chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.1
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 11 month old patient of unknown gender. On an unknown date in April 2014, between 12-APR-2014 and 24-APR-2014, the patient was vaccinated with a dose of VARIVAX lot # J012210, expiry 28-SEP-2015 ("VFC" stock), 0.5 ml, once, intramuscular. The medical assistant stated there was a power outage on 12-APR-2014 and the VARIVAX doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated VARIVAX was exposed to 46F for 1 hour, at worst. There were no prior excursions. There was a site visit from local health department on an unspecified date. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 34.0
Sex: M
Vaccine: HEPA, TDAP, TYP
Symptoms: Convulsion, Immediate post-injection reaction
Clinical narrative: Patient had a seizure immediately after administration of vaccine 911 was called however the patient recovered after a few moments.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 4 year old patient of unknown gender. On an unknown date in April 2014, between 12-APR-2014 and 24-APR-2014, the patient was vaccinated with a dose of VARIVAX lot # J012210, expiry 28-SEP-2015 ("VFC" stock), 0.5 ml, once, intramuscular. The medical assistant stated there was a power outage on 12-APR-2014 and the VARIVAX doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated VARIVAX was exposed to 46F for 1 hour, at worst. There were no prior excursions. There was a site visit from local health department on an unspecified date. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 4 year old patient of unknown gender. On an unknown date in April 2014, between 12-APR-2014 and 24-APR-2014, the patient was vaccinated with a dose of VARIVAX lot # J006358, expiry 23-MAY-2015 ("VFC" stock), 0.5 ml, once, intramuscular. The medical assistant stated there was a power outage on 12-APR-2014 and the VARIVAX doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated VARIVAX was exposed to 46F for 1 hour, at worst. There were no prior excursions. There was a site visit from local health department on an unspecified date. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
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. The patient's pertinent medical history was not reported. On 02-NOV-2010 the patient was vaccinated with first dose of VAQTA (Dose: 0.5 milliliter (ml)), intramuscularly. Concomitant medications were not reported. The patient was vaccinated with second dose of VAQTA on 11-MAR-2011 and third dose of VAQTA on 22-MAY-2014. No adverse effects reported. The outcome of the patient was vaccinated with second dose of VAQTA on 11-MAR-2011 and third dose of VAQTA on 22-MAY-2014 and no adverse effects reported was unknown. 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 a patient of unknown age and gender. There was no pertinent medical history, concurrent conditions and drug reactions/allergies reported. On an unknown date the patient was vaccinated with GARDASIL, 0.5 ml intramuscular (dose number, lot# not reported). No concomitant medications were reported. The nurse reported that 40 patients were administered GARDASIL that has been stored improperly. No adverse effects reported. Additional information has been requested.
Age: 3.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 3 year old patient of unknown gender. On an unknown date in April 2014, between 12-APR-2014 and 24-APR-2014, the patient was vaccinated with a dose of VARIVAX lot # J012210, expiry 28-SEP-2015 ("VFC" stock), 0.5 ml, once, intramuscular. The medical assistant stated there was a power outage on 12-APR-2014 and the VARIVAX doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated VARIVAX was exposed to 46F for 1 hour, at worst. There were no prior excursions. There was a site visit from local health department on an unspecified date. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 4 year old patient of unknown gender. On an unknown date in April 2014, between 12-APR-2014 and 24-APR-2014, the patient was vaccinated with a dose of VARIVAX (Merck) lot # J006358, expiry 23-MAY-2015 ("VFC" stock), 0.5 ml, once, intramuscular. The medical assistant stated there was a power outage on 12-APR-2014 and the VARIVAX (Merck) doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated VARIVAX (Merck) was exposed to 46F for 1 hour, at worst. There were no prior excursions. There was a site visit from local health department on an unspecified date. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a female patient, who was over 26 years of age regarding herself. The patient's pertinent medical history was not reported. On 21-MAY-2014 the patient was vaccinated with first dose of GARDASIL for the prevention of Human papillomavirus (HPV) infection. Concomitant medications were not reported. No adverse effect was reported. The outcome of over 25 years of age and received her first dose of GARDASIL was unknown. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Asthenia, Cough, Dyspnoea, Oropharyngeal pain, Pain
