chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: M
Vaccine: DTAP
Symptoms: Headache, Injection site swelling, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: 06/24/2013 - Call to states L arm was sore on 6/21 and on 6/22 L arm was sore and shoulder and neck and between shoulder blades. States dime size swelling at injection site. States headache for 24 hrs post injection has resolved. No fever. 6/27/13- States a lot better- still a little tenderness.
Age: 34.0
Sex: M
Vaccine: DTAP
Symptoms: Tenderness
Clinical narrative: 06/24/2013 - Call to states L arm was sore on 6/21 and on 6/22 L arm was sore and shoulder and neck and between shoulder blades. States dime size swelling at injection site. States headache for 24 hrs post injection has resolved. No fever. 6/27/13- States a lot better- still a little tenderness.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Swelling
Clinical narrative: Flu shot admininstered 8/26 and today patient has a red, swollen area the size of about 3 inches in diameter. Today is day 3. Mother states has been getting progressively worse. She is not startled based on patient's reaction 2 years ago.
Age: 67.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Herpes zoster, Laboratory test abnormal, Rash
Clinical narrative: 10 days after receiving the shingles vaccine, I broke out with shingles rash. Was treated with valacyclovir HCL 1 gram tablet 3 times a day for one week. Prednisone 3 5mg tablets for 3 days, then 2 5mg tablets per day.
Age: 21.0
Sex: F
Vaccine: TD
Symptoms: Dizziness, Loss of consciousness, Muscle rigidity, Syncope
Clinical narrative: Post vaccine became dizzy, fainted. Brief LOC Ginger ale/crackers given. No loss of urinary/bowel function. Per front office staff student's upper and lower ext became rigid.
Age: 86.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Swelling at the injection site and severe pain.
Sex: U
Vaccine: MNQ
Symptoms: Drug hypersensitivity, Erythema, Local swelling, Skin warm
Clinical narrative: Vaccine administered on 8/19/13. Patient returned on 8/21 with a swollen arm that was red and hot to the touch. Patient is allergic to Diphenhydramine so advised to go to ER.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Headache
Clinical narrative: Patient experienced headache after shot. She also had a little dizziness. Had her sit for a while. Gave her 2 ibuprofen OTC for headache. Gave her some water. Took blood pressure and was normal. Patient felt weak. Feeling better after an hour or so.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Fatigue, Hyperhidrosis, Insomnia, Mobility decreased
Clinical narrative: Feeling fine. About 9 PM arm started to really really hurt and she cannot move her arm. About 12 Midnight, she started profusely sweating and she couldn't see well, as if there was a black laced curtain in front of her and couldn't see well. Fee were sweaty, whole body was soaking wet w/sweat, went to deck got air, iced arms. Couldn't sleep all night long, real week and shaky, next day feels exhausted but can see better, arm not quite as sore. Recovering as of reporting time. Pt has hx of autoimmune disorder, lichen pleura.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Tremor, Visual acuity reduced
Clinical narrative: Feeling fine. About 9 PM arm started to really really hurt and she cannot move her arm. About 12 Midnight, she started profusely sweating and she couldn't see well, as if there was a black laced curtain in front of her and couldn't see well. Fee were sweaty, whole body was soaking wet w/sweat, went to deck got air, iced arms. Couldn't sleep all night long, real week and shaky, next day feels exhausted but can see better, arm not quite as sore. Recovering as of reporting time. Pt has hx of autoimmune disorder, lichen pleura.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Parents noticed the vaccine reaction around 03:00 pm at home. Symptoms: redness, swelling and hard on the right thigh from PENTACEL vaccine. 30 x 20 mm.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Raised bump on arm. About two inches in diameter and red.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Rash vesicular
Clinical narrative: Non-injection site zoster like rash developed around trunk and anterior side of left arm 5 to 7 days after injection. Treating itching with topical medication. Not treating pain as patient not uncomfortable from rash.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: This spontaneous report was received from a certified medical assistant via a company representative refers to a 83 year old male patient with no drug reactions/allergies. On 20-AUG-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # J001690, expiration date 08-MAY-2014) subcutaneously. On 22-AUG-2013, 3 days after onset of therapy the patient developed a pruritic ras on (his) lower back. The patient was on dialysis for chronic kidney disease and had renal failure. The outcome of th event was unknown. The patient was prescribed ATARAX (unspecified dose and frequency) as treatment for the event. Laboratory diagnostic studies were unspecified by the reporter. The patient sought medical attention by visiting the physician on an unspecified date. Causality was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Injection site reaction, Pruritus, Skin warm, Swelling
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX 19400 plaque-forming units (PFU) (dose, route and lot number unknown). On an unknown date the patient experienced injection site reactions following the administration of ZOSTAVAX. The patient developed redness, warmth, swelling and pruritus. The outcome of the events was unknown. The patient had sought medical attention via office visit. Nurse was offered the VZVIP packet, which she declined. This is one of the two reports from the same reporter. Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: HPV4
