chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: M
Vaccine: UNK, DTAPHEPBIP
Symptoms: Rash erythematous, Rash macular, Swelling face, Urticaria, Vomiting
Clinical narrative: Facial swelling; Hives in legs, thighs, buttocks, and torso; Fever of 102.5; Rash in legs, thighs, buttocks and torso; Vomiting; Diarrhea; Lethargy; This case was reported by a consumer via call center representative and described the occurrence of vomiting in a 3-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number Z4R9R, expiry date 14th May 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st September 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 4th September 2022, 3 days after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced fever and rash. On 5th September 2022, the patient experienced facial swelling and hives. In September 2022, the patient experienced vomiting, diarrhea and lethargy. The patient was treated with benadryl (nos) (Benadryl) and prednisone. On an unknown date, the outcome of the vomiting, diarrhea, fever, rash, facial swelling, hives and lethargy were recovered/resolved.   The reporter considered the vomiting, diarrhea, fever, rash, facial swelling, hives and lethargy to be related to Pediarix and Pediarix Pre-Filled Syringe Device.   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: 07-SEP-2022 Reporter's Comment: The reporter reported that the patient received Pediarix vaccine. The reporter stated that 12 hours after received Pediarix vaccine the patient experienced vomiting and 48 hours after received vaccine patient had diarrhea. The reporter reported after received vaccine on September 2022 Sunday patient also experienced a fever of 102.5 and a rash that covered the legs, thighs, buttocks and torso. On September 2022 Monday, patient was experienced facial swelling and the rash had turned into hives covered the same areas as the rash.  The reporter stated patient received Benadryl for the rash on Sunday, which seemed to resolve the hives. The hives reappeared later in the week, resulting in patient being taken to the emergency room (ER), where patient was given Prednisone on September 6 2022.  Reporter reported that the several tests were conducted on patient to rule out other possible causes of the reaction and everything came back clear. The reporter reported that the everything was coming back clear from the tests. The reporter believe the Pediarix is the likely cause of patient's symptoms. The reporter stated Prednisone resolved all symptoms.  The reporter does not known the patient previously Pediarix received or which dose patient was received. The reporter did consent to follow up.
Age: 3.0
Sex: M
Vaccine: UNK, DTAPHEPBIP
Symptoms: Diarrhoea, Lethargy, Pyrexia, Rash, Swelling face
Clinical narrative: Facial swelling; Hives in legs, thighs, buttocks, and torso; Fever of 102.5; Rash in legs, thighs, buttocks and torso; Vomiting; Diarrhea; Lethargy; This case was reported by a consumer via call center representative and described the occurrence of vomiting in a 3-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number Z4R9R, expiry date 14th May 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st September 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 4th September 2022, 3 days after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced fever and rash. On 5th September 2022, the patient experienced facial swelling and hives. In September 2022, the patient experienced vomiting, diarrhea and lethargy. The patient was treated with benadryl (nos) (Benadryl) and prednisone. On an unknown date, the outcome of the vomiting, diarrhea, fever, rash, facial swelling, hives and lethargy were recovered/resolved.   The reporter considered the vomiting, diarrhea, fever, rash, facial swelling, hives and lethargy to be related to Pediarix and Pediarix Pre-Filled Syringe Device.   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: 07-SEP-2022 Reporter's Comment: The reporter reported that the patient received Pediarix vaccine. The reporter stated that 12 hours after received Pediarix vaccine the patient experienced vomiting and 48 hours after received vaccine patient had diarrhea. The reporter reported after received vaccine on September 2022 Sunday patient also experienced a fever of 102.5 and a rash that covered the legs, thighs, buttocks and torso. On September 2022 Monday, patient was experienced facial swelling and the rash had turned into hives covered the same areas as the rash.  The reporter stated patient received Benadryl for the rash on Sunday, which seemed to resolve the hives. The hives reappeared later in the week, resulting in patient being taken to the emergency room (ER), where patient was given Prednisone on September 6 2022.  Reporter reported that the several tests were conducted on patient to rule out other possible causes of the reaction and everything came back clear. The reporter reported that the everything was coming back clear from the tests. The reporter believe the Pediarix is the likely cause of patient's symptoms. The reporter stated Prednisone resolved all symptoms.  The reporter does not known the patient previously Pediarix received or which dose patient was received. The reporter did consent to follow up.
