chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Crying, Dysphagia, Feeling cold, Influenza virus test negative, Malaise
Clinical narrative: Patient is a 17 y.o. female who presents to the emergency department with chief complaint of shaking and fever. She reports that she received her HPV and meningococcal vaccination today as well as a TB skin test in preparation for international travel this summer. This evening, she went to a yoga class, and when she arrived home she started to feel unwell. She reports that she began experiencing aching in her arms that was spreading to her whole body. She states that during the event she felt shaky and achy. She started to feel very cold and "shaky." Her mom reports that her lips were even quivering, though she was still alert and able to communicate. She reported that she was crying and stated that she could not swallow while she was crying. During the event, the patient's mother appreciated a subjective fever and states the patient felt very warm. Mom attempted to measure a temperature, but they were unable to find a working thermometer. The patient's mother gave her 2 ADVIL which she was able to swallow without difficulty, then drove her to the ED for evaluation. Patient back to baseline by 2200.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Pain, Pain in extremity, Pyrexia, Skin warm, Tremor
Clinical narrative: Patient is a 17 y.o. female who presents to the emergency department with chief complaint of shaking and fever. She reports that she received her HPV and meningococcal vaccination today as well as a TB skin test in preparation for international travel this summer. This evening, she went to a yoga class, and when she arrived home she started to feel unwell. She reports that she began experiencing aching in her arms that was spreading to her whole body. She states that during the event she felt shaky and achy. She started to feel very cold and "shaky." Her mom reports that her lips were even quivering, though she was still alert and able to communicate. She reported that she was crying and stated that she could not swallow while she was crying. During the event, the patient's mother appreciated a subjective fever and states the patient felt very warm. Mom attempted to measure a temperature, but they were unable to find a working thermometer. The patient's mother gave her 2 ADVIL which she was able to swallow without difficulty, then drove her to the ED for evaluation. Patient back to baseline by 2200.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pyrexia, Skin warm, Urticaria
Clinical narrative: Today 03/25/2019 I got a call that from patient about a reaction to a SHINGRIX vaccine she received in December. A couple of days after receiving SHINGRIX her upper arm become swollen and hot. She reported having a slight fever and hives. She took BENADRYL, TYLENOL, and used a cold compress on her arm. The swelling lasted for about a week, and the hives lasted a couple of weeks.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Pain, Pain in extremity
Clinical narrative: The patient had a swelling at the site of injection that started hours after getting the shot. Patient states it hurt when she tried to use that arm. The swelling and pain subsided the next day without any treatment.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Patient complained of high fever, shivering and muscle pains a day after taking the shot. Patient was advised by the pharmacist to take motrin and call her physician.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: Patient was vaccinated on Friday March 22nd, and broke out in a severe all body rash on Sunday the 24th of March.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: Patient presented to pharmacy 3 days after immunization asking for an evaluation on her arm. Her arm was visibly bruised with a localized erythema around the injection site. She stated that the reaction started the day after receiving the injection. The skin was warm to the touch where red, and painful. She stated the pain had not improved, nor worsened since the onset, and no other symptoms had appeared since the onset of symptoms.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Bone pain, Joint range of motion decreased, Musculoskeletal pain, Nausea, Pain in extremity
Clinical narrative: Approx 8 hours after receiving the vaccine I was awakened in my sleep by EXCRUCIATING pain in my shoulder/upper arm (elbow to shoulder)/ which then radiated into the clavicle area. It felt as though I'd been hit with a baseball bat multiple times. Although my arm appeared normal, it felt broken. I had zero range of motion and my whole arm tingled from shoulder to fingers. I became very nauseous from the pain but did not vomit. It was impossible to find a comfortable position.  This went on for approx 2 hours. I took two 350 mg acetaminophen. It was AWFUL and terrifying.  I'm uncertain I would EVER receive this vaccine again (ie 5 yrs) and will caution all friends/family who are contemplating receiving it.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Paraesthesia
Clinical narrative: Approx 8 hours after receiving the vaccine I was awakened in my sleep by EXCRUCIATING pain in my shoulder/upper arm (elbow to shoulder)/ which then radiated into the clavicle area. It felt as though I'd been hit with a baseball bat multiple times. Although my arm appeared normal, it felt broken. I had zero range of motion and my whole arm tingled from shoulder to fingers. I became very nauseous from the pain but did not vomit. It was impossible to find a comfortable position.  This went on for approx 2 hours. I took two 350 mg acetaminophen. It was AWFUL and terrifying.  I'm uncertain I would EVER receive this vaccine again (ie 5 yrs) and will caution all friends/family who are contemplating receiving it.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: Had pain/weakness in right leg - she's pretty sure it's related to SHINGRIX vaccine.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Chest pain, Paranasal sinus discomfort, Paranasal sinus hypersecretion
Clinical narrative: About 10 minutes passed after the shot was given, patient returned to pharmacy counter in pain, self described as chest pain 6/10 initially then trending to 1-2/10 couple minutes after we sat her down with water given, also self claimed left unilateral pain 9/10 initially intermittently then went down to 0/10 after about 30-40 minutes since symptoms started. Upon observation, she stated that she started having sinus drainage and pressure after 30 minutes post shot. We have provided hydration and anti-histamine per guidelines to alleviate her symptoms. We have reached to her primary care provider for an appointment to check up and as of 12:35pm@3/25/19 we have yet to be able to set up an apt but will cont. to try.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Injection site pain, Pain, Pruritus
Clinical narrative: Patient stated pain at injection site and pain traveled down to the elbow for the next 3 days. It hurt to touch plus started to itch by the elbow around the 3rd day. Took TYLENOL on the 2nd and 3rd day. Still achy on the fourth but not enough to take anymore TYLENOL.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain
Clinical narrative: Shoulder pain for over 48 hours. Pain relievers; heat; ice.
