chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR
Symptoms: Incorrect dose administered, No adverse event, Product reconstitution issue
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown demographics. On unspecified dates, the patient were vaccinated with MMR II (dose, frequency unknown). No concomitant medication was reported. The healthcare worker reported patients received less than recommended dose of MMR II due to incorrect reconstitution methods. Healthcare worker reported that the full amount of diluent was being drawn up to reconstitute the product but then only 0.5 milliltre of reconstituted product was being administered to the patients. No adverse effects were reported. No product quality complaint was reported. The outcome of events was unknown. This case is related to 1407USA008555, 1407USA008556, 1407USA008557, 1407USA008558 and 1407USA008559 via same reporter link. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Patient became, dizzy, lightheaded, and had to lay down. She had not eaten anything that day. She was given water, a small snack, and remained seated in office for about 10 minutes.
Age: 0.19
Sex: F
Vaccine: 6VAX-F, PNC13, RV1, 6VAX-F, PNC13, RV1
Symptoms: Apparent life threatening event, Blood culture negative, C-reactive protein increased, Culture urine negative, Differential white blood cell count normal
Clinical narrative: This female subject was enrolled in a study. On 09 July 2014, she received a dose of INFANRIX HEXA, Pfizer's PREVENAR 13 and ROTARIX. On 09 July 2014, on the same day after the 1st dose of INFANRIX HEXA, on the same day after the 1st dose of PREVNAR 13, on the same day after the 1st dose of ROTARIX, this two-month-old subject developed an apparent life threatening event with leukocytosis. The subject was hospitalised. The event resolved on 09 July 2014. The investigator considered that there was a reasonable possibility that the apparent life threatening event with leukocytosis may have been caused by INFANRIX HEXA, PREVNAR 13 and ROTARIX. Investigator Comments: On the evening of the 09 July 2014 baby was very irritable then finally went to sleep. Mom went to check on the baby and the skin was pale and the lips were pale, breathing was noted to be very shallow and baby tried to go back to sleep. Lips were not blue at all. Mom states that the baby acts like she is trying to let out a big cry and can't quite get it out. Was instructed by the after hours nurse on call to take baby to the ER to be evaluated. Baby was taken in and from there admitted to the hospital. Baby did well with some mild fussiness and decreased stooling. Was discharged from the hospital on 10 July 2014. Baby is to return to the clinic for a check up on 11 July 2014. Mom also reported limp floppy extremities.
Age: 0.19
Sex: F
Vaccine: 6VAX-F, PNC13, RV1, 6VAX-F, PNC13, RV1
Symptoms: Faecal volume decreased, Floppy infant, Full blood count normal, Hypopnoea, Hypotonia
Clinical narrative: This female subject was enrolled in a study. On 09 July 2014, she received a dose of INFANRIX HEXA, Pfizer's PREVENAR 13 and ROTARIX. On 09 July 2014, on the same day after the 1st dose of INFANRIX HEXA, on the same day after the 1st dose of PREVNAR 13, on the same day after the 1st dose of ROTARIX, this two-month-old subject developed an apparent life threatening event with leukocytosis. The subject was hospitalised. The event resolved on 09 July 2014. The investigator considered that there was a reasonable possibility that the apparent life threatening event with leukocytosis may have been caused by INFANRIX HEXA, PREVNAR 13 and ROTARIX. Investigator Comments: On the evening of the 09 July 2014 baby was very irritable then finally went to sleep. Mom went to check on the baby and the skin was pale and the lips were pale, breathing was noted to be very shallow and baby tried to go back to sleep. Lips were not blue at all. Mom states that the baby acts like she is trying to let out a big cry and can't quite get it out. Was instructed by the after hours nurse on call to take baby to the ER to be evaluated. Baby was taken in and from there admitted to the hospital. Baby did well with some mild fussiness and decreased stooling. Was discharged from the hospital on 10 July 2014. Baby is to return to the clinic for a check up on 11 July 2014. Mom also reported limp floppy extremities.
Age: 0.19
Sex: F
Vaccine: 6VAX-F, PNC13, RV1, 6VAX-F, PNC13, RV1
Symptoms: Irritability, Leukocytosis, Pallor, White blood cell count normal
Clinical narrative: This female subject was enrolled in a study. On 09 July 2014, she received a dose of INFANRIX HEXA, Pfizer's PREVENAR 13 and ROTARIX. On 09 July 2014, on the same day after the 1st dose of INFANRIX HEXA, on the same day after the 1st dose of PREVNAR 13, on the same day after the 1st dose of ROTARIX, this two-month-old subject developed an apparent life threatening event with leukocytosis. The subject was hospitalised. The event resolved on 09 July 2014. The investigator considered that there was a reasonable possibility that the apparent life threatening event with leukocytosis may have been caused by INFANRIX HEXA, PREVNAR 13 and ROTARIX. Investigator Comments: On the evening of the 09 July 2014 baby was very irritable then finally went to sleep. Mom went to check on the baby and the skin was pale and the lips were pale, breathing was noted to be very shallow and baby tried to go back to sleep. Lips were not blue at all. Mom states that the baby acts like she is trying to let out a big cry and can't quite get it out. Was instructed by the after hours nurse on call to take baby to the ER to be evaluated. Baby was taken in and from there admitted to the hospital. Baby did well with some mild fussiness and decreased stooling. Was discharged from the hospital on 10 July 2014. Baby is to return to the clinic for a check up on 11 July 2014. Mom also reported limp floppy extremities.
