chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: First symptoms 22Jun22/rebound positive antigen tests 01Jul, 03Jul, 04Jul, 06Jul continuing; First symptoms 22Jun22/rebound positive antigen tests 01Jul, 03Jul, 04Jul, 06Jul continuing; 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 male patient received BNT162b2 (BNT162B2), on 12Apr2022 at 12:00 as dose 3 (booster), single (Lot number: F15682) 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) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: FINASTERIDE, start date: 02Jun1995, stop date: 06Jul2022; HYDROCHLOROTHIAZIDE, start date: 01Jul2011, stop date: 06Jul2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 22Jun2022, outcome "not recovered" and all described as "First symptoms 22Jun22/rebound positive antigen tests 01Jul, 03Jul, 04Jul, 06Jul continuing". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Jun2022) Positive, notes: First symptoms 22Jun2022; (30Jun2022) Negative, notes: Negative antigen test 30Jun; (01Jul2022) Positive, notes: rebound positive antigen tests 01Jul, 03Jul, 04Jul, 06Jul continuing; (03Jul2022) Positive, notes: rebound positive antigen tests 01Jul, 03Jul, 04Jul, 06Jul continuing; (04Jul2022) Positive, notes: rebound positive antigen tests 01Jul, 03Jul, 04Jul, 06Jul continuing; (06Jul2022) Positive, notes: rebound positive antigen tests 01Jul, 03Jul, 04Jul, 06Jul continuing. Therapeutic measures were taken as a result of drug ineffective, covid-19. Rebound covid post paxlovid. First symptoms 22Jun22; paxlovid 23Jun-29Jun: Negative antigen test 30Jun; rebound positive antien tests 01Jul, 03Jul, 04Jul, 06Jul continuing.; Sender's Comments: Based on the available information and possible temporal association the causal relationship between the  reported events and  suspect drug  cannot be excluded. The case will be reviewed further with FU information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site discolouration, Vaccination site mass
Clinical narrative: Injection site has a black round spot/bump from vaccination; Injection site has a black round spot/bump from vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 16-year-old male patient received BNT162b2 (BNT162B2), on 11Jan2022 as dose 3 (booster), single (Lot number: 331308A) at the age of 16 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 2, SINGLE, Lot Number: EW0182, Anatomical location: Right arm), administration date: 02Jun2021, when the patient was 15-year-old, for COVID-19 immunization; BNT162b2 (DOSE 1, SINGLE, Lot Number: EW0167, Anatomical location: Right arm), administration date: 12May2021, when the patient was 15-year-old, for COVID-19 immunization. The following information was reported: VACCINATION SITE DISCOLOURATION (non-serious), VACCINATION SITE MASS (non-serious) all with onset 11Jan2022, outcome "not recovered" and all described as "Injection site has a black round spot/bump from vaccination". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site discolouration, vaccination site mass.  Additional information: The patient did not have any medical history or allergy. The patient did not have covid prior to vaccination. It was unknown if other vaccine was administered in four weeks. In two weeks, other medications were not administered. On 03Jun2022, the patient was tested for covid post vaccination (Nasal swab test) and at home test done. The result of test was negative.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Apr2022 at 13:00 as dose 4 (booster), single (Lot number: FM7553) at the age of 71 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. Concomitant medication(s) included: BUPROPION, start date: Jan2004, stop date: Jul2022. The following information was reported: DRUG INEFFECTIVE (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: (05Jul2022) positive, notes: But after 8 days, I developed symptoms again and tested positive; (Jul2022) negative, notes: After 5 days of taking Paxlovid, I tested negative for COVID (antibody test), and again after 7 days; (unspecified date) Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment of COVID-19 included Paxlovid from 27Jun2022 to 02Jul2022.  Clinical course: No known allergies were reported. Patient received Bupropion in two weeks. After 5 days of taking Paxlovid, patient tested negative for COVID (antibody test), and again after 7 days. But after 8 days on 05Jul2022, patient developed symptoms again at 10:00 pm and tested positive.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Running nose, sneezing, sore throat, no temp, positive covid home test. Possible covid rebound. Tested positive for covid two weeks earlier and recovered.; Running nose, sneezing, sore throat, no temp, positive covid home test. Possible covid rebound. Tested positive for covid two weeks earlier and recovered.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: en6205), on 22Mar2021 as dose 2, single (Lot number: er8727), on 27Sep2021 as dose 3 (booster), single (Lot number: 301458a), in right arm and on 30Mar2022 as dose 4 (booster), single (Lot number: fjs682) at the age of 72 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "liver issue" (unspecified if ongoing); "kidney issue" (unspecified if ongoing). The patient did not have known allergies. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "recovered" (2022) and all described as "Running nose, sneezing, sore throat, no temp, positive covid home test. Possible covid rebound. Tested positive for covid two weeks earlier and recovered.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: positive covid home test; (unspecified date) Unknown results, notes: Indication= Covid-19 treatment; (Jun2022) Positive, notes: Tested positive for covid two weeks earlier and recovered. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid from 23Jun2022 to 27Jun2022.
