chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Muscular weakness, Myalgia, Wheelchair user
Clinical narrative: 11-28-2016 Patient received HPV #2, from these he progressively developed generalized muscle weakness/pain to the point of becoming wheelchair bearer.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an other health professional refers to an unspecified number of patients of unknown ages and genders. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # M043582 for prophylaxis. Other suspect therapies included sterile diluent. On an unknown date, the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event was unknown. The reporter considered incorrect product storage and no adverse event to be not related to sterile diluent and VARIVAX. This is one of two reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA011729.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a multiple patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On multiple unknown dates, the multiple unknown patients were vaccinated with improperly stored doses of PROQUAD (lot# M037651 with expiry date: 28-FEB-2018, lot# M034691 with expiry date: 24-JAN-2018, lot# M031945 with expiry date: 27-DEC-2017 and lot# M029801 with expiry date: 10-DEC-2017) for prophylaxis along with properly stored sterile diluent (lot and expiration date unknown by the reporter). The doses of PROQUAD were exposed to temperature excursion of 6 degree Fahrenheit (°F) to 14 °F for 5 hours. There were no previous temperature excursion reported. The call was not due to data logger. No adverse effects were reported. No product quality complaint was filed. This is one of three reports received from the same reporter. Sender's Comments: US-009507513-1709USA001926: US-009507513-1709USA001928.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a female patient of unknown age. The patient's medical history, concomitant medications and concurrent conditions were not reported. On an unknown date in approximately 2015 (reported as about two years ago), the patient was vaccinated with ZOSTAVAX (dose, route, anatomical location, lot# and expiration date were not reported) for prevention of shingles. On an unknown date in approximately 2017 (reported as about two years after receiving ZOSTAVAX), the patient developed shingles. The outcome of the event and the relatedness between the event and ZOSTAVAX were not reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to unspecified number of patients of unknown ages and genders. There was no information about the patients' pertinent medical history, drug reactions or allergies and concomitant therapies provided. On unspecified dates, the patients were vaccinated with improperly stored doses of VARIVAX (dose number, exact dose, route of administration were not provided; lot # N014371 with the expiration date of 09-MAY-2019), for prophylaxis. The vaccines were reconstituted with properly stored sterile diluent (lot# and expiration date were not reported). No adverse effects were reported. The administered doses of vaccines experienced a temperature excursion between 6 and 14 Fahrenheit degrees for 40 minutes. Digital data logger was used to capture the temperature excursion. There were no previous temperature excursions reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 14-AUG-2017, the patient was vaccinated with an improperly stored VARIVAX at a dose of 0.5 (units not specified) from lot # N000683 with expiry date: 06-JAN-2019 (dose number, route, anatomical location and site of administration were not reported) for prophylaxis. Concomitant medications included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA004945.
Age: 2.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 2 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 16-AUG-2017, the patient was vaccinated with an improperly stored VARIVAX at a dose of 0.5 (units not specified) from lot # N000683 with expiry date: 06-JAN-2019 (dose number, route, anatomical location and site of administration were not reported) for prophylaxis. Concomitant medications included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA004945.
Age: 6.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 6 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 14-AUG-2017, the patient was vaccinated with an improperly stored VARIVAX at a dose of 0.5 (units not specified) from lot # N000683 with expiry date: 06-JAN-2019 (dose number, route, anatomical location and site of administration were not reported) for prophylaxis. Concomitant medications included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter.
Age: 9.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 9 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 20-JUL-2017, the patient was vaccinated with an improperly stored VARIVAX at a dose of 0.5 (units not specified) from lot # N000683 with expiry date: 06-JAN-2019 (dose number, route, anatomical location and site of administration were not reported) for prophylaxis. Concomitant medications included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA004945.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia
Clinical narrative: This spontaneous report was received from a 81 year old female patient, who was referring to herself. The patient's current conditions included high blood pressure and an unspecified thyroid disorder. The patient was allergic to sulfonamides. The patient's historical medication included a pill for eye pressure vision. On an unknown date in approximately 2012 (reported as 4 to 5 years ago), the patient was vaccinated with ZOSTAVAX in the left arm to prevent shingles (dose, route of administration, lot # and expiration date were not reported). Concomitant medications included high blood pressure medication and thyroid medication. On an unknown date in approximately 2014 (reported as about 2 to 3 years after the vaccination), the patient got shingles two times. On an unknown date, the patient started experiencing nerve ending twinges in her back, intermittently, that lasted for 2 to 5 minutes at a time, but the last one lasted longer than most. The patient did not receive treatment for the adverse events. The outcome of the adverse events and the relatedness between the adverse events and ZOSTAVAX were not reported.
