chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthritis, Burning sensation, Chills, Headache, Influenza like illness
Clinical narrative: "Big patches of painful itching that moved from site to site every day. The itching was different than any I'd had before: it itched but it also burned. I could not sleep and Gold Bond or Bactine didn't help. My sister (the nurse) said to try athlete's foot cream, which did help a little. There was no rash."  The symptoms are almost resolved four weeks later. "I also had flu-like issues - chills (but no fever), nausea, cramps, for example, for several days." "I had daily headaches for the first couple of weeks that reminded me of the ones I get when I don't drink coffee.  Aleve did help with the headaches." "Finally, I had strange muscle pains, oddly they were mostly in my left arm, but with my arthritis and the headaches, I just figured it was a new normal."
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle spasms, Myalgia, Nausea, Pain, Pruritus
Clinical narrative: "Big patches of painful itching that moved from site to site every day. The itching was different than any I'd had before: it itched but it also burned. I could not sleep and Gold Bond or Bactine didn't help. My sister (the nurse) said to try athlete's foot cream, which did help a little. There was no rash."  The symptoms are almost resolved four weeks later. "I also had flu-like issues - chills (but no fever), nausea, cramps, for example, for several days." "I had daily headaches for the first couple of weeks that reminded me of the ones I get when I don't drink coffee.  Aleve did help with the headaches." "Finally, I had strange muscle pains, oddly they were mostly in my left arm, but with my arthritis and the headaches, I just figured it was a new normal."
Age: 2.0
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Dysstasia, Gait inability, Injection site cellulitis, Pain, Pyrexia
Clinical narrative: DEVELOPED PAIN, FEVER, CELLULITIS TO THE SITE, WONT WALK OR STAND.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, X-ray limb
Clinical narrative: CLIENT RETURNED TO CLINIC 6/1/17 AND 7/26/17 DUE TO COMPLAINT OF RIGHT ARM PAIN.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Atrial fibrillation, Chest X-ray, Laboratory test, Pneumonia, Pyrexia
Clinical narrative: 48 hours after administration patient experienced fever - temp max 104 degrees, admitted to hospital x 5 days with diagnosis of pneumonia and A fib.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: PATIENT BEGAN COMPLAINING OF PAIN, WARMTH AND REDNESS IN HER ARM AT INJECTION SITE A FEW HOURS AFTER ADMINISTRATION. BY THE NEXT MORNING THE PAIN HAD INCREASED AND THE REDNESS HAD EXPANDED. THE PAIN INCREASED AND REDNESS PROGRESSED THROUGHOUT THE DAY. BY THE SECOND MORNING AFTER ADMINISTRATION, THE PATIENT WAS VERY UNCOMFORTABLE AND SOUGHT MEDICAL ATTENTION AT THE EMERGENCY ROOM. SHE WAS DIAGNOSED WITH LOCALIZED CELLULITIS.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Headache, Limb mass, Mobility decreased, Pain in extremity
Clinical narrative: They said this was the vacinne given. I do NOT know the manufacturer. I had my first dose in 1998, then in 2003, and then 2008. I thought I was done.. Dr. insisted at last visit for physical that I should do it again and one more time when I turn 65 in 5 years. Don't think I want to repeat this! Okay reaction - A few hours after injection, arm was so painful I could not lift it. It was warm/tender. Next day very painful, but tryed to keep it moving and used heat packs occasionally throughout the day. The 2nd day I woke up and my arm was itching up a storm. I went to scratch and felt lumps all over it. Went to bathroom and discovered several red lumps all over upper arm.  Some were as small as dimes and others the size of quarters. Went to dr. office and saw a nurse who prescribed steriods for 3 days and benadryl. Had hideous headache that I guess came from steriods so rested for 3 days. Now I appear to be fine after a miserable week.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus, Skin warm, Tenderness
Clinical narrative: They said this was the vacinne given. I do NOT know the manufacturer. I had my first dose in 1998, then in 2003, and then 2008. I thought I was done.. Dr. insisted at last visit for physical that I should do it again and one more time when I turn 65 in 5 years. Don't think I want to repeat this! Okay reaction - A few hours after injection, arm was so painful I could not lift it. It was warm/tender. Next day very painful, but tryed to keep it moving and used heat packs occasionally throughout the day. The 2nd day I woke up and my arm was itching up a storm. I went to scratch and felt lumps all over it. Went to bathroom and discovered several red lumps all over upper arm.  Some were as small as dimes and others the size of quarters. Went to dr. office and saw a nurse who prescribed steriods for 3 days and benadryl. Had hideous headache that I guess came from steriods so rested for 3 days. Now I appear to be fine after a miserable week.