chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Exposure during pregnancy, Injection site erythema
Clinical narrative: This spontaneous prospective pregnancy report was received from registered nurse refers to a female patient of unknown age. On 04-APR-2013, the patient was vaccinated with a dose of ZOSTAVAX, (lot number, expiry date and route not reported). On an unknown date, the patient had quarter size reddened area at injection site. The patient was found to be pregnant. The estimated date of conception was on 17-JUL-2012. The patient enquired if it was safe to have contact with 1 and half year old and a new born expected on April 9th (estimated due date). The outcome of the event was unknown. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain upper, Vomiting
Clinical narrative: Stomach cramps. Vomiting 6 hrs after 4th/last pill. Symptoms disappeared.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from health care worker refers to 4 unspecified patients of unknown age. On 06-APR-2013, the patients were vaccinated with a dose of 0.5 ml GARDASIL, (lot number, expiry date was not reported and route was intramuscular) and could not support the temperatures they went down to. Concomitant medications were not reported. No adverse reactions were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a health care student refers to a patient of unknown age. In July 2011, the patient was vaccinated with GARDASIL dose 1. Lot number, expiration date, anatomical location and route of administration were not reported. On 05-APR-2013 the patient was vaccinated with GARDASIL dose 2. Lot number, expiration date, anatomical location and route of administration were not reported. No adverse event was reported, treatment information was not reported. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Urticaria
Clinical narrative: Rec'd vaccinations at approx 9-10 a.m. Started breaking out in hives over chest area and back and legs at 500 p.m. Went to ER and rec'd BENADRYL I.V.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Chills, Erythema, Pyrexia, Swelling
Clinical narrative: Swelling; Erythema; Fever; Chills; Poly arthralgia.
Age: 19.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Dizziness, Dyskinesia, Loss of consciousness, Pallor
Clinical narrative: Hep A vaccine administered in (R) delt, Tdap administered in (L) delt. Pt was sitting during injections and remained sitting after injections. Approx. 3-5 minutes after injections pt became pale, dizzy and proceeded to pass out. Pt awoke after approximately 30 sec. Pt's (R) arm and (R) leg made jerking motions while pt was passed out. Pt then woke up was alert and oriented. Laid down for approximately 5 minutes, then drank apple juice and sat up approximately 10 minutes. Pt then felt he was recovered completely.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient called 48 hours after receiving injection and complained of "redness, round, long and heat" at the injection site of the outer part of the left arm. She made a doctor's visit and she was being treated with antibiotics by Dr. Spoke to physician's nurse and she confirmed the treatment and that the patient will do well.
Age: 0.34
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Auricular swelling, Rash macular
Clinical narrative: Patient woke up from nap with blotchy red spots, swollen ears. No fever.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis of injection site treated with NSAIDs, cold packs.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Candidiasis, Pyrexia, Rash, Vaccination complication
Clinical narrative: Mother states rash developed first to left leg on 3/20 and then spread to right leg and pelvis 3/21. Mother states blisters developed in mouth and fever of 101 developed on 3/22. Mother states fever of 101 still present on 3/23 but that rash began to fade. Fever of 101 still present on 3/24 but that rash was gone. Denies fever on 3/25. Seen in ER on 3/22 and diagnosed with thrush. ER record denies rash with ROS and physical exam reports skin as free of rashes. ER told mom rash was reaction to vaccine.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Convulsion
Clinical narrative: This spontaneous report as received from a nurse practitioner via company representative refers to a 15 years old female patient. Approximately on an unknown date in December 2012 (reported as 4-5 months ago), the patient was vaccinated with a first dose of GARDASIL (Lot number, expiry date were not reported) 0.5 milliliter (ml) (reported as standard dose), intramuscular. Concomitantly the patient also received HAVRIX in the same visit on the opposite arm. Approximately on an unknown date in December 2012, the patient developed short seizure after receiving her first dose of GARDASIL. The event occurred in the office. No treatment was provided for the event. On an unknown date, the event short seizure was recovered/resolved. Upon internal review the event short seizure was considered as medically significant. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injury associated with device, Needle issue
Clinical narrative: Needle tip broke off (bevel area) and was discovered when trying to penetrate skin. Needle was blunted and left tiny circular mark on arm - piece of bevel seen in MMR vial and in stopper. New dose drawn up and given - prev. dose wasted.
Age: 24.0
Sex: F
Vaccine: FLU3, TDAP, FLU3, TDAP, FLU3, TDAP
Symptoms: Blood test, Chest X-ray, Muscle twitching, Oedema peripheral, Urine analysis
Clinical narrative: Bilateral edema of legs from knee down, with 10 lb weight gain. Muscle twitching noted during fluctuating weight loss period. Employee is still in process of weight loss. PMD in process of performing blood and urine testing.
Age: 24.0
Sex: F
Vaccine: FLU3, TDAP, FLU3, TDAP, FLU3, TDAP
Symptoms: Weight increased
Clinical narrative: Bilateral edema of legs from knee down, with 10 lb weight gain. Muscle twitching noted during fluctuating weight loss period. Employee is still in process of weight loss. PMD in process of performing blood and urine testing.
