chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.13
Sex: F
Vaccine: HIBV, MMR, PPV, VARCEL
Symptoms: Abnormal behaviour, Diarrhoea, Diet refusal, Irritability, Personality change
Clinical narrative: Patient is not herself for weeks at a time after being vaccinated. Her personality completely changes. She is fussy and refuses to eat the foods she likes for weeks. She doesn't act like her normal self: no babbling, smiling, laughing for weeks at a time. Also had a fever for four days that would not go down with Tylenol or Motrin. Diarrhea for longer than one week also.
Age: 1.13
Sex: F
Vaccine: HIBV, MMR, PPV, VARCEL
Symptoms: Pyrexia
Clinical narrative: Patient is not herself for weeks at a time after being vaccinated. Her personality completely changes. She is fussy and refuses to eat the foods she likes for weeks. She doesn't act like her normal self: no babbling, smiling, laughing for weeks at a time. Also had a fever for four days that would not go down with Tylenol or Motrin. Diarrhea for longer than one week also.
Age: 18.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, pain at the injection site.
Age: 1.04
Sex: F
Vaccine: MMR
Symptoms: Decreased appetite, Dermatitis, Diarrhoea, Ear discomfort, Pyrexia
Clinical narrative: High fever and loss of appetite for +/- 72 hours. Vomited once at onset of fever. Small red dots on face during fever. After fever subsided measles type rash appeared on lower back accompanied with diarrhea every bowel movement inflaming skin on contact. Appears to have some ear discomfort. Symptoms ongoing as of 06/13.
Age: 1.04
Sex: F
Vaccine: MMR
Symptoms: Rash, Rash erythematous, Rash morbilliform, Vomiting
Clinical narrative: High fever and loss of appetite for +/- 72 hours. Vomited once at onset of fever. Small red dots on face during fever. After fever subsided measles type rash appeared on lower back accompanied with diarrhea every bowel movement inflaming skin on contact. Appears to have some ear discomfort. Symptoms ongoing as of 06/13.
Age: 46.0
Sex: F
Vaccine: YF
Symptoms: Pruritus, Urticaria
Clinical narrative: Itching of palms; 24 hours post injection-hives, on legs. Benadryl 50mg po q 6 hours prn.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Biopsy skin abnormal, Injection site mass, Purulent discharge, Soft tissue inflammation
Clinical narrative: Mother noticed a lump on the right thigh at the site of injection.
Age: 1.01
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Pyrexia, Roseola
Clinical narrative: Very high fever for 4 days, red swollen leg from the vaccine injection...roseola on the 4th day....for sure from varicella injection!!!!
Age: 1.31
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Pain, Pyrexia, Rash, Skin lesion
Clinical narrative: Pt presented to the office with non pruritic rash which initiated 1-2 days prior to OV on 5/6/2013. Developed fever to 102F two days after visit with painful lesions following.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a physician concerning a patient of unknown age and gender. On 10-JUN-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number and expiry date reported as J000427 and 10-APR-2014 respectively), subcutaneously instead of VARIVAX (Merck). No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site urticaria, Pyrexia
Clinical narrative: Day after immunizations pateint complained of leg pain, has a large red bump. Saw provider today, looks like a hive, pt has a fever since last night, 101?.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a Registered Nurse refers to a 1 year old patient(gender unknown). No medical history was reported. On 07-JUN-2013, the patient was vaccinated with a dose of PROQUAD (Merck) (instead of M-M-R II)(lot #, expiry not reported). On 07-JUN-2013, the patient was concomitantly vaccinated with VARIVAX (Merck) (lot #, expiry not reported). On 07-JUN-2013, the medication error occurred as the person who administered the PROQUAD was not familiar with the PROQUAD and saw measles, mumps, rubella on the PROQUAD label and thought the PROQUAD was M-M-R II. No adverse event reported. Additional information is not expected.
Age: 20.0
Sex: M
Vaccine: HEP
Symptoms: Antibody test negative, Hepatitis B antibody negative
Clinical narrative: This spontaneous report as received from a physician refers to the physician's nephew, a 20 year old male patient. No medical history was reported. The physician administered 3 doses of RECOMBIVAX HB to the patient when he was a child. However, recently, the physician found that the patient had negative antibody titers. Therefore, the physician administered one dose of RECOMBIVAX HB on an unspecified date and then a second dose of RECOMBIVAX HB 3 weeks later. At the time of the report, the current hepatitis B antibody titer was unknown. The patient did not take any concomitant medications. No further information provided. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. Pertinent medical history or drug reactions/allergies were not provided. The registered nurse reported that on 02-SEP-1994, the patient was vaccinated with a first dose of RECOMBIVAX HB (route, lot and expiration date were not provided); on 20-SEP-1994, the patient received the second dose of RECOMBIVAX HB (route, lot and expiration date were not provided); and on 10-MAR-1995, the patient received the third dose of RECOMBIVAX HB (route, lot and expiration date were not provided). No adverse effect was reported. Additional information is not expected.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Site where DTaP given has large area of redness around injection site. Area is the size of an orange. Area hot to touch. Pt. has no pain or fever.