Age: 0.08
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Respiration abnormal
Clinical narrative: Initial unsolicited report received from a consumer (patient's mother) on 01-Sep-2017. This case involves 2 month old male patient who was vaccinated with a first dose of PENTACEL, ROTATEQ and PREVENAR 13 (batch number, expiry date, site, route, dose were not reported) on an unknown date of Jun-2017. Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) were none as per reporter and illness at the time of vaccination were not reported. Had family history of Parkinson's. Any other vaccinations within four weeks of vaccinations were also not reported. On an unknown date, few days following vaccination patient had funny breathing when sleeping or weird breathing pattern when sleeping. It was also reported that at 4 month of age physician visit only received ROTATEQ and PREVNAR vaccines and had the same events. Stated had not informed physician of the symptoms but has another appointment for her son in this month, September, 2017, and she planned to discuss with physician at time of that visit. Laboratory investigations and corrective treatment were not reported. Event outcome was unknown. List of documents held by sender: none.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration
Clinical narrative: Central 4cm hard red area in tricep region of R arm with 17x9 cm redness around that. Using OTC hydrocort and ice. Patient does have a fold and hold rx for Keflex in case of worsening symptoms.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Influenza, Insomnia, Malaise, Sleep disorder
Clinical narrative: H1N1 vaccine 9-23-09 about 2 weeks later came down with the flu. Was very sick I lost my ability to go to sleep. It never returned will be 8 years in Oct 2017!! The sleep disorder I developed is deadly without sleep medication and is very debilitating. I developed some rare freak sleep disorder that has almost killed me on more than one occasion-It began in Oct 2009 and I have desperately been looking for answers ever since. No one seemed to be able to help me. I was finally able to put a huge piece of the puzzle together about 6 months ago when I was reading through my diary which I noted my flu vac. date and when I came down with the flu as well as like a switch my ability to sleep was turned off-literally overnight and was never to return!!! All in Oct 2009-I read about the 800 children in another country who developed narcolepsy from the H1N1 flu vaccine. I developed the opposite of that: I can NEVER go to sleep-I have been to countless Doctors and on countless medications for this problem for almost 8 years now!! My life has never been the same and my Doctor says I will need to be on sleep medications the rest of my life. I am currently on 60 mg temazepam every night. I have been on 10 mg SILENOR the temazepam since 2011. That gives me some quality of life however I went from a 9-10 hrs a night sleeper to 5 hrs (Average) per night. This is a very debilitating sleep disorder that I probably should not have survived. I hope and pray that someone can shed some light on this horrible disorder and maybe save someone else from having to go through what I have and still am going through.
Age: 65.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Erythema, Headache, Injected limb mobility decreased, Injection site swelling, Nausea
Clinical narrative: Pain at 9 (1-10 scale) in arm, up neck and down left side, can't raise or use arm, headache, low grade fever, hot red skin, swollen at shot site and moving down arm towards elbow, rash, nausea.
