chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pain, Pain in extremity, Poor quality sleep, Skin warm
Clinical narrative: Within a few minutes felt dizzy (light headed). In 4 hours developed left arm pain - mild. Slept restless most of night, with moderate deltoid pain. Woke up at 7:00 AM feeling dizzy, had to sit in recliner. Woke up with moderate mid epigastric discomfort lasting 9 hours. Delirious x 8 hours - rested in recliner. Moderate shivering x 7 hours. Felt warm - did not take temp. Had generalized body aches x 20 hours. Ringing in both ears (moderate) x 30 hours. Fatigue x 24 hours. Lightheadedness lasted 24 hours. The worse symptom was the shivering and delirium. Woke up Wednesday AM feeling fine, no symptoms, no concerns. Question: Should I continue with the 2nd series of shot?
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Tinnitus
Clinical narrative: Within a few minutes felt dizzy (light headed). In 4 hours developed left arm pain - mild. Slept restless most of night, with moderate deltoid pain. Woke up at 7:00 AM feeling dizzy, had to sit in recliner. Woke up with moderate mid epigastric discomfort lasting 9 hours. Delirious x 8 hours - rested in recliner. Moderate shivering x 7 hours. Felt warm - did not take temp. Had generalized body aches x 20 hours. Ringing in both ears (moderate) x 30 hours. Fatigue x 24 hours. Lightheadedness lasted 24 hours. The worse symptom was the shivering and delirium. Woke up Wednesday AM feeling fine, no symptoms, no concerns. Question: Should I continue with the 2nd series of shot?
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Mobility decreased, Pain
Clinical narrative: Soreness, Redness, inflammation at injection site and body aches (so severe that patient cannot get out of bed).
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Peripheral swelling, Pyrexia, Rash
Clinical narrative: Patient just stated today, 5/17/18, of reaction of IMZ on day of 1st SHINGRIX vaccination given 3/17/18. We were calling for shot #2 reminder. Reaction described as redness and swelling near site, then progressed to swelling and rash on vaccinated arm below elbow. This and fever subsided after 3 days.
Age: 29.0
Sex: F
Vaccine: YF
Symptoms: Injection site reaction, Local reaction, Musculoskeletal stiffness
Clinical narrative: Client called with c/o neck stiffness 2 days after receiving yellow fever vaccine. She denies any other symptoms such as fever, vomiting, vision changes, parasthesias or weakness. She does report a local reaction around the injection site. She cannot attribute the neck stiffness to exercise, strenuous activity, or sleeping on it wrong.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, VARCEL
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: 5 Y/o M received Dtap-IPV and Varicella on his Rt lateral thigh on 15MAY2018 at 1030. Pt did not experience any symptoms the day of the vaccines. On 16MAY2018 MOP believes Pt had a mild fever, but did not take Pt's temperature. Pt states that the site is itchy and swollen. MOP brought Pt to ER around 2030 on 17MAY2018. An ultrasound was preformed and no fluid was found. MOP states that Pt received BENADRYL as treatment. Upon examination 17MAY2018  at 1000 the site is red, hot, and inflamed. Pt was discharged form the hospital at 0330 with no fever.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, VARCEL
Symptoms: Pyrexia, Ultrasound scan normal
Clinical narrative: 5 Y/o M received Dtap-IPV and Varicella on his Rt lateral thigh on 15MAY2018 at 1030. Pt did not experience any symptoms the day of the vaccines. On 16MAY2018 MOP believes Pt had a mild fever, but did not take Pt's temperature. Pt states that the site is itchy and swollen. MOP brought Pt to ER around 2030 on 17MAY2018. An ultrasound was preformed and no fluid was found. MOP states that Pt received BENADRYL as treatment. Upon examination 17MAY2018  at 1000 the site is red, hot, and inflamed. Pt was discharged form the hospital at 0330 with no fever.
