chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoxia, Metabolic function test, Pyrexia, Tachycardia, Tremor
Clinical narrative: Patient is a 37-year-old male presents to the emergency department with fever.  Patient has history of TBI and short-term memory dysfunction, mother at bedside and provides a history.  Patient was recently admitted at facility from 4/10 to 4/25 for a left hip abscess.  This required I&D and IV antibiotics.  Patient was discharged to facility.  Finished antibiotics.  Patient was found to be hypoxic today with a fever of 100.9.  Tachycardic as well.  Mother notes his tremor has also become worse.  Patient complaining of a headache and chills.  He arrived on 2 L of oxygen.  Denies chest pain or shortness of breath.  Denies cough, abdominal pain.  Denies pain at his I&D site.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Urine analysis
Clinical narrative: Patient is a 37-year-old male presents to the emergency department with fever.  Patient has history of TBI and short-term memory dysfunction, mother at bedside and provides a history.  Patient was recently admitted at facility from 4/10 to 4/25 for a left hip abscess.  This required I&D and IV antibiotics.  Patient was discharged to facility.  Finished antibiotics.  Patient was found to be hypoxic today with a fever of 100.9.  Tachycardic as well.  Mother notes his tremor has also become worse.  Patient complaining of a headache and chills.  He arrived on 2 L of oxygen.  Denies chest pain or shortness of breath.  Denies cough, abdominal pain.  Denies pain at his I&D site.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Influenza like illness, Pain in extremity
Clinical narrative: first dose of Shingrix around 4 years ago in 2020 and would like to complete the Shingrix series; flu-like symptoms; Arm pain; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced influenza-like symptoms (Verbatim: flu-like symptoms), pain in arm (Verbatim: Arm pain) and incomplete course of vaccination (Verbatim: first dose of Shingrix around 4 years ago in 2020 and would like to complete the Shingrix series). The outcome of the influenza-like symptoms and pain in arm were resolved (duration 1 week) and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the influenza-like symptoms and pain in arm to be related to Shingrix.     It was unknown if the company considered the influenza-like symptoms and pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-APR-2024 The registered pharmacist reported that the patient received the first dose of Shingrix around 4 years ago in 2020 and would like to complete the Shingrix series.  The patient had flu-like symptoms and experienced arm pain for one week after receiving the first dose. The reporter asked did the patient need to start over or can they get the second dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow-up.
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: adult patient received a pediatric dose; pediatric dose was given to an adult patient by mistake; This non-serious case was reported by a nurse via call center representative and described the occurrence of accidental underdose in a 33-year-old female patient who received HBV (Engerix B pediatric) (batch number 9K74F, expiry date 27-OCT-2025) for prophylaxis.   On 15-APR-2024, the patient received Engerix B pediatric. On 15-APR-2024, an unknown time after receiving Engerix B pediatric, the patient experienced accidental underdose (Verbatim: adult patient received a pediatric dose) and adult use of a child product (Verbatim: pediatric dose was given to an adult patient by mistake). The outcome of the accidental underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 19-APR-2024 The reporter reported that a pediatric dose was given to an adult patient by mistakenly which led to, adult use of a child product and accidental underdose . The reporter reported that the LPN  (licensed practical nurse) grabbed the pediatric dose instead of the adult dose and when the RN (Registered Nurse) entered in the record then realized the mistake. The reporter stated that it was an human error. The reporter did not consent to follow-up.
Age: 55.0
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: 2nd dose not received yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 55-year-old female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (1st dose received on 20th October 2023, batch number 2PG392PG39).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: 2nd dose not received yet). The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 22-APR-2024 Pharmacist called and reported that our patient did not follow the exact guidelines of getting the shot. On 10th October 2023 was her first dose, she was looking to get her second dose on the day of reporting, which means she missed the dose that she was going to get a month later (than the first dose). The patient did not follow the exact guidelines of getting the shot. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: RSV
Symptoms: Diarrhoea, Fatigue
Clinical narrative: Patient developed fatigue; Diarrhea; This non-serious case was reported by a nurse via sales rep and described the occurrence of fatigue in a 83-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced fatigue (Verbatim: Patient developed fatigue ) and diarrhea (Verbatim: Diarrhea). The outcome of the fatigue and diarrhea were not reported.   It was unknown if the reporter considered the fatigue and diarrhea to be related to Arexvy.     It was unknown if the company considered the fatigue and diarrhea to be related to Arexvy.   Additional Information: GSK Receipt Date: 22-APR-2024 The reporter reported a patient developed fatigue and diarrhea after receiving the arexvy vaccine.  Patient's date of birth and initials were not available.  No other information was available.  The reporter consented to follow-up.
