chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
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 26-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Lot number: EN6203), in right arm, on 26Mar2021 as dose 2, single (Lot number: EN6200), in left arm and on 09Sep2021 as dose 3 (booster), single (Lot number: 381308A) at the age of 25 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "History of cancer (Hodgkins lymphoma)", stop date: Aug2019, notes: History of cancer (Hodgkins lymphoma), NED since Aug2019; "Known allergies: Shellfish" (unspecified if ongoing); "History of asthma (childhood + allergy" (unspecified if ongoing), notes: History of asthma (childhood + allergy, induced); "chronic muscular pain" (unspecified if ongoing), notes: chronic muscular pain; "TMJ" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing). Concomitant medication(s) included: DULOXETINE, start date: 01Sep2021; BUPROPION(MFG Lupin), start date: 01Feb2022; SPIRONOLACTONE, start date: 01Aug2021; CETIRIZINE HCL, start date: 01Jun2022; ACETAMINOPHEN, start date: 26Jun2022, stop date: 03Jul2022; IBUPROFEN, start date: 26Jun2022; ALBUTEROL SULFATE HFA( inhaler, Prasco), start date: 27Jun2022, stop date: 28Jun2022; SUPER OMEGA 3 [COLECALCIFEROL;FOLATE SODIUM;MAGNESIUM;OMEGA-3 FATTY ACIDS;PYRIDOXINE HYDROCHLORIDE;VITAMIN B12 NOS;VITAMIN E NOS], start date: 01Apr2022; COQ10 [UBIDECARENONE](Nitrigold), start date: 15Mar2022; Mini Multi vitamin, start date: 01Apr2022. 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 started Paxlovid on day 1 (the day after symptom onset) and completed it on day 6. The patient's symptoms resolved on day 8, she tested negative at home on an antigen test on days 7 and 8. The patient began experiencing symptoms again on day 11, symptoms progressed and she tested positive at home on an antigen test on day 12. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results; Positive, notes: day 12; Negative, notes: day 7; Negative, notes: day 8. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid(lot number: GA2851) from  27Jun2022 to 01Jul2022.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test, Vaccination failure
Clinical narrative: Tested positive for Covid; Tested positive for Covid; 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 female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Feb2021 at 12:30 as dose 1, single (Lot number: EM9809), in left arm, on 01Mar2021 at 12:30 as dose 2, single (Lot number: EM6203), in left arm and on 02Nov2021 at 12:00 as dose 3 (booster), single (Lot number: FG3527) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "blood pressure abnormal" (unspecified if ongoing), notes: high blood pressure; "cholesterol" (unspecified if ongoing); "obesity" (unspecified if ongoing). Concomitant medication(s) included: ZOCOR, start date: 29Jun2022, stop date: 29Jun2022; PRINIVIL; COREG; VITAMIN D3. Past drug history included: Tetracycline, reaction(s): "known allergies: tetracycline", notes: known allergies: tetracycline. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Jun2022, outcome "not recovered" and all described as "Tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (29Jun2022) positive, notes: Tested positive for Covid on 29Jun2022; (06Jul2022) Negative, notes: tested negative on 06Jul2022; (09Jul2022) positive, notes: tested positive again on 09Jul2022. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical details: Tested positive for Covid on 29Jun2022, took PAXLOVID for 5 days, tested negative on 06Jul2022. Symptoms returned again on 08Jul2022, tested positive again on 09Jul2022. The events did not result in emergency room visit, physician office visit.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Feb2021 as dose 1, single (Batch/Lot number: unknown), on 03Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 22Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 45 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 Jun2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient received Paxlovid as treatment of COVID-19 from 24Jun2022 to 29Jun2022. Patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. Patient previously received COVID-19 vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 51.0
Sex: F
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 a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Mar2021 as dose 1, single (Lot number: ER8732), in left arm and on 09Apr2021 as dose 2, single (Lot number: ER8729) at the age of 51 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 01Nov2021 as dose 3 (booster), single (Lot number: 939903), in left arm and on 06Apr2022 as dose 4 (booster), single (Lot number: 066K21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "cancer" (unspecified if ongoing), notes: Other medical history: cancer, Crohn's; "Crohn's" (unspecified if ongoing), notes: Other medical history: cancer, Crohn's; "Known allergies: mild laytex" (unspecified if ongoing), notes: Known allergies: neo/poly sporin; mild laytex. Concomitant medication(s) included: MESALAMINE. Past drug history included: Neo/poly sporin, reaction(s): "Known allergies: neo/poly sporin", notes: Known allergies: neo/poly sporin; mild laytex; Neo/poly sporin, reaction(s): "Known allergies: neo/poly sporin", notes: Known allergies: neo/poly sporin; mild laytex.