Age: 44.0
Sex: M
Vaccine: FLUC4
Symptoms: Asthenia, CSF protein increased, Constipation, Facial paralysis, Guillain-Barre syndrome
Clinical narrative: Patient is a 44 y.o. male who was in his usual state of health. 3 weeks ago he received flu vaccine. For the days after the flu vaccine his feet felt cold. This resolved. His feet and legs began feeling numb. His hands began feeling numb about a week after the flu vaccine. Wife reports he had some flu-like symptoms, patient states he did not. He does admit to having some upper respiratory infections. One week ago the patient presented to the emergency room with left-sided facial drooping. He was diagnosed with Bell's palsy. He was given prednisone and VALTREX without relief. He's had tingling and numbness in his hands and legs since that time. Leg numbness has progressed and is worsening. He does not have leg weakness. His right leg went out from under him and he twisted his right ankle quite severely. He did not experience as much pain as he would've expected for that degree of injury. He's had some sluggishness to his bowels but no other bladder or bowel symptoms. He has not had chest pain or heaviness but the tingling is coming up to his chest. He denies shortness of breath or difficulty getting a deep breath. High probability Guillain-Barré syndrome given the symptoms. I spoke to neurology on the phone. Spinal tap was recommended. We'll proceed with spinal tap and including IgG index. We'll get MRI brain as demyelinating central process is also a possibility though less likely. Admitted to the hospital to evaluate for negative history for's. Consider EMG. IMAGING: Xr Ankle 3 Or More Vw Right. Result Date: 12/11/2017 NO ACUTE OSSEOUS ABNORMALITY. Electronically signed on 12/11/2017 7:40 PM by MD. Xr Foot 3 Or More Vw Right Result Date: 12/11/2017 NO ACUTE OSSEOUS ABNORMALITY. Electronically signed on 12/11/2017 7:40 PM MD. MRI Brain Without Contrast Result Date: 12/12/2017 NO ACUTE INTRACRANIAL FINDINGS. MILD PARANASAL SINUS DISEASE. Electronically signed on 12/12/2017 3:18 PM by MD. Fl Lumbar Puncture W Opening Pressures And CSF Result Date: 12/12/2017 TECHNICALLY SUCCESSFUL LUMBAR PUNCTURE UNDER FLUOROSCOPIC GUIDANCE. FINAL PATHOLOGY RESULTS ARE PENDING. Electronically signed on 12/12/2017 4:32 PM by MD. HOSPITAL COURSE: This is a 44-year-old male that was admitted for ascending weakness with numbness and tingling in the perineal area and legs. He was found to have elevated protein on LP and was treated with IVIG. Patient did get 5 doses of IVIG. He is mostly independent but still requiring walker to ambulate. Still having some issues with bowel movements and is getting good bowel health for this. Patient will continue with his same medications prescribed as well as starting some SENEKOT at home to try to improve his bowel function I did get home health involved to check on them for a couple of days to ensure that he continues to get better make sure that his bowels continue to get better. He will also be referred to right physical therapy by his outpatient doctor once he feels safe to continue.
Age: 44.0
Sex: M
Vaccine: FLUC4
Symptoms: Hypoaesthesia, Immunoglobulin therapy, Ligament sprain, Lumbar puncture abnormal, Muscular weakness
Clinical narrative: Patient is a 44 y.o. male who was in his usual state of health. 3 weeks ago he received flu vaccine. For the days after the flu vaccine his feet felt cold. This resolved. His feet and legs began feeling numb. His hands began feeling numb about a week after the flu vaccine. Wife reports he had some flu-like symptoms, patient states he did not. He does admit to having some upper respiratory infections. One week ago the patient presented to the emergency room with left-sided facial drooping. He was diagnosed with Bell's palsy. He was given prednisone and VALTREX without relief. He's had tingling and numbness in his hands and legs since that time. Leg numbness has progressed and is worsening. He does not have leg weakness. His right leg went out from under him and he twisted his right ankle quite severely. He did not experience as much pain as he would've expected for that degree of injury. He's had some sluggishness to his bowels but no other bladder or bowel symptoms. He has not had chest pain or heaviness but the tingling is coming up to his chest. He denies shortness of breath or difficulty getting a deep breath. High probability Guillain-Barré syndrome given the symptoms. I spoke to neurology on the phone. Spinal tap was recommended. We'll proceed with spinal tap and including IgG index. We'll get MRI brain as demyelinating central process is also a possibility though less likely. Admitted