Age: 46.0
Sex: M
Vaccine: HEPA
Symptoms: Fatigue, Hyperhidrosis, Pyrexia, Vomiting
Clinical narrative: Vomiting, fever, diaphoresis, fatigue.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Computerised tomogram head normal, Convulsion, Lumbar puncture, Pyrexia
Clinical narrative: Initial report received from a consumer who is the parent of the patient on 03 June 2013. An 11 year old male patient was administered MENACTRA, site, route, dose and batch number not reported on 07 July 2007. Concomitant medications and medical history were not reported. The patient did not have an illness at the time of vaccination and had no known allergies. The patient had an onset of a high fever (temperature not reported) and seizure on an unreported date and was seen in the ER. He was treated with IV ceftriaxone, dose not specified. He returned to the hospital later the same day and was kept for 3 days. A spinal tap was performed on an unreported date and was inconclusive. A head CT was negative on an unreported date. The patient recovered on an unreported date. Further details were not available at the time of this report. Documents held by sender: None.
Age: 52.0
Sex: M
Vaccine: HEP
Symptoms: Blood creatine phosphokinase normal, Blood magnesium normal, Blood phosphorus normal, Cardiac telemetry abnormal, Dizziness
Clinical narrative: M reports that he developed tachycardia the evening of receiving his 2nd hepatitis B vaccination. Received the vaccine at 1300 that day. States since that evening he has had multiple tachycardic episodes when he feels palpitations and at times experiences dizziness. The following day after the vaccination his episodes worsened and he went to the ER. He has been seen by cardiology who diagnosed SVT. He is still having multiple episodes/day. Denies any other systemic symptoms. He states he will be scheduled for an ablation in the near future. Has been started on long acting beta blocker which he states have lessened the intensity of episodes. Squatting triggers episodes or they can occur with no triggers. Sitting down or valsalva maneuver will lessen / abort symptoms. He questions whether or not his new cardiac condition is related to receipt of this Hep B vaccine. The vaccine package insert states that rare instances of tachycardia and syncope have been reported after receiving this vaccine.
Age: 52.0
Sex: M
Vaccine: HEP
Symptoms: Fibrin D dimer normal, International normalised ratio normal, Lipase normal, Metabolic function test normal, Palpitations
Clinical narrative: M reports that he developed tachycardia the evening of receiving his 2nd hepatitis B vaccination. Received the vaccine at 1300 that day. States since that evening he has had multiple tachycardic episodes when he feels palpitations and at times experiences dizziness. The following day after the vaccination his episodes worsened and he went to the ER. He has been seen by cardiology who diagnosed SVT. He is still having multiple episodes/day. Denies any other systemic symptoms. He states he will be scheduled for an ablation in the near future. Has been started on long acting beta blocker which he states have lessened the intensity of episodes. Squatting triggers episodes or they can occur with no triggers. Sitting down or valsalva maneuver will lessen / abort symptoms. He questions whether or not his new cardiac condition is related to receipt of this Hep B vaccine. The vaccine package insert states that rare instances of tachycardia and syncope have been reported after receiving this vaccine.
Age: 52.0
Sex: M
Vaccine: HEP
Symptoms: Supraventricular extrasystoles, Supraventricular tachycardia, Tachycardia, Thyroid function test normal, Troponin normal
Clinical narrative: M reports that he developed tachycardia the evening of receiving his 2nd hepatitis B vaccination. Received the vaccine at 1300 that day. States since that evening he has had multiple tachycardic episodes when he feels palpitations and at times experiences dizziness. The following day after the vaccination his episodes worsened and he went to the ER. He has been seen by cardiology who diagnosed SVT. He is still having multiple episodes/day. Denies any other systemic symptoms. He states he will be scheduled for an ablation in the near future. Has been started on long acting beta blocker which he states have lessened the intensity of episodes. Squatting triggers episodes or they can occur with no triggers. Sitting down or valsalva maneuver will lessen / abort symptoms. He questions whether or not his new cardiac condition is related to receipt of this Hep B vaccine. The vaccine package insert states that rare instances of tachycardia and syncope have been reported after receiving this vaccine.
Age: 52.0
Sex: M
Vaccine: HEP
Symptoms: Valsalva maneuver
Clinical narrative: M reports that he developed tachycardia the evening of receiving his 2nd hepatitis B vaccination. Received the vaccine at 1300 that day. States since that evening he has had multiple tachycardic episodes when he feels palpitations and at times experiences dizziness. The following day after the vaccination his episodes worsened and he went to the ER. He has been seen by cardiology who diagnosed SVT. He is still having multiple episodes/day. Denies any other systemic symptoms. He states he will be scheduled for an ablation in the near future. Has been started on long acting beta blocker which he states have lessened the intensity of episodes. Squatting triggers episodes or they can occur with no triggers. Sitting down or valsalva maneuver will lessen / abort symptoms. He questions whether or not his new cardiac condition is related to receipt of this Hep B vaccine. The vaccine package insert states that rare instances of tachycardia and syncope have been reported after receiving this vaccine.
