chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
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 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 31Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 65 years 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: "known allergies: Sulfa drugs" (unspecified if ongoing). There were no concomitant medications. Other medication in 2weeks: No. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19, covid-19 was Paxlovid from 05Dec2022 to 10Dec2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
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 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 at 14:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 63 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: "known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: The patient did not receive other medication in 2 weeks.  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: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive for COVID-19; positive for COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "cholesterol" (unspecified if ongoing), notes: on cholesterol medication. The patient took concomitant medications which included unspecified cholesterol medication. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 17Dec2022, outcome "unknown" and all described as "positive for COVID-19". The event "positive for covid-19" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Dec2022) Positive, notes: Saturday, 17Dec2022, her husband (patient) was positive for COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid (start date: 17Dec2022 at night and completed on an unspecified date).  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Breast cancer, Investigation
Clinical narrative: breast cancer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown).  A female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 immunization; Bnt162b2 (Dose: 2), for COVID-19 immunization. The following information was reported: BREAST CANCER (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: Investigation: lft breast cancer.  Clinical information: This case was for reporters 1st cousin. The reporter was trying to reach out to others or to medical world about Covid vaccine causing breast cancer. We do not have a family history. No genetics per either of our tests. Both myself and my 1st cousin were diagnosed this past year with the exact same type left breast cancer, same side, (we are different ages), same arm (vaccines all given in left arm). Both within 8-10 months of getting Pfizer 2 shots and 1 booster. The reporter even had pet scan month before my first shot due to funny blood work, negative.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity
Clinical narrative: Sore arm; lump in lymph node under arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Feb2021 as dose 1, single (Lot number: EL9269), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer resulting in mastectomy 7 years ago" (unspecified if ongoing), notes: Breast cancer resulting in mastectomy 7 years ago; "SVT" (unspecified if ongoing); "Breast cancer resulting in mastectomy 7 years ago" (unspecified if ongoing), notes: Breast cancer resulting in mastectomy 7 years ago. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "Sore arm"; LYMPHADENOPATHY (non-serious) with onset 2021, outcome "recovered" (2021), described as "lump in lymph node under arm". Therapeutic measures were not taken as a result of pain in extremity, lymphadenopathy.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201387349 Same Reporter/Patient, Different AE/Vaccine Dose;US-PFIZER INC-202201373767 Same Reporter/Patient, Different AE/Vaccine Dose;US-PFIZER INC-202201373781 Same Reporter/Patient, Different AE/Vaccine Dose;US-PFIZER INC-202201373782 Same Reporter/Patient, Different AE/Vaccine Dose (LOE case);
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity
Clinical narrative: Sore arm; lump in lymph node under arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Mar2021 as dose 2, single (Lot number: EN6204), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing), notes: Breast cancer resulting in mastectomy 7 years ago; "mastectomy" (unspecified if ongoing), notes: Breast cancer resulting in mastectomy 7 years ago; "SVT (Supraventricular tachycardia)" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1 Batch/Lot No: EL9269 Location of injection: Arm Right), administration date: 13Feb2021, for COVID-19 Immunization, reaction(s): "lump in lymph node under arm", "Sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "Sore arm"; LYMPHADENOPATHY (non-serious) with onset 2021, outcome "recovered" (2021), described as "lump in lymph node under arm". Therapeutic measures were not taken as a result of pain in extremity, lymphadenopathy.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-202201387339 Same Reporter/Patient, Different AE/Vaccine Dose;PFIZER INC-202201373767 Same Reporter/Patient, Different AE/Vaccine Dose;PFIZER INC-202201373781 Same Reporter/Patient, Different AE/Vaccine Dose;PFIZER INC-202201373782 Same Reporter/Patient, Different AE/Vaccine Dose (LOE case);
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, UNK
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: covid; covid; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-4178192.  A 64-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years intramuscular for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at 40 mg (40 mg (citrate free)), subcutaneous for rheumatoid arthritis, crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 10Oct2022, outcome "recovering" and all described as "covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Oct2022) Positive. The action taken for adalimumab was unknown. The reporter's causality for the event(s) of covid with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Reasonable Possibility.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drugs BNT162B2 and BNT162b2, BNT162b2 omi ba.4-5 cannot be excluded. The case will be reassessed once new information is available.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Deep vein thrombosis, Drug ineffective, SARS-CoV-2 test