Clinical narrative: Information has been received from Baxter (2014BAX023872) on 28-MAY-2014, concerning a currently 34 year old patient. On an unknown date the patient was vaccinated with a dose of HepB vaccine (manufacturer unknown). On an unknown date the patient experienced sore throat, coughing, aching, weakness and shortness of breath. It was unknown if the patient sought medical attention. The outcome of sore throat, coughing, aching, weakness and shortness of breath is unknown. The original reporting source was not provided. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant (C.M.A.) refers to an unspecified number of unspecified patients of unknown gender and age. On an unknown date, an unspecified number of unspecified patients were vaccinated with doses of ROTATEQ vial (lot#, dose, frequency and route not provided) that were exposed to temperatures that were outside of the recommended temperature range. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a currently 12 month old patient of unknown gender. On an unknown date in April 2014, between 12-APR-2014 and 24-APR-2014, the patient was vaccinated with a dose of VARIVAX lot # J006358, expiry 23-MAY-2015 ("VFC" stock), 0.5 ml, once, intramuscular. The medical assistant stated there was a power outage on 12-APR-2014 and the VARIVAX doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated VARIVAX was exposed to 46F for 1 hour, at worst. There were no prior excursions. There was a site visit from local health department on an unspecified date. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown gender between 60 and 65 years of age. It was reported that pharmacist got this information about 2 years ago. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose and Lot# not reported). On an unknown date, the patient experienced patient developed a rash on the patient's lower back. The outcome of a rash on the patient's lower back was unknown. The pharmacist declined VZVIP (Varicella Zoster Identification Program) packet sent for this patient. Causality assessment was not provided. This is one of several report from the same source. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 75 year old female patient with breast cancer in remission and allergy to amoxicillin. The patient's medical history included breast cancer. On 09-MAY-2014 the patient was vaccinated with ZOSTAVAX (19400 PFU, dose 0.65 ml, subcutaneous). Concomitant therapies included MYRBETRIQ. On 13-MAY-2014, the patient experienced pinpoint, dense rashes on her toes, mid-shin and continued to spread. The outcome of pinpoint, dense rashes on her toes, mid-shin and continued to spread was reported as not recovered. Causality assessment was not provided. This is one of several reports from the same source. 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 healthcare worker refers to unspecified number of patients (age and gender unknown). The healthcare worker reported that GARDASIL which was exposed to 34F for 28.5 hours, may had been administered to unspecified number of patients on an unspecified dates (dose, route and lot# not reported). No adverse effects reported. Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 6 month old patient. On 24-MAY-2014 the 6 month old patient was vaccinated with a first dose of GARDASIL (dose, route and lot # not reported). No adverse symptoms reported. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Local swelling, Pain, Paraesthesia, Pyrexia
Clinical narrative: 5/15/14 pt got Tdap. On drive home (+) burning pain to neck, low grade fever, swelling to (L) shoulder, deltoid and arm, shooting pains, body aches, numb and tingling.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: Childs dose accidentally given to adult.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: Pt. awoke at 2am on 4/24/14 secondary (L) deltoid pain - had area of redness and swelling x 3-4" at site of PNEUMOVAX injection. Pt. reported local reaction only. Used ice packs and ALEVE x 2d. sx resolved completely by day 4-5.
Age: 5.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Cough, Pyrexia, Rash vesicular, Respiratory tract congestion
Clinical narrative: Pt had Varicella booster 4-29-14 and developed cough, fever, congestion and vesicular rash on (L) arm today later - now with zoster rash on (L) flank and (L) arm.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient received flu vaccine on 10/11/12. Later reported to his allergist on 10/16 and to his PCP on 10/18 that he had experienced localized swelling and redness at the injection site, appearing within one day, and resolving after a couple of days.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Induration, Pain, Tenderness
Clinical narrative: MENVEO was administered on (R) deltoid region on 5/27/14. Developed pain tenderness which progressed in 24hrs. area of induration on 5/28/14 12". No fever. No other constitutional lymph. Started improving in 48 hrs.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Blood glucose increased, Diabetes mellitus, Nodule, Pyrexia
Clinical narrative: Administered Tdap 5-21-14 / "knot appeared 5-23-14" "got fever in it 5-27-14" went to hospital due to being diabetic. Was told it was from shot. Was given clindamycin at hospital with script for BACTRIM and metformin (due to increased blood sugar). If increased or not decreased will "drain".
