chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, Feeling abnormal, Heart rate
Clinical narrative: Covid; Covid; Covid 3 times; sicker/more ill; losing some heart muscle mass; heart rate was going up; felt funky; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A male patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "felt funky"; HEART RATE INCREASED (non-serious) with onset 2021, outcome "unknown", described as "heart rate was going up"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid"; DISEASE RECURRENCE (medically significant), outcome "unknown", described as "Covid 3 times"; ILLNESS (non-serious), outcome "unknown", described as "sicker/more ill"; MUSCLE ATROPHY (non-serious), outcome "unknown", described as "losing some heart muscle mass". The patient underwent the following laboratory tests and procedures: Heart rate: (2021) going up. Clinical course: Reporter, a patient, called about the Covid vaccine. He mentioned that they've been really sicker and more ill after taking the shot. He mentioned he got Covid 3 times and he would like to know what was in the vaccine that they took because they got sick. He was trying to find out what's in the shots he, his wife, and his daughter got. They had been sick all the time ever since they got the Covid-19 vaccine back in spring of 2021. Within 5 to 10 minutes of getting the vaccine, he noticed his heart rate was going up and he felt funky. According to him, he might have been losing some heart muscle mass.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400278624 same reporter/product, different patient/events;US-PFIZER INC-202400278621 same reporter/product, different patient/events;
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Illness, Muscle atrophy
Clinical narrative: Covid; Covid; Covid 3 times; sicker/more ill; losing some heart muscle mass; heart rate was going up; felt funky; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A male patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "felt funky"; HEART RATE INCREASED (non-serious) with onset 2021, outcome "unknown", described as "heart rate was going up"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid"; DISEASE RECURRENCE (medically significant), outcome "unknown", described as "Covid 3 times"; ILLNESS (non-serious), outcome "unknown", described as "sicker/more ill"; MUSCLE ATROPHY (non-serious), outcome "unknown", described as "losing some heart muscle mass". The patient underwent the following laboratory tests and procedures: Heart rate: (2021) going up. Clinical course: Reporter, a patient, called about the Covid vaccine. He mentioned that they've been really sicker and more ill after taking the shot. He mentioned he got Covid 3 times and he would like to know what was in the vaccine that they took because they got sick. He was trying to find out what's in the shots he, his wife, and his daughter got. They had been sick all the time ever since they got the Covid-19 vaccine back in spring of 2021. Within 5 to 10 minutes of getting the vaccine, he noticed his heart rate was going up and he felt funky. According to him, he might have been losing some heart muscle mass.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400278624 same reporter/product, different patient/events;US-PFIZER INC-202400278621 same reporter/product, different patient/events;
Age: 80.0
Sex: M
Vaccine: COVID19, PPV
Symptoms: Blood test, Chest X-ray, Culture urine, Fall, Gait disturbance
Clinical narrative: Ambulatory dysfunction; falling; UTI; flu like symptoms; Muscle weakness; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  An 80-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 09Oct2024 as dose 1, single (Batch/Lot number: unknown) at the age of 80 years, in arm for covid-19 immunisation; pneumococcal vaccine (PNEUMOCOCCAL VACCINE), on 09Oct2024 as dose number unknown, single), in arm. The patient's relevant medical history included: "defibrillator placed 10 years ago", start date: 2014 (unspecified if ongoing); "heart condition diagnosed about 10 years ago", start date: 2014 (unspecified if ongoing); "Arthritis diagnosed a long time ago" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MUSCULAR WEAKNESS (non-serious) with onset 10Oct2024, outcome "recovering", described as "Muscle weakness"; INFLUENZA LIKE ILLNESS (non-serious) with onset 10Oct2024, outcome "recovered" (13Oct2024), described as "flu like symptoms"; GAIT DISTURBANCE (hospitalization), outcome "unknown", described as "Ambulatory dysfunction"; FALL (hospitalization), outcome "unknown", described as "falling"; URINARY TRACT INFECTION (non-serious), outcome "unknown", described as "UTI".  The patient was not able to walk the next day, and he has the flu like symptoms plus keeps on falling and he was not able to walk . He got the flu like symptoms and he experienced muscle weakness. He was not able to walk. He took the covid and the pneumonia in each arm. The physician told them next time take one shot at a time do not take both. Flu like symptoms, muscle weakness, and not being able to walk started the next day on 10Oct2024. They ran some tests in the emergency room on him like blood work, checked his urine culture and did a chest Xray. Confirms he was admitted to the hospital.  