chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old male patient received BNT162b2 (BNT162B2), on 11Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 42 years 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: "Chronic migraine" (unspecified if ongoing), notes: Other medical history: Chronic Migraine. Concomitant medication(s) included: DULOXETINE; MEMANTINE. Past drug history included: Galcanezumab, reaction(s): "Known allergies: Galcanezumab", notes: Known allergies: Galcanezumab.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective. Additional information: Other medication in 2weeks product: Duloxetine 60mg and Memantine 10mg. Anti-viral details: Product = COVID 19 Treatment. Brand = Paxlovid. Treatment start date = 10Aug2022. Treatment stop date = 04Sep2022. Adverse event: Paxlovid rebound. Started course of Paxlovid on day 1 on symptoms onset (aches, chilles, fever, sore throat). By Day 5 He felt normal and started returning to routine activities. By Day 10 covid symptoms returned (congestion, fever, fatigue, aches). By day 15 He was starting to recover from the second bout but he was still experiencing sore throat, congestion and periodic fever. His partner was away during the initial symptoms and appears to have caught covid from him during the rebound. Adverse event start date: 30Aug2022. AE resulted in: [None of the above]. If treatment AE: No. The patient was recovering.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 66.0
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). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Lot number: EM9810), in left arm, on 26Feb2021 as dose 2, single (Lot number: EN6198), in left arm and on 17Nov2021 as dose 3 (booster), single (Lot number: FH8028) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Sep2022) Negative; (15Sep2022) Negative; (15Sep2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Antiviral details included PAXLOVID for COVID 19 Treatment (Treatment start date: 05Sep2022; Treatment stop date: 10Sep2022. On 05Sep2022 prescribed PAXLOVID, on 12Sep2022, tested negative; on 15Sep2022 tested negative; on 15Sep2022 tested positive. On 15Sep2022 tested positive told by doctor the patient had COVID rebound.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: 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 45-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: "Known allergies: Sulfa" (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 Sep2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken with Paxlovid as a result of drug ineffective, covid-19.  Clinical information: Reported seriousness was No. Patient received treatment with Paxlovid from 06Sep2022 to 12Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient. A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Dec2020 as dose 1, single (Lot number: EJ1685), on 13Jan2021 as dose 2, single (Lot number: EL0142) and on 23Nov2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 53 years for covid-19 immunisation. The patient's relevant medical history included: "Aortic valve insufficiency" (unspecified if ongoing); "Mitral valve prolapse" (unspecified if ongoing); "Borderline/ Mild hypertension well controlled" (unspecified if ongoing), notes: Borderline/ Mild hypertension well controlled; "GERD" (unspecified if ongoing); "Seasonal allergies" (unspecified if ongoing); "arthritis neck" (unspecified if ongoing). Concomitant medication(s) included: Coreg; Nexium [Esomeprazole Sodium]; Mucinex; Flonase [Mometasone Furoate]; Zyrtec [Cetirizine Hydrochloride]; Vitamin C [Ascorbic Acid]; Vit D3; Menaquinone; Omega 3 Fish Oils; Turmeric [Curcuma Longa]; L-Theanine; Methyl B12; Methylfolate; D-Mannose Cranberry Extra. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: my rebound symptoms started and it was positive; (Aug2022) Positive; (15Sep2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: 7 days after finishing Paxlovid, patient experienced Paxlovid rebound symptoms such as sneezing, nasal congestion, slight dry cough. Patient also did a home Covid test 12 days after  first tested positive which was when patient's rebound symptoms started and it was positive. Patient had no known drug allergies, only diagnosed with seasonal allergies. No follow-up attempts are possible. No further information is expected. Sender's Comments: Based on the available information in the case, the causal association between the events Drug ineffective, COVID-19 and the suspect drug BNT162B2 cannot be excluded.
