chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2, Vaccine lot unknown reason: Not available/provided to reporter at the time of report completion), on 28Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 22Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 13Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 02May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 72 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Known allergies: No. Other medical history: None. There were no concomitant medications in 2weeks. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Anti Viral Details: Product: COVID 19 Treatment [Brand: Pfizer  Treatment start date: 28Sep2022, Treatment stop date: 02Oct2022, Lot number: 00069-1085-30, Indication: Treatment of COVID-19]. Rebound of Covid Symptoms 9 days after completing 5 days of Paxlovid and testing negative. Adverse event start date: 11Oct2022 07:00 PM. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; negative, notes: Rebound of Covid Symptoms 9 days after completing 5 days of Paxlovid and testing negative; Positive. Therapeutic measures were taken as a result of covid-19, vaccination failure.  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, Interchange of vaccine products
Clinical narrative: Patient stated his HCP recommended Paxlovid; Patient stated his HCP recommended Paxlovid; got the Moderna bivalent booster 2 days ago noting that his other vaccines were Pfizer; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 11Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 11Oct2022, outcome "unknown", described as "got the Moderna bivalent booster 2 days ago noting that his other vaccines were Pfizer"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Patient stated his HCP recommended Paxlovid".  Clinical course: Patient stated he just got the Moderna bivalent booster 2 days ago noting that other vaccines were Pfizer. Patient stated his HCP recommended Paxlovid. Patient wanted to know if Paxlovid will harm the immune response to the booster.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20May2021 as dose 2, single (Lot number: EW0185), in left arm and on 22Dec2021 as dose 3 (booster), single (Lot number: FL3197) at the age of 64 years, in left arm 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 was not reported. There were no concomitant medications. Past drug history included: Phenothiazines, reaction(s): "Drug Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Patient did not take other medication in 2 weeks.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; 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 male patient received BNT162b2 (BNT162B2), on 08Jun2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "AFIB" (unspecified if ongoing). Patient had no Known allergies. Concomitant medication(s) included: DABIGATRAN; PRADAXA (Other medication in 2 weeks). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (unspecified date) high; SARS-CoV-2 test: (2022) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 and treatment included Paxlovid (Lot number: Fw6344) from 01Oct2022 to 06Oct2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Audiogram, Deafness unilateral
Clinical narrative: significant loss of hearing in right ear; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient received BNT162b2 (BNT162B2), on 27Dec2021 at 15:45 as dose 1, single (Lot number: 330368D) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hearing Impared" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DEAFNESS UNILATERAL (disability, medically significant) with onset 04Oct2022, outcome "not recovered", described as "significant loss of hearing in right ear". The event "significant loss of hearing in right ear" required physician office visit. The patient underwent the following laboratory tests and procedures: Audiogram: (04Oct2022) loss, notes: My 2020 audiogram didnt show this loss but 04Oct2022 did. Therapeutic measures were taken as a result of deafness unilateral.   Clinical course: I am hearing impaired and have a documented significant loss of hearing in right ear after hearing being stable for 17 years. My 2020 audiogram didnt show this loss but 04Oct2022 did. Patient didn't receive other vaccine in four weeks. Ae resulted in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. Ae treatment Was reffered for Cochlear Implant. Patient didn't have covid prior vaccination. Patient didn't tested covid post vaccination. No known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Vaccination site rash
Clinical narrative: Rash at injection site; rash around both ankles, and a little up from the ankles on both legs.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 87-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 87 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. The following information was reported: VACCINATION SITE RASH (non-serious) with onset Oct2022, outcome "unknown", described as "Rash at injection site"; RASH (non-serious) with onset Oct2022, outcome "unknown", described as "rash around both ankles, and a little up from the ankles on both legs.". Additional information: Patient reported that he got the latest booster shot a week ago. It was the Pfizer Covid 19 vaccine, the newest one, but he was unsure if it was the bivalent. He had a rash, and still has a little rash at the injection site. He also has a rash around both ankles, and a little up from the ankles on both legs. He asked if this was a common thing, and if there was something he could put on it to make the rash go away.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Pyrexia
