chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort
Clinical narrative: On the left side of her throat feels like something is in there.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient received BNT162b2 (BNT162B2), on 26Apr2022 as dose 4 (booster), 0.3 ml single (Lot number: FM0698, Expiration Date: 31May2022) at the age of 61 years, in left hand for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Manufacturer: Pfizer, NDC: Unknown, Lot: EW0151   , Expiration: 31Jul2021, Time given: She said time is not listed but she received during the day., Anatomical location: Left hand side, Dosage: 0.3 ml), administration date: 08Apr2021, when the patient was 60-year-old, for COVID-19 immunization, reaction(s): "Caller said just the sore arm and that was it."; BNT162b2 (Dose 2, Manufacturer: Pfizer, NDC: Unknown, Lot: EW0167, Expiration: 31Aug2021, Time given: During the day , Anatomical location: Left hand side, Dosage: 0.3 ml), administration date: 30Apr2021, when the patient was 60-year-old, for COVID-19 immunization, reaction(s): "Caller said just the sore arm and that was it."; BNT162b2 (Dose 3 (First Booster), Manufacturer: Pfizer, NDC: Unknown, Lot: FH8020, Expiration: 31Jan2022, Time given: During the day, Anatomical location: Left hand side, Dosage: 0.3 ml), administration date: 03Nov2021, when the patient was 61-year-old, for Covid-19 immunization, reaction(s): "Caller said just the sore arm and that was it.". The following information was reported: OROPHARYNGEAL DISCOMFORT (non-serious) with onset 27Apr2022, outcome "not recovered", described as "On the left side of her throat feels like something is in there.". The event "on the left side of her throat feels like something is in there." required physician office visit.  Additional information : Prior Vaccinations (within 4 weeks) prior to the first administration date of the suspect vaccine was reported as none.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
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 contactable reporter(s) (Physician).  A 37-year-old male patient received BNT162b2 (BNT162B2), on 06Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 36 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 20Feb2021 as dose 1, single (Batch/Lot number: unknown) and on 20Mar2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE oral. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset May2022, 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: symptoms improved, had negative rapid; (24May2022) Positive, notes: Then on 24May2022 again with symptoms and positive rapid test. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Additional information: Report about covid treatment was yes. If vaccine received reported as yes. Other medications in two weeks reported as yes. Adverse event: rebound covid. took paxlovid 12May2022-17May2022. Symptoms improved, had negative rapid. Then on 24May2022 again with symptoms and positive rapid test. Known allergies reported as no. Other medical history reported as obesity. Anti-viral details: Product :COVID 19 treatment, Brand: Pfizer-Paxlovid, Treatment start date: 12May2022, Treatment stop date: 17May2022, 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 reported information, causal association of event drug ineffective, covid-19 with BNT162b2 cannot be excluded. However, response to vaccine can vary in individuals.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Breast mass, Pain in extremity
Clinical narrative: Took the booster developed a lump underneath armpit near breast. Two inch in diameter arm hurt when arm is raised or make movements.; Took the booster developed a lump underneath armpit near breast. Two inch in diameter arm hurt when arm is raised or make movements. This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 40 years for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: FM8020, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 29Oct2021, when the patient was 40-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: FF2590, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 08Oct2021, when the patient was 40-year-old, for COVID-19 immunization. The following information was reported: BREAST MASS (non-serious) with onset 23May2022 at 02:00, outcome "not recovered", PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "Took the booster developed a lump underneath armpit near breast. Two inch in diameter arm hurt when arm is raised or make movements.". Therapeutic measures were not taken as a result of breast mass. Additional Information: No other medication received in 2weeks. Adverse event Patient Took the booster developed a lump underneath armpit near breast. Two inch in diameter arm hurt when arm is raised or make movements. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 46-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunization; 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 immunization. The patient had no relevant medical history and no known allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid. Clinical course was reported as, On 11May2022 the patient experienced weird taste and mild lightheaded. Therapeutic measures were not taken as result of weird taste and mild lightheaded. The patient was recovered from symptoms.  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.
