chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 26 Patient received a vaccine expired on 16-Apr-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (26 Patient received a vaccine expired on 16-Apr-2022) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007J21-2a) for COVID-19 vaccination.     Patient does not have any allergies or other chronic conditions. The patient never had COVID positive test or diagnosis.  Patient didn't received any other vaccines within 1 month prior to Moderna COVID-19 vaccine.     On 20-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (26 Patient received a vaccine expired on 16-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (26 Patient received a vaccine expired on 16-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  The received first booster dose. It was unknown whether seek medical care or whether the patient experienced a similar event in the past.  No treatment medication information was provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (26 Patient received a expired vaccine 16Apr2022) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007J21-2a) for COVID-19 vaccination. Concurrent medical conditions included Diabetes. On 20-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (26 Patient received a expired vaccine 16Apr2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (26 Patient received a expired vaccine 16Apr2022) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was provided. It was reported that the patient never had COVID positive test or diagnosis and patient didn't received any other vaccines within 1 month prior to Moderna COVID-19 vaccine. No treatment medication was provided. This case was linked to MOD-2022-548975 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Vision blurred
Clinical narrative: blurry vision; expired dose administered; This spontaneous case was reported by a patient and describes the occurrence of VISION BLURRED (blurry vision) and EXPIRED PRODUCT ADMINISTERED (expired dose administered) in a male patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 051F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 20-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered). On 24-Apr-2022, the patient experienced VISION BLURRED (blurry vision). At the time of the report, VISION BLURRED (blurry vision) and EXPIRED PRODUCT ADMINISTERED (expired dose administered) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Oropharyngeal pain, Swelling face
Clinical narrative: Swelling in the right side of her face after 2nd booster; Pain traveling down her throat after 2nd booster; Swollen Lymph-node under the right side of her chin (Between Chin and Ear) after 2nd booster; This spontaneous case was reported by a patient family member or friend and describes the occurrence of SWELLING FACE (Swelling in the right side of her face after 2nd booster), OROPHARYNGEAL PAIN (Pain traveling down her throat after 2nd booster) and LYMPHADENOPATHY (Swollen Lymph-node under the right side of her chin (Between Chin and Ear) after 2nd booster) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002M21A, 939904, 038A21A and 014M20A) for COVID-19 vaccination.     Patient was totally healthy. She never had COVID disease and never had a positive PCR.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2022, the patient experienced SWELLING FACE (Swelling in the right side of her face after 2nd booster), OROPHARYNGEAL PAIN (Pain traveling down her throat after 2nd booster) and LYMPHADENOPATHY (Swollen Lymph-node under the right side of her chin (Between Chin and Ear) after 2nd booster). At the time of the report, SWELLING FACE (Swelling in the right side of her face after 2nd booster), OROPHARYNGEAL PAIN (Pain traveling down her throat after 2nd booster) and LYMPHADENOPATHY (Swollen Lymph-node under the right side of her chin (Between Chin and Ear) after 2nd booster) outcome was unknown.            Patient did not take  concomitant medications. Reporter stated that his wife did not inform the doctor and she had not taken any medication to relieve the swelling and pain.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Immunisation reaction, Nausea
Clinical narrative: First booster had a stronger reaction than the other two; Tired; Nauseated; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (First booster had a stronger reaction than the other two), FATIGUE (Tired) and NAUSEA (Nauseated) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient had no allergies  Patient did not received ther vaccines within 1 month prior to Moderna COVID-19 vaccine.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (First booster had a stronger reaction than the other two), FATIGUE (Tired) and NAUSEA (Nauseated). At the time of the report, VACCINATION COMPLICATION (First booster had a stronger reaction than the other two), FATIGUE (Tired) and NAUSEA (Nauseated) outcome was unknown.      Patient never had COVID  test.  No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2022-549088, MOD-2022-550488 (Patient Link).
