chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Hypoaesthesia, Mastication disorder, Paraesthesia
Clinical narrative: Information has been received from a healthcare worker concerning a 73 year old male patient with a history of lymphoma five years ago and with no known drug reactions/allergies who on 20-JAN-2011, was vaccinated with a standard dose of ZOSTAVAX (Merck) (Lot # 669192/1457Z, Exp. Date: 29-JAN-2012) (dose not reported), subcutaneously. There was no concomitant medication. The healthcare worker reported that on 20-JUN-2011, the office first saw the patient with shingles. The patient also could not chew well because of the postherpetic neuralgia he developed after receiving ZOSTAVAX (Merck). The patient was given steroids and antiviral medications for the treatment of the events. No laboratory tests were performed. The healthcare worker also reported that the patient did not have the lesions anymore but still had tingling, burning and numbness sensations. At the time of the report, the patient had not recovered. The patient's postherpetic neuralgia was considered to be disabling by the reporter. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Post herpetic neuralgia, Skin lesion
Clinical narrative: Information has been received from a healthcare worker concerning a 73 year old male patient with a history of lymphoma five years ago and with no known drug reactions/allergies who on 20-JAN-2011, was vaccinated with a standard dose of ZOSTAVAX (Merck) (Lot # 669192/1457Z, Exp. Date: 29-JAN-2012) (dose not reported), subcutaneously. There was no concomitant medication. The healthcare worker reported that on 20-JUN-2011, the office first saw the patient with shingles. The patient also could not chew well because of the postherpetic neuralgia he developed after receiving ZOSTAVAX (Merck). The patient was given steroids and antiviral medications for the treatment of the events. No laboratory tests were performed. The healthcare worker also reported that the patient did not have the lesions anymore but still had tingling, burning and numbness sensations. At the time of the report, the patient had not recovered. The patient's postherpetic neuralgia was considered to be disabling by the reporter. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: FLU3, FLUN3
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnant female (approximately 2 months) given 1/2 dose of nasal flu vaccine prior to nurse noting that recipient pregnant. Flu immunization completed with approved for pregnant women vaccine.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Pt received a FLUVIRIN shot IM in deltoid muscle on 8-30-2011. It hurt during administration. It burned while it was being injected. She has a severely sore arm to date (10-1-11). She can not lift her arm. She requires her other arm to lift her arm (left arm).
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Eyelid oedema, Hypersensitivity, Oedema peripheral, Rash
Clinical narrative: Hands, around eyes red and edematous. Scattered rash on back. Was given Kenalog 40mg IM once, Prednisone 20mg 3x day for 4 days. Zyrtec 10 mg 1 tab daily for 30 days.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Convulsion, Erythema, Pyrexia, White blood cell count increased
Clinical narrative: Mother states when child was picked up from babysitter Friday pm 09/23/11, while being held, fever noted, on ride to hospital, child had seizure
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, redness and swelling at injection site.  Patient states severe pain.
Age: 29.0
Sex: F
Vaccine: UNK
Symptoms: Chest discomfort, Dizziness, Electrocardiogram, Headache, Muscle tightness
Clinical narrative: Pain, swelling, and extreme itching distal to injection site; shoulder pain; headache; dizziness; lightheaded; chest tightness, back tightness.
Age: 29.0
Sex: F
Vaccine: UNK
Symptoms: Musculoskeletal pain, Pain, Pruritus, Swelling
Clinical narrative: Pain, swelling, and extreme itching distal to injection site; shoulder pain; headache; dizziness; lightheaded; chest tightness, back tightness.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Headache, Nausea, Pain
Clinical narrative: Temperature of 100.5 (usual 97.7) Headache Body aches Some Nausea Lasted about 4 days (symptoms lessening each day)
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Muscle strain, Nausea
Clinical narrative: Pt reports muscle pulling in back and back nerves burning. When to emergency room morning of 10-2-2011 and got shots. Called today to report same and says is also nauseous now.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Bone pain, Musculoskeletal pain, Myalgia, Pain in extremity
Clinical narrative: Shoulder/upper arm soreness.  Soreness is described as being to in the muscle and into the bone.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal discomfort, Fatigue, Headache, Nausea, Pain
Clinical narrative: Began with headache which got continually worse and was eventually accompanied by mild nausea and some fatigue. At 5:30 took Advil 400 mg.  Headache did not respond so 1 hour later I took 1 Percocet 7.5 mg (I had left over from a foot surgery in June). Severe headache continued to persist along with mild nausea. At 10:00pm I took 2 Tylenol and tried to go to bed. Headache was keeping me awake so at 12:30 I took an oxcodone 7.5 mg (prescribed from another foot surgery the year before).  I was finally able to get to sleep.  Woke up this morning (10/5) with stomach upset and mild body aches.  Headache is better. Almost not present now.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Hypotonia
Clinical narrative: Initial report was received from a health care professional on 26 September 2011. A 49 year-old female patient with a history of scleroderma had received on an unspecified date in 2011 an intramuscular right deltoid injection of FLUZONE No Preservative 2011-2012, lot number UH442AB (reported as possibly) and an unspecified amount of time later experienced a "limp" arm. Concomitant medication included NORVASC, omeprazole, SYMBALTA, quinidine, atropine and Enalapril. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Chills, Diarrhoea, Headache, Injection site erythema
Clinical narrative: Approximately 18 hr after admin. pt reported injection site reaction including swelling, pain, warmth, redness at injection site. Pt also reported increased blood pressure, headache, chills, and diarrhea. Pt did not have fever. Pt rec'd hydroxyzine, tramadol & prednisone from MD.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Approximately 18 hr after admin. pt reported injection site reaction including swelling, pain, warmth, redness at injection site. Pt also reported increased blood pressure, headache, chills, and diarrhea. Pt did not have fever. Pt rec'd hydroxyzine, tramadol & prednisone from MD.
