chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Rheumatoid arthritis
Clinical narrative: RA flare up; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4172137-00 (RA).  A 68 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 11Feb2021 (Batch/Lot number: unknown) as dose 1, single and intramuscular, administration date 04Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous since 2019 (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "RA flare up". Causality as per reporter (Drug/Vaccine): Possible The reporter considered "ra flare up" related to bnt162b2.The reporter considered "ra flare up" not reasonably possible to adalimumab (HUMIRA). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided the causal association between the event rheumatoid arthritis flare up and the usage of the suspect vaccine BNT162B2 cannot be 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 RAs, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Bone pain, Immunisation, Influenza, Rheumatoid arthritis
Clinical narrative: Booster; Rheumatoid arthritis flare up; Bones were achy; patient had flu; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4170198-00 (AbbVie).  A 67 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation; upadacitinib (RINVOQ), oral (Lot number: 1150509) for rheumatoid arthritis. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number Unknown, Manufacturer Unknown, Dose:2), for Covid-19 Immunization; Covid-19 vaccine (Dose Number Unknown, Manufacturer Unknown, Dose:1), for Covid-19 Immunization. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; RHEUMATOID ARTHRITIS (medically significant), outcome "not recovered", described as "Rheumatoid arthritis flare up"; BONE PAIN (non-serious), outcome "recovered" (2021), described as "Bones were achy"; INFLUENZA (non-serious), outcome "recovered" (2021), described as "patient had flu". The action taken for upadacitinib was unknown. Therapeutic measures were taken as a result of rheumatoid arthritis.The patient had no other relevant history and had No known allergies. It was unknown if the patient was enrolled in a covid-19 vaccine trial.  Causality for rinvoq (upadacitinib): The reporter's causality for the event(s) of bones were achy like patient had flu unknown onset and bones were achy like patient had flu unknown onset with rinvoq (upadacitinib) was no reasonable possibility. The reporter's causality for the event(s) of rheumatoid arthritis flare up with rinvoq (upadacitinib) was a reasonable possibility.  Causality for pfizer biontech covid-19 vaccine (Tozinameran)(tozinameran), unknown: 1)bone pain (bone pain): Causality as per reporter (drug/vaccine) : possible 2)flu (influenza): Causality as per reporter (drug/vaccine): possible 3)rheumatoid arthritis flare up (rheumatoid arthritis): Causality as per reporter (drug/vaccine): not reported   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on current information available, the events mostly represented intercurrent condition in this patient with advanced age, unrelated to Bnt162b2.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, COVID-19, Drug ineffective, Influenza like illness, SARS-CoV-2 test
Clinical narrative: Long haul bronchitisis; the patient experienced Covid; COVID; Arm sore after first covid vaccination; Got big red rash afterward; Got big red rash afterward; Flu like symptoms; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4168977-00.  A 74 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 04Apr2021 (Batch/Lot number: unknown) at the age of 73 years as dose 1, single for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]), subcutaneous (Batch/Lot number: unknown) for psoriasis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 13Sep2021, outcome "recovered" (2021), described as "the patient experienced Covid"; DRUG INEFFECTIVE (medically significant) with onset 13Sep2021, outcome "unknown", described as "COVID"; INFLUENZA LIKE ILLNESS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Flu like symptoms"; BRONCHITIS (non-serious) with onset 04Oct2021, outcome "unknown", described as "Long haul bronchitisis"; VACCINATION SITE PAIN (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "Arm sore after first covid vaccination"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE RASH (non-serious) all with onset Apr2021, outcome "recovered" (Apr2021) and all described as "Got big red rash afterward". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) unknown result. The action taken for risankizumab was unknown.  Additional information: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for SKYRIZI(RISANKIZUMAB) The reporter's causality for the event(s) of covid, flu like symptoms, long haul Bronchitisis, arm sore after first covid vaccination/got big red rash afterward/ache and shoot out pain onset in Apr2021, was not provided.  Causality for BNT162B2 The reporter's assessment of the causal relationship of the event(s) of covid, flu like symptoms, long haul Bronchitisis, arm sore after first covid vaccination/got big red rash afterward/ache and shoot out pain onset in Apr2021, with the suspect product 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.    The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile and temporal relationship there is reasonable possibility of causal association between the reported events COVID-19, Drug Ineffective, Influenza like illness, Bronchitis, Vaccination site pain, vaccination site erythema, vaccination site rash and the suspect drug BNT162B2.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site rash