Age: 0.19
Sex: F
Vaccine: 6VAX-F, PNC13, RV1, 6VAX-F, PNC13, RV1
Symptoms: Blood culture negative, C-reactive protein increased, Culture urine negative, Faecal volume decreased, Full blood count
Clinical narrative: This female subject was enrolled in a study. On 09 July 2014, she received a dose of INFANRIX HEXA, Pfizer's PREVENAR 13 and ROTARIX. On 09 July 2014, on the same day after the 1st dose of INFANRIX HEXA, on the same day after the 1st dose of PREVNAR 13, on the same day after the 1st dose of ROTARIX, this two-month-old subject developed an apparent life threatening event with leukocytosis. The subject was hospitalised. The event resolved on 09 July 2014. The investigator considered that there was a reasonable possibility that the apparent life threatening event with leukocytosis may have been caused by INFANRIX HEXA, PREVNAR 13 and ROTARIX. Investigator Comments: On the evening of the 09 July 2014 baby was very irritable then finally went to sleep. Mom went to check on the baby and the skin was pale and the lips were pale, breathing was noted to be very shallow and baby tried to go back to sleep. Lips were not blue at all. Mom states that the baby acts like she is trying to let out a big cry and can't quite get it out. Was instructed by the after hours nurse on call to take baby to the ER to be evaluated. Baby was taken in and from there admitted to the hospital. Baby did well with some mild fussiness and decreased stooling. Was discharged from the hospital on 10 July 2014. Baby is to return to the clinic for a check up on 11 July 2014. Mom also reported limp floppy extremities.
Age: 0.19
Sex: F
Vaccine: 6VAX-F, PNC13, RV1, 6VAX-F, PNC13, RV1
Symptoms: Hypopnoea, Hypotonia, Irritability, Leukocytosis, Pallor
Clinical narrative: This female subject was enrolled in a study. On 09 July 2014, she received a dose of INFANRIX HEXA, Pfizer's PREVENAR 13 and ROTARIX. On 09 July 2014, on the same day after the 1st dose of INFANRIX HEXA, on the same day after the 1st dose of PREVNAR 13, on the same day after the 1st dose of ROTARIX, this two-month-old subject developed an apparent life threatening event with leukocytosis. The subject was hospitalised. The event resolved on 09 July 2014. The investigator considered that there was a reasonable possibility that the apparent life threatening event with leukocytosis may have been caused by INFANRIX HEXA, PREVNAR 13 and ROTARIX. Investigator Comments: On the evening of the 09 July 2014 baby was very irritable then finally went to sleep. Mom went to check on the baby and the skin was pale and the lips were pale, breathing was noted to be very shallow and baby tried to go back to sleep. Lips were not blue at all. Mom states that the baby acts like she is trying to let out a big cry and can't quite get it out. Was instructed by the after hours nurse on call to take baby to the ER to be evaluated. Baby was taken in and from there admitted to the hospital. Baby did well with some mild fussiness and decreased stooling. Was discharged from the hospital on 10 July 2014. Baby is to return to the clinic for a check up on 11 July 2014. Mom also reported limp floppy extremities.
Age: 0.19
Sex: F
Vaccine: 6VAX-F, PNC13, RV1, 6VAX-F, PNC13, RV1
Symptoms: White blood cell count normal
Clinical narrative: This female subject was enrolled in a study. On 09 July 2014, she received a dose of INFANRIX HEXA, Pfizer's PREVENAR 13 and ROTARIX. On 09 July 2014, on the same day after the 1st dose of INFANRIX HEXA, on the same day after the 1st dose of PREVNAR 13, on the same day after the 1st dose of ROTARIX, this two-month-old subject developed an apparent life threatening event with leukocytosis. The subject was hospitalised. The event resolved on 09 July 2014. The investigator considered that there was a reasonable possibility that the apparent life threatening event with leukocytosis may have been caused by INFANRIX HEXA, PREVNAR 13 and ROTARIX. Investigator Comments: On the evening of the 09 July 2014 baby was very irritable then finally went to sleep. Mom went to check on the baby and the skin was pale and the lips were pale, breathing was noted to be very shallow and baby tried to go back to sleep. Lips were not blue at all. Mom states that the baby acts like she is trying to let out a big cry and can't quite get it out. Was instructed by the after hours nurse on call to take baby to the ER to be evaluated. Baby was taken in and from there admitted to the hospital. Baby did well with some mild fussiness and decreased stooling. Was discharged from the hospital on 10 July 2014. Baby is to return to the clinic for a check up on 11 July 2014. Mom also reported limp floppy extremities.