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Local swelling
Clinical narrative: Left arm ans hand swollen. Faint erythema at injection site with firm arm approx 3.5 inch diameter. C/o difficulty moving left arm.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This spontaneous report as received from a 71 year old female consumer refers to herself with allergy about phenobarbital. On 13-MAY-2014 the patient was vaccinated with a dose of ZOSTAVAX (strength, dosage, frequency not reported). Concomitant therapies included SYNTRHOID and VIVELLE (reported as VIVELLE (hormone patch). On 14-MAY-2014, the patient experienced a stinging sensation along with feeling achy and warm at the injection site. She said "it feels like a bee sting". The patient was treated with BENADRYL (also reported as BENEDRYL) cream and ice. The outcome the events was reported as not recovered. It was reported that the patient still had redness at injection site. Additional information has been requested.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Lip swelling, Pharyngeal oedema
Clinical narrative: 5-21-14 OV for cholesterol screen. Pt reports that "flu shot you gave me" caused reaction. Swollen lips/throat. States did OK with regular dose. She could not give onset of reaction after shot. Also hx of allergy s/s x yrs and found was Lisinopril.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Abasia, Arthralgia, Gait disturbance, Joint swelling
Clinical narrative: Patient is having joint swelling, tenderness, pain. All joints are visibly swollen and achy. Pt is limping and barely able to walk.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Blood test normal, Dizziness, Electrocardiogram normal, Syncope, Vomiting
Clinical narrative: 10 min after Tdap vaccine, pt told her friend she felt like she was going to faint so he helped her sit down. I asked how she was doing, she drank some water, then threw up. We called 9-1-1. EMT gave ZOFRAN. BP 80/50, HR 50. Took her to ER diagnosed w/ syncope.
Age: 5.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site warmth, Local reaction, Pain
Clinical narrative: Local reaction to DTaP inj given on 5/19/14 red, warm area to (L) thigh, pain with walking.
Age: 1.26
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Rash, Urticaria
Clinical narrative: Developed rash/hives on face within 2-3 hours of administration went to Urgent Care; treated with BENADRL.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Local swelling, Pruritus
Clinical narrative: Vaccine given 4:20 P.M. on 5/21/14. Patient had some itchiness evening of 5/21/14. 5/22 evening became hot and red. Used ice pack evening 5/22 and 5/23 morning. Area became swollen and more red 5/23 late morning. Started really itching 5/23 12 to 12:30 PM. Pt. had Dr. visit 5/23 2:15. Dr. prescribed clindamycin and prednisone 20mg. Prednisone to be used only if red area gets larger.
Age: 67.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site irritation, Injection site warmth
Clinical narrative: Local redness, warmth and irritation around site of injection. Diagnosis: Adverse reaction. Treatment: MOTRIN Bid with meals, may use TYLENOL, warm compress; CLARITIN, BENADRYL for discomfort. Patient education reviewed and received by patient. Follow up in 3-5 days.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Oedema, Pain
Clinical narrative: Severe pain, could not lift left arm more than halfway and edema.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Dehydration, Diarrhoea, Pyrexia, Vomiting
Clinical narrative: DIARRHEA, VOMITING, DEHYDRATION, FEVER.
Age: 1.01
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site pain, Local swelling, Pyrexia
Clinical narrative: Fever of up to 104 for 3 days; local swelling; pain at injection site.
Age: 29.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Bradyphrenia, Fatigue, Feeling abnormal, Headache
Clinical narrative: Pain started in the left arm (site of administration). I got a headache at around 11:30am. Started experiencing brain fog (slowed thinking, poor memory). As the day progressed the headache and brain fog remained. The pain in my left arm worsened. It is 5/29/2014, 2:45pm and I still have all the same symptoms as well as a very tender arm that is hard to move. My joints in my knees and elbows are painful. I am tired, lethargic, and unable to think clearly.
Age: 29.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Lethargy, Memory impairment, Mental impairment, Mobility decreased
Clinical narrative: Pain started in the left arm (site of administration). I got a headache at around 11:30am. Started experiencing brain fog (slowed thinking, poor memory). As the day progressed the headache and brain fog remained. The pain in my left arm worsened. It is 5/29/2014, 2:45pm and I still have all the same symptoms as well as a very tender arm that is hard to move. My joints in my knees and elbows are painful. I am tired, lethargic, and unable to think clearly.