Age: 13.0
Sex: F
Vaccine: FLU4, HEPA, HPV4
Symptoms: Rash
Clinical narrative: Mother states that patient woke up overnight with a rash on her entire face. At the moment the mother gave the patient a dose of liquid BENADRYL and splatter the water on the face. Since she was not improving she took patient to the ER and she was given medicine. She was in observation and was discharged. She had rash for 4 days.
Age: 0.42
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Cold sweat, Dyspnoea, Immediate post-injection reaction, Irritability
Clinical narrative: Had PENTACEL and PREVNAR on 3/22/19. Extreme fussiness immediately after receiving vaccines which lasted off on for the next 2 days. Slight increase in work of breathing and clammy to touch per mother.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Skin lesion
Clinical narrative: Patient developed localized and soreness and swelling within minutes after receiving flu/and HPV9 vaccines on his LU arm no wheezing/chest tightness no generalized rash. On exam (L) upper arm with a 3 cm diameter raised, non erythema circular lesion on vaccine site. No facial/mouth/lip swelling.
Age: 1.25
Sex: M
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Electroencephalogram normal, Febrile convulsion
Clinical narrative: Patient had febrile seizure a little more than 24 hours after the vaccines were given. Generalized tonic-clonic seizure which lasted for about 45 secs-1 minute. He was seen at Emergency Dept at 7:16PM on 2/9/18 and was diagnosed with Febrile Seizure, Influenza A, and Pneumonia, RLL. He was started on Amoxicillin, and Oseltamivir. On 3/4/18, about 7:30 pm, patient had another seizure lasting about 1 min with 15 seconds of apnea. He brought to ED and had 3 episodes of staring episodes lasting 5-20 secs each. He was diagnosed with Complex Febrile Seizure and was admitted for observation (3/4/18-3/5/18). Another Seizure 8/5/18, lasting approximately 2min.
Age: 1.25
Sex: M
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Apnoea, Electroencephalogram normal, Febrile convulsion, Generalised tonic-clonic seizure, Influenza
Clinical narrative: Patient had febrile seizure a little more than 24 hours after the vaccines were given. Generalized tonic-clonic seizure which lasted for about 45 secs-1 minute. He was seen at Emergency Dept at 7:16PM on 2/9/18 and was diagnosed with Febrile Seizure, Influenza A, and Pneumonia, RLL. He was started on Amoxicillin, and Oseltamivir. On 3/4/18, about 7:30 pm, patient had another seizure lasting about 1 min with 15 seconds of apnea. He brought to ED and had 3 episodes of staring episodes lasting 5-20 secs each. He was diagnosed with Complex Febrile Seizure and was admitted for observation (3/4/18-3/5/18). Another Seizure 8/5/18, lasting approximately 2min.
Age: 1.25
Sex: M
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Nuclear magnetic resonance imaging normal, Pneumonia, Seizure, Staring
Clinical narrative: Patient had febrile seizure a little more than 24 hours after the vaccines were given. Generalized tonic-clonic seizure which lasted for about 45 secs-1 minute. He was seen at Emergency Dept at 7:16PM on 2/9/18 and was diagnosed with Febrile Seizure, Influenza A, and Pneumonia, RLL. He was started on Amoxicillin, and Oseltamivir. On 3/4/18, about 7:30 pm, patient had another seizure lasting about 1 min with 15 seconds of apnea. He brought to ED and had 3 episodes of staring episodes lasting 5-20 secs each. He was diagnosed with Complex Febrile Seizure and was admitted for observation (3/4/18-3/5/18). Another Seizure 8/5/18, lasting approximately 2min.
