chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Blood test abnormal, Computerised tomogram, Dizziness, Gait disturbance, Headache
Clinical narrative: 2009 til present day, I began feeling dizzy, and noticed a slight imbalance in my gait. I started to get headaches, and my wife told me that I would stop breathing for a few seconds at night then I started to get sinus infections once every 6 months. 2012- yearly failed my first physical fitness exam for the run part. I took the exam again and passed it within a 6 month training time. 2013. I failed the fitness exam again. This time seeking medical assistance from my family doctor. Whom referred me to a Neurologist. 2014 - Diagnosed with Spinocerebellar Ataxia. Causing me to medically separate from the military. Early retirement.
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Impaired work ability, Nuclear magnetic resonance imaging abnormal, Sinusitis, Sleep apnoea syndrome, Spinocerebellar ataxia
Clinical narrative: 2009 til present day, I began feeling dizzy, and noticed a slight imbalance in my gait. I started to get headaches, and my wife told me that I would stop breathing for a few seconds at night then I started to get sinus infections once every 6 months. 2012- yearly failed my first physical fitness exam for the run part. I took the exam again and passed it within a 6 month training time. 2013. I failed the fitness exam again. This time seeking medical assistance from my family doctor. Whom referred me to a Neurologist. 2014 - Diagnosed with Spinocerebellar Ataxia. Causing me to medically separate from the military. Early retirement.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Abdominal pain upper, Aggression, Defiant behaviour, Dysarthria, Injection site erythema
Clinical narrative: It started the morning after his shots on his left thigh with a 4-5 inch red, itchy circumference that had a fever of 104. The infection site was very large and extremely hard. His body temp. reached 101. By that evening his entire leg was swollen and red. Still with a fever of 104. He became very lethargic, slurring his words, and had a really hard time keeping his eyes open. He complained of pain all over his body and terrible stomach pains. He has been very aggressive and defiant since. He is acting like a completely different child. He has been violent and having temper tantrums, which is not him at all.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site induration, Injection site infection, Injection site pruritus, Injection site swelling, Lethargy
Clinical narrative: It started the morning after his shots on his left thigh with a 4-5 inch red, itchy circumference that had a fever of 104. The infection site was very large and extremely hard. His body temp. reached 101. By that evening his entire leg was swollen and red. Still with a fever of 104. He became very lethargic, slurring his words, and had a really hard time keeping his eyes open. He complained of pain all over his body and terrible stomach pains. He has been very aggressive and defiant since. He is acting like a completely different child. He has been violent and having temper tantrums, which is not him at all.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Pain, Pyrexia, Somnolence
Clinical narrative: It started the morning after his shots on his left thigh with a 4-5 inch red, itchy circumference that had a fever of 104. The infection site was very large and extremely hard. His body temp. reached 101. By that evening his entire leg was swollen and red. Still with a fever of 104. He became very lethargic, slurring his words, and had a really hard time keeping his eyes open. He complained of pain all over his body and terrible stomach pains. He has been very aggressive and defiant since. He is acting like a completely different child. He has been violent and having temper tantrums, which is not him at all.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Insomnia, Musculoskeletal pain, Pain
Clinical narrative: I am a male, 5' 10" height; 172 lbs weight. Received injection with no issues. Approx 1:45PM. Felt fine until about 8:30PM when my nose starting draining and my hips and shoulders started to ache. By 9:30PM, I was shaking hard and had severe full body aches. I had to put my winter coat on with a blanket. Indoor temp was 74F. I had decided that I was getting the flu and better just get to bed. Thought I should have gotten the shot a month earlier. I had to wear a sweatshirt and pants in bed to overcome chills and shaking. Did not really sleep unitl about 2AM. Woke up at 7:45AM. Sat up on the bed and assessed my condition fully expecting that I would be laying down again. I felt as if nothing had ever happened. No chills, no shaking, no fever, no aches.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Rhinorrhoea, Tremor
Clinical narrative: I am a male, 5' 10" height; 172 lbs weight. Received injection with no issues. Approx 1:45PM. Felt fine until about 8:30PM when my nose starting draining and my hips and shoulders started to ache. By 9:30PM, I was shaking hard and had severe full body aches. I had to put my winter coat on with a blanket. Indoor temp was 74F. I had decided that I was getting the flu and better just get to bed. Thought I should have gotten the shot a month earlier. I had to wear a sweatshirt and pants in bed to overcome chills and shaking. Did not really sleep unitl about 2AM. Woke up at 7:45AM. Sat up on the bed and assessed my condition fully expecting that I would be laying down again. I felt as if nothing had ever happened. No chills, no shaking, no fever, no aches.
