chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19, 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 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 72 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 included: "Artificial aortic heart valve" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Statins for known allergies: statins. 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: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment/ Had COVID rebound; COVID 19 Treatment/ Had COVID rebound; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Dec2021 as dose number unknown, single (Lot number: 33025bd) at the age of 49 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Thyroid disorder" (unspecified if ongoing); "food allergies" (unspecified if ongoing); "Known allergies: amoxicillin families" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; PROGESTERONE; MELOXICAM. Past drug history included: Keflex, reaction(s): "Known allergies: Keflex". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment/ Had COVID rebound". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Positive, notes: COVID rebound. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid (treatment start date: 01Aug2022; treatment stop date: 06Aug2022).
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Disease recurrence, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19; COVID 19; tested positive a 2nd time for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 59 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: "Asscending Aorta Anyersuem" (unspecified if ongoing), notes: Asscending Aorta Anyersuem; "tumor on kidney and adrenal" (unspecified if ongoing), notes: tumor on kidney and adrenal; "mulit-polps removed Colonscopy" (unspecified if ongoing), notes: mulit-polps removed Colonscopy; "Hysterhectmy" (unspecified if ongoing); "Known allergies: some Beta Blockers" (unspecified if ongoing), notes: known allergies: some Beta Blockers; "known allergies: penicillin" (unspecified if ongoing); "tumor on kidney and adrenal" (unspecified if ongoing), notes: tumor on kidney and adrenal. There were no concomitant medications. Past drug history included: Amoxin, reaction(s): "known allergies: Amoxin"; Codene, reaction(s): "known allergies: codene". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14Aug2022, outcome "unknown" and all described as "COVID 19"; DISEASE RECURRENCE (medically significant) with onset 14Aug2022, outcome "unknown", described as "tested positive a 2nd time for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (14Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, 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
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mRNA (mRNA 1273) (MODERNA 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 concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (Aug2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
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 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Mar2021 at 09:00 as dose 1, single (Lot number: EN6198), in left arm, on 26Mar2021 at 09:00 as dose 2, single (Lot number: ER8732), in left arm, on 01Oct2021 at 09:00 as dose 3 (booster), single (Lot number: 30145BA), in left arm and on 26May2022 at 10:00 as dose 4 (booster), single (Lot number: FM9992) at the age of 67 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), 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. Therapeutic measures were taken as a result of vaccination failure, covid-19 (Paxlovid).
Age: 55.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 11May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 55 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 02Aug2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Aug2022) positive. Mucinex were taken from 03Aug2022 to 11Aug2022 as a result of drug ineffective, covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
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) (Physician).  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Mar2021 as dose 1, single (Batch/Lot number: unknown), on 03Apr2021 as dose 2, single (Batch/Lot number: unknown), on 15Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 01Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 40 years for covid-19 immunisation. The patient's relevant medical history included: "carrier of IPEX syndrome with unspecified immune deficiency that is thought to be related" (unspecified if ongoing); "Celiac disease" (unspecified if ongoing); "psoriasis" (unspecified if ongoing); "Known allergies: latex" (unspecified if ongoing); "Known allergies: PCN" (unspecified if ongoing). Concomitant medication(s) included: PREGABALIN; DULOXETINE; OTEZLA; PANTOPRAZOLE; TRULANCE. Past drug history included: Etanercept, reaction(s): "Known allergies: etanercept"; Celebrex, reaction(s): "Known allergies: Celebrex". The following information was reported: VACCINATION FAILURE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset 12Aug2022, 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) Positive; (12Aug2022) Positive, notes: Tested positive again on 12Aug. Therapeutic measures were taken as a result of vaccination failure, 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 information currently available, a causal association between the reported event and BNT162b2 cannot be excluded.