Age: 24.0
Sex: F
Vaccine: FLU3, TDAP, FLU3, TDAP, FLU3, TDAP
Symptoms: Blood test, Chest X-ray, Muscle twitching, Oedema peripheral, Product quality issue
Clinical narrative: Bilateral edema of legs from knee down, with 10 lb weight gain. Muscle twitching noted during fluctuating weight loss period. Employee is still in process of weight loss. PMD in process of performing blood and urine testing.
Age: 24.0
Sex: F
Vaccine: FLU3, TDAP, FLU3, TDAP, FLU3, TDAP
Symptoms: Urine analysis, Weight increased
Clinical narrative: Bilateral edema of legs from knee down, with 10 lb weight gain. Muscle twitching noted during fluctuating weight loss period. Employee is still in process of weight loss. PMD in process of performing blood and urine testing.
Age: 24.0
Sex: F
Vaccine: FLU3, TDAP, FLU3, TDAP, FLU3, TDAP
Symptoms: Weight fluctuation, Weight increased
Clinical narrative: Bilateral edema of legs from knee down, with 10 lb weight gain. Muscle twitching noted during fluctuating weight loss period. Employee is still in process of weight loss. PMD in process of performing blood and urine testing.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report has been received from a pharmacist, concerning a 66 year old obese, and retired female patient with current conditions of hypertension, hyperlipidaemia, Crohn's disease and obesity. On 04-JAN-2013 at 11:00, the patient received the first dose of ZOSTAVAX (lot number H020000) (dose not reported, subcutaneous route). No concomitant medications were reported. The patient did not have any illness at time of vaccination. On 08-JAN-2013 at 10:00 a.m., a few days after receiving the vaccine, the patient developed mild shingles outbreak across upper lip. The patient required emergency room/doctor visit and received a prescription of ZOVIRAX from primary doctor. At the time of the report the patient's outcome was recovered. This case is linked to MARRS 1212USA011063. Additional information is not expected.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Influenza virus test negative, Pain, Pyrexia
Clinical narrative: 4/8 - Nurse received phone call from pt's spouse stated pt woke up with a high fever and chills. Sat 4/6 ached all over. Pt still running fever on 4/8 still aching. RN encouraged spouse so take pt to provider.
Age: 21.0
Sex: F
Vaccine: TD
Symptoms: Movement disorder, Unresponsive to stimuli
Clinical narrative: 10-15 second episode - unresponsiveness to verbal stimuli, flexion of torso and all extremities with turning of upper extremities medially. Pt claims previous similar episodes had work-up at facility. Referred to ER.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Pain in extremity, Pruritus
Clinical narrative: Vaccinated on 4-1-13, pain in Rt arm next day. On 4-3-13 noted marked erythema over injection site, some pain and itching. Today 4/4/13 noted 7 1/2 x 8 1/2 cm induration with overlying erythema on Rt arm injection site. No adenopathy.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 1.08
Sex: M
Vaccine: FLU3, HEPA, MMR, PNC13, VARCEL
Symptoms: Rash
Clinical narrative: Pt came in to get 12 month W.C.C. & got 12 month vaccines. Pt was waiting in exam room as instructed for 15 minutes to ensure no adverse events when pt developed a rash on the face. Temp normal, breathing normal. BENADRYL 12.5mg/5ml (1.25 ml) given to pt.
Age: 1.08
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Convulsion, Pyrexia
Clinical narrative: Patient presented with seizures x 2 times and high fever.
Age: 1.14
Sex: M
Vaccine: DTAP, FLU3, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Angiogram pulmonary normal, Rash papular
Clinical narrative: 1-25-13 after 15 min of monitoring post vaccines - observed mild spotty rash on face only (1-2 m papules erythematous scattered sparsely over face). No other areas of body were affected. Lung CTA bilaterally unaffected, breathing unaffected. Exam otherwise unchanged. Mom was instructed to monitor closely & seek medical help if worsening sx. Mom expresses understanding and agrees. 1-30-13 Nurse called mom states rash went away no other sx.
Age: 32.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Left arm pain two days after redness, swelling, pain at site of injection.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Nodule, Swelling
Clinical narrative: Raised red knot with burning.
Age: 1.26
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site papule
Clinical narrative: (R) upper thigh 1 cm cluster of erythematous papules. Will observe for now, monitor for signs of infection.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: Erythematous flat lesion 3 x 2.5 irregular area (L) lower arm without other symptom. Rash developed 3 days post injection.