to the hospital to evaluate for negative history for's. Consider EMG. IMAGING: Xr Ankle 3 Or More Vw Right. Result Date: 12/11/2017 NO ACUTE OSSEOUS ABNORMALITY. Electronically signed on 12/11/2017 7:40 PM by MD. Xr Foot 3 Or More Vw Right Result Date: 12/11/2017 NO ACUTE OSSEOUS ABNORMALITY. Electronically signed on 12/11/2017 7:40 PM MD. MRI Brain Without Contrast Result Date: 12/12/2017 NO ACUTE INTRACRANIAL FINDINGS. MILD PARANASAL SINUS DISEASE. Electronically signed on 12/12/2017 3:18 PM by MD. Fl Lumbar Puncture W Opening Pressures And CSF Result Date: 12/12/2017 TECHNICALLY SUCCESSFUL LUMBAR PUNCTURE UNDER FLUOROSCOPIC GUIDANCE. FINAL PATHOLOGY RESULTS ARE PENDING. Electronically signed on 12/12/2017 4:32 PM by MD. HOSPITAL COURSE: This is a 44-year-old male that was admitted for ascending weakness with numbness and tingling in the perineal area and legs. He was found to have elevated protein on LP and was treated with IVIG. Patient did get 5 doses of IVIG. He is mostly independent but still requiring walker to ambulate. Still having some issues with bowel movements and is getting good bowel health for this. Patient will continue with his same medications prescribed as well as starting some SENEKOT at home to try to improve his bowel function I did get home health involved to check on them for a couple of days to ensure that he continues to get better make sure that his bowels continue to get better. He will also be referred to right physical therapy by his outpatient doctor once he feels safe to continue.
Age: 44.0
Sex: M
Vaccine: FLUC4
Symptoms: Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging brain normal, Paraesthesia, Peripheral coldness, Sinus disorder
Clinical narrative: Patient is a 44 y.o. male who was in his usual state of health. 3 weeks ago he received flu vaccine. For the days after the flu vaccine his feet felt cold. This resolved. His feet and legs began feeling numb. His hands began feeling numb about a week after the flu vaccine. Wife reports he had some flu-like symptoms, patient states he did not. He does admit to having some upper respiratory infections. One week ago the patient presented to the emergency room with left-sided facial drooping. He was diagnosed with Bell's palsy. He was given prednisone and VALTREX without relief. He's had tingling and numbness in his hands and legs since that time. Leg numbness has progressed and is worsening. He does not have leg weakness. His right leg went out from under him and he twisted his right ankle quite severely. He did not experience as much pain as he would've expected for that degree of injury. He's had some sluggishness to his bowels but no other bladder or bowel symptoms. He has not had chest pain or heaviness but the tingling is coming up to his chest. He denies shortness of breath or difficulty getting a deep breath. High probability Guillain-Barré syndrome given the symptoms. I spoke to neurology on the phone. Spinal tap was recommended. We'll proceed with spinal tap and including IgG index. We'll get MRI brain as demyelinating central process is also a possibility though less likely. Admitted to the hospital to evaluate for negative history for's. Consider EMG. IMAGING: Xr Ankle 3 Or More Vw Right. Result Date: 12/11/2017 NO ACUTE OSSEOUS ABNORMALITY. Electronically signed on 12/11/2017 7:40 PM by MD. Xr Foot 3 Or More Vw Right Result Date: 12/11/2017 NO ACUTE OSSEOUS ABNORMALITY. Electronically signed on 12/11/2017 7:40 PM MD. MRI Brain Without Contrast Result Date: 12/12/2017 NO ACUTE INTRACRANIAL FINDINGS. MILD PARANASAL SINUS DISEASE. Electronically signed on 12/12/2017 3:18 PM by MD. Fl Lumbar Puncture W Opening Pressures And CSF Result Date: 12/12/2017 TECHNICALLY SUCCESSFUL LUMBAR PUNCTURE UNDER FLUOROSCOPIC GUIDANCE. FINAL PATHOLOGY RESULTS ARE PENDING. Electronically signed on 12/12/2017 4:32 PM by MD. HOSPITAL COURSE: This is a 44-year-old male that was admitted for ascending weakness with numbness and tingling in the perineal area and legs. He was found to have elevated protein on LP and was treated with IVIG. Patient did get 5 doses of IVIG. He is mostly independent but still requiring walker to ambulate. Still having some issues with bowel movements and is getting good bowel health for this. Patient will continue with his same medications prescribed as well as starting some SENEKOT at home to try to improve his bowel function I did get home health involved to check on them for a couple of days to ensure that he continues to get better make sure that his bowels continue to get better. He will also be referred to right physical therapy by his outpatient doctor once he feels safe to continue.
