chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Arm began to hurt Thursday, 5 pm. Then, got fever and body aches. All night Thursday and through Friday had headache. Missed work Friday. Still have sore arm Sunday. It has a knot at injection site and is not to touch.
Age: 39.0
Sex: F
Vaccine: MMR
Symptoms: Asthma, Condition aggravated, Fatigue, Pruritus, Rash
Clinical narrative: It started with 3 small, bright red bumps on my inner right ankle which looked more like mosquito bites.  It was the tiny bright, raised bump on my left leg that appeared the next day that alarmed me.  A bright red "patch" then surrounded that bump the following day.  Other small bumps appeared on my legs 5/28 and then left arm 5/29.  On 5/30 I had bumps and really bad, itchy hives on both arms upon exiting the shower.  I called my job who told me to return to office to be checked out.  No bumps appeared on my trunk until 6/2 when a small, bright red bump unaccompanied by rash appeared on the right, lower, outside edge of my breast.  I have had no fever this entire time.  I have experienced fatigue.  I have had one episode of wheezing that I was unable to distinguish from the ongoing asthma attack I was already experiencing at the onset of symptoms.
Age: 39.0
Sex: F
Vaccine: MMR
Symptoms: Rash erythematous, Urticaria, Viral titre, Wheezing
Clinical narrative: It started with 3 small, bright red bumps on my inner right ankle which looked more like mosquito bites.  It was the tiny bright, raised bump on my left leg that appeared the next day that alarmed me.  A bright red "patch" then surrounded that bump the following day.  Other small bumps appeared on my legs 5/28 and then left arm 5/29.  On 5/30 I had bumps and really bad, itchy hives on both arms upon exiting the shower.  I called my job who told me to return to office to be checked out.  No bumps appeared on my trunk until 6/2 when a small, bright red bump unaccompanied by rash appeared on the right, lower, outside edge of my breast.  I have had no fever this entire time.  I have experienced fatigue.  I have had one episode of wheezing that I was unable to distinguish from the ongoing asthma attack I was already experiencing at the onset of symptoms.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Patient returned to our pharmacy 6-13-15 stating her arms was red swollen and was sore. She asked if BENADRYL would help and she was going to try that. Her arm was consistent with normal side effects to a ZOSTAVAX shot but  insisted report filed.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored (Oka/Merck) PROQUAD (lot # K008185, expiry date: 05-DEC-2015, dose and route unknown). The temperature excursion for (Oka/Merck) PROQUAD was supported with in-house stability date. No adverse symptoms were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: Information has been received from a physician referring to an 18.5 old male patient. The patient's medical history, concurrent condition and concomitant therapy were not provided. On an unknown date the patient was vaccinated with RECOMBIVAX HB (lot #, expiration date, dose and route not provided). On an unknown date the patient with completed primary Hep B series required quantitative Hep B immunity which was 6 (unit not provided), the physician gave adult dose as a booster. The outcome of "hepatitis b surface antibody negative" was unknown. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a physician referring to a 66 years old female patient. The patient's medical history included pain management unspecified and other unspecified medical history. The patient had drug allergy to hydrocodone and TYLENOL. On 09-JUN-2015 the patient was vaccinated with PNEUMOVAX23 injection (lot # K020215, exp 15-MAY-2016) 0.5 ml, intramuscularly in the left shoulder. Concomitant therapies included tramadol hydrochloride, FLEXERIL, simvastatin(manufacturer unknown) and hydrochlorothiazide/lisinopril. The physician reported with adverse event: Patient came into the office today(10-JUN-2015) with a left arm reaction by 4 by 8 inch induration and swelling that went down into the left biceps area and wraps around in that direction. The site was hot to the touch too. Physician stated he thinks it was a cellulitis-like reaction, and normally his patients did not experience such an significant adverse event such as this one. Physician stated he had not yet determined what treatment he would initiate (no treatment given to the patient). No lab was performed. The outcome was reported as not recovered/not resolved. No product quality issue(PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates these patients were vaccinated with ROTATEQ (lot#, expiration date and dose not reported), orally. No adverse events were reported. This is one of several reports received from the same reporter. Additional information is not expected since the reporter did not want to be contacted.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site discolouration, Injection site inflammation, Injection site pain
Clinical narrative: Large blackened patch like inflammed skin surrounding injection site with tenderness and pain even after 2 weeks of immunization, which developed couple of days after vaccination.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates these patients were vaccinated with improperly stored doses of GARDASIL (lot #, expiration date, dose and route not reported) (incorrect product storage). No adverse events were reported. This is one of several reports received from the same reporter. Additional information is not expected since the reporter did not want to be contacted.
