chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: severe pain in my right foot/wife developed the same thing; This severely affects our Mobility; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Consumer reported for two patients. This is one of two cases.  A female patient received bnt162b2 (BNT162B2) (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: Bnt162b2 (Dose Number: 1), for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (disability), outcome "not recovered", described as "severe pain in my right foot/wife developed the same thing"; MOBILITY DECREASED (disability), outcome "not recovered", described as "This severely affects our Mobility".  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : PFIZER INC-202200157481 Same reporter/ drug/ event for different patients
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Patient tested positive for Covid 19 with mild cold like symptoms, headache, cough; Patient tested positive for Covid 19 with mild cold like symptoms, headache, cough; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 54 year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administration date 11Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Patient tested positive for Covid 19 with mild cold like symptoms, headache, cough". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. The clinical course is as follows: the patient tested positive for Covid 19 after taking an at home rapid antigen test. The patient experienced mild cold like symptoms, headache, cough. The patient was vaccinated with the Moderna Covid-19 vaccine for his 2 dose primary series and then received a booster dose of the Pfizer/BioNTech Covid 19 vaccine on 11Nov2021.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Patient tested positive for Covid 19 with mild cold like symptoms, headache, cough; Patient tested positive for Covid 19 with mild cold like symptoms, headache, cough; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 54 year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administration date 11Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Patient tested positive for Covid 19 with mild cold like symptoms, headache, cough". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. The clinical course is as follows: the patient tested positive for Covid 19 after taking an at home rapid antigen test. The patient experienced mild cold like symptoms, headache, cough. The patient was vaccinated with the Moderna Covid-19 vaccine for his 2 dose primary series and then received a booster dose of the Pfizer/BioNTech Covid 19 vaccine on 11Nov2021.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I have got contracted COVID; I have got contracted COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "I have got contracted COVID". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Jan2022) positive, notes: No just an antigen test, they had PCR test this morning but we don't have those results. The antigen test were positive. Therapeutic measures were taken as a result of covid-19. Clinical Course: Vaccination Facility details, consumer stated, withheld got at Pfizer. Withheld got it at town Withheld. Patient treatment received was reported as Tylenol.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200158065 same AE/drug, different patient
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: husband contacted covid-19 in spite having their vaccination/lack of efficacy; husband contacted covid-19 in spite having their vaccination/lack of efficacy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 45 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 45 years 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26Jan2022, outcome "unknown" and all described as "husband contacted covid-19 in spite having their vaccination/lack of efficacy". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. Therapeutic measures were taken as a result of covid-19 included Tylenol.Reporter stated, she was a Pfizer employee. Concern, reporter stated, Her boss said because she have got contracted COVID that she was supposed to call and report it as a safety event since she was vaccinated. Adverse event experienced, reporter stated, She did not get any, she just didnt have efficacy so she actually got covid-19. Well her daughter she actually dont have positive test but her daughters and husband contacted covid-19 in spite having their vaccination. Anatomical site of vaccination: Reporter stated, Right. Medical conditions and other medications, reporter stated, Yes but she dont have them listed right now. (withheld) takes Zyrtec, (withheld) takes no, nothing and she dont have a list of medication for (withheld). This was the second case out of four cases in which reporter was reporting for her husband.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200157655 same AE/drug, different patient
