chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 11Feb2021 at 10:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 11Mar2021 at 10:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 23Oct2021 at 10:00 as dose 3 (booster), single (Lot number: 301458A) at the age of 72 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 23May2022 at 09:00 as dose 4 (booster), single (Lot number: 038A22A), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: TYLENOL, start date: 20Jul2022, stop date: 22Jul2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Jul2022, outcome "recovered" (04Aug2022) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Jul2022) Positive; (30Jul2022) Positive; (04Aug2022) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course included: Other medical history was noted as none. Patient had no known allergies. Vaccine received was noted as yes. Other medication in 2 weeks was noted as Tylenol; start date was noted as 20Jul2022 and stop date was noted as 22Jul2022. Patient was tested positive on 20Jul2022, started Paxlovid for COVID 19 Treatment (indication also noted as treatment of COVID-19) (renal dose) on 21Jul2022, finished Paxlovid on 25Jul2022. COVID symptoms went away in 22Jul2022, but then had rebound Covid symptoms was noted on 30Jul2022 and tested positive. Patient tested daily, finally was negative on 04Aug2022.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for COVID-19; tested positive for 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 27-year-old male patient received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EM9809), in right arm, on 18Mar2021 as dose 2, single (Lot number: EN6207), in right arm and on 04Nov2021 at 17:00 as dose 3 (booster), single (Lot number: FF2589) at the age of 27 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Colitis ulcerative" (unspecified if ongoing), notes: Other medical history: Ulcerative colitis. There was no known allergies. Concomitant medication(s) (other medication in 2weeks) included: MUCINEX, start date: 11Aug2022, stop date: 16Aug2022; NYQUIL, start date: 11Aug2022, stop date: 18Aug2022.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10Aug2022, outcome "not recovered" and all described as "tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Aug2022) Positive, notes: On Wednesday,10Aug2022, I tested positive for COVID-19; (17Aug2022) Positive, notes: tested positive again on Wednesday the 17Aug; (18Aug2022) Negative, notes: Negative on thursday the 18th and Friday the 19th. I woke up with Thursday the 18Aug and Friday the 19Aug; (19Aug2022) Negative, notes: Negative on Thursday the 18th and Friday the 19th. I woke up with Thursday the 18Aug and Friday the 19Aug; (21Aug2022) Positive, notes: Sunday the 21Aug and tested positive again. Therapeutic measures were taken as a result of vaccination failure, covid-19 includes Paxlovid which started from 12Aug2022 and ended on 16Aug2022. Clinical course: On Wednesday, 10Aug2022, patient tested positive for COVID-19. He was isolated and was prescribed Paxlovid, which he started taking on Friday the 12Aug. He finished that course on Tuesday the 16Aug.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: My husband had the Pfizer BioNTech vaccine and he tested positive for covid today; My husband had the Pfizer BioNTech vaccine and he tested positive for covid today; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 45-year-old male patient received BNT162b2 (BNT162B2), on 15Mar2021 as dose 1, single (Lot number: EN6207), in arm, on 05Apr2021 as dose 2, single (Lot number: ER8734), in arm and on 09Oct2021 as dose 3 (booster), single (Lot number: 301308H) at the age of 44 years, in arm, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 21Aug2022, outcome "unknown" and all described as "My husband had the Pfizer BioNTech vaccine and he tested positive for covid today". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Aug2022) Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Rebound COVID with symptoms and positive antigen test; Rebound COVID with symptoms and positive antigen test; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from product quality group. The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Jun2022 as dose 4 (booster), single (Lot number: FL3197) at the age of 39 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 11Jan2021 as dose 1, single (Lot number: 011L20A), in left arm, on 08Feb2021 as dose 2, single (Lot number: 030L20A), in left arm and on 13Sep2021 as dose 3 (booster), single (Lot number: 939902), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "peanut allergy" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Rebound COVID with symptoms and positive antigen test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Rebound COVID with symptoms and positive antigen test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2 weeks was reported as no. Anti viral details: COVID 19 Treatment, Paxlovid treatment started on 10Aug2022 and stop on 15Aug2022.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) cannot be ruled out.
