chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Weight
Clinical narrative: all booster shots she takes she gets sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  An 80-year-old female patient received BNT162b2 (BNT162B2), on 17Dec2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 79 years for covid-19 immunization. The patient's relevant medical history included: "Blood pressure", start date: 2012 (unspecified if ongoing); "pacemaker", start date: 2012 (ongoing). Concomitant medication(s) included: VALSARTAN taken for blood pressure abnormal, start date: 2012 (ongoing). Vaccination history included: BNT162b2 (DOSE 1, SINGLE, lot ER8729), administration date: 15Apr2021, when the patient was 78-year-old, for Covid-19 immunization, reaction(s): "heart started racing", "She took a test and she caught the virus", "She took a test and she caught the virus"; BNT162b2 (DOSE 2, SINGLE, Lot: EW0175), administration date: 20May2021, when the patient was 78-year-old, for Covid-19 immunization, reaction(s): "all booster shots she takes she gets sore arm"; Flu shot (Also had a Flu shot unknown date. Manufacturer unknown.), for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "all booster shots she takes she gets sore arm". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: arm soreness - when she takes any vaccine her arm is sore for a little bit and goes away. When queried what vaccines cause arm soreness caller states all booster shots, she takes she gets sore arm. Unable to clarify further. Pfizer Covid 19 vaccine booster on 17Nov2022. lot GH9703 in her left side arm in the afternoon, after going to the gym. late evening at (Withheld).; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300100075 same reporter/patient, different dose number/event;
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Pain in extremity, Weight
Clinical narrative: all booster shots she takes she gets sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  An 80-year-old female patient received BNT162b2 (BNT162B2), on 17Dec2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 79 years for covid-19 immunization. The patient's relevant medical history included: "Blood pressure", start date: 2012 (unspecified if ongoing); "pacemaker", start date: 2012 (ongoing). Concomitant medication(s) included: VALSARTAN taken for blood pressure abnormal, start date: 2012 (ongoing). Vaccination history included: BNT162b2 (DOSE 1, SINGLE, lot ER8729), administration date: 15Apr2021, when the patient was 78-year-old, for Covid-19 immunization, reaction(s): "heart started racing", "She took a test and she caught the virus", "She took a test and she caught the virus"; BNT162b2 (DOSE 2, SINGLE, Lot: EW0175), administration date: 20May2021, when the patient was 78-year-old, for Covid-19 immunization, reaction(s): "all booster shots she takes she gets sore arm"; Flu shot (Also had a Flu shot unknown date. Manufacturer unknown.), for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "all booster shots she takes she gets sore arm". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: arm soreness - when she takes any vaccine her arm is sore for a little bit and goes away. When queried what vaccines cause arm soreness caller states all booster shots, she takes she gets sore arm. Unable to clarify further. Pfizer Covid 19 vaccine booster on 17Nov2022. lot GH9703 in her left side arm in the afternoon, after going to the gym. late evening at (Withheld).; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300100075 same reporter/patient, different dose number/event;
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Sinusitis
Clinical narrative: Sinus infection, Antibiotics (cipro), 10 days
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No AE; PROQUAD that experienced temperature excursion was administered; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent.  Per the reporter, on 11-FEB-2023 a temperature excursion occurred to a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # W032152 with expiration date 07-APR-2024) that was later administered to the patient on 15-FEB-2023 (route and anatomical location were not provided). No additional adverse event was reported.  The temperature excursion lasted 1 hour at a temperature between 6°F to 14°F. No previous temperature excursion occurred.   Lot number W032152 has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD).  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2302USA005310:
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/PQC; HCP called to report late order of of VARIVAX that was administered to a patient.; This spontaneous report as received from a physician refers to a patient of unknown age and gender.      No pertinent medical history, concurrent conditions, drug reactions, allergies or concomitant therapies  were provided.  On 07-MAR-2023 the patient was vaccinated with a late order of  varicella virus vaccine live (oka/merck)(VARIVAX) 1 dose for prophylaxis, expiration date: 05-OCT-2024 (dosage schedule, route, anatomical location and lot number) (product use issue). It was unknown if the vaccine was improperly stored.  No adverse events were reported.