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Hypersensitivity, Injection site pain, Injection site reaction, Injection site swelling, Skin tightness
Clinical narrative: Mother was at health department today (7/18/2014) and was told by her pediatrician to report this adverse event next time she was here (which was for appt today). Mother states that child had severe swelling to right thigh ("2-3 times the regular size of his thigh") which began approximately 2 days after vaccine administration. Right thigh became extremely "tight" (swollen) and was painful to the touch. Her pediatrician initially thought it was a cellulitis, and then later told her it was an allergic reaction. The area did not subside until the child received steroids. The pediatrician told mother that patient should not receive this vaccine again for fear of respiratory difficulties or anaphylaxis.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Loss of consciousness
Clinical narrative: Passed out while checking out/paying at counter - nurses had me sit in chair and gave me ginger ale and crackers until I regained strength.
Age: 0.52
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Blood glucose normal, Electrocardiogram normal, Electroencephalogram, Grand mal convulsion, Nuclear magnetic resonance imaging brain
Clinical narrative: 2 minute tonic clonic seizure with no preceding fever or fever following event.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fatigue, Idiopathic thrombocytopenic purpura, Immediate post-injection reaction, Pancytopenia
Clinical narrative: Immediately became light headed but remained oriented.  Vitals stable after resting for 20 minutes. Was diagnoses 4/2014 with mycoplasma pneumonia. Presented 5/8/14 in office for extreme fatigue.  Patient was found to have pancytopenia and ITP.  Mom believes the fatigue, pancytopenia, and ITP are result of Gardasil.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Pneumonia mycoplasmal
Clinical narrative: Immediately became light headed but remained oriented.  Vitals stable after resting for 20 minutes. Was diagnoses 4/2014 with mycoplasma pneumonia. Presented 5/8/14 in office for extreme fatigue.  Patient was found to have pancytopenia and ITP.  Mom believes the fatigue, pancytopenia, and ITP are result of Gardasil.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient called on 07/16/14 about 4pm, spoke with RN Supervisor. Patient reported pain, redness, swelling to left arm (injection site). Patient also reported headache and possible fever.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Redness around injection site.
Age: 0.25
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Grand mal convulsion, Pyrexia
Clinical narrative: Pt with 4 grand mal/tonic clonic seizures and fever to tmax of 104.
Age: 0.53
Sex: F
Vaccine: DTAPIPVHIB, HEP, PPV
Symptoms: Convulsion, Hyporesponsive to stimuli, Lethargy, Mobility decreased, Postictal state
Clinical narrative: Threw up entire contents of stomach until vomiting bile. Seizure in crib, unwitnessed, but found in post-ictal state covered in vomit and lethargic and not moving anything.
Age: 0.53
Sex: F
Vaccine: DTAPIPVHIB, HEP, PPV
Symptoms: Vomiting
Clinical narrative: Threw up entire contents of stomach until vomiting bile. Seizure in crib, unwitnessed, but found in post-ictal state covered in vomit and lethargic and not moving anything.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: First my son complained his arm that the shot was in was really hurting, he couldn't lay on it in bed. Then when he awoke the following day his arm was very swollen, red, a tiny bubble was where the shot went in and it was extremely hot to touch. The following day we went back to dr b/c it was still very red & hurt etc. Our dr put him on antibiotics in case of infection, she didn't like how hot & red it was.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Delirium, Erythema, Herpes zoster, Induration, Local swelling
Clinical narrative: Arm very sore and hard. Temp went as high as 104. Delirious, nauseas, painful. Friend was using ice to cool her off. Arm swelled up and was red. Still sore as of 7/11/14. Thinks she is breaking cut in shingles now. Has developed a rash and spots. Lasted 2-3 days (the temp did).
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pain in extremity, Pyrexia, Rash
Clinical narrative: Arm very sore and hard. Temp went as high as 104. Delirious, nauseas, painful. Friend was using ice to cool her off. Arm swelled up and was red. Still sore as of 7/11/14. Thinks she is breaking cut in shingles now. Has developed a rash and spots. Lasted 2-3 days (the temp did).
