chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Noticed softball sized lump on left arm at injection site. Showered and went to bed. Fever of unknown intensity until 2:00 AM, 6/3/14; 100.3 degrees. Site red, very sore and hot to the touch. Swelling slightly decreased at injection site; swelling moving to encompass bicep and tricep areas. Six to 8 hives around swelling and on left leg. Extremely sore at shoulder and tricep. Called doctor @ 8:00 Am, 6/3/14. Temp @ 100.1 degrees. Advised to alternate cold an hot packs, take Tylenol. Temp continued to drop throughout the day until normal; swelling did not dissipate. Visited urgent care clinic on 6/8/2014. Dr. diagnosed reaction and cellulitis. Steroids and antibiotics prescribed. Steroid treatment completed; swelling gone. Antibiotics still being taken.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Pruritus, Skin warm, Tenderness
Clinical narrative: 5cm x 6cm induration/wheal; red, itchy, achy, firm, warm and tender to touch. Patient presented to pharmacy, had tried cold compress with no benefit, advised to see physician.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: 5cm x 6cm induration/wheal; red, itchy, achy, firm, warm and tender to touch. Patient presented to pharmacy, had tried cold compress with no benefit, advised to see physician.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Pruritus, Skin warm, Tenderness
Clinical narrative: Patient presented to pharmacy on 6/9/2014 with erythematous wheal, 3 cm induration, warm to touch, itchy and slightly tender. Denies shortness of breath, throat tightening, dizziness, spread of reaction. Patient advised to try OTC Benadryl for 1-2 days, if not improved or condition worsened to see PCP or visit local ED. Patient seen in MD office this afternoon, prescriber recommended oral Benadryl and monitoring for improvement.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Patient presented to pharmacy on 6/9/2014 with erythematous wheal, 3 cm induration, warm to touch, itchy and slightly tender. Denies shortness of breath, throat tightening, dizziness, spread of reaction. Patient advised to try OTC Benadryl for 1-2 days, if not improved or condition worsened to see PCP or visit local ED. Patient seen in MD office this afternoon, prescriber recommended oral Benadryl and monitoring for improvement.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Pyrexia, Vomiting
Clinical narrative: Tactile fever, repeated emesis overnight, resolved in the a.m., <24h.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Pain and tingling in Left upper extremity.
Age: 0.37
Sex: M
Vaccine: RV5
Symptoms: Abdominal pain upper, Crying, Discomfort, Feeding disorder, Gastrointestinal disorder
Clinical narrative: This spontaneous report as received from a pharmacist refers to her currently 4 month old son with milk allergy. In February 2014, reported as "at 2 months", the patient was vaccinated at pediatrician's office with first dose of ROTATEQ (oral, dose and Lot # not reported). After the first dose in 2014 the reporter noticed a problem with baby's feeding, it was not good. On 05-MAY-2014, the patient was vaccinated with second dose of ROTATEQ (oral, dose and Lot# number not reported). On 12-MAY-2014, the baby received another set of vaccines like pneumococcal vaccine (manufacturer unknown). Concomitant therapies included MYLICON drops. The pharmacist stated that after the second dose, in May 2014 the same signs occurred (the baby's feeding was not good). In addition, his stomach was painful, he cried in sleep and appeared to be in constant discomfort. There was no vomiting or diarrhoea. On an unknown date the patient experienced a sensitive tummy. The pharmacist used Elementum for a sensitive tummy. The pharmacist contacted the pediatrician who stated that baby might have been getting used to live virus. On 06-MAY-2014, the baby developed fever and was given TYLENOL for and the fever went away (unspecified date in May 2014). No lab diagnostics studies were performed. The patient's outcome was reported as not recovered from problem with baby's feeding, painful stomach, crying in sleep, constant discomfort, sensitive tummy and fever. Causality assessment was not -provided. Additional information has been requested.
