chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: U
Vaccine: MMR
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 demography. The reporter stated that the patient received the first dose of VARIVAX (Merck) (dose, route and frequency were not reported) on 31-AUG-2009. On 29-JUN-2012, the patient received the first dose of M-M-R II (dose, route and frequency were not reported). The reporter stated that on 01-AUG-2012, the patient received the recommended dose of VARIVAX (Merck) Lot# H006462, (dose, route and frequency were not reported). On 23-AUG-2012, within the 28 day interval, the patient received the recommended dose of M-M-R II. No adverse effects reported. No further information was reported. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Breast tenderness
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 57 year old female patient. Patients medical history, drug reactions and allergies were reported as none. On 18-MAR-2014, the patient was vaccinated with ZOSTAVAX vial, strength 19400 plaque-forming units (PFU), (lot number and expiry date were unspecified), dose 0.65 ml, subcutaneous. Concomitant therapy was reported as none. Approximately in March 2014, the patient experienced tenderness in one breast on the outer aspect of the breast. The patient called pharmacist and stated that her breast felt like when someone became pregnant and her breasts get tender, except for it was only in one breast. No treatment was given for the event. No lab diagnostics studies were performed. No product quality complaint was involved. The outcome of tenderness in breast was reported as not recovered. The reporters causality assessment for the event tenderness in one breast with the therapy of ZOSTAVAX was not reported. No further information provided. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown demographics. There was no pertinent medical history, current conditions reported. It was unknown the patient was vaccinated with ROTATEQ, (dose, frequency, lot#, route not reported). No concomitant medications reported. On an unknown date medication error was reported were doses of ROTATEQ were exposed to highest temperature of 53F for 21 hours. The healthcare worker does not know whether or not any of these improperly stored doses were administered to any patients since these excursions occurred. This case is linked to 1403USA012857, 1403USA012858, 1403USA012859, 1403USA012860, 1403USA005464 (same reporter link) Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown demographics. There was no pertinent medical history, current conditions reported. It was unknown the patient was vaccinated with M-M-R II or HSA (human serum albumin), dose, frequency, lot#, route not reported). No concomitant medications reported. On an unknown date medication error was reported were doses of measles, mumps, and rubella were exposed to 53F for 3.5 hours. The healthcare worker does not know whether or not any of these improperly stored doses were administered to any patients since these excursions occurred. This case is linked to 1403USA012856, 1403USA012857, 1403USA012858, 1403USA012859, 1403USA014860, (same reporter link) Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse. The nurse reported that improperly stored GARDASIL (lot # not provided) many have been administered. No adverse event was reported. This is one of several cases from the same reporter. Additional information is not expected.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a male consumer of unknown age refers to himself. In 2012, the patient was vaccinated with the first dose of GARDASIL (lot # and dose not reported), injection and had not received the second or third dose. No side effects were reported. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: This spontaneous report as received from a healthcare student refers to a female patient of unknown age. Medical history, drug reactions or allergies were not reported. On 10-MAR-2014, the patient was vaccinated with a dose of ZOSTAVAX (LOT#, expiration date and dose not reported) subcutaneous. Concomitant medication was not reported. On 11-MAR-2014, the patient experienced rash and redness with no pustule near the ZOSTAVAX injection site. No laboratory diagnostics were performed. The outcome of rash and redness with no pustule near the ZOSTAVAX injection site was reported as not recovered/not resolved. The patient sought medical attention by visiting the pharmacist. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Rash
Clinical narrative: 2 days post vaccination pt noted redness and itching at site of injection - approx quarter size area. Also noted area on back of itching and small bumps or rash - sx lasted about 2 days although slight itch persists at site of injection 1 week later.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Electrocardiogram, Gait disturbance, Injection site cellulitis, Injection site erythema
Clinical narrative: Patient with acute onset of severe vertigo and disequilibrium, also with redness, pain and swelling at injection site. Patient had unstable gait on neurologic exam and positive Dix Hallpike. She had an urgent MRI brain that was negative. She was treated with antibiotics for cellulitis at injection site.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Neurological examination abnormal, Nuclear magnetic resonance imaging brain normal, Vertigo
Clinical narrative: Patient with acute onset of severe vertigo and disequilibrium, also with redness, pain and swelling at injection site. Patient had unstable gait on neurologic exam and positive Dix Hallpike. She had an urgent MRI brain that was negative. She was treated with antibiotics for cellulitis at injection site.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Vestibular function test abnormal
Clinical narrative: Patient with acute onset of severe vertigo and disequilibrium, also with redness, pain and swelling at injection site. Patient had unstable gait on neurologic exam and positive Dix Hallpike. She had an urgent MRI brain that was negative. She was treated with antibiotics for cellulitis at injection site.
Age: 45.0
Sex: M
Vaccine: YF
Symptoms: Abdominal pain upper, Fatigue, Gastrooesophageal reflux disease, Hyperaesthesia
Clinical narrative: Minor fatigue, acid reflux event, 5 days of low level gut ache, widespread skin sensitivity.