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Immunisation reaction, Nausea
Clinical narrative: First booster had a stronger reaction than the other two,; They felt more tired; They felt a little nauseated; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (First booster had a stronger reaction than the other two,), FATIGUE (They felt more tired) and NAUSEA (They felt a little nauseated) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient had no allergy to medications, food and other products. Patient never had COVID positive test or diagnosis. Patient had no acute and chronic illness at the time of vaccination and up to one month before. Patient had no vaccine within one month prior to Moderna vaccine.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (First booster had a stronger reaction than the other two,), FATIGUE (They felt more tired) and NAUSEA (They felt a little nauseated). At the time of the report, VACCINATION COMPLICATION (First booster had a stronger reaction than the other two,), FATIGUE (They felt more tired) and NAUSEA (They felt a little nauseated) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication reported. It had been stated that could not provided information about the other doses or the lot numbers. The events did not cause the patient to seek medical care. just rested for a day. No treatment medication reported.   This case was linked to MOD-2022-549088, MOD-2022-550463 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: bruising; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (bruising) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Multiple sclerosis. Concurrent medical conditions included Skin discoloration, Weight gain and Blurry vision. Concomitant products included PREGABALIN (LYRICA) and OCRELIZUMAB (OCREVUS) for an unknown indication.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CONTUSION (bruising). At the time of the report, CONTUSION (bruising) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication were reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: unbelievable pain on her right knee/Severe Pain/ Extreme Pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (unbelievable pain on her right knee/Severe Pain/ Extreme Pain) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient never had COVID positive test. The patent had no allergies. No medical history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.     On 14-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2022, the patient experienced ARTHRALGIA (unbelievable pain on her right knee/Severe Pain/ Extreme Pain). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. In April 2022, ARTHRALGIA (unbelievable pain on her right knee/Severe Pain/ Extreme Pain) had resolved. Not Provided  No Concomitant product use was reported. AE caused patient to seek medical care. The patient  went to see the primary doctor and an orthopedic surgeon who ran tests on patient, but had no explanation on what was going on.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 69-year-old male patient received BNT162b2 (COMIRNATY), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: controlled well with medication. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 12Apr2022, outcome "unknown" and all described as "tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Apr2022) positive.  Clinical course:The reporter accompanied by her husband, her son and a friend have all been vaccinated and boosted with Pfizer Covid vaccine. While vacationed together on a cruise ship the week from 05Apr2022 to 12Apr2022, they were notified on 12Apr2022 having been tested positive for Covid.They were therefore removed from the shipped and self quarantined in a hotel. Since being quarantined they have all developed mild to moderate Covid symptoms. Symptoms developed by patient: cough, congestion, fever for 2 days  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Audiogram, Deafness neurosensory
Clinical narrative: Sudden Sensorineural hearing loss of right ear occurred 5 days after vaccine injection/Deafness Neurosensory; This is a literature report for the following literature source(s).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), 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: DEAFNESS NEUROSENSORY (medically significant), 5 days after the suspect product(s) administration, outcome "unknown", described as "Sudden Sensorineural hearing loss of right ear occurred 5 days after vaccine injection/Deafness Neurosensory". The patient underwent the following laboratory tests and procedures: Audiogram: (05Jul2021) Unknown results.  The reporter considered "sudden sensorineural hearing loss of right ear occurred 5 days after vaccine injection/deafness neurosensory" related to BNT162b2. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: A possibly contributory role of BNT162B2 in triggering the onset of event cannot be fully excluded, considering the temporal relationship.  More immunological and biomolecular evidence would be needed to explore the plausible physiopathologic mechanism between the vaccination and the event occurrence.  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-202200341969 Same article/ drug; different patient and event