Age: 66.0
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  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 (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. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Sep2022) Negative, notes: negative tests in the morning and evening of Friday 09Sep (09Sep2022) Negative, notes: negative tests in the morning and evening of Friday  09Sep; (Sep2022) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: Patient received anti viral. treatment start date: 03Sep2022, treatment stop date: 07Sep2022 for Treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Dec2021 at 14:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 26 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 and concomitant medications were not reported. Past drug history included: Cephalexin, reaction(s): "Known allergies:cephalexin". The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", 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: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid.Treatment start date:04Sep2022 and stop date: 08Sep2022.  Clinical course: Patient was given other medication in 2weeks, Walsom from 04Aug2022 tao 16sep2022 . Treatment start date:04Sep2022 and stop date: 08Sep2022. Foul taste in mouth, impact of taste of food, late period with no sexual activity while on daily birth control.  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: Arteriovenous malformation, Asthenia, Chills, Dizziness, Hypoaesthesia
Clinical narrative: This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team, Program ID: Private. The reporter is the patient. A 65-year-old male patient received BNT162b2 (BNT162B2), on 18Aug2021 as dose 1, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "I have asthma" (unspecified if ongoing); "I have bronchitis" (unspecified if ongoing); "I have COPD" (unspecified if ongoing); "the sickle lung disease" (unspecified if ongoing); "the genetic bone disease" (unspecified if ongoing); "chronic arthritis" (unspecified if ongoing); "chronic spinal cord damage" (unspecified if ongoing); "Osteoporosis head to toe" (unspecified if ongoing); "Rheumatoid arthritis" (unspecified if ongoing); "5 guard region in my leg" (unspecified if ongoing); "two blood clots in my left leg" (unspecified if ongoing); "I collapse lung" (unspecified if ongoing); "COVID collapse my lung and gave me 'actual' blood clot" (unspecified if ongoing); "headache" (unspecified if ongoing); "COVID" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ARTERIOVENOUS MALFORMATION (medically significant), outcome "unknown", described as "like AVM"; THROMBOSIS (medically significant), outcome "unknown", described as "blood clotting"; ILLNESS (non-serious), outcome "unknown", described as "1st shot made him sick and destroyed him"; CHILLS (non-serious), outcome "unknown"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "leg numb/hand numb"; DIZZINESS (non-serious), outcome "unknown", described as "dizzy"; VOMITING (non-serious), outcome "unknown", described as "throwing up"; MIGRAINE (non-serious), outcome "unknown", described as "severe migraine"; ASTHENIA (non-serious), outcome "unknown", described as "weak". The patient underwent the following laboratory tests and procedures: White blood cell count: 2.3 (Low), notes: he had low white blood cells at 2.3. Therapeutic measures were taken as a result of thrombosis. Clinical course: The first shot made him sick and destroyed him. He mentioned that he was on the blood thinner (Unspecified Medication), no blood thinner because after getting the vaccine, he had blood clotting. When he first got the first shot, it gave him chills, it made his leg numb, it made his hand numb, and it made him dizzy. He was throwing up. He had like AVM, he had severe migraine, and he was very weak. He stayed in bed for 3 days. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Linked Report(s): US-PFIZER INC-202201166692 same patient/drug, different dose/event.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Migraine, Thrombosis, Vomiting, White blood cell count
Clinical narrative: This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team, Program ID: Private. The reporter is the patient. A 65-year-old male patient received BNT162b2 (BNT162B2), on 18Aug2021 as dose 1, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "I have asthma" (unspecified if ongoing); "I have bronchitis" (unspecified if ongoing); "I have COPD" (unspecified if ongoing); "the sickle lung disease" (unspecified if ongoing); "the genetic bone disease" (unspecified if ongoing); "chronic arthritis" (unspecified if ongoing); "chronic spinal cord damage" (unspecified if ongoing); "Osteoporosis head to toe" (unspecified if ongoing); "Rheumatoid arthritis" (unspecified if ongoing); "5 guard region in my leg" (unspecified if ongoing); "two blood clots in my left leg" (unspecified if ongoing); "I collapse lung" (unspecified if ongoing); "COVID collapse my lung and gave me 'actual' blood clot" (unspecified