chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: FLUX
Symptoms: Demyelination, Electromyogram abnormal, General physical health deterioration, Gliosis, Immunoglobulin therapy
Clinical narrative: This literature report, initially received on 23-Jul-2018, was reported by other health professional and concerns a 65-year-old, elderly, male patient. The patient's current conditions included human immunodeficiency virus (HIV) infection (CD4 count 533/uL), hypertension, diabetes mellitus type II and blindness (since an unspecified date). On an unspecified date, the patient was administered Influenza Vaccine (dose, route of administration, batch number, anatomical location and expiry date, manufacturer and trade name: not reported). On an unspecified date, 03 days after vaccination, the patient was admitted to the hospital for acute weakness of all extremities. Initial laboratory workup was performed and showed elevated protein in cerebrospinal fluid and no evidence of infection was noted. Anti-nuclear, anti-VGCC (voltage-gated calcium channel), anti-MUSK and anti-GQ1b antibodies were found to be negative. The patient was treated with intravenous immunoglobulin and steroids for possible Guillan-Barre Syndrome, however his condition deteriorated, and he developed respiratory failure which required mechanical ventilation. The patient also experienced complete quadriplegia, nystagmus and multilobar pneumonia. Electromyography (EMG) showed a severe diffuse demyelinating pattern. On 16th day of hospitalization, magnetic resonance imaging (MRI) of brain showed innumerable foci of T2 flair hyperintensity involving brain and spinal cord. On 17th day of hospitalization, the patient died and permission for autopsy was granted. The autopsy was performed and neuropathologic examination showed multiple soft lesions with tan discoloration throughout the brain and spinal cord, predominantly involving periventricular white matter, bilateral basal ganglia, corpus callosum, cerebellar white matter, pons, medulla and upper cervical spinal cord. Microscopic examination showed discrete areas of demyelination surrounding vessels, with patchy macrophage aggregation, sparse CD8+ lymphocyte infiltration and mild reactive gliosis at the periphery. In a few of the lesions, the infiltrate was composed of neutrophils. Inflammation was perivascular or in the brain parenchyma and did not involve the vessel wall. No hemorrhage or viral inclusions were identified. Luxol fast blue stain demonstrated loss of myelin within the lesions. Neurofilament Immunohistochemical stain highlighted relative preservation of axons, although spheroids and axonal disruption were also present. The findings were more consistent with diagnosis of acute disseminated encephalomyelitis (ADEM). The outcome of the events respiratory failure, multilobar pneumonia and symptoms of ADEM (acute weakness of all extremities, complete quadriplegia, nystagmus, elevated protein in cerebrospinal fluid and severe diffuse demyelinating pattern) was not reported. The reporter assessed this case as serious (death and hospitalization).
Sex: M
Vaccine: FLUX
Symptoms: Mechanical ventilation, Muscular weakness, Noninfective encephalitis, Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging spinal abnormal
Clinical narrative: This literature report, initially received on 23-Jul-2018, was reported by other health professional and concerns a 65-year-old, elderly, male patient. The patient's current conditions included human immunodeficiency virus (HIV) infection (CD4 count 533/uL), hypertension, diabetes mellitus type II and blindness (since an unspecified date). On an unspecified date, the patient was administered Influenza Vaccine (dose, route of administration, batch number, anatomical location and expiry date, manufacturer and trade name: not reported). On an unspecified date, 03 days after vaccination, the patient was admitted to the hospital for acute weakness of all extremities. Initial laboratory workup was performed and showed elevated protein in cerebrospinal fluid and no evidence of infection was noted. Anti-nuclear, anti-VGCC (voltage-gated calcium channel), anti-MUSK and anti-GQ1b antibodies were found to be negative. The patient was treated with intravenous immunoglobulin and steroids for possible Guillan-Barre Syndrome, however his condition deteriorated, and he developed respiratory failure which required mechanical ventilation. The patient also experienced complete quadriplegia, nystagmus and multilobar pneumonia. Electromyography (EMG) showed a severe diffuse demyelinating pattern. On 16th day of