Symptoms: Hypoaesthesia, Paraesthesia, Vision blurred, Vomiting
Clinical narrative: Vomiting four times 8-10 hours after vaccine with blurring of left eye with numbness and tingling of the left arm. Symptoms have resolved.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX 19400 plaque-forming units (PFU) (dose, route and lot number unknown). On an unknown date, the patient experienced injection site reactions following the administration of ZOSTAVAX. The patient developed redness, warmth, swelling and pruritus. The patient also developed a rash at the injection site. The outcome of the events was unknown. The patient has sought medical attention via office visit. Nurse was offered the VZVIP packet, which she declined. This is one of the two reports from the same reporter.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Head injury, Syncope
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. On an unspecified date in 2013 the patient was vaccinated with the first dose of GARDASIL (lot #, expiration date, dose, route not reported). There was no concomitant medication. The patient fainted multiple times within minutes after receiving the first dose of GARDASIL. She hit her head as a result of the fainting and was given ice for her head. The patient did the blood work test and the results unspecified. The patient was instructed to rest for a few moments and then was allowed to go home. The patient did not seek medical attention. The patient planned to continue with the series. The outcome of the events was unknown. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Rash, Upper extremity mass
Clinical narrative: Rash on face. ZYRTEC once a day. Lump still in arm.
Age: 11.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a 11 year old female patient. The physician reported that on 26-AUG-2013 (reported as yesterday), the patient was inadvertently vaccinated with a dose of ZOSTAVAX 0.65 ml, subcutaneously in the right arm. No adverse effects reported. Physician stated that the child had previously been vaccinated with 2 doses of VARIVAX (Merck). The first dose was administered in the year 2002 and the second dose was administered in the year 2007. Physician stated she called VAERS, Vaccine Adverse Event Reporting System, but they said she does not have to report this incident, if no adverse effects occurred. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: DTAP, HEP, HEPA, HIBV, IPV, PNC
Symptoms: Injection site erythema
Clinical narrative: Redness at injection site. Right thigh. Left thigh.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling, Injection site warmth, Local swelling
Clinical narrative: According to patient about 1 hr after vaccination her arm (left) started swelling and was warm to touch from shoulder to elbow and by 8/25/13 (2 days after) the swelling had gone all the way to her middle arm. Patient treated swelling with ice and around 3 AM (8/25) swelling started going down.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This spontaneous report was received from a pharmacist regarding a male patient of unknown age with no pertinent medical history and no drug reactions or allergies. ON 22-AUG-2013 the patient was vaccinated with ZOSTAVAX (0.65 ml, intramuscular). There were no other suspect therapies or concomitant medications. After administration, on 22-AUG-2013, the patient complained of soreness at the injection site. The outcome of soreness at the injection site was reported as not recovered. No treatment was given for the event.  No laboratory diagnostic studies were performed. The patient sought medical attention by reporting the event to the pharmacist. The pharmacist did not assess the causality between soreness at the injection site and ZOSTAVAX. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt called 2 days after having received pneumonia vaccine stating that he is having a reaction. Pt states that the left arm is red, hot to the touch, swollen, and painful all at the site of the injection.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to "unspecified anonymous patients. Medical history and drug reactions were not reported. In 2013 the patients were vaccinated with improperly stored PNEUMOVAX23 lot number J006082, expiration date 12-APR-2014. Route and concentration were not reported. No concomitant therapies were reported. Since 18-AUG-2013 to 21-AUG-2013 (3 days) PNEUMOVAX23 was improperly storage it was exposed to as low as 22F going in and out of range at least seven times. The reporter was unsure if any of the PNEUMOVAX23 was administered within the following dates that the temperature excursion occurred. Six vials of PNEUMOVAX23 were involved.  No adverse events were reported. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Feeling hot, Headache
Clinical narrative: Feeling warm (pt did not take temperature). Diarrhea. Frontal and occipital headache.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from an office manager (also reported as a healthcare worker) via a company representative concerning a patient of unknown age and gender. It was reported that the patient was vaccinated with GARDASIL doses outside the regimen. On an unknown date, the patient was vaccinated with the first dose of GARDASIL (lot number, expiry date, dose and route unspecified) and then was vaccinated with the second dose of GARDASIL (lot number, expiry date, dose and route unspecified) one year later. The patient was vaccinated with the third dose of GARDASIL (lot number, expiry date, dose and route unspecified) 4 weeks after the second dose. No concomitant therapy was reported. It was unknown if the patient had any side effects. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Abnormal behaviour, Depression, Mood altered, Suicidal ideation
Clinical narrative: Complaining of behavioral change - moody, depressed, suicidal.