Sex: F
Vaccine: FLUX
Symptoms: Allergy test positive, Food allergy, Loss of consciousness, Multiple allergies, Mycotic allergy
Clinical narrative: Initial report was received from a consumer on 24 September 2011, who is also the patient. An adult female patient (who was 49 years of age at the time of the report) had received an injection of INFLUENZA VACCINE (manufacturer, lot number, route, site and date of administration unknown) in the late 1980's as an adult. Approximately 15 minutes post vaccination, the patient passed out while still at the doctor's office. The event lasted a few seconds. She was administered what she thought was BENADRYL, felt fine, recovered and then left the office for home. Two days later, she developed a mild rash which lasted two days, and then rash recovered. Allergy testing performed at a later point in time (dates unknown), revealed multiple allergies; including tree nuts, egg yolks, mold and ragweed. The patient stated that her doctor probably reported these events when they occurred and she had no additional information to provide. Documents held by sender: None.
Sex: F
Vaccine: FLUX
Symptoms: Rash, Seasonal allergy
Clinical narrative: Initial report was received from a consumer on 24 September 2011, who is also the patient. An adult female patient (who was 49 years of age at the time of the report) had received an injection of INFLUENZA VACCINE (manufacturer, lot number, route, site and date of administration unknown) in the late 1980's as an adult. Approximately 15 minutes post vaccination, the patient passed out while still at the doctor's office. The event lasted a few seconds. She was administered what she thought was BENADRYL, felt fine, recovered and then left the office for home. Two days later, she developed a mild rash which lasted two days, and then rash recovered. Allergy testing performed at a later point in time (dates unknown), revealed multiple allergies; including tree nuts, egg yolks, mold and ragweed. The patient stated that her doctor probably reported these events when they occurred and she had no additional information to provide. Documents held by sender: None.
Age: 1.9
Sex: F
Vaccine: DTAPIPVHIB, HEP, MMR, PNC13, VARCEL
Symptoms: Injection site abscess, Pyrexia
Clinical narrative: Pt was TBR (new patient) no hx of vaccines per mom; no medical care. Child had all immunizations noted below at visit. Had a rash viral in etiology that comes and goes per mom. Child was brought to hospital 10/2/2011 with abscess to (R) thigh. I&D consult/surgery consult mode - child has fever and is on antibx.
Age: 0.4
Sex: F
Vaccine: DTP
Symptoms: Convulsion, Death, Developmental delay, Hypoxic-ischaemic encephalopathy, Laboratory test
Clinical narrative: Initial case retrieved from the scientific literature on 22 September 2011. The authors evaluated clinical-pathological features of 37 infants/children whose parents alleged a relationship between vaccination and death or permanent central nervous system (CNS) damage, and sought compensation through the National Vaccine Injury Compensation Program during the years from 1990 through 1999. CNS tissue was available for evaluation by a pediatric neuropathologist in these 37 cases: 23 males (62%) and 14 females (38%) ranging in age from 1 month to 17 years at time of death or biopsy. Thirty-three of the 37 patients were dead at the time the case was evaluated. Most commonly implicated vaccines were DTP or DTaP (33 cases), followed by MMR and IPV/OPV (25 cases each). The authors concluded that there was no obvious relationship between type of vaccine (or vaccines simultaneously administered) to time of onset of symptoms, nature of symptoms, or the lesions found. No CNS lesions were found in 5 of 37 cases. There were a variety of CNS lesions amongst the 32 remaining cases, but pathogenesis of the majority was apparent and not considered a complication of vaccination. Of the 37 patients described in the article, the vaccines received by eight of these patients were specified. This case captures one patient; and the other seven patients are captured in case numbers 2011-09242, -09245, -09246, -09247, -09248, -09249 and 2011-09250. A five-month-old female patient had received a DTP vaccination (manufacturer unknown; lot number, route, site and date of administration not reported) and within 24 hours developed onset of seizures, but later manifested developmental delay. The patient died at seven years of age at which time acute anoxic encephalopathy was found and was most likely a consequence of terminal seizures. No lesions that may have accounted for the developmental delay were found. Documents held by sender: None.