Age: 29.0
Sex: F
Vaccine: FLUC4
Symptoms: Abortion spontaneous, Maternal exposure before pregnancy
Clinical narrative: Patient was vaccinated about 3 days before conceiving, patient's mother reported a miscarriage to pharmacy that occurred about 6 weeks after receiving vaccine.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a 16 week old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 14-DEC-2017, the patient was vaccinated with the first dose of ROTATEQ oral liquid, lot # M045544, expiration date: 23-JUN-2018, for prophylaxis (strength and dose were not reported) due to "provider error". No adverse effects reported.
Sex: M
Vaccine: MMRV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant via patient's mother and refers to a male child patient of unknown age. The patient's pertinent medical history, drug reactions and allergies were not reported. Concomitant therapies were not provided. On an unknown date in November 2017, the patient was vaccinated with PROQUAD (albumin status was not provided) lot # N014634 with an expiration date 07-NOV-2018 , subcutaneously for prophylaxis (dose and anatomical location were not reported). Medical assistant reported the patient's mother was not sure if her child received the proper dose of the PROQUAD as there was a wet spot on the paper on the exam table after he received the vaccine. No adverse effects were reported.
Age: 15.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a 15-year-old female patient who received BEXSERO. Concomitant products included BEXSERO. On 8th January 2018, the patient received the 2nd dose of BEXSERO. On 8th January 2018, less than a day after receiving BEXSERO, the patient experienced injection site erythema. On 9th January 2018, the patient experienced injection site burning. On an unknown date, the outcome of the injection site erythema and injection site burning were not recovered/not resolved. It was unknown if the reporter considered the injection site erythema and injection site burning to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. GlaxoSmithKline representative reported the vaccine coordinator at the hospital told that one of the patients came to the office on 8th January 2018 for 2nd dose of BEXSERO. The patient had no side effects for first time that she received the vaccine. On 9th January 2018, 1 day after receiving BEXSERO, the patient experienced injection site burning. The patient was taken to the emergency room for the burning. The sales representative did not have full address of the reporter. The patient did not receive any other vaccine other than BEXSERO.
Age: 88.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Mobility decreased, Myalgia, Thrombophlebitis
Clinical narrative: Muscle pain with inability to raise arm, cellulitis to arm, thrombophlebitis.
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Patient had a hive reaction that began the day after patient had the injection, no other symptoms.
Age: 36.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Pneumonia, Pyrexia
Clinical narrative: Patient called to report she's still having fevers to >102 F unless taking ibuprofen. She reports running out of Tylenol so she has been taking Advil and has taken atleast 3 tablets today. She reports her symptoms of high fevers > 103 F started hours after receiving Flu vax and PNEUMOVAX together at a recent office visit for presumed viral bronchitis. She believes her respiratory symptoms are unchanged compared to her office visit.  She is using her rescue inhaler occasionally which she thinks is helpful.  She denies pleuritic chest pain, increased purulent sputum, wheezing, or shortness of breath. She reports injection sites for both vaccines are red and swollen. She does not believe redness is progressing. Given 1 dose of ceftriaxone on 11/18 and given azithromycin for concnurrent pneumonia. Patient went to the ED on 11/19/17 because she felt that the cellulitis got worse, as given IV cephalexin and hydrated, given additional PO cephalexin.
Age: 36.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Respiratory symptom
Clinical narrative: Patient called to report she's still having fevers to >102 F unless taking ibuprofen. She reports running out of Tylenol so she has been taking Advil and has taken atleast 3 tablets today. She reports her symptoms of high fevers > 103 F started hours after receiving Flu vax and PNEUMOVAX together at a recent office visit for presumed viral bronchitis. She believes her respiratory symptoms are unchanged compared to her office visit.  She is using her rescue inhaler occasionally which she thinks is helpful.  She denies pleuritic chest pain, increased purulent sputum, wheezing, or shortness of breath. She reports injection sites for both vaccines are red and swollen. She does not believe redness is progressing. Given 1 dose of ceftriaxone on 11/18 and given azithromycin for concnurrent pneumonia. Patient went to the ED on 11/19/17 because she felt that the cellulitis got worse, as given IV cephalexin and hydrated, given additional PO cephalexin.
Age: 60.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Erythema, Gout, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: 5 days 1/5/18 after receiving injection, I felt my pointer finger on right hand become tender, by 1/8/2018 my right hand was throbbing, swollen, red, and very hot. I have had gout before only on my toe so knew this was gout.
Age: 60.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Tenderness
Clinical narrative: 5 days 1/5/18 after receiving injection, I felt my pointer finger on right hand become tender, by 1/8/2018 my right hand was throbbing, swollen, red, and very hot. I have had gout before only on my toe so knew this was gout.
Age: 60.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Erythema, Gout, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: 5 days 1/5/18 after receiving injection, I felt my pointer finger on right hand become tender, by 1/8/2018 my right hand was throbbing, swollen, red, and very hot. I have had gout before only on my toe so knew this was gout.
