chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Blood clot; Booster dose after Janssen vaccine; booster; muscle pulled like sensation on each outer side of torso, below clavicle, across chest, high on the chest, same sensation left side to right side; could not walk on her right calf; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 20211239219.  A 72 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 17Nov2021 (Lot number: FH8028) at the age of 71 years as dose 2 (booster), single for covid-19 immunisation; janssen covid-19 vaccine (JANSSEN COVID-19 VACCINE), administration date 10Mar2021 (Lot number: 180522) as dose 1, single for immunisation. Relevant medical history included: "Cigarette Smoker" (not ongoing), notes: as a teenager, stopped cigarette smoking at 18-years-old.; "Non-Alcohol User" (ongoing). The patient's concomitant medications were not reported. Past drug history included: Cipro, reaction(s): "Allergic to Cipro"; Benadryl, reaction(s): "Allergic to Benadryl". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Nov2021, outcome "unknown", described as "Booster dose after Janssen vaccine"; IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "booster"; THROMBOSIS (medically significant) with onset 27Nov2021, outcome "unknown", described as "Blood clot"; MUSCLE STRAIN (medically significant) with onset Nov2021, outcome "unknown", described as "muscle pulled like sensation on each outer side of torso, below clavicle, across chest, high on the chest, same sensation left side to right side"; GAIT INABILITY (non-serious) with onset Nov2021, outcome "unknown", described as "could not walk on her right calf". The patient underwent the following laboratory tests and procedures: blood test: (27Nov2021) blood clot, notes: Classification: UNK. Therapeutic measures were taken as a result of thrombosis. Clinical course details: First week after the Pfizer vaccine, the patient was fine. In Nov2021 (second week), on an unspecified date, the patient experienced odd things like muscle pulled like sensation on each outer side of torso, below clavicle, across chest, high on the chest, same sensation left side to right side. She woke up and could not walk on her right calf. 10 days after taking the Pfizer shot, on 27Nov2021, the patient was diagnosed with a blood clot. Treatment medications (dates unspecified) included Xarelto (rivaroxaban) for blood clot prescribed by the doctor.  Additional information: Other pre-existing medical conditions included no drug abuse or illicit drug usage. This report was serious (other medically important condition). This event (s) is considered unassessable. The event (s) has a compatible/ suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Immunisation, Suspected COVID-19
Clinical narrative: getting the booster dose; after getting the booster dose COVID-19 vaccine got COVID; after getting the booster dose COVID-19 vaccine got COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) for a sponsored program (159558).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (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: IMMUNISATION (medically significant), outcome "unknown", described as "getting the booster dose"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "after getting the booster dose COVID-19 vaccine got COVID".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: contracted COVID-19; Booster; contracted COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "haemodialysis" (unspecified if ongoing), notes: I am a haemodialysis patient I immediately went to the hospital as a precaution. The patient's concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; VACCINATION FAILURE (medically significant), COVID-19 (hospitalization, medically significant), outcome "unknown" and all described as "contracted COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test positive, notes: I was scheduled for surgery and was required to take a pre-surgical COVID test. As a result, thereof, I learned that I had contracted COVID-19.  Clinical course: Last year I was vaccinated with the Pfizer vaccine. Just days before I would have been eligible for the "BOOSTER" shot, I was scheduled for surgery and was required to take a pre-surgical COVID test. As a result, thereof, I learned that I had contracted COVID-19. Because I am a haemodialysis patient I immediately went to the hospital as a precaution. I was admitted ONLY to quarantine. I did not have a single symptom. The vaccine works and my experience should be marketed in a live commercial.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Immunisation, Pain, Pain in extremity
