chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
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 39-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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Neoplasm malignant
Clinical narrative: diagnosed with cancer; This is a spontaneous report received from a contactable reporter(s) (Physician), Program ID: (159558).  A male patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) and in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), 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: NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "diagnosed with cancer".  Clinical information: Patient diagnosed with cancer and was fully vaccinated and want to knew the necessary dosing for booster so patient would be fully immunized. Caller relays the patient had 2 doses of Pfizer last year and when he went for the booster he got the Moderna booster which he believe a half dose like 50 and the patient was waiting around until he got the 2nd booster. Patient was over 50 at a time of reporting. While waiting for his 2nd booster he was diagnosed with cancer. The patient falls into a category, what first came to his mind was like the pediatric population, by the time they come for their 2nd shot they might be in different age bracket. That was the best he could thought to describe it. Caller had no idea the process to report or if the patient needs to be involved. Caller stated patient was not able to report at this time, he had a patient walking in any minute.   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  a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of malignant neoplasm. 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
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective
Clinical narrative: Rebound case after treatment with Paxlovid; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  An elderly male patient received BNT162b2 (BNT162B2), on 24Feb2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Htn" (unspecified if ongoing), notes: Htn; "Hyperlipid" (unspecified if ongoing), notes: Hyperlipid. 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 Treatment"; DISEASE RECURRENCE (medically significant), outcome "unknown", described as "Rebound case after treatment with Paxlovid". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: It was unknown whether the patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. Relevant past drug history includes Allergy. Patient previously receive a COVID-19 Vaccine. Rebound case after treatment with Paxlovid. Patient received Paxlovid for treatment of Covid 19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events  (DRUG INEFFECTIVE, COVID-19 )cannot be completely excluded.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Pharmacist) from product quality group. The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Jan2021 as dose 1, single (Lot number: EL9263), on 10Feb2021 as dose 2, single (Lot number: EM9809) and on 09Oct2021 as dose 3 (booster), single (Lot number: EW186) at the age of 40 years for covid-19 immunisation. The patient's relevant medical history included: "Hashimotos" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "Insomnia" (unspecified if ongoing); "nightmares" (unspecified if ongoing); "migraines" (unspecified if ongoing); "Allergy: sulfa antibiotics" (unspecified if ongoing). Concomitant medication(s) included: SEASONIQUE, start date: 01Oct2004, stop date: 06Aug2022; ADDERALL, start date: 01May2015, stop date: 08Aug2022; WELLBUTRIN XL, start date: 01Nov2017, stop date: 10Aug2022; PRAZOSIN, start date: 03Sep2012; ARMOUR THYROID, start date: 01Mar2015. Past drug history included: Bactrim ds, reaction(s): "Known allergies: Bactrim DS"; Zinc oxide, reaction(s): "Known allergies: Zinc oxide". The following information was reported: VACCINATION FAILURE (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 vaccination failure, covid-19.  Clinical Course: The patient received Other medication in 2weeks.Patient received Paxlovid for COVID 19 treatment , Started on 10Aug2022 and stopped on 15Aug2022.Pateint reported that "Very horrible flavor in the mouth that was bitter or staled, that would not go away even if brush teeth or tongue, eat or drink it stayed. It even woke her up in the middle of the night. It won't let her fill it out below but the side effect lasted until a little after therapy ended, after around a day (Tuesday after finishing the day before). She still cannot taste or smell 30% of things but she don't know if it's from COVID or the drug.    No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events (VACCINATION FAILURE, COVID 19 )cannot be completely excluded.
Sex: M
Vaccine: 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 73-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm, as dose 2, single (Batch/Lot number: unknown), in left arm, as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High BP" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. He previously received a COVID-19 Vaccine. Proprietary medicinal product name was Paxlovid. Date of start of drug was on 17Aug2022 and date of last administration was on 22Aug2022. Reported Events were Congestion, cough on 26Aug2022 at 12:00 AM. No treatment received for AE.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid-19 rebound after Paxlovid treatment; Treatment of COVID-19; Treatment of COVID-19; 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 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Apr2021 as dose 1, single (Lot number: ER8729), in left arm, on 05Jun2021 as dose 2, single (Lot number: EW0153), in left arm, on 09Dec2021 as dose 3 (booster), single (Lot number: FF2590), in left arm and on 03May2022 as dose 4 (booster), single (Lot number: FM7553) at the age of 60 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Nsaid's, reaction(s): "Known allergies: NSAID's". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "recovered" (Aug2022) and all described as "Treatment of COVID-19"; DISEASE RECURRENCE (medically significant) with onset 27Aug2022, outcome "not recovered", described as "Covid-19 rebound after Paxlovid treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Aug2022) Positive, notes: iHealth COVID-19 Antigen Rapid Test; (17Aug2022) Negative, notes: RT-CTR COVID-19 Antigen Test; (27Aug2022) Positive, notes: COVID-19 Antigen Rapid Test:. Therapeutic measures were taken as a result of drug ineffective, covid-19. Therapeutic measures were not taken as a result of disease recurrence.Clinical course:Covid-19 rebound after Paxlovid treatment and 14-day quarantine (fully vaccinated/2x boosted).