Age: 41.0
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 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Apr2021 as dose 1, single (Lot number: ER8729), in left arm and on 26Apr2021 as dose 2, single (Lot number: ER8735) at the age of 41 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 31Oct2021 as dose 3 (booster), single (Lot number: 071F21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Migraine with aura" (unspecified if ongoing); "Prosopagnosia" (unspecified if ongoing); "High BMI" (unspecified if ongoing), notes: High BMI; "Dose:2, 1 Pfizer/Dose:3 Moderna" (not ongoing), notes: Dose:2, 1 Pfizer/Dose:3 Moderna. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11May2022) Positive; (19May2022) Negative; (20May2022) Negative; (21May2022) Negative; (22May2022) Negative; (23May2022) Positive; (23May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. The clinical course included anti viral details: Product: COVID 19 Treatment, brand: Paxlovid, treatment start date: 3May2022, treatment stop date: 11May2022 and indication: Treatment of COVID-19. Tested positive on 11May2022, took first (PM) dose of Paxlovid on 12May2022. Symptoms improved greatly. Took final dose of Paxlovid on 18May2022 (AM). Tested negative on 19May2022, 20May2022, 21May2022 and 22May2022. Symptoms returned and tested positive on 23May2022 and 24May2022.  No follow-up attempts are possible, no further information expected.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 25Sep2021 at 06:00 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 had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". 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.; 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: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive  for COVID-19; tested positive  for COVID-19; 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 45-year-old female patient received BNT162b2 (BNT162B2), on 29Jan2021 as dose 1, single (Lot number: EL9264), on 17Feb2021 as dose 2, single (Lot number: EL9266) and on 21Sep2021 as dose 3 (booster), single (Lot number: 301458A) at the age of 44 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (ongoing); "Seasonal allergy" (ongoing); "Allergies" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION; PANTOPRAZOLE [PANTOPRAZOLE SODIUM SESQUIHYDRATE]; XYZAL taken for hypersensitivity; FLONASE ALLERGY RELIEF taken for hypersensitivity; PROVENTIL [SALBUTAMOL] taken for asthma. The following information was reported: VACCINATION FAILURE (medically significant) with onset May2022, outcome "unknown", COVID-19 (medically significant) with onset May2022, outcome "not recovered" and all described as "tested positive  for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14May2022) Positive; (19May2022) Negative; (24May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: increased fatigue; body aches; 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 17Mar2021 as dose 1, single (Lot number: EN6208) at the age of 48 years, in left arm, on 07Apr2021 as dose 2, single (Lot number: EW0151), in left arm and on 06Dec2021 at 10:30 as dose 3 (booster), single (Lot number: 3303080), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "Hashimoto's" (unspecified if ongoing), notes: Hashimoto's; "Migraine" (unspecified if ongoing); "Diabetes type 2" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa; "Known allergies: Antibiotics" (unspecified if ongoing), notes: Known allergies: Antibiotics; "Known allergies: Narcotics/ Opioids" (unspecified if ongoing), notes: Known allergies: Narcotics/ Opioids; "Known allergies: Narcotics" (unspecified if ongoing), notes: Known allergies: Narcotics/ Opioids. Concomitant medication(s) included: SYNTHROID; CELEXA [CELECOXIB]; METFORMIN. The following information was reported: PAIN (non-serious) with onset 17Mar2021, outcome "not recovered", described as "body aches"; FATIGUE (non-serious) with onset 17Mar2021, outcome "not recovered", described as "increased fatigue". The events "increased fatigue" and "body aches" required physician office visit. Therapeutic measures were not taken as a result of fatigue, pain.  Additional information: The patient did not receive any other vaccines within four weeks prior to the prior to the COVID-19 vaccine. The patient experienced increased fatigue and body aches for 3-4 weeks after first dose; for 6-7 weeks after second dose and after third dose, 5-6 months of increased fatigue and body aches, still happening. The patient did not experienced covid-19 prior to the COVID-19 vaccine. The patient was not tested positive post COVID-19 vaccine.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 79-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Jan2021 as dose 1, single (Lot number: El3302), in left arm, on 02Feb2021 as dose 2, single (Lot number: 6200), in left arm and on 09Sep2021 as dose 3 (booster), single (Lot number: 7485) at the age of 78 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing). Concomitant medication(s) included: MOBIC; ACTONEL. 