chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Brachial plexopathy, Hypoaesthesia, Injection site pain, Muscular weakness, Musculoskeletal pain
Clinical narrative: On 21 September 2012 patient received Influenza vaccine (Sanofi Pasteur, preservative free) in his left deltoid. On 28 September 2012 he received Pneumovax in his right deltoid. He relates that approximately 1-2 weeks after receiving the Influenza vaccine he awakened with a sharp pain at the base of his right shoulder blade that progressively worsened and radiated into the right shoulder and right arm. As the pain resolved over the next several weeks he noted numbness over his right fourth and fifth fingers as well as weakness of his right arm and hand. The weakness has since improved but he still notes numbness of his fingers. He was seen by Neurology with abnormal NCV of the right Ulnar nerve and MRI of the brachial plexus demonstrated neuropathic signal changes of the inferior root of the right brachial plexus. He was diagnosed with idiopathic brachial plexopathy. In the week prior to the onset of symptoms he denies any rhinoconjunctival, cutaneous, pulmonary, GI or cardiovascular symptoms. Denies constitutional symptoms. Denies antecedent surgery/procedure, known injury or infection/illness.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Nerve conduction studies abnormal, Nuclear magnetic resonance imaging abnormal, Pain in extremity
Clinical narrative: On 21 September 2012 patient received Influenza vaccine (Sanofi Pasteur, preservative free) in his left deltoid. On 28 September 2012 he received Pneumovax in his right deltoid. He relates that approximately 1-2 weeks after receiving the Influenza vaccine he awakened with a sharp pain at the base of his right shoulder blade that progressively worsened and radiated into the right shoulder and right arm. As the pain resolved over the next several weeks he noted numbness over his right fourth and fifth fingers as well as weakness of his right arm and hand. The weakness has since improved but he still notes numbness of his fingers. He was seen by Neurology with abnormal NCV of the right Ulnar nerve and MRI of the brachial plexus demonstrated neuropathic signal changes of the inferior root of the right brachial plexus. He was diagnosed with idiopathic brachial plexopathy. In the week prior to the onset of symptoms he denies any rhinoconjunctival, cutaneous, pulmonary, GI or cardiovascular symptoms. Denies constitutional symptoms. Denies antecedent surgery/procedure, known injury or infection/illness.
Age: 39.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness and pain at site of injection for 7 days, no treatment.
Age: 1.01
Sex: M
Vaccine: DTAP, FLU3, MMR, VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: RED RAISED AREA WITH POSSIBLE CHICKENPOX IN IT.
Age: 53.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Erythema, Injection site erythema, Injection site swelling, Melanodermia, Pruritus
Clinical narrative: With Shingle shot, patient's shot site became red and swollen.  Patient also reported to her doctor itching, redness, swollen tongue and black spots.
Age: 53.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Swollen tongue
Clinical narrative: With Shingle shot, patient's shot site became red and swollen.  Patient also reported to her doctor itching, redness, swollen tongue and black spots.
Age: 1.02
Sex: F
Vaccine: MMRV, PPV
Symptoms: Convulsion, Dyskinesia
Clinical narrative: Experienced a seizure (jerking) for about 30 seconds while in car. Took to emergency room immediately.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Medication error, Wrong drug administered
Clinical narrative: This spontaneous report as received from a consumer reporting on her 67 years old husband with immune system of 3 year old and lymphoma. Pertinent medical history included radiation, chemotherapy and stem cell transplant who was vaccinated by error with a dose of live ZOSTAVAX (dose, route and lot # not provided) instead of live VARIVAX (Merck) on 30-JAN-2013. No other co-suspects were reported. No concomitant medications were reported. The patient's wife stated that on 30-JAN-2013, the evening after live ZOSTAVAX her husband was sweating profusely although his temperature was 96 F. There was no treatment given for the events. The patient called the physician. The outcome of sweating profusely was reported as not recovered/not resolved. The relatedness for sweating profusely and patient received ZOSTAVAX when supposed to received VARIVAX was unknown for live ZOSTAVAX was unknown. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Confusional state, Hypoaesthesia, Malaise
Clinical narrative: This spontaneous report as received from a doctor of medicine refers to a 25 years old female patient with no pertinent medical history and sulfa allergy, penicillin allergy, ibuprofen allergy and aspirin allergy. The patient was vaccinated with first dose GARDASIL (lot # 672193/1524AA) on 28-JAN-2013. There was no concomitant medications. On 29-JAN-2013 the patient developed confusion, malaise and numbness in the arm where she received the GARDASIL. The patient did not receive treatment. No lab diagnostics studies were performed. The patient sought unspecified medical attention. At the time of reporting, the patient's outcome was not recovered. Action taken and the relatedness for all events and GARDASIL were both unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. It was reported that the patient was vaccinated with five doses of PNEUMOVAX 23 in the year of 2012. No adverse effect reported. It was unknown if the patient sought medical attention or not. Additional information is not expected.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site swelling, Urticaria