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site reaction, Rash pruritic
Clinical narrative: Patient reported today 7-7-14, 2 days after injection, got an itchy rash under breasts and down Rt arm below injection site. Lasted 10 days.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Left lateral arm with expanding redness. 6 cm diameter mild warmth to the touch. No pain or itching. No fever. Minimal firmness. Treatment = Recommended ice application to site three times per day for 5 days. Continue ZYRTEC.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Head injury, Syncope
Clinical narrative: Pt was given vaccine, advised to lay down for several min after shots. After approximately 10 min he walked to front of office and fainted at check out desk. He was carried back to room O2 sat 100% HR was 70. Patient was responsive and appropriate. Patient did hit the back of his head when he fell. No sign/symptoms of head injury.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal pain, Pain, X-ray limb normal
Clinical narrative: (L) shoulder pain, especially with ROM in any place worse with lifting. Denies neurological symptoms, no neurological impairment found.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Diarrhoea, Dizziness, Fatigue, Headache, Pyrexia
Clinical narrative: Within 3-4 hours of receiving vaccine, he began with headache, vomiting, diarrhea. These lasted overnight along with low grade fever (about 100). Today he is fatigued and slightly dizzy. They are attempting rehydration with rest.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Vomiting
Clinical narrative: Within 3-4 hours of receiving vaccine, he began with headache, vomiting, diarrhea. These lasted overnight along with low grade fever (about 100). Today he is fatigued and slightly dizzy. They are attempting rehydration with rest.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site reaction, Injection site urticaria
Clinical narrative: Left axillary lymph node swelling after 1st day. Subjective fever and chill after 1st day. 1-2nd day with left deltoid pain, stiffness at injection site. 2nd day with reddened raised wheals 4-5 areas around injection site about 1cm. TYLENOL given, warm compresses.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Lymphadenopathy, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Left axillary lymph node swelling after 1st day. Subjective fever and chill after 1st day. 1-2nd day with left deltoid pain, stiffness at injection site. 2nd day with reddened raised wheals 4-5 areas around injection site about 1cm. TYLENOL given, warm compresses.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Feeling hot, Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Shots given 7/14/14 at 10:30 AM, that afternoon developed fever (felt hot) rash at site of MMRV noted about 24 hours after shot given - (L) thigh - red, sl. raised irregularly shaped wheal 4 x 3 cm, itches, not getting bigger, did have sore throat AM 7/16/16. Otherwise feels well.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site urticaria, Oropharyngeal pain, Pyrexia
Clinical narrative: Shots given 7/14/14 at 10:30 AM, that afternoon developed fever (felt hot) rash at site of MMRV noted about 24 hours after shot given - (L) thigh - red, sl. raised irregularly shaped wheal 4 x 3 cm, itches, not getting bigger, did have sore throat AM 7/16/16. Otherwise feels well.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Vaccines administered at 1037. Pt. c/o dizziness at 1038. Water and sucker given at this time, fan. N/V at 1043. Pt. ate granola bar at 1047. BP 91/53 at 1050. More water and another sucker given. BP 110/75 at 1055. Pt left with mother at 1059. Instructed to hydrate and eat lunch. Encouraged to notify Dr. of event. Dr for any follow up needed.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Dizziness, Injection site pain, Injection site pruritus, Injection site warmth, Pain
Clinical narrative: Pt. c/o needle phobia before shot was given. C/O dizziness, itchiness and pain when shot was given. Went to walk-in clinic 1 day after shot c/o generalized itching - slight relief with BENADRYL. Pain - slight relief with Ibuprofen. Main relief with ice.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus generalised
Clinical narrative: Pt. c/o needle phobia before shot was given. C/O dizziness, itchiness and pain when shot was given. Went to walk-in clinic 1 day after shot c/o generalized itching - slight relief with BENADRYL. Pain - slight relief with Ibuprofen. Main relief with ice.
