chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PNC13
Symptoms: Drug ineffective, Pneumonia
Clinical narrative: patient received 1 dose of Prevnar 13 in 2015. Patient also had pneumonia; patient received 1 dose of Prevnar 13 in 2015. Patient also had pneumonia; This is a spontaneous report received from a contactable reporter (Pharmacist) from medical information team.  A patient (no qualifiers provided) received pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 13), in 2015 as dose number unknown, single (Batch/Lot number: unknown) for immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), PNEUMONIA (medically significant), outcome "unknown" and all described as "patient received 1 dose of Prevnar 13 in 2015. Patient also had pneumonia". Pharmacist said a patient received 1 dose of Prevnar 13 in 2015. Patient also had pneumonia and was recommended by the doctor to get Prevnar 20.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the information currently available, a lack of efficacy with PREVNAR 113 vaccine in this patient cannot be completely excluded.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Pfizer-BioNTech Vaccine administered / COVID-19 test positive result; Pfizer-BioNTech Vaccine administered / COVID-19 test positive result; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for COVID-19 immunization; 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 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Pfizer-BioNTech Vaccine administered / COVID-19 test positive result". The patient underwent the following laboratory tests and procedures: COVID-19 test: positive, notes: positive test result after recovery; negative, notes: negative test results.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 64-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) at the age of 64 years for Covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: indication=Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course: Other medication in 2 weeks is No. Patient received Paxlovid, started from 14Jun2022 to 18Jun2022 for Treatment of COVID-19. On 24Jun2020, patient had Chest congestion, cough, mucus and its recovering. Patient received Nyquil as a treatment drug for events. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 75.0
Sex: M
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 75-year-old male patient received BNT162b2 (BNT162B2), on 21Feb2022 as dose 2, single (Batch/Lot number: unknown) at the age of 75 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: "CAD" (unspecified if ongoing); "RA" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course: No other medication was reported 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. Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events DRUG INEFFECTIVE and COVID 19 and the suspect drug BNT162b2.
Sex: M
Vaccine: COVID19
Symptoms: Blood immunoglobulin G, Cytomegalovirus infection, Lymphocyte count, Polymerase chain reaction, SARS-CoV-2 antibody test
Clinical narrative: Cytomegalovirus infection; This is a literature report. A 73-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: Unknown) for covid-19 immunisation. The patient relevant medical history included: "Heart transplant" (unspecified if ongoing), notes: Time since transplant- 14y, "kidney transplant" (unspecified if ongoing), notes: Time since transplant- 6 y, "schemic cardiomyopathy" (unspecified if ongoing), "prophylaxis" (unspecified if ongoing). The patient concomitant medications were not reported. Past drug history included: Tacrolimus for Immunosuppression, Mycophenolate for Immunosuppression, notes: 500 mg BID, Prednisone for Immunosuppression, notes: 5 mg. Vaccination history included: Bnt162b2 (Dose 1, Single) for COVID-19 immunisation. The following information was reported: CYTOMEGALOVIRUS INFECTION (medically significant), 30 days after the suspect product(s) administration, outcome "unknown". The patient underwent the following laboratory tests and procedures: Blood immunoglobulin G: None of the recipients developed; Lymphocyte count: 1.35, notes: Admission; Polymerase chain reaction: 363 IU/ml, notes: CMV highest; SARS-CoV-2 antibody test: Negative; White blood cell count: 5.4, notes: Admission.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event CYTOMEGALOVIRUS INFECTION 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.,Linked Report(s) : US-PFIZER INC-PV202200004629 Same article/ drug/event and different patient;
Sex: M
Vaccine: COVID19
Symptoms: White blood cell count
Clinical narrative: Cytomegalovirus infection; This is a literature report. A 73-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: Unknown) for covid-19 immunisation. The patient relevant medical history included: "Heart transplant" (unspecified if ongoing), notes: Time since transplant- 14y, "kidney transplant" (unspecified if ongoing), notes: Time since transplant- 6 y, "schemic cardiomyopathy" (unspecified if ongoing), "prophylaxis" (unspecified if ongoing). The patient concomitant medications were not reported. Past drug history included: Tacrolimus for Immunosuppression, Mycophenolate for Immunosuppression, notes: 500 mg BID, Prednisone for Immunosuppression, notes: 5 mg. Vaccination history included: Bnt162b2 (Dose 1, Single) for COVID-19 immunisation. The following information was reported: CYTOMEGALOVIRUS INFECTION (medically significant), 30 days after the suspect product(s) administration, outcome "unknown". The patient underwent the following laboratory tests and procedures: Blood immunoglobulin G: None of the recipients developed; Lymphocyte count: 1.35, notes: Admission; Polymerase chain reaction: 363 IU/ml, notes: CMV highest; SARS-CoV-2 antibody test: Negative; White blood cell count: 5.4, notes: Admission.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event CYTOMEGALOVIRUS INFECTION 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.,Linked Report(s) : US-PFIZER INC-PV202200004629 Same article/ drug/event and different patient;
Age: 27.0