Clinical narrative: Long haul bronchitisis; the patient experienced Covid; COVID; Arm sore after first covid vaccination; Got big red rash afterward; Got big red rash afterward; Flu like symptoms; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4168977-00.  A 74 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 04Apr2021 (Batch/Lot number: unknown) at the age of 73 years as dose 1, single for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]), subcutaneous (Batch/Lot number: unknown) for psoriasis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 13Sep2021, outcome "recovered" (2021), described as "the patient experienced Covid"; DRUG INEFFECTIVE (medically significant) with onset 13Sep2021, outcome "unknown", described as "COVID"; INFLUENZA LIKE ILLNESS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Flu like symptoms"; BRONCHITIS (non-serious) with onset 04Oct2021, outcome "unknown", described as "Long haul bronchitisis"; VACCINATION SITE PAIN (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "Arm sore after first covid vaccination"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE RASH (non-serious) all with onset Apr2021, outcome "recovered" (Apr2021) and all described as "Got big red rash afterward". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) unknown result. The action taken for risankizumab was unknown.  Additional information: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for SKYRIZI(RISANKIZUMAB) The reporter's causality for the event(s) of covid, flu like symptoms, long haul Bronchitisis, arm sore after first covid vaccination/got big red rash afterward/ache and shoot out pain onset in Apr2021, was not provided.  Causality for BNT162B2 The reporter's assessment of the causal relationship of the event(s) of covid, flu like symptoms, long haul Bronchitisis, arm sore after first covid vaccination/got big red rash afterward/ache and shoot out pain onset in Apr2021, with the suspect product 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.    The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile and temporal relationship there is reasonable possibility of causal association between the reported events COVID-19, Drug Ineffective, Influenza like illness, Bronchitis, Vaccination site pain, vaccination site erythema, vaccination site rash and the suspect drug BNT162B2.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Hallucination
Clinical narrative: Hallucinations of death; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Oct2021 (Batch/Lot number: unknown) at the age of 25 years as dose 1, single for covid-19 immunisation in Pharmacy/drug store. Relevant medical history included: "Mental disorder (reported as mental health)" (unspecified if ongoing); "Premenstrual dysphoric disorder(Pmdd)" (unspecified if ongoing); "Mood disorder" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "Known allergies: bananas" (unspecified if ongoing). Past drug history included: Iodine, reaction(s): "iodine allergy". The patient's concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient didn't receive other vaccines within 4 weeks. Since the vaccination, the patient has not been tested for COVID-19. The following information was reported: HALLUCINATION (medically significant) with onset 14Oct2021, outcome "not recovered", described as "Hallucinations of death". The event "hallucinations of death" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of hallucination. The events were reported as non-serious. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation, Pain in extremity
Clinical narrative: booster; my left hand has severe pain, as well my left leg; my left hand has severe pain, as well my left leg; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.   Vaccination history included: Bnt162b2 (DOSE: 1), for COVID-19 immunization; Bnt162b2 (DOSE: 2), administration date: Apr2021, for COVID-19 immunization, reaction(s): "my left arm went dead- could not raise my arm"; Bnt162b2 (dose: 2), administration date: Apr2021, for COVID-19 immunization, reaction(s): "my left arm was numb, and hurting"; Bnt162b2, administration date: Apr2021, for COVID-19 immunization, reaction(s): "sciatic vein had been irritated"; Bnt162b2 (Dose: 2), administration date: Apr2021, for COVID-19 immunization, reaction(s): "my arm was better-the pain in leg diminished, but did not disappear".  