chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Bronchitis, Convulsion, Cough, Furuncle
Clinical narrative: Fever, cough, "red dots on me" (trunk, arms, legs), painful muscles, joint, pt reports " my whole body aches ". Pt reports seizure.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Incisional drainage, Myalgia, Pain, Pyrexia, Rash
Clinical narrative: Fever, cough, "red dots on me" (trunk, arms, legs), painful muscles, joint, pt reports " my whole body aches ". Pt reports seizure.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: Fever, cough, "red dots on me" (trunk, arms, legs), painful muscles, joint, pt reports " my whole body aches ". Pt reports seizure.
Age: 1.62
Sex: M
Vaccine: DTAP
Symptoms: Decreased appetite, Diarrhoea, Fluid intake reduced, Hypophagia, Vomiting
Clinical narrative: Lack of appetite and then wouldn't drink anything. Then starting around 7:00 AM I was awaken to my son vomiting, then diarrhea, lying around the house not wanting to do anything, not wanting to eat or drink. Today on 6/24/13 he still has the diarrhea, not wanting to eat, or drink. This is what happens when he gets shots. Also we have 8 kids and none of them are sick.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash macular
Clinical narrative: Itching, Red Blotch.
Age: 27.0
Sex: F
Vaccine: YF
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling, Injection site warmth, Rash papular
Clinical narrative: Had raised warm red area at site of injection on Saturday morning, 6/22. Then later that day had papular rash noted to neck, arms, and upper thighs. Patient seen in our office (her PCP) today. Diagnosed as allergic reaction. Given two days of Xyzal 5mg TID. To return to clinic for follow up in two days. No fever. Clear Bilat breath sounds. Area at injection still red and raises, measure 9 x 9.5cm.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Pruritus, Rash generalised
Clinical narrative: Rash in various areas of body, itching and redness. Grew progressively worse.
Age: 0.87
Sex: M
Vaccine: HIBV
Symptoms: Body temperature, Crying, Decreased appetite, Diet refusal, Emotional distress
Clinical narrative: He has been screaming and crying in his sleep.  Tossing and turning all night, not sleeping well at all.  He's upset, irritable and inconsolable.  He seems to have lost much of his appetite and is refusing food and milk.
Age: 0.87
Sex: M
Vaccine: HIBV
Symptoms: Irritability, Poor quality sleep, Screaming
Clinical narrative: He has been screaming and crying in his sleep.  Tossing and turning all night, not sleeping well at all.  He's upset, irritable and inconsolable.  He seems to have lost much of his appetite and is refusing food and milk.
Age: 0.17
Sex: F
Vaccine: RVX
Symptoms: Haematochezia, Mucous stools, Occult blood
Clinical narrative: Mucosy blood in the stool.
Age: 32.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Convulsion, Feeling abnormal, Loss of consciousness, Respiratory arrest
Clinical narrative: Patient was talking to RN, stated she "felt funny", lost consciousness, seemed to seize and lost respirations. Epi pen administered and she began breathing and regained consciousness. Went to emergency department for evaluation and released to home.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Patient came to pharmacy on 6/24/13 with a deep red area about 3 inches in diameter and a lighter red area about 10 inches in diameter arm was hot to touch and swollen.  Called patient dr and they saw her immediately and marked diameter and told her to come back if progesses also gave her antibiotics.
Age: 17.0
Sex: M
Vaccine: HPVX
Symptoms: Blood glucose, Dyskinesia, Hypoacusis, Pallor, Peripheral coldness
Clinical narrative: Fainted, slight jerking movement. Pale, muffled hearing, cold hands, white fingers.
Age: 17.0
Sex: M
Vaccine: HPVX
Symptoms: Syncope
Clinical narrative: Fainted, slight jerking movement. Pale, muffled hearing, cold hands, white fingers.
Age: 45.0
Sex: M
Vaccine: VARCEL
Symptoms: Dysphagia, Lymphadenitis, Pyrexia
Clinical narrative: Fever of 103.7, severe cervical lymph inflammation, hard time swallowing.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Arteriogram carotid, Asthenia, Barium swallow, Chest X-ray, Computerised tomogram head
Clinical narrative: Generalized weakness, following flu like symptoms.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Echocardiogram, Influenza like illness, Laboratory test, Nuclear magnetic resonance imaging brain
Clinical narrative: Generalized weakness, following flu like symptoms.
Age: 1.09
Sex: M
Vaccine: DTAP, HBHEPB, HEPA, IPV, MMR
Symptoms: Measles, Rash, Rash generalised
Clinical narrative: Rash started on face, spread to entire body. Examined by doctor, diagnosed as measles. No treatment.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX dose, route, indication and lot # not reported. On an unknown date the patient got shingles. The outcome of adverse event was unknown. The relatedness between adverse event and therapy with ZOSTAVAX was unknown. This case is linked to same reporter's report # 1306USA007892. Additional information has been requested.
