chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: Heart problems; This is a spontaneous report from a contactable consumer (patient). A 71-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscularly administered in left arm on 04Mar2021 13:00 (Batch/Lot Number: EN6204) as dose 1, single for COVID-19 immunisation. Medical history included diabetes from May1994 and ongoing. Concomitant medication included dulaglutide (TRULICITY) taken for diabetes. The patient reported the heart problems started after 1st vaccination on an unspecified date in 2021. The event heart problems was considered serious by the patient due to Life-threatening, Persistent / Significant disability / Incapacity and Important medical event. The event required visit to physician office. Therapeutic measures were taken as a result of heart problems which included ongoing 5 MOS (as reported) and cardiology SVT medicine. The event outcome was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101013907 same patient/reporter/product, different dose, similar event
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Fatigue, Swelling face
Clinical narrative: swollen eyes; swelling of face 'it was in my sinus'; Tired; The initial case was missing the following minimum criteria: no AE. Upon receipt of follow-up information on 17Aug2021 this case now contains all required information to be considered valid.  This is a spontaneous report from a from a contactable consumer via the Pfizer sponsored program.  A 68-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EM9809), dose 1 intramuscular, administered in arm left on 12Feb2021 at 12:30 (at the age of 68-years-old ) as single dose for covid-19 immunisation.  Medical history included back pain and high cholesterol. Concomitant medication(s) included ibuprofen (ADVIL 12HOUR) taken for back pain; atorvastatin 20 Mg taken for high cholesterol; ubidecarenone (COQ-10) taken for an unspecified indication, fish oil taken for an unspecified indication; colecalciferol (VIT D3) taken for an unspecified indication,  magnesium taken for an unspecified indication, chondroitin sulfate sodium, glucosamine hydrochloride, manganese gluconate, sodium borate decahydrate (GLUCOSAMINE & CHONDORITIN) taken for an unspecified indication and monascus purpureus (RED YEAST RICE) taken for an unspecified indication.  The patient reported that after the first vaccine, she woke up the next morning on 13Feb2021 with swollen eyes/ swollen face, 'it was in my sinus'.  She took benadryl & within 2 days she was fine. Just tired. The outcome of the event tired was unknown.   Follow-up attempts are completed. No further information is expected.  Follow-up (26Aug2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101075506 same patient/ dose 2
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Neck mass, Product storage error
Clinical narrative: Those weren't frozen; a large bump came up on my neck right side; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 16Aug2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA VACCINE, lot number:UNKNOWN), dose 2 via an unspecified route of administration, administered in upper right arm on 15Apr2021 10:30 as a single dose for COVID-19 immunization. The patient had no medical history. Concomitant medication included ongoing metronidazole taken for rosacea on face every night. Past drug included BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6204)), dose 1 via an unspecified route of administration, administered in upper right arm on 18Mar2021 12:00 as a single dose for COVID-19 immunization. The patient had no prior vaccinations. A large lump or bubble came upon the patient's neck on the right side on 17Apr2021. She went to the emergency room. It lasted 2min but she was afraid it will come bad again and possibly burst, she was terrified. No treatment was given. She was afraid she would die. She knew this event happened because of vaccine, she had no issues with her heart or other things. She thought she might die that night if it ever happened again, it might burst, she guessed that would kill her. Relevant Tests include CAT scan and other (unspecified) on 19Apr2021 with result they found no blockage from the cat scan. The patient asked if the product really needs to be frozen. Those weren't frozen. While she was waiting in line, she had looked and said that those weren't frozen, they were just taken out, and the facility didn't have freezers. She wondered how they are doing it and were the vaccines still good if it was hot. The outcome of large lump or bubble on neck was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Blood pressure measurement, Body temperature, Computerised tomogram, Dizziness
