chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Herpes zoster, Secondary transmission
Clinical narrative: This spontaneous report as received from an office manager (healthcare worker) via a company representative refers to a 30 year old female patient. The patient's medical history included chicken pox (in June 1984 as about 13 months) and delivery of a baby girl via C-section on 02-AUG-2013. The consumer (the mother of the patient) received ZOSTAVAX (lot # reported as J003399, EXP date 21-JUN-2014, route not reported) 0.5 ml on 29-AUG-2013. The consumer saw her daughter after received ZOSTAVAX on the following dates: 01-SEP-2013, 06-SEP-2013, 07-SEP-2013, 12-SEP-2013, 13-SEP-2013, 14-SEP-2013, 19-SEP-2013, 25-SEP-2013 and 29-SEP-2013. At all times her arms and the immunization site was covered by long sleeved clothing and her daughter likely hugged her when she arrived and left. Her typical visit would have been for perhaps 2 hours. And shortly after her receiving the ZOSTAVAX, her 30 year old daughter developed symptoms of shingles and she was convinced that she transmitted the shingles due to receiving the ZOSTAVAX. Her daughter experienced a burning sensation on her hip where the seatbelt was when returning home on 23-SEP-2013 from a weekend trip (6 hours drive) with a "clear, circular area about 2-3 inches in diameter on the front of her hip which was densely and finely blistered with raised white blisters". Her daughter noticed the burning sensation when wearing the seatbelt and the blisters came later. When she saw the blistered area, it did not look like the pictures of shingles she had seen on the Internet (bands, red). it was in a very specific round shape, almost like a contact dermatitis. The patient sought medical attention by seeing physician which time the blisters were healing. Her daughter was diagnosed with the shingles by the doctor on 08-OCT-2013. She stated that her daughter no longer had a rash. The outcome of patient was unknown. Lot number J003399 is an invalid lot number for zoster vaccine live. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMR, VARCEL
Symptoms: Gait disturbance, Pain, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Mother of child states she saw erythema and swelling at site of vaccine administration. Pt c/o pain and difficulty walking.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Injection site pain, X-ray limb
Clinical narrative: Within 5 hours of receiving the vaccine, my arm/shoulder were extremely painful and I had limited range of motion. The next morning it was worse. I looked at the site and realized the shot had been administered at site top of my arm - nearly on top of my shoulder. Improvement has been gradual. PCP, Ortho, PT, ?Bone ?Bursal sac ?Tendon.
Age: 23.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a 23 year old male patient. On 30-SEP-2013, (reported on 31-OCT-2013 as "about one month ago") the patient was vaccinated with PNEUMOVAX 23, 0.5 ml, intramuscular. Lot number, expiry date and anatomical location were not reported. On an unknown date patient experienced redness and soreness at the site of PNEUMOVAX injections. Treatment for the events included aspirin and anti-inflammatory drugs, not further specified. The outcome of redness at the site of PNEUMOVAX injections and soreness at the site of PNEUMOVAX injections was reported as recovered/resolved, date of recovery was unknown. Additional information has been requested.