Age: 59.0
Sex: F
Vaccine: DTAP
Symptoms: Body temperature increased, Chills, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Severe throbbing pain to left arm at injection site radiating up to left neck & behind ear area followed with chills & shivering, site red, swollen, & hard to touch then temperature up to 101.6- took ibuprofen, Tylenol & warm pad place to site.
Age: 59.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site swelling, Neck pain
Clinical narrative: Severe throbbing pain to left arm at injection site radiating up to left neck & behind ear area followed with chills & shivering, site red, swollen, & hard to touch then temperature up to 101.6- took ibuprofen, Tylenol & warm pad place to site.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Decreased appetite, Lethargy, Pyrexia, Rash erythematous, Vomiting
Clinical narrative: Vomiting, lethargy, fever, red rash-like spots, lack of appetite.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Tremor
Clinical narrative: Mother describes "shaking left leg followed by shaking all over." Evaluated at ER- no neurological deficits noted.
Age: 20.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Condition aggravated, Headache, Pruritus generalised
Clinical narrative: Patient has headaches resulting from MVA that took place May 2013 yet approx a wk and a half after vaccine headaches became worse and had all over body itching also.  The itching has resolved yet still has headaches managed with meds.
Age: 20.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Headache, Rash generalised
Clinical narrative: Patient has headaches resulting from MVA that took place May 2013 yet approx a wk and a half after vaccine headaches became worse and had all over body itching also.  The itching has resolved yet still has headaches managed with meds.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, Epistaxis, Fall, Fatigue, Haemoglobin decreased
Clinical narrative: Arms, legs very weak and couldn't lift them for very well for 8 days, severe sinus drainage with bloody buildup everyday, neuropathy got 50% worse. The muscles (thigh) in my legs became very weak with only walking short distances now and become very painful. I have always gotten the flu shot for the past 13 years that I worked in the medical field and never had a reaction before. Nor had any after shot symptoms, but when I got this flu shot this time and when the needle was being injected into my arm and the nurse pushing the fluid in and I never felt such pain before as it's being injected in my arm, and kind of had a slight burning feeling, so my (L) arm became sore very quick and stayed like that up until 8 pm when I started to become tired very quickly and my (B) arms and (B) legs started to become very painful and weak. Then I started to have nosebleeds throughout the night. The next morning I didn't wake up until 10:45am and I usually don't wake up that late and when I went to stand up I fell back down in severe weakness and pain in my legs and couldn't lift my arms as they was to weak. I went to the bathroom and back to bed I went until 3:40pm  and pushed myself to get up and the nosebleed started all over again and the thigh muscles was hurting really bad in both legs and the nerve pain is so painful, and it hurts to walk short distances. My current neuropathy I have already have for Lyme disease was not as bad as it is now after the flu shot and had to increase the dose of KLONOPIN as the neuropathy got worse from the shot.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site pain, Mobility decreased, Muscular weakness, Myalgia
Clinical narrative: Arms, legs very weak and couldn't lift them for very well for 8 days, severe sinus drainage with bloody buildup everyday, neuropathy got 50% worse. The muscles (thigh) in my legs became very weak with only walking short distances now and become very painful. I have always gotten the flu shot for the past 13 years that I worked in the medical field and never had a reaction before. Nor had any after shot symptoms, but when I got this flu shot this time and when the needle was being injected into my arm and the nurse pushing the fluid in and I never felt such pain before as it's being injected in my arm, and kind of had a slight burning feeling, so my (L) arm became sore very quick and stayed like that up until 8 pm when I started to become tired very quickly and my (B) arms and (B) legs started to become very painful and weak. Then I started to have nosebleeds throughout the night. The next morning I didn't wake up until 10:45am and I usually don't wake up that late and when I went to stand up I fell back down in severe weakness and pain in my legs and couldn't lift my arms as they was to weak. I went to the bathroom and back to bed I went until 3:40pm  and pushed myself to get up and the nosebleed started all over again and the thigh muscles was hurting really bad in both legs and the nerve pain is so painful, and it hurts to walk short distances. My current neuropathy I have already have for Lyme disease was not as bad as it is now after the flu shot and had to increase the dose of KLONOPIN as the neuropathy got worse from the shot.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Neuralgia, Neuropathy peripheral, Pain, Pain in extremity, Paranasal sinus hypersecretion
Clinical narrative: Arms, legs very weak and couldn't lift them for very well for 8 days, severe sinus drainage with bloody buildup everyday, neuropathy got 50% worse. The muscles (thigh) in my legs became very weak with only walking short distances now and become very painful. I have always gotten the flu shot for the past 13 years that I worked in the medical field and never had a reaction before. Nor had any after shot symptoms, but when I got this flu shot this time and when the needle was being injected into my arm and the nurse pushing the fluid in and I never felt such pain before as it's being injected in my arm, and kind of had a slight burning feeling, so my (L) arm became sore very quick and stayed like that up until 8 pm when I started to become tired very quickly and my (B) arms and (B) legs started to become very painful and weak. Then I started to have nosebleeds throughout the night. The next morning I didn't wake up until 10:45am and I usually don't wake up that late and when I went to stand up I fell back down in severe weakness and pain in my legs and couldn't lift my arms as they was to weak. I went to the bathroom and back to bed I went until 3:40pm  and pushed myself to get up and the nosebleed started all over again and the thigh muscles was hurting really bad in both legs and the nerve pain is so painful, and it hurts to walk short distances. My current neuropathy I have already have for Lyme disease was not as bad as it is now after the flu shot and had to increase the dose of KLONOPIN as the neuropathy got worse from the shot.