Age: 65.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Neck pain, Pain in extremity, Pyrexia, Rash, Skin warm
Clinical narrative: Pain at 9 (1-10 scale) in arm, up neck and down left side, can't raise or use arm, headache, low grade fever, hot red skin, swollen at shot site and moving down arm towards elbow, rash, nausea.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Glycosylated haemoglobin, Headache, Lipids, Malaise
Clinical narrative: Pt got vaccine on 8/23/17. On 8/24/17, he had a fever (pt did not specify how high) and didn't feel well for 24 hours. On 8/31/17, pt again had a fever of 100.5, joints hurt, severe headache. Fever lasted 2 days. On 9/1/17, his scrotum was swollen and very painful. Still having joint pain and headaches. Pt was seen in office on 9/5/17. The fever, joint pain, and headache had resolved. Pt still had swollen testicles. The swelling had decreased and they were no longer painful.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Metabolic function test, Pyrexia, Scrotal pain, Scrotal swelling, Testicular swelling
Clinical narrative: Pt got vaccine on 8/23/17. On 8/24/17, he had a fever (pt did not specify how high) and didn't feel well for 24 hours. On 8/31/17, pt again had a fever of 100.5, joints hurt, severe headache. Fever lasted 2 days. On 9/1/17, his scrotum was swollen and very painful. Still having joint pain and headaches. Pt was seen in office on 9/5/17. The fever, joint pain, and headache had resolved. Pt still had swollen testicles. The swelling had decreased and they were no longer painful.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site inflammation, Injection site pruritus
Clinical narrative: Minor Cellulitis Reaction to ZOSTAVAX vaccine. Patient came to the pharmacy and showed pharmacist the injection site which was red, slightly inflamed, and itching. The diameter covered approximately 5-6 inches from the injection site. The patient was counseled to apply cool compress/ice to the area to help with inflammation and BENADRYL to help with the itching. She was further counseled to report any worsening symptoms to MD. After review, there was no reason to believe that the vaccine was administered improperly, so we are deciding the patient is simply having a minor cellulitis reaction because of it.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a 14 patients of unknown ages and genders. On unknown dates, starting from 18-MAY-2016, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot# M011840, expiration date 01-FEB-2018; lot# M026306, expiration date 30-APR-2018; lot# M031557, expiration date 07-APR-2018; lot# K016966, expiration date 10-MAY-2017; lot# K010215, expiration date 05-MAY-2017 for prophylaxis. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD albumin status rHa, lot # M032496, expiration date 02-JAN-2018 (dose and route of administration were not reported). Administered doses of vaccines experienced the temperature excursions from 15 degrees Fahrenheit to 46 degrees Fahrenheit (also reported as 34.4 degrees Fahrenheit) for 9 hours and 30 minutes and then from 15 degrees Fahrenheit to 46 degrees Fahrenheit (also reported as 25.3 degrees Fahrenheit) for 17 hours and 30 minutes. There was no adverse effect reported. The data logger was not involved. This is one of two reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA011668.
Age: 0.0
Sex: F
Vaccine: HEP
Symptoms: Blood bilirubin increased, Jaundice neonatal
Clinical narrative: This spontaneous report has been received from a patient's mother and refers to a 4-day-old non-pregnant female patient. The patient had no concomitant medications, pertinent medical history and drug reactions or allergies. In January 2009, the patient was vaccinated with RECOMBIVAX HB lot # 662390/1039X, dose 1, intramuscularly (dose and expiration date were not reported). On an unknown date, the patient experienced jaundice. A bilirubin test and blood work was given and the patient had elevated high numbers (no specific or other symptoms were given). It took about six weeks to reach a "normal reading". No specific number ranges were provided. No subsequent doses were received. The reporter stated that the patient was 8 years old at the reporting time and has since recovered. No product quality complaint was involved. The reporter requested a total number of manufactured doses of this particular lot #. The outcome of jaundice was reported as recovered (unspecified date). The relatedness between the event and RECOMBIVAX HB was not reported. Additional information is not expected because there was no consent to contact the patient's physician.
Sex: U
Vaccine: MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age or gender. No information was provided regarding the patient's pertinent medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was inadvertently vaccinated with an unintended extra dose of M-M-R II (exact dose, therapy type, route of administration, lot number and expiration date were not reported), for prophylaxis. The vaccine was reconstituted with sterile diluent (lot# and expiration date were not reported). No adverse effects were reported.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant medications were not provided. On 06-SEP-2017, the patient was vaccinated with an expired dose of ZOSTAVAX lot # M026876 expiration date on 24-JUL-2017, subcutaneous for prophylaxis which was reconstituted with sterile diluent. At the reporting time, no adverse events were reported.
