chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Nov2021 at 15:45 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 41 years, in left arm for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "I have an IUD" (unspecified if ongoing); "haven't had a menstrual cycle in 4 years" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, Covid-19 with Paxlovid started from 14Jul2022 and stopped on 18Jul2022. Clinical Course: Patient have an IUD, haven't had a menstrual cycle in 4 years. While taking Paxlovid, she started bleeding for the first time in 4 years, days after she started having immense uterine pain. After many doctor visits, the IUD relocated in her uterus, caused an infection, and needs to be removed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID -9 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 50-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 49 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "not recovered", described as "COVID -9 Treatment"; COVID-19 (medically significant), outcome "not recovered", described as "COVID -19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Psoriatic arthropathy
Clinical narrative: Psoriatic arthritis break out/flare up spots on lower leg; This is a solicited report received from contactable reporter(s) (Consumer or other non-healthcare professional). The reporter is the patient. Other Case identifier(s): 22K-163-4477236-00 (Company). A 63-year-old male patient received BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Batch/Lot number: Unknown), on 11Feb2021 as dose 2, single (Batch/Lot number: Unknown) and on 26Aug2021 as dose 3 (booster), single (Batch/Lot number: Unknown) at the age of 62 years, all intramuscular for covid-19 immunisation, adalimumab (HUMIRA), (Lot number: 1159670) at citrate free, subcutaneous for psoriatic arthropathy, ankylosing spondylitis. The patient relevant medical history and concomitant medications were not reported. The following information was reported: PSORIATIC ARTHROPATHY (medically significant), outcome "not recovered", described as "Psoriatic arthritis break out/flare up spots on lower leg". The action taken for adalimumab was unknown.  Clinical information: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter considered "psoriatic arthritis break out/flare up spots on lower leg" related to BNT162b2. The reporter causality for the event of psoriatic arthritis break out/flare up spots on lower leg with Humira (Adalimumab) was no reasonable possibility.   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 current available limited information in the case provided, the causal association between the event and the use of suspect product BNT162B2 cannot be fully 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: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): LRN4666936.  A 49-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 included: "Multiple Sclerosis" (unspecified if ongoing). Concomitant medication(s) included: OCREVUS. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Sick".  Additional information: Patient's concurrent condition included: Multiple Sclerosis. Patient's concomitant medication included: Ocrevus We have no further information regarding the reported event(s) described above. Any additional material information received will be forwarded to you in accordance with policies and procedures.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Neutropenia, Neutrophil count
Clinical narrative: Neutropenia/neutrophil absolute count was down; 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), on 13Jun2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization. The following information was reported: NEUTROPENIA (hospitalization, medically significant), outcome "unknown", described as "Neutropenia/neutrophil absolute count was down". The patient was hospitalized for neutropenia (hospitalization duration: 4 day(s)). The event "neutropenia/neutrophil absolute count was down" required emergency room visit. The patient underwent the following laboratory tests and procedures: Neutrophil count: down to 0.1, notes: My neutrophil absolute count was down to 0.1 and normal  range started at 1.7.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Back pain, Blood test, Cerebrospinal fluid leakage, Chest X-ray normal, Chills
Clinical narrative: Neutropenia/neutrophil absolute count was down; 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), on 13Jun2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization. The following information was reported: NEUTROPENIA (hospitalization, medically significant), outcome "unknown", described as "Neutropenia/neutrophil absolute count was down". The patient was hospitalized for neutropenia (hospitalization duration: 4 day(s)). The event "neutropenia/neutrophil absolute count was down" required emergency room visit. The patient underwent the following laboratory tests and procedures: Neutrophil count: down to 0.1, notes: My neutrophil absolute count was down to 0.1 and normal  range started at 1.7.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Critical illness, Economic problem, Emotional distress, Exercise tolerance decreased, Headache
Clinical narrative: Neutropenia/neutrophil absolute count was down; 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), on 13Jun2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization. The following information was reported: NEUTROPENIA (hospitalization, medically significant), outcome "unknown", described as "Neutropenia/neutrophil absolute count was down". The patient was hospitalized for neutropenia (hospitalization duration: 4 day(s)). The event "neutropenia/neutrophil absolute count was down" required emergency room visit. The patient underwent the following laboratory tests and procedures: Neutrophil count: down to 0.1, notes: My neutrophil absolute count was down to 0.1 and normal  range started at 1.7.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Impaired work ability, Loss of personal independence in daily activities, Lumbar puncture normal, Malaise, Neck pain