Age: 3.0
Sex: M
Vaccine: HEP
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Rash, Rash generalised
Clinical narrative: Pt developed large area of erythema, edema, induration at injection site, same day hours later. Day 3 post injection pt developed rash on arm and at one week pt had diffuse body rash. Pt received telephone triage on day 3 and reported to RN and MD at PCP 4-3-13.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Abnormal behaviour, Atrial fibrillation, Crying, Depressed mood, Hypothyroidism
Clinical narrative: I received the ZOSTAVAX vaccine at the office on November 14, 2012. At first a slight swelling of the left arm (site of injection area) was noted a gradually warmth was felt over a 6-12 hr period. A few days (just before a scheduled appointment with my primary physician I noticed I seemed a little saddened not so obviously so, but I felt "down". At the doctor's office while awaiting his entrance I shook my head at the nurse's question of how I felt that I did not feel "well". Dr's entrance was enough to make me completely silent, looking downward and tearing up very profusely - there was no reason for this behavior and he sat close to me and asked what was the problem - he had never in 17 years ever experienced this person - nor had I ever behaved so unusually. I was finally able to utter that I didn't feel well that I was sad over what I didn't know. He advised me to go home lie down and breathe deeply and whole forcibly and to return the next day. At home I began reading over the information sheet that was supplied me at the health clinic as I was vaccinated and realized that I had had a reaction to the vaccination. When I saw Dr and related what I believed had happened he questioned me further and we both agreed that I do seem very sensitive to many medications - ie penicillin, vancomycin, DEMEROL and a host of others. The extra rest and deep breathing and explosive exhalation did aide me but intuitively the understanding of possible reaction to the vaccine seemed the correct answer. I have been diagnosed with atrial fibrillation and have had thyroid cancer with complete recovery but naturally am hypothyroid and require medication for that loss. I believe this "note" will have answered questions # 7, 18, 19 and 21. A year before November 2012 I had a very light case of the shingles which did not produce the "usual" painful after effects that I understand is very common and usual and can last for years. I have no other recollections of the adverse reaction of a "melt down" as I had with the vaccination and have not had any repeat performance since. I don't feel any further after affects and believe this was just one of those strange occurrences. Dr did not have to prescribe any medication at the time of the occurrence and we are both content to know it was just one of those occurrences - no need to test or prescribe further. If there is further need for information just keep me informed.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Malaise, Vaccination complication
Clinical narrative: I received the ZOSTAVAX vaccine at the office on November 14, 2012. At first a slight swelling of the left arm (site of injection area) was noted a gradually warmth was felt over a 6-12 hr period. A few days (just before a scheduled appointment with my primary physician I noticed I seemed a little saddened not so obviously so, but I felt "down". At the doctor's office while awaiting his entrance I shook my head at the nurse's question of how I felt that I did not feel "well". Dr's entrance was enough to make me completely silent, looking downward and tearing up very profusely - there was no reason for this behavior and he sat close to me and asked what was the problem - he had never in 17 years ever experienced this person - nor had I ever behaved so unusually. I was finally able to utter that I didn't feel well that I was sad over what I didn't know. He advised me to go home lie down and breathe deeply and whole forcibly and to return the next day. At home I began reading over the information sheet that was supplied me at the health clinic as I was vaccinated and realized that I had had a reaction to the vaccination. When I saw Dr and related what I believed had happened he questioned me further and we both agreed that I do seem very sensitive to many medications - ie penicillin, vancomycin, DEMEROL and a host of others. The extra rest and deep breathing and explosive exhalation did aide me but intuitively the understanding of possible reaction to the vaccine seemed the correct answer. I have been diagnosed with atrial fibrillation and have had thyroid cancer with complete recovery but naturally am hypothyroid and require medication for that loss. I believe this "note" will have answered questions # 7, 18, 19 and 21. A year before November 2012 I had a very light case of the shingles which did not produce the "usual" painful after effects that I understand is very common and usual and can last for years. I have no other recollections of the adverse reaction of a "melt down" as I had with the vaccination and have not had any repeat performance since. I don't feel any further after affects and believe this was just one of those strange occurrences. Dr did not have to prescribe any medication at the time of the occurrence and we are both content to know it was just one of those occurrences - no need to test or prescribe further. If there is further need for information just keep me informed.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: 4/2/13 1:30 Pm Severe Pain in Left Arm and could not move arm because of the pain. Pain 12 on 0-10 scale 4/3/13 went to PCP in the morning around 10 AM 4/9/13 pain still and difficulty moving arm. Pain 6 on 0-10 scale
Age: 40.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Arthralgia, Generalised erythema, Influenza like illness
Clinical narrative: Started to feel flu like symptoms which proceeded to get get with severe joint pains. on 04/07/2013 appeared to get measle like looking errythema over entire body.
Age: 40.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Arthralgia, Measles, Mobility decreased, Pyrexia
Clinical narrative: Started to feel flu like symptoms which proceeded to get get with severe joint pains. on 04/07/2013 appeared to get measle like looking errythema over entire body.
Age: 43.0
Sex: F
Vaccine: RAB
Symptoms: Body temperature increased, Dysphagia, Full blood count, Mobility decreased, Nausea
Clinical narrative: 3/27/13 Patient awoke with neck pain, neck pain continued to get worse 3/28 & 29 as well as some difficulty in swallowing although no sore throat was noted, she had difficulty bending her neck as well, 3/30 she began with vomiting, nausea and low grade (100 degree F.) temp. She went to ER and received oral PCN which she could not take due to vomiting and had a CBC done. 4/1 she called HD and CHN called Vaccine Hotline at CDC. Call was transferred to pox virus and rabies branch of CDC. On 4/4 hotline consultant returned phone call to CHN and put her in touch with Dr. at pox virus and rabies branch. Consutation with Dr. stated that patient needed to consult with her own physician for medical evaluation and to determine if pre-exposure treatment should continue at patient works in a vetinary hospital. Patient was advised and was recovered.