hospitalization, magnetic resonance imaging (MRI) of brain showed innumerable foci of T2 flair hyperintensity involving brain and spinal cord. On 17th day of hospitalization, the patient died and permission for autopsy was granted. The autopsy was performed and neuropathologic examination showed multiple soft lesions with tan discoloration throughout the brain and spinal cord, predominantly involving periventricular white matter, bilateral basal ganglia, corpus callosum, cerebellar white matter, pons, medulla and upper cervical spinal cord. Microscopic examination showed discrete areas of demyelination surrounding vessels, with patchy macrophage aggregation, sparse CD8+ lymphocyte infiltration and mild reactive gliosis at the periphery. In a few of the lesions, the infiltrate was composed of neutrophils. Inflammation was perivascular or in the brain parenchyma and did not involve the vessel wall. No hemorrhage or viral inclusions were identified. Luxol fast blue stain demonstrated loss of myelin within the lesions. Neurofilament Immunohistochemical stain highlighted relative preservation of axons, although spheroids and axonal disruption were also present. The findings were more consistent with diagnosis of acute disseminated encephalomyelitis (ADEM). The outcome of the events respiratory failure, multilobar pneumonia and symptoms of ADEM (acute weakness of all extremities, complete quadriplegia, nystagmus, elevated protein in cerebrospinal fluid and severe diffuse demyelinating pattern) was not reported. The reporter assessed this case as serious (death and hospitalization).
Sex: M
Vaccine: FLUX
Symptoms: Nystagmus, Pneumonia, Quadriplegia, Respiratory failure, White matter lesion
Clinical narrative: This literature report, initially received on 23-Jul-2018, was reported by other health professional and concerns a 65-year-old, elderly, male patient. The patient's current conditions included human immunodeficiency virus (HIV) infection (CD4 count 533/uL), hypertension, diabetes mellitus type II and blindness (since an unspecified date). On an unspecified date, the patient was administered Influenza Vaccine (dose, route of administration, batch number, anatomical location and expiry date, manufacturer and trade name: not reported). On an unspecified date, 03 days after vaccination, the patient was admitted to the hospital for acute weakness of all extremities. Initial laboratory workup was performed and showed elevated protein in cerebrospinal fluid and no evidence of infection was noted. Anti-nuclear, anti-VGCC (voltage-gated calcium channel), anti-MUSK and anti-GQ1b antibodies were found to be negative. The patient was treated with intravenous immunoglobulin and steroids for possible Guillan-Barre Syndrome, however his condition deteriorated, and he developed respiratory failure which required mechanical ventilation. The patient also experienced complete quadriplegia, nystagmus and multilobar pneumonia. Electromyography (EMG) showed a severe diffuse demyelinating pattern. On 16th day of hospitalization, magnetic resonance imaging (MRI) of brain showed innumerable foci of T2 flair hyperintensity involving brain and spinal cord. On 17th day of hospitalization, the patient died and permission for autopsy was granted. The autopsy was performed and neuropathologic examination showed multiple soft lesions with tan discoloration throughout the brain and spinal cord, predominantly involving periventricular white matter, bilateral basal ganglia, corpus callosum, cerebellar white matter, pons, medulla and upper cervical spinal cord. Microscopic examination showed discrete areas of demyelination surrounding vessels, with patchy macrophage aggregation, sparse CD8+ lymphocyte infiltration and mild reactive gliosis at the periphery. In a few of the lesions, the infiltrate was composed of neutrophils. Inflammation was perivascular or in the brain parenchyma and did not involve the vessel wall. No hemorrhage or viral inclusions were identified. Luxol fast blue stain demonstrated loss of myelin within the lesions. Neurofilament Immunohistochemical stain highlighted relative preservation of axons, although spheroids and axonal disruption were also present. The findings were more consistent with diagnosis of acute disseminated encephalomyelitis (ADEM). The outcome of the events respiratory failure, multilobar pneumonia and symptoms of ADEM (acute weakness of all extremities, complete quadriplegia, nystagmus, elevated protein in cerebrospinal fluid and severe diffuse demyelinating pattern) was not reported. The reporter assessed this case as serious (death and hospitalization).
