chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, 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. In OCTOBER of 2014, the patient was inoculated with ZOSTAVAX vaccine (Dose, route of administration, site of administration, Lot number and expiration date were not provided) at a healthcare facility, 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 06-JUL-2016, the patient was treated by a physician at the healthcare facility, for a vesicular outbreak, which was diagnosed as herpes zoster.  The patient has been prescribed VALTREX and gabapentin to manage her painful symptoms and chronic 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. The reporter considered the events to be related to ZOSTAVAX.  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. Medical history, concurrent conditions, and concomitant medications were not provided. In 2013, 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. On or about 25-JUN-2016, the patient was treated at an urgent care health care facility (by an unspecified health care professional) for the onset of a severe vesicular rash, which was diagnosed as herpes zoster. 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. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was 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 or about 13-APR-2010, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 01-JUL- 2016, the patient was treated by a physician for a severe 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, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome 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. In 2015, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. During 2016, the patient was treated for a blistering vesicular outbreak, which was diagnosed as severe 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. The outcome 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 05-MAR-2015, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. In July 2016, the patient was treated for a blistering vesicular outbreak, which was diagnosed as severe 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. The outcome 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 (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In August 2015, the patient was inoculated 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. In July of 2016, the patient was treated by a physician for a persistent and severe vesicular rash, 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, 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: 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 09-JUL-2012, the patient was inoculated 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. In 2015, the patient was treated by a physician located in for a persistent and severe vesicular rash, 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, 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: 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.  In September 2011 the patient was inoculated 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 22-OCT-2016, the patient was treated at a health care facility for a persistent and severe vesicular rash, which was diagnosed as herpes zoster. The patient was prescribe valacyclovir and prednisone for management of her painful symptoms and chronic 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 had 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: 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. In January 2013 the patient was inoculated 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-JUL-2016, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster. The patient has been prescribed acyclovir and MEDROL for management of her painful symptoms and chronic 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 as 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: 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. In 2007, the patient was inoculated 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 2015, the patient was treated by a physician for a persistent and severe vesicular rash, 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, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: 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 12-MAR-2015, the patient was inoculated 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. In 2016, the patient was treated at a clinic for a persistent and severe vesicular rash, 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, 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: HPV9
Symptoms: Fatigue, Hypotension, Postural orthostatic tachycardia syndrome
Clinical narrative: Information has been received from a physician via a company representative reporting on a female patient of unknown age. There was no information about the patient's concurrent conditions, medical history or concomitant medication. In approximately 2015 (reported as "2-3 years ago"), the patient received the third dose of GARDASIL 9 as prevention of HPV (strength dose, route of administration, lot number and expiration date were not reported). On an unknown date, the patient developed postural orthostatic tachycardia syndrome. The patient had "fatigue, and low blood pressure". The patient sought for medical attention and received treatment for the adverse event. At the reporting time, the patient had recovered from postural orthostatic tachycardia syndrome. The reporter did not assess the causal relationship between the event postural orthostatic tachycardia syndrome and therapy with GARDASIL 9.
Age: 0.08
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse refers to 6 weeks old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant therapy was unknown. On 20-NOV-2017, patient was vaccinated with improperly stored doses of ROTATEQ (dose, units and frequency were unknown) (Lot# N005972 and expiration date 12-OCT-2018) at a temperature excursion from 9 C to 25 C (degree centigrade) for 1 hour 50 minutes. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. There was no product quality compliant reported. This is one of several reports received from the same reporter (1711USA009377, 1806USA004061, 1806USA004062, 1806USA004063, 806USA004064 and 1806USA004065).
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 has been received regarding the patient's past medical history, concurrent conditions, or concomitant medications. On an unknown date in 2014, 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. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date in 2015, the patient was treated at an urgent care for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. 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: 0.75
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse refers to 9 months old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant therapy was unknown. On 15-NOV-2017, patient was vaccinated with improperly stored doses of ROTATEQ (dose, units and frequency were unknown) (Lot# N005972 and expiration date 12-OCT-2018) at a temperature excursion from 9 C to 25 C (degree centigrade) for 1 hour 50 minutes. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. There was no product quality compliant reported. This is one of several reports received from the same reporter (1711USA009377, 1806USA004013, 1806USA004062, 1806USA004063, 806USA004064 and 1806USA004065).