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Illness, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19 infection/ she received the Pfizer COVID-19 vaccine and still got infected with COVID; tested positive for COVID-19 infection/ she received the Pfizer COVID-19 vaccine and still got infected with COVID; sicker and sicker; 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 69 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Jan2022, outcome "unknown" and all described as "tested positive for COVID-19 infection/ she received the Pfizer COVID-19 vaccine and still got infected with COVID"; ILLNESS (non-serious) with onset Jan2022, outcome "unknown", described as "sicker and sicker". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (25Jan2022) negative; (27Jan2022) positive, notes: the test turned out positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, illness.   Clinical course: Caller stated that she had received most of her vaccines confirmed that she received the Pfizer COVID-19 vaccine and still got infected with COVID. She mentioned that she tested negative Tuesday on 25Jan2022 but she was getting sicker and sicker and got tested again today on 27Jan2022 and the test turned out positive. Patient stated that she has been prescribed Paxlovid because she tested positive for COVID-19 infection today on 27Jan2022. She took her last dose of Augmentin this morning and the patient was wanting to know if there was an interaction between Augmentin and Paxlovid.    The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, SARS-CoV-2 test, Swollen tongue, Urticaria
Clinical narrative: angioedema; urticaria; tongue swelling; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 03Dec2021 14:00 (Lot number: FJ8762) at the age of 45 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma", start date: 2011 (unspecified if ongoing), notes: diagnosed in 2011 but have had no events since 2014); "Angioedema", start date: 2011 (unspecified if ongoing), notes: diagnosed in 2011 but have had no events since 2014); "Urticaria", start date: 2011 (unspecified if ongoing), notes: diagnosed in 2011 but have had no events since 2014). Concomitant medication(s) included: ACYCLOVIR [ACICLOVIR]. Past drug history included: Demerol, reaction(s): "Known allergies:Demerol". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN5318, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 13Feb2021, when the patient was 44 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EN5206, Location of injection: Arm Right, Vaccine Administration Time: 12:00 PM), administration date: 06Mar2021, when the patient was 44 years old, for COVID-19 Immunization. The following information was reported: SWOLLEN TONGUE (medically significant) with onset 25Dec2021, outcome "not recovered", described as "tongue swelling"; ANGIOEDEMA (medically significant) with onset 21Jan2022, outcome "not recovered", described as "angioedema"; URTICARIA (medically significant) with onset 27Dec2021, outcome "not recovered", described as "urticaria". Clinical course was reported as follows. Since receiving the 3rd dose, she had experienced angioedema and urticaria. It started on 25Dec2021 with tongue swelling. She was seen in the ER. On 27Dec2021, she got a hive on my back leg, 31Dec2021 and 11Jan2022 more hives. On 21Jan2022, angioedema top and bottom lip, right side. On 25Jan2022 hive on her hand, and on 27Jan2022 a hive on my right shoulder. The adverse events resulted in emergency room/department or urgent care visit. The patient was given IV epinephrine.; Sender's Comments: Based on temporal relationship the possibility of causal association between the reported events angioedema, urticaria, swollen tongue 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: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness, Dizziness, Syncope, Tremor
Clinical narrative: He began to say that he did not see; Fainted; Dizzy; Tremble; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 13 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Jan2022 15:00 (Lot number: FJ5683) at the age of 13 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asma bronchial" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2, Batch/Lot No: FC3181, Arm Left, Vaccine Administration Time: 01:00 AM), administration date: 25Aug2021, when the patient was 12 years old, for COVID-19 immunization; Bnt162b2 (Dose 1, Batch/Lot No: FA7485, Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 04Aug2021, when the patient was 12 years old, for COVID-19 immunization. The following information was reported: BLINDNESS (medically significant) with onset 25Jan2022 15:00, outcome "unknown", described as "He began to say that he did not see"; SYNCOPE (medically significant) with onset 25Jan2022 15:00, outcome "recovered" (25Jan2022), described as "Fainted"; DIZZINESS (non-serious) with onset 25Jan2022 15:00, outcome "unknown", described as "Dizzy"; TREMOR (non-serious) with onset 25Jan2022 15:00, outcome "unknown", described as "Tremble". Patient began to say that he did not see, and dizzy to go to the side tremble and fainted for seconds. The events "he began to say that he did not see", "fainted", "dizzy" and "tremble" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of blindness, syncope, dizziness, tremor.