Sex: F
Vaccine: FLUX
Symptoms: Anti-neutrophil cytoplasmic antibody positive vasculitis, Antineutrophil cytoplasmic antibody positive, Computerised tomogram thorax abnormal, Culture negative, Dyspnoea exertional
Clinical narrative: This serious literature case, initially received on 23-Jul-2018, reported by other health professional and concerns a 75-year-old, elderly, female patient. In past (reported as 5 months ago), the patient's Computerized Axial Tomography (CAT) scan of the chest was essentially unremarkable. On an unspecified date, the patient was administered with INN Flu Vaccine Seasonal (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date, 3 weeks after a flu vaccine, the patient presented with sudden onset fatigue and extreme dyspnoea with minimal exertion. Patient had no joint pain or rashes. On an unspecified date, the patient had different lab investigations. Complete blood count and renal function both were found to be un-remarkable. A CAT scan of the lung showed diffuse bilateral patchy consolidation with coalesced nodularity in the upper and mid lung fields. All respiratory cultures were negative. Vasculitis workup was found positive for cytoplasmic-ANCA (c-ANCA). Hence, the patient was diagnosed with Anti-Neutrophilic Cytoplasmic Antibody (ANCA)-associated vasculitis. The reporter stated that Systemic reactions to the flu vaccine are rare and include Guillain-Barre Syndrome (GBS), and hypersensitivity reactions. Reported autoimmune reactions include non-clinical antibody productions or flare ups or flare-existing conditions. ANCA (Anti-Neutrophilic Cytoplasmic Antibody) associated vasculitis (AAV) is rare with incidence of 1 in 20 million annually. Its association with flu vaccine reported only in few cases in the literature. AAV has been reported to occur within 2-4 weeks after flu vaccine only in 8 cases. There was an equal distribution of c-ANCA (cytoplasmic pattern) and perinuclear-ANCA (p-ANCA) in these cases. The kidneys and the lungs are the most affected organs. Cyclophosphamide and prednisone are effective treatments for most. The etiology of AAV in this case is presumed to be an auto-immune mediated response much like in the idiopathic AAV. However, it is unclear if there is a genetic predisposition for flu vaccine associated AAV. At the time of this report, the outcome of the events was not reported. The reporter assessed the event Anti-Neutrophilic Cytoplasmic Antibody (ANCA)-associated vasculitis as related to flu vaccine.
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Full blood count normal, Lung consolidation, Pulmonary mass, Renal function test normal
Clinical narrative: This serious literature case, initially received on 23-Jul-2018, reported by other health professional and concerns a 75-year-old, elderly, female patient. In past (reported as 5 months ago), the patient's Computerized Axial Tomography (CAT) scan of the chest was essentially unremarkable. On an unspecified date, the patient was administered with INN Flu Vaccine Seasonal (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date, 3 weeks after a flu vaccine, the patient presented with sudden onset fatigue and extreme dyspnoea with minimal exertion. Patient had no joint pain or rashes. On an unspecified date, the patient had different lab investigations. Complete blood count and renal function both were found to be un-remarkable. A CAT scan of the lung showed diffuse bilateral patchy consolidation with coalesced nodularity in the upper and mid lung fields. All respiratory cultures were negative. Vasculitis workup was found positive for cytoplasmic-ANCA (c-ANCA). Hence, the patient was diagnosed with Anti-Neutrophilic Cytoplasmic Antibody (ANCA)-associated vasculitis. The reporter stated that Systemic reactions to the flu vaccine are rare and include Guillain-Barre Syndrome (GBS), and hypersensitivity reactions. Reported autoimmune reactions include non-clinical antibody productions or flare ups or flare-existing conditions. ANCA (Anti-Neutrophilic Cytoplasmic Antibody) associated vasculitis (AAV) is rare with incidence of 1 in 20 million annually. Its association with flu vaccine reported only in few cases in the literature. AAV has been reported to occur within 2-4 weeks after flu vaccine only in 8 cases. There was an equal distribution of c-ANCA (cytoplasmic pattern) and perinuclear-ANCA (p-ANCA) in these cases. The kidneys and the lungs are the most affected organs. Cyclophosphamide and prednisone are effective treatments for most. The etiology of AAV in this case is presumed to be an auto-immune mediated response much like in the idiopathic AAV. However, it is unclear if there is a genetic predisposition for flu vaccine associated AAV. At the time of this report, the outcome of the events was not reported. The reporter assessed the event Anti-Neutrophilic Cytoplasmic Antibody (ANCA)-associated vasculitis as related to flu vaccine.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Balance disorder, Dizziness, Fall, Fatigue