Age: 0.67
Sex: M
Vaccine: PNC13
Symptoms: Death, Pneumonia streptococcal, Streptococcus test positive
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program received from a contactable consumer (patient's parent). A male patient of unspecified age and race/ethnicity received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. Relevant medical history and concomitant medications were not reported. The patient experienced Streptococcus pneumoniae serotype 35B. On an unspecified date the patient underwent lab tests and procedures which included serology test: serotype 35B. The patient died due to the event on 05May2017, he was almost 9 months old. It was unknown if an autopsy was performed. Reported Cause(s) of Death: Streptococcus pneumoniae serotype 35B.
Sex: F
Vaccine: PNC13
Symptoms: Allergy to vaccine, Pruritus, Urticaria
Clinical narrative: This is a spontaneous report from a contactable nurse for a patient enrolled in a Pfizer-sponsored program; this report is in regards to events reported in the patient's past medical history. A currently 23-year-old female patient of an unspecified ethnicity received PREVNAR, via an unspecified route of administration on an unspecified date at single dose for immunisation and CIPRO, via an unspecified route of administration on an unspecified date at an unspecified dose for an unspecified indication. Medical history included allergy to sulfa. The patient's concomitant medications were not reported. On unknown dates, the patient experienced drug allergies to PREVNAR and CIPRO in the form of hives and itching. The action taken in response to the event for PREVNAR was not applicable and for CIPRO was unknown. The clinical outcome of the events, drug allergy, hives, and itching, was unknown.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Malaise, Oropharyngeal pain, Productive cough
Clinical narrative: This is a spontaneous report from a contactable consumer reported for his wife. A 77-years-old female patient received PREVNAR 13, via an unspecified route of administration at the right arm on 31Aug2017 at 0.5 ml, single for prevention of pneumonia. The patient medical history was not reported. Concomitant medication included Vitamin D3 5000 IU every other day, started a couple of years ago, IMODIUM 2mg one tablet a day over the counter started 3-4 years ago for diverticulitis. She got sick on Monday 04Sep2017 and it started with a sore throat. It was sore this morning but is better now. A lot of phlegm started on Monday 04Sep2017. It is a little better now but not much. The doctors told her to take MUCINEX but she has not started that yet. She had headache on Monday 04Sep2017. She took some aspirin this morning because the headache was bad when she got up this morning. She had no reaction around the injection site. The outcome of sore throat and a lot of phlegm was recovering, of headache was not recovered, of feeling sick was unknown.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient's wife said his arm is very sore and seems to have inability to move it freely. She thinks we may have irritated a nerve in the arm. She suggested that they may have to seek medical care for treatment.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash
Clinical narrative: Rash on patient's face, itching. Patient reported taking BENADRYL.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: On day after vaccine, developed redness and swelling of Lt arm from injection site to elbow. Itchy from elbow. Slight warmth to touch. No pain. Seen 9/8/17.
Age: 11.0
Sex: F
Vaccine: FLU4, MNQ, TDAP
Symptoms: Contusion, Erythema, Injected limb mobility decreased, Pain in extremity
Clinical narrative: The day of it was red, mother put cold packs on and give her TYLENOL. The next day it look green like a bruise couldn't move arm. Patient got better after 2 days just had a little arm pain. Mother told us this morning 09/11/2017 that patient is doing better now. Left arm.
Age: 0.33
Sex: F
Vaccine: DTAPIPV, PNC13, RV1
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Wrong vaccine was given. (KINREX instead of PENTACEL) No reaction.
Age: 81.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Peripheral swelling, Pyrexia, Rash, Tenderness
Clinical narrative: Patient reported feeling weak, fever, severely swollen and tender arm, and localized rash. Symptoms lasted 9/7/17 through 9/11/17. Rash is still present as of 9/11/17.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Discomfort, Erythema, Injection site reaction, Peripheral swelling
Clinical narrative: Large area of arm Swelling, redness, discomfort, liquid filled blisters with clear fluids, then irritation reduced and then skin started to flake. Patient came to see me on 09/11/2017 and skin was flaking around injection site.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin exfoliation
Clinical narrative: Large area of arm Swelling, redness, discomfort, liquid filled blisters with clear fluids, then irritation reduced and then skin started to flake. Patient came to see me on 09/11/2017 and skin was flaking around injection site.