Age: 0.08
Sex: F
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (C.M.A.) refers to a 4 week old infant. On 15-NOV-2013, the patient was vaccinated with oral ROTATEQ lot # J003813, expiration date: 10-AUG-2014 (dose and route were not reported). No concomitant medications were reported. The infant was not experiencing any adverse effects at the time of the report. Additional information has been requested.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse refers to a female patient of unknown age. The nurse reported that the patient, who was pregnant (unspecified gestation) (Last Menstrual Period (LMP) and expected date of delivery (EDD) were unknown), was administered the first dose of GARDASIL (Lot# unspecified), dose and location unspecified on 20-NOV-2013. No adverse effected reported. The outcome of pregnant was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous report was received from a Registered Nurse refers to a female patient of unknown age. The nurse reported that the patient, who was pregnant (unspecified gestation) (Last Menstrual Period (LMP) and expected date of delivery (EDD) were unknown), was administered the first dose of GARDASIL (Lot# unspecified), dose and location unspecified on 20-NOV-2013. No adverse effected reported. The outcome of pregnant was unknown. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Infection, Lip swelling, Myalgia, Pain
Clinical narrative: This spontaneous report as received from approximately 79 year old female consumer regarding herself. The patient concurrent condition included drug reactions/allergies to acrylate and methacrylate. The patient's medical history included high blood pressure and Lyme disease. On 07-MAY-2013 the patient was vaccinated with ZOSTAVAX (dose unknown) for prevention of shingles. Concomitant therapies included MAXZIDE, QUINAPRIL HYDROCHLORIDE and levothyroxine sodium (manufacturer unknown). On an unknown date in May 2013, after administration of ZOSTAVAX the patient experienced weight loss, muscle aches and pains, developed a rash, an infection and hives. The patient also stated that after administration, the patient needed to have a dental partial reline performed and developed puffy lips. On an unknown date in 2013 the patient underwent blood work - result unspecified. The patient sought medical attention and had unspecified office visits. The patient was prescribed with unspecified antibiotics (unspecified names, dosages/frequencies and manufacturers) for her muscle pain and aches and a pill (unspecified name) for infection. The outcome of weight loss, muscle aches, rash, puffy lips, hives, an infection and pains was reported as not recovered/not resolved. The outcome of dental partial reline performed is unknown. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Urticaria, Weight decreased
Clinical narrative: This spontaneous report as received from approximately 79 year old female consumer regarding herself. The patient concurrent condition included drug reactions/allergies to acrylate and methacrylate. The patient's medical history included high blood pressure and Lyme disease. On 07-MAY-2013 the patient was vaccinated with ZOSTAVAX (dose unknown) for prevention of shingles. Concomitant therapies included MAXZIDE, QUINAPRIL HYDROCHLORIDE and levothyroxine sodium (manufacturer unknown). On an unknown date in May 2013, after administration of ZOSTAVAX the patient experienced weight loss, muscle aches and pains, developed a rash, an infection and hives. The patient also stated that after administration, the patient needed to have a dental partial reline performed and developed puffy lips. On an unknown date in 2013 the patient underwent blood work - result unspecified. The patient sought medical attention and had unspecified office visits. The patient was prescribed with unspecified antibiotics (unspecified names, dosages/frequencies and manufacturers) for her muscle pain and aches and a pill (unspecified name) for infection. The outcome of weight loss, muscle aches, rash, puffy lips, hives, an infection and pains was reported as not recovered/not resolved. The outcome of dental partial reline performed is unknown. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: FLU3, HEPA, HPV4
Symptoms: Amnesia, Pain in extremity
Clinical narrative: Patient had Hep A, HPV, and flu vaccine on 11/7 experienced amnesia and lots of arm pain.
Age: 1.55
Sex: F
Vaccine: DTAP, FLU3, HIBV, MMRV, PNC13
Symptoms: Pyrexia, Rash
Clinical narrative: Fever and rash.
Age: 0.6
Sex: M
Vaccine: DTAP, RVX
Symptoms: Urticaria
Clinical narrative: 20 minutes after injection of DTaP hives on leg spreading over entire body all limbs and torso, BENADRYL administered orally hives remained until next am.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Joint effusion, Nuclear magnetic resonance imaging abnormal, Pain, Tenderness
Clinical narrative: Flu shot received in left arm with typical mild soreness as with past flu shots in muscle, lasting 2 days. Soreness persisted. About 3-4 days after immunization, got up, got into shower, noticed poorer ability to raise arm, as well as move arm backward and forward, due to pain in upper lateral arm.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: X-ray limb normal
Clinical narrative: Flu shot received in left arm with typical mild soreness as with past flu shots in muscle, lasting 2 days. Soreness persisted. About 3-4 days after immunization, got up, got into shower, noticed poorer ability to raise arm, as well as move arm backward and forward, due to pain in upper lateral arm.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Injected limb mobility decreased, Pain in extremity, Sensation of heaviness
Clinical narrative: Received flu vaccine 10/26/13 felt some discomfort at the time. Over the last 3 weeks arm has become "heavy" and painful. Unable to lift (L) arm up, straight.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Arm pain and decreased range of motion starting after injection was given and continues to the present time.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dyspnoea, Eye discharge, Headache, Ocular hyperaemia
Clinical narrative: Wihin 2 hrs developed deep chronic cough, SOB, sore throat, vomiting. Later eyes (whites became pink) and drainage. HA.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Vomiting
Clinical narrative: Wihin 2 hrs developed deep chronic cough, SOB, sore throat, vomiting. Later eyes (whites became pink) and drainage. HA.
