chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: rebound Covid; rebound Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "rebound Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: I am still testing positive.  Clinical information included: Forwarded as an Adverse Event on 14Jul2022. Reporter provided verification of contact address on 14Jul2022 Patient need to update your records on rebound COVID after taking your antiviral medication. In her small circle patient know 7 people that have gotten COVID again. I am was too see if I do my husband has it again and I am still testing positive. Patient never would have taken it if I knew that percentage of peoples that get it again. It should only be given to very high risk people.  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-PV202200023743 same drug /event, different patient.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: rebound Covid; rebound Covid; This is a spontaneous report received from a contactable reporter, Program ID: (005570). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "rebound Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: I am still testing positive.  Clinical course:  on 14Jul2022. Reporter provided verification of contact address on 14Jul2022 You need to update your records on rebound Covid after taking antiviral medication. In my small circle I know 7 people that have gotten Covid again. Reporter was too see if she do her husband has it again and she was still testing positive. She never would have taken it if she knew that percentage of peoples that get it again. It should only be given to very high risk people.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.;
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: rebound Covid; rebound Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown,single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "rebound Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: 7 people that have got COVID again.  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-PV202200023743 PV202200023743;
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: rebound Covid; rebound Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570).  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "rebound Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results.  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-PV202200023743 same drug /event, different patient.;
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: rebound Covid; rebound Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "rebound Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Covid again.  Clinical course: Case Category: Product Specific Inquiry, Case Subcategory: Adverse Event/Product Complaint, Description of Event Outcome, Forwarded as an Adverse Event by the medical team on 14Jul2022. Reporter provided verification of contact address on 14Jul2022 You need to update your records on rebound Covid after taking your antiviral medication. In patient small circle patient know 7 people that have gotten covid again. Patient was wait too see if patient do my husband has it again and patient was still testing positive. Patient never would have taken it if patient knew that percentage of peoples that get it again . It should only be given to very high risk people. Event Awareness Date:14Jul2022.  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-PV202200023743 same drug /event, different patient.;
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: rebound Covid; rebound Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "rebound Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Covid again.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200023743 same drug /event, different patient.;
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: rebound Covid; rebound Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. 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 "rebound Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: 7 people that have gotten COVID again.  Clinical Course: You need to update your records on rebound COVID after taking your antiviral medication. In my small circle I know 7 people that have gotten COVID again. I am wait too see if I do my husband has it again and I am still testing positive. I never would have taken it if I knew that percentage of peoples that get it again. It should only be given to very high risk people.  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-PV202200023743 same drug /event, different patient.;
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: rebound Covid; rebound Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "rebound Covid". Clinical information: Description of Event Outcome: Forwarded as an Adverse Event by the Escalation team on 14Jul2022. Reporter provided verification of contact address on 14Jul2022 You need to update your records on rebound Covid after taking your antiviral medication. In my small circle I know 7 people that have gotten Covid again . I am wai Too see if I do My husband has it again and I am still testing positive. I never would have taken it if I knew that percentage of peoples that get it again . It should only be given to very high risk people. Event Awareness Date 14Jul2022,CEP Number CEP 005570, Date Sent to DSU 14Jul2022.  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-PV202200023743 same drug /event, different patient.;
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: her arm where she had the injection under her armpits was swollen by her lymph nodes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient received BNT162b2 (BNT162B2), on 11Jul2022 at 12:00 as dose 4 (booster), single (Lot number: FP4554) at the age of 64 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EN6202), administration date: 22Mar2021, when the patient was 63-year-old, for COVID-19 immunisation; BNT162b2 (DOSE 3 (BOOSTER), SINGLE; Lot number: FF2593), administration date: 29Oct2021, when the patient was 64-year-old, for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE; Lot number: EN6207; Date of administration: 13Jun2021 or 13Apr2021- Patient can not tell if the month is a 4 or 6), administration date: 2021, for COVID-19 immunisation. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 13Jul2022, outcome "not recovered", described as "her arm where she had the injection under her armpits was swollen by her lymph nodes".  Additional information: Patient was fine on 11Jul2022 and 12Jul2022 but woke up on 13Jul2022 morning and her arm where she had the injection under her armpits was swollen by her lymph nodes. This was not hurting but was still swollen in morning. She thought that swelling was the same but clarifies yesterday (as reported) was a little more puffy. The swelling had improved just a tad but was still there. She could still feel the swelling and saw the difference when she raised her hands and looked at both arms. Her armpit was visibly swollen. She just took her regular medications that her primary care prescribed and did not provide her medications. Indication as reported by the primary source or Indication for use in the case also reported as Diabetic. Additional vaccines administered on same date of the Pfizer suspect reported as no. Prior Vaccinations (within 4 weeks) were also reported as no. Adverse events following prior vaccinations mentioned as none.
