chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Interchange of Vaccine products; testing positive for COVID; testing positive for COVID; 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 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 59 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 20Jan2021 as dose 1, single (Lot number: EL3248), on 12Feb2021 as dose 2, single (Lot number: EL9269) and on 22Aug2022 as dose 4 (booster), single (Lot number: FM533) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 23Nov2021 as dose 3 (booster), single (Lot number: 039F21A) for covid-19 immunisation. The patient's relevant medical history included: "Alpha-1 antitrypsin deficiency, hypercholesterolemia, hypertension" (unspecified if ongoing); "Known allergies Bee stings" (unspecified if ongoing); "hypercholesterolemia" (unspecified if ongoing); "hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22Nov2022, outcome "unknown" and all described as "testing positive for COVID"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Nov2022) Positive; (30Nov2022) Negative, notes: I improved and tested negative on 30Nov2022. Therapeutic measures were taken as a result of vaccination failure, covid-19 for which included PF-07321332, ritonavir (PAXLOVID) from 22Nov2022 to 26Nov2022.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: developed diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization Series Complete; Unknown Manufacturer), for COVID-19 Immunization. The following information was reported: DIARRHOEA (non-serious), outcome "unknown", described as "developed diarrhea".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: got COVID and I have been battling with it for over four months; got COVID and I have been battling with it for over four months; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "not recovered" and all described as "got COVID and I have been battling with it for over four months". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: Thank you for all the COVID shots. He had received all three, plus the one (Bivalent, on 11Nov2022, at Withheld. He somewhere, somehow, got COVID and he have been battling with it for over four months. Last time he went to the Dr's PA (Physician assistant), with all the appropriate meds taken, how long will it take be do he have before he was rid of it? Response "Never" then why was he putting chemicals in his body, when it was obvious that he was going to the end.  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: Drug ineffective, Suspected COVID-19
Clinical narrative: received your 2 doses of the covid vaccine last Apr and May/ I have a horrible case of covid; received your 2 doses of the covid vaccine last Apr and May/ I have a horrible case of covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in Apr2022 as dose 1, single (Batch/Lot number: unknown) and in May2022 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "received your 2 doses of the covid vaccine last Apr and May/ I have a horrible case of covid".  Clinical course: Patient received 2 doses of the covid vaccine last April and May. Why do she had a horrible case of covid? Yes. She wash and sanitize her hands very frequently, keet distance from others. She would be missing work for at least a week. This did not stop people from getting covid, or a mild case at that. She was a single parent who absolutely could not afford to miss a week of work! This vaccine did not live up to its expectations.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID infection and provider prescribed paxlovid/Missed taking the bivalent vaccine/been a while since she was boosted; COVID infection and provider prescribed paxlovid/Missed taking the bivalent vaccine/been a while since she was boosted; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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 "recovering" and all described as "COVID infection and provider prescribed paxlovid/Missed taking the bivalent vaccine/been a while since she was boosted". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: finished a course of paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: She is 70 years of age and had not been boosted in a while. She notes that she couldn't find the time to "get sick" as she often does after she receives vaccines. Caller says from what she has read, it "looks like you cannot get a vaccine right away if you have finished a course of paxlovid, but if it was monoclonal treatment you can have it right away." Will file for AE reported regarding "vaccines" identified after call. Appreciate taking the Paxlovid it's an amazing drug and I hope Pfizer gets it approved more than what it is already approved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid 19 positive; Covid 19 positive; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 32-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Nsaid, reaction(s): "Known allergies: NSAID", notes: Known allergies: NSAID.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Dec2022, outcome "recovering" and all described as "Covid 19 positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Dec2022) Positive, notes: Covid 19 positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical course: Patient had not received any other vaccine in four weeks and not received any other medications in two weeks of vaccination. Patient had no covid prior vaccination. Patient had not received any treatment.  