Sex: M
Vaccine: VARZOS
Symptoms: Gout
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a male patient of unknown age. On an unknown date in August 2013 (reported as some time last week) the patient was vaccinated with a "standard dose" of ZOSTAVAX (lot # not reported), subcutaneously. Patient developed a severe gout attack later in the day on the day of the vaccination. Patient sought medical attention by talking to the doctor. Prednisone was given to patient as treatment, 40 mg once daily. The outcome of severe gout attack was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Arthralgia, Myalgia
Clinical narrative: Arthralgias and myalgias resolving at 1 week.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Rash erythematous, Rash vesicular
Clinical narrative: 2 days after pt received the shingles vaccine she developed right-sided upper abdominal pain, then 2 days after shot, she developed an erythematous, vesicular rash along the T10-T12 distribution on the (R) side. She is being treated with VALTREX and gabapentin.
Age: 1.27
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Abnormal behaviour, Crying, Diet refusal, Irritability, Screaming
Clinical narrative: She became very irritable shortly after leaving the doctor's office. Refused to eat and not herself, crying a lot and wanting to be held..unwilling to sleep. When I tried to put her down in her crib, she completely lost control, screaming violently and throwing herself against the sides of the crib. She continued to so this every time we put her down until I rocked her and calmed her to the point of almost sleeping. She has never displayed this type of behavior before.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Burning sensation, Crying, Injection site pain
Clinical narrative: As the injection was being administered, my daughter cried, and she is a very strong, stoic child, who normally does little more than wince. She said it hurt, burned like fire and just felt odd going in.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Dyspnoea, Respiration abnormal, Sensory disturbance
Clinical narrative: Unsure of exact times. Stated everything was fine, but over the weekend she started having problems with her breathing. On 8/29/2013 she called our nurse triage line and stated she could not take a full deep breathe, funny feeling in the back of her throat and chest area. She was advised to seek medical treatment. Disposition unknown at this time.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Blood glucose normal, Convulsion, Crying, Face injury, Fall
Clinical narrative: Went back to the exam room at approximately 9:15, and would estimate the shot was administered about 9:45.  Afterwards I held patient and we helped her doll also get a Band-Aid.  We waited several minutes for the nurse to bring back a printed shot record.  Before she could come back we walked out of the room together.  Patient was starting to walk funny on her leg that received the shot.  She walked up to the front desk, I would estimate 15 feet.  Next she picked out a sticker and waited for me to make her a new appointment.  I could tell she was still having trouble walking on the leg with the shot.  We turned to walk out of the door and as she neared the fireplace she stumbled sideways and fell on her face, letting out a cry.  She stopped crying almost immediately as I picked her up and she went limp, blinking her eyes.  I immediately ran back to the desk and got the scheduler's attention that she was acting funny.  She led me back to an exam room where I laid patient down and she had a seizure and did not appear to have control of her arms and legs.  I saw her eyes roll and she was not responding to my voice.  The nurse came in to see what was happening and went to get Dr.   I'm pretty sure Dr. was in the room for at least part of the seizure.  First she took her blood pressure as I held her.  During this time patient was very pale.  The report from the doctor was that her blood pressure was low but pulse was good.  Dr. also ordered a blood sugar test that was given immediately.  During the test patient began to breathe rapidly and then returned to normal.  Sugar test was fine.  Patient seemed very lethargic after this ordeal and we stayed at the Dr. office for an hour.  Little by little she began to perk up and become more alert.  The office provided a snack of V8 fruit juice and dried fruit.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Gait disturbance, Gaze palsy, Hypotension, Hypotonia, Lethargy
Clinical narrative: Went back to the exam room at approximately 9:15, and would estimate the shot was administered about 9:45.  Afterwards I held patient and we helped her doll also get a Band-Aid.  We waited several minutes for the nurse to bring back a printed shot record.  Before she could come back we walked out of the room together.  Patient was starting to walk funny on her leg that received the shot.  She walked up to the front desk, I would estimate 15 feet.  Next she picked out a sticker and waited for me to make her a new appointment.  I could tell she was still having trouble walking on the leg with the shot.  We turned to walk out of the door and as she neared the fireplace she stumbled sideways and fell on her face, letting out a cry.  She stopped crying almost immediately as I picked her up and she went limp, blinking her eyes.  I immediately ran back to the desk and got the scheduler's attention that she was acting funny.  