Age: 43.0
Sex: F
Vaccine: RAB
Symptoms: Neck pain, Vomiting
Clinical narrative: 3/27/13 Patient awoke with neck pain, neck pain continued to get worse 3/28 & 29 as well as some difficulty in swallowing although no sore throat was noted, she had difficulty bending her neck as well, 3/30 she began with vomiting, nausea and low grade (100 degree F.) temp. She went to ER and received oral PCN which she could not take due to vomiting and had a CBC done. 4/1 she called HD and CHN called Vaccine Hotline at CDC. Call was transferred to pox virus and rabies branch of CDC. On 4/4 hotline consultant returned phone call to CHN and put her in touch with Dr. at pox virus and rabies branch. Consutation with Dr. stated that patient needed to consult with her own physician for medical evaluation and to determine if pre-exposure treatment should continue at patient works in a vetinary hospital. Patient was advised and was recovered.
Age: 19.0
Sex: F
Vaccine: ADEN_4_7, DTAP, FLU3, HEPAB, MNQ
Symptoms: Erythema, Pruritus
Clinical narrative: itching sensation and erythema. Treatment administered: Benedryl 50mg at 12:02PM. oxygen at 8L via non-rebreather
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Burning sensation, Pruritus, Rash erythematous, Swelling
Clinical narrative: Raised red rash, burns, itches, 2"x 1" oval, slight swelling. No treatment. 11:30 A.M.
Age: 28.0
Sex: M
Vaccine: ADEN_4_7, DTAP, FLU3, HEPAB, MNQ
Symptoms: Flushing, Rash, Urticaria
Clinical narrative: Rash, hives, wheals, flushed. Benedryl 25mg at 10:18am. benedryl 25mg 10:32 am.
Age: 30.0
Sex: F
Vaccine: HEPA
Symptoms: Erythema, Erythema nodosum, Hypersensitivity, Pain, Pyrexia
Clinical narrative: Body had felt sore all day I figured it was from the cold. Got home from work and took a bath and that when I started seeing red welts forming on the skin. On April 6th at 8 PM went to the emergency room where I saw a doctor who said I had an allergic reaction to the hepatitis a shot. Diagnosed me with erythema nodosum. Prescribed me Motrin and sent me on my way. I have red welts all over my legs and arms. They are very painful. I have had a fever for 5 days now on and off.
Age: 30.0
Sex: F
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Body had felt sore all day I figured it was from the cold. Got home from work and took a bath and that when I started seeing red welts forming on the skin. On April 6th at 8 PM went to the emergency room where I saw a doctor who said I had an allergic reaction to the hepatitis a shot. Diagnosed me with erythema nodosum. Prescribed me Motrin and sent me on my way. I have red welts all over my legs and arms. They are very painful. I have had a fever for 5 days now on and off.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Pain, Paraesthesia, Pruritus
Clinical narrative: Pt reported blisters on the vaginal and rectal area. Pt experienced pain, itching, burning and tingling.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Musculoskeletal stiffness, Pain, Swelling
Clinical narrative: Symptoms: severe stiffness and swelling, followed by redness around injection site. These symptoms increased in strength to excruciating pain due to any movement of right shoulder. Used ice packs, heat, Tylenol, ibuprofen with no relief. I suffer from chronic pain of the back, so I am used to dealing with pain. This pain is severe and debilitating. Any movement of the arm or shoulder is excruciating. The only relief comes from immobilizing the area, and then it's only temporary.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13
Symptoms: Apnoea test, Cough, Cyanosis, Dyspnoea, Laboratory test normal
Clinical narrative: BREATHING HARD,OCC COUGH, SOME CYANOSIS(STOPPED BREATHING),NO FEVER
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13
Symptoms: Respiratory arrest, Respiratory syncytial virus test negative
Clinical narrative: BREATHING HARD,OCC COUGH, SOME CYANOSIS(STOPPED BREATHING),NO FEVER
Age: 14.0
Sex: F
Vaccine: HPV4, TYP
Symptoms: Alopecia areata
Clinical narrative: Dx-Alopecia Areata post 1 month of HPV inj.
Age: 0.52
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Abnormal behaviour, Childhood disintegrative disorder, Convulsion, Decreased eye contact, Electroencephalogram normal
Clinical narrative: Patient fell asleep shortly after having the vaccination. When I came home from work at 11pm it was difficult to wake her. She had a 104 fever. When I did manage to wake her she was making strange fish like motions with her mouth, couldn't seem to make eye contact and acted almost intoxicated, dizzy and completely out of it. We took her to the emergency room where they gave her a fever reducer. Four hours later when we finally saw a doctor she seemed better. The next day we noticed her having spacing episodes which we were later told were seizures. She no longer made eye contact, would no longer self feed or try to sit up. She regressed back to being a baby for 3 months. By the time we got an EEG and MRI scheduled the spacing episodes had subsided. The EEG and MRI were normal. She continues to have developmental delay, poor eye contact, and no speech. No ability to communicate, follow direction, or play constructively. She is walking, but very clumsy.
Age: 0.52
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Feeling abnormal, Foaming at mouth, Gait disturbance, Nuclear magnetic resonance imaging normal, Pyrexia
Clinical narrative: Patient fell asleep shortly after having the vaccination. When I came home from work at 11pm it was difficult to wake her. She had a 104 fever. When I did manage to wake her she was making strange fish like motions with her mouth, couldn't seem to make eye contact and acted almost intoxicated, dizzy and completely out of it. We took her to the emergency room where they gave her a fever reducer. Four hours later when we finally saw a doctor she seemed better. The next day we noticed her having spacing episodes which we were later told were seizures. She no longer made eye contact, would no longer self feed or try to sit up. She regressed back to being a baby for 3 months. By the time we got an EEG and MRI scheduled the spacing episodes had subsided. The EEG and MRI were normal. She continues to have developmental delay, poor eye contact, and no speech. No ability to communicate, follow direction, or play constructively. She is walking, but very clumsy.
Age: 0.52
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Somnolence, Speech disorder developmental
Clinical narrative: Patient fell asleep shortly after having the vaccination. When I came home from work at 11pm it was difficult to wake her. She had a 104 fever. When I did manage to wake her she was making strange fish like motions with her mouth, couldn't seem to make eye contact and acted almost intoxicated, dizzy and completely out of it. We took her to the emergency room where they gave her a fever reducer. Four hours later when we finally saw a doctor she seemed better. The next day we noticed her having spacing episodes which we were later told were seizures. She no longer made eye contact, would no longer self feed or try to sit up. She regressed back to being a baby for 3 months. By the time we got an EEG and MRI scheduled the spacing episodes had subsided. The EEG and MRI were normal. She continues to have developmental delay, poor eye contact, and no speech. No ability to communicate, follow direction, or play constructively. She is walking, but very clumsy.
Age: 53.0
Sex: F
Vaccine: SMALL
Symptoms: Erythema, Rash generalised, Rash macular, Skin warm
Clinical narrative: Developed a fine bright red macular rash on face, neck, arms, chest, back and thighs resembled a sun burn.   Palms of hands and ears were cherry red.   Skin felt warm to touch but no Temp. No itching.  No difficulty breathing. No enlarged lymph nodes. Treated with Benadryl which resolved some of the redness, but it reoccurred within 6 hours. Seen at facility told to continue on Benadryl or Claritin.
Age: 29.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal pain
Clinical narrative: Patient indicated on 11/20/12 had shoulder pain from receiving flu shot. Left shoulder rating a 9/10.  Has been in to clinic with continued pain.
Age: 66.0
Sex: F
Vaccine: TD
Symptoms: Abasia, Blister, Pain, Rash
Clinical narrative: After shingle vaccine, 2 days later I felt painful rash underneath my both foot...painful blister..can't walk. I am unable to visit a doctor. I have no health insurance.
Age: 0.36
Sex: F
Vaccine: DTAPIPVHIB, RV5
Symptoms: Blood test normal, Convulsion, Electrocardiogram normal, Electroencephalogram, Eye movement disorder
Clinical narrative: Was sleeping in carseat and when we got home she awoke and began to go into a seizure.  Lasted about 30 seconds or so (just a guess).  Eyes rolled back and to the right, tongue spasmed, and mouth twitched.  We took her to the ER at a hospital and she was evaluated, ran bloodwork, and EKG.  All were normal.  When we were getting ready to leave (around 3:30 a.m. on March 20, 2013), she had another seizure that lasted 1.5 minutes with the same symptoms listed above except her eyes went back and forth before rolling up.  At that point she was admitted.  During EEG she had another seizure (around 9:00 AM) with the same symptoms as in ER and it lasted just over 3 minutes.  Then had another seizure at 10:55 AM when Neurologist was examining her.  Lasted about 2 minutes and had same symptoms as in ER except her left arm straightened out.  When she came out of it, they gave her Ativan and 2 other meds to stop her from having anymore seizures.  Then they started her on Trileptal which she takes 2 times a day.  They then did an MRI of the brain which was normal, thankfully!
Age: 0.36
Sex: F
Vaccine: DTAPIPVHIB, RV5
Symptoms: Gaze palsy, Joint hyperextension, Muscle twitching, Nuclear magnetic resonance imaging brain normal, Tongue spasm
Clinical narrative: Was sleeping in carseat and when we got home she awoke and began to go into a seizure.  Lasted about 30 seconds or so (just a guess).  Eyes rolled back and to the right, tongue spasmed, and mouth twitched.  We took her to the ER at a hospital and she was evaluated, ran bloodwork, and EKG.  All were normal.  When we were getting ready to leave (around 3:30 a.m. on March 20, 2013), she had another seizure that lasted 1.5 minutes with the same symptoms listed above except her eyes went back and forth before rolling up.  At that point she was admitted.  During EEG she had another seizure (around 9:00 AM) with the same symptoms as in ER and it lasted just over 3 minutes.  Then had another seizure at 10:55 AM when Neurologist was examining her.  Lasted about 2 minutes and had same symptoms as in ER except her left arm straightened out.  When she came out of it, they gave her Ativan and 2 other meds to stop her from having anymore seizures.  Then they started her on Trileptal which she takes 2 times a day.  They then did an MRI of the brain which was normal, thankfully!
