chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, COVID-19, Cardiac murmur, Drug ineffective, Dysstasia
Clinical narrative: a large heart murmur; Numbness in hands, arms, legs, feet; Extreme sensitivity when anything touches these limbs; Unable to walk, stand or balance; Unable to walk, stand or balance; Unable to walk, stand or balance; COVID Test: Nasal Swab / Result: Positive; COVID Test: Nasal Swab / Result: Positive; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received BNT162b2, administered in arm left, administration date 18Sep2021 (Batch/Lot number: unknown) at the age of 52 years as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history. There were no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no other medications the patient received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The following information was reported: CARDIAC MURMUR (hospitalization, disability) with onset 27Sep2021, outcome "not recovered", described as "a large heart murmur"; HYPOAESTHESIA (hospitalization, disability) with onset 27Sep2021, outcome "not recovered", described as "Numbness in hands, arms, legs, feet"; HYPERAESTHESIA (hospitalization, disability) with onset 27Sep2021, outcome "not recovered", described as "Extreme sensitivity when anything touches these limbs"; GAIT INABILITY (hospitalization, disability), DYSSTASIA (hospitalization, disability), BALANCE DISORDER (hospitalization, disability) all with onset 27Sep2021, outcome "not recovered" and all described as "Unable to walk, stand or balance"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID Test: Nasal Swab / Result: Positive". Clinical course: Numbness in hands, arms, legs, feet. Extreme sensitivity when anything touches these limbs, unable to walk, stand or balance. Also gave the patient a large heart murmur. The patient was hospitalized for cardiac murmur, hypoaesthesia, hyperaesthesia, gait inability, dysstasia, balance disorder (hospitalization duration: 2 days). The events "a large heart murmur", "numbness in hands, arms, legs, feet", "extreme sensitivity when anything touches these limbs", "unable to walk, stand or balance", "unable to walk, stand or balance" and "unable to walk, stand or balance" were evaluated at the physician office visit and emergency room visit. The patient underwent COVID test: Nasal Swab (unspecified date) with result positive, notes: Post vaccination. Therapeutic measures were not taken as a result of cardiac murmur, hypoaesthesia, hyperaesthesia, gait inability, dysstasia, balance disorder.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Hyperaesthesia, Hypoaesthesia, Investigation, SARS-CoV-2 test
Clinical narrative: a large heart murmur; Numbness in hands, arms, legs, feet; Extreme sensitivity when anything touches these limbs; Unable to walk, stand or balance; Unable to walk, stand or balance; Unable to walk, stand or balance; COVID Test: Nasal Swab / Result: Positive; COVID Test: Nasal Swab / Result: Positive; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received BNT162b2, administered in arm left, administration date 18Sep2021 (Batch/Lot number: unknown) at the age of 52 years as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history. There were no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no other medications the patient received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The following information was reported: CARDIAC MURMUR (hospitalization, disability) with onset 27Sep2021, outcome "not recovered", described as "a large heart murmur"; HYPOAESTHESIA (hospitalization, disability) with onset 27Sep2021, outcome "not recovered", described as "Numbness in hands, arms, legs, feet"; HYPERAESTHESIA (hospitalization, disability) with onset 27Sep2021, outcome "not recovered", described as "Extreme sensitivity when anything touches these limbs"; GAIT INABILITY (hospitalization, disability), DYSSTASIA (hospitalization, disability), BALANCE DISORDER (hospitalization, disability) all with onset 27Sep2021, outcome "not recovered" and all described as "Unable to walk, stand or balance"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID Test: Nasal Swab / Result: Positive". Clinical course: Numbness in hands, arms, legs, feet. Extreme sensitivity when anything touches these limbs, unable to walk, stand or balance. Also gave the patient a large heart murmur. The patient was hospitalized for cardiac murmur, hypoaesthesia, hyperaesthesia, gait inability, dysstasia, balance disorder (hospitalization duration: 2 days). The events "a large heart murmur", "numbness in hands, arms, legs, feet", "extreme sensitivity when anything touches these limbs", "unable to walk, stand or balance", "unable to walk, stand or balance" and "unable to walk, stand or balance" were evaluated at the physician office visit and emergency room visit. The patient underwent COVID test: Nasal Swab (unspecified date) with result positive, notes: Post vaccination. Therapeutic measures were not taken as a result of cardiac murmur, hypoaesthesia, hyperaesthesia, gait inability, dysstasia, balance disorder.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Laboratory test