She led me back to an exam room where I laid patient down and she had a seizure and did not appear to have control of her arms and legs.  I saw her eyes roll and she was not responding to my voice.  The nurse came in to see what was happening and went to get Dr.   I'm pretty sure Dr. was in the room for at least part of the seizure.  First she took her blood pressure as I held her.  During this time patient was very pale.  The report from the doctor was that her blood pressure was low but pulse was good.  Dr. also ordered a blood sugar test that was given immediately.  During the test patient began to breathe rapidly and then returned to normal.  Sugar test was fine.  Patient seemed very lethargic after this ordeal and we stayed at the Dr. office for an hour.  Little by little she began to perk up and become more alert.  The office provided a snack of V8 fruit juice and dried fruit.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Pallor, Respiratory rate increased, Unresponsive to stimuli
Clinical narrative: Went back to the exam room at approximately 9:15, and would estimate the shot was administered about 9:45.  Afterwards I held patient and we helped her doll also get a Band-Aid.  We waited several minutes for the nurse to bring back a printed shot record.  Before she could come back we walked out of the room together.  Patient was starting to walk funny on her leg that received the shot.  She walked up to the front desk, I would estimate 15 feet.  Next she picked out a sticker and waited for me to make her a new appointment.  I could tell she was still having trouble walking on the leg with the shot.  We turned to walk out of the door and as she neared the fireplace she stumbled sideways and fell on her face, letting out a cry.  She stopped crying almost immediately as I picked her up and she went limp, blinking her eyes.  I immediately ran back to the desk and got the scheduler's attention that she was acting funny.  She led me back to an exam room where I laid patient down and she had a seizure and did not appear to have control of her arms and legs.  I saw her eyes roll and she was not responding to my voice.  The nurse came in to see what was happening and went to get Dr.   I'm pretty sure Dr. was in the room for at least part of the seizure.  First she took her blood pressure as I held her.  During this time patient was very pale.  The report from the doctor was that her blood pressure was low but pulse was good.  Dr. also ordered a blood sugar test that was given immediately.  During the test patient began to breathe rapidly and then returned to normal.  Sugar test was fine.  Patient seemed very lethargic after this ordeal and we stayed at the Dr. office for an hour.  Little by little she began to perk up and become more alert.  The office provided a snack of V8 fruit juice and dried fruit.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Blood test, Bronchitis, Computerised tomogram, X-ray
Clinical narrative: This spontaneous report as received from a consumer refer to his 78 year old wife without any pertinent medical history or drug reactions/allergies. In 1995 the patient was vaccinated with PNEUMOVAX23 (dose and lot# not reported). Concomitant therapies included LYRICA and LUNESTA. It was reported that in the last 6 months, about in February 2013, the patient had suffered from 2 bouts of bronchial infections. The patient was hospitalized for 3 nights. The patient was treated with unspecified antibiotics. Blood work, x-rays and computed tomography (CT) scan were performed without result. The patient had recovered from the event on 25-AUG-2013. The patient sought medical attention by seeing the physician. Additional information is not expected.
Age: 1.23
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Convulsion, Dermatitis infected, Electroencephalogram, Pyrexia, Rash
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 1 year old female patient. Pertinent medical history, drug reactions/allergies were reported as no. On 01-APR-2010, the patient was vaccinated (route not provided) with VARIVAX (Merck) (lot number 1328Y, expiry date 16-SEP-2011) dose 1. Other suspect therapies included hepatitis A virus vaccine (unspecified) (manufactured by GlaxoSmithKline) and M-M-R II. Concomitant therapies included ACCUNEB and PULMICORT. The patient presented on 12-APR-2010 in the emergency room with seizures (life threatening and medically significant), a 103.5F temperature (life threatening) and a rash that was documented as varicella (life threatening). The nurse practitioner stated that the patient continued to have a persistent rash on her face, hands and on the side of her body (life threatening). The nurse practitioner stated that the patient received an unspecified treatment for this rash, which goes away and later comes back. The nurse practitioner stated that the rash was now getting infected (life threatening) and she was not sure if this rash was shingles (life threatening). The patient was treated with TYLENOL, MOTRIN and OMNICEF. A EEG was performed on an unknown date but no results were reported. The outcome of the rash is now getting infected, not sure if this rash is shingles, patient continues to have a persistent rash on her face, hands and on the side of her body, rash that was documented as varicella, a 103.5F temperature and seizure was reported as not recovered/not resolved. The event seizures was assessed to be medically significant upon internal review. Additional information has been requested.
