chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, CSF test, Investigation, Magnetic resonance imaging head, Myasthenia gravis
Clinical narrative: Immune Mediated Bulbar Myasthenia Gravis; This is a literature report.  A 32-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: MYASTHENIA GRAVIS (hospitalization, medically significant), outcome "recovering", described as "Immune Mediated Bulbar Myasthenia Gravis". The patient underwent the following laboratory tests and procedures: Antibody test: non-reactive; without explanatory pathological findings; CSF test: without explanatory pathological findings; anti-MuSK serologic studies: non-reactive; without explanatory pathological findings; AChR binding and blocking antibodies were, notes: ultimately detected; Magnetic resonance imaging head: without explanatory pathological findings; Nerve stimulation test: decrement in facial nerve-nasalis CMAPs with low f, notes: repetitive stimulation, consistent with a post-synaptic neuromuscular disorder; post-exercise and, notes: repetitive stimulation-induced decrements in median-abductor policus brevis and spinal accessorytrapezius CMAPs, confirming a systemic post-synaptic neuromuscular disorder. Therapeutic measures were taken as a result of myasthenia gravis.; Sender's Comments: Based on the information available  a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Immune Mediated Bulbar Myasthenia Gravis. 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-202200966563 Same article/ drug/patient and different event;
Sex: M
Vaccine: COVID19
Symptoms: Nerve stimulation test
Clinical narrative: Immune Mediated Bulbar Myasthenia Gravis; This is a literature report.  A 32-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: MYASTHENIA GRAVIS (hospitalization, medically significant), outcome "recovering", described as "Immune Mediated Bulbar Myasthenia Gravis". The patient underwent the following laboratory tests and procedures: Antibody test: non-reactive; without explanatory pathological findings; CSF test: without explanatory pathological findings; anti-MuSK serologic studies: non-reactive; without explanatory pathological findings; AChR binding and blocking antibodies were, notes: ultimately detected; Magnetic resonance imaging head: without explanatory pathological findings; Nerve stimulation test: decrement in facial nerve-nasalis CMAPs with low f, notes: repetitive stimulation, consistent with a post-synaptic neuromuscular disorder; post-exercise and, notes: repetitive stimulation-induced decrements in median-abductor policus brevis and spinal accessorytrapezius CMAPs, confirming a systemic post-synaptic neuromuscular disorder. Therapeutic measures were taken as a result of myasthenia gravis.; Sender's Comments: Based on the information available  a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Immune Mediated Bulbar Myasthenia Gravis. 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-202200966563 Same article/ drug/patient and different event;
Sex: F
Vaccine: COVID19
Symptoms: Blood immunoglobulin G, Blood immunoglobulin M, COVID-19, Drug ineffective, Oxygen saturation
Clinical narrative: tested positive for Covid-19 during screening; tested positive for Covid-19 during screening; This is a literature report.  A 30-year-old female patient 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 included: "multiple sclerosis (MS)" (unspecified if ongoing).  The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant), all with latency 4 months after the suspect product(s) administration, outcome "recovered" and all described as "tested positive for Covid-19 during screening". The patient was hospitalized for drug ineffective, covid-19 (hospitalization duration: 23 day(s)). The patient underwent the following laboratory tests and procedures: Blood immunoglobulin G: revealed persistent low levels of IgG and IgM and, notes: negative covid specific antibodies; Blood immunoglobulin M: revealed persistent low levels of IgG and IgM and, notes: IgM and negative covid specific antibodies; Oxygen saturation: 90 %, notes: on room air; SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: She was started on dexamethasone and nasal cannula oxygen. Her oxygen requirements increased significantly within 72 hours of admission and she was placed on high flow nasal cannula. Despite supportive care, her hypoxic respiratory failure persisted for 2 weeks. After extensive multidisciplinary discussion, Remdesivir with compassionate use of monoclonal antibodies was given. The patient received one infusion of 4000 mg of Casirivimab and Indevimab. She improved within six days of administration and was discharged home without any oxygen supplementation on hospital day 23.; Sender's Comments: Based on the available information in the case, the causal association between the event COVID-19, Drug ineffective and the suspect drug BNT162B2 cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: tested positive for Covid-19 during screening; tested positive for Covid-19 during screening; This is a literature report.  A 30-year-old female patient 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 included: "multiple sclerosis (MS)" (unspecified if ongoing).  