Age: 0.37
Sex: M
Vaccine: RV5
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist refers to her currently 4 month old son with milk allergy. In February 2014, reported as "at 2 months", the patient was vaccinated at pediatrician's office with first dose of ROTATEQ (oral, dose and Lot # not reported). After the first dose in 2014 the reporter noticed a problem with baby's feeding, it was not good. On 05-MAY-2014, the patient was vaccinated with second dose of ROTATEQ (oral, dose and Lot# number not reported). On 12-MAY-2014, the baby received another set of vaccines like pneumococcal vaccine (manufacturer unknown). Concomitant therapies included MYLICON drops. The pharmacist stated that after the second dose, in May 2014 the same signs occurred (the baby's feeding was not good). In addition, his stomach was painful, he cried in sleep and appeared to be in constant discomfort. There was no vomiting or diarrhoea. On an unknown date the patient experienced a sensitive tummy. The pharmacist used Elementum for a sensitive tummy. The pharmacist contacted the pediatrician who stated that baby might have been getting used to live virus. On 06-MAY-2014, the baby developed fever and was given TYLENOL for and the fever went away (unspecified date in May 2014). No lab diagnostics studies were performed. The patient's outcome was reported as not recovered from problem with baby's feeding, painful stomach, crying in sleep, constant discomfort, sensitive tummy and fever. Causality assessment was not -provided. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse (registered nurse, RN) refers to an unspecified number of unspecified patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unspecified dates, improperly stored doses of MMR II (strength, dose number, dose, frequency, lot number and indication were not reported) were administered to an unspecified number of unspecified patients. No adverse effects were reported. Concomitant medications were not specified. This is one of several reports received from the same reporter (linked to MARRS # 1406USA000382, 1406USA000549, 1406USA000551, 1406USA000552). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a Licensed Nurse Practitioner refers to a patient of unknown gender and unknown age. On 21-MAY-2014, the patient was vaccinated with a dose of VARIVAX, subcutaneous (lot/batch number, expiration date, strength, dose number and indication not reported). It was reported that the patient received VARIVAX in error. No known adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse (registered nurse, RN) refers to an unspecified number of unspecified patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unspecified dates, improperly stored doses of ROTATEQ (strength, dose number, dose frequency, lot number and indication were not reported) were administered to an unspecified number of unspecified patients. No adverse effects were reported. Concomitant medications were not specified. This is one of several reports received from the same reporter (linked to MARRS # 1406USA000382, 1406USA000550, 1406USA000551, 1406USA00552). Additional information has been requested.
Age: 44.0
Sex: M
Vaccine: TYP
Symptoms: Abdominal pain, Constipation, Decreased appetite, Malaise, Pyrexia
Clinical narrative: Patient was given vaccines on 4/28/14 but did not start oral typhoid until 5/28/14. States he started not feeling well during taking doses, but by last dose on 6/3/14, he was very uncomfortable with abdominal pain. Did not feel like eating and also had some constipation. States he had fever 6/7-8 but by 6/9 was beginning to feel better.
Age: 18.0
Sex: U
Vaccine: HIBV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. No information about medical history, concurrent conditions and concomitant medications were reported. The reporter stated that on an unknown date when the patient was vaccinated with LIQUID PEDVAXHIB lot J003724, expiration date 06-JUL-2015 (route dosage not reported) the patient was old than 71 months old on 10-DEC-2013. No adverse effects have been observed or reported. The outcome events reported is unknown. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to unspecified patients. It was reported that unspecified patients were vaccinated with improperly stored M-M-R II lot#, dose, strength and frequency were unknown) subcutaneous. No adverse effects were reported. Follow up information has been received from registered nurse. 61 unspecified patients received the improperly stored M-M-R II, lot # J003785 and expiration date: 28-MAR-2015. She states that the dates of administration of the M-M-R II for the 61 unspecified patients were as followed: 09-JAN-2014, 13-JAN-2014, 14-JAN-2014, 15-JAN-2014, 17-JAN-2014, 20-JAN-2014, 21-JAN-2014, 22-JAN-2014, 24-JAN-2014, 28-JAN-2014, 29-JAN-2014, 31-JAN-2014, 03-FEB-2014, 05-FEB-2014, 06-FEB-2014, 10-FEB-2014, 11-FEB-2014, 12-FEB-2014, 13-FEB-2014, 20-FEB-2014, 21-FEB-2014, 24-FEB-2014, 25-FEB-2014, 26-FEB-2014, and 27-FEB-2014. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: MMR
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 4 month old male patient. The child was supposed to be vaccinated with PREVNAR, but inadvertently received MMR II 0.5ml (dose, route, frequency, lot# and expire date were unknown). No adverse effects reported. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Local swelling, Lymphadenopathy, Pain
Clinical narrative: Redness site of injection - baseball size. (B) axilla pea size lymph nodes 2-3. (L) axilla swelling - pain 9/10 lasted 3-4 days. Resolved now.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to unspecified patients. It was reported that unspecified patients were vaccinated with improperly stored M-M-R II (lot #, dose, strength and frequency were unknown) subcutaneous. No adverse effects were reported. Follow up information has been received from registered nurse. 61 unspecified patients received the improperly stored M-M-R II, lot # J003785 and expiration date:28-MAR-2015. She stated that the dates of administration of the M-M-R II for the 61 unspecified patient were as followed: 09-JAN-2014, 13-JAN-2014, 14-JAN-2014, 15-JAN-2014, 17-JAN-2014, 20-JAN-2014, 21-JAN-2014, 22-JAN-2014, 24-JAN-2014, 27-JAN-2014, 28-JAN-2014, 29-JAN-2014, 31-JAN-2014, 03-FEB-2014, 05-FEB-2014, 06-FEB-2014, 10-FEB-2014, 11-FEB-2014, 12-FEB-2014, 13-FEB-2014, 20-FEB-2014, 21-FEB-2014, 24-FEB-2014, 25-FEB-2014, 26-FEB-2014, and 27-FEB-2014. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR, MMRV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 30-MAY-2014, the patient was inadvertently administered a 0.5 ml dose of PROQUAD (lot # and route were not reported) and a 0.5 ml dose of MMR II (subcutaneously, lot# not reported). Concomitant therapy was not reported. No adverse effects reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Biopsy muscle, Biopsy soft tissue, Dermatomyositis, Lethargy, Neck pain
Clinical narrative: This spontaneous report as received from a male physician of unknown age with no pertinent medical history reporting on himself. In January 2014, the patient was vaccinated with a dose of ZOSTAVAX (dose and lot # not reported) subcutaneously. There was no concomitant medication. The physician reported that two weeks after vaccination, he was diagnosed with dermatomyositis. The physician felt lethargic, had neck pain and lost 17 pounds. The patient was treated with steroids. Muscle and tissue biopsies were performed (results not provided). At the time of the report, the patient was recovering. Dermatomyositis, felt lethargic, neck pain and lost 17 pounds were considered to be life threatening and disabling by the physician. Additional information is not expected.
