chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: COVID infection, tested positive; COVID infection, tested positive; received Booster shot; Runny nose; Nasal congestion; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 17 year-old female patient received bnt162b2 (BNT162B2), administration date 16Dec2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation in Workplace Clinic; covid-19 vaccine (COVID-19 VACCINE) (Batch/Lot number: unknown, Manufacturer Unknown) as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history(No underlying conditions). There were no concomitant medications. The following information was reported: IMMUNISATION (medically significant) with onset 16Dec2021, outcome "unknown", described as "received Booster shot"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 22Dec2021, outcome "unknown" and all described as "COVID infection, tested positive"; RHINORRHOEA (non-serious) with onset Dec2021, outcome "unknown", described as "Runny nose"; NASAL CONGESTION (non-serious) with onset Dec2021, outcome "unknown", described as "Nasal congestion"; HEADACHE (non-serious) with onset Dec2021, outcome "unknown", described as "Headache". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (14Dec2021) negative; (19Dec2021) negative; (22Dec2021) positive.  Clinical course: the patient had a PCR test and results came negative on 14Dec2021(two days before vaccination). She received the Pfizer/BioNTech booster shot on 16Dec2021. She was informed on 17Dec2021 that she had been exposed to a classmate that tested positive to COVID-19 on this same day. She performed another rapid home-test on 19Dec2021 that came again negative. She tested positive using a rapid home-test kit in the evening of 22Dec2021. She had mild symptoms included runny nose, nasal congestion and headache.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation
Clinical narrative: The 3 doses of the anti COVID vaccine; After taking the 3 doses of the anti COVID vaccine, unfortunately I got the virus; After taking the 3 doses of the anti COVID vaccine, unfortunately I got the virus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number: unknown) at an unspecified age as dose 3 (booster), single, via an unspecified route of administration on an unspecified date (Batch/Lot number: unknown) at an unspecified age as dose 2, single, and via an unspecified route of administration on an unspecified date (Batch/Lot number: unknown) at an unspecified age as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported IMMUNISATION (medically significant), outcome unknown; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome unknown. The patient was currently not working.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Herpes zoster
Clinical narrative: she has covid-19; she has covid-19; Pt reports having shingles; This is a spontaneous report received from contactable reporter (Other HCP and Consumer).  A 52 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19, outcome not recovered ; HERPES ZOSTER (non-serious) with onset 2021, outcome unknown.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available, lack of efficacy  of the suspected vaccine BNT162B2 cannot be completely excluded. Similarly the reported event of HERPES ZOSTER cannot be excluded, very limited information is provided for proper medical review, Case will be reassessed should the additional information be 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: 63.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Intervertebral disc operation
Clinical narrative: Replace two discs in neck; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4194031-00 (Agency).  A 63 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 18Feb2021 (Batch/Lot number: unknown) at the age of 63 years as dose 1, single and intramuscular, administration date 10Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at citrate free for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERVERTEBRAL DISC OPERATION (medically significant) with onset 2021, outcome "unknown", described as "Replace two discs in neck". The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of intervertebral disc operation.  Clinical information: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 18Feb2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer Biontech. On 10Mar2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer.   Causality for HUMIRA (ADALIMUMAB) The reporter's causality for the event(s) of 'Replace Two discs in neck was not provided. Agency's opinion is that there is no reasonable possibility that the event of Replace two discs in neck is related to Humira (Adalimumab).  The reporter's assessment of the causal relationship of the events with the suspect product HUMIRA was not reported. The reporter's assessment of the causal relationship of the events with the suspect product BNT162B2 was reported as possible  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The event of Intervertebral disc operation is assessed as not related to BNT162B2, and more likely due to underlying medical condition of Rheumatoid arthritis as patient was on Co suspect HUMIRA.