Clinical narrative: Fever of 102 F; Headache lasted a day; Dose 3; Body aches; Chills; Pain in the arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Dec2021 18:45 (Lot number: FI8757) at the age of 36 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Birth control" (ongoing). Concomitant medication(s) included: YASMIN taken for contraception (ongoing). Vaccination history included: Bnt162b2 (Dose: 1, Time: 9:57 am, Anatomical site of injection: Left Arm, Route of administration: Intramuscular, Batch/lot number: EW0161), administration date: 18Apr2021, when the patient was 35 years old, for COVID-19 immunization, reaction(s): "Skin rash/all over body skin rash"; Bnt162b2 (Dose: 2, Time: 10:13 am, Anatomical site of injection: Left Arm, Batch/lot number: EW0183), administration date: 09May2021, when the patient was 35 years old, for COVID-19 immunization, reaction(s): "High fever (above 103F)/fever of 103.1", "Body aches", "Chills", "Measles likes rashes".  The following information was reported: IMMUNISATION (non-serious) with onset 09Dec2021 18:45, outcome "unknown", described as "Dose 3"; PYREXIA (non-serious) with onset 10Dec2021 06:45, outcome "recovered" (11Dec2021), described as "Fever of 102 F"; HEADACHE (non-serious) with onset 10Dec2021 06:45, outcome "recovered" (Dec2021), described as "Headache lasted a day"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "Body aches"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "Chills"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "Pain in the arm". The events "fever of 102 f" and "headache lasted a day" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, headache.  Additional information: It was reported that after dose 3 the patient had fever of 102 F. It started 12h after the 3rd dose. It persisted for 1 day. The patient did not take any Tylenol. Also headache, lasted a day. She was experiencing headache after covid vaccine, Other effects included body ache, chills and pain in the arm. Prior vaccination within 4 weeks was none.   Follow-up attempts are completed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever of 102 F; Headache lasted a day; Dose 3; Body aches; Chills; Pain in the arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Dec2021 18:45 (Lot number: FI8757) at the age of 36 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Birth control" (ongoing). Concomitant medication(s) included: YASMIN taken for contraception (ongoing). Vaccination history included: Bnt162b2 (Dose: 1, Time: 9:57 am, Anatomical site of injection: Left Arm, Route of administration: Intramuscular, Batch/lot number: EW0161), administration date: 18Apr2021, when the patient was 35 years old, for COVID-19 immunization, reaction(s): "Skin rash/all over body skin rash"; Bnt162b2 (Dose: 2, Time: 10:13 am, Anatomical site of injection: Left Arm, Batch/lot number: EW0183), administration date: 09May2021, when the patient was 35 years old, for COVID-19 immunization, reaction(s): "High fever (above 103F)/fever of 103.1", "Body aches", "Chills", "Measles likes rashes".  The following information was reported: IMMUNISATION (non-serious) with onset 09Dec2021 18:45, outcome "unknown", described as "Dose 3"; PYREXIA (non-serious) with onset 10Dec2021 06:45, outcome "recovered" (11Dec2021), described as "Fever of 102 F"; HEADACHE (non-serious) with onset 10Dec2021 06:45, outcome "recovered" (Dec2021), described as "Headache lasted a day"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "Body aches"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "Chills"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "Pain in the arm". The events "fever of 102 f" and "headache lasted a day" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, headache.  Additional information: It was reported that after dose 3 the patient had fever of 102 F. It started 12h after the 3rd dose. It persisted for 1 day. The patient did not take any Tylenol. Also headache, lasted a day. She was experiencing headache after covid vaccine, Other effects included body ache, chills and pain in the arm. Prior vaccination within 4 weeks was none.   Follow-up attempts are completed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Bone pain, Immunisation, Pain in extremity, SARS-CoV-2 test
Clinical narrative: experienced pain around left collarbone area, pain comes and goes; pain has spread to left shoulder and left upper arm; pain has spread to left shoulder and left upper arm; dose number: 3; experienced red painful bump over injection site; experienced red painful bump over injection site; experienced red painful bump over injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Dec2021 10:00 (Lot number: EJ8757) at the age of 30 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "sulfa drug allergy" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0168, Location of injection: Arm Left), administration date: 04May2021, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8734, Location of injection: Arm Left), administration date: 13Apr2021, when the patient was 29 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 15Dec2021 10:00, outcome "unknown", described as "dose number: 3"; VACCINATION SITE MASS (non-serious), VACCINATION SITE PAIN (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 15Dec2021, outcome "recovered" (Dec2021) and all described as "experienced red painful bump over injection site"; BONE PAIN (non-serious) with onset 25Dec2021, outcome "not recovered", described as "experienced pain around left collarbone area, pain comes and goes"; ARTHRALGIA (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 25Dec2021, outcome "not recovered" and all described as "pain has spread to left shoulder and left upper arm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site mass, vaccination site pain, vaccination site erythema, bone pain, arthralgia, pain in extremity.  