Age: 22.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Loss of consciousness, Posture abnormal
Clinical narrative: Patient received 2 immunizations (HAV/Tdap); after getting both patient became quiet and started leaning out of his chair. Nurse attempted to catch patient, and slow his fall to the floor. Patient quickly regained consciousness and sat up, nurse assisted him to recliner to lie down. Patient stated he had "passed out" before, when giving blood. VS B/P118/60, P86, R16. Patient drank a Gatorade and waited 30 minutes before leaving. Stated he felt fine. Patient seen by physician immediately after incident.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Induration, Injection site erythema, Nodule, Pyrexia, Swelling
Clinical narrative: Patient stated they experienced the following: redness at injection site, fever, swelling, hard knot that they have never experienced with any other vaccine before.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Pyrexia
Clinical narrative: Fever to 102.4, upper arm redness and swelling.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 24-JUN-2011 the patient was vaccinated with ZOSTAVAX, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 08-FEB-2013 the patient was treated at an Urgent Care clinic for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient was referred by the urgent care facility to a physician for subsequent treatment of her severe shingles. The patient has been prescribed acyclovir for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Ophthalmic herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 02-JAN-2008 the patient was vaccinated with ZOSTAVAX, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 11-AUG-2015, the patient was treated by a Physician Assistant for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles accompanied by trigeminal neuralgia. On or about 12-AUG-2015, the patient received subsequent treatment from another physician at an Urgent Care facility for continued and worsening symptoms or shingles and progressive trigeminal neuralgia. On or about 13-AUG-2015 the patient was treated by another physician for worsening outbreaks of shingles and complications. Shingles has spread to the patient's back, neck, scalp and eyes, resulting in ocular adnexa, herpes zoster conjunctivitis, and keratitis. Because of the serious complications of zoster infections throughout the body and in the eye and trigeminal neuralgia, the patient has been prescribed acyclovir, baclofen, NORCO, ARTIFICIAL TEARS, lid care therapy, VALTREX, EMYCIN and other medications for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Upon internal review herpes zoster conjunctivitis was considered a medically significant event. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Trigeminal neuralgia
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 02-JAN-2008 the patient was vaccinated with ZOSTAVAX, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 11-AUG-2015, the patient was treated by a Physician Assistant for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles accompanied by trigeminal neuralgia. On or about 12-AUG-2015, the patient received subsequent treatment from another physician at an Urgent Care facility for continued and worsening symptoms or shingles and progressive trigeminal neuralgia. On or about 13-AUG-2015 the patient was treated by another physician for worsening outbreaks of shingles and complications. Shingles has spread to the patient's back, neck, scalp and eyes, resulting in ocular adnexa, herpes zoster conjunctivitis, and keratitis. Because of the serious complications of zoster infections throughout the body and in the eye and trigeminal neuralgia, the patient has been prescribed acyclovir, baclofen, NORCO, ARTIFICIAL TEARS, lid care therapy, VALTREX, EMYCIN and other medications for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Upon internal review herpes zoster conjunctivitis was considered a medically significant event. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report was received from a nurse refers to an adult patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were unknown. On 17-AUG-2017, the adult patient was vaccinated with one pediatric dose of VAQTA 25/0.5 (unit unspecified) (lot # M015290, expiry date: 20-SEP-2017) (dose volume and route unspecified) for prophylaxis (drug administered to patient of inappropriate age). No adverse effects were reported. No product quality complaint was involved.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from other health professional (licensed practical nurse) and refers to a unspecified multiple patients of unknown demographics. There was no information on patient's medical history, concurrent condition, concomitant medication and drug allergies/reactions.  On an unknown date, unspecified multiple patients were vaccinated with improperly stored GARDASIL 9 (dose, frequency, lot#, expiration date and indication not provided). No adverse effects were reported. The vaccine was stored at temperature of 0.3 degree Celsius for 6 hours. Data logger was involved. There was no previous temperature excursions. No additional information provided. No product quality complaint was involved. No further information provided. This case has been linked with the 1709USA004997, 1709USA004998 and 1709USA004999 as same reporter link. Sender's Comments: US-009507513-1709USA004998: US-009507513-1709USA004999: US-009507513-1709USA004997.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history, or concomitant medications. The reporter stated that on 19-JUL-2017, the patient received a dose of VAQTA 25/0.5 (units not provided) (route of administration, lot# and expiration date were not provided). On 29-AUG-2017, the patient was vaccinated with the second dose of VAQTA,25/0.5 (units not provided) lot # N014945, expiration date 31-AUG-2018, for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product quality issue