Age: 80.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a patient of unknown gender. The age of the patient was reported as in the 80's. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX dose, route, indication and lot # not reported. On an unknown date the patient got shingles. The outcome of adverse event was unknown. The relatedness between adverse event and therapy with ZOSTAVAX was unknown. This case is linked to same reporter's report # 1306USA006218. Additional information has been requested.
Age: 27.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 27 year old male patient. On 18-JUN-2013 the patient was vaccinated subcutaneously with 0.5 ml dose of properly reconstituted ZOSTAVAX (lot # J001010, expired date: 24-APR-2014) instead of (Merck) VARIVAX due to staff error, not product confusion. No adverse effect reported. The patient didn't seek any medical attention. Additional information has been requested.
Sex: U
Vaccine: HEP, HEPA
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 nurse reported that the patient received the 1st dose of RECOMBIVAX HB and VAQTA on 21-DEC-2012 and the second dose of RECOMBIVAX HB on 18-FEB-2013. The patient was in the office about to receive the 3rd dose of RECOMBIVAX HB and their dose of VAQTA on 17-JUN-2013.No adverse effect reported. This is one of two reports from the same source. Additional information has been requested.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin reaction
Clinical narrative: Pt came to clinic 6/24/12 with small skin reaction to Zoster vaccine. No fever or discomfort. Dr. advised warm soaks.
Age: 0.54
Sex: M
Vaccine: HEP, HIBV, IPV, PNC13, RV5
Symptoms: Body temperature increased, Urticaria
Clinical narrative: Pt seen on 6-21-13 for vaccines. DTaP to be held per MD due to prolonged crying with 1st vaccines on 2-20-13. Give IPV, Hep B, HIB, PCV-13 and RV5. Pt broke out in hives over entire body by night of 6-21-13. Vaccines given about 11:00 AM on 6-21-13 also had 101 degrees temp.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Oedema peripheral, Pruritus, Rash, Skin warm
Clinical narrative: Immunized 6/18/2013 presented to clinic 6/20/2013 with rash and swollen/red arms. (L) arm 25 cm (R) arm 22.5 cm. Raised red welts on arms, trunk, legs. Warm to touch, itchy.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Immunized 6/18/2013 presented to clinic 6/20/2013 with rash and swollen/red arms. (L) arm 25 cm (R) arm 22.5 cm. Raised red welts on arms, trunk, legs. Warm to touch, itchy.
Sex: U
Vaccine: HEP, HEPA
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 nurse reported that the patient the 1st dose of RECOMBIVAX HB and VAQTA on 21-DEC-2012 and the second dose of RECOMBIVAX HB on 18-FEB-2013. The patient was in the office about to receive their 3rd dose of RECOMBIVAX HB and their 2nd dose of VAQTA on 17-JUN-2013.No adverse effect reported. This is one of the two reports from the same source. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash vesicular
Clinical narrative: This spontaneous report was received from a physician assistant refers to a 52 year old female patient. The patients medical history included history of chicken pox and no known drug allergies. On 07-JUN-2013, the patient was vaccinated with a dose of 0.5 ml ZOSTAVAX ,(lot # J001009, in the right arm). Concomitant therapies included SYNTHROID, MAXALT, and ZOCOR. On 08-JUN-2013, the patient experienced vesicular eruption at the site of injection at the dermatome C4-C5. The maximum temperature was 98 degree centigrade. There were no other systemic symptoms. The patient did not have recent exposure to chicken pox or shingles. The outcome of vesicular eruption at the site of injection was reported as recovering. Additional information is not expected.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Full blood count, Headache, Myalgia, Petechiae
Clinical narrative: Myalgias, arthralgias, fever, HA, petechial rash.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Red blood cell sedimentation rate
Clinical narrative: Myalgias, arthralgias, fever, HA, petechial rash.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye irritation, Eye pain, Medication error
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 70 year old female patient. The patient's medical history included "cancer" and "shingles in the left eye area". On 27-MAY-2013 the patient was vaccinated with ZOSTAVAX (0.65 ml, subcutaneous injection in the left arm). Concomitant therapies included PRILOSEC, glipizide (manufacturer unknown), glipizide/metformin hydrochloride (manufacturer unknown), LOSARTIN, gabapentin (manufacturer unknown) and tamoxifen citrate (manufacturer unknown). On 02-JUN-2013 the patient returned to the pharmacist to report that she is experiencing "pain and burning around her left eye area". The pharmacist is unsure of how long the patient has been experiencing these symptoms. No treatment was given. The patient previously experienced a case if shingles (date unspecified), in the same "left eye area". The outcome is not reported. It was reported therapy with ZOSTAVAX was not discontinued.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a female patient of unknown age. No medical history was reported. On an unknown date in May 2013 (reported as a month ago), the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiry not reported) and needs to have an epidural steroid injection for an unspecified reason on an unspecified date. No concomitant medications were reported. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the unspecified number of patients were vaccinated with unspecified doses of RECOMBIVAX HB (Lot number, expiry date, route and dose were not reported) that were left sitting out at unspecified temperature for an unspecified time frame. This had occurred at an unspecified location in the district where the reporter works. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. On 08-MAY-2013 the patient was vaccinated with an unsupported dose of GARDASIL (lot number 0101AE, expiry date 10-OCT-2014). No adverse effect reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Crying, Injection site discolouration, Injection site induration, Injection site pain, Irritability
Clinical narrative: This spontaneous report was received from a physician concerning an approximately 12 month old female patient with no pertinent medical history and no drug reactions or allergies. On 06-JUN-2013, the patient was vaccinated with a dose of PROQUAD (Merck) (lot number and expiry date reported as J000132 and 04-JUL-2014 respectively), subcutaneously in lateral side of the left leg. No concomitant therapy was reported. Approximately on an unknown date in June 2013, the patient experienced not sleeping well and a one inch brownish induration on lateral side of left leg which was mildly tender to touch. On 07-JUN-2013, the patient experienced irritability, a red rash on an unspecified location and crying. The patient was seen in the emergency room two days ago (approximately on 15-JUN-2013). The patient sought medical attention (unspecified0. It was unspecified if any treatment was given. The outcome of all the events was unknown. The relatedness for the events was unknown for PROQUAD (Merck). Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Poor quality sleep, Rash erythematous
Clinical narrative: This spontaneous report was received from a physician concerning an approximately 12 month old female patient with no pertinent medical history and no drug reactions or allergies. On 06-JUN-2013, the patient was vaccinated with a dose of PROQUAD (Merck) (lot number and expiry date reported as J000132 and 04-JUL-2014 respectively), subcutaneously in lateral side of the left leg. No concomitant therapy was reported. Approximately on an unknown date in June 2013, the patient experienced not sleeping well and a one inch brownish induration on lateral side of left leg which was mildly tender to touch. On 07-JUN-2013, the patient experienced irritability, a red rash on an unspecified location and crying. The patient was seen in the emergency room two days ago (approximately on 15-JUN-2013). The patient sought medical attention (unspecified0. It was unspecified if any treatment was given. The outcome of all the events was unknown. The relatedness for the events was unknown for PROQUAD (Merck). Additional information has been requested.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Headache, Hypoacusis, Pain
Clinical narrative: Approx 3 hours after receiving PNEUMOVAX 23, had sudden onset generalized headache. Since then, as of 5/31/13, has had episodes of "ice pick syndrome" HA's, lasting 10-45 minutes. Debilitating pain. Given Gabapentin 100 mg (1-6 tabs tid prn) TORADOL IM. 6/3/13 OV, 2 ice pick HA's since 5/31/13. Occurred during sleep. Given INDOCIN. Also decrease hearing (L) ear since PNEUMOVAX. 6/13/13 phone consult ice pick episodes yesterday, 3 while sleeping. Neuro eval recommended. Pt. declined.
Age: 61.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Malaise, Pyrexia, Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: This spontaneous report as received from a 61 year old female patient with "possibly: penicillin allergy. The patient's medical history included chickenpox as a child. The patient reported that the "whole inside of her mouth got swollen" after having had penicillin previously. On 03-MAY-2013 the patient was vaccinated with ZOSTAVAX, .65 ml, subcutaneous. Concomitant therapies included COZAAR, ZYRTEC, hydrochlorothiazide (manufacturer unknown) and unspecified other "blood pressure medicine". Although the patient was also taking COZAAR at the time of the reaction, the patient did not indicate any suspicion that COZAAR could have contributed to the development of the chickenpox. On 26-MAY-2013, 24 days after onset of therapy the patient began to develop chickenpox. On 26-MAY-2013, she began to get bumps on her body, including on her head, face, arms, torso, and feet. She reported that she at first thought that the bumps were "mosquito bites" but then realized that the reaction resembled chickenpox. On 28-MAY-2013, the patient developed a "high fever of" over 101 degrees" Fahrenheit and felt "really bad" and "really sick". She reported that her bumps were itchy and that her bumps were now in the stage of crusting over. The patient had e-mailed the physician for medical attention. The patient was treated with "anti-itch cream", ice and unspecified "hydrocortisone". At the time of this report, the patient was recovering. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report as received from a 61 year old female patient with "possibly: penicillin allergy. The patient's medical history included chickenpox as a child. The patient reported that the "whole inside of her mouth got swollen" after having had penicillin previously. On 03-MAY-2013 the patient was vaccinated with ZOSTAVAX, .65 ml, subcutaneous. Concomitant therapies included COZAAR, ZYRTEC, hydrochlorothiazide (manufacturer unknown) and unspecified other "blood pressure medicine". Although the patient was also taking COZAAR at the time of the reaction, the patient did not indicate any suspicion that COZAAR could have contributed to the development of the chickenpox. On 26-MAY-2013, 24 days after onset of therapy the patient began to develop chickenpox. On 26-MAY-2013, she began to get bumps on her body, including on her head, face, arms, torso, and feet. She reported that she at first thought that the bumps were "mosquito bites" but then realized that the reaction resembled chickenpox. On 28-MAY-2013, the patient developed a "high fever of" over 101 degrees" Fahrenheit and felt "really bad" and "really sick". She reported that her bumps were itchy and that her bumps were now in the stage of crusting over. The patient had e-mailed the physician for medical attention. The patient was treated with "anti-itch cream", ice and unspecified "hydrocortisone". At the time of this report, the patient was recovering. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Feeling abnormal, Malaise, Pyrexia, Rash generalised, Rash pruritic
Clinical narrative: This spontaneous report as received from a 61 year old female patient with "possibly: penicillin allergy. The patient's medical history included chickenpox as a child. The patient reported that the "whole inside of her mouth got swollen" after having had penicillin previously. On 03-MAY-2013 the patient was vaccinated with ZOSTAVAX, .65 ml, subcutaneous. Concomitant therapies included COZAAR, ZYRTEC, hydrochlorothiazide (manufacturer unknown) and unspecified other "blood pressure medicine". Although the patient was also taking COZAAR at the time of the reaction, the patient did not indicate any suspicion that COZAAR could have contributed to the development of the chickenpox. On 26-MAY-2013, 24 days after onset of therapy the patient began to develop chickenpox. On 26-MAY-2013, she began to get bumps on her body, including on her head, face, arms, torso, and feet. She reported that she at first thought that the bumps were "mosquito bites" but then realized that the reaction resembled chickenpox. On 28-MAY-2013, the patient developed a "high fever of" over 101 degrees" Fahrenheit and felt "really bad" and "really sick". She reported that her bumps were itchy and that her bumps were now in the stage of crusting over. The patient had e-mailed the physician for medical attention. The patient was treated with "anti-itch cream", ice and unspecified "hydrocortisone". At the time of this report, the patient was recovering. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Scab, Varicella
Clinical narrative: This spontaneous report as received from a 61 year old female patient with "possibly: penicillin allergy. The patient's medical history included chickenpox as a child. The patient reported that the "whole inside of her mouth got swollen" after having had penicillin previously. On 03-MAY-2013 the patient was vaccinated with ZOSTAVAX, .65 ml, subcutaneous. Concomitant therapies included COZAAR, ZYRTEC, hydrochlorothiazide (manufacturer unknown) and unspecified other "blood pressure medicine". Although the patient was also taking COZAAR at the time of the reaction, the patient did not indicate any suspicion that COZAAR could have contributed to the development of the chickenpox. On 26-MAY-2013, 24 days after onset of therapy the patient began to develop chickenpox. On 26-MAY-2013, she began to get bumps on her body, including on her head, face, arms, torso, and feet. She reported that she at first thought that the bumps were "mosquito bites" but then realized that the reaction resembled chickenpox. On 28-MAY-2013, the patient developed a "high fever of" over 101 degrees" Fahrenheit and felt "really bad" and "really sick". She reported that her bumps were itchy and that her bumps were now in the stage of crusting over. The patient had e-mailed the physician for medical attention. The patient was treated with "anti-itch cream", ice and unspecified "hydrocortisone". At the time of this report, the patient was recovering. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Aspartate aminotransferase, Back pain, Blood glucose, Computerised tomogram abdomen, Computerised tomogram head
Clinical narrative: Initial report was received on 12 June 2013 from a health care professional. An 11 year-old female patient who had not acute or chronic illness at the time of vaccination and who had seasonal allergies had received on 06 March 2013 an intramuscular left deltoid dose of MENACTRA, lot number U4418AA and an intramuscular left deltoid dose of ADACEL, lot number C4366AA and on 17 April 2013 developed headaches, weakness of both legs and arms from elbows to fingers, fever 101-103, difficulty walking and back pain. The patient was diagnosed with GBS and was hospitalized for five days on 28 May 2013. Diagnostic tests and laboratory data included a lumbar puncture, CT scan of head and abdomen, lumbar films, sinus x-rays, CBC (complete blood count), UA/C&S (urine for culture and sensitivity), AST and glucose (results were not reported). Concomitant therapy included allergy shots. The patient was receiving at home PT (physical therapy). No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Culture urine, Face and mouth X-ray, Full blood count, Gait disturbance, Guillain-Barre syndrome