Clinical narrative: Chest pain; longer and stronger for the second one; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 59 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Apr2021 (Lot number: ER8736) at the age of 59 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Heart palpitations" (unspecified if ongoing); "Glaucoma" (unspecified if ongoing). Concomitant medication(s) included: LATANOPROST taken for glaucoma. Past drug history included: Ampicillin, reaction(s): "drug allergy". Vaccination history included: Bnt162b2 (First dose, Lot: ER8734, Location: left upper arm or shoulder), administration date: 08Apr2021, when the patient was 59 years old, for Covid-19 Immunization, reaction(s): "Chest pain", "left breast pain", "sharp pain, like pleuritic pain, especially on inhalation". The following information was reported: CHEST PAIN (non-serious) with onset Apr2021, outcome "unknown", described as "Chest pain; longer and stronger for the second one". The event "chest pain; longer and stronger for the second one" was evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chest pain. Additional information: The patient also took vitamins as concomitant therapy. The patient had a reaction to shot number one and shot number two of the Pfizer,  shot number two had a much more 'exacerbated' reaction. There was no any other vaccine shortly before the vaccination, within 4 weeks. The patient went into the Emergency Room, they ruled out Pulmonary embolism and sent the patient on her way.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021549918 same patient, vaccine different dose, similar AE
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Immunisation, Influenza like illness
Clinical narrative: Booster; 4 hours after the shoot began to feel tired; light headache; low grade Fever; Flu like body ache; Flu like body ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Lot number: FF8899, Expiration Date: Mar2022) as dose number unknown (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, manufacturer unknown), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 2021, outcome "unknown", described as "Booster"; FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "4 hours after the shoot began to feel tired"; HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021), described as "light headache"; PYREXIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "low grade Fever"; INFLUENZA LIKE ILLNESS (non-serious), PAIN (non-serious) all with onset 2021, outcome "recovered" (2021) and all described as "Flu like body ache". Relevant laboratory tests and procedures are available in the appropriate section.   Additional information: Description of event: Booster shot. 4 hours after the shoot began to feel tired by next day, light headache and low grade fever, flu like body ache. Everything lasted about 2 days. Name of Product: PFE Covid-19 Vaccine. Event took place after use of product.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Booster; 4 hours after the shoot began to feel tired; light headache; low grade Fever; Flu like body ache; Flu like body ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Lot number: FF8899, Expiration Date: Mar2022) as dose number unknown (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, manufacturer unknown), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 2021, outcome "unknown", described as "Booster"; FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "4 hours after the shoot began to feel tired"; HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021), described as "light headache"; PYREXIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "low grade Fever"; INFLUENZA LIKE ILLNESS (non-serious), PAIN (non-serious) all with onset 2021, outcome "recovered" (2021) and all described as "Flu like body ache". Relevant laboratory tests and procedures are available in the appropriate section.   Additional information: Description of event: Booster shot. 4 hours after the shoot began to feel tired by next day, light headache and low grade fever, flu like body ache. Everything lasted about 2 days. Name of Product: PFE Covid-19 Vaccine. Event took place after use of product.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Immunisation
