chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. An 84-year-old patient received BNT162b2 (BNT162B2), on 22Feb2021 as dose 2, single (Lot number: EN6210) for covid-19 immunisation. The patient's relevant medical history included: "canker sores in mouth and on tongue" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, lot# EL1283), administration date: 01Feb2021, for COVID-19 Immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "only had 3 Canker sores/a potential solution to the treatment of canker sores". Additional information: it was reported that in all the patient's life had canker sores in mouth and  tongue on a constant basis. This began as young as 4 years old. Through in childhood was examined and treated by several dentist. There were times the dentist had told the patient and the parents that the patient had as many as 21 canker sores with some of them as large as a dime. They could never eliminate them. Through adult life this continued and caused extreme discomfort. Patient always had at least 4 to 5 canker sores in the mouth. On 28Oct2021, patient received a 3rd booster lot# 320308D. Since the vaccinations patient only had 3 Canker sores and all 3 occurred where the patient bit the cheek or tongue while eating. Patient thought that this might be interesting  potential solution to the treatment of canker sores.  Follow-up attempts are completed. No further information is expected. Sender's Comments: Linked Report(s) : FIZER INC-202201049932 same patient/product/event, different dose; PFIZER INC-PV202200038491 same patient/product/event, different dose;
Sex: U
Vaccine: COVID19
Symptoms: Investigation, Therapeutic response unexpected
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. An 84-year-old patient received BNT162b2 (BNT162B2), on 28Oct2021 as dose 3 (booster), single (Lot number: 320308D) for covid-19 immunisation. The patient's relevant medical history included: "canker sores in my mouth and on my tongue " (unspecified if ongoing), notes: I have had canker sores in my mouth and on my tongue on a constant basis. This began as young as 4 years old. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 1, Lot: EL1283), administration date: 01Feb2021, for COVID-19 immunization, reaction(s): "a potential solution to the treatment of Canker Sores"; BNT162b2 (Dose: 2, Lot: EN6210), administration date: 22Feb2021, for COVID-19 immunization, reaction(s): "a potential solution to the treatment of Canker Sores". The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "a potential solution to the treatment of Canker Sores". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Almost all my life I have had Canker Sores in my mouth and on my tongue on a constant basis. This began as young as 4 years old. Through my childhood I was examined and treated by several Dentist. There were times the Dentist told me and my Parents that I had as many as 21 Canker Sores with some of them as large as a Dime. They could never eliminate them. Through my adult life this continued and caused me extreme discomfort. I always have had at least 4 to 5 Canker Sores in my mouth. I was born and raised in (withheld) and over the years have lived in (addresses withheld). Since the Vaccinations I have only had 3 Canker Sores and all 3 occurred where I bit my cheek or tongue while eating. I thought you might be interested in this as a potential solution to the treatment of Canker Sores. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: 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 24Nov2021 at 17:30 as dose 3 (booster), single (Lot number: FH8027), in left arm and on 09May2022 at 10:30 as dose 4 (booster), single (Lot number: FK9894), in left arm for covid-19 immunisation; coviD-19 vaccine mRNA (mRNA 1273) (MODERNA COVID-19 VACCINE), on 30Dec2020 as dose 1, single (Lot number: 025J20-2A), in left arm and on 04Feb2021 as dose 2, single (Lot number: 042L20A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Type 2 DM" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Known allergies: Sulfa drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Sex: F
Vaccine: COVID19
Symptoms: Sinus disorder
