chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Burning sensation, Injection site rash, Rash papular, Rash pruritic
Clinical narrative: On Wednesday 4/8/20, patient noticed erythematous papules on his right deltoid, his right abdomen, and behind his right ear. They are mildly itchy.
Age: 0.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Autopsy, Cardiac arrest, Crying, Cyanosis, Death
Clinical narrative: Baby had been in the office for a new patient well baby check and needed vaccine. Baby had been fine  for the 48 hrs prior to event. Mom heard baby crying about 11: 30 on 4/8/2020. She went in to get him . She picked him up and heard a gasp. He then went limp and turned blue. She started CPR and grandmother called 911. Paramedics found the baby in asystole. They intubated the baby but never got a heart beat . The medical examiner was called. She sent the baby for autopsy.   She started that on her exam she could find nothing obviously wrong with the baby.
Age: 0.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Dyspnoea, Endotracheal intubation, Hypotonia, Resuscitation
Clinical narrative: Baby had been in the office for a new patient well baby check and needed vaccine. Baby had been fine  for the 48 hrs prior to event. Mom heard baby crying about 11: 30 on 4/8/2020. She went in to get him . She picked him up and heard a gasp. He then went limp and turned blue. She started CPR and grandmother called 911. Paramedics found the baby in asystole. They intubated the baby but never got a heart beat . The medical examiner was called. She sent the baby for autopsy.   She started that on her exam she could find nothing obviously wrong with the baby.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Muscle tightness, Musculoskeletal stiffness, Myalgia, Neck pain
Clinical narrative: About 3 hours after injection,  Very significant pain and stiffness along cervical spine. Tight feeling  up cerivial spine and swelling along sides of neck. Still had quite a bit of pain and stiffness after 2 months. PCM referred me to physical therapy.  Feb. 13, 2020 was first appt. of 4.  Stopped after 4 as  PT treatments made it worse. Pain in neck continues still today in muscles along neck and cervical spine (4/9/2020) with crackling and stiffness, tight feeling .  Some relief with muscles in sides of neck (not spine), with Airrosti treatments to release knots in sides of my neck.  Pain and stiffness never completely goes away, an is much worse at night, affecting sleep.  HOPING THIS IS NOT PERMANENT.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Spinal X-ray, Spinal pain, Swelling
Clinical narrative: About 3 hours after injection,  Very significant pain and stiffness along cervical spine. Tight feeling  up cerivial spine and swelling along sides of neck. Still had quite a bit of pain and stiffness after 2 months. PCM referred me to physical therapy.  Feb. 13, 2020 was first appt. of 4.  Stopped after 4 as  PT treatments made it worse. Pain in neck continues still today in muscles along neck and cervical spine (4/9/2020) with crackling and stiffness, tight feeling .  Some relief with muscles in sides of neck (not spine), with Airrosti treatments to release knots in sides of my neck.  Pain and stiffness never completely goes away, an is much worse at night, affecting sleep.  HOPING THIS IS NOT PERMANENT.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Abdominal X-ray, Enema administration, Intussusception, Lethargy, Ultrasound abdomen abnormal
Clinical narrative: Pt presented with vomiting, intermittent Lethargy to office x 2-3 hours. Instructions given on Feeding + hydration. but parents also instructed if sx continued (> 3 more hours), to ED for Eval. Pt went to ED about 6 hours later. DX intussusception
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Vomiting, X-ray abnormal
Clinical narrative: Pt presented with vomiting, intermittent Lethargy to office x 2-3 hours. Instructions given on Feeding + hydration. but parents also instructed if sx continued (> 3 more hours), to ED for Eval. Pt went to ED about 6 hours later. DX intussusception
Age: 18.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Hep A#2 was given 1 month too soon
Age: 20.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain, Limb discomfort, Pain, Paraesthesia, Tenderness
Clinical narrative: Front of right bicep is extremely sore, majority of pain is localized to top, rear area of the deltoid, dull pain reaches down to elbow with occasional finger tingling, great discomfort and tightness when arm is laid on or raised from horizontal or higher, pain increases with pressure. 400mg of ibuprofen taken once for pain.