Age: 17.0
Sex: F
Vaccine: TYP, YF
Symptoms: Back pain, Body temperature increased, Pain, Pain in extremity, Vomiting
Clinical narrative: Client took 1st typhoid tablet 6-8-13 in the evening 6-9-13 client c/o severe body ache, temp of 103.4 degrees F, back and leg pain. Client took 2nd typhoid tablet 6-9-13 in the evening and vomited within 10 minutes.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema
Clinical narrative: School noticed redness around left arm injection site on Tuesday morning notified mom and applied ice to the area. Redness started to spread down (L) arm on Tuesday afternoon. Child was seen in Dr. office on Thursday am. Treatment included MOTRIN and cool compress.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying
Clinical narrative: Unconsolable crying x 4 hr which got progressively worse.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Drug administration error
Clinical narrative: Misadministration of Hep A vaccine. It was meant to be given to her sister and nurse gave it to patient on accident.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Flushing, Hypersensitivity
Clinical narrative: Heat - hands first then shoulder then toe and feet. Face very flushed and neck. Each day continued to get worse. Doc prescribed steroid pack and BENADRYL then again had to see him steroid shot almost 4 wk still happening. I am still taking BENADRYL 3 x day.
Age: 28.0
Sex: F
Vaccine: HPV4
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: This spontaneous report was received from a consumer concerning her 28 year old daughter. On 26-MAR-2013, the patient was vaccinated with the first dose of GARDASIL (lot number, expiry date, dose and route unspecified) when she was 28 years old. It was reported that the patient had received only one dose of GARDASIL. It was unspecified if the further vaccination was discontinued. No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse concerning an unknown number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with doses of improperly stored GARDASIL (lot number, expiry date, dose and route unspecified) which were exposed to 30 degrees Fahrenheit (F) on 19-APR-2013. No concomitant medications were reported. No adverse effect was reported. This is one of the several reports from the same source. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: Rash started 45 minutes after injection. Started on her back --> shoulders, head, around ears and arms.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse concerning an unknown number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with doses of improperly stored RECOMBIVAX HB (lot number, expiry date, dose and route unspecified) which were exposed to 30 degrees Fahrenheit (F) on 19-APR-2013. No concomitant medications were reported. No adverse effect was reported. This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse concerning an unknown number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with doses of improperly stored VAQTA (lot number, expiry date, dose and route unspecified) which were exposed to 30 degrees Fahrenheit (F) on 19-APR-2013. No concomitant medications were reported. No adverse effect was reported. This is one of the several reports from the same source. Additional information has been requested.
Age: 1.74
Sex: M
Vaccine: DTAP, HEPA, HIBV, VARCEL
Symptoms: Blood test, Convulsion, Lumbar puncture, Pyrexia, Varicella post vaccine
Clinical narrative: Started run a fever 103F and vomited at 0100 AM had a fever straight through til 10:00am when he had a seizure and we called 911.
Age: 1.74
Sex: M
Vaccine: DTAP, HEPA, HIBV, VARCEL
Symptoms: Vomiting
Clinical narrative: Started run a fever 103F and vomited at 0100 AM had a fever straight through til 10:00am when he had a seizure and we called 911.
Age: 1.01
Sex: M
Vaccine: MMR
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Febrile Seizure, High Fever Not Controlled by Medication.
Age: 89.0
Sex: M
Vaccine: TDAP
Symptoms: Fatigue
Clinical narrative: Extreme tiredness. I had to lie down; slept for an hour and woke up tireder than before. This state continued until about 10:00 PM, followed by rapid recovery to normalcy. I think it worth reporting because never before, as far as I know, have I received an injection of Tdap. I was given it this time principally for the tetanus protection--which I had not had for more than a decade. None of the medical professionals were aware that at age 3 months I had nearly died of whooping-cough. I am reporting now in the belief that the Pertussis portion of the vaccine may have caused the reaction I experienced.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Fatigue, Influenza like illness, Injection site pain, Injection site swelling
Clinical narrative: Arm began to ache and swell at the site of the injection. The site got hot. I began to have flu-like symptoms- exhaustion, muscle aches. The pain kept me awake so I took a Tylenol 3 and put ice on the injection site.  I slept all night with ice on my upper arm.  Changed the ice bag once.  In the morning the arm ached, was hot and turned red.  The site is tender to the touch and hurts when I move my arm. I called the Medical Arts Building and talked with the Physician Assistant's assistant.  Later, around 1:30 PM someone from that office called me back.  She said to put ice on the site and take Tylenol.  She said if it doesn't go away by Monday come in so they can examine it.  She amended it and said come in tomorrow if it is worse.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Insomnia, Myalgia, Pain, Pain in extremity
Clinical narrative: Arm began to ache and swell at the site of the injection. The site got hot. I began to have flu-like symptoms- exhaustion, muscle aches. The pain kept me awake so I took a Tylenol 3 and put ice on the injection site.  I slept all night with ice on my upper arm.  Changed the ice bag once.  In the morning the arm ached, was hot and turned red.  The site is tender to the touch and hurts when I move my arm. I called the Medical Arts Building and talked with the Physician Assistant's assistant.  Later, around 1:30 PM someone from that office called me back.  She said to put ice on the site and take Tylenol.  She said if it doesn't go away by Monday come in so they can examine it.  She amended it and said come in tomorrow if it is worse.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Arm began to ache and swell at the site of the injection. The site got hot. I began to have flu-like symptoms- exhaustion, muscle aches. The pain kept me awake so I took a Tylenol 3 and put ice on the injection site.  I slept all night with ice on my upper arm.  Changed the ice bag once.  In the morning the arm ached, was hot and turned red.  The site is tender to the touch and hurts when I move my arm. I called the Medical Arts Building and talked with the Physician Assistant's assistant.  Later, around 1:30 PM someone from that office called me back.  She said to put ice on the site and take Tylenol.  She said if it doesn't go away by Monday come in so they can examine it.  She amended it and said come in tomorrow if it is worse.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Computerised tomogram head, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy
Clinical narrative: Pt developed numbness, tingling, weakness - mainly fingers, face, legs/feet - Guillain-Barre. Tx - IVIG.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Lumbar puncture, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal, Paraesthesia
Clinical narrative: Pt developed numbness, tingling, weakness - mainly fingers, face, legs/feet - Guillain-Barre. Tx - IVIG.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Swollen & painful leg at the vaccine side for 5 days.