Age: 3.0
Sex: M
Vaccine: UNK, DTAPHEPBIP
Symptoms: Urticaria, Vomiting
Clinical narrative: Facial swelling; Hives in legs, thighs, buttocks, and torso; Fever of 102.5; Rash in legs, thighs, buttocks and torso; Vomiting; Diarrhea; Lethargy; This case was reported by a consumer via call center representative and described the occurrence of vomiting in a 3-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number Z4R9R, expiry date 14th May 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st September 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 4th September 2022, 3 days after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced fever and rash. On 5th September 2022, the patient experienced facial swelling and hives. In September 2022, the patient experienced vomiting, diarrhea and lethargy. The patient was treated with benadryl (nos) (Benadryl) and prednisone. On an unknown date, the outcome of the vomiting, diarrhea, fever, rash, facial swelling, hives and lethargy were recovered/resolved.   The reporter considered the vomiting, diarrhea, fever, rash, facial swelling, hives and lethargy to be related to Pediarix and Pediarix Pre-Filled Syringe Device.   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: 07-SEP-2022 Reporter's Comment: The reporter reported that the patient received Pediarix vaccine. The reporter stated that 12 hours after received Pediarix vaccine the patient experienced vomiting and 48 hours after received vaccine patient had diarrhea. The reporter reported after received vaccine on September 2022 Sunday patient also experienced a fever of 102.5 and a rash that covered the legs, thighs, buttocks and torso. On September 2022 Monday, patient was experienced facial swelling and the rash had turned into hives covered the same areas as the rash.  The reporter stated patient received Benadryl for the rash on Sunday, which seemed to resolve the hives. The hives reappeared later in the week, resulting in patient being taken to the emergency room (ER), where patient was given Prednisone on September 6 2022.  Reporter reported that the several tests were conducted on patient to rule out other possible causes of the reaction and everything came back clear. The reporter reported that the everything was coming back clear from the tests. The reporter believe the Pediarix is the likely cause of patient's symptoms. The reporter stated Prednisone resolved all symptoms.  The reporter does not known the patient previously Pediarix received or which dose patient was received. The reporter did consent to follow up.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blast cells present, Computerised tomogram abdomen abnormal, Laboratory test abnormal, Leukopenia, Neutropenia
Clinical narrative: leukopenia; neutropenia; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  An 80-year-old male patient received BNT162b2 (BNT162B2), on 19Mar2021 as dose 2, single (Lot number: EP6955) at the age of 79 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (1 Dose, Lot EN6198, Intramuscular in the left arm), administration date: 26Feb2021, when the patient was 79-year-old, for Covid-19 Immunization. The following information was reported: LEUKOPENIA (hospitalization, life threatening) with onset 29Jun2021, outcome "not recovered"; NEUTROPENIA (hospitalization, life threatening) with onset 29Jun2021, outcome "not recovered". The events "leukopenia" and "neutropenia" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Biopsy bone marrow: (unspecified date) Unknown Results; Computerised tomogram: (20Jan2022) splenomegaly; SARS-CoV-2 test: (08Sep2022) Negative; Ultrasound scan: (unspecified date) Unknown Reaults, notes: diagnosis  being confirmed and then treatment will be  discussed. Therapeutic measures were taken as a result of leukopenia, neutropenia. Clinical course: Patient received his first dose of Pfizer COVID vaccine 26Feb2021 and second dose 19Mar2021. On labs from 29Jun2021 he had leukopenia and neutropenia for the first time and this has been persistent since. He had his third dose of Pfizer COVID vaccine 18Oct2021. CT 20Jan2022 showed splenomegaly. He had his 4th dose of COVID vaccine 02May2022. On 08Sep2022 he presented to the ED for an unrelated injury and was found to have worsening leukopenia and neutropenia and new blast cells. This patient is scheduled for bone marrow biopsy to confirm leukemia diagnosis.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events: "Leukopenia", "Neutropenia" and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Splenomegaly