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Symptoms recur + test 25Aug; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 19Dec2020 at 09:00 as dose 1, single (Lot number: EH9899), in left arm and on 09Jan2021 at 08:00 as dose 2, single (Lot number: EL1284) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN, start date: 01Oct2020. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 17Aug2022, outcome "unknown" and all described as "Treatment of COVID-19"; DISEASE RECURRENCE (medically significant) with onset 25Aug2022, outcome "unknown", described as "Symptoms recur + test 25Aug". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Aug2022) Positive; (24Aug2022) Negative; (25Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: If vaccine received was Yes. Other medication in 2 weeks was Yes. Known allergies was None. Antiviral details: Product=COVID 19 Treatment, brand=Paxlovid. Treatment start date=17Aug2022. Treatment stop date=21Aug2022. Indication=Treatment of COVID-19. Administrator route=Oral. Adverse event Paxlovid rebound + test 17Aug, -test 24Aug, Symptoms recur + test 25Aug.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provided and known drug safety profile, the causality between the suspect drug BNT162B2 in the occurrence of the event  Vaccination failure, covid-19, Disease recurrence  cannot be excluded.
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 contactable reporter(s) (Other HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events DRUG INEFFECTIVE and COVID-19 and BNT162B2.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, SARS-CoV-2 test, Vaccination failure
Clinical narrative: she again tested positive on an antigen test on Day 9 (28Aug2022); Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 22-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Feb2021 as dose 1, single (Lot number: EN6198), in right arm, on 21Mar2021 as dose 2, single (Lot number: EP7534), in left arm and on 11Dec2021 as dose 3 (booster), single (Lot number: 331308A) at the age of 21 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies Lentils and Peas" (unspecified if ongoing), notes: Known allergies Lentils and Peas. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19"; DISEASE RECURRENCE (medically significant) with onset 28Aug2022, outcome "unknown", described as "she again tested positive on an antigen test on Day 9 (28Aug2022)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Aug2022) Negative, notes: tested negative on an antigen test on Day 7; (Aug2022) positive; (28Aug2022) Positive, notes: tested positive on an antigen test on Day 9. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient received Paxlovid from 20Aug2022 to 24Aug2022 for treatment of COVID-19. She stated that she was symptomatic and tested positive for COVID. She started Paxlovid on Day 1 (20Aug2022) and completed the dosage on Day 5 (24Aug2022). She recovered from all symptoms by the Day 5. She tested negative on an antigen test on Day 7 (26Aug2022). Then she again tested positive on an antigen test on Day 9 (28Aug2022). There was no reappearance of symptoms. She believes that she was experiencing the symptoms and also the rebound effect. Other medical history.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, 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) from product quality group. The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Lot number: EW0151), on 22Apr2021 as dose 2, single (Lot number: EW0175), on 21Nov2021 as dose 3 (booster), single (Lot number: 33030BD) and on 08Apr2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 56 years for covid-19 immunisation. The patient's relevant medical history included: "diabetes" (unspecified if ongoing); "asthma" (unspecified if ongoing); "paroxysmal a-fib" (unspecified if ongoing), notes: paroxysmal a-fib; "hypertension" (unspecified if ongoing); "left atrial fascicular block" (unspecified if ongoing), notes: left atrial fascicular block; "Right bundle branch block" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (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 vaccination failure, covid-19.  Clinical course: The patient had no known allergies. The patient received Paxlovid from 22Aug2022 to 26Aug2022 for the treatment of COVID-19.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. An 81-year-old male patient received BNT162b2 (BNT162B2), on 01Sep2021 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 17Feb2022 at 15:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 80 years, 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's relevant medical history included: "Recovering from prostate cancer" (unspecified if ongoing), notes: Recovering from prostate cancer. Concomitant medication(s) included: AMLODIPINE, start date: 25Mar2019. Past drug history included: Quinine derivatives, reaction(s): "known allergies: Quinine derivatives", notes: Quinine derivatives. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Aug2022) Very faint line; (27Aug2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient was treated with Paxlovid for Covid-19 from 14Aug2022 to 19Aug2022. The was patient taking other medications/products within 2 weeks of starting COVID-19 treatment. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 18Mar2021 as dose 2, single (Lot number: EN6204), in right arm, on 25Sep2021 as dose 3 (booster), single (Lot number: 30145BA), in right arm and on 03May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 70 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (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: positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient was given anti-viral Paxlovid 17Aug2022 to 22Aug2022 for treatment of COVID-19. Rebound of COVID symptom two day after completing Paxlovid treatment. No known allergies.