chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19, HPVX
Symptoms: Dizziness
Clinical narrative: felt dizzy after getting both covid-19 and hpv vaccine; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team.  A 9-year-old patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; hpv vaccine (HPV VACCINE), as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "felt dizzy after getting both covid-19 and hpv vaccine".  Additional Information: The patient had a COVID-19 vaccine and HPV vaccine co-administered on same day and felt dizzy.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12May2023 at 19:00 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: HERPES ZOSTER (non-serious) with onset 14May2023, outcome "not recovered", described as "Shingles". Therapeutic measures were taken as a result of herpes zoster.  Additional information: Was diagnosed with shingles officially yesterday on 15May2023. However, the outbreak started on Sunday 14May2023. The time the outbreak started was unknown. The outbreak occurred on her right buttocks. She mentioned her husband also got the same shot and had no reaction. She has had all the previous Covid 19 Vaccines and this was the next one. The only thing was when she got the second singles shot she also got shingles and it was in the same location. Reporter declined to continue to complete report. Stated she had made it to her destination and had to go.  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.
Age: 73.0
Sex: M
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: Moderna; Vaccine brand: Pfizer/BioNTech; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), on 28Aug2020 at 12:00 as dose 1, single (Lot number: 1031), in left arm, on 18Sep2020 as dose 2, single (Lot number: 1001), in left arm and on 21Jul2021 at 12:00 as dose 3 (booster), single (Lot number: 1031) at the age of 73 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 22Mar2022 at 09:30 as dose 4 (booster), single (Lot number: 016J21-2A), in left arm and on 20Oct2022 at 16:00 as dose 5 (booster), single (Lot number: 049D22A), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22Mar2022 at 09:30, outcome "unknown", described as "Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2023) Positive, notes: rebound tested positive on day 9. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient do not have any known allergies.; Sender's Comments: Based on the information available, the events Drug ineffective, COVID-19 and Interchange of vaccine products are assessed as related to BNT162B2 administration.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick/very-ill; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  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 and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), for COVID-19 immunization, reaction(s): "sick/very-ill".  The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick/very-ill".  Additional information: The patient reported that "I'm seeking from Pfizer for the effects that its covid-19 vaccine had on me. Everyday I'm sick. I want to just settle this thing outside of court. I've been very-ill every since I got the two shots".  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-PV202300088160 same reporter/ patient/ event, different dose;
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 71-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Dec2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 70 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: sulfa drugs" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Morphine, reaction(s): "Known allergies: morphine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient did not receive any other medication in 2 weeks. Treatment included Paxlovid from 07May2023 to 12May2023. Patient experienced rebound Covid after 5 days of Paxlovid on 16May2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 78-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 78 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "very mild hypothyroidism" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19; Positive, notes: retesting positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had received vaccine and other medication in 2 weeks. No known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 35-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 4 (booster), single (Lot number: GT2524) at the age of 35 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included paxlovid from 15May2023 to unknown date in May2023.