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". Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical information: It was reported that the patient had no known allergies.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Apr2021 at 15:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 03Jun2021 at 12:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 14Dec2021 at 10:00 as dose 3(booster), single (Lot number: 33130BA) at the age of 37 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sulfa drugs allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (07May2022) Negative, notes: Tested negative 8 days after I began my Paxlovid treatment; (09May2022) Positive, notes: 2 days later I tested positive again. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical closure: The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment (Ibuprofen from 28Apr2022 to 02may2022 and Prednisone from 29-Apr2022 to 05May2022). The patient previously received a COVID-19 Vaccine. Tested negative 8 days after she began her Paxlovid treatment. From 29Apr2022 to 03May2022 2 days later she tested positive again and had completely different symptoms and felt worse than she did the first time around.  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 vaccination failure, covid-19 with BNT162b2 cannot be excluded. However, response to vaccine can vary in individuals.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Jan2021 as dose 1, single (Lot number: EL3246), in left arm, on 02Feb2021 as dose 2, single (Lot number: EL9269), in left arm and on 05Nov2021 at 18:00 as dose 3 (booster), single (Lot number: 32030BD) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Other medical history: Asthma. Concomitant medication(s) included: BREZTRI AEROSPHERE; MONTELUKAST; VITAMIN C [ASCORBIC ACID]; VITAMIN D [ERGOCALCIFEROL]; CALCIUM. The following information was reported: VACCINATION FAILURE (medically significant) with onset 2022, outcome "unknown", COVID-19 (medically significant) with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19.; Sender's Comments: Based on reported information, causal association of event vaccination failure, covid-19 with BNT162b2 cannot be excluded. However, response to vaccine can vary in individuals.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid; Tested positive for Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm, as dose 2, single (Lot number: 016522), in left arm, on 26Mar2022 at 17:30 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 20Apr2022 at 16:45 as dose 4 (booster), single (Lot number: 016522) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "vonWillibrands" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa; "Known allergies: Anchovies" (unspecified if ongoing), notes: Known allergies: Anchovies; "Known allergies: Environmental" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE, start date: 01Jan2020; ESCITALOPRAM, start date: 01Jan2022; PIOGLITAZONE, start date: 01Jan2022; METFORMIN, start date: 01Jan2022; JARDIANCE, start date: 01Jan2022; GLYBURIDE, start date: 01Jan2022; ATORVASTATIN, start date: 01Jan2022; MONTELUKAST, start date: 01Jan2022; ENALAPRIL, start date: 01Jan2022. Past drug history included: Compozine, reaction(s): "Known allergies:compozine", notes: compozine. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 07May2022, outcome "not recovered" and all described as "Tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07May2022) Positive; (May2022) Negative; (23May2022) Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective included Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Lot number: ER2613), in left arm, on 16Apr2021 as dose 2, single (Lot number: ER8729), in left arm and on 26Oct2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 47 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic rhinitis" (unspecified if ongoing) ; "fibromyalgia" (unspecified if ongoing); "lyme" (unspecified if ongoing); "Sulfas" (unspecified if ongoing). Concomitant medication(s) included: DULOXETINE, start date: 15Jul2021; METHENAMINE, start date: 01Apr2021. Past drug history included: Metronidazole, reaction(s): "known allergies: metronidazole". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 16May2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16May2022) Positive, notes: I have yet to test negative since my diagnosis on 16May2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