Clinical narrative: High Fever; Extreme chills; Extreme dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 at 15:00 as dose 3 (booster), single (Lot number: GH9703) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes type 2" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "Trigeminal neuralgia" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing); "Known allergies: PCN" (unspecified if ongoing); "Known allergies: Latex" (unspecified if ongoing); "Known allergies: iodine" (unspecified if ongoing). Concomitant medication(s) included: VARICELLA ZOSTER VACCINE taken for immunisation, on 19Sep2022 as dose 2, single; INFLUENZA VACCINE taken for immunisation, on 19Sep2022 as dose 2, single; ROBAXIN; NEURONTIN; SINGULAIR; LIPITOR; LISINOPRIL. Past drug history included: Zinc oxide, reaction(s): "Allergy"; Coricidan, reaction(s): "Allergy". Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: FTZ9993, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 22Apr2022, when the patient was 63-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: FM9992, Location of injection: Arm Left, Vaccine Administration Time: 05:00 PM), administration date: 14May2022, when the patient was 63-year-old, for Covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset 13Oct2022 at 08:00, outcome "not recovered", described as "Extreme chills"; DIZZINESS (non-serious) with onset 13Oct2022 at 08:00, outcome "not recovered", described as "Extreme dizziness"; PYREXIA (non-serious) with onset 13Oct2022 at 08:00, outcome "not recovered", described as "High Fever". Therapeutic measures were taken as a result of pyrexia, chills, dizziness.  Additional information: Patient had not been diagnosed with COVID-19 prior vaccination and had not been tested for COVID-19 since vaccination. Patient took Tylenol as treatment for the events.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Interchange of vaccine products, Muscular weakness, Myalgia, Oropharyngeal pain
Clinical narrative: Muscle weakness; Muscle pain; Fever; severe fatigue; Sore throat; brand=Pfizer / prev dose brand=Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 5 (booster), single (Lot number: GH9703) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (dose 4, administered in the right arm at 12:00, Lot number: 025L2B), administration date: Apr2022, when the patient was 63 years old, for Covid-19 immunization; Moderna (dose 3, administered in the right arm at 12:00, Lot number: 065F21A), administration date: Nov2021, when the patient was 63 years old, for Covid-19 immunization; Moderna (dose 2, administered in the right arm at 12:00, Lot number: 006C21A), administration date: May2021, when the patient was 62 years old, for Covid-19 immunization; Moderna (dose 1, administered in the right arm at 12:00, Lot number: 040B21A), administration date: Apr2021, when the patient was 62 years old, for Covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 10Oct2022, outcome "not recovered", described as "Fever"; MYALGIA (non-serious) with onset 10Oct2022, outcome "not recovered", described as "Muscle pain"; MUSCULAR WEAKNESS (non-serious) with onset 10Oct2022, outcome "not recovered", described as "Muscle weakness"; OROPHARYNGEAL PAIN (non-serious) with onset 10Oct2022, outcome "not recovered", described as "Sore throat"; FATIGUE (non-serious) with onset 10Oct2022, outcome "not recovered", described as "severe fatigue"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset Oct2022, outcome "unknown", described as "brand=Pfizer / prev dose brand=Moderna". Therapeutic measures were not taken as a result of muscular weakness, myalgia, pyrexia, fatigue, oropharyngeal pain.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Muscle weakness; Muscle pain; Fever; severe fatigue; Sore throat; brand=Pfizer / prev dose brand=Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 5 (booster), single (Lot number: GH9703) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (dose 4, administered in the right arm at 12:00, Lot number: 025L2B), administration date: Apr2022, when the patient was 63 years old, for Covid-19 immunization; Moderna (dose 3, administered in the right arm at 12:00, Lot number: 065F21A), administration date: Nov2021, when the patient was 63 years old, for Covid-19 immunization; Moderna (dose 2, administered in the right arm at 12:00, Lot number: 006C21A), administration date: May2021, when the patient was 62 years old, for Covid-19 immunization; Moderna (dose 1, administered in the right arm at 12:00, Lot number: 040B21A), administration date: Apr2021, when the patient was 62 years old, for Covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 10Oct2022, outcome "not recovered", described as "Fever"; MYALGIA (non-serious) with onset 10Oct2022, outcome "not recovered", described as "Muscle pain"; MUSCULAR WEAKNESS (non-serious) with onset 10Oct2022, outcome "not recovered", described as "Muscle weakness"; OROPHARYNGEAL PAIN (non-serious) with onset 10Oct2022, outcome "not recovered", described as "Sore throat"; FATIGUE (non-serious) with onset 10Oct2022, outcome "not recovered", described as "severe fatigue"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset Oct2022, outcome "unknown", described as "brand=Pfizer / prev dose brand=Moderna". Therapeutic measures were not taken as a result of muscular weakness, myalgia, pyrexia, fatigue, oropharyngeal pain.