Age: 63.0
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) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included PAXLOVID from 05May2023 to 10May2023.  Clinical course: Other medication in 2 weeks was reported as no.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chronic obstructive pulmonary disease, Cough, Dyspnoea, Headache, Hypoxia
Clinical narrative: He is on oxygen and a CPAP; Double pneumonia; Cough; Wheezing; Sore throat; stuffed up; almost couldn't breath; COPD; Has all RSV symptoms except for fever; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPOXIA (medically significant), outcome "unknown", described as "He is on oxygen and a CPAP"; PNEUMONIA (medically significant), outcome "unknown", described as "Double pneumonia"; COUGH (non-serious), outcome "unknown"; WHEEZING (non-serious), outcome "unknown"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "Sore throat"; NASAL CONGESTION (non-serious), outcome "unknown", described as "stuffed up"; DYSPNOEA (non-serious), outcome "unknown", described as "almost couldn't breath"; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (non-serious), outcome "unknown", described as "COPD"; RESPIRATORY SYNCYTIAL VIRUS INFECTION (non-serious), outcome "unknown", described as "Has all RSV symptoms except for fever"; HEADACHE (non-serious), outcome "unknown". The event "has all rsv symptoms except for fever" required emergency room visit. The patient underwent the following laboratory tests and procedures: Respiratory syncytial virus test: Unknown results; SARS-CoV-2 test: Negative, notes: he tested negative for COVID-19 with self testing and testing at pharmacies. He was tested 4 or 5 times.  Clinical course: Patient doesn't know if he is calling about a Pfizer product but he tested negative for COVID-19 with self-testing and testing at pharmacies. He was tested 4 or 5 times. He has symptoms that could be RSV. He has everything except the fever. Has a cough, wheezing, sore throat, headache, is stuffed up,. He is on oxygen and a CPAP. Is 75 years old and worried about his symptoms. The only almost couldn't breath place that tests for RSV is (Withheld) Urgent Care. Doesn't know what Pfizer could do about RSV or RSV testing. Clarified he doesn't know what RSV stands for but knows RSV is a lung disease. He also has COPD. Clarified he is not calling about a specific Pfizer product related to RSV he is calling about research that Pfizer completed regarding COPD and COVID-19, even though what he may have is not COVID-19 but may be RSV. The CDC is putting a warning out about RSV and testing for RSV. He will be tested for RSV but doesn't know if his insurance will cover it or not. He has all the RSV symptoms except the fever. He had double pneumonia and almost died. He has used Pfizer products for COVID-19. Clarified he did have the Pfizer COVID-19 Shot brand.   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: Nasal congestion, Oropharyngeal pain, Pneumonia, Respiratory syncytial virus infection, Respiratory syncytial virus test
Clinical narrative: He is on oxygen and a CPAP; Double pneumonia; Cough; Wheezing; Sore throat; stuffed up; almost couldn't breath; COPD; Has all RSV symptoms except for fever; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPOXIA (medically significant), outcome "unknown", described as "He is on oxygen and a CPAP"; PNEUMONIA (medically significant), outcome "unknown", described as "Double pneumonia"; COUGH (non-serious), outcome "unknown"; WHEEZING (non-serious), outcome "unknown"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "Sore throat"; NASAL CONGESTION (non-serious), outcome "unknown", described as "stuffed up"; DYSPNOEA (non-serious), outcome "unknown", described as "almost couldn't breath"; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (non-serious), outcome "unknown", described as "COPD"; RESPIRATORY SYNCYTIAL VIRUS INFECTION (non-serious), outcome "unknown", described as "Has all RSV symptoms except for fever"; HEADACHE (non-serious), outcome "unknown". The event "has all rsv symptoms except for fever" required emergency room visit. The patient underwent the following laboratory tests and procedures: Respiratory syncytial virus test: Unknown results; SARS-CoV-2 test: Negative, notes: he tested negative for COVID-19 with self testing and testing at pharmacies. He was tested 4 or 5 times.  