Sex: U
Vaccine: DTP, OPV
Symptoms: Biopsy brain abnormal, Brain lobectomy, Central nervous system lesion, Convulsion, Drug administered to patient of inappropriate age
Clinical narrative: Initial case retrieved from the scientific literature on 22 September 2011. The authors evaluated clinical-pathological features of 37 infants/children whose parents alleged a relationship between vaccination and death or permanent central nervous system (CNS) damage, and sought compensation through the National vaccine Injury Compensation Program during the years from 1990 through 1999. CNS tissue was available for evaluation by a pediatric neuropathologist in these 37 cases: 23 males (62%) and 14 females (38%) ranging in age from 1 month to 17 years at the time of death or biopsy. Thirty-three of the 37 patients were dead at the time the case was evaluated. Most commonly implicated vaccines were DTP or DTAP (33 cases), followed by MMR and IPV/OPV (25 cases each). The authors concluded that there was no obvious relationship between type of vaccine (or vaccines simultaneously administered) to time of onset of symptoms, nature of symptoms, or the lesions found. No CNS lesions were found in 5 of 37 cases. There were a variety of CNS lesions amongst the 32 remaining cases, but pathogenesis of the majority was apparent and not considered a complication of vaccination. Of the 37 patients described in the article, the vaccines received by eight of these patients were specified. This case captures one patient; and the other seven patients are captured in case numbers 2011-09242, -09243, -09245, -09247, -09248, -09249 and 2011-09250. An unidentified patient (infant/child) had received a DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE (DTP) vaccine (manufacturer unknown) and OPV vaccine (other manufacturer) at four weeks of age (lot numbers, routes, sites and dates of administration were not reported) and an unspecified amount of time later, manifested seizures and mental retardation. A lobectomy was performed at 22 months which showed chronic meningitis and phlebitis, grey matter heterotopias and gliosis reflecting both developmental and acquired inflammatory lesions. CNS lesions were diagnosed on brain biopsy. Pathological diagnosis was unknown. Outcome was not reported. Of note, this case involved misuse (inappropriate age at vaccine administration). Documents held by sender: None.
Sex: U
Vaccine: DTP, OPV
Symptoms: Gliosis, Inflammation, Meningitis, Mental retardation, Nervous system disorder
Clinical narrative: Initial case retrieved from the scientific literature on 22 September 2011. The authors evaluated clinical-pathological features of 37 infants/children whose parents alleged a relationship between vaccination and death or permanent central nervous system (CNS) damage, and sought compensation through the National vaccine Injury Compensation Program during the years from 1990 through 1999. CNS tissue was available for evaluation by a pediatric neuropathologist in these 37 cases: 23 males (62%) and 14 females (38%) ranging in age from 1 month to 17 years at the time of death or biopsy. Thirty-three of the 37 patients were dead at the time the case was evaluated. Most commonly implicated vaccines were DTP or DTAP (33 cases), followed by MMR and IPV/OPV (25 cases each). The authors concluded that there was no obvious relationship between type of vaccine (or vaccines simultaneously administered) to time of onset of symptoms, nature of symptoms, or the lesions found. No CNS lesions were found in 5 of 37 cases. There were a variety of CNS lesions amongst the 32 remaining cases, but pathogenesis of the majority was apparent and not considered a complication of vaccination. Of the 37 patients described in the article, the vaccines received by eight of these patients were specified. This case captures one patient; and the other seven patients are captured in case numbers 2011-09242, -09243, -09245, -09247, -09248, -09249 and 2011-09250. An unidentified patient (infant/child) had received a DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE (DTP) vaccine (manufacturer unknown) and OPV vaccine (other manufacturer) at four weeks of age (lot numbers, routes, sites and dates of administration were not reported) and an unspecified amount of time later, manifested seizures and mental retardation. A lobectomy was performed at 22 months which showed chronic meningitis and phlebitis, grey matter heterotopias and gliosis reflecting both developmental and acquired inflammatory lesions. CNS lesions were diagnosed on brain biopsy. Pathological diagnosis was unknown. Outcome was not reported. Of note, this case involved misuse (inappropriate age at vaccine administration). Documents held by sender: None.
Sex: U
Vaccine: DTP, OPV
Symptoms: Phlebitis
Clinical narrative: Initial case retrieved from the scientific literature on 22 September 2011. The authors evaluated clinical-pathological features of 37 infants/children whose parents alleged a relationship between vaccination and death or permanent central nervous system (CNS) damage, and sought compensation through the National vaccine Injury Compensation Program during the years from 1990 through 1999. CNS tissue was available for evaluation by a pediatric neuropathologist in these 37 cases: 23 males (62%) and 14 females (38%) ranging in age from 1 month to 17 years at the time of death or biopsy. Thirty-three of the 37 patients were dead at the time the case was evaluated. Most commonly implicated vaccines were DTP or DTAP (33 cases), followed by MMR and IPV/OPV (25 cases each). The authors concluded that there was no obvious relationship between type of vaccine (or vaccines simultaneously administered) to time of onset of symptoms, nature of symptoms, or the lesions found. No CNS lesions were found in 5 of 37 cases. There were a variety of CNS lesions amongst the 32 remaining cases, but pathogenesis of the majority was apparent and not considered a complication of vaccination. Of the 37 patients described in the article, the vaccines received by eight of these patients were specified. This case captures one patient; and the other seven patients are captured in case numbers 2011-09242, -09243, -09245, -09247, -09248, -09249 and 2011-09250. An unidentified patient (infant/child) had received a DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE (DTP) vaccine (manufacturer unknown) and OPV vaccine (other manufacturer) at four weeks of age (lot numbers, routes, sites and dates of administration were not reported) and an unspecified amount of time later, manifested seizures and mental retardation. A lobectomy was performed at 22 months which showed chronic meningitis and phlebitis, grey matter heterotopias and gliosis reflecting both developmental and acquired inflammatory lesions. CNS lesions were diagnosed on brain biopsy. Pathological diagnosis was unknown. Outcome was not reported. Of note, this case involved misuse (inappropriate age at vaccine administration). Documents held by sender: None.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Urticaria
Clinical narrative: Around 10PM in the evening on 10/04/2011, I begun to have hives on the back of both my arms. This cleared up by morning, however, when I woke up 7AM on 10/05/2011, I had hives on my abdomen. They disappeared by 10AM on 10/05/2011. I have also had a headache since the shot.
