chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Generalised tonic-clonic seizure
Clinical narrative: On 3/8/15 late afternoon/evening patient was transported to hospital ED after experiencing a witnessed grand mal seizure. Pt has no hx of sz.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Erythema, Hypoacusis
Clinical narrative: This spontaneous report was received from a 69 year old female patient with allergy to amoxicillin. No medical history was reported. On an unspecified date in 2000, the patient was vaccinated with ZOSTAVAX (dose, strength, frequency, route of administration and lot number were not provided). Other suspect therapies included PNEUMOVAX 23 (dose, strength, frequency, route of administration and lot number were not provided), applied two weeks after ZOSTAVAX (dose, strength, frequency, route of administration and lot number were not provided). Concomitant therapies included levothyroxine (manufacturer unknown). On 04-MAR-2015, the patient experienced erythema ("spider like bite pimple that started on the back of the ear, the red spot had grown to her right temple area just above her eye, area that looked like a curling iron was rolled across it, not blistered however"). Patient also mentioned that she had recently on an unspecified date needed hearing aids (hypoacusis). Patient sought medical attention and the erythema was treated with famciclovir and also an unspecified blood test was performed (unspecified results). At the time of the report, the outcome of hypoacusis and erythema was unknown. The causal relationship between the events and vaccination with ZOSTAVAX and PNEUMOVAX 23 was unknown. Upon internal review the event hypoacusis was determined to be medically significant. Additional information has been requested.
Age: 1.02
Sex: M
Vaccine: MMR
Symptoms: Cyanosis, Hyperglycaemia, Hypothermia, Screaming, Seizure
Clinical narrative: BEGINNING THE EVENING OF THE DAY THE BABY WAS VACCINATED, HE HAD LONG PERIODS (SEVERAL HOURS) OF INCONSOLABLE SCREAMING.  THIS CONTINUED UNTIL THE MORNING OF 03/06/2014, AT WHICH POINT HE EXPERIENCED ABOUT 30 MINUTES OF INTERMITTENT SEIZURE ACTIVITY, FOLLOWED BY A PERIOD OF UNRESPONSIVENESS, CYANOSIS, HYPERGLYCEMIA, AND HYPOTHERMIA.
Age: 1.02
Sex: M
Vaccine: MMR
Symptoms: Unresponsive to stimuli
Clinical narrative: BEGINNING THE EVENING OF THE DAY THE BABY WAS VACCINATED, HE HAD LONG PERIODS (SEVERAL HOURS) OF INCONSOLABLE SCREAMING.  THIS CONTINUED UNTIL THE MORNING OF 03/06/2014, AT WHICH POINT HE EXPERIENCED ABOUT 30 MINUTES OF INTERMITTENT SEIZURE ACTIVITY, FOLLOWED BY A PERIOD OF UNRESPONSIVENESS, CYANOSIS, HYPERGLYCEMIA, AND HYPOTHERMIA.
Age: 8.0
Sex: M
Vaccine: FLUX
Symptoms: Tic, Tourette's disorder
Clinical narrative: We went in for his flu shot on Oct 9th, 2014 and my son who has controlled epilepsy (seizure free with medication for over 2 years) received the inactive influenza shot on his arm. The very next day he woke up and began ticing a few times. I wasn't sure what he was doing at first but after a few days it was evident that his ticing was getting progressively worse. By October 18th, he was ticing with full Tourettes syndrome (copralalia). This lasted for 3 months, subsiding in mid January 2015. Every time I suggested that the shot caused his tics, I was told by his medical team that flu shots would not cause this type of reaction. This is the second time this reaction happened immediately after my son received his flu shot.  Two years prior, my same son began ticing with a milder type of vocalization just three days after receiving his flu shot and it lasted just over 3 months. At that time, I wasn't sure if it was the flu shot or something else that caused it, so I skipped the next year's flu shot. After this second experience, I am 100% sure the flu shot caused his severe tics. He has been seizure free since March 2011 and has only had these symptoms of Tourettes immediately after receiving his flu shot.
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Bursitis, Exostosis, Mobility decreased, Pain in extremity, Tendon injury
Clinical narrative: SEVERE PAIN IN ARM AND SHOULDER, COULDN'T MOVE ARM. PAIN LESSENED BUT DID NOT GO AWAY.  WENT TO DOCTOR IN DECEMBER, HAD XRAYS AND MRI. DIAGNOSIS- PERIPHERALLY DOWNSLOPING TYPE II ACROMIUM WITH KEEL-SHAPED SUBACROMIAL BONES SPURS, LIKELY RESULTING IN IMPINGEMENT, FRAYING AND PARTIAL TEARING OF THE SUPRASPINATUS AND INFRASPINATUS TENDONS, MODERATE SUBACROMION/SUBDELTOID BURSITIS.