Clinical narrative: Severe fatigue rest of day vaccine given. 18 hours later, I awoke with a fever and severe dizziness and weakness. I lost balance and fell on the ground. Could not see anything but white for about 15 minutes and had extreme sweating like never before. Took the entire day to recover. Also, my arm was very painful for 48 hours after receiving the vaccine. Had a headache all day after vaccine.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hyperhidrosis, Pain in extremity, Pyrexia, Visual impairment
Clinical narrative: Severe fatigue rest of day vaccine given. 18 hours later, I awoke with a fever and severe dizziness and weakness. I lost balance and fell on the ground. Could not see anything but white for about 15 minutes and had extreme sweating like never before. Took the entire day to recover. Also, my arm was very painful for 48 hours after receiving the vaccine. Had a headache all day after vaccine.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Tinnitus
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of fatigue in a 61-year-old female patient who received SHINGRIX (batch number LN9TL, expiry date 30th January 2020) for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fatigue, ringing in ears and myalgia. On an unknown date, the outcome of the fatigue, ringing in ears and myalgia were unknown. It was unknown if the reporter considered the fatigue, ringing in ears and myalgia to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The representative called in to report the adverse event and stated that, the healthcare professional (HCP) was very reluctant to provide any further information. Follow up information was received by a nurse via sales rep on 8th May 2018: The reporter's contact details were updated. The patient's demographic details were updated. The batch number and expiry date of SHINGRIX were updated. On 10th April 2018, the patient received 0.5 ml 1st dose of SHINGRIX via intramuscular route. On 11th April 2018, within 24 hours after receiving SHINGRIX, the patient experienced fatigue, ringing in ears and myalgia. On the next day, the patient reported that she was receving Antibiotics for a sinus infection. As of 1st May 2018, the patient still continued to report ringing in the ears that was worse in the AM. The nurse requested that the patient should contact primary care physician for recommendation on 2nd dose. The VAERS details were updated. This case (US2018062462) was identified as duplicate of US2018GSK129128. Case US2018GSK129128 would be deleted and all future correspondence will be added in present case which would stands as case of record for this patient. Follow up information was received by nurse on 18th July 2018: The reporters details were updated. Healthcare professional reported that, the follow up was that the ENT doctor states that the tinnitus indeed came from the SHINGRIX vaccine and was not due to hearing loss because of its sudden onset.; Sender's Comments: US2018062462: Previous VAERS submission in paper format
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Myalgia, Sinusitis, Tinnitus
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of fatigue in a 61-year-old female patient who received SHINGRIX (batch number LN9TL, expiry date 30th January 2020) for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fatigue, ringing in ears and myalgia. On an unknown date, the outcome of the fatigue, ringing in ears and myalgia were unknown. It was unknown if the reporter considered the fatigue, ringing in ears and myalgia to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The representative called in to report the adverse event and stated that, the healthcare professional (HCP) was very reluctant to provide any further information. Follow up information was received by a nurse via sales rep on 8th May 2018: The reporter's contact details were updated. The patient's demographic details were updated. The batch number and expiry date of SHINGRIX were updated. On 10th April 2018, the patient received 0.5 ml 1st dose of SHINGRIX via intramuscular route. On 11th April 2018, within 24 hours after receiving SHINGRIX, the patient experienced fatigue, ringing in ears and myalgia. On the next day, the patient reported that she was receving Antibiotics for a sinus infection. As of 1st May 2018, the patient still continued to report ringing in the ears that was worse in the AM. The nurse requested that the patient should contact primary care physician for recommendation on 2nd dose. The VAERS details were updated. This case (US2018062462) was identified as duplicate of US2018GSK129128. Case US2018GSK129128 would be deleted and all future correspondence will be added in present case which would stands as case of record for this patient. Follow up information was received by nurse on 18th July 2018: The reporters details were updated. Healthcare professional reported that, the follow up was that the ENT doctor states that the tinnitus indeed came from the SHINGRIX vaccine and was not due to hearing loss because of its sudden onset.; Sender's Comments: US2018062462: Previous VAERS submission in paper format
