chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: Side effects; This case was reported by a consumer via interactive digital media and described the occurrence of adverse event in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient received Shingrix and experinced adverse event. The patient asked was it ok to take tylenol for adverse event.
Sex: U
Vaccine: VARZOS
Symptoms: Nerve injury, Pain
Clinical narrative: Nerve damage; expressed continued soreness; This case was reported by a pharmacist via other manufacturer and described the occurrence of nerve damage in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 2 months after receiving Shingrix, the patient experienced nerve damage and pain. On an unknown date, the outcome of the nerve damage and pain were unknown.   The reporter considered the nerve damage to be related to Shingrix. The reporter considered the pain to be possibly related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and had a patient and expressed continued soreness some 2 months later.  The reporter then speculated if this could be due to nerve damage caused by the shot and wanted to know what thought.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise, Pain in extremity
Clinical narrative: arm soreness; feeling under the weather; This case was reported by a consumer and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm and feeling unwell. On an unknown date, the outcome of the pain in arm and feeling unwell were unknown.   The reporter considered the pain in arm and feeling unwell to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient received Shingrix and experiencing arm soreness and feeling under the weather.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: side effects; This case was reported by a consumer and described the occurrence of adverse reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown 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 details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient had many of the side effects and asked, how long do they usually last.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: little sore arm in arm of injection; This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th May 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The patient had very little problem with either dose of the Shingrix vaccine; a little sore arm in arm of injection, but minimal problems. For tolerance of 2nd dose of Shingrix, refer case US2020AMR135183. The reporter desclined consent to follow up. ; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR135183:same reporter
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, Pain, Rash
Clinical narrative: received 3 doses of Shingrix; rash; pain; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number 924T3, expiry date 3rd June 2022) for prophylaxis.   Previously administered products included Shingrix (received 2 doses of Shingrix on unknown date).   On 8th July 2020, the patient received the 3rd dose of Shingrix. On 8th July 2020, unknown after receiving Shingrix, the patient experienced extra dose administered. In July 2020, the patient experienced rash and pain. On an unknown date, the outcome of the rash, pain and extra dose administered were unknown.   It was unknown if the reporter considered the rash and pain to be related to Shingrix.  Additional details were provided as follows: The patient received 3 doses of Shingrix, which led to extra dose administered and patient experienced rash and pain. The reporter consented to follow up. Batch Number and Expiration Date for 3rd dose administered were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: bumps around injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site swelling was unknown.   It was unknown if the reporter considered the injection site swelling to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient had presented small bumps around injection site after dose of Shingrix. The patient required a second dose and they wondered whether it would be safe. The patient only developed small bumps, and there was no rash nor trouble breathing. The reporter consented to follow up
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Herpes simplex, Myalgia
Clinical narrative: had a break out of  Herpes Simplex; Headache; Muscle Ache; This case was reported by a physician via call center representative and described the occurrence of herpes simplex in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th July 2020, the patient received the 2nd dose of Shingrix. In July 2020, less than a week after receiving Shingrix, the patient experienced herpes simplex, headache and muscle pain. On an unknown date, the outcome of the herpes simplex, headache and muscle pain were unknown.   It was unknown if the reporter considered the herpes simplex, headache and muscle pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shigrix and started to experience muscle ache, headache and had a break out of herpes simplex. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Vaccine Failure/ Shingles after 1st dose; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix. In April 2020, between 5 and 7 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The patient received the first dose of Shingrix in October 2019 and experienced shingles in April 2020 hence she did not receive 2nd dose of vaccine within the time frame. The reporter wanted to know the recommendation for the 2nd dose vaccination. The reporter consented to follow up.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Erythema, Pain, Peripheral swelling, Pruritus