The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant), all with latency 4 months after the suspect product(s) administration, outcome "recovered" and all described as "tested positive for Covid-19 during screening". The patient was hospitalized for drug ineffective, covid-19 (hospitalization duration: 23 day(s)). The patient underwent the following laboratory tests and procedures: Blood immunoglobulin G: revealed persistent low levels of IgG and IgM and, notes: negative covid specific antibodies; Blood immunoglobulin M: revealed persistent low levels of IgG and IgM and, notes: IgM and negative covid specific antibodies; Oxygen saturation: 90 %, notes: on room air; SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: She was started on dexamethasone and nasal cannula oxygen. Her oxygen requirements increased significantly within 72 hours of admission and she was placed on high flow nasal cannula. Despite supportive care, her hypoxic respiratory failure persisted for 2 weeks. After extensive multidisciplinary discussion, Remdesivir with compassionate use of monoclonal antibodies was given. The patient received one infusion of 4000 mg of Casirivimab and Indevimab. She improved within six days of administration and was discharged home without any oxygen supplementation on hospital day 23.; Sender's Comments: Based on the available information in the case, the causal association between the event COVID-19, Drug ineffective and the suspect drug BNT162B2 cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: CSF test, Chronic inflammatory demyelinating polyradiculoneuropathy, Magnetic resonance imaging, Magnetic resonance imaging head, Nerve conduction studies
Clinical narrative: Chronic inflammatory demyelinating polyneuropathy; This is a literature report for the following literature source(s): Neurology, 2022; Vol:98(18 SUPPL), pgs:3371.  A 34-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (medically significant), 2 weeks after the suspect product(s) administration, outcome "recovering", described as "Chronic inflammatory demyelinating polyneuropathy". The patient underwent the following laboratory tests and procedures: CSF test: albuminocytologic dissociation; Magnetic resonance imaging: no abnormalities; Magnetic resonance imaging head: no abnormalities; Nerve conduction studies: were consistent with demyelination; Neurological examination: 4/5 strength in upper and lower extremities, notes: generalized hyporeflexia, decreased vibration, and proprioception. Therapeutic measures were taken as a result of chronic inflammatory demyelinating polyradiculoneuropathy.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information in the case the reported event is assessed as unrelated to suspect drug and more likely related to intercurrent/ underlying medical condition.
Sex: M
Vaccine: COVID19
Symptoms: Neurological examination
Clinical narrative: Chronic inflammatory demyelinating polyneuropathy; This is a literature report for the following literature source(s): Neurology, 2022; Vol:98(18 SUPPL), pgs:3371.  A 34-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (medically significant), 2 weeks after the suspect product(s) administration, outcome "recovering", described as "Chronic inflammatory demyelinating polyneuropathy". The patient underwent the following laboratory tests and procedures: CSF test: albuminocytologic dissociation; Magnetic resonance imaging: no abnormalities; Magnetic resonance imaging head: no abnormalities; Nerve conduction studies: were consistent with demyelination; Neurological examination: 4/5 strength in upper and lower extremities, notes: generalized hyporeflexia, decreased vibration, and proprioception. Therapeutic measures were taken as a result of chronic inflammatory demyelinating polyradiculoneuropathy.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information in the case the reported event is assessed as unrelated to suspect drug and more likely related to intercurrent/ underlying medical condition.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Respiration abnormal
Clinical narrative: I contracted Covid in late April; I contracted Covid in late April; breathing issue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Lung Disease" (unspecified if ongoing), notes: lung issue. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I contracted Covid in late April"; RESPIRATION ABNORMAL (non-serious), outcome "unknown", described as "breathing issue". The event "breathing issue" required emergency room visit. Clinical course: Patient had 2 Pfizer vaccine plus the booster. He continued covid in late April while travelling. He was not thin and having a pre-existing lung issue. As mentioned he was 6 -12 hrs was from having to go to the ER due to his breathing issue. He started the not Paxlovid and instant after 6 -10 hours was "stable" not better that 700 to a bit longer but no longer on the cusp of hospitalization. He absolutely believe paxlovid was the only reason he did not end up intubated. Product Information: Name of the product (Both commercial and genetic name if known): pf-07321332, ritonavir (Paxlovid), patient was taking for Covid. The patient started treatment with Paxlovid for COVID-19 on 04May2022 and stopped on 08May2022. Other product taken together for same indication included Ibuprofen and was overlapping and still taking. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid.  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: COVID-19, Drug ineffective