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Temperature Excursion; Initial Report Received on 05-Jan-2023 and 09-Jan-2023  A medical assistant and a pharmacy purchaser in the  reported that a 51-year-old male patient (race and ethnicity unknown) [Patient 1] received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization that had a temperature excursion issue.   Medical history, concomitant medications, and allergies at the time of vaccination were not reported.  On 23-Dec-2022, there was a power outage at 04:00 AM the health center. There was no backup generator to the vaccine refrigerator. When the medical assistants came into work, they heard the vaccine refrigerator's alarm go off. The refrigerator was warm with a temperature of 54.5°F at 06:45 AM. All the vaccines were removed and put into coolers with ice. Pharmacy Centralized Services was notified, and all the vaccines affected by the power outage were counted.   On 03-Jan-2023, 12 days later, the patient received a dose of HEPLISAV-B (Lot # 940486, expiration date 10-Nov-2024, and NDC # 43528-003-01) in the right deltoid (route not reported) by a medical assistant. It was discovered the next day on 04-Jan-2023 that a couple of boxes were missed being removed after the power outage, and the patient had received the HEPLISAV-B vaccine that had the temperature excursion of 54.5°F for 2 hours and 45 minutes.  No further information was provided. Additional information was requested.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Temperature Excursion; Initial Report Received on 05-Jan-2023 and 09-Jan-2023  A medical assistant and a pharmacy purchaser reported that a 46-year-old female patient (race and ethnicity unknown) [Patient 2] received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization that had a temperature excursion issue.   Medical history, concomitant medications, and allergies at the time of vaccination were not reported.  On 23-Dec-2022, there was a power outage at 04:00 AM at the health center. There was no backup generator to the vaccine refrigerator. When the medical assistants came into work, they heard the vaccine refrigerator's alarm go off. The refrigerator was warm with a temperature of 54.5°F at 06:45 AM. All the vaccines were removed and put into coolers with ice. Pharmacy was notified, and all the vaccines affected by the power outage were counted.   On 03-Jan-2023, 12 days later, the patient received a dose of HEPLISAV-B (Lot # 938794, expiration date 09-Oct-2023, and NDC # 43528-003-01) in the right deltoid (route not reported) by a medical assistant. It was discovered the next day on 04-Jan-2023 that a couple of boxes were missed being removed after the power outage, and the patient had received the HEPLISAV-B vaccine that had the temperature excursion of 54.5°F for 2 hours and 45 minutes.  No further information was provided. Additional information was requested.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Temperature Excursion; Initial Report Received on 05-Jan-2023 and 09-Jan-2023  A medical assistant and a pharmacy purchaser in the reported that a 38-year-old female patient (race and ethnicity unknown) [Patient 3] received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization that had a temperature excursion issue.   Medical history, concomitant medications, and allergies at the time of vaccination were not reported.  On 23-Dec-2022, there was a power outage at 04:00 AM at the health center. There was no backup generator to the vaccine refrigerator. When the medical assistants came into work, they heard the vaccine refrigerator's alarm go off. The refrigerator was warm with a temperature of 54.5°F at 06:45 AM. All the vaccines were removed and put into coolers with ice. Pharmacy was notified, and all the vaccines affected by the power outage were counted.   On 03-Jan-2023, 12 days later, the patient received a dose of HEPLISAV-B (Lot # 939304, expiration date 16-Mar-2024, and NDC # 43528-003-01) in the left deltoid (route not reported) by a medical assistant. It was discovered the next day on 04-Jan-2023 that a couple of boxes were missed being removed after the power outage, and the patient had received the HEPLISAV-B vaccine that had the temperature excursion of 54.5°F for 2 hours and 45 minutes.  No further information was provided. Additional information was requested.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Temperature Excursion; Initial Report Received on 05-Jan-2023 and 09-Jan-2023  A medical assistant and a pharmacy purchaser reported that a 51-year-old male patient (race and ethnicity unknown) [Patient 4] received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization that had a temperature excursion issue.   Medical history, concomitant medications, and allergies at the time of vaccination were not reported.  On 23-Dec-2022, there was a power outage at 04:00 AM at the health center. There was no backup generator to the vaccine refrigerator. When the medical assistants came into work, they heard the vaccine refrigerator's alarm go off. The refrigerator was warm with a temperature of 54.5°F at 06:45 AM. All the vaccines were removed and put into coolers with ice. Pharmacy was notified, and all the vaccines affected by the power outage were counted.   On 03-Jan-2023, 12 days later, the patient received a dose of HEPLISAV-B (Lot # 939305, expiration date 29-Mar-2024, and NDC # 43528-003-01) in the right deltoid (route not reported) by a medical assistant. It was discovered the next day on 04-Jan-2023 that a couple of boxes were missed being removed after the power outage, and the patient had received the HEPLISAV-B vaccine that had the temperature excursion of 54.5°F for 2 hours and 45 minutes.  No further information was provided. Additional information was requested.