The following information was reported: Immunisation (non-serious) with onset nov2021, outcome "unknown", described as "booster"; pain in extremity (non-serious), pain in extremity (non-serious) all with onset nov2021, outcome "not recovered" and all described as "my left hand has severe pain, as well my left leg". the event "my left hand has severe pain, as well my left leg" was evaluated at the physician office visit. therapeutic measures were taken as a result of pain in extremity, pain in extremity.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: He had normal site pain and swelling which was no big deal. It wasn't as bad as the second time.; He had normal site pain and swelling which was no big deal. It wasn't as bad as the second time.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 23Apr2021 (Lot number: EN5318) at the age of 42 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing); "knee issues" (unspecified if ongoing); "degeneration in her joints" (unspecified if ongoing); "torn rotator cuff" (unspecified if ongoing). Concomitant medication(s) included: DULOXETINE (ongoing). Vaccination history included: Bnt162b2 (First Dose, Lot number: ER8734.), administration date: 02Apr2021, when the patient was 42 years old, for COVID-19 Immunization, reaction(s): "Pain in arm ". The following information was reported: VACCINATION SITE PAIN (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 2021, outcome "unknown" and all described as "He had normal site pain and swelling which was no big deal. It wasn't as bad as the second time.".  Additional information: The report was not related to a study or programme. She got Pfizer BioNTech for the first two in the series six months ago. She had normal site pain and swelling which was no big deal. It wasn't as bad as the second time. She got her six-month booster on 29Nov2021 in the left arm muscle of shoulder. The first times it was given, and she had the same nurse both times. Caller thought it was done in the right arm, but she was not 100 percent positive. She knew they notate it in their system. The first was six months ago, so she is not 100 percent sure which arm it was given in. The difference between the first two times was caller didn't ice the arm. This time she iced the arm.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive; Tested positive; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group.  A 31 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 17Feb2021 (Lot number: EN5318) at the age of 30 years as dose 2, single and intramuscular, administration date 28Jan2021 (Lot number: EN5318) 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 06Dec2021, outcome "recovering" and all described as "Tested positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (06Dec2021) positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Facility type vaccine: clinic.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the vaccination failure and covid19 and the suspect drug BNT162B2.
Sex: U
Vaccine: COVID19
Symptoms: Gait inability, Paralysis, Pericarditis
Clinical narrative: developed pericarditis; became paralyzed from the knees down; unable to walk days after the Pfizer vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  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: PERICARDITIS (hospitalization, medically significant), outcome "not recovered", described as "developed pericarditis"; PARALYSIS (hospitalization, medically significant), outcome "not recovered", described as "became paralyzed from the knees down"; GAIT INABILITY (hospitalization, medically significant), outcome "not recovered", described as "unable to walk days after the Pfizer vaccine".Therapeutic measures were taken as a result of pericarditis, paralysis, gait inability. It was reported that at the time of reporting the patient remains in a hospital, undergoing therapy to learn how to walk and function normally again.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Immunisation, Pain
Clinical narrative: Fever (102F); Sore Arm; Fatigue; Headache; Body ache; Dose received: 3; This is a spontaneous report from a contactable reporter (consumer or other non HCP). The reporter is the patient.   A 46-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in right arm, administration date 06Dec2021 at 09:15 (Lot number: FF8839) at the age of 46 years as dose 3 (booster), 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 2, SINGLE, Lot number: EN6203, Anatomical location: Right arm, Administration time: 11:00, Route of administration: Intramuscular), administration date: 23Mar2021, when the patient was 45 years old, and Bnt162b2 (DOSE 1, SINGLE, Lot number: EN6203, Anatomical location: Right arm), administration date: 01Mar2021, when the patient was 45 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 06Dec2021 at 09:15, outcome "unknown", described as "Dose received: 3"; PYREXIA (non-serious) with onset 07Dec2021 at 01:00, outcome "recovering", described as "Fever (102F)"; PAIN IN EXTREMITY (non-serious) with onset 07Dec2021 at 01:00, outcome "recovering", described as "Sore Arm"; FATIGUE (non-serious) with onset 07Dec2021 at 01:00, outcome "recovering", described as "Fatigue"; HEADACHE (non-serious) with onset 07Dec2021 at 01:00, outcome "recovering", described as "Headache"; PAIN (non-serious) with onset 07Dec2021 at 01:00, outcome "recovering", described as "Body ache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, pain in extremity, fatigue, headache and pain. 