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Acupuncture, Mobility decreased, Pain in extremity
Clinical narrative: SEVERE PAIN IN ARM AND SHOULDER, COULDN'T MOVE ARM. PAIN LESSENED BUT DID NOT GO AWAY.  WENT TO DOCTOR IN DECEMBER, HAD XRAYS AND MRI. DIAGNOSIS- PERIPHERALLY DOWNSLOPING TYPE II ACROMIUM WITH KEEL-SHAPED SUBACROMIAL BONES SPURS, LIKELY RESULTING IN IMPINGEMENT, FRAYING AND PARTIAL TEARING OF THE SUPRASPINATUS AND INFRASPINATUS TENDONS, MODERATE SUBACROMION/SUBDELTOID BURSITIS.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Lethargy, Protrusion tongue
Clinical narrative: Information has been received from a patient's father concerning his son who was an approximately 2 year old male patient. The patient's medical history included ear infection. The patient had no known drug allergies. In approximately 2012 (reported as "when patient was approximately 2 years old") the patient was vaccinated with the first dose (0.5 ml) of M-M-R II (route, lot # and expiration date not reported). There was no concomitant medication reported. Twenty minutes after receiving the vaccine, during the car ride home from the unspecified physician's office, the patient experienced lethargy and his tongue was sticking out the side of his mouth. The father called the unspecified physician's office and was told that could have been a mini seizure. The father was advised to keep his son under observation. The father did not seek any additional medical attention for his son. No treatment was given for the event. No lab diagnostics studies performed. On an unspecified date, the outcome of the event was reported as fully recovered. Upon internal review, the event of a mini seizure was considered to be medically significant. Additional information is not expected because no reporter contact detail provided.
Age: 60.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Computerised tomogram head abnormal, Dysarthria, Eye irritation, Hypoaesthesia, VIIth nerve paralysis
Clinical narrative: Eye irritation then numbing of face and slurred speech.  Went to ER, was put on STROKE ALERT, received CT Scan of head. Result diagnoses; BELLS PALSY.
Age: 60.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Computerised tomogram abnormal, Dysarthria, Eye irritation, Hypoaesthesia, VIIth nerve paralysis
Clinical narrative: Eye irritation then numbing of face and slurred speech.  Went to ER, was put on STROKE ALERT, received CT Scan of head. Result diagnoses; BELLS PALSY.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Feeling hot, Throat tightness
Clinical narrative: Feeling hot, throat closure, difficulty to breathe.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Death, Epistaxis, Eye swelling, Mouth haemorrhage, Resuscitation
Clinical narrative: Pt was discovered in parent's bed in the morning on his side with swollen eye, nasal bleeding, swollen tongue, perioral petechiae. He was taken via paramedics to Hospital and was unable to be resuscitated.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Swollen tongue
Clinical narrative: Pt was discovered in parent's bed in the morning on his side with swollen eye, nasal bleeding, swollen tongue, perioral petechiae. He was taken via paramedics to Hospital and was unable to be resuscitated.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 6 month old patient of unknown gender. Patient's concurrent conditions and relevant medical history was not reported. Approximately on an unknown date in December 2014 (reported as vaccination at 2.5 months of age), the patient was vaccinated with first dose of ROTATEQ (lot number, dose and frequency unspecified), orally. Concomitant medications were not reported. On 05-MAR-2015, the patient will receive second dose of ROTATEQ (lot number, dose and frequency unspecified), which was longer that the recommended interval (inappropriate schedule of drug administration). No adverse effects were reported. The outcome of the events was unknown. The causality of the events with ROTATEQ was not reported. Product quality issue was not involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to an unspecified number of patients of unknown age and gender. On unspecified dates, doses of ROTATEQ (dose, frequency, route and lot# were not reported), which were exposed to a temperature excursion, had been administered to unspecified patients. No adverse experience had been reported. This is one of several reports received from same reporter. Additional information has been requested.
Age: 28.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Burning sensation, Chest pain, Dysphagia, Dyspnoea, Fatigue
Clinical narrative: Trouble swallowing, chest pain and shortness of breath.
Age: 28.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Goitre, VIIth nerve paralysis
Clinical narrative: Trouble swallowing, chest pain and shortness of breath.
Age: 28.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Chest pain, Dysphagia, Dyspnoea, Fatigue, Goitre
Clinical narrative: Trouble swallowing, chest pain and shortness of breath.
Age: 28.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Skin burning sensation, VIIth nerve paralysis
Clinical narrative: Trouble swallowing, chest pain and shortness of breath.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Headache, Lymphocyte percentage decreased, Neutrophil percentage increased, Petechiae, Pyrexia
Clinical narrative: HEADACHE, VOMITING, FEVER, SMALL PETECHIA CHEEKS AND UNDER EYES APPROXIMATELY 12-14 HRS FOLLOWING MENINGOCOCCAL, T-DAP, AND HPV VACCINES RESULTING IN ED VISIT, TREATED AND RELEASED, INSTRUCTED TO FOLLOW UP WITH PCM IN 2 WEEKS FOR CBC REPEAT.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Vomiting, White blood cell count decreased
Clinical narrative: HEADACHE, VOMITING, FEVER, SMALL PETECHIA CHEEKS AND UNDER EYES APPROXIMATELY 12-14 HRS FOLLOWING MENINGOCOCCAL, T-DAP, AND HPV VACCINES RESULTING IN ED VISIT, TREATED AND RELEASED, INSTRUCTED TO FOLLOW UP WITH PCM IN 2 WEEKS FOR CBC REPEAT.
Age: 11.0
Sex: F
Vaccine: MEN, TDAP, DTAP, MNQ
Symptoms: Fatigue, Headache, Malaise, Pyrexia
Clinical narrative: Fever, tired, overall feeling of not feeling well. Headache.