Age: 29.0
Sex: F
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Pain started in the left arm (site of administration). I got a headache at around 11:30am. Started experiencing brain fog (slowed thinking, poor memory). As the day progressed the headache and brain fog remained. The pain in my left arm worsened. It is 5/29/2014, 2:45pm and I still have all the same symptoms as well as a very tender arm that is hard to move. My joints in my knees and elbows are painful. I am tired, lethargic, and unable to think clearly.
Age: 31.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal discomfort, Immediate post-injection reaction, Paraesthesia, Pruritus
Clinical narrative: Patient reports as soon as vaccine was given, tingling of Left leg, Left arm, Right leg, itching of Left arm and Left leg.  He also stated he felt a sensation that "went through his stomach".
Age: 1.07
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site macule, Injection site reaction, Injection site vesicles, Injection site warmth
Clinical narrative: PT DEVELOPED A RED MACULE MEASURING 6 CM DIAMETER ON THE THIGH WHERE VZV AND HEP A WERE GIVEN. THERE WERE 3 SMALL VESICLES INSIDE OF THE MACULE THAT LOOKED LIKE VARICELLA LESIONS.  AREA WAS HOT TO TOUCH.
Age: 1.07
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Rash vesicular
Clinical narrative: PT DEVELOPED A RED MACULE MEASURING 6 CM DIAMETER ON THE THIGH WHERE VZV AND HEP A WERE GIVEN. THERE WERE 3 SMALL VESICLES INSIDE OF THE MACULE THAT LOOKED LIKE VARICELLA LESIONS.  AREA WAS HOT TO TOUCH.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Myalgia
Clinical narrative: Patient began noticing in the afternoon sore muscles and pain increasing throughout the day.  He could not "use that arm very well" for about 24 hours.  Still reports some soreness though much improved.  Noted ASA with help.  No swelling, warmth or erythema noted at the injection site per patient.
Age: 3.0
Sex: F
Vaccine: MMR
Symptoms: Injection site reaction, Rash, Rash erythematous, Rash maculo-papular
Clinical narrative: Diffuse erythematous maculopapular rash along arms and legs.
Age: 74.0
Sex: M
Vaccine: TDAP
Symptoms: Ecchymosis, Erythema, Local reaction, Local swelling, Pain
Clinical narrative: Patient returned to clinic 05/29/14 at 3:00pm with a localized reaction to Left arm, redness and swelling, ecchymosis, warm to touch, 30mm diameter. Patient stated pain to the area and it started the morning after receiving the vaccine. Denies any other symptoms. Advised to take ibuprofen, Benadryl and cold compress to area. Also to follow up with primary care provider.
Age: 74.0
Sex: M
Vaccine: TDAP
Symptoms: Skin warm
Clinical narrative: Patient returned to clinic 05/29/14 at 3:00pm with a localized reaction to Left arm, redness and swelling, ecchymosis, warm to touch, 30mm diameter. Patient stated pain to the area and it started the morning after receiving the vaccine. Denies any other symptoms. Advised to take ibuprofen, Benadryl and cold compress to area. Also to follow up with primary care provider.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: 5/28/14 Woke up with a hard lump on both arms where shots were given.  There was no redness or tenderness.  5/29/14 Pt woke up and the lump on the left arm had gotten bigger (4x4.5 inches) Right arm remained the same size (1.5 inch circle) but both lumps had become very red.  Pt was examined by MD.  No medication given.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Contusion, Erythema, Skin mass, Skin warm, Urticaria
Clinical narrative: Red welt and bruising appx 1.5 inch. Next day, fire red raised welt more than doubled in size, warm to touch, subdural knot appx 4 inches by 2.5 inches.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: By 7am-22 hours after injection, parent described redness at site with inflammation and heat present.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient states 3 days post injection the injection site became swollen and red. Patient states that she has taken BENADRYL which did help with her symptoms. Today is day 6 post injection and site is still red no swelling noted.
Age: 1.29
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Fever 3 days after followed by rash lasted 14 days after shot.
Age: 65.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Erythema multiforme, Injection site erythema
Clinical narrative: Erythema multiform and erythema of injection site.