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 a contactable reporter(s) (Physician).  A 27-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "anxiety" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti-viral Paxlovid start date was reported as 26Jun2022 and treatment stop date was 29Jun2022, administrator route was reported as oral for Treatment of COVID-19. The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient had previously receive a COVID-19 Vaccine.   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 current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown). The reporter is the patient. A 69-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for Covid-19 immunisation; CoviD-19 vaccine miRNA (miRNA 1273) (MODERNA COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: he has Covid. Clinical course: He had high blood pressure and he was prescribed with Paxlovid today and he said he has Covid. He mentioned he was vaccinated with the Pfizer and Moderna vaccines and now he has Covid. He said he would like to double check if herbal supplements (Unspecified Herbal Supplements) would have any reaction to Paxlovid. He was asking if there will be a rebound case and will rebound be a worse case for a 69 year old even with good health. He has not started taking Paxlovid and he has been prescribed and he wanted to hear from the medical information department if this would be reasonable. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, Off label use, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; Pfizer / BioNTech Dose Number: 3; Moderna Dose Number: 2/Dose Number: 1; Pfizer / BioNTech Dose Number: 3; Moderna Dose Number: 2/Dose Number: 1; 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 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 29 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA 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: Sulfa drugs" (unspecified if ongoing), notes: Known allergies: Sulfa drugs. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment"; OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown" and all described as "Pfizer / BioNTech Dose Number: 3; Moderna Dose Number: 2/Dose Number: 1". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti viral details: Product-COVID 19 Treatment, Brand: Paxlovid was considered as COVID 19 Treatment, start date: 20Jun2022 and stop date: 25Jun2022.  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, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Caller took 2 doses of the Pfizer COVID-19 vaccine. No problems with the vaccine, no side effects from the vaccine, just the terrible side effects from the Paxlovid.; Caller took 2 doses of the Pfizer COVID-19 vaccine. No problems with the vaccine, no side effects from the vaccine, just the terrible side effects from the Paxlovid.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), 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: "thyroid cancer" (unspecified if ongoing), notes: Caller is a cancer patient, and takes Synthroid because caller doesn't take have a thyroid. Caller also takes caprelsa which is a chemo medication for caller's thyroid cancer. Concomitant medication(s) included: SYNTHROID; CAPRELSA taken for thyroid cancer. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Caller took 2 doses of the Pfizer COVID-19 vaccine. No problems with the vaccine, no side effects from the vaccine, just the terrible side effects from the Paxlovid.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: Patient was calling about Paxlovid, patient's doctor prescribed the medication for the patient and she took the medication for 1 and a half day only, so patient only took 9 pills total of the medication. Patient had a side effect which was horrendous, patient's stomach was burning, felt like an upset stomach. Patient went to take a bowel movement and the feces burned so much as the feces was coming out of the patient and at the end of the bowel movement there was a little bit of blood in the feces. Felt like acid coming out when patient was taking a bowel movement so patient stopped taking the medication. Patient stated this was good for Pfizer to know about, the pharmacists, because maybe the medicine was not for every patient. Patient was a cancer patient and takes Synthroid because patient doesn't have a thyroid. Patient also takes Caprelsa which was a chemo medication for patient's thyroid cancer. Patient was taking Paxlovid and stated that caller took 2 doses of the Pfizer COVID-19 vaccine. Unable to confirm the indication for why caller was taking Paxlovid because caller declined to continue completing the report.  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, 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) (Physician). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 31Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 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 was not reported. Concomitant medication(s) included: LIPITOR; LOSARTAN; METFORMIN; SILDENAFIL; VITAMIN D NOS. 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.  Clinical course: The patient received other medication in 2weeks.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to all the reported events drug ineffective, covid 19 cannot be completely excluded based on temporal association and known drug safety profile
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old male patient received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: ER8727), in left arm, on 12Apr2021 as dose 2, single (Lot number: EP7533), in left arm and on 23Sep2021 as dose 3 (booster), single (Lot number: 301308A) at the age of 31 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) unknown results, notes: Treatment of COVID-19; (26Jun2022) Negative, notes: Tested positive on COVID test three days after testing negative; (29Jun2022) Positive, notes: Tested positive on COVID test three days after testing negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Tested positive on COVID test three days after testing negative. Completed Paxlovid course two days earlier than last negative test. Experiencing mild symptoms.