Age: 1.03
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Endotracheal intubation, Pneumonia moraxella, Pyrexia, Respiratory failure, Seizure
Clinical narrative: MMR, VZV and Hep A given 1/30/15 and 16 days later had complex seizure with respiratory failure requiring intubation also had Moraxella pneumonia and fever at time. No past hx of febrile seizures. No FHX of seizures.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site erythema, Injection site irritation, Injection site pain
Clinical narrative: Received PREVNAR on 3/2/15. Redness at injection site started same day and progressed to very large redness extending from the deltoid area to the elbow, causing extreme pain. Returned to my PCP on 3/6/15 for follow up. Provider started me on Clindamycin 300mg three times a day. Also started CLARITIN 10mg daily. Redness and pain began to subside after on antibiotic for 24hr. Irritated area began to fade although redness continued to move down the arm toward fingertips on 3/7/15.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Erythema
Clinical narrative: This is a spontaneous report obtained from a contactable nurse through a Pfizer sales representative. This nurse reported for two patients. A 79 year-old female patient received, on 20Feb2015, PREVNAR 13 single dose. Relevant medical history was unknown. Concomitant medications included COZAAR, pravastatin, atenolol, and levothyroxine. On an unspecified date, in 2015, probably the day after the shot, the patient had very large red area on the arm that was cellulitis. Cellulitis went down into the armpit. The patient did not recover from the event at time of this report. There was a reasonable possibility that the event was related to PREVNAR 13.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Arthropathy, Condition aggravated, Immunology test abnormal, Joint stiffness
Clinical narrative: This is a spontaneous report from a contactable consumer reporting on herself. This 79-year-old female patient started to receive PREVNAR 13, via an unspecified route of administration at single dose in the right arm on 14Jan2015. Medical history included ongoing hypothyroidism for about 20-30 years, ongoing hypertension for 25 years, ongoing estrogen therapy for years, amputee from 1949, ongoing rheumatoid arthritis. Concomitant medication included ESTRACE, CELEXA 1 pill daily unknown strength for amputee phantom pain and helps with sleep, ZESTRIL 10mg twice daily for high blood pressure. In the evening of 14Jan2015, the patient experienced joints stiffening up, joints swelling and throbbing, wrists are bad, hand pain and a full blown rheumatoid arthritis flare up. She had rheumatoid arthritis but without any flare up in 5 years and she thought it was related to the vaccine. Relevant Tests: Rheumatologist did an immune system test for rheumatoid arthritis, unsure when and the results were abnormal and high. Sedimentation rate values were unknown. The outcome of the events was not recovered.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Joint swelling, Pain in extremity, Red blood cell sedimentation rate, Rheumatoid arthritis
Clinical narrative: This is a spontaneous report from a contactable consumer reporting on herself. This 79-year-old female patient started to receive PREVNAR 13, via an unspecified route of administration at single dose in the right arm on 14Jan2015. Medical history included ongoing hypothyroidism for about 20-30 years, ongoing hypertension for 25 years, ongoing estrogen therapy for years, amputee from 1949, ongoing rheumatoid arthritis. Concomitant medication included ESTRACE, CELEXA 1 pill daily unknown strength for amputee phantom pain and helps with sleep, ZESTRIL 10mg twice daily for high blood pressure. In the evening of 14Jan2015, the patient experienced joints stiffening up, joints swelling and throbbing, wrists are bad, hand pain and a full blown rheumatoid arthritis flare up. She had rheumatoid arthritis but without any flare up in 5 years and she thought it was related to the vaccine. Relevant Tests: Rheumatologist did an immune system test for rheumatoid arthritis, unsure when and the results were abnormal and high. Sedimentation rate values were unknown. The outcome of the events was not recovered.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Lethargy, Pyrexia
Clinical narrative: Very high fever progressed by 4:00am 03/10/2015 to 105.2 degrees Fahrenheit pain and burning in upper right arm gave her 2 500 MG of Tylenol fever started coming down at around 6:00 am on 03/10/2015 at present time she is sleeping pain still on upper arm and lethargic.
Age: 63.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain
Clinical narrative: Pt reports moderate pain at injection site still 4 months later.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness and heat at injection site.
Age: 19.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Diffuse itchy red, rash that started on arms and legs, spread to trunk and neck over several days.
Age: 19.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Rash pruritic
Clinical narrative: Diffuse itchy red, rash that started on arms and legs, spread to trunk and neck over several days.