Age: 44.0
Sex: M
Vaccine: FLUC4
Symptoms: Upper respiratory tract infection, Walking aid user, X-ray limb normal
Clinical narrative: Patient is a 44 y.o. male who was in his usual state of health. 3 weeks ago he received flu vaccine. For the days after the flu vaccine his feet felt cold. This resolved. His feet and legs began feeling numb. His hands began feeling numb about a week after the flu vaccine. Wife reports he had some flu-like symptoms, patient states he did not. He does admit to having some upper respiratory infections. One week ago the patient presented to the emergency room with left-sided facial drooping. He was diagnosed with Bell's palsy. He was given prednisone and VALTREX without relief. He's had tingling and numbness in his hands and legs since that time. Leg numbness has progressed and is worsening. He does not have leg weakness. His right leg went out from under him and he twisted his right ankle quite severely. He did not experience as much pain as he would've expected for that degree of injury. He's had some sluggishness to his bowels but no other bladder or bowel symptoms. He has not had chest pain or heaviness but the tingling is coming up to his chest. He denies shortness of breath or difficulty getting a deep breath. High probability Guillain-Barré syndrome given the symptoms. I spoke to neurology on the phone. Spinal tap was recommended. We'll proceed with spinal tap and including IgG index. We'll get MRI brain as demyelinating central process is also a possibility though less likely. Admitted to the hospital to evaluate for negative history for's. Consider EMG. IMAGING: Xr Ankle 3 Or More Vw Right. Result Date: 12/11/2017 NO ACUTE OSSEOUS ABNORMALITY. Electronically signed on 12/11/2017 7:40 PM by MD. Xr Foot 3 Or More Vw Right Result Date: 12/11/2017 NO ACUTE OSSEOUS ABNORMALITY. Electronically signed on 12/11/2017 7:40 PM MD. MRI Brain Without Contrast Result Date: 12/12/2017 NO ACUTE INTRACRANIAL FINDINGS. MILD PARANASAL SINUS DISEASE. Electronically signed on 12/12/2017 3:18 PM by MD. Fl Lumbar Puncture W Opening Pressures And CSF Result Date: 12/12/2017 TECHNICALLY SUCCESSFUL LUMBAR PUNCTURE UNDER FLUOROSCOPIC GUIDANCE. FINAL PATHOLOGY RESULTS ARE PENDING. Electronically signed on 12/12/2017 4:32 PM by MD. HOSPITAL COURSE: This is a 44-year-old male that was admitted for ascending weakness with numbness and tingling in the perineal area and legs. He was found to have elevated protein on LP and was treated with IVIG. Patient did get 5 doses of IVIG. He is mostly independent but still requiring walker to ambulate. Still having some issues with bowel movements and is getting good bowel health for this. Patient will continue with his same medications prescribed as well as starting some SENEKOT at home to try to improve his bowel function I did get home health involved to check on them for a couple of days to ensure that he continues to get better make sure that his bowels continue to get better. He will also be referred to right physical therapy by his outpatient doctor once he feels safe to continue.
