chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.6
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Anti-NMDA antibody positive, Central venous catheterisation, Decreased activity, Demyelination, Drug administered to patient of inappropriate age
Clinical narrative: Case number PHHY2016US059733 is an initial literature report received on 28 Apr 2016. The author described about a case of antibody-verified anti-N-methyl-D-aspartate (anti-NMDA) receptor encephalitis in a neonate following influenza vaccination. This report refers to a 7 month old female patient. She was previously healthy. She was vaccinated with a booster dose of influenza vaccine (manufacturer and batch number: not reported) during her first influenza season (vaccination date was not reported). Within 48 hours of vaccination, she presented with acute onset of altered mental status, decreased activity, roving eye movements and opisthotonic posturing. She was initially diagnosed with acute demyelinating encephalomyelitis (ADEM) and treated with a short burst of corticosteroids followed by a taper. Symptoms subjectively improved during steroid therapy, but did not persist, prompting further diagnostic evaluations. Anti-NMDA receptor encephalitis was confirmed by cerebrospinal fluid antibody titer 68 days after onset of symptoms. Treatment was then undertaken with serial courses of intravenous immunoglobulin (IVIG) and rituximab. The patient's hospital course was protracted and she required utilization of intensive care unit resources due to aspiration risk, surgical placement of nutritional and vascular access devices and paroxysmal autonomic hyperactivity (PAH). Minimal improvement in her neurologic exam was observed at time of hospital discharge and might be due to delayed start of treatment as well as the cumulative effect of unrecognized seizures early in her illness course. The author stated that this case described the youngest patient with ant-NMDA receptor encephalitis yet reported and the first to suggest correlation with recent influenza vaccination. The author concluded the article stating that as higher likelihood of neurologic recovery was associated with early initiation of treatment, providers were encouraged to consider autoimmune neurologic disorders like anti-NMDA receptor encephalitis when mental status abnormalities and developmental regression persist, regardless of patient's age.
Age: 0.6
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Encephalitis autoimmune, Eye movement disorder, Gastrointestinal tube insertion, Immunoglobulin therapy, Intensive care
Clinical narrative: Case number PHHY2016US059733 is an initial literature report received on 28 Apr 2016. The author described about a case of antibody-verified anti-N-methyl-D-aspartate (anti-NMDA) receptor encephalitis in a neonate following influenza vaccination. This report refers to a 7 month old female patient. She was previously healthy. She was vaccinated with a booster dose of influenza vaccine (manufacturer and batch number: not reported) during her first influenza season (vaccination date was not reported). Within 48 hours of vaccination, she presented with acute onset of altered mental status, decreased activity, roving eye movements and opisthotonic posturing. She was initially diagnosed with acute demyelinating encephalomyelitis (ADEM) and treated with a short burst of corticosteroids followed by a taper. Symptoms subjectively improved during steroid therapy, but did not persist, prompting further diagnostic evaluations. Anti-NMDA receptor encephalitis was confirmed by cerebrospinal fluid antibody titer 68 days after onset of symptoms. Treatment was then undertaken with serial courses of intravenous immunoglobulin (IVIG) and rituximab. The patient's hospital course was protracted and she required utilization of intensive care unit resources due to aspiration risk, surgical placement of nutritional and vascular access devices and paroxysmal autonomic hyperactivity (PAH). Minimal improvement in her neurologic exam was observed at time of hospital discharge and might be due to delayed start of treatment as well as the cumulative effect of unrecognized seizures early in her illness course. The author stated that this case described the youngest patient with ant-NMDA receptor encephalitis yet reported and the first to suggest correlation with recent influenza vaccination. The author concluded the article stating that as higher likelihood of neurologic recovery was associated with early initiation of treatment, providers were encouraged to consider autoimmune neurologic disorders like anti-NMDA receptor encephalitis when mental status abnormalities and developmental regression persist, regardless of patient's age.
