chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Patient  was admitted to hospital for underlying health condition. Tested positive for Covid during stay and passed away.; Patient  was admitted to hospital for underlying health condition. Tested positive for Covid during stay and passed away.; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group.  A 49 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 18Feb2021 (Lot number: EL3247) at the age of 49 years as dose 2, single and intramuscular, administered in arm right, administration date Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Chronic health condition" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (death, hospitalization, medically significant), COVID-19 (death, hospitalization, medically significant) all with onset 26Nov2021, outcome "fatal" and all described as "Patient  was admitted to hospital for underlying health condition. Tested positive for Covid during stay and passed away.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (26Nov2021) positive. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19. The patient date of death was 05Dec2021. The reported cause of death was covid-19. It was not reported if an autopsy was performed.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Drug ineffective and COVID-19 and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.; Reported Cause(s) of Death: Patient  was admitted to hospital for underlying health condition. Tested positive for Covid during stay and passed away.
Sex: F
Vaccine: COVID19
Symptoms: Colitis ulcerative
Clinical narrative: Ulcerative colitis flare up; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (NOT AVAILABLE). The reporter is the patient. Other Case identifier(s): 21K-163-4036289-00 (MFR Control No).  A 38 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk (citrate free) for colitis ulcerative. The patient's relevant medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The following information was reported: COLITIS ULCERATIVE (medically significant), outcome "not recovered", described as "Ulcerative colitis flare up". The action taken for adalimumab was unknown. Clinical course: The reporter's causality for the event (s) of ulcerative colitis flare up/not sure if Humira was working unknown onset with Humira (adalimumab) was a reasonable possibility. The reporter's causality for the event (s) of Ulcerative colitis flare up/not sure if Humira was working unknown onset was not provided/reported. The reporter's causality for the event (s) of ulcerative colitis flare up/not sure if Humira was working unknown onset with Humira (adalimumab) was possible.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event ulcerative colitis and BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Chills, Ear pain, Headache
Clinical narrative: Pain in left arm; Severe body aches - full body; Chills; Nausea; Headache; Earache (both ears); Sore throat; Temperature - 100.8; Dose received: 3/ Dose number=3/ Had the following symptoms/reaction after 3rd Vaccination (Booster); This is a spontaneous report from a contactable reporter (consumer or other non hcp). The reporter is the patient. A 56-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Dec2021 at 13:15 (Lot number: FF8839) at the age of 56 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LISINOPRIL and PROPRANOLOL and CENTRUM VITAMIN. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Lot number: EL3248, Anatomical location: Left arm), administration date: 21Apr2021 and Bnt162b2 (DOSE 1, SINGLE, Lot number: EL3248, Anatomical location: Left arm), administration date: 31Mar2021, for COVID-19 immunisation.The following information was reported: IMMUNISATION (non-serious) with onset 06Dec2021 at 13:15, outcome "unknown", described as "Dose received: 3/ Dose number=3/ Had the following symptoms/reaction after 3rd Vaccination (Booster)"; PAIN IN EXTREMITY (non-serious) with onset 06Dec2021 at 19:00, outcome "recovering", described as "Pain in left arm"; PAIN (non-serious) with onset 06Dec2021 at 19:00, outcome "recovering", described as "Severe body aches - full body"; CHILLS (non-serious) with onset 06Dec2021 at 19:00, outcome "recovering", described as "Chills"; NAUSEA (non-serious) with onset 06Dec2021 at 19:00, outcome "recovering", described as "Nausea"; HEADACHE (non-serious) with onset 06Dec2021 at 19:00, outcome "recovering", described as "Headache"; EAR PAIN (non-serious) with onset 06Dec2021 at 19:00, outcome "recovering", described as "Earache (both ears)"; OROPHARYNGEAL PAIN (non-serious) with onset 06Dec2021 at 19:00, outcome "recovering", described as "Sore throat"; BODY TEMPERATURE INCREASED (non-serious) with onset 06Dec2021 at 19:00, outcome "recovering", described as "Temperature - 100.8". Relevant laboratory tests and procedures included body temperature test on 06Dec2021 and the result was 100.8 (unspecified units). Therapeutic measures were not taken as a result of pain in extremity, pain, chills, nausea, headache, ear pain, oropharyngeal pain and body temperature increased. Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Nausea, Oropharyngeal pain, Pain, Pain in extremity