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. A 75-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization; Bnt162b2 (Dose 3 (booster)), for COVID-19 immunization. The following information was reported: SINUS DISORDER (non-serious), outcome "unknown", described as "has sinus problems". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: experienced symptoms and potential positive self-home test several days ago and he called his doctor who prescribed Paxlovid; experienced symptoms and potential positive self-home test several days ago and he called his doctor who prescribed Paxlovid; This is a spontaneous report received from contactable Consumer. The reporter is the patient. An 82-year-old male patient received BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Lot number: EL1283, Expiration Date: Apr2021), in left arm, on 10Feb2021 as dose 2, single (Lot number: EM9810, Expiration Date: Jun2021) and on 23Sep2021 as dose 3 (booster), single (Lot number: FE3592, Expiration Date: Nov2021) at the age of 81 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 04Jun2022 as dose 4(booster), single (Lot number: 037422B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "latent asthma" (ongoing), the only comorbidity he has other than age is latent asthma condition for which he has Albuterol inhaler and he only uses it 2-3 times a year and it is not a big deal and was diagnosed with asthma about 10 years ago. Concomitant medications included: ALBUTEROL [SALBUTAMOL]; ELIQUIS, start date: 2020, he only has the Eliquis lot 1882638 and SN number and NDC of 0003-0894-21 and expiry date Aug2024; ATORVASTATIN [ATORVASTATIN CALCIUM]. Patient has not had as much as a runny nose or sore throat since he was first given the covid vaccines until this occurred and was not sick with anything the entire course of when he started with the covid vaccines in 2021 and they worked like a charm and thought he was impervious and then was shocked with these symptoms and he had not had a runny nose or had that in all this time.  Had no side effects and had zero side effects from all the covid vaccines. The patient did not have additional Vaccines Administered on Same Date of the Pfizer Suspect. The patient did not have any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. 2nd booster covid vaccine of Moderna on 04Jun2022 and looked like it was handwritten on his patient card for the lot 037422B and the 4 in the lot number might actually be the letter A and it was more like an A. Patient went in for the 1st PCR test to see if he was ok as he had been at a picnic with a group of people that had covid the week before so he thought he was exposed to them and better get tested and it was a negative PCR test on 21Jul2022 at 11:30am. He experienced symptoms and potential positive self-home test several days ago and he called his doctor who prescribed Paxlovid for him and picked it up on 24Jul2022 and started taking it that evening with the first dose. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) potential positive, notes: potential positive self home test; (21Jul2022) negative, notes: at 11:30am. Therapeutic measures were taken as a result of drug ineffective, covid-19. Outcome of the events was unknown.
Age: 65.0
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 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Dec2020 as dose 1, single (Lot number: EL0140), in left arm, on 20Jan2021 as dose 2, single (Lot number: EL3302), in left arm, on 04Oct2021 as dose 3 (booster), single (Lot number: 30145BA), in left arm and on 09Jun2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 65 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient received Paxlovid from 14Jul2022 to 19Jul2022 as treatment of COVID-19.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Fall
Clinical narrative: Confusion; Falling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient received BNT162b2 (BNT162B2), on 05Mar2021 as dose 2, single (Lot number: EN6199) at the age of 76 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Pituitary gland removal" (unspecified if ongoing), notes: Pituitary gland removal Caller states that she had this procedure done 25 years ago. Concomitant medication(s) included: HYDROCORTISONE taken for hypothalamo-pituitary disorder. Vaccination history included: BNT162b2 (Dose number: 1, Lot Number: EM9810), administration date: 11Feb2021, when the patient was 76-year-old, for COVID-19 Immunization. The following information was reported: CONFUSIONAL STATE (hospitalization) with onset Mar2021, outcome "unknown", described as "Confusion"; FALL (hospitalization) with onset Mar2021, outcome "unknown", described as "Falling". The patient was hospitalized for confusional state, fall (start date: 06Mar2021, discharge date: 09Mar2021, hospitalization duration: 3 day(s)).  