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED 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: (unspecified date) Unknown Results; (05Jul2022) positive, notes: tested positive again four days after stopping Paxlovid. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: Patient had Paxlovid from 26Jun2022 to 01Jul2022 for COVID 19 Treatment. Paxlovid rebound. Symptom returned and tested positive again four days after stopping Paxlovid. Patient also had treatment of Ipratropium Bromide.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200945085 Same patient/drug, different dose/events;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter (Other HCP). The reporter is the patient.  A 31-year-old female patient (pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient had no known allergies. The patient was 20 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 27Nov2022. Concomitant medication(s) included: SERTRALINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Anti-viral drug Paxlovid.  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 available information and known product profile, the causal relationship of the reported drug ineffective and the use of BNT162B2 cannot be fully excluded.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Mar2021 as dose 1, single (Lot number: ER8730), in left arm, on 20Apr2021 as dose 2, single (Lot number: EW0170), in left arm and on 23Sep2021 as dose 3 (booster), single (Lot number: 301458A) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Mild allergy to dairy products" (unspecified if ongoing), notes: Mild allergy to dairy products; "excess oil in cooking" (unspecified if ongoing), notes: excess oil in cooking. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: never tested positive again. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical Course: It was reported that other medication details included other medication in 2 weeks product atorvastatin 10mg, Lipitor (Twice a week/Mon & Thurs), multivitamin, Centrum Silver, Vitamin D3 2000 IU, Calcium 500mg. It was also reported that patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. Patient was previously receive a COVID-19 Vaccine. It was also reported that on 03Jul, 6.5 days after completing 5 day treatment, cough and nasal drip into throat started. Symptoms continued through Friday evening 08Jul. No symptoms on Saturday 09Jul. Conducted several at home Covid tests during this period, never tested positive again.
Age: 74.0
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) from product quality group. The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Feb2021 at 12:00 as dose 1, single (Lot number: EN6202), in right arm, on 26Mar2021 at 12:00 as dose 2, single (Lot number: ER8730), in right arm, on 01Oct2021 at 12:00 as dose 3 (booster), single (Lot number: FF2589), in right arm and on 11Apr2022 at 12:00 as dose 4 (booster), single (Lot number: FJ9943) at the age of 74 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: statin drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Percocet, reaction(s): "Known allergies: Percocet"; Naproxen, reaction(s): "Known allergies: Naproxen".  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. Clinical course: No chronic conditions or illnesses at this time other than Covid.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Lymphadenopathy, Nasal congestion, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: sore throat; swollen gland; nasal congestion; COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Apr2021 as dose 1, single (Lot number: ER8737), in left arm, on 24Apr2021 as dose 2, single (Lot number: EW0161), in left arm and on 02May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 29Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "migraines" (unspecified if ongoing); "hx of breast cancer" (unspecified if ongoing), notes: hx of breast cancer and chemo damaged my heart.; "chemo damaged my heart." (unspecified if ongoing), notes: hx of breast cancer and chemo damaged my heart.; "chemo damaged my heart." (unspecified if ongoing), notes: hx of breast cancer and chemo damaged my heart.; "Known allergies: Itchy with latex" (unspecified if ongoing). Concomitant medication(s) or other medication in 2 weeks included: AIMOVIG and THYROID MEDICATIONS. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID-19"; NASAL CONGESTION (non-serious) with onset 08Jul2022, outcome "recovering"; OROPHARYNGEAL PAIN (non-serious) with onset 08Jul2022, outcome "recovering", described as "sore throat"; LYMPHADENOPATHY (non-serious) with onset 08Jul2022, outcome "recovering", described as "swollen gland". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jul2022) Negative, notes: Had a negative home test on 06Jul2022; (08Jul2022) Positive, notes: home test had a very slight mark for positive; (09Jul2022) Positive, notes: 09Jul2022 home test was positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 29Jun2022 to 04Jul2022. Therapeutic measures were not taken as a result of oropharyngeal pain, lymphadenopathy, nasal congestion. The patient had a negative home test on 06Jul2022. Started with nasal congestion on 08Jul2022 and home test had a very slight mark for positive. On 09Jul2022, the home test was positive and had more symptoms, sore throat, swollen gland, nasal congestion.