chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Respiration abnormal
Clinical narrative: administration date: 28May2021, dose number: 2/prev dose administration date=14May2021, prev dose dose number: 1; A week after I got the shot 1 morning I just couldn't catch my breathe and it's been since 2021 it's now 2 years later and I still can't breathe right; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 21-year-old male patient received BNT162b2 on 28May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 21 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Other medical history: Asthma; "Known allergies: Food which includes shellfish" (unspecified if ongoing), notes: Known allergies: Food which includes shellfish and most fruits; "Known allergies: most fruits" (unspecified if ongoing), notes: Known allergies: Food which includes shellfish and most fruits. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Right), administration date: 14May2021, when the patient was 21-year-old, for COVID-19 immunization. The following information was reported: RESPIRATION ABNORMAL (non-serious) with onset May2021, outcome "not recovered", described as "A week after I got the shot 1 morning I just couldn't catch my breathe and it's been since 2021 it's now 2 years later and I still can't breathe right"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 28May2021, outcome "unknown", described as "administration date: 28May2021, dose number: 2/prev dose administration date=14May2021, prev dose dose number: 1". Therapeutic measures were taken as a result of respiration abnormal.  Additional information: Patient not had covid prior vaccination. Patient tested covis post vaccination. Patient not had any other vaccine in four weeks. A week after patient got the shot 1 morning and he just couldn't catch his breathe and it's been since 2021 it's now 2 years later and he still could not breathe right. AE treatment includes many asthma relieves/steroids/oxygen.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Batch/Lot number: unknown), on 07Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 21Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High BP" (unspecified if ongoing); "Afib" (unspecified if ongoing); "Tachycardia" (unspecified if ongoing); "Bradycardia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amlopine, reaction(s): "Drug allergy"; Anastrozle, reaction(s): "Drug allergy"; Lisinopril, reaction(s): "Drug allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "unknown" and all described as "COVID-19". The clinical course was reported as follow-us: The patient started PF-07321332, RITONAVIR (PAXLOVID) on 17May2023 for covid-19 treatment. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Sick from first 2 shots/I got so sick from the first 2 shots; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  An adult female patient received BNT162b2, as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), for COVID-19 immunization, reaction(s): "Sick from first 2 shots". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Sick from first 2 shots/I got so sick from the first 2 shots".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine product; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Nov2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 64 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 22Mar2021 as dose 1, single (Lot number: 046A21A), in right arm, on 23Apr2021 as dose 2, single (Lot number: 027B21A), in right arm and on 07Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "glaucoma" (ongoing), notes: Only take two RX and those are eye drops for glaucoma and dry eye disease; "dry eye disease" (ongoing), notes: Only take two RX and those are eye drops for glaucoma and dry eye disease. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23Nov2021, outcome "unknown", described as "Interchange of vaccine product"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2023) Negative, notes: Tested three times negative within two days; (May2023) Negative, notes: Tested three times negative within two days; (May2023) Negative, notes: Tested three times negative within two days; (May2023) Positive, notes: Took the test again three times showing positive to the virus; (May2023) Positive, notes: Took the test again three times showing positive to the virus; (May2023) Positive, notes: Took the test again three times showing positive to the virus. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received Paxlovid for COVID 19 Treatment from 11May2023 to 16May2023 (Lot number: 00069-0345-30). The patient had no known allergies.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: Debilitating effects from vaccine and booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP), Program ID: The reporter is the patient.  An elderly female patient received BNT162b2, as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Covid", start date: 2020 (unspecified if ongoing), notes: having Covid in 2020. The patient's concomitant medications were not reported. The following information was reported: ASTHENIA (non-serious), outcome "unknown", described as "Debilitating effects from vaccine and booster".  