Additional information: The patient didn't received any other vaccines within 4 weeks prior to the COVID. The patient not received any other medications within two weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Vaccinated on 15Dec2021 - experienced red painful bump over injection site for 1 week.  On 25Dec2021 - experienced pain around left collarbone area, pain comes and goes, pain has spread to left shoulder and left upper arm.  No follow-up attempts were possible. No further information was expected.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pain
Clinical narrative: experienced pain around left collarbone area, pain comes and goes; pain has spread to left shoulder and left upper arm; pain has spread to left shoulder and left upper arm; dose number: 3; experienced red painful bump over injection site; experienced red painful bump over injection site; experienced red painful bump over injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Dec2021 10:00 (Lot number: EJ8757) at the age of 30 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "sulfa drug allergy" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0168, Location of injection: Arm Left), administration date: 04May2021, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8734, Location of injection: Arm Left), administration date: 13Apr2021, when the patient was 29 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 15Dec2021 10:00, outcome "unknown", described as "dose number: 3"; VACCINATION SITE MASS (non-serious), VACCINATION SITE PAIN (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 15Dec2021, outcome "recovered" (Dec2021) and all described as "experienced red painful bump over injection site"; BONE PAIN (non-serious) with onset 25Dec2021, outcome "not recovered", described as "experienced pain around left collarbone area, pain comes and goes"; ARTHRALGIA (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 25Dec2021, outcome "not recovered" and all described as "pain has spread to left shoulder and left upper arm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site mass, vaccination site pain, vaccination site erythema, bone pain, arthralgia, pain in extremity.  Additional information: The patient didn't received any other vaccines within 4 weeks prior to the COVID. The patient not received any other medications within two weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Vaccinated on 15Dec2021 - experienced red painful bump over injection site for 1 week.  On 25Dec2021 - experienced pain around left collarbone area, pain comes and goes, pain has spread to left shoulder and left upper arm.  No follow-up attempts were possible. No further information was expected.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Discomfort, Hypoaesthesia, Musculoskeletal stiffness, Pain
Clinical narrative: experienced pain around left collarbone area, pain comes and goes; pain has spread to left shoulder and left upper arm; pain has spread to left shoulder and left upper arm; dose number: 3; experienced red painful bump over injection site; experienced red painful bump over injection site; experienced red painful bump over injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Dec2021 10:00 (Lot number: EJ8757) at the age of 30 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "sulfa drug allergy" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0168, Location of injection: Arm Left), administration date: 04May2021, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8734, Location of injection: Arm Left), administration date: 13Apr2021, when the patient was 29 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 15Dec2021 10:00, outcome "unknown", described as "dose number: 3"; VACCINATION SITE MASS (non-serious), VACCINATION SITE PAIN (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 15Dec2021, outcome "recovered" (Dec2021) and all described as "experienced red painful bump over injection site"; BONE PAIN (non-serious) with onset 25Dec2021, outcome "not recovered", described as "experienced pain around left collarbone area, pain comes and goes"; ARTHRALGIA (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 25Dec2021, outcome "not recovered" and all described as "pain has spread to left shoulder and left upper arm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site mass, vaccination site pain, vaccination site erythema, bone pain, arthralgia, pain in extremity.  Additional information: The patient didn't received any other vaccines within 4 weeks prior to the COVID. The patient not received any other medications within two weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Vaccinated on 15Dec2021 - experienced red painful bump over injection site for 1 week.  On 25Dec2021 - experienced pain around left collarbone area, pain comes and goes, pain has spread to left shoulder and left upper arm.  No follow-up attempts were possible. No further information was expected.
