chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Hypertension, Hypoaesthesia, Laboratory test normal
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 25 August 2016. This case involves a female patient (age was not reported) who was vaccinated with a dose of MENACTRA (batch number, expiration date, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, one day following vaccination, patient had stoke and patient was taken to hospital. On an unspecified date, following vaccination, patient was not able to use their right side. On an unspecified date, patient was hospitalized. Lab data and corrective treatment was not reported. Outcome of events was not reported. List of documents held by sender: none. Sender's Comments: This is poorly documented not medically confirmed case in which stroke is reported after administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. However, investigation results ruling out a concurrent infection and other etiologies would be helpful to further assess this case.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Cerebrovascular accident
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 25 August 2016. This case involves a female patient (age was not reported) who was vaccinated with a dose of MENACTRA (batch number, expiration date, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, one day following vaccination, patient had stoke and patient was taken to hospital. On an unspecified date, following vaccination, patient was not able to use their right side. On an unspecified date, patient was hospitalized. Lab data and corrective treatment was not reported. Outcome of events was not reported. List of documents held by sender: none. Sender's Comments: This is poorly documented not medically confirmed case in which stroke is reported after administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. However, investigation results ruling out a concurrent infection and other etiologies would be helpful to further assess this case.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood magnesium normal, Blood phosphorus normal, Electroencephalogram normal, Full blood count normal, Metabolic function test normal
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of seizure in a 4-month-old female patient who received PEDIARIX (batch number 33E9E, expiry date November 2018). Concomitant products included Hib vaccine, PREVNAR and ROTATEQ. On 23rd August 2016, the patient received PEDIARIX .5 ml. On 23rd August 2016, less than a day after receiving PEDIARIX, the patient experienced seizure (serious criteria GSK medically significant and other: serious as per reporter) and unresponsive to stimuli (serious criteria GSK medically significant and other: serious as per reporter). On 23rd August 2016, the outcome of the seizure and unresponsive to stimuli were recovered/resolved. The reporter considered the seizure and unresponsive to stimuli to be possibly related to PEDIARIX. Additional details were provided as follows: The patient received a dose of PEDIARIX in her left thigh. On the same day, the patient received Hib, PREVNAR and ROTATEQ vaccines concomitantly. When the patient's mother went home and nursed her, the patient experienced a seizure. She was unresponsive for 25 minutes. The patient was taken to the emergency room (ER). The blood work came back as normal. The reporter was informed that a follow up would be conducted. This case has been linked with cases US2016125176 and US2016GSK128180, reported by the same reporter.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Seizure like phenomena
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of seizure in a 4-month-old female patient who received PEDIARIX (batch number 33E9E, expiry date November 2018). Concomitant products included Hib vaccine, PREVNAR and ROTATEQ. On 23rd August 2016, the patient received PEDIARIX .5 ml. On 23rd August 2016, less than a day after receiving PEDIARIX, the patient experienced seizure (serious criteria GSK medically significant and other: serious as per reporter) and unresponsive to stimuli (serious criteria GSK medically significant and other: serious as per reporter). On 23rd August 2016, the outcome of the seizure and unresponsive to stimuli were recovered/resolved. The reporter considered the seizure and unresponsive to stimuli to be possibly related to PEDIARIX. Additional details were provided as follows: The patient received a dose of PEDIARIX in her left thigh. On the same day, the patient received Hib, PREVNAR and ROTATEQ vaccines concomitantly. When the patient's mother went home and nursed her, the patient experienced a seizure. She was unresponsive for 25 minutes. The patient was taken to the emergency room (ER). The blood work came back as normal. The reporter was informed that a follow up would be conducted. This case has been linked with cases US2016125176 and US2016GSK128180, reported by the same reporter.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood test normal, Seizure, Unresponsive to stimuli
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of seizure in a 4-month-old female patient who received PEDIARIX (batch number 33E9E, expiry date November 2018). Concomitant products included Hib vaccine, PREVNAR and ROTATEQ. On 23rd August 2016, the patient received PEDIARIX .5 ml. On 23rd August 2016, less than a day after receiving PEDIARIX, the patient experienced seizure (serious criteria GSK medically significant and other: serious as per reporter) and unresponsive to stimuli (serious criteria GSK medically significant and other: serious as per reporter). On 23rd August 2016, the outcome of the seizure and unresponsive to stimuli were recovered/resolved. The reporter considered the seizure and unresponsive to stimuli to be possibly related to PEDIARIX. Additional details were provided as follows: The patient received a dose of PEDIARIX in her left thigh. On the same day, the patient received Hib, PREVNAR and ROTATEQ vaccines concomitantly. When the patient's mother went home and nursed her, the patient experienced a seizure. She was unresponsive for 25 minutes. The patient was taken to the emergency room (ER). The blood work came back as normal. The reporter was informed that a follow up would be conducted. This case has been linked with cases US2016125176 and US2016GSK128180, reported by the same reporter.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13