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 did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Fever (102F); Sore Arm; Fatigue; Headache; Body ache; Dose received: 3; This is a spontaneous report from a contactable reporter (consumer or other non HCP). The reporter is the patient.   A 46-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in right arm, administration date 06Dec2021 at 09:15 (Lot number: FF8839) at the age of 46 years as dose 3 (booster), 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 2, SINGLE, Lot number: EN6203, Anatomical location: Right arm, Administration time: 11:00, Route of administration: Intramuscular), administration date: 23Mar2021, when the patient was 45 years old, and Bnt162b2 (DOSE 1, SINGLE, Lot number: EN6203, Anatomical location: Right arm), administration date: 01Mar2021, when the patient was 45 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 06Dec2021 at 09:15, outcome "unknown", described as "Dose received: 3"; PYREXIA (non-serious) with onset 07Dec2021 at 01:00, outcome "recovering", described as "Fever (102F)"; PAIN IN EXTREMITY (non-serious) with onset 07Dec2021 at 01:00, outcome "recovering", described as "Sore Arm"; FATIGUE (non-serious) with onset 07Dec2021 at 01:00, outcome "recovering", described as "Fatigue"; HEADACHE (non-serious) with onset 07Dec2021 at 01:00, outcome "recovering", described as "Headache"; PAIN (non-serious) with onset 07Dec2021 at 01:00, outcome "recovering", described as "Body ache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, pain in extremity, fatigue, headache and pain. 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 did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia, SARS-CoV-2 test, Vomiting
Clinical narrative: Fever; Chills; Vomiting; Headache; This is a spontaneous report from a contactable reporter (other healthcare professional). The reporter is the parent.  A 5-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 04Dec2021 at 14:00 (Lot number: unknown) at the age of 5 years as dose 2 (tris), single for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medications included: FLUORIDE and MELATONIN. Vaccination history included: Bnt162b2 (DOSE 1 (TRIS), SINGLE, Lot Number: FK5127, Anatomical site: Left Arm, Administration time: 13:45, Route of administration: Intramuscular), administration date: 13Nov2021, when the patient was 5 years old, for COVID-19 immunisation.  The following information was reported: PYREXIA (non-serious) with onset 05Dec2021 at 18:00, outcome "recovered" (an unknown date in Dec2021), described as "Fever"; CHILLS (non-serious) with onset 05Dec2021 at 18:00, outcome "recovered" (an unknown date in Dec2021), described as "Chills"; VOMITING (non-serious) with onset 05Dec2021 at 18:00, outcome "recovered" (an unknown date in Dec2021), described as "Vomiting"; HEADACHE (non-serious) with onset 05Dec2021 at 18:00, outcome "recovered" (an unknown date in Dec2021), described as "Headache". The events "Fever", "Chills", "Vomiting" and "Headache" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, chills, vomiting and headache. Additional Information: The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included unspecified multivitamins. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient underwent the following laboratory tests and procedures which included: SARS-CoV2 test by test type nasal swab on 06Dec2021 and the result was negative. The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: My son has a red rash all over his body.; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the parent.  A 11-year-old male patient received bnt162b2 (BNT162B2), administered in left arm, administration date 06Dec2021 at 18:30 (Lot number: FK5127) at the age of 11 years as dose 2 (tris), single for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1 (TRIS), SINGLE, Lot number: FK5127, vaccine location: left arm, Administration time: 18:15), administration date: 15Nov2021, when the patient was 11 years old, for COVID-19 immunisation. The following information was reported: RASH ERYTHEMATOUS (non-serious) with onset 07Dec2021, outcome "not recovered", described as "My son has a red rash all over his body". Therapeutic measures were not taken as a result of rash erythematous.  Additional information: The patient had no known allergies. 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. Since the vaccination, the patient had not been tested for COVID-19. The event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Sinus disorder
