chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19, FLUR4
Symptoms: Immunisation, Interchange of vaccine products, Lymphadenopathy, Off label use
Clinical narrative: Swollen and tender lymph nodes on left side of body under clavicle.; Off-label use (due to interchange); Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Dec2021 11:15 (Lot number: FJA762) at the age of 43 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine rha 4v (baculovirus) (FLUBLOK QUADRIVALENT), administered in deltoid right, administration date 09Dec2021 (Batch/Lot number: unknown) as dose 1, single for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PROPRANOLOL; DICLOFENAC; DIPHENHYDRAMINE; ACETAMINOFEN. Past drug history included: Pcn, reaction(s): "Known allergies". Vaccination history included: Moderna (Dose Number: 2, Batch/Lot No: 042B21A, Location of injection: Arm Left, Vaccine Administration Time: 12:45 PM), administration date: 15Apr2021, when the patient was 42 years old, for Covid-19 immunization; Moderna (Dose Number: 1, Batch/Lot No: 003A21A, Location of injection: Arm Right, Vaccine Administration Time: 12:45 PM), administration date: 18Mar2021, when the patient was 42 years old, for Covid-19 Immunization. The following information was reported: OFF LABEL USE (non-serious) with onset 09Dec2021, outcome "unknown", described as "Off-label use (due to interchange)"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 09Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (non-serious) with onset 09Dec2021, outcome "unknown", described as "Booster"; LYMPHADENOPATHY (non-serious) with onset 11Dec2021 18:30, outcome "unknown", described as "Swollen and tender lymph nodes on left side of body under clavicle.". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information:  Patient was not pregnant at time of vaccination. The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.   No follow-up attempts are possible. No further information is expected.  Follow-Up (23Dec2021): Follow-up attempts are completed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Eye swelling, Immunisation, Lacrimation increased, Ocular hyperaemia
Clinical narrative: my right eye - hurting; I developed pink eye in my right eye; my right eye - swollen; my right eye - would not stop watering; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Dec2021 17:15 (Lot number: 330268D) at the age of 27 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, start date: 26Nov2021, stop date: 26Nov2021. Vaccination history included: Bnt162b2 (prev dose product: COVID 19, prev dose brand: Pfizer, prev dose brand unknown: False, prev dose lot number: EP7533, prev dose lot unknown: False, prev dose administration date: 05Apr2021, prev dose number: 2, prev dose vaccine location: Left arm), administration date: 05Apr2021, when the patient was 26 years old, for Covid-19 Immunization; Bnt162b2 (prev dose brand: Pfizer, prev dose brand unknown: False, prev dose lot number: EL9266, prev dose lot unknown: False, prev dose administration date: 15Mar2021, prev dose number: 1, prev dose vaccine location: Left arm), administration date: 15Mar2021, when the patient was 26 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 08Dec2021, outcome "not recovered", described as "booster"; EYE PAIN (non-serious) with onset 11Dec2021 04:00, outcome "not recovered", described as "my right eye - hurting"; OCULAR HYPERAEMIA (non-serious) with onset 11Dec2021 04:00, outcome "not recovered", described as "I developed pink eye in my right eye"; EYE SWELLING (non-serious) with onset 11Dec2021 04:00, outcome "not recovered", described as "my right eye - swollen"; LACRIMATION INCREASED (non-serious) with onset 11Dec2021 04:00, outcome "recovered" (2021), described as "my right eye - would not stop watering". Therapeutic measures were not taken as a result of immunisation, eye pain, ocular hyperaemia, eye swelling, lacrimation increased.  Additional information: The patient got booster on Wednesday. On Friday overnight she developed pink eye in her right eye, it was swollen, hurting, red and would not stop watering. As she was writing this the swelling and redness remains. The watering had stopped. The patient did not have covid prior to vaccination and not tested post vaccination. The patient did not have known allergy. The patient did not receive any other vaccine in four weeks and other medications in two weeks. Facility type vaccine was pharmacy or drug store.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101780454 Same product and event, different patient
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: on 03Sep2021, tested positive for Covid, was hospitalized; on 03Sep2021, tested positive for Covid, was hospitalized; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 56 year-old female patient received bnt162b2 (BNT162B2), administration date 19Mar2021 (Batch/Lot number: unknown) as DOSE 2, SINGLE and (Batch/Lot number: unknown) as DOSE 1, SINGLE for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset 03Sep2021, outcome "unknown" and all described as "on 03Sep2021, tested positive for Covid, was hospitalized". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (03Sep2021) positive. Therapeutic measure immunoglobulin was taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on limited information in the case , a possible causal association between the reported  events  Drug ineffective , Covid -19 and the suspect drug BNT162B2 cannot be excluded
