chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Feeling cold, Neuralgia, Paraesthesia
Clinical narrative: This spontaneous report as received from a nurse refers to a 55 year old female patient with asthma and breast cancer. The patient had no allergies or drug reactions. On 19-NOV-2014 the patient was vaccinated with PNEUMOVAX 23, (intramuscular, 1 dose, dosage and dose number unknown; lot number reported as: K005402 EXP 07-NOV-2015). Concomitant therapies included DULERA and an unspecified rescue inhaler. On 22-NOV-2014, the patient felt "cold", tingling sensation (like BENGAY), and pain to the touch "like nerve pain" down her right arm, chest, abdomen, and the entire right side of her body, which was the same side on which she was vaccinated. The patient sought medical attention (nurse practitioner office visit) but received no treatment. No lab diagnostic studies were performed. The outcome of the events was reported as not recovered. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information was received from a physician concerning a 55 year old female patient with no known drug allergies, hypercholesterolemia and hypertension. On 25-NOV-2014, the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneously in the left deltoid region. Concomitant therapies included LIPITOR and losartan (manufacturer unknown). The following day, 26-NOV-2014, the patient developed "flank pain". On 27-NOV-2014, she began to develop a rash, which the physician examined on 01-DEC-2014, when the patient sought medical attention. The physician stated that the patient presented with a "classic shingles" rash in the T10 dermatome. The physician wrote prescriptions for gabapentin (manufacturer unknown) and VALTREX, though is was not known if the patient had initiated therapy with those medications. The physician reported that the patient missed work on 01-DEC-2014 when she sought medical attention. The outcome of the classic shingles rash was reported as not recovered. This is one of two reports from this physician (see case #1412USA009532). Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Activities of daily living impaired, Flank pain, Herpes zoster, Rash
Clinical narrative: Information was received from a physician concerning a 55 year old female patient with no known drug allergies, hypercholesterolemia and hypertension. On 25-NOV-2014, the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneously in the left deltoid region. Concomitant therapies included LIPITOR and losartan (manufacturer unknown). The following day, 26-NOV-2014, the patient developed "flank pain". On 27-NOV-2014, she began to develop a rash, which the physician examined on 01-DEC-2014, when the patient sought medical attention. The physician stated that the patient presented with a "classic shingles" rash in the T10 dermatome. The physician wrote prescriptions for gabapentin (manufacturer unknown) and VALTREX, though is was not known if the patient had initiated therapy with those medications. The physician reported that the patient missed work on 01-DEC-2014 when she sought medical attention. The outcome of the classic shingles rash was reported as not recovered. This is one of two reports from this physician (see case #1412USA009532). Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: FLUN4
Symptoms: Abnormal behaviour, Aggression, Anxiety, Muscle twitching, Obsessive-compulsive disorder
Clinical narrative: Developed tics: head twitching and nose sniffing, started having shoulder rolling, barking, change in personality - aggression, OCD, anxiety, regression as a 2 year old behavior.
Age: 4.0
Sex: F
Vaccine: FLUN4
Symptoms: Personality change, Regressive behaviour, Rhinorrhoea, Tic
Clinical narrative: Developed tics: head twitching and nose sniffing, started having shoulder rolling, barking, change in personality - aggression, OCD, anxiety, regression as a 2 year old behavior.
Age: 82.0
Sex: F
Vaccine: TTOX
Symptoms: Chills, Dizziness, Dyspnoea, Headache, Malaise
Clinical narrative: Dizziness, nausea, arm throbbing and muscle pain and weakness, headache, breathing problem fever, chills.   All within 2 hours of shot. Today is 12/18/2014 and still ill with moderate symptoms.
Age: 82.0
Sex: F
Vaccine: TTOX
Symptoms: Muscular weakness, Myalgia, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Dizziness, nausea, arm throbbing and muscle pain and weakness, headache, breathing problem fever, chills.   All within 2 hours of shot. Today is 12/18/2014 and still ill with moderate symptoms.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report as received from a nurse practitioner via a company representative refers to a 53 year old female patient. On 07-NOV-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, frequency and route were unknown, lot# was reported as K009A76, expiration date was reported as 19-MAR-2016). On 09-NOV-2014, the patient went to the emergency room after experiencing redness at the injection site and feeling 'hot' in the area surrounding the injection site, and the patient was diagnosed with cellulitis. On an unknown date in 2014, the patient was admitted to the hospital for an unspecified amount of time. The patient sought medical attention by visit the emergency room. The outcome of the event was unknown. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Dysphemia
Clinical narrative: My daughter was a fluent speaker without any problems at all.  She now has a definite stutter.  It was not there before this shot.  It has progressively gotten worse over the course of the last week, so we want to report the incident.  Hopefully it will go away.  Very scary as this child had absolutely no problems before the shot and now cannot start sentences without a prolonged stutter.  She is still very alert, thank God.