Age: 1.23
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 1 year old female patient. Pertinent medical history, drug reactions/allergies were reported as no. On 01-APR-2010, the patient was vaccinated (route not provided) with VARIVAX (Merck) (lot number 1328Y, expiry date 16-SEP-2011) dose 1. Other suspect therapies included hepatitis A virus vaccine (unspecified) (manufactured by GlaxoSmithKline) and M-M-R II. Concomitant therapies included ACCUNEB and PULMICORT. The patient presented on 12-APR-2010 in the emergency room with seizures (life threatening and medically significant), a 103.5F temperature (life threatening) and a rash that was documented as varicella (life threatening). The nurse practitioner stated that the patient continued to have a persistent rash on her face, hands and on the side of her body (life threatening). The nurse practitioner stated that the patient received an unspecified treatment for this rash, which goes away and later comes back. The nurse practitioner stated that the rash was now getting infected (life threatening) and she was not sure if this rash was shingles (life threatening). The patient was treated with TYLENOL, MOTRIN and OMNICEF. A EEG was performed on an unknown date but no results were reported. The outcome of the rash is now getting infected, not sure if this rash is shingles, patient continues to have a persistent rash on her face, hands and on the side of her body, rash that was documented as varicella, a 103.5F temperature and seizure was reported as not recovered/not resolved. The event seizures was assessed to be medically significant upon internal review. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an 11 year old male consumer. On an unspecified date, the patient was vaccinated with the first dose of VARIVAX (Merck) (lot#, dose and route was not reported). On 23-AUG-2013, the patient was vaccinated with the second dose of VARIVAX (Merck) (lot# G007580, dose and route was not reported) which was expired on 04-AUG-2013. No adverse effect was reported. It was unspecified if the patient seek medical attention. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 4 years old patient. On an unknown date the patient was vaccinated with a dose of PROQUAD (Merck) (lot #, dose number were not provided), 0.5 ml, intramuscular. The licensed practical nurse stated that she had a patient who received a dose of PROQUAD (Merck) and came in with injection site reactions that were red and swollen. The outcome of the event is unknown. No lab diagnostics studies were performed. The patient sought medical attention by office visit. This is one of several reports received from the same source. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse refers to an approximately 2 year old female patient. On an unknown date in 2005, the patient was vaccinated with dose 1 of VARIVAX (Merck) (lot#, expiry not reported). On an unknown date in 2006, the patient developed shingles. Patient sought medical attention(saw the doctor). The patient received the second dose of VARIVAX (Merck) (lot#, expiry not reported) in July 2009. The outcome of shingles was reported as recovered. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 4 years old patient. On an unknown date the patient was vaccinated with a dose of PROQUAD (Merck) (lot#, dose number were not provided), 0.5 ml, intramuscular. The licensed practical nurse stated that she had a patient who received a dose of PROQUAD (Merck) and came in with injection site reactions that were red and swollen. The outcome of the event is unknown. No lab diagnostics studies were performed. The patient sought medical attention by office visit. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacy doctor refers to 4 patients of unknown demographics. Approximately on an unknown date in 2013 (reported as within the past 2 weeks) 4 patients were vaccinated with ZOSTAVAX (lot #, expiration date and route not reported) that was stored in a freezer which was not temperature monitored at any time. No adverse effect reported. Additional information has been requested. This is a corrected report. The encoding of "administered ZOSTAVAX stored in a freezer which was not temperature monitored at any time" was changed from "Circumstance or information capable of leading to medication error" to "incorrect storage of drug".
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Human papilloma virus test positive, Smear cervix abnormal
Clinical narrative: This spontaneous report was received from a physician concerning an approximately 21 year old female patient with no pertinent medical history and no drug reactions or allergies. On unknown dates in 2003, the patient was vaccinated with GARDASIL series (lot number, expiry date, dose and route unspecified). Concomitant therapy included BEYAZ. On an unknown date in August 2012, the patient had a Pap test result that showed ASCUS (Atypical squamous cells of undetermined significance). On 20-AUG-2013, the patient had a Pap test result that showed LGSIL (Low grade squamous intraepithelial lesion), and positive for high risk HPV. The patient sought medical attention (office visit). No treatment was given. The patient was not recovered from the adverse events. The relatedness for the adverse events was unknown for GARDASIL. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of drug administration, Sinusitis
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 54 year old female patient. On 15-AUG-2013 the patient was vaccinated with M-M-R II (lot number, dose, site, indication unspecified) by the intramuscular route. "Now" on 23-AUG-2013, the patient felt like she was getting a sinus infection. The outcome of sinus infection was reported as not recovered/not resolved. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Chills, Myalgia, Pyrexia, Rash
Clinical narrative: This spontaneous report as received from a physician via the Company representative refers to a male patient of unknown age. On an unknown date the patient was vaccinated intramuscularly with PNEUMOVAX23 (dose, lot number and expiration date were not reported). On an unknown date the patient experienced chills, arthralgia, myalgia, rash and fever. The physician reported that on an unknown date the patient recovered from adverse events. The relatedness between chills, arthralgia, myalgia, rash, fever and the vaccination with PNEUMOVAX23 was not reported. Additional information is not expected.