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Gastrooesophageal reflux disease, Laboratory test abnormal, Viral test negative, Vomiting, Weight decreased
Clinical narrative: 3 hours post vaccinations, my daughter began vomiting. The follow 36 hours, the vomiting became more frequent in that she was no longer maintaining any feeds. At hour 48, I took my daughter to the ER afraid of dehydration. We were then admitted and kept at hospital for 3 days and transferred to another hospital for a following 4 days. During those 7 days in the hospital my daughter did not keep any feedings down and lost 2 lbs.  All tests ran by doctors found no abnormalities of her anatomy to have caused this persistent vomiting. We were discharged from the hospital in the seventh day after my daughter maintained 2 feedings and gained a minimal amount of weight. The days following hospital dishacrge, my daughter was able to eat more and more ounces during feedings and is now playing catch up for weight gain.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Activities of daily living impaired, Allergy test negative, Chronic spontaneous urticaria, Eyelid oedema
Clinical narrative: I have never had hives or swelling, and this was the first flu shot I've ever had.  I developed chronic urticaria idiopathic, chronic angioedema idiopathic, and chronic swelling of other body parts.  I have been through extensive allergy testing and autoimmune testing and have found no known allergies or specific auto-immune diseases.  These symptoms can be debilitating when on my feet (can't walk) and in my hands/wrists (can't drive/hold items in my hands).  Again, I have never experienced these symptoms and they occurred within weeks of having my first ever flu shot.  I have been on copious amounts of antihistamines including, Zantec, Zyrtec, Allegra, and Singulair, all of which have helped but not alleviated my pain/swelling/hives completly.  The next treatment is a very expensive drug called "Xolair" which if my insurance refuses to pay, I cannot afford to get.  I was admitted to the hospital once when I woke up in the middle of the night and my face was extremely swollen, eye swelled shut, hives over entire face/scalp, neck, shoulders, back and chest.  I was also on 3 different prednisone tappers trying to get rid of the hives and control the swelling in my face, hands and feet.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Idiopathic angioedema, Immunology test normal, Impaired driving ability, Pain, Peripheral swelling
Clinical narrative: I have never had hives or swelling, and this was the first flu shot I've ever had.  I developed chronic urticaria idiopathic, chronic angioedema idiopathic, and chronic swelling of other body parts.  I have been through extensive allergy testing and autoimmune testing and have found no known allergies or specific auto-immune diseases.  These symptoms can be debilitating when on my feet (can't walk) and in my hands/wrists (can't drive/hold items in my hands).  Again, I have never experienced these symptoms and they occurred within weeks of having my first ever flu shot.  I have been on copious amounts of antihistamines including, Zantec, Zyrtec, Allegra, and Singulair, all of which have helped but not alleviated my pain/swelling/hives completly.  The next treatment is a very expensive drug called "Xolair" which if my insurance refuses to pay, I cannot afford to get.  I was admitted to the hospital once when I woke up in the middle of the night and my face was extremely swollen, eye swelled shut, hives over entire face/scalp, neck, shoulders, back and chest.  I was also on 3 different prednisone tappers trying to get rid of the hives and control the swelling in my face, hands and feet.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Skin test negative, Swelling, Swelling face, Thyroid function test normal, Urticaria
Clinical narrative: I have never had hives or swelling, and this was the first flu shot I've ever had.  I developed chronic urticaria idiopathic, chronic angioedema idiopathic, and chronic swelling of other body parts.  I have been through extensive allergy testing and autoimmune testing and have found no known allergies or specific auto-immune diseases.  These symptoms can be debilitating when on my feet (can't walk) and in my hands/wrists (can't drive/hold items in my hands).  Again, I have never experienced these symptoms and they occurred within weeks of having my first ever flu shot.  I have been on copious amounts of antihistamines including, Zantec, Zyrtec, Allegra, and Singulair, all of which have helped but not alleviated my pain/swelling/hives completly.  The next treatment is a very expensive drug called "Xolair" which if my insurance refuses to pay, I cannot afford to get.  I was admitted to the hospital once when I woke up in the middle of the night and my face was extremely swollen, eye swelled shut, hives over entire face/scalp, neck, shoulders, back and chest.  I was also on 3 different prednisone tappers trying to get rid of the hives and control the swelling in my face, hands and feet.
Age: 36.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Abscess, Cellulitis, Discomfort, Erythema, Incisional drainage
Clinical narrative: Pt reported increasing discomfort after receiving vaccinations in R deltold on 3/3/15. Pain awakened her night of 3/4 and she noticed redness and swelling. Redness and swelling increased and pt was seen in ER 3/5 and dx'd with cellulitis and early abscess. I/D performed and discharged with Clindamycin oral. Pt returned to ER 3/7 with complaints of worsening rednss/pain and Bactrim DS bid for 7 days was added to regimen. Pt has pending f/u with PMD 3/12.
Age: 36.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Middle insomnia, Pain, Swelling
Clinical narrative: Pt reported increasing discomfort after receiving vaccinations in R deltold on 3/3/15. Pain awakened her night of 3/4 and she noticed redness and swelling. Redness and swelling increased and pt was seen in ER 3/5 and dx'd with cellulitis and early abscess. I/D performed and discharged with Clindamycin oral. Pt returned to ER 3/7 with complaints of worsening rednss/pain and Bactrim DS bid for 7 days was added to regimen. Pt has pending f/u with PMD 3/12.
Age: 9.0
Sex: F
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Pt was adminestered a PCV23 per RN who previously spoke to allergist and decided it was ok to give vaccine. Around 5 mons after administration patient started developing a rash on face, and body. Epi was given by RN.
Age: 9.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Rash
Clinical narrative: Rash, arm pain.