Age: 60.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Skin warm, Tenderness
Clinical narrative: 5 days 1/5/18 after receiving injection, I felt my pointer finger on right hand become tender, by 1/8/2018 my right hand was throbbing, swollen, red, and very hot. I have had gout before only on my toe so knew this was gout.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: I have been having extreme pain in my left arm, unable to move it all the time, and numbness. I mentioned this to my doctor on 12-12-17 but was told it's normal. I am worried because this is going on two months and the pain is unbearable at times. I have tried taking Tylenol and ibup. but it's not helping.
Age: 24.0
Sex: F
Vaccine: HEPA
Symptoms: Neck pain, Swelling, Tenderness
Clinical narrative: Patient woke up the next morning with tender right neck. She states that it's swollen and a little painful to touch. Advised patient to take Ibuprofen and ice the affected area. Will follow up with patient for the next few days to see the outcome.
Age: 10.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Product preparation error
Clinical narrative: MENVEO mixed with sterile water not mencyw-135 liquid.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Dry skin, Herpes zoster, Impetigo, Vaccination complication
Clinical narrative: Rectangular area R torso, impetiginous lesion at center; dry skin on chest, R antecub, R back, finger , toe - DX:  SHINGLES- VACCINE INDUCED.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Deafness unilateral, Hypoacusis, Injection site erythema, Injection site oedema
Clinical narrative: Moderate pain left shoulder to elbow, fever 101.5, chills, nausea and vomiting, Took 2 regular ASA, but did not help pain. Ice did not help the pain. Saturday 2 days later he awoke with pain in upper left arm and other sx resolved, except for limited hearing in right ear. At 10am he took 2 caplets to decrease fever and help pain. Recommended warm compresses and monitor. On Saturday 10/2/17 patient had edema and erythema of upper left arm, deltoid area and below. Next day persistent soreness even with moist compresses. Still with limited hearing in right ear. After 3 months of complete hearing loss in right ear, hearing fully returned on 12/31/17 after ear popped.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Nausea, Pyrexia, Vomiting
Clinical narrative: Moderate pain left shoulder to elbow, fever 101.5, chills, nausea and vomiting, Took 2 regular ASA, but did not help pain. Ice did not help the pain. Saturday 2 days later he awoke with pain in upper left arm and other sx resolved, except for limited hearing in right ear. At 10am he took 2 caplets to decrease fever and help pain. Recommended warm compresses and monitor. On Saturday 10/2/17 patient had edema and erythema of upper left arm, deltoid area and below. Next day persistent soreness even with moist compresses. Still with limited hearing in right ear. After 3 months of complete hearing loss in right ear, hearing fully returned on 12/31/17 after ear popped.
Age: 45.0
Sex: M
Vaccine: FLU4
Symptoms: Back pain, Injected limb mobility decreased, Musculoskeletal pain, Myalgia, Pain in extremity
Clinical narrative: Patient states he was unable to move arm after having vaccine. Presented to office 1/11/18 reports he has pain right arm, entire right shoulder blade, right back, has muscle soreness in right upper chest. "Pain is increasingly getting worse". Patient reports he has taken Motrin and muscle relaxers "not helping pain". RN referred patient to Physician for further evaluation. Recommended ROM exercises, icing/heating on/off, continue taking anti-inflammatory medication. Patient verbalized understanding. Scheduled appointment with Physician for the afternoon of 1/12/18.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Asthenia, Blood test normal, Endotracheal intubation, Gait disturbance, Immunoglobulin therapy
Clinical narrative: 11-year-old female who was admitted to medical center on 1/2/18 with a sudden onset of weakness of the lower extremities. The father states that she was in her usual state of health until the morning of 1/1 at which time she complained to her father that her legs and shoulders were hurting when she was walking to the bathroom. She stated that she felt weak and was unable to walk to the bathroom without help. The father states that the rest of the day she was unable to ambulate without help because of the weakness. There was no history of pre-existing symptoms such as URI symptoms, cough, congestion, vomiting or diarrhea. No one else was sick at home either. The weakness and pain worsened so she was brought to the emergency room. There was no history of numbness or tingling associated with this. She did come from another country approximately 1-1/2 years ago and has not returned. There were no known sick contacts. She was admitted to the pediatric ICU for further management. Neurology consult was obtained who recommended an LP in addition to blood work and MRI of the head and spine. The MRIs were unremarkable as was the blood work. She was started on IVIG. They did send a respiratory virus panel which was negative. I was consulted today because she now has a fever associated with this weakness. Overnight her condition worsened requiring intubation and mechanical ventilation. There is no family history of similar type symptoms in anyone in the family. The father states that she is normally a healthy 11-year-old female attending 4th grade. Her vaccines are up-to-date according to the father. She is currently intubated and sedated. She was started on IV ceftriaxone because of fever.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Intensive care, Mechanical ventilation, Muscular weakness, Musculoskeletal pain, Nuclear magnetic resonance imaging brain normal