Age: 28.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a physician referring to a currently 28 years old male patient. The patient had no medical history or drug reactions/allergies. On an unknown date the patient was vaccinated with a dose of RECOMBIVAX HB (strength: 2.5 MCG/0.5ML; dose, frequency and lot# were not reported) as a child (vaccine underdose). There was no concomitant therapy. In 2015(reported as "now") the patient experienced low antibodies titer for Hepatitis B. The patient sought medical attention via seeing physician. On an unknown date, blood test was performed which showed low antibodies. The outcome of low antibodies titer for Hepatitis B was reported as not recovereInformation has been received from a physician referring to a currently 28 years old male patient. The patient had no medical history or drug reactions/allergies. On an unknown date the patient was vaccinated with a dose of RECOMBIVAX HB (strength: 2.5 MCG/0.5ML; dose, frequency and lot# were not reported) as a child (vaccine underdose). There was no concomitant therapy. In 2015(reported as "now") the patient experienced low antibodies titer for Hepatitis B. The patient sought medical attention via seeing physician. On an unknown date, blood test was performed which showed low antibodies. The outcome of low antibodies titer for Hepatitis B was reported as not recovered/not resolved. Causality was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored ZOSTAVAX (lot # L003218, expiry date: 30-APR-2016, dose and route unknown). The temperature excursion for ZOSTAVAX was supported with in-house stability data. No adverse symptoms were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored VARIVAX (Merck) (lot # K002916, expiry date: 26-FEB-2016, dose and route unknown). The temperature excursion for VARIVAX (Merck) was supported with in-house stability data. No adverse symptoms were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: DTAP, HEPA, MMR, PNC13, VARCEL
Symptoms: Cough, Pyrexia, Respiratory tract congestion
Clinical narrative: Temp of 104.2 degrees F 24 hours after vaccines were given. Had cough and congestion 3 days before vaccines. Fever resolved in 24 hrs.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 9mm radius swelling around injection site. Recommend-Take BENADRYL.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling
Clinical narrative: 9mm radius swelling around injection site. Recommend-Take BENADRYL.
Age: 5.0
Sex: M
Vaccine: MMRV, MMRV
Symptoms: Erythema, Pain
Clinical narrative: 18 hours after vaccination: 2.5" diameter irregularly shaped pink irritated area, inflammation of entire thigh area, 2" diameter yellow colored and rough patch in center of irritated area, inflammation centered on injection site.  Accompanied by pain, but no fever.  36 Hours after injection: The pink area has grown to ~5" diameter. Still irregular.  Still very swollen upper thigh, hard to the touch. Davin reports it is very painful.  The 2" diameter rough yellow patch did not spread, but has formed pustules filled with yellow clear fluid.  Most pustules are 2-3mm in diameter, but the largest are 10-20mm in diamter and raised 5-10mm.  The blisters are bursting and the affected area is bandaged.
Age: 5.0
Sex: M
Vaccine: MMRV, MMRV
Symptoms: Blister, Injection site erythema, Injection site induration, Injection site inflammation, Injection site irritation
Clinical narrative: 18 hours after vaccination: 2.5" diameter irregularly shaped pink irritated area, inflammation of entire thigh area, 2" diameter yellow colored and rough patch in center of irritated area, inflammation centered on injection site.  Accompanied by pain, but no fever.  36 Hours after injection: The pink area has grown to ~5" diameter. Still irregular.  Still very swollen upper thigh, hard to the touch. Davin reports it is very painful.  The 2" diameter rough yellow patch did not spread, but has formed pustules filled with yellow clear fluid.  Most pustules are 2-3mm in diameter, but the largest are 10-20mm in diamter and raised 5-10mm.  The blisters are bursting and the affected area is bandaged.