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 an unspecified number of patients (demographics unknown). Pertinent medical history, drug reactions or allergies were not provided. On unknown dates, the patients were vaccinated with RECOMBIVAX HB (dose, lot and route were not reported) which was improperly stored outside the temperature stated in the prescribing information. No adverse reactions reported. This is one of multiple cases from the same reporter. Additional information is not expected.
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 an unspecified number of patients (demographics unknown). Pertinent medical history, drug reactions or allergies were not reported. On unknown dates, the patients were vaccinated with PNEUMOVAX 23 (dose, lot and route were not reported) which was improperly stored outside the temperature stated in the prescribing information. No adverse reactions reported. This is one of multiple cases from the same reporter. Additional information is not expected.
Age: 16.0
Sex: M
Vaccine: TYP, YF, TYP, YF
Symptoms: Chest pain, Vomiting
Clinical narrative: Mother of pt called said pt had vomited once. After advising mother to watch pt for continued vomit or fever she states "what about chest pain" at that time I advised her to seek emergency care immediately.
Age: 16.0
Sex: M
Vaccine: TYP, YF, TYP, YF
Symptoms: Anaphylactic reaction, Chest pain, Vomiting
Clinical narrative: Mother of pt called said pt had vomited once. After advising mother to watch pt for continued vomit or fever she states "what about chest pain" at that time I advised her to seek emergency care immediately.
Age: 20.0
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 20 year old patient. On 03-AUG-2009, the patient was vaccinated with the first dose of GARDASIL (dose, route and lot # not reported) and on 28-MAY-2014, the patient received the second dose of GARDASIL (dose, route and lot # not reported). No adverse symptoms were reported. 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 an unspecified number of patients (demographics unknown). Pertinent medical history, drug reactions or allergies were not reported. On unknown dates, the patients were vaccinated with GARDASIL (dose, lot and route were not reported) which was improperly stored outside the temperature stated in the prescribing information. No adverse reactions reported. This is one of multiple cases from the same reporter. Additional information is not expected.
Age: 23.0
Sex: U
Vaccine: TDAP
Symptoms: Dizziness, Nausea
Clinical narrative: Lightheaded, nausea.
Age: 18.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Feeling hot, Hyperhidrosis, Thirst
Clinical narrative: MENACTRA and Hep A (HAVRIX Peds) vaccines given at 1254. Patient states she hot and thirsty about 10 seconds after these vaccinations. Patient get a little diaphoretic but denies dizziness/fainting. Water and sucker given and patient states she feels fine after drinking water and sucker. Advised pt. to go home and eat lunch and drink fluids.
Age: 1.06
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Injection site rash, Pyrexia, Rash generalised
Clinical narrative: Pt started rash on leg of injection site the all over body 6-7 days after date of vaccine. Pt started fever after that for 4 days 101-102.
Age: 19.0
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a 19 year old patient of unknown gender. It was reported that on 22-FEB-2012 the patient received the first dose of GARDASIL (route, lot number and expiration date not reported), then the patient received the second dose on 24-MAY-2013 of GARDASIL (route, lot number and expiration date not reported). There was no concomitant medicaiton reported. The nurse reported that the patient recieved doses of GARDASIL outside of the recommended dosing schedule. It was reproted that at the reporting time the third dose of GARDASIL had not been administered yet. No adverse effects reported. Additional information is not expected.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients (demographics unknown). Pertinent medical history, drug reactions or allergies were not reported. On unknown dates, the patients were vaccinated with PEDVAXHIB (dose, lot and route were not reported) which was improperly stored outside the temperature stated in the prescribing information. No adverse reactions reported. This is one of multiple cases from the same reporter. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients (demographics unknown). Pertinent medical history, drug reactions or allergies were not reported. On unknown dates, the patients were vaccinated with VARIVAX (Merck) (dose, lot and route were not reported) which was improperly stored outside the temperature stated in the prescribing information. No adverse reactions reported. This is one of multiple cases from the same reporter. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients (demographics unknown). Pertinent medical history, drug reactions or allergies were not reported. On unknown dates, the patients were vaccinated with ZOSTAVAX (dose, lot and route were not reported) which was improperly stored outside the temperature stated in the prescribing information. No adverse reactions reported. This is one of multiple cases from the same reporter. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients (demographics unknown). Pertinent medical history, drug reactions or allergies were not reported. On unknown dates, the patients were vaccinated with ROTATEQ (dose, lot and route were not reported) which was improperly stored outside the temperature stated in the prescribing information. No adverse reactions reported. This is one of multiple cases from the same reporter. Additional information is not expected.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients (demographics unknown). Pertinent medical history, drug reactions or allergies were not reported. On unknown dates, the patients were vaccinated with VAQTA (dose, lot and route were not reported) which was improperly stored outside the temperature stated in the prescribing information. No adverse reactions reported. This is one of multiple cases from the same reporter. Additional information is not expected.
