chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID infection; COVID infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EN5318), as dose 2, single (Lot number: EN6199) and as dose 3 (booster), single (Lot number: FF8841) at the age of 38 years 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) with onset 01Jun2022, outcome "unknown", COVID-19 (medically significant) with onset 01Jun2022, outcome "recovering" and all described as "COVID infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jun2022) Positive, notes: COVID test type post vaccination: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical course: There was no COVID prior to vaccination, patient tested with COVID post vaccination, COVID test type of post vaccination was Nasal swab, on 01Jun2022 test result was positive.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19 treatment; COVID-19 treatment; This is a spontaneous report received from a contactable reporter(s) (Physician) from Regulatory Authority.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Jan2022 as dose 1, single (Batch/Lot number: unknown) and on 02Feb2022 as dose 2, single (Batch/Lot number: unknown) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID-19 treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course- The patient receive any other vaccines within 4 weeks prior to the COVID vaccine. There was list of other medications the patient received within 2 weeks of vaccination. Nasal congestion and post nasal drip and had positive covid test again 02Jun2022 but was negative.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; tested positive for Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An 85-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 85 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) 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) with onset 30May2022, outcome "unknown", COVID-19 (medically significant) with onset 30May2022, outcome "recovering" and all described as "tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30May2022) Positive; (31May2022) Positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical course: The patient was not diagnosed Prior to vaccination.   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-202200794138 same reporter/product/event, different patient
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 17Mar2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 19Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 73 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 05Apr2022 as dose 4 (booster), single (Lot number: 033B21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Vaccine brand other=Moderna, Dose: 4/ Vaccine brand=Pfizer / BioNTech, Dose: 3, 2 and 1" (unspecified if ongoing), notes: Vaccine brand other=Moderna, Dose: 4/ Vaccine brand=Pfizer / BioNTech, Dose: 3, 2 and 1. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Serious, Seriousness criteria-results in death, Seriousness criteria-life threatening, Seriousness criteria- caused/prolonged hospitalization, Seriousness criteria- disabling/incapacitating, Seriousness criteria-congenital anomaly/birth defect reported as No. Report about COVID treatment Yes. If vaccine received and other medication in 2 weeks reported as Yes. Antiviral details Product: COVID 19 Treatment, brand: Paxlovid by Pfizer, Treatment start date: 30May2022, Treatment stop date: 02Jun2022, Lot number: GA3581, indication: Treatment of COVID-19. Known allergies reported as No. Other medical history reported as None.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, COVID-19, SARS-CoV-2 test, Vaccination failure, Vital signs measurement
Clinical narrative: positive for Covid; positive for Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 75-year-old female patient received BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: EL8982), on 15Feb2021 as dose 2, single (Lot number: EM9810), on 05Oct2021 as dose 3 (booster), single (Lot number: FF2589) and on 05Apr2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history included: "oversized bladder" (unspecified if ongoing), notes: oversized bladder; "diabetes" (ongoing); "Blood pressure high" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Reflux" (unspecified if ongoing), notes: Reflux; "Memory Issue" (unspecified if ongoing), notes: Memory Issue. Concomitant medication(s) included: OZEMPIC taken for diabetes mellitus; ARICEPT taken for memory impairment; METFORMIN taken for diabetes mellitus; AMLODIPINE taken for hypertension; SUDAFED [XYLOMETAZOLINE HYDROCHLORIDE]; LIPITOR; SERTRALINE taken for anxiety; FAMOTIDINE taken for gastrooesophageal reflux disease.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26May2022, outcome "unknown" and all described as "positive for Covid". The patient underwent the following laboratory tests and procedures: Blood test: (unspecified date) looks good, notes: every 6 months; SARS-CoV-2 test: (24May2022) Negative; (26May2022) Positive; Vital signs measurement: (2022) Okay. Therapeutic measures were taken as a result of covid-19.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
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 25-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 17May2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 06Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 24 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "common variable immune deficiency" (unspecified if ongoing), notes: common variable immune deficiency; "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical Course: The patient received Paxlovid from 21May2022 to 25May2022 as treatment of COVID-19. The patient reported to had, Covid symptoms rebounded and tested positive after completing the 5-day course. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Feeling abnormal, SARS-CoV-2 test, Sinus disorder, Vaccination failure