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 10-JUL-2017, the patient was vaccinated with improperly stored dose of ZOSTAVAX lot # N012493, expiration 17-MAR-2018 (dose and route of administration were not reported) for prophylaxis. No adverse event reported. Temperature: 15 degrees Fahrenheit (°F) to 46°F . Time Frame: 12 hours 19 minutes. No previous temperature excursion. Digital Data logger report was involved. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information was received from a medical assistant regarding a 14-year-old male who received a dose of GARDASIL 9 on 19-AUG-2015 (lot # L019287, expiration 14-SEP-2017) and a second dose of GARDASIL 9 on 01-DEC-2016 (lot # M016193 expiration 24-APR-2018) which is outside of the indication per prescribing information. Concomitant medications and medical history were not reported. No adverse effect was reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Pyrexia, Rash, Rash pruritic
Clinical narrative: This spontaneous report as received from a 61 year old female consumer referring to herself with a history of receiving a "flu shot about 20 years ago and it made her fall to the floor". The patient's concurrent conditions and concomitant medication were not reported. On 15-MAY-2017, the patient was vaccinated with ZOSTAVAX "1 time vaccine" (dose, route of administration, site of administration, lot number and expiration date were not reported) for prophylaxis. On 29-MAY-2017, the patient experienced a rash all over her chest and arm (NOS) that was itchy and hurt. The patient was taking prednisone 40 to 60 mg and cortisone cream 1%. The patient reported that the rash was clearing up but was experiencing vomiting and diarrhoea. In JUL-2017, reported as "this last Sunday", the patient broke out all over again and had terrible chills and fever. The patient reported the rash look like diamond patterns and round circles. The patient reported that she was going to use cortisone cream, about 2.5%. The patient also reported that she uses her inhaler and nebulizer treatments several times since she got the vaccine. The patient reported that she has no pets. The outcome of rash, fever, diarrhoea and vomiting was unknown. Causality assessment was not reported. No further information was provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: This spontaneous report as received from a 61 year old female consumer referring to herself with a history of receiving a "flu shot about 20 years ago and it made her fall to the floor". The patient's concurrent conditions and concomitant medication were not reported. On 15-MAY-2017, the patient was vaccinated with ZOSTAVAX "1 time vaccine" (dose, route of administration, site of administration, lot number and expiration date were not reported) for prophylaxis. On 29-MAY-2017, the patient experienced a rash all over her chest and arm (NOS) that was itchy and hurt. The patient was taking prednisone 40 to 60 mg and cortisone cream 1%. The patient reported that the rash was clearing up but was experiencing vomiting and diarrhoea. In JUL-2017, reported as "this last Sunday", the patient broke out all over again and had terrible chills and fever. The patient reported the rash look like diamond patterns and round circles. The patient reported that she was going to use cortisone cream, about 2.5%. The patient also reported that she uses her inhaler and nebulizer treatments several times since she got the vaccine. The patient reported that she has no pets. The outcome of rash, fever, diarrhoea and vomiting was unknown. Causality assessment was not reported. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Medical Assistant referring to multiple unspecified patients of unknown age and gender. Information regarding the patients' pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided. On multiple unspecified dates, the patients were vaccinated with improperly stored doses of M-M-R II lot # M045101 and expiration date on 10-NOV-2018 reconstituted with a properly stored sterile diluent (reported lot # K012930, expiration date 26-JUN-2017) for prophylaxis. M-M-R II was involved on a temperature excursion if 9 °C to 25°C for 1 hour 11 minutes. Information was provided due to a data logger. No adverse effects were reported and no product quality issue was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1707USA011887.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia, Pain, Post herpetic neuralgia, Rash pustular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient was inoculated with ZOSTAVAX on or about 02-OCT-2013, 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 05-FEB-2016 the patient was treated at his Primary Care Physician's office for the onset of severe residual pain in the area where shingles pustules has been. The patient was diagnosed with post-herpetic neuralgia, a chronic condition of nerve damage secondary to herpes zoster. On or about 01-APR-2016 the patient was treated again by the physician for continued and worsening symptoms of nerve pain, at which time the diagnosis of neuralgia was affirmed and stronger medication was prescribed. On or about 27-JUL-2016, the patient underwent continued treatment for worsening symptoms, which was then diagnosed as post-herpetic neuropathy. The patient has been prescribed oxycodone, NEURONTIN, LYRICA, FAMVIR and PERCOCET. 