chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Rash, Rash pruritic, Rash vesicular, SARS-CoV-2 test
Clinical narrative: shingles rash near injection site; shingles rash near injection site/this rash is consistent with shingles; shingles rash near injection site/this rash is consistent with shingles/eruptions are irregular in size and shape; this rash itches; pain associated with the rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (COMIRNATY), on 29Apr2022 at 15:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: penicillin. The patient's concomitant medications were not reported. Past drug history included: Ampicillin, reaction(s): "Drug allergy", notes: Known allergies: ampicillin; E mycin, reaction(s): "Drug allergy", notes: Known allergies: e mycin. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: Unknown; Anatomical location: Arm Left, Vaccine Administration Time: 10:15 AM), administration date: Jan2021, when the patient was 68 years old, for Covid-19 immunisation; Bnt162b2 (DOSE 2, SINGLE; Lot Number: Unknown; Anatomical location: Arm Left, Vaccine Administration Time: 01:15 PM), administration date: Mar2021, when the patient was 68 years old, for COVID-19 immunisation. The following information was reported: RASH (non-serious) with onset May2022, outcome "not recovered", described as "pain associated with the rash"; VACCINATION SITE RASH (non-serious) with onset May2022, outcome "not recovered", described as "shingles rash near injection site"; HERPES ZOSTER (non-serious) with onset May2022, outcome "not recovered", described as "shingles rash near injection site/this rash is consistent with shingles"; RASH VESICULAR (non-serious) with onset May2022, outcome "not recovered", described as "shingles rash near injection site/this rash is consistent with shingles/eruptions are irregular in size and shape"; RASH PRURITIC (non-serious) with onset May2022, outcome "not recovered", described as "this rash itches". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site rash, herpes zoster, rash vesicular, rash pruritic, rash.  Additional information: It was reported that two weeks after first booster, third vaccine, patient developed a shingles rash near injection site. The patient inoculated with a shingles vaccine, but this rash is consistent with shingles in that it itches, eruptions are irregular in size and shape, and there is pain associated with the rash.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: shingles rash near injection site; shingles rash near injection site/this rash is consistent with shingles; shingles rash near injection site/this rash is consistent with shingles/eruptions are irregular in size and shape; this rash itches; pain associated with the rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (COMIRNATY), on 29Apr2022 at 15:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: penicillin. The patient's concomitant medications were not reported. Past drug history included: Ampicillin, reaction(s): "Drug allergy", notes: Known allergies: ampicillin; E mycin, reaction(s): "Drug allergy", notes: Known allergies: e mycin. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: Unknown; Anatomical location: Arm Left, Vaccine Administration Time: 10:15 AM), administration date: Jan2021, when the patient was 68 years old, for Covid-19 immunisation; Bnt162b2 (DOSE 2, SINGLE; Lot Number: Unknown; Anatomical location: Arm Left, Vaccine Administration Time: 01:15 PM), administration date: Mar2021, when the patient was 68 years old, for COVID-19 immunisation. The following information was reported: RASH (non-serious) with onset May2022, outcome "not recovered", described as "pain associated with the rash"; VACCINATION SITE RASH (non-serious) with onset May2022, outcome "not recovered", described as "shingles rash near injection site"; HERPES ZOSTER (non-serious) with onset May2022, outcome "not recovered", described as "shingles rash near injection site/this rash is consistent with shingles"; RASH VESICULAR (non-serious) with onset May2022, outcome "not recovered", described as "shingles rash near injection site/this rash is consistent with shingles/eruptions are irregular in size and shape"; RASH PRURITIC (non-serious) with onset May2022, outcome "not recovered", described as "this rash itches". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site rash, herpes zoster, rash vesicular, rash pruritic, rash.  Additional information: It was reported that two weeks after first booster, third vaccine, patient developed a shingles rash near injection site. The patient inoculated with a shingles vaccine, but this rash is consistent with shingles in that it itches, eruptions are irregular in size and shape, and there is pain associated with the rash.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
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 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Apr2021 as dose 1, single (Lot number: EW0164), on 06May2021 as dose 2, single (Lot number: EW0182) and on 02Dec2021 as dose 3 (booster) single (Lot number: 330308D) at the age of 32 years for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ATENOLOL; OMEPRAZOLE; AMLODIPINE; PAXIL [PIROXICAM]; FENOFIBRATE. Past drug history included: Cipro iv, reaction(s): "Known allergies: Cipro IV". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 04May2022, outcome "not recovered" and all described as "indication=Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04May2022) positive; (08May2022) Negative; (10May2022) Negative; (18May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09May2022 at 12:00 as dose 4 (booster), single (Lot number: FJ4989) at the age of 57 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: "Type 2 DM" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN, start date: 01Mar2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Covid-19 Treatment; (17May2022) negative, notes: Negative antigen test two days after stopping Paxlovid;; (19May2022) Positive, notes: positive antigen test four days later. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, SARS-CoV-2 test