Symptoms: Chest X-ray normal, Irritability, Pyrexia, Screaming, Urine analysis normal
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of irritability in a 2-month-old female patient who received PEDIARIX (batch number 33E9E, expiry date November 2018). Previously administered products included Antibiotics (prior vaccination with PEDIARIX). Concomitant products included Hib vaccine and PREVENAR. On 23rd August 2016, the patient received PEDIARIX .5 ml. On 23rd August 2016, less than a day after receiving PEDIARIX, the patient experienced irritability (serious criteria other: serious as per reporter), swelling of legs (serious criteria other: serious as per reporter), screaming (serious criteria other: serious as per reporter) and redness of legs (serious criteria other: serious as per reporter). The patient was treated with TYLENOL. On an unknown date, the outcome of the irritability, swelling of legs, screaming and redness of legs were unknown. The reporter considered the irritability to be probably related to PEDIARIX. The reporter considered the swelling of legs, screaming and redness of legs to be possibly related to PEDIARIX. Additional details were provided as follows: The patient received a dose of PEDIARIX on her left thigh. The patient concomitantly received Hib and PREVENAR vaccines at the same time. At 10:30 am, the patient was fussy and at 3:30 pm, she was screaming, her leg was swollen and red. The patient's mother gave the patient TYLENOL. The patient came back to physician's office and she was still fussy. The mother took the patient to emergency room (ER) where they took white blood cell (WBC) count and it came back as normal. The reporter was informed that a follow up would be conducted. This case has been linked with cases US2016GSK128179 and US2016GSK128180, reported by the same reporter.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13
Symptoms: White blood cell count increased
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of irritability in a 2-month-old female patient who received PEDIARIX (batch number 33E9E, expiry date November 2018). Previously administered products included Antibiotics (prior vaccination with PEDIARIX). Concomitant products included Hib vaccine and PREVENAR. On 23rd August 2016, the patient received PEDIARIX .5 ml. On 23rd August 2016, less than a day after receiving PEDIARIX, the patient experienced irritability (serious criteria other: serious as per reporter), swelling of legs (serious criteria other: serious as per reporter), screaming (serious criteria other: serious as per reporter) and redness of legs (serious criteria other: serious as per reporter). The patient was treated with TYLENOL. On an unknown date, the outcome of the irritability, swelling of legs, screaming and redness of legs were unknown. The reporter considered the irritability to be probably related to PEDIARIX. The reporter considered the swelling of legs, screaming and redness of legs to be possibly related to PEDIARIX. Additional details were provided as follows: The patient received a dose of PEDIARIX on her left thigh. The patient concomitantly received Hib and PREVENAR vaccines at the same time. At 10:30 am, the patient was fussy and at 3:30 pm, she was screaming, her leg was swollen and red. The patient's mother gave the patient TYLENOL. The patient came back to physician's office and she was still fussy. The mother took the patient to emergency room (ER) where they took white blood cell (WBC) count and it came back as normal. The reporter was informed that a follow up would be conducted. This case has been linked with cases US2016GSK128179 and US2016GSK128180, reported by the same reporter.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13
Symptoms: Erythema, Irritability, Peripheral swelling, Screaming, White blood cell count normal
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of irritability in a 2-month-old female patient who received PEDIARIX (batch number 33E9E, expiry date November 2018). Previously administered products included Antibiotics (prior vaccination with PEDIARIX). Concomitant products included Hib vaccine and PREVENAR. On 23rd August 2016, the patient received PEDIARIX .5 ml. On 23rd August 2016, less than a day after receiving PEDIARIX, the patient experienced irritability (serious criteria other: serious as per reporter), swelling of legs (serious criteria other: serious as per reporter), screaming (serious criteria other: serious as per reporter) and redness of legs (serious criteria other: serious as per reporter). The patient was treated with TYLENOL. On an unknown date, the outcome of the irritability, swelling of legs, screaming and redness of legs were unknown. The reporter considered the irritability to be probably related to PEDIARIX. The reporter considered the swelling of legs, screaming and redness of legs to be possibly related to PEDIARIX. Additional details were provided as follows: The patient received a dose of PEDIARIX on her left thigh. The patient concomitantly received Hib and PREVENAR vaccines at the same time. At 10:30 am, the patient was fussy and at 3:30 pm, she was screaming, her leg was swollen and red. The patient's mother gave the patient TYLENOL. The patient came back to physician's office and she was still fussy. The mother took the patient to emergency room (ER) where they took white blood cell (WBC) count and it came back as normal. The reporter was informed that a follow up would be conducted. This case has been linked with cases US2016GSK128179 and US2016GSK128180, reported by the same reporter.
Age: 31.0
Sex: M
Vaccine: TDAP, TYP
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Severe pain in arm and shoulder, loss of range of motion in arm.
