chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site joint movement impairment, Vaccination site pain
Clinical narrative: no longer able to use a throwing motion without pain; no longer able to use a throwing motion without pain; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Oct2021 as dose 3 (booster), single (Lot number: ew0183) at the age of 38 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: BNT162b2 (Dose 2, single, Batch/Lot No: el3249), administration date: 18Jan2021, for COVID-19 immunization; BNT162b2 (Dose 1, single, Batch/Lot No: ek9231), administration date: 28Dec2020, for COVID-19 immunization. The following information was reported: VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 06Oct2021, outcome "not recovered" and all described as "no longer able to use a throwing motion without pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site joint movement impairment, vaccination site pain.  Additional Information: It was reported that the patient received other vaccine in four weeks of BNT162B2. The patient was not tested to covid prior vaccination and the patient was tested positive post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Nasal Swab  Positive; Nasal Swab  Positive; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Dec2020 as dose 1, single (Lot number: ek9231), on 18Jan2021 as dose 2, single (Lot number: el3249) and on 06Oct2021 as dose 3 (booster), single (Lot number: ew0183), in right arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 06Oct2021 as dose 1, single (Lot number: 3pn2b), in left arm for 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 07Nov2021, outcome "unknown" and all described as "Nasal Swab Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Nov2021) Positive, notes: covid test type post vaccination. This Report was about covid vaccine. Patient received other vaccine in four weeks. The other vaccine product was for flu. Patient had tested with COVID test post vaccination by nasal swab.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded.
Age: 72.0
Sex: M
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) (Physician). The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 24Sep2021 as dose 3 (booster), single (Lot number: EWO162) at the age of 72 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: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: ATENOLOL. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19, drug ineffective.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded.
Age: 50.0
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 a contactable reporter(s) (Nurse).  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Sep2021 as dose 1, single (Batch/Lot number: unknown) and on 17Feb2022 as dose 2, single (Batch/Lot number: unknown) at the age of 50 years for covid-19 immunisation. The patient's relevant medical history included: "RA" (unspecified if ongoing), notes: other medical history: RA; "Crohn disease" (unspecified if ongoing), notes: other medical history: crohn disease; "Thyroid disease" (unspecified if ongoing), notes: other medical history:Thyroid disease; "known allergies: sheelfish" (unspecified if ongoing), notes: known allergies: sheelfish. Concomitant medication(s) included: TOPAMAX oral; SYNTHROID oral; PLAQUENIL [HYDROXYCHLOROQUINE SULFATE] oral; CYTOMEL oral; BENTYL oral. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jun2022) Positive; (19Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, 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 current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
Age: 41.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received BNT162b2 (BNT162B2), on 27Apr2021 as dose 1, single (Lot number: EW0170), in left arm and on 18May2021 as dose 2, single (Lot number: EW0185) at the age of 41 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 30Dec2021 as dose 3 (booster), single (Lot number: 084J21A), in left arm for covid-19 immunisation; ornithine aspartate (DETOX [ORNITHINE ASPARTATE]), (Lot number: 20003813). The patient had no relevant medical history. Concomitant medication(s) included: VITAMIN D3; ZINC. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient had other medication in 2 weeks. No known allergies. The patient was treated for COVID-19 with Paxlovid (lot number FY6859) from 09Jun2022 to 14Jun2022. Eight days after initial covid infection and treatment with Paxlovid, symptoms disappeared, and tested negative on at-home antigen test. 1.5 days after negative test, symptoms returned and tested positive again on at-home antigen test.
