chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information was received from a patient's mother regarding a patient (demographics not provided). The patient's mother reported that the patient was administered dose one of GARDASIL (dosage and route of administration not provided) on 03OCT2013. Dose two of GARDASIL (dosage and route of administration not provided) was administered on 31OCT2013. The doses were administered less than one month apart, which is other-than-indicated in the prescribing information. The reporter confirmed that the patient had not yet received her third dose in the series. No adverse effects were reported. Follow-up information was received from a physician's assistant regarding a female patient, age unknown. The physician's assistant reported that the patient came into the office on 02APR2014 to receive a dose of GARDASIL (dosage and route of administration not provided), and that the patient had not reported any adverse experiences. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information was received from an unspecified healthcare worker regarding a male patient, age unknown. The patient received the first dose of GARDASIL (dosage and route of administration not provided) on 14-NOV-2012. The patient received the second dose of GARDASIL (dosage and route of administration not provided) on 04-DEC-2012. No adverse effect reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information was received from a medical assistant regarding a female patient, age unknown, who on 30-AUG-2010 received her first dose of GARDASIL (dosage and route of administration not provided). On 01-MAR-2012, the patient received her second dose of GARDASIL (dosage and route of administration not provided). It was reported that the patient was in the office on 27-MAR-2014 inquiring if she could receive the third dose (unclear if administered). No adverse symptoms reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information was received from a medical assistant regarding a patient, demographics not provided. The patient was administered the first dose of GARDASIL series on 25-SEP-2013, the second dose on 08-JAN-2014, and the third dose on 26-MAR-2014 (dosages and routes of administration not provided). No adverse effect reported. Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Abdominal pain, Full blood count normal, Henoch-Schonlein purpura, Purpura, Urine analysis normal
Clinical narrative: Patient developed abdominal pain and emesis 4/13/14 - these symptoms resolved and then he developed purpuric rash on lower legs 4/16/14. He was seen today (4/17/14) and diagnosed with Henoch Schonlein Purpura.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Vomiting
Clinical narrative: Patient developed abdominal pain and emesis 4/13/14 - these symptoms resolved and then he developed purpuric rash on lower legs 4/16/14. He was seen today (4/17/14) and diagnosed with Henoch Schonlein Purpura.
Age: 0.12
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Immunodeficiency
Clinical narrative: Pt with undiagnosed SCID was given ROTATEQ on 4/11/14. Pt age was 6 wk 3d at time of vaccine. Pos SCID screen received in office on 4/17/14. Pt's care was transferred to another Dr. R/T SCID dx.
Age: 14.0
Sex: F
Vaccine: HEPA
Symptoms: Dyspnoea, Urticaria
Clinical narrative: Patient called 6 1/2 hours after receiving Hep A vaccine. Mother stated patient was covered in hives and having difficulty breathing. We instructed to call 911.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information was received from a registered nurse, regarding unspecified patients (demographics not provided). The nurse reported that PEDVAX HIB; GARDASIL (case #1404USA000049); and ROTATEQ (case #1404USA010716)were potentially exposed to a 33F and a 24F recording, which she believed to be erroneous recordings of a digital Vaccines for Children (VFC) Thermometer, and have been administered to unspecified patients (dates of administration, lot numbers, dosages and routes of administration not provided). The nurse reported that she believed that the thermometer that gave her the readings is inaccurate. She stated that her facility has a mercury thermometer that read temperatures that were in the recommended range. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information was received from a registered nurse, regarding unspecified patients (demographics not provided). The nurse reported that ROTATEQ; GARDASIL (case #1404USA000049); and PEDVAX HIB (case #1404USA010717) were potentially exposed to a 33F and a 24F recording, which she believed to be erroneous recordings of a digital Vaccines for Children (VFC) Thermometer, and have been administered to unspecified patients (dates of administration, lot numbers, dosages and route of administration not provided). The nurse reported that she believed that the thermometer that gave her the readings is inaccurate. She stated that her facility has a mercury thermometer that read temperatures that were in the recommended range. No adverse effect reported. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: FLUX
Symptoms: Rash
Clinical narrative: Small break out on right side of stomach.
Age: 5.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Injection site mass, Injection site reaction, Injection site warmth, Local reaction
Clinical narrative: Large Local Reaction in the left thigh (warm red lump at injection site measuring 4x6cm).
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information was received from a registered nurse, regarding unspecified patients (demographics not provided). The nurse reported that GARDASIL; ROTATEQ (case #1404USA010716); and PEDVAXHIB (case #1404USA010717) were potentially exposed to a 33F and a 24F recording, which she believed to be erroneous recordings of a digital Vaccines for Children (VFC) thermometer, and have been administered to unspecified patients (dates of administration, lot numbers, dosages and routes of administration not provided). The nurse reported that she believed that the thermometer that gave her the readings is inaccurate. She stated that her facility has a mercury thermometer that read temperatures that were in the recommended range. No adverse effect reported. Additional information has been requested.