Clinical narrative: Pain in left arm; Severe body aches - full body; Chills; Nausea; Headache; Earache (both ears); Sore throat; Temperature - 100.8; Dose received: 3/ Dose number=3/ Had the following symptoms/reaction after 3rd Vaccination (Booster); This is a spontaneous report from a contactable reporter (consumer or other non hcp). The reporter is the patient. A 56-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Dec2021 at 13:15 (Lot number: FF8839) at the age of 56 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LISINOPRIL and PROPRANOLOL and CENTRUM VITAMIN. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Lot number: EL3248, Anatomical location: Left arm), administration date: 21Apr2021 and Bnt162b2 (DOSE 1, SINGLE, Lot number: EL3248, Anatomical location: Left arm), administration date: 31Mar2021, for COVID-19 immunisation.The following information was reported: IMMUNISATION (non-serious) with onset 06Dec2021 at 13:15, outcome "unknown", described as "Dose received: 3/ Dose number=3/ Had the following symptoms/reaction after 3rd Vaccination (Booster)"; PAIN IN EXTREMITY (non-serious) with onset 06Dec2021 at 19:00, outcome "recovering", described as "Pain in left arm"; PAIN (non-serious) with onset 06Dec2021 at 19:00, outcome "recovering", described as "Severe body aches - full body"; CHILLS (non-serious) with onset 06Dec2021 at 19:00, outcome "recovering", described as "Chills"; NAUSEA (non-serious) with onset 06Dec2021 at 19:00, outcome "recovering", described as "Nausea"; HEADACHE (non-serious) with onset 06Dec2021 at 19:00, outcome "recovering", described as "Headache"; EAR PAIN (non-serious) with onset 06Dec2021 at 19:00, outcome "recovering", described as "Earache (both ears)"; OROPHARYNGEAL PAIN (non-serious) with onset 06Dec2021 at 19:00, outcome "recovering", described as "Sore throat"; BODY TEMPERATURE INCREASED (non-serious) with onset 06Dec2021 at 19:00, outcome "recovering", described as "Temperature - 100.8". Relevant laboratory tests and procedures included body temperature test on 06Dec2021 and the result was 100.8 (unspecified units). Therapeutic measures were not taken as a result of pain in extremity, pain, chills, nausea, headache, ear pain, oropharyngeal pain and body temperature increased. Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Diarrhoea, Drug ineffective
Clinical narrative: Lack of drug effect; Lack of drug effect; Diarrhea; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. Other Case identifier: 21K-163-4179780-00 (Abbvie).  Solicited report by a consumer of an elderly female with events of non-serious lack of effect and diarrhea with humira (adalimumab). There was no reported medical history. On unknown dates, the patient experienced lack of effect and diarrhea. Pfizer Biontech Covid-19 vaccine (PFIZER) was also considered suspect. It was unknown if patient was enrolled in a covid-19 vaccine trial. On 27Jan2021, patient received 1st dose covid-19 vaccine manufactured by Pfizer/Biontech. On 17Feb2021, patient received 2nd dose covid-19 vaccine manufactured by Pfizer/Biontech. Primary reporter did not have the lot number information, because the packaging was discarded.  The reporter's causality for the event(s) of lack of effect with humira (adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of diarrhea was not provided.  The reporter assessment of the causal relationship of the events with BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information and the drug temporal relationship, the causality between the reported events and the suspect drug "BNT162B2" cannot be completely excluded.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.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Oligomenorrhoea
Clinical narrative: Extremely heaving periods. Bleeding went from light for 4-5 days to bleeding heavy for 14+ days; Cycle went from 29 days normally to 44 days.; Cramping is bad; This is a spontaneous report from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.   A 31year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Aug2021 at 13:00 (Lot number: FC3180) at the age of 31 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: Penicillin. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EW0198, Anatomical location: Left arm, Administration Time: 13:00, Route of administration: Unspecified), administration date: 26Jul2021, when the patient was 31 years old, for COVID-19 immunisation.  The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious) with onset 04Sep2021 at 13:00, outcome "not recovered", described as "Extremely heaving periods. Bleeding went from light for 4-5 days to bleeding heavy for 14+ days"; OLIGOMENORRHOEA (non-serious) with onset 04Sep2021 at 13:00, outcome "not recovered", described as "Cycle went from 29 days normally to 44 days"; DYSMENORRHOEA (non-serious) with onset 04Sep2021 at 13:00, outcome "not recovered", described as "Cramping is bad". The events "Extremely heaving periods. Bleeding went from light for 4-5 days to bleeding heavy for 14+ days", "Cycle went from 29 days normally to 44 days." and "Cramping is bad" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of heavy menstrual bleeding, oligomenorrhoea and dysmenorrhoea. Additional Information: The patient did not receive other vaccines within four weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events resulted in doctor or other healthcare professional office/ clinic visit.   No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Muscle aches, mild fever, chills, headache, fatigue for approximately 18 hours