Clinical narrative: Initial report was received on 12 June 2013 from a health care professional. An 11 year-old female patient who had not acute or chronic illness at the time of vaccination and who had seasonal allergies had received on 06 March 2013 an intramuscular left deltoid dose of MENACTRA, lot number U4418AA and an intramuscular left deltoid dose of ADACEL, lot number C4366AA and on 17 April 2013 developed headaches, weakness of both legs and arms from elbows to fingers, fever 101-103, difficulty walking and back pain. The patient was diagnosed with GBS and was hospitalized for five days on 28 May 2013. Diagnostic tests and laboratory data included a lumbar puncture, CT scan of head and abdomen, lumbar films, sinus x-rays, CBC (complete blood count), UA/C&S (urine for culture and sensitivity), AST and glucose (results were not reported). Concomitant therapy included allergy shots. The patient was receiving at home PT (physical therapy). No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Headache, Lumbar puncture, Muscular weakness, Pyrexia, Spinal X-ray
Clinical narrative: Initial report was received on 12 June 2013 from a health care professional. An 11 year-old female patient who had not acute or chronic illness at the time of vaccination and who had seasonal allergies had received on 06 March 2013 an intramuscular left deltoid dose of MENACTRA, lot number U4418AA and an intramuscular left deltoid dose of ADACEL, lot number C4366AA and on 17 April 2013 developed headaches, weakness of both legs and arms from elbows to fingers, fever 101-103, difficulty walking and back pain. The patient was diagnosed with GBS and was hospitalized for five days on 28 May 2013. Diagnostic tests and laboratory data included a lumbar puncture, CT scan of head and abdomen, lumbar films, sinus x-rays, CBC (complete blood count), UA/C&S (urine for culture and sensitivity), AST and glucose (results were not reported). Concomitant therapy included allergy shots. The patient was receiving at home PT (physical therapy). No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Urine analysis
Clinical narrative: Initial report was received on 12 June 2013 from a health care professional. An 11 year-old female patient who had not acute or chronic illness at the time of vaccination and who had seasonal allergies had received on 06 March 2013 an intramuscular left deltoid dose of MENACTRA, lot number U4418AA and an intramuscular left deltoid dose of ADACEL, lot number C4366AA and on 17 April 2013 developed headaches, weakness of both legs and arms from elbows to fingers, fever 101-103, difficulty walking and back pain. The patient was diagnosed with GBS and was hospitalized for five days on 28 May 2013. Diagnostic tests and laboratory data included a lumbar puncture, CT scan of head and abdomen, lumbar films, sinus x-rays, CBC (complete blood count), UA/C&S (urine for culture and sensitivity), AST and glucose (results were not reported). Concomitant therapy included allergy shots. The patient was receiving at home PT (physical therapy). No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Blood culture negative, CSF test normal, Computerised tomogram head normal, Lumbar puncture normal, Pain
Clinical narrative: Initial report received on 13 June 2013 from a healthcare professional, medical assistant. A 23 year old female patient was vaccinated on 21 May 2013 with ADACEL batch number C4365AA intramuscularly into the left deltoid. The patient had a history of allergies to chicken feathers, cockroaches and pollen. The patient's prior tetanus doses were not on file. According to the reporter, the patient did not have an illness at the time of vaccination. On 22 May 2013, the patient experienced a shooting pain down the entire left side of her body from her face to her feet. The patient was admitted to the hospital on 22 May 2013 and was evaluated by a neurologist and an infectious disease specialist on an unreported date who were unable to determine the cause of the shooting pains. The patient had a CT of the brain, lumbar puncture/spinal tap, CSF and blood cultures which results were negative. The patient was discharged on an unreported date with the discharge summary: vaccine reaction. The patient is recovering and will follow-up with the neurologist, ID specialist and PCP. The patient outcome was reported as unknown. Documents held by sender: None.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Initial report was received 14 June 2013 from an employee at a physician's office. This case is not medically confirmed. A 60-year-old female patient had received a left deltoid injection of ADACEL, lot number C4432AB (route of administration not reported) on 07 June 2013 and six days later, she presented to the physician's office due to redness, raised area, warm to touch, approximately 2.5 inches at the injection site; then a second one distal to that one, not touching. Corrective treatment consisted of cefalexin (cephalexin) 500mg TID for one week and warm compresses. The patient had no concurrent illness and no relevant medical history at the time of vaccination. The patient had previously received a first dose of ADACEL on an unspecified date. Outcome was not recovered. Documents held by sender: None.
Age: 17.0
Sex: M
Vaccine: HPV4, TDAP
Symptoms: Disturbance in attention, Exercise tolerance decreased, Fatigue, Feeling abnormal, Laboratory test
Clinical narrative: Pots (Postural Orthostatic Tachycardia Syndrome); Chronic fainting, fatigue, body pain, migraine, nausea, exercise intolerance, brain fog, difficulty concentrating - worsened after second dose.