Age: 5.0
Sex: M
Vaccine: MMRV, MMRV
Symptoms: Injection site swelling, Rash pustular
Clinical narrative: 18 hours after vaccination: 2.5" diameter irregularly shaped pink irritated area, inflammation of entire thigh area, 2" diameter yellow colored and rough patch in center of irritated area, inflammation centered on injection site.  Accompanied by pain, but no fever.  36 Hours after injection: The pink area has grown to ~5" diameter. Still irregular.  Still very swollen upper thigh, hard to the touch. Davin reports it is very painful.  The 2" diameter rough yellow patch did not spread, but has formed pustules filled with yellow clear fluid.  Most pustules are 2-3mm in diameter, but the largest are 10-20mm in diamter and raised 5-10mm.  The blisters are bursting and the affected area is bandaged.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Painful injection - quadrivalent vaccine. Upper right arm pain with persistent throbbing ache now for 6 months+, difficulty raising arm without pain.
Age: 1.26
Sex: M
Vaccine: DTAPH
Symptoms: Bronchitis, Cough, Fatigue, Insomnia, Irritability
Clinical narrative: Began with fussiness and fever of 101.5; fever evolved to 102 by Thursday.  Has been fussy and continues to have fever (101.9)--today is Sunday, more than 96 hours after. Fever is resistant to ibuprofen. Drops a degree only to rise back to 102 within 2 hours. Placed call to ped on 6/11.  Coughing and runny nose began on Friday.  Coughing is preventing sleep and sounds like a seal barking.  Took to hospital ER at 11 PM on 6/13.  They noted fever and diagnosed bronchitis.  Took a 7 hour nap today and then went back to bed--excessive tiredness.  He showed no sign of illness before the shot.  There are 2 adults and 3 other children in the house, all healthy.
Age: 1.26
Sex: M
Vaccine: DTAPH
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: Began with fussiness and fever of 101.5; fever evolved to 102 by Thursday.  Has been fussy and continues to have fever (101.9)--today is Sunday, more than 96 hours after. Fever is resistant to ibuprofen. Drops a degree only to rise back to 102 within 2 hours. Placed call to ped on 6/11.  Coughing and runny nose began on Friday.  Coughing is preventing sleep and sounds like a seal barking.  Took to hospital ER at 11 PM on 6/13.  They noted fever and diagnosed bronchitis.  Took a 7 hour nap today and then went back to bed--excessive tiredness.  He showed no sign of illness before the shot.  There are 2 adults and 3 other children in the house, all healthy.
Age: 57.0
Sex: M
Vaccine: PNC13
Symptoms: Inflammation, Injection site pain, Joint swelling, Myalgia, Peripheral swelling
Clinical narrative: Day 1, pain in left deltoid, left elbow and left shoulder, multiple myalgias and inflammation. Day 2, increased arthritic symptoms and myalgias in left arm, wrist, hand, neck. Day 3, increased arthritic symptoms and multiple myalgias throughout both arms and upper torso. Day 4, continued spread of symptoms to entire upper body and hips. Day 5, continued spread to legs and knees. Visibly swollen fingers and knees. On day 2-3, visited physician for evaluation. Instituted 3gm acetaminophen/day. Symptoms continued to worsen and spread through day 7, then began to subside by day 10, and had resolved by day 14. * The underlying auto-immune disease had be well controlled and an event of this magnitude had not been experienced for at least 10-15 years.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Blood pressure increased, Dizziness, Pain, Pyrexia
Clinical narrative: BP 193/90, fever, body aches, dizziness.
Age: 51.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Musculoskeletal pain, Nerve injury
Clinical narrative: Patient states that she has had nerve damage/constant pain in her shoulder the past 6 months. The patient claims the flu shot back in October 2014 caused this.
Age: 51.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Bursitis, Neck pain, Nuclear magnetic resonance imaging abnormal, Pain in extremity, Paraesthesia
Clinical narrative: Patient states that she has had nerve damage/constant pain in her shoulder the past 6 months. The patient claims the flu shot back in October 2014 caused this.
Age: 51.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: X-ray limb
Clinical narrative: Patient states that she has had nerve damage/constant pain in her shoulder the past 6 months. The patient claims the flu shot back in October 2014 caused this.