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Dec2021 as dose 3 (booster), single (Lot number: 33036BD), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Migraine headaches" (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 "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient has no known allergies. The patient has experienced Awful taste in mouth Severe lower abdominal pain (start date: 28Jun2021) and was not recovered. The patient has taken Paxlovid for the treatment of covid-19 (treatment start date=25Jun2022, Treatment stop date=29Jun2022, Lot number=GC6416).
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 66-year-old male patient received BNT162b2 (BNT162B2), on 02Mar2021 at 12:15 as dose 2, 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) for Covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "heart disease" (unspecified if ongoing) and patient had no known allergies. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Jun2022, outcome "not recovered", described as "COVID 19 Treatment"; DRUG INEFFECTIVE (medically significant) with onset Jun2022, outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results; (Jun2022) negative, notes: 4 days negative testing; (Jun2022) positive, notes: than tested positive. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course was reported as Paxlovid rebound all symptoms returned after 4 days negative testing and then tested positive. Antiviral details included that patient had COVID 19 treatment on 19Jun2022 to 23Jun2022, Lot number: FY7031. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received BNT162b2 (BNT162B2), on 17Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 75 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: "Hypertension" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN, start date: 31Jul2018, stop date: 20Jun2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Jun2022) negative, notes: tested negative on day 1 after treatment; (28Jun2022) positive, notes: Tested positive after 9 days. 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. Clinical information: Anti viral details: product was COVID 19 Treatment, brand was Paxlovid, treatment start date was 14Jun2022, treatment stop date was 18Jun2022, indication was Treatment of COVID-19. Adverse event: Tested positive after 9 days post Paxlovid treatment. Previously had tested negative on day 1 after treatment. Adverse event start date was 29Jun2022. If patient recovered: Recovering, If treatment ae: No.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 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); "Endometriosis" (unspecified if ongoing); "TMJ" (unspecified if ongoing); "Allergies" (unspecified if ongoing). Concomitant medication(s) included: NUVARING; FLONASE [FLUTICASONE PROPIONATE]. Past drug history included: Biaxin, reaction(s): "Allergies: Biaxin". 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: (16Jun2022) Positive, notes: First tested positive for Covid 16Jun2022; (22Jun2022) Negative, notes: Received negative test 22Jun2022; (01Jul2022) Positive, notes: Tested positive again on 01Jul2022. Therapeutic measures were taken as a result of drug ineffective, covid-19. The vaccine received reported as yes. Other medication in 2weeks was yes. Patient received Covid 19 Treatment (Paxlovid) from 15Jun2022 and 19Jun2022. Other medication in 2weeks product was Nuva ring. Other medication in 2weeks brand was Flonase.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Nasal congestion, Pain, Pyrexia, Rhinorrhoea
Clinical narrative: Fever; Chills; Body pains; Runny nose; Congestion; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old male patient received BNT162b2 (BNT162B2), on 02Dec2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 44 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1 SINGLE; Lot number: EN6203), administration date: 24Feb2021, when the patient was 43-year-old, for Covid-19 Immunisation; BNT162b2 (DOSE 2 SINGLE; Lot number: EP7534), administration date: 17Mar2021, when the patient was 43-year-old, for Covid-19 Immunisation. The following information was reported: PAIN (non-serious) with onset 30Jun2022, outcome "not recovered", described as "Body pains"; CHILLS (non-serious) with onset 30Jun2022, outcome "not recovered"; NASAL CONGESTION (non-serious) with onset 30Jun2022, outcome "not recovered", described as "Congestion"; PYREXIA (non-serious) with onset 30Jun2022, outcome "not recovered", described as "Fever"; RHINORRHOEA (non-serious) with onset 30Jun2022, outcome "not recovered", described as "Runny nose". Therapeutic measures were not taken as a result of pyrexia, chills, pain, rhinorrhoea, nasal congestion.  Additional information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
