chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Physician.  A 56-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 56 years for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "restless leg syndrome" (unspecified if ongoing). The patient had no known allergies. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 20Mar2021, when the patient was 53-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE), administration date: 10Apr2021, when the patient was 53-year-old, for COVID-19 immunization; moderna (DOSE 3 (BOOSTER), SINGLE), administration date: 29Oct2021, when the patient was 54-year-old, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Feb2024) Positive, notes: faintly positive in AM. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid from 06Feb2024 to 10Feb2024. Clinical course: Rapid antigen home test faintly positive in AM. First dose of Paxlovid started 06Feb2024 2pm. Mild symptoms improved over the next few days, and felt normal for a few days. Strict home isolation in one room, with N95 use within house walking between rooms 06Feb-15Feb.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of suspect vaccine cannot be excluded for the reported LOE events.
Age: 50.0
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; Vaccine brand=Other, vaccine brand other=Moderna/vaccine brand=Pfizer BioNTech; This is a spontaneous report received from a Consumer or other non HCP.  A 51-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 50 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 15Apr2021 as dose 1, single (Lot number: EW0164), in left arm, on 08May2021 as dose 2, single (Lot number: EW0183), in left arm and on 21May2022 as dose 4 (booster), single (Lot number: FM9992), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 26Nov2021 as dose 3 (booster), single (Lot number: 939909), in left arm and on 30Nov2023 at 14:30 as dose 6 (booster), single (Lot number: 3032445), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Celiac disease" (unspecified if ongoing); "Ehlers-Danlos Syndrome" (unspecified if ongoing); "Sleep apnea" (unspecified if ongoing); "DCIS", start date: 2019 (unspecified if ongoing); "Known allergies: Sulfa antibiotics" (unspecified if ongoing); "Known allergies: Flagyl" (unspecified if ongoing). Concomitant medication(s) included: TAMOXIFEN, start date: 20Apr2020. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 26Nov2021, outcome "recovered", described as "Vaccine brand=Other, vaccine brand other=Moderna/vaccine brand=Pfizer BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "recovered" (Feb2024) and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2024) Negative, notes: Two days of negative antigen tests. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 03Feb2024 to 08Feb2024.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Upper arm soreness; limited range-of-motion; This is a spontaneous report received from a Pharmacist.  A 68-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 07Nov2023 as dose 1, single (Lot number: HD9876) at the age of 68 years intramuscular, in right arm for covid-19 immunisation; influenza vaccine inact sag 3v (FLUAD), on 07Nov2023 (Lot number: 371595) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 01Jan2024, outcome "not recovered", described as "Upper arm soreness"; JOINT RANGE OF MOTION DECREASED (non-serious) with onset 01Jan2024, outcome "not recovered", described as "limited range-of-motion".  No follow-up attempts are possible.