Clinical narrative: leukopenia; neutropenia; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  An 80-year-old male patient received BNT162b2 (BNT162B2), on 19Mar2021 as dose 2, single (Lot number: EP6955) at the age of 79 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (1 Dose, Lot EN6198, Intramuscular in the left arm), administration date: 26Feb2021, when the patient was 79-year-old, for Covid-19 Immunization. The following information was reported: LEUKOPENIA (hospitalization, life threatening) with onset 29Jun2021, outcome "not recovered"; NEUTROPENIA (hospitalization, life threatening) with onset 29Jun2021, outcome "not recovered". The events "leukopenia" and "neutropenia" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Biopsy bone marrow: (unspecified date) Unknown Results; Computerised tomogram: (20Jan2022) splenomegaly; SARS-CoV-2 test: (08Sep2022) Negative; Ultrasound scan: (unspecified date) Unknown Reaults, notes: diagnosis  being confirmed and then treatment will be  discussed. Therapeutic measures were taken as a result of leukopenia, neutropenia. Clinical course: Patient received his first dose of Pfizer COVID vaccine 26Feb2021 and second dose 19Mar2021. On labs from 29Jun2021 he had leukopenia and neutropenia for the first time and this has been persistent since. He had his third dose of Pfizer COVID vaccine 18Oct2021. CT 20Jan2022 showed splenomegaly. He had his 4th dose of COVID vaccine 02May2022. On 08Sep2022 he presented to the ED for an unrelated injury and was found to have worsening leukopenia and neutropenia and new blast cells. This patient is scheduled for bone marrow biopsy to confirm leukemia diagnosis.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events: "Leukopenia", "Neutropenia" and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Biopsy bone marrow, Computerised tomogram, Leukopenia, Neutropenia, SARS-CoV-2 test
Clinical narrative: leukopenia; neutropenia; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  An 80-year-old male patient received BNT162b2 (BNT162B2), on 19Mar2021 as dose 2, single (Lot number: EP6955) at the age of 79 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (1 Dose, Lot EN6198, Intramuscular in the left arm), administration date: 26Feb2021, when the patient was 79-year-old, for Covid-19 Immunization. The following information was reported: LEUKOPENIA (hospitalization, life threatening) with onset 29Jun2021, outcome "not recovered"; NEUTROPENIA (hospitalization, life threatening) with onset 29Jun2021, outcome "not recovered". The events "leukopenia" and "neutropenia" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Biopsy bone marrow: (unspecified date) Unknown Results; Computerised tomogram: (20Jan2022) splenomegaly; SARS-CoV-2 test: (08Sep2022) Negative; Ultrasound scan: (unspecified date) Unknown Reaults, notes: diagnosis  being confirmed and then treatment will be  discussed. Therapeutic measures were taken as a result of leukopenia, neutropenia. Clinical course: Patient received his first dose of Pfizer COVID vaccine 26Feb2021 and second dose 19Mar2021. On labs from 29Jun2021 he had leukopenia and neutropenia for the first time and this has been persistent since. He had his third dose of Pfizer COVID vaccine 18Oct2021. CT 20Jan2022 showed splenomegaly. He had his 4th dose of COVID vaccine 02May2022. On 08Sep2022 he presented to the ED for an unrelated injury and was found to have worsening leukopenia and neutropenia and new blast cells. This patient is scheduled for bone marrow biopsy to confirm leukemia diagnosis.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events: "Leukopenia", "Neutropenia" and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ultrasound scan
Clinical narrative: leukopenia; neutropenia; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  An 80-year-old male patient received BNT162b2 (BNT162B2), on 19Mar2021 as dose 2, single (Lot number: EP6955) at the age of 79 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (1 Dose, Lot EN6198, Intramuscular in the left arm), administration date: 26Feb2021, when the patient was 79-year-old, for Covid-19 Immunization. The following information was reported: LEUKOPENIA (hospitalization, life threatening) with onset 29Jun2021, outcome "not recovered"; NEUTROPENIA (hospitalization, life threatening) with onset 29Jun2021, outcome "not recovered". The events "leukopenia" and "neutropenia" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Biopsy bone marrow: (unspecified date) Unknown Results; Computerised tomogram: (20Jan2022) splenomegaly; SARS-CoV-2 test: (08Sep2022) Negative; Ultrasound scan: (unspecified date) Unknown Reaults, notes: diagnosis  being confirmed and then treatment will be  discussed. Therapeutic measures were taken as a result of leukopenia, neutropenia. Clinical course: Patient received his first dose of Pfizer COVID vaccine 26Feb2021 and second dose 19Mar2021. On labs from 29Jun2021 he had leukopenia and neutropenia for the first time and this has been persistent since. He had his third dose of Pfizer COVID vaccine 18Oct2021. CT 20Jan2022 showed splenomegaly. He had his 4th dose of COVID vaccine 02May2022. On 08Sep2022 he presented to the ED for an unrelated injury and was found to have worsening leukopenia and neutropenia and new blast cells. This patient is scheduled for bone marrow biopsy to confirm leukemia diagnosis.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events: "Leukopenia", "Neutropenia" and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 38.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Blindness transient, Chills, Confusional state, Dizziness, Pyrexia
