chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Diet refusal, Discomfort, Fatigue, Human rhinovirus test positive, Immunoglobulin therapy
Clinical narrative: Patient woke up around 7 and was inconsolably crying and seemed quiet unhappy and uncomfortable.  She had a fever of 103 F. and when she wasn't crying she was looking uncomfortable and tired/quiet and "blank".  She also had a rash which was around her nose and mouth and a little around her eyes, it was red and seemed to be a sheet of read around those areas.  We gave her Tylenol as told to by the doctor and then went to the doctor around 11 AM (first we could get).  There they tested her for all sorts of viruses and took some blood to check for bacteria and then treated her with an antibiotic to be sure to cover their bases.  We continued with the fever reducers and monitoring her over the weekend as well as going back in Saturday for another intramuscular antibiotic dose.  She did not really improve and began to refuse the breast and the bottle.  We had to force feed her milk and Pedialyte just to get her to barely pee every 6 hours. When we went to the doctor's on Monday they sent us to the E.R. because she was "puny" and very dehydrated.  There she was further tested and observed and given fluids.  Her IV had to be put in by the "air care" team because of her dehydration.  She had a spinal tap because they were concerned about meningitis.  She was then admitted to the hospital and that evening her rash spread more and became more spot-like.  She also began to swell all over her whole body.  They gave her Benadryl, Tylenol, a new antibiotic because they worried the rash was allergic.  The rash was confirmed as not allergic and not viral later on.  I believe it was an autoimmune type of reaction within her whole body (meaning all her symptoms).  She also received a medication to reduce swelling because she had gone up a whole diaper size as a result of it (I cannot remember the name).  After a couple days her rash cleared and her swelling started to go down. Her fever remained hardly changed until they decided her immune system had been overwhelmed and to treat her with IV IG.  They had to treat her twice before they could rid her of the fevers she was having for this whole time.  She lost a few pounds in this process and I had to pump to keep my breast milk supply up.  This is my first baby and I am going to be scarred for life.  She did go home and has been doing well, but I will never ever forget this.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Lumbar puncture, Pyrexia, Rash, Rash erythematous, Rash generalised
Clinical narrative: Patient woke up around 7 and was inconsolably crying and seemed quiet unhappy and uncomfortable.  She had a fever of 103 F. and when she wasn't crying she was looking uncomfortable and tired/quiet and "blank".  She also had a rash which was around her nose and mouth and a little around her eyes, it was red and seemed to be a sheet of read around those areas.  We gave her Tylenol as told to by the doctor and then went to the doctor around 11 AM (first we could get).  There they tested her for all sorts of viruses and took some blood to check for bacteria and then treated her with an antibiotic to be sure to cover their bases.  We continued with the fever reducers and monitoring her over the weekend as well as going back in Saturday for another intramuscular antibiotic dose.  She did not really improve and began to refuse the breast and the bottle.  We had to force feed her milk and Pedialyte just to get her to barely pee every 6 hours. When we went to the doctor's on Monday they sent us to the E.R. because she was "puny" and very dehydrated.  There she was further tested and observed and given fluids.  Her IV had to be put in by the "air care" team because of her dehydration.  She had a spinal tap because they were concerned about meningitis.  She was then admitted to the hospital and that evening her rash spread more and became more spot-like.  She also began to swell all over her whole body.  They gave her Benadryl, Tylenol, a new antibiotic because they worried the rash was allergic.  The rash was confirmed as not allergic and not viral later on.  I believe it was an autoimmune type of reaction within her whole body (meaning all her symptoms).  She also received a medication to reduce swelling because she had gone up a whole diaper size as a result of it (I cannot remember the name).  After a couple days her rash cleared and her swelling started to go down. Her fever remained hardly changed until they decided her immune system had been overwhelmed and to treat her with IV IG.  They had to treat her twice before they could rid her of the fevers she was having for this whole time.  She lost a few pounds in this process and I had to pump to keep my breast milk supply up.  This is my first baby and I am going to be scarred for life.  She did go home and has been doing well, but I will never ever forget this.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Staring, Swelling, Urine output decreased, Viral test negative, Weight decreased
Clinical narrative: Patient woke up around 7 and was inconsolably crying and seemed quiet unhappy and uncomfortable.  She had a fever of 103 F. and when she wasn't crying she was looking uncomfortable and tired/quiet and "blank".  She also had a rash which was around her nose and mouth and a little around her eyes, it was red and seemed to be a sheet of read around those areas.  We gave her Tylenol as told to by the doctor and then went to the doctor around 11 AM (first we could get).  There they tested her for all sorts of viruses and took some blood to check for bacteria and then treated her with an antibiotic to be sure to cover their bases.  We continued with the fever reducers and monitoring her over the weekend as well as going back in Saturday for another intramuscular antibiotic dose.  She did not really improve and began to refuse the breast and the bottle.  We had to force feed her milk and Pedialyte just to get her to barely pee every 6 hours. When we went to the doctor's on Monday they sent us to the E.R. because she was "puny" and very dehydrated.  There she was further tested and observed and given fluids.  Her IV had to be put in by the "air care" team because of her dehydration.  She had a spinal tap because they were concerned about meningitis.  She was then admitted to the hospital and that evening her rash spread more and became more spot-like.  She also began to swell all over her whole body.  They gave her Benadryl, Tylenol, a new antibiotic because they worried the rash was allergic.  The rash was confirmed as not allergic and not viral later on.  I believe it was an autoimmune type of reaction within her whole body (meaning all her symptoms).  She also received a medication to reduce swelling because she had gone up a whole diaper size as a result of it (I cannot remember the name).  After a couple days her rash cleared and her swelling started to go down. Her fever remained hardly changed until they decided her immune system had been overwhelmed and to treat her with IV IG.  They had to treat her twice before they could rid her of the fevers she was having for this whole time.  She lost a few pounds in this process and I had to pump to keep my breast milk supply up.  This is my first baby and I am going to be scarred for life.  She did go home and has been doing well, but I will never ever forget this.