Age: 16.0
Sex: F
Vaccine: MEN, MENB
Symptoms: Injection site rash, Rash papular
Clinical narrative: locally-situated rash; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team.  A 16-year-old female patient received meningococcal group b Rlp2086 (TRUMENBA), on 11Apr2022 as 0.5 ml, single (Lot number: AT1920, Expiration Date: May2022) at the age of 16 years, in left arm for immunisation; meningococcal vaccine (MENINGOCOCCAL VACCINE), on 11Apr2022 as 0.5 ml, single (Lot number: U6920AB, Expiration Date: 15Apr2022), in left arm for immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: meningococcal vaccine (Dose 1), administration date: 16Nov2016, for vaccination. The following information was reported: RASH (non-serious) with onset 16Apr2022, outcome "recovering", described as "locally-situated rash". Therapeutic measures were not taken as a result of rash.  Additional information: The patient developed the rash on the 16th. She has not seen the rash, but the mom said when she called that the rash was around the area of the site and was kind of raised a little bit, and it never spread anywhere else other than to the arm of where injections were. She thinks it got better. She clarified that this was her first dose of Meningitis B. It was the patient's second dose of NCV vaccine. She said her first dose of NCV vaccine was given 16Nov2016, and the patient wasn't their patient at that time, they do not have NDC/LOT/EXP to provide for that dose, only the date it was given.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis, Pericarditis
Clinical narrative: myocarditis; pericarditis; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), 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: MYOCARDITIS (medically significant), outcome "unknown"; PERICARDITIS (medically significant), outcome "unknown".  The reporter's assessment of the causal relationship of "myocarditis" and "pericarditis" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case report, a possible causal relationship between the reported events: "Myocarditis", "Pericarditis" and the suspect drug BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Nasal congestion, SARS-CoV-2 test, Vaccination failure
Clinical narrative: positive Antigen; positive Antigen; cough; congestion; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 53-year-old male patient received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Lot number: EL3247), on 23Mar2021 as dose 2, single (Lot number: EL3247) and on 28Sep2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 52 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SEQIRUS taken for immunisation, on 28Sep2021 as dose 1, single. The following information was reported: NASAL CONGESTION (non-serious) with onset 18Apr2022, outcome "unknown", described as "congestion"; COUGH (non-serious) with onset 18Apr2022, outcome "unknown"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Apr2022, outcome "unknown" and all described as "positive Antigen". The events "positive antigen", "cough" and "congestion" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Apr2022) Negative, notes: on 18Apr but negative Antigen test; (20Apr2022) Positive. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, cough, nasal congestion.  Clinical course: Patient had received other vaccine in four week and the dose number of vaccine was 1. Patient had Traveled on plan 14Apr & back on 17Apr, on 18Apr negative Antigen test then cough and congestion and positive Antigen on 20Apr.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events Vaccination failure, COVID-19  and the use of suspect product BNT162B2 cannot be fully excluded.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Headache, Nausea, Night sweats
Clinical narrative: Fever greater 100.4; profuse night sweats; horrible head ache; severe joint pain throughout; nausea greater than 2 days now; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Apr2022 at 09:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2), for Covid-19 immunization; Bnt162b2 (Dose Number: 1), for Covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 19Apr2022, outcome "recovering", described as "Fever greater 100.4"; HEADACHE (non-serious) with onset 19Apr2022, outcome "recovering", described as "horrible head ache"; NAUSEA (non-serious) with onset 19Apr2022, outcome "recovering", described as "nausea greater than 2 days now"; NIGHT SWEATS (non-serious) with onset 19Apr2022, outcome "recovering", described as "profuse night sweats"; ARTHRALGIA (non-serious) with onset 19Apr2022, outcome "recovering", described as "severe joint pain throughout". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, night sweats, headache, arthralgia, nausea.  Additional information: Batch/lot numbers were not available/provided to reporter at the time of report completion. Hospitalization Prolonged was no. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Treatment received for the adverse event with unspecified medications. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever greater 100.4; profuse night sweats; horrible head ache; severe joint pain throughout; nausea greater than 2 days now; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Apr2022 at 09:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2), for Covid-19 immunization; Bnt162b2 (Dose Number: 1), for Covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 19Apr2022, outcome "recovering", described as "Fever greater 100.4"; HEADACHE (non-serious) with onset 19Apr2022, outcome "recovering", described as "horrible head ache"; NAUSEA (non-serious) with onset 19Apr2022, outcome "recovering", described as "nausea greater than 2 days now"; NIGHT SWEATS (non-serious) with onset 19Apr2022, outcome "recovering", described as "profuse night sweats"; ARTHRALGIA (non-serious) with onset 19Apr2022, outcome "recovering", described as "severe joint pain throughout". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, night sweats, headache, arthralgia, nausea.  Additional information: Batch/lot numbers were not available/provided to reporter at the time of report completion. Hospitalization Prolonged was no. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Treatment received for the adverse event with unspecified medications. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Vaccination site pain, Vaccination site swelling
Clinical narrative: Day 3-4 swollen and painful lymph nodes under arm; Day 3-4 swollen and painful lymph nodes under arm; Day 1-3 swollen and tender injection site.; Day 1-3 swollen and tender injection site.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Apr2022 at 10:00 as dose 1, single (Lot number: FK9893) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 18Apr2022 at 22:00, outcome "not recovered" and all described as "Day 1-3 swollen and tender injection site."; LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 21Apr2022 at 22:00, outcome "not recovered" and all described as "Day 3-4 swollen and painful lymph nodes under arm". Therapeutic measures were not taken as a result of vaccination site swelling, vaccination site pain, lymphadenopathy, lymph node pain.  Additional information: Patient was not taken any other vaccine in four weeks, Day 1-3 swollen and tender injection site. Day 3-4 swollen and painful lymph nodes under arm. No COVID prior vaccination, Not tested for COVID post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Antiphospholipid syndrome
Clinical narrative: COVID mRNA Vaccine linked Antiphospholipid Syndrome; This is a literature report. A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, 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: ANTIPHOSPHOLIPID SYNDROME (medically significant), outcome "unknown", described as "COVID mRNA Vaccine linked Antiphospholipid Syndrome".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available limited information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported event which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 27.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Dry skin, Rheumatoid arthritis, Rhinorrhoea
Clinical narrative: Worsened Rheumatoid Arthritis Flareups; Runny Nose; Dry Scalp/ Dry Skin; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4364310-00.  A 28-year-old female patient received BNT162b2 (BNT162B2), on 04Jul2021 as dose 1, single (Batch/Lot number: unknown) and on 28Jul2021 as dose 2, single (Batch/Lot number: unknown) at the age of 27 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "recovering", described as "Worsened Rheumatoid Arthritis Flareups"; RHINORRHOEA (non-serious), outcome "recovering", described as "Runny Nose"; DRY SKIN (non-serious), outcome "recovering", described as "Dry Scalp/ Dry Skin". The action taken for adalimumab was unknown. It was unknown if patient was enrolled in a Covid-19 vaccine Trail. The primary reporter did not have the lot number information, because the packaging was discarded.  The reporter's assessment of the causal relationship of the events Rheumatoid arthritis, Rhinorrhoea, Dry skin. with the suspect product was provided Possible at the time of this report. Since determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Rheumatoid arthritis, Rhinorrhea, dry skin and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Haematuria, Pyrexia
