chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pericarditis, Pneumonia, Pneumothorax
Clinical narrative: Pericarditis; Partially Collapsed Lung Resulting in Pneumonia; Partially Collapsed Lung Resulting in Pneumonia; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Nov2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 54 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE , Batch/Lot No: EW0151), administration date: Apr2021, when the patient was 53 years old, for COVID-19 immunization; Bnt162b2 (DOSE 1, SINGLE , Batch/Lot No: FH6204), administration date: Mar2021, when the patient was 53 years old, for COVID-19 immunization. The following information was reported: PNEUMONIA (hospitalization), PNEUMOTHORAX (hospitalization) all with onset Nov2021, outcome "unknown" and all described as "Partially Collapsed Lung Resulting in Pneumonia"; PERICARDITIS (hospitalization) with onset Nov2021, outcome "unknown". The patient was hospitalized for pericarditis, pneumonia, pneumothorax (hospitalization duration: 3 day(s)). The events "pericarditis" and "partially collapsed lung resulting in pneumonia" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of pericarditis, pneumonia, pneumothorax.  Additional information: The patient had pericarditis & partially collapsed lung resulting in pneumonia. But the most concerning was pericarditis. Prior to vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had been tested for COVID-19. The patient received the fourth dose of BNT162b2 (lot number: FM0173 9122) in Jun2022.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Sep2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 44-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), in right arm 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. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing), notes: High Blood Pressure; "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "COVID-19". Therapeutic measure, PAXLOVID was taken as a result of drug ineffective, covid-19, from 05Sep2022 to 10Sep2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events DRUG INEFFECTIVE and COVID-19 and BNT162B2.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male 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: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 Immunization. The following information was reported: RASH (non-serious), outcome "unknown". Additional information:The reporter mentioned that her brother got a rash after the 1st Pfizer Covid19 booster vaccine.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 66.0
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 dose number=1, vaccine dose number=2: Moderna, Vaccine dose number=3, vaccine dose number=4: Pfizer; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 22Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 21Jan2021 as dose 1, single (Batch/Lot number: unknown) and on 24Feb2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "MS" (unspecified if ongoing); "High BP" (unspecified if ongoing), notes: high bp; "Thyroid (hypo)" (unspecified if ongoing), notes: Thyroid (hypo). No known allergies. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 04Sep2021, outcome "unknown", described as "Vaccine dose number=1, vaccine dose number=2: Moderna, Vaccine dose number=3, vaccine dose number=4: Pfizer"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Positive, notes: Day 0-9 tested positive; (Sep2022) Negative, notes: Day 10 tested negative; (Sep2022) Positive, notes: Day 11 tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19; Paxlovid was received since 08Sep2022 to 12Sep2022. 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: Death
Clinical narrative: later on died 9 hours after getting the vaccine; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 98-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (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, 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. The following information was reported: DEATH (death), 9 hrs after the suspect product(s) administration, outcome "fatal", described as "later on died 9 hours after getting the vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  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 events with 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.; Reported Cause(s) of Death: later on died 9 hours after getting the vaccine
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report from contactable consumer. The reporter is the patient. A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single, on 21Apr2021 as dose 1, single, on 20Oct2021 as dose 3 (booster), single and on 02Apr2022 as dose 4 (booster), single at the age of 65 years for covid-19 immunisation. The patient had no relevant medical history. Concomitant medications (other medication in 2 weeks) included: METFORMIN; FLONASE ALLERGY RELIEF; CLARITIN ALLERGIC. The following information was reported: vaccination failure (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: COVID-19 test: positive. Therapeutic measures were taken as a result of vaccination failure, covid-19: Paxlovid from 11Sep2022 to 15Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Disease recurrence, Gastric emptying study, Impaired gastric emptying, Sitophobia
Clinical narrative: Disease recurrence; Gastroparesis; Sitophobia; Syncope; This is a literature report for the following literature source(s):.  A 57-year-old man developed gastroparesis following COVID-19 vaccination with tozinameran, and developed akathisia during treatment with metoclopramide for gastroparesis. Additionally, he exhibited lack of efficacy during treatment with ondansetron, baclofen, famotidine and prochlorperazine for gastroparesis [dosages not stated; not all routes, time to reactions onset and outcomes stated]. The man previously healthy, received the first dose of tozinameran [Pfizer BioNTech COVID-19 vaccine] in December 2020. Five days after the vaccination, he developed intractable nausea, hiccups and vomiting. During following week, he needed three emergency department visits for symptoms, which were refractory to oral prochlorperazine, ondansetron and fluid resuscitation. Subsequently, he received baclofen, but showed no symptom relief. For presumed gastroparesis, he started receiving metoclopramide which provided significant relief; however, he developed extrapyramidal symptoms of akathisia. Therefore, metoclopramide was withdrawn. Due to persistent symptoms, the man received erythromycin, which nearly resolved on second week. Therefore, his prokinetics were tapered off. He received the second dose of tozinameran following 23 days of the first dose. He again developed recurrent intractable nausea, hiccups and vomiting within 2h associated with near syncope and sitophobia. Domperidone was initiated providing minimal improvement. Gastric emptying study revealed delayed gastric emptying. Thereafter, high-dose famotidine was given with no relief. After initiating prednisone, his symptoms resolved within few days. Prednisone was successfully taper off within 2 weeks. At 2 months after cessation of steroid, he remained asymptomatic.  Sender's Comments: Based on the information provided in the narrative , a possible contributory role of the suspect vaccine BNT162B2 to reported event of gastroparesis , syncope and disease recurrence cannot be excluded. 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-202101668421 Same article/patient/drug and Different event;
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Disease recurrence; Gastroparesis; Sitophobia; Syncope; This is a literature report for the following literature source(s):.  A 57-year-old man developed gastroparesis following COVID-19 vaccination with tozinameran, and developed akathisia during treatment with metoclopramide for gastroparesis. Additionally, he exhibited lack of efficacy during treatment with ondansetron, baclofen, famotidine and prochlorperazine for gastroparesis [dosages not stated; not all routes, time to reactions onset and outcomes stated]. The man previously healthy, received the first dose of tozinameran [Pfizer BioNTech COVID-19 vaccine] in December 2020. Five days after the vaccination, he developed intractable nausea, hiccups and vomiting. During following week, he needed three emergency department visits for symptoms, which were refractory to oral prochlorperazine, ondansetron and fluid resuscitation. Subsequently, he received baclofen, but showed no symptom relief. For presumed gastroparesis, he started receiving metoclopramide which provided significant relief; however, he developed extrapyramidal symptoms of akathisia. Therefore, metoclopramide was withdrawn. Due to persistent symptoms, the man received erythromycin, which nearly resolved on second week. Therefore, his prokinetics were tapered off. He received the second dose of tozinameran following 23 days of the first dose. He again developed recurrent intractable nausea, hiccups and vomiting within 2h associated with near syncope and sitophobia. Domperidone was initiated providing minimal improvement. Gastric emptying study revealed delayed gastric emptying. Thereafter, high-dose famotidine was given with no relief. After initiating prednisone, his symptoms resolved within few days. Prednisone was successfully taper off within 2 weeks. At 2 months after cessation of steroid, he remained asymptomatic.  Sender's Comments: Based on the information provided in the narrative , a possible contributory role of the suspect vaccine BNT162B2 to reported event of gastroparesis , syncope and disease recurrence cannot be excluded. 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-202101668421 Same article/patient/drug and Different event;
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Nov2021 as dose 1, single (Lot number: FG3527), in left arm, on 21Nov2021 as dose 2, single (Lot number: FG3527), in left arm and on 01Feb2022 as dose 3 (booster), single (Lot number: FM9698) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sickle Cell" (unspecified if ongoing); "diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Dilaudid for Allergy. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". 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 covid-19 which included a Anti-viral and treatment stop date: 15Sep2022, Lot number=1918535A. Clinical course: The patient received other medication in 2 weeks.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), on 28Oct2021 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 "unknown" and all described as "COVID 19 Treatment". 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.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, sigle (Lot number: EL3248), in right arm, on 22Mar2021 as dose 2, single (Lot number: EL3248), in right arm and on 14Dec2021 as dose 3 (booster), single (Lot number: 33030BD) at the age of 44 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Jan2021 at 11:00 as dose 1, single (Lot number: EL9263), in left arm, on 14Feb2021 at 13:00 as dose 2, single (Lot number: EN6201), in left arm, on 16Aug2021 at 15:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 31Mar2022 at 15:30 as dose 4 (booster), single (Lot number: FC3181) at the age of 54 years, in left arm for covid-19 immunisation; BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 at 13:30 as dose 5 (booster), single (Lot number: GH9694), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "cholesterol" (unspecified if ongoing); "Known allergies: Shellfish" (unspecified if ongoing), notes: known allergies: Fish and shellfish; "Known allergies: Fish" (unspecified if ongoing), notes: known allergies: Fish and shellfish. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: covid-19 Treatment; (Sep2022) Positive, notes: Positive, test occurred on Day 12 following initial positive result; (17Sep2022) Negative, notes: Days 6-11 tested negative; (18Sep2022) Negative, notes: Days 6-11 tested negative; (19Sep2022) Negative, notes: Days 6-11 tested negative; (20Sep2022) Negative, notes: Days 6-11 tested negative; (21Sep2022) Negative, notes: Days 6-11 tested negative; (22Sep2022) Negative, notes: Days 6-11 tested negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201182507 same reporter/patient, different drug/AE;US-PFIZER INC-202201183881 same reporter/patient, different dose/AE;
Sex: M
Vaccine: COVID19
Symptoms: Diplopia, Headache, Thrombosis
Clinical narrative: Clot blood; Diplopia; Headache; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from a sales representative. The reporter is the patient.  An adult male patient received BNT162b2 (COMIRNATY), in 2021 as dose 2, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Dose 1), administration date: 2021, for COVID-19 Immunization, reactions: "diplopia", "headaches", "blood clots". The following information was reported: THROMBOSIS (medically significant) with onset 2021, outcome "unknown", described as "blood clots"; DIPLOPIA (non-serious) with onset 2021, outcome "unknown"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headaches". The events "blood clots", "headaches" and "diplopia" required physician office visit. Therapeutic measures were taken as a result of thrombosis, headache, diplopia. Clinical course: The patient described various health issues following initial two-dose vaccine series and booster dose since 2021. Patient is an adult male approximately 40 years old. Patient described symptoms of headaches, diplopia, and blood clots that he recalled following vaccine doses and was actively being treated by his physician.  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-PV202200069596 same patient/product/event, different dose;US-PFIZER INC-202201184242 same patient/product/event, different dose;
Sex: M
Vaccine: COVID19
Symptoms: Diplopia, Headache, Thrombosis
Clinical narrative: blood clots; headaches; diplopia; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  An adult male patient received BNT162b2 (COMIRNATY), in 2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Dose 1), administration date: 2021, for COVID-19 immunization, reaction(s): "diplopia", "Headaches", "blood clots"; Comirnaty (Dose 2), administration date: 2021, for COVID-19 immunization, reaction(s): "diplopia", "Headaches", "blood clots". The following information was reported: THROMBOSIS (medically significant) with onset 2021, outcome "unknown", described as "blood clots"; DIPLOPIA (non-serious) with onset 2021, outcome "unknown"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headaches". The events "blood clots", "headaches" and "diplopia" required physician office visit.  Additional information: During a routine phone call, he described various health issues following initial two-dose vaccine series and booster dose since 2021. Patient described symptoms of headaches, diplopia and blood clots that he recalls following vaccine doses and is actively being treated by his physician.  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-202201184241 same patient/product/event, different dose number;US-PFIZER INC-PV202200069596 same patient/product/event, different dose number;
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), on 20Dec2021 as dose 1, single (Lot number: 33130BA), in left arm and on 13May2022 as dose 2, single (Lot number: FM9992) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: AZITHROMYCIN, start date: 14Sep2022, stop date: 18Sep2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID-19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201184890 same reporter/patient/product, different dose;
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: Caller wanted information about the Pfizer COVID-19 Vaccine Bivalent being able to cause vaginal bleeding; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (primary immunization series completed with unknown manufacturer.), for COVID-19 immunization. The following information was reported: VAGINAL HAEMORRHAGE (non-serious), outcome "unknown", described as "Caller wanted information about the Pfizer COVID-19 Vaccine Bivalent being able to cause vaginal bleeding". Therapeutic measures were taken as a result of vaginal haemorrhage.  Additional information: Caller wanted information about the Pfizer COVID-19 Vaccine Bivalent being able to cause vaginal bleeding. She received the booster yesterday. Caller stated she takes warfarin and that she's over the period of being able to have babies. Caller also felt concerned that she was asked if she takes any blood medication before receiving the 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.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 94-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Batch/Lot number: unknown) and in Feb2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Macular degeneration" (unspecified if ongoing); "osteoporosis" (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 "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient had Paxlovid treatment for COVID-19 from 11Sep2022 to 15Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; 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 male patient received BNT162b2 (BNT162B2), on 11Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PRAVASTATIN, start date: 10Jan2022, stop date: 12Sep2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (23Sep2022) Positive, notes: Positive test 7 days after paxlovid 5 day dosage. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid treatment from 12Sep2022 to 16Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm 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. The patient's relevant medical history was not reported. Concomitant medication(s) included: DEXTROMETHORPHAN, start date: 14Sep2022, stop date: 21Sep2022. Past drug history included: Known allergies: amoxicillin, reaction(s): "Known allergies: Amoxicillin".  The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Biopsy skin, Hypersensitivity, Skin test, Tryptase
Clinical narrative: 1 had a negative result of skin prick testing to PEG 2000 but developed symptoms of an immediate allergic reaction after the second dose of the Pfizer vaccine; The initial case was missing the following minimum criteria: unidentifiable patient. Upon receipt of follow-up information on (21Sep2022), this case now contains all required information to be considered valid.  This is a literature report.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "history of atopy" (unspecified if ongoing), notes: most commonly allergic rhinitis and drug allergy, anaphylaxis. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: HYPERSENSITIVITY (medically significant), outcome "unknown", described as "1 had a negative result of skin prick testing to PEG 2000 but developed symptoms of an immediate allergic reaction after the second dose of the Pfizer vaccine". The patient underwent the following laboratory tests and procedures: Biopsy skin: Unknown result, notes: suggestive of a hypersensitivity reaction; Skin test: Unknown result, notes: to identify allergy to PEG 3350 was performed using methylprednisolone acetate; negative, notes: skin prick testing to PEG 2000; Unknown result, notes: skin testing to PEG 3350 via Miralax; Unknown result, notes: skin testing to polysorbate 80; Unknown result, notes: skin testing to methylprednisolone acetate; Tryptase: 5.7 ng/ml.  Clinical course: 1 patient had a negative result of skin prick testing to PEG 2000 but developed symptoms of an immediate allergic reaction after the second dose of the Pfizer vaccine. This patient had an event-related tryptase level that did not show any elevation from baseline (5.7 ng/mL). This patient did not have a severe adverse event, and the symptoms were the same as the previous symptoms but more rapid in onset.; Sender's Comments: Based on the temporal relation, the association between the event of hypersensitivity and the suspect product BNT162B2 cannot be completely ruled out. 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: Therapeutic response unexpected
Clinical narrative: stopped my Shingles; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) 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. Vaccination history included: Shingrix shots (I got shingrix shots my shingles were still coming monthly), for Shingles. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "stopped my Shingles".  Additional information: Patient stated that the patient wanted to share that all COVID 19 shots and the two booster also stopped Shingles. Patient known that Pfizer shots for COVID were not for Shingles but it was an added benefit. Even after patient got shingrix shots, shingles would still come monthly.  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-PV202200068024 same patient/drug/event, different dose;US-PFIZER INC-PV202200068026 same patient/drug/event, different dose;
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: stopped my Shingles; 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 4 (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), for Covid-19 immunization, reaction(s): "stopped my Shingles"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization, reaction(s): "stopped my Shingles"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE, guessing the 3rd booster is not as strong.), for Covid-19 immunization, reaction(s): "Even after I got shingrix shots my shingles were still coming monthly", "So I am guessing the 3rd booster is not as strong", "all COVID 19 shorts and the two booster also stopped my Shingles. This third booster did not, I broke back out a week after 3rd booster.". The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "stopped my Shingles". Additional information: Patient stated that the patient wanted to share that all COVID 19 shots and the two booster also stopped Shingles. Patient known that Pfizer shots for COVID were not for Shingles, but it was an added benefit. Even after patient got shingrix shots, shingles would still come monthly.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Incorrect dose administered, Myalgia
Clinical narrative: headache; muscle aches; fifth shot; 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 20Sep2022 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: Covid-19 vaccine (Dose Number: 04, Unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose Number: 03, Unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose Number: 02, Unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose Number: 01, Unknown manufacturer), for COVID-19 Immunization. The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious) with onset 20Sep2022, outcome "unknown", described as "fifth shot"; HEADACHE (non-serious), outcome "unknown"; MYALGIA (non-serious), outcome "unknown", described as "muscle aches". Additional information: The reporter said that she got her Pfizer shot yesterday. It's her fifth shot and she has a headache and muscle aches and whatnot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 42-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown". Therapeutic measures were taken as a result of headache.  Additional information: Patient received bivalent covid vaccine booster around noon, then developed very painful headache around 8 pm that evening. Pain was felt behind the forehead (squeezing pain) and lasted overnight and into the morning. Patient took tylenol following day and experienced some relief of headache but not complete resolution. Patient has no underlying conditions or medications. Event took place after use of product.  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: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: patient that got the primary series of the Pfizer Covid-19 vaccine and had covid; patient that got the primary series of the Pfizer Covid-19 vaccine and had covid; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A patient (no qualifiers provided) received 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "patient that got the primary series of the Pfizer Covid-19 vaccine and had covid". Additional information: The patient wanted to know how long they need to wait after they recover from COVID-19 before getting the new vaccine.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case, an association between the reported events Drug ineffective and covid 19 and suspect product bnt162b2 cannot be ruled out.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Fever; arm pain at the site of injection; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history 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: PYREXIA (non-serious), outcome "unknown", described as "Fever"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "arm pain at the site of injection".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report received from non-contactable reporter(s) (Pharmacist) from a sales representative. The reporter is the patient.  A male patient received BNT162b2 (COMIRNATY), 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: DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea".  Additional information: Event took place after the use of vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation, Oxygen saturation decreased
Clinical narrative: Oxygen saturation decreased; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient. Other Case identifier: NVSC2022US207878_OS.  A 72-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (Primary immunisation series completed, Unknown manufacturer), for COVID-19 immunization. The following information was reported: OXYGEN SATURATION DECREASED (non-serious), outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Aphthous ulcer, Blood culture, Body temperature, Heart rate, Herpes simplex
Clinical narrative: This is a literature report for the following literature source Vulvar Aphthous Ulcers in an Adolescent After Coronavirus Disease 2019 (COVID-19) Vaccination, Obstetrics and Gynecology. A 15-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing); "menarche" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: APHTHOUS ULCER (medically significant), 1 day after the suspect product(s) administration, outcome "recovered", described as "vulvar aphthous ulcers". The event "vulvar aphthous ulcers" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood culture: Unknown result, notes: health care professional was concerned for a labial abscess and collected Neisseria gonorrhoeae and Chlamydia trachomatis polymerase chain reaction tests; Body temperature: afebrile; Heart rate: 101, notes: isolated; Herpes simplex: negative; Polymerase chain reaction: Unknown result, notes: health care professional was concerned for a labial abscess and collected Neisseria gonorrhoeae and Chlamydia trachomatis polymerase chain reaction tests; Pregnancy test: negative. Therapeutic measures were taken as a result of aphthous ulcer. Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with 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.