Clinical narrative: blood pressure spiked 165/115; 13 hour later could not move lower extremity without stabbing pains all over; Heart palpitations; Fever for 3-4 days of 103; about 9 days later noticed dizziness starting; Vestibular vertigo diagnosed, been for physical therapy; Other vaccine same date vaccine date 16Jan2021; Other vaccine same date vaccine date 16Jan2021; 10 weeks still unable to drive or work; This is a spontaneous report from a contactable healthcare professional (the patient). A 60-year-old non-pregnant female patient received, BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL3246) dose 1 intramuscular, administered in left arm on 16Jan2021 12:00 as a single dose, and dose 2 via an unspecified route of administration, administered in left arm on 16Jan2021 (Lot Number: EN5318) as a single dose for COVID-19 immunization. Medical history included Arthritis, hip replacement, pre diabetes. Concomitant medications taken within two weeks included Vitamin A, B12, C, D, One a day vitamin, esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM]) and fish oil. The patient took no other vaccines within 4 weeks. The patient did not have COVID-19 prior to vaccination. It was unknown if the patient was tested for COVID-19 after vaccination.Within 30 minutes of vaccination left arm ran temperature. 13 hours later, the patient could not move lower extremity without stabbing pains all over which lasted 10 hours, blood pressure spiked to 165/115. She had heart palpitations, fever for 3-4 days of 103. This cleared up, about 9 days later she noticed dizziness starting. She contacted her doctor 4 days later. Vestibular vertigo diagnosed, she went for physical therapy, chiropractic, ultra sounds, Cat scans, MRI with/without contrast, VNG, 10 weeks still unable to drive or work. It had been over 70 days. The adverse event started on 06Feb2021 at 12:30. It resulted in a doctor or other healthcare professional office/clinic visit. Treatment was being given. The outcome of vestibular vertigo, could not move lower extremity without stabbing pains all over, blood pressure spiked, heart palpitations, fever, dizziness, unable to drive or work was not recovered  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on plausible dose- event relationship post-vaccination  and no alternate explanation the causal role of BNT162B2 vaccine cannot be excluded for the reported events  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Loss of personal independence in daily activities, Magnetic resonance imaging, Nystagmus, Off label use
Clinical narrative: blood pressure spiked 165/115; 13 hour later could not move lower extremity without stabbing pains all over; Heart palpitations; Fever for 3-4 days of 103; about 9 days later noticed dizziness starting; Vestibular vertigo diagnosed, been for physical therapy; Other vaccine same date vaccine date 16Jan2021; Other vaccine same date vaccine date 16Jan2021; 10 weeks still unable to drive or work; This is a spontaneous report from a contactable healthcare professional (the patient). A 60-year-old non-pregnant female patient received, BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL3246) dose 1 intramuscular, administered in left arm on 16Jan2021 12:00 as a single dose, and dose 2 via an unspecified route of administration, administered in left arm on 16Jan2021 (Lot Number: EN5318) as a single dose for COVID-19 immunization. Medical history included Arthritis, hip replacement, pre diabetes. Concomitant medications taken within two weeks included Vitamin A, B12, C, D, One a day vitamin, esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM]) and fish oil. The patient took no other vaccines within 4 weeks. The patient did not have COVID-19 prior to vaccination. It was unknown if the patient was tested for COVID-19 after vaccination.Within 30 minutes of vaccination left arm ran temperature. 13 hours later, the patient could not move lower extremity without stabbing pains all over which lasted 10 hours, blood pressure spiked to 165/115. She had heart palpitations, fever for 3-4 days of 103. This cleared up, about 9 days later she noticed dizziness starting. She contacted her doctor 4 days later. Vestibular vertigo diagnosed, she went for physical therapy, chiropractic, ultra sounds, Cat scans, MRI with/without contrast, VNG, 10 weeks still unable to drive or work. It had been over 70 days. The adverse event started on 06Feb2021 at 12:30. It resulted in a doctor or other healthcare professional office/clinic visit. Treatment was being given. The outcome of vestibular vertigo, could not move lower extremity without stabbing pains all over, blood pressure spiked, heart palpitations, fever, dizziness, unable to drive or work was not recovered  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on plausible dose- event relationship post-vaccination  and no alternate explanation the causal role of BNT162B2 vaccine cannot be excluded for the reported events  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Sex: F
Vaccine: COVID19
Symptoms: Pain, Palpitations, Pyrexia, Ultrasound scan, Vertigo