Clinical narrative: On 7/17/2020, patient reported swollen arm and redness with small blisters that resembled shingles to her. Instructed to take 25mg tablets of Benadryl at night and 150 mg of Allegra during the day along with applying ice to the swollen area. On 7/21/2020 patient reported that the area is getting better but and she is taking 4 tablets of 25 mg Benadryl at night and 2 tablets of 150mg of Allegra during the day. She is also taking 4 tablets of 200mg Motrin during the day and reports itching, pain, redness and heat to the touch. Reports that the area is feeling better and that she feels the issue is resolving itself.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash vesicular, Skin warm
Clinical narrative: On 7/17/2020, patient reported swollen arm and redness with small blisters that resembled shingles to her. Instructed to take 25mg tablets of Benadryl at night and 150 mg of Allegra during the day along with applying ice to the swollen area. On 7/21/2020 patient reported that the area is getting better but and she is taking 4 tablets of 25 mg Benadryl at night and 2 tablets of 150mg of Allegra during the day. She is also taking 4 tablets of 200mg Motrin during the day and reports itching, pain, redness and heat to the touch. Reports that the area is feeling better and that she feels the issue is resolving itself.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Computerised tomogram thorax abnormal, Deep vein thrombosis, Dyspnoea, Ejection fraction normal, Electrocardiogram abnormal
Clinical narrative: Patient asks that this be reported. He attributes the following to vaccination. He reported worsening dyspnea and heart pounding, was referred to emergency department in local hospital for evaluation and was found to have bilateral PE and DVT.  Diagnosis acute bilateral pulmonary emboli and bilateral deep venous thrombosis unprovoked. He was also found to have PVC and he he has chronic right bundle branch block He was prescribed Eliquis and discharged home
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Palpitations, Pulmonary embolism, Ultrasound scan abnormal, Ventricular extrasystoles
Clinical narrative: Patient asks that this be reported. He attributes the following to vaccination. He reported worsening dyspnea and heart pounding, was referred to emergency department in local hospital for evaluation and was found to have bilateral PE and DVT.  Diagnosis acute bilateral pulmonary emboli and bilateral deep venous thrombosis unprovoked. He was also found to have PVC and he he has chronic right bundle branch block He was prescribed Eliquis and discharged home
Age: 44.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Erythema, Lymphadenopathy, Pain, Swelling
Clinical narrative: Redness, swelling, pain, swollen lymph nodes
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Abdominal pain, Back pain, Bacterial test, Borrelia test, CSF cell count normal
Clinical narrative: Patient had fever & abd. pain on 7/5/2020-went to UC and was swabbed for COVID19 (negative) Later that night child had a seizure and was taken to ER. Subsequently admitted to PICU. Admitted from 7/6 to 7/8, dx: fever, new onset seizure, altered mental status, meningoencephalitis. Patient was in PICU at hospital for two days following new onset seizure and to R/O meningoencephalitis. Labs done. CSF Protein, glucose cell count, culture (protein & WBC were elevated rest WNL). Also had testing done for COVID19, Respiratory virus panel, meningitis/encephalitis panel, Lyme, Respiratory Atypical bacterial panel, ICU panel & Arbovirus Antibody panel - IGM CSF. Also several misc labs sent for variety of infectious etiologies - CSF serum. EEG & MRI also done and were unremarkable. Most labs have been negative for infectious agents but some encephalitis lab tests are still pending. Patient had follow up in our office on 7/10/2020 and is currently stable, except for c/o headache and back pain at times. She has planned follow up with Neurology.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: CSF culture negative, CSF glucose normal, CSF protein increased, CSF test, CSF white blood cell count increased
Clinical narrative: Patient had fever & abd. pain on 7/5/2020-went to UC and was swabbed for COVID19 (negative) Later that night child had a seizure and was taken to ER. Subsequently admitted to PICU. Admitted from 7/6 to 7/8, dx: fever, new onset seizure, altered mental status, meningoencephalitis. Patient was in PICU at hospital for two days following new onset seizure and to R/O meningoencephalitis. Labs done. CSF Protein, glucose cell count, culture (protein & WBC were elevated rest WNL). Also had testing done for COVID19, Respiratory virus panel, meningitis/encephalitis panel, Lyme, Respiratory Atypical bacterial panel, ICU panel & Arbovirus Antibody panel - IGM CSF. Also several misc labs sent for variety of infectious etiologies - CSF serum. EEG & MRI also done and were unremarkable. Most labs have been negative for infectious agents but some encephalitis lab tests are still pending. Patient had follow up in our office on 7/10/2020 and is currently stable, except for c/o headache and back pain at times. She has planned follow up with Neurology.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Electroencephalogram normal, Encephalitis, Headache, Intensive care, Magnetic resonance imaging normal