Age: 0.15
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RVX
Symptoms: Irritability, Myoclonus, Seizure like phenomena
Clinical narrative: Approximately 5-6 hours after receiving his 2-month shots, patient began to exhibit severe fussiness, which was followed by myoclonic jerks which continued for 2-3 hours. The seizure-type activity resolved spontaneously.
Age: 5.0
Sex: F
Vaccine: FLU3, HEPA, MNQ, TDAP, VARCEL
Symptoms: Lip dry, Pyrexia, Somnolence, Swelling
Clinical narrative: Mom states child had dry lips, swelling, fever which was not measured, and sleeping more then usual.
Age: 31.0
Sex: F
Vaccine: HEPA, TDAP, TYP
Symptoms: Abdominal pain, Appendicitis
Clinical narrative: During the middle of the night on 7-8-12 extreme abdominal pain. Went to the emergency room and was diagnosed with appendicitis.
Age: 0.58
Sex: F
Vaccine: FLU3, RV5
Symptoms: Dehydration, Diarrhoea, Rotavirus infection
Clinical narrative: Pt was diagnosed with Rotavirus by urgent care. Diarrhea since 03/28/13 with dehydration. Baby sitter stated she had kept another child with rotavirus.
Age: 31.0
Sex: M
Vaccine: HPV4
Symptoms: Asthenia, Hyperhidrosis, Hypotension, Pain in extremity, Paraesthesia
Clinical narrative: Syncope.  Hypotension BP 90/60 diaphoresis treated with PO fluids and candy.  BP gradually improved to 115/70 after about an hour. Patient had pain in his arm and tingling in his fingers.  After episode felt weak.
Age: 31.0
Sex: M
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Syncope.  Hypotension BP 90/60 diaphoresis treated with PO fluids and candy.  BP gradually improved to 115/70 after about an hour. Patient had pain in his arm and tingling in his fingers.  After episode felt weak.
Age: 42.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site warmth
Clinical narrative: I received an MMR vaccine as a recommendation from my fertility doctor.  Few days ago I noticed that the area in which I was shot was inflamed.  It looks pink and a it is more warm the the other areas of my arm.   It hurst, but not too, much.  I don't know if it is normal.  I am concern about.  I don't know if I have to go to the doctor, or if I have to postpone my fertility treatment to avoid other problems.    Can you please advise.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: CSF glucose normal, CSF lymphocyte count normal, CSF protein increased, CSF white blood cell count negative, Grand mal convulsion
Clinical narrative: Papular rash on 6/6/13, generalized tonic-clonic seizure on 6/11/13.  Admitted to hospital on 6/12/13, started on IV Acyclovir.  DFA of the skin lesion positive for VZV.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Polymerase chain reaction, Rash papular, Red blood cells CSF positive, Skin lesion, Varicella virus test positive
Clinical narrative: Papular rash on 6/6/13, generalized tonic-clonic seizure on 6/11/13.  Admitted to hospital on 6/12/13, started on IV Acyclovir.  DFA of the skin lesion positive for VZV.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Injection site bruising, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Patient presents with a 1.25" x 1.5" bruise at injection site surrounded by a 3" x 4" area of redness. Location is hard to the touch and produces heat. Injection site is painful.
Age: 12.0
Sex: F
Vaccine: HPV4, HPVX
Symptoms: Condition aggravated, Convulsion
Clinical narrative: Pt is a complex, medically fragile child with numerous health issues, including seizure disorder, although her seizures have been well controlled. On 6/12/13, she had an unusually long seizure (approx. 5 min) than her norm. It was at that time that mom realized that last time she had a seizure (same length) was one day after vaccine (GARDASIL) was given. Mom treated her with DIASTAT, and seizure resolved.