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Temperature Excursion; Initial Report Received on 11-Jan-2023  A registered nurse in the reported that a patient (Patient 1) [gender, race, and ethnicity unknown] received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization that had a temperature excursion issue.   Medical history, concomitant medications, and allergies at the time of vaccination were not reported.  On an unknown date, the patient received a dose of HEPLISAV-B (Lot # 937233, expiration date 11 Mar 2023 or Lot # 938794, expiration 09-Oct-2023). The NDC #s, injection site, and route of administration were unknown. The two HEPLISAV-B lot #s affected by the temperature excursion occurred between 22-Aug to 15-Nov (year not reported). For 97% of the time, the temperature was between 8°C - 12.31°C.   No further information was provided. Additional information was requested.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Temperature Excursion; Initial Report Received on 11-Jan-2023  A registered nurse in the reported that a patient (Patient 2) (gender, race, and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization that had a temperature excursion issue.   Medical history, concomitant medications, and allergies at the time of vaccination were not reported.  On an unknown date, the patient received a dose of HEPLISAV-B (Lot # 937233, expiration date 11 Mar 2023 or Lot # 938794, expiration 09-Oct-2023). The NDC #s, injection site, and route of administration were unknown. The two HEPLISAV-B lot #s affected by the temperature excursion occurred between 22-Aug to 15-Nov (year not reported). For 97% of the time, the temperature was between 8°C - 12.31°C.   No further information was provided. Additional information was requested.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Temperature Excursion; Initial Report Received on 11-Jan-2023  A registered nurse in the reported that a patient (Patient 3) (gender, race, and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization that had a temperature excursion issue.   Medical history, concomitant medications, and allergies at the time of vaccination were not reported.  On an unknown date, the patient received a dose of HEPLISAV-B (Lot # 937233, expiration date 11 Mar 2023 or Lot # 938794, expiration 09-Oct-2023). The NDC #s, injection site, and route of administration were unknown. The two HEPLISAV-B lot #s affected by the temperature excursion occurred between 22-Aug to 15-Nov (year not reported). For 97% of the time, the temperature was between 8°C - 12.31°C.   No further information was provided. Additional information was requested.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Temperature Excursion; Initial Report Received on 11-Jan-2023  A registered nurse in the reported that a patient (Patient 4) (gender, race, and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization that had a temperature excursion issue.   Medical history, concomitant medications, and allergies at the time of vaccination were not reported.  On an unknown date, the patient received a dose of HEPLISAV-B (Lot # 937233, expiration date 11 Mar 2023 or Lot # 938794, expiration date 09-Oct-2023). The NDC #, injection site, and route of administration were unknown. These two HEPLISAV-B Lot #s affected by the temperature excursion occurred between 22-Aug to 15-Nov (year not reported). For 97% of the time, the temperature was between 8°C - 12.31°C.   No further information was provided. Additional information was requested.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Temperature Excursion; Initial Report Received on 11-Jan-2023  A registered nurse reported that a patient (Patient 5) (gender, race, and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization that had a temperature excursion issue.   Medical history, concomitant medications, and allergies at the time of vaccination were not reported.  On an unknown date, the patient received a dose of HEPLISAV-B (Lot # 937233, expiration date 11 Mar 2023 or Lot # 938794, expiration date 09-Oct-2023). The NDC #, injection site, and route of administration were unknown. These two HEPLISAV-B Lot #s affected by the temperature excursion occurred between 22-Aug to 15-Nov (year not reported). For 97% of the time, the temperature was between 8°C - 12.31°C.   No further information was provided. Additional information was requested.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Temperature Excursion; Initial Report Received on 11-Jan-2023  A registered nurse reported that a patient (Patient 6) (gender, race, and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization that had a temperature excursion issue.   Medical history, concomitant medications, and allergies at the time of vaccination were not reported.  On an unknown date, the patient received a dose of HEPLISAV-B (Lot # 937233, expiration date 11 Mar 2023 or Lot # 938794, expiration date 09-Oct-2023). The NDC #, injection site, and route of administration were unknown. These two HEPLISAV-B Lot #s affected by the temperature excursion occurred between 22-Aug to 15-Nov (year not reported). For 97% of the time, the temperature was between 8°C - 12.31°C.   No further information was provided. Additional information was requested.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Temperature Excursion; Initial Report Received on 11-Jan-2023  A registered nurse in the reported that a patient (Patient 7) (gender, race, and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization that had a temperature excursion issue.   Medical history, concomitant medications, and allergies at the time of vaccination were not reported.  