Clinical narrative: Patient had fever & abd. pain on 7/5/2020-went to UC and was swabbed for COVID19 (negative) Later that night child had a seizure and was taken to ER. Subsequently admitted to PICU. Admitted from 7/6 to 7/8, dx: fever, new onset seizure, altered mental status, meningoencephalitis. Patient was in PICU at hospital for two days following new onset seizure and to R/O meningoencephalitis. Labs done. CSF Protein, glucose cell count, culture (protein & WBC were elevated rest WNL). Also had testing done for COVID19, Respiratory virus panel, meningitis/encephalitis panel, Lyme, Respiratory Atypical bacterial panel, ICU panel & Arbovirus Antibody panel - IGM CSF. Also several misc labs sent for variety of infectious etiologies - CSF serum. EEG & MRI also done and were unremarkable. Most labs have been negative for infectious agents but some encephalitis lab tests are still pending. Patient had follow up in our office on 7/10/2020 and is currently stable, except for c/o headache and back pain at times. She has planned follow up with Neurology.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Mental status changes, Neisseria test, Pyrexia, Respiratory viral panel, SARS-CoV-2 test
Clinical narrative: Patient had fever & abd. pain on 7/5/2020-went to UC and was swabbed for COVID19 (negative) Later that night child had a seizure and was taken to ER. Subsequently admitted to PICU. Admitted from 7/6 to 7/8, dx: fever, new onset seizure, altered mental status, meningoencephalitis. Patient was in PICU at hospital for two days following new onset seizure and to R/O meningoencephalitis. Labs done. CSF Protein, glucose cell count, culture (protein & WBC were elevated rest WNL). Also had testing done for COVID19, Respiratory virus panel, meningitis/encephalitis panel, Lyme, Respiratory Atypical bacterial panel, ICU panel & Arbovirus Antibody panel - IGM CSF. Also several misc labs sent for variety of infectious etiologies - CSF serum. EEG & MRI also done and were unremarkable. Most labs have been negative for infectious agents but some encephalitis lab tests are still pending. Patient had follow up in our office on 7/10/2020 and is currently stable, except for c/o headache and back pain at times. She has planned follow up with Neurology.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Seizure, Viral test
Clinical narrative: Patient had fever & abd. pain on 7/5/2020-went to UC and was swabbed for COVID19 (negative) Later that night child had a seizure and was taken to ER. Subsequently admitted to PICU. Admitted from 7/6 to 7/8, dx: fever, new onset seizure, altered mental status, meningoencephalitis. Patient was in PICU at hospital for two days following new onset seizure and to R/O meningoencephalitis. Labs done. CSF Protein, glucose cell count, culture (protein & WBC were elevated rest WNL). Also had testing done for COVID19, Respiratory virus panel, meningitis/encephalitis panel, Lyme, Respiratory Atypical bacterial panel, ICU panel & Arbovirus Antibody panel - IGM CSF. Also several misc labs sent for variety of infectious etiologies - CSF serum. EEG & MRI also done and were unremarkable. Most labs have been negative for infectious agents but some encephalitis lab tests are still pending. Patient had follow up in our office on 7/10/2020 and is currently stable, except for c/o headache and back pain at times. She has planned follow up with Neurology.
Age: 66.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Cellulitis, Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Pt. received 2 vaccines on 7/9, on 7/12 after a hot shower noticed (R) was swollen, fever red, & painful. Continued to get worse. Pt. went to ER on 7/14 dx: cellulitis. started Keflex 500mg 1 QID. followed up w/PCP on 7/17. who started Bactrim DS 1 BID in addition to Keflex. Pt. notified me today & he is healing well. follow up w/PCP again 7/21
Age: 5.0
Sex: M
Vaccine: MMRV, MNQ
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no current adverse events
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Injection site induration, Injection site swelling, Skin warm
Clinical narrative: On the evening of the vaccination, patient noticed his arm was warm to the touch, red, and that the injection site was swollen and hard. He came to the pharmacy on Tuesday of the following week, and I also observed these symptoms. The patient left the bandaid on the entire time after the vaccine. I had him remove it so I could check the injection site. There was no visible area where the needle had pierced the skin. Before he removed the bandaid, I measured using the 3 finger and V technique to make sure the vaccine was administered in the deltoid correctly, and the location of administration was correct. We will follow up with patient tomorrow to see how his arm is.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient's father called to report that the patient's right arm  is red and swollen. He states that she is having no pain or itching. The symptoms began in the am on 07/21/2020.  Dr, the medical director advised the father to complete a tele health visit. They were referred to clinic since they have no insurance at this time. They were also advised to apply cool compresses and monitor for worsening symptoms.