Clinical narrative: blood pressure spiked 165/115; 13 hour later could not move lower extremity without stabbing pains all over; Heart palpitations; Fever for 3-4 days of 103; about 9 days later noticed dizziness starting; Vestibular vertigo diagnosed, been for physical therapy; Other vaccine same date vaccine date 16Jan2021; Other vaccine same date vaccine date 16Jan2021; 10 weeks still unable to drive or work; This is a spontaneous report from a contactable healthcare professional (the patient). A 60-year-old non-pregnant female patient received, BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL3246) dose 1 intramuscular, administered in left arm on 16Jan2021 12:00 as a single dose, and dose 2 via an unspecified route of administration, administered in left arm on 16Jan2021 (Lot Number: EN5318) as a single dose for COVID-19 immunization. Medical history included Arthritis, hip replacement, pre diabetes. Concomitant medications taken within two weeks included Vitamin A, B12, C, D, One a day vitamin, esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM]) and fish oil. The patient took no other vaccines within 4 weeks. The patient did not have COVID-19 prior to vaccination. It was unknown if the patient was tested for COVID-19 after vaccination.Within 30 minutes of vaccination left arm ran temperature. 13 hours later, the patient could not move lower extremity without stabbing pains all over which lasted 10 hours, blood pressure spiked to 165/115. She had heart palpitations, fever for 3-4 days of 103. This cleared up, about 9 days later she noticed dizziness starting. She contacted her doctor 4 days later. Vestibular vertigo diagnosed, she went for physical therapy, chiropractic, ultra sounds, Cat scans, MRI with/without contrast, VNG, 10 weeks still unable to drive or work. It had been over 70 days. The adverse event started on 06Feb2021 at 12:30. It resulted in a doctor or other healthcare professional office/clinic visit. Treatment was being given. The outcome of vestibular vertigo, could not move lower extremity without stabbing pains all over, blood pressure spiked, heart palpitations, fever, dizziness, unable to drive or work was not recovered  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on plausible dose- event relationship post-vaccination  and no alternate explanation the causal role of BNT162B2 vaccine cannot be excluded for the reported events  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 49.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Back pain, Blood test, Joint stiffness, Magnetic resonance imaging neck, Magnetic resonance imaging thoracic
Clinical narrative: upper/ mild back pain; nerve issues down left arm; weakness in fingers/hands upon awakening each day; super tight left shoulder/neck side; super tight left shoulder/neck side; The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on (20Aug2021), this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient).  A 49-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EW0175, expiration date was not reported), via intramuscular route, in left arm, on 01May2021(at the age of 49-year-old), at dose 2, single for covid-19 immunization at Pharmacy/drug store. The patient had no medical history. There were no concomitant medications. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: ER8729, expiration date was not reported), via intramuscular route, in left arm, on 08Apr2021, (at the age of 49-year-old) at dose 1, single for covid-19 immunization. The patient experienced upper/ mild back pain (4 days after second dose) which started in lower back then moved to bra line, nerve issues down left arm, weakness in fingers/hands upon awakening each day, super tight left shoulder/neck side. The events onset date was on 05May2021 at 18:00. The seriousness criteria was persistent/significant disability/incapacity and the event required visit to intensive care unit with treatment of chiropractor, acupuncture, Herbal supplement. The patient underwent lab tests and procedures which included blood test, urine analysis, magnetic resonance imaging cervical/thoracic: normal on an unspecified date, COVID-19 CoV-2 RNA on 30Mar2021, COVID-19 on 05Jul2021; both tested negative. The outcome of the events was recovering (not yet fully recovered).
Age: 49.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Muscle tightness, Muscular weakness, Nerve injury, SARS-CoV-2 RNA, SARS-CoV-2 test
Clinical narrative: upper/ mild back pain; nerve issues down left arm; weakness in fingers/hands upon awakening each day; super tight left shoulder/neck side; super tight left shoulder/neck side; The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on (20Aug2021), this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient).  A 49-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EW0175, expiration date was not reported), via intramuscular route, in left arm, on 01May2021(at the age of 49-year-old), at dose 2, single for covid-19 immunization at Pharmacy/drug store. The patient had no medical history. There were no concomitant medications. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: ER8729, expiration date was not reported), via intramuscular route, in left arm, on 08Apr2021, (at the age of 49-year-old) at dose 1, single for covid-19 immunization. The patient experienced upper/ mild back pain (4 days after second dose) which started in lower back then moved to bra line, nerve issues down left arm, weakness in fingers/hands upon awakening each day, super tight left shoulder/neck side. The events onset date was on 05May2021 at 18:00. The seriousness criteria was persistent/significant disability/incapacity and the event required visit to intensive care unit with treatment of chiropractor, acupuncture, Herbal supplement. The patient underwent lab tests and procedures which included blood test, urine analysis, magnetic resonance imaging cervical/thoracic: normal on an unspecified date, COVID-19 CoV-2 RNA on 30Mar2021, COVID-19 on 05Jul2021; both tested negative. The outcome of the events was recovering (not yet fully recovered).
