chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: developed redness of left arm at injection site where given meningococcal and HPV vaccines on day of inoculation. next day was swollen and red with itching. no pain. swelling progressed and increased over subsequent two days. had not rec'd either of these vaccines before. rec'd tdap in contralateral arm on same day, but no redness or swelling or discomfort on that side.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Hypoaesthesia, Muscular weakness, Nausea
Clinical narrative: Fierce head fever, tingling in lips, face, and extremities, muscle weakness, slight nausea, debilitating fatigue, numb impassiveness. Treatment: Rest, involving occasional naps; Acetaminophen. Outcome: Symptoms began to appreciably abate Thursday night, the 5th. As of the night of the 6th, the fatigue and muscle weakness, and impassiveness are what remain, but are abating slowly.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Paraesthesia oral, Pyrexia
Clinical narrative: Fierce head fever, tingling in lips, face, and extremities, muscle weakness, slight nausea, debilitating fatigue, numb impassiveness. Treatment: Rest, involving occasional naps; Acetaminophen. Outcome: Symptoms began to appreciably abate Thursday night, the 5th. As of the night of the 6th, the fatigue and muscle weakness, and impassiveness are what remain, but are abating slowly.
Age: 46.0
Sex: F
Vaccine: UNK
Symptoms: Burning sensation, Rash erythematous, Skin exfoliation, Swelling
Clinical narrative: Extreme burning on left side chest and breast it became very enlarged , burning continued left side clavicle. Then burning redness rash move right side Che?s not as severe as left , left side of chest began peeling.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Vaccination complication
Clinical narrative: Itching, redness, warm to touch, slightly raised at injection site approximately 5" x 5".  "Covid arm"
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccine positive rechallenge
Clinical narrative: Itching, redness, warm to touch, slightly raised at injection site approximately 5" x 5".  "Covid arm"
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Cardiac discomfort, Chest discomfort, Chest pain
Clinical narrative: Chest and/or heart pain and discomfort.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Acupuncture, Allergy test negative, Alopecia, Blood test normal, Rash
Clinical narrative: Exactly two weeks after my second shot, I broke out in horrendous hives. Nothing else in my life changed. The hives have been persistent for 3 months despite multiple steroid rounds, allergy testing, and months of acupuncture. No history of hives for me and my family, though I did get a brief outbreak of hives after taking penicillin at age 2.  The hives are constant, daily, and cover all parts of my body.   I had an alopecia spot appear on my scalp at a similar time.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Streptococcus test negative, Urticaria
Clinical narrative: Exactly two weeks after my second shot, I broke out in horrendous hives. Nothing else in my life changed. The hives have been persistent for 3 months despite multiple steroid rounds, allergy testing, and months of acupuncture. No history of hives for me and my family, though I did get a brief outbreak of hives after taking penicillin at age 2.  The hives are constant, daily, and cover all parts of my body.   I had an alopecia spot appear on my scalp at a similar time.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Visual impairment
Clinical narrative: I have had brain fog and get dizzy and light headed constantly since the injection. I feel out of it and my vision has been off.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Echocardiogram normal, Myocarditis, Troponin increased
Clinical narrative: Myocarditis - chest pain with significantly elevated troponin.