Clinical narrative: caught COVID; caught COVID; DVT; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from a sales representative.  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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "caught COVID"; DEEP VEIN THROMBOSIS (medically significant), outcome "recovering", described as "DVT". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: caught COVID. Therapeutic measures were taken as a result of deep vein thrombosis.  Clinical course: Mother was vaccinated with the Pfizer COVID 19 vaccine, caught COVID traveled and developed a DVT after the flight. She is currently being treated with ELIQUIS for the DVT. The patient is doing well.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Has COVID/ tested positive twice; Has COVID/ tested positive twice; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 92-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; 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 10Dec2022, outcome "unknown" and all described as "Has COVID/ tested positive twice". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Course of events: Patient is the reporter's mother. She had no fever yet. She was at her apartment isolating. She got Paxlovid Mon 11Dec (as reported). She had very bad cough. No fever. Her symptoms started Saturday (09Dec2022 as reported). She got worse Sunday (11Dec2022). She has tested positive twice. She was sick. She took all vaccines including Omicron.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: professional cyclist accuse heart problems after Pfizer vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) 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: CARDIAC DISORDER (non-serious), outcome "unknown", described as "professional cyclist accuse heart problems after Pfizer vaccine".  The information on the batch/lot number for BNT162b2 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 a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A 63-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 and concomitant medications were not reported.  The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Sick".  Additional information: Patient got one and two [Pfizer COVID vaccinations] but not going to pollute her body with any more boosters. One and two let the flu get her sick. It's best to rely on her immune system.  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) :PFIZER INC-202201384889 Same Reporter/Patient/Drug/AE, Different Vaccine Dose;
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Covid until my wife caught in in the Covid until my wife caught in in the  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 76-year-old female patient received BNT162b2 (BNT162B2), 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: Bnt162b2 (Primary Immunization series complete), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Covid until my wife caught in in the". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results.  Clinical information: I am 69 years old, my wife is 76. Covid changed our lives. We were first in line for your vaccine and all boosters. We avoided Covid until my wife caught in. I have yet to have any symptoms. I wanted to tell all of your executives and scientists thank you for saving our lives.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Immunodeficiency
Clinical narrative: immunocompromised; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown). The reporter is the patient.  An 88-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single, Batch/Lot number: unknown), for COVID-19 immunisation; Bnt162b2 (Dose 2, single, Batch/Lot number: unknown), for COVID-19 immunisation; Bnt162b2 (Dose 3 (booster), single, Batch/Lot number: unknown), for COVID-19 immunisation; Bnt162b2 (Dose 4 (booster), single, Batch/Lot number: unknown), for COVID-19 immunisation. The following information was reported: IMMUNODEFICIENCY (medically significant), outcome "unknown", described as "immunocompromised".Clinical course: It was reported that patient was immunocompromised, taken two shots primary series and three booster doses from Pfizer she would like to know if they should get another booster shot. It was further mentioned that patient was immunocompromised and took Pfizer COVID-19 vaccine.  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-PV202200126655 same reporter/drug/event, different patient.;
Sex: U
Vaccine: COVID19
Symptoms: Immunodeficiency
Clinical narrative: immunocompromised; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  An 88-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunisation; Bnt162b2 (Dose 2), for COVID-19 immunisation; Bnt162b2 (Dose 3 (booster)), for COVID-19 immunisation; Bnt162b2 (Dose 4 (booster)), for COVID-19 immunisation. The following information was reported: IMMUNODEFICIENCY (medically significant), outcome "unknown", described as "immunocompromised". Clinical course: Patient was reported to be 88 years old and immunocompromised, have taken two shots primary series and three booster doses from Pfizer. Reporter was inquiring if patient should get another booster shot.   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-PV202200126653 same reporter/drug/event, different patient.;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 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; 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Per clinical course, the patient called in regard to the Pfizer COVID-19 Vaccine testing kit. The patient needed 3 testing kits since she has COVID-19, and she already received all the vaccinations and booster shot.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Blindness, Drug ineffective, Suspected COVID-19
