chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: M
Vaccine: HPV9, MNQ, HPV9, MNQ
Symptoms: Antibody test, Blood glucose, Glycosylated haemoglobin increased, Insulin C-peptide, Type 1 diabetes mellitus
Clinical narrative: Diagnosis of Type 1 Diabetes, onset of symptoms of Type 1 Diabetes began 1 year after vaccination. Diagnosis of Type 1 Diabetes was on 1/20/2015 with a A1C of 12.1, which means I had Type 1 Diabetes undiagnosed for 3 months if not longer.
Age: 77.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: Patient reported with inflammation, redness, and injection site area warm to touch.
Age: 0.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Diet refusal, Fatigue, Gastrointestinal tube insertion, Infantile spitting up, X-ray with contrast upper gastrointestinal tract
Clinical narrative: Within one hour of the HepB vaccine, our daughter was extremely tired, didn't nurse and spit up bright yellow fluid. We went to hospital emergency room the same evening.
Age: 0.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Decreased appetite, Fatigue, Vomiting
Clinical narrative: Within one hour of the HepB vaccine, our daughter was extremely tired, didn't nurse and spit up bright yellow fluid. We went to hospital emergency room the same evening.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Myalgia, Nausea, Peripheral swelling
Clinical narrative: Red, swollen arm, fever, severe headache, nausea, muscle aches for one week.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Red, swollen arm, fever, severe headache, nausea, muscle aches for one week.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Musculoskeletal pain, Pain, Sleep disorder
Clinical narrative: Awoke after turning on left side. Severe shoulder pain along with pain and redness.
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site swelling
Clinical narrative: UPON GIVING INJECTION PATIENT BEGAN TO HAVE IMMEDIATE SWELLING AT INJECTION SITE.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fall, Head injury, Malaise, Neck pain
Clinical narrative: Patient started not feeling well the next day after receiving the vaccine, she got lightheaded and had a fall, hitting her head. Her neck was sore after and she was unsure if this fainting episode was due to the vaccine or not. She followed up with her doctor, who was also unsure if the vaccine would be the cause. He ordered her an X-ray since the neck pain was still lingering.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Injection site swelling, Joint range of motion measurement, Lethargy
Clinical narrative: Severe pain & swelling at site, headache, muscular aching all over body, lethargy.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Severe pain & swelling at site, headache, muscular aching all over body, lethargy.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Erythema
Clinical narrative: From elbow to shoulder became bright red for three days. Had chills for one night.
Age: 91.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Around 3 pm, patient's arm started aching, really red and swollen, painful and also feverish.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Migraine, Nausea, Vomiting
Clinical narrative: Awoke with severe chills even when under covers and electric heated blanket. Eventually subsided with extra heating. About 3 hrs later, awoke with severe headache, which developed into migraine with nausea. Only 16 hrs later could I get out of bed when symptoms subsided. No treatment possible due to vomiting.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Low grade fever, shivering. redness soreness and swelling at the injection site.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Anger, Balance disorder, Disturbance in attention, Dizziness, Electrocardiogram normal
Clinical narrative: I received the vaccine around 10:30am on 12/26/2018. At around 9:00pm on 12/26/2018, my calf muscles in both legs started twitching. Over the course of the next few days, the twitches extended into my thighs in both legs. I felt extremely tired, sleeping 10-12 hours a night and I felt warm.I visited my doctor on 12/31/2018 presenting with high blood pressure and an elevated heart rate. An EKG was performed, which was normal (other than the fast heart rate). The doctor checked for Guillain Baree Syndrom, but did not think I had it. I went home and continued to have muscle twitches in my legs, mostly my calves but also some into my thighs and hamstrings. I felt pins and needles in my feet and some numbness in my lower legs. I saw my doctor again on 1/2/2018. My blood pressure and heart rate had stabilized. However, I was and continue to experience the following symptoms, which I fully believe are from the flu vaccine as these symptoms started the night of the flu vaccine and I have never had them before: --Twitching of muscles in both legs, mostly my calves. The muscle twitches appear somewhat small, yet I have video recordings of them where you can see the muscles twitching in my calves. This happens all day long to varying degrees and is in both legs, mostly the calves but also extending up into my knees and thighs. --Tiredness. I have been sleeping 9-10 hours a night and still need a 1-2 hour nap. I get tired very easily and it is difficult for me to concentrate. --Odd sensations in my legs, mostly my calves, including numbness, cramping, tingling and pain. None are debilitating, yet they are bothersome and noticeable and completely not normal for me. My legs feel weaker, but this is hard to tell. I seem to be able to walk fine. --Sometimes muscles in my shoulders and arms will twitch. --A general feeling of being sick or out of it. --Bouts of dizziness where it is difficult to concentrate or where I am off balance walking (I have not fallen, but the other day I unsteadily walked into someone and then later unsteadily stepped on someone's toes). --Feeling hot when my temperature is normal. --General feelings of panic and anger and fear as I was perfectly healthy right before the flu shot and was told that it was extremely safe. That clearly has not been the case with me and I am extremely upset.