Age: 1.27
Sex: M
Vaccine: FLU4, HEPA, PNC13, VARCEL
Symptoms: Body temperature increased, C-reactive protein normal, Crying, Discomfort, Full blood count normal
Clinical narrative: Grandmother had ped's md see child due to "blotches on arms, back of legs, and big red swollen (quarter size knot) area with blisters at injection site on right leg. Temp. was 99.5. Md said that it was a local reaction. Grandmother called to report the symptoms to Co. Health Dept., nurse advised to get a 2nd opinion with blotches on body and nurse could hear the child crying. GM said that the child seemed uncomfortable. Grandmother being a nurse at a hospital got a second opinion with the E.R. doctor that afternoon at Hospital. C. Reactive Protein and CBC was drawn and was WNL. Child was started on steroids. Grandmother said since starting steroids symptoms have almost went completely away and child is doing much better.
Age: 1.27
Sex: M
Vaccine: FLU4, HEPA, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles, Local reaction, Rash macular
Clinical narrative: Grandmother had ped's md see child due to "blotches on arms, back of legs, and big red swollen (quarter size knot) area with blisters at injection site on right leg. Temp. was 99.5. Md said that it was a local reaction. Grandmother called to report the symptoms to Co. Health Dept., nurse advised to get a 2nd opinion with blotches on body and nurse could hear the child crying. GM said that the child seemed uncomfortable. Grandmother being a nurse at a hospital got a second opinion with the E.R. doctor that afternoon at Hospital. C. Reactive Protein and CBC was drawn and was WNL. Child was started on steroids. Grandmother said since starting steroids symptoms have almost went completely away and child is doing much better.
Age: 1.25
Sex: M
Vaccine: DTPIPV, HEPA
Symptoms: Abnormal faeces, Diarrhoea, Faeces discoloured, Frequent bowel movements, Irritability
Clinical narrative: The night he got the vaccine he had a mild fever, very fussy and did not sleep well. Woke up fussing multiple times. The next day he started to have normal stools (solid) about 4-6 times per day and it continued and got increasingly loose. Now 8 days later he is having very THICK cottage cheese yellow/greenish/gray looking diahhrea very thick and ALOT in 1 diaper. This happens multiple times per day.
Age: 1.25
Sex: M
Vaccine: DTPIPV, HEPA
Symptoms: Middle insomnia, Poor quality sleep, Pyrexia
Clinical narrative: The night he got the vaccine he had a mild fever, very fussy and did not sleep well. Woke up fussing multiple times. The next day he started to have normal stools (solid) about 4-6 times per day and it continued and got increasingly loose. Now 8 days later he is having very THICK cottage cheese yellow/greenish/gray looking diahhrea very thick and ALOT in 1 diaper. This happens multiple times per day.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV4, MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling on right deltoid.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site atrophy, Injection site bruising, Injection site discolouration, Injection site haemorrhage, Injection site pain
Clinical narrative: Reports excessive bleeding from site, then bruising, pain. Now at 2 months s/p injection, has tissue loss and deformity to deltoid muscle, skin discoloration and intermittent pain.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Limb deformity
Clinical narrative: Reports excessive bleeding from site, then bruising, pain. Now at 2 months s/p injection, has tissue loss and deformity to deltoid muscle, skin discoloration and intermittent pain.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Nerve conduction studies normal, Pain
Clinical narrative: Ongoing left shoulder pain around vaccine injection site. Complains of area hurting to touch and increased pain with use of left shoulder.
Age: 10.0
Sex: M
Vaccine: HEP
Symptoms: Apnoea, Blood glucose decreased, Loss of consciousness, Musculoskeletal stiffness, Stress
Clinical narrative: Loss of conciousness,stiffening, loss of respiration. Respirations begun- heartbeat present.  Spontaneous respirations returned. Given juice and animal crackers.  Blood sugar 110 after those.  BP 100/70.
