chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 82-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "diabetes II" (unspecified if ongoing), notes: diabetes II; "high blood pressure" (unspecified if ongoing), notes: high blood pressure. Concomitant medication(s) included: TELMISARTAN; ALOGLIPTIN; REPAGLINIDE. 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: Unknown results, 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.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 08Apr2021 as dose 2, single (Batch/Lot number: unknown), in left leg, on 29Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 01May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 61 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "Mild high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL, start date: 01Jan2008. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (27May2022) Negative, notes: at home test on 27May and on 30May; (30May2022) Negative, notes: at home test on 27May and on 30May; (01Jun2022) Positive, notes: home test taken in the of Jun one showed positive. As therapeutic measure Paxlovid was taken from 19May2022 to 24May2022 for the events.  Clinical Course: Patient felt symptom-free after her five-day course which ended on 24May2022. She was negative on an at home test on 27May and on 30May, Symptoms started in the evening of 31May. At home test taken in the of June one showed positive. Mild symptoms or congestion head fog and a little sore throat.  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-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.   A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2, Solution for injection), as dose 2, single (Batch/Lot number: unknown, Expiration date: Unknown) for COVID-19 immunization; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown, Expiration date: Unknown) for COVID-19 immunization. Batch/Lot number Not available/provided to reporter at the time of report completion. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "breast cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. Other medication in 2 weeks was Unknown. Past drug history included: Feldene, reaction(s): "Knonwn allergies: Feldene"; Selene, reaction(s): "Knonwn allergies: Selene"; Brethine for Knonwn allergies: brethine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective and COVID-19 which included COVID-19 treatment, brand: Pfizer from 24May2022 to 29May2022. On 26May2022, the patient experienced Nausea, gastric burning, diarrhea, dark stools. The outcome of the events were not recovered and treatment was not received.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available , a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of LOE .
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Suspected 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). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Mar2021 as dose 1, single (Lot number: EN6208), on 07Apr2021 as dose 2, single (Lot number: ER8733) and on 12Nov2021 as dose 3 (booster), single (Lot number: FHS028) at the age of 30 years for covid-19 immunisation. The patient's relevant medical history included: "Attention deficit hyperactivity disorder" (unspecified if ongoing), notes: ADHD. Concomitant medication(s) included: VYVANSE. The following information was reported: VACCINATION FAILURE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of suspected covid-19.Clinical course: Antiviral details: Brand: Paxlovid, Treatment start date: 21May2022, Treatment stop date: 25May2022, Indication: Treatment of COVID-19. Was the patient taking any other medications, products within 2 weeks of starting COVID-19 treatment was reported as Yes. the patient previously receive a COVID-19 Vaccine was reported as Yes. Reported Event: Rebound of symptoms after Paxlovid approx 2 days after recovery. known allergies was reported as No.  No follow-up attempts are possible. No further information is expected.