Age: 10.0
Sex: M
Vaccine: HPV9, HPV9, TDAP
Symptoms: Abdominal pain upper, Dehydration, Diarrhoea, Intensive care, Laboratory test
Clinical narrative: Patient started to have severe stomach aches and diarrhea.  Occasionally he would throw up.  this went on for about 3 or 4 days.  He had severe body aches and we took him to urgent care.  the doctor thought it was his appendix.  He referred us to Hospital and we took him to the ER.  ER administered IV saline and did several tests they could not find anything and we were sent home.  The next day he continued vomiting and having diarrhea so we took him back to the ER.  He was admitted on Sunday 2019.  By Tuesday night he was in the intensive care unit and was basically in an induced Coma for approx. 10 days.   They never could figure out what he had.  The amount of flutids they gave him once they figured out he was dehydrated to the point of death was too m mkuch and all most killed him (sepsis I think they called it)  He has since recovered and was
Age: 10.0
Sex: M
Vaccine: HPV9, HPV9, TDAP
Symptoms: Medical induction of coma, Pain, Sepsis, Vomiting
Clinical narrative: Patient started to have severe stomach aches and diarrhea.  Occasionally he would throw up.  this went on for about 3 or 4 days.  He had severe body aches and we took him to urgent care.  the doctor thought it was his appendix.  He referred us to Hospital and we took him to the ER.  ER administered IV saline and did several tests they could not find anything and we were sent home.  The next day he continued vomiting and having diarrhea so we took him back to the ER.  He was admitted on Sunday 2019.  By Tuesday night he was in the intensive care unit and was basically in an induced Coma for approx. 10 days.   They never could figure out what he had.  The amount of flutids they gave him once they figured out he was dehydrated to the point of death was too m mkuch and all most killed him (sepsis I think they called it)  He has since recovered and was
Age: 10.0
Sex: M
Vaccine: HPV9, HPV9, TDAP
Symptoms: Abdominal pain upper, Dehydration, Diarrhoea, Intensive care, Laboratory test normal
Clinical narrative: Patient started to have severe stomach aches and diarrhea.  Occasionally he would throw up.  this went on for about 3 or 4 days.  He had severe body aches and we took him to urgent care.  the doctor thought it was his appendix.  He referred us to Hospital and we took him to the ER.  ER administered IV saline and did several tests they could not find anything and we were sent home.  The next day he continued vomiting and having diarrhea so we took him back to the ER.  He was admitted on Sunday 2019.  By Tuesday night he was in the intensive care unit and was basically in an induced Coma for approx. 10 days.   They never could figure out what he had.  The amount of flutids they gave him once they figured out he was dehydrated to the point of death was too m mkuch and all most killed him (sepsis I think they called it)  He has since recovered and was
Age: 75.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site pain, Neck pain, Pain in extremity
Clinical narrative: The patient came in on 4/9/20 stating that she has had pain in her right arm/neck/shoulder ever since she received her first Shingrix vaccine. She said that she expected there to be pain at first, but after a month she thought that there might be something wrong. She says it feels like a sprain in her shoulder.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache
Clinical narrative: patient complains of chills and headache.  Warm clothing and blanket and Tylenol for 6 hours
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Pt fainted upon standing
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Angioedema, Injection site pain, Injection site reaction
Clinical narrative: GIANT HIVE AT INJECTION SITE, LIKE A  BEE  STING SELF TREATED FOR 5 DAYS WITH TOPICAL LIDOCAINE CONTINUED FOR SEVERAL  WEEKS WITH RANDOM STINGING
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Acute respiratory failure, Blood test normal, Cardiac pharmacologic stress test, Computerised tomogram thorax, Continuous positive airway pressure
Clinical narrative: Left Diaphragm Paralysis identified by a SNIFF test Following 1st flu Vaccination on September 20th 2019.  Four days in ER with Acute respiratory failure on September 29th.  Extensive blood panel test, PFT, EMG, heart echo, Ultrasounds on legs, Xrays, 2 chest CT?s, head & neck MRi, Chem stress test and two visits to ER on September 29th & October 7th.  I have seen numerous doctors with no improvement in my shortness of breath, which is exasperated laying down with CPAP.  I have tried everything recommended to resolve this problem.  My condition has not been identified as GBS, but the flu shot has caused my immune system to damage my nerves and muscles.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Diaphragmatic paralysis, Dyspnoea, Echocardiogram, Electromyogram, Immune system disorder