Age: 12.0
Sex: F
Vaccine: HPV4, HPVX
Symptoms: Convulsion
Clinical narrative: Pt is a complex, medically fragile child with numerous health issues, including seizure disorder, although her seizures have been well controlled. On 6/12/13, she had an unusually long seizure (approx. 5 min) than her norm. It was at that time that mom realized that last time she had a seizure (same length) was one day after vaccine (GARDASIL) was given. Mom treated her with DIASTAT, and seizure resolved.
Age: 30.0
Sex: F
Vaccine: FLU3, MMRV, TDAP
Symptoms: Pharyngitis streptococcal, Wrong drug administered
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 30 year old female patient with no pertinent medical history or allergies. On 06-MAY-2013 the patient was vaccinated with the first dose of PROQUAD (merck), (lot number H015781, expiration date 24-FEB-2014), (anatomical location unspecified), dose 0.5 ml via subcutaneous. The patient also received ADACEL and FLUZONE on 06-MAY-2013. There were no concomitant medications. On 06-MAY-2013 the patient was administered of PROQUAD (merck) (instead of her first dose of M-M-R II). On an unspecified date between 06-MAY-2013 and 09-MAY-2013, the patient developed strep throat, the patient returned to the physician's office on 09-MAY-2013 and penicillin (manufacturer unknown) was prescribed. Lab diagnostics studies were not performed. The outcome of strep throat was unknown. Additional information has been requested.
Sex: U
Vaccine: HEPA, MNQ
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified number of patients who on an unknown date received a dose of hepatitis a vaccine, inactivated (manufacturer unknown) (lot # not reported) (dose and route not reported) and a dose of MENACTRA. (On an unknown date the patients experienced fainting. The outcome of fainting was unknown. This case is linked to MARRS 1305USA013836. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: 6VAX-F, PNC13, RV5
Symptoms: Blood culture negative, C-reactive protein increased, CSF glucose normal, CSF protein normal, Chest X-ray normal
Clinical narrative: Information has been received from an investigator concerning an 8 week old male with concurrent conditions of ankyloglossia congenital and gastrooesophageal reflux disease who entered a study. Previous therapy history on 06-OCT-2011 included RECOMBIVAX HB, IM 0.5 ml IM injection one dose. On 06-DEC-2011 the subject was randomized to receive DTaP-HepB-Hib-IPV, PREVNAR 13 and ROTATEQ at 2, 4, and 6 months of age. On 06-DEC-2011, the subject was vaccinated with the first dose in series of 0.5 ml IM dose (injection site not provided) of DTaP-HepB-Hib-IPV. Other study vaccines received on 06-DEC-2011 included the first dose of 0.5 ml IM (injection site not provided) PREVNAR 13 and the first 2.0 ml oral dose of ROTATEQ as part of the study to complete the childhood immunization series. Concomitant therapy included TRI-VI-SOL. On 06-DEC-2011, the patient experienced fever (moderate intensity) and was hospitalized on the same day. On 06-DEC-2011, the subject was admitted to the local hospital after being seen in the ER for fever of 100.9 (unit of measure not reported) for work up of possible sepsis. The subject received first doses of study therapy on 06-DEC-2011 and was admitted that evening. The subject was treated with ROCEPHIN IV suspension, IV (06-DEC-2011 to 07-DEC-2011) (dose and frequency reported as unknown). On 06-DEC-2011, the subject had the following lab tests and results: blood culture was negative and urine culture was negative, CSF showed normal glucose and protein, ESR normal at 14, CRP was 1.0, CBC normal (not further specified), urinalysis was normal (not further specified), BMP normal (not further specified) and a chest x-ray was normal. On 06-DEC-2011, the subject was recovered from the fever. On 08-DEC-2011, the subject was discharged from the hospital in stable condition; discharge diagnosis was fever with sepsis ruled out. The action taken with study therapy was none. The reporting investigator considered that the fever was possibly related to all study vaccines. The investigator's impression was reported as fever reaction to vaccine, mild. Follow-up information was received on 14-DEC-2011 from the investigator, the following fields were updated: labs/diagnostics and the narrative. Follow-up information was obtained on 10-JAN-2012 from the investigator. The following fields were updated: labs/diagnostics and narrative. Follow-up information was received on 13-JAN-2012 from the investigator. The following fields were updated: labs/diagnostics and narrative. Additional information is not expected. This is an amended report, it was requested to reconcile the Relationship to Pneumococcal and ROTATEQ as related.
