: EP7534 and expiration date: not reported), via an unspecified route of administration,  in Left Arm on 2021 (as DOSE 1, SINGLE and BNT162B2 (PFIZER-BIONTECH COVID-19  VACCINE, Solution for injection; lot number: EW0151 and expiration date: not reported), via an unspecified route of administration, in Left Arm on 2021, as DOSE 2, SINGLE both for covid-19 immunization in Pharmacy or Drug Store. Medical history included cancer (Cancer survivor),  and allergies to many medications (Too many medications to list). Concomitant medications included levothyroxine, buspirone, hydroxyzine and sucralfate. The patient was not pregnant at time of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID -19 vaccine. It was unknown if the Patient had been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient experienced losing vision in right eye on Mar2021.The event resulted in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. No treatment was received for the adverse event. The Outcome of the event was not recovered at time of report.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Hyperpyrexia
Clinical narrative: his wife's relative got a fever of 107F after the second dose of the Pfizer COVID-19 vaccine.; This is a spontaneous report from a non-contactable consumer received from a Pfizer-sponsored program via medical information team. A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported), via an unspecified route of administration, on an unspecified date as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that his wife's relative got a fever of 107 F after the second dose of the pfizer COVID-19 vaccine on an unspecified date. The reporter would like to know if Pfizer can provide any guarantee or anything that will say that the Pfizer COVID-19 vaccine is safe for the next 10 years and wanted to know that how long this vaccine immunity last. The reporter also stated that how would he know that the vaccine is not going to cause cancer and how would he know that it will not cause any long term side effects and added if he's going to be dead if he takes the vaccine. The reporter also wanted to know that if it's normal to have a fever of 107 F after receiving the second dose of the Pfizer COVID-19 vaccine and also asked is Pfizer mandating its employees to get the Pfizer COVID-19 vaccine. The reporter also stated that how could they say that the vaccine was safe. They have drugs out there for 10 years on the market and they pull over, change the formula and put it back on the market (referring to ranitidine). The outcome of the event was unknown at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Abscess, Myalgia, Pain in extremity, Peripheral swelling, Rash
Clinical narrative: severe swelling and muscle ache in left deltoid; Rash on left deltoid; abscess formation; warm; painful; swollen; severe swelling and muscle ache in left deltoid; This is a spontaneous report from a contactable nurse (Patient). A 41-year-old non pregnant female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0186), via an unspecified route of administration, administered in Arm Left on 23Aug2021 16:00 as dose 1, single and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0186) via an unspecified route of administration, administered in Arm Left on 23Aug2021 16: as dose 2, single for covid-19 immunisation. Medical history included penicillin allergy. Concomitant medication include Vitamin d3, folate, zinc, b12 [CYANOCOBALAMIN]) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with covid prior to vaccination. The patient experienced rash on left deltoid, severe swelling and muscle ache in left deltoid, abscess formation, warm, painful, and swollen on 13Sep2021 15:00. The patient received treatment in response to the events. The patient underwent lab tests and procedures which included Covid antibody IgH/IgM test, Blood test was negative on 22Aug2021.  The outcome of the event as not recovered.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Skin warm, Swelling
Clinical narrative: severe swelling and muscle ache in left deltoid; Rash on left deltoid; abscess formation; warm; painful; swollen; severe swelling and muscle ache in left deltoid; This is a spontaneous report from a contactable nurse (Patient). A 41-year-old non pregnant female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0186), via an unspecified route of administration, administered in Arm Left on 23Aug2021 16:00 as dose 1, single and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0186) via an unspecified route of administration, administered in Arm Left on 23Aug2021 16: as dose 2, single for covid-19 immunisation. Medical history included penicillin allergy. Concomitant medication include Vitamin d3, folate, zinc, b12 [CYANOCOBALAMIN]) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with covid prior to vaccination. The patient experienced rash on left deltoid, severe swelling and muscle ache in left deltoid, abscess formation, warm, painful, and swollen on 13Sep2021 15:00. The patient received treatment in response to the events. The patient underwent lab tests and procedures which included Covid antibody IgH/IgM test, Blood test was negative on 22Aug2021.  The outcome of the event as not recovered.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Overdose, Rheumatoid arthritis