Sex: M
Vaccine: VARZOS
Symptoms: Weight decreased
Clinical narrative: This spontaneous report as received from a male physician of unknown age with no pertinent medical history reporting on himself. In January 2014, the patient was vaccinated with a dose of ZOSTAVAX (dose and lot # not reported) subcutaneously. There was no concomitant medication. The physician reported that two weeks after vaccination, he was diagnosed with dermatomyositis. The physician felt lethargic, had neck pain and lost 17 pounds. The patient was treated with steroids. Muscle and tissue biopsies were performed (results not provided). At the time of the report, the patient was recovering. Dermatomyositis, felt lethargic, neck pain and lost 17 pounds were considered to be life threatening and disabling by the physician. Additional information is not expected.
Sex: F
Vaccine: HPVX
Symptoms: Loss of consciousness
Clinical narrative: This spontaneous report as received from a physician's nurse via a company representative refers to a female patient of unknown age. In approximately 1998 (reported as 15 or 16 years ago, also reported as a couple of years ago) the patient was vaccinated with GARDASIL injection (lot#, strength, dose, frequency not provided). The patient came back to the office 10 minutes after receiving the GARDASIL and passed out at the front desk. The outcome of passed out is unknown. The causality of the event passed out and GARDASIL was not provided. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Ear swelling, Eyelid oedema, Oedema mouth, Swelling face, Urticaria
Clinical narrative: Hives, swelling eyelids, nose, mouth, ears 30-45 min after doses given. No hx of egg allergy or allergy to known component. We administered BENADRYL and SOLU-MEDROL.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker concerning patients of unknown age. On an unknown date, 25 doses of (Oka/Merck) VARIVAX injection (other details unspecified) which was improperly stored at 15.3F for 36 hours, vaccinated to an unspecified number of patients at physician's office. No concomitant therapy was reported. No adverse effects were reported. No product quality complaint (PQC) was filed. The action taken was assessed as not applicable. The outcome of event was not reported. The causality was assessed as not related to the therapy with (Oka/Merck) VARIVAX. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Adverse reaction, Urticaria
Clinical narrative: This spontaneous report as received from a pharmacist who read the case report from the National Vaccine Information Center refers to a 64 year old female patient with hives from horse serum. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose and route not reported). The following day, the patient had a very dehabilitating adverse reaction, which was unspecified. The outcome of the event was unknown. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: No adverse effects noted.
Age: 63.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Condition aggravated, Death, Incorrect route of drug administration, Neoplasm malignant, No adverse event
Clinical narrative: No adverse effects noted.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site pruritus
Clinical narrative: On 06/08/2014 notice itching and a red knot appearing on the arm (area of injection). The redness has disperse slightly down the arm. Patient start taking Zyrtec daily and has not experienced any other side effects.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse (registered nurse, RN) refers to an unspecified number of unspecified patients of unknown age and gender. On unspecified dates, improperly stored doses of PNEUMOVAX23 (strength, dose number, dose, frequency, lot numbers and indication were not administered to an unspecified number of unspecified patients. No adverse effects were reported. This is one of several reports received from the same reporter (linked to MARRS # 1406USA000382, 1406USA000549, 1405USA000550, 1406USA000551). Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test, Neurological examination normal, Syncope, Tonic clonic movements
Clinical narrative: Pt had syncopal event with subsequent tonic clonic movement. Lasted 20 sec with spontaneous resolution. Pt observed over 45 min and discharged after normal neurologic exam/vitals.
