chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Death, Herpes zoster disseminated, Multi-organ disorder
Clinical narrative: severe outbreak of disseminated shingles/ affected other organs and other bodily systems; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient (pt) of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   Pt visited pharmacy to fill a prescription and pharmacist suggested that she should get zoster vaccine live (ZOSTAVAX) vaccination. On 28-APR-2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).   Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, on or before 01-JUN-2015, pt suffered a severe outbreak of disseminated shingles that eventually covered her body which forced her to be admitted to hospital. Due to the debilitating and severe shingles outbreak, which affected other organs and other bodily systems, pt died on 03-JUL-2015. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), pt's injuries and death were caused by the zoster vaccine live (ZOSTAVAX) vaccine. Due to the shingles and resulting injuries, pt suffered excruciating physical pain and suffering, mental anguish and emotional distress, and loss of enjoyment of life prior to her death.  Upon internal review, the event of disseminated shingles was considered to be medically significant.; Reported Cause(s) of Death: severe outbreak of disseminated shingles/ debilitating and severe shingles outbreak which affected other organs and other bodily systems
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and referring to a currently 81 years old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or about 16-APR-2019, the patient was administered with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose number and route was not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles. The outcome of the shingles was not reported. The reporter considered the shingles to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report has been received from a lawyer regarding a case in litigation and refers to a currently 72 years old female patient. No information was provided regarding medical history, concurrent conditions or concomitant medications.     On or about 02-NOV-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, dose#, route, batch/lot# and expiration date were unknown) for the long-term prevention of shingles and zoster-related conditions.       On an unknown date, the patient experienced shingles. On an unknown date, the patient was treated by a healthcare provider for shingles. The outcome of the event of shingles was not reported. The reporter considered the event to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This spontaneous report was received from a lawyer regarding a case in litigation referring to a currently 86-year-old female patient. the patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. In 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage and route of administration not specified) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient was treated by a physician for the following injuries resulting from patient's zoster vaccine live (ZOSTAVAX) use: herpes zoster. At the time of the report, the outcome of herpes zoster was unknown. The reporter considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This spontaneous report was received from a lawyer regarding a case in litigation referring to a currently 83-year-old male patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On 12-MAY-2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage and route of administration not specified) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient was treated by a physician for the following injuries resulting from patient's zoster vaccine live (ZOSTAVAX) use: herpes zoster. At the time of the report, the outcome of herpes zoster was unknown. The reporter considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report was received from a lawyer regarding a case in litigation referring to a currently 74-year-old male patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On 04-OCT-2007, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage and route of administration not specified) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient was treated by a healthcare professional for the following injuries resulting from patient's zoster vaccine live (ZOSTAVAX) use: shingles. At the time of the report, the outcome of shingles was unknown. The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Peripheral swelling, Rash, Rash erythematous
Clinical narrative: Left arm all the way down to elbow is red, very itchy and the right arm also has 2 or 3 nickel sized red dots that are itchy as well; Left arm all the way down to elbow is red, very itchy and the right arm also has 2 or 3 nickel sized red dots that are itchy as well; Left arm all the way down to elbow is red, very itchy and the right arm also has 2 or 3 nickel sized red dots that are itchy as well; Left arm looks slightly swollen and a little larger than the right arm; This spontaneous report was received from a pharmacist refers to a 83 year old female patient with immunisation.    On 03-JUL-2019 the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX 23) lot # R018732, intramuscular in the left arm for immunisation.    Concomitant therapies included cetirizine hydrochloride(ZYRTEC).   On 03-JUL-2019, 1 day after onset of therapy the patient experienced injection site erythema, injection site reaction, vaccination site pruritus and peripheral swelling.    The outcome of injection site erythema, peripheral swelling, injection site reaction and vaccination site pruritus was reported as not recovered/not resolved.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Rash pruritic