Age: 1.42
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site rash, Injection site swelling, Local reaction
Clinical narrative: Pt suffered localized reaction to injection areas bilaterally to thighs. BENADRYL injection 12.5mg IM and cold compresses applied to thighs as well. 20 mins post treatment, pt doing better, rash and swelling subsided. Pt reevaluated by Provider and dc home with mom and rx for BENADRYL. RTC PRN.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Chills, Decreased appetite, Diarrhoea, Fatigue, Injection site cellulitis
Clinical narrative: Redness, swelling, pain at injection site approximately 4 inch in diameter on day one of reaction. Redness and warmth continued to spread to just above the elbow. Rash consistent with evolving cellulitis, emanating from injection site. Patient also with generalized symptoms including itching all over, fatigue, decreased appetitie , loose stool, urge incontinence, fever/chills Tmax 103.6. Patient treated with doxycycline 100 mg BID for 10 days. Patient will return next week for follow up.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, pain at injection site approximately 4 inch in diameter on day one of reaction. Redness and warmth continued to spread to just above the elbow. Rash consistent with evolving cellulitis, emanating from injection site. Patient also with generalized symptoms including itching all over, fatigue, decreased appetitie , loose stool, urge incontinence, fever/chills Tmax 103.6. Patient treated with doxycycline 100 mg BID for 10 days. Patient will return next week for follow up.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Pruritus generalised, Pyrexia, Urge incontinence
Clinical narrative: Redness, swelling, pain at injection site approximately 4 inch in diameter on day one of reaction. Redness and warmth continued to spread to just above the elbow. Rash consistent with evolving cellulitis, emanating from injection site. Patient also with generalized symptoms including itching all over, fatigue, decreased appetitie , loose stool, urge incontinence, fever/chills Tmax 103.6. Patient treated with doxycycline 100 mg BID for 10 days. Patient will return next week for follow up.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Redness, swelling, pain at injection site approximately 4 inch in diameter on day one of reaction. Redness and warmth continued to spread to just above the elbow. Rash consistent with evolving cellulitis, emanating from injection site. Patient also with generalized symptoms including itching all over, fatigue, decreased appetitie , loose stool, urge incontinence, fever/chills Tmax 103.6. Patient treated with doxycycline 100 mg BID for 10 days. Patient will return next week for follow up.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Cephalhaematoma, Computerised tomogram head, Confusional state, Fall, Headache
Clinical narrative: Syncopal episode in the lobby of the office and fell to the floor striking his right parietal scalp with associated loss of consciousness for less than 1 minute, then was confused with severe headache and a right parietal cephalhematoma. Was admitted to hospital for observations.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Loss of consciousness, Skin injury, Syncope
Clinical narrative: Syncopal episode in the lobby of the office and fell to the floor striking his right parietal scalp with associated loss of consciousness for less than 1 minute, then was confused with severe headache and a right parietal cephalhematoma. Was admitted to hospital for observations.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Patient with syncope post injection. Patient regained consciousness about 5-6 seconds after syncopal event. Alert and oriented x3. Had patient remain in supine position for 5 min, then allowed her to sit up in the chair. Patient given graham crackers and Sprite to drink. BP: 110/66, P: 72. Patient waited a total of 30 min in the office post event prior to leaving.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Rash, Rash erythematous, Urticaria
Clinical narrative: Spoke with mom, she states pt had redness at injection site and red raised bumps on chest and arms which mom said looks like hives. Mom gave BENADRYL, pt went swimming. No SOB or follow-up appointment needed per mom. Within 3 hours rash was resolved. Today no redness at injection site or other adverse events noted. Pt is attending school today.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Arrhythmia, Bradycardia, Hypotension, Injection site erythema, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of bradycardia in a 53-year-old female patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020). On 27th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, 21 days after receiving SHINGRIX, the patient experienced bradycardia (serious criteria GSK medically significant), cardiac arrhythmia (serious criteria GSK medically significant), fever, injection site erythema, pain in arm, hypotension and palpitation. On an unknown date, the outcome of the bradycardia and hypotension were not recovered/not resolved and the outcome of the cardiac arrhythmia and palpitation were recovering/resolving and the outcome of the fever, injection site erythema and pain in arm were recovered/resolved. The reporter considered the bradycardia, cardiac arrhythmia, hypotension and palpitation to be unlikely related to SHINGRIX. The reporter considered the fever, injection site erythema and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported that the patient received the SHINGRIX first injection of a two vaccine series, and experienced the common side effects of redness at injection site, sore arm, and low grade fever which had all resolved. The pharmacist reported that the patient said she was a very healthy person prior to receiving the SHINGRIX vaccine, and since that time, the patient developed hypotension, bradycardia, arrhythmias, and palpitations 3 to 4 week after receiving the SHINGRIX vaccine and at the time of reporting, the patient was seeing a cardiologist. The pharmacist was unable to obtain physician's name and phone number and permission to contact physician since reporter was pharmacist.