She had to call an ambulance since he was falling since he could not walk, and he was taken to emergency room. States he was admitted the hospital mostly for the walking since he fell, clarifies that his diagnosis for admission to the hospital was ambulatory dysfunction. She thinks he was admitted to the hospital after midnight, and he may have been admitted on 11Oct2024. He was discharged from the hospital on Sunday 13Oct2024 to homecare. Not being able to walk outcome: walking is a little unsteady, they want him walking with a walker. He has a whole list of medications.  In the hospital did blood work, chest xray, checked his urine culture. She was told that he had a little bit of a UTI.   The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 80.0
Sex: M
Vaccine: COVID19, PPV
Symptoms: Influenza like illness, Muscular weakness, Urinary tract infection
Clinical narrative: Ambulatory dysfunction; falling; UTI; flu like symptoms; Muscle weakness; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  An 80-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 09Oct2024 as dose 1, single (Batch/Lot number: unknown) at the age of 80 years, in arm for covid-19 immunisation; pneumococcal vaccine (PNEUMOCOCCAL VACCINE), on 09Oct2024 as dose number unknown, single), in arm. The patient's relevant medical history included: "defibrillator placed 10 years ago", start date: 2014 (unspecified if ongoing); "heart condition diagnosed about 10 years ago", start date: 2014 (unspecified if ongoing); "Arthritis diagnosed a long time ago" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MUSCULAR WEAKNESS (non-serious) with onset 10Oct2024, outcome "recovering", described as "Muscle weakness"; INFLUENZA LIKE ILLNESS (non-serious) with onset 10Oct2024, outcome "recovered" (13Oct2024), described as "flu like symptoms"; GAIT DISTURBANCE (hospitalization), outcome "unknown", described as "Ambulatory dysfunction"; FALL (hospitalization), outcome "unknown", described as "falling"; URINARY TRACT INFECTION (non-serious), outcome "unknown", described as "UTI".  The patient was not able to walk the next day, and he has the flu like symptoms plus keeps on falling and he was not able to walk . He got the flu like symptoms and he experienced muscle weakness. He was not able to walk. He took the covid and the pneumonia in each arm. The physician told them next time take one shot at a time do not take both. Flu like symptoms, muscle weakness, and not being able to walk started the next day on 10Oct2024. They ran some tests in the emergency room on him like blood work, checked his urine culture and did a chest Xray. Confirms he was admitted to the hospital.  She had to call an ambulance since he was falling since he could not walk, and he was taken to emergency room. States he was admitted the hospital mostly for the walking since he fell, clarifies that his diagnosis for admission to the hospital was ambulatory dysfunction. She thinks he was admitted to the hospital after midnight, and he may have been admitted on 11Oct2024. He was discharged from the hospital on Sunday 13Oct2024 to homecare. Not being able to walk outcome: walking is a little unsteady, they want him walking with a walker. He has a whole list of medications.  In the hospital did blood work, chest xray, checked his urine culture. She was told that he had a little bit of a UTI.   The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Disease recurrence, Vertigo
Clinical narrative: vertigo/only having vertigo one other time; vertigo/only having vertigo one other time; This is a spontaneous report received from a Pharmacist from a sales representative.  A 71-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) at the age of 71 years for covid-19 immunisation. The patient's relevant medical history included: "vertigo" (not ongoing), notes: only having vertigo one other time and that is when she had transmitted COVID last winter; "transmitted COVID", start date: 2023, stop date: 2023. The patient's concomitant medications were not reported. The following information was reported: VERTIGO (non-serious), DISEASE RECURRENCE (non-serious), all with latency 8 days after the suspect product administration, outcome "recovered" and all described as "vertigo/only having vertigo one other time". Therapeutic measures were not taken as a result of vertigo, disease recurrence.  The information on the batch/lot number for [BNT162B2 OMICRON (KP.2)] will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400278048 Same patient, different vaccine dose number and event.;US-PFIZER INC-2021161355 Same patient, different vaccine dose number and event.;
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Tremor