Age: 42.0
Sex: M
Vaccine: DTAP, TDAP
Symptoms: Injection site abscess, Injection site cellulitis, Injection site pain, Injection site swelling
Clinical narrative: LARGE AREA OF SWELLING, HARDNESS, REDNESS, PAIN AROUND INJECTION SITE BEGINNING THE SAME DAY AND CONTINUING FOR APPROXIMATELY 18 TO 20 DAYS. MUSCLE WEAKNESS, FATIGUE, ACHINESS, HEADACHE CONTINUED FOR APPROXIMATELY 5 TO 7 DAYS.
Age: 42.0
Sex: M
Vaccine: DTAP, TDAP
Symptoms: Fatigue, Headache, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: LARGE AREA OF SWELLING, HARDNESS, REDNESS, PAIN AROUND INJECTION SITE BEGINNING THE SAME DAY AND CONTINUING FOR APPROXIMATELY 18 TO 20 DAYS. MUSCLE WEAKNESS, FATIGUE, ACHINESS, HEADACHE CONTINUED FOR APPROXIMATELY 5 TO 7 DAYS.
Age: 42.0
Sex: M
Vaccine: DTAP, TDAP
Symptoms: Injection site swelling, Muscular weakness, Pain
Clinical narrative: LARGE AREA OF SWELLING, HARDNESS, REDNESS, PAIN AROUND INJECTION SITE BEGINNING THE SAME DAY AND CONTINUING FOR APPROXIMATELY 18 TO 20 DAYS. MUSCLE WEAKNESS, FATIGUE, ACHINESS, HEADACHE CONTINUED FOR APPROXIMATELY 5 TO 7 DAYS.
Age: 59.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Drug administered at inappropriate site, Feeling abnormal, Inflammation, Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient received rabies vaccine in L arm at time felt sensation of "spreading out" Pt thought shot was higher than usual and more forward. Over next few days pain in area increased in shoulder. Over 2 weeks period of time had more pain and decreased range of motion. Saw ortho MD who felt injection was not incorrect spot and inflammation developed . Pt followed up with ortho MD.
Age: 59.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Injection site reaction
Clinical narrative: Patient received rabies vaccine in L arm at time felt sensation of "spreading out" Pt thought shot was higher than usual and more forward. Over next few days pain in area increased in shoulder. Over 2 weeks period of time had more pain and decreased range of motion. Saw ortho MD who felt injection was not incorrect spot and inflammation developed . Pt followed up with ortho MD.
Age: 59.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Inflammation, Joint range of motion decreased, Musculoskeletal pain, Sensory disturbance
Clinical narrative: Patient received rabies vaccine in L arm at time felt sensation of "spreading out" Pt thought shot was higher than usual and more forward. Over next few days pain in area increased in shoulder. Over 2 weeks period of time had more pain and decreased range of motion. Saw ortho MD who felt injection was not incorrect spot and inflammation developed . Pt followed up with ortho MD.
Age: 68.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, VARZOS
Symptoms: Axillary pain, Erythema, Injection site discolouration, Injection site pain, Pain in extremity
Clinical narrative: Per patients report - redness/itching at the injection site.
Age: 68.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, VARZOS
Symptoms: Peau d'orange, Pruritus
Clinical narrative: Per patients report - redness/itching at the injection site.
Age: 68.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Per patients report - redness/itching at the injection site.
Age: 11.0
Sex: F
Vaccine: FLUX, MEN, FLUN4, MEN
Symptoms: Confusional state, Dizziness, Fatigue, Hypotonia, Immediate post-injection reaction
Clinical narrative: Patient fainted with 1 (one) minute after administration. Face turned white, body limp, then body began shaking. Patient woke up 20 seconds later, confused, dizzy, nauseous. Patient fainted about 2 mins. later, same symptoms and woke up 15 seconds later. Patient remained in doctors office 1 hr. Dizziness and fatigue persisted for 48 hrs.
Age: 11.0
Sex: F
Vaccine: FLUX, MEN, FLUN4, MEN
Symptoms: Nausea, Pallor, Syncope, Tremor
Clinical narrative: Patient fainted with 1 (one) minute after administration. Face turned white, body limp, then body began shaking. Patient woke up 20 seconds later, confused, dizzy, nauseous. Patient fainted about 2 mins. later, same symptoms and woke up 15 seconds later. Patient remained in doctors office 1 hr. Dizziness and fatigue persisted for 48 hrs.