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Dec2021 at 13:00 as dose 3 (booster), single (Lot number: FH8028) at the age of 36 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: "allergies: PCN" (unspecified if ongoing); "connective tissue disorder" (unspecified if ongoing); "Polyarthralgia" (unspecified if ongoing); "allergies" (unspecified if ongoing); "hyperhyrdosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Allergies: daypro, reaction(s): "allergies:daypro"; Allergies: azithromycin, reaction(s): "allergies:Azithromycin"; Allergies: pertussis vaccines, reaction(s): "allergies". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "not recovered" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Sunday I tested negative w/ a home test, Monday symptoms returned stuffiness, post nasal drip, cough; 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 65-month-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Lot number: FG3527), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "cancer treated" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DISEASE RECURRENCE (medically significant) with onset 22Aug2022 at 20:00, outcome "not recovered", described as "Sunday I tested negative w/ a home test, Monday symptoms returned stuffiness, post nasal drip, cough"; 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: Positive; Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Therapeutic measures were not taken as a result of disease recurrence.  Clinical course: Reporter stated that, patient had no known allergies. Therapeutic measures were taken as a result of drug ineffective, COVID-19 included Paxlovid 13Aug2022 to 18Aug2022.
Age: 71.0
Sex: M
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 reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 01Feb2022 at 12:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 71 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "heart" (unspecified if ongoing); "deaf" (unspecified if ongoing); "gastric" (unspecified if ongoing); "Known allergis: Peanuts" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Bactrim, reaction(s): "Known allergies: Bactrim". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was treated with Paxlovid, Treatment start date was 18Jul2022 and stop date was 23Jul2022. it was unknown that patient took other medications in two weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 02Feb2022 at 16:15 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 50 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 "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Aug2022) Positive, notes: Rebound COVID-19 infection with symptoms 4 days after completion of treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Information: Anti-viral COVID 19 Treatment with Paxlovid and Treatment start date was 19Aug2022 and stop date was 24Aug2022, Lot number was GE5197. Adverse events start date was on 27Aug2022 at 12:00 PM. No treatment was reported, no known allergies and outcome was not recovered.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
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 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 17Feb2021 as dose 2, single (Lot number: EN9581), in right arm and on 25Oct2021 as dose 3 (booster), single (Lot number: 32030BD) at the age of 69 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diverticulitis" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing). Concomitant medication(s) included: ZOVIRAX [ACICLOVIR]; LEVOTHYROXINE; VITAMIN D3; ALLERCLEAR; ROBITUSSIN DM; FLUTICASONE PROPIONATE; ACETAMINOPHEN. The following information was reported: VACCINATION FAILURE (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 vaccination failure, covid-19.  Clinical course: Anti viral details COVID 19 Treatment, brand Paxlovid. treatment start date was 24Aug2022 treatment stop date was 25Aug2022 .  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 51.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 18Feb2021 as dose 1, single (Lot number: EL9267), in left arm, on 11Mar2021 as dose 2, single (Lot number: EN6205), in left arm and on 16Nov2021 as dose 3 (booster), single (Lot number: FJ1611) at the age of 51 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LATANOPROST. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 13Aug2022, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Aug2022) Positive, notes: Antigen test on night of 21st turned positive quickly; (26Aug2022) Positive, notes: Still positive on antigen test 26th; (13Aug2022) Positive, notes: Original positive on the 13th felt as bad as originally minus a fever for about 3 days then symptoms improving. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, SARS-CoV-1 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; Rebound of covid virus because of Paxlovid.; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old male patient received BNT162b2 (BNT162B2), on 29Jan2021 as dose 1, single (Lot number: EL9264), in right arm and on 22Feb2021 as dose 2, single (Lot number: EN6203) at the age of 45 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 05Nov2021 as dose 3 (booster), single (Lot number: 017F21A), in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: COVID-19 (medically significant) with onset Aug2022, outcome "recovered" (Aug2022), VACCINATION FAILURE (medically significant) with onset 26Aug2022, outcome "not recovered" and all described as "COVID 19 Treatment"; DISEASE RECURRENCE (medically significant) with onset 26Aug2022, outcome "recovering", described as "Rebound of covid virus because of Paxlovid.". The patient underwent the following laboratory tests and procedures: SARS-CoV-1 test: (24Aug2022) Negative, notes: Tested negative by day 8 and again on day 10; (26Aug2022) Negative, notes: Tested negative by day 8 and again on day 10; (26Aug2022) Positive, notes:Left isolation, my negative test had turned positive when I saw it that night; (27Aug2022) Positive, notes: so retested and was positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Therapeutic measures were not taken as a result of disease recurrence. Clinical course:Symptoms of virus returned morning of day 11 with sore throat. No other medication in 2weeks was reported.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Deafness
Clinical narrative: hearing deficit / hearing loss; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A 72-year-old 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 3 (BOOSTER), SINGLE, verbatim: I received your Covid "vaccine" in 2 doses, as well as 2 boosters/I have always experienced very acute hearing), for COVID-19 immunization, reaction(s): "hearing deficit / hearing loss"; Bnt162b2 (DOSE 2, SINGLE, verbatim: I received your Covid "vaccine" in 2 doses, as well as 2 boosters/I have always experienced very acute hearing), for COVID-19 immunization, reaction(s): "hearing deficit / hearing loss"; Bnt162b2 (DOSE 1, SINGLE, verbatim: I received your Covid "vaccine" in 2 doses, as well as 2 boosters/I have always experienced very acute hearing), for COVID-19 immunization, reaction(s): "hearing deficit / hearing loss".  The following information was reported: DEAFNESS (medically significant), outcome "unknown", described as "hearing deficit / hearing loss".  Clinical course: It was reported that patient received Covid "vaccine" in 2 doses, as well as 2 boosters. Patient was 72. Patient had always experienced very acute hearing & had no family history of hearing loss.That past year patient's grandchildren brought to his/her attention, Pt. had a hearing deficit. After an ear examination & hearing test by 2 doctors, patient was then a prime candidate for hearing aids. In retrospect patient believed he/she might had his/her hearing loss due to the boosters. No one could be sure. Patient felt this information was important for the records.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: hearing deficit / hearing loss; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A 72-year-old 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 3 (BOOSTER), SINGLE, verbatim: I received your Covid "vaccine" in 2 doses, as well as 2 boosters/I have always experienced very acute hearing), for COVID-19 immunization, reaction(s): "hearing deficit / hearing loss"; Bnt162b2 (DOSE 2, SINGLE, verbatim: I received your Covid "vaccine" in 2 doses, as well as 2 boosters/I have always experienced very acute hearing), for COVID-19 immunization, reaction(s): "hearing deficit / hearing loss"; Bnt162b2 (DOSE 1, SINGLE, verbatim: I received your Covid "vaccine" in 2 doses, as well as 2 boosters/I have always experienced very acute hearing), for COVID-19 immunization, reaction(s): "hearing deficit / hearing loss".  The following information was reported: DEAFNESS (medically significant), outcome "unknown", described as "hearing deficit / hearing loss".  Clinical course: It was reported that patient received Covid "vaccine" in 2 doses, as well as 2 boosters. Patient was 72. Patient had always experienced very acute hearing & had no family history of hearing loss.That past year patient's grandchildren brought to his/her attention, Pt. had a hearing deficit. After an ear examination & hearing test by 2 doctors, patient was then a prime candidate for hearing aids. In retrospect patient believed he/she might had his/her hearing loss due to the boosters. No one could be sure. Patient felt this information was important for the records.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, Interchange of vaccine products, Off label use
Clinical narrative: COVID 19; COVID 19; off label use; Dose Number: 1 Moderna; Dose Number: 1 Moderna; Dose Number: 3 Moderna; Dose Number: 4 Pfizer / BioNTech; BOOSTER; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 30Dec2020 as dose 1, single (Batch/Lot number: unknown), in right arm, on 01Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 12Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "gastric bypass" (unspecified if ongoing); "hernia repair" (unspecified if ongoing); "gallbladder removed" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN; FAMOTIDINE; CALCIUM; and Multivitamin, all received in 2 weeks of the vaccination. Past drug history included: Rocephin, reaction(s): "known allergies: Rocephin". The following information was reported: IMMUNISATION (medically significant) with onset 22Apr2022, outcome "unknown", described as "BOOSTER"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22Apr2022, outcome "unknown", described as "Dose Number: 1 Moderna; Dose Number: 1 Moderna; Dose Number: 3 Moderna; Dose Number: 4 Pfizer / BioNTech"; OFF LABEL USE (medically significant) with onset 22Apr2022, outcome "unknown"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (26Aug2022) Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective. 