Clinical course: Patient doesn't know if he is calling about a Pfizer product but he tested negative for COVID-19 with self-testing and testing at pharmacies. He was tested 4 or 5 times. He has symptoms that could be RSV. He has everything except the fever. Has a cough, wheezing, sore throat, headache, is stuffed up,. He is on oxygen and a CPAP. Is 75 years old and worried about his symptoms. The only almost couldn't breath place that tests for RSV is (Withheld) Urgent Care. Doesn't know what Pfizer could do about RSV or RSV testing. Clarified he doesn't know what RSV stands for but knows RSV is a lung disease. He also has COPD. Clarified he is not calling about a specific Pfizer product related to RSV he is calling about research that Pfizer completed regarding COPD and COVID-19, even though what he may have is not COVID-19 but may be RSV. The CDC is putting a warning out about RSV and testing for RSV. He will be tested for RSV but doesn't know if his insurance will cover it or not. He has all the RSV symptoms except the fever. He had double pneumonia and almost died. He has used Pfizer products for COVID-19. Clarified he did have the Pfizer COVID-19 Shot brand.   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: SARS-CoV-2 test, Wheezing
Clinical narrative: He is on oxygen and a CPAP; Double pneumonia; Cough; Wheezing; Sore throat; stuffed up; almost couldn't breath; COPD; Has all RSV symptoms except for fever; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPOXIA (medically significant), outcome "unknown", described as "He is on oxygen and a CPAP"; PNEUMONIA (medically significant), outcome "unknown", described as "Double pneumonia"; COUGH (non-serious), outcome "unknown"; WHEEZING (non-serious), outcome "unknown"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "Sore throat"; NASAL CONGESTION (non-serious), outcome "unknown", described as "stuffed up"; DYSPNOEA (non-serious), outcome "unknown", described as "almost couldn't breath"; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (non-serious), outcome "unknown", described as "COPD"; RESPIRATORY SYNCYTIAL VIRUS INFECTION (non-serious), outcome "unknown", described as "Has all RSV symptoms except for fever"; HEADACHE (non-serious), outcome "unknown". The event "has all rsv symptoms except for fever" required emergency room visit. The patient underwent the following laboratory tests and procedures: Respiratory syncytial virus test: Unknown results; SARS-CoV-2 test: Negative, notes: he tested negative for COVID-19 with self testing and testing at pharmacies. He was tested 4 or 5 times.  Clinical course: Patient doesn't know if he is calling about a Pfizer product but he tested negative for COVID-19 with self-testing and testing at pharmacies. He was tested 4 or 5 times. He has symptoms that could be RSV. He has everything except the fever. Has a cough, wheezing, sore throat, headache, is stuffed up,. He is on oxygen and a CPAP. Is 75 years old and worried about his symptoms. The only almost couldn't breath place that tests for RSV is (Withheld) Urgent Care. Doesn't know what Pfizer could do about RSV or RSV testing. Clarified he doesn't know what RSV stands for but knows RSV is a lung disease. He also has COPD. Clarified he is not calling about a specific Pfizer product related to RSV he is calling about research that Pfizer completed regarding COPD and COVID-19, even though what he may have is not COVID-19 but may be RSV. The CDC is putting a warning out about RSV and testing for RSV. He will be tested for RSV but doesn't know if his insurance will cover it or not. He has all the RSV symptoms except the fever. He had double pneumonia and almost died. He has used Pfizer products for COVID-19. Clarified he did have the Pfizer COVID-19 Shot brand.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Blister
Clinical narrative: blisters on my hands; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLISTER (non-serious), outcome "unknown", described as "blisters on my hands".  Additional Information: It was reported that the patient was concerned for having blisters on the hands from the COVID shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac failure
Clinical narrative: Heart failure; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC FAILURE (medically significant), outcome "unknown", described as "Heart failure".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected..; Sender's Comments: Based on the information in the case report, a possible causal relationship between the event cardiac failure and suspect drug BNT162B2 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.