Clinical narrative: RA flare"bonus" period; Inappropriate schedule of vaccine administered; product=COVID 19, lot =EN6202; other_vaccine_same_date_lot =ER8730, other_vaccine_same_date_dose =2; other_vaccine_same_date_lot =FC182, other_vaccine_same_date_dose =1; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number FC182 and expiry date not reported), via an unspecified route of administration, on 12Sep2021, as dose 1, single, and then second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number ER8730 and expiry date not reported) via an unspecified route of administration, on 12Sep2021, as dose 2, single and then third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EN6202 expiry date not reported) via an unspecified route of administration, administered in Arm Left, on 12Sep2021 11:00, as dose 3, single, all for covid-19 immunisation at the age of 51-year-old from Pharmacy or Drug Store. Medical history included ongoing rheumatoid arthritis (RA), penicillin allergy and sulfa allergy. Patient was not pregnant at the time of vaccination. Patient received unspecified medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was scheduled with inappropriate schedule of vaccine on 12Sep2021 11:00 and had overdose. The patient experienced RA flare "bonus" period on 14Sep2021. Patient received no treatment due to the event. The patient was not recovered from the event.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Hallucination
Clinical narrative: Possible hallucinations. Seeing things that are still, moving out of the corner of my eye; This is a spontaneous report from a non-contactable consumer (patient). A 27-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration, administered in arm left on 13Sep2021 10:00 at the age of 27-year-old as dose number unknown, single for covid-19 immunisation. The patient medical history was none and had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications were received within 2 weeks of vaccination. The patient was not diagnosed with covid prior to vaccination and patient was not tested for COVID-19 post vaccination. The patient experienced possible hallucinations. seeing things that are still, moving out of the corner of my eye on 14Sep2021 12:00. The patient did not receive any treatment in response to the event and patient was not hospitalized. The outcome of event was recovering.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Immune system disorder, Pain in extremity, Pyrexia
Clinical narrative: Low immune system; Feeling very tired; Fever; Vaccine arm was very sore; This is a spontaneous report based on information received by Pfizer from Corporation (Reference ID: NVSC2021US203163) via a non-contactable consumer (patient's daughter). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number and expiration date was not reported) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number and expiration date was not reported) as dose 1, single for COVID-19 immunization. The patient experienced low immune system, was feeling very tired, had fever, and vaccine arm was very sore on an unspecified date. The patient was hospitalized for low immune system for 2 days. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Haemoptysis, Investigation, Pulmonary thrombosis
Clinical narrative: I have developed blood clots in my lungs; I get my first shot that when I developed; I can not get my breath; I started coughing the blood; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration, in Feb2021 (reported as 07Feb2021 or 17Feb2021), as dose 1, single, for COVID-19 immunisation. The patient had no medical history and no concomitant medications. After first COVID shot in February, the patient developed blood clots in lungs. The patient could not get breath and started coughing the blood. The patient was hospitalized due to the events. It was reported that, the patient was going through so much problem. Before COVID shot the patient was in real good state. The patient was put on a blood thinner, Eliquis due to blood clot in lungs he was still sick, and a team of doctors got together 2 weeks ago and determined that it was from the Pfizer vaccine. It was also reported that, the patient was given a test in hospital, the result was not reported. The outcome for blood clots in lungs was not recovered while for other events was unknown.   The lot number for BNT162B2, was not provided and will be requested during follow up.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; This is a spontaneous report from a contactable consumer (patient). This 88-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28May2021, at the age of 88 years, as the second single dose, for COVID-19 immunization. No other vaccine was administered in four weeks. Medical history included penicillin allergy, sulfa allergy and COVID-19 prior vaccination. The patient was not pregnant. The patient received the first dose of BNT162B2 vaccine 06May2021 at 10:00 AM, experiencing rash and itching 10 days after vaccination. Concomitant medications were not reported. The patient received the second dose of vaccine on 28May2021. Rash was still on body after 4 months. COVID was not tested after vaccination. Rash had not yet resolved.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101206952 same pt/drug, event from diff dose
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Dyspnoea, Inappropriate schedule of product administration, Oxygen saturation, Oxygen saturation decreased