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 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 09Mar2021 as dose 1, single (Lot number: en6205), in left arm, on 30Mar2021 as dose 2, single (Lot number: ew0150), in left arm, on 06Oct2021 as dose 3 (booster), single (Lot number: 3015584), in left arm and on 14Apr2022 as dose 4 (booster), single (Lot number: fj9943), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "salicylates" (unspecified if ongoing), notes: known allergies: salicylates and small pox vaccination. Concomitant medication(s) included: FOLIC ACID, start date: 03Nov2018, stop date: 19Jun2022; CIMZIA, start date: 02Jun2022, stop date: 02Jun2022; METHOTREXATE, start date: 03Jun2022, stop date: 03Jun2022. Past drug history included: Small pox vaccination, reaction(s): "known allergies: small pox vaccination", notes: known allergies: salicylates and small pox vaccination. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 19Jun2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Jun2022) Positive, notes: reinfection on day 10- was symptom free after initial covid but still testing positive until 19Jun2022. overnight 19Jun into 20Jun sinus pressure built and cold like symptoms developed. No fever, no appetite, no energy and positive covid test; (20Jun2022) Positive, notes: reinfection on day 10- was symptom free after initial covid but still testing positive until 19Jun2022. overnight 19Jun into 20Jun sinus pressure built and cold like symptoms developed. No fever, no appetite, no energy and positive covid test. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 treatment, 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). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), in Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), in Feb2021 as dose 1, single (Batch/Lot number: unknown), in Mar2021 as dose 2 , single (Batch/Lot number: unknown) and in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "HTN (controlled)" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Ibuprofen, reaction(s): "Known allergies: Ibuprofen". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19".The patient underwent the following laboratory tests and procedures: COVID-19 treatment: Positive, notes: Recurrence of COVID 4 days after the last dose of Paxlovid. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Adverse event: Recurrence of COVID 4 days after the last dose of Paxlovid. Device timestamp: 20Jun2022.  Follow-up attempts are completed. No further information is expected.
Age: 60.0
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 contactable reporter(s) (Physician). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Oct2021 as dose 3 (booster), single (Lot number: 30155BA) at the age of 60 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 20Apr2022 as dose 4 (booster), single (Lot number: 046L21A) 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: "hypertension" (unspecified if ongoing); "hypercholesterolemia" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; ATORVASTATIN; HYDROCHLOROTHIAZIDE.  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: (12Jun2022) Negative; (unspecified date) Unknown results; (13Jun2022) Negative, notes: I had four successive days of negative rapid antigen tests and no symptoms; (14Jun2022) Negative, notes: I had four successive days of negative rapid antigen tests and no symptoms; (15Jun2022) Negative, notes: I had four successive days of negative rapid antigen tests and no symptoms; (16Jun2022) Negative, notes: I had four successive days of negative rapid antigen tests and no symptoms; (20Jun2022) Positive, notes: did a rapid antigen test on 20Jun which was positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received Anti viral product for COVID 19 Treatment, brand Paxlovid, treatment start date 07Jun2022, treatment stop date 12Jun2022. The patient stopped the Paxlovid on 13Jun and had been testing negative on the antigen test starting on 12Jun. The patient had four successive days of negative rapid antigen tests and no symptoms. She developed symptoms on 19Jun and did a rapid antigen test on 20Jun which was positive. The patient had no known allergies.; Sender's Comments: Based on the available reported information, the causal association between the events and the suspect drug BNT162B2 cannot be excluded.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Feb2021 as dose 1, single (Lot number: el9269), in right arm, on 03Jun2021 as dose 2, single (Lot number: en6098), in left arm and on 04Nov2021 as dose 3 (booster), single (Lot number: 30145BA) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Thyroid" (unspecified if ongoing). Patient had no known allergies. Concomitant medication(s) included: LEVO [LEVOFLOXACIN] taken for thyroid disorder, start date: Sep2018. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid from 12Jun2022 to 14Jun2022, for the treatment of COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 58-year-old female patient received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 07Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 27Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "lactose intolerant to ice cream" (unspecified if ongoing). Concomitant medication(s) included: ALKA SELTZER [ACETYLSALICYLIC ACID], start date: 07Jun2022, stop date: 19Jun2022. The following information was reported: VACCINATION FAILURE (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: Negative, notes: previously tested negative on Day 7; Positive, notes: Paxlovid Rebound; Tested Positive again on Day 10. Therapeutic measures were taken as a result of vaccination failure, Covid-19. Clinical course: COVID 19 Treatment: Paxlovid, treatment start date-06Jun2022 and stop date-10Jun2022. On 16Jun2022, Paxlovid Rebound; Tested Positive again on Day 10 and symptoms appeared again and they were not mild; previously tested negative on Day 7 and had started to improve. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