Age: 53.0
Sex: M
Vaccine: PPV
Symptoms: Activities of daily living impaired, Asthenia, Impaired work ability, Mobility decreased, Musculoskeletal pain
Clinical narrative: I awoke to severe pain in my shoulder and could not lift my arm.  The pain persisted throughout the evening despite taking Advil so much that I was unable to find a comfortable sleeping position.  No change this morning.  I am unable to lift my arm and am not able to do normal household chores or work efficiently. I am a computer administrator and can't even lift my arm to type on the keyboard.  The pain feels like a deep bone bruise. I hope this goes away soon because I am completely debilitated in my left arm.  I've never had pain like this before from any injection ever!
Age: 53.0
Sex: M
Vaccine: PPV
Symptoms: Sleep disorder
Clinical narrative: I awoke to severe pain in my shoulder and could not lift my arm.  The pain persisted throughout the evening despite taking Advil so much that I was unable to find a comfortable sleeping position.  No change this morning.  I am unable to lift my arm and am not able to do normal household chores or work efficiently. I am a computer administrator and can't even lift my arm to type on the keyboard.  The pain feels like a deep bone bruise. I hope this goes away soon because I am completely debilitated in my left arm.  I've never had pain like this before from any injection ever!
Age: 26.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Soreness, swelling and redness of left arm.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Furuncle, Vaccination site induration, Vaccination site pain, Vaccination site reaction
Clinical narrative: Huge boil covering inside of upper arm that stretched from elbow to shoulder. It was on the same arm that vaccine was given, opposite side of arm, however. Area where the vaccine was actually administered felt hard and was painful upon touching.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pain, Pyrexia
Clinical narrative: Fever, aches, erythema, and swelling at injection site. Patient reported to ER getting vaccine at 11am eating seafood seafood that night (known shellfish allergy) and then having injection site redness, swelling and felling achy. Oral temp of 100 degrees noted on ER report.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Blood test, Chest X-ray, Computerised tomogram, Dizziness
Clinical narrative: Trouble speaking, dizziness, trouble walking, weakness-almost fell (I caught her). Got her inside, sat her down, got her a drink of tea. She seemed ok at that point, but did call after hours doctor. Told to check blood pressure (a little high, but not out of norm). Doctor said the shot did not cause.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Electrocardiogram, Gait disturbance, Nuclear magnetic resonance imaging brain, Speech disorder, Ultrasound scan
Clinical narrative: Trouble speaking, dizziness, trouble walking, weakness-almost fell (I caught her). Got her inside, sat her down, got her a drink of tea. She seemed ok at that point, but did call after hours doctor. Told to check blood pressure (a little high, but not out of norm). Doctor said the shot did not cause.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Confluent redness left upper arm onto the shoulder, warm and tender. Secondary cellulitis.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm, Sleep disorder, Tenderness
Clinical narrative: Redness and swelling of upper arm (more than normal).  Pt could not sleep on that arm for 2 nights, was painful to the touch and warm.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Vomiting & diarrhea. The vomiting lasted for about 5 minutes & resulted in 5 or 6 purges. Diarrhea lasted on & off until 09/02/2016. The only treatment given was Pedialyte.
Age: 73.0
Sex: M
Vaccine: PNC13
Symptoms: Back pain, Immunoglobulin therapy, Muscular weakness, Paraesthesia
Clinical narrative: Back pain, tingling in fingers, weakness bilateral lower extremities, bilateral upper extremities. Pt treated with IVIG. Pt currently in rehab facility.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Computerised tomogram, Electrocardiogram, Full blood count, Hypotension, Injection site inflammation
Clinical narrative: Wed-Swelling and inflammation at injection site; Thurs-Sat nausea, fever; Sunday passed out; symptoms progressed until Friday. Went to ER and was admitted to hospital for 3 days with extremely low blood pressure and pain both of unknown origin. Continues to experience symptoms.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site swelling, Laboratory test, Loss of consciousness, Nausea, Nuclear magnetic resonance imaging brain
Clinical narrative: Wed-Swelling and inflammation at injection site; Thurs-Sat nausea, fever; Sunday passed out; symptoms progressed until Friday. Went to ER and was admitted to hospital for 3 days with extremely low blood pressure and pain both of unknown origin. Continues to experience symptoms.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Pyrexia, Ultrasound biliary tract
Clinical narrative: Wed-Swelling and inflammation at injection site; Thurs-Sat nausea, fever; Sunday passed out; symptoms progressed until Friday. Went to ER and was admitted to hospital for 3 days with extremely low blood pressure and pain both of unknown origin. Continues to experience symptoms.
Age: 91.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site rash, Pyrexia
Clinical narrative: RASH TO INJECTION SITE, HEADACHE, FEVER, CHILLS.