Age: 25.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain upper, Diarrhoea, Headache, Nausea
Clinical narrative: Nausea, diarrhea, headache, stomach ache.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect dose administered, Product reconstitution issue
Clinical narrative: This spontaneous report as received from a healthcare workr refers to unspecified number of patients of unknown demographics. On unspecified dates, the patients were vaccinated with PROQUAD (merck) (dose, frequency unknown). No concomitant medication was reported. The healthcre worker reported patients received less than recommended dose of PROQUAD due to incorrect reconstitution methods. Healthcare worker reported that the full amount of diluent was being drawn up to reconstitute the product but then only 0.5 millilitre of reconstituted product was being administered to the patients. No adverse effects were reported. No product quality complaint was reported. The outcome of events was unknown. This case is related with 1407USA008555, 1407USA008557, 1407USA008558, 1407USA007501 and 1407USA008559 via same reporter link. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema
Clinical narrative: 15.5 x 13 cm area of erythema at varicella site right upper arm.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Lt Deltoid red warm 2.5 x 2
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product reconstitution issue
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown demographics. On unspecified dates, the patients were vaccinated with VARIVAX (Merck) (dose, frequency unknown). No concomitant medication was reported. The healthcare worker reported vaccines were reconstituted with less than the recommended amount of diluent. No adverse effects were reported. Product quality complaint was not reported. The outcome of events was unknown. This case is related with 1407USA008555, 1407USA008556, 1407USA007501, 1407USA008557 and 1407USA008559 via same reporter link. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Injection site infection, Pain, Pruritus
Clinical narrative: This spontaneous report as received from a consumer refers to a 62 year old female patient reporting on herself. None pertinent medical history, drug reactions or allergies reported. On 22-JUN-2014, the patient was vaccinated with ZOSTAVAX dose 1, subdermal in the left upper arm (lot # was not reported). Concomitant medication was not reported. On 23-JUN-2014, the patient experienced mild redness, warmth, swelling, itching, bruising, pain and the spread of the injection looked infected. The patient started that pain was more than just getting a shot, work sent her to the work doctor to seek medical attention. The patient was treated with antibiotics cephalexin capsules and hot compresses every 15 minutes. The patient was out of work for 2 days. Lab tests were not performed. Therapy was reported as not discontinued. The outcome of mild redness, warmth, swelling, itching, bruising, pain and the spread of the injection looked infected was reported as recovered on 27-JUN-2014. Causality was not reported. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm, Swelling
Clinical narrative: This spontaneous report as received from a consumer refers to a 62 year old female patient reporting on herself. None pertinent medical history, drug reactions or allergies reported. On 22-JUN-2014, the patient was vaccinated with ZOSTAVAX dose 1, subdermal in the left upper arm (lot # was not reported). Concomitant medication was not reported. On 23-JUN-2014, the patient experienced mild redness, warmth, swelling, itching, bruising, pain and the spread of the injection looked infected. The patient started that pain was more than just getting a shot, work sent her to the work doctor to seek medical attention. The patient was treated with antibiotics cephalexin capsules and hot compresses every 15 minutes. The patient was out of work for 2 days. Lab tests were not performed. Therapy was reported as not discontinued. The outcome of mild redness, warmth, swelling, itching, bruising, pain and the spread of the injection looked infected was reported as recovered on 27-JUN-2014. Causality was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product reconstitution issue
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown demographics. On unspecified dates, the patients were vaccinated with M-M-R II (dose, frequency unknown). No concomitant medication was reported. The healthcare worker reported that the vaccines were reconstituted with less than the recommended amount of diluent. No adverse effects were reported. No product quality complaint was reported. The outcome of events was unknown. This case is related with 1407USA008555, 1407USA008556, 1407USA007501, 1407USA008558 and 1407USA008559 via same reporter link. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 2 year old female patient. Pertinent medical history, drug reactions or allergies were not reported. On 30-DEC-2011, the patient was vaccinated with VAQTA (25/0.5) dose 1, 0.5 ml, intramuscular (lot# was not reported). On 25-JUL-2012, the patient was vaccinated with VAQTA (25/0.5) dose 2, 0.5 ml, intramuscular (lot# was not reported). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant who reported that (Oka/Merck) PROQUAD reached temperatures that were outside the prescribing information. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Abdominal discomfort, Colitis, Colonoscopy, Diarrhoea, Endoscopy
Clinical narrative: This spontaneous report was received from a patient's mother refers to her child of unknown gender and age. The reporter stated that on an unknown date, her child was vaccinated with a dose of unspecified vaccine that she believed might have been the chicken pox vaccine-(Oka/Merck) (Manufacturer unknown). Consumer stated that her child developed rashes, diarrhoea and colitis after receiving the unspecified (Oka/Merck) (Manufacturer unknown). Consumer stated that her child's stomach was a mess and they had to see a specialist who performed colonoscopies and endoscopies. Specialist prescribed the child with Crohn's medications to control symptoms. Outcome of the events were not reported. No product quality complaint (PQC) was reported. Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a patient's mother refers to her child of unknown gender and age. The reporter stated that on an unknown date, her child was vaccinated with a dose of unspecified vaccine that she believed might have been the chicken pox vaccine-(Oka/Merck) (Manufacturer unknown). Consumer stated that her child developed rashes, diarrhoea and colitis after receiving the unspecified (Oka/Merck) (Manufacturer unknown). Consumer stated that her child's stomach was a mess and they had to see a specialist who performed colonoscopies and endoscopies. Specialist prescribed the child with Crohn's medications to control symptoms. Outcome of the events were not reported. No product quality complaint (PQC) was reported. Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant who reported that VARIVAX (Merck) reached temperatures that were outside the prescribing information. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema
Clinical narrative: Onset of redness around injection site measuring 5" long nd 3" wide.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site vesicles
Clinical narrative: Redness, pain at injection site, tenderness and blisters present. (Right arm).