Clinical narrative: The pain in legs and muscles started in Dec2021 or Jan2022; The pain in legs and muscles started in Dec2021 or Jan2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 09Dec2021 as dose 3 (booster), single (Lot number: 33030BD) at the age of 61 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: high blood pressure diagnosed about twenty years ago; "Immunization" (unspecified if ongoing). Concomitant medication(s) included: RAMIPRIL oral taken for hypertension, taking for 20 years; METOPROLOL TARTRATE oral taken for hypertension, taking for 20 years; SHINGRIX taken for immunisation; FLU VACCINE VII. Vaccination history included: BNT162b2 (First dose Pfizer covid 19 vaccine: 17Apr2021, Lot: EW0162, Expiration: 31Jul2021, NDC: unknown), administration date: 17Apr2021, for COVID-19 immunization; BNT162b2 (Second dose Pfizer covid 19 vaccine: 22May2021, Lot: EW0177 (populated lot number), Expiration: 31Aug2021), administration date: 22May2021, for COVID-19 immunization, reaction(s): "mental brain fog"; BNT162b2 (Second dose Pfizer covid 19 vaccine: 22May2021, Lot: EW0177 (populated lot number), Expiration: 31Aug2021), administration date: 22May2022, for COVID-19 immunization, reaction(s): "having electric shock in the feet / sharp pain pain and very brief sensation", "cognitive disorder/disassociated disorder", "pain in the joints and muscles", "pain in the joints and muscles", "mental issues". The following information was reported: PAIN IN EXTREMITY (non-serious), MYALGIA (non-serious), outcome "not recovered" and all described as "The pain in legs and muscles started in Dec2021 or Jan2022". The events "the pain in legs and muscles started in dec2021 or jan2022" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity, myalgia.   Additional information: The report was not related to a study or programme. The event was ongoing, he took a pain tablet a week ago and the pain tablet lasts a week, so his pain was not severe. He tried to avoid taking medication. No family medical history relevant to AE(s). He tested multiple times and haven't had covid.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200750480 similar report from same reporter
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 34-year-old male patient received BNT162b2 (BNT162B2), on 23May2021 as dose 1, single (Lot number: EW0183) and on 13Jun2021 as dose 2, single (Lot number: EW0187) at the age of 33 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: URTICARIA (non-serious) with onset Jan2022, outcome "recovering", described as "hives". Therapeutic measures were taken as a result of urticaria. Additional information: If other vaccine in four weeks: Unknown. Other medications in two weeks: Unknown. Had never experienced allergies before. He could not remember the date he first observed hives. However, Ever since he was vaccinated, he gets hives when he is out for run, when he is sunbathing and after sauna. Ae treatment: anti-histamine. If covid prior vaccination: No. If covid tested post vaccination: No. Known allergies: No. Other medical history: N/A.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), 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. Past drug history included: Neomycin, reaction(s): "Known allergies: Neomycin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Apr2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional Information: The patient received antiviral for treatment of COVID-19 as other medication in 2weeks. The start date of the treatment was reported as 06May2022 and stop date was 10May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of covid-19; Treatment of covid-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 40-year-old male patient received BNT162b2 (BNT162B2), on 03May2021 as dose 3 (booster), single (Lot number: EW0161) at the age of 39 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Apr2022) Unknown results; (02May2022) Negative, notes: He tested negative for COVID via rapid antigen on day 6; (06May2022) Positive, notes: He tested positive via rapid antigen on day 10; (26Apr2022) Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: If vaccine received: Yes, Other medication in 2 weeks: No. Adverse event: Patient tested and Covid-19 via rapid antigen and PCR on 26Apr2022, he completed Paxlovid on 01May22. He tested negative for Covid via rapid antigen on day6. Symptoms reoccurred on day 10 consisting of nasal congestion, headache, and diarrhea, he tested positive via rapid antigen on day 10. Known allergies: No. Other medical History: GERD; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Eustachian tube dysfunction, Hyperacusis, Lumbar puncture, Magnetic resonance imaging head, SARS-CoV-2 test