Age: 8.0
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 consumer or other non-HCP (patient's parent). An 8-year-old female patient (not pregnant) received the 1st and 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 8, in right arm, in 2021, single dose, for COVID-19 immunisation. The patient's medical history not reported. Concomitant medication included Zyrtec (cetirizine hydrochloride). The patient experienced ineffective drug/lack of efficacy in the vaccine (medically significant), and suspected COVID-19/reporter's daughters and husband contacted COVID-19 despite having their vaccination (medically significant), onset Jan 26, 2022, with outcome of unknown. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan 26, 2022) positive; (Jan 26, 2022) unknown results. Therapeutic measures were taken as a result of suspected COVID-19. Treatment taken, reporter stated, "Tylenol." The batch/lot number for BNT162B2 not provided and will be requested during follow-up.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac failure, Chronic obstructive pulmonary disease, Herpes zoster
Clinical narrative: heart failure; shingles; COPD; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): US-PFIZER INC-202200158713 (Pfizer).  A 98 year-old male patient received bnt162b2 (BNT162B2), administration date Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PREDNISONE. The following information was reported: CARDIAC FAILURE (medically significant), outcome "unknown", described as "heart failure"; HERPES ZOSTER (non-serious), outcome "unknown", described as "shingles"; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (non-serious), outcome "unknown", described as "COPD". It was also reported that the patient received a trivalent dna influenza vaccine, had body aches and pain, given Tylenol (it helped) (2-3 days), was given oxygen (after this was vocal) was 88%. Then he got worse, quiet and died on 23Dec2021.    The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: has Covid; has Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient in her 20's received bnt162b2 (Formulation: Solution for injection) (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. Withheld is in mid-twenties. May be half of #. Withheld currently has Covid. This is the second time they have gotten Covid. I believe they are at least fully vaccinated. Not sure if the first time was before or after vaccination.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "has Covid".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Video showing individual in mid-twenties over holiday getting handed presents outside from balcony since they have Covid.Do not know vaccine status of individual - reporting out of caution. Sourc; Video showing individual in mid-twenties over holiday getting handed presents outside from balcony since they have Covid.Do not know vaccine status of individual - reporting out of caution. Sourc; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown; Solution for injection) 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Video showing individual in mid-twenties over holiday getting handed presents outside from balcony since they have Covid.Do not know vaccine status of individual - reporting out of caution. Sourc".  No follow-up attempts are possible, No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: breakthrough infection; breakthrough infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient received bnt162b2 (BNT162B2) (Lot number: FJ1620) at the age of 35 years as dose 3 (booster), single, (Lot number: EL9267) as dose 2, single and (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications, he took prescription medication on a regular basis. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "breakthrough infection". Therapeutic measures were not taken as a result of drug ineffective, covid-19. The patient stated she was just calling to 'report' a breakthrough infection after a two dose permanent series and a booster dose that she was aware of.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, SARS-CoV-2 test
Clinical narrative: shingles; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Aug2021 12:00 (Lot number: ew0196) at the age of 44 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, single, Batch/Lot No: ew0191, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 28Jul2021, when the patient was 44 years old, for COVID-19 Immunization, reaction(s): "I also contracted Covid", "I also contracted Covid/Lost of taste and smell". The following information was reported: HERPES ZOSTER (non-serious) with onset 28Aug2021, outcome "recovered with sequelae", described as "shingles". The event "shingles" was evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of herpes zoster.  Additional information: The patient had no Known allergies, had not taken other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19, Since the vaccination, the patient had been tested for COVID-19. The patient did not receive if any other vaccine in four weeks. The patient received treatment with Valtrex. The patient stated that she developed shingles exactly 10 days after the second vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: positive of covid 19; positive of covid 19; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program (141003).  A 35 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 35 years 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 was not reported. Concomitant medication(s) included: IBUPROFEN; TYLENOL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "positive of covid 19".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis with thrombocytopenia syndrome