Age: 10.0
Sex: M
Vaccine: HEP
Symptoms: Syncope
Clinical narrative: Loss of conciousness,stiffening, loss of respiration. Respirations begun- heartbeat present.  Spontaneous respirations returned. Given juice and animal crackers.  Blood sugar 110 after those.  BP 100/70.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Contraindicated drug administered, Ophthalmic herpes zoster, Visual impairment
Clinical narrative: This spontaneous report as received from a physician via Company Representative refers to a female patient in her 80's. Patient had history of a transplant recipient (organ not specified). On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, strength, lot number and route were not reported). Patient was taking unspecified concomitant medications. Physician reported that patient received ZOSTAVAX and developed shingles on her eyelid and round her eye. The patient was diagnosed with Herpes Zoster Ophthalmicus. Physician stated that "the patient should not had received ZOSTAVAX because she was an organ transplant recipient". The patient's prior physician was the healthcare professional who prescribed the ZOSTAVAX vaccine and direct the patient to the pharmacy to received ZOSTAVAX injection. The outcome of herpes zoster ophthalmicus was not reported. It was reported that the patient received unspecified type of treatment. The physician considered that herpes zoster ophthalmicus as disability because it affected the vision. Causality was not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Contraindication to vaccination, Ophthalmic herpes zoster, Visual impairment
Clinical narrative: This spontaneous report as received from a physician via Company Representative refers to a female patient in her 80's. Patient had history of a transplant recipient (organ not specified). On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, strength, lot number and route were not reported). Patient was taking unspecified concomitant medications. Physician reported that patient received ZOSTAVAX and developed shingles on her eyelid and round her eye. The patient was diagnosed with Herpes Zoster Ophthalmicus. Physician stated that "the patient should not had received ZOSTAVAX because she was an organ transplant recipient". The patient's prior physician was the healthcare professional who prescribed the ZOSTAVAX vaccine and direct the patient to the pharmacy to received ZOSTAVAX injection. The outcome of herpes zoster ophthalmicus was not reported. It was reported that the patient received unspecified type of treatment. The physician considered that herpes zoster ophthalmicus as disability because it affected the vision. Causality was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a certified medical assistant concerning multiple unspecified patients, who on unknown dates, were vaccinated with ROTATEQ that were exposed to temperatures outside of recommended condition. No adverse events were reported. No further information was provided. This is one of four reports from the same reporter. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Injection site bruising, Injection site swelling
Clinical narrative: IMMEDIATE SWELLING AND BRUISING AT INJECTION SITE.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site reaction, Myalgia, X-ray
Clinical narrative: Left arm muscular pain persists, especially at night, left deltoid muscle, months later, I went to my doctor, X-ray was done. I am still having intermittent left deltoid muscular pain.
Age: 11.0
Sex: F
Vaccine: FLUN4, TDAP
Symptoms: Activities of daily living impaired, Cough, Dyspnoea, Eye swelling, Eyelid oedema
Clinical narrative: Per Mom via telephone on 12/18/14: On 12/13/14 patient started having the sniffles and couldn't stop sneezing.  She got progressively worse with more stuffiness, hard to breathe (due to nasal congestion not chest congestion), her eyes were tearing excessively, like she was crying, and she started to cough.  She never had a fever that her Mom was aware of but her eyes got more swollen and red "like she was crying". She never had any green or yellow discharge.  Patient was sent home from school on 12/17/14 because her eyes were red and swollen and she was sick.  This afternoon (12/18/14) her Mom states she looks like she is getting better, her eyes are puffy and a little red, like she has been crying, not like pink eye.
Age: 11.0
Sex: F
Vaccine: FLUN4, TDAP
Symptoms: Lacrimation increased, Malaise, Nasal congestion, Ocular hyperaemia, Rhinorrhoea
Clinical narrative: Per Mom via telephone on 12/18/14: On 12/13/14 patient started having the sniffles and couldn't stop sneezing.  She got progressively worse with more stuffiness, hard to breathe (due to nasal congestion not chest congestion), her eyes were tearing excessively, like she was crying, and she started to cough.  She never had a fever that her Mom was aware of but her eyes got more swollen and red "like she was crying". She never had any green or yellow discharge.  Patient was sent home from school on 12/17/14 because her eyes were red and swollen and she was sick.  This afternoon (12/18/14) her Mom states she looks like she is getting better, her eyes are puffy and a little red, like she has been crying, not like pink eye.
Age: 11.0
Sex: F
Vaccine: FLUN4, TDAP
Symptoms: Sneezing
Clinical narrative: Per Mom via telephone on 12/18/14: On 12/13/14 patient started having the sniffles and couldn't stop sneezing.  She got progressively worse with more stuffiness, hard to breathe (due to nasal congestion not chest congestion), her eyes were tearing excessively, like she was crying, and she started to cough.  She never had a fever that her Mom was aware of but her eyes got more swollen and red "like she was crying". She never had any green or yellow discharge.  Patient was sent home from school on 12/17/14 because her eyes were red and swollen and she was sick.  This afternoon (12/18/14) her Mom states she looks like she is getting better, her eyes are puffy and a little red, like she has been crying, not like pink eye.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling & redness at inj site. Patient assessed and given cold compress to area. Pt denies any other complaints.  Pt told if any other symptoms arise to seek emergent medical attn.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling and pain at site (R arm). 10 x 17 cm erythematous area with patches of induration. No pustules, discharge or streaking.