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: positive covid test post vax
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: positive covid post vaccination
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Headache, Hypoaesthesia
Clinical narrative: After receiving the Jannsen shot around 8:50 am at the morning on Tuesday August 3rd 2021, later within an hour I had a mild pain at my forehead. In addition, I had fatigue, muscle pain, and low blood pressure, and weakness for five days, which slightly got better after the first two days following vaccination day. However, my forehead pain first disappeared from left forehead completely to right forehead. And Today, by the time of writing this report in August 7 early morning I feel less pain and more numbness in my right forehead. However, after morning, now around 11 am, the numbness distributed to my whole right side of my head, and now dizziness also appeared. I searched for Jannsen Vaccine side effects, since I did not see similar symptoms, I felt to report this. I do not know what will happen or how the symptoms will change,  and look forward to hearing from you.   Thanks
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Hypotension, Myalgia
Clinical narrative: After receiving the Jannsen shot around 8:50 am at the morning on Tuesday August 3rd 2021, later within an hour I had a mild pain at my forehead. In addition, I had fatigue, muscle pain, and low blood pressure, and weakness for five days, which slightly got better after the first two days following vaccination day. However, my forehead pain first disappeared from left forehead completely to right forehead. And Today, by the time of writing this report in August 7 early morning I feel less pain and more numbness in my right forehead. However, after morning, now around 11 am, the numbness distributed to my whole right side of my head, and now dizziness also appeared. I searched for Jannsen Vaccine side effects, since I did not see similar symptoms, I felt to report this. I do not know what will happen or how the symptoms will change,  and look forward to hearing from you.   Thanks
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Severe chest pain; This is a spontaneous report from a contactable consumer (patient). A 14-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EW0198), dose 2 via an unspecified route of administration, administered in Arm Left on 17Jul2021 at 15:30 (at the age of 14-years-old) as a DOSE 2, SINGLE for covid-19 immunisation at Pharmacy or perfumery. The patient medical history was none. The patient's concomitant medications were not reported. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EW0178), dose 1 via an unspecified route of administration, administered in Arm Left on 26Jun2021 at 02:30 PM (at the age of 14-years-old) as a DOSE 1, SINGLE for covid-19 immunisation. Patient had no known allergies. Patient did not receive any other vaccines within 4 weeks PRIOR to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. The patient experienced severe chest pain on 18Jul2021 at 05:00. No treatment was received for the event. device timestamp was reported as, 19Jul2021. Outcome of the event was recovered in 2021.  Follow-Up (06Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Menstrual disorder, SARS-CoV-2 test
Clinical narrative: After second dose, 24 hours later I could not feel my legs.; I got my menstrual cycle for every two weeks for two months following the second dose  vaccine.; This is a spontaneous report from a contactable consumer (patient). A female non pregnant patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: Solution for injection, Lot number: Ew0161) via an unspecified route of administration in left arm on 11Apr2021 at 13:00 as single dose for COVID-19 immunization. Medical history included stroke (cerebrovascular accident) at 39 years old and eclampsia at second birth, allergies to sulfa and singulair. Concomitant medication(s) (within 2 weeks of vaccination) included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]). Previously patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: Solution for injection, Lot number: Ep7534) via an unspecified route of administration in left arm on 21Mar2021 15:00 as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has been tested for COVID-19. The patient experienced after second dose, 24 hours later i could not feel my legs, i got my menstrual cycle for every two weeks for two months following the second dose vaccine on 12Apr2021 14:00. The patient reported that, she got her menstrual cycle for every two weeks for two months following the second dose vaccine. Also, after second dose, 24 hours later she could not felt her legs. The patient underwent lab tests and procedures which included sars-cov-2 test (PCR): negative on an unspecified date. The patient did not receive any treatment for the events. Device Date: 24Jul2021. The outcome of the events was recovered on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash, Swelling
Clinical narrative: Swollen neck; Rash on neck; Red neck; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the left arm on 09Apr2021 at 12:30 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included hashimoto's disease and penicillin allergy. The patient did not receive any other medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021 at 03:00, the patient experienced rash on neck and swollen and red neck. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of rash on neck and swollen and red neck and included treatment with Benadryl at the time of event. The clinical outcome of the events rash on neck and swollen and red neck was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: re-administering the 1st V ARlV AX dose on unknown, future date with, per Physician's order; had missed the 2nd V ARlV AX dose; No additional AE; This spontaneous report was received from a pharmacist refers to a currently 33 years old female patient with hiv test positive. The patient's historical conditions and concomitant therapies were not provided.      In 2018, the patient was vaccinated with her first dose of varicella virus vaccine live (oka/merck)(VARIVAX), subcutaneously (dose and vaccination site were not provided), for prophylaxis.  On an unknown date, the patient had missed the 2nd  varicella virus vaccine live (oka/merck)(VARIVAX), dose and, at call time, had yet to be administered this 2nd  varicella virus vaccine live (oka/merck)(VARIVAX), dose. Pharmacist had received an, as of yet, un-dispensed, new Physician prescription order specific for re-administering the 1st  varicella virus vaccine live (oka/merck)(VARIVAX), dose on unknown, future date with, per Physician's order, the 2nd  varicella virus vaccine live (oka/merck)(VARIVAX), dose scheduled for '90 days' after the 1st  varicella virus vaccine live (oka/merck)(VARIVAX) dose.
