chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
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 a contactable reporter(s) (Nurse). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Jan2021 as dose 1, single (Lot number: EL3246), in left arm, on 03Feb2021 as dose 2, single (Lot number: EM9810), in left arm, on 23Sep2021 as dose 3 (booster), single (Lot number: FF2587), in left arm and on 15Apr2022 at 15:30 as dose 4 (booster), single (Lot number: FK9893) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "polymyalgia rheumatica" (unspecified if ongoing); "osteopenia" (unspecified if ongoing). Concomitant medication(s) included: PREDNISONE, start date: 02Dec2021; NEXIUM [ESOMEPRAZOLE SODIUM]; VITAMIN D [COLECALCIFEROL]; VITAMIN C [ASCORBIC ACID]; XYZAL; CALCIUM CARBONATE; ALBUTEROL [SALBUTAMOL]. The following information was reported: COVID-19 (medically significant) with onset 28May2022, outcome "not recovered", VACCINATION FAILURE (medically significant) with onset 29May2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28May2022) negative; (29May2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid, treatment start date 20May2022, treatment stop date 24May2022 for Treatment of COVID-19. Clinical course: Other medication in 2 weeks product Iron supplement. The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. Completed Paxlovid on Tuesday evening felt fine. Did rapid test 28May2022 (Saturday) morning and was negative. 28May2022 (Saturday) afternoon started sneezing, runny nose. Symptoms continued to worsen on 29May2022 (Sunday) so patient did a rapid test and it was positive. Patient had no known allergies.; Sender's Comments: Based on the information in the case report, a causal association between reported events and suspect BNt162B2 cannot be excluded.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Apr2022 as dose 4 (booster), single (Lot number: Fp4554) at the age of 51 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), 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); "allergies" (unspecified if ongoing); "high BP" (unspecified if ongoing); "known allergies: Allergic to shellfish" (unspecified if ongoing); "known allergies:kiwi fruit" (unspecified if ongoing); "known allergies: mold" (unspecified if ongoing). Concomitant medication(s) included: SINGULAIR; SYNTHROID; ESCITALOPRAM; RAMIPRIL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EN6202), in left arm, on 18Mar2021 as dose 2, single (Lot number: EN6204), in left arm and on 24Sep2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Mild emphysema" (unspecified if ongoing), notes: Mild emphysema; "Lobectomy" (unspecified if ongoing), notes: Lobectomy; "Known allergies: Pineapple" (unspecified if ongoing), notes: Known allergies: Pineapple. Concomitant medication(s) included: VITAMIN D3, start date: 06Jun2019, stop date: 12May2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11May2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11May2022) Positive, notes: Initially tested positive for COVID on 11May2022; (20May2022) Negative, notes: Finally had tested negative; (24May2022) Positive, notes: I again tested positive for COVID. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Treatment start date was 11May2022 and stop date was 17May2022.  7 days after her last dose of Paxlovid (17May2022), and 3/4 days after she finally had tested negative (20May) she again tested positive for COVID on 24May2022. (Initially tested positive for COVID on 11May2022, and started Paxlovid the evening of 12May2022). Report about COVID treatment: Yes. The patient received Other medication in 2weeks is reported as Yes.
Age: 56.0
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 contactable reporter(s) (Other HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), on 15Mar2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 56 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: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive; (May2022) Negative. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical course: After dramatically reducing both symptoms and viral load (as measured by intensity of positive test on health rapid antigen test), symptoms began to return on 28May2022 and are nearly as severe as Day 1 of treatment. Intensity of positive antigen test, after testing negative on Day 5 of Paxlovid treatment, was now stronger than any earlier test. The patient had no other medications in 2 weeks. The patient was treated with Paxlovid (lot number: FY7031) for covid-19. Treatment start date was 22My2022 and stop date was 26May2022. The patient had no known allergies. The patient had OTC medications as treatment for the adverse event.   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 in the case report, a causal association between reported events and suspect BNT162B2 cannot be excluded.