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: sore throat; swollen gland; nasal congestion; COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Apr2021 as dose 1, single (Lot number: ER8737), in left arm, on 24Apr2021 as dose 2, single (Lot number: EW0161), in left arm and on 02May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 29Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "migraines" (unspecified if ongoing); "hx of breast cancer" (unspecified if ongoing), notes: hx of breast cancer and chemo damaged my heart.; "chemo damaged my heart." (unspecified if ongoing), notes: hx of breast cancer and chemo damaged my heart.; "chemo damaged my heart." (unspecified if ongoing), notes: hx of breast cancer and chemo damaged my heart.; "Known allergies: Itchy with latex" (unspecified if ongoing). Concomitant medication(s) or other medication in 2 weeks included: AIMOVIG and THYROID MEDICATIONS. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID-19"; NASAL CONGESTION (non-serious) with onset 08Jul2022, outcome "recovering"; OROPHARYNGEAL PAIN (non-serious) with onset 08Jul2022, outcome "recovering", described as "sore throat"; LYMPHADENOPATHY (non-serious) with onset 08Jul2022, outcome "recovering", described as "swollen gland". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jul2022) Negative, notes: Had a negative home test on 06Jul2022; (08Jul2022) Positive, notes: home test had a very slight mark for positive; (09Jul2022) Positive, notes: 09Jul2022 home test was positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 29Jun2022 to 04Jul2022. Therapeutic measures were not taken as a result of oropharyngeal pain, lymphadenopathy, nasal congestion. The patient had a negative home test on 06Jul2022. Started with nasal congestion on 08Jul2022 and home test had a very slight mark for positive. On 09Jul2022, the home test was positive and had more symptoms, sore throat, swollen gland, nasal congestion.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 70-year-old male patient received BNT162b2 (BNT162B2), on 27May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. There was no known allergy. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 22Jun2022, outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid for COVID 19 from 25Jun2022 to 30Jun2022.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2, on 12Feb2021 as dose number unknown, single (Batch/Lot number: unknown), in left arm, on 19Mar2021 as dose number unknown, single (Batch/Lot number: unknown), in left arm and on 12Nov2021 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 58 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 "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had no known allergies. Patient received paxlovid from 28Jun2022 to 03Jul2022 for treatment of COVID-19. After completing paxlovid for COVID infection, 4 days without positive test, now positive again.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 30.0
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 31-year-old male patient received BNT162b2 (BNT162B2), on 05Mar2021 at 11:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 26Mar2021 at 11:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 01Oct2021 at 11:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 30 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: COVID-19 (medically significant) with onset 08Jul2022 at 11:00, outcome "recovering", VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: anti viral details product: COVID 19 Treatment, brand: Paxlovid (from 29Jun2022 to 04Jul2022).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 54 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Jul2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results; (08Jul2022) Positive; (09Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course details: Rapid testing on 08Jul2022 showed faint positive, but was solid positive on 09Jul2022. Sore throat, nasal congestion, cough, and watery eyes flared up on 09Jul2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
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) (Other HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22May2022 at 03:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 48 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: "Inflammatory arthritis" (unspecified if ongoing); "asthma" (unspecified if ongoing). Concomitant medication(s) included: HYDROXYCHLOROQUINE. 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: Negative, notes: Symptoms returned after negative test. Therapeutic measures were taken as a result of covid-19.  Clinical course: Patient did not have any known allergies. Patient received anti-viral as Covid-19 treatment from 28Jun2022 to 02Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The company cannot completely exclude the possible causality between the reported COVID-19, which is considered as failure of vaccine BNT162B2, and the administration of BNT162B2, as the efficacy of a vaccine varies individually and may be affected by different factors including drug potency.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
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 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Lot number: EP7534), on 20Apr2021 as dose 2, single (Lot number: ER8733), in right arm and on 02Dec2021 as dose 3 (booster), single (Lot number: FJ8762) at the age of 62 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. No known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. The patient received Paxlovid from 01Jul2022 to 06Jul2022 as treatment of COVID-19.