On an unknown date, the patient received a dose of HEPLISAV-B (Lot # 937233, expiration date 11 Mar 2023 or Lot # 938794, expiration date 09-Oct-2023). The NDC #, injection site, and route of administration were unknown. These two HEPLISAV-B Lot #s affected by the temperature excursion occurred between 22-Aug to 15-Nov (year not reported). For 97% of the time, the temperature was between 8°C - 12.31°C.   No further information was provided. Additional information was requested.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; Patient was administered a dose of PROQUAD after it was involved in a temperature excursion; This spontaneous report was received from a certified medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 15-FEB-2023, the patient was vaccinated with a measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (0.5 milliliter, subcutaneously, lot # W024980 with expiration date 05-FEB-2024, for prophylaxis) that suffered a temperature excursion. No additional adverse events were reported.  The temperature excursion lasted 3 hours and 50 minutes at a temperature of 34.7°F. No temperature excursion occurred previously.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Neoplasm malignant, Vaccination failure
Clinical narrative: This happened to me after cancer and a shingles shot; Suspected vaccination failure; Cancer; This happened to me after cancer and a shingles shot; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: This happened to me after cancer and a shingles shot; Suspected vaccination failure) (serious criteria GSK medically significant), cancer (Verbatim: Cancer) (serious criteria GSK medically significant) and shingles (Verbatim: This happened to me after cancer and a shingles shot). The outcome of the vaccination failure, cancer and shingles were not reported.   It was unknown if the reporter considered the vaccination failure, cancer and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, cancer and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-FEB-2023 This case was reported by the patient via interactive digital media. The patient reported that this happened to him/her after cancer and a Shingles shot. This case was considered as suspected vaccination failure as details regarding primary schedule, laboratory test and time to onset confirming shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash, Vaccination failure
Clinical narrative: Suspected Vaccination Failure; Shingles; Pain, hurts; Rash is from my stomach around to my spine; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination Failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles), pain (Verbatim: Pain, hurts) and rash (Verbatim: Rash is from my stomach around to my spine). The outcome of the vaccination failure and rash were not reported and the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and rash to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, pain and rash to be related to Shingles vaccine.   Additional Information: GSK receipt date: 03-MAR-2023 The case was received from the patient via interactive digital media. The patient had shingles now (at the time of reporting) and horrible pain for a week now and he/she had Shingles vaccines.  The patient had rash from stomach around to spine.  The patient stated that it hurt and it was no joke, everyone should get vaccinated for shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in right arm 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), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: and testing positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 49 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) negative, notes: testing negative for the past 5 days; (08Mar2023) positive, notes: Testing positive 4 days after paxlovid treatment ended. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: no Other medication in 2 weeks and no known allergies. The patient was treated with Paxlovid from 27Feb2023 to 03Mar2023.  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: Linked Report(s) : US-PFIZER INC-202300102035 same reporter/patient, different product/event;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: she received the booster dose on 08Sep2022 and got COVID in Dec2022; she received the booster dose on 08Sep2022 and got COVID in Dec2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient in her 60's received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose number unknown (booster), single (Lot number: GH9694) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "immunocompromised" (unspecified if ongoing), notes: I am moderately immunocompromised; "reactive airway disease" (unspecified if ongoing), notes: reactive airway disease with an open throat where I cough horrendously; "Cough" (unspecified if ongoing), notes: reactive airway disease with an open throat where I cough horrendously; "COVID-19" (unspecified if ongoing), notes: 6 months prior. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "she received the booster dose on 08Sep2022 and got COVID in Dec2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Caller stated that she did get COVID in Dec2022 (after receiving the Pfizer COVID booster vaccine on 08Sep2022), it was not severe, like she got 6 months prior. She did get Paxlovid. But this time, she did not need it, because she got COVID in December. She was in my early 60's and she was moderately immunocompromised and at risk of severe COVID due to having a reactive airway disease with an open throat where she cough horrendously." Caller stated that she received the booster dose on 08Sep2022 and got COVID in Dec2022. Caller was wondering if she should be getting another bivalent booster since she got COVID again. Caller stated she's in her early 60's and is moderately immunocompromised and at risk of severe covid due to having a reactive airway disease with an open throat. Caller asking if Pfizer was working on the next vaccine at this point. Caller then stated no need for further research with no further inquiry. Response: Offered to research and place caller on hold, however, caller stated no need and did not want agent to research further. Thus, no further inquiry.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy, Computerised tomogram, Lymphoma, Peripheral swelling, SARS-CoV-2 test