if ongoing); "headache" (unspecified if ongoing); "COVID" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ARTERIOVENOUS MALFORMATION (medically significant), outcome "unknown", described as "like AVM"; THROMBOSIS (medically significant), outcome "unknown", described as "blood clotting"; ILLNESS (non-serious), outcome "unknown", described as "1st shot made him sick and destroyed him"; CHILLS (non-serious), outcome "unknown"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "leg numb/hand numb"; DIZZINESS (non-serious), outcome "unknown", described as "dizzy"; VOMITING (non-serious), outcome "unknown", described as "throwing up"; MIGRAINE (non-serious), outcome "unknown", described as "severe migraine"; ASTHENIA (non-serious), outcome "unknown", described as "weak". The patient underwent the following laboratory tests and procedures: White blood cell count: 2.3 (Low), notes: he had low white blood cells at 2.3. Therapeutic measures were taken as a result of thrombosis. Clinical course: The first shot made him sick and destroyed him. He mentioned that he was on the blood thinner (Unspecified Medication), no blood thinner because after getting the vaccine, he had blood clotting. When he first got the first shot, it gave him chills, it made his leg numb, it made his hand numb, and it made him dizzy. He was throwing up. He had like AVM, he had severe migraine, and he was very weak. He stayed in bed for 3 days. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Linked Report(s): US-PFIZER INC-202201166692 same patient/drug, different dose/event.
Age: 59.0
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) (Other HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 03Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 18Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (not ongoing), notes: High cholesterol- resolved; "Known allergies: Poison oak" (unspecified if ongoing); "Depression" (unspecified if ongoing), notes: Depression/anxietycontrolled; "Anxiety" (unspecified if ongoing), notes: Depression/anxiety-controlled; "Tachycardia" (unspecified if ongoing), notes: Tachycardia/hypertension- controlled.; "hypertension" (unspecified if ongoing), notes: Tachycardia/hypertension- controlled. Concomitant medication(s) included: METOPROLOL; BUPROPION; AMITRIPTYLINE; ESTRADIOL; PROGESTERONE; SIMVASTATIN; ASPIRIN (E.C.); COQ10 [UBIDECARENONE]; OMEGA 3 [DOCOSAHEXAENOIC ACID;EICOSAPENTAENOIC ACID;TOCOPHERYL ACETATE]; NEURIVA BRAIN PERFORMANCE; VIT D [VITAMIN D NOS]; MAGNESIUM GLYCINATE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: COVID 19 Treatment of Paxlovid was started on 15Sep2022, Lot number: 1919253A, Indication was treatment of COVID-19. Concomitant product was Probiotic/multi-enzyme. Known allergies was poison oak. Other medical history was high cholesterol, which was resolved. Depression/anxiety was in controlled. Tachycardia/hypertension was in controlled.  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 available information in the case, the causal association between the events Vaccination failure, COVID-19 and the suspect drug BNT162B2 cannot be excluded.
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: If vaccine received was reported as Yes. No other medication in 2 weeks reported and no known allergies was reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 25.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 25 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. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Unknown result, notes: Rebounding Covid symptoms after initial symptoms disappeared for 2-3 days after paxlovid completion. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient received other medication in 2 weeks. Covid was treated. Anti-viral details: Treatment start date was 06Sep2022 and treatment stop date was 11Sep2022. Indication- Treatment of COVID-19. Adverse event: Rebounding Covid symptoms after initial symptoms disappeared for 2-3 days after paxlovid completion.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "obesity" (unspecified if ongoing); "pcos" (unspecified if ongoing). Concomitant medication(s) included: GUANFACINE; WELLBUTRIN; PRISTIQ. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Indication: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Antiviral details Paxlovid. Product: COVID 19 Treatment, Treatment start date: 14Sep2022, Indication: Treatment of COVID-19. Adverse event: diarrhea, bad taste in mouth, abdominal cramps. The patient has been received vaccine and the patient received Other medication in 2 weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
