chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
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 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm and on 26Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 46 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 16Nov2021 as dose 3 (booster), single (Lot number: 033f21a), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Overweight" (unspecified if ongoing). There were no concomitant medications.The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Jun2022 at 07:00, 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) positive, notes: Treatment of COVID-19; (unspecified date) negative, notes: Rebound case after testing negative I am positive again; (29Jun2022) positive, notes: Rebound case after testing negative I am positive again. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical Course: Anti-viral details; product: COVID 19 Treatment, brand= Paxlovid; treatment start date: 20Jun2022; treatment stop date= 24Jun2022, Indication=Treatment of 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: 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 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) 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. The patient took 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: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of covid-19.The patient took COVID-19 Treatment with Paxlovid Pfizer from 01Jun2022 to 05Jun2022. The patient received vaccine and other medication in 2 weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 60.0
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 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Lot number: EN6201), in right arm, on 28Mar2021 as dose 2, single (Lot number: EN6199), in right arm, on 12Oct2021 as dose 3 (booster), single (Lot number: FF2587), in right arm and on 17Apr2022 at 16:00 as dose 4 (booster), single (Lot number: FK9893) at the age of 60 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "hypothyroidism" (unspecified if ongoing); "herpes II" (unspecified if ongoing), notes: Other medical history: herpes II. Concomitant medication(s) included: ARMOUR THYROID, start date: Dec1989; METOPROLOL, start date: Apr2021; VALACYCLOVIR HYDROCHLORIDE, start date: Dec2017. Past drug history included: Augmentin, reaction(s): "Known allergies: augmentin", notes: Known allergies: augmentin. The following information was reported: VACCINATION FAILURE (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: (unspecified date) Positive, notes: COVID 19 Treatment; (Jun2022) Negative, notes: two days of negative tests; (Jun2022) Negative, notes: two days of negative tests. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Information: Anti-viral details included; Product: COVID 19 Treatment, Brand was Pfizer, Treatment start date was on 16Jun2022, Treatment Stop date was on 20Jun2022, Lot number was unknown, Indication was for treatment of COVID-19. After Paxlovid treatment, and two days of negative tests, symptoms came on very intensely 7 days after final dose. Much sicker than first illness with chest and head congestion, headache, cough. No fever. Adverse event start & time was 25Jun2022 at 12:00 PM. Patient was not recovered, and no treatment given for it.  No follow-up attempts possible. No further information expected.
Age: 46.0
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 46-year-old male patient received BNT162b2 (BNT162B2), on 25Nov2021 at 20:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 46 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: "Managed/treated hypertension" (unspecified if ongoing), notes: Other medical history- Managed/treated hypertension. Concomitant medication(s) included: LISINOPRIL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" 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: Covid-19 treatment; (20Jun2022) Negative; (30Jun2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received other medications in two weeks. Patient started their Anti-viral Covid-19 treatment of Pfizer on 14Jun2022 to 18Jun2022.  Patient took other medication in 2 weeks was Lisinopril. Adverse event- Rebound - Tested Negative with at home antigen test on 20Jun2022 - Tested Positive with at-home antigen test on 30Jun2022. Adverse event start date was 29Jun2022. Adverse event start time was 10:00 AM. No known allergies reported. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid Positive; Covid Positive; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 76-year-old male patient received BNT162b2 (BNT162B2), on 24Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 75 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19Jun2022, outcome "not recovered" and all described as "Covid Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Positive, notes: Retested for Covid and positive again on home antigen test; (19Jun2022) Positive; (27Jun2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: It is unknown if patient received any other medication in 2 weeks. Patient received treatment with Paxlovid from 19Jun2022 to 25Jun2022 (route of administration: oral) for Covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on possible temporal association the causal association  of suspect  cannot be excluded for  reported events .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: 49.0