Age: 0.17
Sex: M
Vaccine: 6VAX-F, PNC13, RV5
Symptoms: Culture urine negative, Full blood count normal, Laboratory test normal, Metabolic function test, Pyrexia
Clinical narrative: Information has been received from an investigator concerning an 8 week old male with concurrent conditions of ankyloglossia congenital and gastrooesophageal reflux disease who entered a study. Previous therapy history on 06-OCT-2011 included RECOMBIVAX HB, IM 0.5 ml IM injection one dose. On 06-DEC-2011 the subject was randomized to receive DTaP-HepB-Hib-IPV, PREVNAR 13 and ROTATEQ at 2, 4, and 6 months of age. On 06-DEC-2011, the subject was vaccinated with the first dose in series of 0.5 ml IM dose (injection site not provided) of DTaP-HepB-Hib-IPV. Other study vaccines received on 06-DEC-2011 included the first dose of 0.5 ml IM (injection site not provided) PREVNAR 13 and the first 2.0 ml oral dose of ROTATEQ as part of the study to complete the childhood immunization series. Concomitant therapy included TRI-VI-SOL. On 06-DEC-2011, the patient experienced fever (moderate intensity) and was hospitalized on the same day. On 06-DEC-2011, the subject was admitted to the local hospital after being seen in the ER for fever of 100.9 (unit of measure not reported) for work up of possible sepsis. The subject received first doses of study therapy on 06-DEC-2011 and was admitted that evening. The subject was treated with ROCEPHIN IV suspension, IV (06-DEC-2011 to 07-DEC-2011) (dose and frequency reported as unknown). On 06-DEC-2011, the subject had the following lab tests and results: blood culture was negative and urine culture was negative, CSF showed normal glucose and protein, ESR normal at 14, CRP was 1.0, CBC normal (not further specified), urinalysis was normal (not further specified), BMP normal (not further specified) and a chest x-ray was normal. On 06-DEC-2011, the subject was recovered from the fever. On 08-DEC-2011, the subject was discharged from the hospital in stable condition; discharge diagnosis was fever with sepsis ruled out. The action taken with study therapy was none. The reporting investigator considered that the fever was possibly related to all study vaccines. The investigator's impression was reported as fever reaction to vaccine, mild. Follow-up information was received on 14-DEC-2011 from the investigator, the following fields were updated: labs/diagnostics and the narrative. Follow-up information was obtained on 10-JAN-2012 from the investigator. The following fields were updated: labs/diagnostics and narrative. Follow-up information was received on 13-JAN-2012 from the investigator. The following fields were updated: labs/diagnostics and narrative. Additional information is not expected. This is an amended report, it was requested to reconcile the Relationship to Pneumococcal and ROTATEQ as related.
Age: 0.17
Sex: M
Vaccine: 6VAX-F, PNC13, RV5
Symptoms: Red blood cell sedimentation rate increased, Urine analysis normal
Clinical narrative: Information has been received from an investigator concerning an 8 week old male with concurrent conditions of ankyloglossia congenital and gastrooesophageal reflux disease who entered a study. Previous therapy history on 06-OCT-2011 included RECOMBIVAX HB, IM 0.5 ml IM injection one dose. On 06-DEC-2011 the subject was randomized to receive DTaP-HepB-Hib-IPV, PREVNAR 13 and ROTATEQ at 2, 4, and 6 months of age. On 06-DEC-2011, the subject was vaccinated with the first dose in series of 0.5 ml IM dose (injection site not provided) of DTaP-HepB-Hib-IPV. Other study vaccines received on 06-DEC-2011 included the first dose of 0.5 ml IM (injection site not provided) PREVNAR 13 and the first 2.0 ml oral dose of ROTATEQ as part of the study to complete the childhood immunization series. Concomitant therapy included TRI-VI-SOL. On 06-DEC-2011, the patient experienced fever (moderate intensity) and was hospitalized on the same day. On 06-DEC-2011, the subject was admitted to the local hospital after being seen in the ER for fever of 100.9 (unit of measure not reported) for work up of possible sepsis. The subject received first doses of study therapy on 06-DEC-2011 and was admitted that evening. The subject was treated with ROCEPHIN IV suspension, IV (06-DEC-2011 to 07-DEC-2011) (dose and frequency reported as unknown). On 06-DEC-2011, the subject had the following lab tests and results: blood culture was negative and urine culture was negative, CSF showed normal glucose and protein, ESR normal at 14, CRP was 1.0, CBC normal (not further specified), urinalysis was normal (not further specified), BMP normal (not further specified) and a chest x-ray was normal. On 06-DEC-2011, the subject was recovered from the fever. On 08-DEC-2011, the subject was discharged from the hospital in stable condition; discharge diagnosis was fever with sepsis ruled out. The action taken with study therapy was none. The reporting investigator considered that the fever was possibly related to all study vaccines. The investigator's impression was reported as fever reaction to vaccine, mild. Follow-up information was received on 14-DEC-2011 from the investigator, the following fields were updated: labs/diagnostics and the narrative. Follow-up information was obtained on 10-JAN-2012 from the investigator. The following fields were updated: labs/diagnostics and narrative. Follow-up information was received on 13-JAN-2012 from the investigator. The following fields were updated: labs/diagnostics and narrative. Additional information is not expected. This is an amended report, it was requested to reconcile the Relationship to Pneumococcal and ROTATEQ as related.