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 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose1, 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: "High blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Jun2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: started it the day after I tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course- The patient had a bitter metallic taste in mouth while taking the medication. Other than that it worked very well. The patient started it the day after  tested positive and got better very quickly.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: My husband and I had three doses of the Covid vaccine, and we contracted COVID anyway/I have no faith any longer that the Covid vaccine is effective; My husband and I had three doses of the Covid vaccine, and we contracted COVID anyway/I have no faith any longer that the Covid vaccine is effective; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), 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), outcome "unknown" and all described as "My husband and I had three doses of the Covid vaccine, and we contracted COVID anyway/I have no faith any longer that the Covid vaccine is effective".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200006399 same reporter/product/event, different patient;
Age: 40.0
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 41-year-old male patient received BNT162b2 (BNT162B2), on 30Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 40 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 Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) positive, notes: Symptoms and positive test recurred about 5 days after end of Paxlovid treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Known allergies were reported as No. It was reported that the patient received Paxlovid from 09Jun2022 to 13Jun2022 as COVID-19 treatment. The patient experienced rebound Covid after treatment with Paxlovid. Symptoms and positive test recurred about 5 days after end of Paxlovid treatment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: the psoriasis returned; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, MANUFACTURER UNKNOWN), for covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE, MANUFACTURER UNKNOWN, after my second shot in Apr2021, my psoriasis cleared right up! It lasted through my first booster I received in Oct2021. In May2022, the psoriasis returned.), administration date: Apr2021, for covid-19 immunization, reaction(s): "psoriasis". The following information was reported: PSORIASIS (non-serious) with onset May2022, outcome "unknown", described as "the psoriasis returned". Additional information: Patient just wanted to let all know about an exciting side effect the patient had from shots: after patient's second shot in Apr2021, psoriasis cleared right up. It lasted through first booster patient received in Oct2021. In May2022, the psoriasis returned. Patient just got second booster yesterday and was hoping for the same psoriasis remission. Obviously, the shot was boosting patient's immune system. Seems like this was something that would be of great help to psoriasis suffers.  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, SARS-CoV-2 test
Clinical narrative: Finished Paxlovid treatment of 5 days. Tested negative for 2 days straight. Then tested positive again for covid , and have minor symptoms of headache and some congested; Finished Paxlovid treatment of 5 days. Tested negative for 2 days straight. Then tested positive again for covid , and have minor symptoms of headache and some congested; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "pcos" (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 "Finished Paxlovid treatment of 5 days. Tested negative for 2 days straight. Then tested positive again for covid , and have minor symptoms of headache and some congested". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Tested negative for 2 days straight; Positive, notes: Then tested positive again for covid; Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: The reporter stated that, finished Paxlovid treatment of 5 days. Tested negative for 2 days straight. Then tested positive again for covid, and have minor symptoms of headache and some congestion.   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: Drug ineffective, Suspected COVID-19
Clinical narrative: Received COVID 19 Treatment; Received COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult male patient received BNT162b2 (BNT162B2), as dose 3 (booster) single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown). The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Received COVID 19 Treatment". Therapeutic measures were taken as a result of suspected covid-19, drug ineffective.  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, SARS-CoV-2 test
Clinical narrative: They did a rapid test today to see if she had Covid and it is positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 6-year-old female patient received BNT162b2 (COMIRNATY), on 18Jun2022 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: COVID-19 (non-serious) with onset 20Jun2022, outcome "unknown", described as "They did a rapid test today to see if she had Covid and it is positive". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller says his daughter received the Pfizer Biontech Covid 19 vaccine two days ago. She is 6 years old. She began having symptoms yesterday of a fever, etc. They did a rapid test today to see if she had Covid and it is positive. Is that one of the side effects of the vaccine, causing someone to test positive for Covid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19 after BNT162B2 Immunization; COVID-19 after BNT162B2 Immunization; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Aug2021 as dose 1, single (Lot number: FC3182) and on 15Sep2021 as dose 2, single (Lot number: FC3180) at the age of 28 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 12Jun2022, outcome "recovered" (2022) and all described as "COVID-19 after BNT162B2 Immunization". Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical course: It was reported that the patient had no other vaccine in four weeks and had other medication in two weeks. The patient had no Covid prior vaccination and was not covid tested post vaccination. The patient had no known allergies.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the known safety profile of the vaccine  BNT162b2, a causal relation between the reported event Covid-19, Vaccination failure and the administration of the vaccine cannot be excluded.