Age: 9.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Disease recurrence, Headache, Seizure
Clinical narrative: Had a seizure after each of her doses; disease recurrence; Stomach ache; Headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non healthcare professional) from medical information team. The reporter is the parent.  A 10 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 10Nov2021 17:45 (Lot number: FK5618) at the age of 9 years as DOSE 1 (TRIS), SINGLE and administered in deltoid left, administration date 01Dec2021 17:45 (Lot number: FK5618) as DOSE 2 (TRIS), SINGLE for covid-19 immunisation. Relevant medical history included: "seizures from heterotopia diagnosed about two years ago" (unspecified if ongoing).  The patient had no vaccinations prior to BNT162B2 within 4 weeks. Concomitant medication(s) included: LEVETIRACETAM taken for seizure, two and half tablets in the morning and two tablets at night by mouth. The following information was reported: SEIZURE (medically significant) with onset 2021, outcome "unknown", described as "Had a seizure after each of her doses"; DISEASE RECURRENCE (medically significant) with onset 2021, outcome "unknown", described as "Disease recurrence", ABDOMINAL PAIN UPPER (non-serious) with onset 21, outcome "recovered" (2021), described as "Stomach ache for two days"; HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021), described as "Headache for two days". The event "had a seizure after each of her doses" and "disease recurrence were evaluated at the physician office visit.  Follow up (13Dec2021): This is a follow-up spontaneous report from a contactable consumer. This consumer (father) reported for a 10-year-old female consumer (daughter).  Updated information: Patient details updated.  Additional information: New events added. Vaccine start/stop dates and time added. Lot numbers added. Event duration for events added. Vaccination facility information was added.   No follow-up attempts are needed. No further information is expected.
Age: 9.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Generalised tonic-clonic seizure
Clinical narrative: Had a seizure after each of her doses; disease recurrence; Stomach ache; Headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non healthcare professional) from medical information team. The reporter is the parent.  A 10 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 10Nov2021 17:45 (Lot number: FK5618) at the age of 9 years as DOSE 1 (TRIS), SINGLE and administered in deltoid left, administration date 01Dec2021 17:45 (Lot number: FK5618) as DOSE 2 (TRIS), SINGLE for covid-19 immunisation. Relevant medical history included: "seizures from heterotopia diagnosed about two years ago" (unspecified if ongoing).  The patient had no vaccinations prior to BNT162B2 within 4 weeks. Concomitant medication(s) included: LEVETIRACETAM taken for seizure, two and half tablets in the morning and two tablets at night by mouth. The following information was reported: SEIZURE (medically significant) with onset 2021, outcome "unknown", described as "Had a seizure after each of her doses"; DISEASE RECURRENCE (medically significant) with onset 2021, outcome "unknown", described as "Disease recurrence", ABDOMINAL PAIN UPPER (non-serious) with onset 21, outcome "recovered" (2021), described as "Stomach ache for two days"; HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021), described as "Headache for two days". The event "had a seizure after each of her doses" and "disease recurrence were evaluated at the physician office visit.  Follow up (13Dec2021): This is a follow-up spontaneous report from a contactable consumer. This consumer (father) reported for a 10-year-old female consumer (daughter).  Updated information: Patient details updated.  Additional information: New events added. Vaccine start/stop dates and time added. Lot numbers added. Event duration for events added. Vaccination facility information was added.   No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Eye pain, Eye swelling, Immunisation, Lacrimation increased, Ocular hyperaemia