Age: 42.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site reaction, Pyrexia, Rash erythematous, Rash macular, Vomiting
Clinical narrative: Approximately 5 hrs after receiving FLUVIRIN and PNEUMOVAX the patient had vomiting for 8 hours, fever for 24 hours, red blotchy rash on arm from injection site to elbow.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Patient received vaccination in left deltoid muscle and approximately 6 hours later the area around joint of left arm/shoulder became very sore.
Age: 1.51
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Urticaria
Clinical narrative: This spontaneous report was received from a healthcare professional concerning a 18 month old male patient with no pertinent medical history nor drug reaction/allergies, who on 11-NOV-2013 was vaccinated with dose 1 of VAQTA (Lot No. J003719, exp. 27-SEP-2015), intramuscular for hepatitis A. On the same date the patient received a dose of diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (manufacturer unknown) and HIB conj vaccine (manufactured by Sanofi). Later the same date the patient's parent called the office and noted that the patient had significant hives. The patient received treatment with oral BENADRYL liquid. At the time of the report patient's outcome was unknown. Relationship between hives and therapy with VAQTA was not reported. Additional information has been requested.
Age: 1.79
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Cough, Hypoxia, Influenza B virus test positive, Pyrexia
Clinical narrative: In less than 24 hours after receiving hep A #2 and flu vaccines inactivated injectable developed cough, fever and hypoxia. (+) flu B.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Injection site pain, Injection site reaction, Mobility decreased, Musculoskeletal pain
Clinical narrative: Since injection in Oct. 2012 in deltoid muscle, have had deep muscle ache at exact site. Over several months, this progressed to shoulder pain, stiffness and severe decreased mobility. This has never gotten better. Taking meloxicam for (shoulder bursitis).
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness
Clinical narrative: Since injection in Oct. 2012 in deltoid muscle, have had deep muscle ache at exact site. Over several months, this progressed to shoulder pain, stiffness and severe decreased mobility. This has never gotten better. Taking meloxicam for (shoulder bursitis).
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injected limb mobility decreased, Injection site pain
Clinical narrative: At least one month after shot it was still red in the area. Soreness/pain in upper left arm when trying to use, lift, sleep on left side. Use ice or heat pack to help relieve pain. Pain pills do not help. Pain or sore ever since shot given; some days light some days heavy pain. Use right arm at times to lift left arm.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pityriasis rosea, Pruritus, Urticaria
Clinical narrative: Case number PHEH2013US024297 is an initial spontaneous report from the consumer (patient) received on 13 Nov 2013. This report refers to a 50-year-old female patient. Her medical history included eczema, seborrheic dermatitis, allergic rhinitis and several years ago one episode of shingles. She was vaccinated with FLUVIRIN (batch number: 1308401) at a dose of 0.5 ml intramuscularly on 30 Sep 2013. On 01 Oct 2013, the patient developed red itchy welts all over the front of her torso and over time it spread to her back, neck, buttocks, arms, legs and underarms. She went to a dermatologist and diagnosed with Pityriasis rosea. The patient was treated with a combination LIDEX, loratidine and BENADRYL and variety of creams. The outcome of the events reported as condition improved.