Age: 35.0
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) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Jan2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 35 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: BENZONATATE, start date: 01Jul2022, stop date: 06Jul2022; ALBUTEROL [SALBUTAMOL], start date: 01Jul2022, stop date: 15Jul2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jul2022) negative, notes: I tested negative for covid 6Jul; (13Jul2022) positive, notes: 13Jul my covid symptoms were in full effect again and I tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: I tested negative for covid 6Jul, other than a lingering cough I felt recovered.12Jul I started feeling fatigue and 13Jul my covid symptoms were in full effect again and I tested positive. other medication in 2weeks includes Paxlovid (start date=01Jul2022, stop date=05Jul2022), Benzonatate (start date=01Jul2022, stop date=06Jul2022), Albuterol (start date=01Jul2022, stop date=15Jul2022)  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Maternal exposure during pregnancy, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Gestation period when reaction/event was observed in the fetus; 30; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 38-year-old female patient (pregnant) received BNT162b2 (BNT162B2), on 29Jun2022 as dose 4 (booster), single (Lot number: Eh9899) at the age of 38 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster) single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient was 30 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 19Sep2022. Concomitant medication(s) included: PROTONIX [OMEPRAZOLE], start date: 01Mar2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment"; MATERNAL EXPOSURE DURING PREGNANCY (non-serious), outcome "unknown", described as "Gestation period when reaction/event was observed in the fetus; 30". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: My symptoms recur and my antigen test was positive again; Negative, notes: I have had 2 negative antigen/ rapid tests; Positive, notes: My symptoms recur and my antigen test was positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: After completing paxlovid, my symptoms resolved in 2-3 days. 1 week after completing paxlovid, My symptoms recur and my antigen test was positive again when I have had 2 negative antigen/ rapid tests.  No follow-up attempts are possible. No further information expected.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to the reported events drug ineffective ,covid 19 cannot be completely excluded based on temporal association and known drug safety profile
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive 04Jul2022; Tested positive 04Jul2022; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 74-year-old male patient received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Batch/Lot number: unknown), on 03Mar2021 as dose 2, single (Batch/Lot number: unknown), on 22Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 04Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "allergies" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 04Jul2022, outcome "not recovered" and all described as "Tested positive 04Jul2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Jul2022) Positive; (09Jul2022) Negative; (14Jul2022) Positive; (Jul2022) Positive, notes: he tested positive again. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional Information: It was reported that the patient received vaccine. The patient did not receive any other medication in 2weeks. The patient received Paxlovid for COVID 19 Treatment. The patient had known no allergies. The treatment start date was reported as 04Jul2022 and stop date was 09Jul2022. It was reported that the patient's COVID symptoms started on 02Jul22. The patient completed 5 days of treatment. On 14Jul2022 symptoms of nasal drainage and cough returned and he tested positive again. Reporting this as a rebound case.   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 currently available, a possible contributory role of the suspect drug to the reported events Vaccination failure ,covid 19 cannot be completely excluded based on temporal association and known drug safety profile
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: She tested positive for COVID in Jun2022/as her symptoms just felt like a cold; She tested positive for COVID in Jun2022/as her symptoms just felt like a cold; 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 64-year-old female patient received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: EN6202), in 2021 as dose 2, single (Lot number: EN6207) and on 29Oct2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 64 years for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications, she just takes her regular medications that her primary care prescribed. Caller did not provide her medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "She tested positive for COVID in Jun2022/as her symptoms just felt like a cold". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Positive, notes: Unit: Not Provided. Clinical information includes the patient did not have prior vaccinations (within 4 weeks) and any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No vaccines administered on same date with the Pfizer vaccine considered as suspect. No AE(s) following prior vaccinations. Family medical history relevant to AE(s) was unknown. No relevant tests. Description of complaint: She tested positive for COVID in Jun2022. Her primary care didn't call anything in, as her symptoms just felt like a cold and after 6 days she felt better. It was reported that the patient did not tell properly that received date for 2nd dose was 13Jun2021 or 13Apr2021, as She can't tell if the month was a 4 or 6.
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(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (BNT162B2), on 28Oct2021 at 16:00 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 24Jun2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Jun2022) Positive; (30Jun2022) Negative; (01Jul2022) Negative, notes: Days 6-11 testing negative; (03Jul2022) Negative; (04Jul2022) Negative; (05Jul2022) Negative; (06Jul2022) Negative; (08Jul2022) Positive, notes: testing strong positive both rapid and PCR; (08Jul2022) positive, notes: testing strong positive both rapid and PCR; (07Jul2022) Positive, notes: testing strong positive both rapid and PCR. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Patient received treatment with Paxlovid  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Since the vaccination, has the patient been tested for COVID-19; Covid 19 positive; 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 07Feb2021 as dose 1, single (Lot number: EM9809), on 22Feb2021 as dose 2, single (Lot number: ENG205) and on 14Nov2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 45 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: NORVASC. Past drug history included: Amoxicillin, reaction(s): "known allergies: amoxicillin", notes: known allergies: amoxicillin; Doxycycline for known allergies: doxycycline, notes: known allergies: doxycycline. The following information was reported: COVID-19 (medically significant) with onset 15Jul2022, outcome "not recovered", described as "Covid 19 positive"; DRUG INEFFECTIVE (medically significant) with onset 15Jul2022, outcome "not recovered", described as "Since the vaccination, has the patient been tested for COVID-19". The events "since the vaccination, has the patient been tested for covid-19" and "covid 19 positive" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Jul2022) Positive, notes: covid test type post vaccination=Nasal Swab covid test date=13Jul2022, covid test result=Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID positive; COVID positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Lot number: F07218), in left arm, on 26Mar2021 as dose 2, single (Lot number: EP6955), in left arm and on 10Dec2021 as dose 3 (booster), single (Lot number: EL3248) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Jul2022 at 08:00, outcome "not recovered" and all described as "COVID positive". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (unspecified date) High; SARS-CoV-2 test: (15Jul2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Additional information: No other vaccine in four weeks. There were other medications in two weeks. No covid prior vaccination. No known allergies.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid 19 positive; covid 19 positive; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  An 8-year-old male patient received BNT162b2 (BNT162B2), on 13Nov2021 as dose 1, single (Lot number: FK5127) and on 04Dec2021 as dose 2, single (Lot number: FL0007) at the age of 7 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Jul2022, outcome "recovering" and all described as "covid 19 positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Jul2022) Positive, notes: covid 19 positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
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) (Other HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31May2022 as dose 4 (booster), single (Lot number: Fjs682) at the age of 39 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 13Jan2021 as dose 1, single (Lot number: 012l20a), in right arm, on 10Feb2021 as dose 2, single (Lot number: 007m20a), in right arm and on 21Aug2021 as dose 3 (booster), single (Lot number: 939901), in right 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) all with onset 14Jul2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Jul2022) Negative, notes: Began testing negative for COVID on 10Jul; (12Jul2022) Negative, notes: On 12Jul new symptoms began but continued to test negative; (14Jul2022) Positive, notes: Tested again and on 14Jul, positive result showed on test within 1min. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Took paxlovid as follows: 2 doses each on 7/6,7,8. 1 dose each on 7/9 (missed 2nd dose) & 7/10 (stopped at this point due to severe diarrhea with blood in stool.  Began testing negative for COVID on 7/10. On 7/12 new symptoms began but continued to test negative- very runny nose, watery eyes, and sinus pressure.  Symptoms worsened over the next two days. Tested again and on 7/14, positive result showed on test within 1min. Device Date : 15Jul2022.; Sender's Comments: subsequent to COVID-19 vaccine roll out.  Drug ineffective depends on many factors including pharmacokinetics, severity of disease and patient general health condition. However on conservative basis, the possible causality cannot be excluded.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid 19 positive; covid 19 positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 5-year-old male patient received BNT162b2 (BNT162B2), on 05Jan2022 as dose 1, single (Lot number: FK5618) and on 26Jan2022 as dose 2, single (Lot number: FL0007) at the age of 5 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 12Jul2022, outcome "recovering" and all described as "covid 19 positive". The event "covid 19 positive" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: No other vaccine in four weeks. The patient had inhaler as treatment. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: CSF protein, Cardiac electrophysiologic study, Guillain-Barre syndrome, Neurological examination, Neuropathy peripheral