Age: 49.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Urine analysis
Clinical narrative: upper/ mild back pain; nerve issues down left arm; weakness in fingers/hands upon awakening each day; super tight left shoulder/neck side; super tight left shoulder/neck side; The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on (20Aug2021), this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient).  A 49-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EW0175, expiration date was not reported), via intramuscular route, in left arm, on 01May2021(at the age of 49-year-old), at dose 2, single for covid-19 immunization at Pharmacy/drug store. The patient had no medical history. There were no concomitant medications. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: ER8729, expiration date was not reported), via intramuscular route, in left arm, on 08Apr2021, (at the age of 49-year-old) at dose 1, single for covid-19 immunization. The patient experienced upper/ mild back pain (4 days after second dose) which started in lower back then moved to bra line, nerve issues down left arm, weakness in fingers/hands upon awakening each day, super tight left shoulder/neck side. The events onset date was on 05May2021 at 18:00. The seriousness criteria was persistent/significant disability/incapacity and the event required visit to intensive care unit with treatment of chiropractor, acupuncture, Herbal supplement. The patient underwent lab tests and procedures which included blood test, urine analysis, magnetic resonance imaging cervical/thoracic: normal on an unspecified date, COVID-19 CoV-2 RNA on 30Mar2021, COVID-19 on 05Jul2021; both tested negative. The outcome of the events was recovering (not yet fully recovered).
Age: 49.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Back pain, Blood test, Lymphadenopathy, Magnetic resonance imaging
Clinical narrative: upper/ mild back pain; nerve issues down left arm; weakness in fingers/hands upon awakening each day; super tight left shoulder/neck side; super tight left shoulder/neck side; The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on (20Aug2021), this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient).  A 49-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EW0175, expiration date was not reported), via intramuscular route, in left arm, on 01May2021(at the age of 49-year-old), at dose 2, single for covid-19 immunization at Pharmacy/drug store. The patient had no medical history. There were no concomitant medications. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: ER8729, expiration date was not reported), via intramuscular route, in left arm, on 08Apr2021, (at the age of 49-year-old) at dose 1, single for covid-19 immunization. The patient experienced upper/ mild back pain (4 days after second dose) which started in lower back then moved to bra line, nerve issues down left arm, weakness in fingers/hands upon awakening each day, super tight left shoulder/neck side. The events onset date was on 05May2021 at 18:00. The seriousness criteria was persistent/significant disability/incapacity and the event required visit to intensive care unit with treatment of chiropractor, acupuncture, Herbal supplement. The patient underwent lab tests and procedures which included blood test, urine analysis, magnetic resonance imaging cervical/thoracic: normal on an unspecified date, COVID-19 CoV-2 RNA on 30Mar2021, COVID-19 on 05Jul2021; both tested negative. The outcome of the events was recovering (not yet fully recovered).
Age: 49.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Menstruation irregular, Neck pain, Neurological symptom, Night sweats, Pain
Clinical narrative: upper/ mild back pain; nerve issues down left arm; weakness in fingers/hands upon awakening each day; super tight left shoulder/neck side; super tight left shoulder/neck side; The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on (20Aug2021), this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient).  A 49-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EW0175, expiration date was not reported), via intramuscular route, in left arm, on 01May2021(at the age of 49-year-old), at dose 2, single for covid-19 immunization at Pharmacy/drug store. The patient had no medical history. There were no concomitant medications. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: ER8729, expiration date was not reported), via intramuscular route, in left arm, on 08Apr2021, (at the age of 49-year-old) at dose 1, single for covid-19 immunization. The patient experienced upper/ mild back pain (4 days after second dose) which started in lower back then moved to bra line, nerve issues down left arm, weakness in fingers/hands upon awakening each day, super tight left shoulder/neck side. The events onset date was on 05May2021 at 18:00. The seriousness criteria was persistent/significant disability/incapacity and the event required visit to intensive care unit with treatment of chiropractor, acupuncture, Herbal supplement. The patient underwent lab tests and procedures which included blood test, urine analysis, magnetic resonance imaging cervical/thoracic: normal on an unspecified date, COVID-19 CoV-2 RNA on 30Mar2021, COVID-19 on 05Jul2021; both tested negative. The outcome of the events was recovering (not yet fully recovered).