Clinical narrative: temperature spikes, real bad fever; shakes; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2024-775042 (Moderna).  A female patient received BNT162b2 (BNT162B2), on 06Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Heart disorder" (ongoing), notes: Caller is a "heart patient" since she has plaque in her arteries; "plaque in her arteries" (ongoing); "Blood cholesterol abnormal" (ongoing), notes: She is on rosuvastatin for cholesterol.; "allergic to ampicillin" (ongoing); "sulfa drugs" (ongoing); "Stomach discomfort" (ongoing), notes: She is on stomach medications to calm her stomach. Concomitant medication(s) included: ROSUVASTATIN taken for blood cholesterol abnormal (ongoing). The patient also took other concomitant therapy. Past drug history included: Repatha for cholesterol, reaction(s): "allergic", notes: a cholesterol injection. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 14Jan2021, for Covid-19 immunization, reaction(s): "temperature spikes, real bad fever", "Shakes"; BNT162b2 (DOSE 2, SINGLE), administration date: 04Feb2021, for Covid-19 immunization, reaction(s): "temperature spikes, real bad fever", "Shakes". The following information was reported: TREMOR (non-serious) with onset Oct2021, outcome "unknown", described as "shakes"; PYREXIA (non-serious) with onset Oct2021, outcome "unknown", described as "temperature spikes, real bad fever". The patient underwent the following laboratory tests and procedures: Body temperature: spikes. Clinical course: Caller had always gotten the Pfizer vaccine. She always has had a reaction about 6 to 8 hours later where her temperature spikes, real bad fever, shakes. She had this reaction every time she got the Pfizer vaccine. She has received the Pfizer vaccine on 14Jan2021, 04Feb2021, 06Oct2021, 02Sep2022.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400134322 same reporter/patient, different event/ dose (Dose 4);US-PFIZER INC-202400278002 same reporter/patient, different event/ dose (Dose 2);US-PFIZER INC-202400278003 same reporter/patient, different event/ dose (Dose 1);
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Tremor
Clinical narrative: temperature spikes, real bad fever; shakes; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2024-775042 (Moderna).  A female patient received BNT162b2 (BNT162B2), on 04Feb2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Heart disorder" (ongoing), notes: Caller is a "heart patient" since she has plaque in her arteries; "Cholesterol/Blood cholesterol abnormal" (ongoing), notes: She is on rosuvastatin for cholesterol.; "sulfa drugs" (ongoing); "Stomach discomfort" (ongoing), notes: She is on stomach medications to calm her stomach.; "plaque in her arteries" (ongoing); "Allergic to ampicillin" (ongoing). Concomitant medication(s) included: ROSUVASTATIN taken for blood cholesterol abnormal. The patient also took other concomitant therapy. Past drug history included: Repatha for Cholesterol, reaction(s): "Drug allergy: Repatha", notes: a cholesterol injection. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 14Jan2021, for Covid-19 immunisation, reaction(s): "temperature spikes, real bad fever", "shakes". The following information was reported: TREMOR (non-serious) with onset Feb2021, outcome "unknown", described as "shakes"; PYREXIA (non-serious) with onset Feb2021, outcome "unknown", described as "temperature spikes, real bad fever". The patient underwent the following laboratory tests and procedures: Body temperature: (Feb2021) spikes. Clinical course: Caller had always gotten the Pfizer vaccine. She always has had a reaction about 6 to 8 hours later where her temperature spikes, real bad fever, shakes. She had this reaction every time she got the Pfizer vaccine. She had received the Pfizer vaccine on 14Jan2021, 04Feb2021, 06Oct2021, 02Sep2022.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400134322 same reporter/patient, different dose/event;US-PFIZER INC-202400278001 same reporter/patient, different dose/event;US-PFIZER INC-202400278003 same reporter/patient, different dose/event;
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Tremor
Clinical narrative: temperature spikes, real bad fever; shakes; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2024-775042 (Moderna).  A female patient received BNT162b2 (BNT162B2), on 14Jan2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Heart disorder" (ongoing), notes: Caller is a "heart patient" since she has plaque in her arteries; "Allergic to ampicillin" (ongoing); "plaque in her arteries" (ongoing); "allergic to sulfa drugs" (ongoing); "Cholesterol/Blood cholesterol abnormal" (ongoing), notes: She is on rosuvastatin for cholesterol.; "Stomach discomfort" (ongoing), notes: She is on stomach medications to calm her stomach. Concomitant medication(s) included: ROSUVASTATIN taken for blood cholesterol abnormal (ongoing). The patient also took other concomitant therapy. Past drug history included: Repatha for Cholesterol, reaction(s): "allergic/drug allergy", notes: a cholesterol injection. The following information was reported: TREMOR (non-serious) with onset Jan2021, outcome "unknown", described as "shakes"; PYREXIA (non-serious) with onset Jan2021, outcome "unknown", described as "temperature spikes, real bad fever". The patient underwent the following laboratory tests and procedures: Body temperature: (Jan2021) spikes, notes: real bad fever. Clinical course: Caller had always got the Pfizer vaccine. Caller always has had a reaction about 6 to 8 hours later where her temperature spikes, real bad fever, shakes. Caller had this reaction every time she got the Pfizer vaccine.