chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 85.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Abasia, Blood pressure increased, Blood test, Computerised tomogram, Dysstasia
Clinical narrative: Initial report was received on 02 October 2014 from a consumer, that is also the patient's wife. An 85 year-old male patient with a history of dementia, a pacemaker, and allergies to Amoxicillin and Doxycycline had received on 19 September 2014 an intramuscular right deltoid injection FLUZONE HD (lot number U5022BA) and two hours after vaccination, became weak. According to the patient's wife, by the evening he was unable to stand or walk. The patient was taken to the hospital and was admitted. The patient was found to have a blood pressure of 289/102 and a heart rate of 113. The patient was discharged five days later (date unspecified) to a nursing home and continued to not be able to stand or walk. The reporter was advised that the patient's inability to stand or walk was due to his dementia. No further information was available at the time of the report. Outcome was not recovered. Documents held by sender: none.
Age: 85.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Heart rate increased, Neurological examination
Clinical narrative: Initial report was received on 02 October 2014 from a consumer, that is also the patient's wife. An 85 year-old male patient with a history of dementia, a pacemaker, and allergies to Amoxicillin and Doxycycline had received on 19 September 2014 an intramuscular right deltoid injection FLUZONE HD (lot number U5022BA) and two hours after vaccination, became weak. According to the patient's wife, by the evening he was unable to stand or walk. The patient was taken to the hospital and was admitted. The patient was found to have a blood pressure of 289/102 and a heart rate of 113. The patient was discharged five days later (date unspecified) to a nursing home and continued to not be able to stand or walk. The reporter was advised that the patient's inability to stand or walk was due to his dementia. No further information was available at the time of the report. Outcome was not recovered. Documents held by sender: none.
Age: 85.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Abasia, Asthenia, Dysstasia
Clinical narrative: Initial report was received on 02 October 2014 from a consumer, that is also the patient's wife. An 85 year-old male patient with a history of dementia, a pacemaker, and allergies to Amoxicillin and Doxycycline had received on 19 September 2014 an intramuscular right deltoid injection FLUZONE HD (lot number U5022BA) and two hours after vaccination, became weak. According to the patient's wife, by the evening he was unable to stand or walk. The patient was taken to the hospital and was admitted. The patient was found to have a blood pressure of 289/102 and a heart rate of 113. The patient was discharged five days later (date unspecified) to a nursing home and continued to not be able to stand or walk. The reporter was advised that the patient's inability to stand or walk was due to his dementia. No further information was available at the time of the report. Outcome was not recovered. Documents held by sender: none.
Age: 1.01
Sex: M
Vaccine: MMRV
Symptoms: Balance disorder, Fatigue, Irritability, Pyrexia
Clinical narrative: Fever, balance difficulties, irritability, and fatigue.  Gave acetaminophen for fever, fever (100.0) went down to 99.1 after.
Sex: M
Vaccine: UNK
Symptoms: Erythema, Urticaria
Clinical narrative: Red welt on thigh. Child is 14 months now and welt is still apparent.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Audiogram, Blood test, Computerised tomogram head, Confusional state, Dizziness
Clinical narrative: Confusion, dizziness, headache, nausea.  These symptoms have persisted and increased in severity from the time of this shot.  Since the shot, I have also experienced heart palpitations, and extreme fatigue.  These symptoms continue to persist daily.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Ear, nose and throat examination, Fatigue, Headache, Lumbar puncture, Nausea
Clinical narrative: Confusion, dizziness, headache, nausea.  These symptoms have persisted and increased in severity from the time of this shot.  Since the shot, I have also experienced heart palpitations, and extreme fatigue.  These symptoms continue to persist daily.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Neurological examination, Nuclear magnetic resonance imaging, Palpitations, Psychiatric evaluation
Clinical narrative: Confusion, dizziness, headache, nausea.  These symptoms have persisted and increased in severity from the time of this shot.  Since the shot, I have also experienced heart palpitations, and extreme fatigue.  These symptoms continue to persist daily.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection site red, swollen and hot to touch.  Perimeter was marked and area continued to grow. PA was seen 10/03/14 and deemed a site reaction to injection.  Advised to apply ice.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Headache, Influenza, Oropharyngeal pain
Clinical narrative: experienced multi flu symptoms over period of five hours--coughing, sore throat, profound shaking chills, headache, vomiting
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor, Vomiting
Clinical narrative: experienced multi flu symptoms over period of five hours--coughing, sore throat, profound shaking chills, headache, vomiting
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Liquid product physical issue, Pruritus generalised, Rash, Wheezing
Clinical narrative: Vaccine "felt thick" to patient when injected. Reaction began with arm itching, progressed to all over itching, rash, and wheezing within 10 minutes of vaccination. Rec'd IM Benadryl in opposite arm.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Inflammation, Injection site erythema
Clinical narrative: Inflamed large, red area at injection site. worsened next day. pt worried about tissue damage.
Age: 69.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Redness, itching, and rash at injection site. Reported symptoms on 10/08/2014 @ 9:30 AM.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site vesicles
Clinical narrative: Injection site blister, redness, and swelling, and rash.
Age: 68.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever 101, severe chills and body aches lasting about 8 hours
Age: 24.0
Sex: F
Vaccine: YF
Symptoms: Erythema, Local swelling, Pain in extremity
Clinical narrative: Red area on arm 1/2 inch by 1.5 inches. Red and swollen, painful.