Clinical narrative: Booster; eye - hurting; developed pink eye; eye - would not stop watering; eye - swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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, SINGLE), for Covid-19 immunization; Bnt162b2 (Dose 2, SINGLE), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; EYE PAIN (non-serious), outcome "unknown", described as "eye - hurting"; OCULAR HYPERAEMIA (non-serious), outcome "unknown", described as "developed pink eye"; LACRIMATION INCREASED (non-serious), outcome "unknown", described as "eye - would not stop watering"; EYE SWELLING (non-serious), outcome "unknown", described as "eye - swollen". Therapeutic measures were not taken as a result of eye swelling. Additional information: The patient received the booster on Wednesday and on Friday overnight patient developed pink eye in my right eye - it was swollen, hurting, red and would not stop. Also, patient was stated that as I'm writing this the swelling and redness remains, watering has stopped. Patient had no COVID prior vaccination and not COVID tested post vaccination. Patient had no Known allergies.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101780341 Same product and event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Immunisation, Mental impairment, Pain
Clinical narrative: I feel mentally/cognitively very spacey (like I am awake but kind of a dream-like state at the same time); slight fever (100 degrees); exceptional fatigue; some body aches; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non healthcare professional).  An adult female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 11Dec2021 (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 2; Batch/Lot No: Unknown), for Covid-19 immunization; Bnt162b2 (DOSE 1; Batch/Lot No: Unknown), for Covid-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 11Dec2021, outcome "unknown", described as "booster"; MENTAL IMPAIRMENT (medically significant) with onset 13Dec2021, outcome "not recovered", described as "I feel mentally/cognitively very spacey (like I am awake but kind of a dream-like state at the same time)"; PYREXIA (non-serious) with onset 13Dec2021, outcome "not recovered", described as "slight fever (100 degrees)"; FATIGUE (non-serious) with onset 13Dec2021, outcome "not recovered", described as "exceptional fatigue"; PAIN (non-serious) with onset 13Dec2021, outcome "not recovered", described as "some body aches". The patient underwent the following laboratory tests and procedures: body temperature: (13Dec2021) slight fever (100 degrees). Therapeutic measures were not taken as a result of mental impairment, pyrexia, fatigue, pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: I feel mentally/cognitively very spacey (like I am awake but kind of a dream-like state at the same time); slight fever (100 degrees); exceptional fatigue; some body aches; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non healthcare professional).  An adult female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 11Dec2021 (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 2; Batch/Lot No: Unknown), for Covid-19 immunization; Bnt162b2 (DOSE 1; Batch/Lot No: Unknown), for Covid-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 11Dec2021, outcome "unknown", described as "booster"; MENTAL IMPAIRMENT (medically significant) with onset 13Dec2021, outcome "not recovered", described as "I feel mentally/cognitively very spacey (like I am awake but kind of a dream-like state at the same time)"; PYREXIA (non-serious) with onset 13Dec2021, outcome "not recovered", described as "slight fever (100 degrees)"; FATIGUE (non-serious) with onset 13Dec2021, outcome "not recovered", described as "exceptional fatigue"; PAIN (non-serious) with onset 13Dec2021, outcome "not recovered", described as "some body aches". The patient underwent the following laboratory tests and procedures: body temperature: (13Dec2021) slight fever (100 degrees). Therapeutic measures were not taken as a result of mental impairment, pyrexia, fatigue, pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: myocarditis; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP) from medical information team.  A child female patient received bnt162b2 (COMIRNATY) (Lot number: unknown) as single dose for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown", described as "myocarditis". Reporter was fully vaccinated. Reporter's daughter received all the booster everything Pfizer she was in her 40 they were all fine. Reporter's question was about the booster for the 5-11 years old, and the reason that, and reporter wanted to find out if there was, now reporter understand that 5 million children received this Pfizer vaccine reporter didn't know how many, if that was the right number but on the news, reporter was just assuming. Since the schools were mandating many of the private schools were mandating the vaccine by 15Feb2021. Reporter was concerned about myocarditis, had there been any myocarditis case, caused reporter knew one family that who child (patient) got it like a few days ago, that was why was worried about reporter's grandchildren getting it. Patient was a girl, reporter's daughter just told. Reporter's grandchildren would be vaccinated, so reporter asked if there had been any adverse effects from children ages 5-11. Reporter asked if there had been like one or two or there had been a lot of people with myocarditis who are ages 5-11.  No follow up attempts are possible; Information about lot/batch number cannot be requested. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Appendicitis, Constipation, Myalgia, SARS-CoV-2 test