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 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 22Jan2021 as dose 1, single (Lot number: EL9262), in left arm, on 10Feb2021 as dose 2, single (Lot number: EL9262), in left arm and on 16Nov2021 as dose 3 (booster), single (Lot number: FD8448) at the age of 49 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "asthma" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 20Feb2022; ALBUTEROL SULFATE HFA, start date: 31Dec2017. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive; (27Jun2022) positive, notes: Return of symptoms 5 days after completion of full paxlovid course and resumption of positive antigen results. Therapeutic measures were taken as a result of covid-19 which include Paxlovid from 18Jun2022 to 22Jun2022.  Clinical course: The patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Asymptomatic COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid-19/had no symptoms; tested positive for Covid-19/had no symptoms; This is a spontaneous report received from contactable consumer (patient) from medical information team. An 81-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: "Guillain Barre" (unspecified if ongoing), notes: diagnosed at age 10.5 and again at age 15; "blood pressure" (ongoing). Concomitant medications included: SYNTHROID; VITAMIN B COMPLEX [ASCORBIC ACID;CALCIUM PANTOTHENATE;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;VITAMIN B1 NOS;VITAMIN B12 NOS]; she also takes a small dose of a blood pressure medication. She has been taking these medications forever. Vaccination history included: Janssen covid-19 vaccine (DOSE 1, SINGLE, manufacturer: JANSSEN), for Covid-19 immunisation. The patient had had one Johnson and Johnson vaccine, as well as three Pfizer BioNTech Covid 19 vaccines. She took the Johnson and Johnson vaccine first and was waiting and could not get anymore of that and the doctor said for her to start the Pfizer vaccine so she had two doses of the Pfizer Vaccine and the Pfizer booster vaccine so she was over-vaccinated (PV202200013069). She was exposed to Covid-19 after she was with the person on 12Jun2022, she was tested positive and was diagnosed with COVID on 13Jun2022. Her doctor gave her PAXOLID for 5 days and nights from 13Jun2022 to 17Jun2022. Her doctor gave two PCR tests that came back inconclusive. She had no symptoms. She mentioned that on the third day after she took the booster shot she got shingles and it was the Pfizer vaccine. Outcome of the events was unknown.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Herpes zoster, SARS-CoV-2 test
Clinical narrative: tested positive for Covid-19/had no symptoms; tested positive for Covid-19/had no symptoms; This is a spontaneous report received from contactable consumer (patient) from medical information team. An 81-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: "Guillain Barre" (unspecified if ongoing), notes: diagnosed at age 10.5 and again at age 15; "blood pressure" (ongoing). Concomitant medications included: SYNTHROID; VITAMIN B COMPLEX [ASCORBIC ACID;CALCIUM PANTOTHENATE;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;VITAMIN B1 NOS;VITAMIN B12 NOS]; she also takes a small dose of a blood pressure medication. She has been taking these medications forever. Vaccination history included: Janssen covid-19 vaccine (DOSE 1, SINGLE, manufacturer: JANSSEN), for Covid-19 immunisation. The patient had had one Johnson and Johnson vaccine, as well as three Pfizer BioNTech Covid 19 vaccines. She took the Johnson and Johnson vaccine first and was waiting and could not get anymore of that and the doctor said for her to start the Pfizer vaccine so she had two doses of the Pfizer Vaccine and the Pfizer booster vaccine so she was over-vaccinated (PV202200013069). She was exposed to Covid-19 after she was with the person on 12Jun2022, she was tested positive and was diagnosed with COVID on 13Jun2022. Her doctor gave her PAXOLID for 5 days and nights from 13Jun2022 to 17Jun2022. Her doctor gave two PCR tests that came back inconclusive. She had no symptoms. She mentioned that on the third day after she took the booster shot she got shingles and it was the Pfizer vaccine. Outcome of the events was unknown.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Herpes zoster, SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: tested positive for Covid-19/had no symptoms; tested positive for Covid-19/had no symptoms; This is a spontaneous report received from contactable consumer (patient) from medical information team. An 81-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: "Guillain Barre" (unspecified if ongoing), notes: diagnosed at age 10.5 and again at age 15; "blood pressure" (ongoing). Concomitant medications included: SYNTHROID; VITAMIN B COMPLEX [ASCORBIC ACID;CALCIUM PANTOTHENATE;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;VITAMIN B1 NOS;VITAMIN B12 NOS]; she also takes a small dose of a blood pressure medication. She has been taking these medications forever. Vaccination history included: Janssen covid-19 vaccine (DOSE 1, SINGLE, manufacturer: JANSSEN), for Covid-19 immunisation. The patient had had one Johnson and Johnson vaccine, as well as three Pfizer BioNTech Covid 19 vaccines. She took the Johnson and Johnson vaccine first and was waiting and could not get anymore of that and the doctor said for her to start the Pfizer vaccine so she had two doses of the Pfizer Vaccine and the Pfizer booster vaccine so she was over-vaccinated (PV202200013069). She was exposed to Covid-19 after she was with the person on 12Jun2022, she was tested positive and was diagnosed with COVID on 13Jun2022. Her doctor gave her PAXOLID for 5 days and nights from 13Jun2022 to 17Jun2022. Her doctor gave two PCR tests that came back inconclusive. She had no symptoms. She mentioned that on the third day after she took the booster shot she got shingles and it was the Pfizer vaccine. Outcome of the events was unknown.