chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 07-MAY-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB, lot # N022167, expiration date: 08-FEB-2020 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 5 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1806USA001505: US-009507513-1806USA009026: US-009507513-1806USA009027: US-009507513-1806USA009028: US-009507513-1806USA009029: US-009507513-1806USA009030: US-009507513-1806USA009031: US-009507513-1806USA009032: US-009507513-1806USA009033: US-009507513-1806USA009034: US-009507513-1806USA009035: US-009507513-1806USA009037: US-009507513-1806USA009038: US-009507513-1806USA009039: US-009507513-1806USA009040: US-009507513-1806USA009041: US-009507513-1806USA009042: US-009507513-1806USA009043: US-009507513-1806USA009044: US-009507513-1806USA009045: US-009507513-1806USA009046: US-009507513-1806USA009047: US-009507513-1806USA009048: US-009507513-1806USA009049: US-009507513-1806USA009050: US-009507513-1806USA009051: US-009507513-1806USA009052: US-009507513-1806USA009053: US-009507513-1806USA009054: US-009507513-1806USA009055: US-009507513-1806USA009056:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 07-MAY-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB, lot # N022167, expiration date: 08-FEB-2020 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 5 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1806USA001505: US-009507513-1806USA009026: US-009507513-1806USA009027: US-009507513-1806USA009028: US-009507513-1806USA009029: US-009507513-1806USA009030: US-009507513-1806USA009031: US-009507513-1806USA009032: US-009507513-1806USA009033: US-009507513-1806USA009034: US-009507513-1806USA009035: US-009507513-1806USA009036: US-009507513-1806USA009038: US-009507513-1806USA009039: US-009507513-1806USA009040: US-009507513-1806USA009041: US-009507513-1806USA009042: US-009507513-1806USA009043: US-009507513-1806USA009044: US-009507513-1806USA009045: US-009507513-1806USA009046: US-009507513-1806USA009047: US-009507513-1806USA009048: US-009507513-1806USA009049: US-009507513-1806USA009050: US-009507513-1806USA009051: US-009507513-1806USA009052: US-009507513-1806USA009053: US-009507513-1806USA009054: US-009507513-1806USA009055:US-009507513-1806USA009056:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 08-MAY-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB, lot # N022167, expiration date: 08-FEB-2020 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 5 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1806USA001505: US-009507513-1806USA009026: US-009507513-1806USA009027: US-009507513-1806USA009028: US-009507513-1806USA009029: US-009507513-1806USA009030: US-009507513-1806USA009031: US-009507513-1806USA009032: US-009507513-1806USA009033: US-009507513-1806USA009034: US-009507513-1806USA009035: US-009507513-1806USA009036: US-009507513-1806USA009037: US-009507513-1806USA009039: US-009507513-1806USA009040: US-009507513-1806USA009041: US-009507513-1806USA009042: US-009507513-1806USA009043: US-009507513-1806USA009044: US-009507513-1806USA009045: US-009507513-1806USA009046: US-009507513-1806USA009047: US-009507513-1806USA009048: US-009507513-1806USA009049: US-009507513-1806USA009050: US-009507513-1806USA009051: US-009507513-1806USA009052: US-009507513-1806USA009053: US-009507513-1806USA009054: US-009507513-1806USA009055: US-009507513-1806USA009056:
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. On or about 29-DEC-2014, the patient was inoculated with the ZOSTAVAX vaccine by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2017, she was treated by a physician for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result of these malfunctions, 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 2013, the patient was inoculated with the ZOSTAVAX vaccine at a physician office as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2015, she was treated for a blistering vesicular outbreak, that was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2014, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) by a physician, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 24-JUL-2015, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster. The patient was prescribed valacyclovir HCL (VALTREX) for management of his painful symptoms and chronic pain. 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.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Post herpetic neuralgia, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2013, 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 for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 23-JAN-2014, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster. The patient was prescribed famciclovir (FAMVIR), tramadol, and gabapentin for management of her painful symptoms and chronic pain. On or about 11-MAR-2014, the patient sought subsequent treatment from a physician, which was diagnosed as chronic post herpetic neuralgia. 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.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Post herpetic neuralgia, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2007, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), by a physician, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 25-APR-2016, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe shingles and post herpetic neuralgia. The patient was prescribed pregabalin (LYRICA) for management of her painful symptoms and chronic pain. 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.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2014, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On an unknown date in 2015, the patient was treated at an urgent care for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: 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 2012, the patient was inoculated with the ZOSTAVAX vaccine at a physician office as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2016, she was treated by a physician for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Death
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of death nos in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced death nos (serious criteria death, hospitalization and GSK medically significant). On an unknown date, the outcome of the death nos was fatal. The reported cause of death was unknown cause of death. The reporter considered the death nos to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The physician reported that, one of his patient told him that she did not want to get the 2nd shot of SHINGRIX because of what the patient overheard beauty parlor talk that someone was admitted to the hospital and died from the SHINGRIX vaccine. The physician did not have any additional information regarding the patient who died from the SHINGRIX.; Reported Cause(s) of Death: Unknown cause of death.
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a elderly male patient who received vaccine Quadrivalent unspecified season for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, 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 Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The age at vaccination was not reported. For tolerability after receiving SHINGRIX, refer case US2018104483.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased, Hyperhidrosis, Influenza like illness
Clinical narrative: Started feeling flu-like symptoms the next morning with a temperature of 101.7. Took Ibuprofen and laid down around 12:00 PM, woke up in a sweat around 4:00 PM with temperature of 99.5. Felt better soon after.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Alopecia, Alopecia areata, Injection site scar
Clinical narrative: The patient had a scaring at the site of injection. Then a couple weeks after the injection, he developed hair loss in clumps. Over the next couple of months significant alopecia areata of the scalp from a near full head of hair a couple months prior. He currently has been referred to dermatology for treatment.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Abnormal behaviour, Anxiety, Feeling abnormal, Musculoskeletal pain, Neck pain
Clinical narrative: C/O neck pain, arm pain, some anxiety symptoms. Then developed neck pain on both sides, shoulder pain and some leg aches/pain. Just not feeling herself. In addition some behavioral changes. She was not herself. Seen in office on 5/30/18. No further treatment.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: C/O neck pain, arm pain, some anxiety symptoms. Then developed neck pain on both sides, shoulder pain and some leg aches/pain. Just not feeling herself. In addition some behavioral changes. She was not herself. Seen in office on 5/30/18. No further treatment.
Age: 1.0
Sex: F
Vaccine: PNC13
Symptoms: Pneumonia streptococcal, Streptococcus test positive, Vaccination failure
Clinical narrative: Not reporting an adverse event, but a vaccine failure. Child diagnosed with invasive Streptococcus pneumoniae serotype 19F after receiving all doses of PCV13 for age.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Discomfort, Fatigue, Feeling cold, Headache, Hyperhidrosis
Clinical narrative: This is the email from the patient: I did want to follow up and let you know that I think I had a reaction to my tetanus shot the evening after. I am assuming that, but it seemed to fit. Thursday evening I was in store around 8PM and started feeling a tingling in my thumbs and wrist - kind of like a sensitivity when you have a fever. It started in just my right, but then was in my left as well. I felt fine, but was starting to get a little headache (which I rarely get headaches). I went home and went to bed around 9:30. I fell asleep fine, but woke up around midnight with terrible body aches, fierce headache and sweating. I didn't really want to move to get up at all because my body just ached and hurt so bad. But I did get up to check my temperature and it was 103.1 with my in ear electronic thermometer. Even in my messed up state I thought that was crazy, so I tried my older in the mouth digital read out, and that one came up as 102.9. I took some Tylenol and crawled back in bed. Could not sleep much - somewhat just uncomfortable - freezing but sweating, somewhat a bit concerned about the fever temp. After on and off naps and restlessness for a 2.5 hour time span, I took my temp again - 102.1. Contemplated if I needed to go in to ER, but figured it was coming down and I wasn't about to call for transport and I wasn't about to drive. So, I took and 3 ibuprofen, changed into dry pajamas and again tried to sleep. Tossed and turned for another couple of uncomfortable hours, checking my temp every so often. By around 8:00 AM it was down to 101.3  and lingered around 100.5 most of the day and evening Friday, ranging down to 99.5. I called into work Friday (which is another extremely rare doing), but I was exhausted. It felt like a very violent night. I slept fine Friday night and when I woke up on Saturday, I felt fine - temp 99.1. So, all is well now, just thought I should let you know. I have never had a reaction to a tetanus shot before, but that was my Google educated guess. My arm from the shot also was almost like a hard spot of about 3 inches in diameter where the shot was until it started lessening on Saturday - I iced it a few times. My arm was also very sore until about Monday sometime, which is longer than ever before as well. I didn't have a good feeling when it bled as much as it did when she gave me the shot, but I am sure that happens, it just has never to me quite like that before. Anyway, just thought I should tell you.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Impaired work ability, Injection site haemorrhage, Injection site induration, Insomnia, Middle insomnia
Clinical narrative: This is the email from the patient: I did want to follow up and let you know that I think I had a reaction to my tetanus shot the evening after. I am assuming that, but it seemed to fit. Thursday evening I was in store around 8PM and started feeling a tingling in my thumbs and wrist - kind of like a sensitivity when you have a fever. It started in just my right, but then was in my left as well. I felt fine, but was starting to get a little headache (which I rarely get headaches). I went home and went to bed around 9:30. I fell asleep fine, but woke up around midnight with terrible body aches, fierce headache and sweating. I didn't really want to move to get up at all because my body just ached and hurt so bad. But I did get up to check my temperature and it was 103.1 with my in ear electronic thermometer. Even in my messed up state I thought that was crazy, so I tried my older in the mouth digital read out, and that one came up as 102.9. I took some Tylenol and crawled back in bed. Could not sleep much - somewhat just uncomfortable - freezing but sweating, somewhat a bit concerned about the fever temp. After on and off naps and restlessness for a 2.5 hour time span, I took my temp again - 102.1. Contemplated if I needed to go in to ER, but figured it was coming down and I wasn't about to call for transport and I wasn't about to drive. So, I took and 3 ibuprofen, changed into dry pajamas and again tried to sleep. Tossed and turned for another couple of uncomfortable hours, checking my temp every so often. By around 8:00 AM it was down to 101.3  and lingered around 100.5 most of the day and evening Friday, ranging down to 99.5. I called into work Friday (which is another extremely rare doing), but I was exhausted. It felt like a very violent night. I slept fine Friday night and when I woke up on Saturday, I felt fine - temp 99.1. So, all is well now, just thought I should let you know. I have never had a reaction to a tetanus shot before, but that was my Google educated guess. My arm from the shot also was almost like a hard spot of about 3 inches in diameter where the shot was until it started lessening on Saturday - I iced it a few times. My arm was also very sore until about Monday sometime, which is longer than ever before as well. I didn't have a good feeling when it bled as much as it did when she gave me the shot, but I am sure that happens, it just has never to me quite like that before. Anyway, just thought I should tell you.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pain in extremity, Paraesthesia, Pyrexia, Restlessness
Clinical narrative: This is the email from the patient: I did want to follow up and let you know that I think I had a reaction to my tetanus shot the evening after. I am assuming that, but it seemed to fit. Thursday evening I was in store around 8PM and started feeling a tingling in my thumbs and wrist - kind of like a sensitivity when you have a fever. It started in just my right, but then was in my left as well. I felt fine, but was starting to get a little headache (which I rarely get headaches). I went home and went to bed around 9:30. I fell asleep fine, but woke up around midnight with terrible body aches, fierce headache and sweating. I didn't really want to move to get up at all because my body just ached and hurt so bad. But I did get up to check my temperature and it was 103.1 with my in ear electronic thermometer. Even in my messed up state I thought that was crazy, so I tried my older in the mouth digital read out, and that one came up as 102.9. I took some Tylenol and crawled back in bed. Could not sleep much - somewhat just uncomfortable - freezing but sweating, somewhat a bit concerned about the fever temp. After on and off naps and restlessness for a 2.5 hour time span, I took my temp again - 102.1. Contemplated if I needed to go in to ER, but figured it was coming down and I wasn't about to call for transport and I wasn't about to drive. So, I took and 3 ibuprofen, changed into dry pajamas and again tried to sleep. Tossed and turned for another couple of uncomfortable hours, checking my temp every so often. By around 8:00 AM it was down to 101.3  and lingered around 100.5 most of the day and evening Friday, ranging down to 99.5. I called into work Friday (which is another extremely rare doing), but I was exhausted. It felt like a very violent night. I slept fine Friday night and when I woke up on Saturday, I felt fine - temp 99.1. So, all is well now, just thought I should let you know. I have never had a reaction to a tetanus shot before, but that was my Google educated guess. My arm from the shot also was almost like a hard spot of about 3 inches in diameter where the shot was until it started lessening on Saturday - I iced it a few times. My arm was also very sore until about Monday sometime, which is longer than ever before as well. I didn't have a good feeling when it bled as much as it did when she gave me the shot, but I am sure that happens, it just has never to me quite like that before. Anyway, just thought I should tell you.
Age: 18.0
Sex: F
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: The vaccine was administered to a patient outside of the approved age range. The patient is 18 years and 6 months old. Vaccine is for adults 19 years and older.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Injection site discharge, Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling and clear drainage at both sites starting one day after vaccines were given.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Rash erythematous
Clinical narrative: Red rash and itching on large portion of right arm, starting a couple days after injection and continuing currently.
Age: 68.0
Sex: F
Vaccine: TDAP
Symptoms: Contusion, Pain in extremity
Clinical narrative: The patient came into the pharmacy to get a shingles vaccine the following week, and she showed me a bruise on her right arm. She said it appeared the day after she received her Tdap vaccine. She said she had also had pain in her arm, but no longer, and she had been massaging the area.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant therapies and drug reaction or allergies was provided. On 19-JUN-2018, the patient was vaccinated with an expired dose of ROTATEQ lot # M044724, expiry date 13-JUN-2018, orally (exact dose was not reported) for prophylaxis. No known adverse effects were reported.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 08-MAY-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB), lot # N022167, expiration date: 08-FEB-2020 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 5 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1806USA001505: US-009507513-1806USA009026: US-009507513-1806USA009027:  US-009507513-1806USA009028: US-009507513-1806USA009029: US-009507513-1806USA009030: US-009507513-1806USA009031: US-009507513-1806USA009032: US-009507513-1806USA009033: US-009507513-1806USA009034: US-009507513-1806USA009035: US-009507513-1806USA009036: US-009507513-1806USA009037: US-009507513-1806USA009038: US-009507513-1806USA009040: US-009507513-1806USA009041: US-009507513-1806USA009042: US-009507513-1806USA009043: US-009507513-1806USA009044: US-009507513-1806USA009045: US-009507513-1806USA009046: US-009507513-1806USA009047: US-009507513-1806USA009048: US-009507513-1806USA009049: US-009507513-1806USA009050: US-009507513-1806USA009051: US-009507513-1806USA009052: US-009507513-1806USA009053: US-009507513-1806USA009054: US-009507513-1806USA009055: US-009507513-1806USA009056:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 08-MAY-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB, lot # N022167, expiration date: 08-FEB-2020 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 5 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1806USA001505: US-009507513-1806USA009026: US-009507513-1806USA009027: US-009507513-1806USA009028: US-009507513-1806USA009029: US-009507513-1806USA009030: US-009507513-1806USA009031: US-009507513-1806USA009032: US-009507513-1806USA009033: US-009507513-1806USA009034: US-009507513-1806USA009035: US-009507513-1806USA009036: US-009507513-1806USA009037: US-009507513-1806USA009038: US-009507513-1806USA009039: US-009507513-1806USA009041: US-009507513-1806USA009042: US-009507513-1806USA009043: US-009507513-1806USA009044: US-009507513-1806USA009045: US-009507513-1806USA009046: US-009507513-1806USA009047: US-009507513-1806USA009048: US-009507513-1806USA009049: US-009507513-1806USA009050: US-009507513-1806USA009051: US-009507513-1806USA009052: US-009507513-1806USA009053: US-009507513-1806USA009054: US-009507513-1806USA009055: US-009507513-1806USA009056:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 11-MAY-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB, lot # N022167, expiration date: 08-FEB-2020 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 5 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1806USA001505: US-009507513-1806USA009026: US-009507513-1806USA009027: US-009507513-1806USA009028: US-009507513-1806USA009029: US-009507513-1806USA009030: US-009507513-1806USA009031: US-009507513-1806USA009032: US-009507513-1806USA009033: US-009507513-1806USA009034: US-009507513-1806USA009035: US-009507513-1806USA009036: US-009507513-1806USA009037: US-009507513-1806USA009038: US-009507513-1806USA009039: US-009507513-1806USA009040: US-009507513-1806USA009042: US-009507513-1806USA009043: US-009507513-1806USA009044: US-009507513-1806USA009045: US-009507513-1806USA009046: US-009507513-1806USA009047: US-009507513-1806USA009048: US-009507513-1806USA009049: US-009507513-1806USA009050: US-009507513-1806USA009051: US-009507513-1806USA009052: US-009507513-1806USA009053: US-009507513-1806USA009054: US-009507513-1806USA009055: US-009507513-1806USA009056:
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. On or about 27-JAN-2010, the patient was inoculated with the ZOSTAVAX vaccine at a physician office as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 02-JUL-2016, she was treated at a physician office for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: 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 2006, the patient was inoculated with ZOSTAVAX at a university as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2014, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: 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. On or about 06-OCT-2014, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2015, she was treated by a physician for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 12-JAN-2012, 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 for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On an unknown later in 2012, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2013, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), by a physician, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On an unknown date in 2014, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: 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 2011, the patient was inoculated with ZOSTAVAX at a medical office as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2015, the patient was treated at the same medical office for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Age: 0.33
Sex: M
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: On the day stated the patient received a KINRIX shot who did not meet age requirement. Staff did not initially notice the error. Patient was monitored and no adverse reaction noted by Parents.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia, Vomiting
Clinical narrative: Shot late Tuesday, Chills Wednesday, and Thursday, 3:00 AM Fever of 102 with tylenol, Vomiting for 15 hours Symtoms resolved Saturday.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Joint range of motion decreased, Pain in extremity, Pyrexia
Clinical narrative: Severe left arm pain, numbness and immobility that began 24 hours after incident. Patient also experienced fevers.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Insomnia, Neck pain, Pain in extremity
Clinical narrative: Patient received 2nd dose of SHINGRIX in morning of 6/20/18. Within first 24 hours, patient reported chills, soreness in arm, soreness in neck, and had trouble sleeping that night. The following day, patient said symptoms were better however felt sluggish, run down, but did sleep better the 2nd night. On 3rd day, patient reported feeling much better with improvement in symptoms. Patient was directed to apply ice at injection site and take pain reliever (i.e., acetaminophen).
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Sluggishness
Clinical narrative: Patient received 2nd dose of SHINGRIX in morning of 6/20/18. Within first 24 hours, patient reported chills, soreness in arm, soreness in neck, and had trouble sleeping that night. The following day, patient said symptoms were better however felt sluggish, run down, but did sleep better the 2nd night. On 3rd day, patient reported feeling much better with improvement in symptoms. Patient was directed to apply ice at injection site and take pain reliever (i.e., acetaminophen).
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood glucose normal, Brachial plexopathy, C-reactive protein normal, Electromyogram abnormal, Injected limb mobility decreased
Clinical narrative: Received SHINGRIX vaccination on April 28/2018. Developed severe LEFT Deltoid Pain with Markedly decreased ROM x 4 days. 2 weeks post injection developed deep ache in LEFT Upper Arm with severe paresthesiae starting in upper arm radiating mostly into LEFT 4th and 5th fingers but also index and first finger. Responded to very small doses of Prednisone but pain came back after day or 2 and has persisted till now. Routine lab work including ESR, CRP, Sugar, etc. have been normal. Neurology was consulted and confirmed Brachial Plexopathy LEFT Arm, with weakness in Ulnar distribution milder median nerve distribution. EMG confirmed this. MRI C-spine DDD but no acute findings. MRI Brachial plexus Negative. Diagnosis is Post Injection Zoster Neuralgia. Review of available literature: I cannot find anything related to this but Pain and Parethesiae are severe and are same as Post Herpetic Neuralgia symptoms.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site paraesthesia, Intervertebral disc degeneration, Muscular weakness, Nuclear magnetic resonance imaging normal
Clinical narrative: Received SHINGRIX vaccination on April 28/2018. Developed severe LEFT Deltoid Pain with Markedly decreased ROM x 4 days. 2 weeks post injection developed deep ache in LEFT Upper Arm with severe paresthesiae starting in upper arm radiating mostly into LEFT 4th and 5th fingers but also index and first finger. Responded to very small doses of Prednisone but pain came back after day or 2 and has persisted till now. Routine lab work including ESR, CRP, Sugar, etc. have been normal. Neurology was consulted and confirmed Brachial Plexopathy LEFT Arm, with weakness in Ulnar distribution milder median nerve distribution. EMG confirmed this. MRI C-spine DDD but no acute findings. MRI Brachial plexus Negative. Diagnosis is Post Injection Zoster Neuralgia. Review of available literature: I cannot find anything related to this but Pain and Parethesiae are severe and are same as Post Herpetic Neuralgia symptoms.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Nuclear magnetic resonance imaging spinal normal, Paraesthesia, Post herpetic neuralgia, Red blood cell sedimentation rate normal
Clinical narrative: Received SHINGRIX vaccination on April 28/2018. Developed severe LEFT Deltoid Pain with Markedly decreased ROM x 4 days. 2 weeks post injection developed deep ache in LEFT Upper Arm with severe paresthesiae starting in upper arm radiating mostly into LEFT 4th and 5th fingers but also index and first finger. Responded to very small doses of Prednisone but pain came back after day or 2 and has persisted till now. Routine lab work including ESR, CRP, Sugar, etc. have been normal. Neurology was consulted and confirmed Brachial Plexopathy LEFT Arm, with weakness in Ulnar distribution milder median nerve distribution. EMG confirmed this. MRI C-spine DDD but no acute findings. MRI Brachial plexus Negative. Diagnosis is Post Injection Zoster Neuralgia. Review of available literature: I cannot find anything related to this but Pain and Parethesiae are severe and are same as Post Herpetic Neuralgia symptoms.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Patient reported palm-sized hives about an inch below the injection site. She's not sure whether it's from the injection itself or possibly poison ivy. She applied OTC hydrocortisone and the hives began to improve.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Impaired driving ability, Mobility decreased, Pain in extremity
Clinical narrative: Got HPV 2 weeks ago and at first the arm did not hurt (really the other arm hurt from the meningitis vaccine) but now sore at the spot and hard to lift her arm. Nothing done except an ice pack right after the vaccine, not since. Mother says that she isn't driving like normal and not raising the arm well. Not hot or red, no bump palpated at the site. So to summarize was a little sore at first and resolved and then 3 days ago the soreness started and now harder to move.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Left arm beneath the point of entry very sore, swollen, skin fells warm rash area 2"x 4".
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Note: According to the Immunization Registry (IR), patient received ZOSTAVAX 12/2009. I labeled this as the second dose in the series as that's how the IR labels it. This was her first dose of SHINGRIX. Patient noticed pain, swelling, redness below the injection site (not immediately around it as noted by bandage still being in place) that started the day after receiving the SHINGRIX. She came into the pharmacy this morning with same symptoms and the area felt warm to the touch. I recommended for her to continue to monitor, use an ice pack to reduce swelling, and her TYLENOL as needed for the pain. I will follow-up with the patient via phone call 6/25/18 and alert her primary care provider listed above.