Age: 17.0
Sex: M
Vaccine: HPV4, TDAP
Symptoms: Migraine, Nausea, Pain, Postural orthostatic tachycardia syndrome, Syncope
Clinical narrative: Pots (Postural Orthostatic Tachycardia Syndrome); Chronic fainting, fatigue, body pain, migraine, nausea, exercise intolerance, brain fog, difficulty concentrating - worsened after second dose.
Age: 17.0
Sex: M
Vaccine: HPV4, TDAP
Symptoms: Tilt table test
Clinical narrative: Pots (Postural Orthostatic Tachycardia Syndrome); Chronic fainting, fatigue, body pain, migraine, nausea, exercise intolerance, brain fog, difficulty concentrating - worsened after second dose.
Age: 43.0
Sex: M
Vaccine: RAB
Symptoms: Headache, Incorrect dose administered, Muscle spasms, Myalgia, Pyrexia
Clinical narrative: Bitten by raccoon at work on 4/2/2013. Went to ER on 4/5/2013. Started series of rabies vaccinations on 4/8/2013 by Dr. Had very bad side effects - example (headaches, severe muscle pain, muscle spasms, fever) went back 4/15/2013 for second rabies shots - was informed I was given overdose of rabies vaccine.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Rash
Clinical narrative: Rash, shortness of breath occurred several hours after vaccine administered. Patient taken to ER by ambulance for treatment.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Rash, no treatment needed (asymptomatic).
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Vaccination site rash, Vaccination site swelling
Clinical narrative: Rash and swelling started about 1 1/2 hours after vaccine at vaccine site (Right thigh), redness, swelling spread to upper thigh. Redness did get better but then worse again on 7th day. Child was started on steroids. No fever.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Injection site reaction, Myalgia
Clinical narrative: Pt described myalgia-like pain at site of vaccination. Soreness never went away since initial shot.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Pt presented to clinic with 5 cm x 4 cm  reddened, warm, hard area at site where MMRV given 2 days prior to visit. Non-pruritic.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Unevaluable event
Clinical narrative: Monitored for >16s, observed in ED.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm
Clinical narrative: Received shingles vaccine 6-13-13 Rt arm - Quarter size redness developed 6-15-13 getting larger by 6-20-13. Hot to touch. No itching or soreness fatigue off and on.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Dyspnoea, Injection site erythema, Injection site warmth, Nausea
Clinical narrative: 2 days after administration the patient experienced SOB, vesicular rash, the site was warm, red and 2-3 inches in diameter. The pt was dizzy and nauseated.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: 2 days after administration the patient experienced SOB, vesicular rash, the site was warm, red and 2-3 inches in diameter. The pt was dizzy and nauseated.
Age: 14.0
Sex: M
Vaccine: PPV
Symptoms: Abdominal pain upper, Chest pain, Headache, Pyrexia
Clinical narrative: Approx 12 hours after vaccine administered developed fever (approx 102 degrees) headache, chest pains, stomachache. Given TYLENOL, ADVIL, and symptoms gradually resolved within 48 hours.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Local mildly area redness at injection site right deltoid.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Vomiting
Clinical narrative: Pt experienced fever of 102-103 and vomiting about 4 hrs after receiving vaccines. Mom gave TYLENOL/MOTRIN and PEDIALYTE.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Dizziness, Headache, Pain, Pyrexia
Clinical narrative: Vomiting; Abdominal pain; Headache; Aches; Fever; Dizzy.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Vomiting; Abdominal pain; Headache; Aches; Fever; Dizzy.
Age: 15.0
Sex: F
Vaccine: HPV4, TD
Symptoms: Rash, Rash macular, Rash pruritic, Streptococcus test negative, Urticaria
Clinical narrative: Received HPV and Td 6/21/13 - Rash started 6/22/13. Hives - red, blotchy, itchy and spreading.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Rash macular
Clinical narrative: Red blotchy spot, swollen, painful in right upper arm.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injected limb mobility decreased, Urticaria
Clinical narrative: Given shingles vaccine 6/14/2013. Developed redness, "welt". Initially unable to move arm, now she can.
Age: 21.0
Sex: F
Vaccine: RAB, TYP
Symptoms: Borrelia test negative, Laboratory test normal, Rash, Streptococcus test negative
Clinical narrative: Rash to palms, soles surface thighs.
Age: 1.05
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site vesicles, Rash erythematous
Clinical narrative: Small red bumps, one slightly vesicular at site of varicella vaccine - occurred night after IZ, "worse" day by day.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Joint swelling
Clinical narrative: Patient experienced "hot" feeling near her elbow that was red and swollen.
Age: 14.0
Sex: M
Vaccine: TYP
Symptoms: Headache, Nausea
Clinical narrative: Feeling nausea and headache.
Age: 0.41
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Mom called this A.M. Fever all night since 4AM. At 9:15 AM still 103.5 with TYLENOL. Eating/sleeping okay. No swelling at site.
Age: 55.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Erythema, Mass, Swelling
Clinical narrative: Redness, swelling lasted 3 wks for lump to go away. After shot around evening time she noticed redness and swelling.
Age: 4.0
Sex: F
Vaccine: IPV, TDAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: No S and S.
Age: 27.0
Sex: M
Vaccine: FLU3, MMR, TDAP, VARCEL
Symptoms: Headache, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 27 y/o patient calls clinic at 1430 on 14MAR13, reporting swelling, redness, warmth, itching of his right upper extremity (RUE) at 48 hrs s/p receipt of Varicella #1 (SC) and Seasonal Influenza (IM) vaccines in his right upper arm. He also received an adult dose of the Tdap and MMR#2 in his LUE on the same date, but denies any swelling, redness or pain of his LUE. He has not experienced any wheezing, lip swelling, facial swelling or difficulty swallowing or developed hives since receipt of the 4 mentioned vaccines. He is left hand dominant (LHD) and denies any paresthesias, numbness, weakness, change in color (blue) or temperature (cold) of his right arm or hand or fingers since receipt of the Varicella #2 or Seasonal Influenza (IM) vaccines on 12MAR13. He is concerned because the swelling, redness, warmth and itching of his RUE extends from his right deltoid to just above his right elbow. He is able to pick objects up and bend his arm. He endorses a slight HA yesterday, but otherwise denies fever, chills, CP, SOB or systemic malaise.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 62 year old female patient. No medical history and drug allergies were reported. On an unknown date in April 2013, the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiry not reported), 0.65 ml, intramuscularly. No concomitant medications were reported. On an unknown date in 2013, the patient experienced rash after receiving the ZOSTAVAX. No medical attention sought by patient. The Pharmacist stated that the rash was not shingles and the patient received no treatment for the rash, and that it resolved in a few days. Varicella zoster virus (VZV) packet declined. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a registered nurse via company representative refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (Lot number, expiry date, route and dose were not reported). On an unknown date, the patient developed shingles after receiving ZOSTAVAX. The patient sought medical attention for the same(visited the doctor). The outcome of shingles was unknown. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 69 year old female patient. No drug allergies reported. The patient's medical history included dormant tuberculosis. On 17-JUN-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # J001010, expiry: 24-APR-2014) 0.65ml, subcutaneously in the left arm. Concomitant therapies included simvastatin. On 18-JUN-2013, the patient experienced a 2 inch by 1 inch area that was red, raised and warm to the touch at the injection site. Patient sought medical attention: saw pharmacist. No treatment was given. Pharmacist also stated she had another patient that experienced the same reaction when given ZOSTAVAX from the same Lot #. Laboratory diagnostics studies performed was none. The outcome of the events was reported as not recovered. This is one of 2 reports from the same reporter. Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Catatonia, Gait disturbance, Pyrexia, Rash, Speech disorder
Clinical narrative: This spontaneous report was received from an anonymous female attorney who reported seeing information on an unspecified web site on the effects of M-M-R II given at 3 year old. In the unspecified news source, an anonymous male patient (about 16 years ago) had been in perfect health prior to having received M-M-R II, and "ten days later" after having received M-M-R II on an unspecified date, he "was no longer able to go to the bathroom by himself" and had speech impairment. This male had received M-M-R II sometime in the range of when he was "12-18 months old." He was reported to have been able to walk and to speak 20-30 words perfectly before getting M-M-R II and had trouble speaking and moving afterwards. He also was reported to have gotten a fever and a rash followed by a catatonic state" from which it was unspecified if he ever recovered. The male is now 18 years old, is "confined to a wheelchair" because of the effects of M-M-R II. He received vaccination with M-M-R II, by "injection" but whether it was administered subcutaneously was unspecified by reporter. The reporter also stated that the report stated there were events involving 500 other unspecified individuals who received M-M-R II (MARRS case # 1306USA011145). The events of "unable to go to the bathroom by himself", and "confined to a wheelchair" were considered to be disabling. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Wheelchair user
Clinical narrative: This spontaneous report was received from an anonymous female attorney who reported seeing information on an unspecified web site on the effects of M-M-R II given at 3 year old. In the unspecified news source, an anonymous male patient (about 16 years ago) had been in perfect health prior to having received M-M-R II, and "ten days later" after having received M-M-R II on an unspecified date, he "was no longer able to go to the bathroom by himself" and had speech impairment. This male had received M-M-R II sometime in the range of when he was "12-18 months old." He was reported to have been able to walk and to speak 20-30 words perfectly before getting M-M-R II and had trouble speaking and moving afterwards. He also was reported to have gotten a fever and a rash followed by a catatonic state" from which it was unspecified if he ever recovered. The male is now 18 years old, is "confined to a wheelchair" because of the effects of M-M-R II. He received vaccination with M-M-R II, by "injection" but whether it was administered subcutaneously was unspecified by reporter. The reporter also stated that the report stated there were events involving 500 other unspecified individuals who received M-M-R II (MARRS case # 1306USA011145). The events of "unable to go to the bathroom by himself", and "confined to a wheelchair" were considered to be disabling. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Activities of daily living impaired, Catatonia, Gait disturbance, Pyrexia, Rash
Clinical narrative: This spontaneous report was received from an anonymous female attorney who reported seeing information on an unspecified web site on the effects of M-M-R II given at 3 year old. In the unspecified news source, an anonymous male patient (about 16 years ago) had been in perfect health prior to having received M-M-R II, and "ten days later" after having received M-M-R II on an unspecified date, he "was no longer able to go to the bathroom by himself" and had speech impairment. This male had received M-M-R II sometime in the range of when he was "12-18 months old." He was reported to have been able to walk and to speak 20-30 words perfectly before getting M-M-R II and had trouble speaking and moving afterwards. He also was reported to have gotten a fever and a rash followed by a catatonic state" from which it was unspecified if he ever recovered. The male is now 18 years old, is "confined to a wheelchair" because of the effects of M-M-R II. He received vaccination with M-M-R II, by "injection" but whether it was administered subcutaneously was unspecified by reporter. The reporter also stated that the report stated there were events involving 500 other unspecified individuals who received M-M-R II (MARRS case # 1306USA011145). The events of "unable to go to the bathroom by himself", and "confined to a wheelchair" were considered to be disabling. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Speech disorder, Wheelchair user
Clinical narrative: This spontaneous report was received from an anonymous female attorney who reported seeing information on an unspecified web site on the effects of M-M-R II given at 3 year old. In the unspecified news source, an anonymous male patient (about 16 years ago) had been in perfect health prior to having received M-M-R II, and "ten days later" after having received M-M-R II on an unspecified date, he "was no longer able to go to the bathroom by himself" and had speech impairment. This male had received M-M-R II sometime in the range of when he was "12-18 months old." He was reported to have been able to walk and to speak 20-30 words perfectly before getting M-M-R II and had trouble speaking and moving afterwards. He also was reported to have gotten a fever and a rash followed by a catatonic state" from which it was unspecified if he ever recovered. The male is now 18 years old, is "confined to a wheelchair" because of the effects of M-M-R II. He received vaccination with M-M-R II, by "injection" but whether it was administered subcutaneously was unspecified by reporter. The reporter also stated that the report stated there were events involving 500 other unspecified individuals who received M-M-R II (MARRS case # 1306USA011145). The events of "unable to go to the bathroom by himself", and "confined to a wheelchair" were considered to be disabling. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Catatonia, Gait disturbance, Pyrexia, Rash, Speech disorder
Clinical narrative: This spontaneous report was received from an anonymous female attorney who reported seeing information on an unspecified web site on the effects of M-M-R II given at 3 year old. In the unspecified news source, an anonymous male patient (about 16 years ago) had been in perfect health prior to having received M-M-R II and "ten days later" after having received M-M-R II on an unspecified date, he "was no longer able to go to the bathroom by himself" and had speech impairment. This male had received M-M-R II sometime in the range of when he was "12-18 months old." He was reported to have been able to walk and to speak 20-30 words perfectly before getting M-M-R II and had trouble speaking and moving afterwards. He also was reported to have gotten a fever and a rash followed by a catatonic state" from which it was unspecified if he ever recovered. The male is now 18 years old, is "confined to a wheelchair" because of the effects of M-M-R II. He received vaccination with M-M-R II, by "injection" but whether it was administered subcutaneously was unspecified by reporter. The reporter also stated that the report stated there were events involving 500 other unspecified individuals who received M-M-R II (MARRS case # 1306USA011145). The events of "unable to go to the bathroom by himself", and confined to a wheelchair" were considered to be disabling. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Wheelchair user
Clinical narrative: This spontaneous report was received from an anonymous female attorney who reported seeing information on an unspecified web site on the effects of M-M-R II given at 3 year old. In the unspecified news source, an anonymous male patient (about 16 years ago) had been in perfect health prior to having received M-M-R II and "ten days later" after having received M-M-R II on an unspecified date, he "was no longer able to go to the bathroom by himself" and had speech impairment. This male had received M-M-R II sometime in the range of when he was "12-18 months old." He was reported to have been able to walk and to speak 20-30 words perfectly before getting M-M-R II and had trouble speaking and moving afterwards. He also was reported to have gotten a fever and a rash followed by a catatonic state" from which it was unspecified if he ever recovered. The male is now 18 years old, is "confined to a wheelchair" because of the effects of M-M-R II. He received vaccination with M-M-R II, by "injection" but whether it was administered subcutaneously was unspecified by reporter. The reporter also stated that the report stated there were events involving 500 other unspecified individuals who received M-M-R II (MARRS case # 1306USA011145). The events of "unable to go to the bathroom by himself", and confined to a wheelchair" were considered to be disabling. Additional information has been requested.