Age: 0.58
Sex: F
Vaccine: HEP
Symptoms: Pyrexia, Urticaria
Clinical narrative: Fever to 101.8. Urticaria over body.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Grip strength decreased, Hypoaesthesia, Mobility decreased, Musculoskeletal pain
Clinical narrative: Pain in left arm, shoulder, unable to move arm in any direction, weakness, numbness of hand and fingers, unable to grip.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Pain in left arm, shoulder, unable to move arm in any direction, weakness, numbness of hand and fingers, unable to grip.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13
Symptoms: Eye swelling, Petechiae
Clinical narrative: Petechial rash on infant back and upper arms. Mother stated baby woke up with swollen eyes but resolve by the time baby showed up in the clinic @ 12 noon. Mother stated no changes in babys formula, soap. advise to go pmd if condition worses.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, Antibody test abnormal, Benign breast neoplasm, Breast operation, Weight decreased
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a currently 24 year old female patient (age at onset of AE calculated to be approximately 21 years). The patient's medical history included tonsil removal, no drug allergies. Patient received 3 doses of GARDASIL intramuscular (dose strength was not reported), doses were administered in time frame of 2006 and 2007 when the patient was 17 years old. Lot number was not reported. In 2011, the patient experienced hair loss, weight loss and reported that her thyroid was being attacked by antibodies. Antibodies levels were normal at times while elevated levels were also reported to the physician. The patient had breast surgery to remove a benign fibroid tumour (medically significant). No treatment was provided to the patient at this time for autoimmune symptoms. The patient had sought medical attention. The outcome of event benign fibroid tumor and breast surgery to remove a benign fibroid tumor was unknown. The outcome of the rest of the events was reported as not recovered. Physician informed the company representative that these symptoms have been reported to the VAERS. Upon internal review, the event breast surgery was determined to be medically significant. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Lymphoma, Neoplasm malignant
Clinical narrative: This spontaneous report as received from a consumer refers to a 69 year old female patient (caller's sister). In approximately 2012 (reported as two years ago), the patient was vaccinated with ZOSTAVAX one dose (dose and frequency unknown). Lot and dosage information was not provided. Concomitant medication was not reported. In 2013, reported as one year later, the patient learned that she had cancer (medically significant) and lymphoma (medically significant). On an unknown date in February 2014 (reported as 2 months ago) the patient experienced shingles in her vaginal area. The caller was not aware of many of the details of the specific situation her sister was experiencing. The outcome of the events was unknown. Unknown treatment was given for the events. Reporter's causality assessment was not provided. Upon internal review, the events cancer and lymphoma were determined to be medically significant. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Computerised tomogram head, Rhinitis allergic, Upper respiratory tract infection, VIIth nerve paralysis
Clinical narrative: Immunizations given 4/2/14. URI vs allergic rhinitis started on 4/14/14. 4/16/14 pt started with facial droop. Seen 4/16 in urgent care and ED. Dx with Bell's palsy.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema
Clinical narrative: Large 10 cm area of redness noted in (L) UA 1 day after vaccination. Area was assessed by ANP. No fever. No axillary adenopathy. Using arm. Denies pain. TX: Cool compresses; observe and monitor for S/S infection. Mom will follow up as needed.
Age: 39.0
Sex: F
Vaccine: FLUX, PPV, TDAP
Symptoms: Axillary pain, Dizziness, Headache, Neck pain, Pain in extremity
Clinical narrative: 5 hours after injections: pain in right arm, axilla, neck, head. SOB. Near syncope. 1 day after injection: near syncope, headache, dizziness.
Age: 39.0
Sex: F
Vaccine: FLUX, PPV, TDAP
Symptoms: Presyncope
Clinical narrative: 5 hours after injections: pain in right arm, axilla, neck, head. SOB. Near syncope. 1 day after injection: near syncope, headache, dizziness.
Age: 62.0
Sex: M
Vaccine: TDAP, YF
Symptoms: Abdominal discomfort, Chest discomfort, Cough, Increased bronchial secretion, Muscle spasms
Clinical narrative: First reaction was uneasy pressure around or within stomach (upper abdomen area) and similar feeling around lungs but not sure if the feeling came from the stomach or around the lungs.  Later, stomach upset would come and go and somewhat diminish but bronchial tubes and lungs would seem to begin to secrete liquids causing coughing beginning about 04/05/2014.  Respiratory symptoms seemed to grow and more fluids in bronchial tubes needing clearing by strong out-breaths to clear passages or coughing which began to begin to happen in short spasms.
Age: 60.0
Sex: F
Vaccine: PPV, TD, VARZOS
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: She states after 24hr she had fatigue and a headache and possibly low grade fever then, next day she had fever of 102.5 and 3rd day all was fine.