Clinical narrative: Gross haematuria 24 hours after vaccination/This occurred on both the 3rd dose (1st booster on 07Nov21); feverish; 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 received BNT162b2 (BNT162B2), on 07Nov2021 at 10:00 as dose 3 (booster), single (Lot number: EH8027) at the age of 63 years (not pregnant), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Sulfur" (unspecified if ongoing), notes: other medical history: None, known allergies: Sulfur. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization Series Completed, Manufacturer Unknown), for COVID-19 Immunization The following information was reported: HAEMATURIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Gross haematuria 24 hours after vaccination/This occurred on both the 3rd dose (1st booster on 07Nov21)"; PYREXIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "feverish". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Seriousness criteria did not Result in death nor Life threatening; No prolonged hospitalization; No Disabling/Incapacitating; Did not result in Congenital anomaly/birth defect. Patient did not receive any other vaccine in four weeks. No COVID prior vaccination Patient was not tested for COVID post vaccination. patient received BNT162b2 (BNT162B2), on 18Apr2022, at 10:00 as dose 3 (booster), single (Lot number: FR9893). Adverse event: Gross haematuria 24 hours after vaccination. This occurred on both the 3rd dose (1st booster on 07Nov21) and the 4th dose (2nd booster on 18Apr22) of my COVID 19 shots. After the 3rd shot, my urine cleared up after 8-10 days. I still have brown urine from my 4th dose. I was also feverish and down for 36 hours with both these. AE resulted in: [Doctor or other healthcare professional office/clinic visit]. AE treatment: CT scan of lower abdomen.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pain
Clinical narrative: I've had a 50-cent piece sized red area and lump and pain when I lay on it at night.; I've had a 50-cent piece sized red area and lump and pain when I lay on it at night.; I've had a 50-cent piece sized red area and lump and pain when I lay on it at night.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Apr2022 at 11:45 as dose 4 (booster), single (Lot number: FJ4989) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "mild IBS" (unspecified if ongoing), notes: mild IBS; "Known Allergies:penicillin" (unspecified if ongoing); "Known Allergies:latex" (unspecified if ongoing); "Known Allergies:sulfa" (unspecified if ongoing), notes: Known Allergies:sulfa; "Known Allergies:shellfish" (unspecified if ongoing); "Known Allergies:tomatoes" (unspecified if ongoing), notes: Known Allergies:tomatoes. Concomitant medication(s) included: METOPROLOL; ASPIRIN [ACETYLSALICYLIC ACID]. Vaccination history included: Bnt162b2 (Dose: 1), for Covid-19 Immunization, reaction(s): "a little sore"; Bnt162b2 (Dose: 2), for Covid-19 Immunization, reaction(s): "a little sore"; Bnt162b2 (Dose: 3), for Covid-19 Immunization, reaction(s): "a little sore". The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE MASS (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 20Apr2022 at 07:00, outcome "not recovered" and all described as "I've had a 50-cent piece sized red area and lump and pain when I lay on it at night.". Therapeutic measures were taken as a result of vaccination site erythema, vaccination site mass, vaccination site pain.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of other medications the patient received within 2 weeks of vaccination: Metoprolol, Low dose Aspirin, Vitamins. The 1st three Pfizer COVID19 vaccines did not do anything to arm, except a little sore. This last dose was imperceptible the first day, but the next 3 days, She has had a 50-cent piece sized red area and lump and pain when she lay on it at night. She put an ice pack on it. Prior to vaccination, the patient was diagnosed with COVID-19 and since the vaccination, the patient not has been tested for COVID-19. Device Date mentioned as 21Apr2022.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 58 years for Covid-19 immunisation. The patient's relevant medical history included: "Mild IBS" (unspecified if ongoing), notes: Mild IBS; "Known Allergies: Shellfish" (unspecified if ongoing); "Known Allergies: Sulfa" (unspecified if ongoing), notes: Known Allergies: Sulfa; "Known Allergies: Latex" (unspecified if ongoing); "Known Allergies: Tomatoes" (unspecified if ongoing), notes: Known Allergies: Tomatoes; "Known Allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL; ASPIRIN [ACETYLSALICYLIC ACID]. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "The 1st three Pfizer COVID19 vaccines did not do anything to my arm, except a little sore". Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of other medications the patient received within 2 weeks of vaccination: Metoprolol, Low dose Aspirin, Vitamins. The 1st three Pfizer COVID19 vaccines did not do anything to arm, except a little sore. This last dose was imperceptible the first day, but the next 3 days, She has had a 50-cent piece sized red area and lump and pain when she lay on it at night. She put an ice pack on it. Prior to vaccination, the patient was diagnosed with COVID-19 and since the vaccination, the patient not has been tested for COVID-19. Device Date mentioned as 21Apr2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Chronic graft versus host disease
Clinical narrative: Chronic graft versus host disease; This is a literature report.  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "allogeneic haematopoietic stem cell transplantation (HSCT)" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Comirnaty (Dose 1, single), for COVID-19 immunisation. The following information was reported: CHRONIC GRAFT VERSUS HOST DISEASE (medically significant), outcome "unknown".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the currently available information the possibility of causal association between the event chronic graft versus host disease and the suspect drug BNT162B2  cannot be ruled out. 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-202200611693 Same reporter/product/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: Chronic graft versus host disease