Clinical narrative: Neutropenia/neutrophil absolute count was down; 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), on 13Jun2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization. The following information was reported: NEUTROPENIA (hospitalization, medically significant), outcome "unknown", described as "Neutropenia/neutrophil absolute count was down". The patient was hospitalized for neutropenia (hospitalization duration: 4 day(s)). The event "neutropenia/neutrophil absolute count was down" required emergency room visit. The patient underwent the following laboratory tests and procedures: Neutrophil count: down to 0.1, notes: My neutrophil absolute count was down to 0.1 and normal  range started at 1.7.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Neutrophil count decreased, Oropharyngeal pain, Pain, Procedural pain, Pyrexia
Clinical narrative: Neutropenia/neutrophil absolute count was down; 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), on 13Jun2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization. The following information was reported: NEUTROPENIA (hospitalization, medically significant), outcome "unknown", described as "Neutropenia/neutrophil absolute count was down". The patient was hospitalized for neutropenia (hospitalization duration: 4 day(s)). The event "neutropenia/neutrophil absolute count was down" required emergency room visit. The patient underwent the following laboratory tests and procedures: Neutrophil count: down to 0.1, notes: My neutrophil absolute count was down to 0.1 and normal  range started at 1.7.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: White blood cell count decreased
Clinical narrative: Neutropenia/neutrophil absolute count was down; 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), on 13Jun2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization. The following information was reported: NEUTROPENIA (hospitalization, medically significant), outcome "unknown", described as "Neutropenia/neutrophil absolute count was down". The patient was hospitalized for neutropenia (hospitalization duration: 4 day(s)). The event "neutropenia/neutrophil absolute count was down" required emergency room visit. The patient underwent the following laboratory tests and procedures: Neutrophil count: down to 0.1, notes: My neutrophil absolute count was down to 0.1 and normal  range started at 1.7.  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: Computerised tomogram, Migraine
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 Jul2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: MIGRAINE (non-serious) with onset Jul2022, 1 week after the suspect product(s) administration, outcome "unknown", described as "migraines". The event "migraines" required emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: It was reported that patient had booster shot 1 week ago now patient had migraines per doctor in ER due to shot. Had cat scan all was fine. 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: Atrial fibrillation
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: Unknown. 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: Covid-19 vaccine (Dose 1), for COVID-19 immunization. The following information was reported: ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "moderate AFib". Clinical information: I received the 2nd Pfizer Covid Vaccine and am now diagnosed with moderate AFib. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Sinus operation, Sinusitis
Clinical narrative: Sinus surgery; Sinus infection; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4482130-00.  An 18-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1162623) at unk, (citrate free), subcutaneous for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SINUS OPERATION (medically significant) with onset 2019, outcome "unknown", described as "Sinus surgery"; SINUSITIS (non-serious), outcome "recovered", described as "Sinus infection". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "sinus surgery" and "sinus infection" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Causality for Humira (Adalimumab) The reporter's causality for the event(s) of Sinus Surgery, Sinus infection and Flu symptoms was not provided. AbbVie's opinion is that there is no reasonable possibility that the events of Sinus infection and Flu symptoms are related to Humira (Adalimumab). AbbVie's opinion is that the event of Sinus infection is not assessable.  Clinical information: In 2019, patient had sinus surgery. She had sinus infection for 2 weeks. Second covid injection made her feel sick flu symptoms. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on limited information available, the causal relation between the reported events and suspect drug 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 RAs, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Seizure, Tremor
Clinical narrative: seizures; tremors; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the parent.  A 17-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: 2021, for COVID-19 immunization.  The following information was reported: SEIZURE (medically significant), outcome "unknown", described as "seizures"; TREMOR (non-serious), outcome "unknown", described as "tremors". It was reported that patient was now 17-years and got both the Pfizer shot last year. About 2 months after the 2nd shot she started to have tremors and seizures. It was concerned that before the shots none of these happened and was requested to advise.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4482491-00 (AbbVie).  A 36-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous for hidradenitis; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown), all intramuscular 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 Jul2022, outcome "unknown" and all described as "COVID-19". The action taken for adalimumab was unknown.  The reporter considered "covid-19" related to BNT162b2.  Additional information: In Jul2022, the patient experienced SICK WITH COVID. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Primary reporter did not have the lot number information, because the packaging was discarded. Causality for HUMIRA (ADALIMUMAB): The reporter's causality for the event(s) of SICK WITH COVID was not provided. Drug: Pfizer Biontech Covid-19 Vaccine (Tozinameran) (Tozinameran), Unknown, Unknown, Unknown. Causality: Causality as per reporter (Drug/Vaccine): Possible. Did Event Abate After Stopping Drug? NA  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded.