Sex: U
Vaccine: COVID19
Symptoms: Eosinophilic oesophagitis, Immunisation, Investigation
Clinical narrative: booster; eosinophilic esophagitis (EOE); This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (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. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; EOSINOPHILIC OESOPHAGITIS (non-serious), outcome "unknown", described as "eosinophilic esophagitis (EOE)". Relevant laboratory tests and procedures are available in the appropriate section.  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: Heart rate, Heart rate increased, Interchange of vaccine products, Off label use
Clinical narrative: 1st dose Janssen, 2nd dose pfizer; 1st dose Janssen, 2nd dose pfizer; rapid heartbeat; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 20211238479(0) (Janssen).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; covid-19 vaccine janssen (COVID-19 VACCINE JANSSEN) (Batch/Lot number: unknown) as dose 1, single for immunisation. Relevant medical history included: "Headache" (not ongoing); "Rapid heart beat" (not ongoing); "Heart palpitation" (not ongoing); "Coffee drinker" (ongoing); "Stress" (ongoing). The patient's concomitant medications were not reported. The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown" and all described as "1st dose Janssen, 2nd dose pfizer"; HEART RATE INCREASED (non-serious), outcome "recovered", described as "rapid heartbeat". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for covid-19 vaccine janssen was unknown.  Additional information: The action taken with covid-19 vaccine ad26.cov2.s was not applicable. On an unknown date heart rate was high.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: contacted COVID via the latest strain; contacted COVID via the latest strain; This is a spontaneous report received from contactable reporter (Physician) from a sales representative.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "contacted COVID via the latest strain". Patient was vaccinated with Pfizer COVID 19 vaccine and contacted COVID via the latest strain. Patient had multiple medical conditions as well.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) cannot be ruled out.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid test result Positive; covid test result Positive; fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 34 year-old female patient received bnt162b2 (BNT162B2), administration date 17Feb2021 (Lot number: EL3247) at the age of 33 years as dose 2, single and administration date 27Jan2021 (Lot number: EL3247) 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 31Dec2021, outcome "recovered" (2021) and all described as "covid test result Positive"; FATIGUE (non-serious) with onset 31Dec2021, outcome "recovered" (2021), described as "fatigue". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (31Dec2021) positive, notes: covid test type post vaccination=Unknown. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, fatigue.  Clinical course- It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. Since the vaccination the patient had been tested for COVID-19. She was give the PCR results once she gets them.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to vaccination failure cannot be ruled out.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Feeling abnormal, Immunisation, Loss of consciousness, Mass
Clinical narrative: Passed out; Felt terrible; Lump on the head; Sore back and neck; Sore back and neck; Dose number: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Dec2021 14:00 (Lot number: 33130BA) at the age of 53 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "covid prior vaccination" (unspecified if ongoing). If other vaccine in four weeks was reported as unknown. No known allergies. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EWO170, Location of injection: Arm Right, Vaccine Administration Time: 09:00 AM), administration date: 31Aug2021, when the patient was 53 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8733, Location of injection: Arm Right, Vaccine Administration Time: 09:00 AM), administration date: 31Jul2021, when the patient was 53 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 16Dec2021 14:00, outcome "unknown", described as "Dose number: 3"; LOSS OF CONSCIOUSNESS (medically significant) with onset 17Dec2021 09:00, outcome "recovering", described as "Passed out"; FEELING ABNORMAL (non-serious) with onset 17Dec2021 09:00, outcome "recovering", described as "Felt terrible"; MASS (non-serious) with onset 17Dec2021 09:00, outcome "recovering", described as "Lump on the head"; NECK PAIN (non-serious), BACK PAIN (non-serious) all with onset 17Dec2021 09:00, outcome "recovering" and all described as "Sore back and neck". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (04Jan2022) negative. Therapeutic measures were taken as a result of loss of consciousness, feeling abnormal, mass, neck pain, back pain. Patient said that like his first 2 doses, he felt fine for about 12 hours and then really bad for another 10 hours or so. He woke up and felt terrible, so he stayed in bed until 9 am. Finally, he decided to get up and take a shower. He passed out in the shower and woke up with a lump on the head, a sore back and neck. Treatment medication included chiropractor. The patient was tested for covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Neck pain, SARS-CoV-2 test