Age: 1.02
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash maculo-papular
Clinical narrative: 9 days after administration of MMR and Varicella vaccines developed fever to 100.8 and maculopapular rash starting on face and progressing down neck, chest, arms.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Left arm from shoulder to elbow red, swollen, tender and hot to touch. Advised BENADRYL 25mg every 6 hrs. Apply iced compress. TYLENOL for pain. Outline redness with pen.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Face oedema, Facial pain, Injection site oedema, Injection site pain, Pyrexia
Clinical narrative: (L) arm, (L) axillary, (L) facial pain and edema, (L) deltoid - pain and edema. Fever.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported. The physician reported that on an unknown date, the patient developed flu-like symptoms after receiving ZOSTAVAX. The outcome of flu-like symptoms was unknown. Additional information is not expected.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Abdominal pain upper, Pyrexia
Clinical narrative: Fever of 104, stomach pain.
Age: 61.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 61 year old patient of unknown gender. On 13-MAY-2014 the patient was vaccinated with (Oka/Merck) VARIVAX, subcutaneous (0.5 ml, Lot # and expiration date not reported). No concomitant medications and no other relevant medical history were reported. The reporter stated that the patient was intended to receive ZOSTAVAX, however, on 13-MAY-2014 was inadvertently administered with (Oka/Merck) VARIVAX. No adverse effects were reported. No further medical information was provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: This spontaneous report as received via a company representative from a physician, who was notified by his immunization nurse, refers to 3 patient of unknown age and genders. No demographics or medical data provided. It was reported that in May 2014 (reported as "this month") 3 patients were vaccinated with ZOSTAVAX, dose, site and route of administration not reported. Batch, lot# and expiration date were unknown; however, it was reported that all 3 patients received vaccines from the same batch and same lot#. On an unspecified date in May 2014 patients had reactions post vaccination. The severe reactions were injection site reactions of rash, redness, swelling and itching. It was stated that the healthcare professional "have never seen such reactions before". All 3 patient were given unspecified treatment and were better at the time of the report (outcome of the adverse events assessed as "recovering/resolving"). Relatedness between use of ZOSTAVAX and the reported adverse events was unknown. The reporter stated that the office would not use ZOSTAVAX of the same lot# anymore. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Pt, indicated itchy rash at site 24 hours after shot rash was approximately size of silver dollar. She iced the site Sat and Sunday but it still was sore. She made appt but had to cancel appt due to dizziness.
Age: 45.0
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 45 years old patient. On 14-MAY-2014 the 45 years old patient was vaccinated with ZOSTAVAX, 0.65 ml (lot# and route were unknown). No adverse effects reported. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Urticaria
Clinical narrative: Urticaria 18 hours after immunizations, no local reaction. Urticaria is generalized.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse reporting that unspecified number of patients (no patient demographics known) were most likely vaccinated with VARIVAX which went out of temperature condition not supported by their in house stability data. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse reporting that unspecified number of patients (no patient demographics known) were most likely vaccinated with PEDVAXHIB which went out of temperature range and were exposed to temperature condition not supported by their in house stability data. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse reporting that unspecified number of patients (no patient demographics known) were most likely vaccinated with M-M-R II which went out of temperature range and were exposed to temperature condition not supported by their in house stability data. No adverse effects reported. This is one of the several reports received 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 nurse reporting that unspecified number of patients (no patient demographics unknown) were most likely vaccinated with GARDASIL which went out of temperature range and were exposed to temperature condition not supported by their in house stability data. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse reporting that unspecified number of patients (no patient demographics known) were most likely vaccinated with ROTATEQ orally which went out of temperature range and were exposed to temperature condition not supported by their in house stability data. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain, Pyrexia
Clinical narrative: Abdominal pain, feverish.