Age: 22.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Local swelling
Clinical narrative: Swollen arm on same side as shot. Pt dx with cellulitis. Abx successfully cured.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Breast discomfort, Burning sensation
Clinical narrative: States 2 days after receiving flu vaccine in (L) arm, developed burning shooting type discomfort (L) breast near axilla. Slight at first. Notified clinic on 11/15/13 that episodes were continuing and increasing in intensity states happening once or twice a week.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus generalised, Rash macular, Syncope
Clinical narrative: 10 minutes after administration of vaccine, pt became "itchy" all over, esp (R) chest and had faint, ER macular rash of BUE and trunk; itchy esp of (R) chest and (R) axilla. No other sxs or findings; given ZYRTEC 5 mg (syrup), Sx decreased within 10 min and completely resolved after 30 min.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Depressed level of consciousness, Depression, Headache, Malaise, Raynaud's phenomenon
Clinical narrative: Cannot remember exact date of vaccination or onset of symptoms.  Has had severe headaches, depression, symptoms of Raynauds, general malaise.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Fatigue, Nasal congestion, Nasopharyngitis, Oral herpes
Clinical narrative: Very sore arm for about 5 days, with onset of tiredness and slight cold like symptoms with nasal congestion. Loss of appetite. On 11/23 experienced an outbreak of cold sores on the mouth and another outbreak the following day. Tiredness continues.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Very sore arm for about 5 days, with onset of tiredness and slight cold like symptoms with nasal congestion. Loss of appetite. On 11/23 experienced an outbreak of cold sores on the mouth and another outbreak the following day. Tiredness continues.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Headache, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Patient complaints of pain, redness, and edema noted at the injection site of a Pneumovax vacinne (lot#J009689). Patient also complains of generalized fatigue, achiness, and headache.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Pain
Clinical narrative: Patient complaints of pain, redness, and edema noted at the injection site of a Pneumovax vacinne (lot#J009689). Patient also complains of generalized fatigue, achiness, and headache.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Feeling abnormal, Lip swelling, Ocular hyperaemia, Oropharyngeal pain
Clinical narrative: Around 1PM, her throat became very scratchy and slightly sore. Lasted all afternoon. At around 6PM, felt miserable. Eyes blood shot and could hardly breathe from nose. She took two Alka Seltzer Cold and Flu tablets. When awake next AM, eyes and top lip extremely swollen. After arrived at work, swelling had gone down tremendously, and by end of day, face was back to normal.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Throat irritation
Clinical narrative: Around 1PM, her throat became very scratchy and slightly sore. Lasted all afternoon. At around 6PM, felt miserable. Eyes blood shot and could hardly breathe from nose. She took two Alka Seltzer Cold and Flu tablets. When awake next AM, eyes and top lip extremely swollen. After arrived at work, swelling had gone down tremendously, and by end of day, face was back to normal.
Age: 13.0
Sex: M
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Cough, Headache, Oropharyngeal pain, Vomiting
Clinical narrative: Headache; Vomiting; Sore Throat; coughing; missed 2 days of school.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Large red area surrounding injection site.  Area is warmer than rest of arm.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Angiogram, Blood test, Computerised tomogram, Headache, Nuclear magnetic resonance imaging
Clinical narrative: Sudden onset of severe headache with subarachnoid hemorrhage.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Subarachnoid haemorrhage
Clinical narrative: Sudden onset of severe headache with subarachnoid hemorrhage.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Joint stiffness, Tenderness
Clinical narrative: The backs of both knees seem tight and tender.  They are NOT red or swollen on the outside.  About 2 weeks into it the inside of one knee began to hurt - Tylenol and ice does help.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: Dizziness upon reclining to bed.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Extensive swelling of vaccinated limb, Pyrexia
Clinical narrative: Within 6 minutes, child had fever and swollen leg.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Right upper arm became erythematous, swollen, warm, painful around shot injection site.