Clinical narrative: Initial ADE was faxed 1/24/13. After taking 1 capsule diphenhydramine 25mg all symptoms cleared up until 1/30/13 when patient got hives and a large red, raised area around injection site. Patient was prescribed MEDROL dose pack, BENADRYL 50 mg QHS & hydrocortisone 1% cream to be applied during the day on 1/31/13. On 2/5/13 patient has recovered but has darkened area approx 1 1/2" x 1 " around injection site.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from a 58 years old male consumer with chronic obstructive pulmonary disease, heart disease, lung disease, diabetes, ampicillin allergy and shingles reporting on himself. The consumer was vaccinated with a dose of live ZOSTAVAX (route and lot # not reported) on approximately 03-JAN-2013 "about 3 weeks ago" to treat an existing case of shingles which was other than indicated. No other co-suspects were reported. Concomitant medications included phenobarbital and DIOVAN. The consumer reported that on approximately 17-JAN-2013, "about 2 weeks" after receiving live ZOSTAVAX, he developed a rash on both of his arms. There were no labs diagnosis or studies performed. The outcome of rash on both of his arms and shingles was reported as recovering/resolving. The relatedness for rash on both of his arms was unknown for live ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a physician via refers to a female patient of unknown age. The physician reported to the representative that a patient started her HPV vaccines series with one dose of CERVARIX followed by 2 separated doses of GARDASIL (separated by the appropriate time intervals). Dates of administration were not available. No adverse effect reported. It was unknown if the patient had sought medical attention. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician assistant refers to a 71 years old female patient with diabetic with chronic renal failure but not on dialysis. The patient was vaccinated with 0.65 ml live ZOSTAVAX(lot# unspecified) in approximately January 2011("about two years ago"). No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient developed a case of shingles. Acyclovir(manufacturer unknown) was given as treatment. The outcome of shingles was reported as recovering. The relatedness for shingles was unknown for live ZOSTAVAX. The patient had sought unspecified medical attention. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a male patient of unknown age. The patient was vaccinated with a dose of live ZOSTAVAX (route and lot # not reported) on an unspecified date. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that on an unknown date, the patient experienced getting a rash on his scalp and chest. The patient did not receive treatment for the adverse event. The outcome of rash on his scalp and chest was reported as recovered/resolved. The relatedness for rash on his scalp and chest was unknown for live ZOSTAVAX. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a physician and healthcare worker refers to a 18 years old male patient. It was reported that a second dose of GARDASIL was administered to the patient exactly 4 weeks after the first dose. The patient was vaccinated with the first dose of GARDASIL (lot# unspecified) on 04-JAN-2013 and the second dose of GARDASIL (lot# unspecified) on 01-FEB-2013. No other co-suspects were reported. No concomitant medications were reported. No treatment information was reported. The outcome of the event was unknown. Additional information has been requested
Age: 0.15
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Oral administration complication, Regurgitation
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 2 months old male patient. The patient was vaccinated with the first dose of live, oral ROTATEQ(lot# unspecified). 0.2ml orally on 31-JAN-2013. No other co-suspects were reported. No concomitant medications were reported. On 31-JAN-2013, after administration, the infant regurgitated the dose. No treatment was reported. The outcome of the event was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a female patient of unknown age. The patient was vaccinated with dose 1 GARDASIL in APR-2012 in the office and received the second dose of series on 28-JAN-2013. No adverse effects were reported. It was not reported if the patient had sought medical attention. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash generalised, Rash pustular
Clinical narrative: Rash and pustules all over body prednisone 5 mg - 2/3/13. Methylprednisolone 4mg 2/5/13. MD thinks was what was mixed in not shingles or chickenpox.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient started to develop redness and swelling in left upper arm the evening of January 28 after receiving the vaccine that afternoon. The redness and swelling worsened on January 29. The redness, swelling and warmth is localized to the left humerus and elbow. No fever, trouble breathing, swelling elsewhere.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis like reaction at site of lower injection (L) thigh 5 x 4 cm likely a reaction to DTaP.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site redness, pain, swelling, itching.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from the VAERS database via a journalist. This spontaneous report as received from a other refers to a patient of unknown age. The patient was vaccinated with lot # (656412/1476F) ZOSTAVAX on 31-JAN-2007. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced herpes zoster. No treatment information was reported. The outcome of herpes zoster is unknown. The relatedness for herpes zoster is unknown for ZOSTAVAX. Additional information is not expected.
