chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Oxygen saturation decreased
Clinical narrative: This spontaneous report was received from a 65 year old female registered nurse regarding herself. Patient's current condition included chronic obstructive pulmonary disease (COPD), hypertension and codeine allergy. The patient's medical history included hip replacement, swelling and soreness at the injection site following multiple prior doses of unspecified influenza vaccines (brand name and manufacturer unknown). On an unknown date in September 2006 (approximately 6 years ago), the patient was vaccinated with PNEUMOVAX 23 (dose, route and lot number unspecified). Concomitant medications included TOPROL XL tablets, hydrochlorothiazide (manufacturer unknown), SPIRIVA and FLOVENT. On an unknown date, the patient was hospitalized for a hip replacement. On 19-SEP-2012, while she was hospitalized for a hip replacement, she was vaccinated with a dose of PNEUMOVAX 23 (dose, route and lot number unspecified). On 19-SEP-2012, approximately 6 hours following the vaccination, she experienced short of breath, asthmatic, pulse oximetry reading dropped from 96 to 70, her heart rate increased to 140 beats per minute that she needed to use oxygen and albuterol therapy way too often. On the same day, she experienced swelling and soreness at the injection site. Hospitalization was not prolonged. She was discharged on the following day (20-SEP-2012) but the patient was still experiencing the shortness of breath. She followed up with an unspecified physician on the next day the doses of SPIRIVA, FLOVENT were increased. On 22-SEP-2012, her respiratory symptoms were resolved. The outcome of swelling and soreness at the injection site was unknown. The relatedness for all the events was unknown was unknown for PNEUMOVAX 23. This case is related to 1210USA004946 (Same Patient Link). Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. On an unknown date the patients were vaccinated with M-M-R II, route and dose were unknown. No co-suspect drugs or concomitant medications were reported. The reporter stated that 7 vials of expired sterile diluent were used by his facility recently to reconstitute M-M-R II. No adverse experiences have been reported, and he stated that due to the fact that only the lot number and expiration date are recorded for the M-M-R II vial on the patients' records, he does not know which of the patients recently vaccinated received the expired sterile diluent. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Exposure via direct contact, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist referring to a patient of unknown age who was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported) on 13-MAR-2012 and following the vaccination (when the needle was removed from patient's arm) part of a dose leaked out and ran down the patient's arm. No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. Additional information is not expected.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Insomnia, Pyrexia
Clinical narrative: Information has been received from a 59 year old male health care worker, concerning himself. The patient had no pertinent medical history and no known drug allergies. On 24-SEP-2012, the patient was vaccinated with a dose of PNEUMOVAX23, one vial dose, injection in the left arm (route and not reported) (Lot # and expiration date were not reported). On 24-SEP-2012 "by Monday evening", the patient developed a red tender area at the injection site. Then, on 25-SEP-2012, the patient's red area expanded to about 3 inches in diameter 4-5 inches above the elbow. Patient stated that it was quite painful and that he could not sleep on the left side of his body. Patient reported that in addition he had a fever of 99.7 (units not specified). No lab diagnostic studies were performed. The patient sought medical attention by sending a note to his physician. At the time of the report, the patient's outcome of red and tender area at the injection site, quite painful, the patient could not sleep and he had a fever of 99.7 was reported as not recovered/not resolved. The relatedness for red area at the injection site, he had a fever of 99.7, could not sleep, it was quite painful and tender area at the injection site was unknown for PNEUMOVAX23. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician concerning a female patient of unknown age, who on an unknown date was vaccinated with a dose of PNEUMOVAX 23 (dose, route and lot # not reported). No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient developed fever of 102 degrees after receiving PNEUMOVAX 23. On an unknown date the fever of 102 degrees improved and the outcome of the patient was reported as recovered. The relatedness for fever of 102 degrees was unknown for PNEUMOVAX 23. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling, Pruritus
Clinical narrative: Information has been received from a registered nurse via a field representative concerning a female who on an unknown date was vaccinated with a dose of ZOSTAVAX, subcutaneous injection in her arm (not further specified). Two days after she was vaccinated, the nurse reported that most of the patient's upper arm was red, swollen and itching. The field representative did not have knowledge in which arm the vaccine was administered. The patient self-treated herself with hydrocortisone cream, and was recovering at the time of report. No further information is expected.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Cellulitis, Pruritus
Clinical narrative: This spontaneous report as received from a pharmacist referring to a 69 years old female patient who on an unknown date was vaccinated with 0.65 ml ZOSTAVAX, SQ (Lot # not provided) on 20-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. The pharmacist stated that on 29-SEP-2012 the patient experienced burning sensation, itching and eventually developed cellulitis after receiving ZOSTAVAX. The physician mentioned that "just to be clear there was no rash", MOTRIN, BENADRYL and an unspecified antibiotic were given as a treatment for the events. The outcome of cellulitis, itching and burning sensation was reported as recovering/resolving "it's a vaccine". The relatedness for cellulitis, itching and burning sensation was unknown for ZOSTAVAX. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Malaise, Pyrexia