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 limited information in the case , a possible causal association between   the reported events and the suspect drug cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; off label use; Dose Number: 1 Moderna; Dose Number: 1 Moderna; Dose Number: 3 Moderna; Dose Number: 4 Pfizer / BioNTech; BOOSTER; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 30Dec2020 as dose 1, single (Batch/Lot number: unknown), in right arm, on 01Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 12Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "gastric bypass" (unspecified if ongoing); "hernia repair" (unspecified if ongoing); "gallbladder removed" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN; FAMOTIDINE; CALCIUM; and Multivitamin, all received in 2 weeks of the vaccination. Past drug history included: Rocephin, reaction(s): "known allergies: Rocephin". The following information was reported: IMMUNISATION (medically significant) with onset 22Apr2022, outcome "unknown", described as "BOOSTER"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22Apr2022, outcome "unknown", described as "Dose Number: 1 Moderna; Dose Number: 1 Moderna; Dose Number: 3 Moderna; Dose Number: 4 Pfizer / BioNTech"; OFF LABEL USE (medically significant) with onset 22Apr2022, outcome "unknown"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (26Aug2022) Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective. 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 limited information in the case , a possible causal association between   the reported events and the suspect drug cannot be excluded.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, 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 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Lot number: EL9261), in left arm, on 17Feb2021 as dose 2, single (Lot number: EL9265), in left arm, on 08Oct2021 as dose 3 (booster), single (Lot number: 30155BA), in left arm and on 04May2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 66 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: WELLBUTRIN, start date: 09Nov2015. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 65.0
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 Consumer. The reporter is the patient. A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Lot number: EN6208), in left arm, on 02Apr2021 as dose 2, single (Lot number: er8733), in left arm and on 07Oct2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 65 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 04Apr2022 as dose 4 (booster), single (Lot number: 026L21B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Overweight" (unspecified if ongoing); "Oral allergy syndrome" (unspecified if ongoing). Concomitant medication included: PANTOPRAZOLE. Patient received Paxlovid from 15Aug2022 to 19Aug2022 for treatment of COVID-19 in 2022. Outcome of the events was unknown.
Sex: U
Vaccine: PNC13
Symptoms: Abdominal discomfort, Dizziness, Malaise
Clinical narrative: I am sick to my stomach; little dizzy; feel sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: ABDOMINAL DISCOMFORT (non-serious), 3 days after the suspect product(s) administration, outcome "unknown", described as "I am sick to my stomach"; DIZZINESS (non-serious), 3 days after the suspect product(s) administration, outcome "unknown", described as "little dizzy"; MALAISE (non-serious), 3 days after the suspect product(s) administration, outcome "unknown", described as "feel sick".  Additional information: It was reported as patient was sick to His/her stomach and little dizzy, feel sick. Patient was not sure, just know Prevnar was looking online, got my shot on Thursday Pneumonia vaccine (Prevnar) and here 3 days later and patient was sick to my stomach and little dizzy, feel sick.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Possible COVID rebound case.; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 07Mar2021 at 14:00 as dose 1, single (Lot number: EN6203), in left arm, on 28Mar2021 at 15:00 as dose 2, single (Lot number: ER8730), in left arm, on 01Oct2021 at 17:00 as dose 3 (booster), single (Lot number: EW0202), in left arm and on 25Apr2022 at 13:00 as dose 4 (booster), single (Lot number: FK9729) at the age of 57 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19"; DISEASE RECURRENCE (medically significant) with onset 28Aug2022 at 08:00, outcome "unknown", described as "Possible COVID rebound case.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19. Therapeutic measures were not taken as a result of disease recurrence.  Clinical Information: Patient started to took paxlovid from 18Aug2022 for Covid-19Treatment.other medication in 2 weeks product :other medication in 2 weeks product was Pantoprazole with brand name camber started from 12Aug2022. No other medical history.Possible COVID was rebound on 28Aug2022 at 08:00 AM. Patient was not recovered. No treatment taken for this adverse event.
Age: 74.0
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 reporter(s) (Other HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Batch/Lot number: unknown), in Feb2021 as dose 2, single (Batch/Lot number: unknown) and in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 74 years for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), in Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "mild hyperreactive airway (mild asthma)" (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 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 as anti viral product manufactured by Pfizer taken from 16Aug2022 to 20Aug2022.  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 available information in the case the reported events Drug ineffective and Covid 19 are assessed as related to suspect drug .