chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Local reaction
Clinical narrative: 6/20/13 painful (L) deltoid; treated with ice locally, MOTRIN p.o. 6/22/13 (L) deltoid: swelling from elbow to shoulder, sl. red/itchy, took pt to urgent care, dx: local vaccine reaction, prescribed prednisone BID x5 days and naprosyn. 6/26/13: completely better.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a 3rd party claims administrator concerning a female patient (age not provided). On 09JUL2012, the patient received ZOSTAVAX, subcutaneous injection. On an unspecified date the patient developed a shingles outbreak after receiving the vaccine. The outcome of shingles was not provided. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Erythema, Irritability, Local swelling, Skin warm
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 year old male patient with no illness at the time of vaccination and no pre-existing conditions or allergies. On 10-JUN-2013 the patient was vaccinated with a third dose of VARIVAX (Merck), (subcutaneous injection in the right arm, lot number: H018790, exp. date 15-OCT-2014). On 10-JUN-2013, the patient experienced 6.5 x 7.5 cm area of swelling, hot and red arm and the patient was fussy. At the time of report, the patient's outcome was unknown. The relatedness between the patient's events and the patient was fussy and VARIVAX (Merck) was not reported. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Erythema, Feeling hot, Irritability, Swelling
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 year old male patient with no illness at the time of vaccination and no pre-existing conditions or allergies. On 10-JUN-2013 the patient was vaccinated with a third dose of VARIVAX (Merck), (subcutaneous injection in the right arm, lot number: H018790, exp. date 15-OCT-2014). On 10-JUN-2013, the patient experienced 6.5 x 7.5 cm area of swelling, hot and red arm and the patient was fussy. At the time of report, the patient's outcome was unknown. The relatedness between the patient's events and the patient was fussy and VARIVAX (Merck) was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 29-APR-2013, the patient was vaccinated with a dose of GARDASIL (lot # H020002, expiry date 08-AUG-2015), with the same lot of improperly stored GARDASIL. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Feeling hot, Paraesthesia, Vomiting
Clinical narrative: Pt given vaccines and approx 5 min after vaccines given Pt stated that her right arm felt "tingly" and she felt very hot and then had an emesis. Pt states "I feel better now."
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding an unknown number of patients of unknown age and gender. The pharmacist reported that an unspecified patient stated her unspecified primary care physician routinely administers ZOSTAVAX (lot number and expiration date not provided) (dose, route and frequency not provided) for prophylaxis, to an unknown number of patients that are less than 50 years old. No adverse effect reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report was received from a currently 60 years old female, non pregnant, consumer with no pertinent medical history reported. On 15-JUN-2013 the patient was vaccinated with ZOSTAVAX (lot number and expiration date not reported) (1 vaccine, dose and route not specified) in the arm. No other suspect therapies or concomitant medications were reported. The patient stated that on an unknown date (also reported as "06") she had a red mark "as big as a softball" at the injection site. Outcome for red mark at the injection site was unknown at the time of the report. The patient stated that no treatment was given for the red mark at the injection site. It was reported that the patient did not seek medical attention. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Blood immunoglobulin G, Hepatitis B surface antibody, Mumps antibody test
Clinical narrative: This spontaneous report was received from a registered nurse regarding a 15 year old male patient with history of Lemierre disease and no drug reactions or allergies. The patient was vaccinated with M-M-R II (lot number and expiration date not reported) (dose and route were not reported) on 09-NOV-1998 and on 13-AUG-2002. No other suspect therapies were reported, there was no concomitant medication. On 21-JUN-2013 the patient was found to have a Mumps IgG of 0.59 (no reference units and ranges reported). The patient was required to have testing of titers for a camp physical. Outcome for Mumps IgG of 0.59 was unknown at the time of the report. No treatment was given for the above mentioned event. On 21-06-2013 an "m-MR varicell and Hepp B surface antibody" tests were performed (results not reported). It was reported that the patient sought medical attention (reported as "physical for camp"). The reporting nurse did not assess the relatedness between Mumps IgG of 0.59 and M-M-R II. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age who on 03-FEB-2013, on 03-MAY-2011 and on 09-APR-2013, was vaccinated with the first, second and third dose of GARDASIL (doses and lot numbers not reported) respectively. No adverse effects were reported. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a 73 year old female patient reporting on herself with high blood pressure, sulfa allergy, penicillin allergy, "lisitipril" allergy and allergy to eye drops. The patient's medical history included breast cancer. In October 2012 the patient was vaccinated with ZOSTAVAX subcutaneously (1 time vaccine, route, lot number and expiration date not reported). Concomitant therapies included CRESTOR, COREG, SYNTHROID, "Novax" and AVAPRO. On 20-JUN-2013 the patient stated that she had what she believed was an outbreak of shingles on her left injection side, on her left upper arm, and under her left breast. No treatment was given for the event. No lab diagnostics studies were performed. The patient did not seek for medical attention. The outcome of the event was unknown. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Acne, Activities of daily living impaired, Anxiety, Burning sensation, Dry eye