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 report and a plausible temporal relationship, a possible causal relationship between the events drug ineffective, covid-19  and suspect drug BNT162B2 cannot be excluded.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Nausea; Violent vomiting; Chills; Low grade fever; Body aches; Headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 16-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Nov2022 at 16:00 as dose 4 (booster), single (Lot number: GJ3277) at the age of 16 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Polyarthritis" (unspecified if ongoing). Concomitant medication(s) included: HUMIRA; METHOTREXATE; FOLIC ACID. Vaccination history included: Covid-19 vaccine (Dose:01, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose:02, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose:03, Manufacturer: Unknown), for COVID-19 Immunization. The following information was reported: PAIN (non-serious) with onset 08Nov2022 at 06:00, outcome "recovered" (2022), described as "Body aches"; CHILLS (non-serious) with onset 08Nov2022 at 06:00, outcome "recovered" (2022); HEADACHE (non-serious) with onset 08Nov2022 at 06:00, outcome "recovered" (2022); PYREXIA (non-serious) with onset 08Nov2022 at 06:00, outcome "recovered" (2022), described as "Low grade fever"; NAUSEA (non-serious) with onset 08Nov2022 at 06:00, outcome "recovered" (2022); VOMITING (non-serious) with onset 08Nov2022 at 06:00, outcome "recovered" (2022), described as "Violent vomiting". Therapeutic measures were not taken as a result of nausea, vomiting, chills, pyrexia, pain, headache.  Additional information: No known allergy reported. Dose received: More than 3. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store.  Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient not diagnosed with COVID-19. Since the vaccination, has the patient been not tested for COVID-19. Device Date: 04Dec2022.  No follow-up attempts are possible. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Nausea; Violent vomiting; Chills; Low grade fever; Body aches; Headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 16-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Nov2022 at 16:00 as dose 4 (booster), single (Lot number: GJ3277) at the age of 16 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Polyarthritis" (unspecified if ongoing). Concomitant medication(s) included: HUMIRA; METHOTREXATE; FOLIC ACID. Vaccination history included: Covid-19 vaccine (Dose:01, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose:02, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose:03, Manufacturer: Unknown), for COVID-19 Immunization. The following information was reported: PAIN (non-serious) with onset 08Nov2022 at 06:00, outcome "recovered" (2022), described as "Body aches"; CHILLS (non-serious) with onset 08Nov2022 at 06:00, outcome "recovered" (2022); HEADACHE (non-serious) with onset 08Nov2022 at 06:00, outcome "recovered" (2022); PYREXIA (non-serious) with onset 08Nov2022 at 06:00, outcome "recovered" (2022), described as "Low grade fever"; NAUSEA (non-serious) with onset 08Nov2022 at 06:00, outcome "recovered" (2022); VOMITING (non-serious) with onset 08Nov2022 at 06:00, outcome "recovered" (2022), described as "Violent vomiting". Therapeutic measures were not taken as a result of nausea, vomiting, chills, pyrexia, pain, headache.  Additional information: No known allergy reported. Dose received: More than 3. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store.  Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient not diagnosed with COVID-19. Since the vaccination, has the patient been not tested for COVID-19. Device Date: 04Dec2022.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Cough, Respiratory tract congestion, Retching, Wheezing
Clinical narrative: I was gagging to throw up this green stuff that came up but it was not watery because I did not have too much of a stomach; Wheezing; Coughing; chest is very congested now; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1), for COVID-19 immunization; Covid-19 vaccine (Dose: 2), for COVID-19 immunization; Covid-19 vaccine (Dose: 3), for COVID-19 immunization. The following information was reported: COUGH (non-serious) with onset 03Dec2022, outcome "unknown", described as "Coughing"; RETCHING (non-serious) with onset 03Dec2022, outcome "unknown", described as "I was gagging to throw up this green stuff that came up but it was not watery because I did not have too much of a stomach"; WHEEZING (non-serious) with onset 03Dec2022, outcome "unknown"; RESPIRATORY TRACT CONGESTION (non-serious) with onset 03Dec2022, outcome "unknown", described as "chest is very congested now".  Additional information: Consumer stated, patient just wanted, patient had his fourth shot yesterday the COVID shot(Clarified as Pfizer COVID vaccine) yesterday at withheld and patient woke up this morning was gagging to throw up this green stuff that came up but it was not watery because did not have too much of a stomach so whatever happened, you know wheezing and coughing you know that chest was very congested and it was not yesterday before this.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID 19; Tested positive for COVID 19; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 33-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Patient did not receive other vaccine in four weeks. Patient had no COVID prior vaccination. Patient was tested for COVID post vaccination. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 04Dec2022, 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: (04Dec2022) Positive, notes: Nasal Swab, Tested positive for COVID 19. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Blood insulin, Blood insulin abnormal