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 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: No other medication in 2 weeks. No known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Feb2021 at 10:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 05Mar2021 at 12:00 as dose 2, single (Batch/Lot number: unknown), in left arm, on 30Sep2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 15Apr2022 at 14:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE. Past drug history included: Neosporin, reaction(s): "Allergy: Neosporin", notes: Known allergies: Neosporin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28May2022) Negative, notes: on Day 8, I tested negative with a rapid test; (30May2022) Positive, notes: I took a rapid test and was Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Hi Dr. withheld, I wanted to let you know that I went through the 5 day Paxlovid, felt better, but didn't test negative until Day 8, which was last Friday. On Day 10, Sunday, I started to have a stuffy head and a bit headachy, and tested Positive with a rapid test. I did not take anything except Tylenol for the first 3 days. From what I've read, this is probably Paxlovid Rebound, so I just wanted to report this to you. I am still extremely stuffed, no headache and self isolating again for 5 days and will again wear a mask through Day 10. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 67.0
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 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Oct2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. Patient was not pregnant at the time of vaccination. The patient's relevant medical history included: "allergy" (unspecified if ongoing), notes: Known allergies: Yes. Other medical history was none (as reported). There were no concomitant medications (Other medications in two weeks reported as no). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". After Paxlovid, patient got Covid again. Rebound. Patient was great after the medication and negative and then patient tested positive and got very sick on the 4th day following the last Paxlovid dose. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Indication: Covid-19 treatment; (unspecified date) Negative; (May2022) Positive, notes: was great after the medication and negative and then I tested positive and got very sick on the 4th day following the last Paxlovid dose. Therapeutic measures were taken as a result of drug ineffective, covid-19 and treatment included Paxlovid from 16May2022 to 21May2022.  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: 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 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Apr2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in left arm and on 25Apr2021 at 08:30 as dose 2, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 30Nov2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Managed anxiety" (unspecified if ongoing), notes: Managed anxiety. Concomitant medication(s) included: LEXAPRO, start date: 01Aug2018, stop date: 01Jun2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. There were no known allergies. Completed Meds on 25May. Rebound symptoms Monday 29May-01Jun. Congestion returned. Headaches returned. Fatigue persistent throughout illness.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Rebound bout of COVID; Rebound bout of COVID; 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 04Feb2021 as dose 1, single (Lot number: EN5318), in right arm, on 25Feb2022 as dose 2, single (Lot number: EN6203), in right arm, on 21Oct2021 as dose 3 (booster), single (Lot number: FE 3590), in right arm and on 11Apr2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 72 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "surgery for melanoma" (unspecified if ongoing); "allergies" (unspecified if ongoing); "Allergies to soy" (unspecified if ongoing); "Allergies to pine" (unspecified if ongoing); "Allergies to dust" (unspecified if ongoing). Concomitant medication(s) included: SINGULAIR taken for hypersensitivity, asthma; CLARITIN [LORATADINE] taken for hypersensitivity. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Rebound bout of COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR; ACETYLSALICYLIC ACID. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures (COVID 19 Treatment, Paxlovid treatment start date: 19May2022 and treatment stop date: 24May2022) were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: 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.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Lot number: ff2590), in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose 1, single (Lot number: 037kz0A), in left arm and as dose 2, single (Lot number: 042l20A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "mild hypertension" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing); "Interchange of vaccine products" (unspecified if ongoing), notes: DOSE 1 and DOSE 2,, Moderna Vaccine. Concomitant medication(s) included: LOSARTAN, start date: 16Feb2021. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, 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: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: then tested positive; then tested positive; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Nov2021 as dose 3 (booster) , single (Batch/Lot number: unknown) at the age of 31 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2 , single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "allergies" (unspecified if ongoing); "endometriosis" (unspecified if ongoing); "Walnut" (unspecified if ongoing); "shrimp" (unspecified if ongoing). The patient took concomitant medications. There were other medications in two weeks.  