Age: 12.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Arm swelling at injection site with severe pain. 12 hours later redness developed at site. Approx 10cm ring of redness. Tylenol, ice, and Benadryl given. 48 hours later still with pain, swelling, and redness, although lessened in severity.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: On 30 Aug, around 7pm we notice his right arm starting to swell just below the bandaid which was kept on after the shot the day prior. We thought it was a mosquito bite. The next day around 10am his daycare called stating there was a lot of swelling on his arm. We dismissed it and told them it was a mosquito bite because he does tend to swell a lot. When he arrived home around 5pm I saw his whole upper right arm (between his elbow and shoulder) was swollen and hot to the touch. I asked him if it hurt or was it itchy. His answer was no to both. I then gave him a dose of Benadryl and put an ice pack on the site. Around 9pm I gave him another round of Benadryl right before bed. The next morning I called his doctor for an appointment because the site was still very swollen and hot to the touch.
Age: 75.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Prevnar 13 was administered on 09/18/15, and then a second dose on 09/02/16. No adverse effects reported as of the filing of this report.
Age: 18.0
Sex: M
Vaccine: HPV9, MNQ, VARCEL
Symptoms: Pruritus, Rash generalised, Urticaria
Clinical narrative: When patient works out he breaks out in rash all over body. Develops hives on top of hives. Very itchy.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Injection site pain, Nausea, Pyrexia
Clinical narrative: Nausea, light headed, dizziness, severe pain at injection site, fever 102.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Red, swollen, painful arm at and around injection site.
Age: 19.0
Sex: M
Vaccine: HPV9, TDAP
Symptoms: Erythema, Headache, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Fever 101F, headache, arm redness, swelling, pain.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMRV, PNC13, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: None. Child was given MMRV and Varicella in the same day. Followed local reporting procedures, MD and mother notified. Reviewed potential risks to monitor for with mother as per MD, MPH, FACP, FIDSA recommendations. Continued to monitor through days 5-12 as instructed. Mother reported child is doing well with no adverse symptoms.
Age: 11.0
Sex: F
Vaccine: HPVX
Symptoms: Condition aggravated, Platelet count decreased, Thrombocytopenia
Clinical narrative: Thrombocytopenia worsened, levels previously >10k and now thrombocytopenia with baseline levels less than 10k.
Age: 60.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Peripheral swelling, Rash, Skin warm
Clinical narrative: Rash, swollen arm, from shoulder to elbow, hot to touch, painful.
Age: 75.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: No adverse event
Clinical narrative: Contacted patient 9-2-16 no side effects.
Age: 73.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: No adverse event
Clinical narrative: None.
Age: 31.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injected limb mobility decreased, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: The patient's arm swoll up to the size of a baseball, it was hot and red and patient stated difficulty moving arm up and down due to soreness.
Age: 57.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis at or near injection site.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Disorientation, Feeling jittery, Heart rate decreased, Hunger, Nausea
Clinical narrative: Became jittery, looked very pale, was nauseous and gagging, seemed disoriented. HR mildly low (55-60) but good cap refill, normal O2 sat, normal BP. Lasted about 5 minutes, then became hungry.  Returned to baseline after eating a banana and felt completely normal afterward.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Pallor, Retching
Clinical narrative: Became jittery, looked very pale, was nauseous and gagging, seemed disoriented. HR mildly low (55-60) but good cap refill, normal O2 sat, normal BP. Lasted about 5 minutes, then became hungry.  Returned to baseline after eating a banana and felt completely normal afterward.
Age: 25.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Peripheral swelling, Rash
Clinical narrative: SWELLING HALF OF ARM AND RASH DOWN ARM.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Back pain, Differential white blood cell count, Dyspnoea, Full blood count
Clinical narrative: Muscle ache, Headache, Hip Joint Pain, Shortness of Breath, Neck Pain, swollen glands in neck and throat, Back pain, tingling legs/feet, slight numbness of legs.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Hypoaesthesia, Lymphadenopathy, Myalgia, Neck pain
Clinical narrative: Muscle ache, Headache, Hip Joint Pain, Shortness of Breath, Neck Pain, swollen glands in neck and throat, Back pain, tingling legs/feet, slight numbness of legs.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia, Red blood cell sedimentation rate
Clinical narrative: Muscle ache, Headache, Hip Joint Pain, Shortness of Breath, Neck Pain, swollen glands in neck and throat, Back pain, tingling legs/feet, slight numbness of legs.
Age: 29.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Erythema, Mobility decreased, Peripheral swelling, Skin warm
Clinical narrative: Patient stated the following: Swollen, Tomato Red, Hot to Touch, Dead-arm.
Age: 0.64
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Electroencephalogram normal, Muscle contractions involuntary, Seizure, Tic
Clinical narrative: Small seizures. Arms straightened, flexed, fists clenched. Chin to chest, and jaw ticked back and forth.
