chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: Approximately 1.5 cm induration on lateral Lt arm. "Child appears to have had a reaction to recent immunization. Though it has been a month since her last immunizations which included Dtap, meningococcal, flu and HPV. She has continued to have a "lump" in her LT arm. There was initial erythema, but this has resolved and the child is not having pain at the injection site". Taken from office note 1/4/18.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased
Clinical narrative: Patient stated had difficulty moving and rotating arm.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Herpes zoster, Pain, Pruritus, Rash erythematous, Rash vesicular
Clinical narrative: Three days after the vaccine administration patient developed an erythematous and vesicular rash that appeared in a dermatomal pattern. The pain described itching and pain that was described as "needles." He was evaluated at urgent care where a culture was taken (results pending) and the presumptive diagnosis was made of herpes zoster. He was started on acyclovir. I saw him for follow up 13 days after the onset of the rash, which had improved significantly. I did not see any vesicles or active lesions. However, there was healing rash with pinpoint scabbing present along the L2/L3 dermatome.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Scab, Viral test
Clinical narrative: Three days after the vaccine administration patient developed an erythematous and vesicular rash that appeared in a dermatomal pattern. The pain described itching and pain that was described as "needles." He was evaluated at urgent care where a culture was taken (results pending) and the presumptive diagnosis was made of herpes zoster. He was started on acyclovir. I saw him for follow up 13 days after the onset of the rash, which had improved significantly. I did not see any vesicles or active lesions. However, there was healing rash with pinpoint scabbing present along the L2/L3 dermatome.
Age: 18.0
Sex: F
Vaccine: UNK
Symptoms: Injection site reaction, Local reaction
Clinical narrative: Unknown vaccination information-given at PCP. When seen on today's exam, symptoms have resolved. Large localized reaction per cell phone picture 3-4 cm erythema surrounding injection site.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Lip swelling, Sensation of foreign body
Clinical narrative: Lips swelling, a feeling of something down her throat.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 15-DEC-2017, the patient was vaccinated with an improperly stored dose of M-M-R II lot # N009800; expiry date 24-MAR-2019 (dose, frequency, route of administration were not provided). The M-M-R II was reconstituted with properly stored dose of sterile diluent (manufacturer unknown). No adverse effect was reported. The vaccines was stored in between 47 degrees Fahrenheit (F) to 77 F (also reported as: "46.9 F") for 30 minutes. There was no previous excursion. The digital data logger was involved in recording the temperature excursion. Sender's Comments: US-009507513-1801USA002561: US-009507513-1801USA002562: US-009507513-1801USA002563: US-009507513-1801USA002564: US-009507513-1801USA002559: US-009507513-1801USA002560.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling, Local reaction
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 68 year old female patient. The patient had no pertinent medical history, concurrent therapies and drug reactions or allergies. On 29-DEC-2017, the patient was vaccinated with ZOSTAVAX 19400 plaque-forming unit (PFU), subcutaneously, lot # N014942, expiration date 02-FEB-2018 (reported as 20-FEB-2018) (frequency and dose were not reported). Other suspect therapies included administered on the same day sterile diluent (STERILE DILUENT), subcutaneously, lot# N006324, expiration date 24-JUL-2019. On 30-DEC-2017, the patient experienced localized reaction at the injection site, which was swollen and itchy as well as rash. The patient came to the pharmacy on 05-JAN-2018 to report these events. The patient took an unspecified dose of diphenhydramine hydrochloride (BENADRYL) on recommendation of unspecified pharmacist after calling the pharmacy. No laboratory diagnostics were performed. The patient sought medical attention. The outcome of injection site swelling, rash and injection site pruritus was reported as recovering on 05-JAN-2018 (reported as rash was 75% gone). The causality assessment was not provided.
Sex: U
Vaccine: MMRV
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. On 30-NOV-2017, the patient was vaccinated with improperly stored dose of PROQUAD lot # N016089, expiration date 22-NOV-2019 (also reported as 22-NOV-2018), therapy type RHA for prophylaxis. No adverse effects were reported. The PROQUAD underwent a temperature excursion of -14 to -10 degrees Celsius for 96 minutes. There was no previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1801USA002684: US-009507513-1801USA002685: US-009507513-1801USA002686:
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, 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 male patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 13-OCT-2016, at a pharmacy, the patient was inoculated (by an unspecified person) with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 28-OCT-2016, he was treated by a physician assistant at an Urgent care facility for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The male patient has been prescribed Famiciclovir (as reported) for management of his painful symptoms. As a direct and proximate result of these malfunctions, 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 not resolved. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Ophthalmic herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received on 04-JAN-2018 from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 03-MAR-2008, at a physician's office, the patient was inoculated (by an unspecified healthcare professional) with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration, lot # and expiration date were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster.  On or about 06-OCT-2011, the male was treated (by an unspecified healthcare professional) at the eye specialist facility, for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles on the face. On or about 15-DEC-2011, the patient sought subsequent treatment from the eye specialist facility for ongoing and worsening symptoms of Herpes zoster with face and eye interference. The patient has been prescribed acyclovir, gabapentin for management of his painful symptoms. As a direct and proximate result of these malfunctions, 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 not resolved.  The lawyer felt the events were related to ZOSTAVAX. Upon internal review, the event of ongoing and worsening symptoms of herpes zoster with face and eye interference was determined to be medically significant. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Brow ptosis, Canthoplasty, Exposure keratitis, Facial paralysis
Clinical narrative: Information has been received on 04-JAN-2018 regarding a case in litigation from a lawyer and a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapy are unknown. The patient was inoculated with ZOSTAVAX (lot number and expiration unknown) subcutaneous on or about 20-AUG-2013, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster in addition to herpes zoster of the eyelid and Bell's palsy. On or about 14-AUG-2015, the patient was treated at an urgent care clinic for a blistering vesicular outbreak that was diagnosed as severe herpes zoster, or shingles. On or about 18-AUG-2015, the patient was treated at the urgent care clinic for an outbreak that was diagnosed as herpes zoster of the eyelid with lag opthalmos and was ordered to continue antiviral treatments. On or about 25-AUG-2015, the patient received subsequent treatment at the urgent care clinic for ongoing and worsening symptoms, which were diagnosed as "exposure keratitis OS d/t lag opthalmos", 7th nerve palsy related to herpes zoster, and herpes zoster of the eyelid. Bell's palsy is a condition involving permanent contraction of facial muscles, resulting in drooping of the face and lack of muscle function. The patient had consistent treatments at the urgent clinic with an ongoing diagnosis of severe herpes infection, neuralgia of the 7th cranial nerve and herpes zoster of the eyelid. On or about 02-NOV-2015, the patient underwent an operative procedure for repair brow ptosis, canthoplasty and correction eyelid with implant which was performed by a physician at clinic. The patient sought continued treatment at the clinic for his chronic herpes zoster condition. Throughout his extensive treatment, the patient has been prescribed acyclovir in increasing dosages, mineral oil, petrolatum, white (PURALUBE OINTMENT) and latanoprost for management of his painful and bothersome symptoms. As a direct and proximate result of these malfunctions, 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, pain and suffering and other damages. Bell's palsy/7th nerve palsy/repair brow ptosis/canthoplasty/correction eyelid with implant was considered to be disabling. Upon internal review, Bell's palsy/7th nerve palsy/repair brow ptosis/canthoplasty/correction eyelid with implant and herpes zoster of the eyelid were considered to be medically significant. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Lagophthalmos, Neuralgia, Ophthalmic herpes zoster, Pain
Clinical narrative: Information has been received on 04-JAN-2018 regarding a case in litigation from a lawyer and a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapy are unknown. The patient was inoculated with ZOSTAVAX (lot number and expiration unknown) subcutaneous on or about 20-AUG-2013, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster in addition to herpes zoster of the eyelid and Bell's palsy. On or about 14-AUG-2015, the patient was treated at an urgent care clinic for a blistering vesicular outbreak that was diagnosed as severe herpes zoster, or shingles. On or about 18-AUG-2015, the patient was treated at the urgent care clinic for an outbreak that was diagnosed as herpes zoster of the eyelid with lag opthalmos and was ordered to continue antiviral treatments. On or about 25-AUG-2015, the patient received subsequent treatment at the urgent care clinic for ongoing and worsening symptoms, which were diagnosed as "exposure keratitis OS d/t lag opthalmos", 7th nerve palsy related to herpes zoster, and herpes zoster of the eyelid. Bell's palsy is a condition involving permanent contraction of facial muscles, resulting in drooping of the face and lack of muscle function. The patient had consistent treatments at the urgent clinic with an ongoing diagnosis of severe herpes infection, neuralgia of the 7th cranial nerve and herpes zoster of the eyelid. On or about 02-NOV-2015, the patient underwent an operative procedure for repair brow ptosis, canthoplasty and correction eyelid with implant which was performed by a physician at clinic. The patient sought continued treatment at the clinic for his chronic herpes zoster condition. Throughout his extensive treatment, the patient has been prescribed acyclovir in increasing dosages, mineral oil, petrolatum, white (PURALUBE OINTMENT) and latanoprost for management of his painful and bothersome symptoms. As a direct and proximate result of these malfunctions, 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, pain and suffering and other damages. Bell's palsy/7th nerve palsy/repair brow ptosis/canthoplasty/correction eyelid with implant was considered to be disabling. Upon internal review, Bell's palsy/7th nerve palsy/repair brow ptosis/canthoplasty/correction eyelid with implant and herpes zoster of the eyelid were considered to be medically significant. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Ptosis repair, Rash vesicular
Clinical narrative: Information has been received on 04-JAN-2018 regarding a case in litigation from a lawyer and a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapy are unknown. The patient was inoculated with ZOSTAVAX (lot number and expiration unknown) subcutaneous on or about 20-AUG-2013, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster in addition to herpes zoster of the eyelid and Bell's palsy. On or about 14-AUG-2015, the patient was treated at an urgent care clinic for a blistering vesicular outbreak that was diagnosed as severe herpes zoster, or shingles. On or about 18-AUG-2015, the patient was treated at the urgent care clinic for an outbreak that was diagnosed as herpes zoster of the eyelid with lag opthalmos and was ordered to continue antiviral treatments. On or about 25-AUG-2015, the patient received subsequent treatment at the urgent care clinic for ongoing and worsening symptoms, which were diagnosed as "exposure keratitis OS d/t lag opthalmos", 7th nerve palsy related to herpes zoster, and herpes zoster of the eyelid. Bell's palsy is a condition involving permanent contraction of facial muscles, resulting in drooping of the face and lack of muscle function. The patient had consistent treatments at the urgent clinic with an ongoing diagnosis of severe herpes infection, neuralgia of the 7th cranial nerve and herpes zoster of the eyelid. On or about 02-NOV-2015, the patient underwent an operative procedure for repair brow ptosis, canthoplasty and correction eyelid with implant which was performed by a physician at clinic. The patient sought continued treatment at the clinic for his chronic herpes zoster condition. Throughout his extensive treatment, the patient has been prescribed acyclovir in increasing dosages, mineral oil, petrolatum, white (PURALUBE OINTMENT) and latanoprost for management of his painful and bothersome symptoms. As a direct and proximate result of these malfunctions, 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, pain and suffering and other damages. Bell's palsy/7th nerve palsy/repair brow ptosis/canthoplasty/correction eyelid with implant was considered to be disabling. Upon internal review, Bell's palsy/7th nerve palsy/repair brow ptosis/canthoplasty/correction eyelid with implant and herpes zoster of the eyelid were considered to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received on 05-JAN-2018 regarding a case in litigation from a lawyer and a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. The patient was inoculated with ZOSTAVAX (lot number and expiration unknown) subcutaneous on or about 11-JUN-2015, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 02-FEB-2016, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster involving the cervical dermatome. The patient was prescribed VALTREX for management of her painful and persistent symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and 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: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 04-JUN-2015, the patient was vaccinated at a community care 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 vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster, also known as shingles. On or about 01-AUG-2016, the patient was treated by a physician for onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of these malfunctions, 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: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 29-SEP-2011, the patient was vaccinated at a hospital 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 vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster, also known as shingles. On or about 27-JAN-2016 , the patient was treated at a hospital for onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient was prescribed  hydrocodone acetaminophen for the management of his painful symptoms. As a direct and proximate result of these malfunctions, 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: Decreased immune responsiveness, 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. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 15-OCT-2006, the patient was inoculated with ZOSTAVAX, administered by a physician, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 19-JAN-2016, the patient was treated by a physician for the onset of severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as shingles. She was prescribed VALTREX, TYLENOL 3, and methylprednisolone (reported as MEDROL PAC) for management of her painful and persistent symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 18-DEC-2017, the patient was vaccinated with an improperly stored dose of M-M-R II lot # N009800; expiry date 24-MAR-2017 (dose, frequency, route of administration were not provided). The M-M-R II was reconstituted with properly stored dose of sterile diluent (manufacturer unknown). No adverse effect was reported. The vaccines was stored in between 47 degrees Fahrenheit (F) to 77 F (also reported as: "46.9 F") for 30 minutes. There was no previous excursion. The digital data logger was involved in recording the temperature excursion.; Sender's Comments: US-009507513-1712USA010650: US-009507513-1801USA002560: US-009507513-1801USA002564: US-009507513-1801USA002561: US-009507513-1801USA002562: US-009507513-1801USA002563:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 12-DEC-2017, the patient was vaccinated with an improperly stored dose of M-M-R II lot # N009800; expiry date 24-MAR-2017 (dose, frequency, route of administration were not provided). The M-M-R II was reconstituted with properly stored dose of sterile diluent (manufacturer unknown). No adverse effect was reported. The vaccines was stored in between 47 degrees Fahrenheit (F) to 77 F (also reported as: "46.9 F") for 30 minutes. There was no previous excursion. The digital data logger was involved in recording the temperature excursion. Sender's Comments: US-009507513-1712USA010650: US-009507513-1801USA002559: US-009507513-1801USA002561: US-009507513-1801USA002562: US-009507513-1801USA002563: US-009507513-1801USA002564.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 11-DEC-2017, the patient was vaccinated with an improperly stored dose of M-M-R II lot # N009800; expiry date 24-MAR-2017 (dose, frequency, route of administration were not provided). The M-M-R II was reconstituted with properly stored dose of sterile diluent (manufacturer unknown). No adverse effect was reported. The vaccines was stored in between 47 degrees Fahrenheit (F) to 77 F (also reported as: "46.9 F") for 30 minutes. There was no previous excursion. The digital data logger was involved in recording the temperature excursion.; Sender's Comments: US-009507513-1801USA002560: US-009507513-1801USA002562: US-009507513-1801USA002563: US-009507513-1801USA002564: US-009507513-1801USA002559: US-009507513-1712USA010650:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 08-DEC-2017 , the patient was vaccinated with an improperly stored dose of M-M-R II lot # N009800; expiry date 24-MAR-2017 (dose, frequency, route of administration were not provided). The M-M-R II was reconstituted with properly stored dose of sterile diluent (manufacturer unknown). No adverse effect was reported. The vaccines was stored in between 47 degrees Fahrenheit (F) to 77 F (also reported as: "46.9 F") for 30 minutes. There was no previous excursion. The digital data logger was involved in recording the temperature excursion. Sender's Comments: US-009507513-1712USA010650: US-009507513-1801USA002559: US-009507513-1801USA002560: US-009507513-1801USA002561: US-009507513-1801USA002563: US-009507513-1801USA002564.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 29-NOV-2017, the patient was vaccinated with an improperly stored dose of M-M-R II lot # N009800; expiry date 24-MAR-2017 (dose, frequency, route of administration were not provided). The M-M-R II was reconstituted with properly stored dose of sterile diluent (manufacturer unknown). No adverse effect was reported. The vaccines was stored in between 47 degrees Fahrenheit (F) to 77 F (also reported as: "46.9 F") for 30 minutes. There was no previous excursion. The digital data logger was involved in recording the temperature excursion.; Sender's Comments: US-009507513-1712USA010650: US-009507513-1801USA002559: US-009507513-1801USA002560: US-009507513-1801USA002561: US-009507513-1801USA002562: US-009507513-1801USA002564:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 01-DEC-2017, the patient was vaccinated with an improperly stored dose of M-M-R II lot # N009800; expiry date 24-MAR-2017 (dose, frequency, route of administration were not provided). The M-M-R II was reconstituted with properly stored dose of sterile diluent (manufacturer unknown). No adverse effect was reported. The vaccines was stored in between 47 degrees Fahrenheit (F) to 77 F (also reported as: "46.9 F") for 30 minutes. There was no previous excursion. The digital data logger was involved in recording the temperature excursion.; Sender's Comments: US-009507513-1712USA010650: US-009507513-1801USA002559: US-009507513-1801USA002560: US-009507513-1801USA002561: US-009507513-1801USA002562: US-009507513-1801USA002563:
Sex: U
Vaccine: MMRV
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. On 17-OCT-2017, the patient was vaccinated with improperly stored dose of PROQUAD lot # N016089, expiration date 22-NOV-2019 (also reported as 22-NOV-2018), therapy type RHA for prophylaxis. No adverse effects were reported. The PROQUAD underwent a temperature excursion of -14 to -10 degrees Celsius for 96 minutes. There was no previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1801USA002685: US-009507513-1801USA002686: US-009507513-1801USA002315:
Sex: U
Vaccine: MMRV
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. On 12-DEC-2017, the patient was vaccinated with improperly stored dose of PROQUAD lot # N016089, expiration date 22-NOV-2019 (also reported as 22-NOV-2018), therapy type RHA for prophylaxis. No adverse effects were reported. The PROQUAD underwent a temperature excursion of -14 to -10 degrees Celsius for 96 minutes. There was no previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA002684: US-009507513-1801USA002686: US-009507513-1801USA002315:
Sex: U
Vaccine: MMRV
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. On 16-NOV-2017, the patient was vaccinated with improperly stored dose of PROQUAD lot # N016089, expiration date 22-NOV-2019 (also reported as 22-NOV-2018), therapy type RHA for prophylaxis. No adverse effects were reported. The PROQUAD underwent a temperature excursion of -14 to -10 degrees Celsius for 96 minutes. There was no previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1801USA002684: US-009507513-1801USA002685: US-009507513-1801USA002315.
Sex: F
Vaccine: PNC13
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer. A female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration, in Oct2016 at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient was vaccinated in Oct2016 and she cannot move her arm very well, and has a little pain on it on an unspecified date. Outcome of the events was unknown.
Age: 27.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Hypoaesthesia, Pain in extremity, Tenderness
Clinical narrative: Left arm tender after shot given. That night arm was numb. Pain continued and employee reported on 12/8/17 to Employee Health. She was referred to another provider. She did not go and did not respond to email sent on 12/22/17. I spoke with her today. States she hadn't felt the pain "for awhile" until recently going ice fishing. She felt like the cold made her left arm hurt again. She felt the nurse giving the shot gave it too high.
Age: 27.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Hypoaesthesia, Pain in extremity, Product administered at inappropriate site, Temperature intolerance, Tenderness
Clinical narrative: Left arm tender after shot given. That night arm was numb. Pain continued and employee reported on 12/8/17 to Employee Health. She was referred to another provider. She did not go and did not respond to email sent on 12/22/17. I spoke with her today. States she hadn't felt the pain "for awhile" until recently going ice fishing. She felt like the cold made her left arm hurt again. She felt the nurse giving the shot gave it too high.
Age: 54.0
Sex: F
Vaccine: YF
Symptoms: Asthenia, Dizziness, Nausea, Vertigo, Vomiting
Clinical narrative: Within 36 hours of the shot I experienced vertigo while lying down and sleeping. The first morning made me dizzy, weak, light headed, with a couple of vertigo spells. I also had a low grade over all headache and an earache in my right ear. I eventually discovered that turning my head to the left while lying down caused the vertigo. in the afternoon, I felt pretty good., but symptoms started again at bedtime and in the morning on Sunday. Monday Jan. 1, was the worst where vertigo was so bad it caused nausea and vomiting almost the entire day. it was a holiday and I couldn't see a doctor until the next day. The next day was not as bad as monday but worse than over the weekend. I was given a shot by my doctor and 2 rx for nausea. That seemed to help. but still continued to get dizzy and vertigo over night and slightly in the morning. Saturday, Jan 6, was the first morning that I woke up feeling nearly normal. I stopped taking nausea meds. This morning, before getting up, I turned my head to the left to see the alarm clock and got vertigo, but not as bad as previously experienced. This makes my morning a little light headed. But I am able to work. So the worst of the symptoms lasted 7 days from the first symptom. But, it does continue to happen. How much longer am I expected to endure this before it disappears completely?  I did also take HepA&B shot with Yellow Fever, however, that was my second shot. I took my first Hep A&B in November with Zero side effects.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Chest discomfort, Injection site bruising, Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: Patient came to pharmacy to pick up script and show us her arm. She had a black/purple bruise at injection site and a large inflammed red area that was warm to touch and had spread around her arm from injection site. She complained that it itches very bad and is tender, but mostly itches. No rash anywhere else, her neck hurt the next day and she felt ill for the first two days. Her breathing felt a little heavy in the chest but she wasnt sure if it was due to any reaction or just her asthma. Patient was counseled on what to watch for and when to get to a hospital if need be was also showed benadryl and counseled on how to take. Patient bought some and said she will watch herself take the benadryl and continue icing it as before and would let us know and get to a hospital if anything changed or worsened.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pruritus, Injection site warmth, Malaise, Neck pain
Clinical narrative: Patient came to pharmacy to pick up script and show us her arm. She had a black/purple bruise at injection site and a large inflammed red area that was warm to touch and had spread around her arm from injection site. She complained that it itches very bad and is tender, but mostly itches. No rash anywhere else, her neck hurt the next day and she felt ill for the first two days. Her breathing felt a little heavy in the chest but she wasnt sure if it was due to any reaction or just her asthma. Patient was counseled on what to watch for and when to get to a hospital if need be was also showed benadryl and counseled on how to take. Patient bought some and said she will watch herself take the benadryl and continue icing it as before and would let us know and get to a hospital if anything changed or worsened.
Age: 67.0
Sex: F
Vaccine: FLUA3, PPV, FLUA3, PPV
Symptoms: Anxiety, Back pain, Coccydynia, Dysgeusia, Feeling hot
Clinical narrative: Few seconds after completion of both vaccinations pt experienced bad/weird taste in mouth, flushed/warm feeling, feeling of anxious/overwhelm. Immediately sat back down. No trouble breathing, wheezing, rash. After a few minutes reaction moved to a dull throbbing pain in lower back/tailbone area. Approx 30 minutes later most of reaction cleared. Pt had little pain in lower back.
Age: 67.0
Sex: F
Vaccine: FLUA3, PPV, FLUA3, PPV
Symptoms: Flushing, Pain
Clinical narrative: Few seconds after completion of both vaccinations pt experienced bad/weird taste in mouth, flushed/warm feeling, feeling of anxious/overwhelm. Immediately sat back down. No trouble breathing, wheezing, rash. After a few minutes reaction moved to a dull throbbing pain in lower back/tailbone area. Approx 30 minutes later most of reaction cleared. Pt had little pain in lower back.
Age: 67.0
Sex: F
Vaccine: FLUA3, PPV, FLUA3, PPV
Symptoms: Anxiety, Back pain, Coccydynia, Dysgeusia, Feeling abnormal
Clinical narrative: Few seconds after completion of both vaccinations pt experienced bad/weird taste in mouth, flushed/warm feeling, feeling of anxious/overwhelm. Immediately sat back down. No trouble breathing, wheezing, rash. After a few minutes reaction moved to a dull throbbing pain in lower back/tailbone area. Approx 30 minutes later most of reaction cleared. Pt had little pain in lower back.
Age: 67.0
Sex: F
Vaccine: FLUA3, PPV, FLUA3, PPV
Symptoms: Feeling hot, Flushing, Pain
Clinical narrative: Few seconds after completion of both vaccinations pt experienced bad/weird taste in mouth, flushed/warm feeling, feeling of anxious/overwhelm. Immediately sat back down. No trouble breathing, wheezing, rash. After a few minutes reaction moved to a dull throbbing pain in lower back/tailbone area. Approx 30 minutes later most of reaction cleared. Pt had little pain in lower back.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an office manager, referring to a patient of unknown age and gender. Information regarding medical history, concurrent conditions or concomitant medication was not provided. On 16-DEC-2017, the patient was vaccinated with improperly stored dose of M-M-R II (rHA) lot # M049212, expiration date 16-DEC-2018, for prophylaxis (dosage information and route of vaccination were not informed), with properly stored sterile diluent (MERCK) (lot number and expiration date were not informed). No adverse effects were reported. Temperature: 47 F to 77 F (71F). Time frame: 51 hours. There was no previous temperature excursion. The call was because of a data logger.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse, referring to a patient of unspecified age and gender. Information regarding patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported. On 21-DEC-2017, the patient was inadvertently vaccinated with improperly stored doses of GARDASIL 9 lot # N022584, expiration date 15-JUN-2020, for prophylaxis (strength, dose, route and frequency were not reported). The following temperature excursions were reported: temperature below 32°F during 6 hours 9 minutes, 30.8°F during 2 hours 57 minutes and 31.9°F during 3 hours 12 minutes. Temperature excursion was of 32°F to 35°F during 3 hours 4 minutes, multiple excursions were reported. Previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported. This is one of the multiple reports received from the same reporter.; Sender's Comments: US-009507513-1801USA001528: US-009507513-1712USA013720: US-009507513-1801USA002100: US-009507513-1801USA002098: US-009507513-1801USA002099:
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, 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. On or about 09-OCT-2012, the patient was inoculated with ZOSTAVAX, administered by a physician at a medical group, as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 22-JUL-2015, she was treated by a physician at a medical group for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The female patient has been prescribed valacyclovir, for management of her painful and persistent symptoms. As a direct and proximate result of these malfunctions, 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 not resolved.  The lawyer felt the events were related to ZOSTAVAX.   Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, 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. On or about 28-JAN-2016, at a pharmacy, the patient was inoculated with ZOSTAVAX, (by an unspecified healthcare professional) as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 16-JAN-2017, the patient was treated at a hospital (by an unspecified healthcare professional) for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The female patient has been prescribed valacyclovir (VALTREX) and Prednisone for management of her painful and persistent symptoms. As a direct and proximate result of these malfunctions, 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. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Loss of personal independence in daily activities, Mobility decreased, Nervous system disorder, Pain
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, and concomitant medication. On or about 25-JUN-2015, 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. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient a series of debilitating neurological issues. On or about July, 13-AUG-2015, the patient was treated by a physician for sudden and worsening pain in his extremities and difficulty moving. The patient was diagnosed with polymyalgia rheumatica, a serious side effect of ZOSTAVAX. Over the course of six additional medical encounters, the patient was treated for his polymyalgia rheumatica, but his healthcare providers were unable to manage his progressive symptoms and pain. Throughout 2016, the patient was treated by the physician on 16 separate medical encounters, in addition to manage his polymyalgia rheumatica, to no avail. The patient was referred to a hematologist for his atypical and uncontrolled presentation of polymyalgia rheumatica. The patient was prescribed a heavy regimen of prednisone, tramadol, allopurinol, and TYLENOL WITH CODEINE for management of his symptoms. As a result of his painful and dystrophic condition, the patient has been significantly limited in his mobility and ability to live independently. The patient is unable to travel because his immune system has become depleted by his disorder. As a direct and proximate result of these malfunctions, 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, pain and suffering, and other damages. Upon internal review, polymyalgia rheumatica was determined to be medically significant. Polymyalgia rheumatica and debilitating neurological issues were considered to be disabling. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Polymyalgia rheumatica
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, and concomitant medication. On or about 25-JUN-2015, 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. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient a series of debilitating neurological issues. On or about July, 13-AUG-2015, the patient was treated by a physician for sudden and worsening pain in his extremities and difficulty moving. The patient was diagnosed with polymyalgia rheumatica, a serious side effect of ZOSTAVAX. Over the course of six additional medical encounters, the patient was treated for his polymyalgia rheumatica, but his healthcare providers were unable to manage his progressive symptoms and pain. Throughout 2016, the patient was treated by the physician on 16 separate medical encounters, in addition to manage his polymyalgia rheumatica, to no avail. The patient was referred to a hematologist for his atypical and uncontrolled presentation of polymyalgia rheumatica. The patient was prescribed a heavy regimen of prednisone, tramadol, allopurinol, and TYLENOL WITH CODEINE for management of his symptoms. As a result of his painful and dystrophic condition, the patient has been significantly limited in his mobility and ability to live independently. The patient is unable to travel because his immune system has become depleted by his disorder. As a direct and proximate result of these malfunctions, 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, pain and suffering, and other damages. Upon internal review, polymyalgia rheumatica was determined to be medically significant. Polymyalgia rheumatica and debilitating neurological issues were considered to be disabling. Additional information has been requested.