Age: 0.08
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse refers to 4 weeks old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant therapy was unknown. On 09-NOV-2017, patient was vaccinated with improperly stored doses of ROTATEQ (dose, units and frequency were unknown) (Lot # N005972 and expiration date 12-OCT-2018) at a temperature excursion from 9 C to 25 C (degree centigrade) for 1 hour 50 minutes. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. There was no product quality compliant reported. This is one of several reports received from the same reporter (1711USA009377, 1806USA004013, 1806USA004061, 1806USA004063, 806USA004064 and 1806USA004065).
Age: 0.0
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse refers to 4 weeks old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant therapy was unknown. On 08-NOV-2017, patient was vaccinated with improperly stored doses of ROTATEQ (dose, units and frequency were unknown) (Lot# N005972 and expiration date 12-OCT-2018) at a temperature excursion from 9 C to 25 C (degree centigrade) for 1 hour 50 minutes. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. There was no product quality compliant reported. This is one of several reports received from the same reporter (1711USA009377, 1806USA004013, 1806USA004061, 1806USA004062, 1806USA004064 and 1806USA004065).
Age: 0.75
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse refers to 9 months old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant therapy was unknown. On 06-NOV-2017, patient was vaccinated with improperly stored doses of ROTATEQ (dose, units and frequency were unknown) (Lot # N005972 and expiration date 12-OCT-2018) at a temperature excursion from 9 C to 25 C (degree centigrade) for 1 hour 50 minutes. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. There was no product quality compliant reported. This is one of several reports received from the same reporter (1711USA009377, 1806USA004013, 1806USA004061, 1806USA004062, 1806USA004063 and 1806USA004065).
Age: 0.08
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse refers to 4 weeks old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant therapy was unknown. On 02-NOV-2017, patient was vaccinated with improperly stored doses of ROTATEQ (dose, units and frequency were unknown) (Lot# N005972 and expiration date 12-OCT-2018) at a temperature excursion from 9 C to 25 C (degree centigrade) for 1 hour 50 minutes. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. There was no product quality compliant reported. This is one of several reports received from the same reporter (1711USA009377, 1806USA004013, 1806USA004061, 1806USA004062, 1806USA004063 and 806USA004064).
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Dizziness, Dyspnoea, Fatigue, Myalgia, Visual impairment
Clinical narrative: Patient woke up at 0700 on Sunday, 3 June 2018. Pt reported experiencing generalized muscle aches, fatigue, lightheadedness, dizziness, vision changes, and difficulty breathing. Pt did not take any medication for symptoms however, rested for the duration of the day. Symptoms persisted despite resting. Patient did not see a health care provider for the symptoms however, will see a health care provider as soon as possible since symptoms continue to affect him.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt experienced localized redness + swelling at injection site. Symptoms starting approx. 8-12 hours post vaccination and continuing for approx. 48 hours. Required doses of advil and zytrec. No hospitalization no MD visit or consultation required no fever recorded. No systemic symptoms reported.
Age: 9.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site pruritus, Injection site rash, Pruritus, Rash
Clinical narrative: Parents reports itchiness and rash at sight of injection and back. No fever, resp distress or emesis.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Injection site pain, Rash, Rash pruritic, Rash vesicular
Clinical narrative: After a few days a rash broke out on my right lower side. It appeared to look like shingles. Itching and slightly painful. Still there after 13 days but getting better the first two days I was dizzy and was in pain from the shot, 4-weeks later. I still have most of the rash - Pain is almost gone.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeding disorder, Feeling abnormal, Injection site erythema, Injection site pruritus, Nausea
Clinical narrative: Nauseated for 36 hours. Unable to eat or drink. Stayed in bed. Took a week to feel normal again.  Injection site was red and itchy for several weeks.
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Back pain, Biopsy kidney, Blood test, Gait disturbance, Henoch-Schonlein purpura
Clinical narrative: My son woke up on 11/26/17 with swelling and pain in legs and lower back. Would not walk. There were also small petechiae on legs. Later in afternoon took him to ER where the ER doctor diagnosed him with HSP (Henoch-Schonlein purpura). Over next week swelling become widespread and very bad rash on legs. His pediatrician did routine urinalysis to monitor blood and protein in urine. Over next several weeks he developed nephrotic-range proteinuria and was sent to pediatric nephrologist at Hospital. The nephrologist monitored his labs closely and by early January kidney function was declining rapidly so nephrologist ordered kidney biopsy and started long-term immunosuppressant medical treatment. My son is now on 4 different medications to hopefully cure his HSP. Medicines (IMURAN, enalapril, prednisolone, ranitidine). We are hopeful he can be off the medicines in 2 years but nephrologist indicated it could be a lifelong battle since treating HSP has mixed results.