Clinical narrative: Passed out; Felt terrible; Lump on the head; Sore back and neck; Sore back and neck; Dose number: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Dec2021 14:00 (Lot number: 33130BA) at the age of 53 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "covid prior vaccination" (unspecified if ongoing). If other vaccine in four weeks was reported as unknown. No known allergies. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EWO170, Location of injection: Arm Right, Vaccine Administration Time: 09:00 AM), administration date: 31Aug2021, when the patient was 53 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8733, Location of injection: Arm Right, Vaccine Administration Time: 09:00 AM), administration date: 31Jul2021, when the patient was 53 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 16Dec2021 14:00, outcome "unknown", described as "Dose number: 3"; LOSS OF CONSCIOUSNESS (medically significant) with onset 17Dec2021 09:00, outcome "recovering", described as "Passed out"; FEELING ABNORMAL (non-serious) with onset 17Dec2021 09:00, outcome "recovering", described as "Felt terrible"; MASS (non-serious) with onset 17Dec2021 09:00, outcome "recovering", described as "Lump on the head"; NECK PAIN (non-serious), BACK PAIN (non-serious) all with onset 17Dec2021 09:00, outcome "recovering" and all described as "Sore back and neck". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (04Jan2022) negative. Therapeutic measures were taken as a result of loss of consciousness, feeling abnormal, mass, neck pain, back pain. Patient said that like his first 2 doses, he felt fine for about 12 hours and then really bad for another 10 hours or so. He woke up and felt terrible, so he stayed in bed until 9 am. Finally, he decided to get up and take a shower. He passed out in the shower and woke up with a lump on the head, a sore back and neck. Treatment medication included chiropractor. The patient was tested for covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: Booster; Pt tested positive for COVID; Pt tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 28-year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 04Jan2022, outcome "recovered" and all described as "Pt tested positive for COVID"; IMMUNISATION (non-serious), outcome "unknown", described as "Booster". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (04Jan2022) positive, notes: Nasal swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19. Prior to vaccination, was the patient was not diagnosed with COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Allergic reaction to excipient, Disease recurrence, Dyspnoea exertional, Fatigue, Migraine
Clinical narrative: Psoriasis; migraine headaches that she used to get in the past; migraine headaches that she used to get in the past; she is allergic to the other ingredients in the vaccine. Had a reaction that went on for months.; used to be able to walk 2-3 miles without getting winded, but she cannot do that anymore; Tiredness; She was falling asleep during the day; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team for a Pfizer sponsored program. The reporter is the patient. A 70-year-old female patient (reported as currently 71-year-old) received bnt162b2 (BNT162B2), administered in arm left, administration date 19May2021 (Lot number: EW0161) at the age of 70 years as dose 1, single for covid-19 immunisation. Relevant medical history included: chronic lymphocytic Leukemia [CLL] (unspecified if ongoing), notes: doesn't know exactly when she was diagnosed but it was the early part of 2000-2003. Not severe case; and migraine headaches. The patient's concomitant medications were not reported. It was reported that the patient had an allergic reaction to the other ingredients in the vaccine that went on for months. The patient inquired if there was another way to get the messenger RNA into a patient without taking the vaccine. She mentioned that it reactivated problems she had in the past (unspecified). She developed psoriasis which was not a real severe case. She cannot be certain that she could attribute it to the vaccine. She started with migraine headaches that she used to get in the past. She had extreme tiredness. She was falling asleep during the day. She used to be able to walk 2-3 miles without getting winded, but she cannot do that anymore. She had a Total lock down because she had chronic lymphocytic Leukemia CLL. She can walk now, but it took several months or so (maybe took two months). She didn't keep records of exact dates. At that point, she didn't want to get another shot. It was like after one problem something else would pop up. It was mostly minor, but it really bothered her at the time. Since it went away, she has considered it minor. She didn't have a prescribing doctor. She told the doctor about it because she asked him and question. She has had no other vaccines. She has never received a flu shot. She started having side effects the next morning (20May2021). She feels like she has mostly recovered but she is not sure for sure. She did not have laboratory test done. The outcome of the events daytime sleepiness and were recovered on an unspecified date, as for the event allergic reaction to drug excipient was not recovered while the outcome of the other events was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis, Somnolence