Age: 98.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation
Clinical narrative: Patient developed burning sensation to face.  MD was contacted by home RN.  She was given Tylenol and Zovirax ointment. Today, 6/9/14 she has the same symptoms.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Headache
Clinical narrative: Dizziness & headache.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Blood test normal, Chest X-ray normal, Cough, Crying, Decreased appetite
Clinical narrative: Adverse Event Onset Time is only approximation - fever started early afternoon on day of vaccine continued until 06/04/2014, lethargic, fussiness, loss of appetite, extreme crying in middle of night, trouble sleeping prolonged periods of time, coughing intermittently, 06/01/2014 onset of facial rash, 06/02/2014 back to PCP in am, ran blood tests chest x-rays to discover cause of fever, tests negative, back to PCP in PM they could not perform cath for UTI test was sent to Hospital, misdiagnosed son with ear infections, tried to overdose son with medication for 48.9kb baby instead of for 23lb baby, kept medication from being administered and hospital tried to correct dosage mistake, never fixed prior to discharge from ER. UTI negative. Told that rash on face was from living in a desert and to put lotion on baby. Within 2 hours of being in ER, from 5:01pm to 7pm rash spread down trunk, arms and legs and became redder. Doctor concerned but did nothing further to investigate cause. Fever shot to 104. Administered motrin and gave prescription for inner ear infections, amoxicillin 800mg/10ml twice daily which was changed to 400mg/5ml twice daily when I notified hospital staff of over dosage. Discharged around midnight 06/02/2014. Back to PCP 06/04/2014 for follow up with PCP due to rash spreading from scalp to eyelids, finger tips and palms to soles of feet, all over body. PCP determined cause to be side effect from vaccine Rubella and separate virus causing cough and fever. PCP read notes from ER doctor stating that patients ears were red but no bulging of eardrums thus baby did not have ear infections, was misdiagnosed and to stop antibiotic treatment. Last fever was at 12:30pm 06/04/2014, rash completely gone 06/09/2014. Baby eating and playing and laughing like normal. Still a little fussy and not back to sleeping all night.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Ear infection, Erythema, Insomnia, Irritability, Labyrinthitis
Clinical narrative: Adverse Event Onset Time is only approximation - fever started early afternoon on day of vaccine continued until 06/04/2014, lethargic, fussiness, loss of appetite, extreme crying in middle of night, trouble sleeping prolonged periods of time, coughing intermittently, 06/01/2014 onset of facial rash, 06/02/2014 back to PCP in am, ran blood tests chest x-rays to discover cause of fever, tests negative, back to PCP in PM they could not perform cath for UTI test was sent to Hospital, misdiagnosed son with ear infections, tried to overdose son with medication for 48.9kb baby instead of for 23lb baby, kept medication from being administered and hospital tried to correct dosage mistake, never fixed prior to discharge from ER. UTI negative. Told that rash on face was from living in a desert and to put lotion on baby. Within 2 hours of being in ER, from 5:01pm to 7pm rash spread down trunk, arms and legs and became redder. Doctor concerned but did nothing further to investigate cause. Fever shot to 104. Administered motrin and gave prescription for inner ear infections, amoxicillin 800mg/10ml twice daily which was changed to 400mg/5ml twice daily when I notified hospital staff of over dosage. Discharged around midnight 06/02/2014. Back to PCP 06/04/2014 for follow up with PCP due to rash spreading from scalp to eyelids, finger tips and palms to soles of feet, all over body. PCP determined cause to be side effect from vaccine Rubella and separate virus causing cough and fever. PCP read notes from ER doctor stating that patients ears were red but no bulging of eardrums thus baby did not have ear infections, was misdiagnosed and to stop antibiotic treatment. Last fever was at 12:30pm 06/04/2014, rash completely gone 06/09/2014. Baby eating and playing and laughing like normal. Still a little fussy and not back to sleeping all night.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Lethargy, Pyrexia, Rash generalised, Urine analysis normal
Clinical narrative: Adverse Event Onset Time is only approximation - fever started early afternoon on day of vaccine continued until 06/04/2014, lethargic, fussiness, loss of appetite, extreme crying in middle of night, trouble sleeping prolonged periods of time, coughing intermittently, 06/01/2014 onset of facial rash, 06/02/2014 back to PCP in am, ran blood tests chest x-rays to discover cause of fever, tests negative, back to PCP in PM they could not perform cath for UTI test was sent to Hospital, misdiagnosed son with ear infections, tried to overdose son with medication for 48.9kb baby instead of for 23lb baby, kept medication from being administered and hospital tried to correct dosage mistake, never fixed prior to discharge from ER. UTI negative. Told that rash on face was from living in a desert and to put lotion on baby. Within 2 hours of being in ER, from 5:01pm to 7pm rash spread down trunk, arms and legs and became redder. Doctor concerned but did nothing further to investigate cause. Fever shot to 104. Administered motrin and gave prescription for inner ear infections, amoxicillin 800mg/10ml twice daily which was changed to 400mg/5ml twice daily when I notified hospital staff of over dosage. Discharged around midnight 06/02/2014. Back to PCP 06/04/2014 for follow up with PCP due to rash spreading from scalp to eyelids, finger tips and palms to soles of feet, all over body. PCP determined cause to be side effect from vaccine Rubella and separate virus causing cough and fever. PCP read notes from ER doctor stating that patients ears were red but no bulging of eardrums thus baby did not have ear infections, was misdiagnosed and to stop antibiotic treatment. Last fever was at 12:30pm 06/04/2014, rash completely gone 06/09/2014. Baby eating and playing and laughing like normal. Still a little fussy and not back to sleeping all night.