Age: 39.0
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 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03May2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 25Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 39 years, in left 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: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: MONTELUKAST; FLONASE [FLUTICASONE PROPIONATE]; VITAMIN B12 [CYANOCOBALAMIN]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "recovering" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27May2022) Positive; (May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: Paxlovid started on 15May2022 and stopped on 20May2022 for COVID 19 Treatment. Paxlovid ''rebound'' of symptoms and positive antigen test result 1 week after last Paxlovid dose. On 27May2022, event started. No hospitalization prolonged.  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, COVID19
Symptoms: Drug ineffective, Immunisation, Off label use, Suspected COVID-19
Clinical narrative: Booster; Off label use; 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 75-year-old male patient received BNT162b2 (BNT162B2), on 24Sep2021 at 12:00 as dose 3 (booster), single (Lot number: 130130814) at the age of 74 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 14May2022 at 12:00 as dose 4 (booster), single (Lot number: 056m2/h), 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: "Controlled high HBO" (unspecified if ongoing), notes: Other medical history: Controlled high HBO; "Cholesterol" (unspecified if ongoing); "Interchange of vaccine products" (unspecified if ongoing), notes: Moderna: vaccine dose number: 4/Pfizer / BioNTech: vaccine dose number:3. The patient took concomitant medications. The following information was reported: IMMUNISATION (medically significant) with onset 14May2022, outcome "unknown", described as "Booster"; OFF LABEL USE (medically significant) with onset 14May2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Lot number: EP7534), on 09Apr2021 as dose 2, single (Lot number: EW0153), on 16Aug2021 as dose 3 (booster), single (Lot number: FA3120) and on 10Jan2022 as dose 4 (booster), single (Lot number: 33036BD) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN, start date: 01Jul2014, stop date: 20May2022; RAMIPRIL AUROBINDO, start date: 01Oct2019, stop date: 20May2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) negative, notes: I tested negative after treatment; (30May2022) positive, notes: Intested positive again on 30May2022. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical Course: Paxlovid was taken for covid-19 and After finishing the Paxlovid treatment on 25May2022, I had a relapse with all symptoms except fever.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 18Feb2021 at 16:45 as dose 1, single (Lot number: EM9809), in left arm, on 11Mar2021 at 16:00 as dose 2, single (Lot number: EN6205), in left arm, on 14Oct2021 at 17:00 as dose 3 (booster), single (Lot number: EW0172), in right arm and on 21Apr2022 at 17:30 as dose 4 (booster), single (Lot number: FK9894) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VALACYCLOVIR [VALACICLOVIR]; OMEPRAZOLE; MEMANTINE; MAGNESIUM CITRATE; PSYLLIUM [PLANTAGO AFRA]; TURMERIC [CURCUMA LONGA RHIZOME]; TESTOSTERONE; CALCIUM CARBONATE; VITAMIN D [COLECALCIFEROL]; GLUCOSAMINE; CHONDROITIN; VITAMIN D 3; OMEGA-3 FATTY ACIDS; FISH OIL; DICLOFENAC SODIUM. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 20May2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20May2022) Positive. Therapeutic measures were taken as a result of covid-19, vaccination failure. Clinical course: Covid symptoms 18May. Tested positive AM 20May. Took first dose of Paxlovid PM 20May. Symptom free AM 25May. Felt great until PM 28May. Strong positive test. Laid out with Covid as of 29May. No known allergies.   No follow-up attempts are possible. No further information is expected
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Lot number: EN6199), in left arm, on 02Apr2021 as dose 2, single (Lot number: EWO150), in left arm, on 14Oct2021 as dose 3 (booster), single (Lot number: 301558A), in left arm and on 29Apr2022 as dose 4 (booster), single (Lot number: FK9093) at the age of 61 years, in left arm for covid-19 immunization. The patient's relevant medical history was not reported. The patient took concomitant medications (reported as patient received other medications in two weeks of starting COVID-19 treatment). Past drug history included: Codeine, reaction(s): "Allergies: Codeine", notes: Known allergies: Codeine. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Negative, notes: Tested negative again; (24May2022) Negative, notes: Tested negative on 24May2022; (29May2022) Positive, notes: Tested positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 included COVID 19 Treatment started on 29Apr2022 and stopped on 04May2022. Clinical course was reported as, Ended Paxlovid 23May2022, tested negative on 24May2022. 5 days after last dose of Paxlovid - horrible headache. Tested negative again. 28May2022 very tired, 29May2022, Sore throat and low-grade fever. Tested positive. Feels like a sinus infection, lots of drainage on 27May2022. No treatment received for symptoms and patient was not recovered from symptoms.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
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 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2, Solution for injection), on 03Nov2021 as dose 3 (booster), single (Lot number: EW0186) at the age of 41 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: "Known allergies: Sulfa drugs" (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 18May2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Got a negative antigen test 6 days after testing positive; (unspecified date) Negative, notes: Got a negative antigen test 6 days after testing positive; (28May2022) Negative, notes: Continued to test negative until Saturday, 28May2022, when an antigen test showed a faint line; (29May2022) Positive, notes: Continued to be positive on 29May2022 and 30May2022; (30May2022) Positive, notes: Continued to be positive on 29May2022 and 30May2022. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid treatment started on 19May2022 and treatment stopped on 24May2022.  Clinical course: The patient had a mild case of COVID-19, with symptoms starting on 18May2022. Symptoms resolved within 3 days, and got a negative antigen test 6 days after testing positive. Continued to test negative until Saturday.
