chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2014, the patient was inoculated with ZOSTAVAX vaccine (lot number, dosage and route of administration not provided), at a healthcare facility/home (by an unspecified healthcare professional) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2016, the patient was treated (by an unspecified health care professional) at the healthcare facility/home 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 the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. 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 reporter considered the events to be related to ZOSTAVAX. The outcome of the events is unknown. Additional information has been requested.
Sex: M
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 male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 03-OCT-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 or about 19-MAR-2015, the patient was treated at a hospital by a physician for a blistering vesicular outbreak that was diagnosed as severe shingles and post herpetic neuralgia. The patient was prescribed acyclovir and gabapentin 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, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 08-JUL-2010, 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 or about 21-JAN-2016, 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: 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 2013, 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 2014, 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 ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the 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: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report has been received from a medical assistant /office manager, referring to a 22 year old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medications. On 18-JUN-2018, the patient was inadvertently vaccinated with a dose of ZOSTAVAX (strength, dose, frequency, route of administration, lot# and expiration date were not provided) for prophylaxis, instead of VARIVAX No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 21-JAN-2010, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance 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 30-JAN-2016, 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 ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the 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 or about 13-JAN-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 or about 13-APR-2016, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe shingles. The outcome of the events is unknown. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the 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, Neuropathy peripheral, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 20-DEC-2011, the patient was inoculated with ZOSTAVAX vaccine (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 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. On or about 13-JUN-2016, the patient was treated by a physician at a medical center/clinic for a blistering vesicular outbreak, that was diagnosed as severe shingles. The patient was prescribed acyclovir for management of her painful symptoms. On or about 24-JUN-2016, the patient sought subsequent treatment from the medical center/clinic by the physician for the diagnosis of neuropathy a condition that stems from herpes zoster or shingles rash causing incessant pain. The patient was prescribed pregabalin (LYRICA) to relieve her painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. 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 reporter considered the events to be related to ZOSTAVAX. The outcome of the events is unknown. Upon internal review, the event of neuropathy was determined to be a medically significant event.  Additional information has been requested.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB, HEPA, VARCEL
Symptoms: Autopsy, Death, Lethargy
Clinical narrative: This spontaneous report was received from a Registered Nurse via a company representative referring to a 15 month old female patient. The patient's concurrent conditions included hypertrophic cardiomyopathy. There was no concomitant medications reported. On 14-JUN-2018, the patient was vaccinated with VAQTA 25/0.5 (dose, route, lot number and expiration date were not reported) for prophylaxis. Other suspect therapies administered on that same date included VARIVAX (dose, route, lot number and expiration date were not reported) and another unspecified vaccine, both administered for prophylaxis. On 15-JUN-2018, the patient was lethargic and was taken to the office, later she was taken to the hospital and was admitted. The nurse reported that patient died next day (16-JUN-2018). It was also informed that an autopsy was done, but the results were not available at the reporting time. The nurse reported that patient was a twin and that the other unspecified 15 month old twin also received the same vaccinations (no further information was provided). The causality assessment between the events and the suspect therapies was not provided. The event lethargy was considered as disability and life threatening as serious criteria by the reporter.; Reported Cause(s) of Death: death.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. On 21-JUN-2018, the patient was vaccinated with VARIVAX (strength and dosage schedule were not reported) intramuscularly, for prophylaxis (lot number: N014369, expiration date: 21-JUN-2018) which was reconstituted with sterile diluent (lot number: N014365, expiration date: 11-OCT-2019). No side effects were reported.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 year old female patient. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported. On 21-JUN-2018 in the morning, the patient was vaccinated with PNEUMOVAX 23 (dose, frequency and route were not reported) (lot # N020501, expiry date: 03-MAR-2019) for prophylaxis. In the late afternoon on 21-JUN-2018, the patient reported her arm (at the injection site) was swollen, sore, warm and red. No treatment was received for the events. Lab diagnostics/studies was not performed. The outcome of injection site pain, injection site erythema, injection site swelling and injection site warmth was reported as not recovered/not resolved. The relationship between the events and PNEUMOVAX 23 was not provided. No product quality complaint was involved.