Clinical narrative: 11-year-old female who was admitted to medical center on 1/2/18 with a sudden onset of weakness of the lower extremities. The father states that she was in her usual state of health until the morning of 1/1 at which time she complained to her father that her legs and shoulders were hurting when she was walking to the bathroom. She stated that she felt weak and was unable to walk to the bathroom without help. The father states that the rest of the day she was unable to ambulate without help because of the weakness. There was no history of pre-existing symptoms such as URI symptoms, cough, congestion, vomiting or diarrhea. No one else was sick at home either. The weakness and pain worsened so she was brought to the emergency room. There was no history of numbness or tingling associated with this. She did come from another country approximately 1-1/2 years ago and has not returned. There were no known sick contacts. She was admitted to the pediatric ICU for further management. Neurology consult was obtained who recommended an LP in addition to blood work and MRI of the head and spine. The MRIs were unremarkable as was the blood work. She was started on IVIG. They did send a respiratory virus panel which was negative. I was consulted today because she now has a fever associated with this weakness. Overnight her condition worsened requiring intubation and mechanical ventilation. There is no family history of similar type symptoms in anyone in the family. The father states that she is normally a healthy 11-year-old female attending 4th grade. Her vaccines are up-to-date according to the father. She is currently intubated and sedated. She was started on IV ceftriaxone because of fever.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Nuclear magnetic resonance imaging spinal normal, Pain in extremity, Pyrexia, Respiratory viral panel, Sedation
Clinical narrative: 11-year-old female who was admitted to medical center on 1/2/18 with a sudden onset of weakness of the lower extremities. The father states that she was in her usual state of health until the morning of 1/1 at which time she complained to her father that her legs and shoulders were hurting when she was walking to the bathroom. She stated that she felt weak and was unable to walk to the bathroom without help. The father states that the rest of the day she was unable to ambulate without help because of the weakness. There was no history of pre-existing symptoms such as URI symptoms, cough, congestion, vomiting or diarrhea. No one else was sick at home either. The weakness and pain worsened so she was brought to the emergency room. There was no history of numbness or tingling associated with this. She did come from another country approximately 1-1/2 years ago and has not returned. There were no known sick contacts. She was admitted to the pediatric ICU for further management. Neurology consult was obtained who recommended an LP in addition to blood work and MRI of the head and spine. The MRIs were unremarkable as was the blood work. She was started on IVIG. They did send a respiratory virus panel which was negative. I was consulted today because she now has a fever associated with this weakness. Overnight her condition worsened requiring intubation and mechanical ventilation. There is no family history of similar type symptoms in anyone in the family. The father states that she is normally a healthy 11-year-old female attending 4th grade. Her vaccines are up-to-date according to the father. She is currently intubated and sedated. She was started on IV ceftriaxone because of fever.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Walking aid user
Clinical narrative: 11-year-old female who was admitted to medical center on 1/2/18 with a sudden onset of weakness of the lower extremities. The father states that she was in her usual state of health until the morning of 1/1 at which time she complained to her father that her legs and shoulders were hurting when she was walking to the bathroom. She stated that she felt weak and was unable to walk to the bathroom without help. The father states that the rest of the day she was unable to ambulate without help because of the weakness. There was no history of pre-existing symptoms such as URI symptoms, cough, congestion, vomiting or diarrhea. No one else was sick at home either. The weakness and pain worsened so she was brought to the emergency room. There was no history of numbness or tingling associated with this. She did come from another country approximately 1-1/2 years ago and has not returned. There were no known sick contacts. She was admitted to the pediatric ICU for further management. Neurology consult was obtained who recommended an LP in addition to blood work and MRI of the head and spine. The MRIs were unremarkable as was the blood work. She was started on IVIG. They did send a respiratory virus panel which was negative. I was consulted today because she now has a fever associated with this weakness. Overnight her condition worsened requiring intubation and mechanical ventilation. There is no family history of similar type symptoms in anyone in the family. The father states that she is normally a healthy 11-year-old female attending 4th grade. Her vaccines are up-to-date according to the father. She is currently intubated and sedated. She was started on IV ceftriaxone because of fever.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: Developed a fever and chills 12 hours after injection.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Local reaction
Clinical narrative: Mild localized reaction. No treatment needed.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and drug reactions/allergies were not reported. On 18-DEC-2017, the patient was vaccinated with an improperly stored dose of VARIVAX (dose, route, and frequency were not reported) (lot # reported as N008007 and expiration date: 09-MAR-2019) for prophylaxis. The vaccine was administered with sterile diluent (MERCK STERILE DILUENT) (lot # N006806 and expiration date: 12-AUG-2018) which was properly stored.  There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 15 to 46 degrees Fahrenheit (°F) (18.5 °F) for 3 hours and 15 minutes. Data logger was involved and there were no previous excursions reported. Lot number N008007 is an invalid lot number for varicella virus vaccine live.