Age: 49.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: X-ray
Clinical narrative: upper/ mild back pain; nerve issues down left arm; weakness in fingers/hands upon awakening each day; super tight left shoulder/neck side; super tight left shoulder/neck side; The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on (20Aug2021), this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient).  A 49-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EW0175, expiration date was not reported), via intramuscular route, in left arm, on 01May2021(at the age of 49-year-old), at dose 2, single for covid-19 immunization at Pharmacy/drug store. The patient had no medical history. There were no concomitant medications. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: ER8729, expiration date was not reported), via intramuscular route, in left arm, on 08Apr2021, (at the age of 49-year-old) at dose 1, single for covid-19 immunization. The patient experienced upper/ mild back pain (4 days after second dose) which started in lower back then moved to bra line, nerve issues down left arm, weakness in fingers/hands upon awakening each day, super tight left shoulder/neck side. The events onset date was on 05May2021 at 18:00. The seriousness criteria was persistent/significant disability/incapacity and the event required visit to intensive care unit with treatment of chiropractor, acupuncture, Herbal supplement. The patient underwent lab tests and procedures which included blood test, urine analysis, magnetic resonance imaging cervical/thoracic: normal on an unspecified date, COVID-19 CoV-2 RNA on 30Mar2021, COVID-19 on 05Jul2021; both tested negative. The outcome of the events was recovering (not yet fully recovered).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension, SARS-CoV-2 test
Clinical narrative: High blood pressure (159/100) starting a week after vaccination and not reducing despite medication; This is a spontaneous report from a non-contactable consumer (patient). A non-pregnant 48-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 21Apr2021 at 16:30 (Batch/Lot number was not reported) at the age of 48 years, as DOSE 2, SINGLE for covid-19 immunization.  Medical history included High Blood pressure (but controlled by medication). The patient had no known allergies to medication, food, etc. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included benazepril. The patient did not receive any other vaccines within four weeks prior to the vaccination.  Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 30Mar2021 for COVID-19 immunization. It was reported that the patient experienced high blood pressure (159/100) starting a week after vaccination and not reducing despite medication on 01May2021.  The patient had lab tests which included blood pressure measurement: 159/100 on 01May2021, sars-cov-2 test: negative on 07Apr2021.  The patient did not receive any treatment for the event. The clinical outcome of the event high blood pressure was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: DTP
Symptoms: Haemolytic anaemia, Immune thrombocytopenia, Petechiae, Shock
Clinical narrative: ITP; Petechia all over the body; hemolytic anemia; shock; Initial information was received on 12-Aug-2021 regarding an unsolicited valid serious case from a consumer/non-healthcare professional (hcp).  The case is linked to 2021SA274876.  This case involves an unknown age male patient who experienced serious ITP (immune thrombocytopenia), petechia all over the body (petechiae), hemolytic anemia and dying in shock (shock) after receiving DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, (around the time of birth) the patient received dose of suspect DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE produced by unknown manufacturer (lot number and expiry date were not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious ITP (immune thrombocytopenia), petechia all over the body (petechiae), hemolytic anemia and dying in shock (shock) (unknown latency) following the administration of DIPHTHERIA and TETANUS AND NOS PERTUSSIS VACCINE. These events were assessed as medically significant.  It was reported that he was a test kid for Sandoglobulin.  Details of laboratory data was not reported.  It was not reported if the patient received any corrective treatment for the events.  At time of reporting, patient is 38 years old, the outcome was Unknown for all the events.; Sender's Comments: This case involves an unknown age male patient who had immune thrombocytopenia, petechiae, hemolytic anemia and shock after vaccination with DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE (unknown manufacturer). The time to onset is unknown. Additional information regarding medical history, condition at the time of vaccination and lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, role of the vaccine cannot be assessed.
