chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test negative, Varicella virus test negative
Clinical narrative: This spontaneous report as received from a consumer refers to a 23 year old male patient with seasonal allergies. The patient reported that as a child, on an unspecified date the patient was vaccinated with VARIVAX (merck) (dose and route, unspecified). Concomitant therapies included fexofenadine hydrochloride. The patient stated that on 17-MAY-2013, he had varicella titers drawn for Emergency Medical Technician (EMT) School, and the titers came back negative. Patient's outcome was unknown. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Unevaluable event
Clinical narrative: None known.
Age: 1.05
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Injection site haematoma
Clinical narrative: Right thigh 3 x 2 1/2 cm w/ subcut. hematoma/muscular hematoma - apply dry warm heat (not directly to skin).
Age: 0.19
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Cold sweat, Gingival swelling, Pallor, Swollen tongue, VIIth nerve paralysis
Clinical narrative: Gums and tongue swelled. Skin turned pale and clammy. Left side of face drooped. Mom administered TYLENOL. Child afebrile, still eating, and breathing without difficulty per Mom.
Age: 23.0
Sex: U
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist (both e-mail and phone call) via company representative refers to a 23 year old patient, gender not reported. On 15-MAY-2013 the patient was vaccinated with the third dose of GARDASIL lot # 668261/1397AA, expiry date 09-APR-2013, route of administration and dose were not reported. Pharmacist reported that the GARDASIL was administered 36 days past the expiration date. No adverse effects were reported. Additional information has been requested.
Age: 49.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Myalgia, Pyrexia
Clinical narrative: Myalgia and fever.
Age: 69.0
Sex: M
Vaccine: DTP
Symptoms: Blood creatine phosphokinase increased, Myalgia
Clinical narrative: Myalgia and mildly elevated CPK.
Age: 34.0
Sex: F
Vaccine: DTP
Symptoms: Erythema, Pruritus
Clinical narrative: Erythema and pruritus.
Age: 42.0
Sex: F
Vaccine: DTP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Fever and redness, swelling, pain at injection site. Fever x 1 day.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose not reported). The certified medical assistant reported that the vaccine was exposed to temperature of 26 F (Fahrenheit) for a total of 135 hours. No adverse effects reported. Follow-up received. Certified medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the certified medical assistant regarding a 13 years old, male patient with no pertinent medical history reported. On 26-FEB-2013 the patient was vaccinated with the first dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). Concomitant medications included Hep A vaccine (manufacturer unknown) on an unknown date (intramuscular in the right arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose not reported). The certified medical assistant reported that the vaccine was exposed to temperature of 26 F (Fahrenheit) for a total of 135 hours. No adverse effects reported. Follow-up received. Certified medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the certified medical assistant regarding an 11 years old, male patient with no pertinent medical history reported. On 24-SEP-2012 the patient was vaccinated with the first dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). On 26-NOV-2012 the patient received the second dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). On 29-MAR-2013 the patient received the third dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
Age: 56.0
Sex: F
Vaccine: DTP
Symptoms: Agitation, Flushing, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Agitation, fever and fever, flushing, swelling and erythema at injection site.
Age: 45.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Rash, Skin warm
Clinical narrative: Patient came to clinic, Lt arm red/warm from Pneumonia injection on Monday afternoon 10/25/10, patient afebrile, notified Dr. who examined/spoke with patient, antibiotics ordered for window pickup, patient instructed if not showing improvement by late Friday morning come into the clinic, verbalized understanding and agreement. Symptoms: Rash. Treatment: Clindamycin 300 MG TID.
Age: 83.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Fall, Joint swelling, Pain in extremity
Clinical narrative: Vaccine was given on 5/26. Pt came back on 5/27 and complained about pain on arm. Rph consulted pt on soreness on 5/28 am, pt returned to pharmacy with a swollen elbow. Later on that day on 5/28, pt fell and went to ER and was diagnosed with cellulitis.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Blood test, Discomfort, Herpes zoster, Pain
Clinical narrative: This spontaneous report as received from a consumer refers to himself, a 80 years old male patient. The patient's medical history included heart attack and "two stents put in". The patient reported none drug reactions or allergies. Sometime in 2008 the patient was vaccinated with ZOSTAVAX (route reported as "injection", dose and lot number not reported) because he thought it was necessary. Concomitant therapies included lovastatin (manufacturer unknown), lisinopril (manufacturer unknown) and carvedilol On 24-APR-2013 the patient had a case of shingles. The patient stated he had blistering on his body and felt pain and discomfort. Patient received treatment with acyclovir (manufacturer unknown). The patient visited the doctor. Lab diagnostics studies included blood work (results not provided). The outcome of shingles was reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Oedema peripheral
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age and gender, that the pharmacist had heard of. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose and lot number not reported), subcutaneous for prevention. On an unknown date the patient complained of a larger than normal swelling in the upper left arm. The patient did not seek medical attention. The outcome of larger than normal swelling in the upper left arm was unknown. The causal relationship was not reported. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination site rash
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a currently 72 year female patient with hypertension, rheumatoid arthritis and hyperlipidemia. With no drug reactions or allergies. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported). No concomitant medication were reported. On an unknown date the patient experienced bad rash on her arm where the vaccine was administered. No treatment was given for the adverse event. No laboratory test was performed. This nurse also reported another AE with ZOSTAVAX (MARRS # 1305USA005062). The outcome of bad rash on her arm was reported as not recovered/not resolved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported) and PEDVAXHIB (Lot number, expiry date, route and dose were not reported). Certified Medical assistant reported that both vaccines were exposed to temperature of 26 F(Fahrenheit)for a total of 135 hours. No adverse effects reported. Follow-up received. Certified Medical assistant stated other 104 children received GARDASIL and other 18 children received PEDVAXHIB. Follow up information has been received from the certified medical assistant regarding an unknown age (previously reported as child), female patient with no pertinent medical history reported. On 09-OCT-2012 the patient was vaccinated with the first dose of GARDASIL (lot number was vaccinated with the first dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). Other suspect therapies included PEDVAXHIB (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). On 11-DEC-2012 the patient received the second dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 06-MAY-2013 the patient was vaccinated with an expired dose of GARDASIL, 0.5 ml, intramuscular (lot # 668261/1397AA, Exp 09-APR-2013). No adverse effect reported. This is one of several reports from the same reporter. 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 certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The certified medical assistant reported that the vaccine was exposed to temperature of 26F(Fahrenheit) for a total of 135 hours. No adverse effects reported. Follow-up received. Certified Medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the certified medical assistant regarding an unknown age and gender (previously reported as child), patient with no pertinent medical history reported. On 13-SEP-2012 the patient was vaccinated with the first dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). On 11-FEB-2013 the patient received the second dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: PPV, TD
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unknown number of patients who on unknown dates were vaccinated with TD (manufacturer unspecified vaccine) and PNEUMOVAX23 which we stored for up to 228 hours/19 days at 8 hours each day at a highest temperature of 14C. There were multiple excursions and the caller did not have any information on lot numbers. expiration dates, number of patients or when/if they were vaccinated. No adverse effect was reported. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The certified medical assistant reported that the vaccine was exposed to temperature of 26 F(Fahrenheit)for total of 135 hours. No adverse effects reported. Follow-up received. Certified Medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the certified medical assistant regarding a 14 year old, female patient with no pertinent medical history reported. On 15-OCT-2012 the patient was vaccinated with the first dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). Concomitant medications included hepatitis A vaccine (manufacturer unknown) administered on 15-OCT-2012 (intramuscular in the left arm, dose not reported). On 21-FEB-2013 the patient was vaccinated with the second dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 21-MAY-2013 the patient was vaccinated with a dose of M-M-R II lot number H014648, expiring 03-AUG-2014 (dose and route not provided) and a dose of VARIVAX (Merck) lot number H0168784, expiring 15-OCT-2014 is an invalid lot number for VARIVAX (Merck) (dose and route not provided), which were exposed to unknown temperatures for unknown time frame. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HEP
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. In 2009 the patient was vaccinated with the first dose of RECOMBIVAX HB (dose, route, lot # not reported) and now in 15-MAY-2013, was at the pharmacy to receive the second dose in series of RECOMBIVAX HB. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to 2 patients of unknown age. On 20-MAY-2013 the patients were vaccinated with expired dose of GARDASIL, 0.5 ml, intramuscular (lot # 668261/1397AA Exp. 09-APR-2013). No adverse effect reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to 3 patients of unknown age. On 15-NOV-2013 the patients were vaccinated with expired dose of GARDASIL, 0.5 ml, intramuscular (lot # 668261/1397AA, Exp 09-APR-2013). No adverse effect reported. This is one of several reports from the same reporter. 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 33 patients of unknown age and gender, who on an unknown date, were vaccinated with a doses of VAQTA (doses, routes and lot numbers not reported), that were exposed to 23F for 268 hours. The product was unsupported by in-house stability data for this temperature excursion. No adverse symptoms reported. This is one of several reports received from the same source (related MARRS #1305USA016227, # 1305USA016228). Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse, refers to 10 patients of unknown age and gender, who on an unknown dates, were vaccinated with a doses of RECOMBIVAX HB (doses, routes and lot numbers not reported), that were exposed to 23F for 268 hours. The product was unsupported by in-house stability data for this temperature excursion. No adverse symptoms reported. This is one of several reports received from the same source (related MARRS #1305USA013465, #1305USA016228). 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 registered nurse, refers to 35 patients of unknown age and gender, who on an unknown dates, were vaccinated with a doses of GARDASIL (doses, routes and lot numbers not reported), that were exposed to 23F for 268 hours. The product was unsupported by in-house stability data for this temperature excursion. No adverse symptoms reported. This is one of several reports received from the same source (related MARRS # 1305USA016227, # 1305USA013465). Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Bacteraemia, Blood culture positive, Inappropriate schedule of drug administration, Oedema peripheral, Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On unknown dates the patient was vaccinated with 2 doses of PENUMOVAX23 6 days apart. One day after (date unspecified) after receipt of the second dose, the patient's arm swelled and she developed fever. Blood samples were taken and cultured revealing bacteremia due to gram positive bacteria. Patient outcome was unknown. Reporter did not assessed causality. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 51 year old female patient. On 02-APR-2013, the patient was vaccinated with ZOSTAVAX lot # 0422AE and expiry date 27-MAR-2013, .65 ml, subcutaneous. On 02-APR-2013, the patient was vaccinated with expired ZOSTAVAX on 02-apr-2013. No adverse effect reported. The outcome of vaccinated with expired ZOSTAVAX on 02-apr-2013 and no adverse effect is unknown. The reporter considered vaccinated with expired ZOSTAVAX on 02-apr-2013 and no adverse event to be not related to ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age, unknown gender. On an unknown date the patient was vaccinated with GARDASIL (lot number, route, site and dose unspecified). The patient was administered the first two doses in the GARDASIL vaccination series "two years ago" (date unspecified) and the patient would be administered the third dose in the GARDASIL series on 20-MAY-2013. No adverse effect reported. The outcome of the event was unknown. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Age: 0.83
Sex: U
Vaccine: VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from an office worker at a physician's office but not healthcare professional refers to a 10 month old patient. Medical history was not provided. On 12-FEB-2009 the patient was vaccinated with VARIVAX (Merck) dose 1 (route and lot number unknown) on 10 months of age. On 14-DEC-2012 the second dose of VARIVAX (Merck) was administered subcutaneously at physician's office. No adverse effect was reported. No further information was reported. Additional information was requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an 18 year old female patient. The patient was vaccinated with a first dose of GARDASIL 0.5 ml intramuscularly sometime last summer (in 2012) and present to the office on 17-MAY-2013 for a second dose 0.5 ml intramuscularly (lot # not reported). No adverse effects reported. The patient did not seek medical attention. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Contusion, Epistaxis, Idiopathic thrombocytopenic purpura, Platelet count decreased
Clinical narrative: Developed ITP, platelet count less than 8,000 with epistaxis. While we cannot say with certainty, there is concern that patient's vaccination with ZOSTAVAX could have been the precipitating event for her Immune Thrombocytopenia Purpura.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Epistaxis, Idiopathic thrombocytopenic purpura, Platelet count decreased
Clinical narrative: Developed ITP, platelet count less than 8,000 with epistaxis. While we cannot say with certainty, there is concern that patient's vaccination with ZOSTAVAX could have been the precipitating event for her Immune Thrombocytopenia Purpura.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Antisocial behaviour, Autism, Childhood disintegrative disorder, Crying, Decreased eye contact
Clinical narrative: Patient rarely cried for any reason until this vaccine. When I got him home I nursed him and laid him down as usual. He awoke after a short while with a high-pitched squeal/screech/scream that was non-stop for two days, accompanied by diarrhea and fever. The sound was so unusual and alarming I panicked and called my doctor, even told him I thought it was the vaccine because he had never really cried and certainly never cried like this before. I had never heard ANY child cry like this, with the exception of a newborn's screams. I spoke with a nurse who told me the doctor said it was not the vaccine, to keep an eye on him, "wait it out" and if it didn't get better in a couple of days bring him in. If it got dramatically worse that day I could opt to take him to the ER. He cried almost non-stop all day for hours on end, lessening late that evening and starting again with subsequent bouts of bad diarrhea.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Diarrhoea, Dyskinesia, Flat affect, Gastrointestinal disorder, Pyrexia
Clinical narrative: Patient rarely cried for any reason until this vaccine. When I got him home I nursed him and laid him down as usual. He awoke after a short while with a high-pitched squeal/screech/scream that was non-stop for two days, accompanied by diarrhea and fever. The sound was so unusual and alarming I panicked and called my doctor, even told him I thought it was the vaccine because he had never really cried and certainly never cried like this before. I had never heard ANY child cry like this, with the exception of a newborn's screams. I spoke with a nurse who told me the doctor said it was not the vaccine, to keep an eye on him, "wait it out" and if it didn't get better in a couple of days bring him in. If it got dramatically worse that day I could opt to take him to the ER. He cried almost non-stop all day for hours on end, lessening late that evening and starting again with subsequent bouts of bad diarrhea.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Regressive behaviour, Screaming, Staring, Stereotypy, Toe walking
Clinical narrative: Patient rarely cried for any reason until this vaccine. When I got him home I nursed him and laid him down as usual. He awoke after a short while with a high-pitched squeal/screech/scream that was non-stop for two days, accompanied by diarrhea and fever. The sound was so unusual and alarming I panicked and called my doctor, even told him I thought it was the vaccine because he had never really cried and certainly never cried like this before. I had never heard ANY child cry like this, with the exception of a newborn's screams. I spoke with a nurse who told me the doctor said it was not the vaccine, to keep an eye on him, "wait it out" and if it didn't get better in a couple of days bring him in. If it got dramatically worse that day I could opt to take him to the ER. He cried almost non-stop all day for hours on end, lessening late that evening and starting again with subsequent bouts of bad diarrhea.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Unresponsive to stimuli
Clinical narrative: Patient rarely cried for any reason until this vaccine. When I got him home I nursed him and laid him down as usual. He awoke after a short while with a high-pitched squeal/screech/scream that was non-stop for two days, accompanied by diarrhea and fever. The sound was so unusual and alarming I panicked and called my doctor, even told him I thought it was the vaccine because he had never really cried and certainly never cried like this before. I had never heard ANY child cry like this, with the exception of a newborn's screams. I spoke with a nurse who told me the doctor said it was not the vaccine, to keep an eye on him, "wait it out" and if it didn't get better in a couple of days bring him in. If it got dramatically worse that day I could opt to take him to the ER. He cried almost non-stop all day for hours on end, lessening late that evening and starting again with subsequent bouts of bad diarrhea.
Age: 39.0
Sex: F
Vaccine: DTP
Symptoms: Injection site pain, Pain
Clinical narrative: Left shoulder pain with painful movement and palpation. Did not have redness or swelling at the site.
Age: 0.09
Sex: F
Vaccine: HEP
Symptoms: Blood culture, CSF test, Computerised tomogram head, Convulsion, Culture urine
Clinical narrative: Seizure 3-4 hrs after vaccine administration and all other causes ruled out. Hospitalized for 2 days. Readmitted 3-26-13 for 3 days following abnormal EEG.
Age: 0.09
Sex: F
Vaccine: HEP
Symptoms: Electroencephalogram abnormal, Nuclear magnetic resonance imaging, Venogram
Clinical narrative: Seizure 3-4 hrs after vaccine administration and all other causes ruled out. Hospitalized for 2 days. Readmitted 3-26-13 for 3 days following abnormal EEG.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Erythema
Clinical narrative: Rt deltoid with 4x4 (cm) annular area erythema. ZYRTEC given at hm by mom. Will premedicate at 11y Tdap.
Age: 17.0
Sex: F
Vaccine: MEN, UNK
Symptoms: Dizziness, Erythema, Headache, Nausea, Pain
Clinical narrative: When client got in am and was in bathroom, she got light headed, while she was standing up, so she had to sit down; -she was afraid she was going to pass out, her eyes had trouble focusing and became nauseous. C/o HA, but she has HA usually that is why her doctor is checking things out. He had some tests done previous done for diabetics and they were negative. She had no fever.  Also c/o a "bee like sting" looking area in the L arm which is red. Client did go to school.  She had some juice at about 7:30 and later on ate lunch and came home from school at normal time.  Had doctor appt. and mother was going with her. If any problems, will call Health Dept back.
Age: 17.0
Sex: F
Vaccine: MEN, UNK
Symptoms: Thyroid function test, Vision blurred
Clinical narrative: When client got in am and was in bathroom, she got light headed, while she was standing up, so she had to sit down; -she was afraid she was going to pass out, her eyes had trouble focusing and became nauseous. C/o HA, but she has HA usually that is why her doctor is checking things out. He had some tests done previous done for diabetics and they were negative. She had no fever.  Also c/o a "bee like sting" looking area in the L arm which is red. Client did go to school.  She had some juice at about 7:30 and later on ate lunch and came home from school at normal time.  Had doctor appt. and mother was going with her. If any problems, will call Health Dept back.
Age: 51.0
Sex: F
Vaccine: DTAP
Symptoms: Cough, Discomfort, Feeling abnormal, Feeling cold, Headache
Clinical narrative: Entire injected arm swollen and red to the elbow.  Called the Doctor to report.  Swelling got worse through 5/29/2013.  Felt some stinging in arm and body aches, cough, slight fever, headache. Went to bed that night and experienced coldness to the bone.  I couldn't get warm.  I had use a heating pad all over the body.  Through the night my legs and arms felt so strange!  The only way I could get relief was to stretch my limbs for as long as possible.  It was horrible!  I couldn't get comfortable at all.  Woke up and the swelling of the arm was down and the redness not as bad.  It was like it came to a peak and then I sweated it out.  Won't get this shot again.
Age: 51.0
Sex: F
Vaccine: DTAP
Symptoms: Hyperhidrosis, Injection site erythema, Injection site swelling, Pain, Pyrexia
Clinical narrative: Entire injected arm swollen and red to the elbow.  Called the Doctor to report.  Swelling got worse through 5/29/2013.  Felt some stinging in arm and body aches, cough, slight fever, headache. Went to bed that night and experienced coldness to the bone.  I couldn't get warm.  I had use a heating pad all over the body.  Through the night my legs and arms felt so strange!  The only way I could get relief was to stretch my limbs for as long as possible.  It was horrible!  I couldn't get comfortable at all.  Woke up and the swelling of the arm was down and the redness not as bad.  It was like it came to a peak and then I sweated it out.  Won't get this shot again.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: TDAP administered on 5/26.  Swelling and redness locally at injection site.  Reaction was not immediate and occurred 24 or more hours later.  No systemic sx, no fever, lip, face, or throat swelling; no wheezing.  Mild/Moderate severity.
Age: 1.44
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Urticaria
Clinical narrative: Red hives on body started on back and got worse.
Age: 63.0
Sex: F
Vaccine: DTAP
Symptoms: Chills, Fatigue, Feeling cold, Headache, Nausea
Clinical narrative: High fever. Severe coldness, 5 blankets didn't help, terrible shivering. Headache, nausea. Very tired. These symptoms lasted all day & night. Today (5-30) still have headache & tiredness.
Age: 63.0
Sex: F
Vaccine: DTAP
Symptoms: Pyrexia
Clinical narrative: High fever. Severe coldness, 5 blankets didn't help, terrible shivering. Headache, nausea. Very tired. These symptoms lasted all day & night. Today (5-30) still have headache & tiredness.
Age: 16.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Child woke up this morning with red swollen area the size of a baseball to injection site.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Local soreness and pink coloring of skin at injection site no treatment.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Rash, Urticaria
Clinical narrative: Hive rash the evening the day the vaccines were given; unsure of exact time; tx Benadryl; lasted 3 days.
Age: 2.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Decreased appetite, Diarrhoea, Gastric dilatation, Lethargy, Vomiting
Clinical narrative: Vomiting, diarrhea, lethargy, loss of appetite, distended stomach.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Convulsion, Gaze palsy, Muscle rigidity
Clinical narrative: Patient had a seizure - eyes rolled back, arms legs and neck extended stiffly and face stiffened.
Age: 39.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Fever over 102 for 2 days. Swelling around injection area - Up to 3in X 3in and very painful. Treated with low level steroids.
Age: 34.0
Sex: M
Vaccine: PPV
Symptoms: Arthritis, Chills, Erythema, Hypoaesthesia, Influenza like illness
Clinical narrative: Pt states he got flu like sxs at about 1300 on 5/25/13. He also had fever 99 degrees F - 100 degrees F. R arm swelling with reddness, some numbness in lower ext. (thumb), chills, pain in thumb without being able to move it, like bad arthritis. Flu-like symptoms and fever gone. Local reaction improving.
Age: 34.0
Sex: M
Vaccine: PPV
Symptoms: Local reaction, Mobility decreased, Oedema peripheral, Pain in extremity, Pyrexia
Clinical narrative: Pt states he got flu like sxs at about 1300 on 5/25/13. He also had fever 99 degrees F - 100 degrees F. R arm swelling with reddness, some numbness in lower ext. (thumb), chills, pain in thumb without being able to move it, like bad arthritis. Flu-like symptoms and fever gone. Local reaction improving.
Age: 65.0
Sex: M
Vaccine: DTP, VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Erythema and pain at injection site.
Age: 1.02
Sex: M
Vaccine: MMRV
Symptoms: Crying, Decreased appetite, Dysstasia, Gait disturbance, Pyrexia
Clinical narrative: Baby has been walking for weeks now. Suddenly refusing to stand or walk. Cries when I try to stand him on his feet. Decreased appetite and low grade fever 100.0F.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Cough, Paraesthesia oral, Presyncope, Urticaria
Clinical narrative: Hives, cough, tongue tingling, possible throat swelling near syncope. Required oral BENADRYL and oral steroid course, ER visit, PCP visit.
Age: 1.51
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Rash generalised
Clinical narrative: Pt developed pinpoint rash on fingers, arms, trunk/back, legs, feet on 5/29/13 a.m. (some rash on feet/ankles raised); no fever, no cold symptoms, non-pruritic, tried several different sunscreens in past 5 days. Vaccines administered 1 d before rash.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Diarrhoea, Flatulence, Pyrexia, Vomiting
Clinical narrative: Patients mother called on 04/10/2013 and complained that child has had diarrhea since 04/05/2013, one day post vaccines. Mother states that patient had a fever on 04/05/2013 and it went away and he has had 3-4 episodes of diarrhea a day for everyday and very gassy. Mother was told to bring child in. Baby was weighed and examined and had positive weight gain, good urine output, no fever and no vomiting but continues to vomit. MD told mom to to start baby on alimentum formula, MYLICON for the gas and Probiotics. Mother started regimen and no change until the beginning of may as per mother.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 04-MAY-2013 the patient was vaccinated with M-M-R II (lot number not provided), subcutaneous. The expiry date of the vaccine was 26-APR-2013. No adverse event was reported. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The certified medical assistant reported that the vaccine was exposed to temperature of 26 F(Fahrenheit)for a total of 135 hours. No adverse effects reported. Follow-up received. Certified Medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the certified medical assistant regarding a 17years old, male patient with no pertinent medical history reported. On 21-NOV-2012 the patient was vaccinated with the first dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: HEPA
Symptoms: Product expiration date issue
Clinical narrative: This spontaneous report as received from a physician who reported that her practice had returned 650 doses of vaccinated with VAQTA (reported as (VAQTA Pediatric, lot) lot # 670835/0628AA, Expiry date: 13-MAR-14, as expired to Merck. Physician reports that as soon as the practice heard back from the Merck Vaccine Customer Center, the expiration date should be interpreted as 13-MAR-2014, she realized that the practice had made a mistake in interpreting the expiration date. Physician reports that it would make it easier for providers to properly determine expiration dates if the year was expressed 4 digit number, states that if the expiration date had read 13-MAR-2014 the practice would not have made the mistake. Physician expressed concern that while this confusion about interpreting the expiration date led to an early return, and not administration of expired product, the inverse error could result in administration od expired vaccine. Physician encourages Merck to amend the expiration dates to include a four digit year. As the vaccine does not expire until March 2014, no patients received expired vaccine. Additional information is not expected.
Sex: U
Vaccine: HIBV, HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age. The nurse reported that it was possible that on multiple unspecified dates, multiple unspecified patients were administered GARDASIL (lot # H015555, exp 13-APR-2015) and LIQUID PEDVAXHIB (lot # H022058, exp 10-OCT-2015) which were exposed to temperatures below the recommended storage and stability could not be supported with the appropriate spreadsheets. No adverse effects reported. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age with anxiety, arthritis, Gastrooesophageal reflux disease (GERD),  polio in 1948 and dysplasia on her right side. On 13-MAY-2013 the patient was vaccinated with PNEUMOVAX23 (lot # H017759, expiry date on 04-JUL-2014, standard dose and route). Concomitant Medication: Unspecified medications for treatment of GERD, Anxiety, Arthritis, and Dysplasia on her right side. The patient developed swelling similar to Cellulitis in her arm after receiving PNEUMOVAX23. The patient went to the emergency room(ER) for treatment and received ice before being released. The patient re-presented to the doctor's office on 15-MAY-2013 and was given ROCEPHIN for treatment. The swelling was about 7 inches across the injection site and 7 1/4 inches along the length of the arm and possibly spreading. The outcome of event was reported as recovering/resolving. The physician considered the event was significant disability or incapacity as patient was still in pain. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site nodule, Injection site pain, Injection site swelling, Urticaria
Clinical narrative: Started with tender, swollen, knot at injection site followed by hives 24-48 hours later.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Rash erythematous, Skin warm
Clinical narrative: Redness/hardness at injection site. Red rash expanded to an oval shape that was about 6-7 inches long and 4 inches wide. Warm to the touch but only painful at the actual site of injection.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient presented to the pharmacy Sunday, May 26, 2013 at 10:30AM with a large (size of a half-dollar) red, raised circle around the injection site. The circle was also very warm to the touch.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Rash, Urticaria
Clinical narrative: Burning rash with hive like spots on left torso.
Age: 28.0
Sex: M
Vaccine: HEP
Symptoms: Rash erythematous, Rash generalised, Rash macular, Rash pruritic
Clinical narrative: LPN from group home call and stated client developed "Head to Toe" raised red, blotchy, itchy rash approx 3 hours after he recieved HEP B vaccine. No fever, no breathing difficulties.  Rash disappeared approx 30 mins after taking 25mg of Benadryl P.O.
Age: 52.0
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: No adverse reactions reported. Should have received adult Tdap not Kinrix.
Age: 33.0
Sex: M
Vaccine: TDAP
Symptoms: Discomfort, Joint range of motion decreased, Pain
Clinical narrative: Increasing soreness, discomfort, pain, and limitation of range of motion.
Age: 14.0
Sex: M
Vaccine: MEN
Symptoms: Blood pressure decreased, Dizziness, Fatigue, Feeling cold, Nausea
Clinical narrative: Feeling dizzy, drop in blood pressure, white face, almost fainted. Feeling nauseous. Had just left doctors office.  Rushed back to Drs., they had him lay down and monitored him and took blood pressure, which was low.  Observed him until he felt well enough to leave.  Patient felt cold on the way home and tired for the remainder of the day.
Age: 14.0
Sex: M
Vaccine: MEN
Symptoms: Pallor, Presyncope
Clinical narrative: Feeling dizzy, drop in blood pressure, white face, almost fainted. Feeling nauseous. Had just left doctors office.  Rushed back to Drs., they had him lay down and monitored him and took blood pressure, which was low.  Observed him until he felt well enough to leave.  Patient felt cold on the way home and tired for the remainder of the day.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Angina pectoris, Cough, Dermatitis exfoliative, Electrocardiogram, Urticaria
Clinical narrative: 15 minutes after child received vaccines she began coughing, stated heart hurt, began vomiting, generalized erythroderma and hives.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Vomiting
Clinical narrative: 15 minutes after child received vaccines she began coughing, stated heart hurt, began vomiting, generalized erythroderma and hives.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Abscess, Cellulitis, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Mother states 2 days post vaccination that site of injection is red, with swelling, hardness and warmth. No fever. Seen by MD on 05/16/13; note states cellulitis and abscess, unspecified. Mother states child has pain to site but no spread of redness.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Mother states 2 days post vaccination that site of injection is red, with swelling, hardness and warmth. No fever. Seen by MD on 05/16/13; note states cellulitis and abscess, unspecified. Mother states child has pain to site but no spread of redness.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Mixed connective tissue disease
Clinical narrative: Developed weakness several weeks later and diagnosed with mixed connective tissue disease several months later.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The certified medical assistant reported that the vaccine was exposed to temperature of 26 F (Fahrenheit) for a total of 135 hours. No adverse effects reported. Follow-up received. Certified medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the certified medical assistant regarding a 12 years old, female patient with no pertinent medical history reported. On 20-SEP-2012 the patient was vaccinated with the first dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). On 24-JAN-2013 the patient received the second dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood pressure increased, Blood test
Clinical narrative: This spontaneous report was received from a 60 year old male patient with sulfa allergy. The patient's medical history included prostate surgery in August 2011. On 06-MAY-2013, the patient was vaccinated with a dose 1 of ZOSTAVAX (lot # H021292, expiry: 28-APR-2014) in his left arm. Concomitant therapies included atenol, lisinopril, atorvastatin, LEVSIN, amlodipine besylate, benazepril hydrochloride and hydrochlorothiazide. On 09-MAY-2013, the patient's blood pressure skyrocketed after receiving ZOSTAVAX in his left arm. Laboratory tests included unspecified bloodwork(result not reported). Patient received treatment with an increased dose of unspecified hypertension medication. Patient sought medical attention (doctor's visit on 10-MAY-2013). The outcome of events was reported as not recovered. Additional information has been requested.
Age: 0.52
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Ankyloglossia congenital, Tremor
Clinical narrative: Pt presented for his 12 mo WCC and mother reported that patient had fine hand tremors that occurred 5x weekly for a month after his 6 mo WCC and shots. These episodes lasted for a couple of seconds. He did not have a loss of consciousness. Patient has no residual symptoms.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The certified medical assistant reported that the vaccine was exposed to temperature of 26 F (Fahrenheit)for a total of 135 hours. No adverse effects reported. Follow-up received. Certified Medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the certified medical assistant regarding a 14 years old, male patient with no pertinent medical history reported. On 31-AUG-2012 the patient was vaccinated with a dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). On 26-NOV-2012 the patient received another dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). On 21-MAR-2013 the patient received another dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.