Age: 55.0
Sex: F
Vaccine: HIBV, MNQ, PPV
Symptoms: Blood pressure decreased, Cellulitis, Erythema, Feeling hot, Hypersensitivity
Clinical narrative: Cellulitis - extreme swelling, redness, heat, pain and pain to the touch. Couldn't use movement to arm. Went in hospital Friday night (2-28-14). Many bags of antibiotics, BENADRYL, pain med. Blood pressure dropped very low.
Age: 55.0
Sex: F
Vaccine: HIBV, MNQ, PPV
Symptoms: Infection, Mobility decreased, Pain, Swelling, Tenderness
Clinical narrative: Cellulitis - extreme swelling, redness, heat, pain and pain to the touch. Couldn't use movement to arm. Went in hospital Friday night (2-28-14). Many bags of antibiotics, BENADRYL, pain med. Blood pressure dropped very low.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging brain normal, Unevaluable event
Clinical narrative: See attached.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 10-MAR-2014 the patient was vaccinated with M-M-R II lot # 0496AE expiration date 07-MAR-2014, 0.5 ml, subcutaneous (dose unspecified). Co-suspect and concomitant therapies were not reported. Medical assistant stated that on 10-MAR-2014, that a patient was administered an expired dose of properly stored M-M-R II. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. On Monday, 24-MAR-2014, the patient was inadvertently administered ROTATEQ (oral, expiration date 18-MAR-2014, dose, frequency and Lot# not reported). No adverse effects were reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Ear pain, Headache, Herpes zoster
Clinical narrative: This spontaneous report as received from a 65 year old female consumer reporting on herself. Medical history and concurrent conditions were not reported. In February 2014 (reported as 16 or 17 of February 2014), the patient was vaccinated with a dose of ZOSTAVAX in the left arm, 1 shot (dose, strength, lot number and expiration date was not reported). Secondary and concomitant therapies were not reported. Consumer report that even though she got ZOSTAVAX vaccine she got a mild case of shingles on 18-FEB-2014 (reported also as a few days later). Consumer started to felt pain on back of head area and also the ear area. Patient pay her physician a visit, who advised she was having a mild case of shingles. The outcome of shingles was not reported.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus generalised, Rash
Clinical narrative: This spontaneous report as received from a consumer refers to herself: a 73 year old female patient. No details on pertinent medical history provided; the patient had no known drug reactions or allergies. Diazepam, VALTREX was reported as a concomitant drug. On an unspecified date in 2008 the patient was vaccinated with ZOSTAVAX; no lot number, dose or route of administratio was provided. The consumer stated that she "still has episodes of shingles a few years later", usually occurring once a year; the adverse event onset date was reported as "two to three years". On an unknown date in 2014 (reported as "a few weeks ago") the patient suffered with rash and the itching sensation around her body. The patient sought medical attention; unspecified treatment was given to her. No lab diagnostics studies were performed. The outcome of episodes of shingles and the recent rash and itching was unknown. The relatedness between adverse events and the vaccination with ZOSTAVAX was not reported. Additional information is not expected.
Age: 0.53
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 19 year old female patient with unspecified penicillin allergy. No medical history was reported. The first dose of RECOMBIVAX was administered on 15-AUG-1994. The second dose of RECOMBIVAX HB (invalid lot # 1368A2, Expiry date unknown) was administered on 13-SEP-1994. The third dose of RECOMBIVAX HB (lot # 613621/1162A, expiry 27-JUN-1997) was administered on 23-FEB-1995. No concomitant medications were reported. Serological testing was performed approximately on 17-MAR-2014 (reported as on an unspecified date about a week from today, 24-MAR-2014) showed that patient did not had immunity to hepatitis B. Patient sought medical attention-went to physician's office. The patient was then administered another dose of RECOMBIVAX on an unspecified date in order to begin a new RECOMBIVAX HB series. The outcome of the event was unknown. Causality was not reported. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HEPA
Symptoms: Borrelia test, Dyspnoea, Ehrlichia test, Full blood count, Metabolic function test
Clinical narrative: 8/7/13 Seen in ER for urticaria, achy muscles given BENADRYL IM, Prednisone PO, PEPCID. 8/8/13 ER hives, vomiting, short of breath - BENADRYL IM.