Age: 74.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4453153-00. A 74-year-old male patient received BNT162b2 (BNT162B2), on 05Aug2021 as dose 1, single (Batch/Lot number: unknown) at the age of 74 years intramuscular for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: RINVOQ oral. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 2021, outcome "unknown", SUSPECTED COVID-19 (medically significant) with onset 2021, outcome "recovered with sequelae" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2021) Unknown results, notes: the patient experienced COVID-19. Additional information: Causality as per reporter (Drug/Vaccine): Possible  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-PV202200019625 same patient, drug; different dose, event;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 25-year-old male patient received BNT162b2, in Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid from 27Jun2022 to 02Jul2022 for COVID 19 treatment. Patient got paxlovid immediately so although patient had tested positive, was asymptomatic for the duration of paxlovid treatment.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter (Physician). The reporter is the patient. A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Sep2021 as dose 3 (booster), single at the age of 45 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "penicillin allergy" (unspecified if ongoing); "sulfa drugs allergy" (unspecified if ongoing); "shrimp allergy" (unspecified if ongoing). No other medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" (08Jul2022) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive; (Jun2022) remained positive, notes: after 5 day treatment; (Jul2022) negative, notes: 4 days after the recrudescence. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 24Jun2022 to 28Jun2022. Clinical course: Initial COVID symptoms improved while on Paxlovid, but antigen test remained positive after 5 day treatment (test bar became lighter in color). Then the bar began to darken again and patient had recurrence of COVID symptoms on July 4th, 10 days after initial positive test. Symptoms included runny nose and body aches and lasted 3 days. Patient antigen test became negative 4 days after the recrudescence.; Sender's Comments: Based on the available information provided, the causal association between the reported events (Drug ineffective and COVID-19) and BNT162B2, cannot be excluded. Case to be reassessed should a follow-up information becomes available.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a 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 27Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 55 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Migraines" (unspecified if ongoing). Concomitant medication(s) included: CRESTOR. Past drug history included: Dilaudid, reaction(s): "Known allergies: Dilaudid". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received treatment of Paxlovid, Treatment start date: 09Jul2022, Treatment stop date: 10Jul2022, Lot number: .  No follow-up attempts were possible. No further information was expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  A 35-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 14Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 11Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 33 years for covid-19 immunization; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 06Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "ADHD" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Bipolar 2 disorder" (unspecified if ongoing), notes: Bipolar 2 disorder; "Depression" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Chronic pain" (unspecified if ongoing). The patient's concomitant medications were not reported. It was unknown whether the patient was pregnant at time of vaccination. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Therapeutic measures included anti-viral details: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment started on 30Jun2022 and stopped on 05Jul2022 via oral route, Indication: Treatment of COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
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 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 14Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 14Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 32 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "obesity" (unspecified if ongoing). Concomitant medication(s) included: DAYQUIL AND NYQUIL SEVERE+  VAPOCOOL COLD AND FLU, start date: 20Jun2022, stop date: 22Jun2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30Jun2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Jun2022) Negative; (29Jun2022) Negative; (30Jun2022) Positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 41.0
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 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Mar2021 at 09:00 as dose number unknown ,  single (Batch/Lot number: unknown), in right arm, on 12Apr2021 at 14:00 as dose number unknown, single (Batch/Lot number: unknown), in left arm and on 14Oct2021 at 18:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "environmental allergies" (unspecified if ongoing); "miscarriage last month" (unspecified if ongoing); "elevated BMI of 28" (unspecified if ongoing), notes: elevated BMI of 28. Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; FLONASE [FLUTICASONE PROPIONATE]; AZELASTINE; FLOVENT; PREDNISONE, stop date: 22Jun2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07Jul2022 at 08:00, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: Bixnar test was nearly negative (faint line barely detectable); (27Jun2022) Positive, notes: I took Paxlovid on day one of symptoms and day one of a first ever positive test; (05Jul2022) Positive, notes: On 05Jul my test became slightly more positive by 07Jul my test was as clearly positive; (07Jul2022) Positive, notes: On 05Jul my test became slightly more positive by 07Jul my test was as clearly positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. She took Paxlovid on day one of symptoms and day one of a first ever positive test. 4 days later my Bixnar test was nearly negative (faint line barely detectable) her symptoms outside of fatigue that had her sleeping 12-18 hours a day and a slight scratchy throat. On 05Jul her test became slightly more positive by 07Jul my test was as clearly positive as she was on day 1 and symptoms of a head cold became noticeable and bothersome. She asked her doctor for a second round of Paxlovid but that was currently not being offered to any patients. other medication details other medication in 2weeks included Zyrtec, Flonase, asalastine, Flovent, metal prednisone (ended on Jun2022). Ae resulted in None of the above. No Known allergies. Other medical history Asthma, environmental allergies, miscarriage last month, elevated BMI of 28. Treatment started on 27Jun2022 and stopped on 02Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Oct2021 as dose number unknown, single (Lot number: El3246) at the age of 51 years, in left arm for covid-19 immunisation. The patient was not pregnant at time of vaccination. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Gerd" (unspecified if ongoing); "hbp" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Zyrtec, reaction(s): "Known allergies"; Vicodin, reaction(s): "Known allergies". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received treatment brand=paxlovid, treatment start date: 27jun2022, treatment stop date: 02jul2022, Ae treatment: Paxlovid round 2. The patient Known allergies: Zyrtec and Vicodin and Other medical history: Anxiety and depression, Gerd, hbp.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: The company cannot completely exclude the possible causality between the reported COVID-19, which is considered as failure of vaccine BNT162B2, and the administration of BNT162B2, as the efficacy of a vaccine varies individually and may be affected by different factors including drug potency.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
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 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 27Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 31Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 30Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "MS" (unspecified if ongoing); "RSL (restless leg xyndrome)" (unspecified if ongoing); "treating high bp" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "Known allergies: pennicillin" (unspecified if ongoing). Concomitant medication(s) included: ROPINIROLE, start date: Jan2013; LOSARTAN POTASSIUM/HCTZ, start date: Mar2021; AUBAGIO, start date: Feb2011; TELMISARTAN, start date: Jan2022; VIT D3. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Additional information: patient received COVID 19 Treatment (Paxlovid) from 25Jun2022 to 30Jun2022 for Treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 72.0
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 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 02Feb2021 as dose 2, single (Lot number: EL9292), in left arm, on 17Aug2021 as dose 3 (booster), single (Lot number: Fc3180), in left arm and on 02Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Thyroid nodule" (unspecified if ongoing); "osteopenia" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; CELEBREX; SPIRONOLACTONE; TYLENOL; CALCIUM; VITAMIN D3; VITAMIN C [ASCORBIC ACID], start date: 27Jun2022; ZINC; COLACE. Past drug history included: Cipro, reaction(s): "Known allergies: Cipro". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient received anti-viral details: product: COVID 19 Treatment, Brand: Pfizer, from 27Jun2022 to 01Jul2022 as treatment of COVID-19. On 08Jul2022, at 12:00 PM, day 7 return of symptoms- sinus congestion, post nasal drip, no fever Positive test Follows negative test on day 6 with no symptoms. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (07Jul2022) Negative, notes: Follows negative test on day 6 with no symptoms; (08Jul2022) Positive, notes: Day 7 return of symptoms- sinus congestion, post nasal drip, no fever Positive test. Therapeutic measures were taken as a result of vaccination failure, covid-19 from 27Jun2022 to 01Jul2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: developed first COVID symptoms (fever, headache, chills, cough on Tuesday 28Jun/Both COVID PCR and rapid antigen tests were positive on 30Jun); developed first COVID symptoms (fever, headache, chills, cough on Tuesday 28Jun/Both COVID PCR and rapid antigen tests were positive on 30Jun); This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 09Dec2021 as dose 3 (booster), single (Lot number: FH3219) at the age of 64 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "ulcerative colitis" (unspecified if ongoing); "gastroesopheageal reflux" (unspecified if ongoing). Concomitant medication(s) included: MESALAMINE; HYDROCHLOROTHIAZIDE; SIMVASTATIN; AMLODIPINE; RABEPRAZOLE. There were no Known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 28Jun2022, outcome "not recovered" and all described as "developed first COVID symptoms (fever, headache, chills, cough on Tuesday 28Jun/Both COVID PCR and rapid antigen tests were positive on 30Jun)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Jul2022) Positive, notes: strongly positive; (30Jun2022) Positive; (06Jul2022) Negative; (07Jul2022) Negative; (08Jul2022) Negative; (30Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received anti-viral Treatment Paxlovid for COVID 19 from 30Jun2022 to 04Jul2022, approximately 40 hours after symptom onset. The patient completed the 5 day course and had rapid resolution of symptoms. By day 5 of treatment the patient was completely asymptomatic except for a very mild residual cough and had negative COVID rapid antigen tests on 06Jul2022, 07Jul20222 and 08Jul2022. However, on Thursday 07Jul2022, he noted recurrence of nasal congestion and mild cough and on 09Jul2022 his COVID Ag test turned strongly positive. The patient reported this as a likely case of COVID rebound.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.