Age: 84.0
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.  An 85-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Apr2022 as dose 1, single (Lot number: PM 9992) at the age of 84 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. No other medication in 2 weeks. Past drug history included: Fentanyl, reaction(s): "known allergies: fentanyl", notes: known allergies: fentanyl.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Rebound Covid six days after negative test; Positive, notes: Rebound Covid six days after negative test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: patient did not take any other medications with 2 weeks.   The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 25Feb2021 at 09:00 as dose 1, single (Lot number: Gn6200), in left arm, on 16Apr2021 at 14:00 as dose 2, single (Lot number: Er8735), in left arm, on 16Oct2021 as dose 3 (booster), single (Lot number: Fe3590), in left arm and on 19Aug2022 at 16:30 as dose 4 (booster), single (Lot number: Er8735) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Gastroesophageal reflux disease" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 63.0
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 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06May2022 as dose 4 (booster), single (Lot number: DE002652) at the age of 63 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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Symptoms came back and rapid test Positive again after 6days; Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: No other medication received in 2 weeks. Anti-viral details product: covid 19 treatment, Brand: Pfizer, Treatment start date:09Aug2022, Treatment stop date:14Aug2022, Indication: treatment of covid-19. Patient had no known allergies.,  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of Comirnaty vaccine cannot be excluded for the reported events of drug ineffective and covid-19.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: NSAIDs" (unspecified if ongoing); "Known allergies: pencillins" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL SULFATE]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Aug2022) Positive. Therapeutic measures were taken as a result of covid-19. Patient had Paxlovid start date: 06Aug2022, stop date: 11Aug2022 for the indication treatment of COVID-19.  Clinical information: Within 2 weeks of the vaccination patient had Albuterol inhaler.   No follow-up attempts are Possible. Information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events Drug Ineffective and Covid-19 and the suspect drug cannot be excluded.
Age: 43.0
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 a contactable reporter (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Lot number: En6208), in left arm, on 02Apr2021 as dose 2, single (Lot number: Er8737), in right arm and on 10Nov2021 as dose 3 (booster), single (Lot number: Fj1611) at the age of 43 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "Gerd" (unspecified if ongoing); "migraine" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing). Concomitant medication(s) included: PROPRANOLOL XR; FAMOTIDINE; VITAMIN D3. Past drug history included: Azithromycin, reaction(s): "Known allergies: Azithromycin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (21Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient started COVID 19 treatment with Paxlovid from 12Aug2022 to 17Aug2022. And had rebound since 20Aug2022, symptoms began again 3 days after last dose, tested positive again 4 days after last dose, during treatment, bad taste in mouth.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Positive test 09Aug2022; Positive test 09Aug2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 48 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 had no relevant medical history. Concomitant medication(s) included: DEXAMETHASONE, start date: 09Aug2022, stop date: 15Aug2022. Past drug history included: Morphine, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Aug2022, outcome "not recovered" and all described as "Positive test 09Aug2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Aug2022) Positive, notes: Positive test 09Aug2022; (17Aug2022) Negative, notes: Negative test 17Aug2022; (20Aug2022) Positive, notes: Positive Test again 20Aug2022 with symptoms returning runny nose, cough. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: COVID Rebound after treatment. Positive test 09Aug2022. Treatment with Paxlovid starting 09Aug2022. Negative test 17Aug2022. Continued tingling, numbness in the body and significant fatigue. Positive Test again 20Aug2022 with symptoms returning runny nose, cough. Body aches continue.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 11Apr2022 as dose 4 (booster), single (Lot number: FK9729) at the age of 68 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: "Sleep apnoea" (unspecified if ongoing). Concomitant medication(s) included: FLOMAX RELIEF. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (21Aug2022) Positive, notes: with positive at-home test 21Aug2022. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical search: Patient was treated for Covid-19 with anti-viral drug Paxlovid from 10Aug2022 to 14Aug2022. Patient had no known allergies.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 71 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: "Osteoporosis" (unspecified if ongoing), notes: Other medical history: Osteoporosis. Concomitant medication(s) included: GABAPENTIN, start date: Oct2010. 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, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received Paxlovid as a treatment for COVID-19 from 08Aug2022 to 13Aug2022. It was reported that patient received other medication in 2 weeks. No known allergies was reported.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available  a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Coivid-19 and drug ineffective.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test, Vaccination failure
Clinical narrative: COVID Rebound; COVID Rebound; 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 male patient received BNT162b2 (BNT162B2), on 12Feb2021 at 10:00 as dose 1, single (Lot number: EL9266), in left arm and on 05Mar2021 at 09:00 as dose 2, single (Lot number: ER6203) at the age of 72 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID Rebound". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (unspecified date) Positive, notes: COVID 19 Treatment; (18Aug2022) Positive, notes: COVID Rebound. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: No other medication in 2 weeks. Anti viral details includes covid 19 treatment for paxlovid,treatment start date is 05Aug2022 and treatment stop date is 10Aug2022. Indication for treatment of covid-19, no known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis
Clinical narrative: sweating; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Aug2022 as dose 1, single (Lot number: FP7139) at the age of 54 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERHIDROSIS (non-serious) with onset 20Aug2022, outcome "recovered" (20Aug2022), described as "sweating".  Additional information: Approximately one minute after receiving the Pfizer vaccine, the patient started sweating significantly. It subsided after 15 minutes.  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; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "Known allergies: Shrimp" (unspecified if ongoing), notes: Known allergies: Shrimp and mango; "Known allergies: mango" (unspecified if ongoing). Concomitant medication(s) included: ACETAMINOPHEN; GUAIFENESIN; DEXTROMETHORPHAN; PHENYLEPHRINE; LISINOPRIL; HYDROCHLOROTHIAZIDE; PAROXETINE; OMEGA 3 [DOCOSAHEXAENOIC ACID;EICOSAPENTAENOIC ACID;TOCOPHEROL]. 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: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti-viral details, Product COVID 19 Treatment, Brand Paxlovid, Treatment start date 11Aug2022, Treatment stop date 15Aug2022. Other medication in 2weeks product Vegan multivitamin.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
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 a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 41-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) at the age of 41 years for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Aug2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Aug2022) positive, notes: Tested positive for covid; (18Aug2022) negative, notes: Finally tested negative; (20Aug2022) positive, notes: Tested positive for covid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Vaccine was received. Unknown if there was other medications in two weeks. No known allergies. Tested positive for covid 09Aug. Started paxlovid 09Aug. Finished paxlovid 13Aug. Stayed quarantined due to continued positive tests. Finally tested negative Thursday 18Aug. developed a sore throat Friday 19Aug. Tested positive for covid 20Aug. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events Drug Ineffective and Covid-19 and the suspect drug cannot be excluded.
Age: 32.0
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 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Aug2021 as dose 2, single (Batch/Lot number: unknown) at the age of 32 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 included: "Hypothyroisism" (unspecified if ongoing); "Known allergies: Mango" (unspecified if ongoing), notes: Known allergies: Mango. Concomitant medication(s) included: VENLAFAXINE, start date: 01Sep2021, stop date: 06Aug2022; LEVOTHYROXINE, start date: 01Nov2020, stop date: 21Aug2022; THYRONINE, start date: 01Nov2020, stop date: 21Aug2022. 