Sex: U
Vaccine: PNC13
Symptoms: Antibody test negative, Drug ineffective, Ear infection, Infection, Pneumonia pneumococcal
Clinical narrative: Recurring infection (ear sinus, and s pneumo. antibody titers negative after completed series; Recurring infection (ear sinus, and s pneumo. antibody titers negative after completed series; Recurring infection (ear sinus, and s pneumo. antibody titers negative after completed series; Recurring infection (ear sinus, and s pneumo. antibody titers negative after completed series; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), 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: DRUG INEFFECTIVE (medically significant), PNEUMONIA PNEUMOCOCCAL , EAR INFECTION (medically significant), SINUSITIS (medically significant), outcome "unknown" and all described as "Recurring infection (ear sinus, and s pneumo. antibody titers negative after completed series". The patient underwent the following laboratory tests and procedures: Antibody test: Negative, notes: Antibody titers negative after completed series.  Clinical course details: Recurring infection (ear sinus, and s pneumo). Antibody titers negative after completed series.  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely 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-202300192340 same reporter/drug/event, different patient;
Sex: U
Vaccine: PNC13
Symptoms: Sinusitis
Clinical narrative: Recurring infection (ear sinus, and s pneumo. antibody titers negative after completed series; Recurring infection (ear sinus, and s pneumo. antibody titers negative after completed series; Recurring infection (ear sinus, and s pneumo. antibody titers negative after completed series; Recurring infection (ear sinus, and s pneumo. antibody titers negative after completed series; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), 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: DRUG INEFFECTIVE (medically significant), PNEUMONIA PNEUMOCOCCAL , EAR INFECTION (medically significant), SINUSITIS (medically significant), outcome "unknown" and all described as "Recurring infection (ear sinus, and s pneumo. antibody titers negative after completed series". The patient underwent the following laboratory tests and procedures: Antibody test: Negative, notes: Antibody titers negative after completed series.  Clinical course details: Recurring infection (ear sinus, and s pneumo). Antibody titers negative after completed series.  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely 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-202300192340 same reporter/drug/event, different patient;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: had COVID; had COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "allergies" (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 Apr2023, outcome "unknown" and all described as "had COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Unknown results, notes: I took an at home test 3 to 4 times a month; (2023) Negative, notes: The test the week before was negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes Paxlovid 3 pills twice daily from 17Apr2023 to 21Apr2023. Clinical course: Patient thought her allergies and depression were getting worse and it was harder to breath and she was losing her voice. Since Covid, patient began to take home test 3 to 4 times a month. The test the week before was negative. It was also reported that patient have taken covid shots and boosters. Pharmacy sent a test last week that Pfizer has an adult booster for people of her age. Her doctor said she should take it. Patient was asking for suggestion.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID-19; COVID-19; one vaccination is from Moderna and 2 from Pfizer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) and in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in 2021 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: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 2021, outcome "unknown", described as "one vaccination is from Moderna and 2 from Pfizer"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID-19".  Clinical course:  It was reported that the patient had an AE of COVID-19 with previous Pfizer COVID vaccinations. Vaccination Dates included 27Feb2021, 20Mar2021, 28Dec2021. The reporter was informed that one vaccination is from Moderna and 2 from Pfizer. The reporter do not know which vaccines correspond to which dates. Lot numbers were reported as unknown. COVID-19 AE was reported 05Dec2022 to 18Dec2022. Confirmation via a test was not provided. This occurred at a site.  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: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: with tested positive in 2020 on 2021 don't have record but after at least 3 vaccine; with tested positive in 2020 on 2021 don't have record but after at least 3 vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), in 2022 as dose 3 (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "stents placed in his heart" (unspecified if ongoing), notes: a member of stents placed in his heart.; "My husband has had no spleen since high school" (unspecified if ongoing), notes: My husband has had no spleen since high school; "sledding accident" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "with tested positive in 2020 on 2021 don't have record but after at least 3 vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: My husband and I both tested positive in 2022 or 2021; Positive, notes: we both tested positive; Positive, notes: on Sunday tested positive; Positive, notes: Positive covid-19 tests for both within less 48; Positive.  