Age: 55.0
Sex: F
Vaccine: DPP
Symptoms: Erythema, Induration, Local swelling, Pyrexia, Skin warm
Clinical narrative: Developed fever of 103 the never went down below 100 despite Ibuprofen 800 mg QID. Fever lasted for 4 days. Upper third of left arm red, hot to touch, swelling extended to clavicle in front and up toward neck and present for 7 days despite cold packs. Area of induration originally as big as tangerine and two weeks later still the size of walnut. No problems with shortness of breath.
Age: 55.0
Sex: F
Vaccine: DPP
Symptoms: Swelling
Clinical narrative: Developed fever of 103 the never went down below 100 despite Ibuprofen 800 mg QID. Fever lasted for 4 days. Upper third of left arm red, hot to touch, swelling extended to clavicle in front and up toward neck and present for 7 days despite cold packs. Area of induration originally as big as tangerine and two weeks later still the size of walnut. No problems with shortness of breath.
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PPV, RVX
Symptoms: Dyskinesia, Electroencephalogram normal, Muscle spasms, Opisthotonus
Clinical narrative: During her last feeding of the night, she started arching her back. I thought she just wanted out of my lap and to be burped. I sat her up and she started having spasms where she would throw her hands behind her head and turn her head from side to side while her whole body would jerk. She had clusters of them. I thought she was having a seizure. Took her into the emergency room where the doctor told me she was having muscle spasms but nothing was wrong with her. We didn't do blood work or any sort of testing. I scheduled an appointment with our pediatrician who also said there was nothing wrong with her and referred us to a neurologist.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Arthralgia, Eye swelling, Fatigue, Hypersomnia, Mood swings
Clinical narrative: This spontaneous report as received from a consumer refers to a 19 year old male patient. The patient's pertinent medical history was none. In May 2013 the patient was vaccinated with first dose GARDASIL intramuscularly. Concomitant medications were not reported. Approximately in 2013 (reported as with in one week) the patient experienced mood swings and joint pain. On an unknown date the patient was fatigued, his eyes began to swell and sleeping for 2 weeks straight which was unlike him after receiving second shot of GARDASIL on an unspecified date. The outcome of mood swings, fatigue, joint pain, his eyes began to swell and sleeping for 2 weeks straight which was unlike him was reported as not recovered/not resolved. The causality was not reported. The patient sought medical attention by talking to the physician. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 10-APR-2014 the patient was vaccinated with MMR II (lot#0685AE, expiration date: 02-APR-2014, dose and route not reported) dose 1. No adverse symptoms reported. Additional information has been requested.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a health care worker refers to a patient of unknown age. The patient's medical history was not reported. On 15-APR-2014 the patient was vaccinated with MMR II (lot # 0649AE, Expiry date: 27-MAR-2014) (Dose:0.5 milliliter (ml) subcutaneously. Concomitant therapy VARIVAX was administered on 15-APR-2014. The patient administered expired dose of MMR II on 15-APR-2014. The outcome of expired dose of MMR II was administered on 15-APR-2014 was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a physician via company representative refers to two patients of unknown age and unknown gender. The patients medical history was not reported. Approximately in April 2014 (Reported as in the past week) the patient was vaccinated with GARDASIL (Dose number was unknown). Concomitant medications were not reported. Approximately in April 2014 (reported as in the past week) patients were fainted in the reporting physician's office after receiving GARDASIL. The outcome was reported as recovered/resolved. The causality was not reported. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. On 17-APR-2014 the patient was vaccinated with a dose of VARIVAX, 0.5 milliliter (ml), subcutaneously instead of ZOSTAVAX. The pharmacist reported that on 17-APR-2014 the patient had physician order to be administered ZOSTAVAX but was administered VARIVAX instead. No adverse effects noted by patient. No further information was available. It was also reported that no treatment for the event and the patient did not seek medical attention. It was also reported that therapy discontinued as no. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: TDAP, DTAP
Symptoms: Chills, Culture, Diarrhoea, Exposure during pregnancy, Pain
Clinical narrative: Fever 38.1C, chills, body aches, diarrhea non stop tachycardia for mom and baby.
Age: 31.0
Sex: F
Vaccine: TDAP, DTAP
Symptoms: Pyrexia, Tachycardia, Tachycardia foetal, White blood cell count normal
Clinical narrative: Fever 38.1C, chills, body aches, diarrhea non stop tachycardia for mom and baby.
Age: 31.0
Sex: F
Vaccine: TDAP, DTAP
Symptoms: Chills, Diarrhoea, Dizziness, Exposure during pregnancy
Clinical narrative: Fever 38.1C, chills, body aches, diarrhea non stop tachycardia for mom and baby.