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400134322 same reporter/patient, different dose/event (Dose 4);US-PFIZER INC-202400278001 same reporter/patient, different event/ dose (Dose 3);US-PFIZER INC-202400278002 same reporter/patient, different event/ dose (Dose 2);
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Rash, Skin lesion
Clinical narrative: had lesions on my face; eyes are swollen; My face breaks out and stays that way for weeks; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  An adult female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Sep2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Dimethicone, reaction(s): "Dimethicone reaction Allergy". Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: RASH (non-serious) with onset Sep2024, outcome "unknown", described as "My face breaks out and stays that way for weeks"; EYE SWELLING (non-serious) with onset Sep2024, outcome "unknown", described as "eyes are swollen"; SKIN LESION (non-serious) with onset Sep2024, outcome "unknown", described as "had lesions on my face".  Additional information: Patient had question that, Did the shot contain silicone or dimethicone as she had a history of allergy to dimethicone. For the last 3 weeks she had lesions on her face. Her eyes were swollen. She received the updated Pfizer COVID 19 vaccine right around 3 weeks ago (2024). Patient had question that, Ever since she got the new vaccination a few weeks ago and she was allergic to dimethicone and what happened was her face breaks out and stayed that way for weeks. Asked that, Did you know if there was dimethicone because she started to break out? Dimethicone in the shot this time, if there dimethicone or some kind of silicone?". It's the most, it was not the vaccine, I am sorry. It was the booster, the most recent booster. The one that just came out two weeks ago or three weeks ago." (Hence, suspect captured as Unspecified Booster shot). Name of the booster, consumer stated, "No, she could not. she was just telling them, she just got the most recent one, for the most recent one that Pfizer make. She did not know the name of it."  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: body wide pain; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (DOSE 1, SINGLE), administration date: 2021, for Covid-19 immunization, reaction(s): "body wide pain". The following information was reported: PAIN (non-serious) with onset 2021, outcome "not recovered", described as "body wide pain".  Additional information: It was reported that patient had received Pfizer vaccination in 2021, with a subsequent second and booster. After the vaccinations, patient developed body wide pain that was active 24/7. Patient ended up losing career in the service as well.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: body wide pain; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 (BNT162B2), in 2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: 2021, for covid-19 immunization, reaction(s): "body wide pain"; Bnt162b2 (DOSE 2, SINGLE), administration date: 2021, for covid-19 immunization, reaction(s): "body wide pain". The following information was reported: PAIN (non-serious), outcome "not recovered", described as "body wide pain".  Additional information: the patient had received vaccination in 2021, with a subsequent second and booster. The mandated will be vaccinated or lose the job. After the vaccinations, the patient has developed body wide pain that was active 24/7. The patient ended up losing career in the service as well.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick/ more ill; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A female patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "sick/ more ill".  Additional information: Reporter reported that his wife and daughter have been sick all the time ever since they got the COVID-19 vaccine back in spring of 2021.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick/ more ill; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A female patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "sick/ more ill".  Additional information: Reporter mentioned that they had been really sicker and more ill after taking the shot. Reporter wanted to know what was in the shots that he, his wife, and his daughter had received. He reported that all three had been sick since they got the COVID-19 vaccine back in the spring of 2021.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Dizziness, Nausea, Rash
