chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
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 71-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 71 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), 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) 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) Negative, notes: 2 days after negative antigen test - I tested positive again; (2022) Positive, notes: 2 days after negative antigen test - I tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  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: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: EN6205), in left arm, on 22Mar2021 as dose 2, single (Lot number: ER8727), in left arm and on 07Oct2021 at 15:45 as dose 3 (booster), single (Lot number: ff2589) at the age of 53 years, in left arm for covid-19 immunisation; coviD-19 vaccine nrvv MVa (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 20Sep2022 at 15:00 as dose 5 (booster), single (Lot number: AS7145B), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 02May2022 as dose 4 (booster), single (Lot number: 049L21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "ASD w/right to left shunt" (unspecified if ongoing); "platypnea orthodeoxia with portable oxygen prescription for flights and elevations above 4000ft" (unspecified if ongoing), notes: platypnea orthodeoxia with portable oxygen prescription for flights and elevations above 4000ft; "history of bilateral pulmonary embolisms" (unspecified if ongoing); "DVT" (unspecified if ongoing); "inpatient MSSA staph blood infection" (unspecified if ongoing); "Former smoker" (unspecified if ongoing); "Known allergies: Gluten" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Tetracycline" (unspecified if ongoing), notes: Known allergies: Tetracycline; "Known allergies: Bone cement monomer" (unspecified if ongoing); "Known allergies: Nitinol" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Titanium, reaction(s): "Known allergies: Titanium". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 02May2022, outcome "unknown"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Nov2022) Positive; (02Dec2022) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: COVID Test was Positive (PCR) on 25Nov2022. Paxlovid started 25Nov2022. Paxlovid ended 30Nov2022. Tested negative for Covid (rapid test) and asymptomatic on 02Dec2022.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of Paxlovid from 18Nov2022 to 22Nov2022 for COVID-19; Treatment of Paxlovid from 18Nov2022 to 22Nov2022 for COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 67 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 included: "treated for kidney infection" (unspecified if ongoing), notes: 58 years ago; "appendix removed" (unspecified if ongoing), notes: 54 years ago; "Depression" (unspecified if ongoing), notes: taking Citalopram; "high blood pressure" (unspecified if ongoing), notes: taking Losartan. The patient has no known allergies. Concomitant medication(s) included: LOSARTAN taken for hypertension, start date: Jan2020, stop date: Dec2022; EXELAN taken for depression, start date: Jan2017, stop date: Dec2022; CITALOPRAM taken for depression. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "Treatment of Paxlovid from 18Nov2022 to 22Nov2022 for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) showed very faint line on COVID, notes: COVID test during this time showed very faint line on COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
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 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 73 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 18Jan2021 as dose 1, single (Lot number: EC3249), in left arm, on 08Feb2021 as dose 2, single (Lot number: EL9269), in left arm, on 20Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 29Mar2022 as dose 4 (booster), single (Lot number: FK9894), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Prolapsed mitral valve" (unspecified if ongoing); "calcification of heart artery" (unspecified if ongoing); "ED" (unspecified if ongoing); "GERD" (unspecified if ongoing). The patient has no known allergies. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid (treatment start date: 23Nov2022, treatment stop date: 27Nov2022).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, 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 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies Nuts" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 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. Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid, Lot number: GE3010, from 01Nov2022 to 03Dec2022). . The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Gait disturbance, Neck pain, Pain in extremity, Somnolence
Clinical narrative: Sore all over neck, arms, thighs; Sore all over neck, arms, thighs; Walks like a 100 year old man; Wants to go to bed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NECK PAIN (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "Sore all over neck, arms, thighs"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "Walks like a 100 year old man"; SOMNOLENCE (non-serious), outcome "unknown", described as "Wants to go to bed".  Additional information: The patient was asking if it was a normal response to experience soreness as described all over neck, arms, thighs and having issues with walking after receiving the booster. The patient felt like he was run over by a truck or beat up with a baseball bat. Patient was walking like a 100-year-old man and wanted to go to bed. The patient had same symptoms last time, he had a COVID vaccine, unspecified. Patient would never get a COVID vaccine again, after the last time. The caller stated that he was going to take ibuprofen.  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-202201348905 same patient, event and reporter, different dose;