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Palpitations, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of bradycardia in a 53-year-old female patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020). On 27th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, 21 days after receiving SHINGRIX, the patient experienced bradycardia (serious criteria GSK medically significant), cardiac arrhythmia (serious criteria GSK medically significant), fever, injection site erythema, pain in arm, hypotension and palpitation. On an unknown date, the outcome of the bradycardia and hypotension were not recovered/not resolved and the outcome of the cardiac arrhythmia and palpitation were recovering/resolving and the outcome of the fever, injection site erythema and pain in arm were recovered/resolved. The reporter considered the bradycardia, cardiac arrhythmia, hypotension and palpitation to be unlikely related to SHINGRIX. The reporter considered the fever, injection site erythema and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported that the patient received the SHINGRIX first injection of a two vaccine series, and experienced the common side effects of redness at injection site, sore arm, and low grade fever which had all resolved. The pharmacist reported that the patient said she was a very healthy person prior to receiving the SHINGRIX vaccine, and since that time, the patient developed hypotension, bradycardia, arrhythmias, and palpitations 3 to 4 week after receiving the SHINGRIX vaccine and at the time of reporting, the patient was seeing a cardiologist. The pharmacist was unable to obtain physician's name and phone number and permission to contact physician since reporter was pharmacist.
Sex: F
Vaccine: HEP
Symptoms: Burning sensation, Pain
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of burning sensation in a female patient who received ENGERIX B (batch number 94S22, expiry date 4th September 2020). This case was associated with a product complaint. On an unknown date, the patient received ENGERIX B. On an unknown date, 14 days after receiving ENGERIX B, the patient experienced burning sensation and pain. On an unknown date, the outcome of the burning sensation and pain were unknown. It was unknown if the reporter considered the burning sensation and pain to be related to ENGERIX B. Additional information was received as follows: The reporter reported that the patient in the same day received an ENGERIX B injection, it was unspecified if it's for adult or pediatric. The female patient experienced burning and soreness two weeks after the injection. The reporter noted this has never happened before. The patient denied permission to contact their physician. The caller was the nurse practitioner but did not wish any contact. The reporter tried explaining the importance of full information. This was all the information she would give. The nurse practitioner reported that she the batch of ENGERIX-B may had caused the adverse event. The reporter did not wish to provide other specifics, nor wished to be contacted about this report. There was no product to return. This case was linked with case US2018GSK085243, reported by the same reporter.
Age: 65.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 65-year-old female patient who received BOOSTRIX (batch number 95HB3, expiry date 11th July 2019). Concomitant products included SHINGRIX. On 28th April 2018, the patient received BOOSTRIX (intramuscular) .5 ml. In April 2018, 1 day after receiving BOOSTRIX, the patient experienced injection site pain, injection site erythema and injection site swelling. In May 2018, the patient experienced injection site itching. The patient was treated with ibuprofen and BENADRYL. On an unknown date, the outcome of the injection site pain, injection site itching, injection site erythema and injection site swelling were not recovered/not resolved. The reporter considered the injection site pain, injection site itching, injection site erythema and injection site swelling to be almost certainly related to BOOSTRIX. Additional details were provided as follows: The patient concomitantly received SHINGRIX (batch number T5242, expiry date 31st March 2020) on the right arm. The patient received BOOSTRIX on the left arm and approximately 1 day later called to report soreness in the injection arm. The health care professional recommended ibuprofen. A day or 2 later the patient called again to report swelling and redness in the arm, followed by a report of itching. The health care professional recommended BENADRYL. At the time of reporting, the patient went to urgent care and then presented back to the pharmacy. The red, itchy area had spread down the arm, almost to the patient's wrist. The urgent care visit did not result in any prescribed treatment. The health care professional reported that the patient did not experience adverse reaction in the SHINGRIX vaccination arm (right arm).