Clinical narrative: Booster; Slight headache; chills; sweats; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, (booster) single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer unknown), for Covid-19 Immunization; Covid-19 vaccine (Manufacturer unknown), for Covid-19 immunization.  The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; HEADACHE (non-serious), outcome "unknown", described as "Slight headache"; CHILLS (non-serious), outcome "unknown", described as "chills"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "sweats".  The lot number for bnt162b2 was not provided and will be requested during follow up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Basedow's disease
Clinical narrative: Graves disease induced by SARS-CoV-2 infection or vaccine; This is a literature report for the following literature source(s): "A case report of new onset graves disease induced by SARS-CoV-2 infection or vaccine?" The full publication has been requested.   A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BASEDOW'S DISEASE (medically significant), outcome "unknown", described as "Graves disease induced by SARS-CoV-2 infection or vaccine".; Sender's Comments: As there is limited information in the case provided, the causal association between the event Basedow disease and the suspect drug cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Lymphadenopathy, Movement disorder, Off label use, Pain
Clinical narrative: Severe swollen lymph node in armpit; Dose 1: Moderna; Dose 2: Moderna; Dose 1: Moderna; Dose 2: Moderna; hindered my movement; hurt badly; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), administered in arm left, administration date 07Dec2021 (Lot number: FH8030) at the age of 36 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Endometriosis" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Moderna (Dose Number: 2, Batch/Lot No: 013M20A, Location of injection: Arm Left), administration date: 03Feb2021, when the patient was 35 years old, for COVID-19 immunization; Moderna (Dose Number: 1, Batch/Lot No: 027120A, Location of injection: Arm Left), administration date: 06Jan2021, when the patient was 35 years old, for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 08Dec2021, outcome "recovered" (Dec2021), described as "Severe swollen lymph node in armpit"; OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious) all with onset 08Dec2021, outcome "recovered" (Dec2021) and all described as "Dose 1: Moderna; Dose 2: Moderna"; MOVEMENT DISORDER (non-serious) with onset 08Dec2021, outcome "recovered" (Dec2021), described as "hindered my movement"; PAIN (non-serious) with onset 08Dec2021, outcome "recovered" (Dec2021), described as "hurt badly". Therapeutic measures were not taken as a result of lymphadenopathy, off label use, interchange of vaccine products, movement disorder, pain.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Pain, Palindromic rheumatism, SARS-CoV-2 antibody test
Clinical narrative: Palindromic Rheumatism; Developed joint pain that would travel around the body; Developed joint pain that would travel around the body; Pain was absolutely debilitating; This is a spontaneous report received from contactable reporter(s) (Consumer). The reporter is the patient. A 29-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 23Aug2021 18:00 (Lot number: FC3181) at the age of 29 years as dose 1, single for COVID-19 immunization. The patient's relevant medical history was not reported. Concomitant medication(s) included: PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]; PRENATAL DHA; VITAMIN D [VITAMIN D NOS]. The following information was reported: PALINDROMIC RHEUMATISM (disability) with onset 29Aug2021, outcome "not recovered", described as "Palindromic Rheumatism"; ARTHRALGIA (disability), PAIN (disability) all with onset 29Aug2021, outcome "not recovered" and all described as "Developed joint pain that would travel around the body"; ASTHENIA (disability) with onset 29Aug2021, outcome "not recovered", described as "Pain was absolutely debilitating". The events "palindromic rheumatism", "developed joint pain that would travel around the body", "developed joint pain that would travel around the body" and "pain was absolutely debilitating" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: (08Dec2021) negative. Therapeutic measures were taken as a result of palindromic rheumatism, arthralgia, pain, asthenia.  Additional information: The patient was reported to have developed joint pain that would travel around the body. Each joint lasting around 24-48 hours. The pain was absolutely debilitating. After seeing two rheumatologists, it was determined that the patient ended up developing Palindromic Rheumatism - subset of RA following the vaccine and have been advised to not get any more doses.