Clinical narrative: Psoriasis; migraine headaches that she used to get in the past; migraine headaches that she used to get in the past; she is allergic to the other ingredients in the vaccine. Had a reaction that went on for months.; used to be able to walk 2-3 miles without getting winded, but she cannot do that anymore; Tiredness; She was falling asleep during the day; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team for a Pfizer sponsored program. The reporter is the patient. A 70-year-old female patient (reported as currently 71-year-old) received bnt162b2 (BNT162B2), administered in arm left, administration date 19May2021 (Lot number: EW0161) at the age of 70 years as dose 1, single for covid-19 immunisation. Relevant medical history included: chronic lymphocytic Leukemia [CLL] (unspecified if ongoing), notes: doesn't know exactly when she was diagnosed but it was the early part of 2000-2003. Not severe case; and migraine headaches. The patient's concomitant medications were not reported. It was reported that the patient had an allergic reaction to the other ingredients in the vaccine that went on for months. The patient inquired if there was another way to get the messenger RNA into a patient without taking the vaccine. She mentioned that it reactivated problems she had in the past (unspecified). She developed psoriasis which was not a real severe case. She cannot be certain that she could attribute it to the vaccine. She started with migraine headaches that she used to get in the past. She had extreme tiredness. She was falling asleep during the day. She used to be able to walk 2-3 miles without getting winded, but she cannot do that anymore. She had a Total lock down because she had chronic lymphocytic Leukemia CLL. She can walk now, but it took several months or so (maybe took two months). She didn't keep records of exact dates. At that point, she didn't want to get another shot. It was like after one problem something else would pop up. It was mostly minor, but it really bothered her at the time. Since it went away, she has considered it minor. She didn't have a prescribing doctor. She told the doctor about it because she asked him and question. She has had no other vaccines. She has never received a flu shot. She started having side effects the next morning (20May2021). She feels like she has mostly recovered but she is not sure for sure. She did not have laboratory test done. The outcome of the events daytime sleepiness and were recovered on an unspecified date, as for the event allergic reaction to drug excipient was not recovered while the outcome of the other events was unknown.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypoaesthesia, Immunisation, Paraesthesia
Clinical narrative: mild numbness above face area upper lip; tingling in cheeks; brain fog for 5 days; booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Dec2021 11:30 (Lot number: FH8027) at the age of 54 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: some sulfa" (unspecified if ongoing), notes: Known allergies: some sulfa; "Mold allergy" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0183, Location of injection: Arm Left), administration date: 18May2021, when the patient was 53 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No:  EW0175, Location of injection: Arm Left), administration date: 27Apr2021, when the patient was 53 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 21Dec2021 11:30, outcome "unknown", described as "booster"; HYPOAESTHESIA (non-serious) with onset 21Dec2021 11:45, outcome "not recovered", described as "mild numbness above face area upper lip"; PARAESTHESIA (non-serious) with onset 21Dec2021 11:45, outcome "not recovered", described as "tingling in cheeks"; FEELING ABNORMAL (non-serious) with onset 21Dec2021 11:45, outcome "recovered" (26Dec2021), described as "brain fog for 5 days". Therapeutic measures were not taken as a result of hypoaesthesia, paraesthesia, feeling abnormal.  Additional information: It was reported that patient administer vaccine at Doctor's office/urgent care. The patient did not receive any other vaccine in four weeks and received multi vitamin medications in two weeks. It was also reported that patient did not suffer from covid prior vaccination and did not underwent  covid tested post vaccination. The patient had experienced mild numbness above face area upper lip and tingling in cheeks 20 min after shot on drive home, continued mild for 2 more days, brain fog for 5 days. Face numbness tingling issue reappeared 05Jan2022.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Spinal cord injury, Vertigo