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling, Peripheral swelling
Clinical narrative: leg and an ankle had swollen; leg and an ankle had swollen; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (COMIRNATY), on 05Jul2022 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: PERIPHERAL SWELLING (non-serious), JOINT SWELLING (non-serious) all with onset Jul2022, outcome "unknown" and all described as "leg and an ankle had swollen".  Additional information: Reporter mentioned that yesterday he received his booster shot with the COMIRNATY vaccine. He mentioned that his leg and an ankle had swollen and asked if this was a common side effect or if he had heard of this as a negative reaction to the shot. After this, caller mentioned he actually wanted to know what to do about it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Has taken Pfizer, all the shots, vaccinations and the boosters. Tested positive for Covid yesterday; Has taken Pfizer, all the shots, vaccinations and the boosters. Tested positive for Covid yesterday; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Allergy to sulfites" (unspecified if ongoing), notes: Allergy to sulfites. Concomitant medication(s) included: DOXYCYCLINE taken for skin reaction, start date: 2020. Past drug history included: Doxycycline, start date: 2020, for occasionally has skin reactions, reaction(s): "Her throat swells", notes: 2 years ago, in 2020; Doxycycline, start date: 2020, for occasionally has skin reactions, reaction(s): "feeling like fire on the inside of her body", notes: 2 years ago, in 2020; Doxycycline, start date: 2020, for occasionally has skin reactions, reaction(s): "then felt tingly all over/ was like that tingly feeling you get when you hit your elbow/ Felt that tingly feeling all over her body", notes: 2 years ago, in 2020. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Jul2022, outcome "unknown" and all described as "Has taken Pfizer, all the shots, vaccinations and the boosters. Tested positive for Covid yesterday". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jul2022) Positive. Clinical information: It was reported that reaction to her doctor and it happened about 2 years ago, in 2020. Believes it was before Covid. Tested positive for Covid yesterday, Tuesday. Called the doctor immediately and she wanted to make sure the medication didn't have sulfites in it. So she called today. Clarified that she didn't take the Doxycycline after that second dose. When she talked to the pharmacist about her reaction, she told him she was not taking it anymore and pharmacist said that was fine. NDC, LOT, EXP to Sulfites caller had reactions to in past: Unknown When she eats different things, like when going to a restaurant, she tells them she can't have anything with sulfites. Sometimes, they put thing in it, then she has a reaction and takes Benadryl. Once she stopped taking the medication, and it got out of her system she thinks it was fine, at that point. Tried to flush it out of her system with water and it was fine. Has taken Pfizer, all the shots, vaccinations and the boosters and it was just fine.  Description of complaint: had reaction to Doxycycline, which had sulfites in it. Has allergic reactions to sulfites. Product strength and count size dispensed: unknown   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
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 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 29Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 30Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 29Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), 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) all with onset 2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Unknown results; (07Jul2022) Negative, notes: Tested negative 1 day after stopping treatment; (08Jul2022) Positive, notes: Tested negative for 36 hours then positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical Course: The patient had no known allergies. The patient did not receive other medication in 2 weeks. The patient received Paxlovid for treatment of COVID-19 on 24Jun2022 and stopped on 06Jul2022. On 07Jul2022, the patient tested negative 1 day after stopping treatment. Tested negative for 36 hours then positive on 08Jul2022. Going on day 5 of being positive. Experiencing more nasal congestion. Symptoms are more than first round. The medicine was terrible and strong so not sure how bad the original Covid symptoms were. The patient took medicine on day 1 of testing. The patient felt she could have had more and felt there was still Covid in her body on last day of medicine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product administration error