Age: 33.0
Sex: M
Vaccine: RAB
Symptoms: Dizziness, Vision blurred
Clinical narrative: Case number PHHY2013US056702 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 487008) website on 05 Jun 2013 and a follow-up received from Quality Assurance Department (QA, reference number: 234124) on 15 Apr 2014. This report refers to a 33-year-old male patient. His medical history included of depression, anxiety, knee pain, adjustment disorder and an eye surgery (patient did not specify type). He had no allergies. Concomitant medications included doxycycline, primaquine and PROZAC. He had discontinued these medications recently (date not specified). He was vaccinated with RABAVERT (batch number: 517011A) on 05 Mar 2013 via intramuscular route in left arm. On 07 Mar 2013, 2 days after vaccination he had dizziness and stated that the symptoms were mild. He denied headache, nausea, vomiting, and change in gait or balance. He also had blurring of vision from an unknown date. No lab tests or diagnostic tests have been performed on the patient to date. He was advised to see his primary care provider so that he can be examined and all relevant labs or diagnostic test can be determined and performed. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events were not reported. Based on the batch investigation performed, the QA department stated that the RABAVERT (batch number: 517011A) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (QA, reference number: 234124) on 15 Apr 2014: Updated batch review report.
Age: 32.0
Sex: F
Vaccine: RAB
Symptoms: Dyspnoea, Erythema, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Case number PHHY2013US056661, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS Ref: 488244) web site on 05 Jun 2013 and a follow-up received from Quality Assurance Department (QA, reference number: 233465) on 14 Apr 2014. This report refers to a 32 year old female patient. Her medical history included asthma. Concomitant medication included Singulair and albuterol inhaler. She was vaccinated with second dose of RABAVERT (batch number: 504011C) intramuscularly into left arm on 29 Mar 2013. On the same day she developed shortness of breath, rash on neck and chest, redness, swelling, and severe itching of left shoulder-jaw and hair line. Outcome of the events was reported as complete recovery. Seriousness and causality assessment was not reported. Based on the batch investigation performed, the QA department stated that the RABAVERT (batch number: 504011C) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (QA, reference number: 233465) on 14 Apr 2014: Updated batch review report.
Age: 32.0
Sex: F
Vaccine: RAB
Symptoms: Pruritus, Rash, Swelling
Clinical narrative: Case number PHHY2013US056661, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS Ref: 488244) web site on 05 Jun 2013 and a follow-up received from Quality Assurance Department (QA, reference number: 233465) on 14 Apr 2014. This report refers to a 32 year old female patient. Her medical history included asthma. Concomitant medication included Singulair and albuterol inhaler. She was vaccinated with second dose of RABAVERT (batch number: 504011C) intramuscularly into left arm on 29 Mar 2013. On the same day she developed shortness of breath, rash on neck and chest, redness, swelling, and severe itching of left shoulder-jaw and hair line. Outcome of the events was reported as complete recovery. Seriousness and causality assessment was not reported. Based on the batch investigation performed, the QA department stated that the RABAVERT (batch number: 504011C) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (QA, reference number: 233465) on 14 Apr 2014: Updated batch review report.
Age: 23.0
Sex: F
Vaccine: MMR
Symptoms: No adverse event
Clinical narrative: This is a follow-up to a previously submitted VAERS report. No adverse event. Vaccinee delivered healthy baby boy on 14 MAY 2014; APGAR scores: 8 and 9; 10 pounds 11 ounces.
Age: 28.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Blood test, Brain stem auditory evoked response, CSF test, Diplopia, Hypoaesthesia
Clinical narrative: Case number PHHY2014US065672 is an initial spontaneous report received from a consumer via vaccine adverse event reporting system website (VAERS reference number: 525858) on 28 May 2014. This report refers to a 28-years-old female patient. Her medical history included hypothyroidism. Her concomitant medications were levothyroxine. She was vaccinated with rabies vaccine (manufacturer and batch number: not reported) intramuscularly in the right arm on 01 Sep 2000. On 01 Apr 2001, 212 days after vaccination, she woke up in the morning and had numbness and she had no sensation below the waist. She also had double vision. She went to the emergency room at the health center the next day and saw a physician. She was referred immediately to another physician for neurology consultation. Magnetic Resonance Imaging (MRI) of brain and spinal cord and lumbar puncture was done to analyze the cerebrospinal fluid (CSF). She also underwent Brain stem Auditory Evoked Response (BAER), Visual Evoked Potentials (VEP) and multiple blood and urine tests. It was reported that the testing quickly revealed multiple sclerosis. She was treated and was still under treatment with daily Copaxone injections. The final outcome was reported as condition unchanged. The event was reported as disabling. The causality was not reported.