Clinical narrative: Left Diaphragm Paralysis identified by a SNIFF test Following 1st flu Vaccination on September 20th 2019.  Four days in ER with Acute respiratory failure on September 29th.  Extensive blood panel test, PFT, EMG, heart echo, Ultrasounds on legs, Xrays, 2 chest CT?s, head & neck MRi, Chem stress test and two visits to ER on September 29th & October 7th.  I have seen numerous doctors with no improvement in my shortness of breath, which is exasperated laying down with CPAP.  I have tried everything recommended to resolve this problem.  My condition has not been identified as GBS, but the flu shot has caused my immune system to damage my nerves and muscles.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Magnetic resonance imaging brain normal, Magnetic resonance imaging neck, Magnetic resonance imaging normal, Muscle injury, Nerve injury
Clinical narrative: Left Diaphragm Paralysis identified by a SNIFF test Following 1st flu Vaccination on September 20th 2019.  Four days in ER with Acute respiratory failure on September 29th.  Extensive blood panel test, PFT, EMG, heart echo, Ultrasounds on legs, Xrays, 2 chest CT?s, head & neck MRi, Chem stress test and two visits to ER on September 29th & October 7th.  I have seen numerous doctors with no improvement in my shortness of breath, which is exasperated laying down with CPAP.  I have tried everything recommended to resolve this problem.  My condition has not been identified as GBS, but the flu shot has caused my immune system to damage my nerves and muscles.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Pulmonary function test, Ultrasound scan, X-ray
Clinical narrative: Left Diaphragm Paralysis identified by a SNIFF test Following 1st flu Vaccination on September 20th 2019.  Four days in ER with Acute respiratory failure on September 29th.  Extensive blood panel test, PFT, EMG, heart echo, Ultrasounds on legs, Xrays, 2 chest CT?s, head & neck MRi, Chem stress test and two visits to ER on September 29th & October 7th.  I have seen numerous doctors with no improvement in my shortness of breath, which is exasperated laying down with CPAP.  I have tried everything recommended to resolve this problem.  My condition has not been identified as GBS, but the flu shot has caused my immune system to damage my nerves and muscles.
Age: 75.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site pain, Neck pain, Pain, Pain in extremity
Clinical narrative: The patient came into the pharmacy on 4/9/20 complaining of right arm pain that radiates to her shoulder and neck. She said it sarted on the day she received her Shingrix vaccine on 3/3/20, and the pain has not gone away since.
Age: 36.0
Sex: M
Vaccine: VARCEL
Symptoms: Headache, Myalgia, Varicella post vaccine
Clinical narrative: Muscle aches and headache beginning 13 days after vaccination. Development of chickenpox rash (about 20-25 blisters) all over the body. Adverse event still ongoing and has not resolved yet.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Peripheral swelling
Clinical narrative: Right arm swelling after pneumococcal 23-valent on 3/26/2020 DX cellulitis of right upper arm.
Age: 72.0
Sex: U
Vaccine: PPV, PPV, PPV
Symptoms: Oral discomfort, Pruritus, Rash, Urticaria
Clinical narrative: 3/9/2010:  Beginning 1-1/2 days after the  vaccination I have been experiencing Hives (with bumps and severe itching) mostly on legs and a little on lower arms. No hives elsewhere on body. I am now in 3rd day of these hives with no sign yet of abatement.   Also am feeling occasional mild burning sensation of lips and cheeks but not serious and no fever. There was no redness or swelling around needle injection site. ********  4/10/2020: Hives gradually eased but there are still a few now more than one month later (April 10)!  I want to know what in the vaccine caused this!
Age: 72.0
Sex: U
Vaccine: PPV, PPV, PPV
Symptoms: Purulence, Rash erythematous, Rash pruritic
Clinical narrative: 3/9/2010:  Beginning 1-1/2 days after the  vaccination I have been experiencing Hives (with bumps and severe itching) mostly on legs and a little on lower arms. No hives elsewhere on body. I am now in 3rd day of these hives with no sign yet of abatement.   Also am feeling occasional mild burning sensation of lips and cheeks but not serious and no fever. There was no redness or swelling around needle injection site. ********  4/10/2020: Hives gradually eased but there are still a few now more than one month later (April 10)!  I want to know what in the vaccine caused this!