Clinical narrative: Information has been received from a pharmacist, concerning a patient of an unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported. On an unknown date, the patient was vaccinated with an unspecified dose of ZOSTAVAX vial 19400 PFU, lot number: N012615 with expiration date in 16-MAR-2018 (dosage schedule, anatomical location and route of administration were not provided) for prophylaxis. The pharmacist reported that the ZOSTAVAX vial was difficult to pierce, but was still administered to a patient. No symptoms were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from other health professional (licensed practical nurse) and refers to a unspecified multiple patients of unknown demographics. There was no information on patient's medical history, concurrent condition, concomitant medication and drug allergies/reactions. On an unknown date, unspecified multiple patients were vaccinated with improperly stored ROTATEQ via oral route for prophylaxis (dose, frequency, lot#, expiration date not provided). No adverse effects were reported. The vaccine was stored at temperature of 0.3 degree Celsius for 6 hours. Data logger was involved. There was no previous temperature excursions. No additional information provided. No product quality complaint was involved. No further information provided. This case has been linked with the 1709USA000855, 1709USA004998 and 1709USA004999 as same reporter link. Sender's Comments: US-009507513-1709USA000855: US-009507513-1709USA004998: US-009507513-1709USA004999.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from other health professional (licensed practical nurse) and refers to a unspecified multiple patients of unknown demographics. There was no information on patient's medical history, concurrent condition, concomitant medication and drug allergies/reactions. On an unknown date, unspecified multiple patients were vaccinated with improperly stored VAQTA (dose, frequency, lot#, expiration date and indication not provided). No adverse effects were reported. The vaccine was stored at temperature of 0.3 degree Celsius for 6 hours. Data logger was involved. There was no previous temperature excursions. No additional information provided. No product quality complaint was involved. No further information provided. This case has been linked with the 1709USA000855, 1709USA004997 and 1709USA004999 as same reporter link. Sender's Comments: US-009507513-1709USA000855: US-009507513-1709USA004997: US-009507513-1709USA004999.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from other health professional (licensed practical nurse) and refers to a unspecified multiple patients of unknown demographics. There was no information on patient's medical history, concurrent condition, concomitant medication and drug allergies/reactions. On an unknown date, unspecified multiple patients were vaccinated with improperly stored PEDVAXHIB (dose, frequency, lot#, expiration date and indication not provided). No adverse effects were reported. The vaccine was stored at temperature of 0.3 degree Celsius for 6 hours. Data logger was involved. There was no previous temperature excursions. No additional information provided. No product quality complaint was involved. No further information provided. This case has been linked with the 1709USA000855, 1709USA004997 and 1709USA004998 as same reporter link. Sender's Comments: US-009507513-1709USA000855: US-009507513-1709USA004997: US-009507513-1709USA004998.
Age: 75.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Hypoaesthesia, Muscular weakness, Speech disorder
Clinical narrative: Right hand numb/weak. Was using incorrect words during conversation-knew what wanted to say but unable to make words come out. Lasted short time and then completely resolved.
Age: 67.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: On 9/10/17 (a.m.) pt. called stating she has an area of redness at injection site on (R) arm, extending from shoulder to mid-upper arm. Pt. was evaluated at clinic, diagnosed w/cellulitis.
Age: 38.0
Sex: U
Vaccine: MMR
Symptoms: Asthenia, Chills, Dizziness, Headache, Hyperhidrosis
Clinical narrative: About 2 hours after receiving vaccine started having headache on Friday, 9/8, was getting kind of lightheaded and started getting a fever and body aches. States her fever got up to 102, took some TYLENOL for that. States on Sunday, had sweats, Temp 101-102, body aches, dizziness and took TYLENOL. Monday feels little lightheaded and dizzy, weak, chills off and on. Has been eating and drinking ok. Has not taken temperature today.