Clinical narrative: On 24May2022, they started feeling funny so they took self COVID tests and his was positive; On 24May2022, they started feeling funny so they took self COVID tests and his was positive; Caller states the day after he took Paxlovid, his sinuses got better; Feeling funny; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: EL8982), on 15Feb2021 as dose 2, single (Lot number: EM9810), on 05Oct2021 as dose 3 (booster), single (Lot number: FF2589) and on 05Apr2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: None (Other Conditions: No). The following information was reported: SINUS DISORDER (non-serious) with onset May2022, outcome "recovering", described as "Caller states the day after he took Paxlovid, his sinuses got better"; FEELING ABNORMAL (non-serious) with onset May2022, outcome "unknown", described as "Feeling funny"; VACCINATION FAILURE (medically significant) with onset 24May2022, outcome "unknown", COVID-19 (medically significant) with onset 24May2022, outcome "recovering" and all described as "On 24May2022, they started feeling funny so they took self COVID tests and his was positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24May2022) Positive, notes: Result: Positive, Unit: Not Provided. Therapeutic measures were taken as a result of covid-19, sinus disorder.  Clinical Course: Paxlovid, Date and Time of Start of Drug: 24May2022, Date and Time of Last Administration: 28May2022, Dosage text: 2 150mg and 1 100mg in the morning and the same in evening for 5 days, Pharmaceutical form (Dosage form): Tablet, Indication as Reported by the Primary Source: COVID-19. Investigations was reported as Yes. Caller states he and his wife both had all their Pfizer COVID Vaccines and the 2 Booster Doses. Caller states back on 24May2022, they started feeling funny so they took self COVID tests and his was positive so they gave him a Paxlovid script and he took it for 5 days. Caller states the day after he took it, his sinuses got better and his cough went away and he has been progressing since then. Is there a product complaint to report was Yes. Description of Product Complaint: Description of complaint: Tested positive for COVID 19 after receiving 4 doses of the Pfizer COVID 19 Vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Covid infection in May2022; Covid infection in May2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), in Spring 2021 as dose 1, single (Batch/Lot number: unknown), in Spring 2021 as dose 2, single (Batch/Lot number: unknown) and in Dec2021 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: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset May2022, outcome "unknown" and all described as "Covid infection in May2022". Infection was mild. No medical intervention required.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 01Oct2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sarcoidosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Allergy: Codeine", notes: known allergies: Codeine. The following information was reported: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of suspected covid-19, drug ineffective.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 51.0
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 contactable reporter(s) (Physician). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 13Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 51 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 included: "Asthma" (unspecified if ongoing); "GERD" (unspecified if ongoing); "obesity" (unspecified if ongoing). Concomitant medication(s) included: PANTOPRAZOLE, start date: 01Apr2019. Past drug history included: Nickel, reaction(s): "nickel: Drug Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29May2022) negative; (30May2022) 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.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
Age: 54.0
Sex: F
Vaccine: 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) (Other HCP).  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Sep2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 54 years for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID-19 treatment". Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical course of the events: Other medication in 2 weeks: Yes. No known allergies. Historical vaccine: Yes. The patient previously received a COVID-19 Vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case, an association between the reported events and the suspect product BNT162B2 cannot be ruled out.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: First experienced COVID symptoms 08Jan2022.; First experienced COVID symptoms 08Jan2022.; 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 male patient received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 23Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 40 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Known allergies: No. The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination: no. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Jan2022, outcome "recovered" (2022) and all described as "First experienced COVID symptoms 08Jan2022.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2022) Positive, notes: Nasal Swab; (2022) Positive, notes: Tested positive several days later. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical course: First experienced COVID symptoms 08Jan2022. Had nasal swab test performed, and tested positive several days later.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I tested positive for Covid on 18May2022; I tested positive for Covid on 18May2022.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: EN5318), in left arm, on 23Mar2021 as dose 2, single (Lot number: EN5318), in left arm and on 17May2022 as dose 3 (booster), single (Lot number: FJ5683) at the age of 52 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.  