Clinical narrative: Left arm all the way down to elbow is red, very itchy and the right arm also has 2 or 3 nickel sized red dots that are itchy as well; Left arm all the way down to elbow is red, very itchy and the right arm also has 2 or 3 nickel sized red dots that are itchy as well; Left arm all the way down to elbow is red, very itchy and the right arm also has 2 or 3 nickel sized red dots that are itchy as well; Left arm looks slightly swollen and a little larger than the right arm; This spontaneous report was received from a pharmacist refers to a 83 year old female patient with immunisation.    On 03-JUL-2019 the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX 23) lot # R018732, intramuscular in the left arm for immunisation.    Concomitant therapies included cetirizine hydrochloride(ZYRTEC).   On 03-JUL-2019, 1 day after onset of therapy the patient experienced injection site erythema, injection site reaction, vaccination site pruritus and peripheral swelling.    The outcome of injection site erythema, peripheral swelling, injection site reaction and vaccination site pruritus was reported as not recovered/not resolved.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report was received from a lawyer regarding a case in litigation referring to a currently 67-year-old female patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On 12-DEC-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage and route of administration not specified) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient was treated by a healthcare professional for the following injuries resulting from patient's zoster vaccine live (ZOSTAVAX) use: shingles. At the time of the report, the outcome of shingles was unknown. The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 93 year old female patient. No information was provided regarding medical history, concurrent conditions, concomitant medications, drug reactions or allergies. On or about 17-APR-2008, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, lot #, expiration date, route of administration and anatomical location were not provided)) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced Shingles. She was treated by a physician for the event. The outcome of the event of shingles was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 68 year old male patient. No information was provided regarding medical history, concurrent conditions, concomitant medications, drug reactions or allergies. On an unspecified date in September 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, lot #, expiration date, route of administration and anatomical location were not provided)) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced herpes zoster. He was treated by a physician for the event. The outcome of the event of herpes zoster was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported; Pharmacist reported the patient inadvertently received an expired dose of VARIVAX (N017700, expiration 6/9/2019) on 7/3/2019; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 03-JUL-2019, the patient was vaccinated with a dose of expired varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (lot # N017700 has been verified to be a valid lot number, expiration date was reported as 09-JUN-2019 and was confirmed to be valid; exact dose, route of administration and anatomical location were not provided) for prophylaxis. The vaccine was reconstituted with a sterile diluent (lot # S008565 and expiry date 09-SEP-2021). No adverse effects reported.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain
Clinical narrative: Her shoulder is sore but not swollen during palpation and she didn't lose her strength and/or sensibility.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: presents to the office for an acute care visit. Pt is c/o redness/swelling around injection site. Of note, pt was seen last week-7/3/19 by another provider in the office for annual wellness exam. She notes receiving Prevnar 13 immunization. Within a couple days pt noted development of redness, swelling, and warmth around the site. Pt aware that it is not uncommon for some redness/swelling to occur. However, she has noticed the redness spreading and remaining persistent. She notes associated warmth, tenderness to touch. She denies any associated fevers, chills, myalgias, chest pain, SOB, abd pain, N/V. She has not been taking anything OTC for her sxs.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: I do not know exactly which Meningococcal vaccine was given. The sheet the Dr supplied says "Meningococcal ACWY Vaccine" High fever. Highest was 101.4 before patient rested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain lower, Malaise, Migraine, Nausea, Pyrexia
Clinical narrative: This was my second shot in the series.  I also had a bad reaction for the first, but not as bad as the second.  When I woke on the morning of 7/7/2019 I was not feeling well.  As the morning progressed I did not feel any better and finally took my temperature.  I had a fever of that vacillated between 100.1 and 100.9 through the day.  I also had lower abdominal pain, nausea, and a bad headache- migraine like.  Fever finally broke around 8:00 PM, but headache, abdominal pain and nausea remained.  When I woke on 7/8/2019 abdominal pain, and nausea were gone, but I still had a headache that remained until about midday.