Clinical narrative: Information has been received from a pharmacist concerning a 70 year old with high cholesterol, high blood pressure and BPH. The patient was vaccinated with, .65 ml ZOSTAVAX (reported Lot# H011426; exp. 12-SEP-2013) on 25-SEP-2012. Concomitant medications included hydrochlorothiazide, potassium chloride, quinapril hydrochloride and finasteride. On 26-SEP-2012, the patient developed fever, malaise, and shingles on the upper chest and back on the left side. The patient was treated with acyclovir. At the time of this report the patient has not recovered. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to an unknown number of patients of an unknown age. On an unknown dates, the patients were vaccinated with a single dose of ZOSTAVAX subcutaneously in the "back of the arm in the triceps region" (doses, lot numbers not reported). No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. Additional information is not expected.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Joint swelling, Oedema peripheral
Clinical narrative: Information has been received from a pharmacist concerning a 59 years old female patient, who was hospitalized when on an unknown date was vaccinated with a dose of PNEUMOVAX 23 (dose, route and lot # not reported). On an unknown date the patient experienced swelling of the whole arm and shoulder. No other co-suspects were reported. No concomitant medications were reported. The outcome of swelling of the whole arm and shoulder was reported as recovered. The relatedness for swelling of the whole arm and shoulder was unknown for PNEUMOVAX 23. The patient sought unspecified medical attention. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The pharmacist reported that a patient received an expired dose of PNEUMOVAX23 sometime in August 2012 or September 2012. The PNEUMOVAX 23 had an expiration date of 12-DEC-2011. No symptoms reported. This is one of several reports from the same source. (Other patients cases: MARRS#1210USA000858 and MARRS#1210USA000859). Additional information has been requested.
Age: 0.95
Sex: M
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 11 months old patient. The patient was vaccinated with the first dose of VARIVAX (lot number not provided) 17 day prior to his first birthday on 12-JUL-1999. No other co-suspects were reported. No concomitant medications were reported. The second dose was administered on 23-APR-2003. No adverse effects reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a consumer refers to her 64 years old husband with diabetes and no Drug Reactions/Allergies. The patient's medical history included stent. The patient was vaccinated SC with a dose of ZOSTAVAX 0.65 ml (Lot number not reported) on 02-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. Consumer reported that on 03-OCT-2012, after getting ZOSTAVAX the patient noticed a red spot larger than a quarter at the reaction site. It did not itch and has started going away as of 04-OCT-2012. No treatment information was reported and no lab diagnostics were performed. At the time, the spot was getting smaller and the patient was recovering. The patient did not seek medical attention. The relatedness for red spot larger than a quarter at the reaction site is unknown for ZOSTAVAX. Additional information is not expected.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site reaction, Pruritus, Swelling
Clinical narrative: This spontaneous report was received from a 55 years old female consumer reporting on herself with allergy to antibiotics and narcotics and a history of cerebral palsy who on 25-SEP-2012, was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not reported). No other co-suspects were reported. Concomitant medications included PRILOSEC and simvastatin (manufacturer unknown). The consumer reported that on 26-SEP-2012, she experienced an injection site reaction to ZOSTAVAX. After receiving the vaccine, the consumer experienced itching, swelling and redness. Hydrocortisone cream was given as a treatment for the experience. No lab diagnostics studies were performed. The symptoms were gone after 5 days on approximately 02-OCT-2012. The patient sought medical attention by contacting a health care professional. The relatedness for patient experiencing itching, redness and swelling was unknown for ZOSTAVAX. This is one of several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with a dose 0.5 ml PNEUMOVAX 23 (lot # 669579/0595AA) that expired on 30-AUG-2012 approximately on 01-OCT-2012 "last week". 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 is not expected.
Age: 26.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Blood creatine phosphokinase, Computerised tomogram, Convulsion, Electroencephalogram, Injected limb mobility decreased
Clinical narrative: Initial report was received from a health care professional on 03 October 2012. A 26-year-old female patient had received a dose one injection in the left arm of ADACEL, lot number U44308BA, on 06 March 2012 at 9:30 AM. On 12 March 2012, the patient suffered a seizure, her arm where shot was given was red and swollen, her arm and shoulder hurt badly and she had a hard time moving it. She also had another seizure as well. Relevant diagnostic/laboratory testing included a computed tomography (CT), electroencephalogram (EEG) and CPK was drawn. The patient had no illness at the time of vaccination. The patient was under the care of a neurologist and her primary care physician (PCP). The patient's outcome was not recovered. Documents held by sender: None.
Age: 26.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site erythema, Injection site swelling, Musculoskeletal pain, Pain in extremity
Clinical narrative: Initial report was received from a health care professional on 03 October 2012. A 26-year-old female patient had received a dose one injection in the left arm of ADACEL, lot number U44308BA, on 06 March 2012 at 9:30 AM. On 12 March 2012, the patient suffered a seizure, her arm where shot was given was red and swollen, her arm and shoulder hurt badly and she had a hard time moving it. She also had another seizure as well. Relevant diagnostic/laboratory testing included a computed tomography (CT), electroencephalogram (EEG) and CPK was drawn. The patient had no illness at the time of vaccination. The patient was under the care of a neurologist and her primary care physician (PCP). The patient's outcome was not recovered. Documents held by sender: None.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Herpes zoster ophthalmic, Oedema peripheral, Tremor
Clinical narrative: This spontaneous report as received from a patient refers to a 75 years old female patient with allergy to stimulants including epinephrine. The patient was vaccinated with 0.65 ml ZOSTAVAX (lot number not reported) as subcutaneous injection on 16-JUL-2012. No other co-suspects were reported. Concomitant medications included simvastatin (manufacturer unknown) and ubidecarenone. On 19-JUL-2012 (reported as 3 to 4 days after receiving vaccine) the patient experienced pain in the left eye which was diagnosed as shingles. On an unknown date in 2012 (also reported as over the past months) she experienced strep throat, staff infection and fascia pain in her back that affected her "QL" levels. She also reported her injection arm still very weak. The consumer called again to report the continued pain and weakness that is still in her injection arm. She also mentioned she is still experiencing the fascia pain in her back. She was treated with penicillin, doxycycl hyc, eye drops and an unspecified pill for the events. The lab diagnostics studies include strep test, skin swab, ultrasound, Magnetic resonance imaging (MRI) and blood works. The patient sought medical attention since she first saw the eye doctor and later went to the emergency room. The outcome of the events was not recovered. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Autoantibody test, Back pain, Blood test, Culture, Eye pain
Clinical narrative: This spontaneous report as received from a patient refers to a 75 years old female patient with allergy to stimulants including epinephrine. The patient was vaccinated with 0.65 ml ZOSTAVAX (lot number not reported) as subcutaneous injection on 16-JUL-2012. No other co-suspects were reported. Concomitant medications included simvastatin (manufacturer unknown) and ubidecarenone. On 19-JUL-2012 (reported as 3 to 4 days after receiving vaccine) the patient experienced pain in the left eye which was diagnosed as shingles. On an unknown date in 2012 (also reported as over the past months) she experienced strep throat, staff infection and fascia pain in her back that affected her "QL" levels. She also reported her injection arm still very weak. The consumer called again to report the continued pain and weakness that is still in her injection arm. She also mentioned she is still experiencing the fascia pain in her back. She was treated with penicillin, doxycycl hyc, eye drops and an unspecified pill for the events. The lab diagnostics studies include strep test, skin swab, ultrasound, Magnetic resonance imaging (MRI) and blood works. The patient sought medical attention since she first saw the eye doctor and later went to the emergency room. The outcome of the events was not recovered. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster ophthalmic, Muscular weakness, Nuclear magnetic resonance imaging, Pharyngitis streptococcal, Staphylococcal infection
Clinical narrative: This spontaneous report as received from a patient refers to a 75 years old female patient with allergy to stimulants including epinephrine. The patient was vaccinated with 0.65 ml ZOSTAVAX (lot number not reported) as subcutaneous injection on 16-JUL-2012. No other co-suspects were reported. Concomitant medications included simvastatin (manufacturer unknown) and ubidecarenone. On 19-JUL-2012 (reported as 3 to 4 days after receiving vaccine) the patient experienced pain in the left eye which was diagnosed as shingles. On an unknown date in 2012 (also reported as over the past months) she experienced strep throat, staff infection and fascia pain in her back that affected her "QL" levels. She also reported her injection arm still very weak. The consumer called again to report the continued pain and weakness that is still in her injection arm. She also mentioned she is still experiencing the fascia pain in her back. She was treated with penicillin, doxycycl hyc, eye drops and an unspecified pill for the events. The lab diagnostics studies include strep test, skin swab, ultrasound, Magnetic resonance imaging (MRI) and blood works. The patient sought medical attention since she first saw the eye doctor and later went to the emergency room. The outcome of the events was not recovered. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Ultrasound scan
Clinical narrative: This spontaneous report as received from a patient refers to a 75 years old female patient with allergy to stimulants including epinephrine. The patient was vaccinated with 0.65 ml ZOSTAVAX (lot number not reported) as subcutaneous injection on 16-JUL-2012. No other co-suspects were reported. Concomitant medications included simvastatin (manufacturer unknown) and ubidecarenone. On 19-JUL-2012 (reported as 3 to 4 days after receiving vaccine) the patient experienced pain in the left eye which was diagnosed as shingles. On an unknown date in 2012 (also reported as over the past months) she experienced strep throat, staff infection and fascia pain in her back that affected her "QL" levels. She also reported her injection arm still very weak. The consumer called again to report the continued pain and weakness that is still in her injection arm. She also mentioned she is still experiencing the fascia pain in her back. She was treated with penicillin, doxycycl hyc, eye drops and an unspecified pill for the events. The lab diagnostics studies include strep test, skin swab, ultrasound, Magnetic resonance imaging (MRI) and blood works. The patient sought medical attention since she first saw the eye doctor and later went to the emergency room. The outcome of the events was not recovered. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Influenza virus test negative, Intensive care, Nasopharyngitis, Respiratory arrest
Clinical narrative: A report has been received from a physician via medical representative concerning a 3-year-old male patient. The patient had a small hole in his heart. Developmental delay (speech and motor), atrial septal defect and failure to thrive. Concomitant medication was not provided. The patient received nasal FLUMIST on 10-Sep-2012. Seven to ten days after receiving FLUMIST, the child had seizures and was hospitalized. Seven to ten days after the hospitalization, on 21-Sep-2012 the child passed away in the hospital. The outcome of the event of seizure is unknown. Reporter assesses the event of Death to be serious due to Death and Company physician assessed the event of seizures to be serious due to hospitalised.
Age: 3.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Convulsion, Death
Clinical narrative: A report has been received from a physician via medical representative concerning a 3-year-old male patient. The patient had a small hole in his heart. Developmental delay (speech and motor), atrial septal defect and failure to thrive. Concomitant medication was not provided. The patient received nasal FLUMIST on 10-Sep-2012. Seven to ten days after receiving FLUMIST, the child had seizures and was hospitalized. Seven to ten days after the hospitalization, on 21-Sep-2012 the child passed away in the hospital. The outcome of the event of seizure is unknown. Reporter assesses the event of Death to be serious due to Death and Company physician assessed the event of seizures to be serious due to hospitalised.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Erythema, Pyrexia, Swelling
Clinical narrative: Patient developed swelling and redness after getting the pneumonia and flu shot in the same arm, about the size of an apple. The swelling and reddness was there for about 1.5 weeks untill the patient got prednisone. One day after recieving the shots, the patient developed severe chills and fever for 2 days.
Age: 55.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pain, Swelling
Clinical narrative: Noted swelling on L deltoid and severe 10/10 pain approximately 5 hrs after vaccinated with Pneumococcal vaccine. Reported to PCP who prescribed Vicodin. The patient took 2 tablets of Vicodin with pain relief. However, noticed that swelling was spreading and thus, presented to ED for further evaluation. Of note, R deltoid where flu vaccine was administered was normal.
Sex: U
Vaccine: FLUX, VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a "doctor's nurse" refers to 7-8 patients of unknown age and gender. The patients were vaccinated with a 0.65 ml of ZOSTAVAX (lot# and route not reported) on 02-OCT-2012. Concomitant therapy included "flu vaccine" (manufacturer unknown) given in their other arm. On an unknown date, within a couple hours of getting the vaccines, the patients experienced pain and swelling at the injection site. The patient sought unspecified medical attention. No treatment information was reported. The outcome of patients were reported as recovered/resolved "within a day or two". The relatedness for pain and swelling at the injection site were unknown for ZOSTAVAX by reporting nurse. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Balance disorder, Dizziness, Nausea
Clinical narrative: Severe dizziness, nausea, balance issues - at the time I did not think about it being related to flu vaccine - however, it happened every October for several years.
Age: 0.8
Sex: M
Vaccine: FLUX
Symptoms: Acute disseminated encephalomyelitis, Acute respiratory failure, Areflexia, Body temperature increased, Bradycardia
Clinical narrative: This literature report (initial receipt 02-Oct-2012) concerns a 9-month-old male patient. The patient received flu vaccine (manufacturer and batch no. were not provided). The patient's activity and oral intake decreased. He had an oral temperature of 38.3 degrees Celsius and a one day history of runny nose. 2 weeks after vaccination he was admitted to hospital. On admission, the patient was afebrile and lethargic with a weak cry. He had decreased movement in all extremities. His musculature showed decreased tone. A sepsis workup was done and during the lumbar puncture the patient had an episode of bradycardia and was intubated. The patient was admitted with presumed sepsis and acute respiratory failure. The patient was noted to not have spontaneous movement of arms or legs to painful stimuli. Deep tendon reflexes were absent in the arms but preserved in the lower extremities. A magnetic resonance imaging (MRI) showed a non-enhancing signal abnormality in the medial thalami and midbrain extending into the dorsal pons and an expansile, non-enhancing cord lesion centered at C4 with edema/signal abnormality was noted. An inflammatory or demyelinating process, acute disseminated encephalomyelitis (ADEM), was considered most likely. The patient was started on IVIG and high dose dexamethasone for a two week period without clinical effect. The patient was started on IVIG and high dose dexamethasone for a two week period without clinical effect. The patient was subsequently started on five courses of plasmapheresis (alternating days). Intravenous immune globulin (IVIG) was discontinued and dexamethasone was gradually tapered. The patient showed improvement, including spontaneous respiration, oral feeding and some movement of the extremities. He was subsequently discharged to a subacute center.
Age: 0.8
Sex: M
Vaccine: FLUX
Symptoms: Crying, Decreased activity, Endotracheal intubation, Hypokinesia, Hypophagia
Clinical narrative: This literature report (initial receipt 02-Oct-2012) concerns a 9-month-old male patient. The patient received flu vaccine (manufacturer and batch no. were not provided). The patient's activity and oral intake decreased. He had an oral temperature of 38.3 degrees Celsius and a one day history of runny nose. 2 weeks after vaccination he was admitted to hospital. On admission, the patient was afebrile and lethargic with a weak cry. He had decreased movement in all extremities. His musculature showed decreased tone. A sepsis workup was done and during the lumbar puncture the patient had an episode of bradycardia and was intubated. The patient was admitted with presumed sepsis and acute respiratory failure. The patient was noted to not have spontaneous movement of arms or legs to painful stimuli. Deep tendon reflexes were absent in the arms but preserved in the lower extremities. A magnetic resonance imaging (MRI) showed a non-enhancing signal abnormality in the medial thalami and midbrain extending into the dorsal pons and an expansile, non-enhancing cord lesion centered at C4 with edema/signal abnormality was noted. An inflammatory or demyelinating process, acute disseminated encephalomyelitis (ADEM), was considered most likely. The patient was started on IVIG and high dose dexamethasone for a two week period without clinical effect. The patient was started on IVIG and high dose dexamethasone for a two week period without clinical effect. The patient was subsequently started on five courses of plasmapheresis (alternating days). Intravenous immune globulin (IVIG) was discontinued and dexamethasone was gradually tapered. The patient showed improvement, including spontaneous respiration, oral feeding and some movement of the extremities. He was subsequently discharged to a subacute center.
Age: 0.8
Sex: M
Vaccine: FLUX
Symptoms: Hyporeflexia, Hypotonia, Immunoglobulin therapy, Lethargy, Lumbar puncture
Clinical narrative: This literature report (initial receipt 02-Oct-2012) concerns a 9-month-old male patient. The patient received flu vaccine (manufacturer and batch no. were not provided). The patient's activity and oral intake decreased. He had an oral temperature of 38.3 degrees Celsius and a one day history of runny nose. 2 weeks after vaccination he was admitted to hospital. On admission, the patient was afebrile and lethargic with a weak cry. He had decreased movement in all extremities. His musculature showed decreased tone. A sepsis workup was done and during the lumbar puncture the patient had an episode of bradycardia and was intubated. The patient was admitted with presumed sepsis and acute respiratory failure. The patient was noted to not have spontaneous movement of arms or legs to painful stimuli. Deep tendon reflexes were absent in the arms but preserved in the lower extremities. A magnetic resonance imaging (MRI) showed a non-enhancing signal abnormality in the medial thalami and midbrain extending into the dorsal pons and an expansile, non-enhancing cord lesion centered at C4 with edema/signal abnormality was noted. An inflammatory or demyelinating process, acute disseminated encephalomyelitis (ADEM), was considered most likely. The patient was started on IVIG and high dose dexamethasone for a two week period without clinical effect. The patient was started on IVIG and high dose dexamethasone for a two week period without clinical effect. The patient was subsequently started on five courses of plasmapheresis (alternating days). Intravenous immune globulin (IVIG) was discontinued and dexamethasone was gradually tapered. The patient showed improvement, including spontaneous respiration, oral feeding and some movement of the extremities. He was subsequently discharged to a subacute center.
Age: 0.8
Sex: M
Vaccine: FLUX
Symptoms: Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging spinal cord abnormal, Plasmapheresis, Rhinorrhoea, Sepsis
Clinical narrative: This literature report (initial receipt 02-Oct-2012) concerns a 9-month-old male patient. The patient received flu vaccine (manufacturer and batch no. were not provided). The patient's activity and oral intake decreased. He had an oral temperature of 38.3 degrees Celsius and a one day history of runny nose. 2 weeks after vaccination he was admitted to hospital. On admission, the patient was afebrile and lethargic with a weak cry. He had decreased movement in all extremities. His musculature showed decreased tone. A sepsis workup was done and during the lumbar puncture the patient had an episode of bradycardia and was intubated. The patient was admitted with presumed sepsis and acute respiratory failure. The patient was noted to not have spontaneous movement of arms or legs to painful stimuli. Deep tendon reflexes were absent in the arms but preserved in the lower extremities. A magnetic resonance imaging (MRI) showed a non-enhancing signal abnormality in the medial thalami and midbrain extending into the dorsal pons and an expansile, non-enhancing cord lesion centered at C4 with edema/signal abnormality was noted. An inflammatory or demyelinating process, acute disseminated encephalomyelitis (ADEM), was considered most likely. The patient was started on IVIG and high dose dexamethasone for a two week period without clinical effect. The patient was started on IVIG and high dose dexamethasone for a two week period without clinical effect. The patient was subsequently started on five courses of plasmapheresis (alternating days). Intravenous immune globulin (IVIG) was discontinued and dexamethasone was gradually tapered. The patient showed improvement, including spontaneous respiration, oral feeding and some movement of the extremities. He was subsequently discharged to a subacute center.
Age: 0.8
Sex: M
Vaccine: FLUX
Symptoms: Unresponsive to stimuli
Clinical narrative: This literature report (initial receipt 02-Oct-2012) concerns a 9-month-old male patient. The patient received flu vaccine (manufacturer and batch no. were not provided). The patient's activity and oral intake decreased. He had an oral temperature of 38.3 degrees Celsius and a one day history of runny nose. 2 weeks after vaccination he was admitted to hospital. On admission, the patient was afebrile and lethargic with a weak cry. He had decreased movement in all extremities. His musculature showed decreased tone. A sepsis workup was done and during the lumbar puncture the patient had an episode of bradycardia and was intubated. The patient was admitted with presumed sepsis and acute respiratory failure. The patient was noted to not have spontaneous movement of arms or legs to painful stimuli. Deep tendon reflexes were absent in the arms but preserved in the lower extremities. A magnetic resonance imaging (MRI) showed a non-enhancing signal abnormality in the medial thalami and midbrain extending into the dorsal pons and an expansile, non-enhancing cord lesion centered at C4 with edema/signal abnormality was noted. An inflammatory or demyelinating process, acute disseminated encephalomyelitis (ADEM), was considered most likely. The patient was started on IVIG and high dose dexamethasone for a two week period without clinical effect. The patient was started on IVIG and high dose dexamethasone for a two week period without clinical effect. The patient was subsequently started on five courses of plasmapheresis (alternating days). Intravenous immune globulin (IVIG) was discontinued and dexamethasone was gradually tapered. The patient showed improvement, including spontaneous respiration, oral feeding and some movement of the extremities. He was subsequently discharged to a subacute center.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Asthenia, Dizziness, Eye swelling, Foreign body sensation in eyes
Clinical narrative: Shot given about 3:00 pm. Went to ER about 6:00 pm 9-27-12 respiratory, eyes swelling, mouth swelling, dizzy, hard to see, weak, eyes feel like filled with dust.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Oedema mouth, Respiratory disorder, Visual impairment
Clinical narrative: Shot given about 3:00 pm. Went to ER about 6:00 pm 9-27-12 respiratory, eyes swelling, mouth swelling, dizzy, hard to see, weak, eyes feel like filled with dust.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: The arm where injection was given is very painful from the shoulder to the elbow. It is difficult to move, regardless of pain.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dizziness, Erythema, Malaise, Oedema peripheral, Pain
Clinical narrative: Red all around arm, swayed when standing up, painful when lifting arm, some swelling around arm, sick for a week. Benadryl for pain.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling redness pain and tenderness at the injection site.
Age: 78.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, pain and redness at injection site.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea, Pallor, Pruritus generalised, Throat tightness
Clinical narrative: Patient started with paleness & dizziness. Then within the hour she statred itching all over, then broke out in hives, throat started closing up, had shortness of breath and the shakes. We gave patient 50mg of Benadryl and 5 minutes later injected with a 0.3mg Epinephrine pen. After being sent the the ER via ambulance, patient received Steroids.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor, Urticaria
Clinical narrative: Patient started with paleness & dizziness. Then within the hour she statred itching all over, then broke out in hives, throat started closing up, had shortness of breath and the shakes. We gave patient 50mg of Benadryl and 5 minutes later injected with a 0.3mg Epinephrine pen. After being sent the the ER via ambulance, patient received Steroids.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Large red swollen knot that lasted 2 weeks at injection site.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Decreased appetite, Dyspnoea, Fatigue
Clinical narrative: Fever to 101.5 for 2 days, shortness of breath when I walk short distance, shaking chills, sweating, severe joint pains, fatigue, malaise, loss of appetite, need to sleep constantly. Treated with Tylenol, Aleve and sleep. Felt too sick to go out to the doctor's office.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Hyperhidrosis, Malaise, Pyrexia, Somnolence, Tremor
Clinical narrative: Fever to 101.5 for 2 days, shortness of breath when I walk short distance, shaking chills, sweating, severe joint pains, fatigue, malaise, loss of appetite, need to sleep constantly. Treated with Tylenol, Aleve and sleep. Felt too sick to go out to the doctor's office.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Chills, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Severe redness around where the shot was administered and swelling, redness was hot.  Muscle aches, sore throat, chills, arm pit soreness, headache. Pharmacist told me to take Benadryl.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Myalgia, Oropharyngeal pain
Clinical narrative: Severe redness around where the shot was administered and swelling, redness was hot.  Muscle aches, sore throat, chills, arm pit soreness, headache. Pharmacist told me to take Benadryl.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: Large, circular swollen area on thigh where administered, tight, red, itchy not painful... was given Augmentin and told it was Cellulitis and that if it did not clear up in next day or so that we would be admitted to hosp. for intravenous antibiotics.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Skin tightness
Clinical narrative: Large, circular swollen area on thigh where administered, tight, red, itchy not painful... was given Augmentin and told it was Cellulitis and that if it did not clear up in next day or so that we would be admitted to hosp. for intravenous antibiotics.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal discomfort, Headache, Malaise, Nausea, Pain
Clinical narrative: Bad headache, nausea, fever, body aches, gastrointestinal discomfort, general malaise. Went from perfectly healthy to wanting to curl up in a corner and cry.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: Bad headache, nausea, fever, body aches, gastrointestinal discomfort, general malaise. Went from perfectly healthy to wanting to curl up in a corner and cry.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Lip swelling, Paraesthesia, Paraesthesia oral, Swelling face
Clinical narrative: When at home experienced lip and facial tingling and then swelling of the lip and face.  Developed problems with taking a deep breath.  Took Benadryl and in about 45-60 minutes it became easier to breathe.
Age: 1.79
Sex: F
Vaccine: FLUN3
Symptoms: Rash, Urticaria
Clinical narrative: Pt recieve flu mist at providers office - recieved cutaneous rash to face and body - hives.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Fatigue, Feeling abnormal
Clinical narrative: Pt reports he had approximately 2 hours of chills without fever. He states he felt poor and fatigue for approximately 18 hours. Pt feels fine as of today, 10/12/12.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Fall, Head injury, Laboratory test, Loss of consciousness
Clinical narrative: Patient passed out. Because of falling and hitting her head a number of medical issues arose but the issues were due to the fall not the vaccine.
Age: 19.0
Sex: M
Vaccine: FLU3
Symptoms: Pharyngeal oedema, Pruritus generalised
Clinical narrative: Started having itching all over and felt like throat was swelling shut beginning approximately 30 minutes after the vaccine was administered.
Age: 53.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Pruritus
Clinical narrative: Called 9/27/2012 reported palms of hands and bottom of feet itching. Denies any other rash. No fever. No shortness of breath - used topical cortisone and allergy med ALLEGRA x 1 resolved in 10 days.
Sex: U
Vaccine: FLU3
Symptoms: Cellulitis
Clinical narrative: Case number PHEH2012US019924 is an initial spontaneous report received from a nurse on 28 Sep 2012. This case refers to a patient of unspecified age and gender. The patient was vaccinated with FLUVIRIN (batch number: 12262P) on an unspecified date. On an unknown date after vaccination the patient was hospitalized with cellulitis of the arm for two days. The outcome and causality of the event was not reported. A quality investigation was requested for this batch of FLUVIRIN with reference number 186103. No other information was available.
Age: 38.0
Sex: F
Vaccine: FLUN3
Symptoms: Balance disorder, Dizziness, Loss of consciousness, Pain, Reaction to food additive
Clinical narrative: A consumer report has been received. The report concerns a 38 year old, female patient. No concomitant medication was reported. She had no allergy to eggs. On 25-Sep-2012, the patient received nasal FLUMIST. 10 minutes after taking FLUMIST, she passed out and had upper torso pain. On 28-Sep-2012, she also had off-balance and dizziness issues. The patient had an intolerance to monosodium glutamate. The outcome of the event of passed out, upper torso pain, off-balance, dizziness and MSG intolerance was unknown. Company physician assessed the serious criteria for the event of passed out as important medical event and considered the events of off-balance, dizziness and MSG intolerance to be non-serious. The reporter considered the event of upper torso pain to be non-serious.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Influenza virus test positive, Laboratory test abnormal, Polymerase chain reaction, Pyrexia
Clinical narrative: A report has been received from a physician concerning a female patient. The patient had positive test for influenza A on a rapid diagnostic test and PCR on 21-Sep-2012. On 21-Sep-2012, the patient started to received nasal FLUMIST. The patient experienced cough, increased breathing, vomiting and fever. The outcome of the events of cough, increased breathing, vomiting and fever were unknown. The reporting physician assessed the events as serious due to required hospitalisation.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Respiratory rate increased, Vomiting
Clinical narrative: A report has been received from a physician concerning a female patient. The patient had positive test for influenza A on a rapid diagnostic test and PCR on 21-Sep-2012. On 21-Sep-2012, the patient started to received nasal FLUMIST. The patient experienced cough, increased breathing, vomiting and fever. The outcome of the events of cough, increased breathing, vomiting and fever were unknown. The reporting physician assessed the events as serious due to required hospitalisation.
Age: 1.37
Sex: F
Vaccine: DTAP, FLU3, HIBV, PNC
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, and warmth to touch on area around injection site. (Right thigh). No treatment necessary as beginning to heal.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Areflexia, Asthenia, Guillain-Barre syndrome
Clinical narrative: Patient was admitted to hospital for symptoms of weakness and areflexia consistent for Guillain-Barre Syndrome.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Anaphylactic reaction, Cardiac disorder, Cough, Dyspnoea, Erythema
Clinical narrative: Difficulty breathing, rattling cough that wouldn't stop, red/hot face & neck. Diagnosed with anaphylaxis reaction.  A couple more anaphylaxis episodes in 48 hrs hours.  Led to cardiac event. Still in hospital.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Skin warm
Clinical narrative: Difficulty breathing, rattling cough that wouldn't stop, red/hot face & neck. Diagnosed with anaphylaxis reaction.  A couple more anaphylaxis episodes in 48 hrs hours.  Led to cardiac event. Still in hospital.
Age: 10.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Swelling
Clinical narrative: Swelling and redness.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Injected limb mobility decreased, Injection site pain, Oedema peripheral, Pain
Clinical narrative: Patient developed severe pain at left deltoid IM site the next morning, pain worsened, swelling, unable to raise arm, pain traveled down arm and into left upper chest area - went to ER/MD.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Contusion, Erythema, Immediate post-injection reaction, Pain, Pruritus
Clinical narrative: Itching immediately, swelling, sore & painful, travel down to elbow, continue to get red & bruised.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site cellulitis
Clinical narrative: EE developed cellulitis (L) upper arm after flu vaccination. Was treated with antibiotics x 8 days. Sx resolved.
Age: 57.0
Sex: F
Vaccine: DTAP, PPV
Symptoms: Fatigue, Injection site erythema, Myalgia, Pyrexia
Clinical narrative: Myalgias, fatigue, subjective fever, erythematous at injection site second day which has increased in size.
Age: 27.0
Sex: F
Vaccine: FLUX, HEPAB
Symptoms: Feeling hot, Palpitations, Paraesthesia, Pruritus, Rash
Clinical narrative: Bottom of feet started tingling/itching around 8pm. Continued itching on feet and legs started itching at 11pm. Around 11pm I noticed hives forming on my ankles and legs. I called oncall physician and was directed to take BENADRYL. Took BENADRYL but hives continued to spread up my legs/thighs. I was very warm and heart racing. Admitted myself into the ER around 12am on 10/3/2012. Hives continued to spread to my arms while waiting for treatment in the ER. ER administered (3) prednisone tablets, (1) unknown pill and a shot in my arm. Left hospital around 2am. Rash started to dimisnish about 30 minutes after receiving treatment at the hospital. Remained weak and ill 10/3/2012-10/5/2012.
Age: 27.0
Sex: F
Vaccine: FLUX, HEPAB
Symptoms: Urticaria
Clinical narrative: Bottom of feet started tingling/itching around 8pm. Continued itching on feet and legs started itching at 11pm. Around 11pm I noticed hives forming on my ankles and legs. I called oncall physician and was directed to take BENADRYL. Took BENADRYL but hives continued to spread up my legs/thighs. I was very warm and heart racing. Admitted myself into the ER around 12am on 10/3/2012. Hives continued to spread to my arms while waiting for treatment in the ER. ER administered (3) prednisone tablets, (1) unknown pill and a shot in my arm. Left hospital around 2am. Rash started to dimisnish about 30 minutes after receiving treatment at the hospital. Remained weak and ill 10/3/2012-10/5/2012.
Age: 83.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Pyrexia
Clinical narrative: FEVER AND CHILLS. ADMITTED TO HOSPITAL 10/3/2012.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives all over body, specifically arms, chest, thighs, and back.
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Upper respiratory tract infection
Clinical narrative: Upper respiratory infection.
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Fever of 102, chills, body aches, headache.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Fatigue, Head injury, Hyperhidrosis, Loss of consciousness
Clinical narrative: Sore throat, congestion, increased pain and congestion so I took Mucinex D, and an allergy pill thinking I was coming down with severe cold.  Sx continued and I took 2 ibuprofen before bed at 9:30pm.  Within minutes I was nauseated, then began to vomit harshly.  On my 3rd trip to bathroom, I fainted in the bathroom, hitting my head, obviously having passed out and woke up in a sweat and a significant goose egg on my head.  I laid for quite a while til I knew I was ok.  I do not know how long I laid on the floor passed out.  After that episode I was able to fall asleep, had no more sx other than fatigue.  I took it really easy for 1 week but had severe bruising from hitting my head that lasted 16 days.