Sex: M
Vaccine: VARZOS
Symptoms: Bladder operation, Bladder transitional cell carcinoma, Breast pain, Chemotherapy, Flank pain
Clinical narrative: This spontaneous report was received from an 80 year old male patient referring to himself. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date in 1994 or 1995, the patient received a placebo dose of zoster vaccine live (reported as Shingles vaccine) as part of company clinical trial. In approximately 1996 (reported as "two years later"), the patient received a dose of ZOSTAVAX for prevention of Shingles during follow-up visit (dose, route, lot # and expiration date not reported). Concomitant therapies included clopidogrel bisulfate(PLAVIX), rosuvastatin calcium(CRESTOR), tadalafil(CIALIS) and metoprolol succinate(TOPROL). On an unknown date, the patient experienced high blood pressure, heart attacks (myocardial infarction), underwent two stent placement (further not specified), and developed kidney cancer with metastasis to the ribs (renal cancer metastatic, metastases to bone). He received an unspecified chemotherapy for kidney cancer with metastasis to the ribs. Then, on an unknown date he developed transitional cell carcinoma in the bladder (bladder transitional cell carcinoma) for which the patient underwent bladder reconstruction and received more chemotherapy. On approximately 21-DEC-2017 (reported as "about 2 weeks ago") the patient developed shingles (Herpes zoster), began getting pain in his "sides and breast area, nipple pain as well as spots on his back". The patient's physician prescribed valacyclovir hydrochloride(VALTREX) on an unknown date and he began taking it on 04-JAN-2018. The outcome of all the events was unknown. Causality assessment was not provided by the reporter. Upon internal review, bladder transitional cell carcinoma, renal cancer metastatic, metastases to bone, stent placement and myocardial infarction were determined to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Hypertension, Metastases to bone, Myocardial infarction, Nipple pain
Clinical narrative: This spontaneous report was received from an 80 year old male patient referring to himself. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date in 1994 or 1995, the patient received a placebo dose of zoster vaccine live (reported as Shingles vaccine) as part of company clinical trial. In approximately 1996 (reported as "two years later"), the patient received a dose of ZOSTAVAX for prevention of Shingles during follow-up visit (dose, route, lot # and expiration date not reported). Concomitant therapies included clopidogrel bisulfate(PLAVIX), rosuvastatin calcium(CRESTOR), tadalafil(CIALIS) and metoprolol succinate(TOPROL). On an unknown date, the patient experienced high blood pressure, heart attacks (myocardial infarction), underwent two stent placement (further not specified), and developed kidney cancer with metastasis to the ribs (renal cancer metastatic, metastases to bone). He received an unspecified chemotherapy for kidney cancer with metastasis to the ribs. Then, on an unknown date he developed transitional cell carcinoma in the bladder (bladder transitional cell carcinoma) for which the patient underwent bladder reconstruction and received more chemotherapy. On approximately 21-DEC-2017 (reported as "about 2 weeks ago") the patient developed shingles (Herpes zoster), began getting pain in his "sides and breast area, nipple pain as well as spots on his back". The patient's physician prescribed valacyclovir hydrochloride(VALTREX) on an unknown date and he began taking it on 04-JAN-2018. The outcome of all the events was unknown. Causality assessment was not provided by the reporter. Upon internal review, bladder transitional cell carcinoma, renal cancer metastatic, metastases to bone, stent placement and myocardial infarction were determined to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Renal cancer metastatic, Stent placement
Clinical narrative: This spontaneous report was received from an 80 year old male patient referring to himself. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date in 1994 or 1995, the patient received a placebo dose of zoster vaccine live (reported as Shingles vaccine) as part of company clinical trial. In approximately 1996 (reported as "two years later"), the patient received a dose of ZOSTAVAX for prevention of Shingles during follow-up visit (dose, route, lot # and expiration date not reported). Concomitant therapies included clopidogrel bisulfate(PLAVIX), rosuvastatin calcium(CRESTOR), tadalafil(CIALIS) and metoprolol succinate(TOPROL). On an unknown date, the patient experienced high blood pressure, heart attacks (myocardial infarction), underwent two stent placement (further not specified), and developed kidney cancer with metastasis to the ribs (renal cancer metastatic, metastases to bone). He received an unspecified chemotherapy for kidney cancer with metastasis to the ribs. Then, on an unknown date he developed transitional cell carcinoma in the bladder (bladder transitional cell carcinoma) for which the patient underwent bladder reconstruction and received more chemotherapy. On approximately 21-DEC-2017 (reported as "about 2 weeks ago") the patient developed shingles (Herpes zoster), began getting pain in his "sides and breast area, nipple pain as well as spots on his back". The patient's physician prescribed valacyclovir hydrochloride(VALTREX) on an unknown date and he began taking it on 04-JAN-2018. The outcome of all the events was unknown. Causality assessment was not provided by the reporter. Upon internal review, bladder transitional cell carcinoma, renal cancer metastatic, metastases to bone, stent placement and myocardial infarction were determined to be medically significant.