Clinical narrative: Acute complete vision loss in both eyes lasting longer than 5 minutes.; body aches; chills; slight fever(100.6); dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Sep2022 at 09:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 38 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination. Concomitant medication(s) included: TYLENOL; SERTRALINE. Vaccination history included: Covid-19 vaccine (Dose 1, Single, Manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, Single, Manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 3, Single, Manufacturer unknown), for COVID-19 Immunization. The following information was reported: BLINDNESS TRANSIENT (medically significant) with onset 10Sep2022 at 00:30, outcome "recovered" (Sep2022), described as "Acute complete vision loss in both eyes lasting longer than 5 minutes."; PAIN (non-serious) with onset 10Sep2022 at 00:30, outcome "recovered" (Sep2022), described as "body aches"; CHILLS (non-serious) with onset 10Sep2022 at 00:30, outcome "recovered" (Sep2022); DIZZINESS (non-serious) with onset 10Sep2022 at 00:30, outcome "recovered" (Sep2022); PYREXIA (non-serious) with onset 10Sep2022 at 00:30, outcome "recovered" (Sep2022), described as "slight fever(100.6)". The patient underwent the following laboratory tests and procedures: Body temperature: (10Sep2022) 100.6. Therapeutic measures were not taken as a result of blindness transient, pain, chills, pyrexia, dizziness.  Clinical course: Acute complete vision loss in both eyes lasting longer than 5 minutes. Occurred 15 hours after vaccination and in conjunction with body aches, chills, slight fever (100.6), and dizziness. Was conscious and could walk, communicate, etc. returned suddenly. Patient had COVID prior vaccination. Patient was not COVID tested post vaccination. Patient not received other vaccine in four weeks. Patient had no Known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 38.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Blindness transient, Body temperature, Chills, Dizziness, Pain
Clinical narrative: Acute complete vision loss in both eyes lasting longer than 5 minutes.; body aches; chills; slight fever(100.6); dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Sep2022 at 09:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 38 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination. Concomitant medication(s) included: TYLENOL; SERTRALINE. Vaccination history included: Covid-19 vaccine (Dose 1, Single, Manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, Single, Manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 3, Single, Manufacturer unknown), for COVID-19 Immunization. The following information was reported: BLINDNESS TRANSIENT (medically significant) with onset 10Sep2022 at 00:30, outcome "recovered" (Sep2022), described as "Acute complete vision loss in both eyes lasting longer than 5 minutes."; PAIN (non-serious) with onset 10Sep2022 at 00:30, outcome "recovered" (Sep2022), described as "body aches"; CHILLS (non-serious) with onset 10Sep2022 at 00:30, outcome "recovered" (Sep2022); DIZZINESS (non-serious) with onset 10Sep2022 at 00:30, outcome "recovered" (Sep2022); PYREXIA (non-serious) with onset 10Sep2022 at 00:30, outcome "recovered" (Sep2022), described as "slight fever(100.6)". The patient underwent the following laboratory tests and procedures: Body temperature: (10Sep2022) 100.6. Therapeutic measures were not taken as a result of blindness transient, pain, chills, pyrexia, dizziness.  Clinical course: Acute complete vision loss in both eyes lasting longer than 5 minutes. Occurred 15 hours after vaccination and in conjunction with body aches, chills, slight fever (100.6), and dizziness. Was conscious and could walk, communicate, etc. returned suddenly. Patient had COVID prior vaccination. Patient was not COVID tested post vaccination. Patient not received other vaccine in four weeks. Patient had no Known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 38.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Pyrexia
Clinical narrative: Acute complete vision loss in both eyes lasting longer than 5 minutes.; body aches; chills; slight fever(100.6); dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Sep2022 at 09:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 38 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination. Concomitant medication(s) included: TYLENOL; SERTRALINE. Vaccination history included: Covid-19 vaccine (Dose 1, Single, Manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, Single, Manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 3, Single, Manufacturer unknown), for COVID-19 Immunization. The following information was reported: BLINDNESS TRANSIENT (medically significant) with onset 10Sep2022 at 00:30, outcome "recovered" (Sep2022), described as "Acute complete vision loss in both eyes lasting longer than 5 minutes."; PAIN (non-serious) with onset 10Sep2022 at 00:30, outcome "recovered" (Sep2022), described as "body aches"; CHILLS (non-serious) with onset 10Sep2022 at 00:30, outcome "recovered" (Sep2022); DIZZINESS (non-serious) with onset 10Sep2022 at 00:30, outcome "recovered" (Sep2022); PYREXIA (non-serious) with onset 10Sep2022 at 00:30, outcome "recovered" (Sep2022), described as "slight fever(100.6)". The patient underwent the following laboratory tests and procedures: Body temperature: (10Sep2022) 100.6. Therapeutic measures were not taken as a result of blindness transient, pain, chills, pyrexia, dizziness.  Clinical course: Acute complete vision loss in both eyes lasting longer than 5 minutes. Occurred 15 hours after vaccination and in conjunction with body aches, chills, slight fever (100.6), and dizziness. Was conscious and could walk, communicate, etc. returned suddenly. Patient had COVID prior vaccination. Patient was not COVID tested post vaccination. Patient not received other vaccine in four weeks. Patient had no Known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Erythema, Extra dose administered, Injection site pruritus, Pruritus, Rash