Age: 44.0
Sex: F
Vaccine: FLUC4, TDAP
Symptoms: Asthenia, Cardiac stress test normal, Fatigue, Hypersomnia, Palpitations
Clinical narrative: Post vaccination felt weak and fatigued, slept all day on 8/30 then developed palpitations, came to emergency room in evening and ER MD admitted as observation patient to hospital just after midnight, patient had stress test done 8/31 and cardiac event ruled out, patient was sent home. ER MD notes and admitting physician notes did not think event was cardiac related rather viral syndrome vs vaccine reaction
Age: 44.0
Sex: F
Vaccine: FLUC4, TDAP
Symptoms: Vaccination complication, Viral infection
Clinical narrative: Post vaccination felt weak and fatigued, slept all day on 8/30 then developed palpitations, came to emergency room in evening and ER MD admitted as observation patient to hospital just after midnight, patient had stress test done 8/31 and cardiac event ruled out, patient was sent home. ER MD notes and admitting physician notes did not think event was cardiac related rather viral syndrome vs vaccine reaction
Age: 1.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Patient was given a dose of Proquad and Varicella at the same time resulting in over vaccination.
Age: 30.0
Sex: M
Vaccine: HEPA
Symptoms: Hypersensitivity, Throat tightness
Clinical narrative: Allergic feeling (throat fullness).
Age: 20.0
Sex: F
Vaccine: HEPA
Symptoms: Diarrhoea, Gingival swelling, Nausea, Vomiting
Clinical narrative: Gave vaccination around 10 am 8/29/16. talk to pt 9/2/16 and said that swelling of gums, n/v, and diarrhea happened late Tuesday night(8/30/16)/early Wednesday morning (9/1/16). Pt is back to work today 9/2/16.
Age: 6.0
Sex: F
Vaccine: HEP
Symptoms: Extra dose administered, Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Patient was given a Hepatitis B shot that she did not need. She had already completed the shot series 3/25/2011. We transferred to the area 2 months ago and shots were transcribed into the system and they were not transcribed properly. The technician did not verify that everything had transferred over and told me that she needed this shot. Later that day she developed a rash on her leg from the shot. It was very red, hot and itchy. The rash stayed there for over 2 weeks.
Age: 0.75
Sex: M
Vaccine: HEP
Symptoms: Blood test, Dizziness, Dyskinesia, Ear, nose and throat examination, Electroencephalogram normal
Clinical narrative: Child had seizure like convulsions immediately after the shot. Episodes of eye rolling and arms up increased during the next 2 weeks- ranging from 8x per day to 50 times per day. EEG test was done to rule out seizures- no seizure activity was recorded. All the doctors are uncertain why it appears the child has convulsion like activity. Child was also dizzy and had difficulty with cruising and crawling.
Age: 0.75
Sex: M
Vaccine: HEP
Symptoms: Eye movement disorder, Gastrointestinal examination, Immediate post-injection reaction, Inability to crawl, Neurological examination
Clinical narrative: Child had seizure like convulsions immediately after the shot. Episodes of eye rolling and arms up increased during the next 2 weeks- ranging from 8x per day to 50 times per day. EEG test was done to rule out seizures- no seizure activity was recorded. All the doctors are uncertain why it appears the child has convulsion like activity. Child was also dizzy and had difficulty with cruising and crawling.
Age: 0.75
Sex: M
Vaccine: HEP
Symptoms: Ophthalmological examination, Seizure like phenomena
Clinical narrative: Child had seizure like convulsions immediately after the shot. Episodes of eye rolling and arms up increased during the next 2 weeks- ranging from 8x per day to 50 times per day. EEG test was done to rule out seizures- no seizure activity was recorded. All the doctors are uncertain why it appears the child has convulsion like activity. Child was also dizzy and had difficulty with cruising and crawling.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Expired product administered
Clinical narrative: The vaccine that was administered to the patient expired on 4/23/2016.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Injection site pain, Mobility decreased
Clinical narrative: The pain started at the same time she got the shot and got progressively worse. She can barely use her arm. There is no swelling however she cannot even raise her arm. My other daughters had no side affects. But patient is in serious pain and has significant mobility issues.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Initially with pain at site, the swelling continued over 1.5 weeks then slowly decreased.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Swelling
Clinical narrative: Start of swelling, no pain, no erythema. Continue to grow in size at time of evaluation.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Blood pressure increased, Fatigue, Injection site urticaria, Local swelling, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of thirst in a 69-year-old female patient who received FLUARIX TETRA (batch number HX3XT, expiry date 29th June 2017). The patient's past medical history included hypothyroidism, diabetes and thyroidectomy. Concurrent medical conditions included reaction to drug preservatives (allergy to various preservatives). Concomitant products included glimepiride and Thyroid Medication. On 24th August 2016, the patient received FLUARIX TETRA (intramuscular). On 24th August 2016, 10 min after receiving FLUARIX TETRA, the patient experienced thirst (serious criteria other: serious as per reporter), injection site hives (serious criteria other: serious as per reporter), rash (serious criteria other: serious as per reporter), local swelling (serious criteria other: serious as per reporter), pain in extremity (serious criteria other: serious as per reporter), fatigue (serious criteria other: serious as per reporter) and increased blood