Clinical narrative: In a nutshell Gardasil has ruined my life. I was a healthy 23 year old until the day I decided to listen to my pushy gyno and take the shot. That was probably the worst decision ever. After having the set of 3 shots I began to have days where I couldnt get out of bed. All of a sudden I didnt care to go to class (which was completely opposite of what I believed) I began to sweat profusely anytime I had even the slightest anxiety. (I mean soaking wet sweating within a minute) Til this day anytime I get nervous or anxious it happens. I've had a foggy mind and I just down right don't feel good EVER! My once completely normal menstral cycles have now turned into one every 4-5 months if I am lucky. Doctors have told me that I have hormonal imbalances and most likely will not be able to conceive. (I haven't gotten to the pt of accepting it) Not to mention the weight gain, the constantly burning of the soles of my feel, dry eyes, acne- the list goes on. I am no longer the same person and I constantly have a feeling of something is wrong within my body.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Feeling abnormal, Hormone level abnormal, Hyperhidrosis, Infertility female, Menstruation irregular
Clinical narrative: In a nutshell Gardasil has ruined my life. I was a healthy 23 year old until the day I decided to listen to my pushy gyno and take the shot. That was probably the worst decision ever. After having the set of 3 shots I began to have days where I couldnt get out of bed. All of a sudden I didnt care to go to class (which was completely opposite of what I believed) I began to sweat profusely anytime I had even the slightest anxiety. (I mean soaking wet sweating within a minute) Til this day anytime I get nervous or anxious it happens. I've had a foggy mind and I just down right don't feel good EVER! My once completely normal menstral cycles have now turned into one every 4-5 months if I am lucky. Doctors have told me that I have hormonal imbalances and most likely will not be able to conceive. (I haven't gotten to the pt of accepting it) Not to mention the weight gain, the constantly burning of the soles of my feel, dry eyes, acne- the list goes on. I am no longer the same person and I constantly have a feeling of something is wrong within my body.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Progesterone decreased, Weight increased
Clinical narrative: In a nutshell Gardasil has ruined my life. I was a healthy 23 year old until the day I decided to listen to my pushy gyno and take the shot. That was probably the worst decision ever. After having the set of 3 shots I began to have days where I couldnt get out of bed. All of a sudden I didnt care to go to class (which was completely opposite of what I believed) I began to sweat profusely anytime I had even the slightest anxiety. (I mean soaking wet sweating within a minute) Til this day anytime I get nervous or anxious it happens. I've had a foggy mind and I just down right don't feel good EVER! My once completely normal menstral cycles have now turned into one every 4-5 months if I am lucky. Doctors have told me that I have hormonal imbalances and most likely will not be able to conceive. (I haven't gotten to the pt of accepting it) Not to mention the weight gain, the constantly burning of the soles of my feel, dry eyes, acne- the list goes on. I am no longer the same person and I constantly have a feeling of something is wrong within my body.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: As of 6/28 I still have a raised circle area around the vaccine site. It is also very tender.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Shot administered in upper left arm.  Reaction includes redness and extreme swelling of arm from 1" above injection to elbow (about 5" below injection), and wrapping around to back/underside of arm.  The entire area is red, swollen, hot, and hard to the touch.  Patient is complaining of itchiness in entire area.
Age: 1.0
Sex: F
Vaccine: IPV
Symptoms: Rash, Rash erythematous
Clinical narrative: Rash, bright red, on the face, neck and ears. Self corrected.
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Carbon dioxide decreased, Cough, Insomnia, Myalgia, Neck pain
Clinical narrative: Two days after getting the vaccine, had a minor car accident.  Knew there was no injury, and continued driving.  Within the next hour, began to feel muscle or neck soreness, but assumed this to be psychosomatic.  Over the next few days, experienced other symptoms, including difficulty sleeping and a bad cough that sounded like phlegm in the lungs.  Now believe that either (a) at the time of getting the vaccine, was already infected with something that caused all the symptoms, including muscle soreness, cough, etc., and may have contributed to the car accidents, or (b) side effects of the vaccine caused all the symptoms, including muscle soreness, cough, etc., and may have contributed to the car accident.  (Neither the car accident nor a psychosomatic reaction to it could cause phlegm or the cough, which is indicative of a real medical cause.) In previous years, received the intramuscular flu vaccine without any problems.  This year, received the intradermal vaccine for the first time ever.  If the intradermal vaccine causes side effects in patients that don't have the same reaction to the intramuscular version, this should be added to the informed consent disclosures. I have read that the onset of flu can cause accidents.  I don't know if that is true of the vaccine.  If vaccine side effects can cause car accidents, then vaccine administration should, ideally, occur on a day that will result in the onset of possible side effects being on a day when patient is not driving.  This precaution was not taken.
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Road traffic accident
Clinical narrative: Two days after getting the vaccine, had a minor car accident.  Knew there was no injury, and continued driving.  Within the next hour, began to feel muscle or neck soreness, but assumed this to be psychosomatic.  Over the next few days, experienced other symptoms, including difficulty sleeping and a bad cough that sounded like phlegm in the lungs.  Now believe that either (a) at the time of getting the vaccine, was already infected with something that caused all the symptoms, including muscle soreness, cough, etc., and may have contributed to the car accidents, or (b) side effects of the vaccine caused all the symptoms, including muscle soreness, cough, etc., and may have contributed to the car accident.  (Neither the car accident nor a psychosomatic reaction to it could cause phlegm or the cough, which is indicative of a real medical cause.) In previous years, received the intramuscular flu vaccine without any problems.  This year, received the intradermal vaccine for the first time ever.  If the intradermal vaccine causes side effects in patients that don't have the same reaction to the intramuscular version, this should be added to the informed consent disclosures. I have read that the onset of flu can cause accidents.  I don't know if that is true of the vaccine.  If vaccine side effects can cause car accidents, then vaccine administration should, ideally, occur on a day that will result in the onset of possible side effects being on a day when patient is not driving.  This precaution was not taken.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Site of subcutaneous injection was red all around the site. The red site was about a 2.5 inch diameter round. Area was warm to the touch, but its also 109 degrees out. He felt fine, but it itched a lot but no fever.
Age: 2.0
Sex: F
Vaccine: DTAP, PPV
Symptoms: Abdominal pain upper, Bronchiolitis, Chest X-ray, Full blood count, Headache
Clinical narrative: Fever of 102.5.  Listless and generally acting very sick.  Complained of head and stomach pain.
Age: 2.0
Sex: F
Vaccine: DTAP, PPV
Symptoms: Listless, Malaise, Monocyte count increased, Pyrexia, Urine analysis
Clinical narrative: Fever of 102.5.  Listless and generally acting very sick.  Complained of head and stomach pain.
Age: 2.0
Sex: F
Vaccine: DTAP, PPV
Symptoms: White blood cell count decreased
Clinical narrative: Fever of 102.5.  Listless and generally acting very sick.  Complained of head and stomach pain.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling, redness, itching at injection site.
Age: 1.55
Sex: F
Vaccine: DTP, MMR, VARCEL
Symptoms: Dyskinesia, Pyrexia
Clinical narrative: High fever of 104.5 and jerking motions.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Induration, Injection site pain, Pain in extremity
Clinical narrative: Sore at injection and started to feel warm. As day went on arm ached and got hotter and hard and red.  Didn't sleep well that night and next am called pharmacy back.  Suggested Benadryl and Tylenol.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Poor quality sleep
Clinical narrative: Sore at injection and started to feel warm. As day went on arm ached and got hotter and hard and red.  Didn't sleep well that night and next am called pharmacy back.  Suggested Benadryl and Tylenol.
Sex: F
Vaccine: VARZOS
Symptoms: Ear congestion, Myalgia, Paraesthesia, Pyrexia, Rash
Clinical narrative: 1 hour after shot - swelling, fever, rash later - muscle sore, tingle right side of face/ear ear became stopped up - some blurr vision. Today - rash/swelling better > saw her provider given TAC, FLAGYL, cefuroxime.
Sex: F
Vaccine: VARZOS
Symptoms: Swelling, Vision blurred
Clinical narrative: 1 hour after shot - swelling, fever, rash later - muscle sore, tingle right side of face/ear ear became stopped up - some blurr vision. Today - rash/swelling better > saw her provider given TAC, FLAGYL, cefuroxime.
Age: 1.51
Sex: U
Vaccine: DTAP, FLU3, HEPA
Symptoms: Varicella
Clinical narrative: Got chicken pox rash no fever.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria, Laboratory test, Vaccination site swelling
Clinical narrative: Chicken pox #2 dose on 6/25/13 at depart of health. Pt started having itching, swelling with hives at vaccine site on (L) arm. Went to ER on 6/27/13. Given antibiotics. S/S improved. Started having itching, redness, swelling again on 6/29/13.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: One week after administration patient had a large red area about half-dollar size.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Erythema, swelling and pain around injection site.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 25-JUN-2013 the patient was vaccinated with an expired dose of M-M-R II (lot # 6706228/0952AA and expiration date 14-JUN-2013). No adverse effect reported. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Immediate post-injection reaction, Oral herpes
Clinical narrative: This spontaneous report was received from a doctor of pharmacy refers to a 63 year old male patient with no drug reaction or allergies. Medical history included cold sores. On 20-JUN-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date not reported) subcutaneously. Approximately on 20-JUN-2013 the patient experienced headache immediately following administration of ZOSTAVAX that went away approximately on an unknown date in June 2013. It was unknown if patient treated the headache. On 23-JUN-2013, the patient developed a cold sore which had not yet been treated and had not yet gone away. No laboratory diagnostic studies were performed. Causality was not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacy technician and a registered pharmacist refers to a female patient (pharmacy technician) of unknown age with no pertinent medical history and no drug reactions/allergies. The pharmacy technician provided the information on vaccine and the events. On 19-JUN-2013 the patient was vaccinated with 0.65 milliliter (ml) of ZOSTAVAX (lot # J000446, expiration date 11-APR-2014) subcutaneously. Within a day on 20-JUN-2013, the site of injection was red and raised. On 21-JUN-2013 (reported as today), the injection site was painful to touch and was about 6 inches long and 2 inches wide. It was puffy and itched and there was a raised rash (not like chicken pox). Treatment was not rendered for the adverse event. The patient did not recover from the events at the time of this report. Medical attention was not sought for the events. Causality was not reported. Additional information is not expected.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Asthenia, Dehydration, Diarrhoea, Dizziness
Clinical narrative: Waited the 10 min as the Dr requested. Go out to car and immediately get a headache, dizziness, and stomach cramps. Go into severe bowel and stomach problems losing all fluids from my body over the next 24 hours. Get up the next day so weak can not function. Go to the hospital where they infuse me with IV to bring my fluid level back up. Five days later and still having problems but drinking tons of water to try and bring myself back.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Vomiting
Clinical narrative: Waited the 10 min as the Dr requested. Go out to car and immediately get a headache, dizziness, and stomach cramps. Go into severe bowel and stomach problems losing all fluids from my body over the next 24 hours. Get up the next day so weak can not function. Go to the hospital where they infuse me with IV to bring my fluid level back up. Five days later and still having problems but drinking tons of water to try and bring myself back.
Age: 23.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: PT RECEIVED PNEUMOVAX VACCINE ON 6/1/13.  ON 6/2/13 PT NOTED PAIN AND ERYTHEMA AT THE SITE OF THE PNEUMOVAX INJECTION.  CELLULITIS PROGRESSED, AND PT FEBRILE.  ON 6/4/13 INFECTIOUS DISEASE CONSULTED. VANCOMYCIN IV ADDED TO COVER MRSA, LEVAQUIN ALSO CONTINUED.  OVER THE NEXT 24 HOURS THERE WAS A REMARKABLE IMPROVEMENT OF THE CELLULITIS. VANCOMYCIN CONTINUED UNTIL 6/7/13.  PT DISCHARGED 6/7/13 WITH DOXYCYCLINE TO COVER POTENTIAL MRSA.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema multiforme, Pyrexia, Rash pruritic, Streptococcus test negative
Clinical narrative: Within 12 hours of vaccine spikes fever of 103.  Within 72 hours of vaccine broke out in diffuse pruritic rash.  Saw Pediatrician on 06/30/2013 and diagnosed with Erythema Multiforme.
Age: 81.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal pain upper, Diarrhoea, Dizziness, Fatigue, Headache
Clinical narrative: Headache; Dizziness - Tiredness - Almost passed out; Pain in Stomach; Nausea; Diarrhea; Low Pressure; Unable to Sleep; Body Aches.
Age: 81.0
Sex: M
Vaccine: TDAP
Symptoms: Hypotension, Insomnia, Loss of consciousness, Nausea, Pain
Clinical narrative: Headache; Dizziness - Tiredness - Almost passed out; Pain in Stomach; Nausea; Diarrhea; Low Pressure; Unable to Sleep; Body Aches.
Age: 1.02
Sex: M
Vaccine: HIBV, MMR, PNC
Symptoms: Abnormal faeces, Crying, Decreased activity, Decreased appetite, Diarrhoea
Clinical narrative: 8/18- First visit to doctor due to poor eating and loose, frequent, foul smelling bowel movements and black stool. Low grade fever, lethargy, and excessive crying/clingy. 8/25- second visit to doctor due to fever 102-104, intermittent. Lymphadenopathy. Slowed activity/lethargy. Poor eating. Excessive crying/whining. Rash developed on trunk 8/24. Complete CBC ran, showed abnormalties. Test results on file.
Age: 1.02
Sex: M
Vaccine: HIBV, MMR, PNC
Symptoms: Faeces discoloured, Frequent bowel movements, Full blood count abnormal, Irritability, Lethargy
Clinical narrative: 8/18- First visit to doctor due to poor eating and loose, frequent, foul smelling bowel movements and black stool. Low grade fever, lethargy, and excessive crying/clingy. 8/25- second visit to doctor due to fever 102-104, intermittent. Lymphadenopathy. Slowed activity/lethargy. Poor eating. Excessive crying/whining. Rash developed on trunk 8/24. Complete CBC ran, showed abnormalties. Test results on file.
Age: 1.02
Sex: M
Vaccine: HIBV, MMR, PNC
Symptoms: Lymphadenopathy, Pyrexia, Rash
Clinical narrative: 8/18- First visit to doctor due to poor eating and loose, frequent, foul smelling bowel movements and black stool. Low grade fever, lethargy, and excessive crying/clingy. 8/25- second visit to doctor due to fever 102-104, intermittent. Lymphadenopathy. Slowed activity/lethargy. Poor eating. Excessive crying/whining. Rash developed on trunk 8/24. Complete CBC ran, showed abnormalties. Test results on file.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Activities of daily living impaired, Erythema, Induration, Insomnia, Mobility decreased
Clinical narrative: Day one swelling hardness, and deep redness.  Day 2 redness, swelling all the way to elbow and unable to bend arm, pain to the point of not being able to sleep.  Day 3 fever, laying on couch and not moving.  Swelling, and some redness.  Day 4, better but still swelled, no fever.  He woulds have been better off getting the chicken pox.  He would have missed 3 days of school if it was not summer.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Oedema peripheral, Pain, Pyrexia, Swelling
Clinical narrative: Day one swelling hardness, and deep redness.  Day 2 redness, swelling all the way to elbow and unable to bend arm, pain to the point of not being able to sleep.  Day 3 fever, laying on couch and not moving.  Swelling, and some redness.  Day 4, better but still swelled, no fever.  He woulds have been better off getting the chicken pox.  He would have missed 3 days of school if it was not summer.
Age: 24.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Abnormal sensation in eye, Arthralgia, Back pain, Headache, Influenza like illness
Clinical narrative: Migraine headache night of vaccine, severe headaches everyday after that last all day and wake me up at night, pressure behind eyes, groggy feeling, severe joint/body aches, flu-like symptoms, neck/back pain, lump on forearm. Using homeopathic remedies, but symptoms have increased. Two weeks since vaccine on 7/2/13.
Age: 24.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Middle insomnia, Migraine, Neck pain, Pain, Somnolence
Clinical narrative: Migraine headache night of vaccine, severe headaches everyday after that last all day and wake me up at night, pressure behind eyes, groggy feeling, severe joint/body aches, flu-like symptoms, neck/back pain, lump on forearm. Using homeopathic remedies, but symptoms have increased. Two weeks since vaccine on 7/2/13.
Age: 24.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Upper extremity mass
Clinical narrative: Migraine headache night of vaccine, severe headaches everyday after that last all day and wake me up at night, pressure behind eyes, groggy feeling, severe joint/body aches, flu-like symptoms, neck/back pain, lump on forearm. Using homeopathic remedies, but symptoms have increased. Two weeks since vaccine on 7/2/13.
Age: 1.13
Sex: M
Vaccine: BCG, MMRV
Symptoms: Haemorrhage
Clinical narrative: Vaccine recipient started to bleed on both hands and walked over a filled bathtub.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Injection site nodule, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: Huge knot, swelling, fever, hive at site of injection. Fever of 103. Trouble breathing.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Huge knot, swelling, fever, hive at site of injection. Fever of 103. Trouble breathing.
Age: 0.21
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Abdominal distension, Blood test, Flatulence, Rash, X-ray
Clinical narrative: Abdominal swelling, trapped gas and rash.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Headache, Poor quality sleep, Vomiting
Clinical narrative: This spontaneous report as received from a female consumer refers to her 18 years old daughter with migraine headaches. Sometime in June 2013 the patient was vaccinated with the first dose of GARDASIL (lot# and batch# unspecified), formulation and route unspecified, (dose and frequency unspecified). Concomitant therapies included with birth control pills with unspecified "low dosage". Sometime in June 2013 the mother of the patient was reported that her 18-year-old daughter experienced vomiting, restless sleep, acute abdominal pain "like a punch in the stomach" and headaches after receiving the first dose of GARDASIL. The reaction has been reported to the patient's physician, although it was reported that the vaccine was administered at an unspecified clinic. Product lot, expiration date, and full physician information, were unavailable at the time of call but will be provided in a follow-up. The adverse symptoms began about 12 hours after administration of the vaccine and subsided within 24 hours. At the time of report, the second and third doses have not yet been administered. At the time of report, the outcome of the vomiting, restless sleep, acute abdominal pain and headaches were recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to a female patient of unknown age. On 13-AUG-2012, the patient was vaccinated with dose 1 GARDASIL (lot#, expiration date and route not reported). On 26-OCT-2012, the patient was vaccinated with dose 2 GARDASIL (lot#, expiration date and route not reported). On 18-JAN-2013 the patient was vaccinated dose 3, with GARDASIL (lot#, expiration date and route not reported). Third dose of GARDASIL was too close in time to the first dose of GARDASIL per the reporter. Additional information has been requested.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 52 year old male patient with a negative history of chicken pox. On 18-JUN-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # not reported) (dose and route not reported). Concomitant therapy was not reported. It was reported that the patient received ZOSTAVAX instead of VARIVAX (Merck). The patient asked for the shingles vaccine, but after vaccination the patient asked if the shingles vaccine would also protect against varicella (chicken pox). The pharmacist reported that the patient wanted to be vaccinated to protect against chicken pox. No adverse event reported. Additional information is not expected.
Age: 25.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Injection site pain, Injection site reaction, Melanocytic naevus
Clinical narrative: Right arm hurts (throbs) from time to time in point of origin of vaccine, as well as there is now a 2 inch hair grow out in spot as well.
Age: 25.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Hair growth abnormal, Injection site pain, Injection site reaction
Clinical narrative: Right arm hurts (throbs) from time to time in point of origin of vaccine, as well as there is now a 2 inch hair grow out in spot as well.
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Acute febrile neutrophilic dermatosis, Biopsy skin abnormal, Dermatitis bullous, Eczema, Eosinophilia
Clinical narrative: Diffuse rash affecting palms of hands, feet, chin/neck area. Large bullous reaction. Concern for Sweets disease vs Stevens Johnson's syndrome.
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Full blood count abnormal, Herpes simplex, Rash generalised, Simplex virus test positive, Stevens-Johnson syndrome
Clinical narrative: Diffuse rash affecting palms of hands, feet, chin/neck area. Large bullous reaction. Concern for Sweets disease vs Stevens Johnson's syndrome.
Age: 72.0
Sex: M
Vaccine: TTOX
Symptoms: Asthenia, Erythema, Full blood count, Injected limb mobility decreased, Local swelling
Clinical narrative: Within a few hours, pt could not lift his arm. Friday 6/28/13, pt's arm was swollen, pt was weak and running a fever. Saturday AM - red streaks down arm, skin looked like it was going to "pop". Pt. went to ER, IV UNASYN and KEFLEX.
Age: 72.0
Sex: M
Vaccine: TTOX
Symptoms: Pyrexia, White blood cell count increased
Clinical narrative: Within a few hours, pt could not lift his arm. Friday 6/28/13, pt's arm was swollen, pt was weak and running a fever. Saturday AM - red streaks down arm, skin looked like it was going to "pop". Pt. went to ER, IV UNASYN and KEFLEX.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse refers to a patient of unknown age and gender. On 15-JUN-2013, the patient was vaccinated with a dose of M-M-R II (lot # 0597AA, expiry: 28-APR-2013). No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 13-MAY-2013, the patient was vaccinated with a dose of GARDASIL, (lot # H020002, expiry date 08-AUG-2015), with the same lot of improperly stored GARDASIL. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Rotavirus test positive, Stool analysis abnormal
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 2 month old female patient. The patient's medical history included low blood platelets. On 17-MAY-2013 the patient was vaccinated with ROTATEQ dose 1, 2 ml, oral, lot number and expiry date were not reported. On 17-MAY-2013, the patient experienced onset of diarrhea, the patient was brought to the emergency room and was admitted to the hospital for an unspecified amount of time. The patient was tested positive for rotavirus (hospitalization), diagnosis was by means of stool sample. Treatment information was not reported. The outcome of being positive for rotavirus is unknown. Causality assessment was not provided by the reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a nurse refers to numerous patients of unknown age. On an unknown date the patients were vaccinated with GARDASIL. The nurse reported that numerous unspecified patients complain of pain during administration of the GARDASIL. The nurse reported that the pain was reported when the GARDASIL was being injected into the patient's arm. It was also reported that the patients recovered from pain. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: SMALL, SMALL, SMALL
Symptoms: Culture, Exposure to vaccinated person, Orthopoxvirus test positive, Polymerase chain reaction, Skin lesion
Clinical narrative: Patients boyfriend, received smallpox vaccine between May 30th and June 2nd per patient - Patient found lesion on neck June 22nd - found secondary lesion June 25th, cultures done June 27th 2013, Department notified per epidemiologist.
Age: 20.0
Sex: F
Vaccine: SMALL, SMALL, SMALL
Symptoms: Varicella virus test negative, Viral test negative
Clinical narrative: Patients boyfriend, received smallpox vaccine between May 30th and June 2nd per patient - Patient found lesion on neck June 22nd - found secondary lesion June 25th, cultures done June 27th 2013, Department notified per epidemiologist.
Age: 20.0
Sex: F
Vaccine: SMALL, SMALL, SMALL
Symptoms: Fatigue, Malaise, Orthopoxvirus test positive, Paraesthesia, Polymerase chain reaction
Clinical narrative: Patients boyfriend, received smallpox vaccine between May 30th and June 2nd per patient - Patient found lesion on neck June 22nd - found secondary lesion June 25th, cultures done June 27th 2013, Department notified per epidemiologist.
Age: 20.0
Sex: F
Vaccine: SMALL, SMALL, SMALL
Symptoms: Pyrexia, Rash pustular, Secondary transmission
Clinical narrative: Patients boyfriend, received smallpox vaccine between May 30th and June 2nd per patient - Patient found lesion on neck June 22nd - found secondary lesion June 25th, cultures done June 27th 2013, Department notified per epidemiologist.
Age: 20.0
Sex: F
Vaccine: SMALL, SMALL, SMALL
Symptoms: Culture negative, Herpes simplex serology negative, Orthopoxvirus test positive, Polymerase chain reaction, Secondary transmission
Clinical narrative: Patients boyfriend, received smallpox vaccine between May 30th and June 2nd per patient - Patient found lesion on neck June 22nd - found secondary lesion June 25th, cultures done June 27th 2013, Department notified per epidemiologist.
Age: 20.0
Sex: F
Vaccine: SMALL, SMALL, SMALL
Symptoms: Skin lesion, Varicella virus test negative
Clinical narrative: Patients boyfriend, received smallpox vaccine between May 30th and June 2nd per patient - Patient found lesion on neck June 22nd - found secondary lesion June 25th, cultures done June 27th 2013, Department notified per epidemiologist.
Age: 20.0
Sex: F
Vaccine: SMALL, SMALL, SMALL
Symptoms: Culture, Exposure to vaccinated person, Orthopoxvirus test positive, Polymerase chain reaction, Skin lesion
Clinical narrative: Contact transmission. 20yo female who had initimate contact with primary vaccinee on approximately 6/19/13 (vaccination date 6/1/13). According to the pt the site was uncovered on a few occasions or only covered with a Band-Aid. The pt noted a pustular lesion on the nape of her neck on 6/22/13. She saw her pediatrician on 6/24 and was instructed to wash the lesion with dial soap tid, rinse with hydrogen peroxide and apply a medicated cream (name unknown). She noted a lesion (pustular) on her back on 6/25/13. She went to the DOH on 6/26/13. PCR specimens were collected on 6/27/13. Symptoms: Fever, Malaise and fatigue, Disturbance of skin sensation.
Age: 20.0
Sex: F
Vaccine: SMALL, SMALL, SMALL
Symptoms: Varicella virus test negative, Viral test negative
Clinical narrative: Contact transmission. 20yo female who had initimate contact with primary vaccinee on approximately 6/19/13 (vaccination date 6/1/13). According to the pt the site was uncovered on a few occasions or only covered with a Band-Aid. The pt noted a pustular lesion on the nape of her neck on 6/22/13. She saw her pediatrician on 6/24 and was instructed to wash the lesion with dial soap tid, rinse with hydrogen peroxide and apply a medicated cream (name unknown). She noted a lesion (pustular) on her back on 6/25/13. She went to the DOH on 6/26/13. PCR specimens were collected on 6/27/13. Symptoms: Fever, Malaise and fatigue, Disturbance of skin sensation.
Age: 20.0
Sex: F
Vaccine: SMALL, SMALL, SMALL
Symptoms: Fatigue, Malaise, Orthopoxvirus test positive, Paraesthesia, Polymerase chain reaction
Clinical narrative: Contact transmission. 20yo female who had initimate contact with primary vaccinee on approximately 6/19/13 (vaccination date 6/1/13). According to the pt the site was uncovered on a few occasions or only covered with a Band-Aid. The pt noted a pustular lesion on the nape of her neck on 6/22/13. She saw her pediatrician on 6/24 and was instructed to wash the lesion with dial soap tid, rinse with hydrogen peroxide and apply a medicated cream (name unknown). She noted a lesion (pustular) on her back on 6/25/13. She went to the DOH on 6/26/13. PCR specimens were collected on 6/27/13. Symptoms: Fever, Malaise and fatigue, Disturbance of skin sensation.
Age: 20.0
Sex: F
Vaccine: SMALL, SMALL, SMALL
Symptoms: Pyrexia, Rash pustular, Secondary transmission
Clinical narrative: Contact transmission. 20yo female who had initimate contact with primary vaccinee on approximately 6/19/13 (vaccination date 6/1/13). According to the pt the site was uncovered on a few occasions or only covered with a Band-Aid. The pt noted a pustular lesion on the nape of her neck on 6/22/13. She saw her pediatrician on 6/24 and was instructed to wash the lesion with dial soap tid, rinse with hydrogen peroxide and apply a medicated cream (name unknown). She noted a lesion (pustular) on her back on 6/25/13. She went to the DOH on 6/26/13. PCR specimens were collected on 6/27/13. Symptoms: Fever, Malaise and fatigue, Disturbance of skin sensation.
Age: 20.0
Sex: F
Vaccine: SMALL, SMALL, SMALL
Symptoms: Culture negative, Herpes simplex serology negative, Orthopoxvirus test positive, Polymerase chain reaction, Secondary transmission
Clinical narrative: Contact transmission. 20yo female who had initimate contact with primary vaccinee on approximately 6/19/13 (vaccination date 6/1/13). According to the pt the site was uncovered on a few occasions or only covered with a Band-Aid. The pt noted a pustular lesion on the nape of her neck on 6/22/13. She saw her pediatrician on 6/24 and was instructed to wash the lesion with dial soap tid, rinse with hydrogen peroxide and apply a medicated cream (name unknown). She noted a lesion (pustular) on her back on 6/25/13. She went to the DOH on 6/26/13. PCR specimens were collected on 6/27/13. Symptoms: Fever, Malaise and fatigue, Disturbance of skin sensation.
Age: 20.0
Sex: F
Vaccine: SMALL, SMALL, SMALL
Symptoms: Skin lesion, Varicella virus test negative
Clinical narrative: Contact transmission. 20yo female who had initimate contact with primary vaccinee on approximately 6/19/13 (vaccination date 6/1/13). According to the pt the site was uncovered on a few occasions or only covered with a Band-Aid. The pt noted a pustular lesion on the nape of her neck on 6/22/13. She saw her pediatrician on 6/24 and was instructed to wash the lesion with dial soap tid, rinse with hydrogen peroxide and apply a medicated cream (name unknown). She noted a lesion (pustular) on her back on 6/25/13. She went to the DOH on 6/26/13. PCR specimens were collected on 6/27/13. Symptoms: Fever, Malaise and fatigue, Disturbance of skin sensation.