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported.; patients have been administered improperly stored vaccines; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided. On 10-JUN-2020, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot # S016870, expiration date 26-FEB-2022 (exact dose and injection site were not reported) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial, orally, lot # 1660958, expiration date 23-FEB-2021 (exact dose and injection site were not reported), both for prophylaxis.  Administered doses of vaccines experienced the temperature excursion of below 36 degrees Fahrenheit (29.5 degrees Fahrenheit) for 10 minutes. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No additional adverse effects were reported.; Sender's Comments:  US-009507513-2007USA001137: US-009507513-2007USA001780: US-009507513-2007USA001782: US-009507513-2007USA001783: US-009507513-2007USA001777: US-009507513-2007USA001778: US-009507513-2007USA001779:
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported.; patients have been administered improperly stored vaccines; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided. On 12-JUN-2020, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot # S016870, expiration date 26-FEB-2022 (exact dose and injection site were not reported) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial, orally, lot # 1660958, expiration date 23-FEB-2021 (exact dose and injection site were not reported), both for prophylaxis.  Administered doses of vaccines experienced the temperature excursion of below 36 degrees Fahrenheit (29.5 degrees Fahrenheit) for 10 minutes. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No additional adverse effects were reported.; Sender's Comments:  US-009507513-2007USA001137: US-009507513-2007USA001783: US-009507513-2007USA001781: US-009507513-2007USA001780: US-009507513-2007USA001779: US-009507513-2007USA001778: US-009507513-2007USA001777:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported.; patients have been administered improperly stored vaccines; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided. On 22-JUN-2020, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot # S016870, expiration date 26-FEB-2022 (exact dose and injection site were not reported) for prophylaxis.  Administered dose of vaccine experienced the temperature excursion of below 36 degrees Fahrenheit (29.5 degrees Fahrenheit) for 10 minutes. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No additional adverse effects were reported.; Sender's Comments:  US-009507513-2007USA001137: US-009507513-2007USA001782: US-009507513-2007USA001781: US-009507513-2007USA001780: US-009507513-2007USA001779: US-009507513-2007USA001778: US-009507513-2007USA001777:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age and gender. The pt's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unspecified date in 2016, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, subsequent to inoculation, the pt was treated for shingles. The pt had and would continue suffering ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. At the time of the report, the outcome of shingles was unknown. The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Ear discomfort, Ear infection, Erythema, Eye discharge
Clinical narrative: permanent neuropathy on the left side of her face; blurry vision; Zoster/ shingles; Zoster Conjunctivitis; ear infection; vertigo; Information has been received from a lawyer regarding a case in litigation concerning a female patient (pt) of an unknown age. No information regarding the pt's concurrent conditions, medical history, drug reactions or allergies, and concomitant medications was provided. In or around June 2016, the patient was inoculated at a pharmacy with zoster vaccine live (ZOSTAVAX) (dose, dose number, route of administration, anatomical site of vaccination, lot number and expiration date were not provided), for routine adult health maintenance and for its intended purpose: the prevention of shingles. On 16-JUL-2018, the pt presented to a medical center with complaints of dizziness and pressure in her left ear, sinuses and left sided jaw pain. During this admission, the pt was diagnosed with vertigo and ear infection. On 19-JUL-2018, the pt returned to the medical center with complaints of left sided eye and facial pain with redness. During this admission, the pt was noted to have a rash on the left side of her nose and forehead along with clear drainage from her left eye. A doctor diagnosed the pt with zoster and zoster conjunctivitis. The pt's shingles outbreak lasted several weeks. The pt had permanent neuropathy on the left side of her face and she continued to have blurry vision in her left eye that required ongoing treatment. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms had resulted in physical limitations not present prior to using the zoster vaccine live (ZOSTAVAX) vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company wrongful conduct, the pt suffered serious, progressive permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the Company conduct, the pt had incurred and would continue to incur medical expenses and other economic harm as a direct result of zoster vaccine live (ZOSTAVAX). The outcome of zoster was recovered (exact date not provided). The outcomes of the other events were considered not recovered.  The established events were considered to be disabling. Upon internal review the events of zoster conjunctivitis and neuropathy were considered to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Eye pain, Facial pain, Herpes zoster, Neuropathy peripheral, Ocular hyperaemia