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Dose 1: Johnson vaccine and Dose 2: Pfizer; 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 43-year-old male patient received BNT162b2 (BNT162B2), on 01Jun2022 at 12:00 as dose 2 (booster), single (Batch/Lot number: unknown) at the age of 42 years, in right arm for covid-19 immunisation; COVID-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 13Apr2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SERTRALINE, start date: 01Jun2020; VALIUM, start date: 23Nov2022, stop date: 26Nov2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Dose 1: Johnson vaccine and Dose 2: Pfizer". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 22Nov2022 to 26Nov2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 68.0
Sex: F
Vaccine: 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 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04May2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 68 years, in right arm and as dose number unknown, 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 Nov2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) negative, notes: testing negative. 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: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: she was tested positive from COVID 19 six days ago; she was tested positive from COVID 19 six days ago; 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), in Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; 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) all with onset 27Nov2022, outcome "unknown" and all described as "she was tested positive from COVID 19 six days ago". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Nov2022) Positive, notes: tested positive from COVID19 six days ago; (Dec2022) Negative, notes: negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Caller mentioned she had taken all the vaccines and booster shots from Pfizer, even she received the Omicron formulation in Sep2022. But she was tested positive from COVID 19 six days ago. After that she took Paxlovid and already finished her treatment. She has later tested negative, but still had some cold symptoms. She wanted to know if she could take cold medicines at the time that she finished Paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Age: 68.0
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 contactable reporter(s) (Physician).  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 68 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid treatment from 21Nov2022 to 25Nov2022.; Sender's Comments: A contributory role of BNT162B2, BNT162B2 OMI BA.4-5 to event covid-19 cannot be excluded based on temporal association and available information.
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Sep2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Sarcoidosis" (unspecified if ongoing); "Allergies" (unspecified if ongoing), notes: Known allergies: Yes. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: negetive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient received Anti viral with Paxlovid. Paxlovid rebound, contracted COVID again 5 days after finishing paxlovid, two days after testing negative.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 41.0
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 non-contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Dec2021 as dose 3 (booster), single (Lot number: EW0196) at the age of 41 years 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: "Hypertension" (unspecified if ongoing); "known allergies: sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Interchange of vaccine products; COVID 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 73-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 at 14:30 as dose 5 (booster), single (Lot number: 7H9694) at the age of 73 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 30Mar2022 as dose 4 (booster), single (Lot number: FJ9943) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 17Feb2021 as dose 1, single (Lot number: 031M20A), on 17Mar2021 as dose 2, single (Lot number: 001B21A) and on 05Nov2021 as dose 3 (booster), single (Lot number: 032F21A) for covid-19 immunisation. The patient's relevant medical history included: "Slightly high cholesterol" (unspecified if ongoing); "Slightly high BP" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Nov2022, outcome "unknown", described as "COVID 19 treatment"; DRUG INEFFECTIVE (medically significant) with onset Nov2022, outcome "unknown", described as "COVID treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown". Therapeutic measures, Paxlovid from 21Nov2022 to 26Nov2022, were taken as a result of drug ineffective, covid-19. Patient felt much better after the Paxlovid treatment. The patient has no known allergies.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of Paxlovid from 17Nov2022 to 22Nov2022 for COVID-19; Treatment of Paxlovid from 17Nov2022 to 22Nov2022 for COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 36 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown), 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. Dose 2 was also reported to be given on "11May2020" (possible discrepant). The patient had no relevant medical history. The patient has no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "Treatment of Paxlovid from 17Nov2022 to 22Nov2022 for COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: got the Omicron, tested positive for COVID about 4 months ago; got the Omicron, tested positive for COVID about 4 months ago; 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 number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "not recovered" and all described as "got the Omicron, tested positive for COVID about 4 months ago". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) Positive.  Clinical course: Patient got the Omicron, tested positive (later clarified as tested positive for COVID) about 4 months ago and has these ongoing symptoms. Patient got the common side effects like the chest congestion and little bit of brain 'falled' (later clarified as the symptoms of COVID). Patient stated, that it's not from the vaccine, it's from the Omicron. When probed to clarify if patient took the Pfizer COVID-19 Vaccine: Consumer stated, "Right, I took all the shots." (unspecified doses). Patient has not had any side effects from the vaccine. Patient has just had only side effects from the COVID.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: 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.  An elderly female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown), 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 included: "thyroid cancer" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "known allergies: sulfa" (unspecified if ongoing), notes: known allergies: sulfa. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  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: 27.0