Age: 70.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Discomfort, Fluid retention, Headache, Myalgia, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site muscle pain in a 70-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included fibromyalgia. Concomitant products included ADDERALL XR, IMITREX, LINZESS, tramadol and TYLENOL ARTHRITIS. On 22nd May 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 22nd May 2018, immediately after receiving SHINGRIX, the patient experienced injection site muscle pain. On 23rd May 2018, the patient experienced chills, feverish, influenza-like symptoms and pain. On 6th June 2018, the outcome of the chills, feverish, influenza-like symptoms and pain were recovered/resolved. On an unknown date, the outcome of the injection site muscle pain was recovered/resolved. The reporter considered the injection site muscle pain, chills, feverish, influenza-like symptoms and pain to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient. This case was previously reported by the patient to their physician. It was reported that the patient experienced pain as vaccine was being administered into her muscle. The next day of vaccination, the patient experienced flu like symptoms, felt achy, had chills, felt feverish (she did not take her temperature), and had arm pain at site of injection. The reporter stated that events resolved after two weeks except that the arm pain had improved but was still present and it woke her up at night sometimes. Upon review, the following correction was performed on 1st August 2018: The sequence of suspect vaccine (SHINGRIX) was rearranged.
Age: 70.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Chills, Immediate post-injection reaction, Influenza like illness, Injection site pain, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site muscle pain in a 70-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included fibromyalgia. Concomitant products included ADDERALL XR, IMITREX, LINZESS, tramadol and TYLENOL ARTHRITIS. On 22nd May 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 22nd May 2018, immediately after receiving SHINGRIX, the patient experienced injection site muscle pain. On 23rd May 2018, the patient experienced chills, feverish, influenza-like symptoms and pain. On 6th June 2018, the outcome of the chills, feverish, influenza-like symptoms and pain were recovered/resolved. On an unknown date, the outcome of the injection site muscle pain was recovered/resolved. The reporter considered the injection site muscle pain, chills, feverish, influenza-like symptoms and pain to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient. This case was previously reported by the patient to their physician. It was reported that the patient experienced pain as vaccine was being administered into her muscle. The next day of vaccination, the patient experienced flu like symptoms, felt achy, had chills, felt feverish (she did not take her temperature), and had arm pain at site of injection. The reporter stated that events resolved after two weeks except that the arm pain had improved but was still present and it woke her up at night sometimes. Upon review, the following correction was performed on 1st August 2018: The sequence of suspect vaccine (SHINGRIX) was rearranged.
Age: 70.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Pyrexia, Sleep disorder
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site muscle pain in a 70-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included fibromyalgia. Concomitant products included ADDERALL XR, IMITREX, LINZESS, tramadol and TYLENOL ARTHRITIS. On 22nd May 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 22nd May 2018, immediately after receiving SHINGRIX, the patient experienced injection site muscle pain. On 23rd May 2018, the patient experienced chills, feverish, influenza-like symptoms and pain. On 6th June 2018, the outcome of the chills, feverish, influenza-like symptoms and pain were recovered/resolved. On an unknown date, the outcome of the injection site muscle pain was recovered/resolved. The reporter considered the injection site muscle pain, chills, feverish, influenza-like symptoms and pain to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient. This case was previously reported by the patient to their physician. It was reported that the patient experienced pain as vaccine was being administered into her muscle. The next day of vaccination, the patient experienced flu like symptoms, felt achy, had chills, felt feverish (she did not take her temperature), and had arm pain at site of injection. The reporter stated that events resolved after two weeks except that the arm pain had improved but was still present and it woke her up at night sometimes. Upon review, the following correction was performed on 1st August 2018: The sequence of suspect vaccine (SHINGRIX) was rearranged.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Neck pain, Pain
Clinical narrative: Patient continued to complain of pain in arm, even up to her neck; claims shot was given a little higher than where it should been given. Doctor was notified. I still told her to mention to the doctor that she still has pain from the vaccine.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Neck pain, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Patient continued to complain of pain in arm, even up to her neck; claims shot was given a little higher than where it should been given. Doctor was notified. I still told her to mention to the doctor that she still has pain from the vaccine.