Age: 72.0
Sex: U
Vaccine: PPV, PPV, PPV
Symptoms: Burning sensation, Oral discomfort, Pruritus, Rash, Urticaria
Clinical narrative: 3/9/2010:  Beginning 1-1/2 days after the  vaccination I have been experiencing Hives (with bumps and severe itching) mostly on legs and a little on lower arms. No hives elsewhere on body. I am now in 3rd day of these hives with no sign yet of abatement.   Also am feeling occasional mild burning sensation of lips and cheeks but not serious and no fever. There was no redness or swelling around needle injection site. ********  4/10/2020: Hives gradually eased but there are still a few now more than one month later (April 10)!  I want to know what in the vaccine caused this!
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Herpes zoster, Rash pruritic, Vision blurred
Clinical narrative: acquired Shingles on the right side of my head and right eye; acquired Shingles on the right side of my head and right eye; This case was reported by a consumer via call center representative and described the occurrence of ophthalmic herpes zoster in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 14th June 2019, the patient received the 1st dose of Shingles vaccine. In June 2019, less than 2 weeks after receiving Shingles vaccine, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the ophthalmic herpes zoster and shingles were unknown.   It was unknown if the reporter considered the ophthalmic herpes zoster and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient received 1st dose of Zoster vaccine and about one to two weeks later  acquired Shingles on the right side of the head and right eye. The patient asked whether with event happened after 1st dose is it ok to receive second injection of the Zoster vaccine. No other information was reported.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: acquired Shingles on the right side of my head and right eye; acquired Shingles on the right side of my head and right eye; This case was reported by a consumer via call center representative and described the occurrence of ophthalmic herpes zoster in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 14th June 2019, the patient received the 1st dose of Shingles vaccine. In June 2019, less than 2 weeks after receiving Shingles vaccine, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the ophthalmic herpes zoster and shingles were unknown.   It was unknown if the reporter considered the ophthalmic herpes zoster and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient received 1st dose of Zoster vaccine and about one to two weeks later  acquired Shingles on the right side of the head and right eye. The patient asked whether with event happened after 1st dose is it ok to receive second injection of the Zoster vaccine. No other information was reported.
Age: 11.0
Sex: M
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; an unspecified number of patients may have been administered an improperly stored doses of MMRII; This spontaneous report was received from a physician referring to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history and drug reaction/allergies were unknown. Concomitant therapies included sterile diluent. On an unknown dates, the patients may have been administered an improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) of lot # S005249  with expiry date 20-FEB-2021 (dose, strength, dose number, route of administration unspecified) for prophylaxis (product storage error). On an unknown date, the vaccines were exposed to the temperature of 11.73 Celsius for 4 hours and 30 minutes. There was no previous temperature excursion and digital data logger was involved. No adverse effects were reported.   Follow up information was received from physician on 07-NOV-2019.     No vaccine adverse reaction were reported. The only had to recall patients because no data available for temperature excursion. On 23-OCT-2019, during office site visit temperature excursion were noted. 10, measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) doses (Lot # R000550, expiry date: 08-JAN-2020) were stored to 24.08 degree Celsius. Since no data exists were (illegible doc) to revaccinate. No adverse reaction noted.    This is a non-valid case due to lack of patient identifiers.  Follow up information was received from the physician on 08-APR-2020.   This information refers to a 11-year-old male patient. On 18-JUN-2019, the patient was administered with an improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) with Lot number R000550.  This is one of several cases received from the same reporter.  This case was previously considered non-valid, but upon receipt of follow-up it was determined that the case is now valid as the patient demographics were obtained.; Sender's Comments:  US-009507513-2004USA002896: US-009507513-2004USA002897: US-009507513-2004USA002898: US-009507513-2004USA002899: US-009507513-2004USA002900: US-009507513-2004USA002901: US-009507513-2004USA002902: US-009507513-2004USA002903: US-009507513-2004USA002904:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient did not report any adverse events after being vaccinated.; The patient received an improperly stored vaccine M-M-R on unspecified date between 18-MAR-2020 to 24-MAR-2020.; This spontaneous report has been received from a physician, regarding to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported.  