Sex: F
Vaccine: RSV
Symptoms: Postpartum haemorrhage, Premature delivery, Premature separation of placenta, Vaginal haemorrhage
Clinical narrative: The patient delivered early at 34 weeks and 5 days.; Placenta abruption; Heavy vaginal bleeding; Patient received Abrysvo at approximately 32 weeks and 1 day; This is a spontaneous report received from a Physician from a sales representative.  A 38-year-old female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), in Jan2024 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Term pregnancy" (unspecified if ongoing), notes: The patient had an atopic pregnancy and a term pregnancy prior.; "Atopic pregnancy" (unspecified if ongoing), notes: The patient had an atopic pregnancy and a term pregnancy prior. The patient was 34 weeks pregnant at the event onset. The patient is expected to deliver one baby(s). The patient's concomitant medications were not reported. The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (hospitalization) with onset Jan2024, outcome "unknown", described as "Patient received Abrysvo at approximately 32 weeks and 1 day"; POSTPARTUM HAEMORRHAGE (hospitalization) with onset 26Jan2024, outcome "unknown", described as "Heavy vaginal bleeding"; PREMATURE SEPARATION OF PLACENTA (hospitalization) with onset 26Jan2024, outcome "unknown", described as "Placenta abruption"; PREMATURE DELIVERY (hospitalization), outcome "unknown", described as "The patient delivered early at 34 weeks and 5 days.". The patient was hospitalized for maternal exposure during pregnancy, premature delivery, premature separation of placenta, postpartum haemorrhage (start date: Jan2024). The baby was delivered premature. It was unknown if therapeutic measures were taken as a result of maternal exposure during pregnancy, premature delivery, premature separation of placenta, postpartum haemorrhage. No other risk factors reported from the HCP.   The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.; Sender's Comments: There is not a reasonable possibility that the reported event related to the suspect product event most likely due to patient underlying contributory factors   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.,Linked Report(s) : US-PFIZER INC-202400044105 baby case;
Sex: M
Vaccine: PNC20
Symptoms: Asthenia, Injection site pain, Injection site pruritus, Malaise, Pain
Clinical narrative: he had experienced a bad sinus infection for "over a year and a half" and that all his sinus symptoms "went away; weakness; malaise; aching body; injection site hurt and itched; injection site hurt and itched; chronic rhinitis; This is a spontaneous report received from a Nurse from medical information team.  A 65-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "he had experienced a bad sinus infection for "over a year and a half" and that all his sinus symptoms "went away"; ASTHENIA (non-serious), outcome "unknown", described as "weakness"; MALAISE (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "aching body"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE PRURITUS (non-serious), outcome "unknown" and all described as "injection site hurt and itched"; RHINITIS (non-serious), outcome "recovered", described as "chronic rhinitis". Therapeutic measures were taken as a result of vaccination site pruritus. Additional information: Caller reported having experienced beneficial and unexpected side effects 7 days after having been administered Prevnar 20. Caller reported that he had experienced a bad sinus infection for "over a year and a half" and that all his sinus symptoms "went away", which caller attributes to a "boosted immune system". Caller expressed that he would like for beneficial side effects to last. Nonetheless, caller reported that he also experienced "negative side effects", such as "weakness, malaise, aching body" and that the "injection site hurt and itched". Specifically speaking about the itch, caller expressed that "it felt like a mosquito bite 2 inches under the skin", which caller associates with the length and reach of the needle used. Caller added that "cortisone did help" to alleviate the itch experienced. As additional information, caller reported that he "takes Benadryl often", because his sinus symptoms were "unbelievably bad" and "out of control". Although caller does not consider himself immunocompromised, caller speculated that he may have been slightly immunodepressed. Caller did report that he had experienced "chronic [rhinitis]" and that such symptoms "disappeared" 7 days post-injection of Prevnar 20.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Sex: M
Vaccine: PNC20
Symptoms: Rhinitis, Therapeutic response unexpected