Sex: M
Vaccine: HIBV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: planning to administer PEDV AX HIB to a 73 year old male patient; planning to administer PEDV AX HIB to a 73 year old male patient; no adverse event; This spontaneous report was received from a registered nurse and refers to a 73 year old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not provided.  The reporter was planning to administered haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) (dose, route, vaccination site were not provided), for prophylaxis to the patient.
Sex: U
Vaccine: HEPA
Symptoms: Product temperature excursion issue
Clinical narrative: No additional AE/PQC reported.; Caller reported vaccine administered after temperature excursion.; This spontaneous report has been received from a nurse and a consumer referring to an unspecified age and gender patient. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions, or allergies.  On 13-JUL-2021, the patient was vaccinated with a 0.5 milliliters (mL) intramuscular dose of Hepatitis A Vaccine, Inactivated (VAQTA) for prophylaxis (lot number T013205, was verified to be valid for syringe formulation; the expiration date was reported as 12-MAR-2021, but upon internal verification was established as 03-DEC-2021) (dose number, vaccination scheme frequency, and anatomical site of administration were not provided). The involved vaccine was exposed to a temperature excursion of 9.6 degrees Celsius during a time frame of 11 minutes, which was detected by a data logger (product storage error). No previous temperature excursions were reported. No additional adverse events were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013205; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; a dose of VAQTA expired on 6/4/2021 and was administered on 7/19/2021; This spontaneous report has been received from a physician referring to a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not provided.  On 19-JUL-2021, the patient was vaccinated with an expired dose of Hepatitis A vaccine, inactivated (VAQTA) 0.5 milliliter (mL), once, (route of administration, anatomical site of vaccination and vaccination scheme were not reported, lot number T008698 has been verified to be a valid lot number, expiration date reported and established as 04-JUN-2021) (expired product administered) as prophylaxis. It was reported that the vaccine had never had a temperature excursion. No additional adverse events (AEs) were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T008698; expirationdate: 04-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Age: 70.0
Sex: U
Vaccine: PPV, PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: On 24-AUG-2009 pneumococcal vaccine, polyvalent (23-valent) and pneumococcal vaccine (unspecified)/ on 06-JAN-2016 pneumococcal vaccine conj 13v (crm197) and 22-SEP-2016 pneumococcal vaccine, polyvalent (23-valent); This spontaneous report was received from a nurse practitioner, referring to a 70-year-old patient, via a immunization record from a case in litigation for zoster vaccine live (ZOSTAVAX) (Marrs# 1801USA001762). The patient's medical history, previous drug reactions or allergies and concomitant medications were not reported.    On 24-AUG-2009, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) for prophylaxis and with pneumococcal vaccine (unspecified) (strengths, doses, routes of administrations, anatomical locations, lots numbers, and expirations dates were not reported). On 06-JAN-2016, the patient was vaccinated with pneumococcal vaccine conj 13v (crm197) and on 22-SEP-2016, was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (strengths, doses, routes of administrations, anatomical locations, lots numbers, and expirations dates were not reported)(inappropriate schedule of product administration).      This is one of two reports from the same patient.; Sender's Comments:  US-009507513-1801USA001762: US-009507513-2107USA008801:
Age: 65.0
Sex: F
Vaccine: PNC, PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: On 03-NOV-2015 PREVNAR and on 20-DEC-2015, was PNEUMOVAX./On 01-JUN-2016 revaccinated with PNEUMOVAX.; This spontaneous report was received from a physician referring to a 65-year-old female patient via a Medical Record from a case in litigation for zoster vaccine live (ZOSTAVAX) (Marrs# 2107USA007355). The patient's medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 03-NOV-2015, the patient was vaccinated with pneumococcal vaccine conj 7v (crm197) (PREVNAR) and on 20-DEC-2015, was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (strengths, doses, routes of administration, anatomical locations, lots numbers, and expirations dates were not reported). On 01-JUN-2016, the patient was revaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, frequency, indication, lot number, and expiration date were not reported) (inappropriate schedule of product administration).   This is one of two reports received from the same patient.; Sender's Comments:  US-009507513-1805USA005474:
Age: 17.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No additional adverse events reported.; not followed the recommended dosing intervals for GARDASIL 9; This spontaneous report was received from an office manager referring to a 17-year-old patient of unknown gender. The patient's pertinent medical history, concomitant therapies and drug allergy or reactions were not reported.     On 20-JAN-2021, the patient was vaccinated with the fist dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml (strength, route, lot # and expiration date were not reported) for prophylaxis. On 04-MAY-2021 (the second dose was noted as late on this date as recommended), the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml (strength, route, lot # and expiration date were not reported) for prophylaxis. On 27-JUL-2021 (the third dose was also noted as late on this date as recommended), the patient was in the office was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml (strength, route, lot # and expiration date were not reported) for prophylaxis that had not followed the recommended dosing intervals for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (inappropriate schedule of product administration). It was also reported that the interval from first dose to third dose was also past the 5 months as recommended. No other information was given. No additional adverse events was reported.