Age: 29.0
Sex: F
Vaccine: HPVX
Symptoms: Computerised tomogram, Eye pain, Facial pain, Laboratory test, Pain in jaw
Clinical narrative: Information has been received from an investigator concerning a 29 year old female patient enrolled in a study. The patient's current condition includes strawberry allergy, mitral valve prolapse and vasovagal syncope. The patient's medical history included bacterial vaginosis, cesarean and wisdom tooth extraction. On 01-MAY-2009, the patient was randomized into the base study and vaccinated with the first 0.5 ml intramuscular (IM) dose of blinded HPV V503. Subsequently, the patient was vaccinated with the second and third 0.5 ml IM doses of blinded V503 vaccine on 09-JUN-2009 and on 13-OCT-2009, respectively. The patient's status regarding the study was reported as completed. The patient continued into the next trial segment. No concomitant medications were reported. On 28-OCT-2014 (visit 14 month 60), the patient was vaccinated with the first dose of HPV vaccine 0.5 ml intramuscular in the left arm. On 29-OCT-2014, the patient experienced trigeminal neuropathy. That day, the patient complained of facial pain beginning at jaw bone radiating up to the face and behind the ear on the left side. The patient went to the emergency room (ER) on 01-NOV-2014. The patient reported a computerised tomogram (CT) scan and lab work in emergency room (results not reported). The site was waiting for medical records, which were expected by 12-OCT-2014. In the ER, the patient was prescribed TEGRETOL (04-NOV-2014 TO 19-NOV-2014) 200 mg BID PO and ROBAXIN (04-NOV-2014 to 19-NOV-2014) 500 mg PRN PO, both for left side face, jaw, eye pain. She was referred to a neurologist. Neurology visit was not expected until March 2015. The patient reported that as long as she took her medicine daily, the pain was controlled. On 19-NOV-2014, the patient recovered from trigeminal neuropathy. Follow up clinical course was pending at the time of this report. On 09-DEC-2014 (visit 15 month 62), the patient was vaccinated with the second dose of HPV vaccine 0.5 ml intramuscular in the left arm. The action taken regarding study therapy was reported as none. The reporting investigator considered trigeminal neuropathy to be related to study therapy, and not to any other suspect (concomitant) therapy. The reporting investigator considered trigeminal neuropathy to be a disabling event and to be medically significant. Additional information has been requested. Products, event and narrative sections were updated.
Age: 29.0
Sex: F
Vaccine: HPVX
Symptoms: Trigeminal nerve disorder
Clinical narrative: Information has been received from an investigator concerning a 29 year old female patient enrolled in a study. The patient's current condition includes strawberry allergy, mitral valve prolapse and vasovagal syncope. The patient's medical history included bacterial vaginosis, cesarean and wisdom tooth extraction. On 01-MAY-2009, the patient was randomized into the base study and vaccinated with the first 0.5 ml intramuscular (IM) dose of blinded HPV V503. Subsequently, the patient was vaccinated with the second and third 0.5 ml IM doses of blinded V503 vaccine on 09-JUN-2009 and on 13-OCT-2009, respectively. The patient's status regarding the study was reported as completed. The patient continued into the next trial segment. No concomitant medications were reported. On 28-OCT-2014 (visit 14 month 60), the patient was vaccinated with the first dose of HPV vaccine 0.5 ml intramuscular in the left arm. On 29-OCT-2014, the patient experienced trigeminal neuropathy. That day, the patient complained of facial pain beginning at jaw bone radiating up to the face and behind the ear on the left side. The patient went to the emergency room (ER) on 01-NOV-2014. The patient reported a computerised tomogram (CT) scan and lab work in emergency room (results not reported). The site was waiting for medical records, which were expected by 12-OCT-2014. In the ER, the patient was prescribed TEGRETOL (04-NOV-2014 TO 19-NOV-2014) 200 mg BID PO and ROBAXIN (04-NOV-2014 to 19-NOV-2014) 500 mg PRN PO, both for left side face, jaw, eye pain. She was referred to a neurologist. Neurology visit was not expected until March 2015. The patient reported that as long as she took her medicine daily, the pain was controlled. On 19-NOV-2014, the patient recovered from trigeminal neuropathy. Follow up clinical course was pending at the time of this report. On 09-DEC-2014 (visit 15 month 62), the patient was vaccinated with the second dose of HPV vaccine 0.5 ml intramuscular in the left arm. The action taken regarding study therapy was reported as none. The reporting investigator considered trigeminal neuropathy to be related to study therapy, and not to any other suspect (concomitant) therapy. The reporting investigator considered trigeminal neuropathy to be a disabling event and to be medically significant. Additional information has been requested. Products, event and narrative sections were updated.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy
Clinical narrative: This is a prospective pregnancy case. This 31-year-old female subject was enrolled in a study. The subject received Flu Seasonal QIV Dresden on 3rd October 2014. The subject's past medical history included pregnancy (2). The subject's estimated date of delivery was 1st July 2015. The subject received Flu Seasonal QIV Dresden at week 2 of the pregnancy and during the first trimester of pregnancy. On 3rd October 2014, an unknown time after receiving Flu Seasonal QIV Dresden the subject developed vaccine exposure during pregnancy (Non-serious). The outcome of the vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. Additional details provided: The nurse reported that the patient received the flu vaccine in the past without any problems. The patient had no drug allergies. The nurse reported that her colleague/patient received the FLUARIX QUAD vaccine and did not know she was pregnant. Limited information was provided. The nurse wanted to remain anonymous.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This is a prospective pregnancy case. This 35-year-old female subject was enrolled in a study. The subject received Flu seasonal TIV on 11th November 2014. The subject's estimated date of delivery was 26th May 2015. The subject received Flu seasonal TIV during the first trimester of pregnancy. On 11th November 2014, an unknown time after receiving Flu seasonal TIV the subject developed vaccine exposure during pregnancy (Non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. Additional details provided: No adverse events occurred as a result.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to multiple patients of unknown age and gender. No pertinent medical history was reported. On an unknown date, multiple patients were vaccinated with ROTATEQ (lot # K004795 and expiration date 11-FEB-2016) post supported temperature excursion. No adverse effects were reported. This is one of the several reports from the same source. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This is a prospective pregnancy case. This 31-year-old female subject was enrolled in a study. The subject received the 1st dose of Flu seasonal TIV (intramuscular) .5 ml on 6th November 2014. Concurrent medical conditions included thyroid function decreased. Concomitant products included Prenatal Vitamins and SYNTHROID. The subject's estimated date of delivery was 25th March 2015. The subject received Flu seasonal TIV at week 20 of the pregnancy and during the second trimester of pregnancy. On 6th November 2014, an unknown time after receiving Flu seasonal TIV the subject developed vaccine exposure during pregnancy (Non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. The investigator considered the vaccine exposure during pregnancy to be unrelated to Flu seasonal TIV. Additional details: No adverse events reported, the reporter was seeking to provide information for pregnancy registry. LMP was unknown.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Dizziness, Epistaxis, Vomiting
Clinical narrative: Patient stated "Late yesterday my nose stated to bleed and then I became very dizzy. Started vomiting and had serious diarrhea."
Age: 82.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Erythema, warmth, pruritus around injection site, rapidly spread down arm, treated with triamcinolone and Benadryl 50mg TID without success, seen at physician office on 12/19/14 was given prednisone taper and Avelox 400mg for 7 days.
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Dizziness, Face injury, Fall, Hyperhidrosis
Clinical narrative: Patient sat for approximately 2 minutes following injection. After standing for a short period of time, patient fell forward and hit chin/face on floor. She was unresponsive for several minutes. Pulse weak, shallow breathing. Skin pale and diaphoretic. Upon waking up, patient complained of chin and left upper arm tingling. She stated that she felt dizzy and weak before passing out and lost vision.
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Hypopnoea, Injection site reaction, Laboratory test, Pallor, Paraesthesia
Clinical narrative: Patient sat for approximately 2 minutes following injection. After standing for a short period of time, patient fell forward and hit chin/face on floor. She was unresponsive for several minutes. Pulse weak, shallow breathing. Skin pale and diaphoretic. Upon waking up, patient complained of chin and left upper arm tingling. She stated that she felt dizzy and weak before passing out and lost vision.
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Pulse pressure decreased, Unresponsive to stimuli
Clinical narrative: Patient sat for approximately 2 minutes following injection. After standing for a short period of time, patient fell forward and hit chin/face on floor. She was unresponsive for several minutes. Pulse weak, shallow breathing. Skin pale and diaphoretic. Upon waking up, patient complained of chin and left upper arm tingling. She stated that she felt dizzy and weak before passing out and lost vision.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Eye pain, Eye pruritus, Fatigue, Headache
Clinical narrative: Dizzy light headed sore and itchy eyes really red headache and fatigue I layed down in bed and trayed to relax and weight for the symptoms to go away I took ibuprofen for the aches and pain.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Hypersensitivity, Ocular hyperaemia, Pain
Clinical narrative: Dizzy light headed sore and itchy eyes really red headache and fatigue I layed down in bed and trayed to relax and weight for the symptoms to go away I took ibuprofen for the aches and pain.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Chills, Dizziness, Nausea
Clinical narrative: Significant dizziness, nausea, chills and overall weakness.
