chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Cough, Drug ineffective, Fatigue, Illness
Clinical narrative: Her aunt and stuff there are vaccinated and sick as a dog and coughing, hacking, fever, tired.; Her aunt and stuff there are vaccinated and sick as a dog and coughing, hacking, fever, tired.; Her aunt and stuff there are vaccinated and sick as a dog and coughing, hacking, fever, tired.; tired; caught COVID from her; caught COVID from her; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Jul2022, outcome "unknown" and all described as "caught COVID from her"; ILLNESS (non-serious), COUGH (non-serious), PYREXIA (non-serious), outcome "unknown" and all described as "Her aunt and stuff there are vaccinated and sick as a dog and coughing, hacking, fever, tired."; FATIGUE (non-serious), outcome "unknown", described as "tired". The patient underwent the following laboratory tests and procedures: COVID-19: Positive, notes: now positive and are sick. caught COVID from her.  Clinical information: He has a patient on the line and the patient is calling regarding Paxlovid and he was prescribed Paxlovid. He said what is really strange is his family and sons and daughter all went to withheld for a wedding and he stayed there to take care of the dogs. They got back the first day they all were fine and the next day literally out of a group of 7 people 5 are now positive and are sick. His wife came back in the house, and they are together and obliviously caught COVID from her and his symptoms and her mother and aunt and stuff there are vaccinated and sick as a dog and coughing, hacking, fever, tired and his wife is now at her mothers house and sick too trying to help each other. son has it and not as bad. Caller declined report on mother, aunt and others and said it would take all day. He said at the end of the day does he need to contact his doctor and he said he obliviously should not take the pills and asked for call handlers opinion.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Her aunt and stuff there are vaccinated and sick as a dog and coughing, hacking, fever, tired.; Her aunt and stuff there are vaccinated and sick as a dog and coughing, hacking, fever, tired.; Her aunt and stuff there are vaccinated and sick as a dog and coughing, hacking, fever, tired.; tired; caught COVID from her; caught COVID from her; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Jul2022, outcome "unknown" and all described as "caught COVID from her"; ILLNESS (non-serious), COUGH (non-serious), PYREXIA (non-serious), outcome "unknown" and all described as "Her aunt and stuff there are vaccinated and sick as a dog and coughing, hacking, fever, tired."; FATIGUE (non-serious), outcome "unknown", described as "tired". The patient underwent the following laboratory tests and procedures: COVID-19: Positive, notes: now positive and are sick. caught COVID from her.  Clinical information: He has a patient on the line and the patient is calling regarding Paxlovid and he was prescribed Paxlovid. He said what is really strange is his family and sons and daughter all went to withheld for a wedding and he stayed there to take care of the dogs. They got back the first day they all were fine and the next day literally out of a group of 7 people 5 are now positive and are sick. His wife came back in the house, and they are together and obliviously caught COVID from her and his symptoms and her mother and aunt and stuff there are vaccinated and sick as a dog and coughing, hacking, fever, tired and his wife is now at her mothers house and sick too trying to help each other. son has it and not as bad. Caller declined report on mother, aunt and others and said it would take all day. He said at the end of the day does he need to contact his doctor and he said he obliviously should not take the pills and asked for call handlers opinion.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test, Vaccination failure, Weight decreased
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 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Feb2021 at 09:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 05Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 25Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 26Apr2022 at 15:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hypoglycemia" (unspecified if ongoing); "digestive issues" (unspecified if ongoing); "weight loss from two surgeries" (unspecified if ongoing), notes: weight loss from two surgeries; "oysters" (unspecified if ongoing); "Mussels" (unspecified if ongoing). Concomitant medication(s) included: TRAZODONE; LORAZEPAM; FLONASE ALLERGY RELIEF. Past drug history included: Lactose, reaction(s): "Allergy"; Gluten sensentivity, reaction(s): "Allergy". 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: Body temperature: (22Jun2022) I had a temperature, notes: I had a temperature from 22Jun until 05Jul; SARS-CoV-2 test: (unspecified date) Unknown reusult, notes: Covid-19 treatment; Weight decreased: (unspecified date) 6 lbs, notes: I lost an additional 6 pounds. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: Anti -viral details: Product - COVID 19 Treatment, Brand - Paxlovid, Treatment start date - 22Jun2022, Treatment stop date - 27Jun2022, 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