Age: 0.28
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Headache, Loss of consciousness, Pain, Pallor
Clinical narrative: Aches all over, fever of 102 degrees F; weakness, paleness, headache, blacked out for a few seconds.
Age: 0.28
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Aches all over, fever of 102 degrees F; weakness, paleness, headache, blacked out for a few seconds.
Age: 31.0
Sex: F
Vaccine: FLUC3
Symptoms: Erythema, Injection site bruising, Injection site erythema, Injection site haemorrhage, Injection site induration
Clinical narrative: REDNESS, SWELLING, REDNESS RADIATING ACROSS CHEST, ITCHING AT INJECTION SITE, BRUISING, BLEEDING, FEVER TO INJECTION SITE, HARD, FOLLOWING DAY BULLSEYE (RED RING).
Age: 31.0
Sex: F
Vaccine: FLUC3
Symptoms: Injection site pruritus, Injection site warmth, Swelling
Clinical narrative: REDNESS, SWELLING, REDNESS RADIATING ACROSS CHEST, ITCHING AT INJECTION SITE, BRUISING, BLEEDING, FEVER TO INJECTION SITE, HARD, FOLLOWING DAY BULLSEYE (RED RING).
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Influenza, Insomnia, Lethargy, Pain
Clinical narrative: Didn't sleep all night. At 07:00 AM on 10/07/2012 had flu symptoms without fever: sneezing, lethargic, coughing, and aching body. No treatment. Couldn't sleep until 11:30 PM on 10/07/2014.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Sneezing
Clinical narrative: Didn't sleep all night. At 07:00 AM on 10/07/2012 had flu symptoms without fever: sneezing, lethargic, coughing, and aching body. No treatment. Couldn't sleep until 11:30 PM on 10/07/2014.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Feeling hot, Migraine, Nausea, Vomiting
Clinical narrative: Employee states she "felt hot", never did take temperature, felt dizzy, was nauseous but never did have emesis, got a headache-migraine like. Symptoms started a few hours after she received vaccine and continued through the next day. States she felt this way last year too after receiving vaccine at her previous employer.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dizziness, Fatigue, Hypersomnia, Injection site pain, Injection site swelling
Clinical narrative: Within 15 minutes of getting the shot I felt light-headed and a little sick. Within 2 hrs. I could barely lift my arm. The sick feeling and pain and swelling at the injection site continued into that evening. I then slept for 10 hrs., something I never do. The following day (yesterday) I still felt very lethargic and slept 5 hrs. more that afternoon. Today, October 8 I feel somewhat better as is my arm but still totally exhausted.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Lethargy, Malaise, Mobility decreased
Clinical narrative: Within 15 minutes of getting the shot I felt light-headed and a little sick. Within 2 hrs. I could barely lift my arm. The sick feeling and pain and swelling at the injection site continued into that evening. I then slept for 10 hrs., something I never do. The following day (yesterday) I still felt very lethargic and slept 5 hrs. more that afternoon. Today, October 8 I feel somewhat better as is my arm but still totally exhausted.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Rash on bilateral upper extremities, chest, back and neck. Took 50mg of Benadryl PO.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Arm redness, slight swelling, heat from injection site. Denied any other symptoms. Pt was advised to administer Benadryl, apply cold compress, and observe and report any changes or to call 911 if experience shortness of breath or chest pain.
Age: 34.0
Sex: M
Vaccine: HEPA, TDAP, HEPA, TDAP
Symptoms: Laboratory test normal, Pruritus, Rash generalised, Rash pruritic, Serum sickness
Clinical narrative: Generalised skin rash throughout the body. prutitus, felt at around 4:00am. Went to ER at around 9:00am - Prednisone 10mg was prescribed PO/qid/ for 5 days, then 10mg PO/bid for 3 days, 10mg once for 2days. Second treatment Prednisone PO 20mg PO, once a day for five days. Atarax 50mg PO q6h PRN.
Age: 34.0
Sex: M
Vaccine: HEPA, TDAP, HEPA, TDAP
Symptoms: Vaccination complication
Clinical narrative: Generalised skin rash throughout the body. prutitus, felt at around 4:00am. Went to ER at around 9:00am - Prednisone 10mg was prescribed PO/qid/ for 5 days, then 10mg PO/bid for 3 days, 10mg once for 2days. Second treatment Prednisone PO 20mg PO, once a day for five days. Atarax 50mg PO q6h PRN.
Age: 34.0
Sex: M
Vaccine: HEPA, TDAP, HEPA, TDAP
Symptoms: Laboratory test normal, Pruritus, Rash generalised, Rash pruritic, Serum sickness
Clinical narrative: Generalised skin rash throughout the body. Pruritus, felt at around 4:00am. According to Patient went to ER at around 9:00am on 8-8-2014 but printed Hospital documents show 8-9-2014 15:15pm. Rx prescribed: Prednisone 10mg was PO/qid/ for 5 days, then 10mg PO/bid for 3 days, and last 10mg once per day for 2 days. Second treatment Prednisone PO 20mg PO, once per day for five days. Atarax 50mg PO q6h PRN.