Sex: U
Vaccine: HPV9, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of unspecified patients. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot # N022986, expiration date 23-AUG-2019 and ) GARDASIL 9 lot # N020353, expiration date 28-APR-2020 for prophylaxis. The vaccines underwent temperature excursions at or above 0 to 1 degrees Celsius (also reported as 1.2 to 1.4 degrees Celsius) for 83 hours and 38 minutes and at or above -9 to 8 degrees Celsius (also reported as (-5.1 to 1.1 degrees Celsius) for 3 hours and 57 minutes, respectively. Multiple excursions were involved. Digital data logger was involved. No adverse effects were reported.
Sex: F
Vaccine: HPV4
Symptoms: Biopsy cervix abnormal, Cervical dysplasia, Cryotherapy, Human papilloma virus test positive, Smear cervix abnormal
Clinical narrative: This spontaneous report as received from a medical assistant regarding a 26 year old female patient. The patient´s concurrent conditions include gastrooesophageal reflux disease. The patient did not have pertinent medical history, drug reactions or allergies. Concomitant medicines include an unspecified birth control pill and unspecified multivitamins. On an unknown date, the patient was vaccinated with GARDASIL (dose, route, lot# and exp date were not provided) for prophylaxis. The dates of administration for the three doses of GARDASIL were unknown, but it was confirmed that the patient received the full 3-dose series, and completed the GARDASIL  series when she was around 12 years old. The reporter mentioned that around December 2017 the patient had a "pap smear" and the results showed she was "positive for human papillomavirus (HPV)  18". The primary reporter reported that around December 2017 the patient also had a cervical biopsy performed that resulted positive for "squamos intraepithelial lesion" (Cervical dysplasia)". On 08-JAN-2018, the patient underwent an unspecified "Cryosurgery" in the office to treat the 8HPV) 18 and Squamous Intraepithelial Lesion. The patient´s outcome was reported as recovering. The relatedness of GARDASIL and the adverse events was not provided. Upon internal review squamous intraepithelial lesion and positive for human papillomavirus (HPV)  18 requiring cervical cryotherapy were considered medically significant.
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a physician referring to a 15 year old female patient. Information about the patient's concurrent condition, concomitant medication and medical history was not provided. On unknown dates, the patient was vaccinated with improperly stored (Temperature: 47 Fahrenheit to 77 Fahrenheit; Time frame: 40 minutes) doses of GARDASIL 9 (lot # M043731, expiration date: 22-JUN-2019; the dose and route were not reported) for prophylaxis on an unspecified after July 2017. No adverse effect reported. It was reported that there were no previous temperature excursions and there was a data logger involved. This is one of the multiple reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006271:
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Hyperventilation, Muscular weakness, Palpitations
Clinical narrative: As per patient and ER note, she complained of palpitations, hyperventilation, left arm and leg weakness.
Age: 30.0
Sex: F
Vaccine: FLU4, MMR, TDAP, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: 30 year old female requesting MMR vaccine-on assessment patient filled out paperwork assessment-noted not pregnant-Ask whether pregnant-patient said no. Came in stating she was pregnant when she received MMR vaccine.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: This initial spontaneous case was received from other health professional on 04-Oct-2017, concerning a 60-year-old female patient. The patient's medical history and concomitant medications were not reported. On 04-Oct-2017, the patient was administered with FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 1618621, expiry date: Apr-2017). The patient was administered with expired vaccine and no adverse effect was experienced by the patient. It was reported that, the patient had to revaccinate with current season vaccine. The reporter assessed the events as non-serious. Follow-up received on 08-Nov-2017: Added patient details (age: 60-year-old and gender: female), vaccination details (route of administration: intramuscular, anatomical location: deltoid). Narrative amended accordingly.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, Immunisation, No adverse event
Clinical narrative: This initial spontaneous case was received from other health professional on 04-Oct-2017, concerning a female patient. The patient's medical history and concomitant medications were not reported. On 04-Oct-2017, the patient was administered expired vaccine that expired in April of this year FLUVIRIN Thiomersal (dose: 0.5 ml, batch number: 1618621, expiry date: Apr-2017, route of administration: intramuscular, anatomical location: deltoid) (explicitly coded to expired vaccine used). It was reported that, no adverse effect was noted. It was reported that the patient had revaccination with the current season. The reporter assessed the report as non-serious. Significant case correction received with IRD 04-Oct-2017: The LLT coding for the event "no adverse effect note" from no adverse event to no adverse effect was corrected. Follow-up received from the reporter on 08-Nov-2017: Updated patient's gender, age, route of administration and anatomical location. It was reported that, no adverse effect was noted. The narrative was amended accordingly.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: This spontaneous case initially received on 12-Jan-2017, was reported by a health authority and concerns a(n) female patient. Weight: not provided; Height: not provided. Concomitant medication: refer to appropriate report section. Administration of company suspect drug(s): On an unknown date, the patient received Influenza Virus Vaccine (INN) for Indication not reported. Dose regimen: Not reported, site: Not reported, Route of administration: Not Reported. Batch number: Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient experienced Hives (outcome: Not Reported), Itching (outcome: Not Reported), Rash (outcome: Not Reported).