Clinical narrative: Appendicitis; stomach pains; muscle aches; vomiting; constipation; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Dec2021 17:00 (Lot number: 32030BD) at the age of 31 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Pfizer,  lot number=EW0158, on 27May2021 at 03:30PM, Left arm), administration date: 27May2021, when the patient was 30 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Pfizer on 06May2021 at 03:30PM, Right arm), administration date: 06May2021, when the patient was 30 years old, for COVID-19 Immunization. The following information was reported: APPENDICITIS (hospitalization, disability, medically significant) with onset 11Dec2021 04:00, outcome "recovering", described as "Appendicitis"; ABDOMINAL PAIN UPPER (hospitalization, disability) with onset 11Dec2021 04:00, outcome "recovering", described as "stomach pains"; MYALGIA (hospitalization, disability) with onset 11Dec2021 04:00, outcome "recovering", described as "muscle aches"; VOMITING (hospitalization, disability) with onset 11Dec2021 04:00, outcome "recovering", described as "vomiting"; CONSTIPATION (hospitalization, disability) with onset 11Dec2021 04:00, outcome "recovering", described as "constipation". The patient was hospitalized for appendicitis, abdominal pain upper, myalgia, vomiting, constipation (hospitalization duration: 1 day(s)). The events "appendicitis", "stomach pains", "muscle aches", "vomiting" and "constipation" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (11Dec2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of appendicitis, abdominal pain upper, myalgia, vomiting, constipation and included treatment with Appendix Removal. Clinical course: Patient did not have covid prior vaccination.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Appendicitis; stomach pains; muscle aches; vomiting; constipation; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Dec2021 17:00 (Lot number: 32030BD) at the age of 31 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Pfizer,  lot number=EW0158, on 27May2021 at 03:30PM, Left arm), administration date: 27May2021, when the patient was 30 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Pfizer on 06May2021 at 03:30PM, Right arm), administration date: 06May2021, when the patient was 30 years old, for COVID-19 Immunization. The following information was reported: APPENDICITIS (hospitalization, disability, medically significant) with onset 11Dec2021 04:00, outcome "recovering", described as "Appendicitis"; ABDOMINAL PAIN UPPER (hospitalization, disability) with onset 11Dec2021 04:00, outcome "recovering", described as "stomach pains"; MYALGIA (hospitalization, disability) with onset 11Dec2021 04:00, outcome "recovering", described as "muscle aches"; VOMITING (hospitalization, disability) with onset 11Dec2021 04:00, outcome "recovering", described as "vomiting"; CONSTIPATION (hospitalization, disability) with onset 11Dec2021 04:00, outcome "recovering", described as "constipation". The patient was hospitalized for appendicitis, abdominal pain upper, myalgia, vomiting, constipation (hospitalization duration: 1 day(s)). The events "appendicitis", "stomach pains", "muscle aches", "vomiting" and "constipation" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (11Dec2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of appendicitis, abdominal pain upper, myalgia, vomiting, constipation and included treatment with Appendix Removal. Clinical course: Patient did not have covid prior vaccination.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac murmur, Chest X-ray, Cough, Electrocardiogram, Inflammatory marker increased
Clinical narrative: chest x-ray presented like a lung infection; Vomited once; Fever of 100-103.5 for 12 days; Extreme nausea throughout; Swollen lymph nodes in neck; Cough; heart murmur; blood tested high inflammatory markers; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 6 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 22Nov2021 12:30 (Lot number: FK5127) at the age of 6 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Bee venom" (unspecified if ongoing), notes: Known allergies: Bee venom. Family history included: "Family history of vaccine reactions" (unspecified if ongoing), notes: Family history of vaccine reactions. There were no concomitant medications. no other vaccine in four weeks. No other medications in two weeks. No covid prior vaccination. The following information was reported: PNEUMONIA (medically significant) with onset 22Nov2021 19:00, outcome "recovering", described as "chest x-ray presented like a lung infection"; VOMITING (non-serious) with onset 22Nov2021 19:00, outcome "recovering", described as "Vomited once"; PYREXIA (non-serious) with onset 22Nov2021 19:00, outcome "recovering", described as "Fever of 100-103.5 for 12 days"; NAUSEA (non-serious) with onset 22Nov2021 19:00, outcome "recovering", described as "Extreme nausea throughout"; LYMPHADENOPATHY (non-serious) with onset 22Nov2021 19:00, outcome "recovering", described