Age: 34.0
Sex: M
Vaccine: HEPA, TDAP, HEPA, TDAP
Symptoms: Vaccination complication
Clinical narrative: Generalised skin rash throughout the body. Pruritus, felt at around 4:00am. According to Patient went to ER at around 9:00am on 8-8-2014 but printed Hospital documents show 8-9-2014 15:15pm. Rx prescribed: Prednisone 10mg was PO/qid/ for 5 days, then 10mg PO/bid for 3 days, and last 10mg once per day for 2 days. Second treatment Prednisone PO 20mg PO, once per day for five days. Atarax 50mg PO q6h PRN.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Dry mouth, Headache, Oral pain, Oropharyngeal pain, Pain
Clinical narrative: Employee denies fever, denies N/V/D. Reports sore throat, body aches, mouth hurts-more like dryness, head congestion and headache.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Respiratory tract congestion
Clinical narrative: Employee denies fever, denies N/V/D. Reports sore throat, body aches, mouth hurts-more like dryness, head congestion and headache.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Fatigue, Vertigo
Clinical narrative: Very dizzy, near black out, fatigue and dizzy all day on 10/07/2014.  Feel better on morning of 10/08/2014. Still some Vertigo effects. No treatment.  Sister had same symptoms.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Swelling, Urticaria
Clinical narrative: Itching, hives and swelling.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient asked for Pneumovax. Denied ever getting one. Vaccine was given. Patient did receive one in 2013 according to chart.
Sex: F
Vaccine: TDAP
Symptoms: Complication of delivery, Exposure during pregnancy, Hepatic failure, Pre-eclampsia
Clinical narrative: Initial report received from a consumer on 02 October 2014. This case pertains to a maternal patient; information for the infant case is captured in 2014SA136364. A female patient (age and date of birth not reported) received ADACEL (lot number and administration details not reported) in February 2013. Prior to her vaccination, she had a history of pertussis in January 2013; after vaccination she developed preeclampsia for the last five months of her pregnancy. Per the reporter, the patient's delivery was difficult, and she developed liver failure post-delivery due to the preeclampsia. Outcome was not reported. Documents held by sender: None.
Sex: M
Vaccine: TDAP
Symptoms: Autism spectrum disorder, Childhood disintegrative disorder, Convulsion, Decreased eye contact, Electrolyte imbalance
Clinical narrative: Initial report received from a consumer, who is also the patient's parent, on 02 October 2014. This case pertains to an infant patient who received transplacental ADACEL; information for the maternal case can be found in 2014SA137657. A male patient received a transplacental dose of ADACEL (lot number and administration details not reported) in February 2013. Prior to her vaccination, his mother had a history of pertussis while pregnant; after vaccination she developed preeclampsia for the last five months of her pregnancy. Per the reporter, the patient's delivery was difficult. At four days of age, the patient experienced seizures, which the reporter attributed to an electrolyte imbalance due to preeclampsia. He began experiencing poor eye contact and did not want to be held. Between four and nine months of age he was meeting his developmental milestones, but after that time milestones were not met. He was not talking, and did not clap, point, or wave. According to the reporter the patient had been diagnosed with PNOS autism spectrum. Outcome was not reported. Documents held by sender: None.
Sex: M
Vaccine: TDAP
Symptoms: Emotional distress, Foetal exposure during pregnancy, Maternal condition affecting foetus, Speech disorder developmental
Clinical narrative: Initial report received from a consumer, who is also the patient's parent, on 02 October 2014. This case pertains to an infant patient who received transplacental ADACEL; information for the maternal case can be found in 2014SA137657. A male patient received a transplacental dose of ADACEL (lot number and administration details not reported) in February 2013. Prior to her vaccination, his mother had a history of pertussis while pregnant; after vaccination she developed preeclampsia for the last five months of her pregnancy. Per the reporter, the patient's delivery was difficult. At four days of age, the patient experienced seizures, which the reporter attributed to an electrolyte imbalance due to preeclampsia. He began experiencing poor eye contact and did not want to be held. Between four and nine months of age he was meeting his developmental milestones, but after that time milestones were not met. He was not talking, and did not clap, point, or wave. According to the reporter the patient had been diagnosed with PNOS autism spectrum. Outcome was not reported. Documents held by sender: None.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Dysgraphia, Hypoaesthesia, Injection site reaction, Muscle contractions involuntary, Paraesthesia
Clinical narrative: Left arm dominant, received injection in L deltoid on 9/30/2014.  On 10/6/2014 started experiencing intermittent fasciculation of L deltoid muscle; numbness/tingling down L arm and L hand; notes worsened hand writing.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Blood creatine phosphokinase, Cellulitis, Erythema, Full blood count, HIV test
Clinical narrative: Left arm presented red swelling, cellulitis, pain radiating to the fingers and left side of the shoulder and neck areas.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Local swelling, Neck pain, Pain in extremity
Clinical narrative: Left arm presented red swelling, cellulitis, pain radiating to the fingers and left side of the shoulder and neck areas.
Age: 65.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Dysphonia, Eye pruritus, Headache, Injection site swelling
Clinical narrative: Swelling at site, hoarseness, itchy eyes, cough, fever, aches all over, severe headache hives, rubbery legs.