Sex: M
Vaccine: MMR
Symptoms: Product use in unapproved indication
Clinical narrative: a consumer received an MMR vaccine in hopes that if they contract COVID-19, he may possibly have an attenuated response to that disease based on a current plausible medical history.; Information has been received from a Doctor of Veterinary Medicine (V.M.D.), referring to himself, a male patient of unknown age. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  On an unknown date the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown)(strength, dose, frequency, route, lot# and expiration date were unknown) in hopes that if they contract coronavirus disease (COVID-19), he may possibly have an attenuated response to that disease based on a current plausible medical history (product use in unapproved indication).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This spontaneous report was received from a lawyer and a patient of unknown age and gender regarding a case in litigation on 29-JUL-2021. The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with a dose of Zoster Vaccine Live (ZOSTAVAX) (dose, lot #, expiration date, route of administration and anatomical location not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After receiving the Zoster Vaccine Live (ZOSTAVAX) the patient suffered herpes zoster. As a result of these symptoms, the patient was seen and treated by medical providers, and was still under their care. As a direct and proximate result of Zoster Vaccine Live (ZOSTAVAX) vaccine, patient's symptoms had resulted in physical limitations do not present prior to the vaccine, also mental and emotional distress due to resulting physical limitations and seriousness of her condition. Patient sustained severe and permanent personal injuries. Further, as a tragic consequence, patient suffered serious, progressive, permanent and incurable injuries as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Also, had suffered and incurred damages, including medical expenses, loss of accumulations, and other economic and non-economic damages. At the reporting time, the outcome of herpes zoster was considered as not recovered. The reporters considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: F
Vaccine: MMR
Symptoms: Vaccination complication
Clinical narrative: serious reaction to vaccine; This spontaneous report has been received from a registered nurse referring to a female patient of unknown age. No information was provided regarding the patient' medical history, concurrent conditions, drug and allergy history or concomitant medications.  On an unknown date in 1980, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (strength, dose, frequency, route of administration, lot# and expiration date) and sterile diluent for prophylaxis. On an unknown date in1980, the patient experienced a reaction (adverse reaction) and she was hospitalized due to the reaction. The reporter stated the details of the "serious reaction" were not reported by the patient and were unknown at this time.  No additional AE reported. It was unknown if any laboratory diagnostic or studies were performed. Moreover, the event was not considered a cancer event.  Therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) and sterile diluent were discontinued.  The outcome of adverse reaction was reported as recovered/resolved (exact date was not reported). The causal relationship between the event and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) and sterile diluent was not provided.  The reported considered the adverse reaction to be medically significant.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: Product temperature excursion issue
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse and refers to a 13-year-old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications. On  29-JUL-2021, the patient was vaccinated for prophylaxis with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot # T025370 with expiration date on 01-DEC-2022 (strength, dose number, anatomical location, route of administration, lot number and expiration date were not reported), that underwent a temperature excursion that was not called because a digital data logger, bellow 2°C (1.1°C) for 3 hours 9 minutes and 0 seconds, without previous temperature excursion. No adverse events were reported
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; Information has been received from a lawyer referring to a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, history condition and concomitant medication was not reported. On or about 27-AUG-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered herpes zoster. As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events herpes zoster was considered to be not recovered and causal relationship was assessed as related.    The lawyer considered the events herpes zoster to be disability.