Additional information: Patient will not get any further vaccinations due to horrible effects from having Covid in 2020 & then with each vaccine & booster the debilitating effects lasted for 2-3 weeks (original Covid lasted 2 months for me).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: Debilitating effects from vaccine and booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP), Program ID: The reporter is the patient.  An elderly female patient received BNT162b2, as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Covid", start date: 2020 (unspecified if ongoing), notes: will not get any further vaccinations due to horrible effects from having Covid in 2020. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "Debilitating effects from vaccine and booster". The following information was reported: ASTHENIA (non-serious), outcome "unknown", described as "Debilitating effects from vaccine and booster".  Additional information: The patient stated that she would not get any further vaccinations due to horrible effects from having Covid in 2020 and then with each vaccine and booster the debilitating effects lasted for 2-3 weeks (original Covid lasted 2 months for me).  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, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment.; COVID 19 Treatment.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "ADHD" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19; Negative, notes: Reinfected 5 days after testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information : The patient received paxlovid for COVID-19 from 08May2023 till 13May2023. No known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Dec2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 55 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) 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 "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: still testing Positive; Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information : The patient received paxlovid for COVID-19 from 08May2023 till 12May2023. Vaccine was received. No other medication in 2 weeks.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: He states that he had no reaction after his previous shots except for "a little bit of sore arm".; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. Other Case identifier(s): US-MODERNATX-MOC20230519000021.  A 71-year-old male patient received BNT162b2, as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing), notes: but controlled with meds. The patient took concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "He states that he had no reaction after his previous shots except for a little bit of sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "He states that he had no reaction after his previous shots except for "a little bit of sore arm".".  Additional information: Patient did not receive any other vaccines 4 weeks prior to COVID-19 vaccine. Patient later received Moderna Covid-19 Vaccine, Bivalent (Original and omicron BA.4/BA.5), Davesomeran, Elasomeran on 09May2023 (Batch/lot number: 016H22A) via intramuscular route for COVID-19 prophylaxis and experienced achy and arm hurt/a little bit of sore arm (vaccination site pain), chills, fever/Low grade fever on 09May2023, which were not recovered at the time of this report. Patient stated that he had his 6th shot last 09May2023, lot number 016H22A. He had the 1st 4 (Pfizer) and the last 2 were Moderna. He stated that he had no reaction after his previous shots except for "a little bit of sore arm". But the last dose of Moderna which he had 8 days ago, in about 7 hours he had a reaction. He stated it was nothing significant - "little chills, fever, achy and my arm hurt, and he expected that and it was okay because he knew that his body was working". After a day or two almost all of them went away except for a low-grade fever. It had been 8 days and he still had fever which is a little less high than it used to be. He had already consulted with his doctor, but he could not give him an explanation. Had there been reports of fever lasting for about a week after getting the vaccine. The patient was in a rush, so he only provided the details of the last bivalent dose, but he agreed with Safety follow up.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: He states that he had no reaction after his previous shots except for "a little bit of sore arm".; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-MODERNATX-MOC20230519000021 (Moderna).  A 71-year-old male patient received BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing), notes: but controlled with meds. The patient took concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "He states that he had no reaction after his previous shots except for "a little bit of sore arm"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "He states that he had no reaction after his previous shots except for "a little bit of sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "He states that he had no reaction after his previous shots except for "a little bit of sore arm".".  