Age: 14.0
Sex: F
Vaccine: HEPA
Symptoms: Myalgia, Parasite blood test, Urticaria, Vomiting
Clinical narrative: 8/7/13 Seen in ER for urticaria, achy muscles given BENADRYL IM, Prednisone PO, PEPCID. 8/8/13 ER hives, vomiting, short of breath - BENADRYL IM.
Age: 1.01
Sex: F
Vaccine: FLU3, HIBV, MMR, PNC13, VARCEL
Symptoms: Full blood count, Rash, Streptococcus test
Clinical narrative: Broke out in rash started 3-27-14.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients. No demographic data or medical records of the patients were provided. The reported stated that on 20-FEB-2014, 25-MAR-2014 and 26-MAR-2014 doses (unspecified number) of VARIVAX (Merck) and PROQUAD (Merck) were exposed to unspecified temperature excursions not exceeding 11F and for no more than 2 hours at a time and they have been administered (on an unknown date in 2014) to unspecified number of patients since the temperature were above the recommended storage temperature. The vaccines were supported by Merck's stability data. The reporter stated that she does not believe that any patients have experienced any adverse effects. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Child presented in office today with mom saying her arms itch and are red where she got her shots. (L) arm redness measures 5 cm x 7 cm. (R) arm redness 8 1/2 cm x 71/2 cm. Denies tenderness with palpation. (+) warmth to areas. BENADRYL 1 1/2 tsp po Q 6-8 hrs.
Sex: U
Vaccine: PPV
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report as received from a healthcare worker via company representative refers to an unspecified number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with PNEUMOVAX 23 (dose, frequency, Lot# not reported). On an unknown dates, the patient had an unspecified adverse reaction. The patients' outcome was not reported. Relatedness between unspecified reaction and PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Erythema, Injected limb mobility decreased, Local swelling, Pain in extremity, Skin warm
Clinical narrative: Right arm swollen, red, and hot to touch. Patient is unable to lift right arm. Very painful.
Age: 1.68
Sex: F
Vaccine: MMRV, PNC13
Symptoms: Rash generalised, Urticaria
Clinical narrative: Patient developed a widespread skin rash about 1 hour after receiving vaccine. Pt was brought back to the office and found to have hives. A dose of CLARITIN (25 mL) was given with instructions to continue CLARITIN for 10-14 days and give BENADRYL as needed. The following day, patient developed worsening hives which did not respond to ZYRTEC or BENADRYL. Pt eventually sent to ER where she was treated with oral prednisone, oral PEPCID, oral ibuprofen and sent home on oral prednisone and BENADRYL.
Age: 11.0
Sex: M
Vaccine: FLUN4, HPV4, MNQ, TDAP
Symptoms: No adverse event
Clinical narrative: None; no adv. events/rxn. noted.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Fall, Head injury, Headache, Swelling, Syncope
Clinical narrative: Pt got faint et no warning fell et hit head on window sill near (temporal area). Pt assessed after no cuts/lacerations, small nickel size swelling over (R) ear. Pt c/o h/a at "hurts a little". Denies SOB, vision disturbances, N and V. Denies neck pain. Advised mother on s and s to ER. Alert et oriented x 3 able to state name, age, where he was. Reviewed with pt as well after head injury. HD will f/u with parent et call today et tomorrow to ensure he remains stable. 15 min later BP 98/50 P 89 R 12.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Eyelid oedema, Injection site reaction, Injection site warmth, Urticaria
Clinical narrative: A hour after the vaccines my sons eye lids swelled up, called dr said was prob just allergies. I gave him Benadryl thru out night and next morning till the eye lids went down. Then 6 days later 3/27/2014 He gets a huge whelp on his right leg and its hot to the touch. Where he got the Vaccine. Called after hour line told not to come in but give Benadryl and follow up with Dr next day which I did.
Age: 30.0
Sex: M
Vaccine: PPV
Symptoms: Blood sodium decreased, Cellulitis, Chest pain, Dizziness, Hyponatraemia
Clinical narrative: Injection site erythema, swelling, and pain radiating from site across chest.  Fevers to 102 F, myalgias, malaise, dizziness.  Presented to ED with febrile with tachycardia, was admitted overnight due to concern for cellulitis with 2/4 SIRS criteria.  Treated with Tylenol, toradol, and discharged home with supportive measures.
Age: 30.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Malaise, Myalgia
Clinical narrative: Injection site erythema, swelling, and pain radiating from site across chest.  Fevers to 102 F, myalgias, malaise, dizziness.  Presented to ED with febrile with tachycardia, was admitted overnight due to concern for cellulitis with 2/4 SIRS criteria.  Treated with Tylenol, toradol, and discharged home with supportive measures.
