chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: 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) (Nurse). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Jan2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 44 years for covid-19 immunisation. The patient's relevant medical history included: "Htn" (unspecified if ongoing); "obesity" (unspecified if ongoing); "asthma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19.  Clinical course: The patient did not receive other medication in 2 weeks. The patient did not have any allergies. Patient received Paxlovid for Treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events of COVID-19 and Drug ineffective.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 03Jan2021 at 11:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 24Jan2021 at 10:00 as dose 2, single (Batch/Lot number: unknown), in left arm, on 16Aug2021 at 13:00 as dose 3 (booster) , single (Batch/Lot number: unknown), in left arm and on 08Feb2022 at 13:00 as dose 4 (booster) , single (Batch/Lot number: unknown) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. 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: Unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Diabetes mellitus, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; Treatment of 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 66-year-old male patient received BNT162b2 (BNT162B2), on 17Mar2021 as dose number unknown, single (Batch/Lot number: unknown), in right arm, on 21Sep2021 as dose number unknown, single (Batch/Lot number: unknown), in right arm and on 10Mar2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 65 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Borderline Diabetes" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown", described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Diabetes mellitus: Borderline, notes: Borderline Diabetes; SARS-CoV-2 test: Unknown results, notes: indication=Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was treated with paxlovid on 28 Jun for 5 days.The patient had no known allergies. The patient had not received any other medications within 2 weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
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 53-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical information: The patient took Paxlovid (02-Jul-2022 to 06Jul-2022) for COVID 19 Treatment. The patient experienced extreme diarrhea and metallic taste while taking Paxlovid, both symptoms went away when he stopped taking it. On 12Jul he began experiencing worse Covid symptoms than he did before taking Paxlovid, primarily a really runny nose and bad cough. It was now 14Jul and he feel no better. The patient had no known allergies.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: test positive; test positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), on 18Jan2021 as dose 1, single (Lot number: EL3247), on 08Feb2021 as dose 2, single (Lot number: EL9269) and on 03Aug2021 as dose 3 (booster), single (Lot number: FA6780) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 14Apr2022 as dose 4 (booster), single (Lot number: 005M21A) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03Jul2022, outcome "unknown" and all described as "test positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Jul2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Caller confirmed that both him and his wife had all same vaccination dates and Lot numbers, and manufactures. He explains that they were both traveling, after the 4th shot, they had been in 3 different towns and stayed outdoors for the part except when it was raining, so they are convinced because there was no air movement, that's when they got it. His wife and him both caught the same bug. Caller confirmed that all vaccine dates and Lot numbers were identical to his. His wife did not test positive till the 03Jul2022 and she started Paxlovid on 03Jul2022 for her first dose. Her Paxlovid was also discarded.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Pyrexia, SARS-CoV-2 antibody test, Vaccination failure
Clinical narrative: COVID 19 Treatment/Covid symptoms, Fever; COVID 19 Treatment/Covid symptoms, Fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality. The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Jan2021 at 09:15 as dose 1, single (Lot number: EL3247), in left arm, on 09Feb2021 at 08:15 as dose 2, single (Lot number: EL8982), in left arm and on 03Dec2021 at 23:15 as dose 3 (booster), single (Lot number: FJ8757) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (ongoing); "linear IGA dermatosis" (unspecified if ongoing). Concomitant medication(s) included: ORENCIA, stop date: 02Jul2022; DAPSONE; HYDROXYCHLOROQUINE. Past drug history included: Enbrel, reaction(s): "Known allergies: Enbrel". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 04Jul2022, outcome "not recovered" and all described as "COVID 19 Treatment/Covid symptoms, Fever". The patient underwent the following laboratory tests and procedures: Pyrexia: (04Jul2022) 102; SARS-CoV-2 antibody test: (04Jul2022) Positive; (13Jul2022) Negative, notes: antigen test; (14Jul2022) Positive, notes: antigen test. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Rheumatoid arthritis flareup after 2nd and 3rd doses. Flareups was keep getting worse causing patient to start Orencia. Covid symptoms began on 03Jul2022, tested positive on 04Jul2022 with 102 fever. Started Paxlovid treatment in the afternoon of 05Jul2022 and completed on 10Jul2022. Tested Covid negative on antigen test 13Jul2022. Respiratory symptoms began evening of 13Jul2022 and tested positive on antigen test 14Jul2022.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200960543 Same patient, different drug, different event;US-PFIZER INC-202200966407 Same product, patient, different AEs, different dose;US-PFIZER INC-202200966412 Same product, patient, different AEs, different dose;