Clinical narrative: rash; hives; itching on my right arm which the booster was administered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (005570). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 as dose number unknown (booster), 0.3 ml single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, unknown manufacturer), for Covid-19 immunization. The following information was reported: VACCINATION SITE PRURITUS (non-serious) with onset 10Sep2022, outcome "unknown", described as "itching on my right arm which the booster was administered"; URTICARIA (non-serious) with onset 11Sep2022, outcome "unknown", described as "hives"; RASH (non-serious) with onset 11Sep2022, outcome "unknown". Therapeutic measures were taken as a result of vaccination site pruritus, rash, urticaria.  Additional information: Reporter stated, On saturday, 10Sep2022, i took the pfizer bivalent booster. 30mcg/0.3ml. On that evening i began to experience itching on my right arm which the booster was administered. On sunday, 11Sep2022, my right arm began to itch and develope a rash and hives. I contacted the pharmacy that gave me the injection. I also noted in the product info given to me that rash, hives and itching can be a side effect. I contact my pcp and was instructed to use benadryl. When does this side effect end.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Rash, Urticaria, Vaccination site pruritus
Clinical narrative: rash; hives; itching on my right arm which the booster was administered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (005570). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 as dose number unknown (booster), 0.3 ml single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, unknown manufacturer), for Covid-19 immunization. The following information was reported: VACCINATION SITE PRURITUS (non-serious) with onset 10Sep2022, outcome "unknown", described as "itching on my right arm which the booster was administered"; URTICARIA (non-serious) with onset 11Sep2022, outcome "unknown", described as "hives"; RASH (non-serious) with onset 11Sep2022, outcome "unknown". Therapeutic measures were taken as a result of vaccination site pruritus, rash, urticaria.  Additional information: Reporter stated, On saturday, 10Sep2022, i took the pfizer bivalent booster. 30mcg/0.3ml. On that evening i began to experience itching on my right arm which the booster was administered. On sunday, 11Sep2022, my right arm began to itch and develope a rash and hives. I contacted the pharmacy that gave me the injection. I also noted in the product info given to me that rash, hives and itching can be a side effect. I contact my pcp and was instructed to use benadryl. When does this side effect end.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 62.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Anxiety, Chest discomfort, Tachycardia
Clinical narrative: chest tightness; tachycardia; feeling of impending doom; The patient received 5th dose of BNT162B2; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 08Sep2022 at 19:00 as dose 5 (booster), single (Lot number: GH9694) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Heart Disease" (unspecified if ongoing); "ALLERGY" (unspecified if ongoing), notes: Known allergies: Yes. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 Immunisation; Covid-19 vaccine (DOSE 3; MANUFACTUERER UNKNOWN), for COVID-19 Immunisation; Covid-19 vaccine (DOSE 4; MANUFACTUERER UNKNOWN), for COVID-19 Immunisation. The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious) with onset 08Sep2022 at 19:00, outcome "unknown", described as "The patient received 5th dose of BNT162B2"; CHEST DISCOMFORT (non-serious) with onset 08Sep2022 at 19:15, outcome "recovered" (Sep2022), described as "chest tightness"; ANXIETY (non-serious) with onset 08Sep2022 at 19:15, outcome "recovered" (Sep2022), described as "feeling of impending doom"; TACHYCARDIA (non-serious) with onset 08Sep2022 at 19:15, outcome "recovered" (Sep2022). Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chest discomfort, tachycardia, anxiety.  Additional information: The patient had known allergy. The patient did not received any other vaccine within the four weeks of vaccination. The patient received other medication in two weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID -19. It was also reported that five minutes after the vaccination, the patient experienced chest tightness, tachycardia, and the feeling of impending doom. Adverse event treatment included treatment with Benedryl 25mg orally (PO) once a day. Since the vaccination, the patient had been tested for COVID-19.