Age: 38.0
Sex: F
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. On 30-MAY-2013 the patient was vaccinated with the first 0.5 ml dose of M-M-R II (HSA, lot # 669840/0446AA, expiration date 28-MAR-2013), subcutaneous. No adverse effect reported. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Pyrexia
Clinical narrative: Pt. developed fever 3 hrs. after receiving vaccines, Temp was at 103.8 the next morning.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site pain, Injection site reaction
Clinical narrative: 16.5 cm x 11.75 cm Rx (L) thigh site KINRIX decreased pain today but larger today.
Age: 0.19
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Crying, Emotional distress, Hypersomnia
Clinical narrative: Patient had vaccines on 6/10/13 at 1045am. At 1:30 pm, she began crying and was unconsolable for 3 hrs. Then she slept for 21 hrs. Only walking briefly to take 1-2 oz of formula.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Erythema, Oedema peripheral, Pruritus
Clinical narrative: 2 wks ago. 2 patches, 1 on face 1 on neck - Started little blisters, burning, itching, swollen, flaking. Around arm after shot - red and swollen went away after 2 wks.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Skin exfoliation, Swelling
Clinical narrative: 2 wks ago. 2 patches, 1 on face 1 on neck - Started little blisters, burning, itching, swollen, flaking. Around arm after shot - red and swollen went away after 2 wks.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Oedema peripheral
Clinical narrative: Patient states left started to hurt this morning around 10:00 am and noticed arm redness, swelling, and pain. States it is pain of left arm and soreness. Left upper arm is red with small amount of swelling, slightly warm to touch. Referred patient to her private doctor. Appointment on 6-12-13 at 3:50 pm. Instructed pt to use warm compresses to area.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Pain in extremity
Clinical narrative: Patient states left started to hurt this morning around 10:00 am and noticed arm redness, swelling, and pain. States it is pain of left arm and soreness. Left upper arm is red with small amount of swelling, slightly warm to touch. Referred patient to her private doctor. Appointment on 6-12-13 at 3:50 pm. Instructed pt to use warm compresses to area.
Age: 78.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site mass, Injection site warmth, Pruritus
Clinical narrative: Pt reports extreme itching approx 3 days after vaccine lasting 5 days - pt also has redness 3-4" around injection site and it's hot to touch. Marble sized lump present as well. No fever or pain.
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Hyperhidrosis, Pallor
Clinical narrative: 5 mins after injection pt became pale sweating did not pass out cool cloth to head elevated legs juice and crackers. Better after 15 mins.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Given ZOSTAVAX 6/10/13. 1 day later developed itching and redness at injection site. Used OTC HC cream - Area responding to OTC cream.
Age: 36.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Headache, Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site. Headache for a couple days.
Age: 1.06
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Vomiting
Clinical narrative: Vomiting started at 6:30 am only vomited 2 times pt is to start, small amounts of PEDIALIGHT and if tolerated well may advance.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Pt passed out immediately receiving the vaccine (#3/3) v/s were obtained, pt passed out for approx. 30 sec., she was administered 2L of 02 via nasal cannula and monitored. After she was able, she sat up for 20 min, ate crackers, drank 2 juice boxes. Pt left w/mother - walked out on her own. Total amt. of time approx 30 min.
Age: 28.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site vesicles, Local reaction
Clinical narrative: 6/7/13 S and S's (R) arm pain, swelling, redness, from shoulder to elbow. Blistering (R) arm x 1 day after s/p IM injection Typhoid in (R) arm/deltoid. Client notified PCP office for eval, seen at office 6/7/13. Dx, local reaction from vaccine. Tx: IM DEPO MEDROL 80 mgs. and 1% Silverdine cream bid. RTN. 6/10/13 Tx KEFLEX x 10 days.
Age: 12.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Fall, Head injury, Syncope
Clinical narrative: Syncope. Fell striking head. No prior dizziness or lightheadedness. Sent to ER for evaluation of striking head.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Hypotonia
Clinical narrative: After administration infant became limp.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Mass, Oedema peripheral
Clinical narrative: Arm swelling, lump, redness.
Age: 55.0
Sex: F
Vaccine: MMR
Symptoms: Angiogram, Laboratory test normal, Pleurisy
Clinical narrative: Pleurisy, right 5/24/13.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Red, itchy, small cucumber-sized swelling at site of injection 3 day after administration. Applied hydrocortisone cream.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Pt says pain at injection site has radiated to inside of deltoid muscle. She says pain has been constant with times of increased intensity since 4/22/13 when vaccination was given.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain
Clinical narrative: Upper left arm pain (near injection site).
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Upper left arm pain (near injection site).