Age: 0.67
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product preparation error
Clinical narrative: Hib portion of PENTACEL was reconstituted with sterile water and not the DTaP-IPV portion/ no AE; Initial information was received on 23-Aug-2021 regarding an unsolicited valid non-serious case from other healthcare professional, consumer/non-healthcare professional and physician via call center via Global Medical Information (Reference number- 00632994).  This case involves a 8-month-old male patient who received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] which HIB portion was reconstituted with sterile water and not the DTaP-IPV portion (Product preparation error).  The patient's medical history, past medical treatments, vaccinations and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) for prophylactic vaccination.  On 20-Aug-2021, the patient received a second dose of 0.5 mL of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (solution, lot number: UJ389AAA and expiry date: 12-Oct-2021) via an intramuscular route in the left vastus lateralis for prophylactic vaccination.  It was an actual medication error case due to wrong solution used in drug reconstitution (latency: same day).  It was reported "Caller asking if the whole dose is invalid. Caller also asks how soon PENTACEL can be re-administered; caller referred to healthcare provider. Caller also referred to PENTACEL Reconstitution video"  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 10.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: patient inadvertently received DAPTACEL instead of ADACEL/ no AE; 10-year-old patient received DAPTACEL/ no AE; Initial information was received on 23-Aug-2021 regarding an unsolicited valid non-serious case from other healthcare professional and consumer/ non healthcare professional via call center via Medical Information (Reference number- 00736487).  This case is linked to case 2021SA281773(CLUSTER).  This case involves a 10-year-old female patient who received DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (wrong product administered and Product administered to patient of inappropriate age).  The patient's past medical history, medical treatments, vaccinations, concomitant medication and family history were not provided.  On 30-Jul-2021, the patient received a first dose of 0.5 mL of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot number: U6900AA and expiry date: 18-Nov-2022) via an intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration (latency same day).  It was reported, "2 patients inadvertently received DAPTACEL instead of ADACEL. Caller with question on whether a dose of ADACEL now needs to be administered. Caller also with question on when the patients will be due for a booster dose of ADACEL".  At the time of reporting, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of Menactra was given with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health professional via Global Medical Information (Reference number- 00737725) and transmitted to Sanofi on 24-Aug-2021.  This case involves an unknown age male patient who vaccinated with a 0.5mL (total) dose of an expired MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (solution for injection) [lot U6690AA and expiry date 23-Aug-2021] via intramuscular route at an unknown administration site on 24-Aug-2021 for prophylactic vaccination (expired product administered).  Medical history, medical treatment, past vaccination, concomitant medication and family history were not provided.  It was a case of actual medication error due to expired vaccine used (latency was on same day).  At the time of report, no adverse event reported.  Reporter would like to know what is to be done in such a scenario.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient was given Menactra dose on 23JUL2021 and again today, 24AUG2021 with no reported adverse event; Initial information received on 24-Aug-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an 18 years old female patient who received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] on 23-Jul-2021 and again on 24-Aug-2021.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE (HPV VACCINE) for Immunisation.  On 23-Jul-2021, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported via unknown route in unknown administration site for prophylactic vaccination.   On 24-Aug-2021 again received 0.5 mL dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE with lot U7140AA, expiry date- 04-Nov-2022 via intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of actual medication error due to extra dose administered.  At time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Age: 7.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, Medication error, Product administered to patient of inappropriate age
Clinical narrative: The patient was administered an expired vaccine with no reported adverse event; A 7 year old patient was vaccinated with DAPTACEL, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via consumer/non-health care professional via Medical Information (Reference number- 00739783).  This case involves a 7-year-old male patient who was administered an expired DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] [expired product administered and product administered to patient of inappropriate age].  Medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had no concomitant medication.  On an unknown date, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot C5621AA, strength: 0.5 mL, expiry: 23-May-2021) via intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of an actual medication error due to Expired vaccine used and Inappropriate age at vaccine administration (latency same day).  It was reported, "Medical office manager calling back to provide additional details surrounding an expired vaccine that was administered; she stated that the product was expired and given to a patient from the certified medical assistant (CMA). Pasteur adverse event (AE) Reporting Refunds/Credits will not be issued due to adverse events."  No adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling, Lymphadenopathy, Peripheral swelling