Clinical information: This case belongs to husband. Event experienced: husband ended up with symptoms much less than mine. Positive covid-19 tests for both within less 48 but in 4 hrs but husband was only a bit tired. I felt very tired and slept for 10 hrs a day for 3 days as well as sleeping all night. Little to no appetite. No hospitalization for the events. The latest booster was approved after we tested positive this last time. Treated Covid with Paxlovid, took for 4 days and missed one night but continued both the rest to finish. My husband and I both tested positive in 2022 or 2021- do not have record but after at least 3 vaccine injections. He was unfazed by it, but I stayed in bed sleeping for most of the three days and nights. We had our last boosters at of 2022. I am not sure exactly when the most recent booster was offered but before I could organize to get it, we both tested positive. We had heard a man at our church what's had talked to on Sunday tested positive and the sat after the holiday. My husband forced out 5 chair members who had in the insisted we test because I was hoping we could find ourselves negative. My husband has had no spleen since high school and a sledding accident, and a member of stents placed in his heart. This means he is on a number of prescriptive drugs (not necessarily) Pfizer products. But both times have been hit hard while he has slid on through with only some tenderness! We are agreeable to share the meds list with you if you have any interest.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: very-ill/ Everyday patient sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). 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. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "very-ill/ Everyday patient sick".  Additional information: It was reported that patient had effects after covid-19 vaccine. Everyday patient sick. Patient want to just settle this thing outside of court. Patient was very-ill every since got the two shots. No medical inquiry asked.  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-202300194186 same reporter/ patient/ event, different dose;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: had 2 Covid rebounds; had 2 Covid rebounds; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "had 2 Covid rebounds". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included PAXLOVID. The patient's wife reported that the patient had covid rebounds after taking PAXLOVID. The patient had had 2 rebounds (so far).  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300175995 Same reporter, similar events in different patients;
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Infected on May2022 with Omicron; Infected on May2022 with Omicron; 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), in 2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown (booster), single (Batch/Lot number: unknown) and as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Lyme", start date: 2014, stop date: 2015, notes: bad Lyme successfully treated with Amoxicillin and Azithromycin for a year, followed by tinctures. The patient's concomitant medications were not reported. Past drug history included: Amoxicillin for Lyme, notes: bad Lyme successfully treated with Amoxicillin and Azithromycin for a year, followed by tinctures; Azithromycin for Lyme, notes: bad Lyme successfully treated with Amoxicillin and Azithromycin for a year, followed by tinctures. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset May2022, outcome "unknown", COVID-19 (medically significant) with onset May2022, outcome "recovered" and all described as "Infected on May2022 with Omicron". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive, notes: Infected on May2022 with Omicron. Therapeutic measures were taken as a result of covid-19.  Clinical course: Offering to participate in trial of a 6-Valent OspA-Based Lyme Disease Vaccine (VLA15). The patient had bad Lyme in 2014-15; around 6 months after infection, a doctor successfully treated the patient with Amoxicillin and Azithromycin for a year, followed by tinctures. The patient never wanted to repeat that and would be happy to help develop the vaccine. The patient was 76, healthy, physically and professionally active. The patient was also a grateful recipient of Pfizer COVID vaccine, 4x boosted. Infected on May2022 with Omicron a month after 2nd booster: mild symptoms that vanished after beginning Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 16.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: another pregnancy test was done and it was positive with no reported adverse event; Initial information received on 15-May-2023 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 16 years old female patient who was had to vaccine influenza quadrival a-b vaccine [fluzone qiv] in context of another pregnancy test was done and it was positive with no reported adverse event.   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported another pregnancy test was done and it was positive with no reported adverse event occurred at unknown gestation period. The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies.  Concomitant medications included meningococcal vaccine a/c/y/w conj (tet tox) (menquadfi) for prophylactic vaccination; and meningococcal vaccine b (meningococcal vaccine b) for Immunisation.  On 19-Dec-2022, the patient received 0.5 ml once of suspect influenza quadrival a-b vaccine Suspension for injection lot UT7695LA via unknown route, strength, expiration date in unknown administration site for immunisation.  On 19-Dec-2022 the patient developed a non-serious another pregnancy test was done and it was positive with no reported adverse event (exposure during pregnancy)(latency: same day).  Relevant prenatal testing after exposure included was unknown.  Relevant laboratory test results included: Pregnancy test - On 19-Dec-2022: Negative; on an unknown date: Positive  Action taken was not applicable.  Outcome: Unknown for the event another pregnancy test was done and it was positive with no reported adverse event. Additionally, at time of reporting, the outcome of the pregnancy is unknown.; Sender's Comments:  US-SA-2023SA151221:
Age: 0.17
Sex: F
Vaccine: UNK
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: product was administered to a patient and then they noticed that on the chart it says that the product has expired with no reported adverse event; Initial information received on 15-May-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 8 weeks old female patient who was administered Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] and then they noticed that on the chart it says that the product has expired with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Rotavirus Vaccine, Pneumococcal Vaccine Conj (Pneumococcal Conjugate Vaccine) (PCV) and Hepatitis B vaccine (Hepatitis B vaccine) all for Immunisation.  On 15-May-2023, the patient received a 0.5ml dose (dose 1) suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection of lot UJ668AAA and expiry: 13-May-2023 via intramuscular route in the right thigh for immunization.  On 15-May-2023, the patient developed a non-serious event product was administered to a patient and then they noticed that on the chart it says that the product has expired with no reported adverse event (expired product administered) (latency: same day) following the administration of Diphtheria/Tetanus/5 Hybrid ac Pertussis/IPV(VERO)/HIB(PRP/T) vaccine.  No lab data was reported.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event product was administered to a patient and then they noticed that on the chart it says that the product has expired with no reported adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 34.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: nurse administered an expired Menactra vaccine to a patient with no reported adverse event; Initial information received on 16-May-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 34 years old male patient who was administered an expired meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] vaccine to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine CONJ 13V (CRM197) (Prevenar 13) and HIB vaccine (Haemophilus Influenza Type B Vaccine) both for prophylactic vaccination (Immunisation).  On 16-May-2023, the patient received a dose of 0.5 ml (frequency: once every 4 years) of suspect meningococcal A-C-Y-W135 (D CONJ) vaccine (Solution for injection) (lot: U7208AA; expiry date: 10-Feb-2023; strength: normal) via intramuscular route in unknown administration site for prophylactic vaccination (Immunisation).  On 16-May-2023 the patient was administered an expired meningococcal A-C-Y-W135 (D CONJ) vaccine to a patient with no reported adverse event (expired product administered) (latency: same day).  It was reported, " Nurse wants to know what can be done and when to administer the next dose."  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 47.0
Sex: M
Vaccine: PNC20
Symptoms: Arthralgia, Mobility decreased
Clinical narrative: Patient was given Prevnar 20 into his left deltoid at an outside facility on 5/18/23 around 1500.  Several hours after administration, patient began noticing pain in his left shoulder. By 7 hours post administration, patient was experiencing severe pain in his left shoulder making left arm movement impossible. He presented to his primary care facility around 0900 on 5/19/23 complaining of ongoing severe left shoulder pain. The noted vaccine administration site was noted to mid upper third of patient's left deltoid with the puncture mark approx 1 cm inferior to his acromion. Patient with severe pain and guarding with palpation of his subacromiol-subdeltoid bursa and the inability to actively or passively move his left upper extremity due to the pain in his shoulder.
Age: 62.0
Sex: F
Vaccine: PNC20
Symptoms: Dizziness, Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild
Age: 62.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Headache, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Systemic: Headache-Mild
Age: 68.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Pyrexia
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Severe, Systemic: Fever-Mild
Age: 62.0
Sex: F
Vaccine: HEP, TD, VARZOS
Symptoms: Abdominal pain, Back pain, Constipation, Decreased appetite, Diarrhoea
Clinical narrative: Breakthrough fever of 100.3 with 1000 mg Tylenol Q 6 hours, nausea, inappetence, exacerbation of back pain.  Abdominal pain and alternating diarrhea and constipation of 3 weeks afterward
Age: 62.0
Sex: F
Vaccine: HEP, TD, VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: Breakthrough fever of 100.3 with 1000 mg Tylenol Q 6 hours, nausea, inappetence, exacerbation of back pain.  Abdominal pain and alternating diarrhea and constipation of 3 weeks afterward
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Injection site pain, Pain
Clinical narrative: Pain at injection site, headache, body aches, flu-like