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: metallic taste in his mouth/ continues to have this taste; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A male patient received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSGEUSIA (non-serious), 24 hrs after the suspect product(s) administration, outcome "not recovered", described as "metallic taste in his mouth/ continues to have this taste".  Additional Information: The patient experienced a metallic taste in his mouth 24 hours post dose and continued to have that taste. 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.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Sunburn, Vertigo
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2022US167203 (Novartis). A 24-year-old female patient received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, Unknown Manufacturer), for COVID-19 Immunization. The following information was reported: HYPOAESTHESIA (non-serious) with onset 2022, outcome "unknown", described as "Numbness"; SUNBURN (non-serious) with onset 2022, outcome "unknown"; VERTIGO (non-serious) with onset Jul2022, outcome "unknown". Additional information: Patient experienced vertigo after a sunburn in Jul and a couple months ago had numbness after COVID-19 booster shot. The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID; oropharyngeal pain, rhinorrhea, nasal congestion, chills, and pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Batch/Lot number: unknown), on 24Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 06Apr2022 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: VACCINATION FAILURE (medically significant) with onset 28Jul2022, outcome "unknown", described as "Tested positive for COVID"; COVID-19 (medically significant) with onset 28Jul2022, outcome "unknown", described as "oropharyngeal pain, rhinorrhea, nasal congestion, chills, and pain". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Jul2022) Positive.  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: Drug ineffective, Influenza like illness, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; Flu like symptoms; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4482426-00.  A 77-year-old female patient received BNT162b2 (BNT162B2), in Feb2021 as dose 1, single (Batch/Lot number: unknown), in Mar2021 as dose 2, single (Batch/Lot number: unknown) and in Apr2022 as dose 3 (booster) , single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1162124) at citrate free, subcutaneous. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Flu like symptoms". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "covid-19" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter considered "flu like symptoms" related to BNT162b2.  Clinical information: Solicited report by a consumer of an elderly female with events of non-serious COVID and Flu Like Symptoms with HUMIRA (Adalimumab). There was no reported medical history. On unknown dates, the patient experienced COVID and Flu Like Symptoms. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for HUMIRA (Adalimumab) The reporter's causality for the event(s) of COVID and Flu Like Symptoms was not provided. Suspect drug (information): (include generic name) Humira (Solution for injection in pre-filled pen).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information the causal relation between the events Drug ineffective, suspected Covid-19 and Influenza like illness and suspect drug BNT162b2 cannot be excluded.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Error: Incorrect reconstitution.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Loss of consciousness, Syncope
Clinical narrative: Systemic: Dizziness/Lightheadedness-Severe, Systemic: Fainting/Unresponsive-Medium, Systemic: Flushed/Sweating-Medium, Additional Details: Patient had syncopal episode when walking away from vaccination area. Patient became conscious after 10 seconds of unresponsiveness. Patient hydrated and given food. Rested 30 minutes prior to leaving the pharmacy. After 6 hours, patient maintained that they are feeling well and not exhibiting any similar symptoms.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness/Lightheadedness-Severe, Systemic: Fainting/Unresponsive-Medium, Systemic: Flushed/Sweating-Medium, Additional Details: Patient had syncopal episode when walking away from vaccination area. Patient became conscious after 10 seconds of unresponsiveness. Patient hydrated and given food. Rested 30 minutes prior to leaving the pharmacy. After 6 hours, patient maintained that they are feeling well and not exhibiting any similar symptoms.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Injection site bruising, Injection site erythema, Injection site haemorrhage, Injection site pain
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Additional Details: Patient's mother reported at she saw the patient bleed at the site of injection immidiately after getting the injection. Patient later report severe pain and swelling at the injection site.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Additional Details: Patient's mother reported at she saw the patient bleed at the site of injection immidiately after getting the injection. Patient later report severe pain and swelling at the injection site.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too high.