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Loss of consciousness, Mobility decreased, Pain in extremity
Clinical narrative: This spontaneous report as received from a healthcare worker via company representative refers to a 52 year old female patient with ankylosing spondylitis. On 08-NOV-2012 the patient was vaccinated with PNEUMOVAX23 25/0.5 (route, anatomical location, dosage and lot number unknown). Concomitant therapies included REMICADE. The patient developed a sore arm and was unable to move her arm " a couple of hours after" receiving PNEUMOVAX23. The patient also reports that the pain was so extreme the next morning that she "passed out." She also reports that she received PNEUMOVAX23 five years ago and had no reaction after receiving the vaccine. The patient stated that she informed an unspecified doctor she works for on an unspecified date about the symptoms and he prescribed her physical therapy. She reports that she started physical therapy on 21-NOV-2012 and it ended "about two weeks after". Healthcare worker also reports that she spoke with an orthopedic surgeon over the phone on an unspecified date and he prescribed her to take CELEBREX two times per day as well as instructed her to alternate between heat and ice. She stated that the symptoms took "about a month" (on approximately 08-DEC-2012) to resolve. No lab diagnostics studies were performed. Additional information has been requested.
Age: 1.26
Sex: F
Vaccine: DTAP, MMR, VARCEL, VARCEL
Symptoms: Discomfort, Injection site erythema, Injection site pain, Injection site rash, Injection site vesicles
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 1 year old female patient with no pertinent medical history and no drug reactions or allergies. On 27-MAR-2013, the patient was vaccinated with a 0.5 ml dose of VARIVAX (Merck) (Lot # H017243, expiration date 17-SEP-2014) SQ. There was no concomitant medication. The medical assistant reported that on 27-MAR-2013, the patient received VARIVAX (Merc) and had fever greater than 100.3F, soreness at the site, patient not acting herself, lethargic, right upper thigh blistering, developed a red lesion at the injection site that got bigger. The patient came into the office on 09-APR-2013, due to fever and soreness at the injection site. On 03-MAY-2013, the patient was seen in the office regarding conjunctival edema from the eyes, enlargement of lymph nodes and watery discharge from the eye. The patient was treated with TYLENOL and MOTRIN. There were no Lab diagnosis/studies performed. At the time of the report, the patient had not recovered. The medical assistant requested a lot check. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.26
Sex: F
Vaccine: DTAP, MMR, VARCEL, VARCEL
Symptoms: Pain, Pyrexia
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 1 year old female patient with no pertinent medical history and no drug reactions or allergies. On 27-MAR-2013, the patient was vaccinated with a 0.5 ml dose of VARIVAX (Merck) (Lot # H017243, expiration date 17-SEP-2014) SQ. There was no concomitant medication. The medical assistant reported that on 27-MAR-2013, the patient received VARIVAX (Merc) and had fever greater than 100.3F, soreness at the site, patient not acting herself, lethargic, right upper thigh blistering, developed a red lesion at the injection site that got bigger. The patient came into the office on 09-APR-2013, due to fever and soreness at the injection site. On 03-MAY-2013, the patient was seen in the office regarding conjunctival edema from the eyes, enlargement of lymph nodes and watery discharge from the eye. The patient was treated with TYLENOL and MOTRIN. There were no Lab diagnosis/studies performed. At the time of the report, the patient had not recovered. The medical assistant requested a lot check. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.26
Sex: F
Vaccine: DTAP, MMR, VARCEL, VARCEL
Symptoms: Abnormal behaviour, Conjunctival oedema, Eye discharge, Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 1 year old female patient with no pertinent medical history and no drug reactions or allergies. On 27-MAR-2013, the patient was vaccinated with a 0.5 ml dose of VARIVAX (Merck) (Lot # H017243, expiration date 17-SEP-2014) SQ. There was no concomitant medication. The medical assistant reported that on 27-MAR-2013, the patient received VARIVAX (Merc) and had fever greater than 100.3F, soreness at the site, patient not acting herself, lethargic, right upper thigh blistering, developed a red lesion at the injection site that got bigger. The patient came into the office on 09-APR-2013, due to fever and soreness at the injection site. On 03-MAY-2013, the patient was seen in the office regarding conjunctival edema from the eyes, enlargement of lymph nodes and watery discharge from the eye. The patient was treated with TYLENOL and MOTRIN. There were no Lab diagnosis/studies performed. At the time of the report, the patient had not recovered. The medical assistant requested a lot check. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.26
Sex: F
Vaccine: DTAP, MMR, VARCEL, VARCEL
Symptoms: Injection site reaction, Injection site vesicles, Lethargy, Lymphadenopathy, Pyrexia
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 1 year old female patient with no pertinent medical history and no drug reactions or allergies. On 27-MAR-2013, the patient was vaccinated with a 0.5 ml dose of VARIVAX (Merck) (Lot # H017243, expiration date 17-SEP-2014) SQ. There was no concomitant medication. The medical assistant reported that on 27-MAR-2013, the patient received VARIVAX (Merc) and had fever greater than 100.3F, soreness at the site, patient not acting herself, lethargic, right upper thigh blistering, developed a red lesion at the injection site that got bigger. The patient came into the office on 09-APR-2013, due to fever and soreness at the injection site. On 03-MAY-2013, the patient was seen in the office regarding conjunctival edema from the eyes, enlargement of lymph nodes and watery discharge from the eye. The patient was treated with TYLENOL and MOTRIN. There were no Lab diagnosis/studies performed. At the time of the report, the patient had not recovered. The medical assistant requested a lot check. This is one of several reports received from the same source. Additional information has been requested.