chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: got sick after getting the Pfizer Covid 19 vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  An adult patient received BNT162b2 (BNT162B2 NOS), 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), outcome "unknown", described as "got sick after getting the Pfizer Covid 19 vaccine".  Additional information:  Got sick after getting the Pfizer Covid 19 vaccine. She is calling on behalf of her children who got sick after getting the Pfizer Covid 19 vaccine. And also her uncle and her girlfriend that got sick after getting the vaccine. Caller states that she has 2 young adult children that got sick after getting the Pfizer Covid 19 Vaccine, and also her Uncle and her brother. She is only looking to find a medication or product so they can get immediate relief, but she is not finding any products that can help them. Her friend (name withheld) that she works with, has had diarrhea for almost a year and was told that she has long covid. Her other fried (name withheld) that lives in (place withheld) had a heart attack and appendicitis in the same day. Verified that all patients received the Pfizer Covid 19 Vaccine. This report is for the caller's 2 young adult children.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300056731 same reporter, product and event, different patient;
Sex: F
Vaccine: COVID19
Symptoms: Body height, Discomfort
Clinical narrative: The other three shots (COVID Shots) that I had with it the first two and then the first booster(COVID Shots), I did have side effects that you know they are uncomfortable; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing), notes: Blood pressure high; "Diabetes" (unspecified if ongoing), notes: Diabetes; "everything is you know like arthritis related I had multiple spinal surgery" (unspecified if ongoing), notes: everything is you know like arthritis related I had multiple spinal surgery; "everything is you know like arthritis related I had multiple spinal surgery" (unspecified if ongoing), notes: everything is you know like arthritis related I had multiple spinal surgery. Concomitant medication(s) included: ATORVASTATIN taken for blood pressure measurement; METFORMIN taken for diabetes mellitus; METOPROLOL SUCCINATE taken for blood pressure measurement. The following information was reported: DISCOMFORT (non-serious), outcome "recovered", described as "The other three shots (COVID Shots) that I had with it the first two and then the first booster(COVID Shots), I did have side effects that you know they are uncomfortable". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported by the patient that, the other three shots (COVID Shots) that she had with it the first two and then the first booster (COVID Shots), she did have side effects that they were uncomfortable but only lasted like may be a day and half.  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-202300056755 Same product, patient, different AEs, different dose;US-PFIZER INC-202300058251 Same product, patient, different AEs, different dose;US-PFIZER INC-202300058250 Same product, patient, different AEs, different dose;
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Macule, Pain in extremity, Pruritus
Clinical narrative: had a big red spot all around to her arm; normal red spots where the Band-Aid was, then it got bigger, it got like 2 inches, then 4 inches, then 6 inches, had a huge bright red spot that went all the way around her arm; itching; arm is sore; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A 65-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 27Jan2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 65 years, in left arm for immunisation. The patient's family history included: "Pneumonia" (unspecified if ongoing), notes: so many family members that have died from Pneumonia. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 27Jan2023, outcome "recovered" (Jan2023), described as "arm is sore"; PRURITUS (non-serious) with onset 27Jan2023, outcome "not recovered", described as "itching"; ERYTHEMA (non-serious) with onset 28Jan2023, outcome "recovering", described as "normal red spots where the Band-Aid was, then it got bigger, it got like 2 inches, then 4 inches, then 6 inches, had a huge bright red spot that went all the way around her arm"; MACULE (non-serious), outcome "unknown", described as "had a big red spot all around to her arm".  Therapeutic measures were taken as a result of pruritus.  Additional information: How long before her arm stops itching? She got the Prevnar 20 vaccine on 27Jan2023, and normally her arm is sore for a little while, which even happened with the covid vaccines. She had a normal red spot where the adhesive of the Band-Aid touched her skin, but then the red spots got bigger. The red spots got to be like 2 inches, then 4 inches, then 6 inches; she had a huge bright red spot that went almost all the way around her arm. States that she was fine with that and the redness has faded, but it still itches. This reaction to the Prevnar 20 is not life threatening; it's just annoying, her any kind of shot, her arm will hurt. The arm soreness after receiving the Prevnar 20 was gone by Sunday, 29Jan2023 or Monday, 30Jan2023. The itching on her arm might be slightly better, but is pretty much the same. She has been using anti itch creams to calm down the itching.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Peripheral swelling, Vaccination site erythema, Vaccination site swelling