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 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Mar2021 at 10:00 as dose 1, single (Lot number: PAA165969), in left arm, on 06Apr2021 at 11:00 as dose 2, single (Lot number: ERE734), in left arm and on 24Dec2021 at 16:00 as dose 3 (booster), single (Lot number: FJ8757) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Some gastric reflux which is likely why it is worse at night." (unspecified if ongoing), notes: Some gastric reflux which is likely why it is worse at night.; "Known allergies: Yes, antibiotics" (unspecified if ongoing), notes: Known allergies: Yes, antibiotics. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Additional information: Paxlovid caused a foul taste in my mouth starting with the first dose. It is worse at night. The Nirmatrelvir pills seem to be the cause. Brother and Father also had same issue with this antiviral. Some muscle aches also experienced but were resolved with Ibuprofen. No other medication in 2 weeks.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 77-year-old male patient received BNT162b2 (BNT162B2), on 18Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunization; 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 immunization. The patient had no relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. It was also reported that the patient also received Paxlovid from 14May2022 to 19May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Mar2021 at 08:15 as dose 1, single (Lot number: EN6204), in left arm, on 30Mar2021 at 08:15 as dose 2, single (Lot number: EP7533), in right arm and on 16Oct2021 at 14:15 as dose 3 (booster), single (Lot number: FF2590) at the age of 73 years, in right arm for Covid-19 immunisation. The patient's relevant medical history included: "Known Allergies: Sulfa" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, Covid-19. Clinical Course: Other medical history was reported as None. The patient received COVID-19 Treatment as Paxlovid (Lot. Number: GA1513, SN891636340047) from 13May2022 to 17May2022 (Indication treatment of COVID-19).
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old male patient received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 23Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 04Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant) with onset 15May2022, outcome "unknown", COVID-19 (medically significant) with onset 15May2022, outcome "recovered" (19May2022) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results; (10May2022) Negative, notes: Tested negative by day 6; (11May2022) Negative, notes: Continued testing daily, negative until day 10; (12May2022) Negative, notes: Continued testing daily, negative until day 10; (13May2022) Negative, notes: Continued testing daily, negative until day 10; (14May2022) Negative, notes: Continued testing daily, negative until day 10; (15May2022) Positive, notes: but tested positive daily until day 14; (16May2022) Positive, notes: but tested positive daily until day 14; (17May2022) Positive, notes: but tested positive daily until day 14; (18May2022) Positive, notes: but tested positive daily until day 14; (19May2022) Negative, notes: Tested negative again on day 15; (unspecified date) Positive, notes: upon first positive home test. Therapeutic measures were taken as a result of covid-19. Clinical course : Other medication in 2weeks was reported as No, Other medical history was reported as None. Known allergies was reported as no.Anti viral details: product COVID 19 Treatment, Brand Paxlovid, Treatment start date 05May2022, treatment stop date 09May2022, Indication Treatment of COVID-19. Adverse event: Mild symptoms in original cycle slight wet cough, no fever, fatigue. Started Paxlovid on day 2 of symptoms, upon first positive home test. Isolated throughout. Felt symptom-free by day 5, last day of Paxlovid. Tested negative by day 6. Continued testing daily, negative until day 10. Tested positive again on day 11. No symptoms but tested positive daily until day 14. Tested negative again on day 15. No symptoms or testing since. Adverse event start date: 15May2022 Adverse event stop date: 19May2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
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 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Dec2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation; coviD-19 vaccine (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); "hypertension" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Known allergies: Yes" (unspecified if ongoing), notes: Known allergies: Yes. Concomitant medication(s) included: MULTIPLE VITAMINS; BISOPROLOL; BUPROPION. 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; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: other medication in 2weeks product were Multiple vitamins daily, Bisoprolol, Buproprion. Reoccurence of covid symptoms 5 days after paxlovid along with positive covid test.  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.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Nasal disorder, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Positive rapid test on 23May2022; Positive rapid test on 23May2022; slight nasal drip; 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 51-year-old male patient received BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Lot number: EN6205), in left arm, on 27Mar2021 as dose 2, single (Lot number: ER8727), in left arm and on 22Oct2021 as dose 3 (booster), single (Lot number: ff2590) at the age of 51 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 23May2022 at 14:00, outcome "recovering" and all described as "Positive rapid test on 23May2022"; NASAL DISORDER (non-serious) with onset 23May2022 at 14:00, outcome "recovering", described as "slight nasal drip". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23May2022) Posative, notes: Positive rapid test on 23May22. Therapeutic measures were taken as a result of vaccination failure, covid-19. Therapeutic measures were not taken as a result of nasal disorder. clinical course: Positive rapid test on 23May22, 5 days after finishing Paxlovid. At that time, similar mild symptoms returned, specifically slight nasal drip. Other medication in 2weeks: No Conclusion of Previously Completed Investigation: The complaint for lack of effect of the Pfizer biontech covid-19 vaccine lot EN6205, ER8727, FF2590  was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot and product type. The final scope included the reported finished goods lot EN6205, fill lot EN5337, and the formulated drug product lot EN5326.The final scope included the reported finished goods lot ER8727, fill lot EP8679, and the formulated drug product lot EP8566. The final scope was determined to be the reported finished goods lot FF2590, fill lot FF2559, and the bulk formulated drug product lot FE5320. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.   No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Sneezing, Throat irritation
Clinical narrative: scratchy throat; allergy sx serial sneezing; allergy sx serial sneezing; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 27-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 27 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Prev dose product: COVID 19, Prev dose brand: Pfizer , Prev dose brand unknown: False, Prev dose lot number: FF2589, Prev dose lot unknown: False, Prev dose administration date: 23Nov2021, Prev dose dose number: 1), administration date: 23Nov2021, when the patient was 27-year-old, for COVID-19 immunization; Covid-19 vaccine (Prev dose product: COVID 19, Prev dose brand unknown: True, Prev dose brand name unknown: COVID19 Vaccine,, Prev dose lot unknown: True, Prev dose lot unknown reason: Not available/provided to reporter at the time of report completion, Prev dose dose number: 2), for Covid-19 immunization. The following information was reported: HYPERSENSITIVITY (non-serious), SNEEZING (non-serious) all with onset 22May2022, outcome "unknown" and all described as "allergy sx serial sneezing"; THROAT IRRITATION (non-serious) with onset 22May2022, outcome "unknown", described as "scratchy throat". It was unknown if therapeutic measures were taken as a result of throat irritation, hypersensitivity, sneezing.  Additional information: Other vaccine in four weeks were Unknown. Treatment reported as unknown. Patient covid prior vaccination was unknown but tested covid post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pain in extremity
Clinical narrative: very very sore arm.; Headache; chills; body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19May2022 at 10:00 as dose 1, single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Psoriatic arthritis" (unspecified if ongoing), notes: other medical history: Psoriatic arthritis. Concomitant medication(s) included: LOSARTAN; ATORVASTATIN; VITAMIN D3; COQ10 [ASCORBIC ACID;BETACAROTENE;CUPRIC OXIDE;MANGANESE SULFATE;SELENIUM;TOCOPHERYL ACETATE;UBIDECARENONE;ZINC OXIDE]. The following information was reported: HEADACHE (non-serious) with onset 19May2022 at 17:00, outcome "recovered" (May2022); PAIN (non-serious) with onset 19May2022 at 17:00, outcome "recovered" (May2022), described as "body aches"; CHILLS (non-serious) with onset 19May2022 at 17:00, outcome "recovered" (May2022); PAIN IN EXTREMITY (non-serious) with onset 19May2022 at 17:00, outcome "recovered" (May2022), described as "very very sore arm.". Therapeutic measures were not taken as a result of pain in extremity, headache, chills, pain.  Additional information:  No covid was reported prior to vaccination. Not tested to covid post vaccination. No Known allergies were reported. No other vaccine in four weeks. Age group: Adult (18-64 Years). Sore arm and headaches lasted a bit longer.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: covid test result:Positive; covid test result:Positive; This is a spontaneous report received from a non-contactable reporter(s) (Nurse) from product quality.  A 27-year-old male patient received BNT162b2 (BNT162B2), on 23Nov2021 as dose 1, single (Lot number: FF2589), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 23May2022, outcome "unknown" and all described as "covid test result:Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23May2022) Positive, notes: Nasal Swab.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Biopsy, Pericardial effusion