Age: 56.0
Sex: F
Vaccine: HEP
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Employee felt sore in her left arm after the vaccination but thought the soreness would go away. Employee states the pain  in her left arm became progressively worse in April and May and she is unable to raise her left arm above shoulder.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV9, MNQ
Symptoms: Dyskinesia, Extremity contracture, Loss of consciousness, Musculoskeletal stiffness
Clinical narrative: About 1 minute after administering Hepatitis A, HPV9, and MCV4 vaccine to patient he became unconscious. As his father and I lowered his body down onto exam table patient's body became stiff and limbs started contracting. Patients body then begin to uncontrollably jerk. I turned patient onto his side and had patient's father stand behind him to help hold him while I paged 911 code over phone system. Jerking lasted about 45 seconds then patient was conscious, alert, and oriented x4 again. Observed patient in clinic room for 20 minutes after incident occurred and then left clinic with father. Referred to PCP for a follow-up visit. Reported incident to County Director in person.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Middle insomnia, Nightmare, Pyrexia, Vomiting
Clinical narrative: Woke the during the night on 07/04/2019-07/05/2019 with nightmares and a fever of 105.  Mother tried to give him Tylenol but he vomited right after taking it.  Called the Dr office the next morning, 07/05/2019, and they could see him at 3 pm.  Mother then called us at 10:35 am.  Stated he still had a fever at that time of 103 and vomited and unable to keep any medicine down.  Encouraged her to take him to the ER for an evaluation.  Was given Zofran and then able to keep Tylenol down.  Mother states by 6pm that evening he was better and didn't have any more fevers or vomiting.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; Improperly stored doses administered; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions/allergies and concomitant medications were not reported.  On 11-JUN-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial, orally (strength and dose were not reported)  lot # R033252, expiry date 29-JUN-2020, for prophylaxis. The suspect vaccine was stored in a temperature below 36 Fahrenheit (F) degrees ( 34 F) for 24 hours. There were no previous temperature excursions. Digital data logger was involved. No adverse effects were reported.  This is one of six reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA002834: US-009507513-1907USA003059: US-009507513-1907USA003060: US-009507513-1907USA003061: US-009507513-1907USA003062:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; Improperly stored doses administered; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions/allergies and concomitant medications were not reported.  On 21-JUN-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial, orally (strength and dose were not reported) lot # R033252, expiry date 29-JUN-2020, for prophylaxis. The suspect vaccine was stored in a temperature below 36 Fahrenheit degrees (F) (34 F) for 24 hours. There were no previous temperature excursions. Digital data logger was involved. No adverse effects were reported.  This is one of six reports received form the same reporter.; Sender's Comments:  US-009507513-1907USA003061: US-009507513-1907USA003060: US-009507513-1907USA003059: US-009507513-1907USA002834: US-009507513-1907USA003058:
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Nonspecific reaction
Clinical narrative: Mild reaction; This case was reported by a other health professional via sales rep and described the occurrence of nonspecific reaction in a 16-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced nonspecific reaction. On an unknown date, the outcome of the nonspecific reaction was recovered/resolved.   It was unknown if the reporter considered the nonspecific reaction to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. After receiving a dose of Shingrix she had a mild reaction (not specified). The injection was given by a licensed practical nurse. This was all the information the sales representative had to report.  For tolerances of 2nd dose, refer case US2019112116, reported by same reporter for the same patient.
Age: 17.0
Sex: U
Vaccine: MEN
Symptoms: Injection site bruising, Injection site mass, Injection site pain
Clinical narrative: bruised injection site; injection site hurts to touch; looks like a ball is growing underneath; This case was reported by a consumer via interactive digital media and described the occurrence of injection site bruising in a 17-year-old patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine at an unknown dose. On an unknown date, less than a year after receiving Meningococcal B vaccine, the patient experienced injection site bruising, injection site pain and injection site lump. On an unknown date, the outcome of the injection site bruising, injection site pain and injection site lump were not recovered/not resolved.   It was unknown if the reporter considered the injection site bruising, injection site pain and injection site lump to be related to Meningococcal B vaccine.  Additional details were provided as follows: This case was reported by the patient's parent. On Eleven and half weeks ago from the date of reporting, the patient received a dose of Meningococcal B vaccine. The patient experienced bruise near injection site and it appears like ball growing underneath and it also hurts to touch, after receiving Meningococcal B vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Immunosuppression
Clinical narrative: Immunosuppression; This case was reported by a other health professional via call center representative and described the occurrence of immunosuppression in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included breast cancer (was diagnosed in December 2018). Concomitant products included chemotherapy, nos (Chemotherapy).   In January 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced immunosuppression (serious criteria GSK medically significant). On an unknown date, the outcome of the immunosuppression was unknown.   The reporter considered the immunosuppression to be unrelated to Shingrix.  Additional details were provided as follows: The age at vaccaination was not reported. At the time of reporting, the patient was completing her chemotherapy and radiation. She stated that, she was having big issues with immunosuppression with the chemotherapy.   The patient really did not see the connection with Shingrix. The reporter consented to follow up.
Age: 58.0
Sex: F
Vaccine: HEPA
Symptoms: Immunisation, Syringe issue
Clinical narrative: While giving the single dose pre-filled Hep A vaccine, it began to leak out of the syringe instead of the needle.  The Ma stopped giving the vaccine immediately and vaccinated patient with another pre-filled Hep A vaccine without any issues.