pressure (serious criteria other: serious as per reporter). The patient was treated with BENADRYL. On 25th August 2016, the outcome of the thirst, injection site hives, local swelling, pain in extremity, fatigue and increased blood pressure were recovered/resolved. On an unknown date, the outcome of the rash was not recovered/not resolved. The reporter considered the thirst, injection site hives, rash, local swelling, pain in extremity, fatigue and increased blood pressure to be almost certainly related to FLUARIX TETRA. Additional details were provided as follows: This case was previously reported to a doctor. The patient received a FLUARIX vaccine 2016-2017 strain on her left arm at her private physician's office. The patient began to feel parched. She went home and was feeling fatigue. The patient also noted red bumps on her arm, but nothing around the injection site. The patient felt pain in her arms and legs. The patient's blood pressure went from 126 per 78 to 154 per 92. The patient went to urgent care and was observed for two hours and given an injection of BENADRYL. On the next day, the symptoms were resolved except some rash on her left forearm.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Rash erythematous, Thirst
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of thirst in a 69-year-old female patient who received FLUARIX TETRA (batch number HX3XT, expiry date 29th June 2017). The patient's past medical history included hypothyroidism, diabetes and thyroidectomy. Concurrent medical conditions included reaction to drug preservatives (allergy to various preservatives). Concomitant products included glimepiride and Thyroid Medication. On 24th August 2016, the patient received FLUARIX TETRA (intramuscular). On 24th August 2016, 10 min after receiving FLUARIX TETRA, the patient experienced thirst (serious criteria other: serious as per reporter), injection site hives (serious criteria other: serious as per reporter), rash (serious criteria other: serious as per reporter), local swelling (serious criteria other: serious as per reporter), pain in extremity (serious criteria other: serious as per reporter), fatigue (serious criteria other: serious as per reporter) and increased blood pressure (serious criteria other: serious as per reporter). The patient was treated with BENADRYL. On 25th August 2016, the outcome of the thirst, injection site hives, local swelling, pain in extremity, fatigue and increased blood pressure were recovered/resolved. On an unknown date, the outcome of the rash was not recovered/not resolved. The reporter considered the thirst, injection site hives, rash, local swelling, pain in extremity, fatigue and increased blood pressure to be almost certainly related to FLUARIX TETRA. Additional details were provided as follows: This case was previously reported to a doctor. The patient received a FLUARIX vaccine 2016-2017 strain on her left arm at her private physician's office. The patient began to feel parched. She went home and was feeling fatigue. The patient also noted red bumps on her arm, but nothing around the injection site. The patient felt pain in her arms and legs. The patient's blood pressure went from 126 per 78 to 154 per 92. The patient went to urgent care and was observed for two hours and given an injection of BENADRYL. On the next day, the symptoms were resolved except some rash on her left forearm.
Age: 66.0
Sex: M
Vaccine: MMR, PPV, VARZOS
Symptoms: Abdominal pain, Biopsy skin, Body temperature increased, Fatigue, Herpes zoster disseminated
Clinical narrative: This spontaneous report was received from a physician referring to a 67 years old male patient with non-Hodgkin's lymphoma. The patient's medical history included stem cell transplant 2 years ago and he had no allergy history. It was reported that the patient was not exposed to chickenpox or shingles. On 16-AUG-2016, the patient was vaccinated with ZOSTAVAX injection, M-M-R II injection and PNEUMOVAX 23 injection, recommended by his physician (strength, lot number, expiration dates, and route of administration were not provided for all the vaccines). Concomitant therapies included atenolol, lorazepam, omeprazole (manufacturer unknown), tamsulosin hydrochloride, temazepam, pantoprazole and LEXAPRO, and intravenous acyclovir. The physician reported that on 23-AUG-2016, the patient was admitted to a medical center due to nausea and abdominal pain which began on an unspecified date in August 2016. The physician stated that it was determined in an unspecified way that the patient had transaminitis and high lipase levels on unspecified date. On 24-AUG-2016, the patient experienced fatigue, rash papulovesicular, herpes zoster disseminated. It was reported that the maximum temperature was 102 (units unspecified). The reporter also stated that the number of lesions of the rash papulovesicular were "too innumerable to count" and were located on the patient's torso and limbs. On 26-AUG-2016, the physician stated that the patient was transferred to another medical center for an unspecified reason. On 29-AUG-2016, A sample was obtained from the patient's skin where the lesion was located. The outcome of the abdominal pain, nausea, transaminitis, high lipase was unknown. The outcome of the rash papulovesicular, fatigue, abdominal pain and herpes zoster disseminated was not resolved. The relationship between the events and the suspect drugs was unknown. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: MMR, PPV, VARZOS
Symptoms: Lipase increased, Nausea, Rash, Rash papular, Transaminases increased
Clinical narrative: This spontaneous report was received from a physician referring to a 67 years old male patient with non-Hodgkin's lymphoma. The patient's medical history included stem cell transplant 2 years ago and he had no allergy history. It was reported that the patient was not exposed to chickenpox or shingles. On 16-AUG-2016, the patient was vaccinated with ZOSTAVAX injection, M-M-R II injection and PNEUMOVAX 23 injection, recommended by his physician (strength, lot number, expiration dates, and route of administration were not provided for all the vaccines). Concomitant therapies included atenolol, lorazepam, omeprazole (manufacturer unknown), tamsulosin hydrochloride, temazepam, pantoprazole and LEXAPRO, and intravenous acyclovir. The physician reported that on 23-AUG-2016, the patient was admitted to a medical center due to nausea and abdominal pain which began on an unspecified date in August 2016. The physician stated that it was determined in an unspecified way that the patient had transaminitis and high lipase levels on unspecified date. On 24-AUG-2016, the patient experienced fatigue, rash papulovesicular, herpes zoster disseminated. It was reported that the maximum temperature was 102 (units unspecified). The reporter also stated that the number of lesions of the rash papulovesicular were "too innumerable to count" and were located on the patient's torso and limbs. On 26-AUG-2016, the physician stated that the patient was transferred to another medical center for an unspecified reason. On 29-AUG-2016, A sample was obtained from the patient's skin where the lesion was located. The outcome of the abdominal pain, nausea, transaminitis, high lipase was unknown. The outcome of the rash papulovesicular, fatigue, abdominal pain and herpes zoster disseminated was not resolved. The relationship between the events and the suspect drugs was unknown. Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Bacterial infection, Blood count abnormal, Hypotension, Pyrexia, Rash erythematous
Clinical narrative: Patient stated that 2 days after receiving 2 vaccines there appeared red round spots on the forehead and top of head of the patient. Then 6 days later he came down with a 102 degree F fever and went to the ER at hospital. The prescriber told him that he is septic and has a low BP and low blood count, and prescribed LEVAQUIN. Patient said he will return to hospital if he doesn't recover.
Age: 59.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Sepsis
Clinical narrative: Patient stated that 2 days after receiving 2 vaccines there appeared red round spots on the forehead and top of head of the patient. Then 6 days later he came down with a 102 degree F fever and went to the ER at hospital. The prescriber told him that he is septic and has a low BP and low blood count, and prescribed LEVAQUIN. Patient said he will return to hospital if he doesn't recover.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: Pt was shaking around 2pm. Shot was given around 9:30 am.
Sex: M
Vaccine: FLU4
Symptoms: Congenital cystic kidney disease, Foetal exposure during pregnancy, Premature baby
Clinical narrative: This retrospective pregnancy case was reported by a nurse and described the occurrence of cystic kidney disease in a neonate male patient exposed to FLUARIX Quadrivalent 2015-2016 season (batch number 25L53, expiry date 30th June 2016) in utero. The mother received the product. The parent's medical history included previous pregnancies included 1 normal birth. On 11th January 2016, the 21-year-old mother received FLUARIX Quadrivalent 2015-2016 season (intramuscular) .5 ml. The mother's last menstrual period was on 17th September 2015 and estimated date of delivery was 17th June 2016. The patient was exposed to FLUARIX Quadrivalent 2015-2016 season at week 16 of gestation and during the second trimester of pregnancy. At 35 weeks and 3 days, the patient was born via vaginal delivery and weighed 2830 grams (6lbs 4oz) at birth. APGAR scores were 8 and 9. The patient was diagnosed with cystic kidney disease (serious criteria GSK medically significant) and maternal vaccine exposure. On an unknown date, the outcome of the cystic kidney disease and maternal vaccine exposure were unknown. It was unknown if the reporter considered the cystic kidney disease to be related to FLUARIX Quadrivalent 2015-2016 season. See case US2016GSK003242 for details regarding the mother case. Additional details were provided as follows: The patient was born with left cystic kidney disease. The birth defect was evident from prenatal test.
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Patient felt lightheaded/faint after receiving vaccine. Gave patient juice box and had her sit for approximately 15 minutes. Patient and mom then said she felt better and was ok to go.
Sex: F
Vaccine: TDAP
Symptoms: Flushing, Lethargy, Pyrexia, Screaming, Tremor
Clinical narrative: Woke up from sleep screaming and had about a minute long shaking episode followed by a period of lethargy. Face was flushed, fever 100.3.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Post herpetic neuralgia, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old male patient. There was none pertinent medical history, concurrent conditions or drug reactions/allergies reported. On 29-AUG-2016, the patient was vaccinated with a dose of ZOSTAVAX (lot # M018593, expiration date 28-JUN-2017 (concentration and dose were not reported). administered via subcutaneous . Concomitant therapy was not reported. On 25-AUG-2016, the patient experienced a rash on his neck with associated herpetic neuralgia (post herpetic neuralgia). The patient saw a health care professional (HCP) who ordered Acyclovir for the rash. Varicella Zoster Virus lgG ELISA kit/(VZV) was offered and refused. Packet not faxed. At the reporting time, the outcome of post herpetic neuralgia and neck rash was reported as not recovered. The relationship between ZOSTAVAX and the events was unknown. A product quality complaint (PQC) was not involved. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Erythema, Fatigue, Myalgia, Pyrexia
Clinical narrative: Fever - low grade (8/11/16 - today), myalgia, dizziness, fatigue. Took CLARITIN to stop redness, ALEVE for pain.