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Mild fever, muscle aches, headache, fatigue, chills for approximately 18-24 hrs following the shot
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Swollen tongue, Thrombosis
Clinical narrative: blood clot on right leg (she is now on blood thinners); swelling in face and tongue; swelling in face and tongue; This is a spontaneous report received from a contactable reporter (Consumer or other non- HCP) from medical information team. An 85-year-old female patient received bnt162b2 (COMIRNATY), administration date Feb2021 (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: THROMBOSIS (medically significant) with onset 2021, outcome "unknown", described as "blood clot on right leg (she is now on blood thinners)"; SWELLING FACE (non-serious), SWOLLEN TONGUE (non-serious) all with onset 2021, outcome "unknown" and all described as "swelling in face and tongue". The events "blood clot on right leg (she is now on blood thinners)", "swelling in face and tongue" and "swelling in face and tongue" were evaluated at the physician office visit (consulted primary care physician, her thyroid specialist and two other doctors). Therapeutic measures were taken as a result of thrombosis included blood thinners.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Body temperature, Chills, Eye disorder
Clinical narrative: She felt like she was going to die; Getting very sick after receiving the second dose; Hives / itching like crazy with hives; Hives / itching like crazy with hives; 101°F fever/ high fever chills; 101°F fever/ high fever chills; Nausea; Headache; Lost sense of taste and smell; Lost sense of taste and smell; Her eyes were not good after the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 67 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Glaucoma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 Immunization, reaction(s): "No adverse events". The following information was reported: NEAR DEATH EXPERIENCE (medically significant), outcome "recovered", described as "She felt like she was going to die"; ILLNESS (non-serious), outcome "recovered", described as "Getting very sick after receiving the second dose"; URTICARIA (non-serious), PRURITUS (non-serious), outcome "recovered" and all described as "Hives / itching like crazy with hives"; PYREXIA (non-serious), CHILLS (non-serious), outcome "recovered" and all described as "101°F fever/ high fever chills"; NAUSEA (non-serious), outcome "recovered", described as "Nausea"; HEADACHE (non-serious), outcome "recovered", described as "Headache"; AGEUSIA (non-serious), ANOSMIA (non-serious), outcome "recovered" and all described as "Lost sense of taste and smell"; EYE DISORDER (non-serious), outcome "recovered", described as "Her eyes were not good after the vaccine". The patient underwent the following laboratory tests and procedures: body temperature: 101 Fahrenheit, notes: High. The patient wanted to know if she can get the Pfizer Covid Booster dose after getting very sick after receiving the second dose in the primary series. The patient had a history of glaucoma but says her eyes were not good after the vaccine. After he second dose she was fine initially. The patient stated 24 hours after her second dose she began to experience everything you can imagine happening. She had a 101F  fever, was itching like crazy with hives. Her husband had to help her and she felt like she was going to die. These symptoms lasted for 7 weeks.  The patient stated she spoke with several doctors, one who was a friend. She asked if she can take the Pfizer Covid Vaccine booster dose.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Nausea, Near death experience, Pruritus