Age: 65.0
Sex: M
Vaccine: COVID19, UNK, UNK
Symptoms: Suspected COVID-19, 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 65-year-old male patient received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Lot number: EN6202), in left arm, on 31Mar2021 as dose 2, single (Lot number: ER8732), in left arm and on 17Nov2021 as dose 3 (booster), single (Lot number: 33026BD) at the age of 65 years, in left arm for covid-19 immunization; carvedilol (CARVEDILOL), (Batch/Lot number: unknown) at 6.25 mg 2x/day for hypertension; losartan (LOSARTAN), (Batch/Lot number: unknown) at 50 mg 1x/day for hypertension and also reported as other medications/products within 2 weeks. The patient's relevant medical history included: "HTN" (unspecified if ongoing), notes: HTN; "High Cholesterol" (unspecified if ongoing); "Stent RCA", start date: Sep2011, stop date: Sep2011, notes: Stent RCA. Concomitant medication(s) included: ASPIRIN. The following information was reported: VACCINATION FAILURE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, suspected covid-19.   Clinical course was reported as, The stopped all medicine for HTN (hypertension), Cholesterol and aspirin day 1 and proceeded on Paxlovid treatment as scheduled with no variation in dosage or application. On day 3 started HTN (hypertension) medicine only (Carvedilol 6.25mg BID and Losartan 50mg once daily), headaches started within a couple of hours and persisted until I took 1300 mg Acetaminophen. Day 4, same results/same treatment. The patient had headaches, so, he thought this was odd. There was no change in routine, and he was well hydrated. Slight diarrhea but not severe. The nasal and mouth taste is awful but the treatment worked. The patient started to feel better on Day 3 and improved measurably over the remaining 2 days of treatment.  No follow-up attempts are possible. No further information is expected.
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old 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) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; ALBUTEROL [SALBUTAMOL]. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset May2022, outcome "unknown", COVID-19 (medically significant) with onset May2022, outcome "not recovered" and all described as "COVID-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) positive, notes: Testing positive again. Therapeutic measures were taken as a result of covid-19. Clinical course: Seriousness criteria-Results in death: No, Life threatening: No, Caused/prolonged hospitalization: No, Disabling/Incapacitating: No, Congenital anomaly/birth defect: No. Anti-viral details: COVID 19 Treatment, Pfizer Paxlovid, Treatment start date: 16May2022, Treatment stop date: 20May2022 AND indication: Treatment of COVID-19. The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. Reported Event: Symptoms came back 1 week after treatment completed. Testing positive again.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 17.0
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 17-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Aug2021 as dose 2, single (Lot number: EW0191) at the age of 17 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. Treatment of COVID-19 with Paxlovid.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the parent.  An 11-year-old male 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 "positive COVID-19 test with symptoms". The patient was very sick for 5 days, coughing, fever, diarrhea and lethargic. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 18Jan2021 as dose 1, single (Lot number: EL0140), in left arm, on 09Feb2021 as dose 2, single (Lot number: EL3200), in left arm and on 16Aug2021 as dose 3 (booster), single (Lot number: EW0168) at the age of 54 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 07Feb2022 as dose 4 (booster), single (Lot number: 013H21B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "CLL" (unspecified if ongoing); "past kidney cancer" (unspecified if ongoing); "nephrectomy" (unspecified if ongoing); "CKD" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "Dose:4 Moderna/  Dose: 1, 2 and 3 Pfizer" (unspecified if ongoing), notes: Dose:4 Moderna/  Dose: 1, 2 and 3 Pfizer. The patient's concomitant medications were not reported. Patient had no known allergies.   The following information was reported: VACCINATION FAILURE (medically significant) with onset May2022, outcome "unknown", COVID-19 (medically significant) with onset May2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive; (May2022) positive, notes: Tested positive (rapid and PCR) and began Paxlovid on evening of day 3 of illness; (May2022) positive, notes: Tested positive (rapid and PCR) and began Paxlovid on evening of day 3 of illness, Symptoms subsided and rapid tests were negative on days 7 and 8 (last morning of Paxlovid use); (May2022) Negative, notes: rapid tests were negative on days 7 and 8 (last morning of Paxlovid use); (May2022) Negative, notes: rapid tests were negative on days 7 and 8 (last morning of Paxlovid use); (May2022) Negative, notes: Tested negative again with rapid tests on day 9 and morning of day 12; (May2022) Positive, notes: Late evening of day twelve symptoms returned and tested positive with rapid antigen. Patient was Still positive and symptomatic on day 15. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: No other medication in 2 weeks. Anti-viral details product: COVID 19 Treatment, brand: Paxlovid, treatment start date:18May2022, treatment stop date: 23May2022, indication: treatment of COVID-19. Adverse event: Rebound following Paxlovid: Tested positive (rapid and PCR) and began Paxlovid on evening of day 3 of illness. Symptoms subsided and rapid tests were negative on days 7 and 8 (last morning of Paxlovid use). Tested negative again with rapid tests on day 9 and morning of day 12. Late evening of day twelve symptoms returned and tested positive with rapid antigen. Still positive and symptomatic on day 15. Adverse event start date: 27May2022, no treatment and no known allergies. Device timestamp: 30May2022.
Age: 54.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Apr2021 as dose 1, single (Lot number: PAA165969), on 10May2021 as dose 2, single (Lot number: EW0185) and on 22Nov2021 as dose 3 (booster), single (Lot number: 32030930) at the age of 54 years 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) all with onset May2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course information: It was reported that the patient had no known allergies and the patient was not taking any other medications in 2 weeks.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Brugada syndrome
Clinical narrative: Brugada syndrome; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EL9265) and as dose 2, single (Lot number: EN6201) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BRUGADA SYNDROME (medically significant), outcome "not recovered".  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Inflammation, Neuropathy peripheral, Pain, Spinal osteoarthritis
Clinical narrative: neuropathy in both feet and calves and in my hands; My neck and upper back have osteoarthritis; extreme inflammation; excruciating pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in 2021 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: PAIN (non-serious) with onset 2021, outcome "not recovered", described as "excruciating pain"; NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "neuropathy in both feet and calves and in my hands"; SPINAL OSTEOARTHRITIS (non-serious), outcome "unknown", described as "My neck and upper back have osteoarthritis"; INFLAMMATION (non-serious), outcome "unknown", described as "extreme inflammation". Our COVID vaccines gave patient neuropathy in both feet and calves and in their hands. Their neck and upper back had osteoarthritis and extreme inflammation which they never had before. A year and 3 months since the vaccines have left them in excruciating pain. Their life as they knew it was destroyed. They were at 3x a week gym before our vaccines and climbed mountains in between. Now they can hardly get to the supermarket. We need to admit and compensate those of them injured by of our vaccine.  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: Dry mouth
Clinical narrative: a severe case of dry mouth; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (dose number unknown 1st Booster dose, unknown manufacturer), for COVID-19 Immunization. The following information was reported: DRY MOUTH (non-serious), outcome "recovering", described as "a severe case of dry mouth".  Additional information: Customer Verbatim: A few weeks after getting the 2nd COVID-19 booster shot, I suddenly got a severe case of dry mouth. I still have it, but it is slightly better. There was no change to my medications or any other indicators to cause this. Could it be a delayed reaction to your vaccine, could this be a super mild reaction to maybe having COVID without knowing it (asymptomatic).  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: Eye pain, Headache, Movement disorder, Muscle spasms, Off label use
Clinical narrative: The pharmacist injected me way too deep in the muscle; Heart racing; body aches; muscle spasms; Headaches; pain behind my eyes; Bled and could barely move my arm for 5 days; Bled and could barely move my arm for 5 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (003110). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown), in arm 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, reaction(s): "had zero side effects"; Covid-19 vaccine (Dose: 2, Manufacturer Unknown), for Covid-19 Immunization, reaction(s): "had zero side effects"; Covid-19 vaccine (Dose: 3, 1st booster, Manufacturer Unknown), for Covid-19 Immunization, reaction(s): "had zero side effects". The following information was reported: OFF LABEL USE (non-serious), outcome "unknown", described as "The pharmacist injected me way too deep in the muscle"; PALPITATIONS (non-serious), outcome "unknown", described as "Heart racing"; PAIN (non-serious), outcome "unknown", described as "body aches"; MUSCLE SPASMS (non-serious), outcome "unknown"; HEADACHE (non-serious), outcome "unknown", described as "Headaches"; EYE PAIN (non-serious), outcome "unknown", described as "pain behind my eyes"; VACCINATION SITE HAEMORRHAGE (non-serious), MOVEMENT DISORDER (non-serious), outcome "unknown" and all described as "Bled and could barely move my arm for 5 days".  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: Pain, Palpitations, Vaccination site haemorrhage