Clinical narrative: Swelling under arm gradually lessened but biopsy showed Lymphoma which was not present in prior CT scans; Swelling under arm gradually lessened but biopsy showed Lymphoma which was not present in prior CT scans; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 at 10:00 as dose 5 (booster), single (Lot number: Gj3277) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history included: "Stage 4 small cell lung cancer" (unspecified if ongoing); "AAA stent" (not ongoing); "Hay fever" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR; SODIUM. Past drug history included: Codeine, reaction(s): "Allergy", notes: known allergies Codeine. Vaccination history included: Covid-19 vaccine (Dose 1, Single), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, Single), for COVID-19 immunisation; Covid-19 vaccine (Dose 3 (Booster), Single), for COVID-19 immunisation; Bnt162b2 (Dose 4 (Booster), Single, Batch/Lot number: Fp4554, Anatomical location: Left arm), for COVID-19 immunisation. The following information was reported: LYMPHOMA (medically significant), PERIPHERAL SWELLING (medically significant), outcome "not recovered" and all described as "Swelling under arm gradually lessened but biopsy showed Lymphoma which was not present in prior CT scans". The event "swelling under arm gradually lessened but biopsy showed lymphoma which was not present in prior ct scans" required physician office visit. The patient underwent the following laboratory tests and procedures: Biopsy: (unspecified date) Lymphoma; Computerised tomogram: (unspecified date) Unknown Results; SARS-CoV-2 test: (28Sep2022) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of lymphoma, peripheral swelling. Clinical Course: Swelling under arm gradually lessened but biopsy showed Lymphoma which was not present in prior CT scans. Adverse Event resulted in: Doctor or other healthcare professional office/clinic visit. If patient was recovered: Not recovered. If treatment of adverse event: Yes. Adverse event treatment: Observation via CT (Computerised Tomography). If COVID prior vaccination: No. If patient tested for COVID post vaccination: Yes.
Sex: M
Vaccine: COVID19
Symptoms: Gastrooesophageal reflux disease, Regurgitation
Clinical narrative: his reflux was aggravated; had regurgitation in the back of his throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 2-year-old male patient received BNT162b2 (BNT162B2), as dose 2 (maroon cap), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "reflux infant" (not ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1 (MAROON CAP), SINGLE, Batch/lot number: FT9142, Expiration date: 31Dec2022), for COVID-19 immunization, reaction(s): "his reflux was aggravated", "fatigue", "his reflux was aggravated", "had regurgitation in the back of his throat". The following information was reported: GASTROOESOPHAGEAL REFLUX DISEASE (non-serious), outcome "unknown", described as "his reflux was aggravated"; REGURGITATION (non-serious), outcome "unknown", described as "had regurgitation in the back of his throat".  Additional information: Mother of patient reported that her son is a "reflux infant" so has a history of reflux but has resolved. She reported that every time he got the vaccine (has received 3 doses), it aggravated his reflux or it started acting up again. This same thing happened with his first two doses in his primary series.  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-202300102461 same patient different dose/drug/event;US-PFIZER INC-202300102439 same patient different dose/drug/event;
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Dec2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Cardiomyopathy" (unspecified if ongoing); "ulcerative colitis" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL, start date: 07Jun2021; CARVEDILOL, start date: 07Jun2021; ATORVASTATIN, start date: 17Oct2022; SPIRONOLACTONE, start date: 17Oct2022. Past drug history included: Sulfasalazine, start date: 10Aug1989; Azathioprine, start date: 20Jul2006. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "recovered"; COVID-19 (medically significant), outcome "recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid was taken from 25Feb2023 to 01Mar2023 as treatment of COVID-19  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: Linked Report(s) : US-PFIZER INC-202300103048 same patient, different drug/event.;
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 as dose 4 (booster), single (Lot number: GH9702) at the age of 55 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 02Apr2022 as dose 3 (booster), single (Lot number: FK9894) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 27Oct2021 as dose 2 (booster), single (Lot number: 939905) for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 03Apr2021 as dose 1, single (Lot number: 1808978) for covid-19 immunisation. The patient's relevant medical history included: "Allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 02Apr2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26Feb2023, outcome "recovered" (03Mar2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Feb2023) Positive; (02Mar2023) Negative; (03Mar2023) Negative; (07Mar2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient took Treatment of COVID-19 from 26Feb2023 to 03Mar2023. She first tested positive on 26Feb2023, first tested negative on 02Mar2023, tested negative on 03Mar2023 and again tested negative on 07Mar2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300103182 Same reporter/patient, different drug/event.;