Clinical narrative: Got a COVID; Got a COVID; Got blind; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP), Program ID.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), 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 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 "Got a COVID"; BLINDNESS (medically significant), outcome "unknown", described as "Got blind".  Clinical course: A caller calling on behalf of the HCP called in to inquire if we have information about the two COVID Vaccines that were administered then the patient got a COVID then got blind?  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information causal association between the reported event Blind cannot be totally excluded,  as there is no conclusive information to exclude the relationship between the event and suspect drug. the case will be reassessed once new information becomes available.     The contributory role of the suspect vaccine to the reported drug ineffective cannot be excluded , as the efficacy of a drug varies individually and may be affected by different factors including drug potency.  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: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: got Covid once after receiving my [Pfizer] initial shots; got Covid once after receiving my [Pfizer] initial shots; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "got Covid once after receiving my [Pfizer] initial shots". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown result.  Clinical course: She thought it was targeted towards everyone, which was sketchy to her because she thought that only people at risk of serious illness should be getting boosted. She was a healthy person who got Covid once after receiving her [Pfizer] initial shots and once again after receiving a [Pfizer] booster. She would not have got the booster if she had not been required by her university.  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-202201382415 Same patient/event, different vaccine dose;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: I have had Covid more than once and my fully vaccinated/ boosted husband has been sicker than me each time; I have had Covid more than once and my fully vaccinated/ boosted husband has been sicker than me each time; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male 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; 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I have had Covid more than once and my fully vaccinated/ boosted husband has been sicker than me each time". The reporter mentioned she have had Covid more than once and her fully vaccinated/ boosted husband has been sicker than her each time.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Hypertensive crisis
Clinical narrative: hypertensive crisis; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single, Batch/Lot number: unknown), for COVID-19 immunisation; Bnt162b2 (dose 2, single, Batch/Lot number: unknown), for COVID-19 immunisation; Bnt162b2 (dose 3 (booster), single, Batch/Lot number: unknown), for COVID-19 immunisation; Bnt162b2 (dose 4 (booster), single, Batch/Lot number: unknown), for COVID-19 immunisation. The following information was reported: HYPERTENSIVE CRISIS (medically significant), outcome "unknown". Therapeutic measures were taken as a result of hypertensive crisis. Clinical course: It was reported that a patient started treatment on an unspecified date with Pfizer BioNTech COVID-19 Vaccine dose 1, dose 2, dose 3, dose 4, and dose 5 for COVID-19 immunization. It was reported the patient developed hypertensive crisis and was on four high blood pressure pills. It was also reported that it all happened four weeks ago.  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: As there is limited information in the case provided, the causal association between the reported event hypertensive crisis with the suspect drug BNT162b2, BNT162b2 omi ba.4-5 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Nasopharyngitis
Clinical narrative: she is having symptoms. She said she knows the headaches; not feeling good; she got a cold or something; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Dec2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE), for COVID-19 immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset Dec2022, outcome "unknown", described as "not feeling good"; NASOPHARYNGITIS (non-serious) with onset Dec2022, outcome "unknown", described as "she got a cold or something"; HEADACHE (non-serious) with onset Dec2022, outcome "unknown", described as "she is having symptoms. She said she knows the headaches".  Additional information: She got the boosters, the first booster shot on Tuesday and she was having symptoms. She said she knows the headaches but she was having symptoms like not feeling good like if she got a cold or something. She wants to know if that was normal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: came down with Covid; came down with Covid; 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; BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Cancer" (unspecified if ongoing); "immune impaired" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "came down with Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: came down with Covid (self-test). The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Sick for 8-10 hours; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NUS2022US274037_LT (Novartis).  A 41-year-old male 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), outcome "recovered", described as "Sick for 8-10 hours".  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: Vaccination site pruritus, Vaccination site rash