Age: 11.0
Sex: F
Vaccine: FLUX, MEN, FLUN4, MEN
Symptoms: Confusional state, Dizziness, Fatigue, Hypotonia, Nausea
Clinical narrative: Patient fainted with 1 (one) minute after administration. Face turned white, body limp, then body began shaking. Patient woke up 20 seconds later, confused, dizzy, nauseous. Patient fainted about 2 mins. later, same symptoms and woke up 15 seconds later. Patient remained in doctors office 1 hr. Dizziness and fatigue persisted for 48 hrs.
Age: 11.0
Sex: F
Vaccine: FLUX, MEN, FLUN4, MEN
Symptoms: Pallor, Syncope, Tremor
Clinical narrative: Patient fainted with 1 (one) minute after administration. Face turned white, body limp, then body began shaking. Patient woke up 20 seconds later, confused, dizzy, nauseous. Patient fainted about 2 mins. later, same symptoms and woke up 15 seconds later. Patient remained in doctors office 1 hr. Dizziness and fatigue persisted for 48 hrs.
Age: 50.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a patient aged between 50 and 60 years and of unknown gender. No medical history was provided. On 28-AUG-2013 the patient was vaccinated with an expired ZOSTAVAX vaccine. No adverse events were reported. The patient did not seek medical attention. No outcome reported. Action taken with ZOSTAVAX was reproted as not applicable. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chills, Cough, Dysphonia, Eye pain, Eye pruritus
Clinical narrative: Throat got thick and full of phlegm. Felt weak and achy starting at head and moved downward through arms, torso, legs, and out through the toes. Went home from work and by 10:00 PM she felt fine.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Ocular hyperaemia, Pain
Clinical narrative: Throat got thick and full of phlegm. Felt weak and achy starting at head and moved downward through arms, torso, legs, and out through the toes. Went home from work and by 10:00 PM she felt fine.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Increased upper airway secretion, Pain
Clinical narrative: Throat got thick and full of phlegm. Felt weak and achy starting at head and moved downward through arms, torso, legs, and out through the toes. Went home from work and by 10:00 PM she felt fine.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Large 2 1/2 inch x 5 in Red/swollen/painful on left arm where injection given. Symptoms started Friday - getting worse - informed patient to call physician. Left arm only.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Gait disturbance, Laboratory test, Muscular weakness, Myositis, Protein total increased
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 17 year old female patient with no pertinent medical history and no drug reactions/allergies. On 09-JUL-2013 the patient was vaccinated with a first dose of GARDASIL (lot # H020002, Exp. 08-AUG-2015) 0.5 ml, intramuscularly in the right deltoid. There was no concomitant medication. On 10-JUL-2013, the patient developed a 102F fever. The patient's mother gave her unspecified "fever reducing" medication and the patient's fever subsided the same evening. On 27-JUL-2013, the patient developed severe muscle weakness, throughout her body but predominantly in the legs. The patient saw her unspecified primary care provider, around 29-JUL-2013, who performed blood work and multiple other tests. The blood work showed an elevated protein level and the unspecified physician diagnosed the patient as having Myositis. The patient stated she was struggling to walk for a week starting on 27-JUL-2013 and was forced to use a wheelchair because of the severe muscle weakness. The patient reported the severe muscle weakness lasted for 3 weeks then subsided on its own. The nurse reported that as of today, 12-SEP-2013, the patient was completely recovered. Myositis was considered to be disabling by reporter. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pyrexia, Wheelchair user
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 17 year old female patient with no pertinent medical history and no drug reactions/allergies. On 09-JUL-2013 the patient was vaccinated with a first dose of GARDASIL (lot # H020002, Exp. 08-AUG-2015) 0.5 ml, intramuscularly in the right deltoid. There was no concomitant medication. On 10-JUL-2013, the patient developed a 102F fever. The patient's mother gave her unspecified "fever reducing" medication and the patient's fever subsided the same evening. On 27-JUL-2013, the patient developed severe muscle weakness, throughout her body but predominantly in the legs. The patient saw her unspecified primary care provider, around 29-JUL-2013, who performed blood work and multiple other tests. The blood work showed an elevated protein level and the unspecified physician diagnosed the patient as having Myositis. The patient stated she was struggling to walk for a week starting on 27-JUL-2013 and was forced to use a wheelchair because of the severe muscle weakness. The patient reported the severe muscle weakness lasted for 3 weeks then subsided on its own. The nurse reported that as of today, 12-SEP-2013, the patient was completely recovered. Myositis was considered to be disabling by reporter. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Gait disturbance, Muscular weakness, Myositis, Protein total increased, Pyrexia