Clinical narrative: She contracted COVID with positive for COVID result on COVID test 07Jan2022; She contracted COVID with positive for COVID result on COVID test 07Jan2022; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A 58-year-old female patient received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: EN6205), in arm and on 23Mar2021 as dose 2, single (Lot number: ER2613) at the age of 58 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "COVID", start date: 11Jan2021 (unspecified if ongoing), notes: Symptom onset 07Jan2021.Tested positive for COVID, test on 11Jan2021.She took 2 or 3 COVID tests that were all positive for COVID.Husband took COVID test and he was negative for COVID. Acute symptoms weren't severe, was mild case of COVID. When developed COVID she was given a week of Prednisone because she developed headaches. It had to have been she would call it mid Jan2021 that she did the Prednisone.; "Seasonal Allergies" (ongoing), notes: Illness/AE: Seasonal Allergies, Onset Date: Childhood; "Seasonal Asthma" (ongoing), notes: Illness/AE: Seasonal Asthma, Onset Date: Childhood. There were no concomitant medications. Vaccination history included: Flu vaccine (She has only had flu vaccine once in her life and has no history of ever having a reaction to a vaccine), for Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "She contracted COVID with positive for COVID result on COVID test 07Jan2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (unspecified date) Positive; (11Jan2021) Positive; (07Jan2022) Positive. Clinical course: COVID: She contracted COVID with positive for COVID result on COVID test 07Jan2022. She can't remember when the onset of COVID symptoms started. She just had some very minimal cold-like symptoms. Acute symptoms weren't severe.: Vaccination Facility Type: Clinic, it was actually just a using whatever they could use, it was a room within the facility.; 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 product bnt162b2 to the reported vaccination failure / COVID-19 cannot be ruled out
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: She contracted COVID with positive for COVID result on COVID test 07Jan2022; She contracted COVID with positive for COVID result on COVID test 07Jan2022; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A 58-year-old female patient received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: EN6205), in arm and on 23Mar2021 as dose 2, single (Lot number: ER2613) at the age of 58 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "COVID", start date: 11Jan2021 (unspecified if ongoing), notes: Symptom onset 07Jan2021.Tested positive for COVID, test on 11Jan2021.She took 2 or 3 COVID tests that were all positive for COVID.Husband took COVID test and he was negative for COVID. Acute symptoms weren't severe, was mild case of COVID. When developed COVID she was given a week of Prednisone because she developed headaches. It had to have been she would call it mid Jan2021 that she did the Prednisone.; "Seasonal Allergies" (ongoing), notes: Illness/AE: Seasonal Allergies, Onset Date: Childhood; "Seasonal Asthma" (ongoing), notes: Illness/AE: Seasonal Asthma, Onset Date: Childhood. There were no concomitant medications. Vaccination history included: Flu vaccine (She has only had flu vaccine once in her life and has no history of ever having a reaction to a vaccine), for Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "She contracted COVID with positive for COVID result on COVID test 07Jan2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (unspecified date) Positive; (11Jan2021) Positive; (07Jan2022) Positive. Clinical course: COVID: She contracted COVID with positive for COVID result on COVID test 07Jan2022. She can't remember when the onset of COVID symptoms started. She just had some very minimal cold-like symptoms. Acute symptoms weren't severe.: Vaccination Facility Type: Clinic, it was actually just a using whatever they could use, it was a room within the facility.; 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 product bnt162b2 to the reported vaccination failure / COVID-19 cannot be ruled out
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Crying, Hyperacusis, Inflammation, Lumbar puncture, Magnetic resonance imaging
Clinical narrative: She contracted COVID with positive for COVID result on COVID test 07Jan2022; She contracted COVID with positive for COVID result on COVID test 07Jan2022; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A 58-year-old female patient received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: EN6205), in arm and on 23Mar2021 as dose 2, single (Lot number: ER2613) at the age of 58 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "COVID", start date: 11Jan2021 (unspecified if ongoing), notes: Symptom onset 07Jan2021.Tested positive for COVID, test on 11Jan2021.She took 2 or 3 COVID tests that were all positive for COVID.Husband took COVID test and he was negative for COVID. Acute symptoms weren't severe, was mild case of COVID. When developed COVID she was given a week of Prednisone because she developed headaches. It had to have been she would call it mid Jan2021 that she did the Prednisone.; "Seasonal Allergies" (ongoing), notes: Illness/AE: Seasonal Allergies, Onset Date: Childhood; "Seasonal Asthma" (ongoing), notes: Illness/AE: Seasonal Asthma, Onset Date: Childhood. There were no concomitant medications. Vaccination history included: Flu vaccine (She has only had flu vaccine once in her life and has no history of ever having a reaction to a vaccine), for Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "She contracted COVID with positive for COVID result on COVID test 07Jan2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (unspecified date) Positive; (11Jan2021) Positive; (07Jan2022) Positive. Clinical course: COVID: She contracted COVID with positive for COVID result on COVID test 07Jan2022. She can't remember when the onset of COVID symptoms started. She just had some very minimal cold-like symptoms. Acute symptoms weren't severe.: Vaccination Facility Type: Clinic, it was actually just a using whatever they could use, it was a room within the facility.; 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 product bnt162b2 to the reported vaccination failure / COVID-19 cannot be ruled out