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Localised infection, Pain in extremity, Peripheral swelling
Clinical narrative: Arm cramping, hand contracted and unable to use, numbness on the left side, redness and swelling at the site. Is now receiving hand therapy at Rehab to regain strength and function of hand and arm affected. Also given a course of antibiotics.
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hypoaesthesia, Injection site erythema, Injection site swelling, Joint contracture, Muscle spasms
Clinical narrative: Arm cramping, hand contracted and unable to use, numbness on the left side, redness and swelling at the site. Is now receiving hand therapy at Rehab to regain strength and function of hand and arm affected. Also given a course of antibiotics.
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Musculoskeletal disorder
Clinical narrative: Arm cramping, hand contracted and unable to use, numbness on the left side, redness and swelling at the site. Is now receiving hand therapy at Rehab to regain strength and function of hand and arm affected. Also given a course of antibiotics.
Age: 24.0
Sex: M
Vaccine: ANTH, ANTH, ANTH
Symptoms: Asthenia, Balance disorder, CSF protein increased, Gait disturbance, Grip strength decreased
Clinical narrative: Patient developed Guillain-Barre syndrome with ascending numbness and weakness which progressed over a two week period before patient received IVIg treatment and symptoms subsequently plateaued and slowly improved over the next several weeks.
Age: 24.0
Sex: M
Vaccine: ANTH, ANTH, ANTH
Symptoms: Muscle spasms, Muscular weakness, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal normal, Paraesthesia
Clinical narrative: Patient developed Guillain-Barre syndrome with ascending numbness and weakness which progressed over a two week period before patient received IVIg treatment and symptoms subsequently plateaued and slowly improved over the next several weeks.
Age: 24.0
Sex: M
Vaccine: ANTH, ANTH, ANTH
Symptoms: Walking aid user, Weight decreased
Clinical narrative: Patient developed Guillain-Barre syndrome with ascending numbness and weakness which progressed over a two week period before patient received IVIg treatment and symptoms subsequently plateaued and slowly improved over the next several weeks.
Age: 24.0
Sex: M
Vaccine: ANTH, ANTH, ANTH
Symptoms: Asthenia, CSF protein increased, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy
Clinical narrative: Patient developed Guillain-Barre syndrome with ascending numbness and weakness which progressed over a two week period before patient received IVIg treatment and symptoms subsequently plateaued and slowly improved over the next several weeks.
Age: 24.0
Sex: M
Vaccine: ANTH, ANTH, ANTH
Symptoms: Lumbar puncture abnormal, Paraesthesia
Clinical narrative: Patient developed Guillain-Barre syndrome with ascending numbness and weakness which progressed over a two week period before patient received IVIg treatment and symptoms subsequently plateaued and slowly improved over the next several weeks.
Age: 24.0
Sex: M
Vaccine: ANTH, ANTH, ANTH
Symptoms: Loss of personal independence in daily activities, Muscle spasms, Muscular weakness, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal normal
Clinical narrative: Patient developed Guillain-Barre syndrome with ascending numbness and weakness which progressed over a two week period before patient received IVIg treatment and symptoms subsequently plateaued and slowly improved over the next several weeks.
Age: 24.0
Sex: M
Vaccine: ANTH, ANTH, ANTH
Symptoms: Paraesthesia, Walking aid user, Weight decreased
Clinical narrative: Patient developed Guillain-Barre syndrome with ascending numbness and weakness which progressed over a two week period before patient received IVIg treatment and symptoms subsequently plateaued and slowly improved over the next several weeks.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Nausea, Pain in extremity, Tremor
Clinical narrative: By evening, body started shaking/shivering violently like nothing before, had slight headache, and aching entire body. Next morning was incredibly dehydrated, felt nauseous, dry heaves, slight headache an no appetite. Patient stayed in bed, drank water, and just lethargic and weak--no shaking. Friday, woke up and there was no trace of anything; felt completely normal and went to work out as usual. Patient did not contact doctor at any time and called pharmacy on Friday. After first dose of SHINGRIX only experienced a sore arm.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Chills, Decreased appetite, Dehydration, Headache
Clinical narrative: By evening, body started shaking/shivering violently like nothing before, had slight headache, and aching entire body. Next morning was incredibly dehydrated, felt nauseous, dry heaves, slight headache an no appetite. Patient stayed in bed, drank water, and just lethargic and weak--no shaking. Friday, woke up and there was no trace of anything; felt completely normal and went to work out as usual. Patient did not contact doctor at any time and called pharmacy on Friday. After first dose of SHINGRIX only experienced a sore arm.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Lethargy, Nausea, Pain, Retching, Tremor