On an unspecified day in March 2020 (also reported as "between 18-MAR-2020 and 24-MAR-2020"), the patient was vaccinated with an improperly stored Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) administered subcutaneously (SC) as prophylaxis (dose, frequency and expiration date were not reported); the lot number S027461 was an invalid lot number for Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live. In addition, the physician stated that it was determined from the stability data, that the suspect vaccine was stable, and that the patient did not report any adverse events after being vaccinated. Additional information was not expected.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2003USA006671: US-009507513-2004USA001737: US-009507513-2004USA001738: US-009507513-2004USA001739: US-009507513-2004USA001740:
Age: 14.0
Sex: M
Vaccine: HPV9, UNK
Symptoms: Alopecia
Clinical narrative: the patient complained of excessive hair loss/shedding from his head; Information has been received from the patient's mother referring to a 14 years old male patient. The patient had none drug reactions/allergies, concomitant medications or pertinent medical history.    On 05-MAR-2020, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # 1621931, expiration date: 26-JAN-2022 for prophylaxis(also reported as normal childhood vaccinations) (strength, dose, frequency and route were not provided).    On around 12-MAR-2020, the patient complained of excessive hair loss/shedding from his head. The patient had not complained of any other symptoms. The patient's mother had spoken with physician. At this time the physician would monitor the situation as she did not want to prescribe corticosteroids (unspecified) during the Coronavirus/corona virus disease (COVID) 19 pandemic. There was no treatment given to the event. The outcome of the event was not recovered. The causality assessment was not 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: 1621931; expirationdate: 26-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Nurse reporting patient inadvertendly received unspecified dose of VARIVAX tah was improperly stored; no symptoms being reported; This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent condition's drug and allergy history or concomitant medication's.  On 13-MAR-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose, frequency and route of administration) lot # S022758, expiration date 22-JUL-2021 for prophylaxis. The reporter stated that the sterile diluent (MRK) used was properly stored.  The doses of varicella virus vaccine live (oka/merck)(VARIVAX) were exposed to a temperature excursion of 22.7°Celsius (°C) during a time frame of 4 hours and 30 minutes. It was unknown if it was detected by the data logger or if there was a previous temperature excursion. No adverse effects were reported.  The reporter stated as a background that the completed stability assessment was provided on 12-DEC-2019, and varicella virus vaccine live (oka/merck)(VARIVAX) was placed into proper storage. Stability assessment provided was supported - used within 3 months.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient received an improperly stored dose of ROTATEQ; No adverse symptoms reported; This spontaneous report was received from a medical assistant referring to a patient of unknown and gender. No information regarding the patients' pertinent medical history, concomitant therapies or previous drug reaction or allergies was provided.  On 02-MAR-2020, the patient was vaccinated with a improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial administered orally (lot # 1660112 and expiration date of 18-OCT-2020; strength, dose, formulation and anatomical location) as prophylaxis. The vaccine was stored at a temperature above 47 degrees Fahrenheit (F) for 15 minutes. Previous temperature excursion: 47 F for 21 minutes (product storage error). Digital data logger was involved. No adverse symptoms were reported (no adverse event).
Sex: U
Vaccine: MMRV, UNK, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional adverse event reported; inadvertent administration of expired VARIVAX to patient; inadvertent administration of PROQUAD and VARIVAX to patient; This spontaneous report was received from the officer manager concerning to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.   On 01-APR-2020, the patient was inadvertently vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) rHA, (dose, route and frequency were not provided), lot# R030801, expiration date 22-APR-2020 and a dose of varicella virus vaccine live (oka/merck) (VARIVAX) (dose, route and frequency were not provided) Lot No. R035221 has been verified to be a valid lot number for varicella virus vaccine live (oka/merck), expiration date reported as 04-DEC-2020, but upon internal validation established as 04-DEC-2019. Both therapies were administered for prophylaxis and were reconstituted with a sterile water diluent (Lot # and expiry date unknown) (Accidental exposure to product). No additional adverse event was reported.