Clinical narrative: She felt like she was going to die; Getting very sick after receiving the second dose; Hives / itching like crazy with hives; Hives / itching like crazy with hives; 101°F fever/ high fever chills; 101°F fever/ high fever chills; Nausea; Headache; Lost sense of taste and smell; Lost sense of taste and smell; Her eyes were not good after the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 67 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Glaucoma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 Immunization, reaction(s): "No adverse events". The following information was reported: NEAR DEATH EXPERIENCE (medically significant), outcome "recovered", described as "She felt like she was going to die"; ILLNESS (non-serious), outcome "recovered", described as "Getting very sick after receiving the second dose"; URTICARIA (non-serious), PRURITUS (non-serious), outcome "recovered" and all described as "Hives / itching like crazy with hives"; PYREXIA (non-serious), CHILLS (non-serious), outcome "recovered" and all described as "101°F fever/ high fever chills"; NAUSEA (non-serious), outcome "recovered", described as "Nausea"; HEADACHE (non-serious), outcome "recovered", described as "Headache"; AGEUSIA (non-serious), ANOSMIA (non-serious), outcome "recovered" and all described as "Lost sense of taste and smell"; EYE DISORDER (non-serious), outcome "recovered", described as "Her eyes were not good after the vaccine". The patient underwent the following laboratory tests and procedures: body temperature: 101 Fahrenheit, notes: High. The patient wanted to know if she can get the Pfizer Covid Booster dose after getting very sick after receiving the second dose in the primary series. The patient had a history of glaucoma but says her eyes were not good after the vaccine. After he second dose she was fine initially. The patient stated 24 hours after her second dose she began to experience everything you can imagine happening. She had a 101F  fever, was itching like crazy with hives. Her husband had to help her and she felt like she was going to die. These symptoms lasted for 7 weeks.  The patient stated she spoke with several doctors, one who was a friend. She asked if she can take the Pfizer Covid Vaccine booster dose.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Urticaria
Clinical narrative: She felt like she was going to die; Getting very sick after receiving the second dose; Hives / itching like crazy with hives; Hives / itching like crazy with hives; 101°F fever/ high fever chills; 101°F fever/ high fever chills; Nausea; Headache; Lost sense of taste and smell; Lost sense of taste and smell; Her eyes were not good after the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 67 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Glaucoma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 Immunization, reaction(s): "No adverse events". The following information was reported: NEAR DEATH EXPERIENCE (medically significant), outcome "recovered", described as "She felt like she was going to die"; ILLNESS (non-serious), outcome "recovered", described as "Getting very sick after receiving the second dose"; URTICARIA (non-serious), PRURITUS (non-serious), outcome "recovered" and all described as "Hives / itching like crazy with hives"; PYREXIA (non-serious), CHILLS (non-serious), outcome "recovered" and all described as "101°F fever/ high fever chills"; NAUSEA (non-serious), outcome "recovered", described as "Nausea"; HEADACHE (non-serious), outcome "recovered", described as "Headache"; AGEUSIA (non-serious), ANOSMIA (non-serious), outcome "recovered" and all described as "Lost sense of taste and smell"; EYE DISORDER (non-serious), outcome "recovered", described as "Her eyes were not good after the vaccine". The patient underwent the following laboratory tests and procedures: body temperature: 101 Fahrenheit, notes: High. The patient wanted to know if she can get the Pfizer Covid Booster dose after getting very sick after receiving the second dose in the primary series. The patient had a history of glaucoma but says her eyes were not good after the vaccine. After he second dose she was fine initially. The patient stated 24 hours after her second dose she began to experience everything you can imagine happening. She had a 101F  fever, was itching like crazy with hives. Her husband had to help her and she felt like she was going to die. These symptoms lasted for 7 weeks.  The patient stated she spoke with several doctors, one who was a friend. She asked if she can take the Pfizer Covid Vaccine booster dose.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain, Pain in extremity, Renal pain
Clinical narrative: Right side of body ache; right side of body ache- Arm shoulder, kidney, hip, and upper leg.; right side of body ache- Arm shoulder, Kidney, hip, and upper leg.; right side of body ache- Arm shoulder, Kidney, hip, and upper leg.; This is a spontaneous report from a contactable reporter (consumer and non HCP). The reporter is the patient.  A 49 year-old male patient received bnt162b2 (BNT162B2), administered in right arm , administration date 17Nov2021 at 13:15 (Lot number: FF2593) at the age of 49 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Diabetic" (unspecified if ongoing); "Toe amputation" , and "Foot amputation"; notes: 5th toe amputation and part of top of left foot. Concomitant medications included: FLU taken for Immunisation, start date: 18Oct2021, stop date: 18Oct2021. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot No: FG3590, vaccine location: right arm, Administration time: 10:00), administration date: 23Oct2021, when the patient was 49 years old, for COVID-19 immunisation. The following information was reported: PAIN (non-serious) with onset 17Nov2021 at 13:30, outcome "not recovered", described as "Right side of body ache"; PAIN IN EXTREMITY (non-serious) with onset 17Nov2021 at 13:30, outcome "not recovered", described as "right side of body ache- Arm and upper leg"; ARTHRALGIA (non-serious) with onset 17Nov2021 at 13:30, outcome "not recovered", described as "Right side of body ache- hip and shoulder"; RENAL PAIN (non-serious) with onset 17Nov2021 at 13:30, outcome "not recovered", described as "Right side of body ache- Kidney". Therapeutic measures were not taken as a result of pain, pain in extremity, arthralgia and renal pain. Additional Information: The patient had no known allergies. 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. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: After second dose of comirnaty patient developed life threatening adverse reactions which ended up being terminal; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (1st dose, UNKNOWN MANUFACTURER), for Covid-19 Immunization. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "After second dose of comirnaty patient developed life threatening adverse reactions which ended up being terminal". Event took place after use of product. The patient date of death was unknown. The reported cause of death was "patient developed life threatening adverse reactions which ended up being terminal". It was not reported if an autopsy was performed. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information available and temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . 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.; Reported Cause(s) of Death: patient developed life threatening adverse reactions which ended up being terminal
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Nausea, Pyrexia, Vomiting
Clinical narrative: Fever 102; Vomiting; Nausea; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the parent.  A 16 year-old male patient received bnt162b2 (BNT162B2), administered in left arm, administration date 08Dec2021 at 11:45 (Lot number: unknown) at the age of 16 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: Unknown, vaccine location: Left arm, administration time: 11:30), administration date: 17Nov2021, when the patient was 15 years old, for COVID-19 immunisation.  The following information was reported: PYREXIA (non-serious) with onset 08Dec2021, outcome "recovering", described as "Fever 102"; VOMITING (non-serious) with onset 08Dec2021, outcome "recovering", described as "vomiting"; NAUSEA (non-serious) with onset 08Dec2021, outcome "recovering", described as "nausea". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of pyrexia, vomiting and nausea.   Additional Information: The patient had no known allergies. 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-19 vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, SARS-CoV-2 test, Urticaria
Clinical narrative: I had a couple of hive outbreaks during the week after the third shot, three hives were all over the body; Dose received 3; This is a spontaneous report received from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in right arm, administration date 30Oct2021 at 12:00 (Lot number: FF2593)at the age of 28 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 1, SINGLE, Lot Number: EP7534, Anatomical site: Left arm, Administration time: 12:45), administration date: 23Mar2021, when the patient was 28 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: EW151, Anatomical site: Left arm, Administration time: 11:45), administration date: 13Apr2021, when the patient was 28 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 30Oct2021 at 12:00, outcome "unknown", described as "Dose received 3"; URTICARIA (non-serious) with onset 03Nov2021, outcome "recovered" (an unknown date in 2021), described as "I had a couple of hive outbreaks during the week after the third shot, three hives were all over the body". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of urticaria.  Additional Information: Prior to 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. Treatment included over the counter (OTC) antihistamine for urticaria. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Haematuria, Immunisation, Menstruation irregular, Protein urine present, Urine analysis
Clinical narrative: Hematuria occurred less than 24 after booster that lasted for 3 days; Protein in urine occurred less than 24 after booster that lasted for 3 days; Dose received=3; Menstrual cycle (off by 7 days); This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Nov2021 at 14:00 (Lot number: FD0809) at the age of 36 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Hepatitis B" (unspecified if ongoing), notes: Hep B and "Hematuria" start date: an unknown date in 2017 (unspecified if ongoing), notes: (2 times - 2017 and 2018). Concomitant medication included: TENOFOVIR DISOPROXIL FUMARATE 300 mg. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE; Lot number: EW0171; Anatomical site: Left arm; Administration time: 12:00; Route of Administration: Unspecified), administration date: 26Apr2021, when the patient was 35 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 1, SINGLE; Lot number: EP7533; Administration time: 11:00; Route of Administration: Unspecified), administration date: 05Apr2021, when the patient was 35 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 27Nov2021 at 14:00, outcome "unknown", described as "Dose received=3"; HAEMATURIA (non-serious) with onset 28Nov2021 at 08:00, outcome "recovered" (01Dec2021), described as "Hematuria occurred less than 24 after booster that lasted for 3 days"; PROTEIN URINE PRESENT (non-serious) with onset 28Nov2021 at 08:00, outcome "recovered" (01Dec2021), described as "Protein in urine occurred less than 24 after booster that lasted for 3 days"; MENSTRUATION IRREGULAR (non-serious) with onset an unknown date in 2021, outcome "recovered" (an unknown date in 2021), described as "Menstrual cycle (off by 7 days)". The events "Hematuria occurred less than 24 after booster that lasted for 3 days", "Protein in urine occurred less than 24 after booster that lasted for 3 days" and "Menstrual cycle (off by 7 days)" 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 haematuria, protein urine present and menstruation irregular.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Vaccination site erythema, Vaccination site mass, Vaccination site warmth
Clinical narrative: Large red bump at injection site; Large red bump at injection site; Bump keeps getting larger, hard, and hot; Dose received: 3; This is a spontaneous report from a contactable reporter (consumer or other non hcp). The reporter is the patient.  A 19-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Dec2021 at 18:00 (Lot number: unknown) at the age of 19 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "None", notes: other medical history: no; known allergies: no. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: unknown; Anatomical site: left arm; Route of administration: unspecified; Administration time: 10:00), administration date: 13Apr2021, when the patient was 19 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: unknown; Anatomical site: left arm; Route of administration: unspecified; Administration time: 08:15), administration date: 04May2021, when the patient was 19 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 07Dec2021 at 18:00, outcome "unknown", described as "Dose received: 3"; VACCINATION SITE MASS (non-serious) and VACCINATION SITE ERYTHEMA (non-serious), all with onset 08Dec2021 at 07:00, outcome "not recovered", all described as "Large red bump at injection site"; VACCINATION SITE WARMTH (non-serious) with onset 08Dec2021 at 07:00, outcome "not recovered", described as "Bump keeps getting larger, hard, and hot". The events "Large red bump at injection site" and "Bump keeps getting larger, hard, and hot" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of vaccination site mass, vaccination site erythema and vaccination site warmth.  Additional information: The patient did not receive any other vaccines within four weeks prior to the prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Along with normal side effects, bump keeps getting larger, hard, and hot. Since the vaccination, the patient had not been tested for COVID-19.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Condition aggravated, Fatigue, Heart rate, Heart rate increased
Clinical narrative: Higher blood pressure 145/100 from normal 130/82; Higher blood pressure 145/100 from normal 130/82; Faster heartbeat 95 from normal 78; Fatigue; Dose received: 3; This is a spontaneous report from a contactable reporter (consumer or other non hcp). The reporter is the patient.  A 60-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Dec2021 at 17:30 (Lot number: FJ8762) at the age of 60 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Hypertension" (ongoing) and "Major depression" (unspecified if ongoing). The patient received unspecified concomitant medications (unspecified if ongoing). Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EN6206; Anatomical site: left arm; Route of administration: unspecified; Administration time: 15:30), administration date: 04Mar2021, when the patient was 60 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: ER8733; Anatomical site: left arm; Route of administration: unspecified; Administration time: 15:30), administration date: 25Mar2021, when the patient was 60 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 02Dec2021 at 17:30, outcome "unknown", described as "Dose received: 3"; HYPERTENSION (non-serious) and CONDITION AGGRAVATED (non-serious), all with onset 03Dec2021 at 17:00, outcome "unknown", and all described as "Higher blood pressure 145/100 from normal 130/82"; HEART RATE INCREASED (non-serious) with onset 03Dec2021 at 17:00, outcome "unknown", described as "Faster heartbeat 95 from normal 78"; FATIGUE (non-serious) with onset 03Dec2021 at 17:00, outcome "unknown", described as "Fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of hypertension, condition aggravated, heart rate increased and fatigue.  Additional information: The patient had no known allergies. The patient did not receive other vaccines within four weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Hypertension, Immunisation