Clinical narrative: the freezer temperature had gone up a little bit for an hour and 15 minutes on Thursday, the vaccines were administered on Friday; the freezer temperature had gone up a little bit for an hour and 15 minutes on Thursday, the vaccines were administered on Friday; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 01Jul2022 as dose number unknown, single (Lot number: FK9894) at the age of 59 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT ADMINISTRATION ERROR (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious) all with onset 01Jul2022, outcome "unknown" and all described as "the freezer temperature had gone up a little bit for an hour and 15 minutes on Thursday, the vaccines were administered on Friday".  Additional Information: reporter stated that, Other Conditions was Not Provided, Investigations was Not Provided, NDC number of Covid Vaccine was mentioned, Expiry Date of Covid Vaccine was Unknown, Other Products was Not Provided. Caller states that two patients received the affected vaccines; this is the follow up report for the first patient. Age was Unknown. Event Details was reported as, Caller states that the freezer temperature had gone up a little bit for an hour and 15 minutes on Thursday, the vaccines were administered on Friday. Suspect Product Expiry Date was Unknown. Non serious report.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200938535 same product, event and different patient;
Age: 72.0
Sex: M
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) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 30Mar2022 at 15:00 as dose 4 (booster), single (Lot number: FM0698) at the age of 72 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Sex: F
Vaccine: COVID19
Symptoms: Brain neoplasm, Brain tumour operation, Thrombosis
Clinical narrative: got a brain tumor and got surgery; got a brain tumor; blood clots in her lungs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:.  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: BRAIN TUMOUR OPERATION (medically significant), outcome "unknown", described as "got a brain tumor and got surgery"; BRAIN NEOPLASM (medically significant), outcome "unknown", described as "got a brain tumor"; THROMBOSIS (medically significant), outcome "unknown", described as "blood clots in her lungs".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 56.0
Sex: F
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 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Feb2021 at 15:45 as dose 1, single (Lot number: En629), in left arm, on 02Mar2021 at 15:45 as dose 2, single (Lot number: En6199), in left arm, on 29Nov2021 at 15:45 as dose 3 (booster), single (Lot number: Fj1620), in left arm and on 08Jun2022 at 19:45 as dose 4 (booster), single (Lot number: Fm7533) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic lymphocytic leukemia (watch and wait)" (unspecified if ongoing), notes: Chronic lymphocytic leukemia (watch, and wait); "immunocompromised patient" (unspecified if ongoing), notes: immunocompromised patient. Concomitant medication(s) included: VITAMIN D [VITAMIN D NOS], start date: 06May2022 and Miacinamide from 06May2022. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "recovering" and all described as "COVID-19". Therapeutic measures were taken as a result of covid-19, vaccination failure.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Lot number: 8727), in left arm, on 25Apr2021 as dose 2, single (Lot number: EW0169), in left arm and on 31Dec2021 as dose 3 (booster), single (Lot number: 330308D) at the age of 35 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Lyme disease" (unspecified if ongoing); "sudden sensorineural hearing loss due to childhood virus" (unspecified if ongoing), notes: sudden sensorineural hearing loss due to childhood virus. There were no concomitant medications. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin". 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: (unspecified date) Unknown results, notes: Treatment of COVID-19; (02Jul2022) Negative, notes: Tested multiple negative Tests 02Jul-05Jul; (03Jul2022) Negative, notes: Tested multiple negative Tests 02Jul-05Jul; (04Jul2022) Negative, notes: Tested multiple negative Tests 02Jul-05Jul; (05Jul2022) Negative, notes: Tested multiple negative Tests 02Jul-05Jul; (06Jul2022) Positive, notes: positive on 06Jul. Therapeutic measures were taken as a result of vaccination failure, covid-19.   No follow-up attempts are possible. No further information is expected.