Age: 33.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site pruritus, Injection site reaction, Rash macular
Clinical narrative: Erythemic maculopapular rash. 3 inch radius around vaccination site. PT states it itches slightly. Rash began 5 days ago. PT received vaccine 11 JUL 18. vitals B/P: 115/70, HR: 64, Temp: 99 Degrees Celsius, SP02: 98%.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Headache, Hyperhidrosis, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Nausea, fevers, sweating, shakes, arm extremely sore, headaches.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Tremor
Clinical narrative: Nausea, fevers, sweating, shakes, arm extremely sore, headaches.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: Chills and fever - not sure this was from vaccine, but have had no problems for months. Soreness in arm, which I expected.
Age: 78.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: Small red spots appear all over my body.
Age: 78.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Rash, Rash macular
Clinical narrative: Small red spots appear all over my body.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist who was referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies, drug reactions or allergies were not reported. On 03-JUL-2018, the patient vas vaccinated with a dose of M-M-R II recombinant human albumin, intramuscularly (lot # N032757, expiration date: 20-NOV-2019, strength, dose and site of administration were not provided) for prophylaxis. The vaccine was reconstituted with sterile diluent (lot # N030846, expiration date: 26-APR-2020). There were no adverse effects reported.
Age: 33.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Dizziness, Erythema, Headache, Muscle tightness, Musculoskeletal stiffness
Clinical narrative: This spontaneous report was received from a medical assistant and vaccine provider and refers to a non-pregnant 33-year-old female patient. The patient's concurrent conditions included vitamin D deficiency, weight loss and nerve pain. There were no drug reactions or allergies reported. On 15-JUN-2018, the patient was vaccinated with PNEUMOVAX 23 0.5 ml, once, intramuscularly in right deltoid (lot # N034512, expiration date: 13-SEP-2019) as prevention of pneumonia and diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (TDAP) in right deltoid (lot # U5829AB, dose, strength, route of administration and expiration date were not provided) for prophylaxis. It was reported that she was well at the time of vaccination. The patient's concomitant therapies included ergocalciferol and phentermine hydrochloride (+) topiramate. On 16-JUN-2018, the patient sought medical attention and was seen by physician. During the office visit she reported body aches. On 16-JUN-2018, the patient had a strep test performed with a positive result and was diagnosed with "strep throat". On 18-JUN-2018 (also reported before as ''15-JUN-2018''), the patient experienced fever. On 18-JUN-2018, the patient also experienced hives on upper right arm, the arm being stiff, tight feeling, lightheaded, slight headache and arm redness and swelling. The patient received an unspecified treatment for the adverse events. Prescription drug treatment was not required. The outcome of the events was reported as recovered on an unknown date in 2018. The relatedness between the adverse events and PNEUMOVAX 23 was not reported.