Age: 0.17
Sex: M
Vaccine: FLU4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: No adverse reaction. Vaccine was just given too early.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Dizziness, Erythema, Localised infection, Peripheral swelling
Clinical narrative: The next day patient was dizzy; arm swollen, red and infected spot on left arm. Patient called primary care MD (on a Sunday) and was told to go the ER. Meclizine, Cephalexin and Bactrim DS prescribed.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Vaccination site pain
Clinical narrative: On 1/12/18 client calls to report that after receiving the vaccine she did not have any pain for about 1 week. Then, she started to feel pain about 6 or 7 days later from the location of the vaccine down to the bend in her arm. Pain has been increasing, she is now having difficulty moving her arm around and above a certain point. She tried to take pain relievers and reports they have not been helpful. She has not noticed any swelling or redness at any point. This RN recommended she have a further evaluation by a health care provider.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Barium swallow, Cardiac failure congestive, Cough, Dyspnoea, Echocardiogram
Clinical narrative: Coughing a few days after, legs started swelling on 12/14 then went to urgent care and was referred to Dr in urgent care. Dr believed she was in congestive heart failure. Then squad came and transferred her to ER. Seen air in chest and was sent to another ER and was home in 24 hours. Performed echo and barium swallow. Next day went back to ER b/c could not breathe again.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Epiglottitis, Peripheral swelling, Scan abnormal, X-ray
Clinical narrative: Coughing a few days after, legs started swelling on 12/14 then went to urgent care and was referred to Dr in urgent care. Dr believed she was in congestive heart failure. Then squad came and transferred her to ER. Seen air in chest and was sent to another ER and was home in 24 hours. Performed echo and barium swallow. Next day went back to ER b/c could not breathe again.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Chest pain, Pain in extremity, Peripheral swelling, Swelling
Clinical narrative: Painful swelling in the arm spreading to the chest resulting in hospital admission. IV antibiotics provided prior to ruling out cellulitis.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Antinuclear antibody, Back pain, Blood thyroid stimulating hormone, C-reactive protein, Chest discomfort
Clinical narrative: This is the 1st time I ever had a flu shot, Dr. advised after husband had heart by-pass surgery and had us take vaccine. After a few days my right hand thumb pain to bottom joint - would lose grip without warning, items would fall out of hand. Also soreness on back of head with headache running on sides of head to front caused some nausea. After a few more days, noticed pain on bottom on right leg when going up my stairs, calf to knee. Leg would fall, had to hold on to stair rails to stabilze leg otherwise leg would just fall out from under me. Set appoint on December 7th with NP in Dr.'s office. Said could be nerves, gave me prescription Naprosyn and would follow up on 12/21/2017. Took Tests, Blood, Urine.  After taking 2 pills, pain mostly gone, went up stairs without holding rails, leg went out from under me.  Then pain started in my left thumb but not as bad as the right and had grip, and pain in bottom back, spine, then left leg from upper thigh to joint and left side top of arm. On 12/21/2017 NP told me that white cell counts elevated but not alarming. Told me I shouldn't take Flu shots, but did not think it was adversly due to flu shot. Schedule in 6 months. Did not think it was Guillian-Barre Syndrome because the patients she saw with that was hospitalized and very bad.  I had asked her about Guillian-Barre Syndrome because the pharmacist I spoke with stated I should be tested for this, and could have only mild symptons and would eventually go away. The pain in my left leg has gone, and only mild soreness on thumbs, very little back pain, but top right  thigh and joint, plus right top joint on arm pain and now some chest and top back tightness/soreness. Hopefully will go away.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Differential white blood cell count, Full blood count, Glycosylated haemoglobin, Grip strength decreased, Headache