Age: 44.0
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). The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 04Jan2022 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 44 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: "Stage 2 liver diseases" (unspecified if ongoing); "migraine headache" (unspecified if ongoing); "Known allergy : Penicillin" (unspecified if ongoing). Concomitant medication(s) included: OZEMPIC; PROPRANOLOL. 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 Treatment". 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 including received Paxlovid from 02Aug2022 to 07Aug022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Jan2022 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 45 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: "Obesity" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "autoimmune disorders" (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 2022, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was received Paxlovid for treatment of Covid-19 from 03Aug2022 to 07Aug2022. The patient did not receive any other medication in 2weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
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) (Nurse). The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), on 05Jul2022 at 10:00 as dose 4 (booster), single (Lot number: Fm7553) at the age of 50 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: "DM" (unspecified if ongoing), notes: controlled, not on DM meds. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". 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.; Sender's Comments: Based on the information currently available, a causal association between the reported event and BNT162b2 cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Transient ischaemic attack
Clinical narrative: she was hauled off, they thought she had a TIA, which she did not and that may not have been related; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EL3247, Expiration Date: 21May2021) for covid-19 immunisation. The patient's relevant medical history included: "Sunburn" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: TRANSIENT ISCHAEMIC ATTACK (medically significant), outcome "unknown", described as "she was hauled off, they thought she had a TIA, which she did not and that may not have been related".  The reporter considered "she was hauled off, they thought she had a tia, which she did not and that may not have been related" not related to BNT162b2.  Additional information: With the first COVID-19 Vaccine, she was hauled off, they thought she had a TIA, which she did not and that may not have been related. With the TIA, she states who knows, she doesn't think that was true either That vaccine did something to her She received a letter from Pfizer with a reference number: # Confirmed she previously filed a report with Pfizer and complained.  Follow-Up (16Aug2022): Follow-up attempts are completed. No further information is expected.; Sender's Comments: The company does not attribute the 'they thought she had a TIA' (PT: Transient ischaemic attack) to BNT162b2 (BNT162B2). The diagnosis is to be confirmed.,Linked Report(s) : US-PFIZER INC-202200403402 Same reporter/patient/ product and different dose/event;US-PFIZER INC-202201057761 Same reporter/patient/ product and different dose/event;US-PFIZER INC-202201037982 Same reporter/patient/ product and different dose/event;
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 01Nov2021 at 13:00 as dose 2, single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient 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), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medications received in two weeks: No. Paxlovid was taken as treatment drug for Covid-19 treatment from 13Aug2022 to Aug2022. Lot number GE4926. Patient have no known allergies. Treatment was not received for AE. No known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received BNT162b2 (BNT162B2), on 06Apr2021 as dose 1, single (Lot number: 8737), in right arm, on 28Apr2021 as dose 2, single (Lot number: EW0170), in right arm and on 07Dec2021 as dose 3 (booster), single (Lot number: FD7218) at the age of 41 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. No known allergies. 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: Positive, notes: by day 11 solid positive on rapid antigen test; Positive, notes: COVID 19 Treatment; Negative, notes: Tested negative on Day 10, by day 11 solid positive on rapid antigen test. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid.