Age: 30.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia, Tachycardia, White blood cell count increased
Clinical narrative: Injection site erythema, swelling, and pain radiating from site across chest.  Fevers to 102 F, myalgias, malaise, dizziness.  Presented to ED with febrile with tachycardia, was admitted overnight due to concern for cellulitis with 2/4 SIRS criteria.  Treated with Tylenol, toradol, and discharged home with supportive measures.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Fatigue, Feeling abnormal, Hypoaesthesia, Immediate post-injection reaction
Clinical narrative: Client recieved vaccine in L Deltoid and immediately stated that afterwards she still felt like vaccine was going into arm. L arm numb, became dizzy, Felt it traveling down her arm to her fingers, number to fingers.  She already had a fear of shots.  Bp 140/100. T 98.7 felt tired. After sitting a few minutes, she felt better and went home.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Poor peripheral circulation
Clinical narrative: Numbness in toes often most noticeable upon waking. In addition, a decrease in circulation in the same toes where numbness occurs. There has been no improvement of symptoms, only a cycling from a greater to lesser degree.
Age: 5.0
Sex: M
Vaccine: MMRV, MMRV
Symptoms: Anxiety, Disturbance in attention, Hearing impaired, Insomnia, Memory impairment
Clinical narrative: Blotchy, red rash. Extreme anxiety and extreme hyperactivity, inability to concentrate, difficulty sleeping, memory issues, obsessive thoughts and OCD behavior, auditory issues.
Age: 5.0
Sex: M
Vaccine: MMRV, MMRV
Symptoms: Obsessive thoughts, Obsessive-compulsive disorder, Psychomotor hyperactivity, Rash erythematous, Rash macular
Clinical narrative: Blotchy, red rash. Extreme anxiety and extreme hyperactivity, inability to concentrate, difficulty sleeping, memory issues, obsessive thoughts and OCD behavior, auditory issues.
Age: 5.0
Sex: M
Vaccine: MMRV, MMRV
Symptoms: Aggression, Anxiety, Autism, Emotional disorder, Obsessive thoughts
Clinical narrative: Blotchy, red rash. Extreme anxiety and extreme hyperactivity, inability to concentrate, difficulty sleeping, memory issues, obsessive thoughts and OCD behavior, auditory issues.
Age: 5.0
Sex: M
Vaccine: MMRV, MMRV
Symptoms: Rash
Clinical narrative: Blotchy, red rash. Extreme anxiety and extreme hyperactivity, inability to concentrate, difficulty sleeping, memory issues, obsessive thoughts and OCD behavior, auditory issues.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Cellulitis, Erythema, Hypersensitivity, Injection site pain
Clinical narrative: On Tuesday 03/04/2014 starting experiencing itching and burning around the site where vaccine has administered.  By Wednesday 03/05/2014 redness, swelling, itching and burning went to an urgent care.  Worse by am of 03/06/2014 and went to Hospital.  Was admitted and treated with antibiotics for cellulitis/allergic reaction.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Pruritus, Scab, Swelling
Clinical narrative: On Tuesday 03/04/2014 starting experiencing itching and burning around the site where vaccine has administered.  By Wednesday 03/05/2014 redness, swelling, itching and burning went to an urgent care.  Worse by am of 03/06/2014 and went to Hospital.  Was admitted and treated with antibiotics for cellulitis/allergic reaction.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Pain in extremity, Tenderness
Clinical narrative: At 12 noon vaccine administered on 2/26/14, that early evening pt c/o sore arm and (R) thigh to behind knee to hip severe pain. Didn't receive any medical care as she didn't report these complaints till 3/25/14. Denied fever, rash, area was sensitive to touch.
Age: 64.0
Sex: F
Vaccine: RAB
Symptoms: Biopsy skin, Psoriasis
Clinical narrative: On 7/15/13 I was given Rabies Immune Globulin and the rabies vaccine. Within 48 hours psoriasis (lesions) erupted across my upper thighs, ankle, arms, and scalp and back. Treated unsuccessfully with KENALOG and LIDEX. Biopsy psoriasis vs psoriasis derm. Clobetasol gave temporary relief. Continues to spread. Starting x TRAX treatment 3/18/14.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site reaction, Varicella post vaccine
Clinical narrative: Lt thigh chickenpox outbreak at site of injection x 2 wk.
Age: 28.0
Sex: F
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Injection site pustule, Injection site scab
Clinical narrative: 29 y/o female presents to clinic concerned re healing of SPV site LUE. Received primary SPV, AVA #1 and Typhoid on 07MAR14 in prep for work in early May 2014. Scab started to form, but came off and now the center of the Jennerian Pustule is still moist and yellow and slightly concave on Day #20 s/p primary SPV. Patient covering area with occlusive waterproof bandage -> preventing air circulation.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Headache, Hiccups, Oropharyngeal pain, Pain in extremity, Vomiting
Clinical narrative: Pt presented back to clinic 1 hour after vaccine administration with c/o sore throat, leg pain, headache, and hiccups. Dr assessed pt in clinic at this time and every c/o resolved except hiccups. Pt was sent home in care of his mother. Mother called at 2:00 stating pt also had vomiting once at home.