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Depressed level of consciousness, Dizziness, Hyperhidrosis, Pain, Pallor
Clinical narrative: Pain, felt faint, color drained from face, profuse sweating, difficulty obtaining verbal response, had to keep rousing her to keep her from fainting.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Unresponsive to stimuli
Clinical narrative: Pain, felt faint, color drained from face, profuse sweating, difficulty obtaining verbal response, had to keep rousing her to keep her from fainting.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from a physician and a licensed practical nurse refers to a 72 year old female patient. On approximately 03-MAR-2013, "1 month ago", the patient was vaccinated with a dose of ZOSTAVAX (route, dose and lot # not reported). The physician and nurse reported that the patient got shingles and on 02-APR-2013, the patient was seen in the office and was admitted to hospital due to a rash on the face. The outcome of shingles was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a doctor of pharmacy concerning an unspecified number of patients of unknown age and gender. On an unknown date, patients were vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. On an unknown date, the patients experienced injection-site swelling and stinging while ZOSTAVAX. Patients sought medical attention (notified pharmacy). On an unknown date, the patients recovered quickly. The relatedness for injection-site swelling and stinging was unknown for ZOSTAVAX. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered pharmacist concerning a patient of unknown age and gender. On 08-APR-2013, the patient was vaccinated with an expired dose of ZOSTAVAX (lot number and expiry date reported as 672676/0069AE and 03-APR-2013 respectively, dose and route unspecified) by a physician. No concomitant mediations were reported. No adverse event was reported. Additional information has been requested.
Age: 0.54
Sex: F
Vaccine: DTAPIPVHIB, HEP
Symptoms: Injection site reaction, Rash erythematous, Rash generalised
Clinical narrative: Generalized red, raised rash on both upper thighs with pimple-like appearance. Afebrile.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling, and itching of the injection site. Redness spread 2-3 inches from site, swelling was localized to injection site. Treated with 50mg of BENADRYL by mouth.
Age: 0.81
Sex: M
Vaccine: DTAPIPVHIB, PNC13, DTAP, DTP, HIBV, IPV, PPV
Symptoms: Injection site haemorrhage, Injection site papule, Injection site vesicles
Clinical narrative: 13 x 9 cm on (L) thigh & 9 x 9 cm on (R) thigh cluster of flesh-colored pinpoint papules & tiny vesicles on a pink base.
Age: 0.81
Sex: M
Vaccine: DTAPIPVHIB, PNC13, DTAP, DTP, HIBV, IPV, PPV
Symptoms: Injection site rash
Clinical narrative: 13 x 9 cm on (L) thigh & 9 x 9 cm on (R) thigh cluster of flesh-colored pinpoint papules & tiny vesicles on a pink base.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Erythema, Injection site mass, Oedema peripheral, Pruritus
Clinical narrative: Pt got red and swollen arm, achy joints, redness extending to upper left chest, itched, skin turned brown then skin peeled. Lasted 7 days, lump below the site of injection, which lasted 3 days.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Skin discolouration, Skin exfoliation
Clinical narrative: Pt got red and swollen arm, achy joints, redness extending to upper left chest, itched, skin turned brown then skin peeled. Lasted 7 days, lump below the site of injection, which lasted 3 days.
Age: 1.3
Sex: F
Vaccine: DTAP, HEPA, HIBV
Symptoms: Band neutrophil percentage, Full blood count abnormal, Gaze palsy, Influenza A virus test negative, Influenza B virus test
Clinical narrative: Fever then arms and legs shaking then eyes rolled back, lasted about 1 min.
Age: 1.3
Sex: F
Vaccine: DTAP, HEPA, HIBV
Symptoms: Influenza virus test negative, Lymphocyte percentage increased, Neutrophil percentage decreased, Pyrexia, Respiratory syncytial virus test negative
Clinical narrative: Fever then arms and legs shaking then eyes rolled back, lasted about 1 min.
Age: 1.3
Sex: F
Vaccine: DTAP, HEPA, HIBV
Symptoms: Tremor, Urine analysis normal, White blood cell count normal
Clinical narrative: Fever then arms and legs shaking then eyes rolled back, lasted about 1 min.