Clinical narrative: By evening, body started shaking/shivering violently like nothing before, had slight headache, and aching entire body. Next morning was incredibly dehydrated, felt nauseous, dry heaves, slight headache an no appetite. Patient stayed in bed, drank water, and just lethargic and weak--no shaking. Friday, woke up and there was no trace of anything; felt completely normal and went to work out as usual. Patient did not contact doctor at any time and called pharmacy on Friday. After first dose of SHINGRIX only experienced a sore arm.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Feeling cold, Headache, Pruritus, Pyrexia
Clinical narrative: In the early morning hours 3/23, I woke up because I was cold. Getting out of bed, I realized all of my muscles were quite sore. When I went to the kitchen to get some Aleve for headache and pain, I was so cold I was shaking but my face was very hot. Unable to sleep the rest of the night.  When I got up Saturday morning around 6:00 am, I saw three places that had little watery blisters, like chicken pox.  All three areas where there was some sort of compromise to the skin...red spot on my neck that appeared Monday of that week, blisters around a scar from yard work, and the worst were blisters in the area of my right wrist where I had a cortizone injection July 2018 for Dequavarian Tendonitis.  All blistered areas were very itchy and uncomfortable.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: In the early morning hours 3/23, I woke up because I was cold. Getting out of bed, I realized all of my muscles were quite sore. When I went to the kitchen to get some Aleve for headache and pain, I was so cold I was shaking but my face was very hot. Unable to sleep the rest of the night.  When I got up Saturday morning around 6:00 am, I saw three places that had little watery blisters, like chicken pox.  All three areas where there was some sort of compromise to the skin...red spot on my neck that appeared Monday of that week, blisters around a scar from yard work, and the worst were blisters in the area of my right wrist where I had a cortizone injection July 2018 for Dequavarian Tendonitis.  All blistered areas were very itchy and uncomfortable.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Discomfort, Erythema, Feeling cold, Feeling hot
Clinical narrative: In the early morning hours 3/23, I woke up because I was cold. Getting out of bed, I realized all of my muscles were quite sore. When I went to the kitchen to get some Aleve for headache and pain, I was so cold I was shaking but my face was very hot. Unable to sleep the rest of the night.  When I got up Saturday morning around 6:00 am, I saw three places that had little watery blisters, like chicken pox.  All three areas where there was some sort of compromise to the skin...red spot on my neck that appeared Monday of that week, blisters around a scar from yard work, and the worst were blisters in the area of my right wrist where I had a cortizone injection July 2018 for Dequavarian Tendonitis.  All blistered areas were very itchy and uncomfortable.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Insomnia, Myalgia, Pain, Pruritus
Clinical narrative: In the early morning hours 3/23, I woke up because I was cold. Getting out of bed, I realized all of my muscles were quite sore. When I went to the kitchen to get some Aleve for headache and pain, I was so cold I was shaking but my face was very hot. Unable to sleep the rest of the night.  When I got up Saturday morning around 6:00 am, I saw three places that had little watery blisters, like chicken pox.  All three areas where there was some sort of compromise to the skin...red spot on my neck that appeared Monday of that week, blisters around a scar from yard work, and the worst were blisters in the area of my right wrist where I had a cortizone injection July 2018 for Dequavarian Tendonitis.  All blistered areas were very itchy and uncomfortable.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash vesicular, Scar, Secretion discharge, Tenosynovitis stenosans, Tremor
Clinical narrative: In the early morning hours 3/23, I woke up because I was cold. Getting out of bed, I realized all of my muscles were quite sore. When I went to the kitchen to get some Aleve for headache and pain, I was so cold I was shaking but my face was very hot. Unable to sleep the rest of the night.  When I got up Saturday morning around 6:00 am, I saw three places that had little watery blisters, like chicken pox.  All three areas where there was some sort of compromise to the skin...red spot on my neck that appeared Monday of that week, blisters around a scar from yard work, and the worst were blisters in the area of my right wrist where I had a cortizone injection July 2018 for Dequavarian Tendonitis.  All blistered areas were very itchy and uncomfortable.
Sex: U
Vaccine: HPV9, HPV9, HPV9, HPV9, HPV9, HPV9, HPV9, HPV9, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 07-MAR-2019, the patient was vaccinated with improperly stored GARDASIL 9 (via intramuscular, lot #: R020948, expiration date: 04-MAY-2021; strength and anatomical location were not reported) for prophylaxis. No adverse effect was reported. The GARDASIL 9 was exposed to 31.6 degree Fahrenheit for 40 minutes and 47.8 degree Fahrenheit for 20 minutes. There was no previous temperature excursion. The data logger was involved. This is one of several reports received form the same reporter. Sender's Comments: US-009507513-1903USA006951: US-009507513-1903USA006952: US-009507513-1903USA006953: US-009507513-1903USA006954: US-009507513-1903USA006955: US-009507513-1903USA006956: US-009507513-1903USA006957: US-009507513-1903USA006958: US-009507513-1903USA006959: US-009507513-1903USA006960: US-009507513-1903USA006285.
Sex: U
Vaccine: HPV9, HPV9, HPV9, HPV9, HPV9, HPV9, HPV9, HPV9, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided.  On 07-MAR-2019, the patient was vaccinated with improperly stored GARDASIL 9 (via intramuscular, lot #: R020948, expiration date: 04-MAY-2021; strength and anatomical location were not reported) for prophylaxis. No adverse effect was reported. The GARDASIL 9 was exposed to 31.6 degree Fahrenheit for 40 minutes and 47.8 degree Fahrenheit for 20 minutes. There was no previous temperature excursion. The data logger was involved. This is one of several reports received form the same reporter.; Sender's Comments: US-009507513-1903USA006951: US-009507513-1903USA006952: US-009507513-1903USA006953: US-009507513-1903USA006954: US-009507513-1903USA006955: US-009507513-1903USA006956: US-009507513-1903USA006957: US-009507513-1903USA006958: US-009507513-1903USA006959: US-009507513-1903USA006960: US-009507513-1903USA006285.
Sex: U
Vaccine: HPV9, HPV9, HPV9, HPV9, HPV9, HPV9, HPV9, HPV9, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided.  On 07-MAR-2019, the patient was vaccinated with improperly stored GARDASIL 9 (via intramuscular, lot #: R020948, expiration date: 04-MAY-2021; strength and anatomical location were not reported)for prophylaxis. No adverse effect was reported. The GARDASIL 9 was exposed to 31.6 degree Fahrenheit for 40 minutes and 47.8 degree Fahrenheit for 20 minutes. There was no previous temperature excursion. The data logger was involved. This is one of several reports received form the same reporter.; Sender's Comments: US-009507513-1903USA006951: US-009507513-1903USA006952: US-009507513-1903USA006953: US-009507513-1903USA006954: US-009507513-1903USA006955: US-009507513-1903USA006956: US-009507513-1903USA006957: US-009507513-1903USA006958: US-009507513-1903USA006959: US-009507513-1903USA006960: US-009507513-1903USA006285.
Sex: U
Vaccine: HPV9, HPV9, HPV9, HPV9, HPV9, HPV9, HPV9, HPV9, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 07-MAR-2019, the patient was vaccinated with improperly stored GARDASIL 9 (via intramuscular, lot #: R020948, expiration date: 04-MAY-2021; strength and anatomical location were not reported)for prophylaxis. No adverse effect was reported. The GARDASIL 9 was exposed to 31.6 degree Fahrenheit for 40 minutes and 47.8 degree Fahrenheit for 20 minutes. There was no previous temperature excursion. The data logger was involved. This is one of several reports received form the same reporter.; Sender's Comments: US-009507513-1903USA006951: US-009507513-1903USA006952: US-009507513-1903USA006953: US-009507513-1903USA006954: US-009507513-1903USA006955: US-009507513-1903USA006956: US-009507513-1903USA006957: US-009507513-1903USA006958: US-009507513-1903USA006959: US-009507513-1903USA006960: US-009507513-1903USA006285.
Sex: U
Vaccine: HPV9, HPV9, HPV9, HPV9, HPV9, HPV9, HPV9, HPV9, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 07-MAR-2019, the patient was vaccinated with improperly stored GARDASIL 9 (via intramuscular, lot #: R020948, expiration date: 04-MAY-2021; strength and anatomical location were not reported)for prophylaxis. No adverse effect was reported. The GARDASIL 9 was exposed to 31.6 degree Fahrenheit for 40 minutes and 47.8 degree Fahrenheit for 20 minutes. There was no previous temperature excursion. The data logger was involved. This is one of several reports received form the same reporter.; Sender's Comments: US-009507513-1903USA006951: US-009507513-1903USA006952: US-009507513-1903USA006953: US-009507513-1903USA006954: US-009507513-1903USA006955: US-009507513-1903USA006956: US-009507513-1903USA006957: US-009507513-1903USA006958: US-009507513-1903USA006959: US-009507513-1903USA006960: US-009507513-1903USA006285:
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthropathy, Blindness, Blood thyroid stimulating hormone decreased, Blood thyroid stimulating hormone increased, Computerised tomogram thorax normal
Clinical narrative: My initial concern is whether the shingles vaccine could have affected my existing HYPOthyroidism and cause the following reactions: limp joints (neck, wrist, ankle), head pressure, double vision, loss of vision. In the 10 years of my HYPOthyroidism, my TSH levels never fluctuated in the direction of HYPERthyroidism. Emergency Room Physician, PCP & Optimologist all thought I was about to stroke or possibly had MS. 2018 was quite the roller coaster ride. I didn't connect the dots until I read the severe side effects  of the shingles vaccine; Shingles (herpes zoster), Death, Autoimmune disorders, Vision problems, Hearing loss, Stroke, Pneumonia, Serious complications. (between 12/1/2017-1/26/2018) I began noticing my left ankle and left wrist randomly went limp. Then my neck began going limp. During this time my thyroid plummeted to HYPERthyroid of .03.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Diplopia, Discomfort, Dyspnoea, Fatigue, Feeling abnormal
Clinical narrative: My initial concern is whether the shingles vaccine could have affected my existing HYPOthyroidism and cause the following reactions: limp joints (neck, wrist, ankle), head pressure, double vision, loss of vision. In the 10 years of my HYPOthyroidism, my TSH levels never fluctuated in the direction of HYPERthyroidism. Emergency Room Physician, PCP & Optimologist all thought I was about to stroke or possibly had MS. 2018 was quite the roller coaster ride. I didn't connect the dots until I read the severe side effects  of the shingles vaccine; Shingles (herpes zoster), Death, Autoimmune disorders, Vision problems, Hearing loss, Stroke, Pneumonia, Serious complications. (between 12/1/2017-1/26/2018) I began noticing my left ankle and left wrist randomly went limp. Then my neck began going limp. During this time my thyroid plummeted to HYPERthyroid of .03.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Head discomfort, Headache, Hyperthyroidism, Hypoaesthesia oral, Mental impairment
Clinical narrative: My initial concern is whether the shingles vaccine could have affected my existing HYPOthyroidism and cause the following reactions: limp joints (neck, wrist, ankle), head pressure, double vision, loss of vision. In the 10 years of my HYPOthyroidism, my TSH levels never fluctuated in the direction of HYPERthyroidism. Emergency Room Physician, PCP & Optimologist all thought I was about to stroke or possibly had MS. 2018 was quite the roller coaster ride. I didn't connect the dots until I read the severe side effects  of the shingles vaccine; Shingles (herpes zoster), Death, Autoimmune disorders, Vision problems, Hearing loss, Stroke, Pneumonia, Serious complications. (between 12/1/2017-1/26/2018) I began noticing my left ankle and left wrist randomly went limp. Then my neck began going limp. During this time my thyroid plummeted to HYPERthyroid of .03.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Migraine with aura, Muscular weakness, Neck pain, Nuclear magnetic resonance imaging brain normal, Pain in extremity
Clinical narrative: My initial concern is whether the shingles vaccine could have affected my existing HYPOthyroidism and cause the following reactions: limp joints (neck, wrist, ankle), head pressure, double vision, loss of vision. In the 10 years of my HYPOthyroidism, my TSH levels never fluctuated in the direction of HYPERthyroidism. Emergency Room Physician, PCP & Optimologist all thought I was about to stroke or possibly had MS. 2018 was quite the roller coaster ride. I didn't connect the dots until I read the severe side effects  of the shingles vaccine; Shingles (herpes zoster), Death, Autoimmune disorders, Vision problems, Hearing loss, Stroke, Pneumonia, Serious complications. (between 12/1/2017-1/26/2018) I began noticing my left ankle and left wrist randomly went limp. Then my neck began going limp. During this time my thyroid plummeted to HYPERthyroid of .03.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Scan with contrast normal, Syncope
Clinical narrative: My initial concern is whether the shingles vaccine could have affected my existing HYPOthyroidism and cause the following reactions: limp joints (neck, wrist, ankle), head pressure, double vision, loss of vision. In the 10 years of my HYPOthyroidism, my TSH levels never fluctuated in the direction of HYPERthyroidism. Emergency Room Physician, PCP & Optimologist all thought I was about to stroke or possibly had MS. 2018 was quite the roller coaster ride. I didn't connect the dots until I read the severe side effects  of the shingles vaccine; Shingles (herpes zoster), Death, Autoimmune disorders, Vision problems, Hearing loss, Stroke, Pneumonia, Serious complications. (between 12/1/2017-1/26/2018) I began noticing my left ankle and left wrist randomly went limp. Then my neck began going limp. During this time my thyroid plummeted to HYPERthyroid of .03.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Nausea
Clinical narrative: I woke up at 4 AM the morning after the shot with uncontrollable shivering. When I woke again at 6 AM, the shivering started again, along with general weakness and nausea.
Age: 11.0
Sex: M
Vaccine: HPV9, MENB, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse reaction; patient was given Men B instead of MENVEO.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 4 months female patient. The patient's medical history and concurrent condition were not provided. Concomitant therapies included a dose of PEDVAXHIB, PEDIARIX and PREVNAR 13. On 04-MAR-2019 the patient was vaccinated with the second dose of ROTATEQ batch/lot # N022001, expiration date 03-FEB-2019 (strength, frequency were not reported), orally for prophylaxis. The dose was expired (expired product administered). No adverse effects reported.
Sex: U
Vaccine: MMR, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant refers multiple unspecified patients of unknown age. There was no information about the patients' concurrent conditions, medical history or concomitant medication. On an unknown date, the patients were vaccinated with an improperly stored vaccine (product storage error), which was either ROTATEQ (lot number R013288 and expiration date 01-DEC-2019) (lot number N030175 and expiration date 16-JUN-2019) (lot number R012954 and expiration date 04-DEC-2019), oral for prophylaxis (strength and dosage schedule were not reported) or with M-M-R II (lot number R002510 and expiration date 25-JAN-2020) ) (lot number R000557 and expiration date 08-JAN-2020) for prophylaxis (strength, dosage schedule and route of administration were not reported). No adverse effects were reported in any of the patients. The temperature excursion was 50 F for 1 hour and 37 minutes, however, the vaccines did not have a previous temperature excursion and the call was done due to a data logger.
Age: 0.75
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Information has been received from a nurse referring to a 9 months old male patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 08-MAR-2019 the patient was vaccinated with one dose of GARDASIL 9 (lot# R017251, expiration date: 04-MAY-2021, frequency unknown) intramuscularly for prophylaxis (Inappropriate age at vaccine administration). No adverse events reported.
Age: 16.0
Sex: F
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 16 year old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On an unknown date, the patient was vaccinated with 1 mL adult dose of VAQTA for prophylaxis (strength, route, lot # and expiration date were not reported). The patient reported no issues and was in a healthy weight and everything.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding to a patient of unknown demographics. The patients medical history, drug reactions/allergies and concomitant medications were not reported. On 18-MAR-2019, the patient was inadvertently vaccinated with expired dose of ROTATEQ (lot # N021308/expiration date: 05-MAR-2019) for prophylaxis (expired product administered). No adverse events were reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications or drug reactions/allergies. On an unknown date, the patient was vaccinated with an improperly stored vaccine of GARDASIL 9, via intramuscular, lot # R016127, expiration date 22-MAR-2020 for prophylaxis (dose was not reported). The administered dose of the vaccine experienced a temperature excursion of 56.3 degrees Fahrenheit (°F) for 3 hours and 20 minutes, as recorded by a data logger. The administered dose of the vaccine experienced a previous temperature excursion of 35.6 degrees Fahrenheit (°F) for 12 minutes. There was no adverse effect reported. The outcome of the event product storage error was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse event in a 70-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was recovered/resolved. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had bad reaction lasted for days after 1st vaccination of SHINGRIX. The patient asked, should she expect the same for the 2nd vaccination.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of muscle soreness in a 77-year-old male patient who received SHINGRIX (batch number CH2X7, expiry date 25th April 2020) and (batch number 27K24, expiry date 2nd February 2021) for prophylaxis. On 9th April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the dose was an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced muscle soreness. On an unknown date, the outcome of the muscle soreness was not recovered/not resolved. It was unknown if the reporter considered the muscle soreness to be related to SHINGRIX. Additional details were provided as follows: The event muscle soreness had been ongoing since receiving the 1st dose. On 25th June 2018, the patient received 2nd dose of SHINGRIX.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of burning sensation in a 63-year-old female patient who received SHINGRIX (batch number 455KD, expiry date 4th May 2021) for prophylaxis. On 14th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In March 2019, 2 days after receiving SHINGRIX, the patient experienced burning sensation. On an unknown date, the outcome of the burning sensation was not recovered/not resolved. It was unknown if the reporter considered the burning sensation to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. The patient was having a burning sensation in both her left and right elbows. The reporter was unable to provide additional information. The reporter did not consent to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of suspected vaccination failure in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On 19th March 2019, 28 days after receiving SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX. Additional details were provided as follows: The age group was not reported but was selected as adult as per vaccine indication. The reporter reported that, the patient had shingles infection 4 weeks post SHINGRIX vaccine. This case was considered as suspected vaccination failure as time to onset for the event, details regarding vaccination schedule was unknown. No additional information was provided.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received SHINGRIX for prophylaxis. On 11th March 2019, the patient received SHINGRIX. In March 2019, less than a month after receiving SHINGRIX, the patient experienced pain in arm and pruritus. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the pruritus was unknown. It was unknown if the reporter considered the pain in arm and pruritus to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On 21st March 2019, the patient would consult with her physician. Her arm was still sore. The patient did not want any follow-up and did not provide her contact information.
Sex: M
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer (parent). A 19-year old male patient received two doses of TRUMENBA on an unspecified date, at single dose, for immunization. Relevant medical history and concomitant medications were unknown. The patient experienced a "slight reaction, arm hurt for an hour after the second dose". Clinical outcome of the event was unknown at time of this report. The information on the lot number has been requested.
Sex: U
Vaccine: MNQ
Symptoms: Maternal exposure during breast feeding
Clinical narrative: Initial information received on 18-Mar-2019 regarding an unsolicited valid non-serious case received from a non healthcare professional by phone. This case involves adult patient of unknown demographics who was vaccinated with a dose of MENACTRA (Batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided. It was a case of exposure during breast feeding. No Lab data was reported. It was not reported if the patient received a corrective treatment. Documents held by the sender: none.
Sex: F
Vaccine: FLUX
Symptoms: Injection site swelling
Clinical narrative: Initial information received on 19-Mar-2019 regarding an unsolicited valid non-serious case received from a consumer. This case involves a female patient (age unknown) who experienced huge bump at the injection site, while she received vaccine INFLUENZA VACCINE (QUADRIVALENT). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (QUADRIVALENT) produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, the patient experienced a non-serious huge bump at the injection site (vaccination site induration) (Unknown latency) following the administration of INFLUENZA VACCINE (QUADRIVALENT). It happened two years in a row. (Other relevant tests included no lab data.) Final diagnosis was huge bump at the injection site. It was not reported if the patient received a corrective treatment. The patient outcome was not reported for huge bump at the injection site. List of documents held by sender: none.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling cold, Pain
Clinical narrative: Dull aches which became worse from head to toe beginning about 7:00 PM; aches continued and worsened along with chills; went to bed at 11:00 PM; had to use 2 additional blankets, couldn't get warm for a few hours, finally fell asleep; awoke at 3:30 AM warm, had to throw off covers; went back to sleep, got up at 7:30 AM, very tired, aches had subsided but still sore; slept soundly for 2 hours on Sat afternoon; felt much better on Sunday. No other symptoms except for body aches/chills/exhaustion.
Age: 16.0
Sex: F
Vaccine: FLU4, HEPA, MENB, MNQ
Symptoms: Exposure during pregnancy
Clinical narrative: Patient reported in March 2019 that she was unknowingly 10-12 weeks pregnant at the time of vaccination.
Age: 1.08
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 13 months old patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 19-FEB-2019, PROQUAD 1 dosage form, lot# R017626, expiration date 18-DEC-2019 (dose number, exact dose and route of administration were not provided), reconstituted with MERCK STERILE DILUENT, were inadvertently administered with VARIVAX, 1 dosage form, lot# R018933, expiration date 02-JUL-2020 (dose number, exact dose and route of administration were not provided) for prophylaxis. No adverse effect was reported.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial paralysis, Immediate post-injection reaction, Injection site rash, Neurological symptom
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of neurological symptom in a 51-year-old female patient who received SHINGRIX (batch number 539A2, expiry date unknown) for prophylaxis. On 11th March 2018, the patient received the 1st dose of SHINGRIX. On 11th March 2018, immediately after receiving SHINGRIX, the patient experienced injection site rash. On an unknown date, the patient experienced neurological symptom (serious criteria hospitalization) and facial droop (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the neurological symptom and facial droop were recovering/resolving and the outcome of the injection site rash was unknown. It was unknown if the reporter considered the neurological symptom, facial droop and injection site rash to be related to SHINGRIX. Additional details were provided as follows: The patient experienced rash at injection site the size of a softball right after receiving SHINGRIX. The patient was taken to emergency room within one month after receiving SHINGRIX with neurological symptoms, face drooping on one side which resulted in hospitalization for work up. The patient had been gradually improving. They did rule out stroke. The reporter agreed to be followed up.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Erythema, Fatigue, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema in a 82-year-old female patient who received SHINGRIX for prophylaxis. On 12th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 13th March 2019, 1 days after receiving SHINGRIX, the patient experienced erythema, rash, pruritus, injection site warmth, upset stomach, tiredness, shivering and fever. On an unknown date, the outcome of the erythema, rash, upset stomach, shivering and fever were recovered/resolved and the outcome of the pruritus, injection site warmth and tiredness were not recovered/not resolved. It was unknown if the reporter considered the erythema, rash, pruritus, injection site warmth, upset stomach, tiredness, shivering and fever to be related to SHINGRIX. Additional details were provided as follows: The next day post vaccination, the patient had redness, rash, itching and heat at the injection site. She also had fever, upset stomach, tiredness and shivering. The patient was mostly feeling better at the time of reporting, but she was still a tired and has some itching and warmth at the injection site. The reporter did not consent to follow-up.