Clinical narrative: Ever since I have got the vaccine I have become insulin, its not working. I am having do double or triple the amount of insulin I am taking; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; insulin (INSULIN), (Batch/Lot number: unknown). The patient's relevant medical history included: "I am a type 1 diabetic" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization.  The following information was reported: BLOOD INSULIN ABNORMAL (non-serious), outcome "unknown", described as "Ever since I have got the vaccine I have become insulin, its not working. I am having do double or triple the amount of insulin I am taking". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for insulin was unknown.  Additional information: The patient was also the reporter. Consumer stated that ever since patient have had the COVID vaccine (Manufacture not clarified), had two vaccines and a booster. patient is a type 1 diabetic and have been entire life. Ever since patient have got the vaccine, patient have become insulin, it was not working (Further clarification unknown, hence Insulin captured as suspect conservatively). patient having do double or triple the amount of insulin  patient taking. Is that a side effect of the COVID that patient having.   No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 at 12:00 as dose 4 (booster), single (Lot number: GH9693) at the age of 56 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: High blood pressure; "Seasonal allergies only" (unspecified if ongoing), notes: Seasonal allergies only; "Stool softener" (unspecified if ongoing), notes: Stool softener. Concomitant medication(s) included: LAXACLEAR taken for abnormal faeces, start date: 01Jan2021, stop date: 04Dec2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No known allergies. COVID 19 Treatment Paxlovid (treatment start date: 28Nov2022 and treatment stop date: 03Dec2022). Other medication in 2 weeks were cold medicines and Dayquil/Nyquil.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (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 18Feb2021 as dose 1, single (Lot number: EL9267), in left arm, on 11Mar2021 as dose 2, single (Lot number: EN6205), in left arm and on 01Oct2021 as dose 3 (booster), single (Lot number: 301358A) at the age of 43 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 included COVID 19 Treatment with Paxlovid from 04Dec2022.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, 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) (Consumer or other non-HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 at 23:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 65 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: "overweight" (unspecified if ongoing), notes: I am overweight, and I have a heart murmur.; "heart murmur" (unspecified if ongoing), notes: I am overweight, and I have a heart murmur. Concomitant medication(s) included: SIMVASTATIN; OMEPRAZOLE; FLUOXETINE; ZOCOR; PROZAC. Past drug history included: Betadine, reaction(s): "allergy", notes: I have a betadine allergy. The following information was reported: DRUG INEFFECTIVE (medically significant), 2 months 5 days 12 hrs 45 min after the suspect product(s) administration, outcome "recovered", COVID-19 (medically significant), 2 months 5 days 45 min after the suspect product(s) administration, outcome "recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) 101; SARS-CoV-2 test: (25Nov2022) Negative, notes: I had taken a COVID test on 25Nov2022 because we were going to be seeing other people in the coming days, and that test was undeniably negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Anti-viral details: Product- COVID 19 Treatment, Paxlovid: Treatment start date: 15Nov2022, Treatment stop date: 20Nov2022, Indication: Treatment of COVID-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, 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 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Apr2021 as dose 1, single (Lot number: EW0171) and on 19May2021 as dose 2, single (Lot number: EW0182) at the age of 49 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 10Dec2021 as dose 3 (booster), single (Lot number: O60H21A), on 22Apr2022 as dose 4 (booster), single (Lot number: O48L21A) and on 28Sep2022 as dose 5 (booster), single (Lot number: AS7163B) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Nuts" (unspecified if ongoing), notes: known allergies: Nuts. 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 "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: COVID 19 Treatment Brand=Pfizer Paxlovid. Treatment start date=03Dec2022, Treatment stop date=03Dec2022, Lot number=GE3010, Indication=Treatment of COVID-19.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 22Feb2022 as dose number unknown, single (Lot number: 033K21-2A) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HIV", start date: 1995 (ongoing), notes: HIV since 1995. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19".Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information:No Other medication in 2 weeks. Paxlovid was taken as COVID 19 Treatment.Treatment start date was 02Dec2022.Treatment stop date was 05Dec2022.