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201050007 same patient/drug/event, different dose;US-PFIZER INC-202201050008 same patient/drug/event, different dose;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a non-contactable reporter (Consumer or other non-HCP). The reporter is the patient. A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "allergy induced asthma" (unspecified if ongoing); "known allergies: eggs" (unspecified if ongoing); "known allergies: gluten" (unspecified if ongoing); "known allergies: soy" (unspecified if ongoing); "known allergies: coconut" (unspecified if ongoing); "known allergies: environmental allergens" (unspecified if ongoing). Concomitant medication(s) included: SINGULAIR, start date: Mar2016. Past drug history included: Tetanus, reaction(s): "known allergies: tetanus"; Morphine, reaction(s): "known allergies: morphine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Jul2022, outcome "not recovered" and all described as "tested positive for Covid 28Jul2022 with symptoms starting 27Jul2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Jul2022) Positive; (06Aug2022) Negative; (08Aug2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included PF-07321332, ritonavir (PAXLOVID) with treatment start date: 29Jul2022, treatment stop date: 03Aug2022. No  follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 32 years 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: "MS" (unspecified if ongoing); "Ankylosing Spondylitis" (unspecified if ongoing); "Crohn's disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "known allergies: Amoxicillin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Anti-viral treatment included nirmatrelvir/ritonavir (PAXLOVID) from 04Aug2022 to 09Aug2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Fall
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 76-year-old female patient received BNT162b2 (BNT162B2), on 20Oct2021 as dose 3 (booster), single (Lot number: 3203080) at the age of 76 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Pituitary gland removal" (unspecified if ongoing), notes: Pituitary gland removal , Caller states that she had this procedure done 25 years ago; "Has no pituitary gland" (unspecified if ongoing). Concomitant medication(s) included: HYDROCORTISONE taken for hypopituitarism. Vaccination history included: BNT162b2 (Dose: 1, she had no issues with the first dose of the vaccine., Lot Number: EM9810, Anatomical Location: right arm), administration date: 11Feb2021, when the patient was 76-year-old, for COVID-19 Immunization; BNT162b2 (Dose: 2, Lot Number: EN6199, Anatomical Location: right arm), administration date: 05Mar2021, when the patient was 76-year-old, for COVID-19 Immunization, reaction(s): "Confusion", "falling". The following information was reported: CONFUSIONAL STATE (non-serious) with onset Oct2021, outcome "unknown", described as "Confusion"; FALL (non-serious) with onset Oct2021, outcome "unknown", described as "Falling". The events "confusion" and "falling" required emergency room visit. Additional information: The patient spent the day in the emergency room in Oct2021. She stated that she was instructed to, and did, increase her dose of Hydrocortisone each time she received a dose of the vaccine. For other medicines Hydrocortisone, she stated that she had been taking this medication for 25 years since her pituitary gland was removed. Stated that she had no issues with the first dose of the vaccine. She had problems after the second dose and both booster doses. She stated that after the second dose of the vaccine and the two boosters; the following day after all three them she experienced confusion and falling. Stated she was hospitalized twice and spent a day in the Emergency Room after her first booster. She stated that after her first booster dose on 20Oct2021, she spent the day in the emergency room, she was not admitted to the hospital.Sender's Comments: Linked Report(s) : US-PFIZER INC-202201049977 same patient/drug/event, different dose;
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Fall
Clinical narrative: Confusion; Falling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient received BNT162b2 (BNT162B2), on 19Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 77 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Pituitary gland removal" (unspecified if ongoing), notes: Caller states that she had this procedure done 25 years ago. Concomitant medication(s) included: HYDROCORTISONE. Vaccination history included: BNT162b2 (Dose: 1, she had no issues with the first dose of the vaccine., Lot Number: EM9810, Anatomical Location: right arm), administration date: 11Feb2021, when the patient was 76-year-old, for COVID-19 Immunization; BNT162b2 (Dose: 2, Lot Number: EN6199, Anatomical Location: right arm), administration date: 05Mar2021, when the patient was 76-year-old, for COVID-19 Immunization, reaction(s): "confusion", "falling"; BNT162b2 (Dose: 3/First