The following information was reported: VACCINATION FAILURE (medically significant) with onset 18May2022, outcome "unknown", described as "I tested positive for Covid on 18May2022"; COVID-19 (medically significant) with onset 18May2022, outcome "unknown", described as "I tested positive for Covid on 18May2022.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18May2022) Positive, notes: Nasal Swab.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old male patient received BNT162b2 (BNT162B2), on 19Mar2021 at 12:00 as dose 1, single (Lot number: EP6955), in right arm, on 09Apr2021 at 12:00 as dose 2, single (Lot number: ER8729), in right arm and on 10Oct2021 at 12:00 as dose 3 (booster), single (Lot number: FF2590) at the age of 31 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive; (2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Autoimmune disorder
Clinical narrative: I received the vaccine Apr2021 and then diagnosed with autoimmune disease Jul2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Apr2021 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: AUTOIMMUNE DISORDER (medically significant) with onset Jul2021, outcome "unknown", described as "I received the vaccine Apr2021 and then diagnosed with autoimmune disease Jul2021". 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: Paraesthesia
Clinical narrative: I received the vaccine Apr2021 and then diagnosed with autoimmune disease Jul2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Apr2021 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: AUTOIMMUNE DISORDER (medically significant) with onset Jul2021, outcome "unknown", described as "I received the vaccine Apr2021 and then diagnosed with autoimmune disease Jul2021". 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: Autoimmune disorder
Clinical narrative: received booster and had tingling in hands and feet 24/7; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 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 (DOSE number unknown; MANUFACTUERER UNKNOWN, received the vaccine Apr2021 and then diagnosed with autoimmune , disease Jul2021.), administration date: Apr2021, for COVID-19 immunization, reaction(s): "autoimmune disease". The following information was reported: PARAESTHESIA (non-serious), outcome "unknown", described as "received booster and had tingling in hands and feet 24/7". Additional information: Patient received the vaccine in Apr2021 and then diagnosed with autoimmune disease in Jul2021. Patient received booster and now have tingling in hands and feet 24/7. Patient's medical expenses were out of control and now not to work after 25 years with employer. 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: Paraesthesia
Clinical narrative: received booster and had tingling in hands and feet 24/7; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 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 (DOSE number unknown; MANUFACTUERER UNKNOWN, received the vaccine Apr2021 and then diagnosed with autoimmune , disease Jul2021.), administration date: Apr2021, for COVID-19 immunization, reaction(s): "autoimmune disease". The following information was reported: PARAESTHESIA (non-serious), outcome "unknown", described as "received booster and had tingling in hands and feet 24/7". Additional information: Patient received the vaccine in Apr2021 and then diagnosed with autoimmune disease in Jul2021. Patient received booster and now have tingling in hands and feet 24/7. Patient's medical expenses were out of control and now not to work after 25 years with employer. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 67.0
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 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Oct2021 at 14:30 as dose 3 (booster), single (Lot number: EW0217) at the age of 67 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 included: "Type 2 diabetes" (unspecified if ongoing), notes: Type 2 diabetes; "high blood pressure" (unspecified if ongoing), notes: high blood pressure; "Known allergies: Sulfa antibiotics" (unspecified if ongoing), notes: Known allergies: Sulfa antibiotics. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30May2022) Positive, notes: Positive test results on 30May2022 and 02Jun2022; (02Jun2022) Positive, notes: Positive test results on 30May2022 and 02Jun2022. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Anti-viral details: COVID 19 Treatment, Treatment start date: 20May2022 and stop date: 25May2022, Indication is used for treatment of COVID-19. Adverse event experienced on 30May2022 at 03:00 PM, Rebound COVID infection. Symptoms headache, sneezing, and sore throat occurred on 30May2022. Positive test results on 30May2022 and 02Jun2022. The outcome of event was not recovered without treatment.  No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Dec2020 as dose 1, single (Lot number: ELC9231), in right arm, on 17Jan2021 as dose 2, single (Lot number: EL3247), in left arm and on 20Oct2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "HTN" (unspecified if ongoing); "GERD" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN, start date: 01Apr2022. Past drug history included: Ceftin, reaction(s): "Known allergies: Ceftin"; Compazine, reaction(s): "Known allergies: Compazine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown Results; (24Apr2022) Negative; (27Apr2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was treated with Paxlovid for COVID-19. Treatment start date was 18Apr2022 and stop date was 22Apr2022. The patient tested negative on 24Apr2022 and returned to work. On 27Apr2022 felt ill and tested positive. Was ill for two weeks.; Sender's Comments: As there is limited information in the case provided, the causal association be-tween the event and the suspect drug cannot be excluded.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Mar2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 60 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Morphene, reaction(s): "known allergies: Morphene", notes: known allergies: Morphene; Valium, reaction(s): "known allergies: Valium", notes: known allergies: Valium; Vicodin, reaction(s): "known allergies: Vicodin", notes: known allergies: Vicodin. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19, drug ineffective.  No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Dizziness, Headache, Myalgia