Age: 6.0
Sex: F
Vaccine: HEP
Symptoms: Crying, Fall
Clinical narrative: Approximately 5 minutes after injection, patient fell down with Nanny in hallway while Dad and sibling were still in exam room with CMA discussing WIR record of sibling. Patient was very still with eyes open and began crying.  RN escorted patient to exam room (she was able to walk) for further examination by RN and PCP and vitals were recorded.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Balance disorder, Dizziness
Clinical narrative: Dizziness and imbalance upon rising from bed.
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Patient called pharmacy 12/19/14 and reported adverse event occurring later in the evening on the day the vaccine- Pneumovax- was administered (started 12/18/14). Severe pain at injection site with pain radiating down sides of arm. Went to bed and slept without a problem, woke up in the morning still with arm pain but it had improved. Called pharmacy to report. Counseled patient to take Tylenol and ice arm 12/19/14. Called patient's primary MD to report adverse event 12/19/14.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Diarrhoea, Faeces discoloured, Frequent bowel movements
Clinical narrative: Profuse watery brownish green diarrhea, up to 10 episodes daily, lasted almost 4 weeks.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Oral mucosal eruption, Vomiting
Clinical narrative: Area of injection red and quite swollen - thigh noticeably larger than other leg. Next day vomited twice.  Rash around mouth.
Age: 1.55
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Diarrhoea, Rash, Rubella antibody test
Clinical narrative: Rash and diarrhea (family member with report of MMR).
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Patient arrived at pharmacy on 12/19/14 with complaints of redness, soreness, and swelling around injection site of Zostavax administered on 12/17/14. PharmD observed approximately 3 inch by 3 inch area on arm above elbow that was red, and swollen.  I advised patient that this is most likely an inject site reaction and to apply cold compresses and possibly take an antihistamine. I informed patient that I would write a store incident report and report event to VAERS.
Age: 7.0
Sex: F
Vaccine: FLUN4
Symptoms: Incorrect dose administered, Vaccination error
Clinical narrative: Patient was given Flu Mist & she has asthma.  She had the flu shot by her Pediatrician, 9/29/14.  This nurse went to the school to give Flu Mist & wrong student was asked to come to the office.  This nurse did not ask her her name.  Mom called @ 4:00 PM asking why her daughter had a Flu Mist.  This nurse called Dr. & his nurse told me to tell Mom to give patient Fluvent treatments bid over the weekend. If child wheezes to give albuterol rescue treatment.  This nurse gave Mom her phone # for her to call if any questions; and Dr's nurse said she could call them if any questions.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Myalgia
Clinical narrative: Otherwise unexplained joint/muscle pain, i.e. no unusual physical exertion, shoulder socket, hip, knee, wrist. Muscle soreness next day after minor exertion. Ongoing issue.
Age: 64.0
Sex: F
Vaccine: FLUX, PNC
Symptoms: Myelitis transverse, Paraplegia
Clinical narrative: Tranverse myelitis with paraplegia.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: Intermitent shoulder pain with activity in the arm that vaccine was administered.
Age: 1.01
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left side injection site (from varicella) erythematous and raised (occurred 10 days after injection).
Age: 61.0
Sex: F
Vaccine: DTAP
Symptoms: Diarrhoea, Erythema, Mobility decreased, Pain, Pyrexia
Clinical narrative: Pt called center medical staff 3 days after injection to report severe swelling, pain, redness, limited movement of arm, hot feeling to arm, fever and diarrhea for the last 48 hrs.
Age: 61.0
Sex: F
Vaccine: DTAP
Symptoms: Skin warm, Swelling
Clinical narrative: Pt called center medical staff 3 days after injection to report severe swelling, pain, redness, limited movement of arm, hot feeling to arm, fever and diarrhea for the last 48 hrs.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Infection, Injection site swelling, Myalgia, Pain
Clinical narrative: SEVERE HEADACHE, BODYACHE, AND ARM MUSCLE PAIN.  ARM WHERE SHOT WAS GIVEN WAS VISIBLY SWOLLEN.
Age: 26.0
Sex: F
Vaccine: TYP
Symptoms: Diarrhoea, Muscular weakness, Myalgia, Nausea, Pyrexia
Clinical narrative: Local muscle soreness - 12 hours. At 08:00 AM on 12/19/2014 onset of 101 degree fever, nausea, vomiting, diarrhea, generalized muscle pain and weakness. Symptoms still present at time of report, no treatment administered at this time.
Age: 26.0
Sex: F
Vaccine: TYP
Symptoms: Vomiting
Clinical narrative: Local muscle soreness - 12 hours. At 08:00 AM on 12/19/2014 onset of 101 degree fever, nausea, vomiting, diarrhea, generalized muscle pain and weakness. Symptoms still present at time of report, no treatment administered at this time.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Allergy test, Cough, Hypoaesthesia, Local swelling, Ocular hyperaemia
Clinical narrative: Dry cough at first then lower jaw went numb and felt as if it was swelling, white of eyes turned blood red.
Age: 1.0
Sex: M
Vaccine: FLUX, MMR, PPV, VARCEL
Symptoms: Pyrexia, Rash generalised, Rash morbilliform
Clinical narrative: Fever, generalized measles type rash.
Age: 63.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Deafness unilateral, Ear irrigation
Clinical narrative: Left ear plugged.
Age: 63.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Ear congestion
Clinical narrative: Left ear plugged.
Age: 0.29
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying
Clinical narrative: Crying for 4 hours after injection, resolved with sleep.
Age: 4.0
Sex: F
Vaccine: FLU3, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Noted redness and swelling on left thigh yesterday. Today is 6 cm in diameter, warm, firm to touch. Will use ice/cool packs and BENADRYL as needed. (Was seen in office by PAC today).
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling, Staphylococcal infection
Clinical narrative: Pt given flu shot on 11/25/14. States her arm was red and swollen a few days later. Pt went to a local ER and was given antibiotics. Pt was then seen by a family doctor who diagnosed as staph infection.
Age: 83.0
Sex: M
Vaccine: FLU3
Symptoms: Contusion, Injection site bruising
Clinical narrative: Per pt, he developed bruises on the injection site as well as on chest areas. He had to go to ER. FYI: (Pt is on 81 mg aspirin).
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Myalgia
Clinical narrative: Pt. has received Inflluenza vaccine on 10/21/14 and PNEUMOVAX on 10/22 and after about 40 days of getting these vaccine complaining of having muscle pain at the site of injection.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling hot, Hyperhidrosis
Clinical narrative: Received flu shot on 12/1/14, after an hour of injection she became hot, sweating with pulse at 130, patient did not receive vaccine at our office. Patient reported through online portal.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse concerning a patient of unknown age. On an unknown date the patient was vaccinated with ROTATEQ, oral. On an unknown date the patient received a second and third dose only one week apart. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a certified medical assistant concerning multiple unspecified patients, who on unknown dates, were vaccinated with GARDASIL that were exposed to temperatures outside of recommended condition. No adverse events were reported. No further information was provided. This is one of four reports from the same reporter. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Area around vaccine swollen, red, hot, painful.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. From on unknown date in February 2014, the patients were vaccinated with M-M-R II (strength, dose, route of administration and lot # were not reported). This vaccine was exposed to unknown temperatures. The reporter was not aware of any adverse effects. This is one of several reports received 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 was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. From on unknown date in February 2014, the patients were vaccinated with GARDASIL (strength, dose, route of administration and lot # were not reported). This vaccine was exposed to unsupported storage temperatures. The reporter was not aware of any adverse effects. 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 was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. From an unknown date in February 2014, the patients were vaccinated with VARIVAX (Merck) (strength, dose, route of administration and lot # were not reported). This vaccine was exposed to unknown temperatures. The reporter was not aware of any adverse effects. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, No therapeutic response
Clinical narrative: This spontaneous report as received from a registered nurse refers to a currently 20 year old no pregnant female patient with no drug reactions or allergies and no pertinent medical history who on unknown date when was an infant was vaccinated with RECOMBIVAX HB (2.5 mcg/ 0.5 ml) (lot #, expiration date and route were not reported). There was no concomitant medication. Recently she was tested for hepatitis b antibodies and the results showed the patient was non-immune, so the patient was revaccinated with two adult doses of RECOMBIVAX HB (lot #, expiration date and route were not reported). The patient was "non-responder". It was unknown if the patient sought medical attention. The outcome of the adverse events was not recovered. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Postural orthostatic tachycardia syndrome
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. Medical history and concurrent conditions were not provided. On 09-DEC-2013, the patient was vaccinated with a first dose of GARDASIL lot # J013777, expiry date 11-AUG-2016 (dose and route were not reported). On 15-MAY-2014, the patient was vaccinated with a second dose of GARDASIL lot # J013777, expiry date 11-AUG-2016 (dose and route were not reported). The reporter stated that the patient developed postural orthostatic tachycardia syndrome after receiving GARDASIL (exact date not provided). The outcome of the patient developed postural orthostatic tachycardia syndrome was reported as not recovered. Relatedness between the therapy with GARDASIL and the event: postural orthostatic tachycardia syndrome was not reported. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site pain, Pain
Clinical narrative: Redness, tenderness, sore at injection site. Chills, body ache.