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: Radiculitis brachial
Clinical narrative: Brachial neuritis.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Immediate post-injection reaction, Musculoskeletal pain, Pain in extremity
Clinical narrative: Severe pain started at time of injection on top and back of (L) shoulder. Pain continued thru noc, slightly better without MOTRIN taken the next day, today on 04/09/13 pain continues as a dull ache on top and back of (L) shoulder and lower part of arm below elbow.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: Pt. was just given 0.5 pediatric dose of Hep B instead of adult dose 1 ml.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Dizziness, Headache, Syncope
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 16 year old female patient with none medical history and none drug allergies. On 24-JAN-2012 the patient was vaccinated with GARDASIL (Lot# 1277Y and exp date 29-JUN-2012) 0.5 ml, intramuscular, once. No other co-suspects were reported. No concomitant therapy was reported. The healthcare worker reported that the patient fainted at home after receiving the first dose of GARDASIL, approximately in January 2012. The patient also developed headaches and dizziness few days after vaccination, so the patient could not go to school for 2-3 days. Treatment was not given. Lab tests were not performed. The outcome of the patient fainted at home after receiving the first dose of GARDASIL, the patient also developed headaches and dizziness a few days after the vaccination and the patient also developed headaches and dizziness a few days after the vaccination was reported as recovered/resolved. Additional information is not expected.
Age: 57.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a physician refers to a 57 year old female patient with no pertinent medical history and with no drug reaction or allergies. On unknown dates the patient received an unknown number doses of (Merck) VARIVAX (Lot#, dose and route not reported). Concomitant therapies included phentermine, LOVAZA, metformin and SYNTHROID. The patient came back with "low level titers" for varicella IgG on 16-MAR-2013. No treatment was given. At the time of this report the patient had not recovered from "low level titers" for varicella. The reporter did not assess the drug relationship. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. The patient received the first 2 doses in the GARDASIL (dose, route not reported) series on unspecified dates in 2008, and then received the 3rd dose (dose, route not reported) on 04-APR-2013. No adverse effect reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Exposure during pregnancy, Foetal disorder, Ultrasound antenatal screen abnormal, Uterine dilation and curettage
Clinical narrative: Case number PHHY2011US115296 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS: 412224) website on 01 Feb 2011 with a follow up information received from the quality assurance department on 06 Feb 2012. This report refers to 39 year old female patient. The patient was vaccinated with S-OIV FLUVIRIN (batch number: 101329) in left arm on 06 Jan 2010. On 13 Jan 2010, exactly one week after the vaccine, she had an ultrasound that showed the baby to appear to be of 9 weeks, but with no heartbeat. She had dilation and curettage the following day. She took pandemic vaccine because her husband was exposed to the virus. She was told since she was in the first trimester, that there was no reason to test the fetus. She had no history of miscarriage. The outcome of events was not reported. No other information was reported. A quality complaint had been registered for the administered vaccine S-OIV FLUVIRIN with reference number 144368. The reporter was anonymous, so this case is considered lost to follow-up. Non-significant follow up information received from the quality assurance department on 06 Feb 2012: Updated only the quality reference number. Follow-up information received on 08 Apr 2013: Lost to follow-up information was updated.
Age: 28.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Burning sensation, Dyspnoea, Exposure during pregnancy
Clinical narrative: Case number PHHY2011US115366 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS: 412642) website on 01 Feb 2011. This report refers to 28 year old female patient. The patient's current condition included pregnancy. This pregnant patient received S-OIV FLUVIRIN (batch number: 10073812) intramuscularly in left arm and flu (batch number: U3226AA, other manufacturer) intramuscularly in left arm on 17 Nov 2009. On 17 Nov 2009, within an hour of receiving both seasonal and H1N1 injectable vaccines, she felt like lungs were on fire and difficulty breathing. She was presented to ER and was given EPIPEN and BENADRYL. She received monitoring and IV fluids and was discharged. The outcome of events was reported as complete recovery. Since the reporter was anonymous, so this case is considered lost to follow-up. Follow-up information received on 08 Apr 2013: Lost to follow-up information was updated.
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Chest pain, Dyspnoea, Electrocardiogram abnormal, Intensive care, Myopericarditis
Clinical narrative: Acute onset of transient chest pain.  Occurred for 10 hours.  Has some shortness of breath and chills. Found to have elevated troponins and diffuse ST segment elevations.
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Troponin increased
Clinical narrative: Acute onset of transient chest pain.  Occurred for 10 hours.  Has some shortness of breath and chills. Found to have elevated troponins and diffuse ST segment elevations.
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Asthenia, Blood creatine phosphokinase MB increased, Blood creatine phosphokinase increased, C-reactive protein normal, Chest X-ray normal
Clinical narrative: Acute onset of transient chest pain.  Occurred for 10 hours.  Has some shortness of breath and chills. Found to have elevated troponins and diffuse ST segment elevations.
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Chest discomfort, Chest pain, Chills, Dyspnoea, Echocardiogram normal
Clinical narrative: Acute onset of transient chest pain.  Occurred for 10 hours.  Has some shortness of breath and chills. Found to have elevated troponins and diffuse ST segment elevations.
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Ejection fraction normal, Electrocardiogram ST segment elevation, Electrocardiogram T wave inversion, Fatigue, Haematocrit decreased
Clinical narrative: Acute onset of transient chest pain.  Occurred for 10 hours.  Has some shortness of breath and chills. Found to have elevated troponins and diffuse ST segment elevations.
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Haemoglobin decreased, Myocarditis, Pericardial effusion, Platelet count normal, Red blood cell count decreased
Clinical narrative: Acute onset of transient chest pain.  Occurred for 10 hours.  Has some shortness of breath and chills. Found to have elevated troponins and diffuse ST segment elevations.