Age: 68.0
Sex: F
Vaccine: HEPAB, PPV
Symptoms: Injection site rash
Clinical narrative: Within 4 hours of receiving the immunizations, patient experienced a rash on her left arm in the spot the immunizations were given. Patient went to urgent care and was prescribed triamcinolone acetonide 0.1% cream on 7/5/19
Age: 18.0
Sex: M
Vaccine: MENB, MENB, MNQ, MNQ
Symptoms: Abdominal discomfort, Blood test, Computerised tomogram, Electrocardiogram, Electroencephalogram abnormal
Clinical narrative: May 27,2018:  Seizure lasted about 2 minutes.  Paramedics came to house and took vitals and then an emergency room visit. postictal about 20 minutes. Put on ______(mg) medication. June 18, 2018:  Seizure while taking an EEG test.  Lasted about 5 minutes.  Post postictal about an hour. June 19, 2018: Seizure while on airline flight.  Lasted about 5 minutes.  Post postictal about an hour.  In flight emergency, ambulance and emergency room visit.  Released 4 hours later.  ______increased to 3 tablets (mg). June 26, 2018:  Seizure while passenger in a vehicle.  Lasted about 5 minutes.  Post postictal about an hour. July 9, 2018:  Medication putting patient into near coma.  Cannot stay awake. Vomiting with any food or  drink.  Emergency room visit.  Lower medication amount. August 31, 2018:  Seizure when waking up.  Unknown duration.  Post postictal about an hour.  Woke up in emergency room after ambulance ride.  Released several hours later. No events since August 31, 2018; however there has been dramatic side effects from the medication including irritability, shakiness with vomiting and upset stomach.   On 5-10-18 he was given Menvio Meingococal Lot #m17035 (Smith Cline)  (2nd shot) His first shot was Menactra (date unknown)
Age: 18.0
Sex: M
Vaccine: MENB, MENB, MNQ, MNQ
Symptoms: Irritability, Postictal state, Seizure, Somnolence, Tremor
Clinical narrative: May 27,2018:  Seizure lasted about 2 minutes.  Paramedics came to house and took vitals and then an emergency room visit. postictal about 20 minutes. Put on ______(mg) medication. June 18, 2018:  Seizure while taking an EEG test.  Lasted about 5 minutes.  Post postictal about an hour. June 19, 2018: Seizure while on airline flight.  Lasted about 5 minutes.  Post postictal about an hour.  In flight emergency, ambulance and emergency room visit.  Released 4 hours later.  ______increased to 3 tablets (mg). June 26, 2018:  Seizure while passenger in a vehicle.  Lasted about 5 minutes.  Post postictal about an hour. July 9, 2018:  Medication putting patient into near coma.  Cannot stay awake. Vomiting with any food or  drink.  Emergency room visit.  Lower medication amount. August 31, 2018:  Seizure when waking up.  Unknown duration.  Post postictal about an hour.  Woke up in emergency room after ambulance ride.  Released several hours later. No events since August 31, 2018; however there has been dramatic side effects from the medication including irritability, shakiness with vomiting and upset stomach.   On 5-10-18 he was given Menvio Meingococal Lot #m17035 (Smith Cline)  (2nd shot) His first shot was Menactra (date unknown)
Age: 18.0
Sex: M
Vaccine: MENB, MENB, MNQ, MNQ
Symptoms: Vomiting, X-ray
Clinical narrative: May 27,2018:  Seizure lasted about 2 minutes.  Paramedics came to house and took vitals and then an emergency room visit. postictal about 20 minutes. Put on ______(mg) medication. June 18, 2018:  Seizure while taking an EEG test.  Lasted about 5 minutes.  Post postictal about an hour. June 19, 2018: Seizure while on airline flight.  Lasted about 5 minutes.  Post postictal about an hour.  In flight emergency, ambulance and emergency room visit.  Released 4 hours later.  ______increased to 3 tablets (mg). June 26, 2018:  Seizure while passenger in a vehicle.  Lasted about 5 minutes.  Post postictal about an hour. July 9, 2018:  Medication putting patient into near coma.  Cannot stay awake. Vomiting with any food or  drink.  Emergency room visit.  Lower medication amount. August 31, 2018:  Seizure when waking up.  Unknown duration.  Post postictal about an hour.  Woke up in emergency room after ambulance ride.  Released several hours later. No events since August 31, 2018; however there has been dramatic side effects from the medication including irritability, shakiness with vomiting and upset stomach.   On 5-10-18 he was given Menvio Meingococal Lot #m17035 (Smith Cline)  (2nd shot) His first shot was Menactra (date unknown)
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Nausea, Pyrexia
Clinical narrative: Within 12 hours had uncomfortable muscle aches and nausea, took 200 ibuprofen. By 24 hrs post injection has shivering with fever of 100F. Took another 200 ibuprofen. Lasted until bedtime, 9:00pm. Felt well by 60 hrs post injection.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: PATIENT HAS DEVELOPED A RASH IN THE SAME LOCATION OF A PREVIOUS SHINGLES OUTBREAK 3 YEARS AGO