Age: 23.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Dermatitis, Rash, Rash pruritic, Vaccination complication
Clinical narrative: 23 y/o male presents to clinic c/o itchy rash on palms of hands and soles of feet since yesterday. Primary SPV, AVA#1, Typhoid on 07MAR14. No aphthous ulcer in buccal mucosa. No fever, systemic malaise, CP or SOB. Onset of rash was on day #19 s/p SPV. Rash is pruritic. C/W non-specific benign dermatitis a/w SPV. Dr saw pt as well and agrees with Dx, even though day #19 is a little later than usual onset around day #14. Papulovesicular / pruritic.
Age: 23.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Dermatitis, Rash papular, Rash pruritic
Clinical narrative: 23 y/o male presents to clinic c/o itchy rash on palms of hands and soles of feet since yesterday. Primary SPV, AVA#1, Typhoid on 07MAR14. No aphthous ulcer in buccal mucosa. No fever, systemic malaise, CP or SOB. Onset of rash was on day #19 s/p SPV. Rash is pruritic. C/W non-specific benign dermatitis a/w SPV. Dr saw pt as well and agrees with Dx, even though day #19 is a little later than usual onset around day #14. Papulovesicular / pruritic.
Age: 17.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Body temperature increased, Dyskinesia, Eye movement disorder
Clinical narrative: I was called by immunization nurse. She told me pt developed involuntary movements after rolled eye with HPV administration.
Age: 29.0
Sex: M
Vaccine: HEP
Symptoms: Hypoaesthesia
Clinical narrative: Noticed numbness to L upper extremity and L lower extremity by the evening after receiving the HBV vaccine in the morning.
Age: 0.92
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: Localized swelling, redness, knot on L leg. Parent gave Tylenol and applied warm compress.
Age: 26.0
Sex: F
Vaccine: ANTH
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin positive, Pregnancy test positive
Clinical narrative: PT HAD POSITIVE HOME PREGNANCY TEST SHORTLY AFTER RECEIVING IMMUNIZATION; CONFIRMED WITH SERUM BHCG TEST POSITIVE.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB, FLU3, MMR
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 73.0
Sex: F
Vaccine: TDAP
Symptoms: Arthropathy, Myalgia, Pain
Clinical narrative: Started with knees giving out.  Ended up with pain traveling throughout torso.  Diagnosed with polymyalgia.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal discomfort, Injection site swelling, Pyrexia, Vomiting
Clinical narrative: Pt with upset stomach and vomiting, had a fever to 100.2. Arm was swollen in area of vaccine.  No warmth or redness. By the next day her fever resolved, she was tolerating chicken noodle soup.  Arm symptoms persisted.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Condition aggravated, Tinnitus
Clinical narrative: The tinnitus that I have became extremely worse, it has not gotten better...
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, IPV, PNC13
Symptoms: Apnoea, Blood culture negative, Blood electrolytes normal, CSF culture negative, Computerised tomogram head normal
Clinical narrative: Seizure: apnea with full body stiffening, facial cyanosis, back arching x4 minutes with fever.
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, IPV, PNC13
Symptoms: Convulsion, Culture urine negative, Cyanosis, Electroencephalogram normal, Full blood count normal
Clinical narrative: Seizure: apnea with full body stiffening, facial cyanosis, back arching x4 minutes with fever.
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, IPV, PNC13
Symptoms: Herpes simplex serology negative, Liver function test normal, Musculoskeletal stiffness, Nuclear magnetic resonance imaging brain normal, Opisthotonus
Clinical narrative: Seizure: apnea with full body stiffening, facial cyanosis, back arching x4 minutes with fever.
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, IPV, PNC13
Symptoms: Polymerase chain reaction, Pyrexia, Viral test negative
Clinical narrative: Seizure: apnea with full body stiffening, facial cyanosis, back arching x4 minutes with fever.
Age: 1.34
Sex: F
Vaccine: HEPA, MMRV, PNC13
Symptoms: Rash
Clinical narrative: Rash on face yesterday with spread to extremities, chest, abdomen, back this morning.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Burning sensation, Chest pain, Dizziness, Headache, Oropharyngeal pain
Clinical narrative: About 15 minutes after receiving the 2nd dose of the Hepatitis B vaccine, I developed an itchy rash on both arms, across my chest, backs of my shoulders, and face.  Over the next few days my symptoms worsened and the rash went from itchy to burning all over my body.  I also developed a headache, dizziness, sore itchy swollen throat, and chest pain as well as sensitivity to light.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Pharyngeal oedema, Photophobia, Rash pruritic, Throat irritation
Clinical narrative: About 15 minutes after receiving the 2nd dose of the Hepatitis B vaccine, I developed an itchy rash on both arms, across my chest, backs of my shoulders, and face.  Over the next few days my symptoms worsened and the rash went from itchy to burning all over my body.  I also developed a headache, dizziness, sore itchy swollen throat, and chest pain as well as sensitivity to light.