Age: 62.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Anxiety, Chest discomfort, Incorrect dose administered, SARS-CoV-2 test, Tachycardia
Clinical narrative: chest tightness; tachycardia; feeling of impending doom; The patient received 5th dose of BNT162B2; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 08Sep2022 at 19:00 as dose 5 (booster), single (Lot number: GH9694) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Heart Disease" (unspecified if ongoing); "ALLERGY" (unspecified if ongoing), notes: Known allergies: Yes. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 Immunisation; Covid-19 vaccine (DOSE 3; MANUFACTUERER UNKNOWN), for COVID-19 Immunisation; Covid-19 vaccine (DOSE 4; MANUFACTUERER UNKNOWN), for COVID-19 Immunisation. The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious) with onset 08Sep2022 at 19:00, outcome "unknown", described as "The patient received 5th dose of BNT162B2"; CHEST DISCOMFORT (non-serious) with onset 08Sep2022 at 19:15, outcome "recovered" (Sep2022), described as "chest tightness"; ANXIETY (non-serious) with onset 08Sep2022 at 19:15, outcome "recovered" (Sep2022), described as "feeling of impending doom"; TACHYCARDIA (non-serious) with onset 08Sep2022 at 19:15, outcome "recovered" (Sep2022). Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chest discomfort, tachycardia, anxiety.  Additional information: The patient had known allergy. The patient did not received any other vaccine within the four weeks of vaccination. The patient received other medication in two weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID -19. It was also reported that five minutes after the vaccination, the patient experienced chest tightness, tachycardia, and the feeling of impending doom. Adverse event treatment included treatment with Benedryl 25mg orally (PO) once a day. Since the vaccination, the patient had been tested for COVID-19.
Age: 68.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Diplopia, Impaired driving ability, Ophthalmic migraine, Vision blurred
Clinical narrative: she noticed that her vision was blurry; Double vision while driving/ saw 2 green lights instead of one; Ocular Migraine; This spontaneous case was reported by a patient and describes the occurrence of VISION BLURRED (she noticed that her vision was blurry), DIPLOPIA (Double vision while driving/ saw 2 green lights instead of one) and OPHTHALMIC MIGRAINE (Ocular Migraine) in a 68-year-old female patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 vaccination.     The patient's past medical history included Ocular migraine (Prior to vaccination she seldom had them.).    On 09-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Sep-2022, the patient experienced VISION BLURRED (she noticed that her vision was blurry), DIPLOPIA (Double vision while driving/ saw 2 green lights instead of one) and OPHTHALMIC MIGRAINE (Ocular Migraine). On 11-Sep-2022, VISION BLURRED (she noticed that her vision was blurry) and DIPLOPIA (Double vision while driving/ saw 2 green lights instead of one) had resolved. On 12-Sep-2022, OPHTHALMIC MIGRAINE (Ocular Migraine) had resolved.            No concomitant medication was reported. First dose: On 04 Jan 2021 (Lot# 025J202A & Exp. Date: unknown). 2nd shot: On 29 Jan 2021 (Lot# 030L20A & Exp. Date: unknown). First Booster shot: On 27 Oct 2021 (Lot#939906 & Exp. Date: unknown). 2nd booster shot: On 06 Apr 2022 (Lot# 007J21-2A & Exp. Date: unknown). The symptoms cleared and she did not need to see a doctor. No treatment information was reported.