Age: 1.1
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Pt was given MMR, VARIVAX, Hep A 11/14/14. Pt was inadvertently given MMR, VARIVAX, Hep A 12/19/14.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information ha been received from a physician concerning an unspecified patient (age and gender not provided), who was vaccinated with ZOSTAVAX (date of vaccination, dosage, and route of administration not provided). On an unspecified date, the patient developed shingles. The outcome of the shingles was not provided. No additional information currently available. This is one of two reports from this physician (see case # 1412USA000930). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event, Syringe issue
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Medical history and concurrent conditions were not provided. On 09-DEC-2014, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot number and expiry date were not reported). There was no concomitant medication reported. The pharmacist reported that the ZOSTAVAX leaked from where the needle was connected to the barrel of the syringe while administering to a patient and patient did not receive the full dose of ZOSTAVAX. No adverse effect was reported. The outcome of the event was unknown. Additional information is not expected, because the reporter refused additional contact.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Nurse reported that the patients were administered improperly stored doses o PEDVAXHIB (doses, route, lot numbers and expiration dates were not provided) on unspecified dates since 13-DEC-2014. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a certified medical assistant concerning multiple unspecified patients, who on unknown dates, were vaccinated with RECOMBIVAX HB (0.5 ml, once, intramuscularly) that were exposed to temperatures outside of recommended condition. No adverse events were reported. No further information was provided. This is one of four reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Patient's concurrent conditions and relevant medical history was not reported. On 17-DEC-2014 the patient was inadvertently vaccinated with (Merck) VARIVAX, subcutaneously instead of (Merck) ZOSTAVAX. Concomitant medications were not reported. The outcome of the events was unknown. The causality of the events with (Merck) VARIVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to multiple patients of unknown age and gender. No pertinent medical history was reported. On an unknown date, multiple patients were vaccinated with RECOMBIVAX HB (lot # J009051 and expiration date 26-MAR-2016) dose 0.5 ml, subcutaneous injection post supported temperature excursion. No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of the several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a female patient of unknown age. The nurse reported that a patient who received a dose of PNEUMOVAX 23, 0.5 ml, intramuscular on 29-JAN-2014, received a second dose of PNEUMOVAX 23, 0.5 ml, intramuscular on 01-NOV-2014. No adverse effect reported. No other information is available at this time. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to multiple patients of unknown age and gender. No pertinent medical history was reported. On an unknown date, multiple patients were vaccinated with VAQTA (lot # J009051 and expiration date 22-SEP-2016, reported as 20-SEP-2016) post supported temperature excursion. No adverse effects were reported. This is one of the several reports from the same source. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: This is a prospective pregnancy case. This 31-year-old female subject was enrolled in a study. The subject received BOOSTRIX .5 ml on an unknown date. The subject received BOOSTRIX at week 31 of the pregnancy and during the third trimester of pregnancy. On an unknown date, an unknown time after receiving BOOSTRIX the subject developed vaccine exposure during pregnancy (Non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. Additional details provided: the patient did not experience any adverse reactions.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 68 year old female patient with high cholesterol and without any drug reactions or allergies. On 28-NOV-2014 the patient was vaccinated with a dose of ZOSTAVAX (subcutaneous injection, lot # K009772, expiration date 09-OCT-2015, dose and frequency were not reported). Concomitant therapies included VYTORIN, meloxicam (manufacturer unknown) and zolpidem tartrate (manufacturer unknown). On 29-NOV-2014 the patient experienced redness at the ZOSTAVAX injection site. On 30-NOV-2014 the patient experienced swelling and warmth at the ZOSTAVAX injection site. Patient sought medical attention by calling the pharmacist. No laboratory tests were performed. No treatment was given for the adverse events. The swelling resolved on 02-DEC-2014. The outcome of redness and warmth at the ZOSTAVAX injection site was reported as recovering/resolving. Relatedness between swelling, redness and warmth at the ZOSTAVAX injection site and ZOSTAVAX was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Feeling abnormal, Pallor, Syncope
Clinical narrative: This spontaneous report was received from patient's mother concerning her daughter, a female patient of unknown age. Patient's concurrent conditions and relevant medical history was not reported. On 16-DEC-2014 the patient was vaccinated with GARDASIL (dose and route unspecified). Concomitant medications were not reported. On the same day of vaccination, the patient experienced syncope. The patient became pale, light headed and felt like passing away. The outcome of syncope was unknown. The causality of the event with GARDASIL was not reported. Additional information has been requested.