Age: 30.0
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 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2021 at 13:00 as dose 1, single (Lot number: EN6206), in left arm, on 25Mar2021 at 13:00 as dose 2, single (Lot number: ER8727), in right arm and on 16Nov2021 at 12:00 as dose 3 (booster), single (Lot number: EW0175) at the age of 30 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Endometriosis" (unspecified if ongoing); "PCOS" (unspecified if ongoing). Concomitant medication(s) included: TRAZODONE, start date: 30Sep2020; VERAPAMIL, start date: 12May2022; SERTRALINE, start date: 30Sep2020; ALLEGRA, start date: 30Apr2019. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2weeks Yes. antiviral details product COVID 19 Treatment, brand Pfizer Paxlovid, treatment start date 13Jun2022, treatment stop date 18Jun2022, indication Treatment of COVID-19. known allergies was reported as no. Adverse event Began testing positive again for Covid with symptoms: headache, congestion, sinus pain, cough, sore throat, fatigue adverse event start date 16Jun2022 adverse event Start time 08:00.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive; Tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Apr2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Still testing positive; Still testing positive; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Dec2021 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 58 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: "Diabetes mellitus" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Still testing positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Still testing positive. Therapeutic measures were not taken as a result of covid-19, drug ineffective. Additional information: There was no other medication in 2 weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The reported Covid 19 positive after both the doses of  COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Pyrexia, 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 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Feb2021 at 14:00 as dose 1, single (Batch/Lot number: unknown), in right arm, on 19Mar2021 at 14:00 as dose 2, single (Batch/Lot number: unknown), in right arm, on 23Aug2021 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 19Mar2022 at 14:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 46 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Sjogrens autoimmune condition" (unspecified if ongoing); "Known allergies: Orange oil" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 09Jun2022, stop date: 14Jun2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10Jun2022, outcome "unknown" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: Pyrexia: (20Jun2022) 100 Centigrade, notes: 100c; SARS-CoV-2 test: (10Jun2022) positive; (Jun2022) Negative; (20Jun2022) positive. Clinical course: On 10Jun I got a positive Covid test. I have cough and shortness of breath, muscle pains, brain fog, headaches took paxlovid since I have an autoimmune condition for 5 days. The symptoms were decreased and got a negative Covid test on day 6. 10 days after getting the positive test I got another positive test on 20Jun. Today I got experienced a fever of 100c cough, shortness of breath, runny nose and started a second 5 day cycle of paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Contracted COVID-19; Contracted COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: EP6955), on 12Apr2021 as dose 2, single (Lot number: EP6955) and on 13Dec2021 as dose 3 (booster), single (Lot number: FF8841) at the age of 42 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Facility type vaccine was Public Health Clinic/RA facility. No other vaccine in four weeks. No covid prior vaccination. The following information was reported: VACCINATION FAILURE (medically significant) with onset 18Jun2022, outcome "recovering", COVID-19 (medically significant) with onset 18Jun2022, outcome "recovering" and all described as "Contracted COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Jun2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Contracted COVID-19; Contracted COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 13-year-old male patient received BNT162b2 (BNT162B2), on 24May2021 as dose 1, single (Lot number: EW0175), on 14Jun2021 as dose 2, single (Lot number: EW0187) and on 07Jan2022 as dose 3 (booster), single (Lot number: FJ5683) at the age of 13 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18Jun2022, outcome "recovering" and all described as "Contracted COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Jun2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19. Clinical course: Patient had no covid prior to vaccination.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Supraventricular tachycardia