Additional information: Patient did not receive any other vaccines 4 weeks prior to COVID-19 vaccine. Patient later received Moderna Covid-19 Vaccine, Bivalent (Original and omicron BA.4/BA.5), Davesomeran, Elasomeran on 09May2023 (Batch/lot number: 016H22A) via intramuscular route for COVID-19 prophylaxis and experienced achy and arm hurt/a little bit of sore arm (vaccination site pain), chills, fever/Low grade fever on 09May2023, which were not recovered at the time of this report. Patient stated that he had his 6th shot last 09May2023, lot number 016H22A. He had the 1st 4 (Pfizer) and the last 2 were Moderna. He stated that he had no reaction after his previous shots except for "a little bit of sore arm". But the last dose of Moderna which he had 8 days ago, in about 7 hours he had a reaction. He stated it was nothing significant - "little chills, fever, achy and my arm hurt, and he expected that and it was okay because he knew that his body was working". After a day or two almost all of them went away except for a low-grade fever. It had been 8 days and he still had fever which is a little less high than it used to be. He had already consulted with his doctor, but he could not give him an explanation. Had there been reports of fever lasting for about a week after getting the vaccine. The patient was in a rush, so he only provided the details of the last bivalent dose, but he agreed with Safety follow up.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: a little bit of sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-MODERNATX-MOC20230519000021.  A 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5, as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Hypertension but controlled with meds. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "a little bit of sore arm"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "a little bit of sore arm"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "a little bit of sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "a little bit of sore arm".  Additional information: Patient received Moderna Covid-19 Vaccine, Bivalent (Original and omicron BA.4/BA.5), Davesomeran, Elasomeran on 09May2023 (Batch/lot number: 016H22A) via intramuscular route for COVID-19 prophylaxis and experienced achy and arm hurt/a little bit of sore arm (vaccination site pain), chills, fever/Low grade fever on 09May2023, which were not recovered at the time of this report. Note to Case Processing Team: "Specific product able to be determined from information provided, the decision tree was not utilized to determine the product. Did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Caller stated that he had his 6th shot last 09May2023, lot number 016H22A. He had the 1st 4 (Pfizer) and the last 2 were Moderna. He stated that he had no reaction after his previous shots except for "a little bit of sore arm". But the last dose of Moderna which he had 8 days ago, in about 7 hours he had a reaction. He stated it was nothing significant - "little chills, fever, achy and my arm hurt, and I expected that and it was okay because I knew that my body was working". After a day or two almost all of them went away except for a low-grade fever. It had been 8 days and he still had fever which is a little less high than it used to be. He had already consulted with his doctor, but he could not give him an explanation. Had there been reports of fever lasting for about a week after getting the vaccine? The caller was in a rush, so he only provided the details of the last bivalent dose, but he agreed with Safety follow up. Preferred method of contact: email. For the reported dose field as Unknown was selected as there is no 6th dose option.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; Covid 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 3 (booster ), single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PANTOPRAZOLE, start date: Dec2020. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "not recovered", described as "COVID 19 Treatment"; COVID-19 (medically significant), outcome "not recovered", described as "Covid 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of Covid-19; (May2023) Positive, notes: Covid symptoms and positive test occurred 3 days after final dose of Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Other medication in 2 weeks: Yes (pantoprazole). Anti-viral details product, COVID 19 Treatment, brand, Paxlovid, treatment start date 11May2023, treatment stop date: 15May2023, indication, Treatment of COVID-19. Covid symptoms and positive test occurred 3 days after final dose of Paxlovid on 18May2023 .  The information on the batch/lot number for [BNT162B2, BNT162B2 OMI BA.4-5], has been requested and will be submitted if and when received.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 18Oct2022 at 14:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 67 years, in left arm 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) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient was treated with Paxlovid from 13May2023 to 18May2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: patient reported positive experience with the vaccine, ie, felt like getting a vitamin B12 shot, felt better after shot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2, omi ba.4-5, as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, single; Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE; Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; Unknown manufacturer), for COVID-19 immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "patient reported positive experience with the vaccine, ie, felt like getting a vitamin B12 shot, felt better after shot".  Additional information: Patient had received more than 3 dose.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pulmonary thrombosis