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging head abnormal, Memory impairment, Post lumbar puncture syndrome, SARS-CoV-2 test, Tinnitus
Clinical narrative: She contracted COVID with positive for COVID result on COVID test 07Jan2022; She contracted COVID with positive for COVID result on COVID test 07Jan2022; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A 58-year-old female patient received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: EN6205), in arm and on 23Mar2021 as dose 2, single (Lot number: ER2613) at the age of 58 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "COVID", start date: 11Jan2021 (unspecified if ongoing), notes: Symptom onset 07Jan2021.Tested positive for COVID, test on 11Jan2021.She took 2 or 3 COVID tests that were all positive for COVID.Husband took COVID test and he was negative for COVID. Acute symptoms weren't severe, was mild case of COVID. When developed COVID she was given a week of Prednisone because she developed headaches. It had to have been she would call it mid Jan2021 that she did the Prednisone.; "Seasonal Allergies" (ongoing), notes: Illness/AE: Seasonal Allergies, Onset Date: Childhood; "Seasonal Asthma" (ongoing), notes: Illness/AE: Seasonal Asthma, Onset Date: Childhood. There were no concomitant medications. Vaccination history included: Flu vaccine (She has only had flu vaccine once in her life and has no history of ever having a reaction to a vaccine), for Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "She contracted COVID with positive for COVID result on COVID test 07Jan2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (unspecified date) Positive; (11Jan2021) Positive; (07Jan2022) Positive. Clinical course: COVID: She contracted COVID with positive for COVID result on COVID test 07Jan2022. She can't remember when the onset of COVID symptoms started. She just had some very minimal cold-like symptoms. Acute symptoms weren't severe.: Vaccination Facility Type: Clinic, it was actually just a using whatever they could use, it was a room within the facility.; 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 product bnt162b2 to the reported vaccination failure / COVID-19 cannot be ruled out
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: She contracted COVID with positive for COVID result on COVID test 07Jan2022; She contracted COVID with positive for COVID result on COVID test 07Jan2022; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A 58-year-old female patient received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: EN6205), in arm and on 23Mar2021 as dose 2, single (Lot number: ER2613) at the age of 58 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "COVID", start date: 11Jan2021 (unspecified if ongoing), notes: Symptom onset 07Jan2021.Tested positive for COVID, test on 11Jan2021.She took 2 or 3 COVID tests that were all positive for COVID.Husband took COVID test and he was negative for COVID. Acute symptoms weren't severe, was mild case of COVID. When developed COVID she was given a week of Prednisone because she developed headaches. It had to have been she would call it mid Jan2021 that she did the Prednisone.; "Seasonal Allergies" (ongoing), notes: Illness/AE: Seasonal Allergies, Onset Date: Childhood; "Seasonal Asthma" (ongoing), notes: Illness/AE: Seasonal Asthma, Onset Date: Childhood. There were no concomitant medications. Vaccination history included: Flu vaccine (She has only had flu vaccine once in her life and has no history of ever having a reaction to a vaccine), for Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "She contracted COVID with positive for COVID result on COVID test 07Jan2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (unspecified date) Positive; (11Jan2021) Positive; (07Jan2022) Positive. Clinical course: COVID: She contracted COVID with positive for COVID result on COVID test 07Jan2022. She can't remember when the onset of COVID symptoms started. She just had some very minimal cold-like symptoms. Acute symptoms weren't severe.: Vaccination Facility Type: Clinic, it was actually just a using whatever they could use, it was a room within the facility.; 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 product bnt162b2 to the reported vaccination failure / COVID-19 cannot be ruled out
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Oxygen saturation abnormal, SARS-CoV-2 test