as "Swollen lymph nodes in neck"; COUGH (non-serious) with onset 22Nov2021 19:00, outcome "recovering", described as "Cough"; CARDIAC MURMUR (non-serious) with onset 22Nov2021 19:00, outcome "recovering", described as "heart murmur"; INFLAMMATORY MARKER INCREASED (non-serious) with onset 22Nov2021 19:00, outcome "recovering", described as "blood tested high inflammatory markers". The events "chest x-ray presented like a lung infection", "vomited once", "fever of 100-103.5 for 12 days", "extreme nausea throughout", "swollen lymph nodes in neck", "cough", "heart murmur" and "blood tested high inflammatory markers" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: chest x-ray: (22Nov2021) presented like a lung infection; electrocardiogram: (22Nov2021) unknown results; inflammatory marker test: (22Nov2021) high inflammatory markers, notes: blood tested high inflammatory markers; pyrexia: (22Nov2021) 100-103.5; sars-cov-2 test: (30Nov2021) negative. Therapeutic measures were taken as a result of pneumonia, vomiting, pyrexia, nausea, lymphadenopathy, cough, cardiac murmur, inflammatory marker increased included Motrin.  No follow-up attempts are possible. No further information is expected.; Reporter's Comments: ~~~
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Inflammatory marker test, Lymphadenopathy, Nausea, Pneumonia, Pyrexia
Clinical narrative: chest x-ray presented like a lung infection; Vomited once; Fever of 100-103.5 for 12 days; Extreme nausea throughout; Swollen lymph nodes in neck; Cough; heart murmur; blood tested high inflammatory markers; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 6 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 22Nov2021 12:30 (Lot number: FK5127) at the age of 6 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Bee venom" (unspecified if ongoing), notes: Known allergies: Bee venom. Family history included: "Family history of vaccine reactions" (unspecified if ongoing), notes: Family history of vaccine reactions. There were no concomitant medications. no other vaccine in four weeks. No other medications in two weeks. No covid prior vaccination. The following information was reported: PNEUMONIA (medically significant) with onset 22Nov2021 19:00, outcome "recovering", described as "chest x-ray presented like a lung infection"; VOMITING (non-serious) with onset 22Nov2021 19:00, outcome "recovering", described as "Vomited once"; PYREXIA (non-serious) with onset 22Nov2021 19:00, outcome "recovering", described as "Fever of 100-103.5 for 12 days"; NAUSEA (non-serious) with onset 22Nov2021 19:00, outcome "recovering", described as "Extreme nausea throughout"; LYMPHADENOPATHY (non-serious) with onset 22Nov2021 19:00, outcome "recovering", described as "Swollen lymph nodes in neck"; COUGH (non-serious) with onset 22Nov2021 19:00, outcome "recovering", described as "Cough"; CARDIAC MURMUR (non-serious) with onset 22Nov2021 19:00, outcome "recovering", described as "heart murmur"; INFLAMMATORY MARKER INCREASED (non-serious) with onset 22Nov2021 19:00, outcome "recovering", described as "blood tested high inflammatory markers". The events "chest x-ray presented like a lung infection", "vomited once", "fever of 100-103.5 for 12 days", "extreme nausea throughout", "swollen lymph nodes in neck", "cough", "heart murmur" and "blood tested high inflammatory markers" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: chest x-ray: (22Nov2021) presented like a lung infection; electrocardiogram: (22Nov2021) unknown results; inflammatory marker test: (22Nov2021) high inflammatory markers, notes: blood tested high inflammatory markers; pyrexia: (22Nov2021) 100-103.5; sars-cov-2 test: (30Nov2021) negative. Therapeutic measures were taken as a result of pneumonia, vomiting, pyrexia, nausea, lymphadenopathy, cough, cardiac murmur, inflammatory marker increased included Motrin.  No follow-up attempts are possible. No further information is expected.; Reporter's Comments: ~~~
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vomiting
Clinical narrative: chest x-ray presented like a lung infection; Vomited once; Fever of 100-103.5 for 12 days; Extreme nausea throughout; Swollen lymph nodes in neck; Cough; heart murmur; blood tested high inflammatory markers; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 6 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 22Nov2021 12:30 (Lot number: FK5127) at the age of 6 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Bee venom" (unspecified if ongoing), notes: Known allergies: Bee venom. Family history included: "Family history of vaccine reactions" (unspecified if ongoing), notes: Family history of vaccine reactions. There were no concomitant medications. no other vaccine in four weeks. No other medications in two weeks. No covid prior vaccination. The following information was reported: PNEUMONIA (medically significant) with onset 22Nov2021 19:00, outcome "recovering", described as "chest x-ray presented like a lung infection"; VOMITING (non-serious) with onset 22Nov2021 19:00, outcome "recovering", described