Sex: M
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Blood alkaline phosphatase, Blood bilirubin, Endoscopic retrograde cholangiopancreatography, Inflammation scan
Clinical narrative: Liver injury following SARS-CoV-2 vaccination; This is a literature report.  A 46 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. Relevant medical history included: "NAFLD" (ongoing); "ERCP with new severe sclerosing cholangitis" (ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "drug-induced liver injury", notes: two years earlier. The following information was reported: LIVER INJURY (medically significant), outcome "recovering", described as "Liver injury following SARS-CoV-2 vaccination". The patient underwent the following laboratory tests and procedures: alanine aminotransferase: 594 IU/l; blood alkaline phosphatase: 197 IU/l; blood bilirubin: 3.9 mg/dl; endoscopic retrograde cholangiopancreatography: diagnosed with "new" sclerosing, notes: cholangitis; inflammation scan: positive; international normalised ratio: 1.3; laboratory test: negative; focal portal and peri portal; magnetic resonance cholangiopancreatography: showed subtle non-diagnostic biliary findings,, notes: raising the possibility of undiagnosed primary sclerosing cholangitis; smooth muscle antibody: 1:40; viral test: negative, notes: ERCP with new severe sclerosing cholangitis. Therapeutic measures were taken as a result of liver injury.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the currently available information the possibility of causal association between the event liver injury and the suspect drug BNT162B2  cannot be ruled out. The case will be reassessed once new information is available. 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-202101846551 Same article/drug/event and different Patient;US-PFIZER INC-202101846555 Same article/drug/event and different patient;US-PFIZER INC-202101846552 Same article/drug/event and different patient.;US-PFIZER INC-202101846560 Same article/drug/event and different patient.;US-PFIZER INC-202101846553 Same article/drug/event and different patient.;US-PFIZER INC-202101846554 Same article/drug/event and different patient.;US-PFIZER INC-202101846556 Same article/drug/event and different patient.;US-PFIZER INC-202101846561 Same article/drug/event and different patient.;US-PFIZER INC-202101846558 Same article/drug/event and different patient.
Sex: M
Vaccine: COVID19
Symptoms: International normalised ratio, Laboratory test, Liver injury, Magnetic resonance cholangiopancreatography, Smooth muscle antibody
Clinical narrative: Liver injury following SARS-CoV-2 vaccination; This is a literature report.  A 46 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. Relevant medical history included: "NAFLD" (ongoing); "ERCP with new severe sclerosing cholangitis" (ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "drug-induced liver injury", notes: two years earlier. The following information was reported: LIVER INJURY (medically significant), outcome "recovering", described as "Liver injury following SARS-CoV-2 vaccination". The patient underwent the following laboratory tests and procedures: alanine aminotransferase: 594 IU/l; blood alkaline phosphatase: 197 IU/l; blood bilirubin: 3.9 mg/dl; endoscopic retrograde cholangiopancreatography: diagnosed with "new" sclerosing, notes: cholangitis; inflammation scan: positive; international normalised ratio: 1.3; laboratory test: negative; focal portal and peri portal; magnetic resonance cholangiopancreatography: showed subtle non-diagnostic biliary findings,, notes: raising the possibility of undiagnosed primary sclerosing cholangitis; smooth muscle antibody: 1:40; viral test: negative, notes: ERCP with new severe sclerosing cholangitis. Therapeutic measures were taken as a result of liver injury.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the currently available information the possibility of causal association between the event liver injury and the suspect drug BNT162B2  cannot be ruled out. The case will be reassessed once new information is available. 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-202101846551 Same article/drug/event and different Patient;US-PFIZER INC-202101846555 Same article/drug/event and different patient;US-PFIZER INC-202101846552 Same article/drug/event and different patient.;US-PFIZER INC-202101846560 Same article/drug/event and different patient.;US-PFIZER INC-202101846553 Same article/drug/event and different patient.;US-PFIZER INC-202101846554 Same article/drug/event and different patient.;US-PFIZER INC-202101846556 Same article/drug/event and different patient.;US-PFIZER INC-202101846561 Same article/drug/event and different patient.;US-PFIZER INC-202101846558 Same article/drug/event and different patient.