Clinical narrative: he had experienced a bad sinus infection for "over a year and a half" and that all his sinus symptoms "went away; weakness; malaise; aching body; injection site hurt and itched; injection site hurt and itched; chronic rhinitis; This is a spontaneous report received from a Nurse from medical information team.  A 65-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "he had experienced a bad sinus infection for "over a year and a half" and that all his sinus symptoms "went away"; ASTHENIA (non-serious), outcome "unknown", described as "weakness"; MALAISE (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "aching body"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE PRURITUS (non-serious), outcome "unknown" and all described as "injection site hurt and itched"; RHINITIS (non-serious), outcome "recovered", described as "chronic rhinitis". Therapeutic measures were taken as a result of vaccination site pruritus. Additional information: Caller reported having experienced beneficial and unexpected side effects 7 days after having been administered Prevnar 20. Caller reported that he had experienced a bad sinus infection for "over a year and a half" and that all his sinus symptoms "went away", which caller attributes to a "boosted immune system". Caller expressed that he would like for beneficial side effects to last. Nonetheless, caller reported that he also experienced "negative side effects", such as "weakness, malaise, aching body" and that the "injection site hurt and itched". Specifically speaking about the itch, caller expressed that "it felt like a mosquito bite 2 inches under the skin", which caller associates with the length and reach of the needle used. Caller added that "cortisone did help" to alleviate the itch experienced. As additional information, caller reported that he "takes Benadryl often", because his sinus symptoms were "unbelievably bad" and "out of control". Although caller does not consider himself immunocompromised, caller speculated that he may have been slightly immunodepressed. Caller did report that he had experienced "chronic [rhinitis]" and that such symptoms "disappeared" 7 days post-injection of Prevnar 20.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Sex: U
Vaccine: RSV
Symptoms: Intensive care, Neonatal respiratory distress, Premature baby
Clinical narrative: delivered early at 34 weeks and 5 days; The baby had respiratory distress; mother received Abrysvo at approximately 32 weeks and 1 day; This is a spontaneous report received from a Physician from a sales representative.  A neonate patient was exposed to rsv vaccine prot.subunit pref 2v (ABRYSVO), transplacental, administration details for the mother: not provided, in Jan2024 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The mother of the patient was 38 years old. Mother medical details: The patient had an atopic pregnancy and a term pregnancy prior. No other risk factors reported from the HCP. The mother was 34 weeks pregnant at the event onset. The mother is expected to deliver one baby(s). The mother's relevant medical history and concomitant medications were not reported. The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (hospitalization) with onset Jan2024, outcome "unknown", described as "mother received Abrysvo at approximately 32 weeks and 1 day"; NEONATAL RESPIRATORY DISTRESS (hospitalization) with onset 26Jan2024, outcome "unknown", described as "The baby had respiratory distress"; PREMATURE BABY (hospitalization) with onset 26Jan2024, outcome "unknown", described as "delivered early at 34 weeks and 5 days". The patient was hospitalized for maternal exposure during pregnancy, premature baby, neonatal respiratory distress (start date: Jan2024). The baby was delivered premature, delivery date 26Jan2024. It was unknown if therapeutic measures were taken as a result of maternal exposure during pregnancy, premature baby, neonatal respiratory distress. Clinical details: The baby had respiratory distress and almost admitted to the NICU (neonatal intensive care unit) (as reported).  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.; Sender's Comments: There is not a reasonable possibility that the reported event related to the suspect product event most likely due to patient underlying contributory factors.  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.,Linked Report(s) : US-PFIZER INC-202400043948 mother case;
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Interchange of vaccine products; This is a spontaneous report received from a Consumer or other non HCP.  A 58-year-old male patient received BNT162b2 (BNT162B2 NOS), on 16Mar2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 57 years, in right arm for covid-19 immunisation; COVID-19 vaccine prot. subunit (nvx cov 2373) (NOVAVAX COVID-19 VACCINE), on 14Sep2023 as dose number unknown, single), in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penecillin" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 14Sep2023, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "unknown" 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: Had negative results on day 8 and 9 of infection; (Feb2024) Positive, notes: New positive test and return of symptoms on day 10 of infection; (Feb2024) Negative, notes: Had negative results on day 8 and 9 of infection; (Feb2024) Positive, notes: till testing positive on day 12 of infection. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid started on 06Feb2024 and stopped on 11Feb2024.  Clinical information: The patient received vaccine. New positive test and return of symptoms on day 10 of infection. Had negative results on day 8 and 9 of infection. Still testing positive on day 12 of infection.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 69-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 16Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Pre diabetic" (unspecified if ongoing); "high Cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: moderna vaccine (DOSE NUMBER UNKNOWN, SINGLE, Anatomical Location: Left arm), administration date: 23Mar2021, when the patient was 66-year-old, for COVID-19 Immunization; moderna vaccine (DOSE NUMBER UNKNOWN, SINGLE, Anatomical Location: Left arm), administration date: 02Apr2021, when the patient was 66-year-old, for COVID-19 Immunization; BNT162b2 (DOSE NUMBER UNKNOWN, SINGLE, Anatomical Location: Left arm), administration date: 08Aug2022, when the patient was 68-year-old, for COVID-19 Immunization, reaction(s): "Interchange of vaccine products". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 30Jan2024 to 03Feb2024.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: RSV