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Eye swelling, Headache, Neck pain, Pyrexia
Clinical narrative: Fever 103/chills/headache/vomiting/swollen eye sockets/pain in neck - started about 8 hours post administration. Treated with acetaminophen and ibuprofen symptoms mostly resolved about 40 hours post administration.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: Fever 103/chills/headache/vomiting/swollen eye sockets/pain in neck - started about 8 hours post administration. Treated with acetaminophen and ibuprofen symptoms mostly resolved about 40 hours post administration.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Paraesthesia
Clinical narrative: Dizzy, tingling, lightheaded 5 mins after shot. Tx- lay down, H2O.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash
Clinical narrative: Rash on face and trunk. No blisters. No exanthema >72 degrees.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site papule, Malaise, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: 24 hours after administration developed erythema and swelling at vaccine site only. 48 hours after administration decreased erythema, increased tenderness with raised papule, no blisters. Afebrile, malaise present.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Local swelling, Pyrexia, Rash, VIIth nerve paralysis
Clinical narrative: This spontaneous report as received from a current 60 year old female patient. On an unknown date, the patient was vaccinated with a dose of PPV23 (manufacturer unknown) (dose, route, lot number and expiration date not reported) and influenza virus vaccine (manufacturer unknown) administered together. On an unknown date, the patient experienced arm swelling rash and fever. On 24-JUN-2014, the patient was vaccinated with a dose of ZOSTAVAX and experienced Bell's palsy (MARRS 1407USA005586). Outcome of arm swelling rash and fever was unknown at the time of the report. This is one of several reports from the same patient. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unknown number of patients with unspecified demographics. The reporter stated that the patients had been administered post supported PNEUMOVAX 23 (injection, strength, route, anatomical location, lot # and expiration date not reported). No adverse events had been noted by any patient. This is one of several reports received from the same source. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 5 year old of unknown gender.  Pertinent medical history and drug reactions were not reported. On 11-JUL-2014, the patient was vaccinated with VARIVAX (lot number, dose and route were not reported) and (Oka/Merck) PROQUAD (lot number, dose and route were not reported). No adverse symptoms reported. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a male patient of unknown age. Pertinent medical  history and drug reaction/allergies were not reported. The patient received unspecified dose of GARDASIL (lot number, dose and route were not reported) separated by approximately 1 year apart on unspecified dates. No adverse effect reported. This is one of two (1407US004333) reports from the same source. Additional information has been requested.
Age: 40.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 40 year old patient of unknown gender. Medical history and concurrent conditions were not reported. On 07-JUL-2014, the patient was vaccinated with the first dose of (Oka/Merck) PROQUAD (dose, strength, lot number and expiration date were not reported). Secondary and concomitant therapies were not reported. Nurse reported that the patient, who was greater than the recommended age to receive (Oka/Merck) PROQUAD, received a first dose of (Oka/Merck) PROQUAD on 07-JUL-2014. No adverse symptoms reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a female patient of unknown age. Pertinent medical history and drug reaction/allergies were not reported. In February 2014, the patient was vaccinated with a first dose of GARDASIL (lot number, dose, and route were not reported). In June 2014, the patient was vaccinated with a second dose of GARDASIL (lot number, dose and route were not reported). No adverse effect reported. This is one of two (1407US008688) reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product reconstitution issue
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown demographics. On an unknown date the patient was vaccinated with (Oka/Merck) PROQUAD (dose, frequency unknown). No concomitant medication was reported. The healthcare worker reported that vaccines were reconstituted with less than the recommended amount of diluent. No adverse effect was reported. No product quality complaint was reported. The outcome of events was unknown. This case is related with 1407USA008555, 1407USA008556, 1407USA007501, 1407USA008558 and 1407USA008557 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unknown number of patients with unspecified demographics. The reporter stated that the patients had been administered post supported GARDASIL (injection, strength, route, anatomical location, lot # and expiration date not reported). No adverse events had been noted by any patient. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant refers to a patient of unknown age and gender. On 21-OCT-2013, the patient was vaccinated with the first dose of RECOMBIVAX HB. On 02-DEC-2013, the patient was vaccinated with the second dose of RECOMBIVAX HB. On 15-JUL-2014, the patient was vaccinated with the third dose of RECOMBIVAX HB. No adverse symptoms reported. At the time of the report the action taken was not reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a male patient consumer of unknown age reporting on himself. On 24-JUN-2014, the patient was vaccinated with a first dose of ZOSTAVAX on the back of the arm (lot number, dose and route were not reported). On 26-JUN-2014, 2 days after onset of therapy, the patient had a red mark at the injection site and it lasted for four days. The outcome of the event was reported as recovered on 30-JUN-2014. He did not see a doctor about it. Relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: DTAP
Symptoms: Wrong drug administered
Clinical narrative: Pt was given Dtap instead of Tdap.