as "Vomited once"; PYREXIA (non-serious) with onset 22Nov2021 19:00, outcome "recovering", described as "Fever of 100-103.5 for 12 days"; NAUSEA (non-serious) with onset 22Nov2021 19:00, outcome "recovering", described as "Extreme nausea throughout"; LYMPHADENOPATHY (non-serious) with onset 22Nov2021 19:00, outcome "recovering", described as "Swollen lymph nodes in neck"; COUGH (non-serious) with onset 22Nov2021 19:00, outcome "recovering", described as "Cough"; CARDIAC MURMUR (non-serious) with onset 22Nov2021 19:00, outcome "recovering", described as "heart murmur"; INFLAMMATORY MARKER INCREASED (non-serious) with onset 22Nov2021 19:00, outcome "recovering", described as "blood tested high inflammatory markers". The events "chest x-ray presented like a lung infection", "vomited once", "fever of 100-103.5 for 12 days", "extreme nausea throughout", "swollen lymph nodes in neck", "cough", "heart murmur" and "blood tested high inflammatory markers" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: chest x-ray: (22Nov2021) presented like a lung infection; electrocardiogram: (22Nov2021) unknown results; inflammatory marker test: (22Nov2021) high inflammatory markers, notes: blood tested high inflammatory markers; pyrexia: (22Nov2021) 100-103.5; sars-cov-2 test: (30Nov2021) negative. Therapeutic measures were taken as a result of pneumonia, vomiting, pyrexia, nausea, lymphadenopathy, cough, cardiac murmur, inflammatory marker increased included Motrin.  No follow-up attempts are possible. No further information is expected.; Reporter's Comments: ~~~
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: got A Fib; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient 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: ATRIAL FIBRILLATION, outcome "unknown", described as "got A Fib". Clinical courses: age was reported as 63 without unit provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pyrexia
Clinical narrative: High fever; Feel tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 18Nov2021 16:30 (Lot number: 30125BA) at the age of 39 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "High fever"; FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "Feel tired". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia. Additional information: No prior vaccination within 4 Weeks. Treatment included Tylenol and Motrin.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Haematoma, Immunisation, Joint swelling, Pain
Clinical narrative: about 24 hours after getting it my shoulder swelled up. I have like a large Hematoma on the outside of it so a large swelling on the outside of my shoulder; about 24 hours after getting it my shoulder swelled up. I have like a large Hematoma on the outside of it so a large swelling on the outside of my shoulder; I can''t put any weight on my arm or lift without having shooting pains; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Dec2021 (Lot number: FH8030) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing), notes: Verbatim: Blood pressure. Concomitant medication(s) included: LISINOPRIL taken for blood pressure measurement. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunization; Bnt162b2 (Dose 2), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 10Dec2021, outcome "unknown", described as "booster"; JOINT SWELLING (non-serious), HAEMATOMA (non-serious), outcome "unknown" and all described as "about 24 hours after getting it my shoulder swelled up. I have like a large Hematoma on the outside of it so a large swelling on the outside of my shoulder"; PAIN (non-serious), outcome "unknown", described as "I can''t put any weight on my arm or lift without having shooting pains". Therapeutic measures were taken as a result of joint swelling, haematoma, pain.  Additional information: Yesterday around 4 o'clock so about 24 hour after my booster shot (10Dec2021). Anatomical site of administration: Left shoulder. The number looks like 4335, that's the only number on here and on the back there is a number that says FH8030, I am not sure which one the Lot number would be. I have FH8030. No lab test (within 2 weeks). Patient was still experiencing the problem. Treatment: Taking Ibuprofen, putting ice on it as well.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Immunisation, Movement disorder, Pain in extremity, Peripheral swelling