Symptoms: Injection site erythema
Clinical narrative: Redness at the injection site; This is a spontaneous report received from a Pharmacist.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), outcome "recovered", described as "Redness at the injection site".  Additional information: The patient was getting redness at the injection site that was lasting for as long as two weeks.   The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective
Clinical narrative: covid-19; covid-19; covid-19; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  An 80-year-old 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: "High blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "covid-19"; DISEASE RECURRENCE (medically significant) with onset 14Feb2024, outcome "unknown", described as "covid-19". Therapeutic measures were taken as a result of drug ineffective, covid-19, disease recurrence. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400044609 Same reporter/drug/AE, different patient;
Age: 53.0
Sex: M
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 Consumer or other non HCP.  A 54-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 (Vaccine administration time=01:00 pm) as dose 1, single (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. No Known allergies. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2024) Positive, notes: Tested positive for COVID-19; (Feb2024) Negative, notes: testing negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 05Feb2024 to 10Feb2024. This case is reported as non-Serious.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Not feeling well; This is a spontaneous report received from a Consumer or other non HCP.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "Not feeling well".  Additional information: Reporter stated, he needed to know, how many people had called Pfizer, with patient's of myocarditis. His sister took Pfizer (Clarified as Pfizer COVID-19 Vaccine) and she was not feeling well and it scared him and he really needed to know if there was a solution for it, he read up online he did not think that his sister should have taken Pfizer. Reporter stated, he hoped didn't take this vaccine because it was not working good and there people who were like 40 years old dropping dead (General statement). So, it was very scary and very serious. Reporter stated, he thought that questions should be asked to his sister because she was the one experiencing things. She was sleeping right now, he just found out about it and was trying to get as much information as he could. Pharmacy details and other details could not be probed as the reporter was unwilling to complete the report. Hence further probing could not be done and limited information available over the call.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from an Other HCP.  A 49-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2; unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 3; unknown manufacturer), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 10Feb2024 to 15Feb2024.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162b2 omi xbb.1.5 in this patient cannot be completely excluded.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  A 76-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 01Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 76 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. No Known allergies. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 4, Manufacturer unknown), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 09Feb2024 to 14Feb2024. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 65-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 15Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "Hypokalemia" (unspecified if ongoing); "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2, unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 3, unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 4, unknown manufacturer), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "recovering" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 06Feb2024 to 10Feb2024. This case is non-Serious. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 45-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. This case was reported as non-Serious. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 69-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Nov2023 as dose 1, single (Lot number: 3030535) at the age of 69 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: AMLODIPINE, start date: Aug2023. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 3, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 4, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 5, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 6, Manufacturer: Unknown), for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 09Feb2024 to 13Feb2024. This case was reported as non-Serious.