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 a non-contactable reporter(s) (Pharmacist). The reporter is the patient.  A 31-year-old male patient received BNT162b2 (BNT162B2), on 12May2021 as dose 2, single (Lot number: EW0150) at the age of 30 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: "Asthma" (unspecified if ongoing); "Known allergies: Wheat" (unspecified if ongoing); "Known allergies: milk" (unspecified if ongoing); "Known allergies: eggs" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Information: Patient did not receive any other medications in 2 weeks. Patient received Paxlovid (anti-viral) from 15Sep2022 to unknown date for treatment of COVID-19.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events drug ineffective, covid-19 and the suspect drug BNT162B2.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I tested positive only my fourth or fifth day of COVID and I have taken Pfizer Vaccines and Booster (Pfizer COVID-19 Vaccine); I tested positive only my fourth or fifth day of COVID and I have taken Pfizer Vaccines and Booster (Pfizer COVID-19 Vaccine); This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I tested positive only my fourth or fifth day of COVID and I have taken Pfizer Vaccines and Booster (Pfizer COVID-19 Vaccine)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I tested positive only my fourth or fifth day of COVID. Therapeutic measures were taken as a result of drug ineffective, COVID-19 including  PF-07321332/ritonavir (PAXLOVID).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19-2
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Gastrointestinal pain, Headache
Clinical narrative: Severe stomach cramps; Diarrhea; nausea; chills; headache; Intense cramps during bowl movement; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 57-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary immunization series completed , COVID-19 Vaccine[unknown manufacturer]), for COVID-19 immunization; Covid-19 vaccine (DOSE: 1st Booster), for COVID-19 immunization.  The following information was reported: DIARRHEA (non-serious) with onset 10Sep2022, outcome "recovering", described as "Diarrhea"; GASTROINTESTINAL PAIN (non-serious) with onset 10Sep2022, outcome "recovering", described as "Intense cramps during bowl movement"; ABDOMINAL PAIN UPPER (non-serious) with onset 10Sep2022, outcome "recovering", described as "Severe stomach cramps"; CHILLS (non-serious) with onset 10Sep2022, outcome "recovering"; HEADACHE (non-serious) with onset 10Sep2022, outcome "recovering"; NAUSEA (non-serious) with onset 10Sep2022, outcome "recovering". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of abdominal pain upper, diarrhea, nausea, chills, headache, gastrointestinal pain.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 57.0
Sex: M
Vaccine: COVID19-2
Symptoms: Nasopharyngeal swab, Nausea
Clinical narrative: Severe stomach cramps; Diarrhea; nausea; chills; headache; Intense cramps during bowl movement; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 57-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary immunization series completed , COVID-19 Vaccine[unknown manufacturer]), for COVID-19 immunization; Covid-19 vaccine (DOSE: 1st Booster), for COVID-19 immunization.  The following information was reported: DIARRHEA (non-serious) with onset 10Sep2022, outcome "recovering", described as "Diarrhea"; GASTROINTESTINAL PAIN (non-serious) with onset 10Sep2022, outcome "recovering", described as "Intense cramps during bowl movement"; ABDOMINAL PAIN UPPER (non-serious) with onset 10Sep2022, outcome "recovering", described as "Severe stomach cramps"; CHILLS (non-serious) with onset 10Sep2022, outcome "recovering"; HEADACHE (non-serious) with onset 10Sep2022, outcome "recovering"; NAUSEA (non-serious) with onset 10Sep2022, outcome "recovering". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of abdominal pain upper, diarrhea, nausea, chills, headache, gastrointestinal pain.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Body temperature, Consciousness fluctuating, Dizziness, Pyrexia
Clinical narrative: sensation of losing consciousness.; Next morning on 14Sep in the morning, caused dizziness; Body temperature spiked to 103F in 12 hrs of vaccination; Experienced distorted dreams through the night.; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 49-year-old female patient (not pregnant) received BNT162b2 (COMIRNATY), on 13Sep2022 at 14:00 as dose 4 (booster), single (Lot number: GH9702) at the age of 49 years for covid-19 immunization at a Clinic/Administration facility. The patient's relevant medical history included: "Undergoing treatment for chronic lymphocytic leukaemia" (unspecified if ongoing), notes: Undergoing treatment for chronic, lymphocytic leukaemia. Concomitant medication(s) included: IBRUTINIB, stop date: 24Aug2022; VALACYCLOVIR [VALACICLOVIR], stop date: 01Sep2022. Vaccination history included: Covid-19 vaccine (Dose: 01, MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (Dose: 02, MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (Dose: 03, MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 13Sep2022, outcome "recovered" (2022), described as "Body temperature spiked to 103F in 12 hrs of vaccination"; ABNORMAL DREAMS (non-serious) with onset 13Sep2022, outcome "recovered" (2022), described as "Experienced distorted dreams through the night."; DIZZINESS (non-serious) with onset 14Sep2022, outcome "recovered" (2022), described as "Next morning on 14Sep in the morning, caused dizziness"; CONSCIOUSNESS FLUCTUATING (medically significant) with onset 14Sep2022, outcome "recovered" (2022), described as "sensation of losing consciousness.". The patient underwent the following laboratory tests and procedures: Body temperature: (13Sep2022) 103 Fahrenheit, notes: Body temperature spiked to 103F in 12 hrs of vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram, Electrocardiogram, Myocarditis