Age: 72.0
Sex: F
Vaccine: RAB
Symptoms: Induration, Injection site erythema, Injection site swelling
Clinical narrative: Pt states day after noticed large red swollen area at site of injection - lasted 4 days. No systemic symptoms. Induration the size of medium tomato.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Migraine, Vomiting
Clinical narrative: This spontaneous report as received from a nurse refers to a 15 year old female patient with no pertinent medical history or drug reactions/allergies. On 16-JUL-2013 the patient was vaccinated with a dose of GARDASIL, 0.5 ml, intramuscularly, lot # not reported. There was no concomitant medication. On 16-JUL-2013, immediately after vaccination, the patient experienced debilitating migraine and vomiting, that lasted for 3 days. There were no lab studies performed. The patient's mother sought medical attention by contacting physician's office. The outcome of debilitating migraine and vomiting was reported as recovered/resolved on approximately 18-JUL-2013, reported as 3 days after she received vaccine. The relatedness between GARDASIL and adverse events was unknown. Upon reporter's assessment the debilitating migraine and vomiting were considered to be disabling. Additional information has been requested.
Age: 0.64
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13
Symptoms: Death, Feeling hot
Clinical narrative: Felt hot but no temp. taken. Died in sleep.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Malaise
Clinical narrative: Headache, extreme malaise, chills throughout night and into following day; still experiencing continued adverse effects. Treated with fluids, rest, and ibuprofen.
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Alopecia
Clinical narrative: Extreme, aggressive hair thinning to baldness.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: Developed Guillain Barre Syndrome.
Age: 53.0
Sex: F
Vaccine: HEP, PPV
Symptoms: Activities of daily living impaired, Chills, Headache, Palpitations
Clinical narrative: I WAS HIGH FEVER, PALPITATIONS, CHILL, HEAD PAIN.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: Patient reported a large local reaction at injection site.  Approx. 5 inches x 2 inches.  Red, raised, achy, itchy.  Lasted 5-7 days duration.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blood test, Dermatitis diaper, Rash generalised
Clinical narrative: Rash started developing on stomach. With 3 days sever rash from head to toe. Diaper rash also spread up stomach and back.  Was hospitalized for 5 nights.
Age: 13.0
Sex: F
Vaccine: HPVX
Symptoms: Chills, Conjunctivitis infective, Cough, Labyrinthitis, Pain
Clinical narrative: High fever, aches, chills led to inner ear infection and pink eye. Upper respiratory problems...bad cough.  This has been ongoing now for two weeks.  Vision changes on 8/21/2013 lasted a few hours.
Age: 13.0
Sex: F
Vaccine: HPVX
Symptoms: Pyrexia, Respiratory disorder, Visual impairment
Clinical narrative: High fever, aches, chills led to inner ear infection and pink eye. Upper respiratory problems...bad cough.  This has been ongoing now for two weeks.  Vision changes on 8/21/2013 lasted a few hours.
Age: 55.0
Sex: M
Vaccine: DTAP
Symptoms: Cyanosis, Erythema, Pain, Skin discolouration
Clinical narrative: Since the vaccine was given, pain, redness continued for 1-2 week. Gradually redness gone, but still intermittent pain - it's been 20 days and still have slight black and blue and period pain feeling.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Feeling hot, Local swelling
Clinical narrative: Local redness warmth, swelling. Also intense burning bottom soles of feet.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Contusion, Erythema, Induration
Clinical narrative: Erythema, induration, bruising of deltoid muscle.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Blister, Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Redness, swelling and warmth to site.  Child reports fluid filled blisters and pain.