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Aug2023 at 10:00 as dose 2, single (Batch/Lot number: unknown) at the age of 38 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single) for covid-19 immunisation. The patient's relevant medical history included: "Migraine Headaches" (unspecified if ongoing); "Thalassemia Minor" (unspecified if ongoing); "Known allergies: Latex" (unspecified if ongoing); "Known allergies: Stone Fruits, Citrus Fruits, Bananas, Apples" (unspecified if ongoing); "Known allergies: Wheat" (unspecified if ongoing); "Known allergies: Gluten" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19, patient took Paxlovid from 18Feb2024 to 19Feb2024. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from an Other HCP.  A 62-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing); "lupus" (unspecified if ongoing), notes: lupus; "Allergies" (unspecified if ongoing). Concomitant medication(s) included: MONTELUKAST, start date: Jan2020; LEVOTHYROXINE, start date: Jan2020; LIOTHYRONINE, start date: Jan2020; LAMOTRIGINE, start date: Jan2020; BUPROPION, start date: Jan2020. Past drug history included: Levofloxacin, reaction(s): "Known allergies: Levofloxacin"; Tramadol, reaction(s): "Known allergies: Tramadol". Vaccination history included: Bnt162b2, bnt162b2 omi ba.4-5 (DOSE 3 (BOOSTER), SINGLE), administration date: Sep2022, when the patient was 61 years old, for COVID-19 immunization; Moderna (DOSE 2, SINGLE), for COVID-19 immunization; Moderna covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19, patient took Paxlovid from 14Feb2024 to 19Feb2024.. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: A causal relationship to the suspect drug BNT162B2 OMI XBB.1.5 cannot be excluded for event vaccination failure. This case will be reassessed upon receipt of additional information.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: vaccination failure; covid-19; This is a spontaneous report received from an Other HCP.  A 71-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Dec2023 as dose 1, single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Mycobacterium Avium Complex" (unspecified if ongoing); "allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Feb2024, outcome "not recovered"; VACCINATION FAILURE (medically significant) with onset Feb2024, outcome "not recovered". Therapeutic measures were taken as a result of vaccination failure, covid-19, patient received Paxlovid from  05Feb2024 to 09Feb2024. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: A causal relationship to the suspect drug BNT162B2 OMI XBB.1.5 cannot be excluded for event vaccination failure. This case will be reassessed upon receipt of additional information.
Age: 42.0
Sex: M
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 Consumer or other non HCP.  A 42-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 42 years for covid-19 immunisation. The patient had no relevant medical history. No Known allergies. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2024) Negative, notes: Rebound COVID, tested negative twice in 48 hours 2 days after finishing Paxlovid; (Feb2024) Negative, notes: Rebound COVID, tested negative twice in 48 hours 2 days after finishing Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 05Feb2024 to 09Feb2024. This case was reported as non-Serious. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  A 41-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) at the age of 41 years for covid-19 immunisation. The patient's relevant medical history included: "Allergies: Sulfa drugs" (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 "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 With Paxlovid from 07Feb2024 to 11Feb2024. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Night sweats
Clinical narrative: My Reactions from Taking the 3-Vaccine Shots/NITE SWEATS, I woke-up Wet and Sweating, Hair Wet, Top & Bottom Sheets, Pillow, (just like I had been in the Shower); This is a spontaneous report received from a Consumer or other non HCP.  An elderly female patient received BNT162b2 (BNT162B2), on 24Aug2021 as dose 3 (booster), single (Lot number: EW0179) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history included: "Complete Hysterectomy", start date: 1994 (unspecified if ongoing), notes: taking Prescription Estradiol- Estrogen Medication every since. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Lot EL3249), administration date: 21Jan2021, when the patient was 75-year-old, for COVID-19 immunization, reaction(s): "Blood pressure increased", "Night sweats", "Insomnia", "Vaginal discharge", "Feeling cold", "Asthenia", "Fatigue", "Restlessness", "Weight gain", "Cold", "Flu", "hot flashes"; BNT162b2 (Dose 2, Lot EM9810), administration date: 12Feb2021, for COVID-19 immunisation, reaction(s): "Night sweats". The following information was reported: NIGHT SWEATS (non-serious), outcome "unknown", described as "My Reactions from Taking the 3-Vaccine Shots/NITE SWEATS, I woke-up Wet and Sweating, Hair Wet, Top & Bottom Sheets, Pillow, (just like I had been in the Shower)".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300350709 same reporter/patient/drug, different dose/event;
Sex: U
Vaccine: COVID19
Symptoms: Myocardial infarction, Palpitations, Pericarditis