Clinical narrative: COVID-19; COVID-19; 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 female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "prone to migraines/ "ocular" migraine" (unspecified if ongoing), notes: prone to migraines/ "ocular" migraine, this is not an "ocular" migraine as she usually. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Jul2022, outcome "unknown", COVID-19 (medically significant) with onset Jul2022, outcome "recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Caller wants to know if she can take Aspirin if she finished her last day of treatment with Paxlovid today. She stated that Paxlovid is a fantastic medication that has eliminated all the COVID symptoms and her husband has started taking it because he also got infected with COVID. Caller started experiencing a migraine starting in the past 15 minutes, she took her last dose of Paxlovid today in at 9 am. She has also received Pfizer COVID-19 vaccines. Caller mentioned that she is prone to migraines and does not want the "reputation of the product to be damaged". She stated that this is not an "ocular" migraine as she usually sees flashes of light that give her time to prevent the migraines, once they have started they can last 4 days. Her current migraine feels like a pressure across the forehead and it feels intense. Caller declined to make a safety report as she was experiencing her migraine.  Caller stated that Paxlovid is a "miracle" that has taken out all of her COVID symptoms, she is very grateful that the product exists and that she was able to get it. She also took the COVID vaccines manufactured by Pfizer which she described as a "wonderful" company.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 76.0
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 77-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Feb2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm and on 13Jun2022 at 12:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 76 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "breast cancer" (not ongoing), notes: 12 years ago. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 02Jul2022 at 09:00, outcome "recovered with sequelae" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Jul2022) Positive, notes: I got Covid; (06Jul2022) Negative, notes: Tested negative by 06Jul; (10Jul2022) Positive, notes: positive again on 10Jul2022 for 9 days with bad symptoms; (19Jul2022) Negative, notes: Tested negative on 19Jul. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that, patient received Paxlovid for treatment of COVID-19. She got Covid on 02Jul2022 and immediately took Paxlovid for 5 days with no following symptoms. Tested negative by 06Jul and then positive again on 10Jul2022 for 9 days with bad symptoms. Tested negative on 19Jul. Rebound. Adverse event start date 02Jul2022 at 09:00 AM. Adverse event stop date was 19Jul2022. No treatment for ae. Patient had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 44.0
Sex: F
Vaccine: COVID19, 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) (Nurse). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 44 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Crohns disease" (unspecified if ongoing). Concomitant medication(s) included: HUMIRA, start date: 11Jul2022, stop date: 11Jul2022.  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: Positive, notes: 3-4 days after finishing the paxlovid, I tested positive again for COVID and have terrible congestion, headache, cough and sneezing; Unknown Result. Therapeutic measures were taken as a result of covid-19.  Clinical course: Reportedly the patient received anti-viral for COVID 19 treatment, which included paxlovid from 16Jul2022 to 20Jul2022 for treatment of COVID-19. It was reported that, 3-4 days after finishing the paxlovid, the patient tested positive again for COVID and have terrible congestion, headache, cough and sneezing.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. ; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors, however a contributory role of the suspect drug BNT162B2 to the reported events drug ineffective and COVID-19 cannot be ruled out.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 47 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Rebound Covid test and symptoms 6 days after completing paxlovid. Patient took 5 days of paxlovid at full dosage from 16Jul2022 to 21Jul2022 for COVID-19 treatment. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 66.0
Sex: F
Vaccine: COVID19, 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 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2022 at 11:15 as dose 4 (booster), single (Lot number: FK9893) at the age of 66 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative, notes: turned positive again 4 days after negative Covid test; (2022) Positive, notes: turned positive again 4 days after negative Covid test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient had taken Paxlovid from 12Jul2022 to 16Jul2022 for Treatment of COVID-19. The patient did not receive any other medications in 2 weeks. There were no known allergies.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anosmia, COVID-19, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test positive