Clinical narrative: Booster; Arm was killing me and couldn't move it.; Right arm is hurting, with red patches, itching, spread to the bicep; Right arm is hurting, with red patches, itching, spread to the bicep; her arm started to feel really sore and swollen; after the booster her arm started to feel really sore; This is a spontaneous report received from a contactable reporter(s) (Consumer) from medical information team. The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 08Dec2021 (Lot number: FG3527, Expiration Date: 28Feb2022) at the age of 67 years as dose 3  (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose: given on 17Apr2021 in the afternoon in the right arm, Lot: ER8731), administration date: 17Apr2021, when the patient was 67 years old, for Covid-19 Immunization, reaction(s): "right arm it hurt"; Bnt162b2 (Dose 2, The second on 08May2021 on right arm), administration date: 08May2021, when the patient was 67 years old, for COVID-19 Immunization, reaction(s): "right arm it was sore". The following information was reported: IMMUNISATION (non-serious) with onset 08Dec2021, outcome "unknown", described as "Booster"; MOVEMENT DISORDER (non-serious) with onset Dec2021, outcome "unknown", described as "Arm was killing me and couldn't move it."; PRURITUS (non-serious), ERYTHEMA (non-serious) all with onset Dec2021, outcome "not recovered" and all described as "Right arm is hurting, with red patches, itching, spread to the bicep"; PERIPHERAL SWELLING (non-serious) with onset Dec2021, outcome "not recovered", described as "her arm started to feel really sore and swollen"; PAIN IN EXTREMITY (non-serious) with onset Dec2021, outcome "unknown", described as "after the booster her arm started to feel really sore". Therapeutic measures were taken as a result of pruritus. Additional information: used a cream for the itchiness. No Emergency Room visit and Physician Office visit. None prior vaccinations (within 4 weeks).  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Booster; Arm was killing me and couldn't move it.; Right arm is hurting, with red patches, itching, spread to the bicep; Right arm is hurting, with red patches, itching, spread to the bicep; her arm started to feel really sore and swollen; after the booster her arm started to feel really sore; This is a spontaneous report received from a contactable reporter(s) (Consumer) from medical information team. The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 08Dec2021 (Lot number: FG3527, Expiration Date: 28Feb2022) at the age of 67 years as dose 3  (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose: given on 17Apr2021 in the afternoon in the right arm, Lot: ER8731), administration date: 17Apr2021, when the patient was 67 years old, for Covid-19 Immunization, reaction(s): "right arm it hurt"; Bnt162b2 (Dose 2, The second on 08May2021 on right arm), administration date: 08May2021, when the patient was 67 years old, for COVID-19 Immunization, reaction(s): "right arm it was sore". The following information was reported: IMMUNISATION (non-serious) with onset 08Dec2021, outcome "unknown", described as "Booster"; MOVEMENT DISORDER (non-serious) with onset Dec2021, outcome "unknown", described as "Arm was killing me and couldn't move it."; PRURITUS (non-serious), ERYTHEMA (non-serious) all with onset Dec2021, outcome "not recovered" and all described as "Right arm is hurting, with red patches, itching, spread to the bicep"; PERIPHERAL SWELLING (non-serious) with onset Dec2021, outcome "not recovered", described as "her arm started to feel really sore and swollen"; PAIN IN EXTREMITY (non-serious) with onset Dec2021, outcome "unknown", described as "after the booster her arm started to feel really sore". Therapeutic measures were taken as a result of pruritus. Additional information: used a cream for the itchiness. No Emergency Room visit and Physician Office visit. None prior vaccinations (within 4 weeks).  No follow-up attempts are possible. No further information is expected.
Age: 11.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain upper, Headache, Pyrexia, Tardive dyskinesia
Clinical narrative: three episodes tardive dyskinesia/seemed like tardive dyskinesia/ It is mainly in his upper body, his arms are moving uncontrollably; headache; stomach ache; fever; This is a spontaneous report received from contactable consumer. The reporter is patient's father. An 11-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Dec2021 17:45 (Lot number: FK5618) at the age of 11 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Pachygyria" (unspecified if ongoing), notes: diagnosed when he was two years old; "thyroid" (unspecified if ongoing); "Seizures" (unspecified if ongoing). Concomitant medications included: LEVOTHYROXINE taken for thyroid disorder (ongoing); OXCARBAZEPINE taken for seizure (ongoing). Vaccination history included: Bnt162b2 (First dose, Lot: FK5618, left shoulder at 17:45), administration date: 10Nov2021, when the patient was 11 years old, for COVID-19 immunization, reactions: "tardive dyskinesia", "Headache", "Stomach ache". The following information was reported: TARDIVE DYSKINESIA (medically significant) with onset Dec2021, outcome "not recovered", described as "three episodes tardive dyskinesia/seemed like tardive dyskinesia/ It is mainly in his upper body, his arms are moving uncontrollably"; HEADACHE (non-serious) with onset Dec2021, outcome "recovered" (Dec2021), described as "headache"; ABDOMINAL PAIN UPPER (non-serious) with onset Dec2021, outcome "recovered" (Dec2021), described as "stomach ache"; PYREXIA (non-serious) with onset Dec2021, outcome "unknown", described as "fever". Therapeutic measures were not taken as a result of tardive dyskinesia, headache, abdominal pain upper, pyrexia.