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 17 year old female patient with no pertinent medical history and no drug reactions/allergies. On 09-JUL-2013 the patient was vaccinated with a first dose of GARDASIL (lot # H020002, Exp. 08-AUG-2015) 0.5 ml, intramuscularly in the right deltoid. There was no concomitant medication. On 10-JUL-2013, the patient developed a 102F fever. The patient's mother gave her unspecified "fever reducing" medication and the patient's fever subsided the same evening. On 27-JUL-2013, the patient developed severe muscle weakness, throughout her body but predominantly in the legs. The patient saw her unspecified primary care provider, around 29-JUL-2013, who performed blood work and multiple other tests. The blood work showed an elevated protein level and the unspecified physician diagnosed the patient as having Myositis. The patient stated she was struggling to walk for a week starting on 27-JUL-2013 and was forced to use a wheelchair because of the severe muscle weakness. The patient reported the severe muscle weakness lasted for 3 weeks then subsided on its own. The nurse reported that as of today, 12-SEP-2013, the patient was completely recovered. Myositis was considered to be disabling by reporter. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Wheelchair user
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 17 year old female patient with no pertinent medical history and no drug reactions/allergies. On 09-JUL-2013 the patient was vaccinated with a first dose of GARDASIL (lot # H020002, Exp. 08-AUG-2015) 0.5 ml, intramuscularly in the right deltoid. There was no concomitant medication. On 10-JUL-2013, the patient developed a 102F fever. The patient's mother gave her unspecified "fever reducing" medication and the patient's fever subsided the same evening. On 27-JUL-2013, the patient developed severe muscle weakness, throughout her body but predominantly in the legs. The patient saw her unspecified primary care provider, around 29-JUL-2013, who performed blood work and multiple other tests. The blood work showed an elevated protein level and the unspecified physician diagnosed the patient as having Myositis. The patient stated she was struggling to walk for a week starting on 27-JUL-2013 and was forced to use a wheelchair because of the severe muscle weakness. The patient reported the severe muscle weakness lasted for 3 weeks then subsided on its own. The nurse reported that as of today, 12-SEP-2013, the patient was completely recovered. Myositis was considered to be disabling by reporter. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: MMR
Symptoms: Rash generalised
Clinical narrative: Noticed that patient was COVERED in a rash.  No other symptoms--no fever, no itching, etc.  At this point, it is still just the rash.
Age: 44.0
Sex: M
Vaccine: TYP
Symptoms: Abdominal distension, Abdominal pain, Diarrhoea, Discomfort, Paraesthesia
Clinical narrative: Rash - left back side of torso. Not itchy, more "tingly" but uncomfortable. As of 11:30 PM on 09/16/2013, entire torso is involved in rash.
Age: 44.0
Sex: M
Vaccine: TYP
Symptoms: Rash
Clinical narrative: Rash - left back side of torso. Not itchy, more "tingly" but uncomfortable. As of 11:30 PM on 09/16/2013, entire torso is involved in rash.
Age: 24.0
Sex: M
Vaccine: FLUN4
Symptoms: Headache
Clinical narrative: Constant headache from Saturday 20130914 - through Tuesday 20130917.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Asthma, Condition aggravated, Culture urine, Dyspnoea, Local swelling
Clinical narrative: Daughter-in-law called to report on 9/14/2013 stated pt had swollen, tender arm, difficulty breathing. 911 was called, pt brought to ER, was diagnosed with UTI with fever, administered nebulizers for asthma exacerbation, started on antibiotics and admitted for observation on evening of 9/13/2013.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Tenderness, Urinary tract infection, Urine analysis
Clinical narrative: Daughter-in-law called to report on 9/14/2013 stated pt had swollen, tender arm, difficulty breathing. 911 was called, pt brought to ER, was diagnosed with UTI with fever, administered nebulizers for asthma exacerbation, started on antibiotics and admitted for observation on evening of 9/13/2013.
Age: 1.27
Sex: M
Vaccine: HIBV, PPV
Symptoms: Depressed mood, Diarrhoea, Irritability, Pyrexia
Clinical narrative: Fever, diarrhea, sad, whiny, time course was 1 day of diarrhea and 3 days of fever. 2 days of whiny sadness.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Client returned to provider with complaint of itchy skin. Hives were present on her extremities. Benadryl 50mg orally prescribed, hives and itching resolved approx. 2 hours after single 50mg oral dose of Benadryl tablets.
Age: 17.0
Sex: M
Vaccine: TYP
Symptoms: Pruritus, Urticaria
Clinical narrative: Hive, itching, every day since.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Patient felt "woozy".
Age: 1.32
Sex: F
Vaccine: MMR
Symptoms: Fatigue, Irritability, Rash generalised
Clinical narrative: Full body rash; tired v cranky
Age: 1.36
Sex: F
Vaccine: FLU3, MMR, VARCEL
Symptoms: Culture urine, Cyanosis, Electrocardiogram, Electroencephalogram, Full blood count
Clinical narrative: MMR, flu, VARIVAX given 8/30/13. On 9/7 pt developed fever, on 9/8 pt had fever, and a syncopal like event that made her limp and blue lips. She aroused within 2 minutes. Possible febrile seizure. No rhythmic movement. Taken to ED. Labs, EKG, Neuro referral, EEG, Cardio referral.