booster , hospitalized twice and spent a day in the Emergency Room, Lot Number: 3203080, Anatomical Location: right arm), administration date: 20Oct2021, when the patient was 76-year-old, for COVID-19 Immunization, reaction(s): "confusion", "falling". The following information was reported: CONFUSIONAL STATE (hospitalization) with onset Jul2022, outcome "unknown", described as "Confusion"; FALL (hospitalization) with onset Jul2022, outcome "unknown", described as "Falling". The patient was hospitalized for confusional state, fall (start date: Jul2022, hospitalization duration: 4 day(s)). The event "confusion" required emergency room visit. Clinical course: Caller states that she was instructed to, and did, increase her dose of Hydrocortisone each time she received a dose of the vaccine. Caller states that she is calling about the Pfizer Product: Pfizer COVID Vaccine. States that she had no issues with the first dose of the vaccine. She had problems after the second dose and both booster doses. Caller states that after the second dose of the vaccine and the two boosters; the following day after all three them she experienced confusion and falling. After her second booster dose on 19Jul2022, the caller states that she was hospitalized for 4 days. Caller states that she takes Hydrocortisone because she has no pituitary gland. States that her pituitary gland was removed 25 years ago, and she has been taking Hydrocortisone ever since then. Caller states that she was instructed to, and did, increase her dose of Hydrocortisone each time she received a dose of the vaccine. Investigations: Caller denies any labs, testing, or treatments relevant to these events. None Vaccines Administered on Same Date of the Pfizer Suspect.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201049977 same patient/drug/event, different dose;
Sex: F
Vaccine: COVID19
Symptoms: Breast cancer metastatic, Diabetes mellitus, Dialysis, Overweight
Clinical narrative: metastatic stage 4 breast cancer; diabetic; kidney dialysis; overweight; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBRANCE. Vaccination history included: Bnt162b2 (Dose 3 (booster)), for Covid-19 Immunization; Bnt162b2 (Dose 2), for Covid-19 Immunization; Bnt162b2 (Dose 1), for Covid-19 Immunization. The following information was reported: BREAST CANCER METASTATIC (medically significant), outcome "unknown", described as "metastatic stage 4 breast cancer"; DIABETES MELLITUS (medically significant), outcome "unknown", described as "diabetic"; RENAL DISORDER (medically significant), outcome "unknown", described as "kidney dialysis"; OVERWEIGHT (non-serious), outcome "unknown". Therapeutic measures were taken as a result of renal disorder. Clinical course: Caller says she has had a total of four shots, with the first two of primary and two doses for boosters and said that she is already 70 years old and has metastatic stage 4 breast cancer, is diabetic, is overweight, and has kidney dialysis. Agent reports caller said someone told her she was qualified to get a fifth shot, and she got her last shot in April, so she wants to know if she is able to get a fifth shot this coming August and be eligible to get one in September or October for new vaccines for new variant for COVID. Caller says she loves Pfizer and gets her monthly Ibrance from Pfizer. She says that they are encouraging her at dialysis to get a fifth dose and she is reluctant to get the fifth dose since there is a newer one coming out in September or October that might be more important since Pfizer is coming out with one for the new variant. She says she is afraid to get one now since she would like to be able to get that one when it comes out.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient. An elderly 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 included: "Diabetes" (unspecified if ongoing); "Known allergies: Sulfa drugs" (unspecified if ongoing), notes: Known allergies: Sulfa drugs. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19"; DISEASE RECURRENCE (medically significant) with onset 05Aug2022 at 16:00, outcome "recovering", described as "Return of symptoms, fever, positive COVID test after being symptom and fever free except for fatigue with negative test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive; (2022) Negative. Therapeutic measures were taken as a result of covid-19. Therapeutic measures were not taken as a result of disease recurrence. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on the available information in the case, the causal association between the events drug ineffective, COVID-19, disease recurrence and the suspect drug cannot be excluded.