Clinical narrative: COVID-19 vaccine-associated Guillain-Barre syndrome; other demyelinating conditions affecting the peripheral nervous system; This is a literature report.  An adult 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: "progressive numbness" (unspecified if ongoing); "weakness" (unspecified if ongoing); "areflexia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: GUILLAIN-BARRE SYNDROME (medically significant), outcome "unknown", described as "COVID-19 vaccine-associated Guillain-Barre syndrome"; NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "other demyelinating conditions affecting the peripheral nervous system". The patient underwent the following laboratory tests and procedures: Cardiac electrophysiologic study: unknown results; CSF protein: unknown results; Neurological examination: unknown results.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Guillain-Barre syndrome"; NEUROPATHY PERIPHERAL and the vaccine (BNT162B2) cannot be excluded "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.",Linked Report(s) : NL-PFIZER INC-PV202200023878 Same article/drug/ event; different patient.;
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, 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 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Feb2021 as dose 1, single (Lot number: EL9265), in left arm, on 24Feb2021 as dose 2, single (Lot number: EN6198), in left arm, on 02Nov2021 as dose 3 (booster), single (Lot number: FF259), in left arm and on 12Apr2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Irritable bladder" (unspecified if ongoing). Concomitant medication(s) included: MYRBETRIQ, start date: 01Sep2021; PRAVASTATIN, start date: 01Jun2019. Past drug history included: Tetracycline, reaction(s): "known allergies:Tetracycline", notes: known allergies:Tetracycline; Erythromycin, reaction(s): "known allergies:erythromycin", notes: known allergies:erythromycin. 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". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course included: Patient received COVID 19 treatment with Paxlovid on 21Jun2022 and stopped on 25Jun2022.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 25Jan2021 as dose 1, single (Lot number: EL9261), in left arm, on 15Feb2021 as dose 2, single (Lot number: EL9261), in right arm and on 29Sep2021 as dose 3 (booster) single (Lot number: 3014BA) at the age of 66 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 21Apr2022 as dose 4 (booster), single (Lot number: 001M21A), 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient was received Paxlovid from 02Jul2022 to 06Jul2022. Return of symptoms after completing Paxlovid on 13Jul2022.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 60 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 had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06Jul2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Virus rebound on 15Jul, after two days with negative test; Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: No other medication in 2weeks. Anti-viral COVID-19 treatment with Paxlovid on 06Jul2022 to 11Jul2022. Virus rebound on 15Jul, after two days with negative test. Feeling fine, just want to report incidence of rebound. No known allergies. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received BNT162b2 (BNT162B2), on 19Oct2021 as dose number unknown,single (Batch/Lot number: unknown) at the age of 39 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ROSUVASTATIN. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Had been testing negative on antigen tests since day 4 on Paxlovid; Positive, notes: testing positive 3 days after finishing the Paxlovid treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 34.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05May2022 as dose 4 (booster), single (Lot number: EM9992) at the age of 34 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Factor v Leiden" (unspecified if ongoing); "Ulcerative colitis" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Jul2022) Negative, notes: I was symptom free and tested negative for Covid 12Jul,13, and 14; (13Jul2022) Negative, notes: I was symptom free and tested negative for Covid 12Jul,13, and 14; (14Jul2022) Negative, notes: I was symptom free and tested negative for Covid 12Jul,13, and 14; (Jul2022) Positive, notes: Tested positive 15Jul. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient reported that she had no known allergy. The patient received other medication in 2weeks was No. Antiviral details, The patient received Paxlovid for COVID 19 Treatment, from 06Jul2022 to 10Jul2022.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
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) (Nurse). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Dec2020 as dose 1, single (Lot number: EH9899), on 19Jan2021 as dose 2, single (Lot number: EL1283) and on 21Oct2021 as dose 3 (booster), single (Lot number: FF8841) at the age of 56 years for covid-19 immunisation. The patient's relevant medical history included: "Bactria sensitivity" (unspecified if ongoing), notes: Known Allergies: Bactria sensitivity. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: Indication: Covid-19 treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19. Additional Information: There was no medication in 2 weeks. The patient received COVID 19 Treatment drug (Lot number: FW4118) from 11Jul2022 to 25Jul2022 for treatment of COVID-19.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 36.0