Clinical narrative: The pharmacist injected me way too deep in the muscle; Heart racing; body aches; muscle spasms; Headaches; pain behind my eyes; Bled and could barely move my arm for 5 days; Bled and could barely move my arm for 5 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (003110). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown), in arm 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, reaction(s): "had zero side effects"; Covid-19 vaccine (Dose: 2, Manufacturer Unknown), for Covid-19 Immunization, reaction(s): "had zero side effects"; Covid-19 vaccine (Dose: 3, 1st booster, Manufacturer Unknown), for Covid-19 Immunization, reaction(s): "had zero side effects". The following information was reported: OFF LABEL USE (non-serious), outcome "unknown", described as "The pharmacist injected me way too deep in the muscle"; PALPITATIONS (non-serious), outcome "unknown", described as "Heart racing"; PAIN (non-serious), outcome "unknown", described as "body aches"; MUSCLE SPASMS (non-serious), outcome "unknown"; HEADACHE (non-serious), outcome "unknown", described as "Headaches"; EYE PAIN (non-serious), outcome "unknown", described as "pain behind my eyes"; VACCINATION SITE HAEMORRHAGE (non-serious), MOVEMENT DISORDER (non-serious), outcome "unknown" and all described as "Bled and could barely move my arm for 5 days".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 53.0
Sex: F
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 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Oct2021 at 12:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 53 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Seasonal allergies" (unspecified if ongoing), notes: Known allergies: Seasonal allergies; "Known allergies: tree nuts" (unspecified if ongoing), notes: Known allergies: tree nuts; "Carotid artery disease" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Familial high cholesterol" (unspecified if ongoing), notes: Familial high cholesterol. Concomitant medication(s) included: ROSUVASTATIN, start date: 01Oct2021, stop date: 17May2022. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset May2022, outcome "unknown", COVID-19 (medically significant) with onset May2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Negative; (28May2022) Positive. Therapeutic measures were taken as a result of covid-19. Clinical course: Antiviral Paxlovid was given from 18May2022 to 23May2022 for the Treatment of COVID-19.Patient finished the medication and tested negative. On 28May2022 she tested positive and got congested and fatigue again.  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: Pyrexia
Clinical narrative: Slight fever after a vaccine, after a booster dose (COVID-19 vaccine); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 90-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Slight fever after a vaccine, after a booster dose (COVID-19 vaccine)". Therapeutic measures were not taken as a result of pyrexia.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: weakness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): LRN4509038.  A 55-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "arthritis" (unspecified if ongoing); "multiple sclerosis" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "depression" (unspecified if ongoing). Concomitant medication(s) included: TAMSULOSIN; PHENAZOPYRIDINE; BIOTIN; VITAMIN D3; FLUCONAZOLE; FLUOXETINE; SULFAMETHOXAZOLE; CEFUROXIME. The following information was reported: ASTHENIA (non-serious), outcome "unknown", described as "weakness".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 36-year-old male patient received BNT162b2 (BNT162B2), on 21Mar2021 as dose 1, single (Batch/Lot number: unknown), on 21Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 13Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 35 years for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The patient did not receive any other medications/products within 2 weeks of starting COVID-19 treatment. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of covid-19 with Paxlovid from 20May2022 to 24May2022. The patient experienced rebound COVID on 28May2022 at 04:00 PM after a full course of Paxlovid. The patient started testing negative one day after completing the five-day course. Two days later, he had fully recovered with no symptoms. 2-3 days after. He started to become Sick again and tested three times positive for COVID. The tests were immediately very positive (more so than any test he took during Paxlovid treatment). The patient was symptomatic and isolating again. While the symptoms were not as severe as the first round, he was quite sick.   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: C-reactive protein, Inappropriate schedule of product administration, Pain