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm which lasted overnight; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), 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: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "sore arm which lasted overnight". 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: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), 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), for Covid-19 immunization, reaction(s): "Sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore 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: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Surgery" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for Covid-19 immunization, reaction(s): "Sore arm"; Bnt162b2 (2nd dose), for Covid-19 immunization, reaction(s): "Sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Sore arm".  Additional  information: Patient wanted to know if the Pfizer Biontech Covid-19 Bivalent Booster vaccine for adults contains formaldehyde. She stated that she already received 3 shots of the Pfizer BionTech Covid-19 Vaccine and stated that she can't get the flu shot or "the other shot for chicken pox" because of the presence of formaldehyde, which caused her to be unable to get off the table after her surgery. She stated that she was fine with the first 3 shots of Pfizer BioNtech Covid-19 Vaccine and only experienced sore arm which lasted overnight.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness in his hand; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "soreness in his hand".  Additional information: It was also reported that the reporter also mentioned all of his 4 COVID 19 vaccines have been from Pfizer, and with the previous ones he did not have any reaction at all, just soreness in his hand.   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: Pain in extremity
Clinical narrative: soreness in his hand; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "soreness in his hand". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "soreness in his hand".  Additional information: The reporter assessed the event as non-serious. The reporter stated with the previous vaccines the patient did not have any reaction at all, just soreness in his hand.  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-202201229835 same reporter/patient, different event/dose.;
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness in his hand; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), 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: Bnt162b2 (Dose 2, all of his 4 COVID 19 vaccines have been from Pfizer, and with the previous ones he did not have any reaction at all, just soreness in his hand), for Covid-19 immunization, reaction(s): "soreness in his hand"; Bnt162b2 (Dose 1, all of his 4 COVID 19 vaccines have been from Pfizer, and with the previous ones he did not have any reaction at all, just soreness in his hand), for Covid-19 immunization, reaction(s): "soreness in his hand". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "soreness in his hand".  Additional information: Caller also mentioned all of his 4 COVID 19 vaccines have been from Pfizer, and with the previous ones he did not have any reaction at all, just soreness in his hand. His Pharmacist told him this new vaccine was different and he might experience more reactions.   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-202201229835 same reporter/patient, different event/dose.;
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness in his hand; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 3, SINGLE; Lot number: Unknown), for COVID-19 immunization, reaction(s): "soreness in his hand"; Bnt162b2 (DOSE 2, SINGLE; Lot number: Unknown), for COVID-19 immunization, reaction(s): "soreness in his hand"; Bnt162b2 (DOSE 1, SINGLE; Lot number: Unknown), for COVID-19 immunization, reaction(s): "soreness in his hand". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "soreness in his hand".  Additional information: Reporter mentioned all of his 4 COVID 19 vaccines have been from Pfizer and with the previous ones he did not have any reaction at all, just soreness in his hand.   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-202201229835 Same reporter/ patient, different event and dose.;
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID; COVID; This is a spontaneous report received from a contactable reporter (Other HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Jun2022 at 12:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 60 years, in right arm for COVID-19 immunisation. The patient's relevant medical history included: "History of pneumonia" (unspecified if ongoing). The patient had no known allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID". On an unspecified date in 2022, the patient had treatment with Paxlovid for COVID-19 treatment. The patient had rebound COVID after Paxlovid with positive COVID test a few days after finishing with return of symptoms on 11Oct2022. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Covid 19 Treatment; (unspecified date) Negative; (11Oct2022) Positive, notes: Rebound COVID. Therapeutic measures were taken as a result of drug ineffective, COVID-19 including PF-07321332/ritonavir (PAXLOVID) from 01Oct2022 to 06Oct2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness and COVID-19 cannot be ruled out.