Age: 38.0
Sex: U
Vaccine: MMR
Symptoms: Pain, Pyrexia
Clinical narrative: About 2 hours after receiving vaccine started having headache on Friday, 9/8, was getting kind of lightheaded and started getting a fever and body aches. States her fever got up to 102, took some TYLENOL for that. States on Sunday, had sweats, Temp 101-102, body aches, dizziness and took TYLENOL. Monday feels little lightheaded and dizzy, weak, chills off and on. Has been eating and drinking ok. Has not taken temperature today.
Age: 59.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Erythema, Influenza like illness, Thirst
Clinical narrative: REDNESS, FLU LIKE SYMPTOMS, WANTING TO DRINK FLUIDS STARTING THE EVENING OF THE DAY OF VACCINE ADMINISTRATION.
Age: 24.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Burning sensation, Injection site erythema, Injection site swelling, Rash erythematous, Rash generalised
Clinical narrative: After both injections, I had swelling, warmth, redness, and itching in a circular rash with a 3 inch diameter around the site. Two days later the symptoms had not subsided and a layer of skin peeled off. Four days later another layer of skin peeled off and several circular 0.5 inch diameter spots began to develop on my left upper arm, armpit, left breast, and forearm. Six days after injection several spots developed on my neck, face, bilateral arms, breast, and scalp. Two weeks after injection I have spots all over my body including hands, face, scalp, feet, legs, trunk, back, and bilateral arms. These spots range from 3 cms to about 2 inches in diameter, they are circular, raised, red, and have areas of white flakey skin that peels off and grows back inside the spots. They are itchy, burn sometimes, and are visually unappealing. The injection site is still swollen, red, raised, and has shed about 5 layers of skin. Since the start of the rash 24 days ago I have not shaved or used any type of razor, have not changed detergents, have only used Dove white unscented bar soap, have not changed shampoos or lotions, have not changed my eating habits, have not changed any medication, and basically to sum it up I have not brought anything new to my body besides my vaccines. I was given Terbinafine HCL 250mg tablets and Clotrimazole cream on 8/31 and have been using them with no relief of symptoms. The rash has not subsided since using the medication and multiple new spots have occurred. An aerobic culture was taken from the injection site and sent by Dr. that resulted in no growth. I contacted the Health Department, talked to 4 different people, and was told "this is normal" by each one. This is clearly not normal.
Age: 24.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash pruritic, Skin exfoliation
Clinical narrative: After both injections, I had swelling, warmth, redness, and itching in a circular rash with a 3 inch diameter around the site. Two days later the symptoms had not subsided and a layer of skin peeled off. Four days later another layer of skin peeled off and several circular 0.5 inch diameter spots began to develop on my left upper arm, armpit, left breast, and forearm. Six days after injection several spots developed on my neck, face, bilateral arms, breast, and scalp. Two weeks after injection I have spots all over my body including hands, face, scalp, feet, legs, trunk, back, and bilateral arms. These spots range from 3 cms to about 2 inches in diameter, they are circular, raised, red, and have areas of white flakey skin that peels off and grows back inside the spots. They are itchy, burn sometimes, and are visually unappealing. The injection site is still swollen, red, raised, and has shed about 5 layers of skin. Since the start of the rash 24 days ago I have not shaved or used any type of razor, have not changed detergents, have only used Dove white unscented bar soap, have not changed shampoos or lotions, have not changed my eating habits, have not changed any medication, and basically to sum it up I have not brought anything new to my body besides my vaccines. I was given Terbinafine HCL 250mg tablets and Clotrimazole cream on 8/31 and have been using them with no relief of symptoms. The rash has not subsided since using the medication and multiple new spots have occurred. An aerobic culture was taken from the injection site and sent by Dr. that resulted in no growth. I contacted the Health Department, talked to 4 different people, and was told "this is normal" by each one. This is clearly not normal.
Age: 53.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Influenza like illness, Pyrexia
Clinical narrative: FLU LIKE SYMPTOMS WITH FEVER, RED ARMS STARTING THE EVENING OF DAY OF VACCINE ADMINISTRATION.
Age: 0.33
Sex: F
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Nothing reported at this time.