Clinical narrative: This is the 1st time I ever had a flu shot, Dr. advised after husband had heart by-pass surgery and had us take vaccine. After a few days my right hand thumb pain to bottom joint - would lose grip without warning, items would fall out of hand. Also soreness on back of head with headache running on sides of head to front caused some nausea. After a few more days, noticed pain on bottom on right leg when going up my stairs, calf to knee. Leg would fall, had to hold on to stair rails to stabilze leg otherwise leg would just fall out from under me. Set appoint on December 7th with NP in Dr.'s office. Said could be nerves, gave me prescription Naprosyn and would follow up on 12/21/2017. Took Tests, Blood, Urine.  After taking 2 pills, pain mostly gone, went up stairs without holding rails, leg went out from under me.  Then pain started in my left thumb but not as bad as the right and had grip, and pain in bottom back, spine, then left leg from upper thigh to joint and left side top of arm. On 12/21/2017 NP told me that white cell counts elevated but not alarming. Told me I shouldn't take Flu shots, but did not think it was adversly due to flu shot. Schedule in 6 months. Did not think it was Guillian-Barre Syndrome because the patients she saw with that was hospitalized and very bad.  I had asked her about Guillian-Barre Syndrome because the pharmacist I spoke with stated I should be tested for this, and could have only mild symptons and would eventually go away. The pain in my left leg has gone, and only mild soreness on thumbs, very little back pain, but top right  thigh and joint, plus right top joint on arm pain and now some chest and top back tightness/soreness. Hopefully will go away.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Lipids, Liver function test, Metabolic function test, Microscopy, Muscle tightness
Clinical narrative: This is the 1st time I ever had a flu shot, Dr. advised after husband had heart by-pass surgery and had us take vaccine. After a few days my right hand thumb pain to bottom joint - would lose grip without warning, items would fall out of hand. Also soreness on back of head with headache running on sides of head to front caused some nausea. After a few more days, noticed pain on bottom on right leg when going up my stairs, calf to knee. Leg would fall, had to hold on to stair rails to stabilze leg otherwise leg would just fall out from under me. Set appoint on December 7th with NP in Dr.'s office. Said could be nerves, gave me prescription Naprosyn and would follow up on 12/21/2017. Took Tests, Blood, Urine.  After taking 2 pills, pain mostly gone, went up stairs without holding rails, leg went out from under me.  Then pain started in my left thumb but not as bad as the right and had grip, and pain in bottom back, spine, then left leg from upper thigh to joint and left side top of arm. On 12/21/2017 NP told me that white cell counts elevated but not alarming. Told me I shouldn't take Flu shots, but did not think it was adversly due to flu shot. Schedule in 6 months. Did not think it was Guillian-Barre Syndrome because the patients she saw with that was hospitalized and very bad.  I had asked her about Guillian-Barre Syndrome because the pharmacist I spoke with stated I should be tested for this, and could have only mild symptons and would eventually go away. The pain in my left leg has gone, and only mild soreness on thumbs, very little back pain, but top right  thigh and joint, plus right top joint on arm pain and now some chest and top back tightness/soreness. Hopefully will go away.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Muscular weakness, Nausea, Pain in extremity, Platelet count, Red blood cell sedimentation rate
Clinical narrative: This is the 1st time I ever had a flu shot, Dr. advised after husband had heart by-pass surgery and had us take vaccine. After a few days my right hand thumb pain to bottom joint - would lose grip without warning, items would fall out of hand. Also soreness on back of head with headache running on sides of head to front caused some nausea. After a few more days, noticed pain on bottom on right leg when going up my stairs, calf to knee. Leg would fall, had to hold on to stair rails to stabilze leg otherwise leg would just fall out from under me. Set appoint on December 7th with NP in Dr.'s office. Said could be nerves, gave me prescription Naprosyn and would follow up on 12/21/2017. Took Tests, Blood, Urine.  After taking 2 pills, pain mostly gone, went up stairs without holding rails, leg went out from under me.  Then pain started in my left thumb but not as bad as the right and had grip, and pain in bottom back, spine, then left leg from upper thigh to joint and left side top of arm. On 12/21/2017 NP told me that white cell counts elevated but not alarming. Told me I shouldn't take Flu shots, but did not think it was adversly due to flu shot. Schedule in 6 months. Did not think it was Guillian-Barre Syndrome because the patients she saw with that was hospitalized and very bad.  I had asked her about Guillian-Barre Syndrome because the pharmacist I spoke with stated I should be tested for this, and could have only mild symptons and would eventually go away. The pain in my left leg has gone, and only mild soreness on thumbs, very little back pain, but top right  thigh and joint, plus right top joint on arm pain and now some chest and top back tightness/soreness. Hopefully will go away.