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 74-year-old male patient received BNT162b2 (BNT162B2), in Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 74 years for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (MANUFACTURER: UNKNOWN, DOSE 3 (BOOSTER), SINGLE), for Covid-19 Immunization; Covid-19 vaccine (MANUFACTURER: UNKNOWN, DOSE 2, SINGLE), for Covid-19 Immunization; Covid-19 vaccine (MANUFACTURER: UNKNOWN, DOSE 1, SINGLE), for Covid-19 Immunization. The following information was reported: SUPRAVENTRICULAR TACHYCARDIA (non-serious) with onset Jun2022, outcome "unknown", described as "SVT". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller (74-year-old) was a consumer asking if there are reports of SVT after getting 2nd booster shot of Pfizer COVID19 vaccine. Caller added that he got the shot yesterday evening at 5 o clock and has SVT that morning at 7:30.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 28Mar2021 at 13:15 as dose 2, single (Batch/Lot number: unknown) at the age of 62 years, in right arm 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: "Psoriasis" (unspecified if ongoing), notes: Other medical history: psoriasis. 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". 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.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
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) (Pharmacist).  A 57-year-old male patient received BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Batch/Lot number: unknown) and in Feb2021 as dose 2, single (Batch/Lot number: unknown) at the age of 56 years for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). Concomitant medication(s) included: PRINZIDE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, 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 available information and the known product safety profile a causal relationship between the reported events, COVID 19, Drug Ineffective and BNT162B2 is considered possible.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: covid-19; covid-19; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 23Oct2021 as dose 3 (booster), single (Lot number: 3015513A), in left arm and on 01Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 72 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 03Feb2021 as dose 1, single (Lot number: 038K20A), in left arm and on 03Mar2021 as dose 2, single (Lot number: 025A21A) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). The patient's 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". 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, suspected covid-19.  Clinical course: The patient was treated for COVID-19 with paxlovid from 14Jun2022 to 19Jun2022. The patient had no known allergies.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: had COVID-19; had COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse), Program ID:. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1 single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "had 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 the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Chest discomfort, Diarrhoea, Gait disturbance, Headache
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown). The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, manufacturer unknown.), for Covid-19 immunization. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "massive blood clot in left leg around knee in calf area that later moved to abdomen"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "arm was burning at the site"; CHEST DISCOMFORT (non-serious), outcome "unknown", described as "something was squeezing so hard on the right side of chest it was taking my breath"; VOMITING (non-serious), outcome "unknown", described as "threw up"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; HEADACHE (non-serious), outcome "unknown", described as "blasting headache"; ASTHENIA (non-serious), outcome "unknown", described as "so weak"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "couldn't hardly walk". Clinical course of the events: After receiving the 2nd Covid vaccine the Pfizer, within mins after taking the shot, patient arm was burning at the site and something was squeezing so hard on the right side of chest it was taking breath, threw up, diarrhoea, blasting headache, and was so week that patient could not hardly walk. 3 weeks to the day patient was diagnosed with massive blood clot in left leg around knee and calf area that later moved to abdomen where patient had to have a venous wall stent. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis, Vaccination site pain, Vomiting
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown). The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, manufacturer unknown.), for Covid-19 immunization. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "massive blood clot in left leg around knee in calf area that later moved to abdomen"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "arm was burning at the site"; CHEST DISCOMFORT (non-serious), outcome "unknown", described as "something was squeezing so hard on the right side of chest it was taking my breath"; VOMITING (non-serious), outcome "unknown", described as "threw up"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; HEADACHE (non-serious), outcome "unknown", described as "blasting headache"; ASTHENIA (non-serious), outcome "unknown", described as "so weak"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "couldn't hardly walk". Clinical course of the events: After receiving the 2nd Covid vaccine the Pfizer, within mins after taking the shot, patient arm was burning at the site and something was squeezing so hard on the right side of chest it was taking breath, threw up, diarrhoea, blasting headache, and was so week that patient could not hardly walk. 3 weeks to the day patient was diagnosed with massive blood clot in left leg around knee and calf area that later moved to abdomen where patient had to have a venous wall stent. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.