Clinical narrative: pulmonary blood clot; 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 male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PULMONARY THROMBOSIS (medically significant), outcome "unknown", described as "pulmonary blood clot". The event "pulmonary blood clot" required emergency room visit. Clinical course: the patient went to the ER (emergency room) where was diagnosed with a pulmonary blood clot, supposedly as a result of the Pfizer COVID 19 vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300199093 same patient, different dose and event;
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: pulmonary blood clot; 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 male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PULMONARY THROMBOSIS (medically significant), outcome "unknown", described as "pulmonary blood clot". The event "pulmonary blood clot" required emergency room visit. Clinical course: the patient went to the ER (emergency room) where was diagnosed with a pulmonary blood clot, supposedly as a result of the Pfizer COVID 19 vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300199093 same patient, different dose and event;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, 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) all with onset May2023, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19, the patient was treated with Paxlovid from 12May2023 to 17May2023.  The information on the batch/lot number for [BNT162B2 NOS] has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Antibody test, Antimitochondrial antibody, Antinuclear antibody, Aspartate aminotransferase
Clinical narrative: COVID-19 Vaccine-Induced Liver Injury; This is a literature report for the following literature source(s):  A 58-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "alcohol use" (unspecified if ongoing), notes: Less than 1 drink/week; "HLD" (unspecified if ongoing); "Hepatic steatosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: LIVER INJURY (medically significant), 12 days after the suspect product(s) administration, outcome "unknown", described as "COVID-19 Vaccine-Induced Liver Injury". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase: Return to baseline; normal; Alanine aminotransferase: 101 IU/l; Antibody test: Unknown results; Negative; Antimitochondrial antibody: Positive; Antinuclear antibody: Negative; Aspartate aminotransferase: Return to baseline; normal; Aspartate aminotransferase: 51 IU/l; Biopsy liver: Mild porto-sinusoidal vascular disease., notes: Mild ferritin and hemosiderin deposition. No evidence of autoimmune hepatitis or steatohepatitis; Blood alkaline phosphatase: 77 IU/l; Blood bilirubin: 0.8 mg/dl; Blood immunoglobulin G: 882; Blood immunoglobulin M: 78; Body mass index: 25.4; Hepatitis viral test: Negative; Liver stiffness measurement: Unknown results; Serum ferritin: 478.12 ng/ml; Transient elastography: CAP 231, notes: kPa - 5.1.; Sender's Comments: Based on the information provided, and a temporal association, a causal association between reported event liver injury and suspect BNT162B2 cannot be excluded. This 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 to regulatory authorities, Ethics Committees, and Investigators, as appropriate., Linked Report(s): US-PFIZER INC-202300195873 Same aticle;suspect;event and different patient;US-PFIZER INC-202300195875 Same aticle;suspect;event and different patient;US-PFIZER INC-202300195874 Same aticle;suspect;event and different patient;
Sex: M
Vaccine: COVID19
Symptoms: Biopsy liver, Blood alkaline phosphatase, Blood bilirubin, Blood immunoglobulin G, Blood immunoglobulin M
Clinical narrative: COVID-19 Vaccine-Induced Liver Injury; This is a literature report for the following literature source(s):  A 58-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "alcohol use" (unspecified if ongoing), notes: Less than 1 drink/week; "HLD" (unspecified if ongoing); "Hepatic steatosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: LIVER INJURY (medically significant), 12 days after the suspect product(s) administration, outcome "unknown", described as "COVID-19 Vaccine-Induced Liver Injury". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase: Return to baseline; normal; Alanine aminotransferase: 101 IU/l; Antibody test: Unknown results; Negative; Antimitochondrial antibody: Positive; Antinuclear antibody: Negative; Aspartate aminotransferase: Return to baseline; normal; Aspartate aminotransferase: 51 IU/l; Biopsy liver: Mild porto-sinusoidal vascular disease., notes: Mild ferritin and hemosiderin deposition. No evidence of autoimmune hepatitis or steatohepatitis; Blood alkaline phosphatase: 77 IU/l; Blood bilirubin: 0.8 mg/dl; Blood immunoglobulin G: 882; Blood immunoglobulin M: 78; Body mass index: 25.4; Hepatitis viral test: Negative; Liver stiffness measurement: Unknown results; Serum ferritin: 478.12 ng/ml; Transient elastography: CAP 231, notes: kPa - 5.1.; Sender's Comments: Based on the information provided, and a temporal association, a causal association between reported event liver injury and suspect BNT162B2 cannot be excluded. This 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 to regulatory authorities, Ethics Committees, and Investigators, as appropriate., Linked Report(s): US-PFIZER INC-202300195873 Same aticle;suspect;event and different patient;US-PFIZER INC-202300195875 Same aticle;suspect;event and different patient;US-PFIZER INC-202300195874 Same aticle;suspect;event and different patient;
Sex: M
Vaccine: COVID19
Symptoms: Body mass index, Hepatitis viral test, Investigation, Liver injury, Serum ferritin
Clinical narrative: COVID-19 Vaccine-Induced Liver Injury; This is a literature report for the following literature source(s):  A 58-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "alcohol use" (unspecified if ongoing), notes: Less than 1 drink/week; "HLD" (unspecified if ongoing); "Hepatic steatosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: LIVER INJURY (medically significant), 12 days after the suspect product(s) administration, outcome "unknown", described as "COVID-19 Vaccine-Induced Liver Injury". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase: Return to baseline; normal; Alanine aminotransferase: 101 IU/l; Antibody test: Unknown results; Negative; Antimitochondrial antibody: Positive; Antinuclear antibody: Negative; Aspartate aminotransferase: Return to baseline; normal; Aspartate aminotransferase: 51 IU/l; Biopsy liver: Mild porto-sinusoidal vascular disease., notes: Mild ferritin and hemosiderin deposition. No evidence of autoimmune hepatitis or steatohepatitis; Blood alkaline phosphatase: 77 IU/l; Blood bilirubin: 0.8 mg/dl; Blood immunoglobulin G: 882; Blood immunoglobulin M: 78; Body mass index: 25.4; Hepatitis viral test: Negative; Liver stiffness measurement: Unknown results; Serum ferritin: 478.12 ng/ml; Transient elastography: CAP 231, notes: kPa - 5.1.; Sender's Comments: Based on the information provided, and a temporal association, a causal association between reported event liver injury and suspect BNT162B2 cannot be excluded. This 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 to regulatory authorities, Ethics Committees, and Investigators, as appropriate., Linked Report(s): US-PFIZER INC-202300195873 Same aticle;suspect;event and different patient;US-PFIZER INC-202300195875 Same aticle;suspect;event and different patient;US-PFIZER INC-202300195874 Same aticle;suspect;event and different patient;
Sex: M
Vaccine: COVID19
Symptoms: Transient elastography
Clinical narrative: COVID-19 Vaccine-Induced Liver Injury; This is a literature report for the following literature source(s):  A 58-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "alcohol use" (unspecified if ongoing), notes: Less than 1 drink/week; "HLD" (unspecified if ongoing); "Hepatic steatosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: LIVER INJURY (medically significant), 12 days after the suspect product(s) administration, outcome "unknown", described as "COVID-19 Vaccine-Induced Liver Injury". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase: Return to baseline; normal; Alanine aminotransferase: 101 IU/l; Antibody test: Unknown results; Negative; Antimitochondrial antibody: Positive; Antinuclear antibody: Negative; Aspartate aminotransferase: Return to baseline; normal; Aspartate aminotransferase: 51 IU/l; Biopsy liver: Mild porto-sinusoidal vascular disease., notes: Mild ferritin and hemosiderin deposition. No evidence of autoimmune hepatitis or steatohepatitis; Blood alkaline phosphatase: 77 IU/l; Blood bilirubin: 0.8 mg/dl; Blood immunoglobulin G: 882; Blood immunoglobulin M: 78; Body mass index: 25.4; Hepatitis viral test: Negative; Liver stiffness measurement: Unknown results; Serum ferritin: 478.12 ng/ml; Transient elastography: CAP 231, notes: kPa - 5.1.; Sender's Comments: Based on the information provided, and a temporal association, a causal association between reported event liver injury and suspect BNT162B2 cannot be excluded. This 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 to regulatory authorities, Ethics Committees, and Investigators, as appropriate., Linked Report(s): US-PFIZER INC-202300195873 Same aticle;suspect;event and different patient;US-PFIZER INC-202300195875 Same aticle;suspect;event and different patient;US-PFIZER INC-202300195874 Same aticle;suspect;event and different patient;
Sex: U
Vaccine: COVID19
Symptoms: Atrioventricular block, Heart rate
Clinical narrative: Patient received vaccine and now had to receive a pace maker for blockage. On no medication only change to life was vaccine; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: ATRIOVENTRICULAR BLOCK (medically significant), outcome "unknown", described as "Patient received vaccine and now had to receive a pace maker for blockage. On no medication only change to life was vaccine". The patient underwent the following laboratory tests and procedures: Heart rate: Unknown result. Therapeutic measures were taken as a result of atrioventricular block.  The information on the batch/lot number for BNT162b2 NOS has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available, a possible contributory role of the suspect product cannot be excluded for the reported events 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
Sex: M
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Antimitochondrial antibody, Antinuclear antibody, Aspartate aminotransferase, Blood alkaline phosphatase
Clinical narrative: Severe Immune-Mediated Liver Injury Following COVID-19 Vaccination Necessitating Liver Transplantation in a Patient with Cirrhosis; This is a literature report for the following literature source(s):   A 65-year-old male patient received BNT162b2, as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "epilepsy" (unspecified if ongoing); "coronary artery disease" (unspecified if ongoing); "excessive alcohol use" (unspecified if ongoing), notes: 30+ years. The patient's concomitant medications were not reported. Past drug history included: Levetiracetam for epilepsy; Metoprolol for coronary artery disease; Ramipril; Aspirin; Omeprazole. The following information was reported: IMMUNE-MEDIATED HEPATIC DISORDER (medically significant, life threatening), 10 days after the suspect product(s) administration, outcome "unknown", described as "Severe Immune-Mediated Liver Injury Following COVID-19 Vaccination Necessitating Liver Transplantation in a Patient with Cirrhosis". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase: 1613; Antimitochondrial antibody: Positive; Antinuclear antibody: Positive; Aspartate aminotransferase: 1786; Blood alkaline phosphatase: 182; Blood creatine: 0.7; 2.6; Blood immunoglobulin G: 1310; Computerized tomogram abdomen: heterogeneous liver with steatosis and mild, notes: nodularity, splenomegaly, ascites, patent vasculature, and no biliary dilation. Liver biopsy: marked portal and lobular inflammation with interface hepatitis and lymphoplasmacytic infiltrates, confluent necrosis with hemorrhage, balloon degeneration, cholestasis and reticulin collapse; Cytomegalovirus test: Negative; Enzyme level test: normal; Epstein-Barr virus test: Negative; Hepatitis A virus test: Negative; Hepatitis B virus test: Negative; Hepatitis C virus test: Negative; HIV test: Negative; International normalised ratio: 2.1; Skin test: 9; Smooth muscle antibody: Positive.  Clinical Information: Reporter reported that Patient was presented with jaundice and ascites on day 10 after first C19V and did not have known liver disease and had normal liver enzymes prior, No family history of autoimmune diseases. Sender's Comments: Based on the information provided, and a temporal association, a causal association between reported event immune mediated hepatic disorder and suspect BNT162B2 cannot be excluded. This 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 to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Blood creatine, Blood immunoglobulin G, Computerised tomogram abdomen, Cytomegalovirus test, Enzyme level test
Clinical narrative: Severe Immune-Mediated Liver Injury Following COVID-19 Vaccination Necessitating Liver Transplantation in a Patient with Cirrhosis; This is a literature report for the following literature source(s):   A 65-year-old male patient received BNT162b2, as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "epilepsy" (unspecified if ongoing); "coronary artery disease" (unspecified if ongoing); "excessive alcohol use" (unspecified if ongoing), notes: 30+ years. The patient's concomitant medications were not reported. Past drug history included: Levetiracetam for epilepsy; Metoprolol for coronary artery disease; Ramipril; Aspirin; Omeprazole. The following information was reported: IMMUNE-MEDIATED HEPATIC DISORDER (medically significant, life threatening), 10 days after the suspect product(s) administration, outcome "unknown", described as "Severe Immune-Mediated Liver Injury Following COVID-19 Vaccination Necessitating Liver Transplantation in a Patient with Cirrhosis". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase: 1613; Antimitochondrial antibody: Positive; Antinuclear antibody: Positive; Aspartate aminotransferase: 1786; Blood alkaline phosphatase: 182; Blood creatine: 0.7; 2.6; Blood immunoglobulin G: 1310; Computerized tomogram abdomen: heterogeneous liver with steatosis and mild, notes: nodularity, splenomegaly, ascites, patent vasculature, and no biliary dilation. Liver biopsy: marked portal and lobular inflammation with interface hepatitis and lymphoplasmacytic infiltrates, confluent necrosis with hemorrhage, balloon degeneration, cholestasis and reticulin collapse; Cytomegalovirus test: Negative; Enzyme level test: normal; Epstein-Barr virus test: Negative; Hepatitis A virus test: Negative; Hepatitis B virus test: Negative; Hepatitis C virus test: Negative; HIV test: Negative; International normalised ratio: 2.1; Skin test: 9; Smooth muscle antibody: Positive.  Clinical Information: Reporter reported that Patient was presented with jaundice and ascites on day 10 after first C19V and did not have known liver disease and had normal liver enzymes prior, No family history of autoimmune diseases. Sender's Comments: Based on the information provided, and a temporal association, a causal association between reported event immune mediated hepatic disorder and suspect BNT162B2 cannot be excluded. This 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 to regulatory authorities, Ethics Committees, and Investigators, as appropriate.