Age: 17.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Hypoaesthesia, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: REDNESS, SWELLING, AND ITCHY AT SITE OF VARICELLA IMMUNIZATION.  REPORTS NUMBING ON BOTH FINGERTIPS AND HANDS. ADMINISTERED HYDROCORTISONE 1% CREAM TO APPLY FOR ITCHINESS AND TYLENOL 325MG TABLETS #6 TO BE TAKEN TWO TABLETS EVERY 4-6 HOURS AS NEEDED.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Body temperature increased, Eyelid oedema, Injection site pain, Irritability, Peripheral swelling
Clinical narrative: The site of the injection became very painful, so patient cried when it was touched or his leg was moved. Patient developed a red rash starting near his hairline by his ears, the rash spread and enlarged across his body, in the groin area, on his stomach, on his arms, face and the nape of his neck. He also developed swollen hands, feet and eyelids. His temperature became elevated and he was very fussy.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Rash erythematous, Rash morbilliform, Urticaria
Clinical narrative: The site of the injection became very painful, so patient cried when it was touched or his leg was moved. Patient developed a red rash starting near his hairline by his ears, the rash spread and enlarged across his body, in the groin area, on his stomach, on his arms, face and the nape of his neck. He also developed swollen hands, feet and eyelids. His temperature became elevated and he was very fussy.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Abdominal distension, Abnormal behaviour, Aggression, Cough, Crying
Clinical narrative: Upon arriving home after the office visit at around 10:30pm on 2/23/15 I noticed patient to be wobbly when she walked and she seemed disoriented. Within 24 hours her belly appeared to be distended. Patient began displaying cold like symptoms of runny nose, cough and sneezing. This lasted for two days. The symptoms appeared to be getting better by 3/3/15 and then on 3/4/15 she began running a low grade fever; not more than 100.3. The fever came and went over the course of the next two days. She was irritable and fussy and began sleeping poorly. Her mood seemed to have changed where she was more easily irritated and would scream a lot at the top of her lungs. She has never showed this behavior before. On 3/6/15 is when she started to get worse. She only took one 35 minute nap and was clearly tired but would not go to sleep. Her appetite was affected as she would not eat very much solid food. She was also not willing to nurse as she normally would.  She went to bed for the night at 7:30pm and then was awake at 11pm and was crying and inconsolable from 11pm to 2am. This was very abnormal behavior and extremely alarming. I have never seen her this upset or crying this much ever in her life. She did not have much interest in nursing or eating solid food on Saturday, 3/7/15. At about 9:30 AM I noticed a red rash all over the trunk of her body (abdomen, chest and back and diaper area). The rash was not raised. I contacted the Dr. to have her seen immediately. The Dr. seemed to think it was a viral issue and not caused by the vaccine. She continued to be easily upset and throw intense temper tantrums when she was unhappy about something. She did not want to take a morning nap that day and took a mid-afternoon nap instead of one mid-morning nap and one late afternoon nap. Her sleep was a bit better on the night of 3/7/15 and she was only up for about 1 hour and was not nearly as upset as the night previously. 3/8/15 was similar to the previous day in terms of sleeping and not wanting to nurse or eat solid food. The rash was almost nearly gone by the morning of 3/9/15 and then reappeared again in the afternoon. It has spread to the lower parts of her face and is now on her legs on 3/10/15. Her mood has improved somewhat along with her appetite, sleeping and willingness to nurse.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Decreased appetite, Disorientation, Emotional distress, Fatigue, Gait disturbance
Clinical narrative: Upon arriving home after the office visit at around 10:30pm on 2/23/15 I noticed patient to be wobbly when she walked and she seemed disoriented. Within 24 hours her belly appeared to be distended. Patient began displaying cold like symptoms of runny nose, cough and sneezing. This lasted for two days. The symptoms appeared to be getting better by 3/3/15 and then on 3/4/15 she began running a low grade fever; not more than 100.3. The fever came and went over the course of the next two days. She was irritable and fussy and began sleeping poorly. Her mood seemed to have changed where she was more easily irritated and would scream a lot at the top of her lungs. She has never showed this behavior before. On 3/6/15 is when she started to get worse. She only took one 35 minute nap and was clearly tired but would not go to sleep. Her appetite was affected as she would not eat very much solid food. She was also not willing to nurse as she normally would.  She went to bed for the night at 7:30pm and then was awake at 11pm and was crying and inconsolable from 11pm to 2am. This was very abnormal behavior and extremely alarming. I have never seen her this upset or crying this much ever in her life. She did not have much interest in nursing or eating solid food on Saturday, 3/7/15. At about 9:30 AM I noticed a red rash all over the trunk of her body (abdomen, chest and back and diaper area). The rash was not raised. I contacted the Dr. to have her seen immediately. The Dr. seemed to think it was a viral issue and not caused by the vaccine. She continued to be easily upset and throw intense temper tantrums when she was unhappy about something. She did not want to take a morning nap that day and took a mid-afternoon nap instead of one mid-morning nap and one late afternoon nap. Her sleep was a bit better on the night of 3/7/15 and she was only up for about 1 hour and was not nearly as upset as the night previously. 3/8/15 was similar to the previous day in terms of sleeping and not wanting to nurse or eat solid food. The rash was almost nearly gone by the morning of 3/9/15 and then reappeared again in the afternoon. It has spread to the lower parts of her face and is now on her legs on 3/10/15. Her mood has improved somewhat along with her appetite, sleeping and willingness to nurse.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Insomnia, Irritability, Mood altered, Nasopharyngitis, Poor quality sleep