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: The patient received treatment with Paxlovid from 06Aug2022 to 09Aug2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Dec2021 at 14:00 as dose 1, single (Lot number: 330368D), in right arm, on 06Mar2022 at 13:30 as dose 2, single (Lot number: EN6203), in right arm and on 07Mar2022 at 12:00 as dose 3 (booster), single (Lot number: EN6203) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthmatic" (unspecified if ongoing), notes: I become asthmatic when I get respiratory Infections; "and can easily get bronchitis and pneumonia" (unspecified if ongoing), notes: I become asthmatic when I get respiratory Infections, and can easily get bronchitis; "and can easily get bronchitis and pneumonia" (unspecified if ongoing), notes: I become asthmatic when I get respiratory Infections, and can easily get pneumonia.; "Known allergies: Amoxicillin" (unspecified if ongoing), notes: Known allergies: Amoxicillin; "Known allergies: Pollen" (unspecified if ongoing), notes: Known allergies: pollen; "Known allergies: Dust" (unspecified if ongoing), notes: Known allergies: dust; "Known allergies: Animal Dander" (unspecified if ongoing), notes: Known allergies: animal Dander; "Known allergies: Strong smells" (unspecified if ongoing), notes: Known allergies: strong smell; "Known allergies:smoke" (unspecified if ongoing), notes: Known allergies: smoke. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Aug2022) Negative, notes: I tested negative on August 12th and 13th after taking a course of Paxlovid; (13Aug2022) Negative, notes: I tested negative on August 12th and 13th after taking a course of Paxlovid; (20Aug2022) Positive, notes: I tested positive for Covid on August 20th. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2 weeks: No. The patient received Paxlovid (Lot number: CD5282) received from 08Aug2022 till 12Aug2022 for treatment of COVID-19.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID+ 21Jul2022 with symp- severe h/a,throat congestion/cough; COVID+ 21Jul2022 with symp- severe h/a,throat congestion/cough; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 17Nov2021 as dose 3 (booster), single (Lot number: FH8030), 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: "HTN" (unspecified if ongoing); "gout" (unspecified if ongoing). Concomitant medication(s) included: ALLOPURINOL; OLMESARTAN. Past drug history included: Tetracycline, reaction(s): "Known allergies: Tetracycline". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Jul2022 at 03:00, outcome "recovered" (10Aug2022) and all described as "COVID+ 21Jul2022 with symp- severe h/a,throat congestion/cough". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: rapidly dark purple positive Covid test; (21Jul2022) Positive; (28Jul2022) Positive; (10Aug2022) Negative; (11Aug2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19, which included Paxlovid from 21Jul2022 to 25Jul2022. Clinical course: COVID+ 21Jul2022 with symptoms- severe h/a, throat congestion/cough- began paxlovid. Ended pax 25Jul22- symp improved/NOT gone. At home test 28Jul2022 very slight pos. 30Jul2022 marked increase in illness- nasal congestion, inc. throat congestion/cough. Test: rapidly dark purple positive Covid test. No further treatment- negative Covid test finally 10Aug2022 and 11Aug2022.  No follow-up attempts are possible. No further information is expected.
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) from product quality group. The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Feb2021 at 12:00 as dose 1, single (Lot number: EL9268), in right arm, on 04Mar2021 at 12:00 as dose 2, single (Lot number: EN6205), in right arm and on 30Sep2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 16Apr2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Antihistamines" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Keflex, reaction(s): "known allergies: Keflex". 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; COVID 19 Treatment Paxlovid from 08Aug2022 to 13Aug2022.  No follow up attempts are possible; Information about lot/batch number cannot be requested. No further information is expected.; Sender's Comments: Considering a plausible drug-event temporal association, a reasonable possibility that the events drug ineffective and Covid-19 are related to BNT162b2 (COMIRNATY) cannot be excluded.  The vaccine efficacy varies from one patient to another and can be affected by different factors. This case will be reassessed should additional information become available.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EL9265), in left arm, on 18Feb2021 as dose 2, single (Lot number: EN6200), in left arm and on 26Sep2021 as dose 3 (booster), single (Lot number: 30145BA) at the age of 73 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 22Apr2022 as dose 4 (booster), single (Lot number: 046L21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "borderline high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: CETIRIZINE HYDROCHLORIDE; FLUTICASONE PROPIONATE; LOSARTAN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Aug2022) Negative; (20Aug2022) Positive; (21Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19; COVID 19 Treatment Paxlovid in Aug2022.  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: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Chronic lymphocytic leukaemia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Procainemide, reaction(s): "known allergies: Procainemide", notes: known allergies: Procainemide. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available  a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of covid-19 and drug ineffective.