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Troponin I increased, Troponin T normal, White blood cell count increased
Clinical narrative: Acute onset of transient chest pain.  Occurred for 10 hours.  Has some shortness of breath and chills. Found to have elevated troponins and diffuse ST segment elevations.
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Blood creatine phosphokinase MB increased, Blood creatine phosphokinase normal, Chest pain, Chills, Dyspnoea
Clinical narrative: Acute onset of transient chest pain.  Occurred for 10 hours.  Has some shortness of breath and chills. Found to have elevated troponins and diffuse ST segment elevations.
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Electrocardiogram ST segment elevation, Troponin I increased
Clinical narrative: Acute onset of transient chest pain.  Occurred for 10 hours.  Has some shortness of breath and chills. Found to have elevated troponins and diffuse ST segment elevations.
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Myocarditis, Pericarditis, Troponin I increased
Clinical narrative: Acute onset of transient chest pain.  Occurred for 10 hours.  Has some shortness of breath and chills. Found to have elevated troponins and diffuse ST segment elevations.
Age: 2.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Febrile convulsion
Clinical narrative: This medically confirmed spontaneous report (initial receipt 26-Mar-2013) concerns a 2 year old male patient. On 24-Jan-2013, the patient was given a dose of AFLURIA (batch: 07949221A). The child developed a febrile seizure the same day as vaccine administration and was taken to the emergency room of a hospital. The event outcome was unknown.
Age: 2.0
Sex: U
Vaccine: RV5
Symptoms: Rotavirus infection
Clinical narrative: This spontaneous report was received from a physician via a company representative concerning a 2 year old patient of unknown gender. On an unknown date, the patient was vaccinated with a dose of 2 milliliter (ml) of ROTATEQ (lot number and expiry date unspecified), orally as per the schedule. No concomitant medications were reported. On an unknown date, the patient was hospitalized for rotavirus. The patient sought medical attention. An unspecified treatment was provided. The outcome of the event was unknown. This is one of the two reports from the same source. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: RV5
Symptoms: Rotavirus infection
Clinical narrative: This spontaneous report was received from a physician via a company representative concerning a 1 year old patient of unknown gender. On an unknown date, the patient was vaccinated with a dose of 2 milliliter (ml) of ROTATEQ (lot number and expiry date unspecified), orally as per the schedule. No concomitant medications were reported. On an unknown date, the patient was hospitalized for rotavirus. The patient sought medical attention. An unspecified treatment was provided. The outcome of the event was unknown. This is one of the two reports from the same source. Additional information has been requested.
Age: 0.81
Sex: M
Vaccine: DTAPIPVHIB, PNC13, DTAP, DTP, HIBV, IPV, PPV
Symptoms: Injection site haemorrhage, Injection site papule, Injection site vesicles
Clinical narrative: Soon after shot, he got a rash and it grew day by day. From top of thighs to his knees. No treatment given.
Age: 0.81
Sex: M
Vaccine: DTAPIPVHIB, PNC13, DTAP, DTP, HIBV, IPV, PPV
Symptoms: Injection site rash
Clinical narrative: Soon after shot, he got a rash and it grew day by day. From top of thighs to his knees. No treatment given.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Hallucination, visual
Clinical narrative: Initial case was received from a healthcare professional on 04 April 2013. A four-year-old female patient received an injection of DAPTACEL, sanofi pasteur Ltd., lot number C4286AA and an injection of IPOL, sanofi pasteur SA, lot number H1452, (routes, sites, sides and dose in series were not reported) on 01 April 2013. The parent reported the child seeing "ghosts and monsters" while awake during the day; but not sure if started day of vaccinations or the day before the child received vaccinations. The parent reported the child asks "when will all these ghosts and monsters go away" during the day. The patient had no fever or any other reaction reported. The patient required a doctor visit. Laboratory or diagnostic testing or treatments were not reported. The patient had no known allergies and no history of medical conditions. The patient had no illness at time of vaccination and did not have any other vaccinations within four weeks of vaccinations. The patient's outcome was reported as not recovered. Documents held by sender: None.
Sex: F
Vaccine: HPV4
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: This spontaneous report as received from a other health professional refers to a female patient of unknown age with no pertinent medical history. On 25-JUL-2012, the patient was vaccinated with 0.5 milliliter (ml) GARDASIL, intramuscularly. On 02-APR-2013 the patient was vaccinated with dose 3 GARDASIL (lot # 0555AE, expiration date 14-DEC-2014). On 03-APR-2013 the patient developed severe headache. She stated that the patient did not have a history of headache or migraine. The patient experienced nausea and vomiting with headache. The patient was not getting relief from ibuprofen and TYLENOL, and was seen in the Emergency department of unspecified hospital. The patient was given a CT scan of her head, and no abnormal findings were determined. She was not admitted. She was prescribed TYLENOL with CODEINE which patient stated gave some relief. The outcome of severe headache, vomiting and nausea was unknown. Causality was not reported. Additional information is not expected.