Age: 33.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Pain, Peripheral swelling, Pharyngitis streptococcal, Pyrexia, Streptococcus test positive
Clinical narrative: This spontaneous report was received from a medical assistant and vaccine provider and refers to a non-pregnant 33-year-old female patient. The patient's concurrent conditions included vitamin D deficiency, weight loss and nerve pain. There were no drug reactions or allergies reported. On 15-JUN-2018, the patient was vaccinated with PNEUMOVAX 23 0.5 ml, once, intramuscularly in right deltoid (lot # N034512, expiration date: 13-SEP-2019) as prevention of pneumonia and diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (TDAP) in right deltoid (lot # U5829AB, dose, strength, route of administration and expiration date were not provided) for prophylaxis. It was reported that she was well at the time of vaccination. The patient's concomitant therapies included ergocalciferol and phentermine hydrochloride (+) topiramate. On 16-JUN-2018, the patient sought medical attention and was seen by physician. During the office visit she reported body aches. On 16-JUN-2018, the patient had a strep test performed with a positive result and was diagnosed with "strep throat". On 18-JUN-2018 (also reported before as ''15-JUN-2018''), the patient experienced fever. On 18-JUN-2018, the patient also experienced hives on upper right arm, the arm being stiff, tight feeling, lightheaded, slight headache and arm redness and swelling. The patient received an unspecified treatment for the adverse events. Prescription drug treatment was not required. The outcome of the events was reported as recovered on an unknown date in 2018. The relatedness between the adverse events and PNEUMOVAX 23 was not reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product use issue
Clinical narrative: This spontaneous report has been received from a medical assistant referring to an unspecified patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medication. The medical assistant reported that on an unspecified date, an unspecified patient received a recalled lot of GARDASIL 9 which had a lot # N029069 with expiration date in 17-MAY-2020. No adverse effects were reported.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to 5 unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were not reported. On an unknown date, 5 unspecified patients were vaccinated with improperly stored VARIVAX (dose and rout unknown, lot# N021318 with expiration date 07-AUG-2019, lot # R002051 with expiration date 22-JAN-2020) and PROQUAD (dose and route unknown, lot# R003292 with expiration date 31-JUL-2019, lot # R002935 with expiration date 29-JUL-2019) for prophylaxis. The sterile diluent (manufacturer unknown) (lot# M012716 with expiration date 20-AUG-2018, lot # N030577 with expiration date 19-APR-2019, lot# N027783 with expiration date 17-NOV-2019,lot# M013220 with expiration date 24-SEP-2018, lot# M035268 with expiration date 19-APR-2019; lot # N006322 with expiration date 11-JUL-2019, lot # M012718 with expiration date 10-NOV-2018, lot # N004190 with expiration date 04-JUL-2019, lot # N022038 with expiration date 27-NOV-2019, lot# N030574 with expiration date 05-JUN-2020, lot# N030178 with expiration date 15-JUL-2020) used to reconstitute the vaccines was properly stored. The medical assistant was not sure which sterile diluent (manufacturer unknown) lot numbers were used.  The vaccines were exposed to temperature excursion of -14 degree Celsius up to -10 degree Celsius for 5 hours total (including the previous exposure to temperature excursion). Data logger was involved. No product quality complaint (PQC) was involved in this case. No symptoms were reported. This is a non-valid case due to lack of patient identifiers. Upon receipt of follow-up information it was determined that this case is now valid because patient identifier was received. Follow up information was received from Licensed Practical Nurse on 30-JUL-2018 and refers to 4 year old female patient. The patient previously received one dose of measles virus vaccine live (Enders-Edmonston) mumps virus vaccine live (Jeryl Lynn) rubella virus vaccine live (Wistar RA 27/3) (M-M-R), one dose of varicella virus vaccine live (unspecified), 4 doses of diphtheria toxoid pertussis acellular vaccine (unspecified) tetanus toxoid and 3 doses of poliovirus vaccine inactivated (unspecified). On 09-JUL-2018 the patient was vaccinated with PROQUAD from lot R003292 dose 1, subcutaneous in the right thigh for prophylaxis. On the same day, the patient was also vaccinated with KINRIX from lot 53NB2 dose 1, intramuscular in the left thigh for prophylaxis. This is one of the several reports linked via same reporter link.; Sender's Comments: US-009507513-1808USA000455: US-009507513-1808USA000456: US-009507513-1808USA000457: US-009507513-1808USA000458: US-009507513-1808USA000459: US-009507513-1808USA000460: US-009507513-1808USA000461: US-009507513-1808USA000462: US-009507513-1808USA000463: US-009507513-1808USA000464: US-009507513-1808USA000465:
Sex: F
Vaccine: HPV9
Symptoms: Death, Hepatic failure
Clinical narrative: This spontaneous report was received from a registered pharmacist via a company representative, who refers to an adult female patient between 20 and 21 years old. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported. On an unknown date in 2013 (reported as approximately 5 years ago), the patient received the complete vaccination series of three doses of GARDASIL 9 (lot #, expiration date, dose, and route of administration were not provided for all) for prevention of human papilloma virus (HPV). On an unknown date in 2013 (reported as approximately 5 years ago after complete series of vaccination), the patient developed liver failure. The outcome of the event was unknown. On an unspecified date, after developing liver failure the patient died. Cause of death was not provided. It was unknown if autopsy was performed. The causal relationship between the events and therapy with GARDASIL 9 was not provided by the reporter. Upon internal review, the event of liver failure was determined to be medically significant. Reported Cause(s) of Death: Unknown by reporter.