Clinical narrative: exacerbation of chronic graft versus host disease; This is a literature report.  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "haematopoietic stem cell transplantation (HSCT)" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Comirnaty (Dose 1), for COVID-19 immunization. The following information was reported: CHRONIC GRAFT VERSUS HOST DISEASE (medically significant), outcome "unknown", described as "exacerbation of chronic graft versus host disease".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event, chronic graft versus host disease cannot be completely ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202200611693 Same reporter/product/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: Chronic graft versus host disease
Clinical narrative: exacerbation of chronic graft versus host disease; This is a literature report, Program ID: (005851) for the following literature source(s): "Chronic graft-versus-host disease exacerbation after SARS-CoV-2 vaccination", Bone-Marrow-Transplant, 2022; Vol:57(3), pgs:502-503.  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "haematopoietic stem cell transplantation (HSCT)" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Comirnaty (Dose 1, single), for COVID-19 immunisation. The following information was reported: CHRONIC GRAFT VERSUS HOST DISEASE (medically significant), outcome "unknown", described as "exacerbation of chronic graft versus host disease".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information currently available,The casual association between the reported event and suspected vaccine BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202200611693 Same reporter/product/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: Chronic graft versus host disease
Clinical narrative: Chronic graft versus host disease; This is a literature report.  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "allogeneic haematopoietic stem cell transplantation (HSCT)" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Comirnaty (Dose 1, single), for COVID-19 immunization. The following information was reported: CHRONIC GRAFT VERSUS HOST DISEASE (medically significant), outcome "unknown".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information currently available,The casual association between the reported event and suspected vaccine BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202200611693 Same reporter/product/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: Chronic graft versus host disease
Clinical narrative: exacerbation of chronic graft versus host disease; This is a literature report.  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "haematopoietic stem cell transplantation (HSCT)" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Comirnaty (DOSE 1, SINGLE), for COVID-19 immunisation.  The following information was reported: CHRONIC GRAFT VERSUS HOST DISEASE (medically significant), outcome "unknown", described as "exacerbation of chronic graft versus host disease".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information currently available,The casual association between the reported event and suspected vaccine BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202200611693 Same reporter/product/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: Chronic graft versus host disease
Clinical narrative: exacerbation of chronic graft versus host disease; This is a literature report.  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "allogeneic haematopoietic stem cell transplantation (HSCT)" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: CHRONIC GRAFT VERSUS HOST DISEASE (medically significant), outcome "unknown", described as "exacerbation of chronic graft versus host disease".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information currently available,The casual association between the reported event and suspected vaccine BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202200611693 Same reporter/product/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: Chronic graft versus host disease
Clinical narrative: Chronic graft versus host disease; This is a literature report, Program ID: ().  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "allogeneic haematopoietic stem cell transplantation (HSCT)" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: CHRONIC GRAFT VERSUS HOST DISEASE (medically significant), outcome "unknown".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information currently available,The casual association between the reported event and suspected vaccine BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202200611693 Same reporter/product/event, different patient