Clinical narrative: 4 shots of Covid, Pfizer Covid Vaccine; 4 shots of Covid, Pfizer Covid Vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old 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 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing), notes: Blood pressure; "Asthma" (unspecified if ongoing), notes: Asthma; "HIV" (unspecified if ongoing); "Heart Conditions" (unspecified if ongoing); "Blood clots in my legs" (unspecified if ongoing); "Hyper S protein deficient" (unspecified if ongoing); "Hypertension" (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 "4 shots of Covid, Pfizer Covid Vaccine". The patient underwent the following laboratory tests and procedures: Oxygen saturation abnormal: 89, notes: my blood oxygen was 89; SARS-CoV-2 test: Unknown result, notes: had COVID / I got second round of COVID. Clinical course: Patient has hyper S protein deficient. Patient got second round of Covid and after prescribed Paxlovid, on three separate occasions, the pharmacies denied patient selling prescription for Paxlovid. Saturday, patient was in the hospital because patient's blood oxygen was 89. They did prescribe the Paxlovid again.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment for COVID-19; Treatment for COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 26-year-old male patient received BNT162b2 (BNT162B2), on 24Mar2021 at 09:30 as dose 1, single (Lot number: EN6201), in left arm, on 14Apr2021 at 09:30 as dose 2, single (Lot number: EW0162), in left arm and on 29Oct2021 at 17:00 as dose 3 (booster), single (Lot number: FH8020), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: TYLENOL oral, start date: 21May2022, stop date: 23May2022; MUCINEX oral, start date: 21May2022, stop date: 23May2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment for COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. No follow-up attempts are needed. No further information is expected.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue
Clinical narrative: no energy/Feeling of washed out; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 88-year-old female patient received BNT162b2 (BNT162B2), on 19May2022 at 13:00 as dose 4 (booster), single (Lot number: FM9992) at the age of 88 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "She has been diagnosed with depression" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 2, LOT: EL3248, Anatomical Location: Left arm), administration date: 01Feb2021, when the patient was 87-year-old, for COVID-19 immunization, reaction(s): "she has received her first dose of the Pfizer Covid-19 vaccine, a second dose (which she referred to as her first booster per RA agent), and third dose (which she referred to as her second booster per RA agent)."; BNT162b2 (Dose: 3 (1st booster), Lot: 30155BA, Anatomical Location: Left arm), administration date: 12Oct2021, when the patient was 88-year-old, for COVID-19 immunization, reaction(s): "she has received her first dose of the Pfizer Covid-19 vaccine, a second dose (which she referred to as her first booster per RA agent), and third dose (which she referred to as her second booster per RA agent)."; Bnt162b2 (Dose: 1, Pfizer Covid Vaccines, LOT: Pfizer EL3TQ8, Anatomical Location: Left arm), administration date: Jan2021, when the patient was 87 years old, for COVID-19 immunization, reaction(s): "she has received her first dose of the Pfizer Covid-19 vaccine, a second dose (which she referred to as her first booster per RA agent), and third dose (which she referred to as her second booster per RA agent).". The following information was reported: ASTHENIA (non-serious), outcome "unknown", described as "no energy/Feeling of washed out"; FATIGUE (non-serious), outcome "unknown". Therapeutic measures were not taken as a result of asthenia, fatigue.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Overdose, Product preparation error
Clinical narrative: An 11y/o female patient who received an undiluted dose of the Pfizer COVID-19 Vaccine Orange Cap.; An 11y/o female patient who received an undiluted dose of the Pfizer COVID-19 Vaccine Orange Cap.; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  A 10-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Lot number: FL8095, Expiration Date: 28Jun2022) at the age of 10 years, in right deltoid for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL] taken for asthma. The following information was reported: OVERDOSE (non-serious), PRODUCT PREPARATION ERROR (non-serious), outcome "unknown" and all described as "An 11y/o female patient who received an undiluted dose of the Pfizer COVID-19 Vaccine Orange Cap.".  Additional Information: Reporter stated there was no other medication taken only albuterol was taken as treatment drug for asthma. Reported stated it looked like she had albuterol pump. It was documented patient was not taking everyday it's when she needed. Reported stated that there were no prior vaccination (with 4 weeks) of suspect vaccination.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Suspected 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 75-year-old male patient received BNT162b2 (BNT162B2), on 13Jan2021 as dose 1, single (Lot number: EL6246), in left arm, on 23Feb2021 as dose 2, single (Lot number: EL9265), in left arm, on 28Sep2021 as dose 3 (booster), single (Lot number: 30145BA), in left arm and on 05Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 75 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, suspected covid-19.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Apr2021 at 10:00 as dose 1, single (Lot number: ER8737), in left arm, on 19Apr2021 at 14:00 as dose 2, single (Lot number: EW0164), in left arm and on 06Dec2021 at 10:00 as dose 3 (booster), single (Lot number: 33130BA) at the age of 54 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course information: It was reported that the patient had no known allergies and the patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.  