Age: 27.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Redness, induration, pain, swelling at site of injection; feverishness (99.8C), malaise, headache, achiness, itching (9/13/13 onset).
Age: 27.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Malaise, Pain, Pruritus, Pyrexia
Clinical narrative: Redness, induration, pain, swelling at site of injection; feverishness (99.8C), malaise, headache, achiness, itching (9/13/13 onset).
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus
Clinical narrative: Arm began to itch at injection site and has never stopped over 1 year later. No redness, swelling, or other reaction but itching.
Age: 44.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Asthenia, Chills, Headache, Injection site erythema, Injection site pain
Clinical narrative: Extremely sore arm, swelling, redness, pain at injection site. 102+ fever for three days, week, achy body, chills, fever, severe headache. Live alone. Was too sick to drive to urgent care or hospital.
Age: 44.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site swelling, Pain, Pain in extremity, Pyrexia
Clinical narrative: Extremely sore arm, swelling, redness, pain at injection site. 102+ fever for three days, week, achy body, chills, fever, severe headache. Live alone. Was too sick to drive to urgent care or hospital.
Age: 86.0
Sex: M
Vaccine: FLU3, TD
Symptoms: Death
Clinical narrative: My co-worker told me Sunday evening that patient died Sunday morning.  I do not know details only that he passed away.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling face, Urticaria
Clinical narrative: Hive developed on right cheek and right side of face slightly swollen.
Age: 25.0
Sex: F
Vaccine: FLUX
Symptoms: Back pain, Joint range of motion decreased, Mobility decreased, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: Severe shoulder and back pain. Loss in range of motion in left shoulder. Unable to raise arm above head. Unable to turn to neck to either side. Pain recedes and comes back within a few days.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Lymphadenopathy, Musculoskeletal pain, Neck pain
Clinical narrative: Low grade fever (99.6), severe body aches, localized swelling/redness injection site over weekend. Pain right arm, shoulder and neck persisted. Seen at urgent care clinic 11/20/13. DX "Reaction to Tdap" told she had an "inflamed lymph node" in right upper back area. Released to full duty. Feeling much better on follow up 11/25/13.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pain in extremity, Pyrexia, Vaccination complication
Clinical narrative: Low grade fever (99.6), severe body aches, localized swelling/redness injection site over weekend. Pain right arm, shoulder and neck persisted. Seen at urgent care clinic 11/20/13. DX "Reaction to Tdap" told she had an "inflamed lymph node" in right upper back area. Released to full duty. Feeling much better on follow up 11/25/13.
Age: 69.0
Sex: M
Vaccine: FLUC3
Symptoms: Guillain-Barre syndrome, Immunoglobulin therapy, Intensive care, Malaise
Clinical narrative: Generally feeling unwell initially. Visit with Dr. on the 28th. Ascending paralysis by the 31st. Admitted to Hospital on January 2nd. 2012
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Brain death, Coagulopathy, Death, Dyspnoea, Feeling abnormal
Clinical narrative: This case was reported by a consumer (patient's mother) and described the occurrence of septic shock in a 48-year-old female patient who was vaccinated with Influenza vaccine (unspecified, manufacturer unspecified). A physician or other health care professional has not verified this report. Concurrent medical conditions included seizure. Concurrent medications included Gabapentin and Herbal medication. Co-suspect medication included LAMICTAL. In early 2012, the patient started Lamotrigine (oral) at 100 mg twice per day. In 2012, the patient initially experienced some numbness and tingling in her fingers (numbness in finger and tingling in finger) that made her fingers feel funny. She then was doing okay on Lamotrigine until she started having some light seizures over the last 6 months [2013]. As a result, the physician had just increased her dosase from 2 pills a day to 3 a day but the mother of the patient was not sure if she had actually started the increased dosage. In October 2013 the patient received a dose of Influenza vaccine unspecified (unknown). On the evening of 30 October 2013 the patient collapsed and lost consciousness. The patient never regained consciousness. She was taken to the hospital right away. The patient was hospitalised and it was discovered that the patient was hemorrhaging. She