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Immunisation, Myalgia, 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 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 20Dec2021 14:00 (Lot number: FH8027) at the age of 51 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Prev dose product: COVID 19,, Prev dose brand: Pfizer,, Prev dose brand unknown: False,, Prev dose lot number: EL3247,, Prev dose lot unknown: False,, Prev dose administrator route: Intramuscular,, Prev dose administration date: 19Feb2021,, Prev dose administration time: 02:00 PM, Prev dose dose number: 2,, Prev dose vaccine location: Left arm,), administration date: 19Feb2021, when the patient was 50 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Previous dose details: , Prev dose product: COVID 19,, Prev dose brand: Pfizer,, Prev dose brand unknown: False,, Prev dose lot number: EL3247,, Prev dose lot unknown: False,, Prev dose administrator route: Intramuscular , Prev dose administration date: 29Jan2021,, Prev dose administration time: 12:45PM, Prev dose dose number: 1,, Prev dose vaccine location: Left arm), administration date: 29Jan2021, when the patient was 50 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 20Dec2021 14:00, outcome "recovered" (2021), described as "booster"; PAIN IN EXTREMITY (non-serious) with onset 20Dec2021 17:00, outcome "recovered" (2021), described as "Sore arm - 72 hours"; MYALGIA (non-serious) with onset 20Dec2021 17:00, outcome "recovered" (2021), described as "muscle aches - 48 hours"; HEADACHE (non-serious) with onset 20Dec2021 17:00, outcome "recovered" (2021), described as "intense headache - 24 hours/mild headache - 54 hours"; FATIGUE (non-serious) with onset 20Dec2021 17:00, outcome "recovered" (2021), described as "fatigue - 54 hours". Therapeutic measures were not taken as a result of immunisation, pain in extremity, myalgia, headache, fatigue. No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Influenza like illness, Rheumatoid arthritis
Clinical narrative: Still rheumatoid arthritis flare ups; Flu-like symptoms; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4192264-00 (Agency).  A 58 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 13Apr2021 (Batch/Lot number: unknown) at the age of 58 years as dose 2, single and intramuscular, administration date 23Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at cf for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant) with onset 2021, outcome "not recovered", described as "Still rheumatoid arthritis flare ups"; INFLUENZA LIKE ILLNESS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Flu-like symptoms". The action taken for adalimumab was unknown.  Clinical course: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for HUMIRA (ADALIMUMAB): The reporter's causality for the event(s) of still rheumatoid arthritis flare ups was not provided. The reporter's causality for the event(s) of flu-like symptoms with Humira (adalimumab) was no reasonable possibility. Causality for PFIZER BIONTECH COVID-19 VACCINE: The reporter's causality for the event(s) of still rheumatoid arthritis flare ups was not provided. The reporter's causality for the event(s) of flu-like symptoms was Possible.  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 in the case, a contributory effect of the vaccine BNT162B2 to the reported events cannot be established.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Received his first dose 14Dec2021 and then was diagnosed on 20Dec2021 with Covid 19; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the parent. Other Case identifier(s): US-PFIZER INC-202101863332 (Pfizer), US-PFIZER INC-202101863400 (Pfizer).  A 11 year-old male patient received bnt162b2 (BNT162B2), administration date 14Dec2021 (Batch/Lot number: unknown) as dose 1 (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (non-serious) with onset 20Dec2021, outcome "unknown", described as "Received his first dose 14Dec2021 and then was diagnosed on 20Dec2021 with Covid 19". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporting nurse stated that her 11-year-old son received his first dose of the Pfizer BioNTech COVID-19 vaccine pediatric formulation (orange cap) on 14Dec2021, and he ended up testing positive for COVID-19 on 20Dec2021. He was scheduled for his second dose on 04Jan2021 and was seeking guidance whether patient has to wait to receive his second dose or not.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 45.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Colitis ulcerative
Clinical narrative: Ulcerative colitis symptoms came back; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4206425-00 (Agency).  A 45 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 14Aug2021 (Batch/Lot number: unknown) at the age of 45 years as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at cf for colitis ulcerative. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COLITIS ULCERATIVE (medically significant) with onset 15Aug2021, outcome "recovered" (2021), described as "Ulcerative colitis symptoms came back". The action taken for adalimumab was unknown.  Additional Information: The reporter's causality for the event ulcerative colitis symptoms came back for HUMIRA(ADALIMUMAB) and Pfizer BioNTech COVID-19 Vaccine (Tozinameran) of was not reported.  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 in the case report and a plausible temporal relationship, a possible causal relationship between the reported event Colitis ulcerative and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Mental impairment