Age: 1.5
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Product storage error
Clinical narrative: patients who received vaccines beyond temperature excursion data .; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a female patient who received HAV (Havrix) (batch number 2YX23, expiry date 10-FEB-2025) for prophylaxis.   Co-suspect products included DTPa (Infanrix) (batch number GG39D, expiry date 07-JUN-2025) for prophylaxis.   On 15-DEC-2023, the patient received Havrix and Infanrix. On an unknown date, an unknown time after receiving Havrix and Infanrix, the patient experienced incorrect storage of drug (Verbatim: patients who received vaccines beyond temperature excursion data .). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-APR-2024 The reporter called if there was any information on  revaccination of patients who received  vaccines beyond temperature excursion data . The reporter consented to follow.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Pyrexia, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 49-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Nonischemic dilated cardiomyopathy" (unspecified if ongoing); "congestive heart failure" (unspecified if ongoing). Concomitant medication(s) included: VALSARTAN, start date: Apr2022; METFORMIN, start date: May2023; SYNTHROID, start date: Jun2023; METOPROLOL, start date: Oct2023; ADVAIR; CETRIZINE, start date: Mar2024. The following information was reported: COVID-19 (medically significant) with onset 13Apr2024, outcome "not recovered", VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Pyrexia: (25Apr2024) 99.6, notes: in evening; SARS-CoV-2 test: (13Apr2024) Positive; (25Apr2024) Positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: patient was feeling better, then she felt crummy and had a low grade fever (99.6) this evening. She tested positive again. she tested positive on 13Apr2024, completed 5 day course of Paxlovid, and tested positive again today- 25Apr2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: all the other 4 were good and did not really have any problems with those, maybe a little pain; This is a spontaneous report received from a Consumer or other non HCP.  A male patient received BNT162b2 (BNT162B2 NOS), as dose 4 (booster), single (Batch/Lot number: unknown), in left arm, as dose 3 (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing), notes: arthritis in knees, spine, the spine disc and feet treated by Aclomore. The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "all the other 4 were good and did not really have any problems with those, maybe a little pain".  Additional information: The other 4 were good and did not really have any problems with those, maybe a little pain.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Now she has COVID again; Now she has COVID again/Affects my lungs/Out of breath; This is a spontaneous report received from a Consumer or other non HCP.  A 65-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing), notes: slightly blood pressure; "COPD" (unspecified if ongoing); "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number unknown single, unknown manufacturer), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "not recovered", described as "Now she has COVID again"; COVID-19 (medically significant), outcome "not recovered", described as "Now she has COVID again/Affects my lungs/Out of breath". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2023) Positive, notes: she had COVID Feb2023 and Nov2023; (Nov2023) Positive, notes: she had COVID Feb2023 and Nov2023; (28Apr2024) Positive, notes: today she tested again positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information:every time get COVID it affects patient's lungs, it makes she out of breath. Patient have not really recovered from that and can't imagine what it would be like without the Paxlovid. Treatment included getting some Prednisone also with the Paxlovid. Information on the batch/Lot number will be requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Now she has COVID again; Now she has COVID again/Affects my lungs/Out of breath; This is a spontaneous report received from a Consumer or other non HCP.  A 65-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing), notes: slightly blood pressure; "COPD" (unspecified if ongoing); "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number unknown single, unknown manufacturer), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "not recovered", described as "Now she has COVID again"; COVID-19 (medically significant), outcome "not recovered", described as "Now she has COVID again/Affects my lungs/Out of breath". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2023) Positive, notes: she had COVID Feb2023 and Nov2023; (Nov2023) Positive, notes: she had COVID Feb2023 and Nov2023; (28Apr2024) Positive, notes: today she tested again positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information:every time get COVID it affects patient's lungs, it makes she out of breath. Patient have not really recovered from that and can't imagine what it would be like without the Paxlovid. Treatment included getting some Prednisone also with the Paxlovid. Information on the batch/Lot number will be requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Now she has COVID again; Now she has COVID again/Affects my lungs/Out of breath; This is a spontaneous report received from a Consumer or other non HCP.  A 65-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing), notes: slightly blood pressure; "COPD" (unspecified if ongoing); "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number unknown single, unknown manufacturer), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "not recovered", described as "Now she has COVID again"; COVID-19 (medically significant), outcome "not recovered", described as "Now she has COVID again/Affects my lungs/Out of breath". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2023) Positive, notes: she had COVID Feb2023 and Nov2023; (Nov2023) Positive, notes: she had COVID Feb2023 and Nov2023; (28Apr2024) Positive, notes: today she tested again positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information:every time get COVID it affects patient's lungs, it makes she out of breath. Patient have not really recovered from that and can't imagine what it would be like without the Paxlovid. Treatment included getting some Prednisone also with the Paxlovid. Information on the batch/Lot number will be requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Vaccination failure; COVID-19; This is a spontaneous report received from an Other HCP.  A 58-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Oct2023 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Patient had no known allergies. The following information was reported: COVID-19 (medically significant) with onset 14Apr2024, outcome "recovered" (19Apr2024); VACCINATION FAILURE (medically significant) with onset 14Apr2024, outcome "recovered" (19Apr2024). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Apr2024) positive; (19Apr2024) negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 with paxlovid from 16Apr2024 to 20Apr2024. Clinical course: Patient started to have symptoms (sore throat, very tired) on 14Apr2024, tested positive on 15Apr2024 (up to 102F fever; sore throat gone), started Paxlovid on 16Apr2024, tested negative with no fever on 19Apr2024 and 21Apr2024. Back to work on 22Apr2024 feeing good enough.; Sender's Comments: Based on the information available, known safety profile the causal association between the reported events Vaccination failure , COVID-19  and suspect drug cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Sickle cell anaemia with crisis
Clinical narrative: vaso-occlusive crisis; This is a literature report, Program ID.  An adult patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "sickle cell disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization. The following information was reported: SICKLE CELL ANAEMIA WITH CRISIS (hospitalization, medically significant), outcome "unknown", described as "vaso-occlusive crisis". Clinical courses: In a retrospective study of 75 patients, conducted between Mar2021 and Jan2022, 4 adult patients [3 women and 1 man; exact ages not stated] were described, who developed acute chest syndrome, injection site pain or vaso-occlusive crisis following immunisation with tozinameran against COVID-19 [routes, dosages and outcomes not stated]. The adult patients with sickle cell disease received the tozinameran injection [Pfizer COVID-19 vaccine] for immunisation against COVID-19. Among them, three out of four had a history of asthma, chronic pain, or anatomic asplenia. Side effects occurred 72h to 7 days after receiving the second dose of tozinameran. Subsequently, three of the four patients who developed acute chest syndrome or vaso-occlusive crisis were hospitalised. Eventually, the patients were discharged after 12-29 days of hospitalisation.  The reporter considered "vaso-occlusive crisis" related to BNT162b2.; Sender's Comments: A possibly contributory role of BNT162B2 in triggering the onset of vaso-occlusive crisis cannot be fully excluded, considering the temporal relationship.  Underlying sickle cell disease is considered as the major contributor.  More epidemiologic and clinical data, together with immunological and biomolecular workups would be needed to determine the causal link and 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-PV202400056195 Same article/drug/event, different patient;