Sex: M
Vaccine: MMR
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a 22 year old male patient. The patient's relevant medical history, concurrent conditions and concomitant medications were unknown. On unknown dates, the patient was vaccinated with a 2 dose series of M-M-R II for prophylaxis (dose, strength, frequency, route of administration, lot# and expiration date were unknown. The patient had 3 additional booster doses of M-M-R II on unknown dates. On an unknown date, the patient showed no titre for M-M-R II. The outcome of the mentioned events was unknown. Causal relationship between M-M-R II and the mentioned events was unknown.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 21-JUN-2007, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 04-AUG-2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster, or shingles. The patient was prescribed acyclovir and oxycodone for management of his painful symptoms and chronic pain.  As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2012, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 02-SEP-2016, the patient was treated for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. On or about 09-SEP-2016, the patient sought subsequent treatment from a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2014, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2007, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On an unknown date in 2013, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 16-DEC-2015, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster. The patient was prescribed gabapentin and lidocaine for management of painful symptoms and chronic pain. The outcome of the events is unknown. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, 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: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided. On 30-JUL-2018, the patient was vaccinated with improperly stored VARIVAX lot # N035941, expiration date 18-DEC-2019 (dose and route were not provided) for prophylaxis. The vaccine was exposed to a temperature excursion of 6°F to 14°F during 1 hour 25 minutes. It was reported that previous temperature excursion occurred at 6°F to 14°F for 3 hours, multiple excursions. It was reported that the call was because of a data logger. The reporter also stated that the sterile diluent was stored appropriately. No adverse effect was reported.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to 16 year old female patient. The patient previously received one dose of varicella virus vaccine live (unspecified). On 29-JUN-2018 the patient was vaccinated with improperly stored VARIVAX from lot R002051 expiry date 22-JAN-2020, subcutaneous in the left arm for prophylaxis. The sterile diluent (manufacturer unknown) (lot# M012716 with expiration date 20-AUG-2018, lot # N030577 with expiration date 19-APR-2019, lot# N027783 with expiration date 17-NOV-2019,lot# M013220 with expiration date 24-SEP-2018, lot# M035268 with expiration date 19-APR-2019; lot # N006322 with expiration date 11-JUL-2019, lot # M012718 with expiration date 10-NOV-2018, lot # N004190 with expiration date 04-JUL-2019, lot # N022038 with expiration date 27-NOV-2019, lot# N030574 with expiration date 05-JUN-2020, lot# N030178 with expiration date 15-JUL-2020) used to reconstitute the vaccines was properly stored. The reporter was not sure which sterile diluent (manufacturer unknown) lot numbers were used.  The vaccines were exposed to temperature excursion of -14 degree Celsius up to -10 degree Celsius for 5 hours total (including the previous exposure to temperature excursion). Data logger was involved. No product quality complaint (PQC) was involved in this case. No symptoms were reported. This is one of the several reports linked via same reporter link. Sender's Comments: US-009507513-1807USA007589.
Sex: M
Vaccine: HEPA
Symptoms: Chest discomfort
Clinical narrative: This spontaneous report was received from a nurse via company representative regarding an unknown age male patient. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On an 30-JUL-2018, the patient was vaccinated with a dose of VAQTA 25/0.5 for routine vaccination (frequency, lot#, expiration date and route of administration were not reported). On the same date, within one hour of administration of the dose of VAQTA the patient developed chest tightness. The patient sought medical attention. The outcome of the event was not reported. The causal relationship between VAQTA and the event was not reported.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Patient experienced a rash that was fairly itchy that lasted at least 1 week. Patient states did not treat, that rash went away on its own.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Mobility decreased, Multiple sclerosis
Clinical narrative: Pseudo exacerbation of MS symptoms, unable to move extremities for approximately 6 hours.
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Expired product administered, Scab
Clinical narrative: Patient received the vaccine from an already expired vial. Vial was opened in May, 2018 and the vaccine was administered on July 14, 2018.