Clinical narrative: patient developed a pericardial effusion post vaccination; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  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: PERICARDIAL EFFUSION (medically significant), outcome "unknown", described as "patient developed a pericardial effusion post vaccination". The patient underwent the following laboratory tests and procedures: Biopsy: patient developed a pericardial effusion, notes: Physician reports that his patient developed a pericardial effusion post vaccination. They have done a biopsy and he is getting paperwork for some possible compensation.    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 available and temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: covid 19; covid 19; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Jan2022 as dose 3 (booster), single (Lot number: 330336BD) at the age of 28 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 had no relevant medical history. Concomitant medication(s) in 2 weeks included: MICRONOR; BUPROPION HCL. There was no known allergy reported.  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 antibody test: (unspecified date) Negative, notes: Tested negative for covid 19 with at home antigen testing 2 days after completion of paxlovid course; (unspecified date) Negative, notes: Again negative 6 days after completion of paxlovid; (unspecified date) positive, notes: Tested positive again on at home antigen test 8 days following completion of paxlovid; (unspecified date) positive, notes: Day 16 since first positive test Antigen test positive; (unspecified date) Unknown results, notes: COVID 19 Treatment; (24May2022) positive, notes: Remain positive today. Therapeutic measures were taken as a result of drug ineffective, covid-19. Anti-Viral details: Product: Covid 19 treatment, Brand: Paxlovid, Treatment Start date: 10May2022, Treatment Stop Date: 14May2022, Indication: Treatment of Covid-19.  No follow-up attempts are possible. 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.
Age: 36.0
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) (Physician).  A 36-year-old male patient received BNT162b2 (BNT162B2), on 26Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 36 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: "Obesity" (unspecified if ongoing); "asthma" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin". 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: (May2022) Positive, notes: On Day 7. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on reported information, causal association of event drug ineffective, covid-19 with BNT162b2 cannot be excluded. However, response to vaccine can vary in individuals.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 39 years, in right arm for COVID-19 immunization; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 12Nov2021 as dose number unknown, single (Batch/Lot number: unknown), in right arm for COVID-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown). The patient's relevant medical history included: "Chronic fatigue" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "Ptsd" (unspecified if ongoing); "Pcos" (unspecified if ongoing); "Acid reflux" (unspecified if ongoing); "Ibs (combat veteran)" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing); "Known allergies: Lemon" (unspecified if ongoing); "Known allergies: Lime" (unspecified if ongoing); "Known allergies: Ginger" (unspecified if ongoing); "Known allergies: Thyme" (unspecified if ongoing); "Known allergies: Oregano" (unspecified if ongoing); "Known allergies: Basil" (unspecified if ongoing); "Known allergies: Some tree nuts" (unspecified if ongoing); "Known allergy:Sulfa" (unspecified if ongoing). Concomitant medication(s) included: PEPCID AC; DESLORATADINE, start date: 01Mar2022. Past drug history included: Known allergies: pseudoephedrine, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of suspected covid-19, covid-19. Patients Anti-viral details: Treatment start date-13May2022 treatment stop date-18May2022.  The information on the batch/lot number for (BNT162B2), has been requested and will be submitted if and when received.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-1 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient received BNT162b2 (BNT162B2), on 22Oct2021 as dose 2, single (Lot number: Ff2593), in left arm and on 04Apr2022 as dose 3 (booster), single (Lot number: Fk9895) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine janssen (COVID-19 VACCINE JANSSEN), on 09Mar2021 as dose 1, single (Lot number: 1805031), in left arm for covid-19 immunisation. The patient's relevant medical history included: "No" (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 "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-1 test: Positive, notes: Covid rebound. Therapeutic measures were not taken as a result of drug ineffective. Therapeutic measures were taken as a result of covid-19.  No follow-up attempts are possible. No further information is expected.