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) (Physician). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09May2021 as dose 1, single (Batch/Lot number: unknown) and on 04Jun2021 as dose 2, single (Batch/Lot number: unknown) at the age of 36 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 04Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 29Jun2022 at 16:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine nrvv ad (chadox1 ncov-19) (COVID-19 VACCINE ASTRAZENECA), on 01Dec2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Vur/atrophied kidney" (unspecified if ongoing); "Bicuspid av" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "B12 def" (unspecified if ongoing); "Low bone mass" (unspecified if ongoing). Concomitant medication(s) included: CRESTOR, start date: 10Sep2020, stop date: 04Jul2022; LAMICTAL, start date: 01Dec2021; B12-VITAMIIN, start date: 01May2021; TRINTELLIX, start date: 08Oct2020; JUNEL, start date: 06Apr2019. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment; Negative, notes: I had one borderline negative test; Positive, notes: Then it was positive Again. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: extreme salt taste on tongue 2 days later; Metallic taste immediately after both vaccines; 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 11May2021 at 10:00 as dose 1, single (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic migraines" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DYSGEUSIA (medically significant) with onset 11May2021 at 10:00, outcome "not recovered", described as "Metallic taste immediately after both vaccines"; DYSGEUSIA (medically significant) with onset 13May2022, outcome "not recovered", described as "extreme salt taste on tongue 2 days later". The events "metallic taste immediately after both vaccines" and "extreme salt taste on tongue 2 days later" required physician office visit. Therapeutic measures were taken as a result of dysgeusia, dysgeusia. She told to take zinc on a daily basis as treatment for AE.  Additional information: No known allergies. No other vaccine in four weeks. No other medications in two weeks. No covid prior vaccination and not tested covid post vaccination. Patient received dose 2 on 01Jun2021 at 10:00 AM in left arm (Batch/Lot number: unknown) for covid-19 immunisation. Metallic taste immediately after both vaccines, then changed to extreme salt taste on tongue 2 days later. It was not improved at all (it had been over a year at the time of report).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Dyspnoea, Hypersensitivity
Clinical narrative: experienced a couple of allergic reactions after receiving both the first; difficulty swallowing water; difficulty breathing; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 58-year-old female patient received BNT162b2 (COMIRNATY), as dose 1, 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: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "experienced a couple of allergic reactions after receiving both the first"; DYSPHAGIA (non-serious), outcome "unknown", described as "difficulty swallowing water"; DYSPNOEA (non-serious), outcome "unknown", described as "difficulty breathing".  Additional information: Caller stated that one patient (female, 58 years of age) experienced a couple of allergic reactions after receiving both the first and the second dose of the Pfizer-BioNTech COVID-19 Vaccine. Caller stated that these 58 years-old patients is supposed to receive Ruxience, but they are concerned that she experiences another allergic reaction like the one she had against Comirnaty. Caller would like if there were ingredients in common between these two products. Caller would like to know if there's information on what ingredients are the patients allergic to, in regard to the Pfizer COVID-19 vaccine.  The first time the patient had difficulty swallowing water and with the 2nd dose even after taking Benadryl she had difficulty breathing. Benadryl: not suspect on product. Caller stated even after taking Benadryl she had difficulty breathing.   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-202200966459 Same patient/product, different dose/event (dose 2);
Age: 52.0
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 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 06Apr2021 as dose 2, single (Batch/Lot number: unknown), in right arm, on 15Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 28Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic bronchitis" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION; ZYRTEC-D; LOSARTAN; OMEPRAZOLE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive, notes: Started feeling sick and tested positive for COVID; (07Jul2022) negative, notes: Tested negative on the day after I completed the Paxlovid prescription; (14Jul2022) positive, notes: I had worse symptoms and tested positive again for COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19. She received other medications in two weeks. She received Paxlovid on 02Jul2022 and stop on 06Jul2022 for COVID 19 treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.