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 25 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "high functioning autism" (unspecified if ongoing); "22q deletion syndrome" (unspecified if ongoing); "asthma" (unspecified if ongoing); "generalized anxiety disorder" (unspecified if ongoing); "milk" (unspecified if ongoing); "tree pollen" (unspecified if ongoing). Concomitant medication(s) included: VENLAFAXINE; GABAPENTIN; CLONAZEPAM. Past drug history included: Trazadone, reaction(s): "Known allergies: trazadone".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient treated with Paxlovid. Treatment start date= 01Dec2022. Treatment stop date= 05Dec2022. This covid medication has helped patient signifyingly recover from his covid infection especially since he have asthma.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Nov2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 48 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Therapeutic measures included Paxlovid from 22Nov2022 to 27Nov2022.    The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: He also said that he received all the Pfizer Covid 19 shots, but even though he was tested positive from COVID 19 a week ago.; He also said that he received all the Pfizer Covid 19 shots, but even though he was tested positive from COVID 19 a week ago.; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. The reporter is the patient.  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), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "He also said that he received all the Pfizer Covid 19 shots, but even though he was tested positive from COVID 19 a week ago.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: tested positive from COVID 19 a week ago. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Patient said that he received all the Pfizer Covid 19 shots, but even though he was tested positive from COVID 19 a week ago. After that, he mentioned that he started to feel congested after finishing his treatment with Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.
Sex: U
Vaccine: COVID19
Symptoms: Diplopia
Clinical narrative: severe double vision issues; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  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: DIPLOPIA (non-serious), outcome "unknown", described as "severe double vision issues".  Additional information: Reporter reported that, he/she felt that the ad was misleading as he/she have witnessed that his/her family member developed severe double vision issues after the vaccine.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Extremity necrosis, Raynaud's phenomenon, Red blood cell sedimentation rate increased
Clinical narrative: severe Raynaud's syndrome; high sedimentation rate; severe arthritis; necrosis of index finger; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series completed, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Dose 3 (Booster), MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: RED BLOOD CELL SEDIMENTATION RATE INCREASED (disability) with onset Oct2022, outcome "not recovered", described as "high sedimentation rate"; EXTREMITY NECROSIS (disability) with onset Oct2022, outcome "not recovered", described as "necrosis of index finger"; RAYNAUD'S PHENOMENON (disability) with onset Oct2022, outcome "not recovered", described as "severe Raynaud's syndrome"; ARTHRITIS (disability) with onset Oct2022, outcome "not recovered", described as "severe arthritis". The events "severe raynaud's syndrome", "high sedimentation rate", "severe arthritis" and "necrosis of index finger" required physician office visit. The patient underwent the following laboratory tests and procedures: Red blood cell sedimentation rate increased: (Oct2022) High, notes: high sedimentation rate. Therapeutic measures were taken as a result of raynaud's phenomenon, red blood cell sedimentation rate increased, arthritis, extremity necrosis.  Clinical course: Female plastic surgeon patient with no prior medical history. Within 3 weeks of receipt of Pfizer bivalent COVID-19 vaccine, developed severe Raynaud's syndrome, severe arthritis, necrosis of index finger, high sedimentation rate. No previous illnesses or conditions. The treatment received for AE was Prednisone, considering methotrexate.    The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: As per the available information the causality of the events  raynaud's phenomenon, red blood cell sedimentation rate increased, arthritis, extremity necrosis with the suspect can not be ruled out completely. 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 Ras, Ethics committees, and Investigators, as appropriate.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Sep2021 at 13:00 as dose 2, single (Batch/Lot number: unknown) at the age of 46 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hashimotos" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: SYNTHYROID, start date: 02Jul2017; LISINOPRIL.  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, notes: Treatment of COVID-19. 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