Clinical narrative: got a little slow after the shot; This is a spontaneous report received from a non-contactable reporter (consumer) for a Pfizer sponsored program. The reporter is the parent.  A 15 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) administration date 22Dec2021 (Batch/Lot number: unknown) at the age of 15 years as dose number unknown, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MENTAL IMPAIRMENT (medically significant) with onset 22Dec2021, outcome "unknown", described as "got a little slow after the shot". The patient had the shot yesterday and got a little slow after the shot. The patient's parent asked if it's a side effect.   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: tested positive for covid, vaccinated with 2 doses by summer 2021; tested positive for covid, vaccinated with 2 doses by summer 2021; This is a spontaneous report received from a contactable reporter Consumer.  An adult female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 2, single and administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. There were no other vaccines received in four weeks. The patient did not have Covid-19 prior vaccination and the patient previously tested multiple times on multiple dates post-vaccination with negative results. The following information was reported DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2021, outcome unknown. The event tested positive for covid, vaccinated with 2 doses by summer 2021 was evaluated at the emergency room visit. Clinical course reported that the patient was showing covid symptoms as of yesterday morning in Dec2021. First indicated that the patient did not feel well at around 11:45 am. The patient has had sore throat, cough, headache, congestion/runny nose, and fatigue. Said felt funky. Still has taste. Seemed to improve over the course of the day (started with what seemed like a lot of coughing and that lessened). Took Tylenol at around 3:20 pm. The patient was present at an engagement party on Sunday, where it has been reported at least 3 people have tested positive for covid that were in attendance. As of this morning (23Dec2021), the patient is now running a fever in addition to the other symptoms. The patient underwent the following laboratory tests and procedures: sars-cov-2 test (Dec2021) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Electromyogram, Guillain-Barre syndrome, Investigation, Nerve conduction studies
Clinical narrative: Guillain-Barre Syndrome; This is a literature report for the following literature source(s): (privacy).  Case Diagnosis: Guillain-Barre Syndrome (GBS) was diagnosed in a female with symptoms of ataxia, paresthesia, and dysmetria, which was confirmed with cerebrospinal fluid (CSF) analysis. Case Description: We present a case report about a 34-year-old female who developed GBS two weeks after receiving the first dose of the Pfizer COVID-19 vaccine. Setting: The diagnosis was made in the acute hospital, and then treatment continued in the acute rehabilitation setting. Assessment/Results: Results from the CSF analysis were conclusive with physical presentation, and the patient was started on the proper treatment protocol, which included IVIG and high-dose steroids. She continually made progress during her rehabilitation period, and an electromyography (EMG) and nerve conduction study (NCS) was scheduled as an outpatient for better confirmation. Discussion: In 1976, there was substantial evidence of a causal link between the swine influenza vaccine and the development of GBS. Thus, the Vaccine Adverse Event Reporting System (VAERS) was then established in 1990 as a system that has helped detect any safety problems with any vaccines. To date, the VAERS has reported four cases of GBS after the 1st dose and three cases reported after the 2nd dose of the Pfizer COVID-19 vaccine. Our case will be the fifth reported case after the 1st Pfizer vaccine dose. Conclusion: It is important to note a patient's past medical history in the acute rehabilitation setting, including any recent vaccinations. This is because the VAERS requires that all healthcare professionals report adverse events, and all vaccine manufacturers must disclose any adverse events reported to them.; Sender's Comments: Based on the temporal relation, the association between the event of Guillain Barre syndrome and the suspect product of BNT162B2 cannot be completely ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Pt complained of sore chest around heart; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 6 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Dec2021 (Lot number: FK5127) at the age of 6 years as dose 2,single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FL0007, Location of injection: Left Arm), administration date: 22Nov2021, when the patient was 5 years old, for Covid-19 immunization. The following information was reported: CHEST PAIN (non-serious) with onset 21Dec2021, outcome "recovered", described as "Pt complained of sore chest around heart". Therapeutic measures were not taken as a result of chest pain.  