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Immunosuppressant drug therapy, Injection site haemorrhage, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: My son woke up on 11/26/17 with swelling and pain in legs and lower back. Would not walk. There were also small petechiae on legs. Later in afternoon took him to ER where the ER doctor diagnosed him with HSP (Henoch-Schonlein purpura). Over next week swelling become widespread and very bad rash on legs. His pediatrician did routine urinalysis to monitor blood and protein in urine. Over next several weeks he developed nephrotic-range proteinuria and was sent to pediatric nephrologist at Hospital. The nephrologist monitored his labs closely and by early January kidney function was declining rapidly so nephrologist ordered kidney biopsy and started long-term immunosuppressant medical treatment. My son is now on 4 different medications to hopefully cure his HSP. Medicines (IMURAN, enalapril, prednisolone, ranitidine). We are hopeful he can be off the medicines in 2 years but nephrologist indicated it could be a lifelong battle since treating HSP has mixed results.
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Protein urine, Proteinuria, Renal impairment, Swelling, Urine analysis
Clinical narrative: My son woke up on 11/26/17 with swelling and pain in legs and lower back. Would not walk. There were also small petechiae on legs. Later in afternoon took him to ER where the ER doctor diagnosed him with HSP (Henoch-Schonlein purpura). Over next week swelling become widespread and very bad rash on legs. His pediatrician did routine urinalysis to monitor blood and protein in urine. Over next several weeks he developed nephrotic-range proteinuria and was sent to pediatric nephrologist at Hospital. The nephrologist monitored his labs closely and by early January kidney function was declining rapidly so nephrologist ordered kidney biopsy and started long-term immunosuppressant medical treatment. My son is now on 4 different medications to hopefully cure his HSP. Medicines (IMURAN, enalapril, prednisolone, ranitidine). We are hopeful he can be off the medicines in 2 years but nephrologist indicated it could be a lifelong battle since treating HSP has mixed results.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Insomnia, Pain in extremity
Clinical narrative: As dose administered (very high on deltoid) could feel medication shooting through shoulder- not normal for a vaccine and was a little painful. That evening arm was very sore but never red or inflamed. Painful from shoulder to elbow with what felt like numbness and tingling down to wrist. This went on for 4-5 days. Could not sleep on that side and even when laying down in other positions, could not sleep because of pain. Could not raise arm high enough to put on deodorant for a couple weeks. Mild tingling and numbness in hand/wrist continues as of today. Shoulder pain continues to today but has lessened. Pain is minimal now throughout the day but for weeks was painful to rest on arm. I believe the shoulder pain was due to inappropriate administration site (way too high on deltoid, felt like it was given in shoulder joint) more than the drug itself.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Paraesthesia, Product administered at inappropriate site
Clinical narrative: As dose administered (very high on deltoid) could feel medication shooting through shoulder- not normal for a vaccine and was a little painful. That evening arm was very sore but never red or inflamed. Painful from shoulder to elbow with what felt like numbness and tingling down to wrist. This went on for 4-5 days. Could not sleep on that side and even when laying down in other positions, could not sleep because of pain. Could not raise arm high enough to put on deodorant for a couple weeks. Mild tingling and numbness in hand/wrist continues as of today. Shoulder pain continues to today but has lessened. Pain is minimal now throughout the day but for weeks was painful to rest on arm. I believe the shoulder pain was due to inappropriate administration site (way too high on deltoid, felt like it was given in shoulder joint) more than the drug itself.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Patient had local reaction on injection site with redness and swelling, after it resolved it left a black mark like a burn mark.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Headache, Nausea
Clinical narrative: Pt reported pretty severe headache, diarrhea, and nausea - lasted for about 1 and 1/2 - 2 days.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Injection site swollen, red. Adverse events. Pharmacist counseled patient to monitor for 24 hours. If symptoms persist, go to MD office/ER.