Age: 12.0
Sex: M
Vaccine: HPVX, MEN, TDAP
Symptoms: Condition aggravated, Herpes ophthalmic
Clinical narrative: Herpes of the eye....He used to get this when he was 1-3 and after an antiviral medication he stopped getting it and hasn't had it for about 9 years until after he got this vaccine.  We put ointment on it and it took about a month to go away.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Incorrect route of drug administration, Injection site bruising
Clinical narrative: Patient stated that she believed she received the incorrect administration of Zostavax.  She thinks that it was administered IM in the bicep.  The inject site and entire arm became bruised and continued to worsen; however, patient did not require medical treatment. She did speak with another health care professional about the incident.
Age: 12.0
Sex: M
Vaccine: HPVX, MEN, TDAP
Symptoms: Rash generalised, Rash pruritic, Streptococcus test negative, Throat irritation
Clinical narrative: Generalized pruritic rash and "scratchy" throat.
Age: 1.01
Sex: F
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Injection site reaction, Lymphadenopathy, Pyrexia, Rash, Rash erythematous
Clinical narrative: My daughter received her 12 month vaccinations on Wednesday morning. That night she started running a fever. (102.6 under the arm). Thursday she woke up with two large red bumps on her back, they almost looked like bug bites. Fever continued. Friday on her leg where she got a bad she had a red bump, similar to the ones on her back. I called her PCP and they said if she got more rash/bumps or higher fever to bring her in. Today, her fever spiked to 103.2 (under the arm) WITH ibuprofen and she started getting red pinpoint dots on her back and neck.  So I took her to urgent care. No bacterial infection, no UTI,  no throat spots. She does have an enlarged lymph node behind her ear. He said it was viral, and no medicine would help. Or he said it could be from the vaccinations. And to come back if it worsens and to see our PCP on Monday.  I'm guessing from my research it is vaccine related and either from Varivax or MMR.
Age: 1.01
Sex: F
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Viral infection
Clinical narrative: My daughter received her 12 month vaccinations on Wednesday morning. That night she started running a fever. (102.6 under the arm). Thursday she woke up with two large red bumps on her back, they almost looked like bug bites. Fever continued. Friday on her leg where she got a bad she had a red bump, similar to the ones on her back. I called her PCP and they said if she got more rash/bumps or higher fever to bring her in. Today, her fever spiked to 103.2 (under the arm) WITH ibuprofen and she started getting red pinpoint dots on her back and neck.  So I took her to urgent care. No bacterial infection, no UTI,  no throat spots. She does have an enlarged lymph node behind her ear. He said it was viral, and no medicine would help. Or he said it could be from the vaccinations. And to come back if it worsens and to see our PCP on Monday.  I'm guessing from my research it is vaccine related and either from Varivax or MMR.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Syncope
Clinical narrative: Patient was vaccinated and sat for about 5 minutes then left the pharmacy. He walked toward his car and fainted got up and fainted again. His breathing was ok but he seem weak. The paramedic took him to the hospital.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Fainting after GARDASIL given. Patient recovered immediately without intervention.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Pt was given ZOSTAVAX 0.65 mL IM by accident instead of SQ. Pt states feeling fine, site of injection no sign of swelling or rash.
Age: 17.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Lip swelling, Swelling face, VIIth nerve paralysis
Clinical narrative: Patient was seen for Well Visit 07/02/14; He received HPV GARADASIL (L) Deltoid and MENVEO (R) Deltoid. Patient return on 7/16/14 with swollen lip and face was drawing to right side; patient stated began 1-2 days after check up and vaccines. Patient evaluated in office determined 1-2 weeks prior to 7/16/14 visit developed Bell's Palsy - left CN7.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Herpes zoster, Ophthalmic herpes zoster, Rash vesicular
Clinical narrative: This spontaneous report as received from a 72 year old female patient refers to herself with severe chronic obstructive pulmonary disease. No information regarding drug reactions/allergies was provided. On an unspecified date of September 2012 the patient was vaccinated with a dose of ZOSTAVAX (lot # H011049, dose, route and frequency were unknown). Concomitant therapies included acyclovir, SPIRIVA, SYMBICORT, prednisone (manufacturer unknown) and antibiotic (unspecified). On 18-JUN-2014 the patient noticed a blistery rash that started around her scalp line and extended to her forehead and surrounded her eye. She was diagnosed with shingles around the second week of June 2014 (date unspecified). The patient claimed that her physician said this was one of the worst cases of shingles he had seen in quite some time. The patient went to the emergency room on Saturday 21-JUN-2014 because of the severe symptoms she was experiencing from her shingles. Lab diagnostics studies performed were reported as "bloodwork" (result unknown). The patient sought for medical attention but didn't receive any treatment for the adverse event. The outcome of the event was reported as not recovered. Causality assessment was not provided by the reporter. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Fatigue, Incorrect dose administered
Clinical narrative: This spontaneous report as received from patient's mother refers to an 11 year old male patient with unspecified drug allergies. The patient's pertinent medical history was none. On 16-JUL-2014 the patient was vaccinated with two doses of GARDASIL at once one in each arm inadvertently. Concomitant medications were none. On 17-JUN-2014 (reported as since received) the patient was very tired and usually he was up playing. The patient did not sought medical attention. The outcome of very tired and usually he was up playing was reported as not recovered. The causality of very tired and usually he was up playing was not reported. No product quality complaint (PQC) was reported for GARDASIL. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: MMR
Symptoms: Asthenia, Decreased appetite, Fatigue, Full blood count normal, Lethargy
Clinical narrative: This was the start of 6 weeks of lethargy, excessive fatigue, random vomiting episodes (at least once a week) and loss of appetite leading to weight loss.