Clinical narrative: Date of First shot: 14Aug2021, Date of Second shot: 28Aug2021; spO2 was at 73 percent; Pretty severe asthma attacks; Had a very hard time breathing; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FC3183; Expiration date was not reported) on the left deltoid on 28Aug2021 as dose 2, single, with route of administration unspecified, for COVID-19 immunization at the hospital. The patient's medical history was not reported. Concomitant medications included an unspecified antidepressant. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: FD8448; Expiration date was not reported) on 14Aug2021 (at the age of 28 years old) for COVID-19 immunization, and had And had difficult time breathing, big rash on the back and chest, back was itching and there were like at least a 100 small red bumps covering the entire back migrating towards the spinal area. On 28Aug2021, the patient had received the second dose of vaccination, when the first dose of vaccination was received on 14Aug2021. On an unspecified date in 2021, after the second dose of vaccination, the patient's oxygen saturation (SpO2) was at 73 percent; patient had pretty severe asthma attacks; and had a very hard time breathing. It took the patient "like 15 days" for the breathing to return to normal; breathing was being so compromised. The event, oxygen saturation at 73 percent, was assessed as serious (medically significant). The patient had received albuterol as treatment for the reported events. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Limb mass, Menstrual disorder, Menstruation delayed
Clinical narrative: lump under left arm; blood clots during menstrual cycle; late menstrual cycle; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at the age of 41-years-old ), dose 1 via an unspecified route of administration, administered in arm left on 22May2021 09:45 (Batch/Lot Number: EN6208) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included ulcerative colitis from an unknown date and unknown if ongoing. Concomitant medication included ethinylestradiol, norgestimate (TRI-CYCLEN LO) taken for an unspecified indication, start and stop date were not reported. The patient was not pregnant. The patient had no other vaccine in four weeks. The patient had no known allergies. She did not have covid-19 prior vaccination. She had not been tested with covid post vaccination. The patient experienced lump under left arm, blood clots during menstrual, and cycle late menstrual cycle on 24May2021 with outcome of not recovered. The patient received no treatment for the events. The second dose of the vaccine was given on 12Jun2021 (lot number: ER8730).  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Exercise tolerance decreased, Loss of personal independence in daily activities, Tremor
Clinical narrative: A Football player ended up and can't run anymore 7 Miles that he used to; when he walks he is trembling only; he doesn't have his life anymore; This is a spontaneous report from a non-contactable consumer (friend's husband).   A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported, via an unspecified route of administration on an unspecified date as dose number unknown, single for an unspecified indication.  The patient medical history and concomitant medications were not reported.  The patient was a football player ended up and can't run anymore 7 Miles that he used to, he quit football and he was in bed, when he walks he was trembling only, crippled and he doesn't have his life anymore. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Cardiac arrest, Interchange of vaccine products, Myocarditis, Off label use
Clinical narrative: myocarditis; In the Emergency truck she had to get and then connect to restart her heart again.; She didn't even wait for 5 months from Moderna and got another vaccine from Pfizer; She didn't even wait for 5 months from Moderna and got another vaccine from Pfizer; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE)  via an unspecified route of administration on an unspecified date in 2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received MODERNA COVID-19 VACCINE in Apr2021 for COVID-19 immunization. The reporter stated that initially in Apr2021 and the patient was hospitalized and out from Hospital with nursing facility for Apr2021, May2021, Jun2021, Jul2021 because she has been in different Hospital. She didn't even wait for 5 months from Moderna and got another vaccine from Pfizer, she got vaccinated by Pfizer on an unspecified date in 2021 and in that time period she got myocarditis. She ended up in the intensive care unit. In the Emergency truck she had to get and then connect to restart her heart again. She never had myocarditis issue before she was been given multiple tablets of sodium (treatment) by her medical doctor. Doctors were treating with morphine but they were giving her multiple tablets but at the end of the day, so what is the combination of Moderna and then getting the Pfizer vaccine within 2 months. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Renal infarct