Age: 65.0
Sex: F
Vaccine: FLUX
Symptoms: Muscular weakness, Pain, Pyrexia, Urticaria
Clinical narrative: Swelling at site, hoarseness, itchy eyes, cough, fever, aches all over, severe headache hives, rubbery legs.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dizziness, Feeling abnormal, Hypoaesthesia, Visual impairment
Clinical narrative: Started feeling funny, tightness in chest, numbness in face, light headed with visual changes. Then progressed to feelings of passing out.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Tremor
Clinical narrative: Slight trembling chills, worsening gradually to shaking chills throughout the next 20 hours.  No fever.  Weakness.
Age: 26.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Local swelling, Pain in extremity
Clinical narrative: Arm sore and swollen.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram abnormal, Headache, Laboratory test normal, Lethargy, Meningitis
Clinical narrative: Headache, shoulder and neck ache, swelling began 10/01/14. 10/02/14 became worse, I was lethargic and my neck was very stiff 10/03/14 unable to move my neck at all it was completley stiff. I went to my family phsician as the vaccine was given to me at my place of employment. She examined me and sent me to the ER for a CT scan and lab work. SHe was concerned that I developed meningitis. Dr. gave put me on prednisone, Flexeril, and naproxen. Put me out of work for three days.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Musculoskeletal stiffness, Neck pain, Swelling
Clinical narrative: Headache, shoulder and neck ache, swelling began 10/01/14. 10/02/14 became worse, I was lethargic and my neck was very stiff 10/03/14 unable to move my neck at all it was completley stiff. I went to my family phsician as the vaccine was given to me at my place of employment. She examined me and sent me to the ER for a CT scan and lab work. SHe was concerned that I developed meningitis. Dr. gave put me on prednisone, Flexeril, and naproxen. Put me out of work for three days.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local swelling, Pain
Clinical narrative: Soreness, erythema, swelling of arm, worsened over 2 days to 12 x 25 cm.  No fever.
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain, Campylobacter infection, Campylobacter test positive, Chills, Dehydration
Clinical narrative: Onset of fever, chills, abdominal cramps and diarrhea, progressed to severe diarrhea and vomiting and by Tuesday morning 09/30/14 he was so dehydrated and had not urinated since Sunday night. I took him to the ER for fluids and they drew lab work that came back positive for campylobacter. Not sure if this was related to the immunization but I wanted to make sure it was reported.
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Pyrexia, Urine output decreased, Vomiting
Clinical narrative: Onset of fever, chills, abdominal cramps and diarrhea, progressed to severe diarrhea and vomiting and by Tuesday morning 09/30/14 he was so dehydrated and had not urinated since Sunday night. I took him to the ER for fluids and they drew lab work that came back positive for campylobacter. Not sure if this was related to the immunization but I wanted to make sure it was reported.
Age: 43.0
Sex: F
Vaccine: FLUC3
Symptoms: Eye pruritus, Hyperventilation, Hypoaesthesia, Paraesthesia, Throat irritation
Clinical narrative: Eyes, nose, and throat itching. Numbness and tingling to extremities. Hyperventilation.
Age: 23.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Abdominal pain, Dizziness, Hyperhidrosis, Hypothermia, Nausea
Clinical narrative: Provider note: "Patient was given influenza and Tdap immunizations in L arm following her office visit today, approximately around 11 AM. Shortly thereafter, patient began feeling lightheaded, warm, had clouding of her vision, and experienced nausea and abdominal pain. On exam she was diaphoretic and pale and tachycardic. She initially improved with lying down, but the abdominal cramping soon escalated leading to intense pain and nausea which lasted for ~30 minutes with persistent diaphoresis and warmth to touch. Patient took few small sips of water. Promethazine IM on standby but not given. Offered to call squad but patient refused. Vitals taken with no change in BP (still ~105-110 / 65-70), but noted patient was hypothermic at 93.5'F. Repeat 10 minutes later was 94.5'F. Toes and feet mildly dusky without change in sensation or pain. Over 30 more minutes, patient fully improved except remained hypothermic when she left at 1 PM."
Age: 23.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Pallor, Skin warm, Tachycardia, Vision blurred
Clinical narrative: Provider note: "Patient was given influenza and Tdap immunizations in L arm following her office visit today, approximately around 11 AM. Shortly thereafter, patient began feeling lightheaded, warm, had clouding of her vision, and experienced nausea and abdominal pain. On exam she was diaphoretic and pale and tachycardic. She initially improved with lying down, but the abdominal cramping soon escalated leading to intense pain and nausea which lasted for ~30 minutes with persistent diaphoresis and warmth to touch. Patient took few small sips of water. Promethazine IM on standby but not given. Offered to call squad but patient refused. Vitals taken with no change in BP (still ~105-110 / 65-70), but noted patient was hypothermic at 93.5'F. Repeat 10 minutes later was 94.5'F. Toes and feet mildly dusky without change in sensation or pain. Over 30 more minutes, patient fully improved except remained hypothermic when she left at 1 PM."
Age: 31.0
Sex: M
Vaccine: FLU4
Symptoms: Dysgeusia
Clinical narrative: Metallic taste in mouth.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Alanine aminotransferase abnormal, Amylase normal, Aspartate aminotransferase abnormal, Chills
Clinical narrative: Pt developed sudden onset of nausea; drive heaves, chills, anorexia and abdominal pain; She went to the ER and was diagnosed with pancreatitis with elevated lipase, abnormal LFTs and an elevated white cell count.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Decreased appetite, Lipase increased, Liver function test abnormal, Nausea, Pancreatitis
Clinical narrative: Pt developed sudden onset of nausea; drive heaves, chills, anorexia and abdominal pain; She went to the ER and was diagnosed with pancreatitis with elevated lipase, abnormal LFTs and an elevated white cell count.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Retching, White blood cell count increased
Clinical narrative: Pt developed sudden onset of nausea; drive heaves, chills, anorexia and abdominal pain; She went to the ER and was diagnosed with pancreatitis with elevated lipase, abnormal LFTs and an elevated white cell count.
Age: 19.0
Sex: M
Vaccine: FLUX, MNQ
Symptoms: Nausea, Nystagmus, Vertigo
Clinical narrative: Sudden onset of vertigo, nausea and bilateral horizontal nystagmus.
Sex: F
Vaccine: TYP
Symptoms: Caesarean section, Cardiomegaly, Chest X-ray abnormal, Developmental delay, Echocardiogram normal
Clinical narrative: This spontaneous report from a physician concerns a newborn female: PDE2014DE119883. The baby weighed 3130 kilograms at birth. The baby's medical history was unknown. Other medical history included the baby's brother, aged 7, also suffered from club feet and retardation in development. The baby's mother received rabies vaccine (unspecified dose and route of administration) on 05-NOV-2014, influenza vaccine virosomal (unspecified dose) on 13-NOV-2013, typhus vaccine (unspecified dose and route of administration) on 18-NOV-2013 and rabies vaccine again on 26-NOV-2013, all for prophylactic vaccination. Non-company suspect drugs included: Tick-borne encephalitis vaccine on 05-NOV-2013, Meningococcal polysaccharide vaccine on 18-NOV-2013 and Japanese encephalitis vaccine on 26-NOV-2013, all for prophylactic vaccination. Concomitant medications were not reported. The baby was delivered by cesarean section (41st week of gestation), due to weak CTG (cardiotocograph). The first assessment after delivery was not normal with weak muscle tonus and malformation of both feet (club feet). The baby was hospitalised. On the third day of life, the baby developed retardation of development and an infection with tachypnea.  Corrective treatment included Ampicillin and Tobramycin for seven days with infusions of flucose, electrolytes and aminio acids.  A decrease in oxygen saturation was observed until 30-AUG-2014. An x-ray revealed a very big sized heart and according to echo cardiac investigations, no evidence for vitium cordis or malfunction of the heart.  Orthopaedic investigations performed on 20-AUG-2014 confirmed club feet (both sites), questionable instable hip and length of achilles tendon was reduced.  The baby's club feet were treated by casts. On 01-SEP-2014, the baby was discharged from hospital in a good general condition. The outcome of the events was not reported. The reporter suspected that the baby's club feet were a genetically caused musculoskeletal syndrome and recommended an appointment with human genetics. The reporter did not suspect a causal relationship between vaccines, club feet and developmental retardation. This report was serious (hospitalization).
Sex: F
Vaccine: TYP
Symptoms: Foetal exposure during pregnancy, Foetal monitoring abnormal, Hypotonia, Infection, Oxygen saturation decreased
Clinical narrative: This spontaneous report from a physician concerns a newborn female: PDE2014DE119883. The baby weighed 3130 kilograms at birth. The baby's medical history was unknown. Other medical history included the baby's brother, aged 7, also suffered from club feet and retardation in development. The baby's mother received rabies vaccine (unspecified dose and route of administration) on 05-NOV-2014, influenza vaccine virosomal (unspecified dose) on 13-NOV-2013, typhus vaccine (unspecified dose and route of administration) on 18-NOV-2013 and rabies vaccine again on 26-NOV-2013, all for prophylactic vaccination. Non-company suspect drugs included: Tick-borne encephalitis vaccine on 05-NOV-2013, Meningococcal polysaccharide vaccine on 18-NOV-2013 and Japanese encephalitis vaccine on 26-NOV-2013, all for prophylactic vaccination. Concomitant medications were not reported. The baby was delivered by cesarean section (41st week of gestation), due to weak CTG (cardiotocograph). The first assessment after delivery was not normal with weak muscle tonus and malformation of both feet (club feet). The baby was hospitalised. On the third day of life, the baby developed retardation of development and an infection with tachypnea.  Corrective treatment included Ampicillin and Tobramycin for seven days with infusions of flucose, electrolytes and aminio acids.  A decrease in oxygen saturation was observed until 30-AUG-2014. An x-ray revealed a very big sized heart and according to echo cardiac investigations, no evidence for vitium cordis or malfunction of the heart.  Orthopaedic investigations performed on 20-AUG-2014 confirmed club feet (both sites), questionable instable hip and length of achilles tendon was reduced.  The baby's club feet were treated by casts. On 01-SEP-2014, the baby was discharged from hospital in a good general condition. The outcome of the events was not reported. The reporter suspected that the baby's club feet were a genetically caused musculoskeletal syndrome and recommended an appointment with human genetics. The reporter did not suspect a causal relationship between vaccines, club feet and developmental retardation. This report was serious (hospitalization).
Sex: F
Vaccine: TYP
Symptoms: Tachypnoea, Talipes, Talipes correction
Clinical narrative: This spontaneous report from a physician concerns a newborn female: PDE2014DE119883. The baby weighed 3130 kilograms at birth. The baby's medical history was unknown. Other medical history included the baby's brother, aged 7, also suffered from club feet and retardation in development. The baby's mother received rabies vaccine (unspecified dose and route of administration) on 05-NOV-2014, influenza vaccine virosomal (unspecified dose) on 13-NOV-2013, typhus vaccine (unspecified dose and route of administration) on 18-NOV-2013 and rabies vaccine again on 26-NOV-2013, all for prophylactic vaccination. Non-company suspect drugs included: Tick-borne encephalitis vaccine on 05-NOV-2013, Meningococcal polysaccharide vaccine on 18-NOV-2013 and Japanese encephalitis vaccine on 26-NOV-2013, all for prophylactic vaccination. Concomitant medications were not reported. The baby was delivered by cesarean section (41st week of gestation), due to weak CTG (cardiotocograph). The first assessment after delivery was not normal with weak muscle tonus and malformation of both feet (club feet). The baby was hospitalised. On the third day of life, the baby developed retardation of development and an infection with tachypnea.  Corrective treatment included Ampicillin and Tobramycin for seven days with infusions of flucose, electrolytes and aminio acids.  A decrease in oxygen saturation was observed until 30-AUG-2014. An x-ray revealed a very big sized heart and according to echo cardiac investigations, no evidence for vitium cordis or malfunction of the heart.  Orthopaedic investigations performed on 20-AUG-2014 confirmed club feet (both sites), questionable instable hip and length of achilles tendon was reduced.  The baby's club feet were treated by casts. On 01-SEP-2014, the baby was discharged from hospital in a good general condition. The outcome of the events was not reported. The reporter suspected that the baby's club feet were a genetically caused musculoskeletal syndrome and recommended an appointment with human genetics. The reporter did not suspect a causal relationship between vaccines, club feet and developmental retardation. This report was serious (hospitalization).
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to an about 5-10 patients of unknown age and gender. Medical history was not reported. The pharmacist informed that in August 2014 the patients were vaccinated with ZOSTAVAX vial, subcutaneous (lot number, expiration date and dosage were not reported) which was improperly exposed to defrost cycling up to 7 F for <1 hour per cycle for 1 cycle per day each day. The date that this ZOSTAVAX was placed into this freezer was unspecified. No known adverse effects were reported. Follow up information has been received from a pharmacist refers to a 65 years old female patient with diabetes. On 05-AUG-2014, the patient was vaccinated with a dose of ZOSTAVAX subcutaneously, (lot# J016257, expiration date: 20-FEB-2015) in the left arm (circle one). This is one of several reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site pruritus
Clinical narrative: A knot developed on the arm at administration site.  It itches.  It is a reddened area about the size of a golf ball.
Age: 11.0
Sex: M
Vaccine: MMR, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient was given vaccines, MCV, MMR, on 10-06-2014 In Left deltoid. Father bought patient in today at 0800 c/o pain, itching, redness swelling at site. Dr. assessed patient and order given to give Benadryl 50mg po. and was given and ice compress applied. And prescription given for Benadryl and instructions given to apply cold compress as needed for pain and swelling and that Benadryl could cause drowsiness and to return if condition worsens.
Age: 66.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Rash and itching around injection site.
Age: 1.02
Sex: F
Vaccine: VARCEL
Symptoms: Rash erythematous
Clinical narrative: A red rash on her shoulders that spread to her arms, the next day it had spread to her face, diaper area, and lower extremities.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness, warmth and swelling to right upper arm. With tenderness.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Vaccination site induration, Vaccination site pain, Vaccination site warmth
Clinical narrative: Redness, induration, warm-to-touch, soreness at vaccine administration site.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Diarrhoea, Hyperhidrosis, Vomiting
Clinical narrative: Vomited, chills, sweats, diarrhea.
Age: 48.0
Sex: F
Vaccine: FLUC3
Symptoms: Dysphagia, Erythema, Pharyngeal oedema, Rash, Skin discolouration
Clinical narrative: Rash (exterior and interior throat), swelling (exterior and interior throat), unable to swallow, discoloration of skin (redness) - Treatment:  Benadryl @ 09:40 AM.
Age: 66.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Erythema, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient received both flu and pneumonia vaccines in the office on 10/7/14. One in each arm. Patient gave verbal consent to have one injection in each arm. Patient waited recommended time in the waiting room after vaccination with no adverse reactions. Patient called the office in the AM on 10/8/14. Patient stated that the previous night he felt "crummy" and "had a fever - although did not check it with a thermometer." Patient stated that left arm was swollen, red and warm. Offered a patient and appointment in the office. During the conversation patient stated that he "just remembered" that he had a Vantas implant in the left arm. Patient called back aproximately an hour later to schedule an office appointment. Patient was seen in the office at 1:45 pm. Patient upper left arm down to elbow was red, warm and swollen. At the injection site on the right arm, area was reddened, raised and warm. MD treated patient with Keflex for cellulitis.
Age: 66.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Local swelling, Malaise, Pyrexia, Skin warm
Clinical narrative: Patient received both flu and pneumonia vaccines in the office on 10/7/14. One in each arm. Patient gave verbal consent to have one injection in each arm. Patient waited recommended time in the waiting room after vaccination with no adverse reactions. Patient called the office in the AM on 10/8/14. Patient stated that the previous night he felt "crummy" and "had a fever - although did not check it with a thermometer." Patient stated that left arm was swollen, red and warm. Offered a patient and appointment in the office. During the conversation patient stated that he "just remembered" that he had a Vantas implant in the left arm. Patient called back aproximately an hour later to schedule an office appointment. Patient was seen in the office at 1:45 pm. Patient upper left arm down to elbow was red, warm and swollen. At the injection site on the right arm, area was reddened, raised and warm. MD treated patient with Keflex for cellulitis.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Adverse reaction, Eye pruritus
Clinical narrative: AFTER ADMINISTERING THE FLU MIST TO THE PATIENT, WITHIN 5 TO 10 MINUTES SHE PRESENTED A SLIGHT REACTION ON RIGHT SIDE OF THE CHEEK AND ON THE UPPER CHEST TOGETHER WITH ITCHING OF THE EYES. NO RESPIRATORY DISTRESS PRESENTED. PATIENT WAS ESCORTED TO PHYSICIAN WHICH AFTER PRESCRIBING PO PREDNISONE AND BENADRYL CLEARED THE PATIENT TO GO HOME FOR THE REMAINDER OF THE DAY. PATIENT WAS INSTRUCTED TO FOLLOW UP NEXT DAY.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Pt complained of reddened area with slight imflammation of injection site of arm from both injections- pt received Fluzone HD and Pneumovax-23.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: Says she has chicken pox.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Partial seizures
Clinical narrative: Pt received flu shot here and per mom within 15 minutes had 7 focal seizures in a row.  Mom took pt to our local pediatric minor care and per them pt was hospitalized.  Pt does have a history of convulsions but has received a flu vaccine every year per our records, did receive Flumist last year.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Discomfort, Injected limb mobility decreased, Injection site pain
Clinical narrative: Right shoulder pain at immunization site, limited ROM. Came to clinic on 10/8 still with discomfort.
Age: 82.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Cellulitis, Injection site erythema, Injection site warmth, Throat irritation, Vaccination complication
Clinical narrative: Injection site (Left Deltoid) sore for a couple days, then developed redness at injection site, area warm to touch. Seen in office 10/06/14 and Dx: Cellulitis and given cephalexin and desloratadine as pt also had itchy throat which Dr felt was a reaction to the vaccine also. As of today 10/8/14 deltoid area is still red and warm but not as "bright" red as was before.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Extreme pain at injection site. Fever of 100.1 degrees upon waking the next morning.
Age: 51.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV
Symptoms: Axillary pain, Blood test, Culture urine, Injection site pain, Injection site vesicles
Clinical narrative: Blistering at site, pain at site, pain under arm.
Age: 51.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV
Symptoms: Blood test, Injection site inflammation, Injection site pain, Injection site vesicles, Pyrexia
Clinical narrative: Blistering at site, pain at site, pain under arm.
Age: 72.0
Sex: F
Vaccine: DTAP
Symptoms: Biopsy skin, Erythema, Pruritus, Swelling
Clinical narrative: Itching, redness and swelling.
Age: 67.0
Sex: F
Vaccine: PPV, FLU3, PPV
Symptoms: Dehydration, Pyrexia
Clinical narrative: Patient reported high fever 101.9 degrees and went to the ER sometime at night, either the day of or the following day. She was given IV saline for dehydration and sent home. She called the pharmacy to report the adverse event on 10/8/14.
Age: 67.0
Sex: F
Vaccine: PPV, FLU3, PPV
Symptoms: Dehydration, Injection site pain, Pyrexia
Clinical narrative: Patient reported high fever 101.9 degrees and went to the ER sometime at night, either the day of or the following day. She was given IV saline for dehydration and sent home. She called the pharmacy to report the adverse event on 10/8/14.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Pt came to the pharmacy today 10/8/2014 showing the redness and itchiness at the site of injection. She reported no SOB nor wheezing. Advised pt to use Benadryl and confirmed later that her itchiness subsided.
Age: 56.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal pain, Laboratory test, Nephrolithiasis, Pruritus, Rash
Clinical narrative: JUST A FEW SMALL BUMPS ACROSS BACK, THEN ITCHING, SWELLING/WELPS, BUMPS ABOVE SKIN BREAKING OPEN.....SEVERE ITCH. ALSO ACUTE KIDNEY FAILURE, 2 STONES.  WENT WED TO ER LEFT HOSP. FRI. 29TH, BACK ON SUN. TIL WED.
Age: 56.0
Sex: M
Vaccine: FLU4
Symptoms: Renal failure acute, Swelling, Urticaria, Vomiting
Clinical narrative: JUST A FEW SMALL BUMPS ACROSS BACK, THEN ITCHING, SWELLING/WELPS, BUMPS ABOVE SKIN BREAKING OPEN.....SEVERE ITCH. ALSO ACUTE KIDNEY FAILURE, 2 STONES.  WENT WED TO ER LEFT HOSP. FRI. 29TH, BACK ON SUN. TIL WED.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis at site injection.
Age: 50.0
Sex: F
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Rash, Swelling
Clinical narrative: Client stated that she had rash and swelling and given steroids by her primary Dr.
Age: 87.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Localized reaction around injection site including raised red ring and hot to touch.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Rash
Clinical narrative: Started as a red spot almost immediately after receiving the injection.  It is now about 3 inches in diamiter and a darb brownish/black rash.
Age: 25.0
Sex: F
Vaccine: PNC13
Symptoms: Lymphadenopathy, Oropharyngeal pain, Pain, Pruritus, Rash erythematous
Clinical narrative: Pain, swelling of the shoulder, onset of raised red rash. Rash spread on Tuesday 10/07/2013 and spread again on Wednesday 10/08/2014. Swollen lymph nodes in armpit and left side of the neck. Sore throat and itchy ears.
Age: 25.0
Sex: F
Vaccine: PNC13
Symptoms: Rash generalised, Swelling
Clinical narrative: Pain, swelling of the shoulder, onset of raised red rash. Rash spread on Tuesday 10/07/2013 and spread again on Wednesday 10/08/2014. Swollen lymph nodes in armpit and left side of the neck. Sore throat and itchy ears.
Age: 66.0
Sex: F
Vaccine: FLUX
Symptoms: Contusion, Local swelling, Mobility decreased, Pain
Clinical narrative: Extreme pain.  Within a few hours I was unable to lift my arm.  That evening I tried ice - did not help.  Entire bicep area felt bruised and swollen for 3 days.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site warmth, Pain
Clinical narrative: Patient notified me about a little bruising and warmth that showed up at the injection site.  She was not sure when it started to come about.  She also stated that she had some general body soreness recently as well.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Rash
Clinical narrative: Blisters and rash on arm/hand.
Age: 46.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Asthenia, Chills, Dizziness, Headache, Mobility decreased
Clinical narrative: Could not lift arm, fever, chills, muscle aches, headache, weakness, dizzy.
Age: 46.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Myalgia, Pyrexia, White blood cell count increased
Clinical narrative: Could not lift arm, fever, chills, muscle aches, headache, weakness, dizzy.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Site of injection was red. Patient experienced itching at localized site of injection.
Age: 5.0
Sex: M
Vaccine: FLUN4
Symptoms: Chills, Diarrhoea, Nausea, Vomiting
Clinical narrative: Diarrhea, nausea, vomiting, chills. Gave him Ppto Bismol and Tylenol.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Eyelid oedema, Rash macular, Swelling face
Clinical narrative: Patient states forehead and eyes got splotches and some swelling. Patient went to physician who could not determine if from vacccine or not. Resolved a few hours later.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Headache, Hypertension, Pain, Palpitations
Clinical narrative: PALPITATIONS; ALL OVER PAIN; HEADACHE; HIGH BLOOD PRESSURE; LIGHTHEADED.
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Rash pruritic, Rash vesicular, Skin lesion
Clinical narrative: Vesicular rash in umbilical area followed by lesions on chest and finally on bilateral forearms. Rash is very pruritic.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Rash, Rash pruritic, Rash vesicular
Clinical narrative: Patient noted vesicular rash on bilateral arms which is very pruritic.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Burning sensation, Fatigue, Flushing, Headache, Herpes zoster
Clinical narrative: Began having SEVERE itching all over my body, flushing, and feeling as if I were running a fever, severe head and body aches, and nausea. After a couple of days everything went away except the headache, muscle aches and general feeling of being "run down", and then I began experiencing severe muscle pain and burning in my right upper back and shoulder blade area. This continued and got progressively worse until I was nearly bedridden from the pain on October 5th, and then a painful, burning rash developed overnight. I went to the doctor and was immediately diagnosed with shingles, and am currently being treated with Acyclovir 800mg five times per day, a Medrol dosepack, and Hydrocodone for the pain. I am 41 years old and have never had shingles or the shingles vaccine, but did have chickenpox at the age of 15. I have learned over the last couple of days that many people have reported developing shingles within several days of getting the flu vaccine, and decided that my situation should be documented as well.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Myalgia, Nausea, Pain, Pruritus generalised, Pyrexia
Clinical narrative: Began having SEVERE itching all over my body, flushing, and feeling as if I were running a fever, severe head and body aches, and nausea. After a couple of days everything went away except the headache, muscle aches and general feeling of being "run down", and then I began experiencing severe muscle pain and burning in my right upper back and shoulder blade area. This continued and got progressively worse until I was nearly bedridden from the pain on October 5th, and then a painful, burning rash developed overnight. I went to the doctor and was immediately diagnosed with shingles, and am currently being treated with Acyclovir 800mg five times per day, a Medrol dosepack, and Hydrocodone for the pain. I am 41 years old and have never had shingles or the shingles vaccine, but did have chickenpox at the age of 15. I have learned over the last couple of days that many people have reported developing shingles within several days of getting the flu vaccine, and decided that my situation should be documented as well.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Rash
Clinical narrative: Began having SEVERE itching all over my body, flushing, and feeling as if I were running a fever, severe head and body aches, and nausea. After a couple of days everything went away except the headache, muscle aches and general feeling of being "run down", and then I began experiencing severe muscle pain and burning in my right upper back and shoulder blade area. This continued and got progressively worse until I was nearly bedridden from the pain on October 5th, and then a painful, burning rash developed overnight. I went to the doctor and was immediately diagnosed with shingles, and am currently being treated with Acyclovir 800mg five times per day, a Medrol dosepack, and Hydrocodone for the pain. I am 41 years old and have never had shingles or the shingles vaccine, but did have chickenpox at the age of 15. I have learned over the last couple of days that many people have reported developing shingles within several days of getting the flu vaccine, and decided that my situation should be documented as well.