Age: 49.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from the VAERS database via a journalist. This spontaneous report as received from a other refers to a patient of unknown age. The patient was vaccinated with lot # (657676/0619U) ZOSTAVAX on 05-JUN-2007. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced herpes zoster. No treatment information was reported. The outcome of herpes zoster is unknown. The relatedness for herpes zoster is unknown for ZOSTAVAX. Additional information is not expected.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from the VAERS database via a journalist. This spontaneous report as received from a other refers to patient of unknown age. The patient was vaccinated with lot # (656609/0015U) ZOSTAVAX on 02-APR-2007. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced herpes zoster. No treatment information was reported. The outcome of herpes zoster is unknown. The relatedness for herpes zoster is unknown for ZOSTAVAX. Additional information is not expected.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from the VAERS database via a journalist. This spontaneous report refers to a patient of unknown age. The patient was vaccinated with lot # (658208/0886U) ZOSTAVAX on 31-OCT-2007. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced herpes zoster. No treatment information was reported. The outcome of herpes zoster is unknown. The relatedness for herpes zoster is unknown for ZOSTAVAX. Additional information is not expected.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Hypoaesthesia, Pain, Pruritus, Skin lesion
Clinical narrative: Initial information has been received from a 70 years old female consumer concerning herself, with migraines and acetaminophen, VICODIN allergy. On 14-MAY-2012, the patient was vaccinated with ZOSTAVAX as prevention of shingles (dose, route, lot number were not reported). No other co-suspects were reported. Concomitant medications included acetaminophen, aspirin, FIORINAL. Four months later, around 24-SEP-2012, the patient began to experience itchiness on her scalp near her hairline. She began to developed watery lesions which spread across her forehead and continued encroaching on her eyelid. The patient went to the doctor. Her doctor looked at the lesions and informed her she had shingles. The doctor was concerned about the lesions going into her eye, so she sent to her to the eye doctor. The lesions did not spread into the eye but were around her left eye. The patient was treated with NEURONTIN 300 mg twice a day and was also given acetaminophen, PERCOCET for pain. About 3 weeks later, she went to a dermatologist for a skin check. Desonide lotion was prescribed by the dermatologist. The patient said the lesions had all went away but she still had numbness and pain where they were. The patient considered herself still recovering from shingles. Laboratory studies were not performed. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Pt received 3rd HPV shot & went to lab to have blood drawn & passed out.
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Chills, Headache, Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received from a 67 years old female patient with allergy to clindamycin. On 10-JAN-2013, the patient was vaccinated with PNEUMOVAX23. Immediately after her getting the vaccine, her arm blew up to the size of a plum and got red. Every fiber in her body ached and at one point, she could not stop shaking. She felt awful. Even after all this time, she can still see the puncture wound and has some swelling. She had sought medical attention. At the time of report, the patient had nor recovered. No treatment was given for the AE. No lab performed. The relatedness for all the events were unknown for PNEUMOVAX. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Feeling abnormal, Immediate post-injection reaction, Injection site reaction, Oedema peripheral
Clinical narrative: This spontaneous report as received from a 67 years old female patient with allergy to clindamycin. On 10-JAN-2013, the patient was vaccinated with PNEUMOVAX23. Immediately after her getting the vaccine, her arm blew up to the size of a plum and got red. Every fiber in her body ached and at one point, she could not stop shaking. She felt awful. Even after all this time, she can still see the puncture wound and has some swelling. She had sought medical attention. At the time of report, the patient had nor recovered. No treatment was given for the AE. No lab performed. The relatedness for all the events were unknown for PNEUMOVAX. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pain, Tremor, Wound
Clinical narrative: This spontaneous report as received from a 67 years old female patient with allergy to clindamycin. On 10-JAN-2013, the patient was vaccinated with PNEUMOVAX23. Immediately after her getting the vaccine, her arm blew up to the size of a plum and got red. Every fiber in her body ached and at one point, she could not stop shaking. She felt awful. Even after all this time, she can still see the puncture wound and has some swelling. She had sought medical attention. At the time of report, the patient had nor recovered. No treatment was given for the AE. No lab performed. The relatedness for all the events were unknown for PNEUMOVAX. Additional information has been requested.
Age: 37.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Arthralgia, Blood test, Body temperature increased, Electromyogram, Headache
Clinical narrative: 1/12 - Had flu shot, intense headache, lower fever, aches in thighs & knees, tingling in fingers & toes. 2/4 - Still have achy knees, twitching muscles in calves, thighs, toes & fingers feel swollen sometimes especially at night. 1/25 - Saw rheumatologist took labs, results not yet available. 1/28 & 1/29 - Had NCV, EMG & EEG which were normal.