Age: 0.92
Sex: U
Vaccine: HIBV, HPV9, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous non-valid report as received from a nurse refers to a multiple unspecified patients. The patients' medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (manufacturer unknown) that was properly stored. On unknown dates, the patients were vaccinated for prophylaxis with improperly stored doses of M-M-R II lot # N013296, expiration date 28-APR-2019, lot # N011005, expiration date 05-APR-2019, lot # reported as N045392, expiration date reported as 14-NOV-2018; LIQUID PEDVAXHIB lot # N012119, expiration date 06-FEB-2020, lot # N034005, expiration date 31-JAN-2020; GARDASIL 9 lot # N022728, expiration date 31-MAY-2020; PNEUMOVAX 23 lot # N025563, expiration date 08-APR-2019. On 09-MAR-2018, the patients were vaccinated with ROTATEQ lot # N013885, expiration date 09-DEC-2018; LIQUID PEDVAXHIB lot # reported as N026569, expiration date reported as 27-FEB-2020; GARDASIL 9 lot # N020353, expiration date 28-APR-2020. These vaccines underwent a temperature excursions of -0.44 degrees Celsius for 1.5 hours. The nurse denied any adverse events reported by patients. Lot number N026569 is an invalid lot number for haemophilus b conjugate vaccine (meningococcal protein conjugate). Lot number N045392 is an invalid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live. Follow-up information has been received from the nurse on 09-APR-2018. The expiration date for LIQUID PEDVAXHIB lot # reported as N026569, was corrected to 07-FEB-2020. Lot number N026569 is an invalid lot number for b conjugate vaccine (meningococcal protein conjugate). Follow up information has been received from the nurse on 08-JUN-2018. The nurse stated that only one patient who was 11 months old was vaccinated with improperly stored dose of LIQUID PEDVAXHIB.
Sex: U
Vaccine: RV5
Symptoms: Choking, Infantile spitting up, Retching
Clinical narrative: This spontaneous report was received from a physician referring to unspecified patients of 2 to 6 months of age of unknown gender. The patients medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. The physician reported that rarely (unspecified) patients received ROTATEQ (dose, frequency, anatomical location, lot # and expiration date were unknown) orally and spit up on unspecified dates. There was no treatment given for the adverse event. As on 01-JUN-2018, an inbound call was received from the physician in regard to a HCP vaccine letter received regarding to infantile spitting up experienced by multiple patients who received ROTATEQ. On an unknown date, the patients were vaccinated with ROTATEQ (dose, frequency, anatomical location, lot # and expiration date not reported). She stated she was unable to fill out as she did not have patient specifics and the reason for her call was to report a chief compliant. Physician stated that infantile spitting up was not the chief complaint, but choking and gagging (retching) after receiving ROTATEQ was. No patient identifiers could be provided as it happened to every baby from 2 to 6 months of age receiving ROTATEQ. It happened at least 95% of the time. The physician could not provide any additional information but she stated that she would report if she had any further information concerning it. Outcome of infantile spitting up was reported as recovered. The outcome of choking and retching was not reported. The physician did not mention the causality assessment between the events and ROTATEQ. Upon internal review, the event choking was determined to be medically significant.
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. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 26-JAN-2015, the patient was inoculated with ZOSTAVAX at a public health center for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not function as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 28-JUL-2016, the patient was treated by a physician at the office 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: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received on 06-JUN-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. In January 2011, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route by a physician as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 15-JUL-2016, the patient was treated by a physician's assistant at a hospital facility for a blistering vesicular outbreak, which was then diagnosed as herpes zoster. The patient has been prescribed prednisone and hydrocortisone 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 has 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: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Rash, Tenderness
Clinical narrative: No reports of joint or muscle pain, no fever at home. Was a small lesion (nickel sized) approximately 24 hours after vaccine administered, and then enlarged to about baseball sized by 72 hours after at provider visit. Rash: From Shingles Vaccine (SHINGRIX). History of Present Illness: Duration of rash: since Friday, 5/18; Location of rash: left deltoid; Color of rash: bright pink; Any crusting or oozing from rash?: no; -Treatments tried for rash: triple antibiotic ointment; Pruritus (itching)?: no; Personal history of a chronic skin condition?: no; Any mouth sores?: no; Recent respiratory tract infection?: no; Fever or recent fever? no; Change in soap, laundry detergent or hygiene products?: no; New or unusual foods?: no; New pets?: no; Recent travel out of state or camping?: no; Recent insect bites?: no; Targeted Review of Systems: Pain?: tender to the touch. Vaccine reaction plan: Provider drew a border in indelible ink and instructed patient to notify office if redness extends beyond ink border. D/C NEOSPORIN ointment, use soap and water to clean skin and moisturize using her usual product. If no expansion beyond border, no further action needed.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Feeling hot, Headache, Injected limb mobility decreased