Clinical narrative: left kidney infarcted; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration, administered in the left arm on 26Aug2021 (Lot Number: FC3184) as dose 2, single for COVID-19 immunization.  Medical history included COVID-19 on an unknown date prior to vaccination. The patient had no known allergies. Concomitant medications included zinc (manufacturer unknown); vitamin c (manufacturer unknown) and vitamin d (manufacturer unknown) all taken for an unspecified indication, start and stop date were not reported. The patient did not receive other vaccines in 4 weeks. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine) on 02Aug2021 (lot number: FA7485) in the left arm for COVID-19 immunization. The patient was not tested for COVID post vaccination. On 01Sep2021, the patient's left kidney infarcted. The patient spent two days in the hospital from 01Sep2021 to 02Sep2021 and was readmitted on 08Sep2021 to 14Sep2021 as the affected kidney area expanded to damage more of his kidney. The event resulted in an emergency room visit, hospitalization and disability/permanent damage. The patient was hospitalized for a total of 9 days. The patient received heparin, Lovenox and coumadin as treatment for the event. The outcome of the event was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Dyspnoea, Eye movement disorder, Gait disturbance, Heart rate irregular
Clinical narrative: Losing my breath; My fingers in my left arm (where I got my vaccine) started going numb; Prolonged panic attack; I was shaking profusely; Lost feeling in my fingers and legs; My heartbeat felt really irregular; My body went limp and I fell out of the bed; Unable to swallow; My eyes rolling in the back of my head; Unable to sit up; This is a spontaneous report from a contactable other HCP (patient). This 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at left arm at single dose for COVID-19 immunisation on 21Dec2020 at 12:30 (35-year-old at the time of vaccination). The Lot number reported as EH9899, EH1284, EW0153 (pending clarification). Relevant history was unknown. Relevant concomitant drug included fluoxetine hydrochloride (PROZAC). No other vaccine in four weeks. Known allergy was None. The patient was not pregnant. Within 30 minutes after receiving the vaccine on 21Dec2020 at 01:15 PM, her fingers in her left arm (where she got her vaccine) started going numb. Her heartbeat felt really irregular and she started losing her breath. Her husband immediately took her to the emergency department. She was shaking profusely, lost feeling in her fingers and legs, was unable to swallow, unable to sit up, and her eyes rolling in the back of her head. She felt as if she was having a prolonged panic attack but with no feeling in her body and that she could not breathe. She arrived at the hospital, they immediately put her in a bed, her body went limp and she fell out of the bed. They then took an EKG and saw her heart was beating irregular and that she needed medication to calm her heart down. Additional lab tests included Holters and MRI with unknown result. AES resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment therapy was received (not specified). Outcome of events was not resolved. No COVID prior vaccination. No COVID test post vaccination.; Sender's Comments: Based on known temporal relationship there is reasonable possibility of causal association between the events Dyspnoea, Hypoaesthesia, Panic attack, tremor, sensory loss, heart rate irregular, gait disturbance, dysphagia, eye movement disorder, sitting disability and the suspect drug BNT162B2.  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: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Panic attack, Sensory loss, Sitting disability, Tremor
Clinical narrative: Losing my breath; My fingers in my left arm (where I got my vaccine) started going numb; Prolonged panic attack; I was shaking profusely; Lost feeling in my fingers and legs; My heartbeat felt really irregular; My body went limp and I fell out of the bed; Unable to swallow; My eyes rolling in the back of my head; Unable to sit up; This is a spontaneous report from a contactable other HCP (patient). This 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at left arm at single dose for COVID-19 immunisation on 21Dec2020 at 12:30 (35-year-old at the time of vaccination). The Lot number reported as EH9899, EH1284, EW0153 (pending clarification). Relevant history was unknown. Relevant concomitant drug included fluoxetine hydrochloride (PROZAC). No other vaccine in four weeks. Known allergy was None. The patient was not pregnant. Within 30 minutes after receiving the vaccine on 21Dec2020 at 01:15 PM, her fingers in her left arm (where she got her vaccine) started going numb. Her heartbeat felt really irregular and she started losing her breath. Her husband immediately took her to the emergency department. She was shaking profusely, lost feeling in her fingers and legs, was unable to swallow, unable to sit up, and her eyes rolling in the back of her head. She felt as if she was having a prolonged panic attack but with no feeling in her body and that she could not breathe. She arrived at the hospital, they immediately put her in a bed, her body went limp and she fell out of the bed. They then took an EKG and saw her heart was beating irregular and that she needed medication to calm her heart down. Additional lab tests included Holters and MRI with unknown result. AES resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment therapy was received (not specified). Outcome of events was not resolved. No COVID prior vaccination. No COVID test post vaccination.; Sender's Comments: Based on known temporal relationship there is reasonable possibility of causal association between the events Dyspnoea, Hypoaesthesia, Panic attack, tremor, sensory loss, heart rate irregular, gait disturbance, dysphagia, eye movement disorder, sitting disability and the suspect drug BNT162B2.  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.