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.included anti-viral product Paxlovid.  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 available information, the reported events  DRUG INEFFECTIVE and  COVID-19 cannot be excluded for the suspect drug BNT162b2.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Lot number: GH9694) for 1 day for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for 1 day 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 "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Result, notes: she mentioned her son had COVID-19.  Clinical course: The reporter stated her son received today a dose of the Pfizer COVID-19 vaccine and wanted to confirm he received the Bivalent. Lot number provided was GH9694. After confirming with caller that indeed it was for the Bivalent, she mentioned her son had COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: chest 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 female patient received BNT162b2 (BNT162B2), in 2020 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Psoriasis" (unspecified if ongoing). Concomitant medication(s) included: COSENTYX taken for psoriasis. The following information was reported: CHEST PAIN (non-serious) with onset 2020, outcome "unknown".  Additional information: Patient reported chest pain once after first dose. She was taking Cosentyx monthly and asked the effectiveness of the Pfizer-BioNTech COVID-19 Vaccine. She Stated that she was forced to get a COVID shot where she was a housekeeper. Seriousness reported as No.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: a little soreness with the initial shot part; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old female patient received BNT162b2 (BNT162B2), on 25Jan2021 as dose 1, single (Lot number: EN53190) at the age of 76 years for covid-19 immunisation. The patient's relevant medical history included: "cholesterol" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "COPD" (unspecified if ongoing). Concomitant medication(s) included: WIXELA INHUB taken for chronic obstructive pulmonary disease. The following information was reported: PAIN (non-serious), outcome "unknown", described as "a little soreness with the initial shot part".  Additional information: The reporter stated she takes a cholesterol pill and as of recently she had to start a high blood pressure medication, it's not that high but they want to make sure.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Positive for COVID; Positive for COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-4129680.  A 73-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) intramuscular 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: "Shoulder issues", start date: 2017 (unspecified if ongoing), notes: On 2017, the patient experienced shoulder issues, On 01Jul2022 she had shoulder surgery. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Sep2021, outcome "recovered" and all described as "Positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Sep2021) Positive; (01Jun2022) 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.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: vaccinated with the Pfizer 2 vaccines; prescribed the Paxlovid; vaccinated with the Pfizer 2 vaccines; prescribed the Paxlovid; 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) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "vaccinated with the Pfizer 2 vaccines; prescribed the Paxlovid". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient vaccinated with the Pfizer 2 vaccines. The patient had not had a booster and was sick enough that the doctor prescribed the Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 20Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 61 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: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19, Paxlovid was given on 29Sep2022 and stopped on 05Oct2022.   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 available information in the case, the causal association between the events 'Drug ineffective', 'COVID-19' and the suspect drug BNT162B2 cannot be excluded.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Oct2021 as dose 3 (booster), single (Lot number: FF2589), in left arm and on 10Jun2022 as dose 4 (booster), single (Lot number: FM0173) at the age of 68 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: "Asthma" (unspecified if ongoing). The patient had no known allergies. Concomitant medication(s) included: ATORVASTATIN, start date: 04Apr2022, stop date: 27Sep2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was treated with Paxlovid. Clinical information: Other medication in 2 weeks product was Atorvastatin. Other medication in 2weeks brand was Generic for Lipitor. The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a covid-19 vaccine. No known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.The patient received Paxlovid from 04Oct022 to 08Oct2022 for the treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Influenza like illness, Pain