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Pain, Sensitive skin
Clinical narrative: PATIENT HAS DEVELOPED A RASH IN THE SAME LOCATION OF A PREVIOUS SHINGLES OUTBREAK 3 YEARS AGO
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; multiple patients were vaccinated with an improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 20-JUN-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 ml, orally, LOT# R027157, expiry date 14-JUL-2020 for prophylaxis. The vaccine was exposed to a temperature of 34.2 F for 4 hours and 54 minutes. This call was made because of a digital data logger. There were no previous temperature excursions. No adverse effects were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674: US-009507513-1907USA000862: US-009507513-1907USA000882: US-009507513-1907USA000883: US-009507513-1907USA000884: US-009507513-1907USA000885: US-009507513-1907USA000886: US-009507513-1907USA000887: US-009507513-1907USA000888: US-009507513-1907USA000890: US-009507513-1907USA000891: US-009507513-1907USA000892: US-009507513-1907USA000893: US-009507513-1907USA000894: US-009507513-1907USA000895: US-009507513-1907USA000896: US-009507513-1907USA000897: US-009507513-1907USA000898: US-009507513-1907USA000899: US-009507513-1907USA000900: US-009507513-1907USA000901: US-009507513-1907USA000902: US-009507513-1907USA000904: US-009507513-1907USA000905: US-009507513-1907USA000906: US-009507513-1907USA000907: US-009507513-1907USA000908: US-009507513-1907USA000909: US-009507513-1907USA000910: US-009507513-1907USA000911: US-009507513-1907USA000912: US-009507513-1907USA000913: US-009507513-1907USA000914: US-009507513-1907USA000915: US-009507513-1907USA000916: US-009507513-1907USA000917: US-009507513-1907USA000918: US-009507513-1907USA000919: US-009507513-1907USA000920: US-009507513-1907USA000921: US-009507513-1907USA000922: US-009507513-1907USA000923: US-009507513-1907USA000924: US-009507513-1907USA000925: US-009507513-1907USA000926: US-009507513-1907USA000927: US-009507513-1907USA000928: US-009507513-1907USA000929: US-009507513-1907USA000930: US-009507513-1907USA000931: US-009507513-1907USA000932: US-009507513-1907USA000933: US-009507513-1907USA000934: US-009507513-1907USA000935: US-009507513-1907USA000936: US-009507513-1907USA000937: US-009507513-1907USA000938: US-009507513-1907USA000903:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; multiple patients were vaccinated with an improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 25-JUN-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 ml, orally, LOT# R027157, expiry date 14-JUL-2020 for prophylaxis. The vaccine was exposed to a temperature of 34.2 F for 4 hours and 54 minutes. This call was made because of a digital data logger. There were no previous temperature excursions. No adverse effects were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674: US-009507513-1907USA000862: US-009507513-1907USA000882: US-009507513-1907USA000883: US-009507513-1907USA000884: US-009507513-1907USA000885: US-009507513-1907USA000886: US-009507513-1907USA000887: US-009507513-1907USA000888: US-009507513-1907USA000889: US-009507513-1907USA000891: US-009507513-1907USA000892: US-009507513-1907USA000893: US-009507513-1907USA000894: US-009507513-1907USA000895: US-009507513-1907USA000896: US-009507513-1907USA000897: US-009507513-1907USA000898: US-009507513-1907USA000898: US-009507513-1907USA000900: US-009507513-1907USA000901: US-009507513-1907USA000902: US-009507513-1907USA000904: US-009507513-1907USA000905: US-009507513-1907USA000906: US-009507513-1907USA000907: US-009507513-1907USA000908: US-009507513-1907USA000909: US-009507513-1907USA000910: US-009507513-1907USA000911: US-009507513-1907USA000912: US-009507513-1907USA000913: US-009507513-1907USA000914: US-009507513-1907USA000915: US-009507513-1907USA000916: US-009507513-1907USA000917: US-009507513-1907USA000918: US-009507513-1907USA000919: US-009507513-1907USA000920: US-009507513-1907USA000921: US-009507513-1907USA000922: US-009507513-1907USA000923: US-009507513-1907USA000924: US-009507513-1907USA000925: US-009507513-1907USA000926: US-009507513-1907USA000927: US-009507513-1907USA000928: US-009507513-1907USA000929: US-009507513-1907USA000930: US-009507513-1907USA000931: US-009507513-1907USA000932: US-009507513-1907USA000933: US-009507513-1907USA000934: US-009507513-1907USA000935: US-009507513-1907USA000936: US-009507513-1907USA000937: US-009507513-1907USA000938: US-009507513-1907USA000903:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; multiple patients