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 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2022 at 11:15 as dose 4 (booster), single (Lot number: FK9893) at the age of 66 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative, notes: turned positive again 4 days after negative Covid test; (2022) Positive, notes: turned positive again 4 days after negative Covid test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient had taken Paxlovid from 12Jul2022 to 16Jul2022 for Treatment of COVID-19. The patient did not receive any other medications in 2 weeks. There were no known allergies.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for covid; Tested positive for covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: EN6200), on 23Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 01Dec2021 as dose 3 (boster), single (Lot number: FA6780) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25Jul2022, outcome "not recovered" and all described as "Tested positive for covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Jul2022) Positive, notes: tested positive for Covid.  Clinical course: Caller states that he tested positive for covid, he went to [Place withheld] on the 14th and came back Monday he started feeling itchy in his throat and Wednesday he took a test, the [Name withheld] laboratory covid at home test and it was positive. His wife and him fully vaccinated, both tested positive. His wife tested positive yesterday. Caller inadvertently remotely disconnected the phone line. Outbound Call was made. His Wife was vaccinated and tested positive, she got her vaccines on all the same dates. Wifes covid vaccines were also all from Pfizer.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
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 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Batch/Lot number: unknown), on 16Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 22Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Narcolepsy" (unspecified if ongoing); "Asthma" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION; FLUOXETINE; SPIRONOLACTONE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "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: COVID 19 Treatment; (20Jul2022) Negative, notes: negative rapid test; (25Jul2022) Positive, notes: Positive rapid test and symptoms 6 days after completing course of Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient received  Paxlovid, Treatment start date:15Jul2022,Treatment stop date: 20Jul2022, 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.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 18Apr2022 as dose 4 (booster), single (Lot number: F59943) at the age of 53 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), 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: "Colitis ulcerative" (unspecified if ongoing). Concomitant medication(s) included: MESALAMINE. 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.  Clinical Course: The patient received Paxlovid anti-viral treatment for COVID-19 which was started on 14Jul2022 and treatment was ended on 18Jul2022. Paxlovid rebound. COVID symptoms started again on day 9 after completing Paxlovid treatment on days 1-5. The patient had adverse event with Paxlovid on 23Jul2022. The privacy policy consent was given. The device timestamp was 26Jul2022.   No follow-up attempts are needed. No further information is expected.
Age: 29.0
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 30-year-old male patient received BNT162b2 (BNT162B2), on 24Nov2021 as dose 3 (booster) single (Batch/Lot number: unknown) at the age of 29 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "n/a" (unspecified if ongoing). Concomitant medication(s) included: ESOMEPRAZOLE.  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: (18Jul2022) Positive; (23Jul2022) Negative; (26Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: It was reported that. Patient received Paxlovid for treatment of covid-19,start date 18Jul2022, Paxlovid End Date 22Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: got Covid after receiving Pfizer Covid-19 vaccines; got Covid after receiving Pfizer Covid-19 vaccines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient received BNT162b2 (BNT162B2), on 13Mar2021 as dose 1, single (Lot number: EN6204, Expiration Date: Jun2021), in left arm (also reported as left shoulder), on 03Apr2021 as dose 2, single (Lot number: ER8729, Expiration Date: Jul2021), in left arm and on 10Nov2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "got Covid after receiving Pfizer Covid-19 vaccines". Therapeutic measures were taken as a result of vaccination failure, covid-19. The report was not related to a study or programme. The patient got Covid after receiving Pfizer Covid-19 vaccines. The patient said she vaccinated and boosted and she went 3 years without Covid.  The reporter confirmed Covid was after being vaccinated. For dose 1, dose 2 and booster, given time were all  in the afternoon. The patient had not had the fourth vaccine. Additional vaccines was not administered on same date of the Pfizer suspect. No Emergency Room or Physician Office required. No relevant tests. No prior vaccinations (within 4 weeks). The patient was prescribed nirmatrelvir; ritonavir (PAXLOVID).