Clinical narrative: vaccines do not help prevent; vaccines do not help prevent; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A 30-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "vaccines do not help prevent". Clinical course: Patient was vaccinated 6-12months ago and caught Covid one month ago (as of 14Jul2022) so the vaccines do not help prevent at all. 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: Drug ineffective, Suspected COVID-19
Clinical narrative: I also got covid in Jan2022 after having the booster in Sep2021; I also got covid in Jan2022 after having the booster in Sep2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP),. The reporter is the patient.  A 74-year-old patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and in Sep2021 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), SUSPECTED COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "I also got covid in Jan2022 after having the booster in Sep2021".  Clinical course: The patient was  interested in a new booster for fall 2022. The patient have had the original vaccines and two boosters, the last booster was in Apr2022. The patient had no side effects from the shots. There was a new covid variant that the boosters the patient have had would not keep the patient from getting covid and it was worse than the ones i got the booster for. The patient also got covid in Jan2022 after having the booster in Sep2021.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 65-year-old female patient received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EN6204) at the age of 64 years, in right arm for covid-19 immunization. The patient's relevant medical history included: "Has lymphedema in left arm" (unspecified if ongoing), notes: Has lymphedema in left arm because of the breast cancer; "13 year breast cancer survivor" (unspecified if ongoing), notes: 13 year breast cancer survivor this October. The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "recovered", described as "was sore for a couple of days with the first 2 doses of the Pfizer COVID-19 vaccine". Additional information: The vaccine was given in right arm. The CSN number 5063307133, MRN number M800348405, HAR number 954293892, on vaccination card. Under the word dose, says EN6204, unknown what that number is.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. An adult female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "while the 1st injection of feeling the vaccine moving thru her arm." 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: Dyskinesia
Clinical narrative: involuntary movements of the hands, arms and shoulders; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:  A female patient received BNT162b2 (BNT162B2), on 21Apr2022 as dose number unknown, single (Lot number: FL8095) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSKINESIA (non-serious) with onset 2022, outcome "unknown", described as "involuntary movements of the hands, arms and shoulders". Additional information: Reporter provided verification of contact address on 15Jul2022 Pedi Pfizer #2 FL8095. Granddaughter has received vaccine 21Jul22. Started with involuntary movements of the hands, arms and shoulders.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Patient was fully vaccinated, but contracted covid.; Patient was fully vaccinated, but contracted covid.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Patient was fully vaccinated, but contracted covid.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes got tested positive for covid. Clinical Course: It was reported that patient was fully vaccinated, but contracted covid and tested positive for covid. Event did not take place after use of the product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Patient tested positive for COVID 19; Patient tested positive for COVID 19; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient received BNT162b2 (COMIRNATY), 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), outcome "unknown" and all described as "Patient tested positive for COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Patient tested positive for COVID 19. Symptoms mild. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient was vaccinated with Comirnaty and received two boosters. Patient tested positive for COVID 19. Symptoms mild. Patient prescribed Paxlovid and is responding well to therapy.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: 4 pfizer vaccinations with no underlying health issues should have not home tested positive for covid for any strain; 4 pfizer vaccinations with no underlying health issues should have not home tested positive for covid for any strain; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), 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 had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "4 pfizer vaccinations with no underlying health issues should have not home tested positive for covid for any strain". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: should have not home tested positive for COVID for any strain. Clinical course: The patient with 4 Pfizer vaccinations with no underlying health issues should have not home tested positive for COVID for any strain. Thus, the patient quarantined away from family and life for the next 5 days. The patient further stated "Pfizer make more potent cocktails. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: This is a spontaneous report received from a contactable nurse (the patient). A 60-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EL0140), at the age of 60, intramuscularly, in left arm, on Jan 8, 2021, at 11:00, single dose, for COVID-19 immunization. Medical history included asthma, start date: 2000 (ongoing); neuropathy, start date: 2017 (ongoing); seasonal allergies, start date: 1990 (ongoing); and celiac disease, start date: 2017 (ongoing). Concomitant medication included gabapentin taken for neuropathy peripheral (ongoing); and Xyzal oral taken for hypersensitivity (ongoing). No prior vaccinations within 4 weeks. The patient experienced pyrexia/fever and rash, onset Jan 2021, with outcome of unknown. Sender's comments: Linked reports: US-PFIZER INC-PV202200024802 (same patient/reporter/event, different dose); US-PFIZER INC-PV202200024803 (same patient/reporter/event, different dose).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Nurse). A 61-year-old female patient received BNT162b2 (BNT162B2), on 28Jan2021 at 11:00 as dose 2, single (Lot number: EL9261) at the age of 60 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "Celiac Dx", start date: 2017 (ongoing); "Asthma", start date: 2000 (ongoing); "Neuropathy", start date: 2017 (ongoing); "Seasonal allergies", start date: 1990 (ongoing). Concomitant medication(s) included: GABAPENTIN oral taken for neuropathy peripheral (ongoing); XYZAL oral taken for hypersensitivity (ongoing). Vaccination history included: BNT162b2 (Dose: 1 ,Single, Date/Time: 08Jan2021, Time: 11:00, Anatomical site of injection: L Arm, Route of administration: Intramuscular, Lot number: EL0140), administration date: 08Jan2021, when the patient was 60-year-old, for COVID-19 Immunization, reaction(s): "fever for 2 days after injection", "also got a rash on R buttock". The following information was reported: RASH (non-serious), outcome "unknown", described as "Rash on R buttock"; PYREXIA (non-serious), outcome "unknown", described as "Fever for 2 days after injection". No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-PV202200024801 same patient/reporter, different dose; PFIZER INC-PV202200024803 same patient/reporter, different dose;
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient. A 61-year-old female patient received BNT162b2 (BNT162B2), on 29Sep2021 at 11:02 as dose 3 (booster), single (Lot number: EW0183) at the age of 61 years intramuscular, in left arm for covid-19 immunization. The patient's relevant medical history included: "Neuropathy", start date: 2017 (ongoing); "Allergies" (ongoing); "Asthma", start date: 2000 (ongoing); "seasonal allergies", start date: 1990 (ongoing); "Celiac Dx", start date: 2017 (ongoing). Concomitant medication(s) included: GABAPENTIN oral taken for neuropathy peripheral (ongoing); XYZAL oral taken for hypersensitivity (ongoing). Vaccination history included: BNT162b2 (DOSE: 1, First Dose: 08Jan2021, Time: 11:00, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: EL0140), administration date: 08Jan2021, when the patient was 60-year-old, for COVID-19 Immunization, reaction(s): "Pyrexia"; BNT162b2 (DOSE: 2, Second Dose: 29Jan2021, Time: 11:00, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: EL9261), administration date: 28Jan2021, when the patient was 60-year-old, for COVID-19 Immunization, reaction(s): "Pyrexia"; BNT162b2 (Dose 1), administration date: 08Jan2021, when the patient was 60-year-old, for COVID-19 immunization, reaction(s): "rash"; BNT162b2 (Dose 2), administration date: 28Jan2021, when the patient was 60-year-old, for COVID-19 immunization, reaction(s): "rash". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever"; RASH (non-serious), outcome "unknown", described as "rash on R buttock". Additional information. Patient did have a fever for 2 days after injection and also got a rash on R buttock. This reaction occurred after all 4 vaccines. The reporter considered the Pfizer product had a causal effect to the adverse events.; Sender's Comments: Linked Report(s) : PFIZER INC-PV202200024801 same patient/reporter, different dose; PFIZER INC-PV202200024802 same patient/reporter, different dose;
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Affected all my joints with great pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:  The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "Affected all my joints with great pain". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive with COVID 19; tested positive with COVID 19; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 21-year-old male patient received BNT162b2 (COMIRNATY), 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), outcome "unknown" and all described as "tested positive with COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Consumer tested positive with COVID 19. Therapeutic measures were taken as a result of drug ineffective, covid-19.Consumer prescribed Paxlovid and is responding well to therapy. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Contracted virus after vaccination; contracted COVID-19; 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 (COMIRNATY), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "Contracted virus after vaccination"; SUSPECTED COVID-19 (medically significant), outcome "unknown", described as "contracted COVID-19".  Clinical Course: Reporter considered that events caused by suspect product. Patient and her husband received the Comiranty vaccine and then contracted COVID-19 after the second dose   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: PNC20