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of adverse reaction in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional information was reported as follows: This case was reported by an administrator. The age at vaccination was not reported. The healthcare professional reported that the patient had reaction to SHINGRIX. When asked the reporter also stated that, she did not believe that the patient was in imminent danger. She then stated that she had no further information and would have to call back.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Rash vesicular
Clinical narrative: Information has been received on 14-MAY-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 01-OCT-2015, the patient was inoculated with ZOSTAVAX vaccine (lot number and expiration unknown), unknown route, administered at a pharmacy. The inoculation was recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended. Instead, the patient contracted a persistent strain of shingles, or herpes zoster. On or about 01-JUN-2016, the patient was treated at a medical facility, for the onset of painful vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the defective ZOSTAVAX, and or as a result of the tenuous efficacy of the vaccine, the patient suffered painful injuries and damages, and required extensive medical care and treatment. Further, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to with ZOSTAVAX vaccine. The outcome of the events was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 22-MAY-2016, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and 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. On or about 01-JUN-2016, only days after being vaccinated, the patient was treated by a physician for the onset of a severe vesicular rash, which was diagnosed as 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: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 12-JUL-2015, the patient was inoculated with ZOSTAVAX vaccine (Dose, route of administration, site of administration, Lot number and expiration date were not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. During 2016, the patient was treated (by an unspecified healthcare professional) at a hospital (not further specified if admitted) for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the 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, she has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: 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 01-AUG-2015, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and 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. During 2016, the patient was treated by a family physician for a vesicular outbreak, which was diagnosed as 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. On or about 16-JUN-2009, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance and 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. In 2016, the patient was treated by a different physician for a blistering vesicular outbreak, which was diagnosed as 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: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 16-JAN-2014, the patient was inoculated at a clinic with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. Zoster vaccine live (ZOSTAVAX) did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 13-JUN-2016, the patient was treated by a physician for a severe vesicular outbreak, which was diagnosed as herpes zoster. The patient was prescribed tramadol, valacyclovir, and oxycodone-acetaminophen for management of his painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX, 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 is unknown. 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 or about 02-JUN-2016, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. Later in 2016, the patient was treated a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, 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 is unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 01-MAR-2016, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. Later in 2016, the patient was treated for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, 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 is unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: 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 during 2006, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 01-JUN-2016, the patient was treated for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, 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 is unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: 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 during 2015, the patient was inoculated at a pharmacy with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date during June 2016, the patient was treated by a physician for a severe vesicular outbreak, which was diagnosed as herpes zoster, or shingles. The patient was prescribed valacyclovir and gabapentin for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX, 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 is unknown.  Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 01-MAR-2016, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 02-JUN-2016, the patient was treated at a clinic for a blistering vesicular outbreak which was then diagnosed as herpes zoster or shingles. As a direct and proximate result of the 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. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 22-MAY-2007, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 15-JUN-2016, the patient was treated at a clinic for a blistering vesicular outbreak which was then diagnosed as herpes zoster or shingles. The patient has been prescribed NEURONTIN, NORCO for management of her painful symptoms and excruciating pain.  As a direct and proximate result of the 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. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 08-MAY-2015, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. During 2016, the patient was treated at medical department for a blistering vesicular outbreak which was then diagnosed as herpes zoster or shingles. As a direct and proximate result of the 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. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dysstasia, Lethargy, Pyrexia, Vomiting
Clinical narrative: This case was reported by a pharmacist via other manufacturer and described the occurrence of lethargy in a 68-year-old female patient who received SHINGRIX (batch number LT533, expiry date 11th October 2020) and (batch number NR4Z4, expiry date 11th October 2020). Previously administered products included SHINGRIX with an associated reaction of adverse reaction (refer case US2018GSK085153). On 1st May 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. In May 2018, less than a week after receiving SHINGRIX, the patient experienced lethargy, weakness, fever, vomiting and difficulty in standing. On an unknown date, the outcome of the lethargy, weakness, fever and vomiting were recovering/resolving and the outcome of the difficulty in standing was not reported. The reporter considered the lethargy, weakness, fever, vomiting and difficulty in standing to be related to SHINGRIX. Additional details were provided as follows: The batch number of the adjuvant was corrected from NR424 to NR4Z4. The patient received SHINGRIX in left deltoid and for 2 days since the vaccination, she had experienced severe lethargy as well as the other events. The patient indicated she could not get up without falling over. The patient felt much better on 4th May 2018 but was still weak. This case has been linked with case US2018GSK085153, reported for same patient.