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID/with fever up to 102.1, rhinorrhea, whole body aches, cough. Much worse than initial infection which consisted mainly of mild sore throat, fatigue; COVID/with fever up to 102.1, rhinorrhea, whole body aches, cough. Much worse than initial infection which consisted mainly of mild sore throat, fatigue; This is a spontaneous report received from a Physician.  A 68-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Oct2023 at 13:00 as dose 1, single (Lot number: HD9876) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "COVID-19" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 5; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 6; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20Apr2024 at 07:00, outcome "unknown" and all described as "COVID/with fever up to 102.1, rhinorrhea, whole body aches, cough. Much worse than initial infection which consisted mainly of mild sore throat, fatigue". Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Experienced rebound COVID 3 starting 20Apr2024 with fever up to 102.1, rhinorrhea, whole body aches, cough. Much worse than initial infection which consisted mainly of mild sore throat, fatigue.; Sender's Comments: A causal relationship to the suspect drug BNT162B2 OMI XBB.1.5 cannot be excluded for event drug ineffective. This case will be reassessed upon receipt of additional information.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Maternal exposure during pregnancy
Clinical narrative: received the Pfizer Covid vaccine when pregnant (in her 2nd trimester); extremely tired, fatigued; very cold; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient (pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient was 2 trimester pregnant at the event onset. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (non-serious), outcome "unknown", described as "received the Pfizer Covid vaccine when pregnant (in her 2nd trimester)"; FATIGUE (non-serious), outcome "unknown", described as "extremely tired, fatigued"; FEELING COLD (non-serious), outcome "unknown", described as "very cold".  Additional information: It was reported that the patient received the Pfizer COVID vaccine when pregnant (in her 2nd trimester) and felt extremely tired, fatigued and very cold within 24 hours of receiving the vaccine.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Sickle cell anaemia with crisis
Clinical narrative: vaso-occlusive crisis; This is a literature report, Program ID.  An adult patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "sickle cell disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization. The following information was reported: SICKLE CELL ANAEMIA WITH CRISIS (hospitalization, medically significant), outcome "unknown", described as "vaso-occlusive crisis". Clinical courses: In a retrospective study of 75 patients, conducted between Mar2021 and Jan2022, 4 adult patients [3 women and 1 man; exact ages not stated] were described, who developed acute chest syndrome, injection site pain or vaso-occlusive crisis following immunisation with tozinameran against COVID-19 [routes, dosages and outcomes not stated]. The adult patients with sickle cell disease received the tozinameran injection [Pfizer COVID-19 vaccine] for immunisation against COVID-19. Among them, three out of four had a history of asthma, chronic pain, or anatomic asplenia. Side effects occurred 72h to 7 days after receiving the second dose of tozinameran. Subsequently, three of the four patients who developed acute chest syndrome or vaso-occlusive crisis were hospitalised. Eventually, the patients were discharged after 12-29 days of hospitalisation.  The reporter considered "vaso-occlusive crisis" related to BNT162b2.; Sender's Comments: A possibly contributory role of BNT162B2 in triggering the onset of vaso-occlusive crisis cannot be fully excluded, considering the temporal relationship.  Underlying sickle cell disease is considered as the major contributor.  More epidemiologic and clinical data, together with immunological and biomolecular workups would be needed to determine the causal link and 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-PV202400056196 Same article/drug, different patient/event;US-PFIZER INC-202400097262 Same article/drug/event, different patient;
Sex: U
Vaccine: COVID19
Symptoms: Acute chest syndrome, Sickle cell anaemia with crisis