Sex: F
Vaccine: COVID19, 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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 at 16:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 27 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 was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (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: (2022) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient received no other medication in 2 weeks. Anti-viral details: [product=COVID 19 Treatment].  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Interchange of vaccine products; 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 71-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 71 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 23Feb2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 23Mar2021 as dose 2, single (Batch/Lot number: unknown), on 14Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 18Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "breast cancer" (unspecified if ongoing), notes: other medical history: History of breast cancer. Concomitant medication(s) included: ANASTROZOLE, start date: 01Jan2021. 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"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional Information: Other medication in 2weeks brand. If treatment ae: No. Known allergies: No.  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: 70.0
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) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 5 (booster), single (Lot number: GJ5342) at the age of 70 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 11Feb2021 as dose 1, single (Lot number: EM9809), in left arm, on 28Feb2022 as dose 2, single (Lot number: EN6200), in left arm, on 22Oct2021 as dose 3 (booster), single (Lot number: FF2593), in left arm and on 15Apr2022 as dose 4 (booster), single (Lot number: FJ4989), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "hay fever" (unspecified if ongoing). The patient has no known allergies. 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 "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Nov2022) Negative; (02Dec2022) Positive, notes: symptoms back. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid treatment from 22Nov2022 to 27Nov2022.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201350100 same reporter/patient, different dose number/event;
Age: 33.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old male patient received BNT162b2 (BNT162B2), on 03Oct2022 as dose 1, single (Lot number: 028A21A) at the age of 33 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. 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) Positive, notes: Treatment of COVID-19; (03Dec2022) Positive, notes: Tested positive again on day 11 (4 days after end of paxlovid course). Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: the patient was treated with PAXLOVID from 23Nov2022 to 28Nov2022 for Covid-19.    No follow-up attempts are possible. No further information is expected.
Age: 58.0
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 contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 58-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 at 09:30 as dose 5 (booster), single (Lot number: GH9693) at the age of 58 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type 1 diabetes (controlled)" (ongoing). Concomitant medication(s) included: NOVOLOG; LISINOPRIL; NIFEDIPINE; HYDROCHLOROTHIAZID; METOPROLOL; ATORVASTATIN. 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: (2022) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical coarse: The patient had no known allergies. He received Paxlovid (anti-viral) for COVID 19 treatment from 18Nov2022 to 22Nov2022.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Interchange of vaccine products; 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 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: EP6955), on 13Apr2021 as dose 2, single (Lot number: ER8134) and on 10Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 57 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 29Apr2022 as dose 4 (booster), single (Lot number: 005MUA) and on 02Sep2022 at 12:00 as dose 5 (booster), single (Lot number: AS714DC), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Known allergies:Amoxicillin", notes: Known allergies:Amoxicillin; Lamictal, reaction(s): "Known allergies:lamictal", notes: Known allergies: Lamictal. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown"; VACCINATION FAILURE (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: Positive, notes: Started Paxlovid one day after symptoms began and positive Covid test- day 1; Negative, notes: Days 8 Tested negative; Positive, notes: Day 12 tested positive For Covid again; Positive, notes: Day 16 tested again, still Positive/ That brings me through today. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient was generally quite healthy and fit. Patient received Treatment from18Nov2022 to 22Nov2022. It was unknown if the patient received any other medication in two weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 61.0
Sex: M
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).  A 61-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 at 09:00 as dose 5 (booster), single (Lot number: GH9693) at the age of 61 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Dec2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Dec2022) Positive, notes: tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid Treatment start date 21Nov2022 to 25Nov2022.