Clinical narrative: Thrombosis With Thrombocytopenia syndrome  after COVID-19 vaccination; This is a literature report.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS WITH THROMBOCYTOPENIA SYNDROME (medically significant), outcome "unknown", described as "Thrombosis With Thrombocytopenia syndrome after COVID-19 vaccination".  Author's Conclusion: Thrombosis with thrombocytopenia syndrome is a rare but serious adverse event associated with Ad26.COV2.S vaccination; different demographic characteristics of the 3 cases reported after mRNA-based vaccines and the much lower reporting rate suggest that these cases represent a background rate.  No follow-up attempts are possible, information about batch/lot number cannot be obtained.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : PFIZER_INC-202200162797 Same article/ drug/event and different patient;US-PFIZER_INC-202200162798 Same article/ drug/event and different patient
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis with thrombocytopenia syndrome
Clinical narrative: Thrombosis with thrombocytopenia syndrome after COVID-19 vaccination; This is a literature report for the Regulatory Authority.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS WITH THROMBOCYTOPENIA SYNDROME (medically significant), outcome "unknown", described as "Thrombosis with thrombocytopenia syndrome after COVID-19 vaccination". Authors conclusion: Thrombosis with thrombocytopenia syndrome is a rare but serious adverse event associated with Ad26.COV2.S vaccination; different demographic characteristics of the 3 cases reported after mRNA-based vaccines and the much lower reporting rate suggest that these cases represent a background rate.  No follow-up attempts are possible, information about batch/lot number cannot be obtained.; Sender's Comments: As there is limited information in the case provided, the causal association between the event thrombosis with thrombocytopenia syndrome with the suspect drug BNT162B2 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 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-202200162796 Same article/ drug/event and different patient;US-PFIZER_INC-202200162798 Same article/ drug/event and different patient
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis with thrombocytopenia syndrome
Clinical narrative: Thrombosis with thrombocytopenia syndrome after COVID-19 vaccination; This is a literature report.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS WITH THROMBOCYTOPENIA SYNDROME (medically significant), outcome "unknown", described as "Thrombosis with thrombocytopenia syndrome after COVID-19 vaccination". Authors conclusion: Conclusion: Thrombosis with thrombocytopenia syndrome is a rare but serious adverse event associated with Ad26.COV2.S vaccination; different demographic characteristics of the 3 cases reported after mRNA-based vaccines and the much lower reporting rate suggest that these cases represent a background rate.; Sender's Comments: A causal association between BNT162B2 and the reported event cannot be excluded based on the limited information provided. Case will be reassessed upon receipt of full publication. 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 RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : PFIZER_INC-202200162796 Same article/ drug/event and different patient; PFIZER_INC-202200162797 Same article/ drug/event and different patient
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: heart problem; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administration date 06Jun2021 (Batch/Lot number: unknown) as dose 2, single and administration date 30Apr2021 10:30 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications (blood thinner). The following information was reported: CARDIAC DISORDER (medically significant), outcome "unknown", described as "heart problem".  The patient (reporter) wanted to have a 3rd shot of Pfizer covid-19 vaccine. The first shot was on 30Apr2021 at 10:30 and the second shot was on 06Jun2021. Patient mentioned that she has a heart problem and blood thinner. Patient said she got a letter from Regulatory Authority for the 3rd shot and she wanted an ambulance to come because she didn't have a car.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Hypertension, Migraine, Muscular weakness, Seizure
Clinical narrative: tremors; muscle weakness's; High Blood Pressure; Atopic Migraines; non Epileptic seizures; abnormal gait; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 31-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Apr2021 11:45 (Lot number: EN206) at the age of 31 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). Patient did not have COVID prior vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. Past drug history included: Advair, reaction: "Known allergies: Advair"; Codeine, reaction: "Known allergies: Codeine". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6205, Location of injection: Arm Left, Vaccine Administration Time: 11:15 AM), administration date: 31Mar2021, when the patient was 31 years old, for COVID-19 Immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The following information was reported: TREMOR (disability) with onset 21Jun2021 06:30, outcome "recovering", described as "tremors"; MUSCULAR WEAKNESS (disability) with onset 21Jun2021 06:30, outcome "recovering", described as "muscle weakness's"; HYPERTENSION (disability) with onset 21Jun2021 06:30, outcome "recovering", described as "High Blood Pressure"; MIGRAINE (disability) with onset 21Jun2021 06:30, outcome "recovering", described as "Atopic Migraines"; SEIZURE (disability) with onset 21Jun2021 06:30, outcome "recovering", described as "non Epileptic seizures"; GAIT DISTURBANCE (disability) with onset 21Jun2021 06:30, outcome "recovering", described as "abnormal gait" (also reported as abnormal gate). Therapeutic measures were not taken as a result of tremor, muscular weakness, hypertension, migraine, seizure, gait disturbance. Patient did not have COVID tested post vaccination. Since the vaccination, the patient had been tested for COVID-19.