Clinical narrative: Increase in pain all in parts; 1st dose 02Feb2021; 2nd dose 19Feb2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 19Feb2021 as dose 2, single (Lot number: EN6198) intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Knee osteoarthritis", start date: 1990 (ongoing), notes: Pertinent details: Knee replaced 2019; "Osteoarthritis moderate", start date: 2018 (ongoing), notes: Pertinent details: mild symptoms plus R hip x-ray showed moderate osteoarthritis. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 1st, Time: AM, Anatomical Site of injection: Left bicept occ, Route of administration: Intramuscular, Batch/Lot Number: EN5318), administration date: 02Feb2021, for Covid-19 Immunization, reaction(s): "PMR", "Severe neck, shoulder, hip pain", "Stiffness". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 19Feb2021, outcome "unknown", described as "1st dose 02Feb2021; 2nd dose 19Feb2021"; PAIN (non-serious) with onset 08Mar2021, outcome "recovering", described as "Increase in pain all in parts". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain.  Additional information: Prior Vaccinations (within 4 weeks): None. Family medical history relevant to ae(s): Patient was able to go down on my prednisone from 15 mg QD (every day) to 7 mg QD (every day) over 6 months then I got my booster and my pain came back even worse and my CRP went from 10 before booster to 85 after booster with really extreme PMR symptoms. After second dose 19Feb2021, symptoms worsened and was treated with 40 mg prednisone for 5 days and symptoms got much better. A few days after patient completed my prednisone all symptoms returned 8Mar2021 patient got my first labs, my CRP 68. Patient was treated PMR with prednisone 15 mg QD (every day). On 08Mar2021, patient had my first CRP but was treated with 40 mg prednisone 5 days which patient finished my 5th dose 05Mar2021.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: M
Vaccine: RAB
Symptoms: Myocarditis
Clinical narrative: myocarditis; Initial information received on 23-May-2022 via healthcare professional regarding an unsolicited valid serious case issued from a literature article.  This case involves a 58-year-old male patient who experienced myocarditis while receiving rabies vaccine (latency: few weeks).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect rabies vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  Few weeks later after 14 injections, the patient developed a serious myocarditis.  Action taken: not applicable. Corrective treatment: vitamin B complex and trihexyphenidyl hydrochloride (Sedrena) extract. Outcome: recovered  Seriousness criteria: medically significant Reporter causality: related Based upon the reported information, the role of a vaccine cannot be assessed.; Sender's Comments: Sanofi company comment dated 31-May-2022:  This case involves a 58-year-old male patient who experienced myocarditis while receiving rabies vaccine. Based upon the information the role of suspect drugs cannot be denied however the lack of information related to past drugs, medical history and concomitant drugs precludes better case assessment.
Sex: F
Vaccine: DTP
Symptoms: Autism spectrum disorder
Clinical narrative: autism; Initial information received on 25-May-2022 regarding an unsolicited valid  serious case received from a consumer/non-hcp.  This case involves Child female patient who experienced autism while receiving vaccine diphtheria, tetanus and nos pertussis vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect diphtheria, tetanus and nos pertussis vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a serious autism (autism spectrum disorder) (unknown latency). This event was assessed as medically significant.  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the event (autism).  At time of reporting, the outcome was Unknown for the event autism.; Sender's Comments: Sanofi Company Comment dated 30-MAY-2022: This case involves Child female patient who experienced autism while receiving vaccine diphtheria, tetanus and nos pertussis vaccine. Further information regarding concurrent condition during vaccination, previous vaccination, concomitant medication and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: No outcoms
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: Systemic: itchy throat about 10 minutes after dose-Mild, Additional Details: pt stated she had allergic rxn(itchy throat) to all 3 doses of pfizer. stated shes cant be given epinephrine due to heart condtion per dr.  At 3:35 pt was given moderna booster. at 3:50 pt had itchy throat, she was given 3 teaspoon of benadryl.  at 4:05 pt stated she felt better but slight itchy throat still present. she was given an additional 1 teaspoon (total given 4 teaspoon=50mg).pt left at 4:15 feeling good. called at 4:57 pt feels good!
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Redness and swelling going down arm of injection to hands-Medium
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: Systemic: patient had no reactions-Mild, Additional Details:  there were no symptoms reported  spoke to the patient