Clinical narrative: acute chest syndrome; vaso-occlusive crisis; This is a literature report, Program ID.  An adult patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "sickle cell disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization. The following information was reported: ACUTE CHEST SYNDROME (hospitalization, medically significant), outcome "unknown"; SICKLE CELL ANAEMIA WITH CRISIS (hospitalization, medically significant), outcome "unknown", described as "vaso-occlusive crisis". Clinical courses: In a retrospective study of 75 patients, conducted between March 2021 and January 2022, 4 adult patients [3 women and 1 man; exact ages not stated] were described, who developed acute chest syndrome, injection site pain or vaso-occlusive crisis following immunisation with tozinameran against COVID-19 [routes, dosages and outcomes not stated]. The adult patients with sickle cell disease received the tozinameran injection [Pfizer COVID-19 vaccine] for immunisation against COVID-19. Among them, three out of four had a history of asthma, chronic pain, or anatomic asplenia. Side effects occurred 72h to 7 days after receiving the second dose of tozinameran. Subsequently, three of the four patients who developed acute chest syndrome or vaso-occlusive crisis were hospitalised. Eventually, the patients were discharged after 12-29 days of hospitalisation.  The reporter considered "acute chest syndrome" and "vaso-occlusive crisis" related to BNT162b2.; Sender's Comments: A possibly contributory role of BNT162B2 in triggering the onset of vaso-occlusive crisis with chest syndrome acute cannot be fully excluded, considering the temporal relationship.  Underlying sickle cell disease is considered as the major contributor.  More epidemiologic and clinical data, together with immunological and biomolecular workups would be needed to determine the causal link and 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-PV202400056195 Same article/drug, different patient/event;
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Audiogram, Deafness, Tinnitus
Clinical narrative: some high-frequency loss of hearing in both ears; Tinnitus/Tinnitus affects both ears; This is a spontaneous report received from a Consumer or other non HCP.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 06Mar2021 at 11:00 as dose 2, single (Lot number: EN6203) at the age of 68 years intramuscular, in arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (1st dose; at 11:00 via intramuscular in arm; Lot number: EM9809), administration date: 13Feb2021, when the patient was 68-year-old, for COVID-19 Immunization. The following information was reported: TINNITUS (non-serious) with onset 13Mar2021, outcome "not recovered", described as "Tinnitus/Tinnitus affects both ears"; DEAFNESS (medically significant), outcome "unknown", described as "some high-frequency loss of hearing in both ears". The patient underwent the following laboratory tests and procedures: Audiogram: Some high frequency loss of hearing in both ears.  Clinical course: No previous symptoms of Tinnitus or any other ear problems. After tinnitus appeared, an audiometry test showed some high-frequency loss of hearing in both ears. No family medical history relevant to AE.
Sex: M
Vaccine: VARZOS
Symptoms: Oropharyngeal pain
Clinical narrative: One day later he began noticing a sore throat; This non-serious case was reported by a consumer via call center representative and described the occurrence of sore throat in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (1st dose received on 27-DEC-2023 for tolerance refer case US2024051382), Covid 19 vaccine with an associated reaction of pyrexia (unknown dose received on 27-DEC-2023 ) and Covid 19 vaccine (unknown dose received on an unknown  date).   On 21-APR-2024, the patient received the 2nd dose of Shingrix (intramuscular, left deltoid). On 22-APR-2024, 1 days after receiving Shingrix, the patient experienced sore throat (Verbatim: One day later he began noticing a sore throat). The outcome of the sore throat was unknown.   It was unknown if the reporter considered the sore throat to be related to Shingrix.     It was unknown if the company considered the sore throat to be related to Shingrix.   Linked case(s) involving the same patient:  US2024051382   Additional Information: GSK Receipt Date: 22-APR-2024 The patient received his 2nd dose, one day later he began noticing a sore throat.; Sender's Comments:  US-GSK-US2024051382:1st dose case
Age: 20.0
Sex: M
Vaccine: TYP
Symptoms: Abdominal discomfort, Cough, Headache, Influenza like illness, Joint stiffness
Clinical narrative: generalized flu like sx, headache, neck pain, nausea, GI upset, dizziness, mildly tachycardic with NSR. skin feeling sensative, joint stiffness and cough.
Age: 20.0
Sex: M
Vaccine: TYP
Symptoms: Nausea, Neck pain, Sensitive skin, Tachycardia
Clinical narrative: generalized flu like sx, headache, neck pain, nausea, GI upset, dizziness, mildly tachycardic with NSR. skin feeling sensative, joint stiffness and cough.
Age: 19.0
Sex: M
Vaccine: HEP
Symptoms: Therapy non-responder
Clinical narrative: Patient came to clinic requesting for Hepatitis B vaccine. States he had titers drawn and he is negative for immunity. Per lab result, patient is negative for immunity.  HepB, Engerix was ordered by this reporter. Dose #1 given by this reporter, HepB, Engerix, 1 ml.
Age: 73.0
Sex: M
Vaccine: COVID19-2
Symptoms: Balance disorder, Fall, Fatigue, Loss of consciousness, Muscular weakness
Clinical narrative: The day of the vaccine I had a sore arm and that evening at approximatley 11 pm I had a fever. The next day I felt fatigued but otherwise no specific symptoms.  Approximately 32 hours after receiving the vaccine, I had the sudden onset of imbalance, and profound muscle weakness in the arms and legs. I blacked out briefly and fell over on my right shoulder, right elbow and right hip. After a minute or two I was able to come to my feet. I took my blood pressure and it was 98/58 about 4 minutes after I had fallen. My normal blood pressure is 140/85. My blood pressure gradually rose over the next hour to my near normal level.  Fortunately I sustained no fractures and do not appear to have any long term issues.
Age: 73.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: The day of the vaccine I had a sore arm and that evening at approximatley 11 pm I had a fever. The next day I felt fatigued but otherwise no specific symptoms.  Approximately 32 hours after receiving the vaccine, I had the sudden onset of imbalance, and profound muscle weakness in the arms and legs. I blacked out briefly and fell over on my right shoulder, right elbow and right hip. After a minute or two I was able to come to my feet. I took my blood pressure and it was 98/58 about 4 minutes after I had fallen. My normal blood pressure is 140/85. My blood pressure gradually rose over the next hour to my near normal level.  Fortunately I sustained no fractures and do not appear to have any long term issues.
Age: 20.0
Sex: F
Vaccine: MMR
Symptoms: Condition aggravated, Ear swelling, Eczema, Lip swelling, Rash erythematous
Clinical narrative: Mild Red itchy rashes on my face 4-5 hours after the vaccine was given. It spread all over my face on the second day and exacerbate my eczema. My face, ears and lips got swollen on the third, 4th and today the 5th day. As well as my eczema on my finger. My belly button also developed a red itchy rash around it. I took Benadryl on the fourth day and recommended Antihistamine medications. On fifth day, my face got swollen. I talked to my doctor and got prescribed steroid.
Age: 20.0
Sex: F
Vaccine: MMR
Symptoms: Rash pruritic, Swelling face
Clinical narrative: Mild Red itchy rashes on my face 4-5 hours after the vaccine was given. It spread all over my face on the second day and exacerbate my eczema. My face, ears and lips got swollen on the third, 4th and today the 5th day. As well as my eczema on my finger. My belly button also developed a red itchy rash around it. I took Benadryl on the fourth day and recommended Antihistamine medications. On fifth day, my face got swollen. I talked to my doctor and got prescribed steroid.
Age: 16.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Balance disorder, Hyperhidrosis
Clinical narrative: Pt received Gardasil and Menveo vaccines in office visit today. Route: Intramuscular Site: Left deltoid (about 1 inch apart from each other). Pt  reported feeling well after administration and was discharged with mom.  Few minutes later office staff were notified that patient was sitting outside on pavement.  Provider in office was notified. This staff went out to check on patient, provided patient with water, juice and crackers. Pt mom states that patient was feeling off balance and became very sweaty and sat on pavement. After a couple of minutes patient was stable enough to stand and was walked back into clinic to be monitored in an exam room. Patient laid on exam table on his back with knees bent. After approximately 5 minutes, patient reported feeling much improved and was discharged home with mother.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Breath sounds abnormal, Chest discomfort, Dizziness, Dyspnoea, Flushing
Clinical narrative: Patient's face became flushed, nausea, dizziness, complained of trouble breathing and tightness of chest and fainted. It sounded like she was struggling to breath (gurgling noises) and epinephrine 0.3mg (1 dose) was given after 2 minutes as a precaution and EMS was called and responded.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Syncope
Clinical narrative: Patient's face became flushed, nausea, dizziness, complained of trouble breathing and tightness of chest and fainted. It sounded like she was struggling to breath (gurgling noises) and epinephrine 0.3mg (1 dose) was given after 2 minutes as a precaution and EMS was called and responded.
Age: 36.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: A few hours after injection the site began to swell, become increasingly red and hot to the touch, this has been going on for 3 days now and each day the swelling, redness and heat continues to grow. On day 2 the area became very itchy as well despite the Antihistamines I take on a daily basis.  my last DTAP vaccine was in 2013 and I had little to no reaction. I have never had a reaction from any vaccines.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain, Pain in extremity, Pyrexia, Rash
Clinical narrative: Widely spread rash on right side, fever 102, headache, body aches, stabbing pain in right foot
Age: 68.0
Sex: F
Vaccine: UNK
Symptoms: Agitation, Chills, Diplopia, Fatigue, Heart rate increased
Clinical narrative: Elevated heart rate, double vision, myalgia, shivers alternating with sweating and agitated state, extreme tiredness,  severe injection site pain and redness/swelling
Age: 68.0
Sex: F
Vaccine: UNK
Symptoms: Hyperhidrosis, Injection site erythema, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: Elevated heart rate, double vision, myalgia, shivers alternating with sweating and agitated state, extreme tiredness,  severe injection site pain and redness/swelling
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received First Dose and Second Dose 16 Days Apart; Initial report received on 12-Apr-2024.  A nurse reported that a 32-year-old female (race and ethnicity not provided) received the first dose and second dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization 16 days apart.  Medical history and concomitant medications at the time of vaccination were not reported. The patient did not have any allergies.   On 13-Mar-2024, the patient received the first dose of HEPLISAV-B (Lot number 943193, expiration date 12-Mar-2026, NDC number 43528-003-05; route of administration and injection site not reported).   On 29-Mar-2024, 16 days after having been vaccinated with HEPLISAV-B, the patient received the second dose of HEPLISAV-B (Lot number 944609, expiration date 29-Jan-2026, NDC number 43528 003 05; route of administration and injection site not reported).   No other information was reported.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Age: 31.0
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, No adverse event, Wrong product administered
Clinical narrative: Received First and Second Dose of Heplisav-B 9 Days Apart; Initial report received on 19-Apr-2024.  A pharmacy technician reported that a 31-year-old female (race and ethnicity not provided) received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization on 10-Apr-2024 and received the second dose of HEPLISAV-B on 19-Apr-2024.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 10-Apr-2024, the patient received the first dose of HEPLISAV-B (lot # 945139, expiration date 22-Jan-2026; NDC # not reported) intramuscularly in the right deltoid from a pharmacist.    On 19-Apr-2024, 9 days after having received the first dose of HEPLISAV-B, the patient received the second dose of HEPLISAV-B (lot # 941428, expiration date 30-Apr-2025, NDC # 43528-003-05) intramuscularly in the left deltoid.  The patient received the first dose of HEPLISAV-B at a different pharmacy location. The patient thought that she was receiving a measles, mumps, and rubella (MMR) vaccine but was actually scheduled to receive HEPLISAV-B. The second pharmacy administered the second dose of HEPLISAV-B as they were not aware that the patient had received the first dose of HEPLISAV-B at a different location. No adverse events were reported.  No additional information was reported.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Age: 4.0
Sex: M
Vaccine: DTAP, MMRV, UNK
Symptoms: Cyanosis, Drooling, Fatigue, Influenza virus test negative, Pyrexia
Clinical narrative: The patient woke with a high fever 5/1/24. He stayed home from daycare and took a long morning nap. When he woke at noon, he did not have a fever but was just more tired in the afternoon. At 3:00 pm, while waiting for his siblings to come out of school, he went unresponsive, drooling with lips turning blue and wet himself (not normal for him).  Paramedical were called and he was taken by ambulance to Medical Center., where he came to. Upon arriving at the hospital, his temperature was 102.5 degrees Fahrenheit. He was given acetaminophen and ibuprofen. He was tested for strep, Covid and influenza, as well as looked over. All tests came back negative with no signs of any viral illness. At 4:30 pm we were discharged and sent home. He slept until 9:00 pm when he woke and finally started to talk and peek up a little more.
Age: 4.0
Sex: M
Vaccine: DTAP, MMRV, UNK
Symptoms: SARS-CoV-2 test negative, Streptococcus test negative, Unresponsive to stimuli, Urinary incontinence
Clinical narrative: The patient woke with a high fever 5/1/24. He stayed home from daycare and took a long morning nap. When he woke at noon, he did not have a fever but was just more tired in the afternoon. At 3:00 pm, while waiting for his siblings to come out of school, he went unresponsive, drooling with lips turning blue and wet himself (not normal for him).  Paramedical were called and he was taken by ambulance to Medical Center., where he came to. Upon arriving at the hospital, his temperature was 102.5 degrees Fahrenheit. He was given acetaminophen and ibuprofen. He was tested for strep, Covid and influenza, as well as looked over. All tests came back negative with no signs of any viral illness. At 4:30 pm we were discharged and sent home. He slept until 9:00 pm when he woke and finally started to talk and peek up a little more.
Age: 31.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Pt present to the clinic with erythema and edema on right deltoid. Pt states erythema and edema began one month ago, when she got her MMR vaccine.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vaccine given early than recommended date.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine expired, no adverse effects
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine expired, no adverse effects
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Allergy test positive, Erythema, Food allergy, Pruritus, Rash
Clinical narrative: Started having hives in hands, itchy and red 3hr after shots. Doctor suggested to give Benadryl, gave 3ml at midnight since the hives had spread all over his body. The rash continued coming and going  for more 3-4 days.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Urticaria
Clinical narrative: Started having hives in hands, itchy and red 3hr after shots. Doctor suggested to give Benadryl, gave 3ml at midnight since the hives had spread all over his body. The rash continued coming and going  for more 3-4 days.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine expired, no adverse effects noted
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine expired, no adverse effects
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was expired, no adverse effects
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine expired, no adverse effects
Age: 1.58
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was given dose of Hep A before recommended date and this dose is not considered valis.
Age: 69.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling, Injection site warmth
Clinical narrative: A COUPLE DAYS AFTER VACCINE ADMINISTRATION, PATIENT'S INJECTION SITE GREW "TO SIZE OF A BASEBALL" AND WAS RED, HOT AND INFLAMMED.    SHE HAS BEEN SELF-TREATING WITH BENADRYL AND ICE.   SWELLING HAS DECREASED TO SIZE OF NICKEL.   PATIENT CLAIMS NO PAIN AT TIME OF INJECTION AND NO PAIN IN THE JOINT, SIMPLY THE INFLAMMATION.
Age: 0.5
Sex: M
Vaccine: DTAPIPV, PNC20
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: The patient received Kinrix (Dtap/IPV) at 6 months routine wellness visit. The vaccine is for ages 4-6 years of age. Reported to manufacturer and it does count as a  dose
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: this was given 3 days after BUD date
Age: 29.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Dizziness
Clinical narrative: CUSTOMER RECEIVED TWINRIX VACCINE FOR HEP B AND A . ALSO RECEIVED TDAP WITH ADACEL , WAITED FOR ABOUT 5 MINUTES IN THE VACCINATION AREA , BEFORE LEAVING , CAME BACK LATER AFTER ABOUT 30 MINUTES WITH HER MOM TO SAY THAT SHE FELT DIZZY WHILE CHECKING OUT HER ITEMS AT THE CASHIER REGISTER AREA , LEANNED OVER THE COUNTER , TOOK A BOTTLE OF SODA , SAT DOWN FOR WHILE , AND FELT BETTER , MOM  DROVE HER HOME.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Diarrhoea, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: May 1, 2024 Patient's guardian noticed swelling, redness, warmth, and spreading redness on the left arm, the following day after vaccine. Mother states patient complains of itching  and left arm hurting.  Mother states patient had diarrhea around 5/6 p.m. (2 episodes).    May 2, 2024 Patient was seen in the office, PCP advised to take Zyrtec, also may take Benadryl PRN.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site warmth
Clinical narrative: May 1, 2024 Patient's guardian noticed swelling, redness, warmth, and spreading redness on the left arm, the following day after vaccine. Mother states patient complains of itching  and left arm hurting.  Mother states patient had diarrhea around 5/6 p.m. (2 episodes).    May 2, 2024 Patient was seen in the office, PCP advised to take Zyrtec, also may take Benadryl PRN.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: this was given 3 days after BUD