Age: 1.08
Sex: M
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Rash, Rash generalised, Rash pruritic
Clinical narrative: Pt was given MMR#1 in (L) anterior lateral thigh on 3/17/14. Was seen in office on 3/26/14 for localized itchy rash in this area. Returned to office on 3/27/14 with full body rash. Pt prescribed BENADRYL orally and cortisone cream.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: 2 days after vaccination, noticed bright red area at site of injection. 1 1/2" x 1 1/2" square area. Also slight rash above site - no lesions - no itch. Color faded over 1 week time period.
Age: 1.13
Sex: M
Vaccine: HEP, MMR, PNC13, VARCEL
Symptoms: Pyrexia
Clinical narrative: Patient ran fever of 102.7 8 days after having had MMR and Varicella vaccines.
Sex: U
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age who on an unknown date, the patient was vaccinated with a dose of GARDASIL (dose, route and lot number not reported). The physician was informed from a nurse, who reported him that on an unknown date, the patient experienced a seizure after receipt GARDASIL. At the time of the report, the patient's outcome was unknown. The relatedness for seizure and GARDASIL was unknown. Upon internal review seizure was considered to be medically significant. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Multiple sclerosis relapse
Clinical narrative: This spontaneous report as received from the patient's husband refers to a 57 year old female patient. The patient's current conditions included asthma, and drug reaction/allergy to penicillin "any-cillin", and IV dye and historical condition of multiple sclerosis. On 20-OCT-2010, the patient was vaccinated with a dose of ZOSTAVAX vial, (dose, route, lot number and expiration date were not reported). The patient's husband stated that after receiving ZOSTAVAX on 27-OCT-2010, the patient had a relapse of her multiple sclerosis (MS). The patient had gone to the hospital on an unspecified date for this relapse. Then "three days later" the patient was discharged. After the patient was discharged, the patient was not improving. Since the patient was not improving, the patient was admitted to different hospital on an unspecified date and stayed there for 2 weeks. The patient was still trying to recover from this relapse. The patient saw a physician for medical attention. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test, Computerised tomogram, Nuclear magnetic resonance imaging, Pancreatitis chronic, X-ray with contrast lower gastrointestinal tract
Clinical narrative: This spontaneous report as received from a 67 year old male consumer reporting on himself with osteoarthritis and allergy to codeine who on 12-JUL-2012, was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not reported). Concomitant therapies included NEXIUM and NIASPAN. The consumer reported that on 23-JUL-2012, he was admitted to the hospital for 17 days with chronic pancreatitis. Unspecified intravenous medication was given as a treatment for the experience. CAT Scan, blood work, MRI and upper and lower GI were performed and unspecified date (results not provided). At the time of the report, the patient had not recovered. The relatedness for chronic pancreatitis and ZOSTAVAX was unknown. Upon internal review chronic pancreatitis was considered to be medically significant. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: X-ray with contrast upper gastrointestinal tract
Clinical narrative: This spontaneous report as received from a 67 year old male consumer reporting on himself with osteoarthritis and allergy to codeine who on 12-JUL-2012, was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not reported). Concomitant therapies included NEXIUM and NIASPAN. The consumer reported that on 23-JUL-2012, he was admitted to the hospital for 17 days with chronic pancreatitis. Unspecified intravenous medication was given as a treatment for the experience. CAT Scan, blood work, MRI and upper and lower GI were performed and unspecified date (results not provided). At the time of the report, the patient had not recovered. The relatedness for chronic pancreatitis and ZOSTAVAX was unknown. Upon internal review chronic pancreatitis was considered to be medically significant. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Nasal congestion, Pruritus, Rash maculo-papular
Clinical narrative: Developed macular-papular rash (lesions 3-7 mm diameter) some with pinpoint whitish center (2 to 3) but overall negative vesicles. Positive pruritus. Rash developed approximately 22 days after receiving Varicella vaccine. Negative fever, only mild nasal congestion. As of March 26, 2014 - patient still with rash and more spots appearing.
Age: 15.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Injection site cellulitis
Clinical narrative: Received Flu vaccine and HPV vaccine #3 to (L) deltoid on 3/24/14. Developed cellulitis (L) deltoid 3/25->3/26 treated with KEFLEX w/ BENADRYL.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Right posterior upper arm with redness, induration, and warmth at the injection site. 10 cm x 7 cm. Tx'd with BACTRIM DS 7 days for poss cellulitis.
Age: 61.0
Sex: M
Vaccine: TDAP, VARZOS, VARZOS
Symptoms: Pruritus
Clinical narrative: 1 hr after administration began to itch and develop a.
Age: 61.0
Sex: M
Vaccine: TDAP, VARZOS, VARZOS
Symptoms: Papule, Rash erythematous, Rash papular, Rash pruritic, Scab
Clinical narrative: 1 hr after administration began to itch and develop a.