Sex: U
Vaccine: PPV
Symptoms: Cerebral artery embolism, Computerised tomogram head abnormal, Feeling abnormal, Memory impairment, Pulmonary embolism
Clinical narrative: This spontaneous report as received from a physician via field representative refers to a patient of unknown age and gender. Last Friday, on 11-APR-2014 the patient was vaccinated with PNEUMOVAX 23 injection for unknown indication (lot #, expiry date, dose and route unknown). The physician reported that the patient experienced "not feeling right" after receiving PNEUMOVAX 23 (onset date unspecified, approximately in April 2014). The physician reported that the patient was also experiencing "trouble with memory" in April 2014. The patient got in contact with the physician, though it was unspecified if patient went to physician's office or if the patient called the physician on the phone. The physician sent the patient to the hospital (hospital unspecified). The hospital performed a CT (Computed Tomography) scan which found a pulmonary embolism in the patient's brain in April 2014. The outcome of pulmonary embolism, trouble with memory and not feeling right was unknown. Upon internal review, pulmonary embolism was considered to be medically significant. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site reaction, Rash macular
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 79 year old female patient. The patient persistent medical history included osteoarthritis and thalassemia. On 16-APR-2014, the patient was vaccinated with ZOSTAVAX lot # J012660, 0.65 ml once subcutaneous. Concomitant therapies included ATIVAN, NEXIUM, Aspirin, MOBIC, TOPROL XL and Meclizine. On 16-APR-2014 (also reported as immediately after receiving ZOSTAVAX) the patient experienced macular rash that was 7 inches in length down her arm past the injection site. The reporter stated that the physician gave the patient BENADRYL and told her an ice pack over it for 20 minutes. The reporter stated that the patient left the office but the rash was still present. The reporter also stated that this was the second time a muscular rash reaction occurred with the lot number J012660. The outcome of the event was reported as not recovered. The reporter did not provide the causality between the event and the suspect drug. This case is linked to the case 1404USA010316 (same reporter link). Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site rash
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a 50 year old female patient. The patient persistent medical history included enlarged lymph nodes. The patient had hay fever allergy. On 09-APR-2014, the patient was vaccinated with ZOSTAVAX (lot # J012660, 0.65 ml once, subcutaneous. On 09-APR-2014 (also reported as immediately after receiving ZOSTAVAX) the patient experienced muscular rash, flat at the injection site. The reporter stated that the physician gave the patient BENADRYL and had her hold an ice pack over it for 20 minutes. The reporter also stated that one of the girls in the office called the patient later that evening and the patient said that the rash was gone. It was reported that this was the second time a muscular rash occurred with this lot number J012660. The outcome of the event was reported as recovering. The reporter did not provided the causality between the event and the suspect drug. This case is linked to the case 1404USA010321 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nuse refers to unknown number of patients of unknown age. The nurse reported that a provider's office (demographics unspecified) reported that unspecified number of doses of (Oka/Merck) VARIVAX and (Oka/Merck) PROQUAD (which captured in MARRS@ 1404USA008917) were adminsitered to patients after experiencing varied, and multiple excursions. VARIVAX vaccine (Oka/Merck), (lot# j007029, expiration date: 05-JUN-2015) were exposerd to 28F for 403.5 hours, and 295 hours at 14F. Next, (Oka/Merck) VARIVAX, (lot# j008170 expiration date: 02-JUL-2015) were exposed to 28F for 392.5 hours. No adverse effects reported. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Dizziness, Pyrexia
Clinical narrative: Chills, fever, dizziness last 4 days. Called pt back 3/25/14 and again 4/19/14.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist (also reported as healthcare worker) refers to a male patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX, single 0.65 ml shot, subcutaneous. On an unknown date the patient developed a case of shingles after the administration of ZOSTAVAX on an unspecified date. The outcome of a case of shingles was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea, Headache, Loss of consciousness
Clinical narrative: This spontaneous report as received from a consumer refers to a his/her female child of unknown age. On 14-OCT-2013 the patient had the first shot of GARDASIL (dose, route, lot # and expiration date not reported). ON 31-JAN-2014 the patient was vaccinated with a second dose of GARDASIL (dose and route not reported, lot # J007354, expiration date 20-FEB-2014). The child had headaches for a month (date unspecified), and did not have a menstrual cycle for 50 days (date unspecified). The child passed out in the office a week and a half ago from the second vaccination (approximately in February 2014). The outcome of the events was not reported. The relatedness between the events and GARDASIL was not reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist who reported that five infant patients between 2 and 10 months of age (gender not provided) were inadvertently administered a third dose of PEDVAX HIB (dose, route, frequency and lot# not provided) two months after a second dose. No adverse effects were reported. Follow up information was received from the pharmacist. Patient identifiers (initials and birth dates) were provided. Lot numbers and expiration dates were unavailable at this time. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist who reported that five infant patients between 2 and 10 months of age (gender not provided) were inadvertently administered a third dose of PEDVAXHIB (dose, route, frequency and lot# not provided) two months after a second dose. No adverse effects were reported. Follow up information was received from the pharmacist. Patient identifiers (initials and birthdates) were provided. Lot numbers and expiration dates were unavailable at this time. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist who reported that five infant patients between 2 and 10 months of age (gender not provided) were inadvertently administered a third dose of PEDVAXHIB (dose, route, frequency and lot# not provided) two months after a second dose. No adverse effects were reported. Follow up information was received from the pharmacist. Patient identifiers (initials and birthdates) were provided. Lot numbers and expiration date were unavailable at this time. This is one of several reports received from the same source. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: FLUX(H1N1), FLUX(H1N1)
Symptoms: Decreased appetite, Diabetic neuropathy, Diplopia, Glycosylated haemoglobin increased, Hepatic steatosis
Clinical narrative: Case number PHHY2014US045752 is an initial literature report received on 14 Apr 2014. The author discussed about the motor palsies of cranial nerves (excluding VII) after vaccination. This report refers to a 71-year-old male patient. His medical history included upper respiratory infection. He was vaccinated with H1N1 (manufacturer and batch number: not reported, so conservatively coded as Pandemic influenza vaccine INN) on an unknown date. On an unknown date, after vaccination he developed fever, malaise and anorexia for two days. He was hospitalized twice and received supportive care. His discharge diagnoses included elevated liver function tests possibly secondary to a viral infection, mesenteric panniculitis, elevated hemoglobin AIC and fatty infiltration of the liver. Twenty-four days after vaccination, he developed diplopia and was evaluated as an outpatient and was diagnosed with diabetic third nerve palsy. The final outcome of the events reported as resolved. The author concluded that passive surveillance data cannot be used to assess causality and the occurrence of cranial nerve palsies after vaccination might be purely coincidental. Post-immunization cranial nerve palsies other than VII might be clinically important and further research was needed.
Age: 71.0
Sex: M
Vaccine: FLUX(H1N1), FLUX(H1N1)
Symptoms: IIIrd nerve paralysis, Liver function test abnormal, Malaise, Mesenteric panniculitis, Pyrexia
Clinical narrative: Case number PHHY2014US045752 is an initial literature report received on 14 Apr 2014. The author discussed about the motor palsies of cranial nerves (excluding VII) after vaccination. This report refers to a 71-year-old male patient. His medical history included upper respiratory infection. He was vaccinated with H1N1 (manufacturer and batch number: not reported, so conservatively coded as Pandemic influenza vaccine INN) on an unknown date. On an unknown date, after vaccination he developed fever, malaise and anorexia for two days. He was hospitalized twice and received supportive care. His discharge diagnoses included elevated liver function tests possibly secondary to a viral infection, mesenteric panniculitis, elevated hemoglobin AIC and fatty infiltration of the liver. Twenty-four days after vaccination, he developed diplopia and was evaluated as an outpatient and was diagnosed with diabetic third nerve palsy. The final outcome of the events reported as resolved. The author concluded that passive surveillance data cannot be used to assess causality and the occurrence of cranial nerve palsies after vaccination might be purely coincidental. Post-immunization cranial nerve palsies other than VII might be clinically important and further research was needed.
Age: 71.0
Sex: M
Vaccine: FLUX(H1N1), FLUX(H1N1)
Symptoms: Decreased appetite, Diplopia, Glycosylated haemoglobin increased, Hepatic steatosis, IIIrd nerve paralysis
Clinical narrative: Case number PHHY2014US045752 is an initial literature report received on 14 Apr 2014. The author discussed about the motor palsies of cranial nerves (excluding VII) after vaccination. This report refers to a 71-year-old male patient. His medical history included upper respiratory infection. He was vaccinated with H1N1 (manufacturer and batch number: not reported, so conservatively coded as Pandemic influenza vaccine INN) on an unknown date. On an unknown date, after vaccination he developed fever, malaise and anorexia for two days. He was hospitalized twice and received supportive care. His discharge diagnoses included elevated liver function tests possibly secondary to a viral infection, mesenteric panniculitis, elevated hemoglobin AIC and fatty infiltration of the liver. Twenty-four days after vaccination, he developed diplopia and was evaluated as an outpatient and was diagnosed with diabetic third nerve palsy. The final outcome of the events reported as resolved. The author concluded that passive surveillance data cannot be used to assess causality and the occurrence of cranial nerve palsies after vaccination might be purely coincidental. Post-immunization cranial nerve palsies other than VII might be clinically important and further research was needed.
Age: 71.0
Sex: M
Vaccine: FLUX(H1N1), FLUX(H1N1)
Symptoms: Liver function test abnormal, Malaise, Mesenteric panniculitis, Pyrexia, Upper respiratory tract infection
Clinical narrative: Case number PHHY2014US045752 is an initial literature report received on 14 Apr 2014. The author discussed about the motor palsies of cranial nerves (excluding VII) after vaccination. This report refers to a 71-year-old male patient. His medical history included upper respiratory infection. He was vaccinated with H1N1 (manufacturer and batch number: not reported, so conservatively coded as Pandemic influenza vaccine INN) on an unknown date. On an unknown date, after vaccination he developed fever, malaise and anorexia for two days. He was hospitalized twice and received supportive care. His discharge diagnoses included elevated liver function tests possibly secondary to a viral infection, mesenteric panniculitis, elevated hemoglobin AIC and fatty infiltration of the liver. Twenty-four days after vaccination, he developed diplopia and was evaluated as an outpatient and was diagnosed with diabetic third nerve palsy. The final outcome of the events reported as resolved. The author concluded that passive surveillance data cannot be used to assess causality and the occurrence of cranial nerve palsies after vaccination might be purely coincidental. Post-immunization cranial nerve palsies other than VII might be clinically important and further research was needed.
Age: 71.0
Sex: M
Vaccine: FLUX(H1N1), FLUX(H1N1)
Symptoms: Viral infection
Clinical narrative: Case number PHHY2014US045752 is an initial literature report received on 14 Apr 2014. The author discussed about the motor palsies of cranial nerves (excluding VII) after vaccination. This report refers to a 71-year-old male patient. His medical history included upper respiratory infection. He was vaccinated with H1N1 (manufacturer and batch number: not reported, so conservatively coded as Pandemic influenza vaccine INN) on an unknown date. On an unknown date, after vaccination he developed fever, malaise and anorexia for two days. He was hospitalized twice and received supportive care. His discharge diagnoses included elevated liver function tests possibly secondary to a viral infection, mesenteric panniculitis, elevated hemoglobin AIC and fatty infiltration of the liver. Twenty-four days after vaccination, he developed diplopia and was evaluated as an outpatient and was diagnosed with diabetic third nerve palsy. The final outcome of the events reported as resolved. The author concluded that passive surveillance data cannot be used to assess causality and the occurrence of cranial nerve palsies after vaccination might be purely coincidental. Post-immunization cranial nerve palsies other than VII might be clinically important and further research was needed.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity
Clinical narrative: This spontaneous report as received from a physician refers to a now 75 year old female patient with allergy to sulphur drugs, MACROBID and RECLAST. On 16-DEC-2013 the patient was vaccinated with PNEUMOVAX 23 lot # J004332 (exp. 26-SEP-2014) in the right arm. Administration route was unspecified. The patient has previously received PNEUMOVAX 23 in October 2007. On an unknown date the patient developed pain in her arm and red streaks around her arm up to her armpits. No date was specified. The outcome of pain in her arm and red streaks around her arm up to her armpits was unknown. The patient contact office to seek medical attention. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: FLU3, HEP, HEPA, HPV4, MNQ, TDAP, FLU3, HEP, HEPA, HPV4, MNQ, TDAP
Symptoms: Serum sickness
Clinical narrative: Case number PHHY2014US027656 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 518480) on 06 Mar 2014 and a follow-up received from Quality Assurance Department (reference number: 287524) on 14 Apr 2014: This report refers to 13 year old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: A12122 and expiry date: Aug 2014), FLUARIX (other manufacturer, batch number: 59YY4), ENGERIX-B (other manufacturer, batch number: AHBVC253BA), HAVRIX (other manufacturer, batch number: JR737), GARDASIL (other manufacturer, batch number: J006850) and BOOSTRIX (other manufacturer, batch number: AC52B097BA) on 01 Nov 2013. It was reported that on 03 Nov 2013 patient presented with serum reaction due to vaccine. The outcome of the event was reported as condition unchanged as of 05 Nov 2013. The seriousness and the causality of the event were not reported. Based on the investigation performed, QA department stated that, the MENVEO (batch number: A12122) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (reference number: 287524) on 14 Apr 2014: Updated batch review report.
Age: 13.0
Sex: F
Vaccine: FLU3, HEP, HEPA, HPV4, MNQ, TDAP, FLU3, HEP, HEPA, HPV4, MNQ, TDAP
Symptoms: Serum sickness, Vaccination complication
Clinical narrative: Case number PHHY2014US027656 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 518480) on 06 Mar 2014 and a follow-up received from Quality Assurance Department (reference number: 287524) on 14 Apr 2014: This report refers to 13 year old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: A12122 and expiry date: Aug 2014), FLUARIX (other manufacturer, batch number: 59YY4), ENGERIX-B (other manufacturer, batch number: AHBVC253BA), HAVRIX (other manufacturer, batch number: JR737), GARDASIL (other manufacturer, batch number: J006850) and BOOSTRIX (other manufacturer, batch number: AC52B097BA) on 01 Nov 2013. It was reported that on 03 Nov 2013 patient presented with serum reaction due to vaccine. The outcome of the event was reported as condition unchanged as of 05 Nov 2013. The seriousness and the causality of the event were not reported. Based on the investigation performed, QA department stated that, the MENVEO (batch number: A12122) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (reference number: 287524) on 14 Apr 2014: Updated batch review report.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, White blood cell count normal
Clinical narrative: Took patient to urgent care.  He was diagnosed with cellulitis.  He was given an IV Rocephin and placed on oral Augmentin.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Coeliac disease
Clinical narrative: Took patient to urgent care.  He was diagnosed with cellulitis.  He was given an IV Rocephin and placed on oral Augmentin.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist refers an approximately 70 years old female patient. Drug reactions/allergies were reported as none. On 31-MAR-2014, the patient was vaccinated with ZOSTAVAX, 0.65 ml (milliliter)/once, subcutaneously, for unknown indication. No concomitant medications were reported. On an unknown date in 2014 (also reported as a few days after the patient received ZOSTAVAX, the patient developed pain in the arm. The patient called into the pharmacy, on an unspecified date, to report this reaction. The patient reported to the pharmacist that the pain was intermittent, it comes and goes and patient did not have a rash. Patient sought medical attention. No treatment given for adverse event. No lab diagnostic studies were performed. Action taken with respect to ZOSTAVAX was not applicable. No product quality complaint was involved. The outcome of pain in the arm was not resolved. Causality was not provided. No further information was provided. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist refers an approximately 70 years old female patient. Drug reactions/allergies were reported as none. On 31-MAR-2014, the patient was vaccinated with ZOSTAVAX, 0.65 ml (milliliter)/once, subcutaneously, for unknown indication. No concomitant medications were reported. On an unknown date in 2014 (also reported as a few days after the patient received ZOSTAVAX, the patient developed pain in the arm. The patient called into the pharmacy, on an unspecified date, to report this reaction. The patient reported to the pharmacist that the pain was intermittent, it comes and goes and patient did not have a rash. Patient sought medical attention. No treatment given for adverse event. No lab diagnostic studies were performed. Action taken with respect to ZOSTAVAX was not applicable. No product quality complaint was involved. The outcome of pain in the arm was not resolved. Causality was not provided. No further information was provided. Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Aspergillus infection, Malaise
Clinical narrative: This spontaneous report was received from a consumer (patient mother) refers to a male patient of unknown age. The patient was allergic to tetracycline. On an unknown date in April 2008 (also reported as 5 or 6 years ago) the patient was vaccinated with ZOSTAVAX (dose, route and frequency were not reported). Concomitant medication included some kind of antibiotic. On an unknown date, the patient experienced aspergillus, which is a fungal infection in the lungs. The reporter state that the patient was diagnosed with this condition after receiving the ZOSTAVAX vaccination. The reporter also stated that she was not known how long after receiving the vaccination his symptoms started. The reporter stated her son was very ill and has sought medical attention several times, and has an upcoming appointment with a specialist. The patient was hospitalized. The outcome of the event was reported as not recovered. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested. This is an amended report. The serious criteria of "Hospitalized" was checked for both AEs. And the sentence "The patient was hospitalized" was added in the narrative.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Itchy site of injection, readiness 1 in by 2 1/2 in, swelling. No treatment was recommended unless child uncomfortable.
Age: 0.35
Sex: M
Vaccine: MEN
Symptoms: Somnolence
Clinical narrative: Brief episode of drowsiness.
Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Dyspnoea, Erythema, Hypersensitivity, Pyrexia
Clinical narrative: High Fever, Severe Allergic Reaction, Severe Swelling which is large round red and swollen and seem to be getting larger and larger everyday, dizziness until today 4/20/2014 with difficulty breathing while sleeping.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Ovarian disorder
Clinical narrative: Low ovarian reserve unknown cause.
Age: 1.02
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Decreased appetite, Insomnia, Pain, Pyrexia, Rash
Clinical narrative: Fever, rash, body aches, not eating. 4/3/14 fever 102.2; 4/4/14 fever 101.4; 4/6/14 full body rash thru 4/8/14. 6-7 days no eating, no sleeping.
Age: 1.02
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Streptococcus test negative
Clinical narrative: Fever, rash, body aches, not eating. 4/3/14 fever 102.2; 4/4/14 fever 101.4; 4/6/14 full body rash thru 4/8/14. 6-7 days no eating, no sleeping.
Age: 30.0
Sex: F
Vaccine: HEPA, PPV
Symptoms: Asthenia, Chills, Ecchymosis, Fatigue, Headache
Clinical narrative: 4/9/14 Pt had stuffy nose from allergies in morning and otherwise felt fine. Had immunizations at 10 am. Felt fine until 5 pm when she felt tired and weak. Temp was 101 around 7 pm. Left arm throbbing and numbing at around 7 pm, resolved in 30 minutes. Fever peaked at 102.3 at 9 pm. Took Advil. Woke up at 2 a.m. with 102 temp and chills and took more Advil. 4/10/14 Temp 8:30 am  101. Took Advil 400 mg. Seen by MD at 9:30 am. Feels tired, slightly achy. Temp 102.4. Left arm sore to raise arm and to palpate but not painful at rest. WBC 13.9 with neutrophilia, no bands. Mild tenderness and induration for 3-4 cm around left deltoid injection site. Took Advil alternating with Tylenol at 2pm, 6 pm and at 12 midnight. 4/11/14 Temp reported by patient: 101.6 Took Tylenol. Left deltoid: 10 cm erythema and warmth, tenderness, no streaking. This is location of pneumococcal vaccine. Due to progression of erythema around injection site, and leukocytosis and continued fever, will treat for possibility of injection site infection. Start Keflex TID. 4/12/14  L upper arm with 8 x 7 cm area of induration deltoid area. 3 blotchy areas of redness over lower deltoid extending to 10 cm above elbow ( 8 x 5, 7 x 4 and 7 x 5 cm each). Entire area mod tender and mod warm to touch. 4 cm area of ecchymosis just distal to area of erythema. 4/15/14  Left arm discoloration has stopped advancing and started fading. No paresthesias or numbness.  Presumed cellulitis after pneumococcal vaccine vs severe immunologic reaction causing severe local and also systemic sx (fever, malaise, headache, nausea, leukocytosis). All sx resolving.
Age: 30.0
Sex: F
Vaccine: HEPA, PPV
Symptoms: Hypoaesthesia, Injection site erythema, Injection site induration, Injection site pain, Injection site reaction
Clinical narrative: 4/9/14 Pt had stuffy nose from allergies in morning and otherwise felt fine. Had immunizations at 10 am. Felt fine until 5 pm when she felt tired and weak. Temp was 101 around 7 pm. Left arm throbbing and numbing at around 7 pm, resolved in 30 minutes. Fever peaked at 102.3 at 9 pm. Took Advil. Woke up at 2 a.m. with 102 temp and chills and took more Advil. 4/10/14 Temp 8:30 am  101. Took Advil 400 mg. Seen by MD at 9:30 am. Feels tired, slightly achy. Temp 102.4. Left arm sore to raise arm and to palpate but not painful at rest. WBC 13.9 with neutrophilia, no bands. Mild tenderness and induration for 3-4 cm around left deltoid injection site. Took Advil alternating with Tylenol at 2pm, 6 pm and at 12 midnight. 4/11/14 Temp reported by patient: 101.6 Took Tylenol. Left deltoid: 10 cm erythema and warmth, tenderness, no streaking. This is location of pneumococcal vaccine. Due to progression of erythema around injection site, and leukocytosis and continued fever, will treat for possibility of injection site infection. Start Keflex TID. 4/12/14  L upper arm with 8 x 7 cm area of induration deltoid area. 3 blotchy areas of redness over lower deltoid extending to 10 cm above elbow ( 8 x 5, 7 x 4 and 7 x 5 cm each). Entire area mod tender and mod warm to touch. 4 cm area of ecchymosis just distal to area of erythema. 4/15/14  Left arm discoloration has stopped advancing and started fading. No paresthesias or numbness.  Presumed cellulitis after pneumococcal vaccine vs severe immunologic reaction causing severe local and also systemic sx (fever, malaise, headache, nausea, leukocytosis). All sx resolving.
Age: 30.0
Sex: F
Vaccine: HEPA, PPV
Symptoms: Injection site warmth, Leukocytosis, Nausea, Neutrophilia, Pain
Clinical narrative: 4/9/14 Pt had stuffy nose from allergies in morning and otherwise felt fine. Had immunizations at 10 am. Felt fine until 5 pm when she felt tired and weak. Temp was 101 around 7 pm. Left arm throbbing and numbing at around 7 pm, resolved in 30 minutes. Fever peaked at 102.3 at 9 pm. Took Advil. Woke up at 2 a.m. with 102 temp and chills and took more Advil. 4/10/14 Temp 8:30 am  101. Took Advil 400 mg. Seen by MD at 9:30 am. Feels tired, slightly achy. Temp 102.4. Left arm sore to raise arm and to palpate but not painful at rest. WBC 13.9 with neutrophilia, no bands. Mild tenderness and induration for 3-4 cm around left deltoid injection site. Took Advil alternating with Tylenol at 2pm, 6 pm and at 12 midnight. 4/11/14 Temp reported by patient: 101.6 Took Tylenol. Left deltoid: 10 cm erythema and warmth, tenderness, no streaking. This is location of pneumococcal vaccine. Due to progression of erythema around injection site, and leukocytosis and continued fever, will treat for possibility of injection site infection. Start Keflex TID. 4/12/14  L upper arm with 8 x 7 cm area of induration deltoid area. 3 blotchy areas of redness over lower deltoid extending to 10 cm above elbow ( 8 x 5, 7 x 4 and 7 x 5 cm each). Entire area mod tender and mod warm to touch. 4 cm area of ecchymosis just distal to area of erythema. 4/15/14  Left arm discoloration has stopped advancing and started fading. No paresthesias or numbness.  Presumed cellulitis after pneumococcal vaccine vs severe immunologic reaction causing severe local and also systemic sx (fever, malaise, headache, nausea, leukocytosis). All sx resolving.