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Muscular weakness
Clinical narrative: weakness, numbness in lower extremities
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Cardiac monitoring, Dysphonia, Dyspnoea, Electrocardiogram, Heart rate increased
Clinical narrative: Rapid irregular heart rate. PVCs  body aches and headache hoarsness and shortness of breath due to the PVC...lasted on into midnite and went to ER...Took Tylenol and Xanax
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Heart rate irregular, Laboratory test, Pain, Ventricular extrasystoles
Clinical narrative: Rapid irregular heart rate. PVCs  body aches and headache hoarsness and shortness of breath due to the PVC...lasted on into midnite and went to ER...Took Tylenol and Xanax
Age: 1.0
Sex: F
Vaccine: MMRV, PPV
Symptoms: Rash, Urticaria
Clinical narrative: Started with mild rash on the evening of the 16th. Worse by morning on the 17th. Called pediatrician who told us to do Benadryl every 4-6 hours. Took to Allergiest the 17th as the rashes/hives weren't getting better.  The allergist prescribed steroids (for 2 days), and Zyrtec every 24 hours with Benadryl as need for breakthrough rash. Rash persisted on and off for over a week.
Age: 31.0
Sex: F
Vaccine: FLUN3
Symptoms: Cold sweat, Feeling hot, Headache, Paraesthesia
Clinical narrative: Headache, Hot, Clammy, Left side including extremities tingling.
Age: 21.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Fatigue, Injection site pruritus, Tremor
Clinical narrative: Itching at vaccination site followed by shakiness, fatigue and then trouble breathing.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Localised oedema, Pain
Clinical narrative: Localized pain, edema, and erythema
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Erythema, Joint swelling, Pain, Swelling
Clinical narrative: RECEIVED FLUZONE HIGH DOSE AND PNEUMOVAX IN THE SAME ARM  (LEFT DELTOID).  CLIENT EXPERIENCE PAIN, REDNESS, AND SWELLING THAT EVENTUALLY EXTENDED TO HER ELBOW.  WAS SEEN BY PRIVATE DOCTOR AND TREATED WITH Z-PACK.  DOCTOR EXPLAINED TO HER THAT SHE HAD RECEIVED A PNEUMOVAX VACCINE 3 YEARS AGO AND SHOULD HAVE WAITED BEFORE RECEIVING ANOTHER.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Severe pain at injection site after 45 minutes, about three hours later developed fever 101 with chills, general malaise.  Following morning arm red hot swollen, erythema circumfirential from top of shoulder to elbow. Continued with significant pain to area until 9/23/11.  Treated with antihistamine (Claritin 10mg) and Ibuprofen 600mg TID.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Malaise, Pyrexia
Clinical narrative: Severe pain at injection site after 45 minutes, about three hours later developed fever 101 with chills, general malaise.  Following morning arm red hot swollen, erythema circumfirential from top of shoulder to elbow. Continued with significant pain to area until 9/23/11.  Treated with antihistamine (Claritin 10mg) and Ibuprofen 600mg TID.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Hallucination, Pain, Pyrexia
Clinical narrative: Patient reported during a lab draw appointment on 10/5/11 that on the evening of his flu vaccination he had a fever of 41.7 (ear thermometer), body aches, and hallucinations (per wife).  He did not seek medical care and by the next afternoon he was recovered.
Sex: F
Vaccine: FLUX
Symptoms: Blood thyroid stimulating hormone, Dizziness, Feeling abnormal, Fibromyalgia, Hypothyroidism
Clinical narrative: Dizziness, lightheaded, mental fog. Severe muscle weakness x 2.5-3 wks then developed hypothyroidism & fibromyalgia.
Sex: F
Vaccine: FLUX
Symptoms: Muscular weakness, Thyroxine, Tri-iodothyronine
Clinical narrative: Dizziness, lightheaded, mental fog. Severe muscle weakness x 2.5-3 wks then developed hypothyroidism & fibromyalgia.
Age: 43.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Dysphagia, Eye swelling, Lip swelling, Local swelling, Ocular hyperaemia
Clinical narrative: Initial report was received on 23 September 2011 from health care professional, who is also the patient. A female patient (date of birth not reported) had received on 23 September 2011 an intramuscular left deltoid injection of FLUZONE SV 2011-2012, lot number UH463AB and shortly after vaccination, experienced swelling of the throat, lips, neck, jaw and eye. She also reported her eyes became bloodshot and she had a hard time swallowing. she was evaluated in the ER (emergency room). Treatments in the emergency room included DECADRON, BENADRYL and PEPSIN. "RX for home" included prednisone and BENADRYL. The patient has a thyroid history. Concomitant medication included SYNTHROID. Illness at the time of vaccination, adverse events following prior vaccinations and any other vaccines within four weeks of suspect vaccine was reported as none. Documents held by sender: none.
Age: 43.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Pharyngeal oedema, Swelling face
Clinical narrative: Initial report was received on 23 September 2011 from health care professional, who is also the patient. A female patient (date of birth not reported) had received on 23 September 2011 an intramuscular left deltoid injection of FLUZONE SV 2011-2012, lot number UH463AB and shortly after vaccination, experienced swelling of the throat, lips, neck, jaw and eye. She also reported her eyes became bloodshot and she had a hard time swallowing. she was evaluated in the ER (emergency room). Treatments in the emergency room included DECADRON, BENADRYL and PEPSIN. "RX for home" included prednisone and BENADRYL. The patient has a thyroid history. Concomitant medication included SYNTHROID. Illness at the time of vaccination, adverse events following prior vaccinations and any other vaccines within four weeks of suspect vaccine was reported as none. Documents held by sender: none.
Age: 43.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Blood pressure abnormal, Dysphonia, Flushing, Heart rate decreased, Heart rate increased
Clinical narrative: Initial report was received on 23 September 2011 from health care professional, who is also the patient. A female patient (date of birth not reported) had received on 23 September 2011 an intramuscular left deltoid injection of FLUZONE SV 2011-2012, lot number UH463AB and shortly after vaccination, experienced swelling of the throat, lips, neck, jaw and eye. She also reported her eyes became bloodshot and she had a hard time swallowing. she was evaluated in the ER (emergency room). Treatments in the emergency room included DECADRON, BENADRYL and PEPSIN. "RX for home" included prednisone and BENADRYL. The patient has a thyroid history. Concomitant medication included SYNTHROID. Illness at the time of vaccination, adverse events following prior vaccinations and any other vaccines within four weeks of suspect vaccine was reported as none. Documents held by sender: none.
Age: 43.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Local swelling, Ocular hyperaemia, Pharyngeal oedema, Sensation of foreign body, Swelling face
Clinical narrative: Initial report was received on 23 September 2011 from health care professional, who is also the patient. A female patient (date of birth not reported) had received on 23 September 2011 an intramuscular left deltoid injection of FLUZONE SV 2011-2012, lot number UH463AB and shortly after vaccination, experienced swelling of the throat, lips, neck, jaw and eye. She also reported her eyes became bloodshot and she had a hard time swallowing. she was evaluated in the ER (emergency room). Treatments in the emergency room included DECADRON, BENADRYL and PEPSIN. "RX for home" included prednisone and BENADRYL. The patient has a thyroid history. Concomitant medication included SYNTHROID. Illness at the time of vaccination, adverse events following prior vaccinations and any other vaccines within four weeks of suspect vaccine was reported as none. Documents held by sender: none.
Age: 43.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Tachycardia
Clinical narrative: Initial report was received on 23 September 2011 from health care professional, who is also the patient. A female patient (date of birth not reported) had received on 23 September 2011 an intramuscular left deltoid injection of FLUZONE SV 2011-2012, lot number UH463AB and shortly after vaccination, experienced swelling of the throat, lips, neck, jaw and eye. She also reported her eyes became bloodshot and she had a hard time swallowing. she was evaluated in the ER (emergency room). Treatments in the emergency room included DECADRON, BENADRYL and PEPSIN. "RX for home" included prednisone and BENADRYL. The patient has a thyroid history. Concomitant medication included SYNTHROID. Illness at the time of vaccination, adverse events following prior vaccinations and any other vaccines within four weeks of suspect vaccine was reported as none. Documents held by sender: none.
Age: 43.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Oropharyngeal pain, Swelling face, Throat tightness
Clinical narrative: Initial report was received on 23 September 2011 from health care professional, who is also the patient. A female patient (date of birth not reported) had received on 23 September 2011 an intramuscular left deltoid injection of FLUZONE SV 2011-2012, lot number UH463AB and shortly after vaccination, experienced swelling of the throat, lips, neck, jaw and eye. She also reported her eyes became bloodshot and she had a hard time swallowing. she was evaluated in the ER (emergency room). Treatments in the emergency room included DECADRON, BENADRYL and PEPSIN. "RX for home" included prednisone and BENADRYL. The patient has a thyroid history. Concomitant medication included SYNTHROID. Illness at the time of vaccination, adverse events following prior vaccinations and any other vaccines within four weeks of suspect vaccine was reported as none. Documents held by sender: none.
Age: 43.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Dysphagia, Eye swelling, Lip swelling, Local swelling, Ocular hyperaemia
Clinical narrative: Having worked the previous night, patient awoke from sleep at 01:00 PM on Friday, 9/23/2011, with a "lump in my throat. I thought I was getting sick from the flu shot I got that morning and went back to sleep." She awoke later at 3:15 PM, her face, neck, and throat swollen and eyes were bloodshot. She reports that she was tachycardic with a heart rate of 130 at this time. She called Hospital and was told to go to the Emergency Department. Upon arrival in ED, patient's blood pressure was 170/110, heart rate 130, as reported by her. ED administered Dexamethasone (dose unkown), Pepsid 20 mg, Benadryl 25 mg, according to patient. Within 15 minutes, heart rate decreased, blood pressure normalized, and her throat "felt better." Patient reports some throat hoarseness, but no wheezing at this time. Patient was discharged from ED later that evening on 9/23/2011 with prescriptions for Prednisone 20 mg, Pepsid 25 mg, and Benadryl 20 mg. On Saturday, 09/24/2011, at approximately 2 PM, patient became flushed, noticed a rapid heart rate, called Primary Care Physician on call, who prescribed Prednisone tapered dose pack for patient. She is still taking this Prednisone and will complete on Wednesday, 10/5/2011. Patient reported on 10/4/2011 per phone that she is doing fine.
Age: 43.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Pharyngeal oedema, Swelling face
Clinical narrative: Having worked the previous night, patient awoke from sleep at 01:00 PM on Friday, 9/23/2011, with a "lump in my throat. I thought I was getting sick from the flu shot I got that morning and went back to sleep." She awoke later at 3:15 PM, her face, neck, and throat swollen and eyes were bloodshot. She reports that she was tachycardic with a heart rate of 130 at this time. She called Hospital and was told to go to the Emergency Department. Upon arrival in ED, patient's blood pressure was 170/110, heart rate 130, as reported by her. ED administered Dexamethasone (dose unkown), Pepsid 20 mg, Benadryl 25 mg, according to patient. Within 15 minutes, heart rate decreased, blood pressure normalized, and her throat "felt better." Patient reports some throat hoarseness, but no wheezing at this time. Patient was discharged from ED later that evening on 9/23/2011 with prescriptions for Prednisone 20 mg, Pepsid 25 mg, and Benadryl 20 mg. On Saturday, 09/24/2011, at approximately 2 PM, patient became flushed, noticed a rapid heart rate, called Primary Care Physician on call, who prescribed Prednisone tapered dose pack for patient. She is still taking this Prednisone and will complete on Wednesday, 10/5/2011. Patient reported on 10/4/2011 per phone that she is doing fine.
Age: 43.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Blood pressure abnormal, Dysphonia, Flushing, Heart rate decreased, Heart rate increased
Clinical narrative: Having worked the previous night, patient awoke from sleep at 01:00 PM on Friday, 9/23/2011, with a "lump in my throat. I thought I was getting sick from the flu shot I got that morning and went back to sleep." She awoke later at 3:15 PM, her face, neck, and throat swollen and eyes were bloodshot. She reports that she was tachycardic with a heart rate of 130 at this time. She called Hospital and was told to go to the Emergency Department. Upon arrival in ED, patient's blood pressure was 170/110, heart rate 130, as reported by her. ED administered Dexamethasone (dose unkown), Pepsid 20 mg, Benadryl 25 mg, according to patient. Within 15 minutes, heart rate decreased, blood pressure normalized, and her throat "felt better." Patient reports some throat hoarseness, but no wheezing at this time. Patient was discharged from ED later that evening on 9/23/2011 with prescriptions for Prednisone 20 mg, Pepsid 25 mg, and Benadryl 20 mg. On Saturday, 09/24/2011, at approximately 2 PM, patient became flushed, noticed a rapid heart rate, called Primary Care Physician on call, who prescribed Prednisone tapered dose pack for patient. She is still taking this Prednisone and will complete on Wednesday, 10/5/2011. Patient reported on 10/4/2011 per phone that she is doing fine.
Age: 43.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Local swelling, Ocular hyperaemia, Pharyngeal oedema, Sensation of foreign body, Swelling face
Clinical narrative: Having worked the previous night, patient awoke from sleep at 01:00 PM on Friday, 9/23/2011, with a "lump in my throat. I thought I was getting sick from the flu shot I got that morning and went back to sleep." She awoke later at 3:15 PM, her face, neck, and throat swollen and eyes were bloodshot. She reports that she was tachycardic with a heart rate of 130 at this time. She called Hospital and was told to go to the Emergency Department. Upon arrival in ED, patient's blood pressure was 170/110, heart rate 130, as reported by her. ED administered Dexamethasone (dose unkown), Pepsid 20 mg, Benadryl 25 mg, according to patient. Within 15 minutes, heart rate decreased, blood pressure normalized, and her throat "felt better." Patient reports some throat hoarseness, but no wheezing at this time. Patient was discharged from ED later that evening on 9/23/2011 with prescriptions for Prednisone 20 mg, Pepsid 25 mg, and Benadryl 20 mg. On Saturday, 09/24/2011, at approximately 2 PM, patient became flushed, noticed a rapid heart rate, called Primary Care Physician on call, who prescribed Prednisone tapered dose pack for patient. She is still taking this Prednisone and will complete on Wednesday, 10/5/2011. Patient reported on 10/4/2011 per phone that she is doing fine.
Age: 43.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Tachycardia
Clinical narrative: Having worked the previous night, patient awoke from sleep at 01:00 PM on Friday, 9/23/2011, with a "lump in my throat. I thought I was getting sick from the flu shot I got that morning and went back to sleep." She awoke later at 3:15 PM, her face, neck, and throat swollen and eyes were bloodshot. She reports that she was tachycardic with a heart rate of 130 at this time. She called Hospital and was told to go to the Emergency Department. Upon arrival in ED, patient's blood pressure was 170/110, heart rate 130, as reported by her. ED administered Dexamethasone (dose unkown), Pepsid 20 mg, Benadryl 25 mg, according to patient. Within 15 minutes, heart rate decreased, blood pressure normalized, and her throat "felt better." Patient reports some throat hoarseness, but no wheezing at this time. Patient was discharged from ED later that evening on 9/23/2011 with prescriptions for Prednisone 20 mg, Pepsid 25 mg, and Benadryl 20 mg. On Saturday, 09/24/2011, at approximately 2 PM, patient became flushed, noticed a rapid heart rate, called Primary Care Physician on call, who prescribed Prednisone tapered dose pack for patient. She is still taking this Prednisone and will complete on Wednesday, 10/5/2011. Patient reported on 10/4/2011 per phone that she is doing fine.
Age: 43.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Oropharyngeal pain, Swelling face, Throat tightness
Clinical narrative: Having worked the previous night, patient awoke from sleep at 01:00 PM on Friday, 9/23/2011, with a "lump in my throat. I thought I was getting sick from the flu shot I got that morning and went back to sleep." She awoke later at 3:15 PM, her face, neck, and throat swollen and eyes were bloodshot. She reports that she was tachycardic with a heart rate of 130 at this time. She called Hospital and was told to go to the Emergency Department. Upon arrival in ED, patient's blood pressure was 170/110, heart rate 130, as reported by her. ED administered Dexamethasone (dose unkown), Pepsid 20 mg, Benadryl 25 mg, according to patient. Within 15 minutes, heart rate decreased, blood pressure normalized, and her throat "felt better." Patient reports some throat hoarseness, but no wheezing at this time. Patient was discharged from ED later that evening on 9/23/2011 with prescriptions for Prednisone 20 mg, Pepsid 25 mg, and Benadryl 20 mg. On Saturday, 09/24/2011, at approximately 2 PM, patient became flushed, noticed a rapid heart rate, called Primary Care Physician on call, who prescribed Prednisone tapered dose pack for patient. She is still taking this Prednisone and will complete on Wednesday, 10/5/2011. Patient reported on 10/4/2011 per phone that she is doing fine.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin warm
Clinical narrative: Pt. was vaccinated on 10/3/11 at approx 3pm. Pt. returned next day with 2 1/2 inch redness. Warm to the touch. No fever, no raise.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: 2 cm x 3 cm raised, warm red area. Rx TYLENOL/Ibuprofen & ice to area.
Sex: U
Vaccine: FLU3
Symptoms: Swelling face
Clinical narrative: Initial report was received 23 September 2011 from a health care professional which involved a cluster of 50-60 unidentified patients. This case represents one patient who experienced face swelling. A second patient who experienced axillary swelling axillary had been captured in case number 2011-09286. The remaining cluster of 50-60 unidentified patients have been captured in case number 2011-09280. An unidentified patient had received an injection of FLUZONE (unspecified; lot number, route, site and date of administration not reported) and an unspecified amount of time later, the patient developed face swelling. Outcome was not reported. NO additional information was provided at the time of the report. Documents held by sender: None.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Hypoaesthesia, Oedema peripheral, Pain, Paraesthesia
Clinical narrative: Left arm swollen, red and itching. Pain/w numbness and tingling.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: Left arm swollen, red and itching. Pain/w numbness and tingling.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Pyrexia, Vomiting
Clinical narrative: 9/29/11 - Fever 103 degrees, vomiting. Cellulitis - right arm.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Red, raised, hot area 6.5 cm L x 8 cm W. TYLENOL & ice packs.
Age: 0.8
Sex: M
Vaccine: DTP
Symptoms: Central nervous system lesion, Cerebral atrophy, Convulsion, Death, Developmental delay
Clinical narrative: Initial case retrieved from the scientific literature on 22 September 2011. The authors evaluated clinical-pathological features of 37 infants/children whose parents alleged a relationship between vaccination and death or permanent central nervous system (CNS) damage, and sought compensation through the National Vaccine Injury Compensation Program during the years from 1990 through 1999. CNS tissue was available for evaluation by a pediatric neuropathologist in these 37 cases: 23 males (62%) and 14 females (38%) ranging in age from 1 month to 17 years at time of death or biopsy. Thirty-three of the 37 patients were dead at the time the case was evaluated. Most commonly implicated vaccines were DTP or DTaP (33 cases), followed by MMR and IPV/OPV (25 cases each). The authors concluded that there was no obvious relationship between type of vaccine (or vaccines simultaneously administered) to time of onset of symptoms, nature of symptoms, or the lesions found. No CNS lesions were found in 5 of 37 cases. There were a variety of CNS lesions amongst the 32 remaining cases, but pathogenesis of the majority was apparent and not considered a complication of vaccination. Of the 37 patients described in the article, the vaccines received by eight of these patients were specified. This case captures one patient; and the other seven patients are captured in case numbers 2011-09242, -09243, -09245, -09246, -09247, -09248 and 2011-09249. A nine-month-old male infant had received a DTP vaccine at six months of age (manufacturer unknown, lot number, route, site and date of administration not reported) and at 9 months of age, developmental delay was noted, along with seizures, complex neurologic dysfunction and eventually microcephaly. The patient died when they were nine years three months of age. At that time, brain lesions were those of classical perinatal hypoxic-ischemic injury, consisting of periventricular leukomalacia and "status marmoratus"; there was associated atrophy. Documents held by sender: None.
Age: 0.8
Sex: M
Vaccine: DTP
Symptoms: Hypoxic-ischaemic encephalopathy, Laboratory test abnormal, Microcephaly, Nervous system disorder, Periventricular leukomalacia
Clinical narrative: Initial case retrieved from the scientific literature on 22 September 2011. The authors evaluated clinical-pathological features of 37 infants/children whose parents alleged a relationship between vaccination and death or permanent central nervous system (CNS) damage, and sought compensation through the National Vaccine Injury Compensation Program during the years from 1990 through 1999. CNS tissue was available for evaluation by a pediatric neuropathologist in these 37 cases: 23 males (62%) and 14 females (38%) ranging in age from 1 month to 17 years at time of death or biopsy. Thirty-three of the 37 patients were dead at the time the case was evaluated. Most commonly implicated vaccines were DTP or DTaP (33 cases), followed by MMR and IPV/OPV (25 cases each). The authors concluded that there was no obvious relationship between type of vaccine (or vaccines simultaneously administered) to time of onset of symptoms, nature of symptoms, or the lesions found. No CNS lesions were found in 5 of 37 cases. There were a variety of CNS lesions amongst the 32 remaining cases, but pathogenesis of the majority was apparent and not considered a complication of vaccination. Of the 37 patients described in the article, the vaccines received by eight of these patients were specified. This case captures one patient; and the other seven patients are captured in case numbers 2011-09242, -09243, -09245, -09246, -09247, -09248 and 2011-09249. A nine-month-old male infant had received a DTP vaccine at six months of age (manufacturer unknown, lot number, route, site and date of administration not reported) and at 9 months of age, developmental delay was noted, along with seizures, complex neurologic dysfunction and eventually microcephaly. The patient died when they were nine years three months of age. At that time, brain lesions were those of classical perinatal hypoxic-ischemic injury, consisting of periventricular leukomalacia and "status marmoratus"; there was associated atrophy. Documents held by sender: None.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: 2 cm round red warm raised area. Rx TYLENOL or ibuprofen ATC w/ice to site.
Age: 29.0
Sex: F
Vaccine: DT
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: (L) arm deltoid area redness, visible swelling, increased warm, tenderness to palpation. Tx: ALEVE, cool compresses.
Age: 1.75
Sex: F
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: Pt developed fever to 101.3 8 days post vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: Red flat round area, approximately 50 cent sized, 1 week after immunization.
Age: 5.0
Sex: F
Vaccine: DTP, OPV
Symptoms: Biopsy brain abnormal, Encephalitis, Exposure to communicable disease, Multiple sclerosis, Nervous system disorder
Clinical narrative: Initial case retrieved from the scientific literature on 22 September 2011. The authors evaluated clinical-pathological features of 37 infants/children whose parents alleged a relationship between vaccination and death or permanent central nervous system (CNS) damage, and sought compensation through the National vaccine Injury Compensation Program during the years from 1990 through 1999. CNS tissue was available for evaluation by a pediatric neuropathologist in these 37 cases: 23 males (62%) and 14 females (38%) ranging in age from 1 month to 17 years at the time of death or biopsy. Thirty-three of the 37 patients were dead at the time the case was evaluated. Most commonly implicated vaccines were DTP or DTAP (33 cases), followed by MMR and IPV/OPV (25 cases each). The authors concluded that there was no obvious relationship between type of vaccine (or vaccines simultaneously administered) to time of onset of symptoms, nature of symptoms, or the lesions found. No CNS lesions were found in 5 of 37 cases. There were a variety of CNS lesions amongst the 32 remaining cases, but pathogenesis of the majority was apparent and not considered a complication of vaccination. Of the 37 patients described in the article, the vaccines received by eight of these patients were specified. This case captures one patient; and the other seven patients are captured in case numbers 2011-09242, -09243, -09245, -09246, -09248, -09249 and 2011-09250. A female child patient had received a DTP vaccine (manufacturer unknown) and OPV vaccine (other manufacturer) at five years of age (lot numbers, routes, sites and dates of administration were not reported) and two weeks post vaccination, she was exposed to measles while playing with an infected child in her neighborhood. Twelve days after the exposure, she exhibited CNS dysfunction and thereafter had a steroid-responsive waxing-waning disorder, diagnosed as multiple sclerosis. Cerebral biopsies were performed twice and showed a chronic viral-type meningoencephalitis; there was no evidence of a demyelinizing component. Pathological diagnosis was unknown. Outcome was not reported. Documents held by sender: None.