Age: 22.0
Sex: F
Vaccine: TYP
Symptoms: Pain, Pain in extremity
Clinical narrative: (L) arm extremely sore & hurts to move. No redness, no swelling, no rash no numbness or tingling. Referred pt to follow-up with physician.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Anxiety, Dyspnoea, Heart rate increased, Palpitations, Throat irritation
Clinical narrative: Information has been received from a nurse practitioner via a company representative concerning a 15 year old male patient. The patient had no medical history and no drug reactions/allergies. On 09-JUN-2015 the patient was vaccinated with his first dose of GARDASIL (dose and lot # were not reported, intramuscular). On 09-JUN-2015, a few minutes after receiving the injection, the patient experienced an itching in his throat, anxiety, and difficulty breathing. The nurse practitioner administered oxygen to the patient and took his vital signs which were normal, except his heart was racing, but his oxygen level was fine. The patient, accompanied by his mother, went to the emergency room where he was not admitted, but treated with oral BENADRYL and his symptoms were improved. The patient would be following up with an allergist. The reporter considered the events to be medical significant. Additional information has been requested.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to three patients of unknown age and gender. Patients' medical history and concurrent conditions were not reported. On 15-MAY-2015, first patient was vaccinated with a dose of improperly stored (Merck) VARIVAX (lot number, dose and route were not reported) and a dose of improperly stored M-M-R II (lot number, dose and route were not reported). On 20-MAY-2015, second patient was vaccinated with a dose of improperly stored (Merck) VARIVAX (lot number, dose and route were not reported) and a dose of improperly stored M-M-R II (lot number, dose and route were not reported). On 28-MAY-2015, third patient was vaccinated with a dose of improperly stored (Merck) VARIVAX (lot number, dose and route were not reported0 and a dose of improperly stored M-M-R II (lot number, dose and route were not reported. Concomitant medications were not reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to unspecified number of patients of unknown age and gender. On unknown dates, multiple patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (dose, route and lot # not provided). No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to unspecified number of patients of unknown age and gender. No medical histories, current conditions and concomitant therapies were reported for them. On an unknown date, the patients were vaccinated with doses of improperly stored (Merck) VARIVAX lot # K015946, expiration date 23-SEP-2016, dose 0.5 ml, subcutaneously. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patients of unknown age and gender. On an unknown date the patients were vaccinated with doses of VARIVAX (Merck) (dose, frequency, route of administration and indication were not reported), which were exposed to temperatures outside of the recommended range. No adverse effect had been reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patients of unknown age and gender. On an unknown date the patients were vaccinated with doses of PROQUAD (Merck) (dose, frequency, route of administration and indication were not reported),  which were exposed to temperatures outside of the recommended range. No adverse effect had been reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Antibody test negative, Chemotherapy, Leukaemia, Measles antibody negative, Mumps antibody test negative
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a currently 16 year old male patient. The patient had no pertinent medical history and had an unspecified reaction to BACTRIM. On an unknown date, reported as "as a child", the patient was vaccinated with M-M-R II (dose, frequency, route of administration, lot# and expiration date not reported) and VARIVAX (Merck) (dose, frequency, route of administration, lot# and expiration date not reported). No information about concomitant medication was provided. The patient developed leukemia (date not specified). As a treatment, patient received chemotherapy. On an unknown date in 2015, also reported as "now when the patient was 16 year old", titers showed no immunity for varicella, measles, mumps and rubella due to the chemotherapy. As a result, the patient was administered PROQUAD (Merck) (reported in MARRS# 1506USA005942). The outcome of events was reported as not recovered/not resolved. The patient sought medical attention, he saw physician. No relatedness between M-M-R II and VARIVAX (Merck) and adverse events was reported. Leukemia was considered by reporter to be serious due to cancer. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rubella antibody negative
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a currently 16 year old male patient. The patient had no pertinent medical history and had an unspecified reaction to BACTRIM. On an unknown date, reported as "as a child", the patient was vaccinated with M-M-R II (dose, frequency, route of administration, lot# and expiration date not reported) and VARIVAX (Merck) (dose, frequency, route of administration, lot# and expiration date not reported). No information about concomitant medication was provided. The patient developed leukemia (date not specified). As a treatment, patient received chemotherapy. On an unknown date in 2015, also reported as "now when the patient was 16 year old", titers showed no immunity for varicella, measles, mumps and rubella due to the chemotherapy. As a result, the patient was administered PROQUAD (Merck) (reported in MARRS# 1506USA005942). The outcome of events was reported as not recovered/not resolved. The patient sought medical attention, he saw physician. No relatedness between M-M-R II and VARIVAX (Merck) and adverse events was reported. Leukemia was considered by reporter to be serious due to cancer. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a currently 16 year old male patient with leukemia. No information about concomitant medication was reported. The patient had no pertinent medical history and had an unspecified reaction to BACTRIM. As a child the patient received M-M-R II (dose, frequency, route of administration, lot# and expiration date not reported) and VARIVAX (Merck) (dose, frequency, route of administration, lot# and expiration date not reported). The patient also received chemotherapy as a treatment for leukemia (reported in MARRS# 1506USA006558). On an unknown date in 2015 (when the patient was 16 year old), the patient was administered PROQUAD (Merck) lot # K001853 (dose, frequency, route of administration, expiration date not reported) as a result of titers showing no immunity for varicella, MMR due to the chemotherpay (reported in MARRS# 1506USA006558). No information about concomitant medication was reported. The patient sought medical attention, he saw physician. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 30-DEC-2014, the patient was vaccinated with the first dose of RECOMBIVAX HB, (dose, route of administration, injection site, lot number and expiration date were not reported). It was also reported that two consecutive doses of RECOMBIVAX HB, (dose, route, of administration, injection site, lot number and expiration date were not provided) were administered on 24-MAR-2015 and 18-MAY-2015, respectively which was outside the recommended dosing schedule. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. Information about concurrent conditions and medical history was not provided. The patient received the 3 doses of GARDASIL series on unspecified dates. On 10-JUN-2015 the patient was vaccinated with the fourth dose of GARDASIL (strength, dose, frequency, route and lot# not provided) (extra dose administered). No adverse effects reported. The outcome of the events was not provided. Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from an 84 year old female patient referring to herself. The patient was allergic to penicillin. No pertinent or historical conditions were reported. On an unknown date (reporter as a few years ago), the patient was vaccinated with ZOSTAVAX, one shot, (lot#, strength and route unknown). Unspecified concomitant medication was reported. On an unknown date in about "a year and a half" later, the patient got a small case of the shingles on her head, lasting a few weeks (2-3 weeks). The patient sought medical attention and was given unspecified treatment. Additional information is not expected since no reporter contact information available.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Dizziness, Laboratory test normal, Limb discomfort, Neurological examination normal
Clinical narrative: Information has been received from a physician assistant referring to a 21 year old female patient with cinnamon bark allergy. The patient had no pertinent medical history. On 21-AUG-2014 the patient was vaccinated with the first dose of GARDASIL (0.5ml, lot# and expiration date were not provided) intramuscularly. The third dose of GARDASIL (0.5ml, lot# K011492, expiration date 22-JUN-2016) was received on 05-MAR-2015, which was confirmed not GARDASIL 9. There was no concomitant medication. On 06-MAR-2015, the patient experienced palpitations, light-headedness, upper and lower extremity heaviness, weakness, and paresthesia. Neurological exam on an unknown date in 2015 was normal and unspecified laboratory testing was normal. The patient was prescribed oral iron and vitamin D supplementation. The paresthesia had resolved on an unknown date in 2015, but other symptoms were ongoing. The patient sought medical attention through office visit. At the time of report, the causality was unknown. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Palpitations, Paraesthesia
Clinical narrative: Information has been received from a physician assistant referring to a 21 year old female patient with cinnamon bark allergy. The patient had no pertinent medical history. On 21-AUG-2014 the patient was vaccinated with the first dose of GARDASIL (0.5ml, lot# and expiration date were not provided) intramuscularly. The third dose of GARDASIL (0.5ml, lot# K011492, expiration date 22-JUN-2016) was received on 05-MAR-2015, which was confirmed not GARDASIL 9. There was no concomitant medication. On 06-MAR-2015, the patient experienced palpitations, light-headedness, upper and lower extremity heaviness, weakness, and paresthesia. Neurological exam on an unknown date in 2015 was normal and unspecified laboratory testing was normal. The patient was prescribed oral iron and vitamin D supplementation. The paresthesia had resolved on an unknown date in 2015, but other symptoms were ongoing. The patient sought medical attention through office visit. At the time of report, the causality was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unknown number of patients of unknown age and gender. On unknown dates the patients were inadvertently vaccinated with GARDASIL (lot#, expiration date, dose and route unspecified), that had been improperly stored. 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 product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unknown number of patients of unknown age and gender. On unknown dates the patients were inadvertently vaccinated with oral ROTATEQ (lot#, expiration date, dose and route unspecified), that had been improperly stored. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 21.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: Information has been received from a registered nurse referring to a 21 year old male patient. There was no information about pertinent medical history or drug reaction/allergies reported. On 09-JUN-2015 the patient was inadvertently administered a 0.5 ml dose of VAQTA (lot# and expiration date were not provided) intramuscularly as his first dose in the series (accidental underdose). No adverse effect was reported. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: VARCEL
Symptoms: Blood test, Exposure during pregnancy, No adverse event
Clinical narrative: Information has been received from a 39 year old female patient who was allergic to vitamin. No other relevant medical history or concurrent conditions were reported. On 17-APR-2015 the patient was vaccinated with (Merck) VARIVAX (lot#, expiration date, dose and route not reported). There was not concomitant medication. The patient reported after receiving the vaccination she found out she was pregnant. The patient's Last Menstrual Period (LMP) was 19-MAY-2015 and Estimated Delivery Date (EDD) was 23-FEB-2016. She sought medical attention by visiting the physician's office. Blood work was performed on an unknown date (result not provided). No treatment was given for the event. No adverse event was reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates these patients were vaccinated with improperly stored RECOMBIVAX HB (lot#, expiration date, dose and route not reported). No adverse events were reported. This is one of several reports received from the same reporter. Additional information is not expected since the reporter did not want to be contacted.
Age: 1.02
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Eating disorder, Full blood count normal, Irritability, Pyrexia
Clinical narrative: Fever 104 with temporal thermometer at home, 101.7 in office, fussy, not eating.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Redness, swelling, warmth measuring 4" long-1 1/2" wide-used ice and BENADRYL prn.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with "few" doses of improperly stored MMR II, lot # K016153, expiration date: 24-SEP-2016, (dose, route and injection site were not reported). No adverse effects were reported. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HEP, MMR, TD, VARCEL
Symptoms: Immediate post-injection reaction, Pallor, Seizure like phenomena, Syncope, Tremor
Clinical narrative: Client stated before injections she was afraid. Immediately after injection client became pale and asked for water. Returning with water. Client appeared to be fainting, then started shaking as if she was having a seizure. Nurse supervisor & charge nurse was called and arrived within 1 minute. Client stated she had never had that reaction before. Given referral to PCP.
Age: 0.21
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: Red flat rash to entire body.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Received Prevnar vaccine one week ago.   On Friday, began to have pain and redness around the injection site.  The pain is getting better, but the area of redness is still increasing. Hasn't taken any pain relievers.  Did use ice on Friday. No systemic symptoms.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Incomplete course of vaccination, Pain
Clinical narrative: This spontaneous report was received from a consumer as part of a Market Research Program refers to one of her daughter's friend a 13 year old female patient. The patient's medical history included lead poisoning as a child. On an unknown date in 2000, the patient was vaccinated with GARDASIL (route and lot# were not reported) dose 1. On an unknown date in 2000, the patient experienced pain lasting a week and the patient was in bed for a week after GARDASIL injection. None of her other friends choose to take GARDASIL because of stated events. Action taken was reported as interrupted as the patient did not receive the second dose. On an unknown date in 2000, the patient recovered. The reporter considered pain to be related to GARDASIL. The reporter considered the seriousness of the event pain lasting a week and the patient in bed for a week to be disability. This is one of the two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with one dose of improperly stored GARDASIL (dose, frequency and indication, lot # K010574 with expiration date: 08-APR-2017). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Incomplete course of vaccination, Pain
Clinical narrative: This spontaneous report was received from a consumer as part of a Market Research program refers to one of her daughter's friend a 13 year old female patient. The patient was reported to be healthy. On an unknown date in 2000, the patient was vaccinated with GARDASIL (route and lot# were not reported) dose 1. On an unknown date in 2000, the patient experienced pain lasting a week and the patient in bed for a week after GARDASIL injection. None of her other friends choose to take GARDASIL because of stated events. Action taken was reported as interrupted as the patient did not receive the second dose. On an unknown date in 2000, the patient recovered. The reporter considered pain to be related to GARDASIL. The reporter considered the seriousness of the event pain lasting a week and the patient in bed for a week to be disabling. This is one of the two reports from the same reporter. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site cellulitis
Clinical narrative: Initial unsolicited report received from a nurse practitioner on 08-Jun-2015. This case is linked to cases: 2015SA081386, 2015SA081404 (same vaccine, same lot number). A 49 years old female patient, had received a dose of ADACEL (Batch number C4712AA, expiry date, route and site of administration was not reported) on 27-May-2015. The pre-existing physician diagnosed allergies, birth defects, medical conditions and illness at the time of vaccination was not reported. The concomitant medications were not provided. On 01-Jun-2015, 5 days post-vaccination, the patient experienced mild injection site reaction (no other symptoms) which was diagnosed with cellulitis. She was treated with MOTRIN. Laboratory investigations were not reported. The patient required ER/doctor visit. The patient had recovered on an unspecified date. Upon medical review, the case was considered as serious due to important medical event. List of documents held by sender: none.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse, refers to an unknown number of patients of unknown age and gender. On an unknown dates, the patients were inadvertently vaccinated with GARDASIL (lot #, expiration date, dose and route were not reported), that had been improperly stored. No adverse effects reported. This is one of several reported received from the same source. Additional information is not expected, because there was no consent to contact a physician.
Sex: M
Vaccine: SMALL
Symptoms: Post vaccination autoinoculation
Clinical narrative: This unsolicited case was received on 05 June 2015 from literature. Abstract: Although naturally occurring smallpox virus was officially declared eradicated in 1980, concern for biological warfare prompted the Government in 2002 to recommend smallpox vaccination for select individuals. Vaccinia, the smallpox vaccine virus, is administered into the skin, typically on the upper arm, where the virus remains viable and infectious until the scab falls off and the epidermis is fully intact - typically 2-4 weeks. Adverse events following smallpox vaccination may occur in the vaccinee, in individuals who have contact with the vaccinee (i.e., secondary transmission), or in individuals who have contact with the vaccinee's contact (i.e., tertiary transmission). In June 2014, two cases of inadvertent inoculation of vaccinia and one case of a non-viral reaction following vaccination occurred. This includes the first reported case of shaving as the likely source of autoinoculation after contact transmission. This paper describes the diagnosis and treatment of these cases, the outbreak investigation, and steps taken to prevent future transmission. A two male patients (age not reported), whose medical history and concomitant medication were not reported, had received a dose of ACAM2000 (lot number: VV04-003-A, manufacturer: Sanofi Pasteur Biologics Co.) on June 2014 (route was not reported). Although the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination. On unspecified date in June 2014 post vaccination, patient experienced inadvertent inoculation of vaccinia. Patient's shaving was likely the source of autoinoculation after contact transmission. Laboratory investigation and corrective treatment were not reported. At the time of this report, outcome of the event was unknown. Upon internal review, the company assessed the event of autoinoculation after contact transmission as serious and medically significant. List of documents held by sender: none.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a three unspecified patients of unknown age and gender. On an unknown date each patient received one dose of improperly stored ROTATEQ (dose, frequency and indication were not reported, route of administration defaulted to oral, lot # reported as K014826 with expiration date: 28-MAY-2016). No adverse effect were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.39
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV1
Symptoms: Immediate post-injection reaction, Injection site urticaria, Urticaria
Clinical narrative: Received 4 month immunizations and immediately developed hives on her thighs, arms and head and rash behind her neck. Spoke with dr and infant given 1/2 tsp. of BENADRYL liquid per his orders. Instructed mother to give infant 1/2 tsp BENADRYL q6 hours per dr prn. Instructed to seek medical attention if respiratory problems occur.
Age: 1.46
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Body temperature increased, Condition aggravated, Febrile convulsion
Clinical narrative: Febrile seizure-temp 101 at time of hospitalization. Mom has a history of febrile seizures.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Redness, induration at injection site.
Age: 20.0
Sex: F
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Gave 2nd Hepatitis A vaccine 3 months too early. No problems noted to patient.
Age: 21.0
Sex: F
Vaccine: UNK
Symptoms: Deafness unilateral, Gait disturbance
Clinical narrative: Could walk on right leg for week felt like I pulled a muscle and can't hear out of right ear.
Age: 1.31
Sex: F
Vaccine: HEPA, HIBV
Symptoms: Injection site bruising, Injection site discolouration, Injection site erythema, Injection site nodule, Injection site reaction
Clinical narrative: Both thighs with large knots where shots given, Minimal warmth, Right knot approx. 1.5 cm and left approx. 1 cm and more raised. Bruised /brown color now, nontender, mom reported peeling of skin after redness of skin went away. Warm compresses and massage.
Age: 1.31
Sex: F
Vaccine: HEPA, HIBV
Symptoms: Injection site warmth, Skin exfoliation
Clinical narrative: Both thighs with large knots where shots given, Minimal warmth, Right knot approx. 1.5 cm and left approx. 1 cm and more raised. Bruised /brown color now, nontender, mom reported peeling of skin after redness of skin went away. Warm compresses and massage.
Age: 10.0
Sex: M
Vaccine: HPV4
Symptoms: Asthenia, Burning sensation, Dysphonia, Injection site pain, Injection site paraesthesia
Clinical narrative: Weakness, hoarseness, painful to take a deep breath, burning and tingling at injection site, muscle aches, burning in toes, fever of unknown orgin.
Age: 10.0
Sex: M
Vaccine: HPV4
Symptoms: Myalgia, Painful respiration, Pyrexia
Clinical narrative: Weakness, hoarseness, painful to take a deep breath, burning and tingling at injection site, muscle aches, burning in toes, fever of unknown orgin.
Age: 30.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site reaction, Rash, Rash papular, Rash pruritic
Clinical narrative: Small papular bumps with itching on both arms at sites of MMR and Varicella vaccines, and across abdomen and back. Treated 6/15/15 with depomedrol injection and prednisone PO.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (dose, route of administration, injection site, lot number and expiration date were not reported). No adverse effects were reported. No product quality complaint (PQC) was involved. Follow up information has been received on 18-MAY-2015 and on 19-MAY-2015 from the reporting medical assistant and the physician, respectively. The physician provided information regarding the patients identifiers, lot number and date of vaccination. It was reported that the patient was vaccinated with an improperly stored dose of VARIVAX (Merck), lot number K015970 on 06-MAR-2015. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of (Merck) VARIVAX, (dose, route of administration, injection site, lot number and expiration date were not reported). No adverse effects were reported. No product quality compliant (PQC) was involved. Follow up information has been received on 18-MAY-2015 and on 19-MAY-2015 form the reporting medical assistant and the physician, respectively. The physician information regarding the patients identifiers, lot number and date vaccination. It was reported that the patient was vaccinated with an improperly stored dose of (Merck) VARIVAX, lot number K015970 on 09-MAR-2015. This is one of several reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a female patient of unknown age. Pertinent medical history or drug allergies/drug reactions were not reported. On an unspecified date in 2008, the patient was vaccinated with the first dose of GARDASIL (dose, strength, anatomical location, lot number and expiration date were not reported). On 03-JUN-2015, a second dose of GARDASIL (dose, strength, anatomical location, lot number and expiration date were not reported) was administered. Concomitant medication was not reported. No adverse event was reported. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HEP, HEPA, TDAP, TYP, YF
Symptoms: Eye swelling, Lymphadenopathy
Clinical narrative: Client's eyes are swelling and has swollen lymph nodes on left side of her neck and around her ear. Started on 5/5/15 after vaccination. Has been to her doctor and to the ER.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pyrexia, Rash, Skin warm, Urticaria
Clinical narrative: Rash developed near injection site 1 wk after injection. Consisted of 2 urticarial type lesion with warmth and erythema. Low grade fever. Treatment with BENADRYL, Hydrocortisone cream.
Age: 56.0
Sex: M
Vaccine: TTOX
Symptoms: Rash
Clinical narrative: Skin rash and rash.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: 2" x 2" darker, red spot at injection site swollen, hard and itching.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13
Symptoms: Erythema
Clinical narrative: Vaccines given and approximately 10 min. later mother noted small red mark on abdomen and side. Watched in office additional 20 min, child doing well, sent home with instructions to call if any further spots noted.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Vaccination site rash
Clinical narrative: Large circular rash around site of vaccine.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pain at injection site. Swelling at injection site.