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (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), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE; ATORVASTATIN; METOPROLOL; LOSARTAN; VITAMIN D [COLECALCIFEROL]; BABY ASPIRIN. 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: Negative; Negative; Positive, notes: Rebound case after testing negative several days in a row and feeling almost completely better - then symptoms returned and tested positive 3 days after last testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Delusion, Hallucination, Psychotic symptom
Clinical narrative: Worsening of psychotic symptoms after receiving the second dose; Hallucinations and delusions were presented within four weeks; Hallucinations and delusions were presented within four weeks; This is a literature report for the following literature source(s).  A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, 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 - manufacturer unknown (DOSE 1 SINGLE), for COVID-19 immunisation, reaction(s): "Psychosis after the administration of the first dose".  The following information was reported: PSYCHOTIC SYMPTOM (medically significant), outcome "recovered", described as "Worsening of psychotic symptoms after receiving the second dose"; HALLUCINATION (medically significant), DELUSION (medically significant), outcome "recovered" and all described as "Hallucinations and delusions were presented within four weeks". Therapeutic measures were taken as a result of psychotic symptom, hallucination, delusion.  Clinical information: Worsening of psychotic symptoms after receiving the second dose. Hallucinations and delusions were presented within four weeks and resolved in three days after the administration of antipsychotics.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and BNT162B2. Based on known drug safety profile, there is reasonable possibility of causal association between the event and BNT162B2. 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.
Age: 71.0
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 72-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Sep2022 at 14:00 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 was not reported. Concomitant medication(s) included: TELMISARTAN, start date: 10May2022.  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, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. It was reported that the patient received treatment of Paxlovid from 25Nov2022, to 05Dec2022 for COVID-19.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Electrocardiogram, Electroencephalogram, Magnetic resonance imaging head, Seizure
Clinical narrative: Seizures; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 13-year-old female patient received BNT162b2 (BNT162B2), on 11Oct2021 as dose 2, single (Lot number: FE3590) at the age of 12 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (COVID-19 Vaccine: Dose 1, Manufacturer: Pfizer, Date: 20Sep2021, Time: 17:30 (Evening), LOT: FF2587, EXP: unknown, NDC: Unknown, Dose and Route: Unknown, Facility: (Hospital name)), administration date: 20Sep2021, when the patient was 12-year-old, for COVID-19 immunization. The following information was reported: SEIZURE (hospitalization, medically significant) with onset 04Jan2022, outcome "recovered" (16Jan2022), described as "Seizures". The patient was hospitalized for seizure (start date: 04Jan2022, discharge date: 05Jan2022, hospitalization duration: 2 day(s)). The event "seizures" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood test: Negative, notes: Everything has been negative; Electrocardiogram: Negative, notes: Everything has been negative; Electroencephalogram: Negative, notes: Everything has been negative; Magnetic resonance imaging head: Negative, notes: Everything has been negative. Therapeutic measures were taken as a result of seizure.  Clinical information: Reported that, Reporter Wants to report that her daughter, the patient, had her vaccines, she had two doses. Ever since the last dose, patient has been getting seizures. Hasn't had time to report. Was going to do it on the computer, but it is hard to report on the computer. The Pediatrician did the thing to report it. Patient had second COVID-19 Vaccine around 14:00 to 15:00 on 11Oct2021. First seizure date was reported as 04Jan2022. Patient had two more seizures on 16Jan2022. Since then, patient has been seizure free. Has been on anti-seizure medication since 16Jan2022. Reporter did not provide product name of anti-seizure medication. Treatment included, for both seizure events patient was at the ER. Was admitted to the hospital after the first seizures on 04Jan2022. Patient had EEG of the head, everything was negative. Ever since then has had other outpatient EEGs as well. There's no recent activity of that. Patient never had seizures as a child. Asked if she needed to call and report to this other number, (Phone number). Advised reporter this number was not in this agent's resources. Advised reporter to use her own discretion to call that number and report. No Prior Vaccinations within 4 weeks. No other vaccines after 20Sep2021 besides second dose COVID-19 Vaccine.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 37 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type 1 diabetes" (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, 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: 02Dec2022, treatment stop date: 05Dec2022 Indication: Treatment of COVID-19. No known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.