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Vaccination failure; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 46 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 10Apr2021 as dose 1, single (Lot number: EW0151), in left arm, on 01May2021 as dose 2, single (Lot number: EW0173), in left arm and on 06Nov2021 as dose 3 (booster), single (Lot number: EW0217), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hemoglobin H disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), outcome "not recovered"; COVID-19 (medically significant), outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: test was possibly positive; Positive, notes: it was definitely positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Other medication in 2weeks: No. The patient received Paxlovid as treatment for COVID-19 from 22Feb2023 to 27Feb2023. Known allergies: no; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300102662 same patient, different product/event;
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 75 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 26Oct2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 29Jan2022 as dose 2, single (Batch/Lot number: unknown), in left arm and on 13Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Positive test occurred 5 days after negative test; Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  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: Linked Report(s) : US-PFIZER INC-202300102870 same patient, different drug and different event;
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Feeding disorder, Lethargy, Pyrexia
Clinical narrative: fever; lethargic; didn't eat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 11-year-old male patient received BNT162b2 (BNT162B2), as dose 1 (orange cap), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID" (unspecified if ongoing), notes: it was the year before he had got the shot.; "had a cold" (unspecified if ongoing), notes: he had got the shot. Not severe, had a cold, came home from school. There were no concomitant medications. The following information was reported: PYREXIA (non-serious), outcome "recovered", described as "fever"; LETHARGY (non-serious), outcome "recovered", described as "lethargic"; FEEDING DISORDER (non-serious), outcome "recovered", described as "didn't eat". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller was reporting on caller's daughter's oldest son. None of her daughter's family will take another one. Her daughter's oldest son had reactions to both the COVID shots. He had temperature, lethargic, and didn't eat. Was sure with his father he will never get another one either. Daughter's oldest son would have been 11 or 12 at the time. It was known that boys were having heart issues at that age. He was in the part where before guys sprout so a little chubby but not overweight. Reaction to the shot happened with both shots he took. Remembered he had one before and on day he had a fever, lethargic, didn't eat, and that was pretty much it. Both times he had a reaction versus his brother who didn't. Doesn't know if age made a difference. Read something that teenage boys had an issue.  Doesn't know if he has had reactions to other shots that she was aware of. He recovered within 24 to 36 hours.  Dates: Whatever was normal. Three months between shots. One before so he had the first one in August. Not this year but probably 2021. Both shots were Pfizer as at that time Pfizer was trusted the most. Dates: Unknown. Full product information for both shots unknown as she does not have her daughter's oldest son's vaccine information. He was a good healthy kid. He did have COVID once, but she can't remember when. Clarified it was the year before he had got the shot. Not severe, had a cold, came home from school. At that time kids had to be tested to go to school even though it sounded like a cough he was positive and had to stay at home.  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-202300094266 similar report from same reporter;
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer). The reporter is the patient. A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 64 years, in right arm for COVID-19 immunization; BNT162b2 (BNT162B2), on 08Apr2022 as dose 4 (booster), single (Lot number: FK9893), in left arm for COVID-19 immunization; BNT162b2 (BNT162B2), on 24Dec2020 as dose 1, single (Lot number: EK9231), on 14Jan2021 as dose 2, single (Lot number: EK4176), in left arm and on 02Oct2021 as dose 3 (booster), single (Lot number: FF8841), in left arm for COVID-19 immunization. The patient's relevant medical history included: "T1DM" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive. Therapeutic measures were taken as a result of vaccination failure and COVID-19. Clinical information: It was reported that the patient had no known allergies. In 2023, the patient had COVID-19 (positive results) and started treatment with PAXLOVID from 27Feb2023 until 03Mar2023.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Pfizer, Date: 14Oct2022; J&J, Date: Unknown; COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 2 (booster), single (Batch/Lot number: unknown) and on 14Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 years, in left arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "not recovered" and all described as "COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Pfizer, Date: 14Oct2022; J&J, Date: Unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2023) Positive. The patient was treated with Paxlovid from 16Feb2023 to 22Feb2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.