Age: 33.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old male patient received BNT162b2 (BNT162B2), on 01Feb2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 33 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: had positive antigen test 5 days after end of treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient took antiviral for COVID 19 treatment, brand from 04Jul2022 till 08Jul2022. COVID rebound. Began experiencing rhinitis and had positive antigen test 5 days after end of treatment, after prior symptoms had resolved. In addition, patient experienced dysgeusia while taking Paxlovid. Resolved 24 hours after final dose was taken. Patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
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) from product quality group. The reporter is the patient.  A 44-year-old male patient received BNT162b2 (BNT162B2), on 08Apr2021 as dose 1, single (Lot number: EWO162), in right arm and on 29Apr2021 as dose 2, single (Lot number: ER8731) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Cipro, reaction(s): "Known allergies: Cipro", notes: known allergies: Cipro. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: indication Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient took anti viral treatment Paxlovid on 30Jun2022 and stopped on 05Jul2022. Patient took other medications in 2 weeks.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Neuralgic amyotrophy, Radiculitis brachial
Clinical narrative: Neuralgic Amyotrophy; Brachial Neuritis; Parsonage-Turner Syndrome in left shoulder/arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old male patient received BNT162b2 (BNT162B2), on 10Jan2022 at 11:30 as dose 2, single (Lot number: FJ683) at the age of 33 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ADDERALL. Vaccination history included: pfizer-biontech (Dose Number: 1, Batch/Lot No: 330308D, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM), administration date: 14Dec2021, when the patient was 33-year-old, for COVID-19 immunization. The following information was reported: RADICULITIS BRACHIAL (disability, medically significant) with onset 11Jan2022 at 10:00, outcome "not recovered", described as "Brachial Neuritis"; NEURALGIC AMYOTROPHY (disability, medically significant) with onset 11Jan2022 at 10:00, outcome "not recovered"; NEURALGIC AMYOTROPHY (disability, medically significant) with onset 11Jan2022 at 10:00, outcome "not recovered", described as "Parsonage-Turner Syndrome in left shoulder/arm". The events "neuralgic amyotrophy", "brachial neuritis" and "parsonage-turner syndrome in left shoulder/arm" required physician office visit. Therapeutic measures were taken as a result of neuralgic amyotrophy, radiculitis brachial, neuralgic amyotrophy.  Clinical course as reported: Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Treatment was Prescribed Amitriptyline. Physical Therapy. Patient had no known allergies. Patient received other medications in two weeks: Adderall. Device timestamp: 14Jul2022.No allergies.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 42 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Jul2022, outcome "unknown", COVID-19 (medically significant) with onset Jul2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Result. Therapeutic measures were taken as a result of drug ineffective, covid-19 which Paxlovid.  Additional information: She received Paxlovid from 05jul2022 till 10Jul2022 and also had rebound of covid infection on day 3 after stopping paxlovid (day 10 overall). New symptoms (cough, congestion, malaise).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 03Feb2021 as dose 1, single (Lot number: em9810), in left arm, on 24Feb2021 as dose 2, single (Lot number: en6200), in left arm and on 08Oct2021 as dose 3 (booster), single (Lot number: ew0181) at the age of 66 years, in left arm for covid-19 immunization. coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 02May2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunization. The patient had no relevant medical history. Concomitant medication(s) included: TAMSULOSIN, start date: 01Dec2020, stop date: 01Jul2022; FINASTERID, start date: 01Dec2020, stop date: 01Jul2022.  The following information was reported: VACCINATION FAILURE (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: (unspecified date) Unknown results, notes: Treatment of COVID-19; (12Jul2022) Positive, notes: tested positive 6 days after completing Paxlovid; (Jul2022) Positive, notes: about 1 day after fully completing the paxlovid I still tested positive; (Jul2022) Negative, notes: about 3 days afterward I tested negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: About 1 day after fully completing the Paxlovid I still tested positive but about 3 days afterward I tested negative. Then I had rebound symptoms and tested positive 6 days after completing Paxlovid.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 55 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "Known allergies: Peanuts" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION; PHENTERMINE. 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid from 04Jul2022 to 08Jul2022 for the treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Apr2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 65 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Jul2022) positive, notes: tested positive. Therapeutic measures were taken as a result of covid-19, drug ineffective.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18May2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 57 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Anaemia" (unspecified if ongoing), notes: Other medical history: Anemia; "Allergy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: COVID 19 Treatment, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional Information: Patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. Patient previously received a COVID-19 Vaccine.  Clinical Course: Morning of day 3 taking medication: throat tightness; morning of day 4: faintness, elevated blood pressure. Medication discontinued. Device Date was 14Jul2022.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: COVID rebound after 4 days being negative; Unknown results, notes: COVID rebound after 4 days being negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid from 05Jul2022 to 08Jul2022 for COVID-19 treatment. The patient had COVID rebound after 4 days being negative. Runny nose and persistent cold symptoms, no fever and no sore throat.