Age: 21.0
Sex: F
Vaccine: HPV4, IPV, VARCEL
Symptoms: Pruritus, Rash
Clinical narrative: RIGTH ARM ITCHING AND BUMPS POST RECEIVING IMMUNIZATION. Benadryl IM GIVEN.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Arthralgia, Asthenia, Back pain, Dizziness
Clinical narrative: The next morning after the second Gardasil shot she felt extremely weak, faint feeling, dizzy, lightheaded, pain in back of neck, headache, complained of tingling in arms and legs, pale lips and face. Complained of joint pain (knees, elbows, and lower back pain. Felt this way entire day with some slight improvement as day went on. The next day 8/30/13 (today) felt the same way as the day before. Extremely tired, fatigued, lower back pain, tingling and weakness in arms and legs, still complaining of joint pain (elbows, knees and ankles) also headache. Took her to see Dr., he would not agree that the Gardasil was the cause. However, All this happened after her 2nd shot.  She is still at this moment very weak. She has missed 2 days of school due to this. Wanted to report this because I feel strongly that the Gardasil shot is the cause behind these symptoms.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Headache, Muscular weakness, Neck pain, Pallor
Clinical narrative: The next morning after the second Gardasil shot she felt extremely weak, faint feeling, dizzy, lightheaded, pain in back of neck, headache, complained of tingling in arms and legs, pale lips and face. Complained of joint pain (knees, elbows, and lower back pain. Felt this way entire day with some slight improvement as day went on. The next day 8/30/13 (today) felt the same way as the day before. Extremely tired, fatigued, lower back pain, tingling and weakness in arms and legs, still complaining of joint pain (elbows, knees and ankles) also headache. Took her to see Dr., he would not agree that the Gardasil was the cause. However, All this happened after her 2nd shot.  She is still at this moment very weak. She has missed 2 days of school due to this. Wanted to report this because I feel strongly that the Gardasil shot is the cause behind these symptoms.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia
Clinical narrative: The next morning after the second Gardasil shot she felt extremely weak, faint feeling, dizzy, lightheaded, pain in back of neck, headache, complained of tingling in arms and legs, pale lips and face. Complained of joint pain (knees, elbows, and lower back pain. Felt this way entire day with some slight improvement as day went on. The next day 8/30/13 (today) felt the same way as the day before. Extremely tired, fatigued, lower back pain, tingling and weakness in arms and legs, still complaining of joint pain (elbows, knees and ankles) also headache. Took her to see Dr., he would not agree that the Gardasil was the cause. However, All this happened after her 2nd shot.  She is still at this moment very weak. She has missed 2 days of school due to this. Wanted to report this because I feel strongly that the Gardasil shot is the cause behind these symptoms.
Age: 48.0
Sex: F
Vaccine: TD
Symptoms: Diarrhoea, Fatigue, Headache, Nausea, Pain
Clinical narrative: Headache - Nausea - Tiredness (acute) - Body Aches - Diarrhea. Lasted throughout the morning and afternoon.
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Moderate to severe ache/pain at the site of administration (deltoid) and extending down to the elbow.  Aches constantly and more severely to the touch.  Cannot lift arm presently.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient reports itching at site of injection during the night of 8/26/26. Woke up at 6 a.m. on 8/27/13 and noted site of injection down to elbow as red, hot, swollen, burning.  Saw school nurse 8/27/2013. Has been using hydrocortisone cream patient has not seen Dr. Says since using cream that swelling has decreased some.
Age: 60.0
Sex: M
Vaccine: FLUX
Symptoms: Abdominal pain, Abdominal pain lower, Back pain, Chest pain, Discomfort
Clinical narrative: Severe lower abdomen cramping/pain with no vomiting or diarrhea, decreasing discomfort by Wednesday. Then light headiness through the night. On Thurs, lower back pain in the morning, then chest pain towards the end of day through Friday morning. Symptoms have subsided by Friday afternoon.
Age: 60.0
Sex: M
Vaccine: FLUX
Symptoms: Dizziness
Clinical narrative: Severe lower abdomen cramping/pain with no vomiting or diarrhea, decreasing discomfort by Wednesday. Then light headiness through the night. On Thurs, lower back pain in the morning, then chest pain towards the end of day through Friday morning. Symptoms have subsided by Friday afternoon.
Age: 15.0
Sex: M
Vaccine: HEPA
Symptoms: C-reactive protein increased, Culture wound, Debridement, Full blood count, Nuclear magnetic resonance imaging
Clinical narrative: 15 y.o. male seen 7.29.13 at PCP office for well exam, given Hep A vaccine left arm. Reported fever x 2 days and pain in left arm. Seen at PCP's office 8/5/13 for c/o symptoms evaluated and referred to hospital.
Age: 15.0
Sex: M
Vaccine: HEPA
Symptoms: Pain in extremity, Pyrexia, White blood cell count increased, X-ray
Clinical narrative: 15 y.o. male seen 7.29.13 at PCP office for well exam, given Hep A vaccine left arm. Reported fever x 2 days and pain in left arm. Seen at PCP's office 8/5/13 for c/o symptoms evaluated and referred to hospital.
Age: 18.0
Sex: F
Vaccine: MEN
Symptoms: Injection site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Increased redness swelling and warmth to area of vaccine administered on 8/20/13 requiring evaluation. Treated with Medrol dose pak.
Age: 16.0
Sex: M
Vaccine: HPV4, VARCEL
Symptoms: Erythema, Hypoaesthesia, Induration, Injection site erythema, Injection site pain
Clinical narrative: Redness, warmth, and pain to the left upper arm (outer). Numbness kicked in on 08/30/2013 in the morning hours. Redness and bump noted. Induration and redness was 3 centimeters in diameter.
Age: 16.0
Sex: M
Vaccine: HPV4, VARCEL
Symptoms: Injection site warmth, Swelling
Clinical narrative: Redness, warmth, and pain to the left upper arm (outer). Numbness kicked in on 08/30/2013 in the morning hours. Redness and bump noted. Induration and redness was 3 centimeters in diameter.