Age: 66.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Mar2021 at 12:00 as dose number unknown, single (Batch/Lot number: unknown), in left arm, on 11Sep2021 at 12:00 as dose number unknown, single (Batch/Lot number: unknown), in left arm and on 14Feb2022 at 12:00 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on an unknown date (12:00 PM) as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Lung cancer" (unspecified if ongoing); "Heart palpitations" (unspecified if ongoing); "Severe peripheral nueropathy" (unspecified if ongoing); "Nasal allergies" (unspecified if ongoing); "Mold allergy" (unspecified if ongoing); "House dust allergy" (unspecified if ongoing). Concomitant medication(s) included: DIAZEPAM (brand= Teva), start date: 17Jan2019; METOPROLOL TARTRATE (brand=Mylan), start date: 01Sep2020; LIPITOR (brand= Lupin), start date: 01Oct2020. Past drug history included: Cipro, reaction(s): "known allergies cipro"; Erythromyacin, reaction(s): "known allergies erythromyacin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, which included Paxlovid (Lot number= 0069108506) from 08Aug2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 46.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old male patient received BNT162b2 (BNT162B2), on 29Nov2021 as dose 3 (booster), single (Lot number: FJ1620) at the age of 46 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); "Hypertension" (unspecified if ongoing). The patient had no known allergy. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Aug2022) positive. Clinical course: The patient had rebound of COVID with symptoms and positive antigen test approximately 6 days after finishing 5 day paxlovid (08Aug2022). Paxlovid was given from 28Jul2022 to 02Aug2022 as COVID 19 treatment.  No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
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 male patient received BNT162b2 (BNT162B2), on 14Jan2021 as dose 1, single (Lot number: EL3246), in left arm, on 04Feb2021 as dose 2, single (Lot number: EL9269), in left arm, on 13Oct2021 as dose 3 (booster), single (Lot number: FF2590), in left arm and on 08Apr2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 78 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SIMVASTATIN, start date: Jan2012, stop date: 28Jul2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09Aug2022, outcome "not recovered" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Aug2022) Negative; (unspecified date) Positive; (09Aug2022) Positive, notes: Tested again 09Aug, strongly Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.
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. An 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Nov2021 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. 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 received Paxlovid for covid-19 from 18Jul2022 to 20Jul2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: who had the first phase of the Pfizer COVID-19 had just recently got an active case of Covid; who had the first phase of the Pfizer COVID-19 had just recently got an active case of Covid; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "who had the first phase of the Pfizer COVID-19 had just recently got an active case of Covid". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4495359-00.  A 33-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 01Aug2021 as dose 1, single (Batch/Lot number: unknown) and on 18Aug2021 as dose 2, single (Batch/Lot number: unknown) at the age of 33 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen from 07Oct2021 (Batch/Lot number: unknown) to 13Jul2022 at 40 mg (40 mg, 1 in 14), subcutaneous and second regimen since 24Jul2022 (ongoing) (Batch/Lot number: unknown) for ankylosing spondylitis. 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 Jan2022, outcome "unknown" and all described as "COVID, positive for corona virus". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Jul2022) Positive. The action taken for adalimumab was dosage not changed. Clinical course: In Jan2022, the patient experienced COVID. On 13Jul2022, the patient experienced positive for corona virus. on 24Jul2022, the positive for corona virus resolved. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter did not provide the causality for Pfizer BioNTech Covid-19 Vaccine. Causality for Humira (Adalimumab): The reporter's causality for the event(s) of positive for corona virus and covid with humira 40mg/0.4ml (adalimumab) was no reasonable possibility.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200040486 same patient, different drug/event;
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable Consumer. The reporter is the patient. A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Apr2022 at 13:15 as dose 4 (booster), single (Lot number: FJ5683) at the age of 64 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 18Mar2021 as dose 1, single (Lot number: 001B21A), on 04Apr2021 as dose 2, single (Lot number: 001C21A) and on 30Nov2021 as dose 3 (booster), single (Lot number: 066F21A) for covid-19 immunisation. The patient's relevant medical history included: "Migraines" (unspecified if ongoing); "depression" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). Concomitant medications included: GABAPENTIN; AMLODIPINE; ATORVASTATIN; BOTOX; CALCIUM; ESCITALOPRAM; FREMANEZUMAB; HYDROCHLOROTHIAZIDE; MAGNESIUM; NARATRIPTAN; SUMATRIPTAN; TYLENOL; VITAMIN D3. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Still testing positive 9 days after going off Paxlovid. Patient received Paxlovid from 27Jul2022 to 31Jul2022.