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Crying, Dyspnoea, Headache, Hypersomnia, Illness
Clinical narrative: got Covid after receiving Pfizer Covid-19 vaccines; got Covid after receiving Pfizer Covid-19 vaccines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient received BNT162b2 (BNT162B2), on 13Mar2021 as dose 1, single (Lot number: EN6204, Expiration Date: Jun2021), in left arm (also reported as left shoulder), on 03Apr2021 as dose 2, single (Lot number: ER8729, Expiration Date: Jul2021), in left arm and on 10Nov2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "got Covid after receiving Pfizer Covid-19 vaccines". Therapeutic measures were taken as a result of vaccination failure, covid-19. The report was not related to a study or programme. The patient got Covid after receiving Pfizer Covid-19 vaccines. The patient said she vaccinated and boosted and she went 3 years without Covid.  The reporter confirmed Covid was after being vaccinated. For dose 1, dose 2 and booster, given time were all  in the afternoon. The patient had not had the fourth vaccine. Additional vaccines was not administered on same date of the Pfizer suspect. No Emergency Room or Physician Office required. No relevant tests. No prior vaccinations (within 4 weeks). The patient was prescribed nirmatrelvir; ritonavir (PAXLOVID).
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Irritability, Malaise, Mental disorder, Moaning, Motor dysfunction
Clinical narrative: got Covid after receiving Pfizer Covid-19 vaccines; got Covid after receiving Pfizer Covid-19 vaccines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient received BNT162b2 (BNT162B2), on 13Mar2021 as dose 1, single (Lot number: EN6204, Expiration Date: Jun2021), in left arm (also reported as left shoulder), on 03Apr2021 as dose 2, single (Lot number: ER8729, Expiration Date: Jul2021), in left arm and on 10Nov2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "got Covid after receiving Pfizer Covid-19 vaccines". Therapeutic measures were taken as a result of vaccination failure, covid-19. The report was not related to a study or programme. The patient got Covid after receiving Pfizer Covid-19 vaccines. The patient said she vaccinated and boosted and she went 3 years without Covid.  The reporter confirmed Covid was after being vaccinated. For dose 1, dose 2 and booster, given time were all  in the afternoon. The patient had not had the fourth vaccine. Additional vaccines was not administered on same date of the Pfizer suspect. No Emergency Room or Physician Office required. No relevant tests. No prior vaccinations (within 4 weeks). The patient was prescribed nirmatrelvir; ritonavir (PAXLOVID).
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle disorder, Myalgia, Nausea, Pain, Pain in extremity
Clinical narrative: got Covid after receiving Pfizer Covid-19 vaccines; got Covid after receiving Pfizer Covid-19 vaccines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient received BNT162b2 (BNT162B2), on 13Mar2021 as dose 1, single (Lot number: EN6204, Expiration Date: Jun2021), in left arm (also reported as left shoulder), on 03Apr2021 as dose 2, single (Lot number: ER8729, Expiration Date: Jul2021), in left arm and on 10Nov2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "got Covid after receiving Pfizer Covid-19 vaccines". Therapeutic measures were taken as a result of vaccination failure, covid-19. The report was not related to a study or programme. The patient got Covid after receiving Pfizer Covid-19 vaccines. The patient said she vaccinated and boosted and she went 3 years without Covid.  The reporter confirmed Covid was after being vaccinated. For dose 1, dose 2 and booster, given time were all  in the afternoon. The patient had not had the fourth vaccine. Additional vaccines was not administered on same date of the Pfizer suspect. No Emergency Room or Physician Office required. No relevant tests. No prior vaccinations (within 4 weeks). The patient was prescribed nirmatrelvir; ritonavir (PAXLOVID).