Clinical narrative: spinal injury; vertigo; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 44 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "has nasal polyps" (unspecified if ongoing), notes: Caller also has nasal polyps. The patient's concomitant medications were not reported.  The following information was reported: SPINAL CORD INJURY (medically significant), outcome "unknown", described as "spinal injury"; VERTIGO (non-serious), outcome "unknown", described as "vertigo".  Clinical Information : The reporter reported that, the day patient got her booster patient woke up with vertigo. Patient had a spinal injury and one of the things that could happen was vertigo. Patient was advised by her Doctor to receive the booster. Then about a week later someone just tested positive. Patient mentioned that patient had an upcoming surgery and kept distance from people.  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, SARS-CoV-2 test, Vaccination failure
Clinical narrative: + PCR covid 26Dec2021, mild dx; + PCR covid 26Dec2021, mild dx; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  An adult female patient received bnt162b2 (BNT162B2), administration date 28Apr2021 (Lot number: EW0175) as dose 2, single and administration date 07Apr2021 (Lot number: ER8729) 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: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 26Dec2021, outcome "recovering" and all described as "+ PCR covid 26Dec2021, mild dx". The event "+ pcr covid 26dec2021, mild dx" and "+ pcr covid 26dec2021, mild dx" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (26Dec2021) positive, notes: if covid tested post vaccination: Yes. It was reported that, It is unknown if prior to the vaccination, the patient was diagnosed with COVID-19. It is unknown if the patient receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the  information in the case report, a possible causal relationship between the events Vaccination failure, Covid-19  and suspect drug BNT162B2 cannot be excluded.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: positive C19 test; positive C19 test; booster; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 22 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 17Nov2021 (Lot number: FD0809) at the age of 22 years as dose 3 (booster), single, intramuscular, administered in arm left, administration date 10Apr2021 (Lot number: EP6955) as dose 2, single and intramuscular, administered in arm left, administration date 20Mar2021 (Lot number: EP6955) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing). The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The following information was reported: IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 05Jan2022 11:30, outcome "recovering" and all described as "positive C19 test". Since the vaccination, the patient had been tested for COVID-19. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (04Jan2022) positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19.; Sender's Comments: Based on limited information in the case , a possible causal association between the reported  events vaccination failure , Immunisation,  Covid 19 and the suspect drug BNT162B2 cannot be excluded.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Immunisation, Interchange of vaccine products, Off label use, Sensory disturbance
Clinical narrative: left side of her face swollen and droopy, warm to the touch; left side of her face swollen and droopy, warm to the touch; left side of her face swollen and droopy, warm to the touch; dose number=1/dose number=2: Moderna; dosenumber=3: Pfizer; dose number=1/dose number=2: Moderna; dosenumber=3: Pfizer; dose number=1/dose number=2: Moderna; dosenumber=3: Pfizer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 44-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 04Jan2022 12:30 (Lot number: 33130BA) at the age of 44 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Past drug history included: Erythromycin, reaction(s): "Known Allergies: Erythromycin". Vaccination history included: Moderna covid-19 vaccine (Dose Number: 1, Batch/Lot No: 025B21A, Location of injection: Arm Right, Route of Administration: Intramuscular), administration date: 31Mar2021, when the patient was 43 years old, for COVID-19 Immunization; Moderna covid-19 vaccine (Dose Number: 2, Batch/Lot No: 009C21A, Location of injection: Arm Right, Route of Administration: Intramuscular), administration date: 26Apr2021, when the patient was 43 years old, for COVID-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious), IMMUNISATION (non-serious) all with onset 04Jan2022 12:30, outcome "unknown" and all described as "dose number=1/dose number=2: Moderna; dosenumber=3: Pfizer"; SWELLING FACE (non-serious), SENSORY DISTURBANCE (non-serious), FEELING HOT (non-serious) all with onset 05Jan2022 06:00, outcome "not recovered" and all described as "left side of her face swollen and droopy, warm to the touch". Therapeutic measures were not taken as a result of swelling face, sensory disturbance, feeling hot.  Additional information: She got the booster (dose 3) on 04Jan2022 and woke up the next morning (05Jan2022) with left side of her face swollen and droopy, warm to the touch. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Birth control pill within 2 weeks of vaccination. The patient was not tested since the vaccination. The patient was not diagnosed with COVID-19 prior to vaccination.  Follow-Up: Follow-up attempts are completed. No further information is expected.