Age: 11.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyskinesia, Tremor
Clinical narrative: three episodes tardive dyskinesia/seemed like tardive dyskinesia/ It is mainly in his upper body, his arms are moving uncontrollably; headache; stomach ache; fever; This is a spontaneous report received from contactable consumer. The reporter is patient's father. An 11-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Dec2021 17:45 (Lot number: FK5618) at the age of 11 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Pachygyria" (unspecified if ongoing), notes: diagnosed when he was two years old; "thyroid" (unspecified if ongoing); "Seizures" (unspecified if ongoing). Concomitant medications included: LEVOTHYROXINE taken for thyroid disorder (ongoing); OXCARBAZEPINE taken for seizure (ongoing). Vaccination history included: Bnt162b2 (First dose, Lot: FK5618, left shoulder at 17:45), administration date: 10Nov2021, when the patient was 11 years old, for COVID-19 immunization, reactions: "tardive dyskinesia", "Headache", "Stomach ache". The following information was reported: TARDIVE DYSKINESIA (medically significant) with onset Dec2021, outcome "not recovered", described as "three episodes tardive dyskinesia/seemed like tardive dyskinesia/ It is mainly in his upper body, his arms are moving uncontrollably"; HEADACHE (non-serious) with onset Dec2021, outcome "recovered" (Dec2021), described as "headache"; ABDOMINAL PAIN UPPER (non-serious) with onset Dec2021, outcome "recovered" (Dec2021), described as "stomach ache"; PYREXIA (non-serious) with onset Dec2021, outcome "unknown", described as "fever". Therapeutic measures were not taken as a result of tardive dyskinesia, headache, abdominal pain upper, pyrexia.
Age: 11.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain upper, Headache, Tardive dyskinesia
Clinical narrative: three episodes tardive dyskinesia/seemed like tardive dyskinesia/ It is mainly in his upper body, his arms are moving uncontrollably; headache; stomach ache; fever; This is a spontaneous report received from contactable consumer. The reporter is patient's father. An 11-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Dec2021 17:45 (Lot number: FK5618) at the age of 11 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Pachygyria" (unspecified if ongoing), notes: diagnosed when he was two years old; "thyroid" (unspecified if ongoing); "Seizures" (unspecified if ongoing). Concomitant medications included: LEVOTHYROXINE taken for thyroid disorder (ongoing); OXCARBAZEPINE taken for seizure (ongoing). Vaccination history included: Bnt162b2 (First dose, Lot: FK5618, left shoulder at 17:45), administration date: 10Nov2021, when the patient was 11 years old, for COVID-19 immunization, reactions: "tardive dyskinesia", "Headache", "Stomach ache". The following information was reported: TARDIVE DYSKINESIA (medically significant) with onset Dec2021, outcome "not recovered", described as "three episodes tardive dyskinesia/seemed like tardive dyskinesia/ It is mainly in his upper body, his arms are moving uncontrollably"; HEADACHE (non-serious) with onset Dec2021, outcome "recovered" (Dec2021), described as "headache"; ABDOMINAL PAIN UPPER (non-serious) with onset Dec2021, outcome "recovered" (Dec2021), described as "stomach ache"; PYREXIA (non-serious) with onset Dec2021, outcome "unknown", described as "fever". Therapeutic measures were not taken as a result of tardive dyskinesia, headache, abdominal pain upper, pyrexia.
Age: 11.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain upper, Headache, Pyrexia, Tardive dyskinesia
Clinical narrative: had a couple episodes that almost seemed like tardive dyskinesia for lack of a better term; headache; stomach ache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent. A 11 year-old male patient received bnt162b2 (BNT162B2), administered in arm left (reported as left shoulder), administration date 10Nov2021 17:45 (Lot number: FK5618) at the age of 11 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Pachygyria" (unspecified if ongoing), notes: Diagnosed when he was two years old; "thyroid" (unspecified if ongoing); "Seizures" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for his thyroid (ongoing), taking almost a year; OXCARBAZEPINE taken for seizure (ongoing), taking for about 3 years. No Family Medical History Relevant to AE(s). No Prior Vaccinations (within 4 weeks). No additional vaccines administered on same date of the Pfizer Suspect. The following information was reported: TARDIVE DYSKINESIA (medically significant) with onset 2021, outcome "unknown", described as "had a couple episodes that almost seemed like tardive dyskinesia for lack of a better term"; HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021), described as "headache"; ABDOMINAL PAIN UPPER (non-serious) with onset 2021, outcome "recovered" (2021), described as "stomach ache". Therapeutic measures were not taken as a result of tardive dyskinesia, headache, abdominal pain upper. The AE(s) didn't require a visit to Emergency Room. Not yet went to physician Office, had a call out to his neurologist and waiting to hear back. No Relevant Tests. No Investigation Assessment.