Clinical narrative: armpit pain a couple hours after booster shot that progressed into armpit ache/full pain with some nerve pain into hand; armpit pain a couple hours after booster shot that progressed into armpit ache/full pain with some nerve pain into hand; armpit pain a couple hours after booster shot that progressed into armpit ache/full pain with some nerve pain into hand; armpit pain a couple hours after booster shot that progressed into armpit ache/full pain with some nerve pain into hand; muscle aches; joint pains; headaches; dizziness; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 23-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 23 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Unknown. Misplaced/discarded, Location of injection: Arm Left), administration date: 05May2021, when the patient was 22-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: Unknown. Misplaced/discarded, Location of injection: Arm Left), administration date: 11Jun2021, when the patient was 23-year-old, for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), AXILLARY PAIN (non-serious), PAIN (non-serious), NEURALGIA (non-serious) all with onset 21Jan2022, outcome "not recovered" and all described as "armpit pain a couple hours after booster shot that progressed into armpit ache/full pain with some nerve pain into hand"; DIZZINESS (non-serious) with onset 21Jan2022, outcome "not recovered"; HEADACHE (non-serious) with onset 21Jan2022, outcome "not recovered", described as "headaches"; ARTHRALGIA (non-serious) with onset 21Jan2022, outcome "not recovered", described as "joint pains"; MYALGIA (non-serious) with onset 21Jan2022, outcome "not recovered", described as "muscle aches". The events "armpit pain a couple hours after booster shot that progressed into armpit ache/full pain with some nerve pain into hand", "muscle aches", "joint pains", "headaches" and "dizziness" required physician office visit. Therapeutic measures were taken as a result of pain in extremity, axillary pain, pain, neuralgia, myalgia, arthralgia, headache, dizziness.  Additional information: Patient did not received any other vaccine in four weeks. No Covid prior vaccination and patient did not Covid tested post vaccination. Patient experienced leg armpit pain a couple hours after booster shot that progressed into armpit ache or full pain with some nerve pain into hand that has persisted ever since (now being June 2nd). Also experiencing muscle aches, joint pains, headaches and dizziness. Adverse event treatment: Celebrex for armpit nerve pain: unresolved.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, Pain, Pain in extremity
Clinical narrative: armpit pain a couple hours after booster shot that progressed into armpit ache/full pain with some nerve pain into hand; armpit pain a couple hours after booster shot that progressed into armpit ache/full pain with some nerve pain into hand; armpit pain a couple hours after booster shot that progressed into armpit ache/full pain with some nerve pain into hand; armpit pain a couple hours after booster shot that progressed into armpit ache/full pain with some nerve pain into hand; muscle aches; joint pains; headaches; dizziness; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 23-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 23 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Unknown. Misplaced/discarded, Location of injection: Arm Left), administration date: 05May2021, when the patient was 22-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: Unknown. Misplaced/discarded, Location of injection: Arm Left), administration date: 11Jun2021, when the patient was 23-year-old, for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), AXILLARY PAIN (non-serious), PAIN (non-serious), NEURALGIA (non-serious) all with onset 21Jan2022, outcome "not recovered" and all described as "armpit pain a couple hours after booster shot that progressed into armpit ache/full pain with some nerve pain into hand"; DIZZINESS (non-serious) with onset 21Jan2022, outcome "not recovered"; HEADACHE (non-serious) with onset 21Jan2022, outcome "not recovered", described as "headaches"; ARTHRALGIA (non-serious) with onset 21Jan2022, outcome "not recovered", described as "joint pains"; MYALGIA (non-serious) with onset 21Jan2022, outcome "not recovered", described as "muscle aches". The events "armpit pain a couple hours after booster shot that progressed into armpit ache/full pain with some nerve pain into hand", "muscle aches", "joint pains", "headaches" and "dizziness" required physician office visit. Therapeutic measures were taken as a result of pain in extremity, axillary pain, pain, neuralgia, myalgia, arthralgia, headache, dizziness.  Additional information: Patient did not received any other vaccine in four weeks. No Covid prior vaccination and patient did not Covid tested post vaccination. Patient experienced leg armpit pain a couple hours after booster shot that progressed into armpit ache or full pain with some nerve pain into hand that has persisted ever since (now being June 2nd). Also experiencing muscle aches, joint pains, headaches and dizziness. Adverse event treatment: Celebrex for armpit nerve pain: unresolved.