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Emotional distress, Fatigue, Fear, Feeling abnormal, Feeling hot
Clinical narrative: I received the vaccine around 10:30am on 12/26/2018. At around 9:00pm on 12/26/2018, my calf muscles in both legs started twitching. Over the course of the next few days, the twitches extended into my thighs in both legs. I felt extremely tired, sleeping 10-12 hours a night and I felt warm.I visited my doctor on 12/31/2018 presenting with high blood pressure and an elevated heart rate. An EKG was performed, which was normal (other than the fast heart rate). The doctor checked for Guillain Baree Syndrom, but did not think I had it. I went home and continued to have muscle twitches in my legs, mostly my calves but also some into my thighs and hamstrings. I felt pins and needles in my feet and some numbness in my lower legs. I saw my doctor again on 1/2/2018. My blood pressure and heart rate had stabilized. However, I was and continue to experience the following symptoms, which I fully believe are from the flu vaccine as these symptoms started the night of the flu vaccine and I have never had them before: --Twitching of muscles in both legs, mostly my calves. The muscle twitches appear somewhat small, yet I have video recordings of them where you can see the muscles twitching in my calves. This happens all day long to varying degrees and is in both legs, mostly the calves but also extending up into my knees and thighs. --Tiredness. I have been sleeping 9-10 hours a night and still need a 1-2 hour nap. I get tired very easily and it is difficult for me to concentrate. --Odd sensations in my legs, mostly my calves, including numbness, cramping, tingling and pain. None are debilitating, yet they are bothersome and noticeable and completely not normal for me. My legs feel weaker, but this is hard to tell. I seem to be able to walk fine. --Sometimes muscles in my shoulders and arms will twitch. --A general feeling of being sick or out of it. --Bouts of dizziness where it is difficult to concentrate or where I am off balance walking (I have not fallen, but the other day I unsteadily walked into someone and then later unsteadily stepped on someone's toes). --Feeling hot when my temperature is normal. --General feelings of panic and anger and fear as I was perfectly healthy right before the flu shot and was told that it was extremely safe. That clearly has not been the case with me and I am extremely upset.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Full blood count normal, Gait disturbance, Heart rate increased, Hypersomnia, Hypertension
Clinical narrative: I received the vaccine around 10:30am on 12/26/2018. At around 9:00pm on 12/26/2018, my calf muscles in both legs started twitching. Over the course of the next few days, the twitches extended into my thighs in both legs. I felt extremely tired, sleeping 10-12 hours a night and I felt warm.I visited my doctor on 12/31/2018 presenting with high blood pressure and an elevated heart rate. An EKG was performed, which was normal (other than the fast heart rate). The doctor checked for Guillain Baree Syndrom, but did not think I had it. I went home and continued to have muscle twitches in my legs, mostly my calves but also some into my thighs and hamstrings. I felt pins and needles in my feet and some numbness in my lower legs. I saw my doctor again on 1/2/2018. My blood pressure and heart rate had stabilized. However, I was and continue to experience the following symptoms, which I fully believe are from the flu vaccine as these symptoms started the night of the flu vaccine and I have never had them before: --Twitching of muscles in both legs, mostly my calves. The muscle twitches appear somewhat small, yet I have video recordings of them where you can see the muscles twitching in my calves. This happens all day long to varying degrees and is in both legs, mostly the calves but also extending up into my knees and thighs. --Tiredness. I have been sleeping 9-10 hours a night and still need a 1-2 hour nap. I get tired very easily and it is difficult for me to concentrate. --Odd sensations in my legs, mostly my calves, including numbness, cramping, tingling and pain. None are debilitating, yet they are bothersome and noticeable and completely not normal for me. My legs feel weaker, but this is hard to tell. I seem to be able to walk fine. --Sometimes muscles in my shoulders and arms will twitch. --A general feeling of being sick or out of it. --Bouts of dizziness where it is difficult to concentrate or where I am off balance walking (I have not fallen, but the other day I unsteadily walked into someone and then later unsteadily stepped on someone's toes). --Feeling hot when my temperature is normal. --General feelings of panic and anger and fear as I was perfectly healthy right before the flu shot and was told that it was extremely safe. That clearly has not been the case with me and I am extremely upset.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Malaise, Metabolic function test normal, Muscle spasms, Muscle twitching
Clinical narrative: I received the vaccine around 10:30am on 12/26/2018. At around 9:00pm on 12/26/2018, my calf muscles in both legs started twitching. Over the course of the next few days, the twitches extended into my thighs in both legs. I felt extremely tired, sleeping 10-12 hours a night and I felt warm.I visited my doctor on 12/31/2018 presenting with high blood pressure and an elevated heart rate. An EKG was performed, which was normal (other than the fast heart rate). The doctor checked for Guillain Baree Syndrom, but did not think I had it. I went home and continued to have muscle twitches in my legs, mostly my calves but also some into my thighs and hamstrings. I felt pins and needles in my feet and some numbness in my lower legs. I saw my doctor again on 1/2/2018. My blood pressure and heart rate had stabilized. However, I was and continue to experience the following symptoms, which I fully believe are from the flu vaccine as these symptoms started the night of the flu vaccine and I have never had them before: --Twitching of muscles in both legs, mostly my calves. The muscle twitches appear somewhat small, yet I have video recordings of them where you can see the muscles twitching in my calves. This happens all day long to varying degrees and is in both legs, mostly the calves but also extending up into my knees and thighs. --Tiredness. I have been sleeping 9-10 hours a night and still need a 1-2 hour nap. I get tired very easily and it is difficult for me to concentrate. --Odd sensations in my legs, mostly my calves, including numbness, cramping, tingling and pain. None are debilitating, yet they are bothersome and noticeable and completely not normal for me. My legs feel weaker, but this is hard to tell. I seem to be able to walk fine. --Sometimes muscles in my shoulders and arms will twitch. --A general feeling of being sick or out of it. --Bouts of dizziness where it is difficult to concentrate or where I am off balance walking (I have not fallen, but the other day I unsteadily walked into someone and then later unsteadily stepped on someone's toes). --Feeling hot when my temperature is normal. --General feelings of panic and anger and fear as I was perfectly healthy right before the flu shot and was told that it was extremely safe. That clearly has not been the case with me and I am extremely upset.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Muscular weakness, Pain in extremity, Panic reaction, Paraesthesia
Clinical narrative: I received the vaccine around 10:30am on 12/26/2018. At around 9:00pm on 12/26/2018, my calf muscles in both legs started twitching. Over the course of the next few days, the twitches extended into my thighs in both legs. I felt extremely tired, sleeping 10-12 hours a night and I felt warm.I visited my doctor on 12/31/2018 presenting with high blood pressure and an elevated heart rate. An EKG was performed, which was normal (other than the fast heart rate). The doctor checked for Guillain Baree Syndrom, but did not think I had it. I went home and continued to have muscle twitches in my legs, mostly my calves but also some into my thighs and hamstrings. I felt pins and needles in my feet and some numbness in my lower legs. I saw my doctor again on 1/2/2018. My blood pressure and heart rate had stabilized. However, I was and continue to experience the following symptoms, which I fully believe are from the flu vaccine as these symptoms started the night of the flu vaccine and I have never had them before: --Twitching of muscles in both legs, mostly my calves. The muscle twitches appear somewhat small, yet I have video recordings of them where you can see the muscles twitching in my calves. This happens all day long to varying degrees and is in both legs, mostly the calves but also extending up into my knees and thighs. --Tiredness. I have been sleeping 9-10 hours a night and still need a 1-2 hour nap. I get tired very easily and it is difficult for me to concentrate. --Odd sensations in my legs, mostly my calves, including numbness, cramping, tingling and pain. None are debilitating, yet they are bothersome and noticeable and completely not normal for me. My legs feel weaker, but this is hard to tell. I seem to be able to walk fine. --Sometimes muscles in my shoulders and arms will twitch. --A general feeling of being sick or out of it. --Bouts of dizziness where it is difficult to concentrate or where I am off balance walking (I have not fallen, but the other day I unsteadily walked into someone and then later unsteadily stepped on someone's toes). --Feeling hot when my temperature is normal. --General feelings of panic and anger and fear as I was perfectly healthy right before the flu shot and was told that it was extremely safe. That clearly has not been the case with me and I am extremely upset.
Age: 70.0
Sex: F
Vaccine: FLUC4
Symptoms: Administration site swelling, Injection site erythema, Injection site warmth
Clinical narrative: Patient report swelling and redness at the administration site. The spot was also warm to the touch. She started experiencing this on 1/5/19. Pharmacist recommended the patient apply a cold compress and taking NSAIDs if tolerable. If it doesn't improve, patient is to follow up with her PCP.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 17-Jul-2018 by Seqirus from VAERS (VAERS ID: 729452), concerns a 56-year-old, adult, female patient. The patient's current condition included diabetes (reported as medical history) (since and unspecified date). On 03-Nov-2017, the patient was administered FLUVIRIN (dose: 0.5 ml [reported as first dose], route of administration: intramuscular, anatomical location: arm, batch number: 170105P and expiry date: not reported). On the same day, after vaccination, the patient's arm became sore. At the time of this report, the patient had not recovered from the event (pain in arm). The reporter assessed the case as non-serious.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Hypoaesthesia, Musculoskeletal pain, Neck pain, Neuropathy peripheral, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pins and needles in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pins and needles, pain in arm and shoulder pain. On an unknown date, the outcome of the pins and needles, pain in arm and shoulder pain were not recovered/not resolved. It was unknown if the reporter considered the pins and needles, pain in arm and shoulder pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. About 5 weeks before the date of reporting the patient received the 2nd dose of SHINGRIX. The patient experienced severe shoulder and arm pain, with pins and needles with no improvement at the time of reporting.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Paraesthesia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pins and needles in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pins and needles, pain in arm and shoulder pain. On an unknown date, the outcome of the pins and needles, pain in arm and shoulder pain were not recovered/not resolved. It was unknown if the reporter considered the pins and needles, pain in arm and shoulder pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. About 5 weeks before the date of reporting the patient received the 2nd dose of SHINGRIX. The patient experienced severe shoulder and arm pain, with pins and needles with no improvement at the time of reporting.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Musculoskeletal pain, Pain in extremity, Paraesthesia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pins and needles in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pins and needles, pain in arm and shoulder pain. On an unknown date, the outcome of the pins and needles, pain in arm and shoulder pain were not recovered/not resolved. It was unknown if the reporter considered the pins and needles, pain in arm and shoulder pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. About 5 weeks before the date of reporting the patient received the 2nd dose of SHINGRIX. The patient experienced severe shoulder and arm pain, with pins and needles with no improvement at the time of reporting.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Received second of 2 required injections of SHINGRIX for shingles. Side effects included soreness, redness and minor swelling at injection site, mild nausea, significant body aches, head ache. Side effects lasted aprox. 36 hours.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Received second of 2 required injections of SHINGRIX for shingles. Side effects included soreness, redness and minor swelling at injection site, mild nausea, significant body aches, head ache. Side effects lasted aprox. 36 hours.
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Nausea, Peripheral coldness
Clinical narrative: If was influenza (quad) shot but not sure which one. Wave of dizziness within a couple minutes of vaccination, followed by a cold sensation in hands, possibly due to a blood pressure change. Sat down and waited in pharmacy for 20 minutes for symptoms to resolve. Did not report reaction to pharmacist. Felt slightly nauseated/light-headed for the next couple hours but not enough to keep from driving/errands. Was previously feeling allergy symptoms that day but no other illness.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Contusion, Scar, Swelling
Clinical narrative: Patient experienced severe swelling and bruising. After a few days said the swelling went down but the bruising was still present. Then after a couples weeks stated that the bruising and swelling was gone but now there was scaring and patient stated it was like it was burned and now scarred. She did not go to ER room or Primary care to get it looked at and treated.
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This spontaneous report was received from the mother of a male patient of unknown age. There were no concurrent conditions, concomitant medications and medical history reported. The patient's mother reported that her son was administered RECOMBIVAX HB outside of the 3 dose schedule for children.  The vaccine was administered on 15-JUN-2012, 09-AUG-2012 and 17-OCT-2012. The last dose was administered at 4 months instead of 6 months. The reporter stated that "the county department of health had informed her that a booster was required, and she needed to reply to the county health department by the beginning of January 2019".
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from an office manager referring to a patient of unknown age and gender. Information on patient's pertinent medical history, drug reactions/allergies and concomitant therapies were not reported. On 12-DEC-2018, the patient was inadvertently vaccinated with an expired dose of VAQTA 25/0.5 (unit unspecified) (lot # N020689 and expiry date: 22-OCT-2018) via intramuscular route for prophylaxis (expired product administered). No adverse effect was reported. There was no product quality complaint (PQC) reported. This is one of the several reports from the same reporter.; Sender's Comments: US-009507513-1901USA001105: US-009507513-1901USA001106: US-009507513-1901USA001107: US-009507513-1901USA001108: US-009507513-1901USA001109: US-009507513-1901USA001110:
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Antibody test negative, Measles antibody negative, Mumps antibody test negative, No adverse event, Rubella antibody negative
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient had no pertinent medical history, concomitant medication and drug reactions/ allergies. On unknown dates, the patient was vaccinated with VARIVAX and M-M-R II (strength, dose, frequency, route, lot # and expiry date were not reported) for prophylaxis. On unknown dates, the patient had low titers for VARIVAX and M-M-R II (antibody test negative). No adverse effects were reported. The patient did not sought medical attention and no treatment was given for the event. The outcome of antibody test negative was reported as not recovered. Causality assessment for antibody test negative was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medication use were not provided. In or around 2017, the patient was inoculated with ZOSTAVAX (dose, route of administration, site of administration and lot # were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (Herpes zoster). Shortly after receiving the ZOSTAVAX vaccine, the patient suffered shingles. As a direct and proximate result of the vaccine, the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of his (Conflicting information, as patient is reported as a female (female name)) condition. As a result of ZOSTAVAX vaccine, the patient sustained severe and permanent personal injuries.  Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the use of the ZOSTAVAX, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of shingles was considered to be not recovered. Causality assessment was related. Shingles was considered to be disabling. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This non-valid spontaneous report as received from a pharmacist refers to an unspecified patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 24-DEC-2018, the patient was vaccinated with expired dose of M-M-R II subcutaneously, lot # M042846, expiry date 21-OCT-2018 (dose was not provided) for prophylaxis. The sterile diluent used to reconstitute the vaccine was stored properly. Vaccine was stored in temperature of 47 to 77 Fahrenheit (also reported as 70 Fahrenheit) during one hour. Digital data logger was not involved. There were no previous excursions reported. No adverse effects were reported. This case is non-valid due to no patient identifiers.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 02-JAN-2019, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 (strength, dose, route of administration were not reported) (lot # R018135 and expiry date: 02-JAN-2019) for prophylaxis (product storage error). The vaccine was stored in between 74 degrees Fahrenheit (F) for 120 hours. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. There was no product quality complaint (PQC) reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a other health care professional (Registered nurse) regarding a patient of unknown age. The patient's relevant medical history, concurrent conditions, concomitant medications and drug/allergies were not reported. On 28-DEC-2018, the patient was vaccinated with improperly stored PROQUAD (strength, frequency and route not reported) lot # R015742 and expiry date: 02-DEC-2019 for prophylaxis. The vaccine PROQUAD was reconstituted with properly stored diluent. No adverse event was reported. Temperature at which vaccine was stored was reported as -14 °C to -10 °C (-12.3 °C) with a time frame of 30 minutes. There was no previous temperature excursion reported. Digital data logger was present.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 02-JAN-2018 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 09-JUN-2009, a healthcare provider at a medical center administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. On or about 10-MAR-2010, the patient was treated by a healthcare provider at a vision clinic for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is not recovered. The causality of the events is related. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 02-JAN-2018 regarding a case in litigation from a lawyer concerning a patient of unknown age and gender. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 15-NOV-2014, a pharmacist at a pharmacy administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. On or about 23-DEC-2016, the patient was treated by a healthcare provider at a physician's office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is not recovered. The causality of the events is related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 02-JAN-2018 regarding a case in litigation from a lawyer concerning a male patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 16-NOV-2015, a pharmacist at a pharmacy administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. On or about 27-MAR-2017, the patient was treated by a healthcare provider at a physician's office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is not recovered. The causality of the events is related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 02-JAN-2018 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2006, a pharmacist at a pharmacy administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. On or about 16-FEB-2015, the patient was treated by a healthcare provider at a physician's office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is not recovered. The causality of the events is related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 02-JAN-2018 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 11-MAY-2016, a physician at a physician's office administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. In December 2016, the patient was treated by a physician at a physician's office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is not recovered. The causality of the events is related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
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. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 13-OCT-2009, a health care provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 2011, the patient was treated by a healthcare provider at a hospital for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of his injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies were not provided. On 02-JAN-2019, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot # N003993, expiration date 20-OCT-2018, strength and route were not provided) for prophylaxis.
Sex: M
Vaccine: VARZOS
Symptoms: Emotional distress, Facial paralysis, Hypoaesthesia oral, Paraesthesia oral, Physical disability
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. In or around 22-APR-2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose the prevention of shingles (herpes zoster). Shortly after receiving the ZOSTAVAX, the patient suffered a sudden left facial droop and was diagnosed with Bell's Palsy. The patient continued to suffer from intermittent numbness and tingling in the left corner of the mouth and suffered from Bell's Palsy a second time. The patient's symptoms have resulted in physical limitations not present prior to using the ZOSTAVAX. The patient has also experienced mental and emotional distress due to resulting physical limitations and the seriousness of his condition. As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered. Upon internal review Bell's Palsy was determined to be medically significant. Bell's Palsy was considered disabling. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Extremely sore arm at injection site for several days, fever of 99.8, fatigue. Also had some dizziness but not certain if caused by vaccine or by sinus problems. Took acetaminophen with some relief, rested. Slight soreness in right arm three days later.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt. mom reported swelling with redness at injection site. She noticed this 2 days after vaccine administered.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, warmth and swelling below the injection site to level of elbow. Since then, erythema, and swelling have increased and now spread beyond level of elbow. Itchy and tender at site and all over body and joint aches.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Pruritus generalised, Tenderness
Clinical narrative: Redness, warmth and swelling below the injection site to level of elbow. Since then, erythema, and swelling have increased and now spread beyond level of elbow. Itchy and tender at site and all over body and joint aches.
Age: 28.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient states when she got home she took off the band-aid and noticed a small red spot that she was not concerned about. Then on 12/26/18 at 7pm she noticed the spot was larger. Patient went to doctor on 12/28/18 in the AM. Patient presented to clinic to find out what vaccine she received in that arm. The site is warm to touch(right arm) has a darker red area that gets lighter as the area spreads creating a bulls eye effect. No visible blisters or rash notes. Patient denies blisters or rash. Patient was given a prescription for triamcinolone cream from the doctor. Patient denies SOB. Patient instructed to be aware of the site and monitor for blisters, if blisters were to occur she would be contagious and need to stay away from anyone immunocompromised, pregnant or anyone who has not had vaccine. Patient states she was only around a 5 month old on day of vaccine.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient. Information about pertinent medical history, concurrent conditions, concomitant medication and drug reactions/allergies was not provided. The pharmacist reported the patient received a dose of VAQTA (strength: 50/1.0 U/ml, dose, frequency, route, lot number and expiration date unspecified) approximately in 2016 (reported as two years ago). The pharmacist reported the patient received a second dose of VAQTA (strength: 50/1.0 U/ml, lot #: R006342, expiration date: 21-APR-2019, dose, frequency, and route were not reported) on 10-DEC-2018 (inappropriate schedule of product administration). No adverse effects reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
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 concurrent conditions, medical history, or concomitant medications. In 2016, a pharmacist at a pharmacy administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot # not provided). In 2017, the patient was treated by a healthcare provider at a primary care office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.