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: got Covid after receiving Pfizer Covid-19 vaccines; got Covid after receiving Pfizer Covid-19 vaccines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient received BNT162b2 (BNT162B2), on 13Mar2021 as dose 1, single (Lot number: EN6204, Expiration Date: Jun2021), in left arm (also reported as left shoulder), on 03Apr2021 as dose 2, single (Lot number: ER8729, Expiration Date: Jul2021), in left arm and on 10Nov2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "got Covid after receiving Pfizer Covid-19 vaccines". Therapeutic measures were taken as a result of vaccination failure, covid-19. The report was not related to a study or programme. The patient got Covid after receiving Pfizer Covid-19 vaccines. The patient said she vaccinated and boosted and she went 3 years without Covid.  The reporter confirmed Covid was after being vaccinated. For dose 1, dose 2 and booster, given time were all  in the afternoon. The patient had not had the fourth vaccine. Additional vaccines was not administered on same date of the Pfizer suspect. No Emergency Room or Physician Office required. No relevant tests. No prior vaccinations (within 4 weeks). The patient was prescribed nirmatrelvir; ritonavir (PAXLOVID).
Age: 49.0
Sex: M
Vaccine: COVID19, 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 51-year-old male patient received BNT162b2 (BNT162B2), on 27Mar2021 at 13:00 as dose 2, single (Batch/Lot number: unknown) at the age of 49 years 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: "CAD" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "drink alcoholic beverage" (unspecified if ongoing), notes: only drink alcoholic beverage very occasionally and did not have alcohol since 01Jun. Concomitant medication(s) included: ATORVASTATIN, stop date: 04Jun2022. 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: Unknown results. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  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, 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 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Nov2021 at 15:00 as dose 3 (booster), single (Lot number: FK9729), in left arm and on 04Apr2022 at 12:15 as dose 4 (booster), single (Lot number: 30155BA) at the age of 51 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 16Feb2021 at 08:00 as dose 1, single (Lot number: 031L201A), in left arm and on 19Mar2021 at 08:00 as dose 2, single (Lot number: 044A21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "depression" (unspecified if ongoing); "known allergies: I am allergice to shellfish" (unspecified if ongoing), notes: Patient allergic to shellfish. Concomitant medication(s) included: BUPROPION, start date: 01Jun2021; ROSUVASTATIN, start date: 05Aug2020. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Jul2022) Postive, notes: Postive PCR test on 13Jul2022; (12Jul2022) Positive, notes: I tested positive for Covid on 12Jul2022 (rapid test); (18Jul2022) negative, notes: I tested negative on 18Jul2022-20Jul2022 (rapid); (19Jul2022) negative, notes: I tested negative on 18Jul2022-20Jul2022 (rapid); (20Jul2022) negative, notes: I tested negative, on 18Jul2022-20Jul2022 (rapid); (24Jul2022) Postive, notes: Tested Positive on 24Jul2022(rapid). Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient tested positive for Covid on 12Jul2022 (rapid test). Positive PCR test on 13Jul2022. Patient started Plaxovid on 13Jul2022 and completed on 17Jul2022. Patient tested negative on 18Jul2022 to 20Jul2022 (rapid). Tested Postive on 24Jul2022 (rapid).
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive again on antigen test a couple of days after the disease was gone; tested positive again on antigen test a couple of days after the disease was gone; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 27Jan2021 as dose 2, single (Lot number: EL9264) at the age of 69 years 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 was not reported. Concomitant medication(s) included: FINASTERIDE; LISINOPRIL. Past drug history included: Atorvastatin, reaction(s): "Known allergies: atorvastatin", notes: Known allergies: atorvastatin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "not recovered" and all described as "tested positive again on antigen test a couple of days after the disease was gone". 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 which included Paxlovid from 17Jul2022 to 22Jul2022.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 05Feb2021 at 14:00 as dose 1, single (Lot number: EL9269), in right arm, on 26Feb2021 at 14:00 as dose 2, single (Lot number: EN6202), in right arm, on 21Aug2021 at 14:00 as dose 3 (booster) single (Lot number: FD8448), in right arm and on 20May2022 at 14:00 as dose 4 (booster), single (Lot number: FM7553) at the age of 55 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "DVT Blood Clots", start date: 2005 (unspecified if ongoing), notes: Other medical history- DVT Blood Clots 2005; "Known allergies- Penicillin" (unspecified if ongoing), notes: Known allergies- Penicillin; "Blood Clots", start date: 2005 (unspecified if ongoing), notes: Other medical history- DVT Blood Clots 2005. The patient's concomitant medications were not reported. Past drug history included: Warfarin, start date: 31Jan2005, notes: Other medication details, Other medication in 2weeks product: Warfarin, Other medication in 2weeks brand: Generic,, Other medication in 2weeks start date: 31Jan2005. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 16Jul2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Jul2022) Positive, notes: Test Covid positive 16Jul; (21Jul2022) Negative, notes: Last dose 21Jul and tested negative; (26Jul2022) Positive, notes: I tested positive again today 26Jul. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Test Covid positive 16Jul. Started Paxlovid 17Jul. Took all doses as prescribed. Documented each dose. Last dose 21Jul and tested negative. Minor sinus issues continued and then became worse. Patient tested positive again today 26Jul.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), 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: "Breast cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid on 11Jul2022 and stopped on 16Jul2022.  The patient had no known allergies.  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 temporal association, there is reasonable possibility of causal association between the Reported events and the suspect drug.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: indication=Treatment of COVID-19; indication=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 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Dec2021 at 16:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 44 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Other medical history: Asthma; "hypothyroidism" (unspecified if ongoing), notes: Other medical history: hypothyroidism. Concomitant medication(s) included: LEVOTHROID, start date: 02Nov2020. Past drug history included: Keflex, reaction(s): "Allergy", notes: known allergies: Keflex; Ciproflaxin, reaction(s): "Allergy", notes: known allergies: Ciproflaxin,; Claritin, reaction(s): "Allergy", notes: known allergies: Claritin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "indication=Treatment of 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.  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: Blood pressure measurement, Hormone level abnormal, Hypertension, Nasopharyngeal swab, Vaginal haemorrhage
Clinical narrative: High Blood pressure 161/110 lasting for 3 months after vaccination and stay elevated 149/90 still 7/27/2022; Hormonal imbalance; perfuse vaginal bleeding; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Jan2022 as dose 1, single (Lot number: FL3198) at the age of 51 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: HYPERTENSION (medically significant) with onset 12Jan2022, outcome "recovered with sequelae" (2022), described as "High Blood pressure 161/110 lasting for 3 months after vaccination and stay elevated 149/90 still 7/27/2022"; HORMONE LEVEL ABNORMAL (non-serious) with onset 12Jan2022, outcome "recovered with sequelae" (2022), described as "Hormonal imbalance"; VAGINAL HAEMORRHAGE (non-serious) with onset 12Jan2022, outcome "recovered with sequelae" (2022), described as "perfuse vaginal bleeding". The events "high blood pressure 161/110 lasting for 3 months after vaccination and stay elevated 149/90 still 7/27/2022", "hormonal imbalance" and "perfuse vaginal bleeding" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (unspecified date) 161/110, notes: High Blood pressure 161/110 lasting for 3 months after vaccination and stay elevated 149/90 still 27Jul2022; (unspecified date) 149/90, notes: High Blood pressure 161/110 lasting for 3 months after vaccination and stay elevated 149/90 still 27Jul2022; Nasopharyngeal swab: (02Mar2022) Negative. Therapeutic measures were taken as a result of hypertension, hormone level abnormal, vaginal haemorrhage.  Clinical course: Patient received dose 2 on 01Feb2022, Lot number=FK9896, Administration time=01:00 AM, Vaccine location=Left arm. If other vaccine in four weeks: No. Other medication in two weeks: No. Hormonal imbalance with perfuse vaginal bleeding lasting 2 months. Ae treatment: High blood pressure medication. No covid Prior vaccination. Covid tested post vaccination: Yes, and was negative. No other medical history.  Follow up attempts are completed. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer drug 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: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 14Feb2021 at 11:00 as dose 1, single (Lot number: EN6200), in left arm, on 28Feb2021 at 11:00 as dose 2, single (Lot number: EN6203), in left arm and on 27Sep2021 as dose 3 (booster), single (Lot number: FF2588) at the age of 68 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 (Lot number: 004M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). No known allergies. Concomitant medication(s) included: LOSARTIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 23Jul2022, outcome "recovering" and all described as "COVID-19". Adverse event resulted in none of the above. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: symptoms & positive rapid test reoccurred about day 6. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.