Age: 1.01
Sex: F
Vaccine: FLU3, HEPA, PNC, VARCEL
Symptoms: Arthropod bite
Clinical narrative: Reported "bug bites" to her left mid-axillary chest. The next day reported more bug bites in the same area. Looked like a line of bites. I became suspicious of shingles. The next day she complained that her shirt hurt her bug bites when it touched them. I called the doctor and scheduled an office visit.
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Body temperature increased, Headache, Injection site erythema, Injection site pruritus, Injection site vesicles
Clinical narrative: REDNESS, ITCHY, AND BLISTERS AROUND INJECTION SITE. THEN DEVELOPED HEADACHE, NAUSEA, AND TEMP OF 99.8.
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Nausea
Clinical narrative: REDNESS, ITCHY, AND BLISTERS AROUND INJECTION SITE. THEN DEVELOPED HEADACHE, NAUSEA, AND TEMP OF 99.8.
Age: 8.0
Sex: M
Vaccine: FLU3, HEPA, FLU3, HEPA
Symptoms: Syncope
Clinical narrative: Patient fainted.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Patient came to pharmacy and asked if the rash/redness around the area of her Zostavax injection site was normal.  She did not express she was in any pain or needed medical help.  We explained she is most likely have an injection site reaction and if further symptoms occur to notify her physician and keep us updated on how she is doing.
Age: 42.0
Sex: M
Vaccine: TDAP
Symptoms: Local swelling, Swelling, Tenderness
Clinical narrative: Relates tenderness in armpit area and swelling.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash erythematous, Rash maculo-papular, Varicella post vaccine
Clinical narrative: Red/pink maculopapular rash on anterior and posterior trunk.  No vesicles noted.  Mild discomfort or itching.  Rash is most prevalent on anterior trunk.  No fever or signs of illness present.  Pt's brother with a few very similar lesions to trunk without any other symptoms.  Varicella vaccine given on 8/13/2013 with other routine immunizations.  Rash is most consistent with varicella.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash erythematous
Clinical narrative: Rash started on wrist and behind neck, was slightly soothed with cold shower and benadryl. But by 1 AM the rash had progressed and covered about 80% of back, continued around stomach, under breasts and arms, and down legs. The rash was red and only raised slightly on stomach.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Nausea, Vomiting
Clinical narrative: Patient called to complain that she was feeling nauseous and had thrown up a little bit. She stated that she stated to feel sick about 30 minutes ago and finally threw up. She wanted to know what to do.  I contacted Sanofi Pasteur for assistance. They recommended asking patient to seek medical attention if symptoms worsen. The patient got in contact with her oncologist and was told that she could have a reaction to the vaccine and to wait 24 hours to see if symptoms improve.  He provided her with his cell phone number if she needed to get in contact with him.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Injection site erythema, Injection site pruritus, Local swelling
Clinical narrative: 8/30/2013 my arm at the injection site was itchy and extremely red. First time I called they said to use warm compress then they called and said to use cold compress and Benadryl. Now arm is swelling so much it looks like I have an extra muscle on my arm. It has small blisters in the area as well. The dimensions are 5 in. By 3 in.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Cellulitis, Erythema, Induration, Skin warm
Clinical narrative: Redness, warmth, induration, left thigh, 10 cm x 8 cm. Treated with cephalexin for suspected cellulitis.
Sex: F
Vaccine: HPV4
Symptoms: Death
Clinical narrative: This spontaneous report as received from a health care worker refers to a female patient of unknown age. On 22-AUG-2013 the patient was vaccinated with a dose of GARDASIL (dose, route, lot number not provided). On 25-AUG-2013 the patient was found dead in her dorm room. The cause of dead had not been specified. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. The patient was administered her first dose of GARDASIL (lot# unspecified) 2 years ago in approximately 2011, and the patient had came into the office on 28-AUG-2013 to receive her second dose of GARDASIL (lot# unspecified). No adverse effects reported. The outcome of the event was unknown. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: This spontaneous report as received from an other health professional refers to an unspecified number of patients, age and gender were not reported. On an unknown date the patients were vaccinated with GARDASIL via the intramuscular route in the gluteal region. Dose, strength, dose number, lot number and expiration date were not reported. On an unknown date GARDASIL was possibly administered as a subcutaneous injection. Dose, strength, dose number, lot number and expiration date were not reported. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. On 22-AUG-2013 the patient was vaccinated with expired dose of GARDASIL (lot # unspecified, expiration 13-AUG-2013), injection. It was unspecified whether the patient had any adverse reactions to the expired dose being administered. Additional information has been requested.