The following information was reported: No adverse even to vaccine. But tested negative day after finishing Paxlovid treatment, then on 26May started feeling symptoms worsen, then tested positive of 27May. Patient was still tested as positive and still have symptoms but they are improving. COVID-19 (medically significant), outcome "recovering", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "then tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: tested positive. Therapeutic measures were taken as a result of covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient. A 62-year-old female patient received BNT162b2 (BNT162B2), on 14Oct2021 as dose 3, (booster) single (Lot number: EW0187) at the age of 62 years, in left arm for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "allergic rhinitis" (unspecified if ongoing). Concomitant medication(s) included: CHLORTHALIDONE; LISINOPRIL. Past drug history included: Bactrim, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Paxlovid rebound Initially testing week negative on antigen test now testing strongly positive since 5/28 with persistent congestion through 6/2; positive, notes: Paxlovid rebound Initially testing week negative on antigen test now testing strongly positive since 5/28 with persistent congestion through 6/2. Therapeutic measures were taken as a result of drug ineffective, Covid-19. No follow-up attempts are possible. No further information is expected. 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.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: stopped taking Paxlovid on 25May2022. On 01Jun tested positive again for COVID; stopped taking Paxlovid on 25May2022. On 01Jun tested positive again for COVID; 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 received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EL9265), in right arm, on 18Feb2021 as dose 2, single (Lot number: En6203), in right arm, on 08Sep2021 as dose 3 (booster) , single (Lot number: Ew0191), in right arm and on 12Apr2022 as dose 4 (booster) , single (Lot number: Fk9895), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "allergies" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "osteoporsis" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: tested positive again for COVID. Concomitant medication(s) included: ADVAIR HFA; ATORVASTATIN. Past drug history included: Erthomycin, reaction(s): "known allergies: Erthomycin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01Jun2022, outcome "unknown" and all described as "stopped taking Paxlovid on 25May2022. On 01Jun tested positive again for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive; (01Jun2022) positive, notes: On 01Jun patient tested positive again for COVID. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient stopped taking Paxlovid on 25May2022. On 01Jun tested positive again for COVID.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement, Chest pain, Electrocardiogram, Head injury
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. An 8-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; Unknown manufacturer), for Covid-19 immunization. Patient experienced chest pain and fainting the day after her Second dose of Covid vaccine. She hit her head. She was taken by ambulance to the ER (Emergency room). Dr. at ER believes the vaccine caused drop in blood pressure due to immune response. Patient was released from the ER as she was stable and her EKG was normal. Her pediatrician will see her for a follow up in two days. Event took place after use of product. The event "hit her head" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: drop; Electrocardiogram: Normal. The outcome of all the events was Unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. An 8-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; Unknown manufacturer), for Covid-19 immunization. Patient experienced chest pain and fainting the day after her Second dose of Covid vaccine. She hit her head. She was taken by ambulance to the ER (Emergency room). Dr. at ER believes the vaccine caused drop in blood pressure due to immune response. Patient was released from the ER as she was stable and her EKG was normal. Her pediatrician will see her for a follow up in two days. Event took place after use of product. The event "hit her head" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: drop; Electrocardiogram: Normal. The outcome of all the events was Unknown. 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
Clinical narrative: Did you/the patient previously receive a COVID-19 Vaccine?: Yes; Did you/the patient previously receive a COVID-19 Vaccine?: Yes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 86-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing), notes: Other medical history: HTN. Concomitant medication(s) included: NORVASC. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Did you/the patient previously receive a COVID-19 Vaccine?: Yes". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that patient received the vaccine. Received other medication in 2 weeks with Norvasc. It was reported that patient take COVID 19 Treatment on 23May2022 to 27May2022 via Oral Administrator route. Vaccine dose number unknown.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 67 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: "Known allergies: Sulfa" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "rosacea" (unspecified if ongoing). The patient's concomitant medications were not reported.  If vaccine received: Yes. Other medication in 2 weeks: Unknown.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. 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.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 66-year-old male patient received BNT162b2 (BNT162B2), on 16Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 02Feb2021 as dose 1, single (Batch/Lot number: unknown), on 02Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 27Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypogonadism" (unspecified if ongoing); "headache" (unspecified if ongoing); "GERD" (unspecified if ongoing); "mild leukopenia" (unspecified if ongoing). Concomitant medication(s) included: MORPHINE oral, start date: 07Jan2022; MIRTAZAPINE, start date: 15Jun2021; TESTOSTERONE intradermal, start date: 17Sep2021; PANTOPRAZOLE oral, start date: 15Sep2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11May2022) Positive, notes: Symptom start date 10May2022 with a positive home antigen 11May2022; (19May2022) Negative, notes: 19May2022 tested negative by home test; (30May2022) Positive, notes: Tested positive 30May2022 by home test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical details: Paxlovid started 12May2022 to 18May2022. 28May had a sore throat, nasal congestion, fatigue. Tested positive 30May2022 by home test.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.