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: Blister, 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 was inoculated with ZOSTAVAX on or about 03-AUG-2015, at a pharmacy, 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 14-SEP-2015, the patient was treated at a medical center for a painful and blistering vesicular outbreak which was diagnosed as herpes zoster, or shingles on the face. The patient was prescribed antibiotics and ointment 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, has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's medical history, concurrent conditions or concomitant medications. On or about 15-MAY-2013, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration unknown), as recommended for routine adult health maintenance and 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 12-SEP-2015, it was reported that the patient was treated for a painful and blistering vesicular outbreak, which was diagnosed by a physician as herpes zoster, or shingles. The patient was prescribed Valacyclovir 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 expense, pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's medical history, concurrent conditions or concomitant medications. The patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration unknown), as recommended for routine adult health maintenance and the prevention of shingles (reported as "on or about 24-OCT-2011"). It was reported that the vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. "On or about 20-NOV-2008," the patient was treated for a painful and blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles (conflicting information: onset of event prior to reported date of vaccination). She was prescribed famciclovir and cortisone cream (manufacturers unknown) 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, pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Decreased immune responsiveness, Herpes zoster, Ophthalmic herpes zoster, Pain
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient was inoculated with ZOSTAVAX on or about 03-MAR-2008, administered by a physician, 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 12-MAR-2016, the patient was treated by a Nurse Practitioner for the onset of a blistering vesicular rash accompanied by weakened immune systems and interference with her vision, which was diagnosed as herpes zoster, or shingles with ocular involvement. The patient was referred to a specialist and was treated at a clinic for the shingles that had spread to her eyes. The patient was prescribed valacyclovir for the 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, or shingles with ocular involvement was considered a medically significant event. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular, Visual impairment
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient was inoculated with ZOSTAVAX on or about 03-MAR-2008, administered by a physician, 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 12-MAR-2016, the patient was treated by a Nurse Practitioner for the onset of a blistering vesicular rash accompanied by weakened immune systems and interference with her vision, which was diagnosed as herpes zoster, or shingles with ocular involvement. The patient was referred to a specialist and was treated at a clinic for the shingles that had spread to her eyes. The patient was prescribed valacyclovir for the 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, or shingles with ocular involvement was considered a medically significant event. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) on or about 11-APR-2012 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 27-NOV-2012, the patient was treated by a physician for the onset of a painful vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. 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.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unknown number of patients with unknown demographics. On unspecified dates, beginning in July 2016, the patients were vaccinated with improperly stored ROTATEQ lot # M039061, expiration date: 28-APR-2018, oral for prophylaxis. No symptoms reported. It was confirmed that no doses were administered past the expiration date. The ROTATEQ was exposed to temperature of 29F for time frame of 5292.5 hours. There was no previous temperature excursion involved. No data logger. No product quality complaint. No further information provided. There was consent to follow up. Sender's Comments: US-009507513-1707USA011869.