Age: 21.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Dizziness, Erythema, Hyperhidrosis, Injection site erythema
Clinical narrative: Patient complained of lightheadedness and malaise on the evening of 06/03/2014. On the morning of 06/04/14 he woke with redness at the site of injection. Per mom, patient was evaluated by his PCP and told to monitor site. On the evening of 06/04/2014 he developed fever, chills, and sweating. On the morning of 06/05/14 he went to the ER. His WBC was 25,000 (per mom). He was given IV antibiotics and was sent home on oral antibiotics. Symptoms worsened and he returned to ER on the evening of 06/05/2014. He was admitted to the hospital and is currently still there receiving IV antibiotics. Per mom, when the antibotics were stopped today the redness and swelling of his left arm increased.
Age: 21.0
Sex: M
Vaccine: PPV
Symptoms: Local swelling, Malaise, Pyrexia, White blood cell count increased
Clinical narrative: Patient complained of lightheadedness and malaise on the evening of 06/03/2014. On the morning of 06/04/14 he woke with redness at the site of injection. Per mom, patient was evaluated by his PCP and told to monitor site. On the evening of 06/04/2014 he developed fever, chills, and sweating. On the morning of 06/05/14 he went to the ER. His WBC was 25,000 (per mom). He was given IV antibiotics and was sent home on oral antibiotics. Symptoms worsened and he returned to ER on the evening of 06/05/2014. He was admitted to the hospital and is currently still there receiving IV antibiotics. Per mom, when the antibotics were stopped today the redness and swelling of his left arm increased.
Age: 0.24
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RV1
Symptoms: Haematochezia, Mucous stools, Occult blood, Urinary system X-ray
Clinical narrative: Mucus and blood in his stool.
Age: 0.99
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Cough, Injection site rash, Pyrexia, Rash, Respiratory tract congestion
Clinical narrative: Runny nose, chest congestion, wet cough, fever of 102, rash at injection site and stomach.
Age: 0.99
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Rhinorrhoea
Clinical narrative: Runny nose, chest congestion, wet cough, fever of 102, rash at injection site and stomach.
Age: 19.0
Sex: F
Vaccine: TYP
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Erythema and induration around injection site, measures 5cm.
Age: 12.0
Sex: M
Vaccine: TYP, YF
Symptoms: Chills, Feeling hot, Generalised erythema, Headache, Oropharyngeal pain
Clinical narrative: Itching, sore throat, hives, first feet turned red then whole body, head ache, chills later, heat pouring off his body. 50mg Benadryl PO, then Shot of Benadryl from Urgent care doctor.
Age: 12.0
Sex: M
Vaccine: TYP, YF
Symptoms: Pruritus, Urticaria
Clinical narrative: Itching, sore throat, hives, first feet turned red then whole body, head ache, chills later, heat pouring off his body. 50mg Benadryl PO, then Shot of Benadryl from Urgent care doctor.
Age: 1.02
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Discomfort, Injection site rash, Injection site swelling, Pyrexia
Clinical narrative: Rash, swelling at sight of injection, fever of 101, discomfort.
Age: 59.0
Sex: M
Vaccine: RAB
Symptoms: Feeling abnormal, Liquid product physical issue, Pain
Clinical narrative: Case number PHEH2014US008493 is an initial spontaneous report from the consumer (patient) received on 25 Apr 2014 and a follow up report received from the consumer on 30 May 2014. This report refers to an adult male patient. The patient was vaccinated with RABAVERT (batch number: C93011/538011A, expiry date: Sep 2016) intramuscularly in Nov 2013. It was reported that the vaccine received by the patient looked like it was bubbling and foaming. The patient felt RABAVERT vaccine was like water with something else in it that he could die of it. On an unknown date, after vaccination he experienced pain. The outcome of the event was unknown. The patient thought that the event pain was due to the RABAVERT vaccine which he received in Nov 2013. Follow up report received from the consumer on 30 May 2014: Changed seriousness from non-serious to life threatening. Added event (feeling abnormal). Updated patient details and expiry date of RABAVERT vaccine.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Rash, Rash erythematous
Clinical narrative: Red pinpoint rash on upper chest extending upward to jawline.
Age: 1.02
Sex: F
Vaccine: DTAP, MMR, PNC13, VARCEL
Symptoms: Body temperature increased, Culture throat, Pharyngitis, Streptococcus test, Vomiting
Clinical narrative: 12 mo old w/ temp 100.9, two episodes of vomiting, pharyngitis, hx of OM s/p PET.