Clinical narrative: rash; large painful welts; back pain; weakness; nausea; dizziness; This is a spontaneous report received from an Other HCP.  A 73-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 08Oct2024 as dose 1, single (Batch/Lot number: unknown) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BACK PAIN (medically significant) with onset 08Oct2024, outcome "unknown"; DIZZINESS (medically significant) with onset 08Oct2024, outcome "unknown"; URTICARIA (medically significant) with onset 08Oct2024, outcome "unknown", described as "large painful welts"; NAUSEA (medically significant) with onset 08Oct2024, outcome "unknown"; RASH (medically significant) with onset 08Oct2024, outcome "unknown"; ASTHENIA (medically significant) with onset 08Oct2024, outcome "unknown", described as "weakness". Therapeutic measures were taken as a result of rash, urticaria, back pain, asthenia, nausea, dizziness: the patient received Kenalog Injection.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Given the compatible time association, the reasonable possibility that the events are related to BNT162B2 OMICRON (KP.2) administration cannot be excluded. This case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: rash; large painful welts; back pain; weakness; nausea; dizziness; This is a spontaneous report received from an Other HCP.  A 73-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 08Oct2024 as dose 1, single (Batch/Lot number: unknown) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BACK PAIN (medically significant) with onset 08Oct2024, outcome "unknown"; DIZZINESS (medically significant) with onset 08Oct2024, outcome "unknown"; URTICARIA (medically significant) with onset 08Oct2024, outcome "unknown", described as "large painful welts"; NAUSEA (medically significant) with onset 08Oct2024, outcome "unknown"; RASH (medically significant) with onset 08Oct2024, outcome "unknown"; ASTHENIA (medically significant) with onset 08Oct2024, outcome "unknown", described as "weakness". Therapeutic measures were taken as a result of rash, urticaria, back pain, asthenia, nausea, dizziness: the patient received Kenalog Injection.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Given the compatible time association, the reasonable possibility that the events are related to BNT162B2 OMICRON (KP.2) administration cannot be excluded. This case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: Patient developed facial palsy; This is a spontaneous report received from a Nurse from a sales representative.  An elderly male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 12Oct2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FACIAL PARALYSIS (medically significant) with onset Oct2024, outcome "unknown", described as "Patient developed facial palsy". It was unknown if therapeutic measures were taken as a result of facial paralysis.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Limited information precludes a comprehensive causality assessment, however based on the implied temporal association, the contributory role of suspect drug BNT162B2 OMICRON (KP.2) cannot be excluded for the reported event. Information on details surrounding patient complete medical history and concomitant medications would aid in comprehensive medical assessment. Case will be reassessed should additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Device breakage, Device leakage, Underdose
Clinical narrative: The prefilled syringes had it's needles on, while administration the PFS was leaking from the hub; it was not obvious that it was cracked, but the syringe was cracked; The prefilled syringes had it's needles on, while administration the PFS was leaking from the hub; This is a spontaneous report received from an Other HCP from medical information team and product quality group.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 02Oct2024 as dose 1, single (Lot number: LM2215, Expiration Date: 15Mar2025) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE LEAKAGE (non-serious), UNDERDOSE (non-serious) all with onset 02Oct2024 and all described as "The prefilled syringes had it's needles on, while administration the PFS was leaking from the hub"; DEVICE BREAKAGE (non-serious) with onset 02Oct2024, described as "it was not obvious that it was cracked, but the syringe was cracked".  Causality for "the prefilled syringes had it's needles on, while administration the pfs was leaking from the hub" and "it was not obvious that it was cracked, but the syringe was cracked" was determined associated to device constituent of BNT162b2 omicron (kp.2) (malfunction).  Additional information: the HCP customer reported their Comirnaty 12 plus 2024-2025 formula has been administered in a couple of patients. The prefilled syringes had it's needles on, while administration the PFS was leaking from the hub. Per the HCP it was not obvious that it was cracked, but the syringe was cracked so they instructed their MA's not to tighten it. They are unsure if it's the cause why it leaked.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400268858 same product/event, different patients;