Age: 0.6
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Mental status changes, Neurological examination abnormal, Opisthotonus, Psychomotor hyperactivity, Seizure
Clinical narrative: Case number PHHY2016US059733 is an initial literature report received on 28 Apr 2016. The author described about a case of antibody-verified anti-N-methyl-D-aspartate (anti-NMDA) receptor encephalitis in a neonate following influenza vaccination. This report refers to a 7 month old female patient. She was previously healthy. She was vaccinated with a booster dose of influenza vaccine (manufacturer and batch number: not reported) during her first influenza season (vaccination date was not reported). Within 48 hours of vaccination, she presented with acute onset of altered mental status, decreased activity, roving eye movements and opisthotonic posturing. She was initially diagnosed with acute demyelinating encephalomyelitis (ADEM) and treated with a short burst of corticosteroids followed by a taper. Symptoms subjectively improved during steroid therapy, but did not persist, prompting further diagnostic evaluations. Anti-NMDA receptor encephalitis was confirmed by cerebrospinal fluid antibody titer 68 days after onset of symptoms. Treatment was then undertaken with serial courses of intravenous immunoglobulin (IVIG) and rituximab. The patient's hospital course was protracted and she required utilization of intensive care unit resources due to aspiration risk, surgical placement of nutritional and vascular access devices and paroxysmal autonomic hyperactivity (PAH). Minimal improvement in her neurologic exam was observed at time of hospital discharge and might be due to delayed start of treatment as well as the cumulative effect of unrecognized seizures early in her illness course. The author stated that this case described the youngest patient with ant-NMDA receptor encephalitis yet reported and the first to suggest correlation with recent influenza vaccination. The author concluded the article stating that as higher likelihood of neurologic recovery was associated with early initiation of treatment, providers were encouraged to consider autoimmune neurologic disorders like anti-NMDA receptor encephalitis when mental status abnormalities and developmental regression persist, regardless of patient's age.
Age: 0.6
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Tonic posturing
Clinical narrative: Case number PHHY2016US059733 is an initial literature report received on 28 Apr 2016. The author described about a case of antibody-verified anti-N-methyl-D-aspartate (anti-NMDA) receptor encephalitis in a neonate following influenza vaccination. This report refers to a 7 month old female patient. She was previously healthy. She was vaccinated with a booster dose of influenza vaccine (manufacturer and batch number: not reported) during her first influenza season (vaccination date was not reported). Within 48 hours of vaccination, she presented with acute onset of altered mental status, decreased activity, roving eye movements and opisthotonic posturing. She was initially diagnosed with acute demyelinating encephalomyelitis (ADEM) and treated with a short burst of corticosteroids followed by a taper. Symptoms subjectively improved during steroid therapy, but did not persist, prompting further diagnostic evaluations. Anti-NMDA receptor encephalitis was confirmed by cerebrospinal fluid antibody titer 68 days after onset of symptoms. Treatment was then undertaken with serial courses of intravenous immunoglobulin (IVIG) and rituximab. The patient's hospital course was protracted and she required utilization of intensive care unit resources due to aspiration risk, surgical placement of nutritional and vascular access devices and paroxysmal autonomic hyperactivity (PAH). Minimal improvement in her neurologic exam was observed at time of hospital discharge and might be due to delayed start of treatment as well as the cumulative effect of unrecognized seizures early in her illness course. The author stated that this case described the youngest patient with ant-NMDA receptor encephalitis yet reported and the first to suggest correlation with recent influenza vaccination. The author concluded the article stating that as higher likelihood of neurologic recovery was associated with early initiation of treatment, providers were encouraged to consider autoimmune neurologic disorders like anti-NMDA receptor encephalitis when mental status abnormalities and developmental regression persist, regardless of patient's age.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Small bumps et injection site, warm to touch, raised. Symptoms started 1 wk after injection.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Pt had swelling, pain, and redness at injection site. Pt states she had fevers on and off. Given KEFLEX to treat.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: PT received TDAP on 5/02/16, by 5/7/16 she had a redness raised mark the size of a dime. PT came back to clinic 5/9/16. By this time red area grew to 7cm. and was painful to touch. PCP ordered f/u with Team RN.
Sex: U
Vaccine: UNK
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant referring to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not provided. On an unknown dates, the patient was vaccinated with an improperly stored dose of one of the following vaccines: ROTATEQ, GARDASIL, GARDASIL 9, PNEUMOVAX 23 or PEDVAXHIB. All of the mentioned vaccines were improperly stored, but the reporter disconnected before indicating which one received the patient. No adverse effects were reported. Additional information has been requested.
Age: 94.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Malaise, Pyrexia
Clinical narrative: Low grade fever, not feeling well, redness near inj. site.
Age: 1.01
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Full blood count, Pyrexia, Rash
Clinical narrative: Rash and fever to 103. Doctor believes reaction was due to MMRV.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Pt developed pain, then redness and induration at site. Area was 2 cm diameter. No SOB, wheals, urticaria or systemic symptoms. Symptoms resolved completely by 5/10/16 exam.