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Cough, Nausea, Product use in unapproved indication, Pyrexia
Clinical narrative: Cellulitis of leg; the patient experienced nausea and vomiting; the patient experienced nausea and vomiting; Indication: vaccinated in an effort to protect patient at high risk for COVID-19; the patient had symptoms of fever and cough and is being tested for COVID-19; the patient had symptoms of fever and cough and is being tested for COVID-19.; This spontaneous report was received from a nurse practitioner referring to an 84-year-old male patient, the patient's pertinent concurrent conditions included unspecified heart disease, chronic kidney disease and heart failure. The patient received pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) and unspecified flu vaccine. It was unknown by the reporter if the patient had previous drug reactions or allergies.  On 26-MAR-2020, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, intramuscular as vaccinated in an effort to protect patient at high risk for COVID-19 (product use in unapproved indication) (concentration, number of administered dose, vaccination scheme frequency were not reported; lot number S033790 and expiration date 02-AUG-2021).  On 29-MAR-2020 (reported as 3 days later), the patient experienced nausea and vomiting. The patient sought medical attention and on 30-MAR-2020 (reported as next day), the patient was hospitalized and the patient was diagnosed with cellulitis of the leg, also the nurse reported that the patient had symptoms of fever (pyrexia) and cough and was being tested for COVID-19. The patient received unspecified treatment for the events, but it was unknown if another laboratory diagnostic or studies were performed.  The outcome of cough, pyrexia, vomiting, nausea and cellulitis was not provided, but it was reported that the patient was still hospitalized.  The causality assessment between therapy with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) and the events pyrexia, vomiting, nausea and cellulitis was not reported.  The events cough, pyrexia, vomiting, nausea and cellulitis were considered as medically significant.  The reporter considered the events cough, pyrexia, vomiting, nausea and cellulitis as a life threatening and disability.
Sex: M
Vaccine: PPV
Symptoms: Viral test, Vomiting
Clinical narrative: Cellulitis of leg; the patient experienced nausea and vomiting; the patient experienced nausea and vomiting; Indication: vaccinated in an effort to protect patient at high risk for COVID-19; the patient had symptoms of fever and cough and is being tested for COVID-19; the patient had symptoms of fever and cough and is being tested for COVID-19.; This spontaneous report was received from a nurse practitioner referring to an 84-year-old male patient, the patient's pertinent concurrent conditions included unspecified heart disease, chronic kidney disease and heart failure. The patient received pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) and unspecified flu vaccine. It was unknown by the reporter if the patient had previous drug reactions or allergies.  On 26-MAR-2020, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, intramuscular as vaccinated in an effort to protect patient at high risk for COVID-19 (product use in unapproved indication) (concentration, number of administered dose, vaccination scheme frequency were not reported; lot number S033790 and expiration date 02-AUG-2021).  On 29-MAR-2020 (reported as 3 days later), the patient experienced nausea and vomiting. The patient sought medical attention and on 30-MAR-2020 (reported as next day), the patient was hospitalized and the patient was diagnosed with cellulitis of the leg, also the nurse reported that the patient had symptoms of fever (pyrexia) and cough and was being tested for COVID-19. The patient received unspecified treatment for the events, but it was unknown if another laboratory diagnostic or studies were performed.  The outcome of cough, pyrexia, vomiting, nausea and cellulitis was not provided, but it was reported that the patient was still hospitalized.  The causality assessment between therapy with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) and the events pyrexia, vomiting, nausea and cellulitis was not reported.  The events cough, pyrexia, vomiting, nausea and cellulitis were considered as medically significant.  The reporter considered the events cough, pyrexia, vomiting, nausea and cellulitis as a life threatening and disability.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; Information had been received on from a lawyer and the patient (pt), regarding a case in litigation referring a female pt of unknown age . Medical history, concurrent conditions, and concomitant medication were not provided. In 2016, the pt was inoculated with a dose of Zoster Vaccine Live (ZOSTAVAX) (dose, route, anatomical location, lot number and expiration date were not provided) long-term prevention of shingles and zoster-related conditions. Subsequently vaccination, the pt was treated by a healthcare provider for shingles.As a direct and proximate result of pt's use of the Zoster Vaccine Live (ZOSTAVAX), the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient did not report any adverse events after being vaccinated.; The patient received an improperly stored vaccine M-M-R on unspecified date between 18-MAR-2020 to 24-MAR-2020.; This spontaneous report has been received from a physician, regarding to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported.  