Age: 49.0
Sex: M
Vaccine: 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) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 21Jan2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 49 years, in right arm and as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovering" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Treatment drug Paxlovid from 29Jul2022 to 02Aug2022 for COVID 19. Other medication in 2weeks: Yes.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EL9265), in left arm, on 25Feb2021 as dose 2, single (Lot number: EL9266), in left arm, on 29Sep2021 as dose 3 (booster), single (Lot number: 301458A), in left arm and on 25Jun2022 as dose 4 (booster), single (Lot number: FP7135) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "hypercholesterolemia" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, stop date: 05Aug2022; DILTIAZEM HYDROCHLORIDE, start date: 03Aug2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Aug2022) Negative, notes: After having tested negative on 12Aug2022; (14Aug2022) Positive, notes: I tested positive today 14Aug2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: vaccine received reported as yes. Other medication in 2weeks reported as yes. COVID 19 Treatment includes Paxlovid with treatment start date 05Aug2022 and stop date 09Aug2022. Other medication in 2weeks product reported as Atorvastatin 40 mg with stop date 05Aug2022 and Diltiazem Er (cd) caps, 120 mg with start date 03Aug2022. Patient reported there were none other than pain add the injection site. If you are talking about adverse events regarding Paxlovid. Patient tested positive 14Aug2022, After having tested negative on 12Aug2022. Patient was asymptomatic. Known allergies reported as no.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 66-year-old female patient received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EL9265) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "hyper- cholesterolemia" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, stop date: 05Aug2022; DILTIAZEM, start date: 03Aug2022. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "pain add the injection site". Therapeutic measures were not taken as a result of vaccination site pain.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: received Paxlovid as the treatment of COVID-19; received Paxlovid as the treatment of COVID-19; This is a spontaneous report received from a contactable consumer. The reporter is the patient. A 79-year-old male patient received BNT162b2 (BNT162B2), on 08Mar2021 as dose 1, single (Batch/Lot number: unknown), on 09Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 08May2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 78 years for covid-19 immunisation. The patient's relevant medical history included: "Parkinson's" (unspecified if ongoing); "Colon Cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Aug2022, outcome "unknown" and all described as "received Paxlovid as the treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Aug2022) Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective.  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-202201057808 same reporter/patient/drug, different dose/event;
Age: 53.0
Sex: F
Vaccine: COVID19, 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 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Dec2021 at 15:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 24May2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penecillin" (unspecified if ongoing). There were no concomitant medications. The patient had no other medications in 2 weeks. 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: Positive, notes: Treatment for covid-19 test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: vaccine brand=Pfizer / BioNTech/vaccine brand other=Johnson and Johnson; 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 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Nov2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation; coviD-19 vaccine janssen (COVID-19 VACCINE JANSSEN), on 01Apr2021 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Neurofibromatosis type II" (unspecified if ongoing). Concomitant medication(s) included: BRIGATINIB, start date: 01Mar2022, stop date: 04Aug2022. Past drug history included: Iodine, reaction(s): "Known allergies", notes: Iodine if injected intravenously. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "vaccine brand=Pfizer / BioNTech/vaccine brand other=Johnson and Johnson"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of interchange of vaccine products, drug ineffective, covid-19.  Clinical course information: Patient took other medication in 2 weeks product. Patient took COVID 19 treatment from 06Aug2022 to 10Aug2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, Off label use, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; dose 1 'Moderna' , dose 2 'Pfizer / BioNTech'; dose 1 'Moderna' , dose 2 'Pfizer / BioNTech'; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Sep2021 at 16:30 as dose 2, single (Lot number: FF2587) at the age of 44 years, in left arm for covid-19 immunisation; COVID-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 23Aug2021 at 19:15 as dose 1, single (Lot number: 939893), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Blood clotting disorder factor 5" (unspecified if ongoing); "asthma" (unspecified if ongoing); "migraines" (unspecified if ongoing); "scleroderma" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL SULFATE]; ELIQUIS; MAXALT taken for migraine; MINOCYCLINE. Past drug history included: Known allergies : reglan, reaction(s): "Allergy"; Known allergies : topamax, reaction(s): "Allergy". The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious) all with onset 18Sep2021, outcome "unknown" and all described as "dose 1 'Moderna' , dose 2 'Pfizer / BioNTech'"; 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: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19: Paxlovid from 08Aug2022 to 13Aug2022.