Age: 61.0
Sex: M
Vaccine: TDAP, VARZOS, VARZOS
Symptoms: Varicella virus test
Clinical narrative: 1 hr after administration began to itch and develop a.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Erythema, mild induration at (R) arm injection site 9 x 7.5 cm.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Redness, swelling, warmth from shoulder to elbow (L) arm. Fever LT max 102.2 -> onset 1 day after injection. Rx OMNICEF.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema
Clinical narrative: Right anterior thigh with erythematous non-raised non-vesicular. No cellulitis hydroxyzine 10 mg/5ml - 2.5 ml by mouth twice daily for 3-5 days ordered by doctor.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Vaccinated 3/25/14. 1st noticed red swelling at site 3/26/14 6 pm. Area increasing in size and seen by MD at clinic 3/27/14. 7 mm x 7 mm firm, swollen, red, hot area at injection site.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Paraesthesia
Clinical narrative: Tingling in the left arm from armpit to fingertips. Redness, itching, and swelling at inj. site (presented 48 hours after vaccine). Pt. taking OTC BENADRYL.
Age: 25.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Eye swelling, Injection site erythema, Injection site swelling, Injection site warmth, Lip swelling
Clinical narrative: Site red, warm, swollen, lips swollen, eyes puffy. (L) arm had rxn.
Sex: F
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: This spontaneous report was received from a female consumer of unknown age regarding herself. Patient's concurrent condition included psoriasis. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose and route were not reported). On an unknown date, shortly after the patient received ZOSTAVAX, she developed rash on her body, both the front and back of the trunk, and on the front and back of her legs. On an unknown date the patient visited an unspecified dermatologist and the rash was considered "undefined". The outcome of rash on her body/rash on the front and back of her legs was unknown. Additional information has been requested.
Age: 0.16
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 8 week old patient of unknown gender. On 08-NOV-2013, the patient was vaccinated with a 0.5 ml pediatric dose of VAQTA in error instead of HepB vaccine (manufacturer unknown). No adverse effect reported, no product confusion, no PQC discovered, just medication error. Additional information is not expected.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Chills, Diarrhoea, Injection site vesicles, Nausea
Clinical narrative: This spontaneous report was received from a 32 years old, female healthcare student reporting on herself with no pertinent medical history and no drug reactions or allergies. On 11-MAR-2014 the patient was vaccinated with a dose of VARIVAX, (subcutaneous, dose not reported). Concomitant therapies included an unspecified multivitamin. On 21-MAR-2014, the patient experienced fever of 101 F, nausea, vomiting, diarrhea, chills, a rash and 4 vesicles. The vesicles were on the injection site, neck, lower right back and on the left knee. It was reported the patient is recovering. No treatment was given for the above mentioned events. No laboratory diagnostic studies were performed. It was reported that the patient sought medical attention by going to see a nurse. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash, Vomiting
Clinical narrative: This spontaneous report was received from a 32 years old, female healthcare student reporting on herself with no pertinent medical history and no drug reactions or allergies. On 11-MAR-2014 the patient was vaccinated with a dose of VARIVAX, (subcutaneous, dose not reported). Concomitant therapies included an unspecified multivitamin. On 21-MAR-2014, the patient experienced fever of 101 F, nausea, vomiting, diarrhea, chills, a rash and 4 vesicles. The vesicles were on the injection site, neck, lower right back and on the left knee. It was reported the patient is recovering. No treatment was given for the above mentioned events. No laboratory diagnostic studies were performed. It was reported that the patient sought medical attention by going to see a nurse. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Laboratory test, Pyrexia, Rash generalised, Rash morbilliform
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 12 month old male infant without pertinent medical history, drug reactions or allergies. On 05-MAR-2014, the patient was vaccinated with a dose of PROQUAD (Merck), 0.5 ml, subcutaneous in the thigh (dose, lot number and expiration date were not reported). Secondary therapies included VAQTA, the same day (on 05-MAR-2014) (dose, route, lot number and expiration date were not reported) on the same tight but different location on the tight. On 14-MAR-2014, the patient developed a fever and then a measles "like rash", all over the body of the patient on 17-MAR-2014. Rash and fever were not better. At the time of the report, the patient had not recovered from fever and measles like rash. Patient received as treatment for fever TYLENOL. The physician was running some labs but healthcare worker was not sure what they were. It was reported that patient's parent sought medical attention by contacty the physcian's office. Additonal information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 62 year old female patient. On 24-MAR-2014, the patient was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX and 15 minutes later the patient experienced redness and warmth at injection site. No treatment was given. No laboratory tests were performed. The outcome of redness and warmth at injection site was reported as not recovered. Causality was not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Skin reaction
Clinical narrative: This spontaneous report was received from a female patient of unknown age via a company representative regarding herself. The representative stated she heard about this report, on Saturday, 22-MAR-2014, from a person who attended the American of Dermatology conference. The attendee at the conference told the representative that she received a dose of ZOSTAVAX (lot#, expiry not reported) on an unknown date about 3 months ago approximately in December 2013 and developed a pretty severe localized reaction, post vaccination. The patient showed her pictures. Representative stated she did not have any identifying patient information or health care provider information. The outcome of a pretty severe localized reaction, post vaccination. The patient showed her pictures. Representative stated she did not have any identifying patient information or health care provider information. The outcome of a pretty severe localized reaction is unknown. Causality was not reported. Additional information has been requested.