Clinical narrative: sinus surgery; This daughter got really sick after the first doses; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Motrin, reaction(s): "allergic"; Tylenol, reaction(s): "allergic". The following information was reported: SINUS DISORDER (medically significant), outcome "unknown", described as "sinus surgery"; ILLNESS (non-serious), outcome "unknown", described as "This daughter got really sick after the first doses". Therapeutic measures were taken as a result of sinus disorder.  Additional information: Reporter asked in pregnant ladies Pfizer also, okay and that's the one patient was receiving. Side effects have been lower. She waited in line nine house cause they were going to [DEIDENTIFIED] and no virus was going to keep [DEIDENTIFIED]. Reporter stated before patient second dose we did a pretreat with some. Patient the one that had three hundred thousand dollars' worth of sinus surgery that came out of nowhere.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events sinus disorder and illness and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Immunisation, Lymphadenopathy, Mammogram
Clinical narrative: This is a spontaneous report from a contactable reporter (consumer or other nonHCP). A 48-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in left arm, administration date 05Dec2021 at 02:15 (Lot number: FF8839) at the age of 48 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "None" (unspecified if ongoing), notes: Not applicable. Concomitant medications included: ADVIL and ATHLETIC GREENS supplement. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: EP6955, Anatomical site: Left Arm, Route of administration: Intramuscular), administration date: 18Mar2021, when the patient was 47 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: EP6955, Anatomical site: Left Arm, Route of administration: Intramuscular), administration date: 08Apr2021, when the patient was 47 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 05Dec2021 at 02:15, outcome "unknown", described as "Dose received: 3"; AXILLARY MASS (non-serious) with onset 07Dec2021 at 08:30, outcome "unknown", described as "Lump under left armpit since morning of 12/07"; LYMPHADENOPATHY (non-serious) with onset 07Dec2021 at 08:30, outcome "unknown", described as "seems like swelling lymph nodes (as described in some web reports)".  Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of axillary mass and lymphadenopathy.Additional Information: The patient had no known allergies. The patient did not receive any 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 patient had a recent (<3 months) negative mammography. The events resulted in doctor or other healthcare professional office/ clinic visit.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Lymph node pain, Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: Dose received: 3; Sore swollen lymph nodes in armpit, neck, clavical on side of vaccine injection; Swollen lymph nodes in armpit, neck, clavical on side of vaccine injection; This is a spontaneous report from a non-contactable reporter (consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Lot number: unknown) at the age of 33 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Graves' disease" (unspecified if ongoing), notes: graves disease and "Blood pressure high" (unspecified if ongoing), notes: high blood pressure. Concomitant medications were not reported. Past drug history included: Bactrim, reaction: "Drug allergy", notes: Known allergies: bactrim. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: UNKNOWN), for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: UNKNOWN), for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Dose received: 3"; LYMPH NODE PAIN (non-serious), outcome "recovering", described as "Sore swollen lymph nodes in armpit, neck, clavical on side of vaccine injection"; LYMPHADENOPATHY (non-serious), outcome "recovering", described as "Swollen lymph nodes in armpit, neck, clavical on side of vaccine injection". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lymph node pain and lymphadenopathy.  Additional Information: Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On an unknown date the patient under went Covid 19 virus test via nasal swab and the result found to be negative. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Constipation, Immunisation, Off label use, SARS-CoV-2 test