Age: 28.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Lumbar puncture, Multiple sclerosis, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal, Sensory loss
Clinical narrative: Case number PHHY2014US065672 is an initial spontaneous report received from a consumer via vaccine adverse event reporting system website (VAERS reference number: 525858) on 28 May 2014. This report refers to a 28-years-old female patient. Her medical history included hypothyroidism. Her concomitant medications were levothyroxine. She was vaccinated with rabies vaccine (manufacturer and batch number: not reported) intramuscularly in the right arm on 01 Sep 2000. On 01 Apr 2001, 212 days after vaccination, she woke up in the morning and had numbness and she had no sensation below the waist. She also had double vision. She went to the emergency room at the health center the next day and saw a physician. She was referred immediately to another physician for neurology consultation. Magnetic Resonance Imaging (MRI) of brain and spinal cord and lumbar puncture was done to analyze the cerebrospinal fluid (CSF). She also underwent Brain stem Auditory Evoked Response (BAER), Visual Evoked Potentials (VEP) and multiple blood and urine tests. It was reported that the testing quickly revealed multiple sclerosis. She was treated and was still under treatment with daily Copaxone injections. The final outcome was reported as condition unchanged. The event was reported as disabling. The causality was not reported.
Age: 28.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Urine analysis, Visual evoked potentials
Clinical narrative: Case number PHHY2014US065672 is an initial spontaneous report received from a consumer via vaccine adverse event reporting system website (VAERS reference number: 525858) on 28 May 2014. This report refers to a 28-years-old female patient. Her medical history included hypothyroidism. Her concomitant medications were levothyroxine. She was vaccinated with rabies vaccine (manufacturer and batch number: not reported) intramuscularly in the right arm on 01 Sep 2000. On 01 Apr 2001, 212 days after vaccination, she woke up in the morning and had numbness and she had no sensation below the waist. She also had double vision. She went to the emergency room at the health center the next day and saw a physician. She was referred immediately to another physician for neurology consultation. Magnetic Resonance Imaging (MRI) of brain and spinal cord and lumbar puncture was done to analyze the cerebrospinal fluid (CSF). She also underwent Brain stem Auditory Evoked Response (BAER), Visual Evoked Potentials (VEP) and multiple blood and urine tests. It was reported that the testing quickly revealed multiple sclerosis. She was treated and was still under treatment with daily Copaxone injections. The final outcome was reported as condition unchanged. The event was reported as disabling. The causality was not reported.
Age: 28.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Blood test abnormal, Brain stem auditory evoked response abnormal, Diplopia, Hypoaesthesia, Lumbar puncture abnormal
Clinical narrative: Case number PHHY2014US065672 is an initial spontaneous report received from a consumer via vaccine adverse event reporting system website (VAERS reference number: 525858) on 28 May 2014. This report refers to a 28-years-old female patient. Her medical history included hypothyroidism. Her concomitant medications were levothyroxine. She was vaccinated with rabies vaccine (manufacturer and batch number: not reported) intramuscularly in the right arm on 01 Sep 2000. On 01 Apr 2001, 212 days after vaccination, she woke up in the morning and had numbness and she had no sensation below the waist. She also had double vision. She went to the emergency room at the health center the next day and saw a physician. She was referred immediately to another physician for neurology consultation. Magnetic Resonance Imaging (MRI) of brain and spinal cord and lumbar puncture was done to analyze the cerebrospinal fluid (CSF). She also underwent Brain stem Auditory Evoked Response (BAER), Visual Evoked Potentials (VEP) and multiple blood and urine tests. It was reported that the testing quickly revealed multiple sclerosis. She was treated and was still under treatment with daily Copaxone injections. The final outcome was reported as condition unchanged. The event was reported as disabling. The causality was not reported.