Clinical narrative: permanent neuropathy on the left side of her face; blurry vision; Zoster/ shingles; Zoster Conjunctivitis; ear infection; vertigo; Information has been received from a lawyer regarding a case in litigation concerning a female patient (pt) of an unknown age. No information regarding the pt's concurrent conditions, medical history, drug reactions or allergies, and concomitant medications was provided. In or around June 2016, the patient was inoculated at a pharmacy with zoster vaccine live (ZOSTAVAX) (dose, dose number, route of administration, anatomical site of vaccination, lot number and expiration date were not provided), for routine adult health maintenance and for its intended purpose: the prevention of shingles. On 16-JUL-2018, the pt presented to a medical center with complaints of dizziness and pressure in her left ear, sinuses and left sided jaw pain. During this admission, the pt was diagnosed with vertigo and ear infection. On 19-JUL-2018, the pt returned to the medical center with complaints of left sided eye and facial pain with redness. During this admission, the pt was noted to have a rash on the left side of her nose and forehead along with clear drainage from her left eye. A doctor diagnosed the pt with zoster and zoster conjunctivitis. The pt's shingles outbreak lasted several weeks. The pt had permanent neuropathy on the left side of her face and she continued to have blurry vision in her left eye that required ongoing treatment. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms had resulted in physical limitations not present prior to using the zoster vaccine live (ZOSTAVAX) vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company wrongful conduct, the pt suffered serious, progressive permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the Company conduct, the pt had incurred and would continue to incur medical expenses and other economic harm as a direct result of zoster vaccine live (ZOSTAVAX). The outcome of zoster was recovered (exact date not provided). The outcomes of the other events were considered not recovered.  The established events were considered to be disabling. Upon internal review the events of zoster conjunctivitis and neuropathy were considered to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster, Pain in jaw, Rash, Sinus pain, Vertigo
Clinical narrative: permanent neuropathy on the left side of her face; blurry vision; Zoster/ shingles; Zoster Conjunctivitis; ear infection; vertigo; Information has been received from a lawyer regarding a case in litigation concerning a female patient (pt) of an unknown age. No information regarding the pt's concurrent conditions, medical history, drug reactions or allergies, and concomitant medications was provided. In or around June 2016, the patient was inoculated at a pharmacy with zoster vaccine live (ZOSTAVAX) (dose, dose number, route of administration, anatomical site of vaccination, lot number and expiration date were not provided), for routine adult health maintenance and for its intended purpose: the prevention of shingles. On 16-JUL-2018, the pt presented to a medical center with complaints of dizziness and pressure in her left ear, sinuses and left sided jaw pain. During this admission, the pt was diagnosed with vertigo and ear infection. On 19-JUL-2018, the pt returned to the medical center with complaints of left sided eye and facial pain with redness. During this admission, the pt was noted to have a rash on the left side of her nose and forehead along with clear drainage from her left eye. A doctor diagnosed the pt with zoster and zoster conjunctivitis. The pt's shingles outbreak lasted several weeks. The pt had permanent neuropathy on the left side of her face and she continued to have blurry vision in her left eye that required ongoing treatment. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms had resulted in physical limitations not present prior to using the zoster vaccine live (ZOSTAVAX) vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company wrongful conduct, the pt suffered serious, progressive permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the Company conduct, the pt had incurred and would continue to incur medical expenses and other economic harm as a direct result of zoster vaccine live (ZOSTAVAX). The outcome of zoster was recovered (exact date not provided). The outcomes of the other events were considered not recovered.  The established events were considered to be disabling. Upon internal review the events of zoster conjunctivitis and neuropathy were considered to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Vision blurred
Clinical narrative: permanent neuropathy on the left side of her face; blurry vision; Zoster/ shingles; Zoster Conjunctivitis; ear infection; vertigo; Information has been received from a lawyer regarding a case in litigation concerning a female patient (pt) of an unknown age. No information regarding the pt's concurrent conditions, medical history, drug reactions or allergies, and concomitant medications was provided. In or around June 2016, the patient was inoculated at a pharmacy with zoster vaccine live (ZOSTAVAX) (dose, dose number, route of administration, anatomical site of vaccination, lot number and expiration date were not provided), for routine adult health maintenance and for its intended purpose: the prevention of shingles. On 16-JUL-2018, the pt presented to a medical center with complaints of dizziness and pressure in her left ear, sinuses and left sided jaw pain. During this admission, the pt was diagnosed with vertigo and ear infection. On 19-JUL-2018, the pt returned to the medical center with complaints of left sided eye and facial pain with redness. During this admission, the pt was noted to have a rash on the left side of her nose and forehead along with clear drainage from her left eye. A doctor diagnosed the pt with zoster and zoster conjunctivitis. The pt's shingles outbreak lasted several weeks. The pt had permanent neuropathy on the left side of her face and she continued to have blurry vision in her left eye that required ongoing treatment. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms had resulted in physical limitations not present prior to using the zoster vaccine live (ZOSTAVAX) vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company wrongful conduct, the pt suffered serious, progressive permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the Company conduct, the pt had incurred and would continue to incur medical expenses and other economic harm as a direct result of zoster vaccine live (ZOSTAVAX). The outcome of zoster was recovered (exact date not provided). The outcomes of the other events were considered not recovered.  The established events were considered to be disabling. Upon internal review the events of zoster conjunctivitis and neuropathy were considered to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age and gender. The pt's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown date in 2011, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, subsequent to inoculation, the pt was treated for shingles. The pt had and would continue suffering ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. At the time of the report, the outcome of shingles was unknown. The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 01-FEB-2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a healthcare provider at a medial group for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.