Clinical narrative: Swelling in left arm and armpit; Swelling in left arm and armpit; Pain at the injection site; This spontaneous case was received on 24-Aug-2021 from a pharmacist via regulatory authority (reference number: SEQW21-01687) and concerned a 51-year-old, female patient.  The patient had no relevant concurrent conditions. The patient's historical vaccine included Shingrix (varicella zoster vaccine rgE (CHO)) in 2020 after which the patient experienced swelling in left arm and armpit along with pain at the injection site. When the patient got anything in her right arm, she had no symptoms. The patient was not taking any concomitant medications.  On 22-Aug-2021, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine; dose: 0.5 ml, anatomical location: left deltoid and route of administration: not reported) as influenza prophylaxis. The batch number reported was P10035097 (Seqirus batch number closest match: P100350397) and expiry date was 21-Jun-2022.  On 23-Aug-2021, one day after receiving Afluria Quadrivalent, the patient experienced swelling in left arm and armpit. The patient also experienced pain at the injection site. The patient was treated with Advil (Ibuprofen) and ice.  The outcome of all events was unknown.  The reporter did not provide a causality assessment.  The reporter assessed the events as non-serious.  Company comment: A 51-year-old patient was vaccinated with Afluria Quadrivalent. One day after receiving Afluria Quadrivalent, the patient experienced vaccination site pain, lymphadenopathy and peripheral swelling (reported as swelling in left arm and armpit). Causal role of the suspect vaccine is assessed as possibly related for all events.; Sender's Comments: A 51-year-old patient was vaccinated with Afluria Quadrivalent. One day after receiving Afluria Quadrivalent, the patient experienced vaccination site pain, lymphadenopathy and peripheral swelling (reported as swelling in left arm and armpit). Causal role of the suspect vaccine is assessed as possibly related for all events.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: pt fully vaccinated and tested positive for covid 8/27/2021. hospitalized 8/30/2021 - received tocilizumb and remdesivir, dexamethasone, Oxygen
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Autoimmune thyroiditis, Blood thyroid stimulating hormone abnormal, Hypothyroidism
Clinical narrative: hypothyroidism, positive for Hashimotos autoimmune
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Seizure day after vaccine was given, which is not normal.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Chest pain, Cough, Dyspnoea
Clinical narrative: Chest pain, hacking cough, shortness of breath, hospitalised three times
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, SARS-CoV-2 test
Clinical narrative: Chest pain, hacking cough, shortness of breath, hospitalised three times
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal abscess, Blood test, Colonoscopy, Computerised tomogram, Endoscopy
Clinical narrative: Abdominal abscess, inflammation of ileum
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Enteritis, Ultrasound scan
Clinical narrative: Abdominal abscess, inflammation of ileum
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: After receiving his second injection, the patient developed a pruritic dermatitis that has not gone away. He has been to the ER twice for this complaint. No dysphagia or dyspnea. Patient very upset symptoms are persistent.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Rash, Urticaria
Clinical narrative: rash; redness; huge welp on my arm; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash, erythema and welts. On an unknown date, the outcome of the rash, erythema and welts were recovered/resolved.   It was unknown if the reporter considered the rash, erythema and welts to be related to Shingrix.  Additional details provided were as follows: Age at vaccination was not reported. The case was reported by patient himself/herself. The patient received a dose of Shingrix vaccine and experienced rash, redness and huge welp on the arm and all the symptoms lasted for several days. The patient would be receiving 2nd dose in January 2022. Follow-up would not be possible as no contact details available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: I got it. Mild case; This case was reported by a consumer and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the consumer for herself/himself. The age at vaccination was not reported. The patient stated that, bingo, he/she got shingles after the Shingles shot.  The patent said it was mild case but still got it. The patient thought he/she only did 1 of the 2 Shingles shots but still got shingles.
Age: 50.0
Sex: U
Vaccine: VARZOS
Symptoms: Back pain, Herpes zoster, Musculoskeletal chest pain, Pain, Swelling
Clinical narrative: Shingles was all internal (no rash/blisters).; Worst pain I've ever experienced! pain turned into stabbing; nerve band was so terribly swollen; This case was reported by a consumer via interactive digital media  and described the occurrence of shingles in a 50-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 60 days after receiving Shingles vaccine, the patient experienced shingles, pain and local swelling. On an unknown date, the outcome of the shingles and local swelling were unknown and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the shingles, pain and local swelling to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the consumer for himself/herself. The patient stated that, he/she took a medication known to increase the risk, but despite appeals based on manufacturer recommendation and medical necessity, insurance still refused to cover the vaccine until the patient turned 50 year old. The patient got first dose few days after he/she hit 50 years, and 60 days later patent had a shingles. The patient experienced worst pain, it felt like someone was ripping his/her rib cage out the body with their bare hand, as it crept around from front to back, the pain was turned into stabbing. Seven weeks later, the patient still had pain but its much less severe. The patient stated that, it was all internal (no rash or blister), the nerve band was so terribly swollen it stuck out from patient's ribs. The patient would receive second dose tomorrow on 23rd August 2021 and hope it never happens again.