Age: 63.0
Sex: M
Vaccine: FLUX
Symptoms: Angioedema, Swelling face
Clinical narrative: Patient is a 63 year old male with history of HTN, HLD, prostate CA (Gleason 7) who presented with acute onset left sided facial swelling. Patient received his flu shot at 11:00am and follow up'ed with Urology later that day. At 2:30pm the patient noted the sudden onset of left sided facial swelling that continued to worsen. He then presented to the ED for further management. He denied any difficulty breathing or difficulty swallowing. He denied any pain, numbness, or tingling. No mouth ulcers or sores. No recent illnesses, fevers, or chills. Suspect Drug #2 Dosing: TAKE ONE-HALF TABLET EVERY DAY FOR BLOOD PRESSURE/HEART. Treatment Drugs Used: 1- RANITIDINE Dose: 50 Units: MG Freq: ONCE Route: IV, 2- METHYLPREDNISOLONE Dose: 125 Units: MG Freq: ONCE Route: IV, 3- DIPHENHYDRAMINE Dose: 50 Units: MG Freq: ONCE Route: IV.
Age: 1.09
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Patient received varicella vaccine #1 in office on 3/21/12. He was seen in office on 5/23/14 and diagnosed with chicken pox.
Age: 1.62
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR
Symptoms: Petechiae, Rash
Clinical narrative: Petechiae type rash on cheeks only - Mom spoke with her private MD office who advised possible vaccine reaction.
Age: 12.0
Sex: M
Vaccine: HPV4, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Local reaction
Clinical narrative: Local reaction, red and itchy 13 cm redness 2 inches below shot injection site.
Age: 34.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Injection site pain, Injection site reaction, Skin warm
Clinical narrative: Muscle aching at site of injection no swelling, erythema, increased warmth. Full ROM of UE. No weakness no sensory. No heard vascular issue. Achiness at time of visit.
Age: 0.38
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Irritability, Pyrexia
Clinical narrative: Fever and irritability since vaccines fever on 6/4/14 at 10:00 am 101.3 (R).
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site dryness, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Golf ball size swelling at injection site. Area is pink, "strange texture" "dry skin" warm to touch, itching at times. No fever. Referred her to ordering physician.
Age: 41.0
Sex: M
Vaccine: YF
Symptoms: Arthralgia, Dyspnoea, Influenza like illness, Pyrexia
Clinical narrative: 12 hours after the yellow fever vaccine he developed joint pains, fever, shortness of breath and just felt like he had the flu. It lasted 1 1/2 days. He didn't call the office or go to the ER. He states he is fine now.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass
Clinical narrative: Lump in arm 2/3 size of golf ball at injection site 3 weeks after injection. Pt. states it is non-tender.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Breath sounds abnormal, Cough, Injection site urticaria, Papule, Throat irritation
Clinical narrative: After vaccines administered pt started coughing, stated throat itched, developed hives to left arm where Varicella vaccine was given, single papule to (R) side of neck, and 2 to forehead, 25 mg BENADRYL was given and pt observed for 30 minutes. Breath sounds improved. EPIPEN sent to pharmacy. Instructed to call if any worsening symptoms or go to ER.
Age: 1.11
Sex: U
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Pyrexia, Rash, Varicella post vaccine
Clinical narrative: Fever, rash, x24hr-MD dx with chicken pox, 10 day s/p MMRV vaccine. Tx with amoxicillian.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Erythema, Pain, Pain in extremity, Skin warm, Tenderness
Clinical narrative: Possible allergic reaction on Rt arm, slightly red, slightly tender and warm to touch. Complains of pain when moving arm. KEFLEX 250mg TID x 10 days given 5/29/14.
Sex: F
Vaccine: HPV4
Symptoms: Rheumatoid arthritis
Clinical narrative: This spontaneous report as received from a physician, via a company representative, refers to a currently 19 years old female, non-pregnant patient. No information on medical history, concurrent conditions or concomitant drugs was provided. It was stated that the patient received all three doses of GARDASIL on an unspecified dates in 2010 (reported as "on schedule"); doses, routes and sites of administrations, lot# and expiration dates not reported. On an unknown date in 2013 the patient presented to the physician's office with unspecified symptoms and was diagnosed with rheumatoid arthritis. The outcome of the rheumatoid arthritis was not recovered/not resolved. Relatedness between the GARDASIL and the adverse event was unknown. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Malaise
Clinical narrative: One day after receiving ZOSTAVAX developed large area of reddness at injection site. Area tenderness swollen hot to touch. Pt feels nauseated and generally under the weather. 15 cm x 17 cm. No vesicles.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: One day after receiving ZOSTAVAX developed large area of reddness at injection site. Area tenderness swollen hot to touch. Pt feels nauseated and generally under the weather. 15 cm x 17 cm. No vesicles.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent conditions or medical history were provided. On 29-MAY-2014, the patient was at the pharmacy to receive their third doses of GARDASIL intramuscular injection (dose, route of administration, lot#, expiry date unspecified) and it has been 4 years since the patient's second dose. No concomitant medications or laboratory test were provided. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This report as received from a health professional via company representative refers to 3 unspecified patients of unknown age and gender. The reporter stated that in two clinic locations, an expired M-M-R II was administered to unspecified patients (dose, route of administration, Lot# and expiration date were not reported) on unspecified dates. At one clinic location this occurred once, at second clinic location this occurred twice. No adverse effects were noted. The reporter went to write in her e-mail to company representative that she had previously reported one of these events herself. However, no additional information identifying this report was provided. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Incorrect route of drug administration, Skin warm, Vaccination complication
Clinical narrative: Pt was given a pneumonia vaccine (in hospital) via sq instead of IM - pt had severe reaction to vaccine. Entire red upper arm/warm to touch.
Age: 1.12
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Patient developed chicken pox.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Chest discomfort, Pruritus, Urticaria
Clinical narrative: Itching scalp on 6/7/14, hives on 6/8/14 knees, elbows and behind ears. Chest tightness on 6/7/14 and used albuterol inhaler and took OTC BENADRYL.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Induration, Local swelling, Pruritus, Skin warm
Clinical narrative: Redness, swelling, itching of (R) arm approximately 2 hours after vaccination. Same sx in (L) arm at 1 hr. later. No prior hx of rxn. and no fever. (L) arm 10cm x 14cm redness warmth induration. (R) arm 17cm x 17xm area of redness, warmth and induration. Treated with cetirizine and hydroxyzine.
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Skin burning sensation
Clinical narrative: This spontaneous report received from a male patient of unknown age refers to himself. Medical history and concurrent conditions were not reported. On 29-OCT-2013 the patient was vaccinated with ZOSTAVAX (dose, frequency, lot#, expiry date and indication were not reported) and ever since he got the vaccination his skin has been burning and breaking out into rashes. Concomitant therapy was not reported. The outcome of the skin has been burning and breaking out into rashes was unknown. The relatedness between ZOSTAVAX and skin burning, breaking out into rashes was unknown. PQC was not involved. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to 3 unspecified patients (gender and age not reported). The nurse reported that on an unknown date, the patients were vaccinated with doses of VARIVAX (dose, route, strength, lot # and expiration date not reported) that were exposed to an excursion outside of the recommended temperature range. There was no adverse effect reported. There was no PQC reported. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse refers to a 63 year old male patient. On 29-MAY-2014 the patient was vaccinated with VARIVAX (dose, route of administration, LOT# and expiration date were not reported). The nurse stated that she wanted to administer ZOSTAVAX to the patient but she inadvertently administered VARIVAX. No adverse effect was reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Paraesthesia, Rash pruritic, Rash vesicular
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient. There was not pertinent medical history and no drug reactions and allergies. On 28-APR-2014, the patient was vaccinated with ZOSTAVAX lot # J007857 expiry date 28-SEP-2014 (dose and route not reported). No concomitant medications that would cause immunosuppression. On approximately 02-MAY-2014 (reported as about 4 or 5 days after the vaccine was administered), the patient experienced a small shingles like blistery rash on her head, under her hairline. Also was reported that the patient experienced itching and tingling at the rash site and also "felt sick". The patient went to see her unspecified physician on 05-MAY-2014 and he prescribed prednisone (unspecified dose, frequency) to treat the symptoms. No lab diagnostics performed. The reporter believed that the patient had recovered from the rash and symptoms but was "not sure". Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: TYP
Symptoms: Allergy test positive, Blood immunoglobulin E increased, Dyspnoea, Eye swelling, Local swelling
Clinical narrative: The pt received typhoid IM #1 11/5/10 without adverse event. The pt reports that she received her second Typhoid vaccination (IM) on 12/13/11 at 1000. Around noon the pt noted that her eyes were swelling and soon after she felt that she was having difficulty breathing. While on route to the nearest ER the pt noted that her hands were swelling which was soon followed by generalized hives and itching. In the ER she was treated with albuterol, BENADRYL and PEPCID. She was seen by medical on the next am. It was noted that all of her symptoms were resolved. The pt required a typhoid vaccination for work.
Age: 21.0
Sex: F
Vaccine: TYP
Symptoms: Pruritus, Radioallergosorbent test positive, Urticaria
Clinical narrative: The pt received typhoid IM #1 11/5/10 without adverse event. The pt reports that she received her second Typhoid vaccination (IM) on 12/13/11 at 1000. Around noon the pt noted that her eyes were swelling and soon after she felt that she was having difficulty breathing. While on route to the nearest ER the pt noted that her hands were swelling which was soon followed by generalized hives and itching. In the ER she was treated with albuterol, BENADRYL and PEPCID. She was seen by medical on the next am. It was noted that all of her symptoms were resolved. The pt required a typhoid vaccination for work.
Sex: U
Vaccine: HEP
Symptoms: Vaccination failure, Viral test positive
Clinical narrative: Information has been received from a published literature article titled as stated above from Sanofi Pasteur MSD. The patients were vaccined with unspecified hepatitis B virus (HBV) vaccine (dose, route unspecified) on an unknown date. To estimate the incidence of perinatal transmission of hepatitis B virus (HBV) among infants born to hepatitis B surface antigen (HBsAG) positive-mothers and to evaluate risk factors associated with immunoprophylaxis failure. Methods: A retrospective case control study was conducted among HBsAg-positive mother and their infants followed by the Department of Public Health perinatal HBV prevention program between 2005 and 2011 Demographic information was collected from birth certificates and laboratory data within one year pre-and post-delivery from providers and reference laboratories. Results: The number of at-risk infants with post-vaccination serologic testing 9PVST) per ACIP guidelines was low; only 64.9% completed testing. Only 77.2% of these infants were tested at the recommended age of 9-18 months. Among 11,473 infants with PVST, 125 (1.1 %) had immunoprophylaxis failure and developed HBV infection. When 110 infected infants (cases) were compared with 131 randomly selected uninfected infants (controls), case mothers were younger (29.4 vs. 31.4 years, p=0.007), more likely to be foreign born 95.5% vs. 87.0%, p=0.024) and (100% vs. 84%, p<0.001) than control mothers. There was no significant difference in post-exposure prophylaxis (PEP) errors (10.9% of cases vs. 14.5% of controls, p=0.406). case mothers were more likely to have detectable viral load (100% vs. 71.8%, p<0.001), higher median HBV DNA levels (1.4x10^8 vs. 5745.5 IU/mL, p<0.001) and HBeAg positivity (892% vs. 29.0%, p<0.001) than control mothers. Timing of HBV DNA testing was significantly different in case mothers (median 75.5 days after delivery) compared to control mothers (median 36 days prior to delivery), p<0.005 in multivariate logistic regression analysis, maternal HBV DNA level >2x10^7 IU/mL was the only significant independent predictor of immunoprophylaxis failure (OR 40.28, 95% Cl 8.80-184.32). Conclusions: Rates of PVST are inadequate and >10% of at-risk infants have PEP errors. Overall, appropriate PEP provides significant protection and is associated with a low rate of perinatal transmission of HEV. High maternal HBV DNA levels were a significance indicator of risk for immunoprophylaxis failure. Maternal HBV DNA level would be an important prenatal screen if targeted antiviral therapy for high-risk mothers became a strategy to reduce HBV transmission. The outcome of immunoprophylaxis failure was unknown. A  copy of the published article is attached as further documentation of the patient's experienced. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 4 year old patient of unknown gender. No information provided regarding concurrent conditions and medical history. On 14-MAY-2014 the patient was vaccinated with PROQUAD and VARIVAX (dose, route, lot number and expiration date not reported) on the same day. No adverse effect reported. No product quality complaint reported. Follow up information was receipt regarding the age of the patient reported as 12 months old which was previously reported as 4 years old. Additional information has been requested.
Age: 0.94
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an 11 month old female patient. On 08-MAY-2013 the patient was vaccinated with MMR II (strength, route, lot number and expiration date not reported) VARIVAX (strength, route, lot number and expiration date not reported) and VAQTA (strength, route, lot number and expiration date not reported) because she was going to be traveling out of the country. No symptoms were reported. At the time of the report the outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with VAQTA (doses, routes, lot # and expiry dates not reported) that were stored at temperatures above (49F for 3 minutes) the recommended temperature range in the prescribing information. No adverse effect reported. No PQC involved. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, IPV
Symptoms: Injection site pain, Injection site warmth
Clinical narrative: (L) thigh - 11 cm x 15 cm , warm, tender, over area.
Age: 70.0
Sex: F
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Patient was given varicella vaccine in left arm SC instead of ordered ZOSTAVAX at 1200 pm. Injection given by employee.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients who were administered vaccines which were stored improperly. This report refers to the patients who on unknown dates were vaccinated with PNEUMOVAX 23 that were stored improperly. No adverse effects reported. Follow up information was from the same registered nurse who stated that patient identifiers and dates of administration were unavailable at this time; however, lot numbers and expiration dates were available: PNEUMOVAX 23, lot # J011998, expiration date 12-FEB-2015. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 68 year old male patient. On 25-JAN-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # H018798, expiration date 15-JAN-2014 (reported as 10/2013), 0.65ml, subcutaneous). Concomitant medications were not reported. On an unspecified date in March 2014 the patient developed shingles after receiving ZOSTAVAX. At time of the report, outcome of the event was reported as not improved. The patient sought medical attention by contacting pharmacist. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients had been administered ROTATEQ, intramuscular, (dose, frequency, lot#, and expired date were not reported) that fell to refrigerator temperature outside the prescribing information, despite being supported. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.