Clinical narrative: Higher blood pressure 145/100 from normal 130/82; Higher blood pressure 145/100 from normal 130/82; Faster heartbeat 95 from normal 78; Fatigue; Dose received: 3; This is a spontaneous report from a contactable reporter (consumer or other non hcp). The reporter is the patient.  A 60-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Dec2021 at 17:30 (Lot number: FJ8762) at the age of 60 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Hypertension" (ongoing) and "Major depression" (unspecified if ongoing). The patient received unspecified concomitant medications (unspecified if ongoing). Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EN6206; Anatomical site: left arm; Route of administration: unspecified; Administration time: 15:30), administration date: 04Mar2021, when the patient was 60 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: ER8733; Anatomical site: left arm; Route of administration: unspecified; Administration time: 15:30), administration date: 25Mar2021, when the patient was 60 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 02Dec2021 at 17:30, outcome "unknown", described as "Dose received: 3"; HYPERTENSION (non-serious) and CONDITION AGGRAVATED (non-serious), all with onset 03Dec2021 at 17:00, outcome "unknown", and all described as "Higher blood pressure 145/100 from normal 130/82"; HEART RATE INCREASED (non-serious) with onset 03Dec2021 at 17:00, outcome "unknown", described as "Faster heartbeat 95 from normal 78"; FATIGUE (non-serious) with onset 03Dec2021 at 17:00, outcome "unknown", described as "Fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of hypertension, condition aggravated, heart rate increased and fatigue.  Additional information: The patient had no known allergies. The patient did not receive other vaccines within four weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Malaise
Clinical narrative: Dose received=3; Feel horrible and can't get out of bed today; This is a spontaneous report from a contactable reporter (consumer or other non-HCP).  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 08Dec2021 (Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history was not reported. It was unknown whether the patient received any other medication within two weeks of vaccination. Vaccination history included: Covid-19 vaccine manufacturer unknown (DOSE 1, SINGLE; Lot number: UNKNOWN; Route of Administration: Unspecified; Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation and Covid-19 vaccine manufacturer unknown (DOSE 2, SINGLE; Lot number: UNKNOWN; Route of Administration: Unspecified; Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 08Dec2021, outcome "unknown", described as "Dose received=3"; MALAISE (non-serious) with onset an unknown date in Dec2021, outcome "unknown", described as "Feel horrible and can't get out of bed today".  Additional information: It was unknown whether the patient received any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, it was unknown whether the patient had been tested for COVID-19.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Immunisation, Pain
Clinical narrative: Left arm pain; Chills; Body aches; Headache; Feeling feverish; Tired; Dose received: 3; This is a spontaneous report from a contactable reporter (consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 08Dec2021 (Lot number: FG3527) at the age of 45 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing), notes: High blood pressure. Concomitant medication included: AMLODIPINE. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EL3247; Anatomical site: unspecified; Route of administration: unspecified), administration date: 22Feb2021, when the patient was 44 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: EL3247; Anatomical site: left arm; Route of administration: intramuscular), administration date: 15Mar2021, when the patient was 44 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 08Dec2021, outcome "unknown", described as "Dose received: 3"; PAIN IN EXTREMITY (non-serious) with onset 08Dec2021 at 22:00, outcome "not recovered", described as "Left arm pain"; CHILLS (non-serious) with onset 08Dec2021 at 22:00, outcome "not recovered", described as "Chills"; PAIN (non-serious) with onset 08Dec2021 at 22:00, outcome "not recovered", described as "Body aches"; HEADACHE (non-serious) with onset 08Dec2021 at 22:00, outcome "not recovered", described as "Headache"; PYREXIA (non-serious) with onset 08Dec2021 at 22:00, outcome "not recovered", described as "Feeling feverish"; FATIGUE (non-serious) with onset 08Dec2021 at 22:00, outcome "not recovered", described as "Tired". Therapeutic measures were taken as a result of pain in extremity, chills, pain, headache, pyrexia and fatigue.  Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Treatment included Ibuprofen for pain in extremity, chills, pain, headache, pyrexia and fatigue.