Sex: M
Vaccine: COVID19
Symptoms: Antinuclear antibody, C-reactive protein, Computerised tomogram thorax, Red blood cell sedimentation rate, SARS-CoV-2 test
Clinical narrative: scleroderma-like reaction secondary to his vaccination; This is a literature report, Program ID.  A 82-year-old man developed scleroderma-like syndrome after receiving tozinameran for immunisation against COVID-19*. The man presented with progressive dyspnoea on exertion and a non-productive cough. His medical history included low-grade urothelial carcinoma.He had no respiratory issues until three months prior to his presentation. He was treated with multiple courses of unspecified antibiotics and empiric inhaler therapy that had minimal effect. He also noticed diffuse thickening of his hands and fingers bilaterally and Raynaud's phenomenon, these symptoms were also absent three months ago. These symptoms emerged within weeks of receiving the tozinameran [BNT162b2 mRNA COVID-19 vaccine].He underwent chest imaging that revealed the presence of non-specific interstitial pneumonia.Laboratory data showed a positive ANA and elevated CRP and ESR, but other test for COVID-19 were negative.Following multidisciplinary discussion with rheumatology, the diagnosis of scleroderma-like reaction secondary to his vaccination was confirmed. The man was treated with prednisone and mycophenolate mofetil after he declined lung biopsy.Following one year of treatment, his lung disease remained stable, and he continued on a maintenance dose of mycophenolate mofetil.; Sender's Comments: A possibly contributory role of BNT162B2 in triggering the onset of scleroderma-like syndrome cannot be fully excluded, considering the temporal relationship.  More immunological and biomolecular evidence would be needed to explore the plausible physiopathologic mechanism between the vaccination and the 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.
Sex: M
Vaccine: COVID19
Symptoms: Scleroderma-like reaction
Clinical narrative: scleroderma-like reaction secondary to his vaccination; This is a literature report, Program ID.  A 82-year-old man developed scleroderma-like syndrome after receiving tozinameran for immunisation against COVID-19*. The man presented with progressive dyspnoea on exertion and a non-productive cough. His medical history included low-grade urothelial carcinoma.He had no respiratory issues until three months prior to his presentation. He was treated with multiple courses of unspecified antibiotics and empiric inhaler therapy that had minimal effect. He also noticed diffuse thickening of his hands and fingers bilaterally and Raynaud's phenomenon, these symptoms were also absent three months ago. These symptoms emerged within weeks of receiving the tozinameran [BNT162b2 mRNA COVID-19 vaccine].He underwent chest imaging that revealed the presence of non-specific interstitial pneumonia.Laboratory data showed a positive ANA and elevated CRP and ESR, but other test for COVID-19 were negative.Following multidisciplinary discussion with rheumatology, the diagnosis of scleroderma-like reaction secondary to his vaccination was confirmed. The man was treated with prednisone and mycophenolate mofetil after he declined lung biopsy.Following one year of treatment, his lung disease remained stable, and he continued on a maintenance dose of mycophenolate mofetil.; Sender's Comments: A possibly contributory role of BNT162B2 in triggering the onset of scleroderma-like syndrome cannot be fully excluded, considering the temporal relationship.  More immunological and biomolecular evidence would be needed to explore the plausible physiopathologic mechanism between the vaccination and the 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.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, Lacunar stroke
Clinical narrative: Stroke/Lacunar Infarct Stroke; COVID-19 (COVID twice); COVID-19 (COVID twice); Interchange of vaccine products; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2024-774908.  A patient (age and gender not provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (SPIKEVAX), as dose 1, single), as dose 2, single) and as dose 3 (booster), single), all unknown for covid-19 immunisation. The patient's relevant medical history included: "Covid-19" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 04Oct2022, outcome "unknown"; LACUNAR STROKE (hospitalization, medically significant) with onset 15Nov2022, outcome "recovered with sequelae", described as "Stroke/Lacunar Infarct Stroke"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 (COVID twice)". Clinical Course: The patient's past medical history included COVID-19. For Spikevax Nos (Spikevax Nos) (Unknown), the reporter did not provide any causality assessments. The concomitant medication was not reported by reporter. The treatment medication was not reported by reporter.  