Clinical narrative: Upon arriving home after the office visit at around 10:30pm on 2/23/15 I noticed patient to be wobbly when she walked and she seemed disoriented. Within 24 hours her belly appeared to be distended. Patient began displaying cold like symptoms of runny nose, cough and sneezing. This lasted for two days. The symptoms appeared to be getting better by 3/3/15 and then on 3/4/15 she began running a low grade fever; not more than 100.3. The fever came and went over the course of the next two days. She was irritable and fussy and began sleeping poorly. Her mood seemed to have changed where she was more easily irritated and would scream a lot at the top of her lungs. She has never showed this behavior before. On 3/6/15 is when she started to get worse. She only took one 35 minute nap and was clearly tired but would not go to sleep. Her appetite was affected as she would not eat very much solid food. She was also not willing to nurse as she normally would.  She went to bed for the night at 7:30pm and then was awake at 11pm and was crying and inconsolable from 11pm to 2am. This was very abnormal behavior and extremely alarming. I have never seen her this upset or crying this much ever in her life. She did not have much interest in nursing or eating solid food on Saturday, 3/7/15. At about 9:30 AM I noticed a red rash all over the trunk of her body (abdomen, chest and back and diaper area). The rash was not raised. I contacted the Dr. to have her seen immediately. The Dr. seemed to think it was a viral issue and not caused by the vaccine. She continued to be easily upset and throw intense temper tantrums when she was unhappy about something. She did not want to take a morning nap that day and took a mid-afternoon nap instead of one mid-morning nap and one late afternoon nap. Her sleep was a bit better on the night of 3/7/15 and she was only up for about 1 hour and was not nearly as upset as the night previously. 3/8/15 was similar to the previous day in terms of sleeping and not wanting to nurse or eat solid food. The rash was almost nearly gone by the morning of 3/9/15 and then reappeared again in the afternoon. It has spread to the lower parts of her face and is now on her legs on 3/10/15. Her mood has improved somewhat along with her appetite, sleeping and willingness to nurse.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash, Rash erythematous, Rhinorrhoea, Screaming
Clinical narrative: Upon arriving home after the office visit at around 10:30pm on 2/23/15 I noticed patient to be wobbly when she walked and she seemed disoriented. Within 24 hours her belly appeared to be distended. Patient began displaying cold like symptoms of runny nose, cough and sneezing. This lasted for two days. The symptoms appeared to be getting better by 3/3/15 and then on 3/4/15 she began running a low grade fever; not more than 100.3. The fever came and went over the course of the next two days. She was irritable and fussy and began sleeping poorly. Her mood seemed to have changed where she was more easily irritated and would scream a lot at the top of her lungs. She has never showed this behavior before. On 3/6/15 is when she started to get worse. She only took one 35 minute nap and was clearly tired but would not go to sleep. Her appetite was affected as she would not eat very much solid food. She was also not willing to nurse as she normally would.  She went to bed for the night at 7:30pm and then was awake at 11pm and was crying and inconsolable from 11pm to 2am. This was very abnormal behavior and extremely alarming. I have never seen her this upset or crying this much ever in her life. She did not have much interest in nursing or eating solid food on Saturday, 3/7/15. At about 9:30 AM I noticed a red rash all over the trunk of her body (abdomen, chest and back and diaper area). The rash was not raised. I contacted the Dr. to have her seen immediately. The Dr. seemed to think it was a viral issue and not caused by the vaccine. She continued to be easily upset and throw intense temper tantrums when she was unhappy about something. She did not want to take a morning nap that day and took a mid-afternoon nap instead of one mid-morning nap and one late afternoon nap. Her sleep was a bit better on the night of 3/7/15 and she was only up for about 1 hour and was not nearly as upset as the night previously. 3/8/15 was similar to the previous day in terms of sleeping and not wanting to nurse or eat solid food. The rash was almost nearly gone by the morning of 3/9/15 and then reappeared again in the afternoon. It has spread to the lower parts of her face and is now on her legs on 3/10/15. Her mood has improved somewhat along with her appetite, sleeping and willingness to nurse.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Sneezing, Viral infection
Clinical narrative: Upon arriving home after the office visit at around 10:30pm on 2/23/15 I noticed patient to be wobbly when she walked and she seemed disoriented. Within 24 hours her belly appeared to be distended. Patient began displaying cold like symptoms of runny nose, cough and sneezing. This lasted for two days. The symptoms appeared to be getting better by 3/3/15 and then on 3/4/15 she began running a low grade fever; not more than 100.3. The fever came and went over the course of the next two days. She was irritable and fussy and began sleeping poorly. Her mood seemed to have changed where she was more easily irritated and would scream a lot at the top of her lungs. She has never showed this behavior before. On 3/6/15 is when she started to get worse. She only took one 35 minute nap and was clearly tired but would not go to sleep. Her appetite was affected as she would not eat very much solid food. She was also not willing to nurse as she normally would.  She went to bed for the night at 7:30pm and then was awake at 11pm and was crying and inconsolable from 11pm to 2am. This was very abnormal behavior and extremely alarming. I have never seen her this upset or crying this much ever in her life. She did not have much interest in nursing or eating solid food on Saturday, 3/7/15. At about 9:30 AM I noticed a red rash all over the trunk of her body (abdomen, chest and back and diaper area). The rash was not raised. I contacted the Dr. to have her seen immediately. The Dr. seemed to think it was a viral issue and not caused by the vaccine. She continued to be easily upset and throw intense temper tantrums when she was unhappy about something. She did not want to take a morning nap that day and took a mid-afternoon nap instead of one mid-morning nap and one late afternoon nap. Her sleep was a bit better on the night of 3/7/15 and she was only up for about 1 hour and was not nearly as upset as the night previously. 3/8/15 was similar to the previous day in terms of sleeping and not wanting to nurse or eat solid food. The rash was almost nearly gone by the morning of 3/9/15 and then reappeared again in the afternoon. It has spread to the lower parts of her face and is now on her legs on 3/10/15. Her mood has improved somewhat along with her appetite, sleeping and willingness to nurse.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Tic
Clinical narrative: Motor tic started late July 2014.