Age: 44.0
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 a contactable reporter(s) (Physician). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Dec2020 as dose 1, single (Lot number: EJ1685), in right arm, on 08Jan2021 as dose 2, single (Lot number: EL0142), in left arm and on 01Oct2021 at 14:00 as dose 3 (booster), single (Lot number: FC3184) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "diabetes type 1" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing). Concomitant medication(s) included: HUMALOG; PROZAC. 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: (19Jun2022) Positive, notes: tested covid positive by PCR and home antigen 19Jun2022; (27Jun2022) Negative, notes: Home antigen negative 27Jun2022; (01Jul2022) Positive, notes: home antigen positive 01Jul2022; (19Jun2022) Positive, notes: tested covid positive by PCR. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received other medication in 2 weeks was product: Insulin, brand: Humalog and product: Fluoxetine, brand: Prozac. Paxlovid rebound: tested COVID positive by PCR and home antigen 19Jun2022. Started Paxlovid 19Jun2022 pm (diabetes risk factor), completed 24Jun2022 am. Home antigen negative 27Jun2022. Symptoms returned 30Jun2022, home antigen positive 01Jul2022. Patient received Paxlovid from 19Jun2022 to 24Jun2022 for COVID 19 treatment.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to all the reported events Drug ineffective ,covid 19 cannot be completely excluded based on temporal association and known drug safety profile
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 36-year-old female patient (pregnant) received BNT162b2 (BNT162B2), on 04Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 35 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: "Depression" (unspecified if ongoing); "overweight" (unspecified if ongoing). Date of last menstrual period: 11Oct2021. The patient was 20 weeks pregnant at the time of exposure to BNT162b2. The patient was 38 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 18Jul2022. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", 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: (20Jun2022) Positive, notes: had positive home antigen and pos PCR on 20Jun; (23Jun2022) Negative, notes: Symptoms improved and had negative home.Antigen tests 23Jun and 24Jun; (24Jun2022) Negative, notes: Symptoms improved and had negative home, antigen tests 23Jun and 24Jun; (01Jul2022) Positive, notes: Onset of rebound symptoms on 01Jul and positive home antigen test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Vaccination failure; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient received BNT162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Lot number: EN6200), in left arm, on 15Mar2021 as dose 2, single (Lot number: EN6199), in left arm and on 12Oct2021 as dose 3 (booster), single (Lot number: FF2587) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Allergies" (unspecified if ongoing), notes: allergies; "known allergies:penicillin" (unspecified if ongoing), notes: penicillin; "known allergies: sulpher drugs" (unspecified if ongoing), notes: sulpher drugs; "known allergies: strawberries" (unspecified if ongoing), notes: strawberries; "known allergies:grasses" (unspecified if ongoing), notes: grasses. Concomitant medication(s) included: SINGULAIR; CLARITIN [CLARITHROMYCIN]; QNASL; ALBUTEROL [SALBUTAMOL SULFATE]. Past drug history included: Ceftin, reaction(s): "allergies:Ceftin"; Avalox, reaction(s): "allergies:avalox"; Forteo, reaction(s): "allergies:forteo"; Tymlos, reaction(s): "allergies: tymlos"; Amoxicillin, reaction(s): "allergies: amoxicillin". The following information was reported: COVID-19 (medically significant) with onset 17Jun2022, outcome "recovered with sequelae"; VACCINATION FAILURE (medically significant) with onset 17Jun2022, outcome "recovered with sequelae". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Positive, notes: Tested positive on homevtest day, 5, 6 though Felt milder cold symptons day 5 and 6; (Jun2022) negative, notes: Day 7 Tested negative on rapid test though still heavy chest and coughing; (17Jun2022) Positive, notes: Pcr Tested positive for covid 17Jun pm; (24Jun2022) negative, notes: Felt fine and tested negative on rapid test on 24Jun; (30Jun2022) Positive, notes: Rebound with same cold symptons and positive rapid test 30Jun. Therapeutic measures were taken as a result of vaccination failure, covid-19.  clinical course: To first shot flu like response. Other 2 shots no symptons.Pcr Tested positive for covid 17Jun pm.Treatment on paxlovid began am 18Jun.On paxlovid just heavy head and chest cold symptons first 3 days and symptons began easing.Felt fine and tested negative on rapid test on 24Jun.