Age: 68.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Diplopia, Ophthalmic migraine, Vision blurred
Clinical narrative: she noticed that her vision was blurry; Double vision while driving/ saw 2 green lights instead of one; Ocular Migraine; This spontaneous case was reported by a patient and describes the occurrence of VISION BLURRED (she noticed that her vision was blurry), DIPLOPIA (Double vision while driving/ saw 2 green lights instead of one) and OPHTHALMIC MIGRAINE (Ocular Migraine) in a 68-year-old female patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 vaccination.     The patient's past medical history included Ocular migraine (Prior to vaccination she seldom had them.).    On 09-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Sep-2022, the patient experienced VISION BLURRED (she noticed that her vision was blurry), DIPLOPIA (Double vision while driving/ saw 2 green lights instead of one) and OPHTHALMIC MIGRAINE (Ocular Migraine). On 11-Sep-2022, VISION BLURRED (she noticed that her vision was blurry) and DIPLOPIA (Double vision while driving/ saw 2 green lights instead of one) had resolved. On 12-Sep-2022, OPHTHALMIC MIGRAINE (Ocular Migraine) had resolved.            No concomitant medication was reported. First dose: On 04 Jan 2021 (Lot# 025J202A & Exp. Date: unknown). 2nd shot: On 29 Jan 2021 (Lot# 030L20A & Exp. Date: unknown). First Booster shot: On 27 Oct 2021 (Lot#939906 & Exp. Date: unknown). 2nd booster shot: On 06 Apr 2022 (Lot# 007J21-2A & Exp. Date: unknown). The symptoms cleared and she did not need to see a doctor. No treatment information was reported.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Systemic lupus erythematosus
Clinical narrative: on booster I got drug induced lupus; the chemical in the vaccine created lupus on my body; is when I got really sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient received BNT162b2 (BNT162B2), in Mar2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 29 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 2), for Covid-19 immunisation, reaction(s): "sick", "Fingers stiffness"; Covid-19 vaccine (Dose 1; Manufacturer Unknown), for Covid-19 immunisation.  The following information was reported: ILLNESS (non-serious) with onset 2022, outcome "unknown", described as "is when I got really sick"; LUPUS-LIKE SYNDROME (medically significant) with onset 2022, outcome "unknown", described as "on booster I got drug induced lupus; the chemical in the vaccine created lupus on my body". The patient underwent the following laboratory tests and procedures: Lab test: Unknown results.  Clinical course: The patient did not receive any Prior vaccinations (within 4 weeks). Medical conditions and Concomitant medications: Consumer stated, No. On the second vaccine got stiff hands like tried to treat hand that needed occupational therapy and then on booster got drug induced lupus and had all kinds of medical records. The patient had 6-7 lab work since sick.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201162561 Same product, patient, different AEs, different dose;
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Illness, Investigation, Lupus-like syndrome
Clinical narrative: on booster I got drug induced lupus; the chemical in the vaccine created lupus on my body; is when I got really sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient received BNT162b2 (BNT162B2), in Mar2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 29 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 2), for Covid-19 immunisation, reaction(s): "sick", "Fingers stiffness"; Covid-19 vaccine (Dose 1; Manufacturer Unknown), for Covid-19 immunisation.  The following information was reported: ILLNESS (non-serious) with onset 2022, outcome "unknown", described as "is when I got really sick"; LUPUS-LIKE SYNDROME (medically significant) with onset 2022, outcome "unknown", described as "on booster I got drug induced lupus; the chemical in the vaccine created lupus on my body". The patient underwent the following laboratory tests and procedures: Lab test: Unknown results.  Clinical course: The patient did not receive any Prior vaccinations (within 4 weeks). Medical conditions and Concomitant medications: Consumer stated, No. On the second vaccine got stiff hands like tried to treat hand that needed occupational therapy and then on booster got drug induced lupus and had all kinds of medical records. The patient had 6-7 lab work since sick.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201162561 Same product, patient, different AEs, different dose;
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dyspnoea, Hypersensitivity, Palpitations