Age: 31.0
Sex: M
Vaccine: PPV
Symptoms: Anaemia, Asthenia, Atelectasis, CSF test normal, Chest X-ray abnormal
Clinical narrative: 0800: new onset fever of 100.7, P 117, R-24 O2 at 97%, BP 130s/80s (left deltoid site of PNEUMOVAX vaccine injection) decreased strength on left arm and decreased range of motion (more than usual). Pain 6/0-10 and tender. No redness, no rash, no swelling. Also rec'd interferon on 3/02/15. 1700: Complains of double vision, weakness left side of body, pain in left arm and loss of bladder control.
Age: 31.0
Sex: M
Vaccine: PPV
Symptoms: Computerised tomogram head normal, Differential white blood cell count abnormal, Diplopia, Electrocardiogram abnormal, Full blood count abnormal
Clinical narrative: 0800: new onset fever of 100.7, P 117, R-24 O2 at 97%, BP 130s/80s (left deltoid site of PNEUMOVAX vaccine injection) decreased strength on left arm and decreased range of motion (more than usual). Pain 6/0-10 and tender. No redness, no rash, no swelling. Also rec'd interferon on 3/02/15. 1700: Complains of double vision, weakness left side of body, pain in left arm and loss of bladder control.
Age: 31.0
Sex: M
Vaccine: PPV
Symptoms: Haemoglobin abnormal, Hemiparesis, Injected limb mobility decreased, Leukocytosis, Pain
Clinical narrative: 0800: new onset fever of 100.7, P 117, R-24 O2 at 97%, BP 130s/80s (left deltoid site of PNEUMOVAX vaccine injection) decreased strength on left arm and decreased range of motion (more than usual). Pain 6/0-10 and tender. No redness, no rash, no swelling. Also rec'd interferon on 3/02/15. 1700: Complains of double vision, weakness left side of body, pain in left arm and loss of bladder control.
Age: 31.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity, Platelet count decreased, Pyrexia, Sinus tachycardia, Tenderness
Clinical narrative: 0800: new onset fever of 100.7, P 117, R-24 O2 at 97%, BP 130s/80s (left deltoid site of PNEUMOVAX vaccine injection) decreased strength on left arm and decreased range of motion (more than usual). Pain 6/0-10 and tender. No redness, no rash, no swelling. Also rec'd interferon on 3/02/15. 1700: Complains of double vision, weakness left side of body, pain in left arm and loss of bladder control.
Age: 31.0
Sex: M
Vaccine: PPV
Symptoms: Thrombocytopenia, Urinary incontinence, White blood cell count increased
Clinical narrative: 0800: new onset fever of 100.7, P 117, R-24 O2 at 97%, BP 130s/80s (left deltoid site of PNEUMOVAX vaccine injection) decreased strength on left arm and decreased range of motion (more than usual). Pain 6/0-10 and tender. No redness, no rash, no swelling. Also rec'd interferon on 3/02/15. 1700: Complains of double vision, weakness left side of body, pain in left arm and loss of bladder control.
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Local swelling
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of local swelling in a adult female patient who received BOOSTRIX. Co-suspect products included TWINRIX and medication unknown. On an unknown date, the patient received BOOSTRIX (injection ) .5 ml, 1st dose of TWINRIX (injection) .5 ml and vaccination unknown at an unknown dose. On an unknown date, unknown after receiving BOOSTRIX and TWINRIX, the patient experienced local swelling. On an unknown date, the outcome of the local swelling was unknown. The reporter considered the local swelling to be possibly related to BOOSTRIX and TWINRIX. Additional information received: The caller reports that a nurse reported adverse events to her about a patient. This patient received 3 vaccines at an unknown date. The caller did not know the name of the 3rd vaccine the patient was given. The patient developed a lump in her arm after receiving the vaccines.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Allergy test, Pruritus generalised, Urticaria
Clinical narrative: The patient received her annual Influenza Vaccine (FLUZONE) on 9/24/13. She was in her normal state of good health at the time. Approximately 30-60 minutes after receipt of the vaccination the patient noted generalized itching and hives on her arms, legs and chest. She returned to medical and was given BENADRYL po and placed in quarters. According to the patient when she awoke a few hours later the itching and the majority of the hives had resolved. The patient denies symptoms of difficulty breathing/swallowing, angioedema, lightheadedness, palpitations, sneezing, rhinorrhea, cough, clearing of her throat, abdominal pain, nausea, vomiting or diarrhea. Previously, the patient received AFLURIA on 9/26/12 and FLUMIST on 10/3/11 without adverse event. The patient states that she had never received an Influenza vaccination prior to entry. Of note, her history is positive for the sensation of "throat tightening" after eating lightly cooked eggs. The patient does not eat foods with egg like potato salad or meringue; she is able to eat baked goods with eggs without issue.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness
Clinical narrative: Very stiff shoulder-soon after vaccination, continuing to this date.
Age: 0.62
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Vomiting, fever and diarrhea onset 3/2/2015.