Sex: F
Vaccine: COVID19
Symptoms: Ovarian cancer
Clinical narrative: Ovarian Cancer; This is a spontaneous report received from a non-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 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing). No known allergies. Concomitant medication(s) included: LEVOTHYROXINE. Vaccination history included: Bnt162b2 (Dose Number: 1; Location of injection: Arm Left), for COVID-19 immunization.  The following information was reported: OVARIAN CANCER (hospitalization, life threatening) with onset 01Dec2021, outcome "unknown". The patient was hospitalized for ovarian cancer (hospitalization duration: 2 day(s)). Therapeutic measures were taken as a result of ovarian cancer included surgery. Clinical course: Facility type vaccine was pharmacy or drug store. No other vaccine in four weeks. Other medications in two weeks: levothyroxine. No Covid prior vaccination. No Covid tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Immunosuppression
Clinical narrative: immunity went down; always get sick/ got sick like many times like 8-9 times; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (BNT162B2), on 16Oct2021 as dose 2, single (Lot number: FH8020) at the age of 37 years for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ADVIL [IBUPROFEN]. Vaccination history included: BNT162b2 (Dose 1), administration date: 18Sep2021, when the patient was 37-year-old, for COVID-19 immunization. The following information was reported: ILLNESS (medically significant) with onset Oct2021, outcome "not recovered", described as "always get sick/ got sick like many times like 8-9 times"; IMMUNOSUPPRESSION (medically significant) with onset Oct2021, outcome "not recovered", described as "immunity went down". The events "immunity went down" and "always get sick/ got sick like many times like 8-9 times" required physician office visit (hospital, urgent care). Therapeutic measures were taken as a result of illness and included antibiotics. Clinical course: The patient already had his first and second dose (COVID-19 vaccine) and after getting vaccinated he experienced side effects of the vaccine. He mentioned that his immunity went down and he always get sick. He stated, "My immunity just went down and it's been long time, it's been more than 6 months, I think October last year (Oct2021). I got sick like many times like 8-9 times. I just need to know what I need to do and no one helps me. I need to know the way out. I think I will have to report and you know every time I go to the hospital the urgent care, whatever I am spending lot of money. This is not what I expected, I was expecting the prevention." Regarding treatment, the patient stated, "I have been sick like many times as I explained. I had some sickness but it was like a months ago. I can't remember the medication, some kind of antibiotics(Further not clarified)."