Age: 89.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erosion, Injection site erythema, Injection site pruritus, Injection site reaction, Xerosis
Clinical narrative: Redness, excoriation, xerosis, and pruritis in vicinity of injection site. Has tried hydrocortisone 1% within the last week with no relief. This was reported to me yesterday by patient' son.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On 06-MAY-2016, the patient was vaccinated with a dose of ZOSTAVAX, lot # L032403 with expiration date of 26-NOV-2016, (dose and frequency were not reported), which was prepared using an expired STERILE DILUENT with lot # reported as L010588 and expiration date of 18-MAR-2016 (dose, frequency and indication were not reported). No concomitant medications, no adverse effects and no product quality complaints were involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant, and refers to 2 patients of unknown age and gender. The medical history, concurrent conditions and drug reactions/allergies of the patients were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally, digital data logger reported as yes, lot # reported as L00456 with expiration date of 07-AUG-2016 (dose and frequency were not reported). No concomitant medications and no adverse symptoms were reported for any patient. No product quality complaint was involved. Additional information about the temperature excursion described that it was not less than 0 degree C for 80 hours. Even though, no previous temperature excursion was reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant, and refers to 3 patients of unknown age and gender. The medical history, concurrent conditions and drug reactions/allergies of the patients were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 digital data logger reported as yes, lot # reported as L00610 with expiration date of 31-JAN-2017 (dose, frequency and route were not reported). No concomitant medications and no adverse symptoms were reported for any patient. No product quality complaint was involved. Additional information about the temperature excursion described that it was not less than 0 degrees C for 80 hours. Even though, no previous temperature excursion was reported. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain, Wrong technique in product usage process
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 22 year old female patient. Pertinent medical history and drug reactions/allergies were none. On 09-APR-2016 the patient received a single injection of sterile water diluent, which was supplied with ZOSTAVAX (0.5 ml, lot # reported as K014920, expiry date: 23-JUL-2017, in the left deltoid, intramuscularly), as a practice injection. Patient received only the sterile water diluent (wrong technique in product usage process). Concomitant medications were none. Pharmacist reported that the patient experienced pain in the bicep region of left arm, immediately following the injection (pain in extremity). The patient sought medical attention by visiting the pharmacist. Treatment for the event included topical BENADRYL cream and TYLENOL. No lab diagnostic studies were performed. The outcome of pain in extremity was reported as recovered/resolved on 09-APR-2016. Causality was not reported for the event pain in extremity. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding an unspecified patients of unknown age. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored LIQUID PEDVAXHIB, lot # K026533, expiration date- 07-AUG-2017 and lot # L012838, expiration date- 10-MAR-2018. No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. Temperature was -3 degree Celsius, Time frame was 6 hours and it was back in range. There was no previous temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding an unspecified patients of unknown age. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored RECOMBIVAX HB, lot # K012874, expiration date 09-JUN-2016. No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. Temperature/Time: 9.5C for 2 hours and 30 minutes, Data Logger: yes, yes it was administered. There was a previous temperature excursion 1.5 C for 1 hour, 10.5C for 1 hour and 30 minutes. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a registered nurse, and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. In JAN-2015, the patient was vaccinated with the first dose of GARDASIL (frequency, route, lot # and expiration date were not reported). Then, in March 2016, the patient received the second dose series GARDASIL 9 (frequency, route, lot # and expiration date were not reported). No concomitant medications, no adverse effects and no product quality complaint were reported. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Autoimmune disorder, Electrocardiogram, Encephalitis, Feeling abnormal
Clinical narrative: This spontaneous report was received from a consumer concerning her approximately 15 year old daughter with asthma. The patient's medical history and concomitant medications were not reported. On 02-OCT-2013, the patient was vaccinated with the first dose of GARDASIL (dose, strength and route of administration were not reported). On 09-DEC-2013, the patient was vaccinated with the second dose of GARDASIL (dose, strength and route of administration were not reported). Lot number J007354 with expiration date 20-FEB-2016 and J011272 with expiration date 21-APR-2016 were reported for the two doses administered. On an unspecified date in December 2013, also reported as after receiving the second vaccination, the patient experienced encephalitis, vertigo, nausea, seizures, autoimmune disease, encephalitis, methylenetetrahydrofolate reductase gene mutation (MTHFR), postural orthostatic tachycardia syndrome (POTS), pediatric acute-onset neuropsychiatric syndrome (PANS), neurologic and central nervous system disease, pain brain fog and neuropathy. Furthermore, dominant Lyme disease was found in the patients system. On 05-MAY-2016, the patient was unconscious for 30 minutes. On an unspecified date, the patient required an electrocardiogram (EKG), "a lot of lab work" and a video test of the brain for unspecified condition with unspecified results. The patient's mother stated that the patient was hospitalized for 3 days on an unspecified date and also reported that the patient received treatment for the reported events. According to reporter, the patient had been sick for 2 years and six months and she was unable to attend school, get a job or drive. In addition, the reporter stated that these conditions made their family life a "living hell" and had "taken a huge toll on them financially". At the time of reporting, the outcome of the reported events was not recovered. The action taken regarding GARDASIL was withdrawn. The reporter did not assess the causal relationship between the reported events and vaccination with GARDASIL. Upon internal review the events encephalitis, Lyme disease, loss of consciousness and autoimmune disorder were determined to be medically significant. All the reported events were considered to be disabling and life threatening by the reporter. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Impaired driving ability, Impaired work ability, Laboratory test, Loss of consciousness, Lyme disease
Clinical narrative: This spontaneous report was received from a consumer concerning her approximately 15 year old daughter with asthma. The patient's medical history and concomitant medications were not reported. On 02-OCT-2013, the patient was vaccinated with the first dose of GARDASIL (dose, strength and route of administration were not reported). On 09-DEC-2013, the patient was vaccinated with the second dose of GARDASIL (dose, strength and route of administration were not reported). Lot number J007354 with expiration date 20-FEB-2016 and J011272 with expiration date 21-APR-2016 were reported for the two doses administered. On an unspecified date in December 2013, also reported as after receiving the second vaccination, the patient experienced encephalitis, vertigo, nausea, seizures, autoimmune disease, encephalitis, methylenetetrahydrofolate reductase gene mutation (MTHFR), postural orthostatic tachycardia syndrome (POTS), pediatric acute-onset neuropsychiatric syndrome (PANS), neurologic and central nervous system disease, pain brain fog and neuropathy. Furthermore, dominant Lyme disease was found in the patients system. On 05-MAY-2016, the patient was unconscious for 30 minutes. On an unspecified date, the patient required an electrocardiogram (EKG), "a lot of lab work" and a video test of the brain for unspecified condition with unspecified results. The patient's mother stated that the patient was hospitalized for 3 days on an unspecified date and also reported that the patient received treatment for the reported events. According to reporter, the patient had been sick for 2 years and six months and she was unable to attend school, get a job or drive. In addition, the reporter stated that these conditions made their family life a "living hell" and had "taken a huge toll on them financially". At the time of reporting, the outcome of the reported events was not recovered. The action taken regarding GARDASIL was withdrawn. The reporter did not assess the causal relationship between the reported events and vaccination with GARDASIL. Upon internal review the events encephalitis, Lyme disease, loss of consciousness and autoimmune disorder were determined to be medically significant. All the reported events were considered to be disabling and life threatening by the reporter. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Malaise, Methylenetetrahydrofolate reductase gene mutation, Nausea, Nervous system disorder, Neuropathy peripheral
Clinical narrative: This spontaneous report was received from a consumer concerning her approximately 15 year old daughter with asthma. The patient's medical history and concomitant medications were not reported. On 02-OCT-2013, the patient was vaccinated with the first dose of GARDASIL (dose, strength and route of administration were not reported). On 09-DEC-2013, the patient was vaccinated with the second dose of GARDASIL (dose, strength and route of administration were not reported). Lot number J007354 with expiration date 20-FEB-2016 and J011272 with expiration date 21-APR-2016 were reported for the two doses administered. On an unspecified date in December 2013, also reported as after receiving the second vaccination, the patient experienced encephalitis, vertigo, nausea, seizures, autoimmune disease, encephalitis, methylenetetrahydrofolate reductase gene mutation (MTHFR), postural orthostatic tachycardia syndrome (POTS), pediatric acute-onset neuropsychiatric syndrome (PANS), neurologic and central nervous system disease, pain brain fog and neuropathy. Furthermore, dominant Lyme disease was found in the patients system. On 05-MAY-2016, the patient was unconscious for 30 minutes. On an unspecified date, the patient required an electrocardiogram (EKG), "a lot of lab work" and a video test of the brain for unspecified condition with unspecified results. The patient's mother stated that the patient was hospitalized for 3 days on an unspecified date and also reported that the patient received treatment for the reported events. According to reporter, the patient had been sick for 2 years and six months and she was unable to attend school, get a job or drive. In addition, the reporter stated that these conditions made their family life a "living hell" and had "taken a huge toll on them financially". At the time of reporting, the outcome of the reported events was not recovered. The action taken regarding GARDASIL was withdrawn. The reporter did not assess the causal relationship between the reported events and vaccination with GARDASIL. Upon internal review the events encephalitis, Lyme disease, loss of consciousness and autoimmune disorder were determined to be medically significant. All the reported events were considered to be disabling and life threatening by the reporter. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Neuropsychiatric syndrome, Pain, Postural orthostatic tachycardia syndrome, Seizure, Vertigo
Clinical narrative: This spontaneous report was received from a consumer concerning her approximately 15 year old daughter with asthma. The patient's medical history and concomitant medications were not reported. On 02-OCT-2013, the patient was vaccinated with the first dose of GARDASIL (dose, strength and route of administration were not reported). On 09-DEC-2013, the patient was vaccinated with the second dose of GARDASIL (dose, strength and route of administration were not reported). Lot number J007354 with expiration date 20-FEB-2016 and J011272 with expiration date 21-APR-2016 were reported for the two doses administered. On an unspecified date in December 2013, also reported as after receiving the second vaccination, the patient experienced encephalitis, vertigo, nausea, seizures, autoimmune disease, encephalitis, methylenetetrahydrofolate reductase gene mutation (MTHFR), postural orthostatic tachycardia syndrome (POTS), pediatric acute-onset neuropsychiatric syndrome (PANS), neurologic and central nervous system disease, pain brain fog and neuropathy. Furthermore, dominant Lyme disease was found in the patients system. On 05-MAY-2016, the patient was unconscious for 30 minutes. On an unspecified date, the patient required an electrocardiogram (EKG), "a lot of lab work" and a video test of the brain for unspecified condition with unspecified results. The patient's mother stated that the patient was hospitalized for 3 days on an unspecified date and also reported that the patient received treatment for the reported events. According to reporter, the patient had been sick for 2 years and six months and she was unable to attend school, get a job or drive. In addition, the reporter stated that these conditions made their family life a "living hell" and had "taken a huge toll on them financially". At the time of reporting, the outcome of the reported events was not recovered. The action taken regarding GARDASIL was withdrawn. The reporter did not assess the causal relationship between the reported events and vaccination with GARDASIL. Upon internal review the events encephalitis, Lyme disease, loss of consciousness and autoimmune disorder were determined to be medically significant. All the reported events were considered to be disabling and life threatening by the reporter. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site pain, Pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 74-year-old female patient who received FLUARIX Quadrivalent 2015/2016 (batch number 497KX, expiry date 30 JUN 2016). Concurrent medical conditions included Sjogren's syndrome (she had it before February 2015 but noted her levels had increased since February 2015). Concomitant products included Leucovorin, Restasis, MVI, Eye ointment NOS, folic acid and Thera Tears. On 13 OCT 2015, the patient received FLUARIX Quadrivalent 2015-2016 season. On 13 OCT 2015, 5 hrs after receiving FLUARIX Quadrivalent 2015-2016 season, the patient experienced injection site pain and irradiating pain. ON 15 OCT 2015, the patient experienced injected limb mobility decreased. The patient was treated with arnica (nos) Amica Gel, medication unknown (ice pack  (NOS) and steroids nos (Steroid shot (NOS)). On an unknown date, the outcome of the injection site pain, irradiating pain and injected limb mobility increased were not recovered/not resolved. The reporter considered the injection site pain, irradiating pain and injected limb mobility to the related to FLUARIX Quadrivalent  2015-2016 season. Additional details were provided as follows: This case was previously reported to a doctor. The patient received the FLUARiX Quadrivalent 2015-2016 season on the right arm at the hospital's occupational health office, where she volunteered. About 5 hours after vaccination, the patient experienced pain in her shoulder. Over the next few days the pain radiated from her shoulder on the inside down to her wrist. The even noted it was difficult getting dressed as she had difficulty  rotating the top of the shoulder. She stated she has tried numerous things as directed by her physician such as Amica gel, heat and ice for 6 months,m physical therapy, a chiropractor, osteopathic medicine and a steroid shot in the shoulder in December 2015 that did relive most of the pain but only for 2 days. She stated it has gotten better over time, but it was still uncomfortable and the pain will radiated down her arm. She stated no other vaccines were given on the day of this vaccine or within 4 weeks. The reporter had reported this case to VAERS.
Age: 5.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Asthenia, Consciousness fluctuating, Somnolence, Vomiting
Clinical narrative: Within 15 min of varicella vaccine administered patient had sore throat, vomiting, passed out. Was admitted to ER was not breathing put on ventilator had multiple seizures took 2 1/2 hours to stabilize enough to transfer to ICU where he stayed in a medical coma for 2 days.
Age: 5.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Intensive care, Loss of consciousness, Mechanical ventilation, Medical induction of coma, Oropharyngeal pain
Clinical narrative: Within 15 min of varicella vaccine administered patient had sore throat, vomiting, passed out. Was admitted to ER was not breathing put on ventilator had multiple seizures took 2 1/2 hours to stabilize enough to transfer to ICU where he stayed in a medical coma for 2 days.
Age: 5.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Respiratory arrest, Seizure, Vomiting
Clinical narrative: Within 15 min of varicella vaccine administered patient had sore throat, vomiting, passed out. Was admitted to ER was not breathing put on ventilator had multiple seizures took 2 1/2 hours to stabilize enough to transfer to ICU where he stayed in a medical coma for 2 days.
Sex: U
Vaccine: PPV, PPV
Symptoms: No adverse event, Product name confusion
Clinical narrative: This spontaneous report was received from a physician via a company representative, and refers to an unspecified number of patients of unknown age. The patients' medical history and concurrent conditions were not provided. It was reported that on an unknown date, unspecified number of patients younger than 2 years of age were vaccinated with a dose of PNEUMOVAX 23 injection (expiration date, dose and route of administration were not reported). Concomitant therapies were not provided. It was stated that the physician's nurses denied that the physician has administered PNEUMOVAX 23 to the patients under the age of 2 years. Furthermore, it was reported that the physician and the nurse might be confusing PNEUMOVAX 23 with PREVNAR. However, no adverse event was reported. Follow up information has been received from the physician on 06-MAY-2016, via a telephone call. The physician reported that since unknown date, she has treated multiple unspecified patients (under age of two years) that had previously received the PREVNAR vaccination with PNEUMOVAX 23 dose. Each patient had lab studies done on an unknown date including Pneumonia 14 serotype. The patients had pneumococcal antigen deficiency. Each patient had an unspecified severe infection resulting in hospitalization. The physician generally listed pneumonia requiring a ventilator and sinusitis requiring intravenous (IV) antibiotics. The physician clarified that the treatment of administration of PNEUMOVAX 23 was a collaborative effort with multiple specialties while the patient was in acute care setting. The physician stated that with each patient, the repeat lab studies for response to vaccination was positive (exact date was not reported). The treatment had therapeutic outcome. Upon internal review, the event of pneumonia was considered as medically significant event. Additional information has been requested. Lab data, event and narrative were updated.
Sex: U
Vaccine: PPV, PPV
Symptoms: Immunodeficiency, Inappropriate schedule of drug administration, Infection, Mechanical ventilation, Pneumonia
Clinical narrative: This spontaneous report was received from a physician via a company representative, and refers to an unspecified number of patients of unknown age. The patients' medical history and concurrent conditions were not provided. It was reported that on an unknown date, unspecified number of patients younger than 2 years of age were vaccinated with a dose of PNEUMOVAX 23 injection (expiration date, dose and route of administration were not reported). Concomitant therapies were not provided. It was stated that the physician's nurses denied that the physician has administered PNEUMOVAX 23 to the patients under the age of 2 years. Furthermore, it was reported that the physician and the nurse might be confusing PNEUMOVAX 23 with PREVNAR. However, no adverse event was reported. Follow up information has been received from the physician on 06-MAY-2016, via a telephone call. The physician reported that since unknown date, she has treated multiple unspecified patients (under age of two years) that had previously received the PREVNAR vaccination with PNEUMOVAX 23 dose. Each patient had lab studies done on an unknown date including Pneumonia 14 serotype. The patients had pneumococcal antigen deficiency. Each patient had an unspecified severe infection resulting in hospitalization. The physician generally listed pneumonia requiring a ventilator and sinusitis requiring intravenous (IV) antibiotics. The physician clarified that the treatment of administration of PNEUMOVAX 23 was a collaborative effort with multiple specialties while the patient was in acute care setting. The physician stated that with each patient, the repeat lab studies for response to vaccination was positive (exact date was not reported). The treatment had therapeutic outcome. Upon internal review, the event of pneumonia was considered as medically significant event. Additional information has been requested. Lab data, event and narrative were updated.
Sex: U
Vaccine: PPV, PPV
Symptoms: Product name confusion, Sinusitis, Streptococcus test positive, Viral test positive
Clinical narrative: This spontaneous report was received from a physician via a company representative, and refers to an unspecified number of patients of unknown age. The patients' medical history and concurrent conditions were not provided. It was reported that on an unknown date, unspecified number of patients younger than 2 years of age were vaccinated with a dose of PNEUMOVAX 23 injection (expiration date, dose and route of administration were not reported). Concomitant therapies were not provided. It was stated that the physician's nurses denied that the physician has administered PNEUMOVAX 23 to the patients under the age of 2 years. Furthermore, it was reported that the physician and the nurse might be confusing PNEUMOVAX 23 with PREVNAR. However, no adverse event was reported. Follow up information has been received from the physician on 06-MAY-2016, via a telephone call. The physician reported that since unknown date, she has treated multiple unspecified patients (under age of two years) that had previously received the PREVNAR vaccination with PNEUMOVAX 23 dose. Each patient had lab studies done on an unknown date including Pneumonia 14 serotype. The patients had pneumococcal antigen deficiency. Each patient had an unspecified severe infection resulting in hospitalization. The physician generally listed pneumonia requiring a ventilator and sinusitis requiring intravenous (IV) antibiotics. The physician clarified that the treatment of administration of PNEUMOVAX 23 was a collaborative effort with multiple specialties while the patient was in acute care setting. The physician stated that with each patient, the repeat lab studies for response to vaccination was positive (exact date was not reported). The treatment had therapeutic outcome. Upon internal review, the event of pneumonia was considered as medically significant event. Additional information has been requested. Lab data, event and narrative were updated.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Decreased appetite, Erythema, Fatigue, Headache
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 57 year old female patient. The patient's concurrent conditions included high blood pressure. The patient had no drug reactions or allergies. On 28-APR-2016, the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX, once, lot # L032184, expiry date 25-NOV-2016, subcutaneously. Concomitant therapies included lisinopril (+) hydrochlorothiazide (manufacturer unknown). On 29-APR-2016, the patient experienced "sore, red lesion" at the ZOSTAVAX injection site. On 30-APR-2016, the patient "began to not feel well, she had loss of appetite, fatigue, and a headache". On 01-MAY-2016, "the lesion became swollen and had yellow discharge coming out". The patient called in to the facility on 02-MAY-2016 to report the reaction and was seen "later in the day" (on 02-MAY-2016) by an unspecified nurse practitioner. No lab diagnostic studies were performed. The patient was given KEFLEX as treatment for the events. The outcome of the "yellow discharge coming out" was reported as recovered on 02-MAY-2016 while the outcome of the rest of the events was unknown. The causality between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Purulent discharge
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 57 year old female patient. The patient's concurrent conditions included high blood pressure. The patient had no drug reactions or allergies. On 28-APR-2016, the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX, once, lot # L032184, expiry date 25-NOV-2016, subcutaneously. Concomitant therapies included lisinopril (+) hydrochlorothiazide (manufacturer unknown). On 29-APR-2016, the patient experienced "sore, red lesion" at the ZOSTAVAX injection site. On 30-APR-2016, the patient "began to not feel well, she had loss of appetite, fatigue, and a headache". On 01-MAY-2016, "the lesion became swollen and had yellow discharge coming out". The patient called in to the facility on 02-MAY-2016 to report the reaction and was seen "later in the day" (on 02-MAY-2016) by an unspecified nurse practitioner. No lab diagnostic studies were performed. The patient was given KEFLEX as treatment for the events. The outcome of the "yellow discharge coming out" was reported as recovered on 02-MAY-2016 while the outcome of the rest of the events was unknown. The causality between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Decreased appetite, Fatigue, Headache, Injection site discharge, Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 57 year old female patient. The patient's concurrent conditions included high blood pressure. The patient had no drug reactions or allergies. On 28-APR-2016, the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX, once, lot # L032184, expiry date 25-NOV-2016, subcutaneously. Concomitant therapies included lisinopril (+) hydrochlorothiazide (manufacturer unknown). On 29-APR-2016, the patient experienced "sore, red lesion" at the ZOSTAVAX injection site. On 30-APR-2016, the patient "began to not feel well, she had loss of appetite, fatigue, and a headache". On 01-MAY-2016, "the lesion became swollen and had yellow discharge coming out". The patient called in to the facility on 02-MAY-2016 to report the reaction and was seen "later in the day" (on 02-MAY-2016) by an unspecified nurse practitioner. No lab diagnostic studies were performed. The patient was given KEFLEX as treatment for the events. The outcome of the "yellow discharge coming out" was reported as recovered on 02-MAY-2016 while the outcome of the rest of the events was unknown. The causality between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Malaise, Skin lesion
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 57 year old female patient. The patient's concurrent conditions included high blood pressure. The patient had no drug reactions or allergies. On 28-APR-2016, the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX, once, lot # L032184, expiry date 25-NOV-2016, subcutaneously. Concomitant therapies included lisinopril (+) hydrochlorothiazide (manufacturer unknown). On 29-APR-2016, the patient experienced "sore, red lesion" at the ZOSTAVAX injection site. On 30-APR-2016, the patient "began to not feel well, she had loss of appetite, fatigue, and a headache". On 01-MAY-2016, "the lesion became swollen and had yellow discharge coming out". The patient called in to the facility on 02-MAY-2016 to report the reaction and was seen "later in the day" (on 02-MAY-2016) by an unspecified nurse practitioner. No lab diagnostic studies were performed. The patient was given KEFLEX as treatment for the events. The outcome of the "yellow discharge coming out" was reported as recovered on 02-MAY-2016 while the outcome of the rest of the events was unknown. The causality between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 0.6
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Acute disseminated encephalomyelitis, Anti-NMDA antibody positive, Decreased activity, Encephalitis autoimmune, Eye movement disorder
Clinical narrative: This medically confirmed literature report (initial receipt 03-May-2016) concerns a 7 month old female patient. The patient was healthy prior to vaccination. On an unspecified date, the patient received an influenza virus vaccine, (manufacturer and batch number not reported). On an unspecified date, 48 hours after vaccination, the patient presented with acute onset of altered mental status, decreased activity, roving eye movements and opisthotonic posturing. She was initially diagnosed with acute demyelinating encephalomyelitis (ADEM) and treated with a short burst of corticosteroids followed by a taper. Symptoms subjectively improved during steroid therapy but did not persist, prompting further diagnostic evaluations. Anti-NMDA receptor encephalitis was confirmed by cerebrospinal fluid antibody titer 68 days after onset of symptoms. Treatment was then undertaken with serial courses of intravenous immunoglobulin (IVIG) and rituximab. The patient's hospital course was protracted, and she required utilization of intensive care unit resources due to aspiration risk, surgical placement of nutritional and vascular access devices, and paroxysmal autonomic hyperactivity (PAH). Minimal improvement in her neurologic exam was observed at time of hospital discharge and may be due to delayed start of treatment, as well as the cumulative effect of unrecognized seizures early in her illness course. The outcome was recovering. Reporter's comments: The author reported that this case described the youngest patient with anti-NMDA receptor encephalitis yet reported, and the first to suggest correlation with recent influenza vaccination. Sender's Comments: Seriousness: Serious. Medically significant. Listedness: Unlisted. Brand of vaccine not specified. Assessment according to the CCDS for CSL Inactivated Influenza Virus Vaccine and the AFLURIA Product Information, anti-NMDA receptor encephalitis and all related events are unlisted. Causality: Possible. Time to onset is 48 hours following vaccination. Anti-NMDA receptor encephalitis was confirmed by cerebrospinal fluid analysis. As per the authors comment, this is the youngest patient with anti-NMDA receptor encephalitis reported. Of note, this was a booster dose indicating the infant had prior exposure to influenza vaccination. Causality considered possibly related due to temporal association and absence of other attributable risk.
Age: 0.6
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Immunoglobulin therapy, Intensive care, Mental status changes, Opisthotonus, Posturing
Clinical narrative: This medically confirmed literature report (initial receipt 03-May-2016) concerns a 7 month old female patient. The patient was healthy prior to vaccination. On an unspecified date, the patient received an influenza virus vaccine, (manufacturer and batch number not reported). On an unspecified date, 48 hours after vaccination, the patient presented with acute onset of altered mental status, decreased activity, roving eye movements and opisthotonic posturing. She was initially diagnosed with acute demyelinating encephalomyelitis (ADEM) and treated with a short burst of corticosteroids followed by a taper. Symptoms subjectively improved during steroid therapy but did not persist, prompting further diagnostic evaluations. Anti-NMDA receptor encephalitis was confirmed by cerebrospinal fluid antibody titer 68 days after onset of symptoms. Treatment was then undertaken with serial courses of intravenous immunoglobulin (IVIG) and rituximab. The patient's hospital course was protracted, and she required utilization of intensive care unit resources due to aspiration risk, surgical placement of nutritional and vascular access devices, and paroxysmal autonomic hyperactivity (PAH). Minimal improvement in her neurologic exam was observed at time of hospital discharge and may be due to delayed start of treatment, as well as the cumulative effect of unrecognized seizures early in her illness course. The outcome was recovering. Reporter's comments: The author reported that this case described the youngest patient with anti-NMDA receptor encephalitis yet reported, and the first to suggest correlation with recent influenza vaccination. Sender's Comments: Seriousness: Serious. Medically significant. Listedness: Unlisted. Brand of vaccine not specified. Assessment according to the CCDS for CSL Inactivated Influenza Virus Vaccine and the AFLURIA Product Information, anti-NMDA receptor encephalitis and all related events are unlisted. Causality: Possible. Time to onset is 48 hours following vaccination. Anti-NMDA receptor encephalitis was confirmed by cerebrospinal fluid analysis. As per the authors comment, this is the youngest patient with anti-NMDA receptor encephalitis reported. Of note, this was a booster dose indicating the infant had prior exposure to influenza vaccination. Causality considered possibly related due to temporal association and absence of other attributable risk.