Clinical narrative: This is a spontaneous report received from 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 22Oct2021 at 15:00 as dose 2 (booster), single (Lot number: 301458A) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing), notes: Known allergies: penicillin. There were no concomitant medications. Vaccination history included: Janssen (product=COVID 19, brand=Janssen, brand unknown=False, lot number=1805022, lot unknown=False, administration date=06Mar2021, administration time=09:00 AM, dose number=2, vaccine location=Left arm), administration date: 06Mar2021, when the patient was 60-year-old, for COVID-19 immunization. The following information was reported: MYOCARDITIS (medically significant) with onset 01Sep2022, outcome "recovered with sequelae", described as "I am concerned I had heart swelling after Pfizer MNRA booster which caused Right Bundle Block". The event "I am concerned I had heart swelling after Pfizer MNRA booster which caused right bundle block" required physician office visit. The patient underwent the following laboratory tests and procedures: Echocardiogram: (Sep2022) no signs of heart problems or disease; Electrocardiogram: (Jul2021) Normal; (Sep2022) Right Bundle Block. Therapeutic measures were not taken as a result of myocarditis. Clinical Course: It was reported that Facility type vaccine: Pharmacy or Drug Store. If other vaccine in four weeks: No. Other medications in two weeks: No. EKG Jul2021 was normal. Pfizer Booster Oct2021 (prior vaccine J&J Mar2021). EKG Sep2022 shows Right Bundle Block. ECHO Sep2022 shows no signs of heart problems or disease. I am concerned I had heart swelling after Pfizer MNRA booster which caused Right Bundle Block. I had no other health changes between the Pfizer booster (Oct2021) and the latest EKG (Sep2022). If Covid prior vaccination: No. If Covid tested post vaccination: No. No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19-2
Symptoms: Urinary tract infection
Clinical narrative: worst UTI; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: URINARY TRACT INFECTION (non-serious), outcome "unknown", described as "worst UTI".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 32.0
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old male patient received BNT162b2 (BNT162B2), on 06Jul2021 at 12:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 32 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: COVID 19 Treatment; (13Sep2022) Negative; (16Sep2022) Positive, notes: tested, immediately positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment included anti-viral Paxlovid from 07Sep2022 to 12Sep2022. Took Paxlovid, felt great, tested negative 13Sep2022, 16Sep2022 felt horrible, tested, immediately positive.  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: Pemphigus
Clinical narrative: pemphigus vulgaris (trunk and back) and mouth; This is a literature report for the following literature source(s).   A 40-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: Bnt162b2 (DOSE 1, SINGLE, experienced events after 5 days after vaccination), for covid-19 immunization, reaction(s): "Pemphigus vulgaris". The following information was reported: PEMPHIGUS (medically significant), 3 days after the suspect product(s) administration, outcome "recovering", described as "pemphigus vulgaris (trunk and back) and mouth". Therapeutic measures were taken as a result of pemphigus.  Clinical information: Consumer reported treatment for reported event as oral prednisone and azathioprine. Clinical outcome was remission without reported relapse (unspecified timeline).; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event PEMPHIGUS 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-PV202200065086 Same article/ drug/ patient and different event;
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: got sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s):  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "got sick".  Additional Information: On 31Aug2022, it was reported that patient started treatment on an unspecified date with Pfizer COVID-19 Vaccine at an unspecified dose and frequency for an unspecified indication. It was reported the patient got sick after taking the Pfizer vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: PNC13
Symptoms: Pain