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: tremors; muscle weakness's; High Blood Pressure; Atopic Migraines; non Epileptic seizures; abnormal gait; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 31-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Apr2021 11:45 (Lot number: EN206) at the age of 31 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). Patient did not have COVID prior vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. Past drug history included: Advair, reaction: "Known allergies: Advair"; Codeine, reaction: "Known allergies: Codeine". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6205, Location of injection: Arm Left, Vaccine Administration Time: 11:15 AM), administration date: 31Mar2021, when the patient was 31 years old, for COVID-19 Immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The following information was reported: TREMOR (disability) with onset 21Jun2021 06:30, outcome "recovering", described as "tremors"; MUSCULAR WEAKNESS (disability) with onset 21Jun2021 06:30, outcome "recovering", described as "muscle weakness's"; HYPERTENSION (disability) with onset 21Jun2021 06:30, outcome "recovering", described as "High Blood Pressure"; MIGRAINE (disability) with onset 21Jun2021 06:30, outcome "recovering", described as "Atopic Migraines"; SEIZURE (disability) with onset 21Jun2021 06:30, outcome "recovering", described as "non Epileptic seizures"; GAIT DISTURBANCE (disability) with onset 21Jun2021 06:30, outcome "recovering", described as "abnormal gait" (also reported as abnormal gate). Therapeutic measures were not taken as a result of tremor, muscular weakness, hypertension, migraine, seizure, gait disturbance. Patient did not have COVID tested post vaccination. Since the vaccination, the patient had been tested for COVID-19.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Caller stated he has had two positive tests for covid since 17Jan2022/  had the primary series of the Pfizer covid 19 vaccine on 18Jan2021 and 8Feb2021 and the booster 26Sep2021; Caller stated he has had two positive tests for covid since 17Jan2022/  had the primary series of the Pfizer covid 19 vaccine on 18Jan2021 and 8Feb2021 and the booster 26Sep2021; 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. The reporter is the patient.  A 69 year-old male patient received bnt162b2 (BNT162B2), administration date 26Sep2021 (Batch/Lot number: unknown) at the age of 68 years as dose 3 (booster), single, administration date 08Feb2021 (Batch/Lot number: unknown) as dose 2, single and administration date 18Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Verbatim: Hepatitis C" (unspecified if ongoing), notes: Verbatim: Hepatitis C, due to drinking during his younger years. The patient's concomitant medications were not reported. Vaccination history included: Flu shot (Caller also said he had the flu shot and the shingles shot.), for Immunization; Shingles shot (Caller also said he had the flu shot and the shingles shot.), for Immunization; Pneumonia shot (he completed getting the pneumonia shot), for Immunization. The following information was reported: VACCINATION FAILURE (medically significant) with onset 17Jan2022, outcome "unknown", COVID-19 (medically significant) with onset 17Jan2022, outcome "not recovered" and all described as "Caller stated he has had two positive tests for covid since 17Jan2022/  had the primary series of the Pfizer covid 19 vaccine on 18Jan2021 and 8Feb2021 and the booster 26Sep2021". The event "caller stated he has had two positive tests for covid since 17jan2022/  had the primary series of the pfizer covid 19 vaccine on 18jan2021 and 8feb2021 and the booster 26sep2021" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (17Jan2022) positive, notes: the test was done on 17Jan2022 and the results came back on 19Jan2022; (26Jan2022) positive. Therapeutic measures were taken as a result of covid-19. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: The son now has myocarditis; This is a spontaneous report received from a contactable reporter(s) (Other HCP: Nurse) from medical information team. A male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), administration date 03Jun2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant) with onset Jan2022, outcome "unknown", described as "The son now has myocarditis".  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and MYOCARDITIS 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.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dizziness, Dyskinesia, Pain in extremity, Paraesthesia
Clinical narrative: Hard stinging electric like pain in the left side on my lower back close to my spine; it was so shocking that forced my whole body to move; Paresthesia; Severe pain in my left arm; problems with the angle of vision. Vision was modified; dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Jan2022 15:00 (Lot number: FJ1611) at the age of 52 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose Number: 1, Batch/Lot No: 33130BA, Location of injection: Arm Left, Vaccine Administration Time: 15:00), administration date: 24Dec2021, when the patient was 52 years old, for COVID-19 immunization. The following information was reported: BACK PAIN (non-serious) with onset 15Jan2022 12:00, outcome "unknown", described as "Hard stinging electric like pain in the left side on my lower back close to my spine"; DYSKINESIA (non-serious) with onset 15Jan2022 12:00, outcome "unknown", described as "it was so shocking that forced my whole body to move"; PARAESTHESIA (non-serious) with onset 15Jan2022 12:00, outcome "unknown", described as "Paresthesia"; VISUAL IMPAIRMENT (non-serious) with onset Jan2022, outcome "unknown", described as "problems with the angle of vision. Vision was modified"; DIZZINESS (non-serious) with onset Jan2022, outcome "not recovered", described as "dizziness"; PAIN IN EXTREMITY (non-serious) with onset 15Jan2022 12:00, outcome "unknown", described as "Severe pain in my left arm". The events "hard stinging electric like pain in the left side on my lower back close to my spine", "it was so shocking that forced my whole body to move" and "paresthesia" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of back pain, dyskinesia, paraesthesia, visual impairment, dizziness, pain in extremity.