Clinical narrative: Rash and itchiness at injection site/arm; Rash and itchiness at injection site/arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Dec2022 as dose number unknown (booster), single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: VACCINATION SITE PRURITUS (non-serious), VACCINATION SITE RASH (non-serious) all with onset Dec2022, outcome "unknown" and all described as "Rash and itchiness at injection site/arm".  Additional information: Patient received Comirnaty bivalent booster on Friday, 16Dec2022. Event took place after use of product. Rash and itchiness at injection sight/arm.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19-2
Symptoms: Peripheral swelling
Clinical narrative: swollen hands; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP), Program ID:   A 74-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 included: "Forgetfullness" (unspecified if ongoing); "rheumatoid arthritis" (unspecified if ongoing), notes: reports generally agree to generally its been hard to cope with rheumatoid arthritis; "Stroke", start date: 2016 (unspecified if ongoing), notes: 3 strokes(2016/2017/2018); "Stroke", start date: 2017 (unspecified if ongoing), notes: 3 strokes(2016/2017/2018); "Stroke", start date: 2018 (unspecified if ongoing), notes: 3 strokes(2016/2017/2018); "ruptured intestines", start date: 2017 (unspecified if ongoing), notes: ruptured intestines resulting in a stoma/2017); "stoma", start date: 2017 (unspecified if ongoing), notes: ruptured intestines resulting in a stoma/2017). The patient's concomitant medications were not reported. Past drug history included: Xeljanz xr for rheumatoid arthritis. Vaccination history included: Covid-19 vaccine (Primary immunization completed, Manufacturer: Unknown), for COVID-19 Immunization. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "swollen hands".  Additional information: Reporter stated that COVID booster received a few months ago (date not provided) told to hold Xeljanz XR for 4-5 days (dates not provided) with adverse effects of swollen hands reported during hold.  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: U
Vaccine: FLUX
Symptoms: Intestinal haemorrhage, Malaise, Pharyngeal swelling, Vomiting
Clinical narrative: I had bad reaction to no more eggs because of swelling in my throat; vomiting 24 times in 8 hrs; Feeling sick for 6 months; bleeding intestine; Initial information received on 11-Dec-2022 regarding an unsolicited valid social media non-serious case received from a consumer/non-hcp.  This case involves 27 years Adult unknown gender patient who experienced i had bad reaction to no more eggs because of swelling in my throat, vomiting 24 times in 8 hrs, feeling sick for 6 months and bleeding intestines after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for flu.  On an unknown date the patient developed i had bad reaction to no more eggs because of swelling in my throat (pharyngeal swelling), vomiting 24 times in 8 hrs (vomiting), feeling sick for 6 months (malaise) and bleeding intestines (Intestinal haemorrhage) (unknown latency) following the administration of influenza vaccine.  Action taken: not applicable  It was not reported if the patient received a corrective treatment for the events    Outcome was Unknown for all the events   Additional information was received on 15-Dec-2022: Case upgraded from non-case to valid case and age of patient and  event of pharyngeal swelling, vomiting, feeling sick and bleeding intestines was added and case updated accordingly.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: we both got our shots and I would hate to think how sick we would be.; Initial information received on 14-Dec-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a patient of an unknown age and gender who experienced we both got our shots and i would hate to think how sick we would be after receiving vaccine INFLUENZA VACCINE.  It is unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, dose, formulation, expiry date and strength not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event "we both got our shots and i would hate to think how sick we would be (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if there were lab data/results available.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: have the flu even though I had a flu shot in October; Covid; Initial information received on 14-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves patient of unknown age and gender who have experienced the flu even though had a flu shot in october and covid after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, Strength, formulation, Expiry date was not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient experienced the flu even though had a flu shot in october (influenza) and covid (covid-19) (unknown latency) following the administration of INFLUENZA VACCINE.  No lab data was reported.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for both the events.  At time of reporting, the outcome was Unknown for both the events.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got the flu shot, still got flu; Initial information received on 15-Dec-2022 regarding an unsolicited valid social media non-serious case received from a consumer/non-healthcare professional (hcp).  This case involves an unknown age and unknown gender patient who got the flu shot, still got flu after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, route, dose: unknown) (lot number and expiry date: not reported) in unknown administration site for Prophylactic Vaccination (Immunisation).  On an unknown date, the patient developed a non-serious event of got the flu shot, still got flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported, but could've been much worse.   It is unknown if the patient had any medical history, concomitant disease or risk factor. It is unknown if there were lab data/results available.   Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (got the flu shot, still got flu).  At time of reporting, the outcome was Unknown for the event got the flu shot, still got flu.
Sex: F
Vaccine: FLUX
Symptoms: Cough, Influenza
Clinical narrative: came down with it; cough; Initial information received on 14-Dec-2022 regarding an unsolicited valid Social media non-serious case received from a consumer/non-health care professional.  This case involves an unknown age female patient who came down with it and cough while receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.    On an unknown date, the patient received unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, formulation, lot number, expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient came down with it (Influenza) and cough (unknown latency) following the administration of influenza vaccine.  It was reported as "Got her Flushot Nov 30th during a check-up at her PCPs. Two days later, her husband came down with it. Was going to get his on Dec 14th during his check-up for A1C. 4 days after, she came down with it which she suppose is because she hadn't yet had 14 days after her flu shot so my body hadn't developed full immunity. They are still recuperating. Can't get rid of cough yet! she wanted to say though that she believe they caught it at my doctor's waiting room (she's a pediatrician also) and there was a kid coughing up a storm. Funny thing is that the day before her husband started having symptoms, he got together with 5 friends who all have chronic underlying conditions and neither one of them got sick. Not all of them were vaccinated."  No lab data was reported.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown.
Age: 5.0
Sex: F
Vaccine: FLUX
Symptoms: Death, Myocarditis
Clinical narrative: myocarditis; Initial information received on 16-Dec-2022 regarding an unsolicited valid serious case received from a consumer/non-hcp received from social media page.  This case involves a 5 years old female patient who experienced myocarditis after receiving vaccine influenza vaccine.  It is unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose (units unspecified) of suspect influenza vaccine produced by unknown manufacturer (formulation; strength; lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient had a serious event of myocarditis (unknown latency) following the administration of influenza vaccine.   It was unknown if there were lab data/results available.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Fatal for the event.  No autopsy was done. The cause of death was reported as Myocarditis.  This event was assessed as medically significant and was leading to death.; Sender's Comments: Sanofi company comment for information received on 21-Dec-2022: This case involves a 5 years old female patient who experienced myocarditis after receiving vaccine influenza vaccine. The causal role of the company suspect vaccine cannot be assessed based on the temporal relevance. The time to onset is not reported with the role of the vaccine. Further information regarding concurrent condition during vaccination, previous vaccination, tolerance, allergic history, laboratory investigations , autopsy results excluding alternative etiologies for the reported event are needed to fully assess this case. Based on the data provided, the role of vaccine cannot be assessed.; Reported Cause(s) of Death: myocarditis
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got the flu aft getting flu shot; Initial information received on 17-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.  This case involves an unknown age male patient who got the flu after getting flu shot of vaccine Influenza Vaccine.   The patient's past medical history included COPD (Chronic obstructive pulmonary disease) and Emphysema. The patient's past medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any concomitant disease or risk factor.    On an unknown date, the patient received a unknown dose of suspect Influenza Vaccine produced by unknown manufacturer (lot number, strength, formulation and expiry date not reported) via unknown route in unknown administration site for flu (Influenza).  On an unknown date the patient developed a non-serious event "got the flu aft getting flu shot end of Sept(influenza)" (unknown latency) following the administration of  Influenza Vaccine.  It was reported that "Spent Sat to Monday in hospital last week. He is doing a bit better on steroids, ended the Tamiflu. Some congestion still, possibly infection ,so doctor put him on Z-Pak Wednesday as well.   It is unknown if there were lab data/results available.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event.    Outcome: Unknown