On an unspecified day in March 2020 (also reported as "between 18-MAR-2020 and 24-MAR-2020"), the patient was vaccinated with an improperly stored Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) administered subcutaneously (SC) as prophylaxis (dose, frequency and expiration date were not reported); the lot number S027461 was an invalid lot number for Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live. In addition, the physician stated that it was determined from the stability data, that the suspect vaccine was stable, and that the patient did not report any adverse events after being vaccinated. Additional information was not expected.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2003USA006671: US-009507513-2004USA001738: US-009507513-2004USA001739: US-009507513-2004USA001740:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient did not report any adverse events after being vaccinated.; The patient received an improperly stored vaccine M-M-R on unspecified date between 18-MAR-2020 to 24-MAR-2020.; This spontaneous report has been received from a physician, regarding to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported.  On an unspecified day in March 2020 (also reported as "between 18-MAR-2020 and 24-MAR-2020"), the patient was vaccinated with an improperly stored Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) administered subcutaneously (SC) as prophylaxis (dose, frequency and expiration date were not reported); the lot number S027461 was an invalid lot number for Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live. In addition, the physician stated that it was determined from the stability data, that the suspect vaccine was stable, and that the patient did not report any adverse events after being vaccinated. Additional information was not expected.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2003USA006671: US-009507513-2003USA009717: US-009507513-2004USA001737: US-009507513-2004USA001739: US-009507513-2004USA001740:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient did not report any adverse events after being vaccinated.; The patient received an improperly stored vaccine M-M-R on unspecified date between 18-MAR-2020 to 24-MAR-2020.; This spontaneous report has been received from a physician, regarding to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported.  On an unspecified day in March 2020 (also reported as "between 18-MAR-2020 and 24-MAR-2020"), the patient was vaccinated with an improperly stored Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) administered subcutaneously (SC) as prophylaxis (dose, frequency and expiration date were not reported); the lot number S027461 was an invalid lot number for Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live. In addition, the physician stated that it was determined from the stability data, that the suspect vaccine was stable, and that the patient did not report any adverse events after being vaccinated. Additional information was not expected.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2003USA006671: US-009507513-2003USA009717: US-009507513-2004USA001737: US-009507513-2004USA001738: US-009507513-2004USA001740:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient did not report any adverse events after being vaccinated.; The patient received an improperly stored vaccine M-M-R on unspecified date between 18-MAR-2020 to 24-MAR-2020.; This spontaneous report has been received from a physician, regarding to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported.  On an unspecified day in March 2020 (also reported as "between 18-MAR-2020 and 24-MAR-2020"), the patient was vaccinated with an improperly stored Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) administered subcutaneously (SC) as prophylaxis (dose, frequency and expiration date were not reported); the lot number S027461 was an invalid lot number for Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live. In addition, the physician stated that it was determined from the stability data, that the suspect vaccine was stable, and that the patient did not report any adverse events after being vaccinated. Additional information was not expected.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2003USA006671: US-009507513-2003USA009717: US-009507513-2004USA001737: US-009507513-2004USA001738: US-009507513-2004USA001739:
Sex: M
Vaccine: VARZOS
Symptoms: Polymyalgia rheumatica
Clinical narrative: polymyalgia rheumatica; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2009, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to the vaccination (date not reported), the patient experienced polymyalgia rheumatica. On an unspecified date, the patient was treated by a physician for polymyalgia rheumatica. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was unknown. The event was considered related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event polymyalgia rheumatica was considered to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: post herpetic neualgia; shingles; Information has been received from a lawyer and a female patient of unknown age regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 07-MAY-2008, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a physician at a physician office for shingles and post herpetic neualgia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the events was unknown. The events were considered related to zoster vaccine live (ZOSTAVAX).