Clinical narrative: arm swelled up and turned red; arm swelled up and turned red; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown" and all described as "arm swelled up and turned red".  Additional information: Patient's arm swelled up and turned red, but she had no itching after getting the Prevnar 20.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm soreness after received the Pfizer COVID-19 Vaccines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Lot number: ER8733) at the age of 63 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 02Apr2021, outcome "recovered" (Apr2021), described as "Arm soreness after received the Pfizer COVID-19 Vaccines".  Additional information: She got the Prevnar 20 vaccine on 27Jan2023, and normally her arm is sore for a little while, which even happened with the COVID vaccines. Other Products was no. Stated that the vaccine was not prescribed by a physician. She is on and they stated that she was eligible for the vaccine. Verified that her arm was sore with all of her Pfizer COVID-19 doses. Stated that if you give her any kind of shot, her arm will hurt. Arm soreness after received the Pfizer COVID-19 Vaccines began the night she received the vaccine and lasted about 2-3 days. Vaccine Administered at Facility. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) and prior vaccinations (within 4 weeks): If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) was none. History was stated that she took vitamins.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm soreness after received the Pfizer Covid 19 Vaccines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 30Apr2021 as dose 2, single (Lot number: EW0173) at the age of 63 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot: ER8733), administration date: 02Apr2021, when the patient was 63-year-old, for COVID-19 Immunization, reaction(s): "Arm soreness after received the Pfizer Covid 19 Vaccines". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 30Apr2021, outcome "recovered" (May2021), described as "Arm soreness after received the Pfizer Covid 19 Vaccines".  Additional information: She got the Prevnar 20 vaccine, and normally her arm is sore for a little while, which even happened with the COVID vaccines, Verifies that her arm was sore with all of her Pfizer COVID-19 doses. States that if you give her any kind of shot, her arm will hurt. Her mother had cancer, and when they did radiation on her, her skin turned green. The doctors took a bunch of pictures and put her in a medical journal. Arm soreness after received the Pfizer COVID-19 Vaccines began the night she received the vaccine and lasted about 2-3 days. No vaccines administered on same date with the Pfizer vaccine considered as suspect. AE(s) Did not require a visit to Emergency Room, Physician Office. No other vaccinations received within four weeks prior to the first administration date of the suspect vaccine.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm soreness after received the Pfizer COVID-19 Vaccines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient received BNT162b2 (BNT162B2), on 24Nov2021 as dose 3 (booster), single (Lot number: FJ8757) at the age of 64 years for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Single, received on 02Apr2021. , Lot: ER8733, Expiry/NDC: Unknown), administration date: 02Apr2021, when the patient was 63-year-old, for COVID-19 Immunization, reaction(s): "arm soreness"; BNT162b2 (Dose 2, Single, received on 30Apr2021. , Lot: EW0173, Expiry/NDC: Unknown), administration date: 30Apr2021, when the patient was 63-year-old, for COVID-19 Immunization, reaction(s): "arm soreness".  Additional information: Verifies that her arm was sore with all of her Pfizer COVID-19 doses. States that if you give her any kind of shot, her arm will hurt. Her mother had cancer, and when they did radiation on her, her skin turned green. The doctors took a bunch of pictures and put her in a medical journal. Arm soreness after received the Pfizer COVID-19 Vaccines began the night she received the vaccine and lasted about 2-3 days. No additional Vaccines Administered on Same Date of the Pfizer Suspect. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Family Medical History Relevant to Adverse Events was None. History: States that she takes vitamins.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 24Nov2021, outcome "recovered" (Nov2021), described as "Arm soreness after received the Pfizer COVID-19 Vaccines".
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm soreness after received the Pfizer COVID 19 Vaccines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 12Apr2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 64 years for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Lot: ER8733, Expiry/NDC: Unknown), administration date: 02Apr2021, when the patient was 63-year-old, for COVID-19 Immunization, reaction(s): "Arm was sore with all of her Pfizer COVID 19 doses"; BNT162b2 (Dose 2, Lot: EW0173, Expiry/NDC: Unknown), administration date: 30Apr2021, when the patient was 63-year-old, for COVID-19 Immunization, reaction(s): "Arm was sore with all of her Pfizer COVID 19 doses"; BNT162b2 (Dose 3, Lot: FJ8757, Expiry/NDC: Unknown), administration date: 24Nov2021, when the patient was 64-year-old, for COVID-19 Immunization, reaction(s): "Arm was sore with all of her Pfizer COVID 19 doses". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Apr2022, outcome "recovered" (Apr2022), described as "Arm soreness after received the Pfizer COVID 19 Vaccines".  Additional information: No Investigations, Other Products reported. States that she takes vitamins. Normally her arm is sore for a little while, which even happened with the COVID vaccines. Has had multiple family members that have died from Pneumonia. Verifies that her arm was sore with all of her Pfizer COVID-19 doses. States that if you give her any kind of shot, her arm will hurt. Her mother had cancer, and when they did radiation on her, her skin turned green. The doctors took a bunch of pictures and put her in a medical journal. Arm soreness after received the Pfizer COVID-19 Vaccines began the night she received the vaccine and lasted about 2-3 days. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available): None. Additional Vaccines Administered on Same Date of the Pfizer Suspect: If applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect: None. Prior Vaccinations (within 4 weeks): If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): None. States that if you give her any kind of shot, her arm will hurt. Each dose was received at a different facility and she doesn't remember where she got which dose. One of the doses was received in a building, and one was in the car at the hospital. If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): None. Family Medical History Relevant to Adverse Events (AEs): None.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm soreness after received the Pfizer COVID 19 Vaccines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Nov2022 as dose 5 (booster), single (Lot number: GJ6739) at the age of 65 years for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: BNT162b2 (1st dose, Lot: ER8733, Expiry/NDC: Unknown), administration date: 02Apr2021, when the patient was 63-year-old, for COVID-19 immunization, reaction(s): "arm was sore"; BNT162b2 (2nd dose, Lot: EW0173, Expiry/NDC: Unknown), administration date: 30Apr2021, when the patient was 63-year-old, for COVID-19 immunization, reaction(s): "arm was sore"; BNT162b2 (3rd dose, Lot: FJ8757, Expiry/NDC: Unknown), administration date: 24Nov2021, when the patient was 64-year-old, for COVID-19 immunization, reaction(s): "arm was sore"; BNT162b2 (4th dose, Lot: FJ9943, Expiry/NDC: Unknown), administration date: 12Apr2022, when the patient was 64-year-old, for COVID-19 immunization, reaction(s): "arm was sore". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 04Nov2022, outcome "recovered" (Nov2022), described as "Arm soreness after received the Pfizer COVID 19 Vaccines".  Additional information: There were no prior Vaccinations (within 4 weeks) reported. There was no family Medical History Relevant to Adverse Events (AEs) reported. The patient stated that she takes vitamins. The patient verifies that her arm was sore with all of her Pfizer COVID 19 doses. Stated that if you give her any kind of shot, her arm will hurt. Arm soreness after received the Pfizer COVID 19 Vaccines began the night she received the vaccine and lasted about 2-3 days. No prior Vaccinations (within 4 weeks), no any other vaccinations within four weeks prior to the first administration date of the suspect vaccine.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Stem cell transplant
Clinical narrative: A patient who recently got a stem cell transplant.; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), 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: STEM CELL TRANSPLANT (medically significant), outcome "unknown", described as "A patient who recently got a stem cell transplant.".Clinical course: Caller (Pharmacist) wants to know if there is any clinical relevance of efficacy of the vaccination for people who receive the COVID-19 vaccine and stem cell transplant. He said that they got a call from a doctor's office requesting recommendation for a patient who recently got a stem cell transplant. He wants to know if they need to start the entire series again.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Had covid 2 times; Had covid 2 times; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown (booster), single (Batch/Lot number: unknown), as dose number unknown, single (Batch/Lot number: unknown) and as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Had covid 2 times".  Clinical course: My whole family is vaccinated with all 3, my son has had covid 2 times, my other son and husband had both had it. Had covid twice. 1st time was not bad, 2nd time was worse and prescribed Paxlovid after 3rd shot , I had frozen shoulder, went to therapy and still have pain and mobility issue during 2nd shot. I had a stroke, then they found one of heart valve isn't working now. I am still having effects of the strokes.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Arthritis, Bedridden, Condition aggravated, Pain, Quality of life decreased
Clinical narrative: I'm my case both my Lupus and arthritis were exacerbated after the jabs; I'm my case both my Lupus and arthritis were exacerbated after the jabs; I'm my case both my Lupus and arthritis were exacerbated after the jabs; There have been days were the pain is so intense; I was always a walker but part of my life has been taken away; I could barely get out of bed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Lupus" (unspecified if ongoing); "arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant), CONDITION AGGRAVATED (medically significant), ARTHRITIS (non-serious), outcome "unknown" and all described as "I'm my case both my Lupus and arthritis were exacerbated after the jabs"; PAIN (non-serious), outcome "unknown", described as "There have been days were the pain is so intense"; QUALITY OF LIFE DECREASED (non-serious), outcome "unknown", described as "I was always a walker but part of my life has been taken away"; BEDRIDDEN (non-serious), outcome "unknown", described as "I could barely get out of bed". Therapeutic measures were taken as a result of pain.  Clinical course: The patient reported that lost more than a year of life due to adhering to what Pfizer stated and your partnership with our government mandating the jab if they wanted to have a little bit of life. But, Pfizer nor the #, had enough information on those with Lupus and arthritis. It appears that about 50 percent of those with Lupus were effected. And some who did not have Lupus were diagnosed with the disease after vaccination. The patient had both Lupus and arthritis were exacerbated after the jabs. The patient always a walker but part of life has been taken away. There were days that patient could barely get out of bed. There had been days were the pain was so intense that the patient can only lied in bed and pray that the medication and sleeping would take away the pain. The patient believe that if more information was given to our doctors they might have explained the possible reactions to an immune suppressed patient. Everything seemed centered on age. The patient not died but there were many days that cursed Pfizer. The patient believe Pfizer owes individuals like patient compensation for the effects of vaccinations that did not need.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Systemic lupus erythematosus
Clinical narrative: I'm my case both my Lupus and arthritis were exacerbated after the jabs; I'm my case both my Lupus and arthritis were exacerbated after the jabs; I'm my case both my Lupus and arthritis were exacerbated after the jabs; There have been days were the pain is so intense; I was always a walker but part of my life has been taken away; I could barely get out of bed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Lupus" (unspecified if ongoing); "arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant), CONDITION AGGRAVATED (medically significant), ARTHRITIS (non-serious), outcome "unknown" and all described as "I'm my case both my Lupus and arthritis were exacerbated after the jabs"; PAIN (non-serious), outcome "unknown", described as "There have been days were the pain is so intense"; QUALITY OF LIFE DECREASED (non-serious), outcome "unknown", described as "I was always a walker but part of my life has been taken away"; BEDRIDDEN (non-serious), outcome "unknown", described as "I could barely get out of bed". Therapeutic measures were taken as a result of pain.  Clinical course: The patient reported that lost more than a year of life due to adhering to what Pfizer stated and your partnership with our government mandating the jab if they wanted to have a little bit of life. But, Pfizer nor the #, had enough information on those with Lupus and arthritis. It appears that about 50 percent of those with Lupus were effected. And some who did not have Lupus were diagnosed with the disease after vaccination. The patient had both Lupus and arthritis were exacerbated after the jabs. The patient always a walker but part of life has been taken away. There were days that patient could barely get out of bed. There had been days were the pain was so intense that the patient can only lied in bed and pray that the medication and sleeping would take away the pain. The patient believe that if more information was given to our doctors they might have explained the possible reactions to an immune suppressed patient. Everything seemed centered on age. The patient not died but there were many days that cursed Pfizer. The patient believe Pfizer owes individuals like patient compensation for the effects of vaccinations that did not need.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arrhythmia
Clinical narrative: arrhythmias; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative. The reporter is the patient.  A female patient received BNT162b2 (COMIRNATY), 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: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: ARRHYTHMIA (hospitalization, medically significant) with onset 2021, outcome "unknown", described as "arrhythmias". Patient reported that after she received the second dose of Comirnaty she was hospitalized due to arrhythmias. This was early 2021 and she just told the story today. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information provided in the case, considering the temporal association that the patient was hospitalized due to the event "arrhythmias" after the second dose of BNT162b2, a possible causal relationship cannot be excluded between the suspect vaccine BNT162b2 and the reported event "arrhythmias". 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. This case will be reassessed once additional information is available.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Post-acute COVID-19 syndrome, Vaccination failure
Clinical narrative: arrhythmias; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative. The reporter is the patient.  A female patient received BNT162b2 (COMIRNATY), 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: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: ARRHYTHMIA (hospitalization, medically significant) with onset 2021, outcome "unknown", described as "arrhythmias". Patient reported that after she received the second dose of Comirnaty she was hospitalized due to arrhythmias. This was early 2021 and she just told the story today. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information provided in the case, considering the temporal association that the patient was hospitalized due to the event "arrhythmias" after the second dose of BNT162b2, a possible causal relationship cannot be excluded between the suspect vaccine BNT162b2 and the reported event "arrhythmias". 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. This case will be reassessed once additional information is available.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: had COVID twice. She was worse both times.; had COVID twice. She was worse both times.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2 NOS), 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "had COVID twice. She was worse both times.".  Clinical course: Reporter had a friend who fits nearly all of high risk areas. He is an overweight, diabetic, that uses a CPAP machine to sleep. He and his wife have had COVID twice. She was worse both times. She is vaccinated he is not. Reporter asked about side effects treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Patient had a stroke post Bivalent vaccination; This is a spontaneous report received from contactable reporter(s) (Nurse).  A 76-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Feb2023 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 76 years for covid-19 immunisation. The patient's relevant medical history included: "Scoliosis" (unspecified if ongoing); "lumbar radicals-Arthur" (unspecified if ongoing), notes: lumbar radicals-Arthur; "Hypertension" (unspecified if ongoing); "chronic atrial fibrillation" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "Lumbar Fusion post surgery" (unspecified if ongoing), notes: Lumbar Fusion post surgery. The patient's concomitant medications were not reported. Past drug history included: Eliquis, notes: Px was restarted on Eliquis post surgery. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant) with onset 02Feb2023, outcome "unknown", described as "Patient had a stroke post Bivalent vaccination".  Clinical information included as event took place after use of product. Pfizer Bivalent given on 02Feb2023. Patient had stroke same day.  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.; Sender's Comments: Based on the information given in narrative, the causal relationship between the reported events CEREBROVASCULAR ACCIDENT and the suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Polymyalgia rheumatica
Clinical narrative: Diagnosed with polymyalgia rheumatica/sparked this especiallythe last of the vaccinations the bi-valant one; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Incredible pain" (unspecified if ongoing), notes: I have been in incredible pain for many months with it getting to the critical point in 22Oct1922. The patient's 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: POLYMYALGIA RHEUMATICA (medically significant), outcome "unknown", described as "Diagnosed with polymyalgia rheumatica/sparked this especiallythe last of the vaccinations the bi-valant one". Therapeutic measures were taken as a result of polymyalgia rheumatica.  Clinical course: I want you to know that I've been diagnosed with polymyalgia rheumatica and it is believed that the vaccinations sparked this especially the last of the vaccinations the bi-valent one. The final vaccination of the series. I have been in incredible pain for many months with it getting to the critical point in 22Oct1922. I've been prescribed steroids in the hopes that that will resolve or diminish this problem. I now regret giving in to the pressure to get this series of vaccinations.  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
Symptoms: Asthma, SARS-CoV-2 test
Clinical narrative: having moderate asthma/worsening asthma symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (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: Covid-19 vaccine (Primary immunization completed; unknown manufacturer), for COVID-19 Immunization. The following information was reported: ASTHMA (non-serious) with onset 03Jan2023, outcome "unknown", described as "having moderate asthma/worsening asthma symptoms". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of asthma.  Additional Information: The patient experienced event rebound symptoms with worse symptoms than original infection. Date started was reported as 13Jan2023. The patient was not admitted to hospital due to adverse event. The patient was treated with pf-07321332, ritonavir (PAXLOVID) for indication of Positive COVID with Asthma 3X a day starting from 03Jan2023 to 07Jan2023. The patient was not taking any other product (s). The patient was diagnosed with COVID on 03Jan2023 and started taking Paxlovid the same day due to having moderate asthma. Started feeling better by 08Jan2023. No symptoms negative test 09Jan2023-12Jan2023. The patient woke up on 13Jan2023 feeling sick with headache ad congestion. Tested positive again and was sick with worsening asthma symptoms through 24Jan2023. Tested negative again on 24Jan2023. The patient was sick with rebound COVID plus had worse symptoms than original sickness. The patient was fully vaccinated with all my boosters.  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
Symptoms: Illness
Clinical narrative: sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2023NVX-000000106.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset May2022, outcome "unknown", described as "sick". The event "sick" required physician office visit. Additional information: the event was non covid-19 related. Their doctor recommended they stop getting the Pfizer and Moderna vaccines as a result.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 0.17
Sex: F
Vaccine: UNK
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired pentacel was administered with no reported adverse event; Initial information received on 06-Feb-2023 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 2 months old female patient who was administered expired diphtheria/ tetanus/ 5 hybrid AC pertussis/ IPV (VERO)/ HIB(PRP/T) vaccine [Pentacel (Vero)] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine CONJ 13V (CRM197) (Prevnar 13) for Immunisation; and rotavirus vaccine live reassort oral 5V (Rotateq) for Immunisation.  On 03-Feb-2023, the patient received 0.5 mL expired dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, suspension for injection (lot: UJ621AAA; expiry date: 28-Jan-2023) via unknown route in unknown administration site with no reported adverse event (expired product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event expired pentacel was administered with no reported adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 38.0
Sex: F
Vaccine: IPV
Symptoms: Medication error, Wrong product administered
Clinical narrative: ipol being administered intradermally instead of tubersol with no reported adverse event; Initial information received on 06-Feb-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case is linked to cases 2023SA043796 and 2023SA043813.  This case involves a 38 years old female patient and it was reported that poliomyelitis vaccine (inactivated) [IPOL] being administered intradermally instead of tubersol with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On 31-Jan-2023, the patient received 0.1 ml (milliliter) of suspect poliomyelitis vaccine (inactivated), suspension for injection (lot W1A191M, expiry date: 16-Feb-2025)  (with unknown strength) via intradermal route in the left forearm for Tuberculin test.  On 31-Jan-2023 the reporter reported that ipol being administered intradermally instead of tubersol with no reported adverse event (wrong product administered) (latency: same day).  No lab data were reported  Action taken: not applicable.  At time of reporting, the outcome was Unknown for an event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.5
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, Medication error
Clinical narrative: administered expired ACTHIB with no adverse event; Initial information was received on 07-Feb-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 18 months old male patient who received administered expired HIB (PRP/T) vaccine [ACT-HIB] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine CONJ 7v (CRM197) (Prevnar) and Influenza vaccine for Immunisation.  On 15-Nov-2022, the patient received expired 0.5 ml dose 4 of suspect HIB (PRP/T) vaccine [ACT-HIB] (strength: standard) (lot number: UJ594AAA, expiry date: 26-Oct-2022, formulation: Unknown) via intramuscular route in the right deltoid for Immunization (Immunisation) with no adverse event (expired product administered) (latency: same day)  It was reported that "seven patients were administered ACTHIB that expired on 26-OCT-2022. Wanting to know next steps to take and what information to tell the parents. See related cases and AE reports: Patient 1: 01481406 Patient 3: 01481502 Patient 4: 01481503 Patient 5: 01481505 Patient 6: 01481508 Patient 7: 01481511"   No lab data reported.  Action taken: not applicable.  Outcome: Unknown for the event administered expired acthib with no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  01481406: 01481502: 01481503: 01481505: 01481508: 01481511:
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, Medication error
Clinical narrative: administered expired ACTHIB with no reported AE; Initial information received on 07-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 19 months old male patient who got administration of expired HIB (PRP/T) vaccine [ACT-HIB] with no reported ae.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal vaccine CONJ 7V (CRM197) (Prevnar) for Prophylactic vaccination.  On 22-Nov-2022, the patient who got administration of expired HIB (PRP/T) vaccine [ACT-HIB] with no reported ae (expired product administered) and received a dose 4 of 0.5 ml once Powder and solvent for solution for injection of standard strength (lot: UJ594AAA, expiry date: 26-Oct-2022) via intramuscular route in the right deltoid.  Action taken: not applicable.  Outcome: Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Received shot, later  got shingles/Suspected vaccination failure; Got shingles, mild and short lived; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   The reporter considered the vaccination failure and shingles to be possibly related to Shingles vaccine.     Additional Information: GSK Receipt Date: 04-FEB-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received Shingles vaccine later got shingles and because of the vaccine the shingles was mild and short lived. The reporter thought that the event might had been related to product/device use. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The suspect product was capture conservatively as Shingles vaccine as per reported description. The follow up would not possible as no contact details were available.
Sex: M
Vaccine: HEPA
Symptoms: Incomplete course of vaccination
Clinical narrative: Failed to get 2nd dose, 1st in 2018; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult male patient who received HAV (Havrix) for prophylaxis.   Previously administered products included Havrix (first dose received in 2018).   On an unknown date, the patient received the 2nd dose of Havrix. On an unknown date, unknown after receiving Havrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 02-Feb-2023  Reporter's Comments: The patient received the first dose of Havrix in 2018. The patient failed to receive the booster or 2nd dose of Havrix. The patient was asking do we need to restart or just give the 2nd dose. The reporter requested Medical Information including product excursions/stability. The patient was asking could Twinrix be given instead. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.