Age: 37.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Insomnia, Malaise, Muscle twitching, Muscular weakness, Pain
Clinical narrative: 1/12 - Had flu shot, intense headache, lower fever, aches in thighs & knees, tingling in fingers & toes. 2/4 - Still have achy knees, twitching muscles in calves, thighs, toes & fingers feel swollen sometimes especially at night. 1/25 - Saw rheumatologist took labs, results not yet available. 1/28 & 1/29 - Had NCV, EMG & EEG which were normal.
Age: 37.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: 1/12 - Had flu shot, intense headache, lower fever, aches in thighs & knees, tingling in fingers & toes. 2/4 - Still have achy knees, twitching muscles in calves, thighs, toes & fingers feel swollen sometimes especially at night. 1/25 - Saw rheumatologist took labs, results not yet available. 1/28 & 1/29 - Had NCV, EMG & EEG which were normal.
Age: 37.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Antinuclear antibody positive, Arthralgia, Electroencephalogram normal, Electromyogram normal, Headache
Clinical narrative: 1/12 - Had flu shot, intense headache, lower fever, aches in thighs & knees, tingling in fingers & toes. 2/4 - Still have achy knees, twitching muscles in calves, thighs, toes & fingers feel swollen sometimes especially at night. 1/25 - Saw rheumatologist took labs, results not yet available. 1/28 & 1/29 - Had NCV, EMG & EEG which were normal.
Age: 37.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Muscle twitching, Nerve conduction studies normal, Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: 1/12 - Had flu shot, intense headache, lower fever, aches in thighs & knees, tingling in fingers & toes. 2/4 - Still have achy knees, twitching muscles in calves, thighs, toes & fingers feel swollen sometimes especially at night. 1/25 - Saw rheumatologist took labs, results not yet available. 1/28 & 1/29 - Had NCV, EMG & EEG which were normal.
Age: 17.0
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Injection site cellulitis
Clinical narrative: Mother indicates pt had an infection from vaccine. Z-PAK for treatment.
Age: 17.0
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Infection
Clinical narrative: Mother indicates pt had an infection from vaccine. Z-PAK for treatment.
Age: 2.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Blood test, Chest X-ray, Convulsion, Drooling, Gaze palsy
Clinical narrative: Mom called and stated patient began running a fever of 102.5 on 1-27-13 which was relieved by TYLENOL. That night around 4:00 AM, Mom heard something coming from patient's room and found her having a seizure, eyes rolled back and jerking and drooling. Mom states took her to ER and was diagnosed with febrile seizure and Pneumonia. Temp. at ER was 102.5, ER did x-ray and noted Pneumonia.
Age: 2.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Nuclear magnetic resonance imaging, Psychomotor hyperactivity, Pyrexia, Unresponsive to stimuli
Clinical narrative: Mom called and stated patient began running a fever of 102.5 on 1-27-13 which was relieved by TYLENOL. That night around 4:00 AM, Mom heard something coming from patient's room and found her having a seizure, eyes rolled back and jerking and drooling. Mom states took her to ER and was diagnosed with febrile seizure and Pneumonia. Temp. at ER was 102.5, ER did x-ray and noted Pneumonia.
Age: 2.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Chest X-ray abnormal, Convulsion, Drooling, Dyskinesia, Febrile convulsion
Clinical narrative: Mom called and stated patient began running a fever of 102.5 on 1-27-13 which was relieved by TYLENOL. That night around 4:00 AM, Mom heard something coming from patient's room and found her having a seizure, eyes rolled back and jerking and drooling. Mom states took her to ER and was diagnosed with febrile seizure and Pneumonia. Temp. at ER was 102.5, ER did x-ray and noted Pneumonia.
Age: 2.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Gaze palsy, Pneumonia, Pyrexia
Clinical narrative: Mom called and stated patient began running a fever of 102.5 on 1-27-13 which was relieved by TYLENOL. That night around 4:00 AM, Mom heard something coming from patient's room and found her having a seizure, eyes rolled back and jerking and drooling. Mom states took her to ER and was diagnosed with febrile seizure and Pneumonia. Temp. at ER was 102.5, ER did x-ray and noted Pneumonia.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Blood glucose decreased, Decreased appetite, Dehydration, Diarrhoea, Fluid intake reduced
Clinical narrative: Information has been received from an investigator concerning the following report: AN# 100410 BL# 0009-00011, a 1 year old male with anemia and reportedly underweight (beginning 17-JAN-2013) and a medical history of jaundice (from September to November of 2011), viral infection (from 25-DEC-2012 to 26-DEC- 2012) and bronchiolitis RSV (from 07-JAN-2013 to 21-JAN-2013) who on 14- SEP-2012 was randomized to study. On 14-SEP-2012, the patient was placed on a study therapy for the prophylactic treatment of MMRV. Concomitant therapy includes albuterol sulfate and acetaminophen. On 23-JAN-2013, the patient reportedly started to vomit. The patient had previous episodes of diarrhea beginning 17-DEC-2012 that had not fully resolved and begin again on 24-JAN-2013. The patient was having episodes of diarrhea roughly 1 time every hour with no blood but sometimes "mucousy" in color. The patient was not eating or drinking well, so on 25-JAN-2013, the patient was taken to the emergency room by his mother. In the ER, the patient was diagnosed with viral gastritis, metabolic acidosis, hypoglycemia, severe dehydration, poor weight gain and chronic diarrhea. The patient was admitted to the hospital the same day. Upon admittance, the patient was given an IV with a total of 180 milligrams of normal saline. Prior to the dose of saline, the patient's glucose performed 25-JAN-2013, showed an abnormal result of 56. The glucose result taken after the administration of normal saline showed a result of 123. This result is considered normal by the reporting investigator. The patient was reportedly discharged home on 26-JAN-2013. No further details related to the patient's current clinical status was provided at this submission. The serious adverse event of chronic diarrhea was considered recovered on 26-JAN-2013. The events of poor weight gain, severe dehydration, hypoglycemia, metabolic acidosis, and viral gastroenteritis are considered not recovered. The patient received an additional dose of study therapy of on 17-DEC-2012. No action was taken with blinded study therapy as a result of the event. At the time of the event, the patient had complete study therapy dosing and no further doses were scheduled. The relationship of the events to study therapy was not provided at the time of this report. This case was unblinded on 06-FEB-2013. Additional information is expected.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Gastritis viral, Hypoglycaemia, Metabolic acidosis, Vomiting, Weight gain poor
Clinical narrative: Information has been received from an investigator concerning the following report: AN# 100410 BL# 0009-00011, a 1 year old male with anemia and reportedly underweight (beginning 17-JAN-2013) and a medical history of jaundice (from September to November of 2011), viral infection (from 25-DEC-2012 to 26-DEC- 2012) and bronchiolitis RSV (from 07-JAN-2013 to 21-JAN-2013) who on 14- SEP-2012 was randomized to study. On 14-SEP-2012, the patient was placed on a study therapy for the prophylactic treatment of MMRV. Concomitant therapy includes albuterol sulfate and acetaminophen. On 23-JAN-2013, the patient reportedly started to vomit. The patient had previous episodes of diarrhea beginning 17-DEC-2012 that had not fully resolved and begin again on 24-JAN-2013. The patient was having episodes of diarrhea roughly 1 time every hour with no blood but sometimes "mucousy" in color. The patient was not eating or drinking well, so on 25-JAN-2013, the patient was taken to the emergency room by his mother. In the ER, the patient was diagnosed with viral gastritis, metabolic acidosis, hypoglycemia, severe dehydration, poor weight gain and chronic diarrhea. The patient was admitted to the hospital the same day. Upon admittance, the patient was given an IV with a total of 180 milligrams of normal saline. Prior to the dose of saline, the patient's glucose performed 25-JAN-2013, showed an abnormal result of 56. The glucose result taken after the administration of normal saline showed a result of 123. This result is considered normal by the reporting investigator. The patient was reportedly discharged home on 26-JAN-2013. No further details related to the patient's current clinical status was provided at this submission. The serious adverse event of chronic diarrhea was considered recovered on 26-JAN-2013. The events of poor weight gain, severe dehydration, hypoglycemia, metabolic acidosis, and viral gastroenteritis are considered not recovered. The patient received an additional dose of study therapy of on 17-DEC-2012. No action was taken with blinded study therapy as a result of the event. At the time of the event, the patient had complete study therapy dosing and no further doses were scheduled. The relationship of the events to study therapy was not provided at the time of this report. This case was unblinded on 06-FEB-2013. Additional information is expected.
Sex: F
Vaccine: PNC13, PPV
Symptoms: Drug administration error
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a female patient of unknown age. The patient was vaccinated with PNEUMOVAX23(lot#unknown) intramuscular on an unknown date. The patient was given PREVNAR 13 and PNEUMOVAX23 concomitantly. There was no treatment information. The patient did not sought medical attention. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus
Clinical narrative: This spontaneous report as received from a physician refers to a 60 years old male patient with high blood pressure and high cholesterol. The patient had a history of prostate cancer. The patient was vaccinated a dose of with ZOSTAVAX on 29-JAN-2013. No other co-suspects were reported. No concomitant medications were reported. The patient experienced itching later the same day as vaccination, on 29-JAN-2013. The next day the patient developed classic shingles on his right abdomen wrapping around to his back, dermatome T10 or T11. The patient was treated with VALTREX and prednisone. The outcome of itching and classic shingles on his right abdomen wrapping around to his back, dermatome T10 or T11 was reported as not recovered/not resolved. The relatedness for classic shingles on his right abdomen wrapping around to his back, dermatome T10 or T11 and itching was unknown for ZOSTAVAX. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 years old female patient. On 30-JAN-2013, the patient was vaccinated subcutaneously with a 0.65 ml dose of expired ZOSTAVAX (lot # 671075/1197AA, expired date 25-OCT-2012)into her left arm. No adverse effect reported at this time. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Flushing, Injection site pruritus, Lymphadenopathy, Myalgia, Oedema mouth
Clinical narrative: This spontaneous report was received from a 67 years old female patient regarding herself. On an unknown date in January 2013, the patient was vaccinated with a dose of ZOSTAVAX. No concomitant medications were reported. On 14-JAN-2013(also reported as 2 days after), the patient started feeling flushed with a swollen mouth and experienced muscle pain all over the body. She had sores on her arm near her wrist. She had also experienced itching and swollen glands near the injection site. No treatment information was reported. The outcome of muscle pain all over the body, itching and swollen glands near the injection site, had soars on her arm near her wrist and flushed with a swollen mouth was unknown. The relatedness for muscle pain all over the body, itching and swollen glands near the injection site, had soars on her arm near her wrist and flushed with a swollen mouth was unknown for ZOSTAVAX. The patient did not seek medical attention. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin ulcer
Clinical narrative: This spontaneous report was received from a 67 years old female patient regarding herself. On an unknown date in January 2013, the patient was vaccinated with a dose of ZOSTAVAX. No concomitant medications were reported. On 14-JAN-2013(also reported as 2 days after), the patient started feeling flushed with a swollen mouth and experienced muscle pain all over the body. She had sores on her arm near her wrist. She had also experienced itching and swollen glands near the injection site. No treatment information was reported. The outcome of muscle pain all over the body, itching and swollen glands near the injection site, had soars on her arm near her wrist and flushed with a swollen mouth was unknown. The relatedness for muscle pain all over the body, itching and swollen glands near the injection site, had soars on her arm near her wrist and flushed with a swollen mouth was unknown for ZOSTAVAX. The patient did not seek medical attention. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a 6month old female patient. On an unknown date, the patient was vaccinated with dose 3 of ROTATEQ. No concomitant medications were reported. On an unknown date, the patient vomited 4 or 5 times during administration of the third dose of ROTATEQ. The patient recovered and the dose was not re administered. The patient had previously received the first and second doses of ROTATEQ without complications. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: VIIth nerve paralysis
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 19 years old female patient with no medical histories and no drug allergies. On 03-JAN-2013, the patient was vaccinated with a first dose of 0.5 milliliter (ml) of GARDASIL (lot number 669265/0181AA and expiry date 31-JUL-2013)intramuscularly. No concomitant medications were reported. On 06-JAN-2013, the patient was diagnosed with Bells palsy, at an outpatient clinic called Patients First. The outcome of the event was unknown. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered pharmacist refers to a patient of unknown age. On 04-FEB-2012, the patient was vaccinated with an expired vaccine dose of 0.65 ml ZOSTAVAX, (lot number reported as (672608/1715AA), expiry date 02-FEB-2013, route subcutaneous). No concomitant medications were reported. No adverse effect reported. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 years old female patient with thyroid and cholesterol. The patients medical history included post breast cancer. On 29-JAN-2013, the patient was vaccinated with 0.65 milliliter (ml) of ZOSTAVAX (lot number was reported as H018510, expiry date was 15-JAN-2014, route was not reported) in the left arm. Concomitant medications included LEXAPRO, metformin, WELLBUTRIN, LUNESTA, simvastatin, SYNTHROID and XANAX. On 01-Feb-2013, the patient had called the pharmacy to reported that approximately on an unknown date in 2013, she has red, circular itchy rash at the injection site of left arm and it is hot to touch. The patient sought medical attention (had called the pharmacy). The pharmacist reported that he would follow-up with her healthcare provider. The pharmacist also stated that the patients husband was a physician. The outcome of all the reported events was not recovered/not resolved.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date, The patient may have been vaccinated with a dose of improperly stored PNEUMOVAX23 (Lot number, expiry date, route and dose was not reported). No concomitant medications were reported. No adverse effects reported. Additional information has been requested.
Age: 0.55
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Hypophagia, Injection site swelling, Insomnia, Irritability, Pyrexia
Clinical narrative: Fever 101.5 degrees & fussiness last night, nurses less. TYLENOL given, provided some relief. "Hardly slept last night." Condition resolved on Feb 1st. Also mentioned pt had swelling on Rt at site of DTaP also resolved.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Nodule, Swelling
Clinical narrative: SMALL KNOT IN ARM AT FIRST THEN SPEADED TO LARGER AREA OVER TIME. HAS REDNESS AND SWELLING OVER A 2.007 SQ METERS. DR PRESCRIBED KEFLEX AND BENADRYL.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Lymphadenopathy, Pain in extremity, Tenderness
Clinical narrative: Noticed sore arm in side where vaccine was received.  Also noted swollen lymph node in axilla on side where vaccine was received.  No redness noted but visibly swollen and tender to touch.   Lymph decreased in size in approximately 3 days but did not completely go away until 3 weeks.
Age: 29.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Received Fluzone intradermal flu shot on 2/3/2012.  Noticed hives on arms, neck, back, and chest on 2/4/2012.  More noticeable and itchy on day three.  Took Claritin on day one and two.  Prescribed Methylprednisolone on day three, with Claritin and Benadryl.
Age: 49.0
Sex: F
Vaccine: HEP
Symptoms: Chapped lips, Diarrhoea, Fatigue, Glossodynia, Lip swelling
Clinical narrative: Noted tongue very sore, diarrhea, wheezing, lip swelling and cracking, sneezing extreme fatigue, runny nose, extreme sore throat. Did not see MD took Benadryl on 1/4/13 and begin to improve. 1/6/13 client is greatly improved continue to take Benadryl when not working.
Age: 49.0
Sex: F
Vaccine: HEP
Symptoms: Oropharyngeal pain, Rhinorrhoea, Sneezing, Wheezing
Clinical narrative: Noted tongue very sore, diarrhea, wheezing, lip swelling and cracking, sneezing extreme fatigue, runny nose, extreme sore throat. Did not see MD took Benadryl on 1/4/13 and begin to improve. 1/6/13 client is greatly improved continue to take Benadryl when not working.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Allergic bronchitis, Balance disorder, Burning sensation, Cough, Dizziness
Clinical narrative: 1- Exhaustion 2- I developed Allergy Induced Bronchitis with severe pain and burning sensation to the lungs and a terrible cough. The cough prevented me from sleeping.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Feeling abnormal, Full blood count, Gait disturbance, Insomnia
Clinical narrative: 1- Exhaustion 2- I developed Allergy Induced Bronchitis with severe pain and burning sensation to the lungs and a terrible cough. The cough prevented me from sleeping.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Painful respiration, Red blood cell sedimentation rate
Clinical narrative: 1- Exhaustion 2- I developed Allergy Induced Bronchitis with severe pain and burning sensation to the lungs and a terrible cough. The cough prevented me from sleeping.
Age: 15.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Rash, Rash pruritic
Clinical narrative: Patient had an itchy rash on face and neck that lasted 2-3 days after receiving the HPV vaccine.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood culture negative, Culture urine negative, Electroencephalogram normal, Full blood count normal, Hypotonic-hyporesponsive episode
Clinical narrative: Hypotonic-hyporesponsive episode following Pediatrix (DTaP/IPV/HepB).
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Liver function test normal, Urine analysis normal
Clinical narrative: Hypotonic-hyporesponsive episode following Pediatrix (DTaP/IPV/HepB).
Age: 0.42
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Convulsion, Dyskinesia, Electroencephalogram abnormal, Gaze palsy, Nuclear magnetic resonance imaging brain normal
Clinical narrative: As reported by mother, the night of 1/3/13 around 10:45 PM patient started flailing arms and legs and eyes rolling up/back- which lasted about 3 minutes. She took her to ER. Patient did the same flailing for 2 days, stopped for a few days, then started again.  Mom states that she then took her to hospital on 1/14/13 where they did an EEG and was told she had slight seizure activity in both sides of brain. They also performed an MRI which was negative. Patient was admitted to hospital that night and Mother met with Neurologist on 1/15/13 mother stated that the doctor thinks the seizures were from the DTaP injection.  Patient was prescribed medication which she takes daily. Mother states the medication is Phenobarbitol 4mL q 12 hours.  Mother stated that they will keep her on the medication for 2 years then try to wean her off.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site vesicles, Pyrexia
Clinical narrative: Patient had vaccine administered on 2/01/13. Seen in office 2/4/13. Low grade fever since administration and erythema and centralized blisters at the injection site.
Age: 0.43
Sex: F
Vaccine: DTAPIPVHIB, FLU3, HEPA, PNC13
Symptoms: No adverse event
Clinical narrative: I was asked by our WIC lady to give vaccines to a child. She gave me pt's name and record states "Just come get her when your ready". So I researched vaccines due. Told them I was ready & father brought in the other child I was unaware of.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness around injection site, warm to touch, swelling.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: Right deltoid muscle became very sore on 1/7/13 the evening of when pt. received her shot. By 1/8/13 the pt. developed a large area of redness below the injection site. The area is hot to touch. Pt. did run some fever.
Age: 11.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Circulatory collapse, Electrocardiogram normal, Gaze palsy, Loss of consciousness, Pallor
Clinical narrative: Patient received 2nd Hep A & 1st VARIVAX in office on 2/4/13. In less than 5 minutes after immunizations given patient turned pale, eyes rolled back into head & he passed out. Did not regain good color, no palpable pulses in extremities. He regained consciousness with a 1 minute color poor vascular collapse until epinephrine was given.
Age: 11.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Pulse absent
Clinical narrative: Patient received 2nd Hep A & 1st VARIVAX in office on 2/4/13. In less than 5 minutes after immunizations given patient turned pale, eyes rolled back into head & he passed out. Did not regain good color, no palpable pulses in extremities. He regained consciousness with a 1 minute color poor vascular collapse until epinephrine was given.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a licensed nurse practitioner (LPN) refers to an unspecified number of patients (demographic details are unknown). On an unknown date, the patients were vaccinated with GARDASIL. The dose and route were not reported. No other co-suspects and no concomitant medications were reported. On an unknown date, the patients received either their second or third dose of GARDASIL late. No treatment information was reported, The outcome of the patients received either their second or third doses of GARDASIL late is unknown. It was reported if the patients experienced any adverse events. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site cellulitis, Injection site erythema, Injection site reaction, Purulent discharge, Scab
Clinical narrative: 1.7 cm circular lesion (R) deltoid area described as "cellulitis", noted to have a crusted drainage of a yellow color with 1 plus erythema to 10-12 cm diameter periwound. Treated w/ cephalexin 500mg TID x 7 days.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Skin lesion
Clinical narrative: 1.7 cm circular lesion (R) deltoid area described as "cellulitis", noted to have a crusted drainage of a yellow color with 1 plus erythema to 10-12 cm diameter periwound. Treated w/ cephalexin 500mg TID x 7 days.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Chest discomfort, Musculoskeletal chest pain, Nausea, Throat tightness
Clinical narrative: Sudden chest tightening lasted 45 min. Throat closing off/on. Tightening/pain around my ribs. Nausea.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a dental hygienist, the patient's mother, refers to a male patient of unknown age. On 11-JUN-2012 the patient was vaccinated with the first dose of GARDASIL. The dose and route were not reported. No other co-suspects and no concomitant medications were reported. On 12-JUL-2012 the patient received a second dose of GARDASIL No adverse symptoms were reported. No treatment information was reported. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report as received from an office manager via a company representative refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with live (Merck) VARIVAX, which was administered subcutaneously at a dose of approximately 0.5 ml. The indication was reported as prevention of varicella. No other co-suspects and no concomitant medications were reported. In Fall 2012, after the administration of live (Merck) VARIVAX, the patient had a breakthrough case of chickenpox. No treatment information was reported. The outcome of breakthrough of chickenpox was unknown. The relatedness for breakthrough of chickenpox is unknown for live (Merck) VARIVAX. The action taken with live (Merck) VARIVAX was not applicable. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a health worker refers to a patient of unknown age. The patient was inadvertently vaccinated with live (Merck) VARIVAX (dose, route and lot # not reported) instead of ZOSTAVAX on an unknown date. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a 78 years old female patient who on 31-JAN-2013 was vaccinated subcutaneously (SQ) with a standard dose of live ZOSTAVAX (Lot # H020001, Exp: 02-FEB-2014) No other co-suspects were reported. No concomitant medications were reported. The patient developed a red rash, bigger than a 1x1 gauze pad in size (approximately in the 2013). The patient received treatment: covered with gauze.   The outcome of the event was unknown. The patient did not seek Medical Attention. The relatedness for the event was unknown for live ZOSTAVAX. Additional information has been requested.
Age: 1.7
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Oedema, Pruritus, Rash erythematous, Varicella post vaccine
Clinical narrative: This spontaneous report as received from a physician refers to a 19 months old male patient. The patient had no pertinent medical history and no history of drug reactions/allergies. The patient was vaccinated subcutaneously with a dose of 0.5 ml VARIVAX (reported lot number h011072, expiry date 07-JUN-2014) on 24-JAN-2013. The patient used no concomitant medications. On 28-JAN-2013, four days after the vaccination, the patient developed red, edematous bumps, pruritus and vesicles all over his body. The patient sought medical attention and visited the doctor's office. The patient was diagnosed with chickenpox. No lab diagnostic studies were performed. The event was treated with BENADRYL, TYLENOL and hydrocortisone cream. At the time of report the patient was recovering. The reporter did not provided a causality assessment. Additional information is not expected.