Sender Comment: The benefit-risk relationship of Spikevax Covid-19 Vaccine Nos vaccine is not affected by this report.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in 2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "unknown" and all described as "COVID-19". It was reported that the patient got COVID-19 three times.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: body wide pain; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "not recovered", described as "body wide pain".  Additional information: Patient had received vaccination in 2021, with a subsequent second and booster. The mandated patient vaccinated or lose job. After the vaccinations, patient had developed body wide pain that is active 24/7. Patient ended up losing career in the service as well.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19, RSV
Symptoms: Dyspnoea, Feeding tube user, Near death experience
Clinical narrative: almost died; Tubes and she was breathing on a breathing machine, was breathing for her and everything; They had to feed her through a feeding tube and everything; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for maternal immunisation; BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEAR DEATH EXPERIENCE (hospitalization, medically significant, life threatening), outcome "unknown", described as "almost died"; DYSPNOEA (hospitalization, medically significant, life threatening), outcome "unknown", described as "Tubes and she was breathing on a breathing machine, was breathing for her and everything"; FEEDING TUBE USER (hospitalization, medically significant, life threatening), outcome "unknown", described as "They had to feed her through a feeding tube and everything". Therapeutic measures were taken as a result of near death experience, dyspnoea, feeding tube user. Clinical course: Phone call received from (withheld) regarding assistance for Abrysvo (Respiratory Syncytial Virus Vaccine). During the call, (withheld) stated, "My daughter almost died from that, that stuff, you know. It got in her lungs, and she almost died. They had her hooked up to all kinds of things in the hospital to save her life. Tubes and she was breathing on a breathing machine, was breathing for her and everything. They had to feed her through a feeding tube and everything. My daughter and I went and got all the COVID shots, and we have to go get another 1 and we always get Pfizer shot for the COVID and all. It was my granddaughter, and I was so scared seeing her like that. I, we all cried because we thought we were going to lose her. We almost did."  Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: vaccinated with Comirnaty the first week in Sep and tested positive for COVID-19 early Tuesday morning (13Oct2024); vaccinated with Comirnaty the first week in Sep and tested positive for COVID-19 early Tuesday morning (13Oct2024); This is a spontaneous report received from a Consumer or other non HCP.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Sep2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 13Oct2024, outcome "unknown" and all described as "vaccinated with Comirnaty the first week in Sep and tested positive for COVID-19 early Tuesday morning (13Oct2024)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Oct2024) Positive. Batch/lot number is not provided, and it cannot be obtained.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID; COVID; This is a spontaneous report received from a Nurse.  A 68-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 07May2024 as dose 1, single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 07Jan2021, when the patient was 64-year-old, for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14Sep2024, outcome "recovered" (24Sep2024) and all described as "COVID". The patient had all of the COVID vaccinations, second until now have managed not to get COVID. The patient was waiting to get the updated vaccine when it came out. Unfortunately, the patient got COVID before doing this but the patient feel fine now. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Sep2024) Positive; (24Sep2024) Negative; (29Sep2024) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 since the patient was prescribed nirmatrelvir/ritonavir (PAXLOVID).; Sender's Comments: A causal relationship to the suspect drug BNT162B2 OMI XBB.1.5 cannot be excluded for the event vaccination failure. This case will be reassessed upon receipt of additional information.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Loss of consciousness
Clinical narrative: Patient temporarily lost consciousness after receiving vaccine - patient was monitored in vaccine room and patient stated she was not having trouble breathing, we offered to call ambulance and patient declined  - patient was okay and walked out of pharmacy with husband and child.
Age: 60.0
Sex: M
Vaccine: VARZOS, FLU3, TDAP, VARZOS
Symptoms: Arthralgia, Blood test, Nausea, Pain, Pain in extremity
Clinical narrative: On the evening of 10/9 patient reports fever (102.0), nausea, and sore arm. Pt reports he's been taking over the counter medication to help with sx. Pt went to the emergency room on 10/16  for left shoulder pain.  Pt reports he continues to have pain and rates it a 10/10 at times. Pt reports difficulty sleeping on the left side. Pt denies redness, but reports that it's warm to the touch. Pt reports the swelling in left arm hasn't worsened since ER visit.  Pt reports he's taking ibuprofen, applying ice and heat, and doing ROM exercises. ER recommended for pt to follow up with physical therapy and orthopedics.  Pt seen ortho in the past for shoulder pain.  Referral to ortho placed. Medrol dosepack prescribed.
Age: 60.0
Sex: M
Vaccine: VARZOS, FLU3, TDAP, VARZOS
Symptoms: Peripheral swelling, Pyrexia, Skin warm, Sleep disorder, Ultrasound Doppler
Clinical narrative: On the evening of 10/9 patient reports fever (102.0), nausea, and sore arm. Pt reports he's been taking over the counter medication to help with sx. Pt went to the emergency room on 10/16  for left shoulder pain.  Pt reports he continues to have pain and rates it a 10/10 at times. Pt reports difficulty sleeping on the left side. Pt denies redness, but reports that it's warm to the touch. Pt reports the swelling in left arm hasn't worsened since ER visit.  Pt reports he's taking ibuprofen, applying ice and heat, and doing ROM exercises. ER recommended for pt to follow up with physical therapy and orthopedics.  Pt seen ortho in the past for shoulder pain.  Referral to ortho placed. Medrol dosepack prescribed.
Age: 60.0
Sex: M
Vaccine: VARZOS, FLU3, TDAP, VARZOS
Symptoms: X-ray limb
Clinical narrative: On the evening of 10/9 patient reports fever (102.0), nausea, and sore arm. Pt reports he's been taking over the counter medication to help with sx. Pt went to the emergency room on 10/16  for left shoulder pain.  Pt reports he continues to have pain and rates it a 10/10 at times. Pt reports difficulty sleeping on the left side. Pt denies redness, but reports that it's warm to the touch. Pt reports the swelling in left arm hasn't worsened since ER visit.  Pt reports he's taking ibuprofen, applying ice and heat, and doing ROM exercises. ER recommended for pt to follow up with physical therapy and orthopedics.  Pt seen ortho in the past for shoulder pain.  Referral to ortho placed. Medrol dosepack prescribed.
Age: 60.0
Sex: M
Vaccine: VARZOS, FLU3, TDAP, VARZOS
Symptoms: Arthralgia, X-ray
Clinical narrative: On the evening of 10/9 patient reports fever (102.0), nausea, and sore arm. Pt reports he's been taking over the counter medication to help with sx. Pt went to the emergency room on 10/16  for left shoulder pain.  Pt reports he continues to have pain and rates it a 10/10 at times. Pt reports difficulty sleeping on the left side. Pt denies redness, but reports that it's warm to the touch. Pt reports the swelling in left arm hasn't worsened since ER visit.  Pt reports he's taking ibuprofen, applying ice and heat, and doing ROM exercises. ER recommended for pt to follow up with physical therapy and orthopedics.  Pt seen ortho in the past for shoulder pain.  Referral to ortho placed. Medrol dosepack prescribed.