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 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 number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (29Jun2022) Positive, notes: Tested positive again. 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: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 13Jan2021 at 14:30 as dose 1, single (Lot number: EL3248), in left arm, on 04Feb2021 at 15:15 as dose 2, single (Lot number: EN5318), in left arm and on 28Oct2021 at 13:15 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "BPH" (unspecified if ongoing); "AdHD" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN, start date: 13Jan2021; TAMSULOSIN HCL, start date: 17Mar2020, stop date: 20Jun2022. Past drug history included: Vyvanse -shire, start date: 11Feb2020, notes: Vyvanse 50 mg; Atarax 25 mg, start date: 13Mar2019, notes: Hydroxyzine 25 mg prn, Atarax 25 mg. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Body temperature: 102 Fahrenheit, notes: controlling my fever, before it was 102F or during treatment and day before. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the Vaccination failure (LOE) and COVID-19 cannot be ruled out.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, in Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and in Aug2021 as dose 3 (booster), single (Lot number: FC3138), in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), in Apr2022 as dose 4 (booster), single (Lot number: 038A22A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "major back surgeries (10, incl. 3 fusions)" (unspecified if ongoing). Concomitant medication(s) included: ZOLPIDEM, start date: 31Mar2006; DIAZEPAM, start date: 31May2017; FISH OIL [FISH OIL;TOCOPHERYL ACETATE], start date: 30Jun2016; OCUVITE ADULT 50+ [ASCORBIC ACID;COPPER GLUCONATE;FISH OIL;TOCOPHEROL;XANTOFYL;ZEAXANTHIN;ZINC OXIDE], start date: 30Jun2016; PROBIOTIC 10, start date: 31May2015; VITAMIN E [TOCOPHEROL], start date: 31Jan2016; CALTRATE + D PLUS, start date: 30Sep2007; ASPIRIN [ACETYLSALICYLIC ACID], start date: 31Jan2020; MIRALAX, start date: 31May2020; TYLENOL, start date: 14Jun2022, stop date: 30Jun2022. Past drug history included: Prednisone; anti-malarials, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown result, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The vaccination start time for the vaccines was reported as for Dose 1: 02:00 PM, Dose 2: 01:00 PM, Dose 3 (Booster): 02:30 PM, Dose 4(Moderna): 12:30 PM. Patient also took Men's 1-A-Day 50+(Bayer brand), start date: 30Sep1997 (Lot no: 86896230) as concomitant.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to all the reported events drug ineffective, covid 19 cannot be completely excluded based on temporal association and known drug safety profile
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) (Consumer or other non HCP) from medical information team. The reporter is the patient. A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Jun2022, outcome "recovered" and all described as "tested positive for Covid-19 after receiving 3 doses of PBCV". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jun2022) Positive, notes: tested positive for Covid-19 after receiving 3 doses of PBCV; (2022) Negative. Clinical course: Reporter declined to be transferred during call. Reporter providing her age also. (Tested positive for Covid-19 after receiving 3 doses of PBCV) Calling regarding the PBCV and her 2nd booster dose. Patient initial 2 dose series was Pfizer and her 1st booster dose was Nov2021. The patient states patient had COVID 19 disease 01Jun2022 and now tests negative. Reporter wanted to know how long should she wait to get her 2nd booster dose? The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Influenza A virus test
Clinical narrative: had 3 shots of the Pfizer COVID-19 Vaccine; had 3 shots of the Pfizer COVID-19 Vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (172086).  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 included: "Clotting disorders" (unspecified if ongoing), notes: Caller mentioned that her husband had clotting disorders and also had spent 100 days in the hospital in the past year. Concomitant medication(s) included: TAMIFLU taken for influenza (ongoing). Past drug history included: Evusheld for Protect against COVID, reaction(s): "Reactions", notes: Caller stated that her husband also took Evusheld to protect against COVID but had reactions to it. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "had 3 shots of the Pfizer COVID-19 Vaccine". The patient underwent the following laboratory tests and procedures: Influenza A virus test: Positive, notes: her husband had come back from travelling and tested positive for Flu A. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Wife of a male patient called asking if her husband can take Tamiflu with Paxlovid. He had been exposed to COVID patients including her and her son. He came back from travelling and tested positive for Flu A and was given Tamiflu. The person her husband travelled with also had COVID. His husband had 3 shots of the Pfizer COVID-19 Vaccine  and also took Evusheld to protect against COVID but had reactions to it. He had clotting disorders and also had spent 100 days in the hospital in the past year.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, SARS-CoV-2 test