Sex: F
Vaccine: COVID19
Symptoms: Basosquamous carcinoma, Neoplasm progression, Vaccination site pain, Vaccination site reaction
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 58-year-old female patient received BNT162b2 (COMIRNATY), as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: MAGNESIUM; ZYRTEC; NEXIUM; ESTRADIOL. Vaccination history included: Comirnaty (Dose 1), for COVID-19 Immunization. The following information was reported: BASOSQUAMOUS CARCINOMA (medically significant), outcome "unknown", described as "squamous basal cell"; NEOPLASM PROGRESSION (non-serious), outcome "unknown", described as "Basal cell also diagnosed on nose that was not previously detected. Another basal cell carcinoma has now been diagnosed on opposite shoulder that was not detected in March"; VACCINATION SITE REACTION (non-serious), VACCINATION SITE PAIN (non-serious), outcome "unknown" and all described as "bump on arm near injection site that was painful to the touch". Additional information: Patient experienced bump on arm near injection site that was painful to the touch. Approximately 3 months after 2nd dose of Comirnaty. Diagnosed as squamous basal cell 8 months later upon skin check by dermatologist in March. Basal cell also diagnosed on nose that was not previously detected or being watched. Another basal cell carcinoma has now been diagnosed on opposite shoulder that was not detected in March during skin check-just appeared. Patient does not have any underlying medical conditions. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: took an at home test and tested positive after testing; took an at home test and tested positive after testing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Oct2021 as dose 3 (booster), single (Lot number: FD0809) at the age of 23 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Nut allergies" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 29May2022, outcome "unknown", COVID-19 (medically significant) with onset 29May2022, outcome "not recovered" and all described as "took an at home test and tested positive after testing". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative; (29May2022) Positive, notes: COVID infection occurred one week after finishing Paxlovid. Therapeutic measures were taken as a result of covid-19 with Pfizer Paxlovid from 17May2022 to 22May2022. Clinical course: Rebound COVID infection occurred one week after finishing Paxlovid. Symptoms were different this time around, but due to the number of rebound reports, she took an at home test and tested positive after testing negative to get out of quarantine.  Follow-Up (06Jun2022): Follow-up attempts are completed. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 10Feb2021 as dose 1, single (Lot number: FL6304), on 03Mar2021 as dose 2, single (Lot number: FL9236) and on 18Nov2021 as dose 3 (booster), single (Lot number: FC3184) at the age of 72 years for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: latex" (unspecified if ongoing), notes: Known allergies: latex; "Mild MS" (unspecified if ongoing), notes: Other medical history: Mild MS,; "diabetes" (unspecified if ongoing), notes: Other medical history: diabetes,; "hyperlipidemia" (unspecified if ongoing), notes: Other medical history:  hyperlipidemia,; "rosacea" (unspecified if ongoing), notes: Other medical history:  rosacea,; "fibromyalgia" (unspecified if ongoing), notes: Other medical history: fibromyalgia. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, suspected covid-19.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Breakthrough COVID 19 infection; Breakthrough COVID 19 infection; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 32-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) and in Feb2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 32 years intramuscular, 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 was not reported. No other vaccines within 4 weeks prior to the COVID vaccine. The patient had no COVID prior vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Facility type vaccine was Pharmacy or Drug Store. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 31May2022, outcome "not recovered" and all described as "Breakthrough COVID 19 infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Did you/the patient previously receive a COVID-19 Vaccine?: Yes; Did you/the patient previously receive a COVID-19 Vaccine?: Yes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), on 09Apr2021 as dose 1, single (Lot number: ER8731) and on 30Apr2021 as dose  2, single (Lot number: ER8736) at the age of 53 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 20Nov2021 as dose 3 (booster) single (Lot number: 027H213), in right 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 May2022, outcome "not recovered" and all described as "Did you/the patient previously receive a COVID-19 Vaccine?: Yes". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25May2022) Negative, notes: recovered and tested negative (home test); (31May2022) positive, notes: tested positive again. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Other medication in 2 weeks: No. Anti viral details: product: COVID 19 Treatment, brand: Paxlovid, treatment start date: 21May2022, treatment stop date: 26May2022, lot number=GA3581, indication: Treatment of COVID-19. Adverse event: recovered and tested negative (home test) on 25May2022. Symptoms started back on 31May2022 and tested positive again. Symptoms are worse now than before Paxlovid. Runny nose, congestion, light cough. Adverse event start date: 31May2022, if patient: recovered : Not recovered, if treatment ae: No. Patient had no known allergies.