Age: 67.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vasculitis
Clinical narrative: vasculitis; other zoster-related conditions; Information has been received from a lawyer as part of litigation and refers to a currenlty 74-years-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On or about 01-JAN-2015, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not reported)  for the long-term prevention of shingles and zoster-related conditions, by a healt professional in a physician's office. Subsequently, the patient was treated by a healthcare provider for the following injuries resulting from patient's use of zoster vaccine live (ZOSTAVAX): vasculitis and other zoster-related conditions. The outcome of the events was not repoted. The reporter considered vasculitis and other zoster-related condition to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: HIBV, PPV
Symptoms: Allergy to vaccine, Dizziness, Drug hypersensitivity, Headache, Injection site erythema
Clinical narrative: Pneumococcal conjugate on 26-JAN-2007, 06-NOV-2006, 08-AUG-2006 and 15-FEB-2006; Pneumococcal conjugate on 26-JAN-2007, 06-NOV-2006, 08-AUG-2006 and 15-FEB-2006; This spontaneous report was received via Pfizer from a consumer regarding herself a female patient of unknown age. No information was provided regarding the patient's medical history or concurrent conditions. The patient was allergic to amoxicillin, penicillin, sulfamethoxazole-trimethoprim, azithromycin and cefdinir. The patient's historical vaccine included: Hepatitis B Vaccine (Recombinant) (manufacturer unknown).  On 15-FEB-2006, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) for prophylaxis (strength, dose number, anatomical location, route of administration, lot number and expiration date were not reported) and haemophilus influenzae type b (Hib).  On 22-MAR-2006, the patient was vaccinated with Hepatitis B Vaccine (Recombinant) (manufacturer unknown), Diphtheria (+) Tetanus (+) Pertussis (DTaP), inactivated poliovirus vaccine (IPV).  On 24-MAY-2006, the patient was vaccinated with Hepatitis B Vaccine (Recombinant) (manufacturer unknown), Diphtheria (+) Tetanus (+) Pertussis (DTaP), haemophilus influenzae type b (Hib).  On 08-AUG-2006, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown), Diphtheria (+) Tetanus (+) Pertussis (DTaP), haemophilus influenzae type b (Hib), inactivated poliovirus vaccine (IPV).  On 06-NOV-2006, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown), influenza vaccine.  On 26-JAN-2007, the patient was vaccinated with Hepatitis A Vaccine, Inactivated (manufacturer unknown) for prophylaxis (strength, dose number, anatomical location, route of administration, lot number and expiration date were not reported) and with Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown).  The patient subsequently experienced allergy to vaccine, redness, soreness and swelling at the vaccination site, nausea, dizziness, headache, drug hypersensitivity and lactose intolerance on vaccination with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine  (GARDASIL), Hepatitis A Vaccine, Inactivated (manufacturer unknown), Hepatitis B Vaccine (Recombinant) (manufacturer unknown), Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown), Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown), Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), varicella virus vaccine live (Oka/Merck) (manufacturer unknown) (case # 2107USA008849) and overdose on vaccination with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) and varicella virus vaccine live (Oka/Merck) (manufacturer unknown) (case # 2108USA000378) and extra dose administered.; Sender's Comments:  US-PFIZER INC-2021644192: US-009507513-2107USA008849: US-009507513-2108USA000378:
Sex: F
Vaccine: HIBV, PPV
Symptoms: Injection site pain, Injection site swelling, Lactose intolerance, Nausea
Clinical narrative: Pneumococcal conjugate on 26-JAN-2007, 06-NOV-2006, 08-AUG-2006 and 15-FEB-2006; Pneumococcal conjugate on 26-JAN-2007, 06-NOV-2006, 08-AUG-2006 and 15-FEB-2006; This spontaneous report was received via Pfizer from a consumer regarding herself a female patient of unknown age. No information was provided regarding the patient's medical history or concurrent conditions. The patient was allergic to amoxicillin, penicillin, sulfamethoxazole-trimethoprim, azithromycin and cefdinir. The patient's historical vaccine included: Hepatitis B Vaccine (Recombinant) (manufacturer unknown).  On 15-FEB-2006, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) for prophylaxis (strength, dose number, anatomical location, route of administration, lot number and expiration date were not reported) and haemophilus influenzae type b (Hib).  On 22-MAR-2006, the patient was vaccinated with Hepatitis B Vaccine (Recombinant) (manufacturer unknown), Diphtheria (+) Tetanus (+) Pertussis (DTaP), inactivated poliovirus vaccine (IPV).  On 24-MAY-2006, the patient was vaccinated with Hepatitis B Vaccine (Recombinant) (manufacturer unknown), Diphtheria (+) Tetanus (+) Pertussis (DTaP), haemophilus influenzae type b (Hib).  