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), on 03Mar2021 at 19:00 as dose 1, single (Batch/Lot number: unknown), in left arm and on 15May2021 at 19:00 as dose 2, single (Batch/Lot number: unknown) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type-2 diabetes" (unspecified if ongoing), notes: Type-2 diabetes. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: indication=Treatment of COVID-19; Negative, notes: Rebound after Paxlovid (return of sore throat, achiness - 6 days after negative test and symptom free...). Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient received anti viral Paxlovid from 04Jul2022 to 08Jul2022 for treatment of COVID-19. Rebound after Paxlovid (return of sore throat, achiness - 6 days after negative test and symptom free. The patient had no known allergies. Other medication in 2 weeks: No.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, 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) from product quality group. The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Feb2021 as dose 1, single (Lot number: EN6203), on 21Mar2021 as dose 2, single (Lot number: ER8727), on 02Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 27May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 59 years for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "rosacea" (unspecified if ongoing); "osteopenia" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 02Feb2022, stop date: 14Jul2022; ORACEA [DOXYCYCLINE], start date: 01Nov2021, stop date: 14Jul2022; VITAMIN D3, start date: 01Jan2021, stop date: 14Jun2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11Jul2022, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Anti-viral COVID-19 treatment with Paxlovid (Lot: GC9416) from 11Jul2022 to 12Jul2022. First dose of Paxlovid at 10 PM 11Jul2022; second dose 12Jul2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 57 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: "Hashimoto hypo thyroidism" (unspecified if ongoing); "Penicillin" (unspecified if ongoing), notes: Known allergies: penicillin. Concomitant medication(s) included: LEVOTHYROXIN; STATIN EZ; METFORMIN. Past drug history included: Amoxocillinn, reaction(s): "Known allergies: Amoxocillinn".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient received other medication in 2 weeks was yes. The patient received COVID 19 treatment from 02Jul2022 to 07Jul2022.  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: Dysphagia, Slow speech, Swollen tongue
Clinical narrative: Swollen tongue; has affected her speech and she speaks slowly; having a little bit of problem swallowing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 06Apr2022 as dose 1, single (Lot number: FK9893) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SWOLLEN TONGUE (non-serious), outcome "not recovered"; SLOW SPEECH (non-serious), outcome "unknown", described as "has affected her speech and she speaks slowly"; DYSPHAGIA (non-serious), outcome "unknown", described as "having a little bit of problem swallowing".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200962221 same product, different dose and event;
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Vaccination site swelling
Clinical narrative: Chills; injection site swelling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 17-year-old male patient received BNT162b2 (BNT162B2), on 13Jul2022 at 16:00 as dose 3 (booster), single (Lot number: FP7139) at the age of 17 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Autism" (unspecified if ongoing); "Seizures" (unspecified if ongoing). Concomitant medication(s) included: TRILEPTAL. Past drug history included: Lamotrigine, reaction(s): "Allergy"; Fentyl, reaction(s): "Allergy"; Ativan, reaction(s): "Allergy". Vaccination history included: pfizer-biontech coviD-19 vaccine (DOSE 2, SINGLE, Batch/Lot No: FA6780, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 24Jun2021, when the patient was 16-year-old, for Covid-19 Immunization; pfizer-biontech coviD-19 vaccine (DOSE 1, SINGLE, Batch/Lot No: EW0191, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 03Jun2021, when the patient was 16-year-old, for Covid-19 Immunization. The following information was reported: CHILLS (non-serious) with onset 14Jul2022, outcome "not recovered"; VACCINATION SITE SWELLING (non-serious) with onset 14Jul2022, outcome "not recovered", described as "injection site swelling". Therapeutic measures were not taken as a result of chills, vaccination site swelling.  Additional information:The patient was not tested prior to vaccination. The patient was not tested for covid after vaccination. The patient did not take any other vaccine in for weeks prior to vaccination.  No follow-up attempts are possible, no information is necessary.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Focal dyscognitive seizures
Clinical narrative: Chills; injection site swelling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 17-year-old male patient received BNT162b2 (BNT162B2), on 13Jul2022 at 16:00 as dose 3 (booster), single (Lot number: FP7139) at the age of 17 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Autism" (unspecified if ongoing); "Seizures" (unspecified if ongoing). Concomitant medication(s) included: TRILEPTAL. Past drug history included: Lamotrigine, reaction(s): "Allergy"; Fentyl, reaction(s): "Allergy"; Ativan, reaction(s): "Allergy". Vaccination history included: pfizer-biontech coviD-19 vaccine (DOSE 2, SINGLE, Batch/Lot No: FA6780, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 24Jun2021, when the patient was 16-year-old, for Covid-19 Immunization; pfizer-biontech coviD-19 vaccine (DOSE 1, SINGLE, Batch/Lot No: EW0191, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 03Jun2021, when the patient was 16-year-old, for Covid-19 Immunization. The following information was reported: CHILLS (non-serious) with onset 14Jul2022, outcome "not recovered"; VACCINATION SITE SWELLING (non-serious) with onset 14Jul2022, outcome "not recovered", described as "injection site swelling". Therapeutic measures were not taken as a result of chills, vaccination site swelling.  Additional information:The patient was not tested prior to vaccination. The patient was not tested for covid after vaccination. The patient did not take any other vaccine in for weeks prior to vaccination.  No follow-up attempts are possible, no information is necessary.