Clinical narrative: Constipation constant and ongoing; Booster dose was administered on 18Sep2021; Dose received: 3; This is a spontaneous report from a contactable reporter (consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received bnt162b2 (BNT162B2), administered in right arm, administration date 18Sep2021 (Lot number: 301308A) at the age of 58 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Food allergy" (unspecified if ongoing), notes: Known allergies: Mint. Concomitant medications were not reported. Other vaccines received within four weeks of vaccination included: FLU taken for Immunisation, start date: 11Sep2021, stop date: 11Sep2021. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Lot number: EN5318, Anatomical location: Right arm), administration date: 05Feb2021, when the patient was 57 years old, and Bnt162b2 (DOSE 1, SINGLE, Lot number: EL3302, Anatomical location: Right arm), administration date: 15Jan2021, when the patient was 57 years old, for COVID-19 immunisation. The following information was reported: OFF LABEL USE (non-serious) with onset 18Sep2021, outcome "unknown", described as "Booster dose was administered on 18Sep2021"; IMMUNISATION (non-serious) with onset 18Sep2021, outcome "unknown", described as "Dose received: 3"; CONSTIPATION (non-serious) with onset 23Sep2021, outcome "not recovered", described as "Constipation constant and ongoing". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of constipation. Additional Information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Treatment included laxative for constipation. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Fatigue, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable reporter (Consumer or other non HCP). The reporter is the patient. A 44-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 10Jun2021 at 15:00 (Lot number: EW0217) at the age of 44 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19: Yes and "Penicillin allergy" (unspecified if ongoing), notes: Known allergy: Penicillin. Concomitant medications included: LISINOPRIL and SIMVASTATIN. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: EW0171, Anatomical Location: Right arm, Administration time :15:45, Route of Administration: Unspecified), administration date: 20May2021, when the patient was 44 years old, for COVID-19 immunisation.  The following information was reported: CHEST DISCOMFORT (non-serious) with onset 10Jun2021 at 23:15, outcome "recovered", described as "Extreme tightness in chest"; PYREXIA (non-serious) with onset 10Jun2021 at 23:15, outcome "recovered", described as "Fever"; CHILLS (non-serious) with onset 10Jun2021 at 23:15, outcome "recovered", described as "Chills"; FATIGUE (non-serious) with onset 10Jun2021 at 23:15, outcome "recovered", described as "Fatigue". Therapeutic measures were not taken as a result of chest discomfort, pyrexia, chills and fatigue.   Additional Information: Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks 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, emergency room/department or urgent care.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Musculoskeletal stiffness, Peripheral swelling
Clinical narrative: dose number: 3; I have  muscle stiffness in my legs which makes it hard to sit, stand, kneel and go down stairs; My feet are swollen; This is a spontaneous report from a contactable reporter (consumer or non HCP). The reporter is the patient. A 71 year-old male patient received bnt162b2 (BNT162B2), administered in left arm, administration date 12Nov2021 at 14:45 (Lot number: FH8030) at the age of 71 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Sulfonamide allergy" (unspecified if ongoing), notes: known allergies: Sulfa. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot No: Unknown), for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot No: ER2613), for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 12Nov2021 at 14:45, outcome "unknown", described as "dose number: 3"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset an unknown date in Nov2021, outcome "not recovered", described as "I have  muscle stiffness in my legs which makes it hard to sit, stand, kneel and go down stairs"; PERIPHERAL SWELLING (non-serious) with onset an unknown date in Nov2021, outcome "not recovered", described as "My feet are swollen". The events "I have  muscle stiffness in my legs which makes it hard to sit, stand, kneel and go down stairs" and "My feet are swollen" were evaluated at the emergency room visit and physician office visit. Therapeutic measures were taken as a result of musculoskeletal stiffness and peripheral swelling.  Additional Information: It had been 4 weeks since his third Covid vaccine at the time of reporting. 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. Treatment as a result of reported events included methylprednisolone 21 pills for 6 days.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance
Clinical narrative: Difficulty walking; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 12-year-old male patient received bnt162b2 (BNT162B2), administered in left arm (Lot number: unknown) at the age of 12 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "High cholesterol" (unspecified if ongoing); "Egg allergy" (unspecified if ongoing), notes: Known allergies: Egg products and "Milk allergy" (unspecified if ongoing), notes: Known allergies: Dairy products. Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: UNKNOWN, Anatomical site: Left arm), for COVID-19 immunisation. The following information was reported: GAIT DISTURBANCE (non-serious), outcome "unknown", described as "Difficulty walking". The event "Difficulty walking " was evaluated at the physician office visit. Therapeutic measures were taken as a result of gait disturbance.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Treatment included physical therapy for GAIT DISTURBANCE. 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: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Immunisation, Pain in extremity, Peripheral swelling, Swelling
Clinical narrative: Pain and swelling in right arm and right axilla; Pain and swelling in right arm and right axilla; Pain and swelling in right arm and right axilla; Pain and swelling in right arm and right axilla; Dose received: 3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP).   A 48-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 07Dec2021 at 16:00 (Lot number: FE3594) at the age of 48 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: Right arm; Route of administration: Intramuscular), administration date: 03Apr2021, when the patient was 48 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: EW0164; Anatomical site: Right arm; Route of administration: Intramuscular), administration date: 24Apr2021, when the patient was 48 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 07Dec2021 at 16:00, outcome "unknown", described as "Dose received: 3"; PAIN IN EXTREMITY (non-serious), PERIPHERAL SWELLING (non-serious), AXILLARY PAIN (non-serious), SWELLING (non-serious) all with onset 08Dec2021 at 17:00, outcome "recovering", and all described as "Pain and swelling in right arm and right axilla". Therapeutic measures were not taken as a result of pain in extremity, peripheral swelling, axillary pain and swelling.  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. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Swelling
Clinical narrative: Swelling in the left underarm area, along the rib cage. The area is roughly 10cm in diameter, and 2-3cm deep in the middle. It is easily compressed and is not sensitive to touch.; Dose received: 3; This is a spontaneous report from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in left arm, administration date 07Dec2021 at 13:45 (Lot number: EW0196) at the age of 57 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "High cholesterol" (unspecified if ongoing). Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Lot Number: EL3247, Route of administration: Intramuscular), administration date: 16Mar2021, when the patient was 56 years old, and Bnt162b2 (DOSE 1, SINGLE, Lot Number: EL3247), administration date: 23Feb2021, when the patient was 56 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 07Dec2021 at 13:45, outcome "unknown", described as "Dose received: 3"; SWELLING (non-serious) with onset 08Dec2021, outcome "not recovered", described as "Swelling in the left underarm area, along the rib cage. The area is roughly 10cm in diameter, and 2-3cm deep in the middle. It is easily compressed and is not sensitive to touch". Therapeutic measures were not taken as a result of swelling.  Additional Information: The patient had no known allergies. The patient did not receive any other vaccine within four weeks prior to the 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 event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Significant veryigo; This is a spontaneous report from a contactable reporter (consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 19Nov2021 at 16:00 (Lot number: FJ8757) at the age of 44 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing). Concomitant medication included: VALTREX.  The following information was reported: VERTIGO (non-serious) with onset 23Nov2021, outcome "recovered with sequelae" (an unknown date in 2021), described as "Significant veryigo". Therapeutic measures were not taken as a result of vertigo.  Additional Information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Hot flush, Pyrexia
Clinical narrative: fever; chills; hot flashes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  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: PYREXIA (non-serious), outcome "unknown", described as "fever"; CHILLS (non-serious), outcome "unknown", described as "chills"; HOT FLUSH (non-serious), outcome "unknown", described as "hot flashes".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Ill; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (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: ILLNESS (non-serious), outcome "unknown", described as "Ill".  Additional information: The reporter asked if a person got the 1st dose of the Pfizer vaccine and gets ill, how long should a patient wait before getting the 2nd dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.