Clinical narrative: experienced more pain compared with other vaccines; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "experienced more pain compared with other vaccines".  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Vaccination site erythema, Vaccination site oedema
Clinical narrative: Patient has a localized injection site reaction (redness and edema).; Patient has a localized injection site reaction (redness and edema).; A COVID-19 vaccine is given subcutaneous and not intramuscular as recommended.; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) subcutaneous for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE EDEMA (non-serious), outcome "unknown" and all described as "Patient has a localized injection site reaction (redness and edema)."; INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "A COVID-19 vaccine is given subcutaneous and not intramuscular as recommended.".  Additional information: Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: the patient already had tinnitus and very shortly after injection it got much worse.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s):   A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "tinnitus" (unspecified if ongoing), notes: It was reported the patient already had tinnitus. The patient's concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "the patient already had tinnitus and very shortly after injection it got much worse.".  Additional information: On 01Sep2022, it was reported that a patient started treatment on an unspecified date with Pfizer BioNTech COVID-19 Vaccine at an unspecified dose and indication. It was reported the patient already had tinnitus and very shortly after injection it got much worse.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive; Tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Aug2022, outcome "recovered" (2022) and all described as "Tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Aug2022) Positive, notes: 3 out of 9 of us tested (+) on Wednesday 03Aug2022; (unspecified date) Positive, notes: 2nd time having COVID. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical information: Was attending a small family gathering 30Jul for a week. 3 out of 9 of us tested (+) on Wednesday 03Aug2022. Individual female 65 fully vaccinated (Pfizer) and 2 boosters (Pfizer) recovered w/o Paxlovid. 2nd time having COVID for female 65.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: numbness and tingling in right side of face; numbness and tingling in right side of face; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s):   A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, 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: PARAESTHESIA (non-serious), HYPOAESTHESIA (non-serious), outcome "recovered" and all described as "numbness and tingling in right side of face".  Additional information: On 02Sep2022, it was reported that a patient started treatment on unspecified date with Pfizer BioNTech COVID-19 Vaccine at dose 1 for an unknown indication. It was reported the patient had numbness and tingling in right side of face following first dose that lasted for months. No further follow-up is anticipated.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from contactable reporter(s) (Pharmacist).  A 36-year-old male patient received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  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: Urticaria
Clinical narrative: Allergic reaction (generalized urticaria); This is a spontaneous report received from contactable reporter(s) (Physician). Other Case identifier(s):   A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: URTICARIA (non-serious), outcome "unknown", described as "Allergic reaction (generalized urticaria)".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: her father has Bell's palsy; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. A male patient received BNT162b2 (BNT162B2), 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. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: BELL'S PALSY (medically significant), outcome "unknown", described as "her father has Bell's palsy". Adverse Event Reporting, I was at an appointment today, and I heard a women say her father has Bell's palsy and the doctor said it was from his 3rd COVID-19 Booster. I wanted to make sure you had this information.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Covid-19; Covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s).  A 44-year-old female patient received BNT162b2 (BNT162B2), on 01Dec2020 as dose 1, single (Batch/Lot number: unknown), on 01Jan2021 as dose 2, single (Batch/Lot number: unknown) and on 01Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 43 years for covid-19 immunisation. The patient's relevant medical history included: "break-through migraines (Migraine)" (unspecified if ongoing). Concomitant medication(s) included: UBRELVY taken for migraine; AIMOVIG taken for migraine. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered with sequelae" and all described as "Covid-19".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.