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Asymptomatic COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I got shingles; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: The reporter is the patient. An 81-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Johnson and Johnson (I have had one Johnson and Johnson. 2 Pfizer and a boost.), for Covid-19 immunization; Bnt162b2 (dose 1, I have had one Johnson and Johnson. 2 Pfizer and a boost.), for Covid-19 immunization; Bnt162b2 (dose 2, I have had one Johnson and Johnson. 2 Pfizer and a boost.), for Covid-19 immunization. The following information was reported: HERPES ZOSTER (non-serious), outcome "unknown", described as "I got shingles". Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: The reporter mentioned that, she had one Johnson and Johnson vaccine, as well as three Pfizer BioNTech Covid 19 vaccines. Three days after her most recent Pfizer vaccine she developed shingles. She is no longer having symptoms but wanted to know if there was any information on patients getting inconclusive PCR results after taking Paxlovid. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Herpes zoster, SARS-CoV-2 test
Clinical narrative: I got shingles; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: The reporter is the patient. An 81-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Johnson and Johnson (I have had one Johnson and Johnson. 2 Pfizer and a boost.), for Covid-19 immunization; Bnt162b2 (dose 1, I have had one Johnson and Johnson. 2 Pfizer and a boost.), for Covid-19 immunization; Bnt162b2 (dose 2, I have had one Johnson and Johnson. 2 Pfizer and a boost.), for Covid-19 immunization. The following information was reported: HERPES ZOSTER (non-serious), outcome "unknown", described as "I got shingles". Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: The reporter mentioned that, she had one Johnson and Johnson vaccine, as well as three Pfizer BioNTech Covid 19 vaccines. Three days after her most recent Pfizer vaccine she developed shingles. She is no longer having symptoms but wanted to know if there was any information on patients getting inconclusive PCR results after taking Paxlovid. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Herpes zoster, SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: I got shingles; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: The reporter is the patient. An 81-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Johnson and Johnson (I have had one Johnson and Johnson. 2 Pfizer and a boost.), for Covid-19 immunization; Bnt162b2 (dose 1, I have had one Johnson and Johnson. 2 Pfizer and a boost.), for Covid-19 immunization; Bnt162b2 (dose 2, I have had one Johnson and Johnson. 2 Pfizer and a boost.), for Covid-19 immunization. The following information was reported: HERPES ZOSTER (non-serious), outcome "unknown", described as "I got shingles". Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: The reporter mentioned that, she had one Johnson and Johnson vaccine, as well as three Pfizer BioNTech Covid 19 vaccines. Three days after her most recent Pfizer vaccine she developed shingles. She is no longer having symptoms but wanted to know if there was any information on patients getting inconclusive PCR results after taking Paxlovid. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a 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 21Oct2021 as dose 3 (booster), single (Lot number: FDO809) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "migraine" (unspecified if ongoing); "neuropathy" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL SUCCINATE. Past drug history included: Kenalog, reaction(s): "Known allergies: kenalog". 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, notes: rebound COVID symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19. as Paxlovid from 14Jun202 to 19Jun2022.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: covid-19; covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Apr2021 as dose 1, single (Lot number: ER8729), in left arm, on 23Apr2021 as dose 2, single (Lot number: ER8736), in left arm and on 27Feb2022 as dose 3 (booster), single (Lot number: FG3527) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Grave's disease" (unspecified if ongoing); "Over weight" (unspecified if ongoing); "Arthritis" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Azuma, reaction(s): "Known allergies", notes: Known allergies: Yes. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovering" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: indication: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19; received Paxlovid from 19Jun2022 to 23Jun2022 as treatment of COVID-19.  No follow-up attempts are possible. No further information is expected.
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 a non-contactable reporter(s) (Physician). The reporter is the patient.  A 28-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's relevant medical history was not reported. Concomitant medication(s) included: LOSARTAN; ZYRTEC ALLERGY; SIMVASTATIN. 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: Unknown results. 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.; Sender's Comments: Based on the known safety profile of the vaccine  BNT162b2, a causal relation between the reported events Covid-19, Drug ineffective and the administration of the vaccine cannot be excluded.