Age: 1.36
Sex: F
Vaccine: FLU3, MMR, VARCEL
Symptoms: Hypotonia, Pyrexia, Syncope, Urine analysis
Clinical narrative: MMR, flu, VARIVAX given 8/30/13. On 9/7 pt developed fever, on 9/8 pt had fever, and a syncopal like event that made her limp and blue lips. She aroused within 2 minutes. Possible febrile seizure. No rhythmic movement. Taken to ED. Labs, EKG, Neuro referral, EEG, Cardio referral.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Pruritus, Urticaria
Clinical narrative: 8/28/13 Date of vaccine, redness, swelling pruritis size of silver dollar. 8/29/13: Redness, swelling, itching at site of injection  1"x3"-the red irritation; 8/31/2013 Mid chest itching, no rash. Benadryl on 8/29, 9/1; 9/1/13 Back covered in hives.
Age: 0.51
Sex: F
Vaccine: RV5
Symptoms: Barium enema, Incorrect route of drug administration
Clinical narrative: None stated.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Pyrexia, Tremor
Clinical narrative: Chills, shakes, fever.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Blood product transfusion, Gastrointestinal hypomotility, Mobility decreased, Paralysis
Clinical narrative: Felt sharp pain in my back. Started losing movement of legs and intestines. Paralyzed from thorax down. Treatment consisted on plasma replacement and RITUXAN infused thru port inserted in chest.
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: VIIth nerve paralysis
Clinical narrative: This spontaneous medically confirmed report (initial receipt 04-Sep-2013) concerns a male patient. On an unspecified date, the patient was administered influenza vaccine (batch number and manufacturer not provided) and ZOSTAVAX (batch number not provided) concomitantly. Then on an unspecified date, he developed Bell's palsy. The overall event outcome was unknown.
Sex: F
Vaccine: ANTH, SMALL, TYP
Symptoms: Chest pain, Dyspnoea, Electrocardiogram normal, Headache, Influenza like illness
Clinical narrative: This study case was received from the investigator in a trial on 04 September 2013. A female subject (age and date of birth not reported) had received the following vaccination on 28 August 2013: ACAM2000 (lot number, route and site not reported). The subject also received the following vaccinations on 23 August 2013: typhoid (Manufacturer Unknown, lot number, route and site not reported), and anthrax (Other Manufacturer, lot number, route and site not reported). Five days post smallpox vaccination, on 02 September 2013, the subject was diagnosed with possible myopericarditis. The subject recovered on the same day, 02 September 2013. The subject experienced "flu-like symptoms". The subject experienced the non-serious event of generalized myalgia (start date 30 August 2013, stop date 02 September 2013), was given unspecified medication, and was considered probably related to vaccination. The subject experienced non-serious event of fever (start date 30 August 2013, stop date 02 September 2013), was given unspecified medication, and was considered probably related to vaccination. The subject experienced non-serious ongoing event of headache (start date 30 August 2013), was given unspecified medication, and was considered probably related to vaccination. The subject experienced serious event of shortness of breath while jogging which lasted a couple minutes with no other symptoms (start date 01 September 2013, stop date 01 September 2013) and was considered possibly related to vaccination. The subject experienced serious event of chest pain that was centered at the sternum but did not radiate anywhere else (start date 02 September 2013, stop date 02 September 2013), was a pain level 3, and was considered possibly related to vaccination. The symptoms started when she woke up and lasted until mid-afternoon. The subject experienced serious event of shortness of breath again (start date 02 September 2013, stop date 02 September 2013) and was considered possibly related to vaccination. The ECG from 03 September 2013 was normal and subject was asymptomatic at time of ECG. The troponin I results were still pending. The subject's rapid troponin was negative. Subject circled "0" on the Wong-Baker scale. The subject did not take any medications for treatment. The subject's outcome was recovered on 02 September 2013. According to the Investigator, the event of possible myopericarditis was considered an important event and possibly related. Documents held by sender: None.
Sex: F
Vaccine: ANTH, SMALL, TYP
Symptoms: Myalgia, Pyrexia, Troponin I, Troponin normal
Clinical narrative: This study case was received from the investigator in a trial on 04 September 2013. A female subject (age and date of birth not reported) had received the following vaccination on 28 August 2013: ACAM2000 (lot number, route and site not reported). The subject also received the following vaccinations on 23 August 2013: typhoid (Manufacturer Unknown, lot number, route and site not reported), and anthrax (Other Manufacturer, lot number, route and site not reported). Five days post smallpox vaccination, on 02 September 2013, the subject was diagnosed with possible myopericarditis. The subject recovered on the same day, 02 September 2013. The subject experienced "flu-like symptoms". The subject experienced the non-serious event of generalized myalgia (start date 30 August 2013, stop date 02 September 2013), was given unspecified medication, and was considered probably related to vaccination. The subject experienced non-serious event of fever (start date 30 August 2013, stop date 02 September 2013), was given unspecified medication, and was considered probably related to vaccination. The subject experienced non-serious ongoing event of headache (start date 30 August 2013), was given unspecified medication, and was considered probably related to vaccination. The subject experienced serious event of shortness of breath while jogging which lasted a couple minutes with no other symptoms (start date 01 September 2013, stop date 01 September 2013) and was considered possibly related to vaccination. The subject experienced serious event of chest pain that was centered at the sternum but did not radiate anywhere else (start date 02 September 2013, stop date 02 September 2013), was a pain level 3, and was considered possibly related to vaccination. The symptoms started when she woke up and lasted until mid-afternoon. The subject experienced serious event of shortness of breath again (start date 02 September 2013, stop date 02 September 2013) and was considered possibly related to vaccination. The ECG from 03 September 2013 was normal and subject was asymptomatic at time of ECG. The troponin I results were still pending. The subject's rapid troponin was negative. Subject circled "0" on the Wong-Baker scale. The subject did not take any medications for treatment. The subject's outcome was recovered on 02 September 2013. According to the Investigator, the event of possible myopericarditis was considered an important event and possibly related. Documents held by sender: None.