Additional Information: Prior vaccination within 4 weeks was reported as none. Prior to vaccination patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: booster; Breakthrough covid case; Breakthrough covid case; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A 46 year-old female patient (not pregnant) received BNT162b2 (BNT162B2, brand: Pfizer) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The following information was reported IMMUNISATION (medically significant), outcome recovering, described as booster; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome recovering. The patient underwent the following laboratory tests and procedures covid test result positive. Therapeutic measures were not taken as a result of immunisation, drug ineffective, covid-19.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Computerised tomogram abdomen, Fibrin D dimer, Haemolysis, Thrombosis
Clinical narrative: Hemolytic flares; peripancreatic fat stranding indicating possible small bowel microvascular thrombosis; Five days after the second dose of the Pfizer-BioNTech vaccine, he developed abdominal pain; This is a literature report.  A male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "PNH" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunisation. The following information was reported: HAEMOLYSIS (medically significant), outcome "recovered", described as "Hemolytic flares"; THROMBOSIS (medically significant), outcome "recovered", described as "peripancreatic fat stranding indicating possible small bowel microvascular thrombosis"; ABDOMINAL PAIN (non-serious), outcome "recovered", described as "Five days after the second dose of the Pfizer-BioNTech vaccine, he developed abdominal pain". The patient underwent the following laboratory tests and procedures: computerised tomogram abdomen: peripancreatic fat, notes: stranding indicating possible small bowel microvascular thrombosis; fibrin d dimer: elevated. Therapeutic measures were taken as a result of haemolysis, thrombosis, abdominal pain.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on the reported information ,a causal relationship between the events haemolysis and Thrombosis and suspected drug cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate,Linked Report(s) : US-PFIZER INC-202101854431 same article, different patients/events;US-PFIZER INC-202101854432 same article, different patients/events;US-PFIZER INC-202101854433 same article, different patients/events
Sex: U
Vaccine: COVID19
Symptoms: Breakthrough haemolysis, Haemolysis
Clinical narrative: Breakthrough hemolysis; Hemolytic flares; This is a literature report.  The author recently showed that the addition of Spike protein didn't increase hemolysis of paroxysmal nocturnal hemoglobinuria (PNH) erythrocytes ex vivo, suggesting that hemolysis isn't due to the direct effect of Spike protein on red blood cells but rather to the activation of the classic pathway after antibody generation. Clinically, 8 PNH patients experiencing hemolytic flares after SARS-CoV-2 vaccine have been reported, including 6 breakthrough hemolysis (BTH) and 2 exacerbations in treatment naïve subjects (Table 2). The author reported six patients with PNH, who received either Moderna or Pfizer-BioNTech vaccine. Four, all on intravenous ravulizumab and one in combination therapy with D inhibitor danicopan, showed signs BTH from the vaccine up to 5 days later, 2 with severe anemia, and 1 requiring transfusion support. Interestingly, only 1 patient who was on therapy naïve experienced a likely thrombotic episode. Although the author observed BTH episodes in patients received COVID-19 vaccine more than 4 weeks after last ravulizumab dose, hemolytic flares may occur as soon as the day after the last complement inhibitor administration, so that it is difficult to suggest a specific timing, although it would be advisable to give vaccinations closer to anti-complement therapy.  Table 2: Hemolytic flares in patients with paroxysmal nocturnal hemoglobinuria after SARS-CoV-2 vaccine. Patient #2: PNH type - aplastic anemia (AA) PNH; Therapy - Ravulizumab; Vaccine - Pfizer; Time to BTH - same day of first dose; Therapy for BTH - Ravulizumab; Outcome - resolved.; Sender's Comments: Based on the reported information ,a causal relationship between the events and suspected drug cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate,Linked Report(s) : US-PFIZER INC-202101854207 same article, different patients/events
Sex: U
Vaccine: COVID19
Symptoms: Haemolysis
Clinical narrative: Hemolytic flares; This is a literature report.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "classic PNH" (ongoing). Concomitant medication(s) included: RAVULIZUMAB taken for paroxysmal nocturnal haemoglobinuria. The following information was reported: HAEMOLYSIS (medically significant), outcome "recovered", described as "Hemolytic flares". Therapeutic measures were taken as a result of haemolysis.; Sender's Comments: Based on the temporal association, a possible contributory role of BT162B2 to the event Hemolysis cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.  ,Linked Report(s) : US-PFIZER INC-202101854207 same article, different patients/events
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Muscle strain, SARS-CoV-2 test
Clinical narrative: strained his back.; back pain; This is a spontaneous report received from a non-contactable consumer from Medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (COMIRNATY), administration date 23Jun2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. Relevant medical history included: "disc issues of the lumbar back and in his back" (unspecified if ongoing); "back issues" (unspecified if ongoing); "lung issues" (unspecified if ongoing); "asthma" (unspecified if ongoing); "psoriasis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (dose 1, manufacturer unknown), administration date: 02Jun2021, for COVID-19 Immunization, reaction(s): "asthma with lung issues.", "asthma with lung issues.", "Left leg started aching", "disc issues/Back disc issues.", "heart diseases", "back pain". The following information was reported: MUSCLE STRAIN (non-serious) with onset 2021, outcome "unknown", described as "strained his back."; BACK PAIN (non-serious) with onset 2021, outcome "unknown", described as "back pain". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient was asking if he needs to be tested as he experienced back pain, indicated by healthcare professional as not related. The patient strained his back. The healthcare professional recommended him to get booster dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Atrial fibrillation, Immunisation, SARS-CoV-2 test
Clinical narrative: Initial diagnosis of atrial fibrillation; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 29Sep2021 12:00 (Batch/Lot number: unknown) at the age of 77 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Rheumatoid Arthritis" (unspecified if ongoing); "known allergies: Sulfa drugs" (unspecified if ongoing). The patient took concomitant medications. No other vaccine in four weeks. No COVID prior vaccination. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL 9264, in left arm, at 03:00 PM), administration date: 29Jan2021, when the patient was 76 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EL9266, in left arm, at 03:00 PM), administration date: 17Feb2021, when the patient was 76 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (medically significant) with onset 29Sep2021 12:00, outcome "unknown", described as "Booster"; ATRIAL FIBRILLATION (medically significant) with onset 09Nov2021 13:30, outcome "unknown", described as "Initial diagnosis of atrial fibrillation". The event "initial diagnosis of atrial fibrillation" was evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (20Dec2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of atrial fibrillation: cardioversion.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Atrial fibrillation, Cardioversion, Echocardiogram, Electrocardiogram
Clinical narrative: Initial diagnosis of atrial fibrillation; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 29Sep2021 12:00 (Batch/Lot number: unknown) at the age of 77 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Rheumatoid Arthritis" (unspecified if ongoing); "known allergies: Sulfa drugs" (unspecified if ongoing). The patient took concomitant medications. No other vaccine in four weeks. No COVID prior vaccination. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL 9264, in left arm, at 03:00 PM), administration date: 29Jan2021, when the patient was 76 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EL9266, in left arm, at 03:00 PM), administration date: 17Feb2021, when the patient was 76 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (medically significant) with onset 29Sep2021 12:00, outcome "unknown", described as "Booster"; ATRIAL FIBRILLATION (medically significant) with onset 09Nov2021 13:30, outcome "unknown", described as "Initial diagnosis of atrial fibrillation". The event "initial diagnosis of atrial fibrillation" was evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (20Dec2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of atrial fibrillation: cardioversion.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Blood test, Condition aggravated, Gait disturbance, Rheumatoid arthritis
Clinical narrative: Initial diagnosis of atrial fibrillation; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 29Sep2021 12:00 (Batch/Lot number: unknown) at the age of 77 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Rheumatoid Arthritis" (unspecified if ongoing); "known allergies: Sulfa drugs" (unspecified if ongoing). The patient took concomitant medications. No other vaccine in four weeks. No COVID prior vaccination. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL 9264, in left arm, at 03:00 PM), administration date: 29Jan2021, when the patient was 76 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EL9266, in left arm, at 03:00 PM), administration date: 17Feb2021, when the patient was 76 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (medically significant) with onset 29Sep2021 12:00, outcome "unknown", described as "Booster"; ATRIAL FIBRILLATION (medically significant) with onset 09Nov2021 13:30, outcome "unknown", described as "Initial diagnosis of atrial fibrillation". The event "initial diagnosis of atrial fibrillation" was evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (20Dec2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of atrial fibrillation: cardioversion.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test, Vaccination failure
Clinical narrative: Break-through COVID; Break-through COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 53 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 16Feb2021 (Lot number: EL3247) at the age of 53 years as dose 2, single and administration date 28Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22Dec2021, outcome "recovering" and all described as "Break-through COVID". The event "break-through covid" and "break-through covid" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: (24Dec2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Prior to Covid-19, no vaccination was provided. No known allergies and no other medical history was provided. No other vaccine was administered in four weeks and no other medications in two weeks.   No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Biopsy stomach, Computerised tomogram, Interchange of vaccine products, Magnetic resonance imaging
Clinical narrative: Astra Zeneca covid vaccine in Aug2021; and on 12Sep2021 had the pfizer covid vaccine; Astra Zeneca covid vaccine in Aug2021; and on 12Sep2021 had the pfizer covid vaccine; abd pain; pancreatitis; pancreatic head mass; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 63 year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administration date 12Sep2021 (Batch/Lot number: unknown) at the age of 63 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "DM" (unspecified if ongoing); "h pylori active infection" (ongoing). The patient took concomitant medications (unspecified diabetes medication). Vaccination history included: Astra zeneca covid-19 vaccine (Dose 1), administration date: Aug2021, for COVID-19 immunization. It was unknown if prior to vaccination whether patient was diagnosed with COVID-19 and unknown if since the vaccination whether the patient been tested for COVID-19.   The following information was reported: OFF LABEL USE (hospitalization), INTERCHANGE OF VACCINE PRODUCTS (hospitalization) all with onset 12Sep2021, outcome "unknown" and all described as "Astra Zeneca covid vaccine in Aug2021; and on 12Sep2021 had the pfizer covid vaccine"; ABDOMINAL PAIN (hospitalization) with onset 12Sep2021, outcome "recovering", described as "abd pain"; PANCREATITIS (hospitalization) with onset 12Sep2021, outcome "recovering", described as "pancreatitis"; PANCREATIC MASS (hospitalization) with onset 12Sep2021, outcome "recovering", described as "pancreatic head mass". The events "abd pain", "pancreatitis" and "pancreatic head mass" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: biopsy stomach: h pylori; computerised tomogram: pancreatitis with pancreatic head mass 3.6 x 3.6; decrease in size; magnetic resonance imaging: pancreatitis with pancreatic head mass 3.6 x 3.6; decrease in size. Therapeutic measures were taken as a result of pancreatitis. The physician reported that on 12Sep2021, patient had the Pfizer covid vaccine. The next day developed abd pain, was admitted to the hospital and found to have pancreatitis with a pancreatic head mass 3.6 x 3.6 cm on CT/MRI; follow-up (f/u) CT/MRI showed a decrease in size. An esophagogastroduodenoscopy (EGD) endoscopic ultrasound (EUS) was performed with fine needle biopsy of pancreatic mass, results were consistent with pancreatitis. Also found to have H. pylori on gastirc biopsy (bx).  The lot number for vaccine, bnt162b2, was not provided and will be requested during follow up.; Sender's Comments: Based on current information available, the events mostly represented intercurrent condition in this patient, unrelated to BNT162B2.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Pancreatic mass, Pancreatitis