Clinical narrative: Heart attack with pericarditis; Heart attack with pericarditis; Heart palpitations; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDIAL INFARCTION (medically significant), PERICARDITIS (medically significant), outcome "unknown" and all described as "Heart attack with pericarditis"; PALPITATIONS (non-serious), outcome "unknown", described as "Heart palpitations". Clinical course: Patient received the Pfizer COVID vaccine had a bad reaction including heart palpitations, and then suffered a heart attack with pericarditis. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Patient developed lymph nodes after covid booster shot/ Patient did not provide date of event; This is a spontaneous report received from a Consumer or other non HCP.  A 44-year-old male patient received BNT162b2 (BNT162B2 NOS), 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. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Patient developed lymph nodes after covid booster shot/ Patient did not provide date of event".  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Anti-aquaporin-4 antibody, Antineutrophil cytoplasmic antibody, Magnetic resonance imaging head, Magnetic resonance imaging spinal, Ophthalmological examination
Clinical narrative: Optic neuritis with unilateral involvement; This is a literature report for the following literature source(s).  A 58-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19 infection" (unspecified if ongoing), notes: three weeks prior. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: OPTIC NEURITIS (medically significant), 2 hrs after the suspect product(s) administration, outcome "recovered", described as "Optic neuritis with unilateral involvement". The patient underwent the following laboratory tests and procedures: Anti-aquaporin-4 antibody: Not associated; Antineutrophil cytoplasmic antibody: Not associated; Magnetic resonance imaging head: right optic nerve enhancement, notes: and non-specific foci of high intensity in the periventricular and centrum semiovale regions of the brain; Magnetic resonance imaging spinal: normal; Ophthalmological examination: Mild left hypertropia on right gaze,, notes: -3 deficit in supraduction on the right, and right eye pain with upgaze. Mild nasal and inferior optic nerve rim elevation; Visual acuity tests: Normal. Therapeutic measures were taken as a result of optic neuritis which included 3-day course of IVMP 250mg every 6 hours with 11-day oral steroid taper.  Additional information: Presenting complaint included bilateral eye pain worsened by eye movement. The patient had covid-19 infection three weeks prior. The patient had no significant ocular or medical history. It was reported that eye pain and motility deficits completely improved following treatment.   No follow-up attempts are possible.; Sender's Comments: As there is limited information in the case provided, the causal association between the event optic neuritis and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer 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: Optic neuritis, Visual acuity tests
Clinical narrative: Optic neuritis with unilateral involvement; This is a literature report for the following literature source(s).  A 58-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19 infection" (unspecified if ongoing), notes: three weeks prior. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: OPTIC NEURITIS (medically significant), 2 hrs after the suspect product(s) administration, outcome "recovered", described as "Optic neuritis with unilateral involvement". The patient underwent the following laboratory tests and procedures: Anti-aquaporin-4 antibody: Not associated; Antineutrophil cytoplasmic antibody: Not associated; Magnetic resonance imaging head: right optic nerve enhancement, notes: and non-specific foci of high intensity in the periventricular and centrum semiovale regions of the brain; Magnetic resonance imaging spinal: normal; Ophthalmological examination: Mild left hypertropia on right gaze,, notes: -3 deficit in supraduction on the right, and right eye pain with upgaze. Mild nasal and inferior optic nerve rim elevation; Visual acuity tests: Normal. Therapeutic measures were taken as a result of optic neuritis which included 3-day course of IVMP 250mg every 6 hours with 11-day oral steroid taper.  Additional information: Presenting complaint included bilateral eye pain worsened by eye movement. The patient had covid-19 infection three weeks prior. The patient had no significant ocular or medical history. It was reported that eye pain and motility deficits completely improved following treatment.   No follow-up attempts are possible.; Sender's Comments: As there is limited information in the case provided, the causal association between the event optic neuritis and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Cholelithiasis, Gallbladder disorder
Clinical narrative: gallbladder stone in my bile duct; gallbladder problems/ gallbladder attacks; This is a spontaneous report received from a Consumer or other non HCP.  An 18-year-old patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: CHOLELITHIASIS (medically significant), outcome "unknown", described as "gallbladder stone in my bile duct"; GALLBLADDER DISORDER (medically significant), outcome "unknown", described as "gallbladder problems/ gallbladder attacks". Clinical course: Gallbladder problems after having the third Covid vaccine, patient was heathy ended up having gallbladder attacks and gallbladder stone in bile duct and needing gallbladder removed.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.