Sex: F
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a female patient of unknown age. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not reported. On 29-MAY-2018, the patient was vaccinated with first dose of VARIVAX (dose, units and frequency not reported) (lot# and expiration date not reported) subcutaneously. On 12-JUN-2018, reported as 2 weeks later, the patient was vaccinated with second dose of VARIVAX (0.5 ml and frequency not reported) (lot# and expiration date not reported) subcutaneously. Reporter stated that, the second dose was not administered as per schedule. No adverse reactions experienced. No product quality complaint was involved.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a child (>12 months) patient of unknown gender. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On an unknown date in January 2018, the patient was vaccinated with improperly stored VARIVAX injection, lot #N022986 and expiration date 23-AUG-2019 (strength, dose, frequency and route of administration were not reported) for prophylaxis. No adverse symptoms were reported. The temperature of excursion was reported as - 6.3 Celsius degrees during a time frame of 1 hour and 26 minutes on 02-JAN-2018. There was no previous temperature of excursion reported. There was a digital data logger involved. This is one among the several reports reported by the medical assistant. Sender's Comments: US-009507513-1801USA002808: US-009507513-1806USA010177: US-009507513-1806USA010179: US-009507513-1806USA010180: US-009507513-1806USA010181: US-009507513-1806USA010176: US-009507513-1806USA010175: US-009507513-1806USA010174: US-009507513-1806USA010173: US-009507513-1806USA010178.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a child (>12 months) patient of unknown gender. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On an unknown date in January 2018, the patient was vaccinated with improperly stored VARIVAX injection, lot # N022986 and expiration date 23-AUG-2019 (strength, dose, frequency and route of administration were not reported) for prophylaxis. No adverse symptoms were reported. The temperature of excursion was reported as - 6.3 Celsius degrees during a time frame of 1 hour and 26 minutes on 02-JAN-2018. There was no previous temperature of excursion reported. There was a digital data logger involved. This is one among the several reports reported by the medical assistant. Sender's Comments: US-009507513-1801USA002808: US-009507513-1806USA010177: US-009507513-1806USA010178: US-009507513-1806USA010179: US-009507513-1806USA010180: US-009507513-1806USA010176: US-009507513-1806USA010181: US-009507513-1806USA010174: US-009507513-1806USA010171: US-009507513-1806USA010175.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a child (>12 months) patient of unknown gender. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On an unknown date in January 2018, the patient was vaccinated with improperly stored VARIVAX injection, lot #N022986 and expiration date 23-AUG-2019 (strength, dose, frequency and route of administration were not reported) for prophylaxis. No adverse symptoms were reported. The temperature of excursion was reported as - 6.3 Celsius degrees during a time frame of 1 hour and 26 minutes on 02-JAN-2018. There was no previous temperature of excursion reported. There was a digital data logger involved. This is one among the several reports reported by the medical assistant. Sender's Comments: US-009507513-1801USA002808: US-009507513-1806USA010177: US-009507513-1806USA010178: US-009507513-1806USA010179: US-009507513-1806USA010180: US-009507513-1806USA010176: US-009507513-1806USA010181: US-009507513-1806USA010171: US-009507513-1806USA010173: US-009507513-1806USA010175.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a child (>12 months) patient of unknown gender. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On an unknown date in January 2018, the patient was vaccinated with improperly stored VARIVAX injection, lot # N022986 and expiration date 23-AUG-2019 (strength, dose, frequency and route of administration were not reported) for prophylaxis. No adverse symptoms were reported. The temperature of excursion was reported as - 6.3 Celsius degrees during a time frame of 1 hour and 26 minutes on 02-JAN-2018. There was no previous temperature of excursion reported. There was a digital data logger involved. This is one among the several reports reported by the medical assistant. Sender's Comments: 1801USA002808: 1806USA010177: 1806USA010178: 1806USA010179: 1806USA010180: 1806USA010176: 1806USA010181: 1806USA010174: 1806USA010173: 1806USA010171.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a child (>12 months) patient of unknown gender. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On an unknown date in January 2018, the patient was vaccinated with improperly stored VARIVAX injection, lot #N022986 and expiration date 23-AUG-2019 (strength, dose, frequency and route of administration were not reported) for prophylaxis. No adverse symptoms were reported. The temperature of excursion was reported as - 6.3 Celsius degrees during a time frame of 1 hour and 26 minutes on 02-JAN-2018. There was no previous temperature of excursion reported. There was a digital data logger involved. This is one among the several reports reported by the medical assistant. Sender's Comments: 1801USA002808: 1806USA010177: 1806USA010178: 1806USA010179: 1806USA010180: 1806USA010171: 1806USA010181: 1806USA010174: 1806USA010173: 1806USA010175.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a child (>12 months) patient of unknown gender. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On an unknown date in January 2018, the patient was vaccinated with improperly stored VARIVAX injection, lot #N022986 and expiration date 23-AUG-2019 (strength, dose, frequency and route of administration were not reported) for prophylaxis. No adverse symptoms were reported. The temperature of excursion was reported as - 6.3 Celsius degrees during a time frame of 1 hour and 26 minutes on 02-JAN-2018. There was no previous temperature of excursion reported. There was a digital data logger involved. This is one among the several reports reported by the medical assistant. Sender's Comments: 1801USA002808: 1806USA010171: 1806USA010178: 1806USA010179: 1806USA010180: 1806USA010176: 1806USA010181: 1806USA010174: 1806USA010173: 1806USA010175.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant concerning a 5 year old child patient of unknown gender. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On an unknown date in January 2018, the patient was vaccinated with improperly stored PROQUAD, lot # N019248 and expiration date 20-DEC-2018, (strength, dose, frequency and route of administration were not reported) for prophylaxis. No adverse symptoms were reported. The temperature of excursion was reported as - 6.3 Celsius degrees during a time frame of 1 hour and 26 minutes on 02-JAN-2018. There was no previous temperature of excursion reported. There was a digital data logger involved. This is one among the several reports reported by the medical assistant. Sender's Comments: US-009507513-1801USA002808: US-009507513-1806USA010177: US-009507513-1806USA010171: US-009507513-1806USA010179: US-009507513-1806USA010180: US-009507513-1806USA010176: US-009507513-1806USA010181: US-009507513-1806USA010174: US-009507513-1806USA010173: US-009507513-1806USA010175:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant concerning a 4 year old child patient of unknown gender. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On an unknown date in January 2018, the patient was vaccinated with improperly stored PROQUAD lot # N019248 and expiration date 20-DEC-2018 (strength, dose, frequency and route of administration were not reported) for prophylaxis. No adverse symptoms were reported. The temperature of excursion was reported as - 6.3 Celsius degrees during a time frame of 1 hour and 26 minutes on 02-JAN-2018. There was no previous temperature of excursion reported. There was a digital data logger involved. This is one among the several reports reported by the medical assistant. Sender's Comments: US-009507513-1801USA002808: US-009507513-1806USA010177: US-009507513-1806USA010178: US-009507513-1806USA010171: US-009507513-1806USA010180: US-009507513-1806USA010181: US-009507513-1806USA010176: US-009507513-1806USA010174: US-009507513-1806USA010173: US-009507513-1806USA010175.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a 4 year old child patient of unknown gender. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On an unknown date in January 2018, the patient was vaccinated with improperly stored PROQUAD, lot # N019248 and expiration date 20-DEC-2018 (strength, dose, frequency and route of administration were not reported) for prophylaxis. No adverse symptoms were reported. The temperature of excursion was reported as - 6.3 Celsius degrees during a time frame of 1 hour and 26 minutes on 02-JAN-2018. There was no previous temperature of excursion reported. There was a digital data logger involved. This is one among the several reports reported by the medical assistant. Sender's Comments: US-009507513-1801USA002808: US-009507513-1806USA010177: US-009507513-1806USA010178: US-009507513-1806USA010179: US-009507513-1806USA010171: US-009507513-1806USA010176: US-009507513-1806USA010181: US-009507513-1806USA010174: US-009507513-1806USA010173: US-009507513-1806USA010175.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant concerning a 10 year old patient of unknown gender. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On an unknown date in January 2018, the patient was vaccinated with improperly stored PROQUAD, lot # N019248 and expiration date 20-DEC-2018 (strength, dose, frequency and route of administration were not reported) for prophylaxis. No adverse symptoms were reported. The temperature of excursion was reported as - 6.3 Celsius degrees during a time frame of 1 hour and 26 minutes on 02-JAN-2018. There was no previous temperature of excursion reported. There was a digital data logger involved. This is one among the several reports reported by the medical assistant. Sender's Comments: US-009507513-1801USA002808: US-009507513-1806USA010174: US-009507513-1806USA010173: US-009507513-1806USA010175: US-009507513-1806USA010176: US-009507513-1806USA010177: US-009507513-1806USA010178: US-009507513-1806USA010180: US-009507513-1806USA010171: US-009507513-1806USA010179.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Influenza like illness, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of influenza-like symptoms in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms, fever and feeling bad. On an unknown date, the outcome of the influenza-like symptoms, fever and feeling bad were recovered/resolved. The reporter considered the influenza-like symptoms, fever and feeling bad to be almost certainly related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The vaccine was administered at a pharmacy. The physician stated that, the patient received SHINGRIX and experienced flu like symptoms, fever, and felt pretty lousy for 3 to 4 days. Events started the night of vaccination to next day, unsure of exact timing on onset of adverse event. The patient called the physician to discuss the issue.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Neuralgia, Peripheral swelling
Clinical narrative: Day 1: the patient talked about redness and soreness at the injection site. Day 2: patient talked about nerve pain down the arm side that swelled up. The swelling and pain lasted about a week.  Patient took ADVIL to ease the pain which only worked a little. Patient has had shingles in the past (11/2016) and she explained this nerve pain as being similar to the shingles pain in the past. Ultimate treatment/cure was with laser treatment from the chiropractor. The pain subsided and eventually went away. Will do further research to see if patient should receive second vaccine.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Laser therapy, Neuralgia, Peripheral swelling
Clinical narrative: Day 1: the patient talked about redness and soreness at the injection site. Day 2: patient talked about nerve pain down the arm side that swelled up. The swelling and pain lasted about a week.  Patient took ADVIL to ease the pain which only worked a little. Patient has had shingles in the past (11/2016) and she explained this nerve pain as being similar to the shingles pain in the past. Ultimate treatment/cure was with laser treatment from the chiropractor. The pain subsided and eventually went away. Will do further research to see if patient should receive second vaccine.
Age: 62.0
Sex: M
Vaccine: HEPAB, VARZOS
Symptoms: Computerised tomogram, Dysarthria, Mobility decreased, Nuclear magnetic resonance imaging heart, Nuclear magnetic resonance imaging normal
Clinical narrative: Patient got 2nd dose of Shingrix, and he got a mini stroke same day in the evening. Wife said he has immobility in left side, he can only lift his left arm half way. He has slurry speech some time of the day. His doctor did his MRI, and his heart was good.
Age: 62.0
Sex: M
Vaccine: HEPAB, VARZOS
Symptoms: Transient ischaemic attack
Clinical narrative: Patient got 2nd dose of Shingrix, and he got a mini stroke same day in the evening. Wife said he has immobility in left side, he can only lift his left arm half way. He has slurry speech some time of the day. His doctor did his MRI, and his heart was good.
Age: 28.0
Sex: M
Vaccine: ANTH
Symptoms: Nodule, Pain, Rheumatic disorder
Clinical narrative: See previous health issues. Had a sore knot on arm after this shot that lasted days.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Myalgia, Nausea
Clinical narrative: Patient reports flu like symptoms including, muscle aches, chills, nausea. Symptoms started around 7PM the evening of the vaccination and continued for 2 days following injection.
Age: 42.0
Sex: M
Vaccine: HEP
Symptoms: Dysgeusia, Vomiting
Clinical narrative: Patient reported vomiting x20 min after receiving vaccine, also reports "funny" taste in mouth; no other s/s reported.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Hyperhidrosis, Hypotension, Loss of consciousness, Syncope
Clinical narrative: Patient had episode of syncope, passed out for 10-15 seconds, became diaphoretic; BP low, 94/58 at lowest point, HR 52; patient monitored in clinic for 30 min following administration until BP returned to normal and remined stable and could take fluid by mouth, patient left with mother.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site discomfort, Myalgia, Nausea
Clinical narrative: Side effects with first dose were negligible. The second dose given on date specified on this report were more pronounced. Including, fever 100.1., muscle aches, fatigue, headache, nausea and injection site discomfort.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Side effects with first dose were negligible. The second dose given on date specified on this report were more pronounced. Including, fever 100.1., muscle aches, fatigue, headache, nausea and injection site discomfort.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Hyperhidrosis, Hypotension, Loss of consciousness, Syncope
Clinical narrative: Patient had episode of syncope, passed out for about 10 seconds, became diaphoretic; patient also became hypotensive; patient monitored in clinic until BP returned to normal and was maintained. Patient left clinic with mother.
Age: 1.5
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, Wrong drug administered
Clinical narrative: PROQUAD was given instead of MMR by MA, Varicella was also given on same day. Was also documented wrong in MCIR, documented as MMR, though in patient's chart was clearly given the PROQUAD. MCIR updated to reflect the PROQUD that was given.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Erythema, Musculoskeletal pain, Nausea, Pain of skin
Clinical narrative: Two days after injection: dizziness, nausea, pain in shoulders (not at injection site) 5 days after injection rash with open pustules on chest and left side of neck and face.... visited md's office.... told not shingles but a reaction to vaccine.... given nine day prednisone treatment.... still have itching and some redness.....other observation: area on hand where plastic surgery was performed to skin following accident: skin has become leathery and painful. No other manifestations.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Rash pustular, Skin texture abnormal, Vaccination complication
Clinical narrative: Two days after injection: dizziness, nausea, pain in shoulders (not at injection site) 5 days after injection rash with open pustules on chest and left side of neck and face.... visited md's office.... told not shingles but a reaction to vaccine.... given nine day prednisone treatment.... still have itching and some redness.....other observation: area on hand where plastic surgery was performed to skin following accident: skin has become leathery and painful. No other manifestations.
Sex: U
Vaccine: TDAP, VARZOS
Symptoms: Chills, Discomfort, Headache, Hyperhidrosis, Injection site erythema
Clinical narrative: Began to feel uncomfortable evening of vaccine, with soreness in SHINGRIX injection site increasing. By the next morning, felt generally uncomfortable with on-and-off headaches. Large reddish area around SHINGRIX injection site (2-in in diameter). Was able to go to work, but felt sluggish. Felt good in the evening, but potentially developed a fever as I got chills mid-evening. Overnight, had alternating chills and sweats. Slept in late the following day (6/23) and felt much better. Injection site still very red, but no other effects remained. Redness mostly absent this morning (6/25).
Sex: U
Vaccine: TDAP, VARZOS
Symptoms: Injection site pain, Sluggishness
Clinical narrative: Began to feel uncomfortable evening of vaccine, with soreness in SHINGRIX injection site increasing. By the next morning, felt generally uncomfortable with on-and-off headaches. Large reddish area around SHINGRIX injection site (2-in in diameter). Was able to go to work, but felt sluggish. Felt good in the evening, but potentially developed a fever as I got chills mid-evening. Overnight, had alternating chills and sweats. Slept in late the following day (6/23) and felt much better. Injection site still very red, but no other effects remained. Redness mostly absent this morning (6/25).
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood glucose increased, Dizziness, Palpitations, Tremor
Clinical narrative: THE PT FELT DIZZY & SAID HER HEART WAS RACING THEN SHE STARTED SHAKING.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Arthritis, Bursitis, Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Patient received flu vaccine during flu vaccine clinic in right deltoid on 10/17/2018. The next day the patient reported shoulder soreness to administrating nurse. Administrating nurse advised patient that shoulder soreness after vaccination is common and to use comfort measures, but to follow up with primary care provider if symptoms persisted greater than 72 hours.
Age: 17.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Eye movement disorder, Fall, Loss of consciousness, Tremor
Clinical narrative: Client was seated in chair in clinic room waiting for his siblings to receive their vaccinations.  Approximately five minutes after receiving his shots, client lost consciousness and started to shake rhythmically in his legs while his arms were drawn to his chest with clenched fists. His eyes rolled back and he fell to the side where his mother caught and supported him from falling out of chair. He regained consciousness about a minute later and asked "what happened?  was I dreaming?" Client was moved with two person assist to a cot where he was placed in the supine position with legs elevated.  Vitals were assessed:  BP 120/62, pulse 96 regular, RRR 16. He was able to drink a juice box and was talkative. Monitored him x 10 minutes and he was then transferred to a chair for 5 minutes. Remained stable and talkative. He sat in our waiting room for another 10 minutes with his family before leaving in stable condition.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Pain, Pyrexia
Clinical narrative: Fever, chills, headache, body aches, muscle pain, taking ibuprofen over the counter.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Facial paralysis, Laboratory test
Clinical narrative: Bell's Palsy- right side.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Disorientation, Erythema, Peripheral swelling, Swelling, Swelling face
Clinical narrative: Swelling, face swelling, arm red to elbow along with swelling, disorientation.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Loss of consciousness, Similar reaction on previous exposure to drug, Syncope
Clinical narrative: Patient passed out momentarily while sitting in patient waiting area following vaccine administration: slid out of chair. Father stated that patient had same reaction to HPV vaccine however did not report this on screening checklist or interview. Syncope episode approximately 30 seconds.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Nausea
Clinical narrative: Child was here for his well checkup and was offered the HPV9. I had the patient lay down, administered the HPV, advised to wait 15 minutes. Patient got up and felt nausea and dizzy. Dr. came and checked on him. Was given orange juice. Monitor until better.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site abscess, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Pt developed what appears to be an abscess to the injection site 1 day post injection. Pt states initially the site was approx., 'golf ball sized', swollen, red, hot to touch. It slowly decreased in size over time. Today is approx. olive sized, semi-firm, tender w/white head to center, warm to touch.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth
Clinical narrative: Pt developed what appears to be an abscess to the injection site 1 day post injection. Pt states initially the site was approx., 'golf ball sized', swollen, red, hot to touch. It slowly decreased in size over time. Today is approx. olive sized, semi-firm, tender w/white head to center, warm to touch.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood pressure increased, Influenza like illness, Mobility decreased, Pyrexia
Clinical narrative: The patient called in the day after his vaccine was administered (6/22/18) and reported that he developed a fever of 100F and had a pulse of 120 BPM and also a elevated blood pressure of 160/100 sometime after he received his second dose of SHINGRIX. He also said he had severe flu like symptoms and could not get out of bed. When he called in the following day he did say he was feeling better and that the symptoms did start to subside. We followed up with the patient on Monday (6/25/18) to see how he was feeling and he stated that everything is back to normal and he feels fine he also stated that the symptoms lasted almost exactly 24 hours and he returned to normal feeling.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Blood glucose normal, Headache, Metabolic function test
Clinical narrative: Headache 30 minutes after receiving vaccine, no previous history of migraines, patient admitted to not having eaten prior to coming to his appointment that morning. He was seen in the ED, glucose and CMP was normal, given the timing and association of the headache with new vaccine administration, concern for subarachnoid hemorrhage was low, headache was treated and improved following TYLENOL and food (he was given a turkey sandwich to eat).
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 22-MAY-2018, the patient was vaccinated with an improperly stored dose of 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-009507513-1806USA009041: US-009507513-1806USA009042: US-009507513-1806USA009043: US-009507513-1806USA009044: US-009507513-1806USA009045: US-009507513-1806USA009046: US-009507513-1806USA009047: US-009507513-1806USA009048: 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 24-MAY-2018, the patient was vaccinated with an improperly stored dose of 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-009507513-1806USA009041: 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-009507513-1806USA009051: 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 31-MAY-2018, the patient was vaccinated with an improperly stored dose of 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-009507513-1806USA009041: 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-009507513-1806USA009052: US-009507513-1806USA009053: US-009507513-1806USA009054: US-009507513-1806USA009055: US-009507513-1806USA009056.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 22-OCT-2009, 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 2016, he 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 2014, the patient was inoculated with the ZOSTAVAX vaccine at a hospital 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. On or about 20-DEC-2015, she was treated at a hospital 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.