Age: 76.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old male patient received BNT162b2 (BNT162B2), on 05Feb2021 at 09:30 as dose 1, single (Lot number: EM981), in left arm, on 26Feb2021 at 09:30 as dose 2, single (Lot number: EN6201), in left arm, on 12Nov2021 at 16:00 as dose 3 (booster), single (Lot number: 320308D), in left arm and on 27May2022 at 16:00 as dose 4 (booster), single (Lot number: FM7553) at the age of 76 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Mild depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "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 "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment; Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient received covid treatment with Paxlovid treatment start date-26Jun2022, treatment stop date-29Jun2022, Lot number: G8236, Indication: Treatment of covid-19.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymphadenopathy, Nausea
Clinical narrative: Fatigue; Headache, Nausea, Swollen lymph nodes; 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 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown"; NAUSEA (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Swollen lymph nodes".  Additional Information: Patient received the booster on Tuesday and since then, patient had a headache and stuff and fatigue and feeling nausea but then patient started getting the swollen lymph nodes. Patient stated they had headache since the last day. So, patient noticed that its in side effect that's reported.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Apr2021 at 13:00 as dose 1, single (Lot number: ew0162), in left arm, on 01May2021 at 13:00 as dose 2, single (Lot number: ew0179), in right arm and on 09Oct2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED 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: Unknown results, notes: Indication: Covid-19 treatment. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  clinical course: Anti viral details: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 03Jul2022, Treatment stop date: 26Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Vaccination failure; 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 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Feb2021 as dose 1, single (Lot number: EN6198), in right arm and on 12Mar2021 as dose 2, single (Lot number: EN6208) at the age of 59 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "Hbp" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Morphine, reaction(s): "Known allergies: Morphine". The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown", described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: High, notes: other medical history: Hbp; SARS-CoV-2 test: UNKNOWN RESULTS. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Mar2021 at 10:00 as dose 1, single (Lot number: EN6208), in right arm, on 13Apr2021 as dose 2, single (Lot number: GR3729), in right arm and on 12Nov2021 as dose 3 (booster), single (Lot number: FH8028) at the age of 65 years, in left arm 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) with onset 20Jun2022, outcome "unknown", COVID-19 (medically significant) with onset 20Jun2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested positive for COVID; Positive, notes: After 15 days, tested positive again with returning symptoms. Therapeutic measures were taken as a result of covid-19.  Clinical course: The patient did not receive no other medications in 2 weeks. The patient received Paxlovid from 21Jun2022 to 26Jun2022 for COVID 19 treatment. Tested positive for COVID. After 15 days, tested positive again with returning symptoms.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
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 49-year-old male patient received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: en6198), in right arm, on 18Mar2021 as dose 2, single (Lot number: en6208), in right arm and on 12Oct2021 as dose 3 (booster), single (Lot number: ff2589) at the age of 48 years, 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), SUSPECTED 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: Negative; Positive.  Clinical information: Covid rebound four days after a five day course of Paxlovid. Tested negative two days after treatment and returned to work. Second day back at work symptoms came back and a subsequent test showed positive for Covid.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Mar2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 60 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL, start date: 30Oct2018. 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: Paxlovid from 19Jun2022 to 23Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 41.0
Sex: U
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 43-year-old patient received BNT162b2 (BNT162B2), on 15Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 41 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Long COVID", start date: Jan2021 (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. COVID-19 Treatment included Paxlovid from 25Jun2022 to 29Jul2022.     The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Pneumonia, Uterine neoplasm