On 08-AUG-2006, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown), Diphtheria (+) Tetanus (+) Pertussis (DTaP), haemophilus influenzae type b (Hib), inactivated poliovirus vaccine (IPV).  On 06-NOV-2006, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown), influenza vaccine.  On 26-JAN-2007, the patient was vaccinated with Hepatitis A Vaccine, Inactivated (manufacturer unknown) for prophylaxis (strength, dose number, anatomical location, route of administration, lot number and expiration date were not reported) and with Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown).  The patient subsequently experienced allergy to vaccine, redness, soreness and swelling at the vaccination site, nausea, dizziness, headache, drug hypersensitivity and lactose intolerance on vaccination with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine  (GARDASIL), Hepatitis A Vaccine, Inactivated (manufacturer unknown), Hepatitis B Vaccine (Recombinant) (manufacturer unknown), Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown), Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown), Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), varicella virus vaccine live (Oka/Merck) (manufacturer unknown) (case # 2107USA008849) and overdose on vaccination with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) and varicella virus vaccine live (Oka/Merck) (manufacturer unknown) (case # 2108USA000378) and extra dose administered.; Sender's Comments:  US-PFIZER INC-2021644192: US-009507513-2107USA008849: US-009507513-2108USA000378:
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Patient was administered an Expired PNEUMOVAX 23; This spontaneous report was received from a registered pharmacist and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 02-AUG-2021 at 14:00, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX) lot # S029542, expiration date 10-JUN-2021 (dose, route of administration and anatomical location were not provided) for prophylaxis (expired vaccine used). There was no additional adverse event reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.;  devicelotnumber: S029542; expirationdate: 10-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Varivax administered after temperature excursion; This spontaneous report was received from a registered nurse, concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, and previous drug reactions or allergies.  On 27-JUL-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX), at a dose of 0.5 milliliter (ml) (lot number T017685, which was verified to be a valid lot number, expiration date reported and upon internal validation established as 21-MAY-2022), as prophylaxis (frequency, route of administration, anatomical location and vaccination scheme were not reported) (product storage error). The administered vaccine experienced a temperature excursion of 5.9F during a time frame of 8 minutes, as recorded by data logger. There was not a previous temperature excursion. No additional adverse events were reported.
Sex: F
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No additional adverse event.; A 5-year-old patient inadvertently received a dose of Gardasil 9.; This spontaneous report was received from an office manager on behalf of a healthcare professional and refers to a 5-year-old female patient. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On 03-AUG-2021, the patient was inadvertently vaccinated at age of 5 years with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliter, lot # T025370 was confirmed to be valid, expiration date 01-DEC-2022, (route and site of administration were not reported) for prophylaxis (inappropriate age at vaccine administration). No additional adverse event was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T025370; expirationdate: 01-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Age: 65.0
Sex: F
Vaccine: PNC13, PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Pneumovax 23 was vaccinted on 16-JAN-2017 and Prevnar 13 was vaccinted on 07-NOV-2016; This spontaneous report has been received from a physician assistant (PA), via a Plaintiff from a case in litigation for zoster vaccine live (ZOSTAVAX) (MARRS # 2102USA006404), concerning a 65-year-old female patient. Information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.  On 07-NOV-2016, the patient was vaccinated with pneumococcal vaccine conj 13v (crm197) (PREVNAR 13), and on 16-JAN-2017 the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (both: dose, route, lot# and expiration date were not reported) for prophylaxis (inappropriate schedule of product administration).   This is one of two cases regarding the same patient.; Sender's Comments:  US-009507513-2102USA006404:
Age: 56.0
Sex: F
Vaccine: HEPA, HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Inappropriate age at vaccine administration; This spontaneous report has been received from a lawyer, via a Plaintiff  from a case in litigation for zoster vaccine live (ZOSTAVAX) (MARRS # 1807USA005466), concerning a 56-year-old female patient. Information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.  On 14-JAN-2000 and 13-DEC-2000, the patient was vaccinated with hepatitis A vaccine, inactivated (manufacturer unknown) (reported as hepatitis A pediatric) (dose, route, lot# and expiration date were not reported) in a clinic for prophylaxis (product administered to patient of inappropriate age).    This case was one of the three reports regarding the same patient.; Sender's Comments:  US-009507513-1807USA005466: US-009507513-2108USA001619:
Age: 56.0
Sex: F
Vaccine: HEPA, HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate age at vaccine administration; This spontaneous report has been received from a lawyer, via a Plaintiff  from a case in litigation for zoster vaccine live (ZOSTAVAX) (MARRS # 1807USA005466), concerning a 56-year-old female patient. Information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.  On 14-JAN-2000 and 13-DEC-2000, the patient was vaccinated with hepatitis A vaccine, inactivated (manufacturer unknown) (reported as hepatitis A pediatric) (dose, route, lot# and expiration date were not reported) in a clinic for prophylaxis (product administered to patient of inappropriate age).    This case was one of the three reports regarding the same patient.; Sender's Comments:  US-009507513-1807USA005466: US-009507513-2108USA001619:
Age: 56.0
Sex: F
Vaccine: HEPA, HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Inappropriate schedule of vaccine administered; This spontaneous report has been received from a lawyer, via a Plaintiff from a case in litigation for zoster vaccine live (ZOSTAVAX) , concerning a 56-year-old female patient. Information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.  On 14-JAN-2000, 21-JUN-2000 and 21-SEP-2000, the patient was vaccinated with hepatitis B vaccine (recombinant) (manufacturer unknown) (dose, route, lot# and expiration date were not reported) at a clinic for prophylaxis (inappropriate schedule of product administration).         This case was one of the three reports regarding the same patient.; Sender's Comments:  US-009507513-1807USA005466: US-009507513-2108USA001612:
Age: 56.0
Sex: F
Vaccine: HEPA, HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine administered; This spontaneous report has been received from a lawyer, via a Plaintiff from a case in litigation for zoster vaccine live (ZOSTAVAX) , concerning a 56-year-old female patient. Information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.  On 14-JAN-2000, 21-JUN-2000 and 21-SEP-2000, the patient was vaccinated with hepatitis B vaccine (recombinant) (manufacturer unknown) (dose, route, lot# and expiration date were not reported) at a clinic for prophylaxis (inappropriate schedule of product administration).         This case was one of the three reports regarding the same patient.; Sender's Comments:  US-009507513-1807USA005466: US-009507513-2108USA001612:
Sex: U
Vaccine: VARZOS
Symptoms: Gait disturbance
Clinical narrative: Couldn't walk for 10 days without holding on to furniture; This case was reported by a consumer via media and described the occurrence of walking difficulty in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included denosumab (Prolia) for product used for unknown indication.   Previously administered products included Shingles vaccine (1st dose received on an unknown date).   On an unknown date, the patient received the 1st dose of Shingles vaccine and Prolia at an unknown dose and frequency. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced walking difficulty. On an unknown date, the outcome of the walking difficulty was recovered/resolved.   It was unknown if the reporter considered the walking difficulty to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient for herself or himself. The age at vaccination was not reported. The patient stated that he/she had first vaccine and then it was replaced with the one that was used now. The patient received Shingles vaccine and experienced very bad side effects from first injection and could not walk for 10 days without holding on to furniture. The case was reported to pharmacy and food and drug administration, The pharmacy and doctor said that the patient was not to get second injection. It was unknown if the reporter considered the walking difficulty to be related to Prolia. The follow up would not be possible as no contact details were available. Note: It was unknown if the patient received Prolia before/with/after Shingles vaccine, hence was conservatively captured as suspect. The clarification has been raised for the same.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got both shots/ Still had a very mild case / suspected vaccination failure; very mild case; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine and Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had both shots of Shingles vaccine and still had a very mild shingle. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure, since the details regarding the laboratory confirmation were not provided.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; Got them; Still got them. Very painful!; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient had the shingle shots and still got shingled. It was very painful. The case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were not reported.