Age: 49.0
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), on 23Mar2021 at 13:00 as dose 1, single (Lot number: ER8732), in left arm, on 13Apr2021 at 13:00 as dose 2, single (Lot number: EW0164), in left arm and on 25Oct2021 at 13:00 as dose 3 (booster), single (Lot number: FF2590) at the age of 49 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing), notes: Other medical history: high blood pressure. 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: Unknown Results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient had not received any other medication in 2weeks. Patient had received Paxlovid from 20Jun2022 to 25Jun2022 with lot number of 1916517A for the treatment of COVID-19. It was reported that 2-3 days after Paxlovid treatment stopped, patient Covid symptoms returned (cough, congestion, fever). Patient had no known allergies.
Sex: M
Vaccine: COVID19
Symptoms: Cytomegalovirus test, Cytomegalovirus viraemia, Lymphocyte count, Polymerase chain reaction, SARS-CoV-2 antibody test
Clinical narrative: Cytomegalovirus viremia; This is a literature report.  A 32-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "kidney transplant" (unspecified if ongoing), notes: since 10 months; "Cessation of prophylaxis mo/y before first CMV vaccine" (unspecified if ongoing); "IgA nephropathy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tacrolimus, notes: 250 thrice a day; Mycophenolate, notes: 250 thrice a day. Vaccination history included: Bnt162b2 (Dose 1), for covid-19 immunisation; Cmv vaccine, for cytomegalovirus.  The following information was reported: CYTOMEGALOVIRUS VIRAEMIA (hospitalization, medically significant), 44 days after the suspect product(s) administration, outcome "unknown", described as "Cytomegalovirus viremia". The patient underwent the following laboratory tests and procedures: Cytomegalovirus test: no; Lymphocyte count: 0.59, notes: admission; Polymerase chain reaction: 755, notes: highest serum; SARS-CoV-2 antibody test: negative; Transplant evaluation: 4, notes: month before first CMV vaccine; ++; Viral test (normal high range 200): 11, notes: greater than; White blood cell count: 6.3. Therapeutic measures were taken as a result of cytomegalovirus viraemia.; 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.,Linked Report(s) : US-PFIZER INC-PV202200004629 Same article/ drug/event and different patient_original case PV202200004629;
Sex: M
Vaccine: COVID19
Symptoms: Transplant evaluation, Viral test, White blood cell count
Clinical narrative: Cytomegalovirus viremia; This is a literature report.  A 32-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "kidney transplant" (unspecified if ongoing), notes: since 10 months; "Cessation of prophylaxis mo/y before first CMV vaccine" (unspecified if ongoing); "IgA nephropathy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tacrolimus, notes: 250 thrice a day; Mycophenolate, notes: 250 thrice a day. Vaccination history included: Bnt162b2 (Dose 1), for covid-19 immunisation; Cmv vaccine, for cytomegalovirus.  The following information was reported: CYTOMEGALOVIRUS VIRAEMIA (hospitalization, medically significant), 44 days after the suspect product(s) administration, outcome "unknown", described as "Cytomegalovirus viremia". The patient underwent the following laboratory tests and procedures: Cytomegalovirus test: no; Lymphocyte count: 0.59, notes: admission; Polymerase chain reaction: 755, notes: highest serum; SARS-CoV-2 antibody test: negative; Transplant evaluation: 4, notes: month before first CMV vaccine; ++; Viral test (normal high range 200): 11, notes: greater than; White blood cell count: 6.3. Therapeutic measures were taken as a result of cytomegalovirus viraemia.; 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.,Linked Report(s) : US-PFIZER INC-PV202200004629 Same article/ drug/event and different patient_original case PV202200004629;
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: the patient had received 4 total Pfizer vaccinations prior to symptom onset and the Positive test result; the patient had received 4 total Pfizer vaccinations prior to symptom onset and the Positive test result; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 54-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and in Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 53 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26Jun2022, outcome "recovering" and all described as "the patient had received 4 total Pfizer vaccinations prior to symptom onset and the Positive test result". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (27Jun2022) Positive; SARS-CoV-2 test: (28Jun2022) Positive. Clinical course: On 27Jun2022 patient began feeling symptoms of fever, fatigue, headache, vision disturbance (everything looks smooth), sore throat and coughing. On 28Jun2022 patient felt worse and took an at home Covid test which was Positive. Patient wife told her mother-in-law about the symptoms. The mother-in-law informed on 30Jun2022 of the symptoms and positive Covid test results. This event was being reported as a Lack of Effect since the patient had received 4 total Pfizer vaccinations prior to symptom onset and the Positive test result. The 4th shot (second booster) was given some time in Mar2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Pfizer / BioNTech: Dose Number: 1, 2 ,3 4; Paxlovid: Treatment of COVID-19/ testing positive; Pfizer / BioNTech: Dose Number: 1, 2 ,3 4; Paxlovid: Treatment of COVID-19/ testing positive; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 61-year-old male patient received BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Lot number: EN6208), on 02Apr2021 as dose 2, single (Batch/Lot number: unknown), on 29Nov2021 as dose 3 (booster), single (Lot number: FJ1620) and on 31Mar2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 61 years for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulfa" (unspecified if ongoing), notes: known allergies: Sulfa. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "recovering" and all described as "Pfizer / BioNTech: Dose Number: 1, 2 ,3 4; Paxlovid: Treatment of COVID-19/ testing positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Positive, notes: again 6 days after completion of Paxlovid; (27Jun2022) Positive, notes: again. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. Patient previously received a COVID-19 Vaccine. Took Paxlovid for breakthrough infection on 17Jun (completed 21Jun2022) with subsequent recurrence of Covid symptoms and testing positive again 6 days after completion of Paxlovid (testing positive again on 27Jun2022).  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 in the case, an association between the reported events and the suspect product BNT162B2 cannot be ruled out.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol, Blood test, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID after receiving two Pfizer vaccines and two Pfizer boosters; Tested positive for COVID after receiving two Pfizer vaccines and two Pfizer boosters; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received BNT162b2 (BNT162B2), on 13Feb2021 as dose 1, single (Lot number: EN6201), in arm, on 06Mar2021 as dose 2, single (Lot number: EN6205), in arm, on 17Sep2021 at 15:00 as dose 3 (booster), single (Lot number: FE3592), in left arm and on 20Mar2022 as dose 4 (booster), single (Lot number: FK9893, Expiration Date: 27May2022) at the age of 75 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Progressive multiple sclerosis", start date: May2009 (ongoing), notes: She takes vitamins, supplements, and Aleve because her multiple sclerosis.; "allergic to sulfa or sulfur" (unspecified if ongoing), notes: allergic to sulfa or sulfur; "total hysterectomy" (unspecified if ongoing), notes: when she was 38 she had a total hysterectomy.; "C-section" (unspecified if ongoing), notes: prior to that she had a C-section.; "Mohs surgery on her ankle for a cancer thing" (unspecified if ongoing), notes: Mohs surgery on her ankle for a cancer thing; "cancer" (unspecified if ongoing), notes: Mohs surgery on her ankle for a cancer thing. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, on 17Sep2021 as dose number unknown, single; ALEVE taken for multiple sclerosis. Past drug history included: Allergic to sulfa or sulfur for acne medication, reaction(s): "made her face really red", notes: allergic to sulfa or sulfur. Vaccination history included: Flu shot (She gets a flu shot every year.  She doesn't know how many years, probably starting in 1989 or so and the only reason she knows that, she had a new job and the first day at the new job she had to get a flu shot and she had never heard of them at that point in 1988 or 1989), for Immunization. The following information was reported: VACCINATION FAILURE (medically significant) with onset 29Jun2022, outcome "unknown", COVID-19 (medically significant) with onset 29Jun2022, outcome "not recovered" and all described as "Tested positive for COVID after receiving two Pfizer vaccines and two Pfizer boosters". The patient underwent the following laboratory tests and procedures: Blood cholesterol: (unspecified date) Result unknown; Blood test: (unspecified date) Result unknown; SARS-CoV-2 test: (unspecified date) Positive, notes: still said it again; (29Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course :No Prior Vaccinations (within 4 weeks) or any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s).Patient did a spinal fluid thing back in 2009 to diagnose her multiple sclerosis but nothing since then.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Pfizer / BioNTech: Dose Number: 1, 2, 3; Paxlovid: Treatment of COVID-19; Pfizer / BioNTech: Dose Number: 1, 2, 3; Paxlovid: 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 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EN5318), on 18Feb2021 as dose 2, single (Lot number: EN6198) and on 19Nov2021 as dose 3 (booster), single (Lot number: EW0185) at the age of 37 years for covid-19 immunisation. The patient's relevant medical history included: "Mild asthma" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "Allergy: Shellfish" (unspecified if ongoing). Concomitant medication(s) included: VENTOLIN [SALBUTAMOL SULFATE]; LEVOTHYROXINE.