Age: 44.0
Sex: F
Vaccine: TD
Symptoms: Injection site cellulitis
Clinical narrative: Case received from a consumer on 05 September 2013. A 44-year-old female patient, with history of allergy to silver sulfadine, Td, had received an intramuscular dose of Td (batch number "U0833AA") in the left deltoid on 25 June 2003. It was unknown if the patient was ill at time of vaccination. On 02 July 2003, the patient presented cellulitis at injection site on left deltoid, requiring a visit to ER/doctor. On an unspecified date the patient fully recovered.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Eye pruritus, Pruritus generalised
Clinical narrative: Initial information was received from a healthcare professional on 06 September 2013 with additional information received on 09 September 2013. A 63-year-old female patient had received an injection of FLUZONE, lot number UH909AA, on 04 September 2013 (route and site not reported). Four to six hours later the patient experienced full body itching which progressed to her eyes the next day. The patient was seen at urgent care and by her own physician. Outcome was not recovered. Documents held by sender: None.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a clinical medical assistant who refers to a patient of unknown age and gender. On 29-AUG-2013 the patient was vaccinated subcutaneously with 0.5 ml an expired dose of M-M-R II HSA (lot # 1293AA, exp. date 09-AUG-2013). No adverse effect reported. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: TDAP
Symptoms: Convulsion, Fatigue, Laboratory test, Musculoskeletal stiffness, Myositis
Clinical narrative: Shot given 02/4/13 at 3 pm by nurse 24 hrs. later I experienced total body convulsions, and stiffness followed by complete exhaustion. Had more episodes in car, ambulance and in ER before being admitted the 1st time on 2/5/13.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a nurse via a company representative concerning an approximately 70 year old (reported as 70-79 year old) male patient. On an unknown date in March 2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. Approximately on an unknown date in 2013, the patient developed shingles after receiving ZOSTAVAX. The patient sought medical attention. The patient went to urgent care center where he was treated with unspecified topical medications. It was unspecified if any lab tests were performed. The outcome of shingles was unknown. The relatedness for shingles was unknown for ZOSTAVAX. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Asthenia, Cyanosis, Depressed level of consciousness, Hypotonia, Oxygen saturation decreased
Clinical narrative: Half an hour after vaccine administered, while in waiting room with mother, patient became pale and limp with change in LOC. Patient found limp and pale with slight cyanosis of lips O2 sat. in high 80's and Heart rate 60s, attempted to give glucose and administered oxygen via nasal cannula with improved O2 sat to 100% - 911 called and pt. transferred to local hospital still weak but responsive.
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Pallor
Clinical narrative: Half an hour after vaccine administered, while in waiting room with mother, patient became pale and limp with change in LOC. Patient found limp and pale with slight cyanosis of lips O2 sat. in high 80's and Heart rate 60s, attempted to give glucose and administered oxygen via nasal cannula with improved O2 sat to 100% - 911 called and pt. transferred to local hospital still weak but responsive.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Diplopia, Herpes zoster, Rash, VIIth nerve paralysis, Vision blurred
Clinical narrative: Guillain Barre? Eye got droopy, blurry vision. April 1st started double vision. 4/15/13 - broke out with rash. 4/17/13 was seen at clinic and placed on meds for shingles. Had on torso chest and back. 4/30/13 saw MD locally sent to see a neurologist and admitted to hospital on 5/8. Released on 7/3. In rehab. Wife called on 9/12/13 to report. She thought hospital had already notified of reaction.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site reaction, Rash
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 60 year old male patient. No drug reaction were reported. The patient previously received PNEUMOVAX23 on 09-APR-2013 and no adverse reaction were reported. On 28-AUG-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # J003798, expiry: 28-JUN-2014). On 30-AUG-2013 (reported as 2 to 3 days after vaccination), the patient developed an injection site reaction and rash following vaccination with ZOSTAVAX. The pharmacist reported that the injection site reaction which developed about 2 to 3 days after the vaccination. The injection site reaction was described initially as a red area at the injection site, which after a couple of days developed into a half-moon shape with raised bumps inside the half-moon shape, described as a rash (pharmacist had a photo of the adverse reaction site). The patient was instructed to use ice packs on the injection site as a treatment. The pharmacist reported that the patient went to see his physician today (name of physician unspecified). The outcome of the events were reported as not recovered. This is 1 of 2 reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: This spontaneous report was received from a male patient of unknown age regarding himself. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23 (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. On an unknown date, the patient experienced injection site pain after receiving PNEUMOVAX23. The outcome of injection site pain was unknown. The relatedness for injection site pain was unknown for PNEUMOVAX23. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a registered pharmacist via a company representative concerning a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. On an unknown date, the patient developed redness, soreness and swelling around injection site. It was unspecified if the patient sought medical attention. It was unspecified if any treatment was provided or if any lab tests were performed. The outcome of redness, soreness and swelling around injection site was unknown. The relatedness for redness, soreness and swelling around injection site was unknown for ZOSTAVAX. Additional information was been requested.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymph node pain, Lymphadenopathy, Rash