Age: 50.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: product: COVID 19 Treatment; product: COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 51-year-old patient received BNT162b2 (BNT162B2), in Dec2020 as dose 1, single (Batch/Lot number: unknown), in left arm, in Jan2021 as dose 2, single (Batch/Lot number: unknown) and in Jun2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 50 years for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing), notes: Other medical history: asthma. Concomitant medication(s) included: ATORVASTATIN, start date: 01Sep2021, stop date: 22May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "product: COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: product: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had no known allergies. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  An adult male patient received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Lot number: EL3247), in Apr2021 as dose 2, single (Lot number: EL3247) and in Dec2021 as dose 3 (booster), single (Lot number: FE3594) 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 31May2022, outcome "recovering" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31May2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19. Clinical information: Age group Adult: , Facility type vaccine: . No other vaccine in four weeks. No Covid prior to vaccination. The patient was tested for Covid post vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Cough, Myalgia
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient. A 66-year-old male patient received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Batch/Lot number: unknown), on 24Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 10Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 64 years, all intramuscular for Covid-19 immunisation. The patient's relevant medical history included: "CVD" (unspecified if ongoing); "Prostate cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MYALGIA (non-serious) with onset 25May2022, outcome "recovered" (2022); VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25May2022, outcome "recovered" (2022) and all described as "Patient tested positive for Covid on 25May2022"; NASAL CONGESTION (non-serious) with onset 25May2022, outcome "recovered" (2022), described as "congestion"; COUGH (non-serious) with onset 25May2022, outcome "recovered" (2022); AGEUSIA (non-serious), ANOSMIA (non-serious) all with onset 25May2022, outcome "recovered" (2022) and all described as "loss of taste and smell". The events "patient tested positive for Covid on 25May2022", "cough", "congestion", "loss of taste and smell" and "myalgia" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25May2022) Positive. Therapeutic measures were not taken as a result of vaccination failure, Covid-19, cough, nasal congestion, ageusia, anosmia, myalgia. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient. A 66-year-old male patient received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Batch/Lot number: unknown), on 24Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 10Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 64 years, all intramuscular for Covid-19 immunisation. The patient's relevant medical history included: "CVD" (unspecified if ongoing); "Prostate cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MYALGIA (non-serious) with onset 25May2022, outcome "recovered" (2022); VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25May2022, outcome "recovered" (2022) and all described as "Patient tested positive for Covid on 25May2022"; NASAL CONGESTION (non-serious) with onset 25May2022, outcome "recovered" (2022), described as "congestion"; COUGH (non-serious) with onset 25May2022, outcome "recovered" (2022); AGEUSIA (non-serious), ANOSMIA (non-serious) all with onset 25May2022, outcome "recovered" (2022) and all described as "loss of taste and smell". The events "patient tested positive for Covid on 25May2022", "cough", "congestion", "loss of taste and smell" and "myalgia" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25May2022) Positive. Therapeutic measures were not taken as a result of vaccination failure, Covid-19, cough, nasal congestion, ageusia, anosmia, myalgia. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Got covid after being vaccinated; Got covid after being vaccinated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Mar2021 as dose 1, single (Lot number: EN6207), in left arm, on 06Apr2021 as dose 2, single (Lot number: EWO151), in left arm and on 19Dec2021 as dose 3 (booster), single (Lot number: 3313OBA) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ADVIL [IBUPROFEN], start date: 27May2022, stop date: 01Jun2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 28May2022, outcome "unknown" and all described as "Got covid after being vaccinated". Therapeutic measures were taken as a result of vaccination failure, covid-19 with PAXLOVID (Start date: 28May2022, stop date: 01Jun2022, lot number=GC0529).   Clinical course: Patient got Covid after being vaccinated and PAXLOVID caused a very bitter taste in patient's mouth the whole time she took it.  Follow-up attempts are completed. No further information is expected.