Sex: U
Vaccine: MMR, RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse who reported that an unspecified number of patients were administered M-M-R II (dose, route and lot # not reported) and ROTATEQ (dose, route and lot # not reported) that may have been exposed to 10 degrees C for an unspecified length of time. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified amount of patients. On unknown dates, the patients were vaccinated with ZOSTAVAX that was stored at -10C for an unspecified amount of time. Pharmacist stated that the overall temperature might not have been at or below -15C. No adverse effect reported. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Abdominal pain upper, Defaecation urgency, Dizziness, Listless, Loss of consciousness
Clinical narrative: Initial report was received from a consumer, who was also the patient's parent, on 19 June 2013. A 15-year-old female patient received an intramuscular injection of MENACTRA (lot number and site not reported) on 18 June 2013 at 5:45 PM. At 11 PM, the patient got out of bed due to stomach pain and felt as if she needed to have a bowel movement. Once she returned from the bathroom, she began feeling dizzy and fainted. The reporter stated she lost consciousness for a little over one minute. After fainting spell, the patient had two more episodes of feeling faint and was listless. She fell asleep at 12:30 AM. The patient had no illness at the time of vaccination and a history of fainting and abdominal pain. Outcome was reported as recovered. Documents held by sender: None.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Syncope
Clinical narrative: Initial report was received from a consumer, who was also the patient's parent, on 19 June 2013. A 15-year-old female patient received an intramuscular injection of MENACTRA (lot number and site not reported) on 18 June 2013 at 5:45 PM. At 11 PM, the patient got out of bed due to stomach pain and felt as if she needed to have a bowel movement. Once she returned from the bathroom, she began feeling dizzy and fainted. The reporter stated she lost consciousness for a little over one minute. After fainting spell, the patient had two more episodes of feeling faint and was listless. She fell asleep at 12:30 AM. The patient had no illness at the time of vaccination and a history of fainting and abdominal pain. Outcome was reported as recovered. Documents held by sender: None.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Redness, warmth and swelling at side of injection.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site scar, Local reaction
Clinical narrative: Redness, warmth and swelling at side of injection.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blister, Erythema, Oedema peripheral, Rash, Skin warm
Clinical narrative: Redness, warmth and swelling at side of injection.
Age: 39.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure to communicable disease, Polymerase chain reaction, Varicella post vaccine, Varicella virus test positive
Clinical narrative: PCR - proven disseminated VZV rash 20 d after 1st dose of VARIVAX (given 4/9/13). Patient exposed to person w/ chickenpox 4/17/13. Patient VZV IgG (-) 2/2013.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Rash, Syncope
Clinical narrative: Pt. fainted directly after receiving vaccine. Pt. also developed rash on R arm.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Kinrix given in left thigh on Friday, June 28, 2013. Site is now red, swollen, measuring 10.5cm. Proquad given in left upper arm subcutaneously. Site is now red/bruised and 2cm. Patient has also been running a fever of 102.0. Patient started on Septra.
Age: 18.0
Sex: F
Vaccine: IPV, TYP, VARCEL, YF
Symptoms: Lip swelling, Pruritus
Clinical narrative: SYMPTOMS BEGAN NIGHT OF VACCINATION. PT BEGAN TO ITCH ON NECK AND SHOULDER AREA, THEN LIPS BEGAN TO SWELL. PATIENT WAS GIVEN BENADRYL.
Age: 0.64
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Decreased activity, Enema administration, Hypophagia, Intussusception, Ultrasound abdomen abnormal
Clinical narrative: Had 3-4 episodes of bilious emesis, decreased PO intake, decreased urine output and less active at home. Pt came to the ED (6/28/13), had an abdominal ultrasound which showed intussusception.  Pt received an barium/air enema to reduce the intussusception.  She was hospitalized overnight and discharged the following day (6/29/13).
Age: 0.64
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Urine output decreased, Vomiting
Clinical narrative: Had 3-4 episodes of bilious emesis, decreased PO intake, decreased urine output and less active at home. Pt came to the ED (6/28/13), had an abdominal ultrasound which showed intussusception.  Pt received an barium/air enema to reduce the intussusception.  She was hospitalized overnight and discharged the following day (6/29/13).
Age: 41.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Injection site reaction, Myalgia, Pain, Pyrexia
Clinical narrative: Extreme muscle soreness in R arm at injection site. Low grade fever, body aches, chills, started next day. Subsided saturday night.
Age: 73.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Patient received Tdap vaccine on 6.12.13 at clinic with no issues at that time. Patient awoke 06/18/2013 AM to a 2 inch by 4 inch area of erythema and edema to right deltoid this AM. Area warm to touch and patient reports area is tender. Erythema circled with a marker. Advised patient to make appointment with PCP for possible cellulitis to right upper arm. Advised that area has been circled and to monitor for spread of infection (erythema extending beyond marked area, streaking redness to ear, fever over 100.5). Advised if this symptoms occur in the next 12-24 hours while waiting for PCP appointment that she must report to urgent care for evaluation. Patient verbalized understanding and has PCP number to call as soon as leaving clinic.