Clinical narrative: This spontaneous report was received from a pharmacist via company representative refers to a 52 year old female patient. Approximately on 30-AUG-2013 (reported as approximately 2 weeks ago on a Friday), the patient was vaccinated with a dose of ZOSTAVAX, (lot number, expiry date was not reported and route was subcutaneous). Approximately on 02-SEP-2013 (reported as on following Monday), the patient experienced rash and swelling in her lymph nodes, the pharmacy called the patient to follow up with her experience on the following Wednesday at which time the patient explained that she was showing some improvement in her symptoms specifically that the pain in her lymph nodes had improved however they were still swollen. The patient sought medical attention. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Feeling hot, Injection site erythema, Injection site pain, Vomiting
Clinical narrative: Hot feeling, weak, sore at site of injection previously red. Vomited 3 times within 3 hours today (9/17/13) T-98.8 orally.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Blood creatine phosphokinase increased, Muscular weakness, Pyrexia
Clinical narrative: Fever of 102 on 7-10-13. Fever reducing meds given. On July 27th patient starting having muscle weakness and lasted for 3 wks.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Endotracheal intubation, Gastrointestinal tube insertion, Gastrostomy, Guillain-Barre syndrome, Ophthalmoplegia
Clinical narrative: Recurrence of Guillain-Barre syndrome with ophthalmoplegia, quadriplegia with acute hypercapnic respiratory failure, requiring intubation, trach placement and PEG insertion.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Quadriplegia, Respiratory failure, Tracheostomy
Clinical narrative: Recurrence of Guillain-Barre syndrome with ophthalmoplegia, quadriplegia with acute hypercapnic respiratory failure, requiring intubation, trach placement and PEG insertion.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Malaise, Syncope
Clinical narrative: The patient received vaccination and after approximately 5-10 min. he felt unwell and was sweaty. There was a possibility he would faint. After paramedics arrived, he was diagnosed as having vasovagal syncope. Paramedics cleared patient for release.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Chills, Feeling hot, Headache, Pain
Clinical narrative: Around midnight had severe chills and shakes, severe headache. Woke up around 2:30 am and hot. Took temp 101.6. Took 2 Tylenol. Fever starting coming down. Gone by morning. General body aches. Woke up after 9 AM. All symptoms gone except headache, which subsided after I took over the counter migraine formula. First time ever had reaction. Also racing heartbeat (84bpm) compared to 70 normal. Subsided by morning.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Palpitations, Tremor
Clinical narrative: Around midnight had severe chills and shakes, severe headache. Woke up around 2:30 am and hot. Took temp 101.6. Took 2 Tylenol. Fever starting coming down. Gone by morning. General body aches. Woke up after 9 AM. All symptoms gone except headache, which subsided after I took over the counter migraine formula. First time ever had reaction. Also racing heartbeat (84bpm) compared to 70 normal. Subsided by morning.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Fatigue, Headache, Pain
Clinical narrative: Within several hours after vaccine - vomiting, severe headache, chills, weakness, aches and fatigue. Symptoms improved within 24 hours except for headache and fatigue.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Within several hours after vaccine - vomiting, severe headache, chills, weakness, aches and fatigue. Symptoms improved within 24 hours except for headache and fatigue.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer for FOSAMAX (MARRS#1210USA003120). The patient reported that in 1999 she participated in a double blind clinical trial for shingles. In 2000 she was given a placebo and given a shingles vaccination ZOSTAVAX at the end of the trial. In JAN 2011 the patient experienced shingles. The outcome of shingles was unknown. This is one of several reports from the same source. Additional information is not expected.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Rash generalised, Vomiting
Clinical narrative: Pt has a raised rash over her entire body. She also is nauseous and vomited. Pt has had the flu shot several years in a row with no problems. She couldn't think of any other contributing factor.
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Body temperature, Bone pain, Chills, Cough
Clinical narrative: (R) arm swollen, rash down to fingers, ill, bones and muscles in pain, et al (i.e, ill, diarrhea, abdominal pain, temperature, sweating, chills etc.) One week! Cough respiratory.
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Hyperhidrosis, Local swelling, Malaise, Myalgia
Clinical narrative: (R) arm swollen, rash down to fingers, ill, bones and muscles in pain, et al (i.e, ill, diarrhea, abdominal pain, temperature, sweating, chills etc.) One week! Cough respiratory.
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: (R) arm swollen, rash down to fingers, ill, bones and muscles in pain, et al (i.e, ill, diarrhea, abdominal pain, temperature, sweating, chills etc.) One week! Cough respiratory.