Age: 40.0
Sex: U
Vaccine: UNK
Symptoms: COVID-19
Clinical narrative: Diagnosed with Covid.  Received Covid vaccine.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Anaphylactic reaction
Clinical narrative: Systemic: Allergic: Anaphylaxis-Medium
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Discomfort, Pain, Tachycardia
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Tachycardia-Medium
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Headache, Injection site pain, Nausea, Product storage error
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Fever-Mild, Systemic: pt is receiving anothoer dose of shingrx because the dose she received on 05/102022 was not within the required temperature-Mild, Systemic: Headache-Mild, Systemic: Nausea-Mild, Systemic: Weakness-Medium
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Fever-Mild, Systemic: pt is receiving anothoer dose of shingrx because the dose she received on 05/102022 was not within the required temperature-Mild, Systemic: Headache-Mild, Systemic: Nausea-Mild, Systemic: Weakness-Medium
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Confusional state, Delirium, Extra dose administered
Clinical narrative: Systemic: Chills-Medium, Systemic: Confusion-Severe, Additional Details: The patient felt delirious after her 4th dose of the Pfizer COVID vaccine which lasted 3 days. The 4th day she tested positive for COVID. She wanted me to report her adverse effects because her previous doses she did not have any adverse effects.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Systemic: Chills-Medium, Systemic: Confusion-Severe, Additional Details: The patient felt delirious after her 4th dose of the Pfizer COVID vaccine which lasted 3 days. The 4th day she tested positive for COVID. She wanted me to report her adverse effects because her previous doses she did not have any adverse effects.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Pain in extremity
Clinical narrative: Patient is <50 years old and not immunocompromised, therefore this 4th total dose (2nd booster) was inadvertently administered, as patient is technically ineligible per EUA. He had a sore arm the day following vaccination.
Age: 4.0
Sex: F
Vaccine: COVID19, DTAPIPV, MMRV
Symptoms: Incorrect dose administered
Clinical narrative: 5-11 year COVID-19 dose administered instead of 6 month to 4-year-old dose. I thought scanned medication would have been a hard stop. I discovered when I went to print immunization record, it had not scanned. Parent notified and RL solution submitted.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: fully vaccinated covid positive pt hospitalized
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Hospitalization of covid positive pt fully vaccinated.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient came in for a booster dose (0.25ml) and was given a full dose (0.50ml).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Feeling abnormal, Headache, Oropharyngeal pain
Clinical narrative: I started getting symptoms on Thursday 07/21. I woke up with a sore throat and a little bit of a headache. And then I felt off throughout the day, by dinner time I felt the chills so I just went to bed. I woke up the next morning with a sore throat. And i took 4 test only one was positive. I called my doctor and told him my symptoms and he gave me Paxlovid. So I isolated for 5 days and i have been testing and it was negative.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: I started getting symptoms on Thursday 07/21. I woke up with a sore throat and a little bit of a headache. And then I felt off throughout the day, by dinner time I felt the chills so I just went to bed. I woke up the next morning with a sore throat. And i took 4 test only one was positive. I called my doctor and told him my symptoms and he gave me Paxlovid. So I isolated for 5 days and i have been testing and it was negative.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19 patient, fully vaccinated plus one booster, admitted to hospital.
Age: 99.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dysarthria, Hemiparesis
Clinical narrative: chest pain, slurred speech, left sided weakness
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine was expired, no temperature excursion occurred and Moderna determined the vial "maintained the activity necessary to protect against the SARS Co-V2 virus at the time of administration".  Patient reported no adverse reactions.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine was expired, no temperature excursion occurred and Moderna determined the vial "maintained the activity necessary to protect against the SARS Co-2 virus at time of administration". Patient reported no adverse reactions.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Ear discomfort, Hypoacusis, Injection site erythema, Injection site swelling
Clinical narrative: To be very clear, this is in regards to my second booster, 4th in the series of Covid shots.  All shots were Moderna.  Within a few hours of receiving the booster I started feeling a little dizzy.  The following day, Tuesday, July 26th, I was very dizzy and my right ear started to feel a little like I had water or an ear plug in it.  I had not gone swimming or showered so it could not have come from another source.  I was on the swim team in High School and College and never had any issues with water getting trapped in my ears.  I had a large, red raised area on my left arm, near the injection site.   On Wednesday, July 27th I had my annual exam with Dr. at a local HCF.   I told her how I was very dizzy the previous day and she felt that might be a temporary reaction to the vaccine.  The dizziness had gotten better and the ear issue was not severe enough at that time to mention.  My arm was still very red.  This had not happened with any of the previous 3 shots I received.  On Thursday the dizziness had pretty much resolved but the right ear hearing had gotten worse and is still present.  I purchased ear drops to clear "swimmers ear" and they have not helped.  I tried  warm compresses and that has also not helped.  I googled if this was somehow perhaps related to the vaccine, as I had never heard of this being a side effect, and saw that some people have reported it.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine was expired, no temperature excursion occurred and Moderna determined the vial "maintained the activity necessary to protect against the SARS CoV-2 virus at the time of administration".  Patient reported no adverse reactions.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine was expired, no temperature excursion occurred and Moderna determined the vial "maintained the activity necessary to protect against the SAR CoV-2 virus at the time of administration".  Patient reported no adverse reactions.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Crying, Gait disturbance, Pain
Clinical narrative: Pain started in lower lumbar spine about three hours after vaccination and progressively worsened. About 1:00 AM Friday morning, the pain became excruciating making walking almost impossible. Attempting to walk resulted in the worse pain I have ever experienced and caused me to double over with tears in my eyes. The pain would subside if I just stood still.  It took me nearly five minutes to shuffle to the bathroom. By Friday noon, the pain was slightly less  although still excruciating. It continued to lessen and was tolerable by Saturday morning although bending at the waist still caused very sharp, shooting pains. It was only slightly noticeable on Sunday and continued to improve fir the next few days; however, bending was a priblem for the remainder of the week.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine was expired, no temperature excursions occurred and Moderna determined the vial "maintained the activity necessary to protect against the SARS CoV-2 virus at the time of administration".  Patient reported no adverse reactions.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Bradykinesia, CSF test abnormal, Cerebral atrophy, Cerebral disorder
Clinical narrative: Feb '22 new evaluation for rapid cognitive decline. Very independent until spring-summer '21 where family began to note to cognitive changes. Impairment in executive function, short and long term memory recall, word finding trouble and regression of language production, and loss of awareness. Deficits are profound for her normal. No behavioral component. No hallucinations. Movements have slowed down. Gait is not shuffling but just very slow for her normal. No tremors. No myoclonus. No sleep disturbance. Routine labs found mild B12 deficiency now on parenteral treatment with normalization of values but no clinical improvement. Brain MRI shows mild global volume and hippocampal loss. Mild-moderate small vessel disease. SLUMS performed in PCP office Jan '22 consistent with severe dementia: 7/30.        INTERIM: My initial visit raised concern for CJD, a rapidly progressive fatal dementia syndrome. Confirmation testing performed through CSF analysis. This was sent off and took longer than normal for results to return. Results as follows:        Prion protein specific RT-QuIC was negative (90% sensitivity and 98% specificity) but the 14-3-3 was very elevated while the T-tau was normal. While this doesn't indicate CJD is the cause of her rapid cognitive decline, she still has objective and subjective evidence of a rapidly progressive neurodegenerative dementing disease.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebral small vessel ischaemic disease, Cognitive disorder, Dementia, Depressed level of consciousness, Gait disturbance
Clinical narrative: Feb '22 new evaluation for rapid cognitive decline. Very independent until spring-summer '21 where family began to note to cognitive changes. Impairment in executive function, short and long term memory recall, word finding trouble and regression of language production, and loss of awareness. Deficits are profound for her normal. No behavioral component. No hallucinations. Movements have slowed down. Gait is not shuffling but just very slow for her normal. No tremors. No myoclonus. No sleep disturbance. Routine labs found mild B12 deficiency now on parenteral treatment with normalization of values but no clinical improvement. Brain MRI shows mild global volume and hippocampal loss. Mild-moderate small vessel disease. SLUMS performed in PCP office Jan '22 consistent with severe dementia: 7/30.        INTERIM: My initial visit raised concern for CJD, a rapidly progressive fatal dementia syndrome. Confirmation testing performed through CSF analysis. This was sent off and took longer than normal for results to return. Results as follows:        Prion protein specific RT-QuIC was negative (90% sensitivity and 98% specificity) but the 14-3-3 was very elevated while the T-tau was normal. While this doesn't indicate CJD is the cause of her rapid cognitive decline, she still has objective and subjective evidence of a rapidly progressive neurodegenerative dementing disease.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test abnormal, Language disorder, Magnetic resonance imaging head abnormal, Memory impairment, Mini mental status examination abnormal