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Jun2022, outcome "recovering" and all described as "Pfizer / BioNTech: Dose Number: 1, 2, 3; Paxlovid: Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient was reported about covid treatment. Patient received vaccine and patient received other medication in 2 weeks. On 16Jun2022 to 21Jun2022 patient took anti-viral drug Paxlovid indicated as treatment of COVID-19. It was reported that rebound Covid symptoms and test positivity on day 11 after starting Paxlovid. Acuity of symptoms was similar to initial onset prior to Paxlovid. Patient had history of Mild asthma, hypothyroidism and known allergies to Shellfish. Patient is Recovering and there were no treatment adverse events.  No follow-up attempts are possible. No further information is expected.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An 80-year-old male patient received BNT162b2 (BNT162B2), on 11Apr2022 as dose number unknown, single (Lot number: FJ5682) at the age of 80 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetics" (unspecified if ongoing); "Shellfish Allergy" (unspecified if ongoing), notes: Known allergies: Shellfish; "latex gloves Allergy" (unspecified if ongoing), notes: Known allergies: latex gloves. There were no concomitant medications or other medication in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid 15Jun2022 to 20Jun2022. On 29Jun2022, the patient had COVID rebound.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, 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 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Mar2021 as dose 1, single (Lot number: EP6955), in left arm, on 25Apr2021 as dose 2, single (Lot number: ER8735), in right arm and on 07Dec2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "Sulfa allergy" (unspecified if ongoing), notes: Known allergy: Sulfa. 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". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient did not taking any other medications/products within 2 weeks of starting COVID-19 treatment. Covid rebound 3 days after ending Paxlovid with recurring symptoms and testing positive 6 days after.
Age: 75.0
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 75-year-old male patient received BNT162b2 (BNT162B2), on 12Jan2021 as dose 1, single (Lot number: EL3246), on 02Feb2021 as dose 2, single (Lot number: EL9263), on 13Oct2021 as dose 3 (booster), single (Lot number: FF2589) and on 06Apr2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history included: "A-Fib A symptomatic" (ongoing), notes: A-Fib A symptomatic; "pacemaker" (ongoing), notes: pacemaker, Continuing: true. Concomitant medication(s) included: XARELTO, stop date: Jun2022; WELLBUTRIN, stop date: Jun2022; TAMSULOSIN, stop date: Jun2022; EPLERENONE, stop date: Jun2022. The following information was reported: VACCINATION FAILURE (medically significant) with onset 27Jun2022, outcome "unknown", COVID-19 (medically significant) with onset 27Jun2022, outcome "not recovered" and all described as "COVID 19 Treatment". The event "covid 19 treatment" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: Tested Positive for Covid 19 on 27Jun2022 after 4 Doses of the Pfizer Covid 19 Vaccine. He had the Pfizer Series of shots including the Second Booster, later clarified as the Pfizer Covid 19 Vaccines. 2 to 3 days ago he must have been in contact with someone with Covid and he tested himself and he had the Covid virus in his nostrils, so he went to his doctor, and they looked at him and prescribed him Paxlovid, the 2-pill version. He noticed it made him very very sleepy, he was just sleeping away the day. He also reported it was almost giving him a bit of a brain fog, he doesn't know how to describe it, but other than that he feels okay. He just wants to lay down and sleep and when he gets up, he was in a brain fog. He could think and he knows where he was, but he doesn't feel right. Caller asking, was that something he should expect and when he was finished with the medication, should it resolve. On Monday, he had a lot of body aches when he woke up so Monday afternoon, he took a Covid test, and it was positive. He made an appointment on Tuesday to see his doctor. He had to stop a few medications before taking the Pfizer antiviral, so he started the medication on Wednesday morning. He stopped taking these medications because of the Antiviral Paxlovid.
Age: 71.0
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 16Mar2021 at 13:00 as dose 1, single (Lot number: EF7534), in right arm, on 06Apr2021 at 13:00 as dose 2, single (Lot number: EW0151), in right arm and on 24Oct2021 at 13:00 as dose 3 (booster), single (Lot number: 30145BA) at the age of 71 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 28Jun2022, outcome "unknown" and all described as "COVID 19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Information: Reporter stated that, Non Serious report, No Seriousness criteria-Results in death, Life threatening, prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect. Report was about COVID treatment. No Other medication in 2 weeks. Antiviral details reported as, Product: COVID 19 treatment, brand: Pfizer. No Known allergies. No Other medical history. Historical vaccine was mentioned as Yes. Case narrative reported as, Patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. patient previously receive a COVID-19 Vaccine. Device date was, 30Jun2022.  No follow-up attempts are possible. No further information is expected.