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. After the 2nd dose of the Covid vaccine shot, the patient suffered of constant dizziness. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: Hard stinging electric like pain in the left side on my lower back close to my spine; it was so shocking that forced my whole body to move; Paresthesia; Severe pain in my left arm; problems with the angle of vision. Vision was modified; dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Jan2022 15:00 (Lot number: FJ1611) at the age of 52 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose Number: 1, Batch/Lot No: 33130BA, Location of injection: Arm Left, Vaccine Administration Time: 15:00), administration date: 24Dec2021, when the patient was 52 years old, for COVID-19 immunization. The following information was reported: BACK PAIN (non-serious) with onset 15Jan2022 12:00, outcome "unknown", described as "Hard stinging electric like pain in the left side on my lower back close to my spine"; DYSKINESIA (non-serious) with onset 15Jan2022 12:00, outcome "unknown", described as "it was so shocking that forced my whole body to move"; PARAESTHESIA (non-serious) with onset 15Jan2022 12:00, outcome "unknown", described as "Paresthesia"; VISUAL IMPAIRMENT (non-serious) with onset Jan2022, outcome "unknown", described as "problems with the angle of vision. Vision was modified"; DIZZINESS (non-serious) with onset Jan2022, outcome "not recovered", described as "dizziness"; PAIN IN EXTREMITY (non-serious) with onset 15Jan2022 12:00, outcome "unknown", described as "Severe pain in my left arm". The events "hard stinging electric like pain in the left side on my lower back close to my spine", "it was so shocking that forced my whole body to move" and "paresthesia" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of back pain, dyskinesia, paraesthesia, visual impairment, dizziness, pain in extremity.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. After the 2nd dose of the Covid vaccine shot, the patient suffered of constant dizziness. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Investigation, Optic nerve disorder, SARS-CoV-2 test, Visual pathway disorder
Clinical narrative: Disorder of Optic Nerve; Optic Chiasm  Disorder; loss of vision; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 03Oct2021 (Lot number: ee8839) at the age of 42 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications in two weeks. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ej1685), administration date: 19Dec2020, when the patient was 41 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: ej0140), administration date: 12Jan2021, when the patient was 41 years old, for COVID-19 Immunization. The patient did not experienced covid prior vaccination. The following information was reported: OPTIC NERVE DISORDER (disability) with onset 14Oct2021, outcome "not recovered", described as "Disorder of Optic Nerve"; VISUAL PATHWAY DISORDER (disability) with onset 14Oct2021, outcome "not recovered", described as "Optic Chiasm Disorder"; BLINDNESS (disability) with onset 14Oct2021, outcome "not recovered", described as "loss of vision". The events "disorder of optic nerve", "optic chiasm disorder" and "loss of vision" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: Multiple tests: (unspecified date) unknown; sars-cov-2 test: (27Jan2022) negative, notes: Nasal Swab. Therapeutic measures Prednisone course were taken as a result of optic nerve disorder, visual pathway disorder, blindness.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events OPTIC NERVE DISORDER, VISUAL PATHWAY DISORDER, and BLINDNESS 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: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: she now has fever reaching 104; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 10 year-old female patient received bnt162b2 (BNT162B2), administration date 27Jan2022 (Lot number: FL0007) at the age of 10 years as dose 2 (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1), for Covid-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset Jan2022, outcome "unknown", described as "she now has fever reaching 104". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: on an unknown date inJan2022, the patient's fever was 104.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Nasopharyngitis, Suspected COVID-19
Clinical narrative: she has Covid 19; she has Covid 19; cold; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2022US016980_NS.  A 74-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), outcome "unknown" and all described as "she has Covid 19"; NASOPHARYNGITIS (medically significant), outcome "unknown", described as "cold".  Clinical information included: Patient advised she has Covid-19, is triple vaccinated, and feels like she has a cold.  The lot number for bnt162b2 was not provided and will be requested during follow up.