Age: 6.0
Sex: M
Vaccine: MMR
Symptoms: Vomiting, Weight decreased
Clinical narrative: This was the start of 6 weeks of lethargy, excessive fatigue, random vomiting episodes (at least once a week) and loss of appetite leading to weight loss.
Age: 2.0
Sex: M
Vaccine: MMRV
Symptoms: Rash erythematous, Rash pruritic, Scab
Clinical narrative: Red itchy mumps like bumps above buttocks stretching across back. Treated with Claritin and calamine lotion. Bumps have since scabbed but still show and sometimes itch.
Age: 0.18
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PPV, RVX
Symptoms: Crying
Clinical narrative: inconsolable crying requiring hospital visit
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Dizziness, Nausea, Pyrexia, Vomiting
Clinical narrative: Extreme dizziness, lightheadedness, nausea, vomiting, fever and chills lasting through Sunday morning, 07/20/2014.
Age: 60.0
Sex: F
Vaccine: TD
Symptoms: Arthralgia, Injection site pain, Injection site swelling
Clinical narrative: Very swollen, painful site of the shot, joints pain.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Hypoaesthesia, Limb discomfort, Limb injury, Pain
Clinical narrative: Had Tetanus shot due to hand injury (couldn't remember when I had a shot ever, so yes I ok'd the shot) Had symptoms that accompany the vaccine normally, was told to take advil and cold compress, but the painfulness and tenderness was extreme. Then 7/20 when I woke up my arm was tense, and  a hot rash was there, and sort of numb feeling around the red area. I know that needed attending to, so called the facility and they had me come in. 07/20/14
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Rash, Skin warm, Tenderness, Tension
Clinical narrative: Had Tetanus shot due to hand injury (couldn't remember when I had a shot ever, so yes I ok'd the shot) Had symptoms that accompany the vaccine normally, was told to take advil and cold compress, but the painfulness and tenderness was extreme. Then 7/20 when I woke up my arm was tense, and  a hot rash was there, and sort of numb feeling around the red area. I know that needed attending to, so called the facility and they had me come in. 07/20/14
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: After getting the shingles vaccine patient has shingles with severe pain.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Adrenal insufficiency, Autonomic nervous system imbalance, Blood test, Decreased appetite, Dizziness
Clinical narrative: Approx 3-4 weeks after vaccine, headaches, extreme fatigue, muscle weakness, tremors, felt shaky internally, mottled skin, severe nausea, decreased appetite, mood swings, light headed/feeling faint. On going, worsened over time. Never improved.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Endocrine test abnormal, Endoscopy normal, Fatigue, Headache, Laboratory test
Clinical narrative: Approx 3-4 weeks after vaccine, headaches, extreme fatigue, muscle weakness, tremors, felt shaky internally, mottled skin, severe nausea, decreased appetite, mood swings, light headed/feeling faint. On going, worsened over time. Never improved.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Livedo reticularis, Mood swings, Muscular weakness, Nausea, Nervousness
Clinical narrative: Approx 3-4 weeks after vaccine, headaches, extreme fatigue, muscle weakness, tremors, felt shaky internally, mottled skin, severe nausea, decreased appetite, mood swings, light headed/feeling faint. On going, worsened over time. Never improved.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Tilt table test positive, Tremor
Clinical narrative: Approx 3-4 weeks after vaccine, headaches, extreme fatigue, muscle weakness, tremors, felt shaky internally, mottled skin, severe nausea, decreased appetite, mood swings, light headed/feeling faint. On going, worsened over time. Never improved.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth, Varicella
Clinical narrative: Pt experienced chickenpox like symptoms on left side of body. Pt also experienced redness and warmness at site of injection. On 7/17/14 instructed pt to call MD. Pt states MD stated it was chickenpox. No further medical action is required at this time.