Sex: M
Vaccine: COVID19
Symptoms: Viral test
Clinical narrative: Liver injury following SARS-CoV-2 vaccination; This is a literature report.  A 46 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. Relevant medical history included: "NAFLD" (ongoing); "ERCP with new severe sclerosing cholangitis" (ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "drug-induced liver injury", notes: two years earlier. The following information was reported: LIVER INJURY (medically significant), outcome "recovering", described as "Liver injury following SARS-CoV-2 vaccination". The patient underwent the following laboratory tests and procedures: alanine aminotransferase: 594 IU/l; blood alkaline phosphatase: 197 IU/l; blood bilirubin: 3.9 mg/dl; endoscopic retrograde cholangiopancreatography: diagnosed with "new" sclerosing, notes: cholangitis; inflammation scan: positive; international normalised ratio: 1.3; laboratory test: negative; focal portal and peri portal; magnetic resonance cholangiopancreatography: showed subtle non-diagnostic biliary findings,, notes: raising the possibility of undiagnosed primary sclerosing cholangitis; smooth muscle antibody: 1:40; viral test: negative, notes: ERCP with new severe sclerosing cholangitis. Therapeutic measures were taken as a result of liver injury.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the currently available information the possibility of causal association between the event liver injury and the suspect drug BNT162B2  cannot be ruled out. The case will be reassessed once new information is available. 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-202101846551 Same article/drug/event and different Patient;US-PFIZER INC-202101846555 Same article/drug/event and different patient;US-PFIZER INC-202101846552 Same article/drug/event and different patient.;US-PFIZER INC-202101846560 Same article/drug/event and different patient.;US-PFIZER INC-202101846553 Same article/drug/event and different patient.;US-PFIZER INC-202101846554 Same article/drug/event and different patient.;US-PFIZER INC-202101846556 Same article/drug/event and different patient.;US-PFIZER INC-202101846561 Same article/drug/event and different patient.;US-PFIZER INC-202101846558 Same article/drug/event and different patient.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: She ended up getting Covid in Aug2021; found out that the vaccine was not effective because of kesimpta; This is a spontaneous report received from contactable reporter. The reporter is the patient. Other Case identifier(s): NVSC2020US302184.  A 51 year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administration date Aug2021 (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; Kesimpta (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SUSPECTED COVID-19 (medically significant) with onset Aug2021, outcome unknown, described as She ended up getting Covid in Aug2021; DRUG INEFFECTIVE (medically significant) with onset Aug2021, outcome unknown, described as found out that the vaccine was not effective because of kesimpta. She had COVID again about 2 weeks ago. The action taken for Kesimpta was unknown.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 51.0
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Colonoscopy, Dizziness, Immunisation, Lymph node pain
Clinical narrative: High fever (102.6 F) - the following day after the booster; dizziness; Having underarm (left arm) lymph node enlarged and painful for four full days; Having underarm (left arm) lymph node enlarged and painful for four full days; Moderate nausea; Dose received: 3; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Dec2021 17:00 (Batch/Lot number: unknown) at the age of 51 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Previous dose lot unknown reason=Not available/provided to reporter at the time of report completion,, Previous dose administration date: 08Jun2021, Previous dose Vaccine location: Left arm), administration date: 08Jun2021, when the patient was 51 years old, for COVID-19 immunization; Bnt162b2 (DOSE 1, SINGLE, Previous dose lot unknown reason=Not available/provided to reporter at the time of report completion,, Previous dose administration date: 18May2021, Previous dose administration time: 11:00, Previous dose Vaccine location: Left arm), administration date: 18May2021, when the patient was 51 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 16Dec2021 17:00, outcome "unknown", described as "Dose received: 3"; DIZZINESS (non-serious) with onset 16Dec2021 21:00, outcome "recovering", described as "dizziness"; LYMPH NODE PAIN (non-serious), LYMPHADENOPATHY (non-serious) all with onset 16Dec2021 21:00, outcome "recovering" and all described as "Having underarm (left arm) lymph node enlarged and painful for four full days"; NAUSEA (non-serious) with onset 16Dec2021 21:00, outcome "recovering", described as "Moderate nausea"; PYREXIA (non-serious) with onset 17Dec2021, outcome "recovering", described as "High fever (102.6 F) - the following day after the booster". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dizziness, lymph node pain, lymphadenopathy, nausea, pyrexia.  Additional information: The patient did not take any other vaccine in four weeks. The patient had Colonoscopy procedure with anaesthesia one week prior. The patient had moderate nausea and dizziness going into 4th day after receiving the booster by Pfizer. All of these side effects were more intense from those the patient dealt with after the previously received vaccines The patient did not have Covid prior vaccination.  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-202101834750 similar report from same reporter
Age: 51.0
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy, Nausea, Pyrexia, SARS-CoV-2 test
Clinical narrative: High fever (102.6 F) - the following day after the booster; dizziness; Having underarm (left arm) lymph node enlarged and painful for four full days; Having underarm (left arm) lymph node enlarged and painful for four full days; Moderate nausea; Dose received: 3; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Dec2021 17:00 (Batch/Lot number: unknown) at the age of 51 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Previous dose lot unknown reason=Not available/provided to reporter at the time of report completion,, Previous dose administration date: 08Jun2021, Previous dose Vaccine location: Left arm), administration date: 08Jun2021, when the patient was 51 years old, for COVID-19 immunization; Bnt162b2 (DOSE 1, SINGLE, Previous dose lot unknown reason=Not available/provided to reporter at the time of report completion,, Previous dose administration date: 18May2021, Previous dose administration time: 11:00, Previous dose Vaccine location: Left arm), administration date: 18May2021, when the patient was 51 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 16Dec2021 17:00, outcome "unknown", described as "Dose received: 3"; DIZZINESS (non-serious) with onset 16Dec2021 21:00, outcome "recovering", described as "dizziness"; LYMPH NODE PAIN (non-serious), LYMPHADENOPATHY (non-serious) all with onset 16Dec2021 21:00, outcome "recovering" and all described as "Having underarm (left arm) lymph node enlarged and painful for four full days"; NAUSEA (non-serious) with onset 16Dec2021 21:00, outcome "recovering", described as "Moderate nausea"; PYREXIA (non-serious) with onset 17Dec2021, outcome "recovering", described as "High fever (102.6 F) - the following day after the booster". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dizziness, lymph node pain, lymphadenopathy, nausea, pyrexia.  Additional information: The patient did not take any other vaccine in four weeks. The patient had Colonoscopy procedure with anaesthesia one week prior. The patient had moderate nausea and dizziness going into 4th day after receiving the booster by Pfizer. All of these side effects were more intense from those the patient dealt with after the previously received vaccines The patient did not have Covid prior vaccination.  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-202101834750 similar report from same reporter
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Suffered from Bell's palsy; This is a spontaneous report received from a non-contactable consumer from medical information team for a Pfizer sponsored program.  A 89 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BELL'S PALSY (medically significant), outcome "unknown", described as "Suffered from Bell's palsy". The patient got the first COVID shot and suffered from Bell's palsy and three doctors told her that it was because of the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Hypersensitivity, Immunisation, Malaise