Age: 42.0
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) (Physician).  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Jan2021 as dose 1, single (Batch/Lot number: unknown), on 29Jan2021 as dose 2, single (Batch/Lot number: unknown) and on 03Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 42 years for covid-19 immunisation. The patient's relevant medical history included: "hypothyroid" (unspecified if ongoing), notes: Other medical history: hypothyroid; "hyperlipidemia" (unspecified if ongoing); "OSA on CPAP" (unspecified if ongoing), notes: Other medical history: OSA on CPAP; "OSA on CPAP" (unspecified if ongoing), notes: Other medical history: OSA on CPAP; "depression" (unspecified if ongoing). The patient has no known allergies. Concomitant medication(s) included: JUNEL; VIIBRYD; BUPROPION; LIOTHYRONINE; LEVOTHYROXINE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) positive, notes: COVID 19 Treatment; (07Aug2022) negative, notes: symptoms had resolved; (10Aug2022) negative, notes: symptoms returned; (12Aug2022) positive, notes: symptoms worsened. It was reported that the patient completed 5-day course of Paxlovid on 07Aug2022 - symptoms had resolved and tested negative for COVID - Symptoms returned on 10Aug2022 and she tested negative again, symptoms worsened and she tested positive on 12Aug2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available, a causal association between the reported event and BNT162b2 cannot be excluded.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Experienced symptoms of and tested positive for covid-19; Experienced symptoms of and tested positive 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 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Lot number: EL3247), on 24Mar2021 as dose 2, single (Lot number: EL3247) and on 26Nov2021 as dose 3 (booster), single (Lot number: FF2587) at the age of 42 years for covid-19 immunisation. The patient's relevant medical history included: "known allergies: penicillin" (unspecified if ongoing), notes: known allergies: penicillin. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Experienced symptoms of and tested positive for covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Experienced symptoms of and tested positive for covid-19. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical information: Patient Experienced symptoms of and tested positive for covid-19. Symptoms primarily include cough and fatigue. Adverse event treated with cough syrup and ibuprofen. patient did not had covid prior vaccination. Patient covid tested post vaccination was answered as yes.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
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 73-year-old male patient received BNT162b2 (BNT162B2), on 09Jan2021 as dose 1, single (Lot number: EC3246), in left arm, on 30Jan2021 as dose 2, single (Lot number: EL9263), in left arm, on 19Sep2021 as dose 3 (booster), single (Lot number: E13184), in left arm and on 07Jul2022 as dose 4 (booster), single (Lot number: FP7150) at the age of 73 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Amphicilin, reaction(s): "Known allergies: amphicilin". The following information was reported: 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. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Sex: M
Vaccine: COVID19, 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), as dose 3 (booster), single (Batch/Lot number: unknown) 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), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 36.0
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 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Nov2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 28Feb2022 as dose 2, single (Lot number: FJ8757) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "PCOS" (unspecified if ongoing); "Depression" (unspecified if ongoing); "known allergies: Eggs" (unspecified if ongoing); "Pain" (unspecified if ongoing); "Cough" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "Sleep aid" (unspecified if ongoing). Concomitant medication(s) included: ADDERALL taken for attention deficit hyperactivity disorder, start date: Aug2007; ZOLPIDEM taken for sleep disorder, start date: Aug2007; ZINC, start date: 31Jul2022; VITAMIN D3, start date: 31Jul2022; VITAMIN C [ASCORBIC ACID], start date: Jun2022; FAMOTIDINE, start date: Jan2020; PROMETHAZINE taken for cough, start date: 01Aug2022, stop date: 04Aug2022; TYLENOL taken for pain, start date: May2022; BUPROPION taken for depression, start date: Aug2007. Past drug history included: Hydrocodone, reaction(s): "known allergies: Hydrocodone"; Z pak, reaction(s): "known allergies: Zpak". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 31Jul2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) positive, notes: took another at home test and it just came up positive; (31Jul2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: 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 3 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number unknown), for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Lot number unknown), for COVID-19 immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "I took the booster I got very very ill". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nasal congestion, Nausea, Oropharyngeal pain