Clinical narrative: Astra Zeneca covid vaccine in Aug2021; and on 12Sep2021 had the pfizer covid vaccine; Astra Zeneca covid vaccine in Aug2021; and on 12Sep2021 had the pfizer covid vaccine; abd pain; pancreatitis; pancreatic head mass; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 63 year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administration date 12Sep2021 (Batch/Lot number: unknown) at the age of 63 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "DM" (unspecified if ongoing); "h pylori active infection" (ongoing). The patient took concomitant medications (unspecified diabetes medication). Vaccination history included: Astra zeneca covid-19 vaccine (Dose 1), administration date: Aug2021, for COVID-19 immunization. It was unknown if prior to vaccination whether patient was diagnosed with COVID-19 and unknown if since the vaccination whether the patient been tested for COVID-19.   The following information was reported: OFF LABEL USE (hospitalization), INTERCHANGE OF VACCINE PRODUCTS (hospitalization) all with onset 12Sep2021, outcome "unknown" and all described as "Astra Zeneca covid vaccine in Aug2021; and on 12Sep2021 had the pfizer covid vaccine"; ABDOMINAL PAIN (hospitalization) with onset 12Sep2021, outcome "recovering", described as "abd pain"; PANCREATITIS (hospitalization) with onset 12Sep2021, outcome "recovering", described as "pancreatitis"; PANCREATIC MASS (hospitalization) with onset 12Sep2021, outcome "recovering", described as "pancreatic head mass". The events "abd pain", "pancreatitis" and "pancreatic head mass" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: biopsy stomach: h pylori; computerised tomogram: pancreatitis with pancreatic head mass 3.6 x 3.6; decrease in size; magnetic resonance imaging: pancreatitis with pancreatic head mass 3.6 x 3.6; decrease in size. Therapeutic measures were taken as a result of pancreatitis. The physician reported that on 12Sep2021, patient had the Pfizer covid vaccine. The next day developed abd pain, was admitted to the hospital and found to have pancreatitis with a pancreatic head mass 3.6 x 3.6 cm on CT/MRI; follow-up (f/u) CT/MRI showed a decrease in size. An esophagogastroduodenoscopy (EGD) endoscopic ultrasound (EUS) was performed with fine needle biopsy of pancreatic mass, results were consistent with pancreatitis. Also found to have H. pylori on gastirc biopsy (bx).  The lot number for vaccine, bnt162b2, was not provided and will be requested during follow up.; Sender's Comments: Based on current information available, the events mostly represented intercurrent condition in this patient, unrelated to BNT162B2.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Immunisation, Pulmonary embolism, SARS-CoV-2 test
Clinical narrative: Pulmonary embolism; shortness of breath and chest with deep breaths; shortness of breath and chest with deep breaths; Dose Number: 3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Oct2021 16:00 (Lot number: 3203060) at the age of 59 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "History of DVT" (unspecified if ongoing); "depression" (unspecified if ongoing). Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID]; FLUOXETINE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL9264, Location of injection: Arm Left), administration date: 30Jan2021, when the patient was 59 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL0142, Location of injection: Arm Left), administration date: 08Jan2021, when the patient was 59 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (disability) with onset 14Oct2021 16:00, outcome "unknown", described as "Dose Number: 3"; PULMONARY EMBOLISM (disability) with onset 01Nov2021, outcome "not recovered", described as "Pulmonary embolism"; DYSPNOEA (disability), CHEST PAIN (disability) all with onset 17Oct2021, outcome "not recovered" and all described as "shortness of breath and chest with deep breaths". The events "pulmonary embolism", "shortness of breath and chest with deep breaths" and "shortness of breath and chest with deep breaths" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Nov2021) negative, notes: If covid tested post vaccination: Yes. Therapeutic measures were taken as a result of pulmonary embolism, dyspnoea, chest pain.  Clinical course: The patient was not diagnosed with COVID-19 prior to vaccination. The patient has been tested for COVID-19 since the vaccination.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Uveitis
Clinical narrative: Uveitis; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Mar2021 10:00 (Lot number: Ep7534) at the age of 41 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "NA" (unspecified if ongoing), notes: NA. The patient's concomitant medications were not reported. Past drug history included: Tetanus, reaction(s): "Known allergies Tetanus", notes: Known allergies Tetanus. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: En6205, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 26Feb2021, when the patient was 41 years old, for COVID-19 immunization. The following information was reported: UVEITIS (disability, medically significant) with onset 06Jun2021 09:00, outcome "not recovered", described as "Uveitis". The event "uveitis" was evaluated at the physician office visit. Therapeutic measures were taken as a result of uveitis. Clinical course- Treatment received for the adverse event was Eye drops. Facility where the most recent COVID-19 vaccine was administered was unknown. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. It was reported Hospitalization was not prolonged. Device Date was 26Dec2021. Dose details: Bnt162b2 (Dose Number: 3, Batch/Lot No: Fe3590, Location of injection: Arm Left, on 01Nov2021 10:00 AM, for COVID-19 immunization.; Sender's Comments: Based on the available reported information, the causal association between the event uveitis and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.