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 infection; COVID-19 infection; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 30-year-old male patient received BNT162b2 (BNT162B2), on 18Dec2020 at 12:00 as dose 1, single (Lot number: EJ1685), in left arm, on 07Jan2021 at 12:00 as dose 2, single (Lot number: EL1284), in left arm and on 08Oct2021 at 12:00 as dose 3 (booster), single (Lot number: 301558A) at the age of 30 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant) with onset 31May2022, outcome "unknown", COVID-19 (medically significant) with onset 31May2022, outcome "recovering" and all described as "COVID-19 infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31May2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of covid-19. Clinical Information: Facility type vaccine: Pharmacy or Drug Store. The patient did not receive other vaccine in four weeks of vaccination. The patient did not receive other medications in two weeks of vaccination. If covid prior vaccination: No, If covid tested post vaccination: Yes. Covid test post vaccination: covid test type post vaccination: Nasal Swab, Covid test name post vaccination: BinaxNow, Covid test date: 31May2022, Covid test result: Positive. Known allergies: No. Other medical history: None. No treatment received for adverse events.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events vaccination failure and COVID-19 cannot be totally excluded.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: 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 47-year-old male patient received BNT162b2 (BNT162B2), on 21Sep2021 as dose 3 (booster), single (Lot number: 301358A), in left arm and on 30Apr2022 as dose 4 (booster), single (Lot number: Fk9894) at the age of 47 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 included: "Crohns" (unspecified if ongoing); "primary sclerosis cholangitis" (unspecified if ongoing), notes: Other medical history: primary sclerosis cholangitis; "known allergies: Sulpha" (unspecified if ongoing). Concomitant medication(s) included: DOXYCYCLINE, start date: 16May2022, stop date: 25May2022; AZITHROMYCIN, start date: 07May2022, stop date: 11May2022; HUMIRA, start date: 22May2022; MERCAPTOPURINE, start date: 01Mar2022; FLOVENT, start date: 12May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: Indication: Treatment of COVID-19; Negative, notes: after Paxlovid treatment I tested negative and this week I am positive again; Positive, notes: after Paxlovid treatment I tested negative and this week I am positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information:-Covid rebound after paxlovid treatment and patient tested negative and after a week patient got positive again.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Got Covid 19 with the vaccine; Got Covid 19 with the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 21-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Apr2021 as dose 1, single (Lot number: ER2613) and on 28Apr2021 as dose 2, single (Lot number: EW016) at the age of 21 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 28Jul2021, outcome "recovered" and all described as "Got Covid 19 with the vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Jul2021) Positive, notes: Nasal Swab. Clinical Information: Facility type vaccine was Health Clinic. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Pharmacist).  A 36-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Penicillin" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Bactrim, reaction(s): "Known allergies: Bactrim", notes: Known allergies: penicillin, Bactrim. The following information was reported: DRUG INEFFECTIVE (medically significant), 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: Indication: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was treated with 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 information available , a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Covid-19 and drug ineffective.
Age: 62.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Aug2021 as dose 3 (booster), single (Lot number: 301308A), in left arm and on 11Apr2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 62 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: "High blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results; (01Jun2022) Negative, notes: Tested negative after completing Paxlovid for 3 days; (Jun2022) Positive, notes: rebounded positive with symptoms on Day 11. Therapeutic measures were taken as a result of drug ineffective, covid-19. Anti viral Paxlovid was given from 24May2022 to 29May2022 for treatment of COVID-19
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19/Fatigue, congestion, and cold-like symptoms/feel like a bad head cold/bad headache and body aches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old male patient received BNT162b2 (BNT162B2), on 02Feb2021 as dose 1, single (Lot number: EL9264), in left arm, on 23Feb2021 as dose 2, single (Lot number: EN6201), in left arm and on 01Nov2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 35 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: XANAX, start date: 01Jan2020; VYVANSE, start date: 01Jan2020; LAMICTAL, start date: 01Jan2021; TRAZODONE, start date: 01Jan2020; PEPCID AC, start date: 01Jan2020; SINGULAIR, start date: 01Jan2020; FLONASE [FLUTICASONE PROPIONATE], start date: 01Jan2020. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "Treatment of COVID-19"; COVID-19 (medically significant), outcome "unknown", described as "Treatment of COVID-19/Fatigue, congestion, and cold-like symptoms/feel like a bad head cold/bad headache and body aches". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Symptoms occurred 9 days after my first positive COVID test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Anti-viral details: brand: Paxlovid, start date: May2022 to: May2022, Indication: Treatment of COVID-19.