Age: 53.0
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 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EN6199), in left arm, on 24Mar2021 as dose 2, single (Lot number: ER8732), in left arm, on 06Nov2021 as dose 3 (booster), single (Lot number: FH8030), in left arm and on 14May2022 as dose 4 (booster), single (Lot number: FM7553) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Celiac Disease" (unspecified if ongoing); "Hashimoto's Disease" (unspecified if ongoing). Concomitant medication(s) included: PROZAC; AMLODIPINE; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; METOPROLOL; VITAMIN D [COLECALCIFEROL]; ZINC; NAC [ACETYLCYSTEINE]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course- Patient received Paxlovid for Treatment of COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, SARS-CoV-2 antibody test
Clinical narrative: after the vaccine I've had two miscarriages.  unable to stay pregnant; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient.  A 27-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, Batch/Lot No: Unknown. Unable to locate or read the details), for COVID-19 Immunization.  The following information was reported: ABORTION SPONTANEOUS (medically significant), outcome "unknown", described as "after the vaccine I've had two miscarriages.  unable to stay pregnant". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: unknown.  Clinical course:  She had three kids. Now all of a sudden after the vaccine she had two miscarriages. unable to stay pregnant. Covid-19 was not prior to vaccination and covid-19 was tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case, an association between the reported event abortion and the suspect product BNT162B2 cannot be ruled out.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Increased appetite, Nasal oedema, Pyrexia, Rash, Weight
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent. A 14-month-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: FT9142) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever"; RASH (non-serious), outcome "unknown"; NASAL OEDEMA (non-serious), outcome "unknown", described as "Swollen up nose"; INCREASED APPETITE (non-serious), outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, rash, nasal edema, increased appetite. Additional information: Reporter stated, calling to report an adverse side effect for Pfizer vaccine for reporter's one year old. Later when probed for age at onset of events, reporter stated, 14 months. When probed for the side effects, reporter stated, fever, rash, swollen up nose, increased appetite. Height and weight: Reporter stated, not sure about the height and the weight was probably around 25 pounds. Expiration date: Reporter stated, It was not on the form. Reporter do not see it on the form. Treatment: Reporter stated, No. Prior vaccinations: Reporter stated, She did not. No other products. Reporter queried, Okay was she safe to get Tylenol for her fever or was she safe to get a second dose.
Age: 62.0
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) from product quality group. The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Jan2021 as dose 1, single (Lot number: EL3246), on 23Jan2021 as dose 2, single (Lot number: EL9261), on 02Oct2021 as dose 3 (booster), single (Lot number: 301558A) and on 21Apr2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 62 years for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer", start date: 2021 (unspecified if ongoing). Concomitant medication(s) included: LETROZOLE, start date: Sep2021; AMITRIPTYLINE, start date: Aug1987; SIMVASTATIN, start date: May2022, stop date: 12Aug2022; ESCITALOPRAM, start date: Jul2000; OMEPRAZOLE; FLUTICASONE; XIIDRA; CALCIUM; MAGNESIUM; FISH OIL; VITAMIN D [COLECALCIFEROL]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Indication: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient had no known allergy. Received other Medication In 2weeks. Antiviral treatment with Paxlovid for COVID 19 from 12Aug2022 to 17Aug2022. No follow-up attempts are possible. No further information is expected.
Age: 80.0
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Jan2021 as dose 1, single (Lot number: EL3249), in left arm, on 04Feb2021 as dose 2, single (Lot number: EN9561), in left arm, on 27Sep2021 as dose 3 (booster), single (Lot number: EW0177), in left arm and on 28Mar2022 as dose 4 (booster), single (Lot number: FK9729) at the age of 80 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Mild COPD" (unspecified if ongoing), notes: Other medical history: Age 80. Mild COPD. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (12Aug2022) Negative, notes: testing negative on 12Aug; (18Aug2022) Positive, notes: I began to feel badly again on 18Aug and tested positive; (22Aug2022) Positive, notes: tested positive again today, 22Aug. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient received Paxlovid from 07Aug2022 to 11Aug2022 as treatment for Covid-19. After a full course of Paxlovid the patient was tested negative on 12Aug2022, she began to feel bad again on 18Aug2022 and tested positive. Still had some symptoms and tested positive again on 22Aug2022. Adverse events started again on 22Aug2022 at 08:30 AM which were not recovered, and no treatment was received.  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: Pfizer / BioNTech Dose Number: 4 / Treatment of COVID-19 start date: 19Aug2022; Pfizer / BioNTech Dose Number: 4 / Treatment of COVID-19 start date: 19Aug2022; 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), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3, (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High BP" (unspecified if ongoing); "stage III Kidney" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "DVT" (unspecified if ongoing). Concomitant medication(s) included: LOSARTIN; FENOFIBRATE; WARFARIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "recovered" (2022) and all described as "Pfizer / BioNTech Dose Number: 4 / Treatment of COVID-19 start date: 19Aug2022". 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 information: Patient received Paxlovid From 19Aug2022 To 20Aug2022 for COVID 19 Treatment. The patient had no known allergies. The patient had Other medication in 2weeks. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.