Clinical narrative: About one hour after getting the shot, my arm started to throb, and it was difficult to move it. Later in the day, I ate a normal dinner and went to bed. About 2:00 a.m. the following morning, I woke up, extremely cold and shivering. My teeth were chattering. I had a terrible headache, and took an ALEVE.  I doubled-up the blankets, and after I went back to sleep, I woke up later very hot and removing the blankets. The next morning, and all of that next day, I didn't feel well. I ate some chicken soup to settle my stomach, and had a bland dinner. I did feel better the next day.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pain, Pain in extremity
Clinical narrative: About one hour after getting the shot, my arm started to throb, and it was difficult to move it. Later in the day, I ate a normal dinner and went to bed. About 2:00 a.m. the following morning, I woke up, extremely cold and shivering. My teeth were chattering. I had a terrible headache, and took an ALEVE.  I doubled-up the blankets, and after I went back to sleep, I woke up later very hot and removing the blankets. The next morning, and all of that next day, I didn't feel well. I ate some chicken soup to settle my stomach, and had a bland dinner. I did feel better the next day.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Feeling hot
Clinical narrative: Extreme cold and shriving for several hours Followed by being extremely warm.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Confusional state, Dizziness, Fall, Myalgia
Clinical narrative: Chills, confusion, dizziness (fell in her house), muscle aches.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Eyelid ptosis, Immediate post-injection reaction, Macule, Paraesthesia
Clinical narrative: This spontaneous report was received from a physician and refers to a currently 20-year-old female patient. The patient's allergies included: morphine, formaldehyde, influenza virus vaccine (unspecified), nickel and bee stings. The patient had any concomitant medication. The patient's pertinent medical history was unknown. On an unknown date in 2007, the patient (9-year-old girl) was vaccinated with an unspecified dose of Oka/Merck VARIVAX, (dose, frequency, route of administration, lot # and expiration date were not reported). On 01-JUN-2018, the patient received an unspecified dose of Oka/Merck VARIVAX, (dose, frequency, route of administration, lot # and expiration date were not reported) as requirement for her job after negative titers (after the previous vaccination). On 01-JUN-2018, the patient experienced left eyelid ptosis, reported as left eye droop, immediately and tingling, itching, macular redness on the arms and legs after 20 minutes of receiving the vaccine. The physician reports that the patient received BENADRYL 50 mg, as an intervention to prevent serious adverse events. The patient was not performed any laboratory tests. At the time of reporting, the patient was still in the physician's office for continued observation. The outcome of antibody negative titers after vaccination was unknown. The outcome of left eyelid ptosis, tingling, itching and macular redness on the arms and legs was reported as not recovered, at the time of this report. The relatedness between the events and the suspect therapy was not reported. The reporter considered the events of left eyelid ptosis, tingling, itching and macular redness on the arms and legs to be medically significant.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus
Clinical narrative: This spontaneous report was received from a physician and refers to a currently 20-year-old female patient. The patient's allergies included: morphine, formaldehyde, influenza virus vaccine (unspecified), nickel and bee stings. The patient had any concomitant medication. The patient's pertinent medical history was unknown. On an unknown date in 2007, the patient (9-year-old girl) was vaccinated with an unspecified dose of Oka/Merck VARIVAX, (dose, frequency, route of administration, lot # and expiration date were not reported). On 01-JUN-2018, the patient received an unspecified dose of Oka/Merck VARIVAX, (dose, frequency, route of administration, lot # and expiration date were not reported) as requirement for her job after negative titers (after the previous vaccination). On 01-JUN-2018, the patient experienced left eyelid ptosis, reported as left eye droop, immediately and tingling, itching, macular redness on the arms and legs after 20 minutes of receiving the vaccine. The physician reports that the patient received BENADRYL 50 mg, as an intervention to prevent serious adverse events. The patient was not performed any laboratory tests. At the time of reporting, the patient was still in the physician's office for continued observation. The outcome of antibody negative titers after vaccination was unknown. The outcome of left eyelid ptosis, tingling, itching and macular redness on the arms and legs was reported as not recovered, at the time of this report. The relatedness between the events and the suspect therapy was not reported. The reporter considered the events of left eyelid ptosis, tingling, itching and macular redness on the arms and legs to be medically significant.
Sex: U
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 patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In October 2009, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (lot #, dose and route 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-AUG-2014, the patient was treated at a hospital for a persistent and 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. No information was provided regarding concomitant medications, concurrent conditions or medical history. In January 2012, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not function as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 11-JUL-2016, the patient was treated by a physician at a primary care office 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: 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. In July 2013, the patient was inoculated with ZOSTAVAX at a family physician's office 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 27-JUN-2016, the patient was treated by a Physician's Assistant and a medical center for a persistent and 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: 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. In 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. In 2016, the patient was treated at a hospital for a persistent and severe vesicular rash, which was diagnosed as herpes zoster. 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.