Symptoms: Vaccination site pain
Clinical narrative: Considerable Injection Site Pain; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from a sales representative.  A 57-year-old male patient received pneumococcal 20- valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Type 2 diabetic" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Considerable Injection Site Pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: contracted COVID 19; contracted COVID 19; 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), 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "contracted COVID 19".  Clinical courses: The patient recently contracted COVID 19 for the first time since the pandemic began. He /she credited the fact that his/her symptoms were mild to the fact that he/she received our vaccine and two booster shots.   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, Influenza like illness, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID; Tested positive for COVID; flu like symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient in his 40's received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Tested positive for COVID"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu like symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Clinical Course: It was reported that her husband, withheld, mid 40s also tested positive for COVID. Both have flu like symptoms.  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-PV202200025192 same reporter/ drug/ event, different patient;
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: got Covid and had been very symptomatic; got Covid and had been very symptomatic; 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), 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. Vaccination history included: MMR vaccine (non responder to the MMR vaccine and Hep B vaccine series, mostly meaning immune for a short time), reaction(s): "non responder"; Hep B vaccine (non responder to the MMR vaccine and Hep B vaccine series, mostly meaning immune for a short time), reaction(s): "non responder". The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "got Covid and had been very symptomatic". 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: COVID-19, Drug ineffective, Influenza like illness, SARS-CoV-2 test
Clinical narrative: tested positive for COVID; tested positive for COVID; flu like symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient in her 40's received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for COVID"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu like symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.  Clinical course: Reporters friend, female, mid-40s, tested positive for COVID. Patient just returned from vacation and had received the Pfizer COVID vaccine.   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-PV202200025180 same reporter/ drug/ event, different patient;
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Joint stiffness, Pain in extremity
Clinical narrative: arm pain; joint stiffness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 55-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 55 years 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; Covid-19 vaccine (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE, 1ST COVID Booster), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm pain"; JOINT STIFFNESS (non-serious), outcome "unknown". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Food allergy
Clinical narrative: a few anaphylactic reactions; many new food allergies post covid vaccines; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the parent.  A 24-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "a few anaphylactic reactions"; FOOD ALLERGY (non-serious), outcome "unknown", described as "many new food allergies post covid vaccines".  Clinical course: Reporter stated that the daughter has started with many new food allergies post covid vaccines- a few anaphylactic reactions too. Reporter asked if they have any other reported cased of this occurring.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Magnetic resonance imaging head, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Illness/AE: COVID-19/Onset date: 15Jan2022; Illness/AE: COVID-19/Onset date: 15Jan2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 13Jan2021 at 12:00 as dose 1, single (Lot number: EL1284), in left arm, on 03Feb2021 at 12:00 as dose 2, single (Lot number: EL9262), in left arm and on 26Sep2021 at 12:00 as dose 3 (booster), single (Lot number: 301358A) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Heart problem/Heart disease", start date: 2004 (ongoing), notes: Heart problem, Pertinent details: 2006 single bypass; "Depression" (unspecified if ongoing); "Allergy" (unspecified if ongoing); "Single bypass", start date: 2006, stop date: 2006, notes: 2006 Single bypass. The patient's family history included: "Heart problem/Heart disease" (unspecified if ongoing), notes: Heart disease runs in family maternal. Concomitant medication(s) included: PLAVIX taken for cardiac disorder (ongoing); CRESTOR taken for cardiac disorder (ongoing); METOPROLOL taken for cardiac disorder (ongoing); CITALOPRAM taken for depression (ongoing); CETRIZINE taken for hypersensitivity (ongoing). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Jan2022, outcome "recovered" (15Feb2022) and all described as "Illness/AE: COVID-19/Onset date: 15Jan2022". The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging head: (01Jun2022) Normal, notes: Normal; SARS-CoV-2 test: (15Jan2022) Positive, notes: Tested positive and 2 weeks or so later negative; (2022) Negative, notes: Tested positive and 2 weeks or so later negative. Clinical course: The Patient reported that on 19May2022 he received the 4th shot (2nd booster) of the Pfizer COVID vaccine at pharmacy at 11 AM. By 2 PM he began losing hearing. By 7 PM complete loss of hearing in right ear. He reported that he made an appointment with ENT Dr. for 24May. A hearing test was conducted and complete loss of hearing in right ear. Treatment plan: One shot prednisone in ear each week for 3 weeks. Also take a regimen of oral prednisone for 2 weeks. Dr. ordered MRI to rule out any order problem. MRI done 01Jun- results normal, Last visit to ENT he said hearing loss likely permanent. Went to neurologist Dr. 30Jun. He believes hearing loss due to booster hot. Has another patient same situation. This week will revisit Dr.  and Dr.
Sex: U
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (the patient), program ID: (005570). A patient (no qualifiers provided) received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), Jan 2022, single dose, for COVID-19 immunization. Medical history and concomitant medications not reported. Vaccination history included BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), Dec 2021, for immunization. The patient developed alopecia (hair loss), with outcome of not recovered. Additional information: Patient experienced great hair loss after vaccination and wanted to know what can be done to stop this. The information on the batch/lot number for BNT162B2 requested and will be submitted if/when received.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: a very mild fever of 99.5 degrees; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 52-year-old male patient received BNT162b2 (COMIRNATY), on 16Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (dose1), for COVID-19 immunization; Covid-19 vaccine (dose2), for COVID-19 immunization; Covid-19 vaccine (dose3), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset Jul2022, outcome "recovered" (Jul2022), described as "a very mild fever of 99.5 degrees". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Approximately 18 hours post-dose, he registered a very mild fever of 99.5 degrees. Later that afternoon, it spiked to 101.1 then decreased over the next couple of hours and was normal at 97.9 at 24 hours post dose. No underlying medical conditions and no medications taken daily except multivitamin.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: viral rebound; viral rebound; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "viral rebound".  Clinical course information: Description of Event: The office reported at least 3 cases of viral rebound. Event took place after use of product.  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 known the information available the Causal relation between the events and suspect drug cannot be excluded completely,Linked Report(s) : US-PFIZER INC-202200981970 Same reporter/ drug/ AE, different patient;US-PFIZER INC-202200981971 same drug /event, different patient.;
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure fluctuation, Blood pressure measurement, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: 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), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD PRESSURE FLUCTUATION (non-serious) with onset 2021, outcome "not recovered", described as "BP swings"; FATIGUE (non-serious) with onset 2021, outcome "not recovered"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "not recovered", described as "brain fog"; DIZZINESS (non-serious) with onset 2021, outcome "not recovered", described as "light-headedness/dizziness"; PARAESTHESIA (non-serious) with onset 2021, outcome "not recovered"; TINNITUS (non-serious) with onset 2021, outcome "not recovered". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Clinical course: Since receiving the vaccine a year ago, patient has been suffering "long COVID" like symptoms: BP swings, light-headedness/dizziness, tinnitus, Paranesthesia, fatigue and brain fog. Patient reported that a brief internet search seemed to indicate that they were not the only one. Patient was querying if remedies for such side effects were pursued of if some was already available. Patient reported that this condition was quite debilitating.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.