Age: 79.0
Sex: M
Vaccine: COVID19, FLUX, COVID19, FLUX
Symptoms: Cardiac disorder, Dysstasia, Herpes zoster, Off label use, Product use issue
Clinical narrative: got COVID virus; got COVID virus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Oct2022 as dose 4 (booster), single (Lot number: GH9702) at the age of 79 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Lot number: EZ3302), on 08Apr2021 as dose 2, single (Lot number: FR8729) and on 20Nov2021 as dose 3 (booster), single (Lot number: FG3527) for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 18Oct2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "got COVID virus". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results.
Age: 79.0
Sex: M
Vaccine: COVID19, FLUX, COVID19, FLUX
Symptoms: Sensory loss
Clinical narrative: got COVID virus; got COVID virus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Oct2022 as dose 4 (booster), single (Lot number: GH9702) at the age of 79 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Lot number: EZ3302), on 08Apr2021 as dose 2, single (Lot number: FR8729) and on 20Nov2021 as dose 3 (booster), single (Lot number: FG3527) for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 18Oct2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "got COVID virus". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results.
Age: 79.0
Sex: M
Vaccine: COVID19, FLUX, COVID19, FLUX
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: got COVID virus; got COVID virus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Oct2022 as dose 4 (booster), single (Lot number: GH9702) at the age of 79 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Lot number: EZ3302), on 08Apr2021 as dose 2, single (Lot number: FR8729) and on 20Nov2021 as dose 3 (booster), single (Lot number: FG3527) for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 18Oct2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "got COVID virus". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results.
Age: 52.0
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 52 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 had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: positive rapid tests. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: the patient was treated with Paxlovid from 23Nov2022 to 28Nov2022 for Covid-19.   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: Contusion, Laboratory test, Thrombocytopenia, Wrong product administered
Clinical narrative: thrombocytopenia; Wrong vaccine administered; minor bruising; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team, Program ID: (Unknown).  A 65-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient didn't receive BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose: 1st booster), for COVID-19 immunization. The following information was reported: THROMBOCYTOPENIA (medically significant), outcome "not recovered"; WRONG PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "Wrong vaccine administered"; CONTUSION (non-serious), outcome "not recovered", described as "minor bruising". The patient underwent the following laboratory tests and procedures: lab test: immune thrombocytopenia -27-47 K, notes: who developed an immune thrombocytopenia (~27-47 K) that was diagnosed serendipitously (minor bruising, no frank bleeding, unresolved after 6 months) on a lab test done 6 weeks after the second COVID booster.  The information on the batch/lot number for BNT162b2, BNT162b2, BNT162b2 omi ba.4-5 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 event thrombocytopenia and the use of suspect product BNT162b2 cannot be fully excluded. The case will be reassessed once further information is available The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in the upper right arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "two plates and numerous screws in the right humorous bone" (unspecified if ongoing). The patient's 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: PAIN IN EXTREMITY (non-serious) with onset Nov2022, outcome "unknown", described as "pain in the upper right arm".  Additional information: A couple of hours after receiving booster and for the next three days, patient had pain in the upper right arm. She was asking clarifications regarding right arm pain, when the injection was placed in the left arm.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201356977 same patient, different vaccine dose/partial same event;
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore Arm; Tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 7-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Dec2022 at 15:15 as dose 3 (booster), single (Lot number: 6K1657) at the age of 7 years intramuscular, 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: 2, Batch/Lot No: FL8094), administration date: 08Jan2022, when the patient was 6-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: FK5618), administration date: 18Dec2021, when the patient was 6-year-old, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 05Dec2022, outcome "recovering", described as "Sore Arm"; FATIGUE (non-serious) with onset 05Dec2022, outcome "recovering", described as "Tired". Therapeutic measures were not taken as a result of pain in extremity, fatigue. No COVID prior vaccination. No COVID tested post vaccination. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Got Covid-19; Got Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "Got Covid-19".  Clinical course: Patient got Covid around Christmas of 2021. She and their son got Covid, but caller did not get it. Declines report for wife. She didn't get the Covid this time. She got Covid after the last shot. The Covid was very mild  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: Illness
Clinical narrative: received booster shot and reported severe illness; This is a spontaneous report received from contactable reporter(s) (Nurse) from a sales representative.  An elderly male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 Immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "received booster shot and reported severe illness".  Additional information: Patient received booster shot and reported severe illness for approximately 2 weeks after receiving dose. Event took place after use of product.  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.