were vaccinated with an improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 27-JUN-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 ml, orally, LOT# R027157, expiry date 14-JUL-2020 for prophylaxis. The vaccine was exposed to a temperature of 34.2 F for 4 hours and 54 minutes. This call was made because of a digital data logger. There were no previous temperature excursions. No adverse effects were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674: US-009507513-1907USA000862: US-009507513-1907USA000882: US-009507513-1907USA000883: US-009507513-1907USA000884: US-009507513-1907USA000885: US-009507513-1907USA000886: US-009507513-1907USA000887: US-009507513-1907USA000888: US-009507513-1907USA000889: US-009507513-1907USA000890: US-009507513-1907USA000892: US-009507513-1907USA000893: US-009507513-1907USA000894: US-009507513-1907USA000895: US-009507513-1907USA000896: US-009507513-1907USA000897: US-009507513-1907USA000898: US-009507513-1907USA000899: US-009507513-1907USA000900: US-009507513-1907USA000901: US-009507513-1907USA000902: US-009507513-1907USA000904: US-009507513-1907USA000905: US-009507513-1907USA000906: US-009507513-1907USA000907: US-009507513-1907USA000908: US-009507513-1907USA000909: US-009507513-1907USA000910: US-009507513-1907USA000911: US-009507513-1907USA000912: US-009507513-1907USA000913: US-009507513-1907USA000914: US-009507513-1907USA000915: US-009507513-1907USA000916: US-009507513-1907USA000917: US-009507513-1907USA000918: US-009507513-1907USA000919: US-009507513-1907USA000920: US-009507513-1907USA000921: US-009507513-1907USA000922: US-009507513-1907USA000923: US-009507513-1907USA000924: US-009507513-1907USA000925: US-009507513-1907USA000926: US-009507513-1907USA000927: US-009507513-1907USA000928: US-009507513-1907USA000929: US-009507513-1907USA000930: US-009507513-1907USA000931: US-009507513-1907USA000932: US-009507513-1907USA000933: US-009507513-1907USA000934: US-009507513-1907USA000935: US-009507513-1907USA000936: US-009507513-1907USA000937: US-009507513-1907USA000938: US-009507513-1907USA000903:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; multiple patients were vaccinated with an improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 22-MAY-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 ml, orally, LOT# R034700, expiry date 16-JUN-2020 for prophylaxis. The vaccine was exposed to a temperature of 34.2 Fahrenheit degrees (F) for 4 hours and 54 minutes. Digital data logger was involved. There were no previous temperature excursions. No adverse effects were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1907USA000862: US-009507513-1907USA000882: US-009507513-1907USA000883: US-009507513-1907USA000884: US-009507513-1907USA000885: US-009507513-1907USA000886: US-009507513-1907USA000887: US-009507513-1907USA000888: US-009507513-1907USA000889: US-009507513-1907USA000890: US-009507513-1907USA000891: US-009507513-1907USA000892: US-009507513-1907USA000893: US-009507513-1907USA000894: US-009507513-1907USA000895: US-009507513-1907USA000896: US-009507513-1907USA000897: US-009507513-1907USA000898: US-009507513-1907USA000899: US-009507513-1907USA000900: US-009507513-1907USA000901: US-009507513-1907USA000902: US-009507513-1907USA000903: US-009507513-1907USA000904: US-009507513-1907USA000905: US-009507513-1907USA000906: US-009507513-1907USA000907: US-009507513-1907USA000908: US-009507513-1907USA000909: US-009507513-1907USA000910: US-009507513-1907USA000911: US-009507513-1907USA000913: US-009507513-1907USA000914: US-009507513-1907USA000915: US-009507513-1907USA000916: US-009507513-1907USA000917: US-009507513-1907USA000918: US-009507513-1907USA000919: US-009507513-1907USA000920: US-009507513-1907USA000921: US-009507513-1907USA000922: US-009507513-1907USA000923: US-009507513-1907USA000924: US-009507513-1907USA000925: US-009507513-1907USA000926: US-009507513-1907USA000927: US-009507513-1907USA000928: US-009507513-1907USA000929: US-009507513-1907USA000930: US-009507513-1907USA000931: US-009507513-1907USA000932: US-009507513-1907USA000933: US-009507513-1907USA000934: US-009507513-1907USA000935: US-009507513-1907USA000936: US-009507513-1907USA000937: US-009507513-1907USA000938: US-009507513-1906USA011674:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; multiple patients were vaccinated with an improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 22-MAY-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 ml, orally (LOT# R034700, expiry date 16-JUN-2020) for prophylaxis. The vaccine was exposed to a temperature of 34.2 Fahrenheit degrees (F) for 4 hours and 54 minutes. Digital data logger was involved. There were no previous temperature excursions. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA000862: US-009507513-1907USA000882: US-009507513-1907USA000883: US-009507513-1907USA000884: US-009507513-1907USA000885: US-009507513-1907USA000886: US-009507513-1907USA000887: US-009507513-1907USA000888: US-009507513-1907USA000889: US-009507513-1907USA000890: US-009507513-1907USA000891: US-009507513-1907USA000892: US-009507513-1907USA000893: US-009507513-1907USA000894: US-009507513-1907USA000895: US-009507513-1907USA000896: US-009507513-1907USA000897: US-009507513-1907USA000898: US-009507513-1907USA000899: US-009507513-1907USA000900: US-009507513-1907USA000901: US-009507513-1907USA000902: US-009507513-1907USA000903: US-009507513-1907USA000904: US-009507513-1907USA000905: US-009507513-1907USA000906: US-009507513-1907USA000907: US-009507513-1907USA000908: US-009507513-1907USA000909: US-009507513-1907USA000910: US-009507513-1907USA000911: US-009507513-1907USA000912: US-009507513-1907USA000914: US-009507513-1907USA000915: US-009507513-1907USA000916: US-009507513-1907USA000917: US-009507513-1907USA000918: US-009507513-1907USA000919: US-009507513-1907USA000920: US-009507513-1907USA000921: US-009507513-1907USA000922: US-009507513-1907USA000923: US-009507513-1907USA000924: US-009507513-1907USA000925: US-009507513-1907USA000926: US-009507513-1907USA000927: US-009507513-1907USA000928: US-009507513-1907USA000929: US-009507513-1907USA000930: US-009507513-1907USA000931: US-009507513-1907USA000932: US-009507513-1907USA000933: US-009507513-1907USA000934: US-009507513-1907USA000935: US-009507513-1907USA000936: US-009507513-1907USA000937: US-009507513-1907USA000938: US-009507513-1906USA011674:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; Improperly stored doses administered; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions/allergies and concomitant medications were not reported.  On 07-JUN-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial, orally (strength and dose were not reported)  lot # R033252, expiry date 29-JUN-2019, for prophylaxis. The suspect vaccine was stored in a temperature below 36 Fahrenheit (F) degrees ( 34 F) for 24 hours. There was no previous temperature excursions. Digital data logger was involved. No adverse effects were reported.  This is one of six reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA003061: US-009507513-1907USA003060: US-009507513-1907USA003059: US-009507513-1907USA003062: US-009507513-1907USA003058:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; Improperly stored doses administered; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions/allergies and concomitant medications were not reported.  On 11-JUN-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial, orally (strength and dose were not reported) lot # R033252, expiry date 29-JUN-2020, for prophylaxis. The suspect vaccine was stored in a temperature below 36 Fahrenheit degrees (F) (34 F) for 24 hours. There were no previous temperature excursions. Digital data logger was involved. No adverse effects were reported.  This is one of six reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA003061: US-009507513-1907USA003060: US-009507513-1907USA002834: US-009507513-1907USA003062: US-009507513-1907USA003058:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; Improperly stored doses administered; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions/allergies and concomitant medications were not reported.  On 13-JUN-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial, orally (strength and dose were not reported) lot # R033252, expiry date 29-JUN-2020, for prophylaxis. The suspect vaccine was stored in a temperature below 36 Fahrenheit degrees (F) (34 F) for 24 hours. There were no previous temperature excursions. Digital data logger was involved. No adverse effects were reported.  This is one of six reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA003061: US-009507513-1907USA002834: US-009507513-1907USA003059: US-009507513-1907USA003062: US-009507513-1907USA003058:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; Improperly stored doses administered; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions/allergies and concomitant medications were not reported.  On 20-JUN-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial, orally (strength and dose were not reported) lot # R033252, expiry date 29-JUN-2020, for prophylaxis. The suspect vaccine was stored in a temperature below 36 Fahrenheit degrees (F) (34 F) for 24 hours. There were no previous temperature excursions. Digital data logger was involved. No adverse effects were reported.  This is one of six reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA002834: US-009507513-1907USA003060: US-009507513-1907USA003059: US-009507513-1907USA003062: US-009507513-1907USA003058:
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Anaphylactic reaction, Cough, Dyspnoea, Irritability, Throat irritation
Clinical narrative: Patient  had ananphylaxis to immunization throat itching and coughing with vomiting about 15 minutes are vaccines were given. Breathing became tight epi pen jr dose given in  claritin 5 mg tabley and  steroid given    hives still present 45 minutes out irritable otherwise ok  to go home epiniphine f/u 1-2 hours  to ER if worse benadryl 25 mg every 6 hours for 24 hours. Pt went to ER due to onset of wheezing was given breathing treatment and observed overnight at Hospital with possible release on 7/9/19.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Urticaria, Vomiting, Wheezing
Clinical narrative: Patient  had ananphylaxis to immunization throat itching and coughing with vomiting about 15 minutes are vaccines were given. Breathing became tight epi pen jr dose given in  claritin 5 mg tabley and  steroid given    hives still present 45 minutes out irritable otherwise ok  to go home epiniphine f/u 1-2 hours  to ER if worse benadryl 25 mg every 6 hours for 24 hours. Pt went to ER due to onset of wheezing was given breathing treatment and observed overnight at Hospital with possible release on 7/9/19.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEP, HEPA
Symptoms: Gait disturbance, Injection site rash, Injection site reaction, Injection site warmth, Rash macular
Clinical narrative: day 1 post immunization: rash/ blotchy redness on left thigh with localized swelling,  seemed to limp on left side was still active per normal does not seem affected by touch, warm to touch. redness continued for 5 days.  no fever.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEP, HEPA
Symptoms: Swelling
Clinical narrative: day 1 post immunization: rash/ blotchy redness on left thigh with localized swelling,  seemed to limp on left side was still active per normal does not seem affected by touch, warm to touch. redness continued for 5 days.  no fever.
Age: 33.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Erythema, Immediate post-injection reaction, Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: Immediately experienced arm pain. As the day went on, the pain escalated substantially. I essentially lost all use of my right arm the pain was so excruciating. My arm also swelled up and turned red and slightly purplish. (Took pictures of it, too.) I would try to move/lift my arm but absolutely could not. By late Sunday/early Monday (Jun 30/Jul1), the pain lessened some. The swelling went down by Wed., 7/3. It is nearly 2 weeks later, and I am still experiencing constant pain with sharp sudden pains when I raise my arm, try to sleep on my side, or use my muscles. I am concerned I may have permanent nerve damage now.
Age: 33.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Peripheral swelling, Skin discolouration
Clinical narrative: Immediately experienced arm pain. As the day went on, the pain escalated substantially. I essentially lost all use of my right arm the pain was so excruciating. My arm also swelled up and turned red and slightly purplish. (Took pictures of it, too.) I would try to move/lift my arm but absolutely could not. By late Sunday/early Monday (Jun 30/Jul1), the pain lessened some. The swelling went down by Wed., 7/3. It is nearly 2 weeks later, and I am still experiencing constant pain with sharp sudden pains when I raise my arm, try to sleep on my side, or use my muscles. I am concerned I may have permanent nerve damage now.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Fall, Head injury, Syncope
Clinical narrative: pt fainted, falling off exam bed and hitting head on floor.  Cool compress applied to knot at forehead, pt to be referred to ER for further evaluation
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Headache, Peripheral swelling, Pyrexia, Rash
Clinical narrative: Swollen arm, fever, headache, stomach ache, rash on arm.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Feeding disorder, Feeling abnormal, Fluid intake reduced
Clinical narrative: Sore arm.  Extreme fatigue.  Could not stay awake for a day and a half.  Nausea. Extreme soreness in joints and muscles.  Unable to eat or drink.  Headache.  Completely "knocked out" feeling.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea, Pain in extremity, Somnolence
Clinical narrative: Sore arm.  Extreme fatigue.  Could not stay awake for a day and a half.  Nausea. Extreme soreness in joints and muscles.  Unable to eat or drink.  Headache.  Completely "knocked out" feeling.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: arm pain intermittently x 2 months