Age: 20.0
Sex: M
Vaccine: FLUN4, SMALL
Symptoms: Abdominal pain upper, Blood creatine phosphokinase MB increased, C-reactive protein increased, Electrocardiogram ST segment elevation, Electrocardiogram abnormal
Clinical narrative: The pt reported that he received his primary SPV in his upper left arm on 29Aug13. He was in his normal state of good health at that time. On 9/8/13 he reported that he had a diffuse, generalized, red, papular (1-3 mm red papular lesions), itchy rash "from head to toe". The rash covered the pt's neck, chest, abdomen, back, arms and was less concentrated on his legs. There were no lesions on the pt's genitalia, in his mouth, on the palms of his hands or the soles of his feet. The pt stated that he thought he had a low grade fever but otherwise he had no complaints (headache, N, V, malaise, generalized body aches). Of note, the pt also reported that he took amoxicillin from Aug 30-Sep 8 after having his wisdom teeth removed. A review of the medical record noted that the pt reports having 3 episodes on 9/4/13 lasting about 10 minutes each relieved with belching. The pt did not note SOB, radiation of the pain, palpitations, N, V, diaphoresis or that the pain was affected by position. The initial EKG was noted to be NSR with ST elevation probably due to early repolarization. The pt was seen in cardiology on 9/6/13; his EKG showed NSR and it was opinioned that this epigastric pain was non-cardiac. On 9/9/13 the pt was seen by his PCM for his rash which was treated with epi 0.3mg, 125mg SOLUMEDROL IV and 25mg BENADRYL po. On 9/10/13 the pt was seen by his PCM who reported that the rash had not progressed and was slightly improved. Additionally, the pt had labs drawn (see lab section). The pt reported complete resolution of his rash on 9/11/13.
Age: 20.0
Sex: M
Vaccine: FLUN4, SMALL
Symptoms: Eructation, Pyrexia, Rash generalised, Rash papular, Rash pruritic
Clinical narrative: The pt reported that he received his primary SPV in his upper left arm on 29Aug13. He was in his normal state of good health at that time. On 9/8/13 he reported that he had a diffuse, generalized, red, papular (1-3 mm red papular lesions), itchy rash "from head to toe". The rash covered the pt's neck, chest, abdomen, back, arms and was less concentrated on his legs. There were no lesions on the pt's genitalia, in his mouth, on the palms of his hands or the soles of his feet. The pt stated that he thought he had a low grade fever but otherwise he had no complaints (headache, N, V, malaise, generalized body aches). Of note, the pt also reported that he took amoxicillin from Aug 30-Sep 8 after having his wisdom teeth removed. A review of the medical record noted that the pt reports having 3 episodes on 9/4/13 lasting about 10 minutes each relieved with belching. The pt did not note SOB, radiation of the pain, palpitations, N, V, diaphoresis or that the pain was affected by position. The initial EKG was noted to be NSR with ST elevation probably due to early repolarization. The pt was seen in cardiology on 9/6/13; his EKG showed NSR and it was opinioned that this epigastric pain was non-cardiac. On 9/9/13 the pt was seen by his PCM for his rash which was treated with epi 0.3mg, 125mg SOLUMEDROL IV and 25mg BENADRYL po. On 9/10/13 the pt was seen by his PCM who reported that the rash had not progressed and was slightly improved. Additionally, the pt had labs drawn (see lab section). The pt reported complete resolution of his rash on 9/11/13.
Age: 20.0
Sex: M
Vaccine: FLUN4, SMALL
Symptoms: Red blood cell sedimentation rate normal, Troponin I normal
Clinical narrative: The pt reported that he received his primary SPV in his upper left arm on 29Aug13. He was in his normal state of good health at that time. On 9/8/13 he reported that he had a diffuse, generalized, red, papular (1-3 mm red papular lesions), itchy rash "from head to toe". The rash covered the pt's neck, chest, abdomen, back, arms and was less concentrated on his legs. There were no lesions on the pt's genitalia, in his mouth, on the palms of his hands or the soles of his feet. The pt stated that he thought he had a low grade fever but otherwise he had no complaints (headache, N, V, malaise, generalized body aches). Of note, the pt also reported that he took amoxicillin from Aug 30-Sep 8 after having his wisdom teeth removed. A review of the medical record noted that the pt reports having 3 episodes on 9/4/13 lasting about 10 minutes each relieved with belching. The pt did not note SOB, radiation of the pain, palpitations, N, V, diaphoresis or that the pain was affected by position. The initial EKG was noted to be NSR with ST elevation probably due to early repolarization. The pt was seen in cardiology on 9/6/13; his EKG showed NSR and it was opinioned that this epigastric pain was non-cardiac. On 9/9/13 the pt was seen by his PCM for his rash which was treated with epi 0.3mg, 125mg SOLUMEDROL IV and 25mg BENADRYL po. On 9/10/13 the pt was seen by his PCM who reported that the rash had not progressed and was slightly improved. Additionally, the pt had labs drawn (see lab section). The pt reported complete resolution of his rash on 9/11/13.