Clinical narrative: Dizzy off balance ever since getting; Dizzy off balance ever since getting; 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 male patient received BNT162b2 (BNT162B2), on 30Mar2021 at 12:00 as dose 2, single (Lot number: Er8737) at the age of 42 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8737), for Covid-19 Immunization. The following information was reported: DIZZINESS (non-serious), BALANCE DISORDER (non-serious) all with onset 2021, outcome "unknown" and all described as "Dizzy off balance ever since getting". The event "dizzy off balance ever since getting" required physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information- The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient tested for COVID-19. Device Date: 01Jul2022  No follow-up attempts are needed. No further information is expected.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered at inappropriate site, Urticaria, Vomiting
Clinical narrative: non-irritating hive/Hives were noticed on arms,  belly, back, face, legs; vomiting; Vaccine location Left leg; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 2-year-old male patient received BNT162b2 (BNT162B2), on 22Jun2022 as dose 1, single (Lot number: FT9142) at the age of 2 years intramuscular, in left leg for covid-19 immunisation. The patient's relevant medical history included: "chronic ear infections" (unspecified if ongoing); "covid" (unspecified if ongoing), notes: Prior vaccination. There were no concomitant medications. The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 22Jun2022, outcome "unknown", described as "Vaccine location Left leg"; URTICARIA (non-serious) with onset 30Jun2022, outcome "recovering", described as "non-irritating hive/Hives were noticed on arms,  belly, back, face, legs"; VOMITING (non-serious) with onset 30Jun2022, outcome "recovering". The events "non-irritating hive/hives were noticed on arms,  belly, back, face, legs" and "vomiting" required physician office visit. Therapeutic measures were not taken as a result of urticaria, vomiting.  Additional information: No other vaccine in four weeks. No other medication in two weeks. Covid was not tested post vaccination. No known allergies. 8 days post covid vaccine, patient had non-irritating hives that came and went and returned sporadically over 2 days. Hives were noticed on arms, belly, back, face, legs. No other symptoms came along with hives or prior to hives except for 1 instance of vomiting on 30Jun2022 when hives started.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Herpes zoster, SARS-CoV-2 test
Clinical narrative: becoming covid positive; becoming covid positive; Shingles; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HERPES ZOSTER (non-serious) with onset 22Jun2022, outcome "not recovered", described as "Shingles"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 22Jun2022, outcome "not recovered" and all described as "becoming covid positive". The events "becoming covid positive" and "shingles" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, herpes zoster.  Clinical course: Patient did not receive any other vaccine within four weeks. Prior to vaccination patient did not experience COVID-19. Patient had shingles after becoming COVID positive and anti-viral was received for shingles.  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: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 33-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Attention deficit disorder" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected COVID-19 with Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 70.0
Sex: M
Vaccine: COVID19
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 70-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: Penicillin. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Jul2022 at 17:00, outcome "not recovered" and all described as "COVID-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative; (01Jul2022) Positive. If treatment ae No. No Other medication in 2 weeks. The patient previously received a COVID-19 Vaccine Yes. Device date: 01Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Feb2021 as dose 1, single (Lot number: EL9260), on 10Mar2021 as dose 2, single (Lot number: EN6202), on 12Sep2021 as dose 3 (booster), single (Lot number: 3013BA) and on 29Mar2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 40 years for covid-19 immunisation. The patient's relevant medical history included: "Psoriasis" (unspecified if ongoing); "psoriatic arthritis" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Jun2022) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: It was reported that rebound after testing negative post paxlovid.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Mar2022 at 03:45 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 47 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: "difficulty breathing" (unspecified if ongoing), notes: Other medical history: difficulty breathing leading to constant use of steroids; "known allergies: sulfa" (unspecified if ongoing), notes: known allergies: sulfa; "known allergies: penacillin" (unspecified if ongoing), notes: known allergies: penacillin. The patient's concomitant medications were not reported. Past drug history included: Amoxacillin, reaction(s): "Allergy: amoxicillin", notes: Known allergies: amoxacillin; Cotrim, reaction(s): "Allergy: cotrim", notes: Known allergies: cotrim; Augmentin, reaction(s): "Allergy: augmentin", notes: Known allergies: augmentin.  The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19, drug ineffective. The patient received paxlovid treatment for COVID-19 on 13Jun2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.