Age: 81.0
Sex: F
Vaccine: PNC20
Symptoms: Insomnia, Malaise, Neck pain, Vaccination site pain, Vaccination site warmth
Clinical narrative: Malaise; shooting pain from the injection site to the side of her neck; shooting pain from the injection site to the side of her neck; difficulty sleeping; warm and tender at the site; This is a spontaneous report received from a contactable reporter (Pharmacist).  An 81-year-old female patient received pneumococcal 20- valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), on 13Jul2022 as dose number unknown, 0.5ml single (Lot number: FJ2604, Expiration Date: 30Jun2023) at the age of 81 years, in right arm for immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). There were no concomitant medications. The following information was reported: MALAISE (non-serious) with onset 13Jul2022, outcome "not recovered"; INSOMNIA (non-serious) with onset 13Jul2022, outcome "not recovered", described as "difficulty sleeping"; VACCINATION SITE PAIN (non-serious), NECK PAIN (non-serious) all with onset 13Jul2022, outcome "not recovered" and all described as "shooting pain from the injection site to the side of her neck"; VACCINATION SITE WARMTH (non-serious) with onset 13Jul2022, outcome "not recovered", described as "warm and tender at the site". Additional information: The patient received the vaccine at about 12:00 on 13Jul2022 and the symptoms started in the afternoon at about 16:00pm or 17:00pm on 13Jul2022.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Mar2021 as dose 1, single (Lot number: EN6208), in left arm, on 13Apr2021 as dose 2, single (Lot number: EW0158), in left arm, on 08Oct2021 as dose 3 (booster), single (Lot number: 30155BA), in left arm and on 28Apr2022 as dose 4 (booster), single (Lot number: FJ4989), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Other medical history: Hypertension. Concomitant medication(s) included: LISINOPRIL; HCTZ. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine", notes: Known allergies: Codeine; Emycin, reaction(s): "Known allergies: Emycin", notes: Known allergies: Emycin. The following information was reported: COVID-19 (medically significant) with onset Jul2022, outcome "recovering", VACCINATION FAILURE (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Anti viral drug paxlovid for COVID 19 treatment started from 01Jul2022 until 05Jul2022.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non- HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2, in Mar2021 at 01:00 pm as dose 1, single (Batch/Lot number: unknown), in left arm, in Apr2021 at 01:00 pm as dose 2, single (Batch/Lot number: unknown), in left arm and in Jan2022 at 10:00 am as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 43 years (as of dose 1 and dose 2), in right arm for covid-19 immunisation. The patient's relevant medical history included: "overweight" (unspecified if ongoing); "Prediabetic" (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 "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 included nirmatrelvir; ritonavir (PAXLOVID) from 03Jul2022 to 07Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 03Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 24Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 11Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN, start date: 01Jan2019, stop date: 02Jul2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Indication: Covid-19 treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical details: On 12Jun2022, covid rebound 6 days after completing 5 day treatment of Paxlovid from 02Jun2022 to 06Jul2022 for covid-19. Mild symptoms initially and in rebound. No treatment given for AE. The AE was recovering.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 74.0
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) from product quality group. The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EN6201), in left arm, on 04Mar2021 as dose 2, single (Lot number: En6201), in left arm, as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 05May2022 as dose 4 (booster), single (Lot number: 2553) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure and no spleen" (unspecified if ongoing); "High blood pressure and no spleen" (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 "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested positive for covid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient did not receive any other medication in 2 weeks. Patient received treatment with Paxlovid on 28Jun2022 and stop date was 01Jul2022. Patient had no known allergies. It was reported that "Adverse event: 2 days after feeling well all the covid symptoms returned and tested positive for covid. I'm still ill today. My wife has the same".   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: Blood potassium, Blood potassium decreased, Diarrhoea, Drug ineffective, Nausea