Clinical narrative: severe reaction, trouble breathing / life threatening reaction / couldn't breathe; life threatening reaction/ heart palpitation so intensified; very scary; This case was reported by a consumer via call center representative and described the occurrence of difficulty breathing in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th August 2022 16:00, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced difficulty breathing (serious criteria life threatening), palpitation (serious criteria life threatening) and fear. On an unknown date, the outcome of the difficulty breathing and palpitation were recovered/resolved and the outcome of the fear was unknown.   It was unknown if the reporter considered the difficulty breathing, palpitation and fear to be related to Shingrix.   Additional Information: GSK Receipt Date: 14-SEP-2022 Reporter's Comment: The case was reported by the patient. The patient had a severe reaction to Shingrix, trouble breathing. The patient had a life-threatening reaction, could not breath, heart palpitation so intensified to midnight thought might need to go to emergency room, very scary to her, lasted to the next day and after 24 hours had passed. The patient never had any reaction to any medication or vaccines ever.  She only had one shot and wanted to know how protected she should. The reporter declined to provide address and date of birth.  The reporter also, unable to provide vaccine details of Lot and expiration.  The patient also reported that, she would not be getting the second Shingrix vaccine. No additional details were provided.  The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dyspnoea, Fear, Palpitations
Clinical narrative: severe reaction, trouble breathing / life threatening reaction / couldn't breathe; life threatening reaction/ heart palpitation so intensified; very scary; This case was reported by a consumer via call center representative and described the occurrence of difficulty breathing in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th August 2022 16:00, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced difficulty breathing (serious criteria life threatening), palpitation (serious criteria life threatening) and fear. On an unknown date, the outcome of the difficulty breathing and palpitation were recovered/resolved and the outcome of the fear was unknown.   It was unknown if the reporter considered the difficulty breathing, palpitation and fear to be related to Shingrix.   Additional Information: GSK Receipt Date: 14-SEP-2022 Reporter's Comment: The case was reported by the patient. The patient had a severe reaction to Shingrix, trouble breathing. The patient had a life-threatening reaction, could not breath, heart palpitation so intensified to midnight thought might need to go to emergency room, very scary to her, lasted to the next day and after 24 hours had passed. The patient never had any reaction to any medication or vaccines ever.  She only had one shot and wanted to know how protected she should. The reporter declined to provide address and date of birth.  The reporter also, unable to provide vaccine details of Lot and expiration.  The patient also reported that, she would not be getting the second Shingrix vaccine. No additional details were provided.  The reporter consented to follow up.
Age: 32.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Induration, Pain
Clinical narrative: Mild pain with quarter-sized induration lasting 3 days
Age: 44.0
Sex: F
Vaccine: HPV9
Symptoms: Back pain, Cardiac flutter, Diarrhoea, Dizziness, Electrocardiogram
Clinical narrative: On the first dose visit , on 6-7-22 The nurse was describing the shot and said wait 1-2 between the shots but no sooner than one month , so i assumed that was for all three .... second shot i did on 8-9-22 and the 3 rd shot with side effects was because i did it one mth after the  2nd and the system never flagged this and as far as i was concerned It was one mths since my last shot . Next day i had cramping & diarhea, so i researched and found out i received the shot wayyy too early , the next few days after that , Nausea , Diarrhea, left side back pain , left side head and skull pain , high pulse rate , high blood pressure, heart flutter, symptoms now are diarrhea , light headed ness , fatigue , cramping
Age: 44.0
Sex: F
Vaccine: HPV9
Symptoms: Fatigue, Headache, Hypertension, Muscle spasms, Nausea
Clinical narrative: On the first dose visit , on 6-7-22 The nurse was describing the shot and said wait 1-2 between the shots but no sooner than one month , so i assumed that was for all three .... second shot i did on 8-9-22 and the 3 rd shot with side effects was because i did it one mth after the  2nd and the system never flagged this and as far as i was concerned It was one mths since my last shot . Next day i had cramping & diarhea, so i researched and found out i received the shot wayyy too early , the next few days after that , Nausea , Diarrhea, left side back pain , left side head and skull pain , high pulse rate , high blood pressure, heart flutter, symptoms now are diarrhea , light headed ness , fatigue , cramping
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test normal, Colonoscopy normal, Endoscopy normal, Haematocrit decreased, Haemoglobin decreased
Clinical narrative: Low Hemoglobin and Hematocrit in blood work. negative endoscopy and colonoscopy looking for blood loss.