Clinical narrative: Chills; Aches; Fatigue; Flu-like symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 at 09:45 as dose 4 (booster), single (Lot number: GJ6742) at the age of 34 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 2, SINGLE; Route of administration: Intramuscular; Anatomical location: Arm left), administration date: 09Feb2021, when the patient was 33-year-old, for COVID-19 immunization, reaction(s): "flu-like symptoms", "Chills", "fatigue", "headache"; BNT162b2 (DOSE 3 (BOOSTER), SINGLE; Lot number: FG3527; Route of administration: Intramuscular; Anatomical location: Arm left), administration date: 07Dec2021, when the patient was 33-year-old, for COVID-19 immunization, reaction(s): "flu-like symptoms", "Chills", "fatigue", "headache"; Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 12Oct2022 at 23:45, outcome "recovering", described as "Aches"; CHILLS (non-serious) with onset 12Oct2022 at 23:45, outcome "recovering"; FATIGUE (non-serious) with onset 12Oct2022 at 23:45, outcome "recovering"; INFLUENZA LIKE ILLNESS (non-serious) with onset 12Oct2022 at 23:45, outcome "recovering", described as "Flu-like symptoms". Therapeutic measures were not taken as a result of chills, pain, fatigue, influenza like illness.  Additional information: the patient had no other vaccine in four weeks, nor other medications in two weeks. The patient had no COVID prior to vaccination and was not tested for COVID post vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101752510 Same patient/vaccine, different event/dose;US-PFIZER INC-2021147534 Same patient/vaccine, different event/dose;
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 at 13:00 as dose 5 (booster), single (Lot number: gj2524) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, latency 12 days 13 hrs after the suspect product(s) administration, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No known allergies. No other medication in 2 weeks. Paxlovid (treatment start date: 01Oct2022 and treatment stop date: 06Oct2022) for treatment of COVID-19.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 26Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Sep2022, outcome "not recovered", described as "COVID 19 Treatment"; DRUG INEFFECTIVE (medically significant) with onset Sep2022, outcome "not recovered", described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: COVID rebound after being negative; Positive, notes: Positive now for a week (self test and test at (pharmacy name withheld) to confirm); Positive, notes: Positive now for a week (self test and test at (pharmacy name withheld) to confirm); Negative, notes: negative for a few days. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: They have had Covid twice, the first time in Jan2021 and the second time on 24Aug2022.; They have had Covid twice, the first time in Jan2021 and the second time on 24Aug2022.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 24Aug2022, outcome "unknown" and all described as "They have had Covid twice, the first time in Jan2021 and the second time on 24Aug2022.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2021) positive, notes: first time in Jan2021; (24Aug2022) positive, notes: the second time on 24Aug2022. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The caller thanked Pfizer for the vaccinations and said her and her husband have taken them all, up to the first booster. They can't take the second booster until 3 months after the Covid from August. The caller stated, they had Covid twice, the first time in Jan2021 and the second time on 24Aug2022. She and her husband took Paxlovid and took all of it, 3 in morning and 3 in "afternoon" after their meal. She stated there is not any age limit from age 16 to 90 and this confused her and then there is nothing for weight and size. She stated, she is taking the same pill as her husband who is almost 70 years old, 6 ft and almost 200 pounds.   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: Cerebrovascular accident
Clinical narrative: he experienced a stroke shortly after receiving his second covid vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4390777-00-2.  A 62-year-old male patient received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Alcohol use/six glasses of beer per day", start date: 2015, stop date: 2022; "Buerger's disease" (unspecified if ongoing); "Tobacco use/six packs of cigarettes per day" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: POTASSIUM taken for supplementation therapy; ATORVASTATIN CALCIUM taken for blood cholesterol abnormal; CALCIUM MAGNESIUM [CALCIUM;MAGNESIUM] taken for supplementation therapy; VITAMIN D [ERGOCALCIFEROL] taken for nutritional supplementation. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Route of administration: Intramuscular), administration date: 2021, for COVID-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (caused and prolonged hospitalization, medically significant), outcome "recovered", described as "he experienced a stroke shortly after receiving his second covid vaccine".  Clinical course: The patient held his Humira injections for 18 months due to concerns regarding the covid pandemic. He resumed Humira when his psoriasis symptoms came back. He experienced a stroke shortly after receiving his second covid vaccine.   The reporter's causality for the event(s) of Stroke with Pfizer BioNTech COVID-19 vaccine (BNT162B2) was reasonable possibility. Pfizer BioNTech COVID-19 vaccine - Stroke, Non-Health Care Professional,  Possible. Pfizer BioNTech COVID-19 vaccine - Stroke.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.