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 14-JUL-2017 the patient was vaccinated with GARDASIL 9 lot # M040412 that underwent a temperature excursion on 17-JUN-2017. No adverse effects reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 27-JUL-2017, the patient was vaccinated with VAQTA lot # L009521 for prophylaxis. On 27-JUL-2017, 1 day after onset of therapy, the patient experienced expired product administered. On an unknown date, the patient experienced no adverse event. The outcome of expired product administered and no adverse event was unknown. The reporter considered expired product administered and no adverse event to be not related to VAQTA.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unknown number of patients with unknown demographics. On unspecified dates, beginning in July 2016, the patients were vaccinated with improperly stored GARDASIL 9 lot # M041990, expiration date: 28-JUN-2019, lot # K011325, expiration date: 08-APR-2017 and lot # M032650, expiration date: 31-MAR-2019 for prophylaxis. No symptoms reported. It was confirmed that no doses were administered past the expiration date. The GARDASIL 9 was exposed to temperature of 29F for time frame of 5292.5 hours. There was no previous temperature excursion involved. No data logger. No product quality complaint. No further information provided. There was consent to follow up. Sender's Comments: US-009507513-1707USA011447.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Medical Assistant referring to multiple unspecified patients of unknown age and gender. Information regarding the patients' pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided. On multiple unspecified dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot # M045206 and expiration date on 27-JUN-2019 and lot # N003698 with expiration date on 31-OCT-2019 reconstituted with a properly stored sterile diluent (reported lot # K012930, expiration date 26-JUN-2017) for prophylaxis. PEDVAXHIB was involved on a temperature excursion if 9 °C to 25°C for 1 hour 11 minutes. Information was provided due to a data logger. No adverse effects were reported and no product quality issue was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1707USA010361.
Sex: M
Vaccine: FLUN4
Symptoms: Influenza, Intensive care, Mechanical ventilation, Thoracostomy
Clinical narrative: A consumer report has been received via medical representative. The report concerns male patient. The patient's medical history, concurrent diseases and concomitant medications were not reported. On an unknown date, the patient received nasal FLUMIST QUADRIVALENT (intranasal) for unknown indication. During 2013, the patient had influenza. He was in the Intensive Care Unit with four chest tubes and a breathing vent. Action taken of FLUMIST QUADRIVALENT was unknown. The patient recovered from the event on an unspecified date. Reported seriousness of event patient had 4 chest tubes, was on a breathing vent and had influenza is given by the reporter as hospitalized. The company physician considered patient had 4 chest tubes and was on a breathing vent as no adverse events. Sender's Comments: Influenza is not listed in the company core data sheet for FLUMIST QUADRIVALENT. Due to limited information on the patient's age, start date, indication and dosing of the suspect drug, exact onset date of the event, relevant medical history, underlying comorbidities, concomitant medications, risk factors for the event present and diagnostic workup it is not possible to make a conclusive assessment of the causal relationship of influenza and FLUMIST QUADRIVALENT.
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site mass, Injection site swelling, Vaccination complication
Clinical narrative: Patient received 2 month vaccines and PEDIARIX given on left thigh. Developed bump/lump to area 3 cm x 3.5 cm, no erythema, non tender.
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Pertussis
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of pertussis in a 3-month-old female patient who received PEDIARIX. On an unknown date, the patient received the 1st dose of PEDIARIX. In July 2017, less than a year after receiving PEDIARIX, the patient experienced pertussis (serious criteria GSK medically significant). On an unknown date, the outcome of the pertussis was unknown. It was unknown if the reporter considered the pertussis to be related to PEDIARIX. Additional details were reported as follows: The age at vaccination was not reported. The patient was diagnosed with pertussis, two and a half weeks ago after receiving her first dose of PEDIARIX.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Fatigue, Pallor, Posture abnormal, Vision blurred
Clinical narrative: After receiving 4 vaccinations the patient had complaints of blurry vision and began dropping his head back and forth, he then began saying he was tired and started closing his eyes, his skin became pale and the patient continued stating how tired he was. Patient was placed in a wheel chair and was placed in an exam room  to lay down  first BP taken at approx. 10:35am was 79/35, Next BP taken at approx. 10:40 was 90/60. The patient was given something to drink and eat and stated he felt better before leaving the clinic.
Age: 54.0
Sex: F
Vaccine: MMR
Symptoms: Pruritus, Rash
Clinical narrative: Rash on face, left ear and neck. No pain, moderate itching. Vaccine was given at 9am and patient states that later that night her left ear started to itch. The next day the rash was on spots of her face and neck. Treated self with Benadryl. Seen in the clinic the next afternoon with main complaint of itching. Denies shortness of breath or difficulty swallowing. Advice to continue with Benadryl and use ice to help relieve the itching. Advised to call 911 if shortness of breath or throat tightening would occur.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Urticaria
Clinical narrative: 4 CM WHEEL
Age: 76.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: The patient had a reaction on the arm the injection was given, this reaction was not at the injection site, but lower. It was red, raised, hot, and she said painful at first. It is currently getting better than it was, but she is still recovering.
Age: 76.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: The patient had a reaction on the arm the injection was given, this reaction was not at the injection site, but lower. It was red, raised, hot, and she said painful at first. It is currently getting better than it was, but she is still recovering.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Insomnia, Rash erythematous, Rash maculo-papular, Rash pruritic
Clinical narrative: Two day history of red itchy rash that began on left arm, spread to right arm and today was in upper thighs. Difficulty sleeping secondary to the pruritic nature of the rash. Came into office 7/28/17 and found to have diffuse macular papular rash on erythematous base on bilateral upper extremities and upper thighs. Treated with Benadryl and Medrol dose pak.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Face injury, Lip injury, Loose tooth, Syncope
Clinical narrative: Patient fainted, her face landing on the floor, loosening her right upper central incisor, and lacerating her lower lip.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pruritus, Rash pustular, Secretion discharge
Clinical narrative: Pt c/o itching, and oozing pus, a little red. Denies area being hot to the touch.
Age: 15.0
Sex: F
Vaccine: FLUN3, HPV4
Symptoms: Menarche, Menstruation irregular
Clinical narrative: The patient's first menstrual cycle occurred weeks after the vaccine, and has been very irregular ever since. The patient is now 24 years old and still has irregular menstrual cycles. It is currently unknown whether sterility has occurred. However, reproductive viability seems questionable as the menstrual cycles do not exceed 21 days on average. The typical range is 17-22 days per cycle.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Inflammation, Pain, Skin warm, Swelling
Clinical narrative: The patient received the vaccine in the deltoid region of her right arm on 7/26. She presented to the pharmacy on 7/27 and had a reaction lower on the same arm, but not at the injection site. The reaction site was red, inflamed, swollen, warm, and painful. She was advised to use ice and benadryl.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: The patient received the vaccine in the deltoid region of her right arm on 7/26. She presented to the pharmacy on 7/27 and had a reaction lower on the same arm, but not at the injection site. The reaction site was red, inflamed, swollen, warm, and painful. She was advised to use ice and benadryl.
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Endotracheal intubation, Generalised tonic-clonic seizure, Pyrexia
Clinical narrative: Patient had a 25 minute generalized tonic-clonic seizure in the setting of a fever. Seizure was broken with ATIVAN and fosphenytoin, and he was intubated and extubated.
Age: 47.0
Sex: M
Vaccine: HEP
Symptoms: Condition aggravated, Full blood count normal, HIV test negative, Laboratory test normal, Metabolic function test normal
Clinical narrative: Optic neuritis, onset one week after initial vaccination; second vaccination one month later and condition worsened.
Age: 47.0
Sex: M
Vaccine: HEP
Symptoms: Optic neuritis, Red blood cell sedimentation rate normal, Treponema test negative
Clinical narrative: Optic neuritis, onset one week after initial vaccination; second vaccination one month later and condition worsened.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Patient develop rash on left arm around the  site of injection.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Unevaluable event
Clinical narrative: None stated.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to 4 patients of an unknown age and gender. The patient's past medical history and concomitant medications were not reported. On an unknown date, the patients were vaccinated with PROQUAD (dose, frequency route unknown) for prophylaxis. The vaccine PROQUAD was reconstituted with properly stored sterile water diluent (unknown lot, unknown expiration) with temperature of 15°F to 46°F for a time frame of 5 days. There was no previous temperature excursion. No digital data logger was involved. No adverse effects were reported. Product quality complaint (PQC) was not involved. No additional information was provided. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1707USA011845.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information was received on 14-JUL-2017 from a nurse who reported that an unknown number of patients, names and other demographics unknown, received an unknown number of doses of VARIVAX (lot# M023383, expiration 11-MAY-2018) and PROQUAD (see MARRS# 1707USA002693) following a temperature excursion of -4.5C for two hours and two minutes. No adverse effects were reported in any patients. No other information is available. There was no previous temperature excursion. Call was because of a data logger. This is one of two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA, HIBV, HPV9, MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant who reported that an unknown number of unspecified patients (demographics not provided) were inadvertently administered "single" doses of VAQTA (lot # N005274, expiration date 03-APR-2018), PEDVAXHIB (lot #M036612, expiration date 19-MAY-2019), VARIVAX (lot #N001530, expiration date 13-JAN-2019 and lot #M043582, expiration date 28-OCT-2018), GARDASIL 9 (lot #M041990, expiration date 28-JUN-2019), and M-M-R II (lot #M040624, expiration date 03-OCT-2018) (routes of administration not provided) that had been improperly stored. Properly stored sterile water diluent (lot numbers unknown) was used to reconstitute the doses of M-M-R II and VARIVAX. No adverse effects reported. For VAQTA (lot # N005274), GARDASIL 9 (lot #M041990), M-M-R II (lot #M040624), and PEDVAXHIB (lot #M036612): Temperature: 51°F Time frame: 48 hours Previous temperature excursion: No Data logger involved: Yes. For VARIVAX (lot #N001530 and lot #M043582): Temperature: 10°F Time frame: 48 hours Previous temperature excursion: No Data logger involved: Yes. Additional information is not expected.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Vaccination site pain
Clinical narrative: Information was received on 17-JUL-2017 from a pharmacist regarding a female patient of unknown age. Medical history, concurrent conditions and concomitant medications were not reported. On 10-JUL-2017, the patient was vaccinated with GARDASIL 9 injection (Merck Sharp and Dohme) (lot # N004798) (dose, route, and site of administration not reported) for the indication of HPV prophylaxis. "A few days later the patient experienced soreness of the arm in the area the vaccine was administered." The patient had an outpatient visit to an unspecified hospital's emergency room on an unspecified date and received unspecified treatment. No further adverse event information provided. The outcome of the event was reported as not recovered. The relationship between the event and GARDASIL 9 was not provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient was inoculated with ZOSTAVAX on or about 02-AUG-2012, at a pharmacy, 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 02-JUN-2013, the patient was treated by a physician at a clinic for a blistering vesicular outbreak which was then diagnosed as herpes zoster. The patient has been prescribed VALTREX, tramadol, and lidocaine topical cream 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, pain and suffering, and other damages. Additional information has been requested.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 51 year old male patient. The patient's concurrent conditions, medical history and drug allergies were not reported. The stock of vaccine was received in April 2016. On 21-FEB-2017, the patient was vaccinated with an improperly stored ZOSTAVAX lot # L046899 with expiration date of 28-FEB-2017 (dose, route and frequency were not reported) reconstituted with properly stored sterile diluent (MRK) for prophylaxis. No adverse effects were reported. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 147 days. It was reported that there was no need to repeat vaccine. No previous temperature excursion. The call was not because of a "data logger". There was no Product Quality Complaint (PQC) involved. No further information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1705USA014052.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an 83 year old male patient. The patient's concurrent conditions, medical history and drug allergies were not reported. The stock of vaccine was received in April 2016. On 16-NOV-2016, the patient was vaccinated with an improperly stored ZOSTAVAX lot # L046899 with expiration date of 28-FEB-2017 (dose, route and frequency were not reported) reconstituted with properly stored sterile diluent (MRK) for prophylaxis. No adverse effects were reported. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 19 days. It was reported that there was no need to repeat vaccine. No previous temperature excursion. The call was not because of a "data logger". There was no Product Quality Complaint (PQC) involved. No further information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1705USA014052.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 79 year old female patient. The patient's concurrent conditions, medical history and drug allergies were not reported. The stock of vaccine was received in April 2016. On 16-NOV-2016, the patient was vaccinated with an improperly stored ZOSTAVAX lot # L046899 with expiration date of 28-FEB-2017 (dose, route and frequency were not reported) reconstituted with properly stored sterile diluent (MRK) for prophylaxis. No adverse effects were reported. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 19 days. It was reported that there was no need to repeat vaccine. No previous temperature excursion. The call was not because of a "data logger". There was no Product Quality Complaint (PQC) involved. No further information was provided. This is one of the several reports received from the same reporter. Sender's Comments:  US-009507513-1705USA014052.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: This spontaneous report was received from a pharmacist refers to a two patients of an unknown age and gender. The patient's past medical history and concomitant medications were not reported. On 16-JUN-2017, the patients were vaccinated with 2 expired doses of PROQUAD (lot # M044719, expiry date 07-MAY-2018, dose, frequency route unknown) for prophylaxis. No further information was provided. Product quality complaint (PQC) was not involved. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA000203.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: Patient developed a local cellulitis at the site of injection starting on 7/26/17. The area of note was hot to touch, erythematous, skin was tight and tender on palpation. Treated with 10 day course of amoxicillin and f/u is prn if not improving.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Skin tightness
Clinical narrative: Patient developed a local cellulitis at the site of injection starting on 7/26/17. The area of note was hot to touch, erythematous, skin was tight and tender on palpation. Treated with 10 day course of amoxicillin and f/u is prn if not improving.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Heart rate increased, Neck pain, Pyrexia, Vomiting
Clinical narrative: Immunizations administered to the patient at 9:30am. Patient then left the office. Grandmother states patient vomited when he got home (approx 30 min after injections). He then laid down and took a nap for several hours. When he awoke he had neck pain, rapid heart rate and a fever. Mother brought patient back to the doctor's office. Patient was transported from the doctor's office to the local emergency room via ambulance. Patient was discharged from the emergency room to home later that same afternoon.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Gait disturbance, Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: Same day onset of fever, right arm pain, tingling in fingers of right hand and gait instability.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Hypersensitivity, Injection site swelling
Clinical narrative: Swelling at site of injection...Cephalexin 500 mg #15...One capsule 3 times daily. Medrol Dospak..As instructed by pkg..Diagnosed as allergic reaction..Site is much better today.
Age: 16.0
Sex: F
Vaccine: MENB, MENB, MNQ
Symptoms: Computerised tomogram, Loss of consciousness, Seizure like phenomena, Urine analysis
Clinical narrative: LOC, with seizure like response.
Age: 16.0
Sex: F
Vaccine: MENB, MENB, MNQ
Symptoms: Altered state of consciousness, Computerised tomogram head normal, Pregnancy test urine negative, Spinal X-ray normal, Syncope
Clinical narrative: LOC, with seizure like response.
Age: 16.0
Sex: F
Vaccine: MENB, MENB, MNQ
Symptoms: Urine analysis abnormal
Clinical narrative: LOC, with seizure like response.
Age: 31.0
Sex: F
Vaccine: DTAP
Symptoms: Fall, Gait disturbance, Muscular weakness, Musculoskeletal disorder, Panic attack
Clinical narrative: After a very deep cut on my leg, I needed stitches. I went into the er. Dr  was the attending, he suggested a tetanus shot since my leg was cut outdoors doing yard work. I clarified several times "tatanus only right" to which him and several nurses replied yes.  Several times. After reviving the shot I was told it was dtap. I left. After receiving this shot, without my consent, I walked home. That night, I lost the function of both my legs for a week. I'd fall while walking. Increasingly leg weakness. Also, that night I began having panic attacks every night for 3 years now. Also that night, my jaw locked up. I've been fighting TMJ symptoms every single day, all day, since 10 pm the night the shot was given. I'm still fighting panic occasionally. My life has become unmanageable from the symptoms.
Age: 31.0
Sex: F
Vaccine: DTAP
Symptoms: Quality of life decreased, Temporomandibular joint syndrome, Trismus
Clinical narrative: After a very deep cut on my leg, I needed stitches. I went into the er. Dr  was the attending, he suggested a tetanus shot since my leg was cut outdoors doing yard work. I clarified several times "tatanus only right" to which him and several nurses replied yes.  Several times. After reviving the shot I was told it was dtap. I left. After receiving this shot, without my consent, I walked home. That night, I lost the function of both my legs for a week. I'd fall while walking. Increasingly leg weakness. Also, that night I began having panic attacks every night for 3 years now. Also that night, my jaw locked up. I've been fighting TMJ symptoms every single day, all day, since 10 pm the night the shot was given. I'm still fighting panic occasionally. My life has become unmanageable from the symptoms.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site pain, Myalgia, Swelling
Clinical narrative: Stinging at time of injection. Swelling and muscular pain for 3 days post vaccination.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Patient complained that she got Shingle Rash appear on her back at west line the next day after she received vaccination. She complained that it is painful. She has not received any treatment. She said she attempted to call dr but they are busy. She did discontinue her valtrex while she received shingles vaccine. She did said it is getting little better.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, RV5
Symptoms: Abdominal pain, Barium enema normal, Enema administration, Intussusception, Ultrasound abdomen abnormal
Clinical narrative: The morning after receiving immunizations, the patient woke up fine. She then developed vomiting and intermittent crampy abdominal pain later that morning. Parents brought her to Medical Center ER, where abdominal ultrasound revealed intussusception. She was then transferred to Medical Center that afternoon. A barium enema was ordered, which revealed no abnormalities at that time. The patient's vomiting subsided, and she was felt stable for discharge.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, RV5
Symptoms: Vomiting
Clinical narrative: The morning after receiving immunizations, the patient woke up fine. She then developed vomiting and intermittent crampy abdominal pain later that morning. Parents brought her to Medical Center ER, where abdominal ultrasound revealed intussusception. She was then transferred to Medical Center that afternoon. A barium enema was ordered, which revealed no abnormalities at that time. The patient's vomiting subsided, and she was felt stable for discharge.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: REDNESS AND SWELLING.
Age: 60.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site inflammation, Injection site pain
Clinical narrative: ADVERSE EVENT: AT INJECTION SITE WAS REDNESS AND INFLAMMATION. IT WAS TENDER AND HARD TO THE TOUCH TWO DAYS AFTER THE INJECTION. THE FOLLOWING DAY, IT TURNED PINK AND THE PATIENT STARTED FEELING SICK (SLIGHT HEADACHE AND WANTING TO THROW UP) TREATMENT: PLACE ICE ON THE INJECTION SITE WHEN IT WAS TENDER AND IT IMPROVED IT TO JUST BEING PINK.
Age: 60.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Malaise, Nausea
Clinical narrative: ADVERSE EVENT: AT INJECTION SITE WAS REDNESS AND INFLAMMATION. IT WAS TENDER AND HARD TO THE TOUCH TWO DAYS AFTER THE INJECTION. THE FOLLOWING DAY, IT TURNED PINK AND THE PATIENT STARTED FEELING SICK (SLIGHT HEADACHE AND WANTING TO THROW UP) TREATMENT: PLACE ICE ON THE INJECTION SITE WHEN IT WAS TENDER AND IT IMPROVED IT TO JUST BEING PINK.
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site induration, Injection site pain, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: Right thigh has swelling and is hard to touch. It is red and blochy, hot to touch. Painful and itching.
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site warmth, Rash macular
Clinical narrative: Right thigh has swelling and is hard to touch. It is red and blochy, hot to touch. Painful and itching.
Age: 72.0
Sex: F
Vaccine: RAB
Symptoms: No adverse event
Clinical narrative: No adverse events.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Redness, warmth to touch. Mild swelling. Plan to start warm compress if not better. Start cephalexin susp. 250mg/5 10mL PO TID x 8d.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Blood glucose, Blood pressure decreased, Dizziness
Clinical narrative: Patient received GARDASIL vaccine, then when performing FS for Hgb pt. became lightheaded and decreased BP 86/40. Pt. laid down, given juice, vitals monitored. Fully recovered, increased BP. Monitored for 1/2 hour then sent home.