Clinical narrative: I am tired; feeling yucky; Sinus and chest congestion; Body aches; Sinus and chest congestion; Feeling ill; Sinuses were so bad. Had lots of mucus. More mucus than normal. Had lots of mucus. More mucus than normal.; She has allergies; booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient.  A 71-year-old female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 14Dec2021 14:30 (Lot number: FJ8757, Expiration Date: 28Feb2022) at the age of 71 years as dose 3 (booster), 0.3 ml single for covid-19 immunisation. Relevant medical history included: "Allergies" (ongoing), notes: Verbatim: Allergies; "Sinus problems" (ongoing), notes: Verbatim: Sinus problems; "Aches and pains" (ongoing), notes: Verbatim: Aches and pains; "Neuropathy" (unspecified if ongoing), notes: Verbatim: Neuropathy. Concomitant medication(s) included: FLU, administration date 22Nov2021. Vaccination history included: Bnt162b2 (First dose: , LOT: EN6200, NDC: Unknown , EXP: 20Jun2021, Dose: Unknown , Route: left shoulder/arm , Formulation: injection), administration date: 23Feb2021, when the patient was 71 years old, for COVID-19 immunization, reaction(s): "Was a little achy"; Bnt162b2 (Second dose:, LOT: EN6207; It's not identified as the lot number. , NDC: Unknown, EXP: 31Jul2021, Dose: Unknown , Route: left shoulder, Formulation: injection), administration date: 16Mar2021, when the patient was 71 years old, for COVID-19 immunization, reaction(s): "No adverse event". The following information was reported: IMMUNISATION (non-serious) with onset 14Dec2021, outcome "unknown", described as "booster"; FATIGUE (non-serious) with onset 15Dec2021, outcome "recovering", described as "I am tired"; FEELING ABNORMAL (non-serious) with onset 15Dec2021, outcome "recovering", described as "feeling yucky"; SINUS CONGESTION (non-serious), RESPIRATORY TRACT CONGESTION (non-serious) all with onset 15Dec2021, outcome "recovering" and all described as "Sinus and chest congestion"; PAIN (non-serious) with onset 15Dec2021, outcome "recovering", described as "Body aches"; MALAISE (non-serious) with onset 15Dec2021, outcome "recovering", described as "Feeling ill"; SECRETION DISCHARGE (non-serious) with onset 15Dec2021, outcome "recovering", described as "Sinuses were so bad. Had lots of mucus. More mucus than normal. Had lots of mucus. More mucus than normal."; HYPERSENSITIVITY (non-serious) with onset 15Dec2021, outcome "recovering", described as "She has allergies". Therapeutic measures were not taken as a result of fatigue, feeling abnormal, sinus congestion, pain, respiratory tract congestion, malaise, secretion discharge, hypersensitivity.  No follow-up attempts are required. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Respiratory tract congestion, Secretion discharge, Sinus congestion
Clinical narrative: I am tired; feeling yucky; Sinus and chest congestion; Body aches; Sinus and chest congestion; Feeling ill; Sinuses were so bad. Had lots of mucus. More mucus than normal. Had lots of mucus. More mucus than normal.; She has allergies; booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient.  A 71-year-old female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 14Dec2021 14:30 (Lot number: FJ8757, Expiration Date: 28Feb2022) at the age of 71 years as dose 3 (booster), 0.3 ml single for covid-19 immunisation. Relevant medical history included: "Allergies" (ongoing), notes: Verbatim: Allergies; "Sinus problems" (ongoing), notes: Verbatim: Sinus problems; "Aches and pains" (ongoing), notes: Verbatim: Aches and pains; "Neuropathy" (unspecified if ongoing), notes: Verbatim: Neuropathy. Concomitant medication(s) included: FLU, administration date 22Nov2021. Vaccination history included: Bnt162b2 (First dose: , LOT: EN6200, NDC: Unknown , EXP: 20Jun2021, Dose: Unknown , Route: left shoulder/arm , Formulation: injection), administration date: 23Feb2021, when the patient was 71 years old, for COVID-19 immunization, reaction(s): "Was a little achy"; Bnt162b2 (Second dose:, LOT: EN6207; It's not identified as the lot number. , NDC: Unknown, EXP: 31Jul2021, Dose: Unknown , Route: left shoulder, Formulation: injection), administration date: 16Mar2021, when the patient was 71 years old, for COVID-19 immunization, reaction(s): "No adverse event". The following information was reported: IMMUNISATION (non-serious) with onset 14Dec2021, outcome "unknown", described as "booster"; FATIGUE (non-serious) with onset 15Dec2021, outcome "recovering", described as "I am tired"; FEELING ABNORMAL (non-serious) with onset 15Dec2021, outcome "recovering", described as "feeling yucky"; SINUS CONGESTION (non-serious), RESPIRATORY TRACT CONGESTION (non-serious) all with onset 15Dec2021, outcome "recovering" and all described as "Sinus and chest congestion"; PAIN (non-serious) with onset 15Dec2021, outcome "recovering", described as "Body aches"; MALAISE (non-serious) with onset 15Dec2021, outcome "recovering", described as "Feeling ill"; SECRETION DISCHARGE (non-serious) with onset 15Dec2021, outcome "recovering", described as "Sinuses were so bad. Had lots of mucus. More mucus than normal. Had lots of mucus. More mucus than normal."; HYPERSENSITIVITY (non-serious) with onset 15Dec2021, outcome "recovering", described as "She has allergies". Therapeutic measures were not taken as a result of fatigue, feeling abnormal, sinus congestion, pain, respiratory tract congestion, malaise, secretion discharge, hypersensitivity.  No follow-up attempts are required. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Lymphadenopathy, Malaise