Age: 9.0
Sex: F
Vaccine: HEP, HEPA, IPV, MMR, TDAP, VARCEL
Symptoms: Dyspnoea, Wheezing
Clinical narrative: Pt was behind on immunizations, was given what was due and behind on, after approx. 1/2 hr pt was still in wait room and started having SOB and wheezing. Was given O2 by mask, 25 mg BENADRYL and Albuterol TX. Pt was able to breath normally and was transferred to ER by ambulance for further eval.
Age: 49.0
Sex: M
Vaccine: DTP, PPV
Symptoms: Chills, Cough, Dyspnoea, Injection site erythema, Injection site swelling
Clinical narrative: Pt presented to the ER 03/30/16 reports bodyaches, fever, chills, sneezing, sore throat, and non-productive cough since 03/28/16 after vaccinations. L deltoid is warm to touch and slightly swollen at injection site. Fever and cough wheeze. Diphenhydramine 25 mg once.
Age: 49.0
Sex: M
Vaccine: DTP, PPV
Symptoms: Injection site warmth, Oropharyngeal pain, Pain, Pharyngeal oedema, Pyrexia
Clinical narrative: Pt presented to the ER 03/30/16 reports bodyaches, fever, chills, sneezing, sore throat, and non-productive cough since 03/28/16 after vaccinations. L deltoid is warm to touch and slightly swollen at injection site. Fever and cough wheeze. Diphenhydramine 25 mg once.
Age: 49.0
Sex: M
Vaccine: DTP, PPV
Symptoms: Sneezing, Wheezing
Clinical narrative: Pt presented to the ER 03/30/16 reports bodyaches, fever, chills, sneezing, sore throat, and non-productive cough since 03/28/16 after vaccinations. L deltoid is warm to touch and slightly swollen at injection site. Fever and cough wheeze. Diphenhydramine 25 mg once.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, VARCEL
Symptoms: Inappropriate schedule of drug administration, Incorrect route of drug administration
Clinical narrative: Varicella was given IM on 8/11/16; MMR and Polio were given IM on 8/18/16 - too early. Parents have been informed.
Age: 76.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Pain in extremity
Clinical narrative: Pt is complaining of right arm pain since vaccine. Pt states she has come in a few times to speak to the pharmacist who gave it to her but she was not here. She says her arm hurts to move it backward. Has been to her MD who recommended Physical therapy.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: LF deltoid region, swelling - red, hyperemia, tender to touch, size 6.5 x 7". No discharge - sharp margin.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Swelling, redness and warmth from just above shoulder down to elbow and around arm circumferentially.
Age: 20.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: Patient with red indurated elevated patch to injection site (2 cm) with surrounding light red flat area (10 x 15 cm). Mildly tender and mildly itchy. No fever, no body aches.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: On evening following vaccine administration, left arm injection site sore and slightly red. Next day large, hot, swollen, red area at injection site. No streaks. No treatment needed.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Asthenia, Chills, Decreased appetite, Headache
Clinical narrative: She says she woke up the next morning with a bad headache, stomach ache, vomiting, fever, chills, body aches and no appetite. She reports having had no energy through 6/8/16.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: She says she woke up the next morning with a bad headache, stomach ache, vomiting, fever, chills, body aches and no appetite. She reports having had no energy through 6/8/16.
Age: 22.0
Sex: M
Vaccine: ANTH, JEV1, SMALL, TYP
Symptoms: Pain, Rash, Skin lesion
Clinical narrative: Rash on bilateral palms and knuckles. Painful lesions. TEMOVATE was prescribed - informed to F/U in 7 days.
Age: 5.0
Sex: F
Vaccine: DTAP, MMRV
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis left upper arm. Treated with antibiotics.
Age: 55.0
Sex: F
Vaccine: HEP, MMR, TDAP
Symptoms: Fatigue, Malaise, Pain
Clinical narrative: Extreme fatigue, aches all over began 6/2/16 eve and lasted several days. Took OTC meds and rested. She was ill for a week.
Age: 84.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Vaccine administered at 3:30pm on  8/21/2016. That night she had swelling in area then it has migrated down arm and near elbow. Patient stated it hurts but arm functioned.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Hyperhidrosis, Immediate post-injection reaction, Nausea, Syncope
Clinical narrative: First given TDAP vaccine. Few minutes later, patient given GARDASIL 9 and MENACTRA. Pt immediately felt lightheaded, nausea, sweaty. Pt then collapsed to ground and few seconds later, pt woke up. Cool pack placed on neck, given fluids. Pt recovered well approx. 15-20 min. later.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: 2:33 pm: mother reports pt vomited, pt reports feeling faint and nauseous. Pt is perspiring. Vomit is on the floor. Pt assist to room, helped to laying position with feet elevated. Cold washcloth placed on forehead. Given cold water to sip. 2:40 pt feels better and leaves clinic.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema
Clinical narrative: Red.