Age: 0.0
Sex: F
Vaccine: HEP
Symptoms: Death, Decreased appetite, Diarrhoea, Irritability, Pain
Clinical narrative: Started with diarrhea the day after her vaccination. Daughter was fussy and seemed to be in pain and not eating much. Patient died at hospital on 04/06/2017. Hospital 1: Medical Center ER, transferred to another city via helicopter. Hospital 2: Hospital.
Age: 62.0
Sex: F
Vaccine: FLUC4, TDAP
Symptoms: Blood test normal, Chest pain, Electrocardiogram normal
Clinical narrative: After leaving store, patient began to experience chest pain. She went with her daughter to Urgent Care, a walk in center. Pain lasted about 1 hour, she was sent to Hospital (assumed for observation) and released later that night ~10pm per patient. Patient says she was feeling better at Urgent Care.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Chills, Cough, Diarrhoea, Feeling hot, Headache
Clinical narrative: 20 yo male presents to clinic for rash onset for about 3 days. Patient states he received the smallpox vaccine on 30 Aug for overseas orders and was told to keep a bandage over it for 7 days. Patient states he did that and the rash just grew 5 times the original size. He admits it itches and painful. Describes it as red and irritated. Admits its having yellowish clear purulent drainage from the area. He admits he's been having body aches, chills, hot sweats, minor cough, minor headache, diarrhea, and feels an onset of a cold. Denies any fever, blood in bowel/urine.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Hyperhidrosis, Nasopharyngitis, Pain, Purulent discharge, Rash erythematous
Clinical narrative: 20 yo male presents to clinic for rash onset for about 3 days. Patient states he received the smallpox vaccine on 30 Aug for overseas orders and was told to keep a bandage over it for 7 days. Patient states he did that and the rash just grew 5 times the original size. He admits it itches and painful. Describes it as red and irritated. Admits its having yellowish clear purulent drainage from the area. He admits he's been having body aches, chills, hot sweats, minor cough, minor headache, diarrhea, and feels an onset of a cold. Denies any fever, blood in bowel/urine.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Rash pruritic, Skin irritation
Clinical narrative: 20 yo male presents to clinic for rash onset for about 3 days. Patient states he received the smallpox vaccine on 30 Aug for overseas orders and was told to keep a bandage over it for 7 days. Patient states he did that and the rash just grew 5 times the original size. He admits it itches and painful. Describes it as red and irritated. Admits its having yellowish clear purulent drainage from the area. He admits he's been having body aches, chills, hot sweats, minor cough, minor headache, diarrhea, and feels an onset of a cold. Denies any fever, blood in bowel/urine.
Age: 77.0
Sex: M
Vaccine: TDAP
Symptoms: Pain in jaw
Clinical narrative: Patient presented with radiating pain up through jawline. Patient was instructed to take 50mg of BENADRYL, to call 911 and/or go the hospital immediately.
Age: 48.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Vomiting
Clinical narrative: Patient received vaccination for influenza today and within 45 minutes began vomiting in the restroom. The patient doesn't feel good. The patient does not have any hives, shortness of breath, or signs of allergic reaction. The patient does not feel light headed.
Age: 48.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Dizziness, Retching
Clinical narrative: Patient received vaccination for influenza today and within 45 minutes began vomiting in the restroom. The patient doesn't feel good. The patient does not have any hives, shortness of breath, or signs of allergic reaction. The patient does not feel light headed.
Age: 48.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Vomiting
Clinical narrative: Dry heaves, light headed, tried cracker, water and ice chips over about 30 minutes.
Age: 48.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Dizziness, Retching
Clinical narrative: Dry heaves, light headed, tried cracker, water and ice chips over about 30 minutes.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Peripheral swelling
Clinical narrative: Swelling, redness, edema from the shoulder to the elbow.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Patient reporting swollen and pain bilaterally in feet.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Over 24hrs after vaccine administration mom noticed a red area on his right thigh. No pain, no itching.  Patient was seen in our office 48hrs after vaccine given and had an 8cm x 9cm area of redness, with mild swelling and warmth just distal to the injection site. Phone f/u with mom today (9/11/17) mom reports area is improved.