Age: 62.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Immediate post-injection reaction, Injection site pain, Pain in extremity
Clinical narrative: Immediately upon receiving shot, significant pain occurred in left shoulder and arm. Pain is constant and is not going away.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. No pertinent medical history was reported. On 06-MAR-2015, the patient was vaccinated with ROTATEQ vial, 1 vial, oral which was expired on 26-FEB-2015. No adverse effects reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Dyspnoea, Injection site pain, Injection site warmth, Muscle spasms, Muscle tightness
Clinical narrative: This case was reported by a consumer via call representative and described the occurrence of muscle pain in a 50-year-old female patient who received BOOSTRIX (batch number LF444, expiry date 10th September 2016). The patient's past medical history included seizure. Concurrent medical conditions included vaginal hysterectomy (partial hysterectomy) and penicillin allergy. Concomitant products included APRISO. On 23rd December 2014 10:00, the patient received BOOSTRIX (intramuscular). On 25th December 2014, 2 days after receiving BOOSTRIX, the patient experienced injection site warmth and injection site pain. On 27 December 2014, the patient experienced muscle pain and muscle spasm. On an unknown date, the patient experienced difficulty breathing. On an unknown date, the outcome of muscle pain and muscle spasm were recovering/resolving and the outcome of the injection site warmth, injection site pain and difficulty breathing were recovered/resolved. The reporter considered the muscle pain, injection site warmth, injection site pain, muscle spasm and difficulty breathing to be related to BOOSTRIX. Additional information received: Caller reports that she has been experiencing extreme muscle pain and spasms since receiving the BOOSTRIX vaccine. About two days after the vaccination she had some pain at the injection site and it was warm to the touch. About 4 days after the vaccination she developed severe muscle pain and spasms. The spasms started in her hands and feet and she couldn't unclench them. Since the spasms have travelled to different parts of her body. About 2 weeks after the vaccination she saw her HCP because the muscle spasms had travelled into her lungs and she had a hard time breathing. The spasms will stay in an area of her for several days and then move to another area. Currently she says the spasms are improving, but have not left. They have been in her neck and shoulders for a couple days. The muscles that are spasming are tight and painful the whole time, until it moves to another part of her body. Her HCP has told her that this is a reaction to the BOOSTRIX vaccine, and that she will just have to wait it out. She did receive a prescription for inflammation pills, but she has completed the course.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Myalgia
Clinical narrative: This case was reported by a consumer via call representative and described the occurrence of muscle pain in a 50-year-old female patient who received BOOSTRIX (batch number LF444, expiry date 10th September 2016). The patient's past medical history included seizure. Concurrent medical conditions included vaginal hysterectomy (partial hysterectomy) and penicillin allergy. Concomitant products included APRISO. On 23rd December 2014 10:00, the patient received BOOSTRIX (intramuscular). On 25th December 2014, 2 days after receiving BOOSTRIX, the patient experienced injection site warmth and injection site pain. On 27 December 2014, the patient experienced muscle pain and muscle spasm. On an unknown date, the patient experienced difficulty breathing. On an unknown date, the outcome of muscle pain and muscle spasm were recovering/resolving and the outcome of the injection site warmth, injection site pain and difficulty breathing were recovered/resolved. The reporter considered the muscle pain, injection site warmth, injection site pain, muscle spasm and difficulty breathing to be related to BOOSTRIX. Additional information received: Caller reports that she has been experiencing extreme muscle pain and spasms since receiving the BOOSTRIX vaccine. About two days after the vaccination she had some pain at the injection site and it was warm to the touch. About 4 days after the vaccination she developed severe muscle pain and spasms. The spasms started in her hands and feet and she couldn't unclench them. Since the spasms have travelled to different parts of her body. About 2 weeks after the vaccination she saw her HCP because the muscle spasms had travelled into her lungs and she had a hard time breathing. The spasms will stay in an area of her for several days and then move to another area. Currently she says the spasms are improving, but have not left. They have been in her neck and shoulders for a couple days. The muscles that are spasming are tight and painful the whole time, until it moves to another part of her body. Her HCP has told her that this is a reaction to the BOOSTRIX vaccine, and that she will just have to wait it out. She did receive a prescription for inflammation pills, but she has completed the course.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of hives ina 4-year-old male patient who received FLUARIX QUADRIVALENT (batch number L5E9G, expiry date unknown). In October 2014, the patient received FLUARIX QUADRIVALENT (injection). In October 2014, 1 hr after receiving FLUARIX QUADRIVALENT, the patient experienced hives. The patient was treated with BENADRYL. On an unknown date, the outcome of the hives was recovered/resolved. The reporter considered the hives to be possibly related to FLUARIX QUADRIVALENT. Additional information received: The caller reports that a patient that comes to their clinic received the flu shot in October 2014. The patient experienced hives about one hour after receiving the shot. The patient has since recovered completely from the hives. The caller did not know the expiration date of the vaccine.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Abdominal pain upper, Activities of daily living impaired, Altered state of consciousness, Blood pressure increased, Dizziness
Clinical narrative: Immediately after the injection his face went numb, couldnt speak clearly, almost passed out, blood pressure skyrocketed, pupils dilated, and he was dizzy. Now, 6 days later he STILL has migraines, stabbing stomach pains, low blood pressure, nausea, and dizziness, and he can barely stay awake. He has not been able to return to school since the vaccine because of how bad the effects are.