Clinical narrative: Feb '22 new evaluation for rapid cognitive decline. Very independent until spring-summer '21 where family began to note to cognitive changes. Impairment in executive function, short and long term memory recall, word finding trouble and regression of language production, and loss of awareness. Deficits are profound for her normal. No behavioral component. No hallucinations. Movements have slowed down. Gait is not shuffling but just very slow for her normal. No tremors. No myoclonus. No sleep disturbance. Routine labs found mild B12 deficiency now on parenteral treatment with normalization of values but no clinical improvement. Brain MRI shows mild global volume and hippocampal loss. Mild-moderate small vessel disease. SLUMS performed in PCP office Jan '22 consistent with severe dementia: 7/30.        INTERIM: My initial visit raised concern for CJD, a rapidly progressive fatal dementia syndrome. Confirmation testing performed through CSF analysis. This was sent off and took longer than normal for results to return. Results as follows:        Prion protein specific RT-QuIC was negative (90% sensitivity and 98% specificity) but the 14-3-3 was very elevated while the T-tau was normal. While this doesn't indicate CJD is the cause of her rapid cognitive decline, she still has objective and subjective evidence of a rapidly progressive neurodegenerative dementing disease.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Neurodegenerative disorder, Vitamin B12 deficiency
Clinical narrative: Feb '22 new evaluation for rapid cognitive decline. Very independent until spring-summer '21 where family began to note to cognitive changes. Impairment in executive function, short and long term memory recall, word finding trouble and regression of language production, and loss of awareness. Deficits are profound for her normal. No behavioral component. No hallucinations. Movements have slowed down. Gait is not shuffling but just very slow for her normal. No tremors. No myoclonus. No sleep disturbance. Routine labs found mild B12 deficiency now on parenteral treatment with normalization of values but no clinical improvement. Brain MRI shows mild global volume and hippocampal loss. Mild-moderate small vessel disease. SLUMS performed in PCP office Jan '22 consistent with severe dementia: 7/30.        INTERIM: My initial visit raised concern for CJD, a rapidly progressive fatal dementia syndrome. Confirmation testing performed through CSF analysis. This was sent off and took longer than normal for results to return. Results as follows:        Prion protein specific RT-QuIC was negative (90% sensitivity and 98% specificity) but the 14-3-3 was very elevated while the T-tau was normal. While this doesn't indicate CJD is the cause of her rapid cognitive decline, she still has objective and subjective evidence of a rapidly progressive neurodegenerative dementing disease.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine was expired, no temperature excursions occurred and Moderna determined the vial "maintained the activity necessary to protect against the SARS Co-V2 virus at the time of administration".  Patient reported no adverse reactions.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Wrong product administered
Clinical narrative: Client was not due for an MCV4 this was given in error by a nurse in our department.  She was scheduled to receive a Men B injection.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Magnetic resonance imaging, Transient ischaemic attack
Clinical narrative: Patient had no side effects from the vaccine.  He did have a mini stroke five days later.   Patient experienced numbness in his arm and hand as well as his leg.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given the Pfizer booster vaccine for ages 5 years to 11 years; patient is 14 years old. Patient did not receive the correct amount of vaccine for his age.
Age: 40.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Rash, Rash erythematous, Rash pruritic, Urticaria
Clinical narrative: Rash developed above the pelvic region, below the stomach, has been present for four days now. It is itchy and red, flat, has hive appearance not found in any other part of the body. Benadryl and caladryl have been applied, over the counter medications.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: Pt was given what was believed to be the 2nd COVID booster today. After administration patient found vax card and turns out that she was given the 2nd booster on 5/18/22 and reimmunized today as the 2nd covid booster was not documented on the EMR or internet site. After looking back in her chart, she did have an appt for 2nd booster and consent was signed. Pt notified of event. No adverse reactions observed while patient was in the clinic 15 minutes post vaccine.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine was expired, no temperature excursion occurred and Moderna determined the vial "maintained the activity necessary to protect against the SARS CoV-2 virus at the time of administration".  Patient reported no adverse reactions.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angiogram abnormal, Anticoagulant therapy, Blood test, Brain stem ischaemia, Cerebrovascular accident
Clinical narrative: Hospitalized May '22 for acute stroke syndrome. Presented with new onset left sided weakness and dizziness. MRI showed acute ischemia in the right pons. CTA showing posterior circulation multifocal stenosis. Was on aspirin and statin at time of event. Treated with the addition of Plavix for 21 days then to remain on monotherapy Plavix. Appears is back on her prior aspirin dose
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram head, Computerised tomogram neck, Dizziness, Echocardiogram, Hemiparesis
Clinical narrative: Hospitalized May '22 for acute stroke syndrome. Presented with new onset left sided weakness and dizziness. MRI showed acute ischemia in the right pons. CTA showing posterior circulation multifocal stenosis. Was on aspirin and statin at time of event. Treated with the addition of Plavix for 21 days then to remain on monotherapy Plavix. Appears is back on her prior aspirin dose