Sex: U
Vaccine: VARZOS
Symptoms: Deafness
Clinical narrative: Hearing loss; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unspecified date in 2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, subsequent to inoculation, the pt was treated for hearing loss. The pt had and would continue suffering ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. At the time of the report, the outcome of hearing loss was unknown. The reporter considered hearing loss to be related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review, hearing loss was considered medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site bruising, Injection site haemorrhage, Injection site pain, Rash pruritic
Clinical narrative: injection site is currently bruised / bruise is a yellow/green color; very itchy rash on my injection arm; it did bleed at the injection; she could not move her right arm; injection site hurt; This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number 75P7G, expiry date 17th April 2022) for prophylaxis.   The patient's past medical history included anxiety disorder (had Anxiety Disorder) and hypersensitivity (had hypersensitivity to medications). Previously administered products included Tetanus shot with an associated reaction of injection site pain (had tetanus shot with pain during injection). Concurrent medical conditions included allergy.   On 9th July 2020, the patient received the 1st dose of Shingrix (intramuscular). On 9th July 2020, immediately after receiving Shingrix, the patient experienced injection site hemorrhage, injection site pain and injected limb mobility decreased. On 14th July 2020, the patient experienced itchy rash. On 15th July 2020, the patient experienced injection site bruising. The patient was treated with non-drug therapy (Ice Pack (No Medication)), ibuprofen and benadryl (nos) (Benadryl Cream). On an unknown date, the outcome of the itchy rash and injection site bruising were not recovered/not resolved and the outcome of the injection site hemorrhage was unknown and the outcome of the injection site pain and injected limb mobility decreased were recovered/resolved.   It was unknown if the reporter considered the itchy rash, injection site hemorrhage, injection site bruising, injection site pain and injected limb mobility decreased to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The patient received dose of Shingrix in the right deltoid. The reporter stated that, the patient did not had more pain during injetion than the past immunization. The reporter stated that it did not hurt worse than a tetnus shot. The reporter stated that the patient had injection site bleeding and currently had injection site bruised. The bruise was a yellowor green color. The patient had injection site pain for 3 days and could not move right arm. On 14th July 2020, the patient had itchy rash on the right deltoid, but the rash was spreading and was about the size of her hand. the patient treated with icing and ibuprofen, and pain and immobility resolved. The patient treated with Benadryl cream for itchy rash.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Rash macular
Clinical narrative: Developed recurrent spots; Sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 30th September 2019, 5 hrs after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the patient experienced spot-like rash. Shingrix was discontinued. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the spot-like rash was recovering/resolving.   It was unknown if the reporter considered the pain in arm and spot-like rash to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient's wife. Approximately 5 to 6 hours after receiving Shingrix, the patient experienced a sore arm that lasted approximately 3 days.  The patient developed recurrent spots on him that came and go within a month or two months after receiving Shingrix. The minor spot outbreaks recurred twice. The reporter consented to follow up. This case has been linked to US2020133250, reprted by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020133250:(same reporter)
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Injection site soreness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th July 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional case details were reported as follows: In July, after receiving the vaccine the patient experienced injection site soreness in the upper right arm. The reporter did not consent to follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: rash the size / diameter of a grapefruit; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th January 2020, the patient received the 1st dose of Shingrix. In January 2020, 24 hrs after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were reported as follows: The patient received vaccine in left deltoid. The patient developed a rash the size or diameter of a grapefruit, with no swelling on left side shoulder with 24 hours of receiving the 1st dose of Shingrix and events took a week to resolve. The reporter consented to follow up.