Clinical narrative: partial hysterotomy from tumor growth; Migraine; Pneumonia; 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-163-4454423-00.  A 49-year-old female patient received BNT162b2 (BNT162B2), on 05Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 47 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), since 11Mar2021 (ongoing) (Batch/Lot number: unknown), subcutaneous for ankylosing spondylitis. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Route of Administration: Intramuscular.), administration date: 04Mar2021, when the patient was 47-year-old, for COVID-19 Immunization. The following information was reported: MIGRAINE (medically significant) with onset 2021, outcome "not recovered"; PNEUMONIA (medically significant) with onset 2021, outcome "recovered" (2022); UTERINE NEOPLASM (hospitalization, medically significant) with onset 2021, outcome "recovered" (2022), described as "partial hysterotomy from tumor growth". The action taken for adalimumab was dosage not changed.  The reporter's assessment of the causal relationship of "pneumonia", "partial hysterotomy from tumor growth" and "migraine" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Causality for Humira (Adalimumab): The reporter's causality for the event(s) of partial hysterotomy from tumor growth was not provided. The reporter's causality for the event(s) of pneumonia after second dose of Pfizer vaccine and migraines with Humira (Adalimumab) was no reasonable possibility. Opinion was that the event of partial hysterotomy from tumor growth was not assessable. Opinion was that there was a reasonable possibility that the events of pneumonia after second dose of Pfizer vaccine and migraines are related to Humira (Adalimumab).  Causality for Pfizer BioNTech COVID-19 Vaccine: The reporter's causality for the event(s) of Uterine neoplasm, Pneumonia & migraine was not reported.  Clinical Information: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Primary reporter contact for lot number information was unsuccessful.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events "pneumonia", "partial hysterotomy from tumor growth" and "migraine" and the suspect drug BNT162b2.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dry throat, Fall, Hip fracture, Interstitial lung disease
Clinical narrative: dry cough and throat; Post nasal drainage; She has had trouble of falling; dry cough and throat; Interstitial lung disease; broken hip; 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-163-4446716-00.  An 85-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk (citrate free), subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HIP FRACTURE (medically significant) with onset 2022, outcome "recovering", described as "broken hip"; INTERSTITIAL LUNG DISEASE (medically significant), outcome "not recovered"; DRY THROAT (medically significant), outcome "recovering", UPPER-AIRWAY COUGH SYNDROME (medically significant), outcome "unknown" and all described as "Post nasal drainage"; FALL (medically significant), outcome "recovering", described as "She has had trouble of falling"; COUGH (non-serious), outcome "unknown", described as "dry cough and throat". The action taken for adalimumab was unknown.  clinical information:On unknown dates, the patient experienced interstitial lung disease, joint pain, dry throat, falling and postnasal drainage. In 2022, the patient experienced broken hip, Pfizer BioNTech COVID-19 Vaccine (Tozinameran) was also considered suspect. The patient had dry cough and throat due to Postnasal drainage. Rheumatoid arthritis has impacted her Interstitial lung disease. She had trouble of falling and broken her hip over five to six months ago. The last booster caused nausea and joint pain. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's assessment of the causal relationship of "interstitial lung disease", "broken hip", "dry cough and throat", "post nasal drainage" and "she has had trouble of falling" 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.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Upper-airway cough syndrome
Clinical narrative: dry cough and throat; Post nasal drainage; She has had trouble of falling; dry cough and throat; Interstitial lung disease; broken hip; 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-163-4446716-00.  An 85-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk (citrate free), subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HIP FRACTURE (medically significant) with onset 2022, outcome "recovering", described as "broken hip"; INTERSTITIAL LUNG DISEASE (medically significant), outcome "not recovered"; DRY THROAT (medically significant), outcome "recovering", UPPER-AIRWAY COUGH SYNDROME (medically significant), outcome "unknown" and all described as "Post nasal drainage"; FALL (medically significant), outcome "recovering", described as "She has had trouble of falling"; COUGH (non-serious), outcome "unknown", described as "dry cough and throat". The action taken for adalimumab was unknown.  clinical information:On unknown dates, the patient experienced interstitial lung disease, joint pain, dry throat, falling and postnasal drainage. In 2022, the patient experienced broken hip, Pfizer BioNTech COVID-19 Vaccine (Tozinameran) was also considered suspect. The patient had dry cough and throat due to Postnasal drainage. Rheumatoid arthritis has impacted her Interstitial lung disease. She had trouble of falling and broken her hip over five to six months ago. The last booster caused nausea and joint pain. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's assessment of the causal relationship of "interstitial lung disease", "broken hip", "dry cough and throat", "post nasal drainage" and "she has had trouble of falling" 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.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.