No follow-up attempts are possible and no further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19/ Positive test; Treatment of COVID-19/ Positive test; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 60 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset May2022, outcome "unknown", COVID-19 (medically significant) with onset May2022, outcome "recovering" and all described as "Treatment of COVID-19/ Positive test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive, notes: Rebound COVID (Symptoms + Positive test). Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Adverse event: Rebound COVID (Symptoms + Positive test), Adverse event start date on 14May2022; anti viral details: treatment was Paxlovid from 09May2022 to 12May2022, Indication: Treatment of COVID-19, Administrator route: Oral.  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 provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) at the age of 30 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 May2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19/ Positive Covid on 08Feb2022; COVID 19/ Positive Covid on 08Feb2022; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown) and in May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 59 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: SINGULAIR, start date: Aug2018; BREO ELLIPTA, start date: Aug2018. Past drug history included: Bactrim, reaction(s): "Drug Allergy"; Asa, reaction(s): "Drug Allergy"; Advil, reaction(s): "Drug Allergy"; Tylenol, reaction(s): "Drug Allergy". The following information was reported: COVID-19 (medically significant) with onset 08Feb2022, outcome "not recovered", VACCINATION FAILURE (medically significant) with onset 08Feb2022, outcome "unknown" and all described as "COVID 19/ Positive Covid on 08Feb2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Feb2022) Positive, notes: Positive COVID on 08Feb2022; (17Apr2022) Positive, notes: Positive COVID on 17Apr2022. Therapeutic measures were taken as a result of covid-19, vaccination failure included Paxlovid. 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 reported information, causal association of event drug ineffective, covid-19 with BNT162b2 cannot be excluded. However, response to vaccine can vary in individuals.
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) (Physician).  An elderly male patient received BNT162b2 (BNT162B2), on 26Feb2022 as dose 4 (booster), single (Lot number: FL3209), 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: "Hypertension" (unspecified if ongoing); "Hypercholersterolemia" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing). Concomitant medication(s) included: IRBESARTAN oral, start date: 01Jan2022, stop date: 24May2022; ROSUVASTATIN oral, start date: 01Jan2022, stop date: 06May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: COVID relapse, notes: low cycle threshold  on PCR testing. Therapeutic measures were taken as a result of covid-19. Clinical Course: Anti-viral details, covid-19 Treatment was Paxlovid started on 07May2022 to 11May2022. Covid relapse 5 d after d/c Paxlovid with low cycle threshold on PCR testing.; Sender's Comments: Based on reported information, causal association of event drug ineffective, covid-19 with BNT162b2 cannot be excluded. However, response to vaccine can vary in individuals.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 treatment; COVID 19 treatment; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 33 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa; "Known allergies: Iodine contrast" (unspecified if ongoing), notes: Known allergies: Iodine contrast; "Known allergies: Latex" (unspecified if ongoing), notes: Known allergies: Latex. Concomitant medication(s) included: ACETAMINOPHEN; TYLENOL; ADVIL [IBUPROFEN]. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID 19 treatment". Therapeutic measures were taken as a result of covid-19, drug ineffective.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on reported information, causal association of event drug ineffective, covid-19 with BNT162b2 cannot be excluded. However, response to vaccine can vary in individuals.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality. The reporter is the patient.  An adult male patient received BNT162b2 (BNT162B2), on 30Oct2021 as dose 2 (booster), single (Lot number: EW0173), in left arm for covid-19 immunisation; coviD-19 vaccine janssen (COVID-19 VACCINE JANSSEN), on 05Apr2021 as dose 1, single (Lot number: 041A21A), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: Multiple days of negative RAT; (22May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (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: AMLODIPINE, stop date: 10May2022. The following information was reported: DRUG INEFFECTIVE (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: (17May2022) Negative, notes: Antigen had been only very slightly negative day 7 and 10; (20May2022) Negative, notes: Antigen had been only very slightly negative day 7 and 10; (unspecified date) Unknown result, notes: COVID 19 Treatment; (23May2022) positive, notes: tested5-23 w new onset worseningsymptoms and noted to be frankly positive within 2 minutes. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the events drug ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.