Clinical narrative: covid-19; covid-19; diarrhea; throwing up; nausea; depleted of potassium; diagnosed with a UTI; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history 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 "covid-19"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; VOMITING (non-serious), outcome "unknown", described as "throwing up"; NAUSEA (non-serious), outcome "unknown"; BLOOD POTASSIUM DECREASED (non-serious), outcome "unknown", described as "depleted of potassium"; URINARY TRACT INFECTION (non-serious), outcome "unknown", described as "diagnosed with a UTI". The events "depleted of potassium" and "diagnosed with a uti" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood potassium: depleted of potassium, notes: she was not admitted just walked in and was told that her body was being depleted of potassium and she also was diagnosed with a UTI which she states happens to her all the time and she sees a urologist and a specialist for that.  Additional information: Caller states she had diarrhea. Caller clarifies that she received a call asking about an adverse event she experienced to the Covid vaccine and states that it was a week after that she went to the hospital, had diarrhea for two weeks from Covid, not the vaccine, states the Covid gave her bad diarrhea and throwing up and nausea. States she had to go into the hospital, she was not admitted just walked in and was told that her body was being depleted of potassium and she also was diagnosed with a UTI which she states happens to her all the time and she sees a urologist and a specialist for that. States she had not been on Paxlovid for a week or two and then went to the hospital. Caller was unable to clarify details. Caller was noticeably frustrated and hard to re direct during call. Caller declines to provide any other contact information, states that she does not want there to be any reports of her having an adverse event because she states she did not have an adverse event to any medication. Caller would like someone to follow up to confirm that she stated she did not have an adverse event reported. States that the lady she spoke with from Pfizer before may have thought she said it was from the product. Caller does not provide any reference numbers.   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: Suspected COVID-19, Urinary tract infection, Vomiting
Clinical narrative: covid-19; covid-19; diarrhea; throwing up; nausea; depleted of potassium; diagnosed with a UTI; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history 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 "covid-19"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; VOMITING (non-serious), outcome "unknown", described as "throwing up"; NAUSEA (non-serious), outcome "unknown"; BLOOD POTASSIUM DECREASED (non-serious), outcome "unknown", described as "depleted of potassium"; URINARY TRACT INFECTION (non-serious), outcome "unknown", described as "diagnosed with a UTI". The events "depleted of potassium" and "diagnosed with a uti" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood potassium: depleted of potassium, notes: she was not admitted just walked in and was told that her body was being depleted of potassium and she also was diagnosed with a UTI which she states happens to her all the time and she sees a urologist and a specialist for that.  Additional information: Caller states she had diarrhea. Caller clarifies that she received a call asking about an adverse event she experienced to the Covid vaccine and states that it was a week after that she went to the hospital, had diarrhea for two weeks from Covid, not the vaccine, states the Covid gave her bad diarrhea and throwing up and nausea. States she had to go into the hospital, she was not admitted just walked in and was told that her body was being depleted of potassium and she also was diagnosed with a UTI which she states happens to her all the time and she sees a urologist and a specialist for that. States she had not been on Paxlovid for a week or two and then went to the hospital. Caller was unable to clarify details. Caller was noticeably frustrated and hard to re direct during call. Caller declines to provide any other contact information, states that she does not want there to be any reports of her having an adverse event because she states she did not have an adverse event to any medication. Caller would like someone to follow up to confirm that she stated she did not have an adverse event reported. States that the lady she spoke with from Pfizer before may have thought she said it was from the product. Caller does not provide any reference numbers.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Nausea, Peripheral swelling, Swelling face
Clinical narrative: Left arm/face swelling; Face swelling; numbness; Neausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Jul2022 at 15:15 as dose 1, single (Lot number: FM9992) at the age of 38 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Pen" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: SWELLING FACE (non-serious) with onset 13Jul2022 at 15:15, outcome "recovering", described as "Face swelling"; PERIPHERAL SWELLING (non-serious) with onset 13Jul2022 at 15:15, outcome "recovering", described as "Left arm/face swelling"; NAUSEA (non-serious) with onset 13Jul2022 at 15:15, outcome "recovering", described as "Neausea"; HYPOAESTHESIA (non-serious) with onset 13Jul2022 at 15:15, outcome "recovering", described as "numbness". Therapeutic measures were taken as a result of peripheral swelling, swelling face, hypoaesthesia, nausea.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination.