chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Skin warm
Clinical narrative: Was very tired after shots, took Tylenol at 1:00 PM with c/o sore arms. Went to bed at 7PM woke up at 10:00 felt hot to touch, did not take temperature, c/o feeling generally bad. The next morning (Fri.) felt generally bad, had fever of 100.4 at 9:15. Refused Tylenol. Just hurt all over, stayed in bed Friday and Saturday with fever and over all achy.  Sunday felt better, able to get up and go to front room, but did not feel  100%.  By Monday no fever, aches were gone, felt back to normal.
Age: 0.51
Sex: M
Vaccine: PNC, RV5
Symptoms: Blister, Swelling, Urticaria
Clinical narrative: Full body hives, blisters, and swelling.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site haematoma
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 71 year old female patient with no drug allergies/Reactions and no pertinent medical history. On 10-APR-2014 the patient was vaccinated with single dose of ZOSTAVAX, subcutaneously. Concomitant medications were none. On 10-APR-2014, the patient experienced an immediate, small hematoma at the injection site. lab diagnostic studies were not performed. The patient sought the medical attention by contacting pharmacist. The outcome of the patient experienced an immediate, small hematoma at the injection site was reported as not recovered/not resolved. The causality was not reported. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 55 years old female patient. On 08-APR-2014, the patient was vaccinated with ZOSTAVAX lot # J012659, expiry date 10-JAN-2015, dose (unknown), frequency (unknown) and route of administration (unknown). No concomitants were reported. On 09-APR-2014, the patient developed as a red, warm area at the site of administration of the ZOSTAVAX that was about 2 inches in diameter. Patient sought medical attention, she contacted pharmacy. No lab diagnostics studies were performed. No treatment was given for adverse events. Action taken with respect to ZOSTAVAX was not applicable. No product quality complaint was involved. The outcome of events was reported as not resolved. No other information was reported. Additional information has been requested.
Age: 1.49
Sex: M
Vaccine: HEPA
Symptoms: Apraxia, Autism, Candida infection, Dyspraxia, Ear infection
Clinical narrative: This spontaneous report as received from a consumer refers to currently 6 years old son with gluten allergy and yeast allergy. In October 2007 (reported as when he was born in the hospital) the patient was vaccinated with RECOMBIVAX HB (lot/batch was not reported). In January 2009 (reported as 15 months age) the patient was vaccinated with (Oka/Merck) VARIVAX and MMR II. In April 2009 (reported as 18 months age) the patient was vaccinated with hepatitis A vaccine (manufacturer unknown) and DTP (manufacturer unknown). It was reported that since birth, her son has always suffered from what she thought was yeast on his bottom. On unknown date the patient took unspecified amoxicillin for a double ear infection. After that the patient was diagnosed with thrush which was transmitted to his mother via breastfeeding. The yeast was later diagnosed as psoriasis, which was exacerbated by the intake of gluten products. Mother also reported that he son was also "always sick", usually with upper respiratory infections and ear infections. It was also reported that in March 2010 her son was diagnosed with Autism (also reported as pertinent medical history). The patient was non verbal, suffering from apraxia. On unknown date the patient began treatment with "CHOLESTEROL", a product that provides the body with cholesterol to enhance brain development). It was reported that since beginning this product, the patient was verbal and had better communication and social skills. The patient received all age appropriate vaccines until he was of age of five. Causality and outcome for all events were unknown, only outcome for dyspraxia was recovering. Additional information has been requested.
Age: 1.49
Sex: M
Vaccine: HEPA
Symptoms: Psoriasis, Upper respiratory tract infection
Clinical narrative: This spontaneous report as received from a consumer refers to currently 6 years old son with gluten allergy and yeast allergy. In October 2007 (reported as when he was born in the hospital) the patient was vaccinated with RECOMBIVAX HB (lot/batch was not reported). In January 2009 (reported as 15 months age) the patient was vaccinated with (Oka/Merck) VARIVAX and MMR II. In April 2009 (reported as 18 months age) the patient was vaccinated with hepatitis A vaccine (manufacturer unknown) and DTP (manufacturer unknown). It was reported that since birth, her son has always suffered from what she thought was yeast on his bottom. On unknown date the patient took unspecified amoxicillin for a double ear infection. After that the patient was diagnosed with thrush which was transmitted to his mother via breastfeeding. The yeast was later diagnosed as psoriasis, which was exacerbated by the intake of gluten products. Mother also reported that he son was also "always sick", usually with upper respiratory infections and ear infections. It was also reported that in March 2010 her son was diagnosed with Autism (also reported as pertinent medical history). The patient was non verbal, suffering from apraxia. On unknown date the patient began treatment with "CHOLESTEROL", a product that provides the body with cholesterol to enhance brain development). It was reported that since beginning this product, the patient was verbal and had better communication and social skills. The patient received all age appropriate vaccines until he was of age of five. Causality and outcome for all events were unknown, only outcome for dyspraxia was recovering. Additional information has been requested.
Age: 0.7
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a "8.5" month old (34 week old) patient. On 31-MAR-2014, the patient received a dose of (Oka/Merck) VARIVAX (0.5 ml, subcutaneously, lot # was not reported) and MMR II (dose, frequency, lot # and indication were not reported). No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 07-APR-2014 the patient was vaccinated with improperly stored PNEUMOVAX 23 (lot # J009723, expiry date 30-JAN-2015), 0.5 ml, intramuscular. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and referred to an unspecified number of patient of unknown age and sex. No pertinent medical history, drug reactions or allergies were reported. On an unknown date the unspecified number of patients have been administered MMR II (lot #, expiration date, dose and route of administration were not reported) injection for prophylaxis as a vaccination which was exposed to temperatures outside the prescribing information although were supported. No adverse effects were reported. No concomitant medications were reported. Follow up information has been received. The reported provided the MMR II therapy type was HSA, lot # was H017027 and expiration date was 14-SEP-2014. The nurse reported also that no doses were administered. This case is linked to case number 1403USA007007 and 1403USA005427. Additional information is not expected.
Age: 0.4
Sex: U
Vaccine: HPV4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse refers to a 5 month old patient. On 26-MAR-2014 the patient was inadvertently vaccinated with a dose of GARDASIL (dose, route, lot # unknown). No adverse effects reported. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse refers to a 14 year old patient of unknown gender. The nurse reported that the patient was administered an expired dose of (Oka/Merck) VARIVAX (lot # H006539, expiry: 09-MAR-2014) on 31-MAR-2014. No adverse effects were reported. No PQC involved. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous report as received from a medical lab technician refers to a "31 or 32" year old female patient. In approximately 2011 (reported as 3 years ago), the patient was vaccinated with series doses of hepatitis b vaccine (manufacturer unspecified and RECOMBIVAX HB could not be ruled out) (lot #, dose and route not reported) and had negative hepatitis B titers. The patient went to school and was tested for hepatitis B titers that were found to be negative on an unspecified date. No treatment was given for adverse event. The patient sought medical attention. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of drug administration, Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health department nurse refers to an unknown number of patients of unknown ages and genders. On unknown dates the patients were vaccinated with VARIVAX injection which underwent a supported temperature excursion, but was outside the recommended temperature provided in the prescribing information, intramuscular for vaccination (lot #, expiry date and dose unknown). No adverse effects reported. Follow up information has been received on 02-APR-2014. A phone call was placed to Registered Nurse. The Program Manager stated that nurse was unavailable at that time, but the VARIVAX underwent a supported temperature excursion (and administered in 2014). On 17-FEB-2014, lot number: J009731, expiration date: 7-AUG-2015, 70 doses were shipped and 70 doses were in the freezer at the time of discovery. Patient identifiers were not available at this time. No further information is available at this time. This is one of several reports from the same source. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Malaise
Clinical narrative: This spontaneous report as received from a pharmacist refers to an approximately 20 year old female patient with no pertinent medical history and not known drug allergies. In approximately 2013, reported as "around one year ago", the patient was vaccinated with first dose of GARDASIL (dose and lot number not reported). Two months later in 2013, the patient did not get the second dose of GARDASIL because she was sick (unspecified type of sickness). The pharmacist stated the patient now (on 08-APR-2014) wanted to receive the second dose of GARDASIL. The patient's outcome was not reported. Relatedness between sickness and GARDASIL was not reported. Additional information is not expected.
Sex: F
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a female patient of unknown age. The patient's medical history, concurrent condition and drug allergies were not reported. On 09-APR-2014 the patient was inadvertently vaccinated with VARIVAX (lot # H007700, expiration date 30-MAR-2014), 0.5 ml, subcutaneous, No adverse effects reported. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients was vaccinated with a dose of GARDASIL (strength reported as 120 microgram, dose, lot# and expiry date not reported) that was exposed to 20 F for an unspecified period of time, which was excursion that was unsupported by in-house stability data. No adverse symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Eye pain, Herpes ophthalmic, Ocular hyperaemia, Ophthalmic herpes zoster
Clinical narrative: This spontaneous report as received from a physician (ophthalmologist) via a company representative refers to a multiple patients of unknown age. On an unknown date the patients were vaccinated with ZOSTAVAX (doses, routes, lot numbers were not reported). The ophthalmologist informed the company representative that an unspecified number of patients previously vaccinated with ZOSTAVAX were seen in his office and were diagnosed with ocular shingles. The ophthalmologist noted also that the patients had redness and eye pain that was herpes zoster but that "it was frequently misdiagnosed". No further information was provided. The outcome of events was unknown and the relatedness between the suspect: ZOSTAVAX and the events was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker who placed a nurse on the line refers to a patient of unknown age. On 27-FEB-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # H011780 expiration date 16-FEB-2014) (dose, frequency and route) unknown. No adverse effect reported. Additional information has been requested.
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 and gender. On 09-APR-2014, the patient was vaccinated with MMR II injection, lot #0184AE, expiry date 18-JAN-2014, 0.5 ml, subcutaneously, for unknown indication. No concomitants were reported. On 09-APR-2014, the patient was inadvertently administered MMR II that had expired on 18-JAN-2014 and no adverse effects reported. The outcome of events was unknown. Action taken with respect to MMR II was not applicable. No PQC (product quality complaint) was reported. No further information provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Health care worker refers to 25 patient of unknown age. The patient pertinent medical history and concurrent conditions were not provided. On an unknown date the patients were vaccinated with improperly stored VARIVAX (Merck) (lot # J009033, Expiry date: 19-JUL-2015, Dose: 0.5 milliliter, Route: subcutaneous) (exposed to -13C for 14 hours). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist via field employee and refers to a patient of unknown age and gender. On an unknown date reported as "a few weeks ago" the patient was vaccinated with ZOSTAVAX (Lot number, expiry date, route and dose not provided). On an unknown date also reported as "3 days later" the patient developed shingles. The patient recovered from shingles " in a few days" on unknown date. The relatedness between ZOSTAVAX and shingles was not provided. Additional information has been requested.
Age: 0.62
Sex: M
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse refers to a 7 month old male patient. On 31-MAR-2014, the patient was vaccinated with expired oral Lot # H016262 (Expiry: 21-MAR-2014) ROTATEQ, 2 ml, oral. The reporter stated that the nurse who gave the vaccine did not look at the expiration date until after she had given it. No adverse effect was reported. No additional information available. 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 nurse refers to a patient of unknown age and gender. On 10-OCT-2013, patient was vaccinated with first dose of GARDASIL injection, dose (unknown) and route of administration (unknown). No concomitants were reported. ON 10-APR-2014, the patient was in office to receive the second dose of GARDASIL. No adverse effects reported. The outcome of events was unknown. No PQC 9product quality complaint) was reported. No other information was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health department nurse refers to an unknown number of patients of unknown ages and genders. On unknown dates the patients were vaccinated with VARIVAX (Merck) injection which underwent a supported temperature excursion, but was outside the recommended temperature provided in the prescribing information, intramuscular (lot #, expiry date and dose unknown). No adverse effects reported. Follow up information has been received on 02-APR-2014. A phone call was placed to Registered Nurse. The Program Manager stated that nurse was unavailable at that time, but the VARIVAX (Merck) underwent a supported temperature excursion. On 10-JUL-2013, lot number: J001647, expiration date 11-FEB-2015-170 doses shipped and 10 doses were in the freezer at the time of discovery. Patient identifiers were not available at this time. No further information is available at this time. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 09-APR-2014 the patient was vaccinated with improperly stored PNEUMOVAX 23 (lot # J009723, expiry date 30-JAN-2015), 0.5 ml, intramuscular. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Enzyme level test, Immediate post-injection reaction, Pain in extremity, Poor quality sleep, Red blood cell count normal
Clinical narrative: This spontaneous report as received from a 46 year old female nurse practitioner who also the patient refers to herself with stage 3c endometrial cancer which she was diagnosed with in December 2013. There were no drug reactions or allergies. On 28-JAN-2014, the patient was vaccinated with a dose of PNEUMOVAX 23 injection, lot # J010332, expiration date 14-JAN-2015 0.5 ml, intramuscular, doctor recommended since she was receiving chemotherapy. Concomitant therapies included TAXOL, carboplatin and cyanocobalamin (also reported as VITAMIN B12). The patient reported that her right arm immediately hurt after receiving the PNEUMOVAX 23. She also reported that her right arm "still" hurt and that she was up "every hour" in the night due to the pain in her right arm and was unable to lay on her right arm. She stated that she had been taking either TYLENOL or ibuprofen "before bed" for the pain of her right arm. She reported that when she received chemotherapy and she was given an unspecified steroid on unspecified dates, her arm did not hurt for "10 days". The patient reported that she had a white blood count, red blood cell count, and enzymes drawn on 24-MAR-2014 and she stated that the results were "good". The patient did not see medical attention. The outcome of the event was not recovered. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Sleep disorder, White blood cell count normal
Clinical narrative: This spontaneous report as received from a 46 year old female nurse practitioner who also the patient refers to herself with stage 3c endometrial cancer which she was diagnosed with in December 2013. There were no drug reactions or allergies. On 28-JAN-2014, the patient was vaccinated with a dose of PNEUMOVAX 23 injection, lot # J010332, expiration date 14-JAN-2015 0.5 ml, intramuscular, doctor recommended since she was receiving chemotherapy. Concomitant therapies included TAXOL, carboplatin and cyanocobalamin (also reported as VITAMIN B12). The patient reported that her right arm immediately hurt after receiving the PNEUMOVAX 23. She also reported that her right arm "still" hurt and that she was up "every hour" in the night due to the pain in her right arm and was unable to lay on her right arm. She stated that she had been taking either TYLENOL or ibuprofen "before bed" for the pain of her right arm. She reported that when she received chemotherapy and she was given an unspecified steroid on unspecified dates, her arm did not hurt for "10 days". The patient reported that she had a white blood count, red blood cell count, and enzymes drawn on 24-MAR-2014 and she stated that the results were "good". The patient did not see medical attention. The outcome of the event was not recovered. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Bruxism, Dyskinesia, Musculoskeletal stiffness, Syncope
Clinical narrative: This spontaneous report as received from a nurse via a company representative refers to a 12 year old female patient. On 01-APR-2014 the patient was vaccinated with the first dose of GARDASIL (dose, route and lot# not reported). The patient's medical history, concurrent condition and drug allergies were not provided. On 01-APR-2014, the patient experienced syncope following administration of GARDASIL. During syncope episode, the patient's hands tightened up, clinched her teeth and jerked a little bit; 5 minutes later the patient was fine. No treatment was given. On 01-APR-2014, the patient recovered from syncope, hands tightened up, clinched her teeth and jerked. Causality was not provided. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Injection site scar, Scab
Clinical narrative: 2nd GARDASIL injection occurred 1/29/14. Pt reported stomach pain after injection as well as skin scabbing and scarring at injection site.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to an unspecified number of patients of unknown age and demographics. The nurse reported that sometime in March 2014 the patients were vaccinated with VARIVAX (Merck), subcutaneous that was improperly stored. No symptoms reported. On an unknown date the patient experienced no symptoms reported. The outcome of administered improperly stored is unknown. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 22 year old female patient with amoxicillin allergy and penicillin allergy. The patient's medical history included tonsils removed. On 14-AUG-2013, the patient was vaccinated with the first dose of GARDASIL (lot number J002641, expiration date 10-DEC-2015) (dose and route not reported). On 13-OCT-2013, the patient was vaccinated with the second dose of GARDASIL (lot number J007354, expiration date 20-FEB-2016)(dose and route not reported). Concomitant therapies included LOESTRIN. On an unknown date, the patient experienced arm pain, following administration of the recalled lot of GARDASIL. The nurse reported that the arm pain developed at an unspecified time frame after the second dose of GARDASIL. On 07-FEB-2014 the patient was vaccinated with the third dose of GARDASIL (lot # H021346, expiration date: 01-OCT-2015)(dose and route not reported). At the time of the report, the patient had not recovered from arm pain. This is one of two reports from the same source. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site reaction, Pyrexia, Rash erythematous
Clinical narrative: Pt. had fever and chills, red rash around inj. site.
Age: 1.26
Sex: F
Vaccine: DTAP, HEPA, HIBV
Symptoms: Rash
Clinical narrative: Rash on trunk.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Fever, onset approx 8-10 hors post vaccine -> 104 degrees; Rx with TYLENOL and cool bath; recurrence on 3/27/14 T 102 degrees. Advised to take ibuprofen alternating with TYLENOL. Fever resolved on 3/28/14.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass
Clinical narrative: Lump to arm where injection was given SQ RUA.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered licensed practical nurse (L.P.N.) refers to a unspecified number of patients of unknown age and gender. On an unknown date unspecified number of patients were vaccinated with doses of improperly stored (8-9 F for 9 days) VARIVAX (lot number, expiration date, strength, dose, route, indication were not reported.) No adverse effects were reported. No product quality complaint (PQC) was reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Flushing, Injection site erythema
Clinical narrative: Red patches to arms, legs, 915 am. Redness/flush to face.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Pyrexia
Clinical narrative: Swelling, pain, itching, in a 5" diameter circle around injection site. Mild fever 24 hrs. later.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Lymphadenopathy
Clinical narrative: (R) upper arm swelling, lymph node enlargement (R) axillary region, reported 3-24-14, 4-7-14 symptoms minimal.
Age: 23.0
Sex: M
Vaccine: TDAP, TYP, YF
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Nausea
Clinical narrative: Approx 7 mins after shot administered pt. and daughter returned to pharmacy check out area. Pt. complained of nausea/lightheadedness. I carried (pt) back into administration room and sat her down. I gave her a bottle of H2O, fanned her, and monitored her. Pt. felt better after 20-25 mins and left pharmacy.
Age: 24.0
Sex: M
Vaccine: TDAP
Symptoms: Chest discomfort, Dyspnoea, Headache, Pain, Pyrexia
Clinical narrative: Pt reports high fever - general body aches headache and difficulty breathing - denies feeling of throat closing - chest tight.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a unspecified number of patients of unknown age and gender. On an unknown date unspecified number of patient were vaccinated with doses if improperly stored (8-9 F for 9 days) PROQUAD (lot number, expiration date, strength, dose, route and indications were not reported). No adverse effects were reported. No product quality complaint (PQC) was reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 1.51
Sex: M
Vaccine: VARCEL
Symptoms: Convulsion, Pyrexia
Clinical narrative: Seizure x 1. Fever of 100.8 F (rectally). Was seen in ER.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Adverse drug reaction, Heart rate increased, Leukocytosis, Pyrexia, Vomiting
Clinical narrative: 3 hours after Hepatitis A given on 3/21/14, child had fever, vomiting, and rapid heart beat. Mom took her to ER. Released and tx with antibiotics IV and to continue at home antibiotics. ER diagnosis - Adverse drug reaction, leukocytosis.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Pruritus
Clinical narrative: Received HPV 1-21-14 PM. Woke up this with face and abdomen itching. Face also red all over. Dad took child to convenient care and was told to bring her to Health Dept. They advised her to take BENADRYL for itching.
Age: 1.3
Sex: M
Vaccine: DTAP, FLU3, MMRV
Symptoms: Skin lesion, Varicella post vaccine
Clinical narrative: Patient received PROQUAD 1-31-14 and mom called 2-7-14 to report break out of varicella - 20-25 lesions.
Age: 38.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Diarrhoea, Headache, Nausea, Vomiting
Clinical narrative: Nausea, vomiting, diarrhea, chills, headache. Sx began 12 hrs after vaccine given. Sx improved in 24 hrs. I was given the TDAP vaccine (0.5ml, Lot# U4329AA) on 5/30/2012 for having a metal wire pierce my foot. To this day I am experiencing: a dull pain, itching, prickly burning sensation in the area at the injection site. There is nothing visually seen in the area on the surface of the Lt deltoid where the vaccine was administered (no swelling, not hot with fever, and not red). There is just an uncomfortable feeling in the area of the dose administration constantly.
Age: 0.76
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Decreased appetite, Injection site erythema, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: Mother of pt. called on the morning of 3/12/14 at approx 9 am, reporting "vomiting", decreased appetite, redness at inj site, swelling (whelp, where inj. was given) and inj site being "Feverish."
Age: 0.76
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Vomiting
Clinical narrative: Mother of pt. called on the morning of 3/12/14 at approx 9 am, reporting "vomiting", decreased appetite, redness at inj site, swelling (whelp, where inj. was given) and inj site being "Feverish."
Sex: U
Vaccine: HEP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 11-APR-2014, the patient was inadvertently administered RECOMBIVAX HB that had expired, (lot number unknown and expiration date 06-APR-2014, thimerosal status was not provided), (dose number and anatomical location unspecified), 1 ml, intramuscular for an unspecified indication. Concomitant medications were not reported. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist via company representative refers to a patient of unknown demography. On an unknown date (also reported as on a Friday) the patient was vaccinated with ZOSTAVAX (dose and frequency were not reported). On an unknown date (also reported as the following Monday) the patient experienced shingles. The outcome of the event shingles was unknown. The reporter did not provide the causality between the event and the suspect drug. This case is linked to the case 1404USA007894 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist via company representative refers to a patient of unknown demography. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose and frequency were not reported). On an unknown date (also reported as a month later) the patient experienced shingles. The outcome of the event shingles was unknown. The reporter did not provide the causality between the event and the suspect drug. This case is linked to the case 1404USA005603 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Doctor of pharmacy refers to a patient of unknown age. On 04-APR-2014, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported) that was improperly stored. No adverse effect was reported. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Left lateral upper arm - 2 well circumscribed circular areas of erythema -2 cm x 2.5 cm, slightly warm, no induration, non tender, no swelling.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist refers to a female patient of unknown age. The patient's medical history included shingles. In approximately January 2014, reported as about 3 months ago, the patient was vaccinated with ZOSTAVAX (Dose, frequency, strength and lot number not provided). Co-suspect or concomitant therapies were not reported. In approximately March 2014, reported as about 2 weeks ago, the patient experienced a "shingles outbreak". Patient sought medical attention by contacting physician. The patient started treatment on acyclovir (manufacturer unknown). At the time of the report, the outcome of the event was unknown. The causal relationship between the event and ZOSTAVAX was unknown. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Pruritus, Rash
Clinical narrative: Couple weeks after injection, started to get rash on my back - attributed it to a tag on shirt - but then got itchy pimples and rash on arms - upper arms - upper legs and all over my back. Called dr. told me to take BENADRYL for the itching.
Age: 58.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Dizziness, Feeling hot, Heart rate increased, Hyperhidrosis
Clinical narrative: High fever first night and second day. Unusual heat start from my toes all the way to my hand, sweating especially my face, fast heart beat, dizziness and weakness on the third day.
Age: 58.0
Sex: F
Vaccine: HEP
Symptoms: Pyrexia
Clinical narrative: High fever first night and second day. Unusual heat start from my toes all the way to my hand, sweating especially my face, fast heart beat, dizziness and weakness on the third day.
Age: 1.27
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC13, VARCEL
Symptoms: Cheilitis, Rash generalised, Rash papular, Scab
Clinical narrative: Vesiculopapular rashes noted 2 days after receiving vaccine here in the office. Rashes all over body including around lips with some crusting.
Age: 0.19
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Expired drug administered
Clinical narrative: N/A, Vaccine was given on 03.17.14 and expiration date was 03.15.14. PENTACEL from UFC stock.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Injection site infection, Malaise, Pain in extremity, Paraesthesia
Clinical narrative: Patient stated on 3-21-14 arm was still sore and numbness and tingling at times, on 3-24-14 employer of patient called stating pt had to go to ER due to she still was not feeling well. ER stated she had a infection at injection site.
Age: 51.0
Sex: F
Vaccine: FLU3, TDAP, FLU3, TDAP
Symptoms: Asthenia, Dizziness, Impaired work ability, Pain in extremity, Tremor
Clinical narrative: Day following vaccines became faint, weak, trembling. Extreme pain (L) arm. Unable to work. To ER x 2. Symptoms remain.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Feeling hot, Injection site pain, Muscular weakness, Nausea
Clinical narrative: About 5 hours after vaccine was administered I experienced seizure-like symptoms.. dizzy, nauseated, light-headed, hot, feverish and couldn't focus. After that subsided I had extreme pain on my left side from the top of my shoulder to my thigh. Arm is still sore and not at full strength.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Pyrexia, Seizure like phenomena, Vision blurred
Clinical narrative: About 5 hours after vaccine was administered I experienced seizure-like symptoms.. dizzy, nauseated, light-headed, hot, feverish and couldn't focus. After that subsided I had extreme pain on my left side from the top of my shoulder to my thigh. Arm is still sore and not at full strength.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site swelling, Joint swelling, Joint warmth
Clinical narrative: Swelling in (L) upper arm and progressed swelling to wrist with redness and warmth.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist (a physician reported to the pharmacist) refers to a 64 year old female patient. Medical history was not reported. No known allergies (NKA). On 31-MAR-2014, the patient was vaccinated with ZOSTAVAX lot # J002240 expiry date 21-MAY-2014 (dose and route not reported) for vaccination. Concomitant therapies included ciprofloxacin (manufacturer unknown). In April 2014 (reported as few days after vaccination), the patient developed shingles. The patient sought for medical attention (contacted physician and pharmacist). The patient received treatment with an unspecified steroid and acyclovir (manufacturer unknown). At the time of the report, action taken regarding therapy with ZOSTAVAX was not reported. The outcome of shingles was reported as not recovered. Additional information has been requested.
Age: 0.67
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Crying, Emotional distress, Irritability, Lethargy
Clinical narrative: Started with increased temp after shot (lasted appx 1 week) was irritable and cried and unable to console unable to lay her down to sleep and had to hold her was checked for strep and neg. Nasal congestion and drainage rash all over symptoms lasted approx 1 week was lethargic - unusual for this child to lay her head down on your shoulder.
Age: 0.67
Sex: F
Vaccine: FLU3
Symptoms: Nasal congestion, Rash generalised, Rhinorrhoea, Streptococcus test negative
Clinical narrative: Started with increased temp after shot (lasted appx 1 week) was irritable and cried and unable to console unable to lay her down to sleep and had to hold her was checked for strep and neg. Nasal congestion and drainage rash all over symptoms lasted approx 1 week was lethargic - unusual for this child to lay her head down on your shoulder.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pain in extremity
Clinical narrative: Client reported arm soreness, pain with movement of injected arm. No redness, swelling or pain at site of injection. No fever reported. Pt was advised to follow up with provider.
Age: 7.0
Sex: M
Vaccine: MMR
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: Received 2nd MMR. Developed large area >10cm redness at vaccine site then febrile illness 4-5 days later.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Pt received PNEUMOVAX (L) deltoid P.E. visit 4/7/14. That night area red/warm , sl. swelling. Pt used TYLENOL for mild pain. Next am 4/8/14 noticed redness moved down arm toward elbow, sl. lump under skin. No pain. Pt called doctors clinic. Spoke with triage RN brought pt in for eval. Pt seen by Dr, put on KEFLEX for precaution, ice, TYLENOL cont prn.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness at injection site, swollen, and tender.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Erythema, Injection site pain, Injection site swelling, Injection site warmth, Local swelling
Clinical narrative: R-arm became increasingly red, swollen mid afternoon after injection. By 4-10-14 entire upper arm swelled, painful, warm to touch per mother. Saw PCP. Swelling increased into 4-11-14 extending beyond previously marked borders called PCP given antibiotic.
Age: 1.1
Sex: M
Vaccine: DTAPHEPBIP, MMRV, PNC13
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Child had fever with febrile convulsion the evening of the vaccination.
Age: 74.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Local swelling, Rash erythematous
Clinical narrative: After next day after receiving vacc. pt. got red rash and swelling in her arm. Went to Dr. visit and had to take BENADRYL for 3 days.
Sex: U
Vaccine: MMR
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 and gender. On 03-APR-2014 the patient was vaccinated with the second dose of MMR II lot # 0496AE (route and dose not provided), which had expired on 07-MAR-2014. Nurse stated the product had not had any previous temperature excursions. No adverse symptoms were reported. Additional information has been requested.
Age: 1.18
Sex: M
Vaccine: MMR
Symptoms: Rash
Clinical narrative: On Day 12 after vaccination, patient got rash. Was seen by a family friend who is ER doc (not PCP) and given child's dose of liquid Benadryl Rash cleared up about 90%, then returned the next day. Benadryl given just before calling facility to alert us to reaction. States this happened after 3rd Dtap also, Not reported.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site haemorrhage, Injection site induration, Injection site oedema
Clinical narrative: Left leg with significatn edema, induration and mild ecchynosis left thigh
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Axillary pain, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: Joint pains/aches since vaccine given. Shoulder/armits aching - elbow/arms stiffening. Received affected Lot GARDASIL (J007354) on 10/04/2013 No Complaints at that time.
Age: 84.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis
Clinical narrative: BOOSTRIX-Tdap administered 4-7-14. Pt. developed cellulitis after injection.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Crying, Emotional distress, Screaming
Clinical narrative: Received vaccines on 2-10-14. On 2-12-14, "screamed" for 12 hours. Could not be consoled. "Blood curdling cry."
Age: 0.35
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Computerised tomogram head normal, Gaze palsy, Glassy eyes, Laboratory test normal, Unresponsive to stimuli
Clinical narrative: Patient was noted to be unresponsive. Eyes were glazed over, looking up. No cyanosis or apnea. Denies generalized shaking/jerking. Lasted about ?5 mins. Seen in the ER. Normal labs and head CT. Observed overnight. No fever.
Age: 0.78
Sex: F
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: PEDIARIX given 6-26-13 - 4th hep B. KINRIX given 8-26-13 (per package insert and coding instructed 4-6 yrs of age) - not on box anywhere. Same dose as DTaP, IPV in PEDIARIX. No pt rxn.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Pain in extremity, Pyrexia
Clinical narrative: Feverish, sore in L-arm, redness at inj. site.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Breast discomfort, Rash
Clinical narrative: She reports a rash on her back, that traveled around to the front and her breast felt "full".
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Immunisation given at clinic on 4/8/2014. Pt seen in office 4/10/14 for complaint of mild pain on palpation and edema, erythema and warmth to (LT) arm start date 4/10/14. (App. 15cm x 12cm) area to upper (LT) arm. Using arm in play. Afebril TX with Ibuprofen and cool compresses PRN.
Age: 52.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: (L) deltoid really swelled up and became red and was very tender initially. This slowly improved over the course of a few days, but now refers that woke up this morning and was red and sore again.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 4 y/o female with (L) upper anterior thigh w/ superficial erythema and mild induration x4 days.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Fall, Gait disturbance
Clinical narrative: Gave pt flu shot, walked out of immunizing room and was talking to her then she staggered and started to fall to floor. I caught her and carefully laid her down and got her talking and had her rest.
Sex: U
Vaccine: HEP
Symptoms: Injection site erythema, Injection site urticaria, Wrong drug administered
Clinical narrative: This spontaneous report was received from a pharmacist refers to an unspecified number of nurses of unknown age and gender. Medical history reported as previously received a Hepatitis B series at unspecified time. On an unspecified date, an unspecified number of staff at unspecified facility were vaccinated with RECOMBIVAX HB, injection, 0.1 cc, dose: 0.1 ml once, intradermal route (lot number not provided). Pharmacist stated that, on an unspecified date, the patients were administered with RECOMBIVAX HB instead of PPD (purified protein derivative). Reporter stated that most patients were nurses who previously received a Hepatitis B (unspecified) series at unspecified time. Reporter stated that when nurses started returning for what was thought to be a PPD check, nurses were reacting positive with a wheal (redness) at the site of the injection. Reporter stated that there was an unspecified infectious disease physician at unspecified facility to care for nurses and he did not think anything will happen. At the time of the report, the outcome of the events was unknown. The causal relationship between the events and RECOMBIVAX HB was unknown. Additional information is not expected.
Age: 0.5
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report as received from a consumer refers to a 6 month old patient of unknown gender, who on unknown date was vaccinated accidentally with a dose of M-M-R II and (Oka/Merck) VARIVAX. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Headache, Injection site pain
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a male patient of unknown age. On 03-APR-2014 the patient was vaccinated with PNEUMOVAX23 (lot # J011714, expiration date 20-FEB-2015), 0.5 ml, intramuscular. On an unknown date the patient experienced headaches and pain at the injection site. The patient called the office and was suggested to use ice compresses and ibuprofen. No lab tests were performed. The outcome of headaches and pain at the injection site was reported as recovering/resolving. The medical assistant was requesting a lot check. This is one of several reports received from the same source. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a physician refers to a 53 year old female patient with no pertinent medical history and no drug reactions/allergies and not pregnant. On 28-MAR-2014 the patient was vaccinated with a dose of ZOSTAVAX, subcutaneous (lot #, dose and site not reported). The patient called physician on 28-MAR-2014 to seek medical attention. On 29-MAR-2014, the patient experienced redness, pain, and swelling at the injection site and a headache after administration of ZOSTAVAX. The patient was advised to use ibuprofen (unspecified dose/frequency and manufacturer) and cold compresses as treatment. The outcome of headache and redness, pain, and swelling at the injection site was unknown. No lab diagnostics studies performed. The reporter did not provide causality assessment. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified patient. On an unknown date (believed to be recently) the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose and route unspecified). On an unknown date (believed to be recently) the patient developed an injection site reaction following vaccination with ZOSTAVAX. The event outcome was unknown. Additional information has been requested.