Clinical narrative: felt ill; a baseball sized lymph node swell under his arm/ She got it too; booster shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2), administration date 16Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, unknown manufacturer), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 16Dec2021, outcome "unknown", described as "booster shot"; MALAISE (non-serious), outcome "unknown", described as "felt ill"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "a baseball sized lymph node swell under his arm/ She got it too".  Additional information: The patient had experienced a close to a baseball sized lymph node swell under her arm at the side of the injection in left arm. swelling had gone down to about the size of a golf ball and also felt ill.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: He is positive for corona/got Covid; He is positive for corona/got Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 15 year-old male patient received bnt162b2 (BNT162B2) (Lot number: FD7218) as dose number unknown, single 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 "He is positive for corona/got Covid ". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Immunisation, Therapeutic response unexpected
Clinical narrative: received Pfizer booster dose 10Dec2021; received Pfizer booster dose 10DEC21, reports ongoing headache ever since; anti-inflammatory response to vaccine; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 30 year-old male patient received bnt162b2 (BNT162B2), administration date 10Dec2021 (Batch/Lot number: unknown) at the age of 30 years as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer Unknown), for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 10Dec2021, outcome "unknown", described as "received Pfizer booster dose 10Dec2021"; HEADACHE (non-serious) with onset 10Dec2021, outcome "not recovered", described as "received Pfizer booster dose 10DEC21, reports ongoing headache ever since"; THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset Dec2021, outcome "unknown", described as "anti-inflammatory response to vaccine".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Pharyngeal swelling, Rhinorrhoea
Clinical narrative: booster; swelling of my throat got worse; Runny nose/The running of nose pretty bad the mucus got stuck on my throat; 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 male patient received bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose:1, Manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose:2, Manufacturer unknown), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset Dec2021, outcome "unknown", described as "booster"; PHARYNGEAL SWELLING (non-serious) with onset Dec2021, outcome "not recovered", described as "swelling of my throat got worse"; RHINORRHOEA (non-serious) with onset Dec2021, outcome "unknown", described as "Runny nose/The running of nose pretty bad the mucus got stuck on my throat".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Immunisation, Pyrexia
Clinical narrative: Fever; Chills; Headache; Little energy; Dose number 3; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 18 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Dec2021 16:45 (Lot number: FL3197) at the age of 18 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Lot Number: EP6955), administration date: 04Apr2021, when the patient was 17 years old, for COVID-19 immunisation, reaction(s): "Inappropriate schedule of vaccine administered"; Bnt162b2 (DOSE 1, SINGLE, Lot Number: EP6955), administration date: 27Mar2021, when the patient was 17 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 16Dec2021 16:45, outcome "unknown", described as "Dose number 3"; PYREXIA (non-serious) with onset 17Dec2021, outcome "recovered" (Dec2021), described as "Fever"; CHILLS (non-serious) with onset 17Dec2021, outcome "recovered" (Dec2021), described as "Chills"; HEADACHE (non-serious) with onset 17Dec2021, outcome "recovered" (Dec2021), described as "Headache"; ASTHENIA (non-serious) with onset 17Dec2021, outcome "recovered" (Dec2021), described as "Little energy". Therapeutic measures were taken as a result of pyrexia, chills, headache, asthenia.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Therapeutic measures taken as a result of reported events included treatment with Tylenol. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.