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient. A male patient received BNT162b2 (BNT162B2), on 20Jul2021 as dose 1, single (Lot number: Unknown) and on 10Aug2021 as dose 2, single (Lot number: Unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "Body ache"; HEADACHE (non-serious), outcome "unknown"; RHINORRHOEA (non-serious), outcome "unknown", described as "Runny nose"; NAUSEA (non-serious), outcome "unknown"; NASAL CONGESTION (non-serious), outcome "unknown", described as "Congestion"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "Sore throat". Additional information: Reporter stated that he had adverse event of the COVID-19 Vaccine. Patient said that he had first shot back on 20Jul2021 and then other on 10Aug2021. He wanted to know the symptoms that he had and wants to find out what kind of symptoms he had. Patient mentioned he had fatigue, body ache, headache, sore throat, congestion, runny nose, nausea and however doesn't have shortness of breathing. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Rhinorrhoea
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient. A male patient received BNT162b2 (BNT162B2), on 20Jul2021 as dose 1, single (Lot number: Unknown) and on 10Aug2021 as dose 2, single (Lot number: Unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "Body ache"; HEADACHE (non-serious), outcome "unknown"; RHINORRHOEA (non-serious), outcome "unknown", described as "Runny nose"; NAUSEA (non-serious), outcome "unknown"; NASAL CONGESTION (non-serious), outcome "unknown", described as "Congestion"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "Sore throat". Additional information: Reporter stated that he had adverse event of the COVID-19 Vaccine. Patient said that he had first shot back on 20Jul2021 and then other on 10Aug2021. He wanted to know the symptoms that he had and wants to find out what kind of symptoms he had. Patient mentioned he had fatigue, body ache, headache, sore throat, congestion, runny nose, nausea and however doesn't have shortness of breathing. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Aug2022 at 17:45 as dose 4 (booster), single (Lot number: FP7131) at the age of 66 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Breast Cancer x2" (unspecified if ongoing); "Arteriosclerosis" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Chronic Pain Syndrome" (unspecified if ongoing); "allergies" (unspecified if ongoing), notes: Known allergies: Yes. The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 3 (BOOSTER), SINGLE lot number FF8841, dose administration time 03:00 PM, vaccine location Right arm), administration date: 01Oct2021, when the patient was 65-year-old, for Covid-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE; Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE; Manufacturer unknown), for Covid-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 13Aug2022 at 06:00, outcome "recovering", described as "Debilitating fatigue"; ARTHRALGIA (non-serious) with onset 13Aug2022 at 06:00, outcome "recovering", described as "extreme joint pain". Therapeutic measures were not taken as a result of fatigue, arthralgia. Additional Information: Patient had known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.
Sex: U
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age, Vaccination site nodule, Vaccination site warmth
Clinical narrative: A 26 year old patient experienced injection site warmth and a bump after being administered  Trumenba; Inappropriate age at vaccine administration; A 26 year old patient experienced injection site warmth and a bump after being administered  Trumenba; This is a spontaneous report received from contactable reporter(s) (Nurse) from a sales representative.  A 26-year-old patient received meningococcal group b Rlp2086 (TRUMENBA), 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: VACCINATION SITE WARMTH (non-serious), outcome "unknown", VACCINATION SITE NODULE (non-serious), outcome "recovered" and all described as "A 26 year old patient experienced injection site warmth and a bump after being administered  Trumenba"; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), outcome "unknown", described as "Inappropriate age at vaccine administration". Follow-up attempts are completed. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4498662-00 (Company).  A 47-year-old male patient received BNT162b2 (BNT162B2), on 06May2021 as dose 1, single (Batch/Lot number: unknown), on 16Jun2021 as dose 2, single (Batch/Lot number: unknown) and on 08Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 47 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", SUSPECTED COVID-19 (medically significant), outcome "recovered" (2022) and all described as "COVID-19". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "covid-19" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter considered "covid-19" related to BNT162b2.  Clinical course: The reporter's causality for HUMIRA for the event(s) of COVID was not provided. Causality for Pfizer Biontech COVID-19 Vaccine reported as Causality as per reporter (Drug/Vaccine) : Possible. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. There was no reported medical history.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Drug ineffective depends on many factors including pharmacokinetics, severity of disease and patient general health condition. However on conservative basis, the possible causality cannot be excluded.