Age: 1.25
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No symptoms being reported.; Healthcare worker reporting vaccine was administered to patient after it had expired. VAQTA pediatric dose.; This spontaneous report was received from a RadiologicTechnologist referring  to a 15 month old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 06-APR-2020, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated(VAQTA) pediatric  (strength, route, dose, frequency, and anatomical location were unknown) with lot # S002507 and expiration date on 04-APR-2020 for prophylaxis. The patient was doing fine and no symptoms were being reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; an unspecified number of unspecified patients were administered a dose of improperly stored ROTATEQ; This non-valid, spontaneous report was received from a nurse and referring to an unspecified number of unspecified patients of unknown age. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 11-MAR-2020 (reported as on or after 11-MAR-2020 ), the patients were administered a dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # S014947, expiration date: 10-DEC-2020, orally, (dose and frequency were not provided) for prophylaxis (PT: product storage error).   Administered doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) experienced the temperature excursion above 9 degrees Celsius (C) (11C) for 30 minutes. There was no previous temperature excursions reported. The digital data logger was involved to capture the temperature excursion. No additional adverse effect reported.  The case is non-valid due to lack of the patients' identifiers.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No symptoms being reported; patient inadvertently received an expired, unspecified dose in VAQTA immunization series; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  On 07-APR-2020 the patient was inadvertently vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) immunization series (lot # S002506, expiration date 04-APR-2020; dose, frequency and route were not reported) for prophylaxis (expired product administered). No symptoms were being reported.
Age: 11.0
Sex: F
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effcet; an unspecified number of patients may have been administered an improperly stored doses of MMRII; This spontaneous report was received from a physician referring to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history and drug reaction/allergies were unknown. Concomitant therapies included sterile diluent. On an unknown dates, the patients may have been administered an improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) of lot # S005249  with expiry date 20-FEB-2021 (dose, strength, dose number, route of administration unspecified) for prophylaxis (product storage error). On an unknown date, the vaccines were exposed to the temperature of 11.73 Celsius for 4 hours and 30 minutes. There was no previous temperature excursion and digital data logger was involved. No adverse effects were reported.   Follow up information was received from physician on 07-NOV-2019.     No vaccine adverse reaction were reported. The only had to recall patients because no data available for temperature excursion. On 23-OCT-2019, during office site visit temperature excursion were noted. 10, measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) doses (Lot # R00550, expiry date: 08-JAN-2020) were stored to 24.08 degree Celsius. Since no data exists were (illegible doc) to revaccinate. No adverse reaction noted.    This is a non-valid case due to lack of patient identifiers.  Follow up information was received from the physician on 08-APR-2020.   This information refers to a 11-year-old female patient. on 18-JUN-2019, the patient was administered with an improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) with lot number R00550.  This is one of several cases received from the same reporter.  This case was previously considered non-valid, but upon receipt of follow-up it was determined that the case is now valid as the patient demographics were obtained.; Sender's Comments:  US-009507513-1910USA016114:
Age: 6.0
Sex: F
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effcet; an unspecified number of patients may have been administered an improperly stored doses of MMRII; This spontaneous report was received from a physician referring to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history and drug reaction/allergies were unknown. Concomitant therapies included sterile diluent. On an unknown dates, the patients may have been administered an improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) of lot # S005249  with expiry date 20-FEB-2021 (dose, strength, dose number, route of administration unspecified) for prophylaxis (product storage error). On an unknown date, the vaccines were exposed to the temperature of 11.73 Celsius for 4 hours and 30 minutes. There was no previous temperature excursion and digital data logger was involved. No adverse effects were reported.   Follow up information was received from physician on 07-NOV-2019.     No vaccine adverse reaction were reported. The only had to recall patients because no data available for temperature excursion. On 23-OCT-2019, during office site visit temperature excursion were noted. 10, measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) doses (Lot # R000550, expiry date: 08-JAN-2020) were stored to 24.08 degree Celsius. Since no data exists were (illegible doc) to revaccinate. No adverse reaction noted.    This is a non-valid case due to lack of patient identifiers.  Follow up information was received from the physician on 08-APR-2020.   This information refers to a 06-year-old female patient. on 11-JUN-2019, the patient was administered with an improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) with Lot number R000550.  This is one of several cases received from the same reporter.  This case was previously considered non-valid, but upon receipt of follow-up it was determined that the case is now valid as the patient demographics were obtained.; Sender's Comments:  US-009507513-1910USA016114: