chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Eating disorder, Eye pain, Facial pain, Facial paralysis
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 17-OCT-2012, the patient was vaccinated with ZOSTAVAX (lot number, dosage and route of administration was unknown) as recommended for routine 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 with extensive complications. On or about 28-OCT-2013, the patient was treated by a physician for the onset of a blistering vesicular outbreak accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. On or about 01-NOV-2013, the patient was treated again for ongoing and worsening symptoms, particularly as they affected her face. The patient was then diagnosed with the condition of trigeminal neuralgia, secondary to shingles. On or about 22-OCT-2014, the patient sought treatment by another physician for worsening facial pain attributable to the shingles which caused her facial paralysis, pain in her eyes, and trouble chewing and eating. On or about 03-JUN-2015, the patient underwent additional treatment from her initial treating physician for new and worsening shingles outbreaks. The patient was also treated by yet another physician, a neurologist, on or about 06-JUN-2015, who affirmed the diagnosis of severe shingles. Subsequently, on or about 14-OCT-2015, the patient was treated by the neurologist for continued facial pain, which was diagnosed as chronic trigeminal neuralgia on the left side, secondary to herpes zoster infections. On or about 12-NOV-2015, the patient was treated by a physician in the emergency department for severe migraines. The patient was then diagnosed with additional herpes zoster infections with visual disturbance and chronic migraines caused by her trigeminal neuralgia. Throughout her extended treatment of these conditions, the patient has been prescribed acyclovir, gabapentin, carbamazepine (TEGRETOL), acetaminophen and hydrocodone (NORCO), and tramadol for management of her excruciating symptoms. As a direct and proximate result of the defect ZOSTAVAX, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further and proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. The outcome of the events was not recovered. Upon internal review, facial paralysis was considered medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Immune system disorder, Mastication disorder, Migraine, Pain
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 17-OCT-2012, the patient was vaccinated with ZOSTAVAX (lot number, dosage and route of administration was unknown) as recommended for routine 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 with extensive complications. On or about 28-OCT-2013, the patient was treated by a physician for the onset of a blistering vesicular outbreak accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. On or about 01-NOV-2013, the patient was treated again for ongoing and worsening symptoms, particularly as they affected her face. The patient was then diagnosed with the condition of trigeminal neuralgia, secondary to shingles. On or about 22-OCT-2014, the patient sought treatment by another physician for worsening facial pain attributable to the shingles which caused her facial paralysis, pain in her eyes, and trouble chewing and eating. On or about 03-JUN-2015, the patient underwent additional treatment from her initial treating physician for new and worsening shingles outbreaks. The patient was also treated by yet another physician, a neurologist, on or about 06-JUN-2015, who affirmed the diagnosis of severe shingles. Subsequently, on or about 14-OCT-2015, the patient was treated by the neurologist for continued facial pain, which was diagnosed as chronic trigeminal neuralgia on the left side, secondary to herpes zoster infections. On or about 12-NOV-2015, the patient was treated by a physician in the emergency department for severe migraines. The patient was then diagnosed with additional herpes zoster infections with visual disturbance and chronic migraines caused by her trigeminal neuralgia. Throughout her extended treatment of these conditions, the patient has been prescribed acyclovir, gabapentin, carbamazepine (TEGRETOL), acetaminophen and hydrocodone (NORCO), and tramadol for management of her excruciating symptoms. As a direct and proximate result of the defect ZOSTAVAX, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further and proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. The outcome of the events was not recovered. Upon internal review, facial paralysis was considered medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular, Trigeminal neuralgia, Vaccination failure, Visual impairment
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 17-OCT-2012, the patient was vaccinated with ZOSTAVAX (lot number, dosage and route of administration was unknown) as recommended for routine 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 with extensive complications. On or about 28-OCT-2013, the patient was treated by a physician for the onset of a blistering vesicular outbreak accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. On or about 01-NOV-2013, the patient was treated again for ongoing and worsening symptoms, particularly as they affected her face. The patient was then diagnosed with the condition of trigeminal neuralgia, secondary to shingles. On or about 22-OCT-2014, the patient sought treatment by another physician for worsening facial pain attributable to the shingles which caused her facial paralysis, pain in her eyes, and trouble chewing and eating. On or about 03-JUN-2015, the patient underwent additional treatment from her initial treating physician for new and worsening shingles outbreaks. The patient was also treated by yet another physician, a neurologist, on or about 06-JUN-2015, who affirmed the diagnosis of severe shingles. Subsequently, on or about 14-OCT-2015, the patient was treated by the neurologist for continued facial pain, which was diagnosed as chronic trigeminal neuralgia on the left side, secondary to herpes zoster infections. On or about 12-NOV-2015, the patient was treated by a physician in the emergency department for severe migraines. The patient was then diagnosed with additional herpes zoster infections with visual disturbance and chronic migraines caused by her trigeminal neuralgia. Throughout her extended treatment of these conditions, the patient has been prescribed acyclovir, gabapentin, carbamazepine (TEGRETOL), acetaminophen and hydrocodone (NORCO), and tramadol for management of her excruciating symptoms. As a direct and proximate result of the defect ZOSTAVAX, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further and proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. The outcome of the events was not recovered. Upon internal review, facial paralysis was considered medically significant. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received on 25-JUL-2017 from a lawyer regarding a case in litigation concerning a male patient of unknown age. The patient was inoculated with the ZOSTAVAX vaccine on or about 29-FEB-2013 (sic) 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 29-JUL-2013, the patient was treated by a physician for the onset of a painful vesicular outbreak accompanied by weakened immune systems, which was diagnosed as severe herpes zoster, or shingles. The patient has been prescribed acyclovir (manufacturer unknown) for management of his 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: M
Vaccine: VARZOS
Symptoms: Amnesia, Cognitive disorder, Headache, Herpes zoster, Loss of personal independence in daily activities
Clinical narrative: Information was received on 25-JUL-2017 from a lawyer regarding a case in litigation concerning a male patient of unknown age. The patient was inoculated with a dose of ZOSTAVAX vaccine on or about 03-OCT-2014, prescribed by a physician and administered at a medical facility, 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. One week later, on or about 11-NOV-2014, the patient was treated at the emergency room for severe headaches, floaters in the eye, and pain, which was diagnosed by a physician as herpes zoster eruptions causing headache and other interferences. On or about 20-NOV-2015, the patient was treated by his physician for ongoing and worsening symptoms of vesicular outbreaks, which were diagnosed as additional herpes zoster infections. On or about 15-APR-2015, the patient was treated by a physician at a medical facility for severe residual pain, which was diagnosed as post-herpetic neuralgia. The patient has been prescribed acyclovir (manufacturer unknown), nortriptyline (manufacturer unknown) and gabapentin (manufacturer unknown) for management of his painful symptoms. The subsequent medications required to treat the patient's recurrent shingles have resulted in memory loss and other cognitive issues that affect his daily life. 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: M
Vaccine: VARZOS
Symptoms: Pain, Post herpetic neuralgia, Rash vesicular, Vitreous floaters
Clinical narrative: Information was received on 25-JUL-2017 from a lawyer regarding a case in litigation concerning a male patient of unknown age. The patient was inoculated with a dose of ZOSTAVAX vaccine on or about 03-OCT-2014, prescribed by a physician and administered at a medical facility, 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. One week later, on or about 11-NOV-2014, the patient was treated at the emergency room for severe headaches, floaters in the eye, and pain, which was diagnosed by a physician as herpes zoster eruptions causing headache and other interferences. On or about 20-NOV-2015, the patient was treated by his physician for ongoing and worsening symptoms of vesicular outbreaks, which were diagnosed as additional herpes zoster infections. On or about 15-APR-2015, the patient was treated by a physician at a medical facility for severe residual pain, which was diagnosed as post-herpetic neuralgia. The patient has been prescribed acyclovir (manufacturer unknown), nortriptyline (manufacturer unknown) and gabapentin (manufacturer unknown) for management of his painful symptoms. The subsequent medications required to treat the patient's recurrent shingles have resulted in memory loss and other cognitive issues that affect his daily life. 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: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Ophthalmic herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received on 25-JUL-2017 from a lawyer regarding a case in litigation concerning a male patient of unknown age. The patient was inoculated with a dose of ZOSTAVAX vaccine on or about 19-FEB-2009 at a medical facility 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 and chronic strain of herpes zoster. On or about 31-JAN-2017, the patient was treated by a registered nurse  for a blistering vesicular outbreak which has spread to the eyes and was then diagnosed as herpes zoster. On or about 08-FEB-2017, the patient was treated by the registered nurse for ongoing and worsening symptoms of shingles. On or about 08-FEB-2017, the patient was treated at an emergency clinic for unbearable shingles pain and was prescribed pain medication. On or about 13-FEB-2017, the patient sought subsequent treatment from a nurse practitioner for treatment of his recurrent and painful symptoms. The patient has been prescribed valacyclovir (VALTREX), gabapentin (manufacturer unknown), and hydrocodone (+) acetaminophen (VICODIN) (manufacturer unknown) to help manage his recurrent 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. Upon internal review, blistering vesicular outbreak which has spread to the eyes and diagnosed as herpes zoster was considered medically significant. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a vaccine coordinator and refers to an unspecified patient of unknown age and gender. Information on medical history, past drugs, concurrent conditions were not reported. On 24-JUL-2017, the patient was vaccinated with M-M-R II, (lot # M047302, exp date: 30-NOV-2018, dose, frequency not reported) for prophylaxis. Concomitant therapy included sterile diluent (Merck injection, lot number: N006322, Exp date: 11-JUL-2019). No adverse effects were reported. All adverse event fields apply to the patient. Temperature was 11 degree Celsius (C), (incorrect product storage). Time frame was for a duration of 46 hours and 30 minutes. There was no previous temperature excursion. Data logger was involved. The outcome of events was unknown. This case is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA011025: US-009507513-1707USA011026.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. Information on pertinent medical history and concurrent condition was not provided. On an unknown date, the patient was vaccinated with improperly stored VARIVAX lot # M038856, expiry date 14-SEP-2018 for prophylaxis. No adverse event was reported. The vaccines were stored at a temperature range of -14°C to-10°C for 483 hours and in the range of -9°C to 8°C for 28 hours. Digital data logger was not involved. There was no previous temperature excursion. No product quality complaint was involved. No additional information was available. Sender's Comments: US-009507513-1707USA010627.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. Information on pertinent medical history and concurrent condition was not provided. On an unknown date, the patient was vaccinated with improperly stored VARIVAX lot # M005971, expiry date 02-FEB-2018 for prophylaxis. No adverse event was reported. The vaccines were stored at a temperature of 12 C for 63 hours, and in the range of -14 degrees C to -10 degrees C for 487.5 hours. Digital data logger was not involved. There was no previous temperature excursion. No product quality complaint was involved. No additional information was available. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1707USA010627.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a vaccine coordinator and refers to three unspecified patient of unknown age and gender. Information on medical history, past drugs, concurrent conditions were not reported. On 24-JUL-2017, the patient was vaccinated with VARIVAX, (lot # N001528, exp date: 13-JAN-2019, dose, frequency were not reported) for prophylaxis. Concomitant therapy included sterile diluent (Merck injection, lot #N006322; Exp date: 11-JUL-2019). No adverse effects were reported. All adverse event fields were applicable to all the patients. Temperature was 11 degree Celsius (C), (incorrect product storage). Time frame was for a duration of 46 hours and 30 minutes. There was no previous temperature excursion. Data logger was involved. The outcome of events was unknown. This case is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA010634.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a vaccine coordinator and refers to an unspecified patient of unknown age and gender. Information on medical history, past drugs, concurrent conditions were not reported. On 24-JUL-2017, the patient was vaccinated with PROQUAD, (lot # M048201, exp date: 05-JUN-2018, dose, frequency not reported) for prophylaxis. Concomitant therapy included sterile diluent (Merck injection, lot # N006322, Exp date: 11-JUL-2019). No adverse effects were reported. All adverse event fields apply to the patient. Temperature was 11 degree Celsius (C). Time frame was for a duration of 46 hours and 30 minutes. There was no previous temperature excursion. Data logger was involved. This case is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA010634.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other refers to a 12 month old patient. On 12-MAY-2017, the patient was vaccinated with M-M-R II lot # M029230 for prophylaxis which were stored in the range of 47 Fahrenheit degrees to77 Fahrenheit degrees for 11 days). No previous temperature excursion was reported.  No adverse effects were reported. Concomitant therapies included sterile diluent.
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: This spontaneous report was received from patient's daughter refers to an 88 year old father. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (strength, dose, frequency, route of administration, lot number and expiration date were not provided) for prophylaxis. On 19-JUL-2017, reported as "1 week ago ", the patient, has had "joint pain in his hip, that he did not have", before getting the vaccine. The outcome of arthralgia was unknown.
Age: 43.0
Sex: M
Vaccine: PPV
Symptoms: Myalgia
Clinical narrative: Myalgia. Methylprednisolone, Famotidine, Diphenhydramine.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Fatigue, Hypersomnia, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Fever 100.4 for 2 days on and off started same day of vac. Tired - slept for 2 days - red and tender at site,  day #3 started to feel better.
Age: 18.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: After vaccine was given, pt. reported redness and swelling at injection site app. 10 - 12 hrs later. The following morning, redness and swelling were worse with pain and firmness at injection site. Indurated area of app. 3" in diameter noted with redness.
Age: 20.0
Sex: M
Vaccine: MNQ
Symptoms: Wrong drug administered
Clinical narrative: Pt came to pharmacy and asked for meningococcal shot on his paper. Pt asked for and received Group B. Pt returned later in the week to ask for MCV for school as he misunderstood requirements. MCV administered 1 week later.
Age: 48.0
Sex: F
Vaccine: MMR
Symptoms: Induration, Rash morbilliform
Clinical narrative: 2.54cm square induration and measles-like rash.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Wrong drug administered
Clinical narrative: None, was given DTaP rather than Tdap.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Chest pain, Chills, Diarrhoea, Erythema, Headache
Clinical narrative: 30 minutes after receiving the vaccines, the patient began having c/o chest pain, headache, chills, diarrhea, and a rash leading from his left ear to his naval. Pt was sent to the ER for evaluation. Pt was administered Benadryl 25mg by parent prior to arriving to the ER. Pt was assessed at Hospital and noted to have faint redness to the center of his chest and upper abdomen. He also c/o of chest pain, fever, and teeth pain. No respiratory distress noted. Pt was administered another dose of Benadryl 25mg. They instructed pt's mom to continue with Benadryl 3-4 times a day for the next 2 days and to follow up with his pediatrician.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Pyrexia, Rash, Toothache
Clinical narrative: 30 minutes after receiving the vaccines, the patient began having c/o chest pain, headache, chills, diarrhea, and a rash leading from his left ear to his naval. Pt was sent to the ER for evaluation. Pt was administered Benadryl 25mg by parent prior to arriving to the ER. Pt was assessed at Hospital and noted to have faint redness to the center of his chest and upper abdomen. He also c/o of chest pain, fever, and teeth pain. No respiratory distress noted. Pt was administered another dose of Benadryl 25mg. They instructed pt's mom to continue with Benadryl 3-4 times a day for the next 2 days and to follow up with his pediatrician.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient called pharmacy on 7/27/2017 and stated she developed a rash on her neck and leg on 7/23/2017 (ZOSTAVAX given on 7/18/2017). She mentioned that she went to her medical provider (did not state date of visit), and now rash has resolved.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Paraesthesia
Clinical narrative: Pt came to clinic 2 weeks after initial vaccine and reported that the day after vaccine was given his Left arm became red and mildly swollen from the deltoid, across the medial area of the arm down the bicep to the antecubital area. He also reported feeling some tingling at that time. He took his 'allergy medication' and the symptoms fully resolved within 5 days. He denies any further deficits from the vaccine.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Apnoea, Bradycardia, Intensive care, Oxygen saturation decreased
Clinical narrative: Bradycardia and apnea, desats requiring oxygen. Patient was scheduled for sedated hearing exam. No sedation was given. Symptoms started before procedure.
Age: 9.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Redness, warmth, and swelling approximately 2.5 inches in diameter
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Diet refusal, Irritability, Vomiting
Clinical narrative: Pt. became extremely irritable, vomiting and refusing baby foods and formula 24 hours after vaccines. Mom contacted the GI specialist they are working with, and on 7/24/17 was told to offer PEDIALYTE, then 1/2 strength NEOCATE formula, then onto full strength formula. By 7/27/17 GI office visit, he was eating less than normal and was vomiting less, needing to use a syringe to feed. Prior to 7/13/17 vaccines,  patient was eating jarred fruits and vegetables. In the GI consult note  dated today 7/27/17 , nurse practitioner feels this was a reaction to the Rotavirus vaccine. I spoke with mom today and today his disposition is much better, eating baby foods but not as much as he had been prior, so mom continues to push fluids, syringing as needed.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, MMRV
Symptoms: Injection site rash, Rash
Clinical narrative: 7/25/17 3 PM rash appeared and disappeared to arms area. At bedtime, all gone. Denies any fever or difficulty breathing. 7/26/17 morning, no rash. 5 PM rash appeared and disappeared every 30 min to arms and legs, nothing on the face. Denies any fever or breathing difficulty. 10P rash started to appear to back, then to face. Taken to Emergency Room. 10:30P, BENADRYL given. 12 min. rash is gone.  Discharged from ER.  7/27/17 slept well. Rash comes and goes on body, face not affected. 1150 AM BENADRYL given.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site pain, Insomnia, Neck pain
Clinical narrative: Patient said the shot was painful and had soreness and pain the night of the shot. Her son and husband got the same vaccine at the same time and they all had some degree of soreness which they thought was normal. However unlike her son and husband, he pain didn't resolve in a couple of days. A couple of days after she said the pain even radiated into the neck and elbow. She says it's hard to sleep. She had very limited range of motion. She has tried warm and cold compresses and OTC analgesics with limited relief.
Age: 4.0
Sex: M
Vaccine: IPV
Symptoms: Myalgia
Clinical narrative: Myalgia, treated with motrin.
Age: 91.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Pruritus, Rash macular
Clinical narrative: Patient came into the pharmacy today at 1pm to show me her arm. Her daughter states that she called the pharmacy on Saturday (7/22/17) to alert the staff  of the reaction. Upon reviewing her arm I saw a dark red blotch at the site of injection. Patient states that it does not hurt, does not feel a bump, nor does it feel hot to the touch. She does complain of itchiness. She says that there were no fevers thus far. The redness has not improved, nor has it gotten any better since Saturday. I told her I would inform her primary care physician and advised her to not put anything on her arm. Patient was thinking about putting alcohol on the arm to help with the itch. I advised her not to. I told her to keep monitoring he site and if there are any changes in redness or if it starts to hurt or if she develops a fever that she should contact myself or her physician immediately.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Chest pain, Erythema, Injection site erythema, Injection site pain
Clinical narrative: Patient received the PNEUMOVAX 23 vaccination on 7/17/17. Per patient, about 30 minutes after receiving vaccine she had a fever of 103 degrees, swelling, pain, and redness at injection site (right deltoid), which migrated down to right bicep area, around the back of patient's arm and across the right side of patient's chest, muscle and joint aches. Patient did not report her symptoms until 7/20/17. At time of reporting, patient had some redness and swelling of her right arm and her temperature was 99 degrees.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Myalgia, Pyrexia, Swelling
Clinical narrative: Patient received the PNEUMOVAX 23 vaccination on 7/17/17. Per patient, about 30 minutes after receiving vaccine she had a fever of 103 degrees, swelling, pain, and redness at injection site (right deltoid), which migrated down to right bicep area, around the back of patient's arm and across the right side of patient's chest, muscle and joint aches. Patient did not report her symptoms until 7/20/17. At time of reporting, patient had some redness and swelling of her right arm and her temperature was 99 degrees.
Age: 18.0
Sex: M
Vaccine: HEPA, MENB
Symptoms: Dyskinesia, Heart rate decreased, Seizure like phenomena, Unresponsive to stimuli
Clinical narrative: AS PT WAS RECEIVING BEXSERO (2ND VACCINE GIVEN), PT JERKED AND EXHIBITED SEIZURE LIKE ACTIVITY TWICE. PT BECAME UNRESPONSIVE AND HIS HEART RATE AND PULSE DROPPED SIGNIFICANTLY. TIME FRAME OF EVENT LASTED >20 MINUTES, SEIZURE ACTIVITY LASTED AROUND 1 MINUTE EACH EPISODE. EMS WAS CALLED AND PATIENT'S PARENT TRANSPORTED HIM TO ER.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Inflammation, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient had second varicella vaccine on 7/25/17. States next day she began to have symptoms.  Denies respiratory difficulties.  Right arm is red at site of injection with minimal swelling. Patient denies pain, but states it is itchy. Denies using any treatment or medications, except states she put some rubbing alcohol on it. Erythema measures about 55 mm x 40 mm. Appears to have normal ROM. Examined by MD who concludes area appears c/w local inflammatory reaction; should improve on its own over next few days.
Age: 9.0
Sex: F
Vaccine: IPV, MMRV
Symptoms: Abdominal pain upper, Feeling abnormal, Syncope, Visual impairment
Clinical narrative: Patient received vaccines. Approximately 2-4 minutes later, patient stated that she didn't feel good and that her stomach was hurting. She then complained that she "can't see too good". She then fainted a few seconds later. V/S were taken. BP: 90/61, P 95, T-97.7, O2 sat 98%. Child came around and began to talk to her mother and staff after approximately 5 minutes.
Age: 24.0
Sex: F
Vaccine: TD
Symptoms: No adverse event
Clinical narrative: WE HAVE THIS TD FOR ALL ADULT PATIENT OVER 18 YEARS OLD.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Patient reported a hard spot, itch and redness on her left arm at site of injection on the first day, possibly on the second day after injection. Patient states that The site was warm to the touch , she had mild pain that was tolerable. No fever was reported. The site went from bright red to dark red . It was reported by the patient that it bothered her for the first 5 days; but she thinks its getting better. I told the patient that I would inform her physician of the reaction and for her to monitor it and contact myself or the doctor immediately should her condition changes.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Fatigue, Headache, Influenza like illness
Clinical narrative: Within 6 hours, pain at site of injection, joint and body aches and pains, fatigue, headache, mild nausea, flu-like symptoms. Around 12 hours post shot, addition of severe chills for 2 hours.. Morning fever temperature of 101.7. Daytime range from 101.3 F -103.1 F. Sent to company urgent care for more thorough eval after calling employee health the day after vaccination.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Nausea, Pain, Pyrexia
Clinical narrative: Within 6 hours, pain at site of injection, joint and body aches and pains, fatigue, headache, mild nausea, flu-like symptoms. Around 12 hours post shot, addition of severe chills for 2 hours.. Morning fever temperature of 101.7. Daytime range from 101.3 F -103.1 F. Sent to company urgent care for more thorough eval after calling employee health the day after vaccination.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to six unspecified patients of unknown age and gender. The patients' concomitant medications, concurrent conditions, pertinent medical histories, drug reactions or allergies were not provided. On 12-JUL-2017 and 13-JUL-2017, the patients were administered 3 different doses of M-M-R II (lot # reported as M042846, expiration date 21-OCT-2018) and VARIVAX (lot # reported as N014366, expiration date 09-MAY-2019) (doses and route of administration were not reported). The administered doses of vaccines were reconstituted with sterile diluent (lot # N003192, expiration date 05-JUL-2019). Administered doses of vaccines experienced a temperature excursion from 47 degrees Fahrenheit to 77 degrees Fahrenheit on 09-JUL-2017, which lasted for a time frame of 12 hours, 10 minutes. There were no previous temperature excursions reported. A digital data logger was involved in recording the excursions. No adverse effects were reported. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: Information was received from a pharmacist regarding an patient of unknown age and gender who received a dose of pneumococcal vaccine (unspecified manufacturer) on an unspecified date (lot and expiration were not reported). The pharmacist reported that the patient's 'hands swelled up' after receiving pneumococcal vaccine. Causality and outcome were not reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received on 14-JUL-2017 from a physician assistant regarding an unspecified number of patients (age and gender not reported). Medical history, concurrent conditions and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L023230, exp 28-JUL-2017; lot # L006428, exp date 30-JUL-2017; and lot # L037554, exp date 25-DEC-2017) (dose, route, and site of administration not reported). No adverse effects were reported. Temperature: 32 degrees Fahrenheit to 35 degrees Fahrenheit. Time Frame: 2 minutes. Previous temperature excursion? Yes 32 degrees Fahrenheit to 35 degrees Fahrenheit for 2 minutes. Total cumulative time: 4 minutes. Was call because of a data logger? Yes. No additional information was provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a female patients of unknown age. The patients' concomitant medications, concurrent conditions, pertinent medical histories, drug reactions or allergies were not provided. On an unknown date, the patient was administered an improperly stored dose of ZOSTAVAX, lot # reported as N012492 with expiration date on 17-MAR-2018 (dose and route of administration were not reported) for prophylaxis. Concomitant medication included diluent (manufacturer, lot # and expiration date were not reported). The administered dose of vaccine was reconstituted with sterile diluent (manufacturer unknown) which was properly stored. No adverse effects were reported. Administered dose of vaccine experienced a temperature excursion from 47 degrees Fahrenheit to 77 degrees Fahrenheit, which lasted for a time frame of 45 minutes. A previous temperature excursion was not reported. A digital data logger was involved in recording the excursions. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received on 24-JUL-2017 regarding a case in litigation from a lawyer and a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient was inoculated with ZOSTAVAX (lot number and expiration were not reported) subcutaneous on or about 11-NOV-2015, 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 07-DEC-2016, the patient was treated by a physician for the onset of a blistering vesicular outbreak accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient has been prescribed valacyclovir hydrochloride (VALTREX) 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: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received on 24-JUL-2017 regarding a case in litigation from a lawyer and a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient was inoculated with ZOSTAVAX (lot number and expiration were not reported) subcutaneous on or about 10-JUL-2013 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 08-JUL-2016, the patient was treated by a  physician at a clinic for a painful and blistering vesicular outbreak, 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, 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 on 25-JUL-2017 regarding a case in litigation from a lawyer and a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient was inoculated with ZOSTAVAX (lot number and expiration were not reported) subcutaneous on or about 08-FEB-2010, 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-JUL-2016, the patient was treated by physician for a painful and blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. The patient has been prescribed acyclovir and dermatologic (unspecified)( LIPODERM) for treatment 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: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. Information on pertinent medical history and concurrent condition was not provided. On an unknown date, the patient was vaccinated with improperly stored VARIVAX lot # M038856, expiry date 14-SEP-2018 for prophylaxis. No adverse event was reported. The vaccines were stored at a temperature range of -14°C to-10°C for 483 hours and in the range of -9°C to 8°C for 28 hours. Digital data logger was not involved. There was no previous temperature excursion. No product quality complaint was involved. No additional information was available. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1707USA010627.
Sex: F
Vaccine: VARZOS
Symptoms: Emotional distress, Eye disorder, Herpes virus test abnormal, Necrotising retinitis, Ophthalmic herpes zoster
Clinical narrative: Information was received on 25-JUL-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. On 24-JUL-2014, the patient received a dose of ZOSTAVAX vaccine for it's intended purpose, the prevention of shingles. On 09-SEP-2015, the patient visited an eye doctor for complaints of a black line and blurriness in her eye. The patient was diagnosed with acute retinal necrosis and laboratory testing was conducted to determine the cause. Laboratory results were positive for herpes zoster and the patient's physician diagnosed this as the cause of the problem with her retina. The patient subsequently experienced retinal detachment and has undergone multiple surgical procedures in an attempt to repair the injury, an injury that continued to this day. As a direct and proximate result of the defective ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations from, and seriousness of, her condition. The patient sustained severe and permanent personal injuries. Further,  the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred and will continue to incur medical expenses and other economic harm as a direct result of use of ZOSTAVAX. Upon internal review, acute retinal necrosis positive for herpes zoster and retinal detachment were considered medically significant. Acute retinal necrosis positive for herpes zoster and retinal detachment were disabling. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Physical disability, Poor quality drug administered, Quality of life decreased, Retinal detachment
Clinical narrative: Information was received on 25-JUL-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. On 24-JUL-2014, the patient received a dose of ZOSTAVAX vaccine for it's intended purpose, the prevention of shingles. On 09-SEP-2015, the patient visited an eye doctor for complaints of a black line and blurriness in her eye. The patient was diagnosed with acute retinal necrosis and laboratory testing was conducted to determine the cause. Laboratory results were positive for herpes zoster and the patient's physician diagnosed this as the cause of the problem with her retina. The patient subsequently experienced retinal detachment and has undergone multiple surgical procedures in an attempt to repair the injury, an injury that continued to this day. As a direct and proximate result of the defective ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations from, and seriousness of, her condition. The patient sustained severe and permanent personal injuries. Further,  the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred and will continue to incur medical expenses and other economic harm as a direct result of use of ZOSTAVAX. Upon internal review, acute retinal necrosis positive for herpes zoster and retinal detachment were considered medically significant. Acute retinal necrosis positive for herpes zoster and retinal detachment were disabling. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Surgery, Vision blurred
Clinical narrative: Information was received on 25-JUL-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. On 24-JUL-2014, the patient received a dose of ZOSTAVAX vaccine for it's intended purpose, the prevention of shingles. On 09-SEP-2015, the patient visited an eye doctor for complaints of a black line and blurriness in her eye. The patient was diagnosed with acute retinal necrosis and laboratory testing was conducted to determine the cause. Laboratory results were positive for herpes zoster and the patient's physician diagnosed this as the cause of the problem with her retina. The patient subsequently experienced retinal detachment and has undergone multiple surgical procedures in an attempt to repair the injury, an injury that continued to this day. As a direct and proximate result of the defective ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations from, and seriousness of, her condition. The patient sustained severe and permanent personal injuries. Further,  the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred and will continue to incur medical expenses and other economic harm as a direct result of use of ZOSTAVAX. Upon internal review, acute retinal necrosis positive for herpes zoster and retinal detachment were considered medically significant. Acute retinal necrosis positive for herpes zoster and retinal detachment were disabling. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a multiple unspecified patients of unknown ages. The patients' medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (lot #s M025867, expiry date 24-MAY-2018 and N002204, expiry date 19-JAN-2019).  Other suspect therapies included sterile diluent (manufacturer unknown). It was reported that the vaccines were improperly stored with a temperature excursions between -14°c to -10°c during 2.5 hours. It was reported because a data logger (yes). The sterile diluent (manufacturer unknown) used to reconstituted all vaccines were properly stored. No adverse effects were reported. The outcome of incorrect product storage and no adverse event was unknown. This is one of two reports from the same reporter source, (linked to MARRS # 1707USA011181). Additional information has been requested. Sender's Comments: US-009507513-1707USA011181.