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient. An 80-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "classic Kaposi sarcoma" (ongoing). The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "Covid-19 vaccine treat his cancer; reporting therapeutic effect with regards with the Covid-19 vaccine/ he has positive result with the cancer". Additional information: He mentioned that he received the Covid-19 vaccine and luckily the Covid-19 vaccine treat his cancer. So, the caller is reporting therapeutic effect with regards with the Covid-19 vaccine and he also mentioned that he has positive result with the cancer. Consumer stated, " I am great (voice not clear) certain years ago and I have cancer now. It's called classic Kaposi sarcoma. It is a very rare cancer and they treat this with your vaccine (not clarified).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Neuralgic amyotrophy
Clinical narrative: Parsonage-Turner syndrome; This is a literature report for the following literature source(s): Case Connect, 2021; Vol:11(4), pgs:e2100577.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, 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: NEURALGIC AMYOTROPHY (medically significant), 5 days after the suspect product(s) administration, outcome "recovering", described as "Parsonage-Turner syndrome". Therapeutic measures were taken as a result of neuralgic amyotrophy.; Sender's Comments: Based on temporal association, the causal association between the administration of BNT162B2 vaccine and the event Parsonage-turner syndrome cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Scar
Clinical narrative: She states she received all 4 COVID-19 Vaccines in her left arm and has 4 tiny scar spots. This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID:  An 88-year-old female patient received BNT162b2 (BNT162B2), on 25Jan2021 as dose 1, single (Lot number: EL9262) at the age of 86 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hypothyroid" (unspecified if ongoing), notes: taking Synthroid for years and thinks 10, years. Concomitant medication(s) included: SYNTHROID taken for hypothyroidism. The following information was reported: SCAR (non-serious), outcome "unknown", described as "She states she received all 4 COVID-19 Vaccines in her left arm and has 4 tiny scar spots.". Sender's Comments: Linked Report(s) : US-PFIZER INC-202200789445 same reporter, patient, drug and different event;
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Scar, Weight
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient. An 87-year-old female patient received BNT162b2 (BNT162B2), on 28Sep2021 as dose 3 (booster), single (Lot number: FF3592) at the age of 87 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hypothyroid" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID taken for hypothyroidism. Vaccination history included: BNT162b2 (Vaccine Name: 1st dose Pfizer COVID-19 Vaccine, Lot Number / Expiry Date: EL9262 or GL9265/ unknown, Route, Anatomical Location: left arm), administration date: 25Jan2021, when the patient was 86-year-old, for COVID-19 Immunization, reaction(s): "received all 4 COVID-19 Vaccines in her left arm and has 4 tiny scar spots"; BNT162b2 (Vaccine Name: 2nd dose Pfizer COVID-19 Vaccine, Lot Number / Expiry Date: EN5318 or GN5318/ unknown, Route, Anatomical Location: left arm), administration date: 16Feb2021, when the patient was 86-year-old, for COVID-19 Immunization, reaction(s): "received all 4 COVID-19 Vaccines in her left arm and has 4 tiny scar spots", "thought this was a rash like her second one". The following information was reported: SCAR (non-serious), outcome "unknown", described as "She states she received all 4 COVID-19 Vaccines in her left arm and has 4 tiny scar spots.". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: She has been taking Synthroid for years and thinks 10 years. Sender's Comments: Linked Report(s) : PFIZER INC-202200789445 same patient and drug, different dose and events;
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pneumothorax, Pulmonary thrombosis
Clinical narrative: clots found in lungs; partial lung collapse; This is a spontaneous report received from a contactable reporter (Other HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Dec2021 as dose 2, single (Batch/Lot number: unknown) at the age of 31 years, in left arm for COVID-19 immunisation. The patient's relevant medical history was not reported. Patient had no COVID-19 prior to vaccination. Concomitant medications included: VENLAFAXINE (other medication in two weeks) and birth control (unspecified). Vaccination history included: Bnt162b2 (dose 1), for COVID-19 immunization. The patient had no other vaccine in four weeks. The following information was reported: PULMONARY THROMBOSIS (hospitalization, life threatening) with onset 28Jul2022, outcome "not recovered", described as "clots found in lungs"; PNEUMOTHORAX (hospitalization, life threatening) with onset 28Jul2022, outcome "not recovered", described as "partial lung collapse". The patient was hospitalized for pneumothorax, pulmonary thrombosis (hospitalization duration: 1 day). The events "partial lung collapse" and "clots found in lungs" required emergency room visit (reported as "Emergency room/department or urgent care"). Therapeutic measures were taken as a result of pneumothorax, pulmonary thrombosis and included Blood thinners and tons of er trips. Clinical course: Patient stated, "I got my last shot in Dec2021 and got COVID in Jan2022. Since then I have had a partial lung collapse as well as clots found in my lungs. There are no other factors that could have played a part in this as my healthcare provider believed this could be from my birth believed this could be from my birth control that I have taken on and off for years." Adverse event start date was reported as 28Jul2022 (pending clarification).  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 known drug safety profile, there is reasonable possibility of causal association between the events and BNT162B2.  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.