did not have any platelets in her blood (low platelet value) and when she was given platelets, her blood just was not clotting. She had a slight infection in her bowel, which cleared up within one day with antibiotics. The patient was also retaining fluid and was all swelled up and puffy. The patient was put on life support because she was not breathing properly. The patient's kidneys failed on 01 November 2013 and on the 02 November 2013 her brain failed. She was therefore taken off life support on 02 November 2013 and died the same day. The death certificate listed septic shock as the cause of death. The patient's mother reported that the doctors did not know what caused the septic shock but did not think it was medication-related. The patient had received the Influenza vaccine unspecified at work and within 2-3 weeks of the events leading to her death. According to the mother, the Influenza vaccine unspecified "may have triggered all of it." The patient had mentioned after receiving the vaccine that she "felt terrible/awfully bad afterwards" (onset less than 2-3 weeks after vaccination). At the time of reporting, the events were fatal. The patient died on 2 November 2013 from septic shock. It is unknown whether an autopsy was performed.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Fluid retention, Gastrointestinal infection, Haemorrhage, Life support, Loss of consciousness
Clinical narrative: This case was reported by a consumer (patient's mother) and described the occurrence of septic shock in a 48-year-old female patient who was vaccinated with Influenza vaccine (unspecified, manufacturer unspecified). A physician or other health care professional has not verified this report. Concurrent medical conditions included seizure. Concurrent medications included Gabapentin and Herbal medication. Co-suspect medication included LAMICTAL. In early 2012, the patient started Lamotrigine (oral) at 100 mg twice per day. In 2012, the patient initially experienced some numbness and tingling in her fingers (numbness in finger and tingling in finger) that made her fingers feel funny. She then was doing okay on Lamotrigine until she started having some light seizures over the last 6 months [2013]. As a result, the physician had just increased her dosase from 2 pills a day to 3 a day but the mother of the patient was not sure if she had actually started the increased dosage. In October 2013 the patient received a dose of Influenza vaccine unspecified (unknown). On the evening of 30 October 2013 the patient collapsed and lost consciousness. The patient never regained consciousness. She was taken to the hospital right away. The patient was hospitalised and it was discovered that the patient was hemorrhaging. She did not have any platelets in her blood (low platelet value) and when she was given platelets, her blood just was not clotting. She had a slight infection in her bowel, which cleared up within one day with antibiotics. The patient was also retaining fluid and was all swelled up and puffy. The patient was put on life support because she was not breathing properly. The patient's kidneys failed on 01 November 2013 and on the 02 November 2013 her brain failed. She was therefore taken off life support on 02 November 2013 and died the same day. The death certificate listed septic shock as the cause of death. The patient's mother reported that the doctors did not know what caused the septic shock but did not think it was medication-related. The patient had received the Influenza vaccine unspecified at work and within 2-3 weeks of the events leading to her death. According to the mother, the Influenza vaccine unspecified "may have triggered all of it." The patient had mentioned after receiving the vaccine that she "felt terrible/awfully bad afterwards" (onset less than 2-3 weeks after vaccination). At the time of reporting, the events were fatal. The patient died on 2 November 2013 from septic shock. It is unknown whether an autopsy was performed.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Platelet count decreased, Platelet transfusion, Renal failure, Septic shock, Swelling
Clinical narrative: This case was reported by a consumer (patient's mother) and described the occurrence of septic shock in a 48-year-old female patient who was vaccinated with Influenza vaccine (unspecified, manufacturer unspecified). A physician or other health care professional has not verified this report. Concurrent medical conditions included seizure. Concurrent medications included Gabapentin and Herbal medication. Co-suspect medication included LAMICTAL. In early 2012, the patient started Lamotrigine (oral) at 100 mg twice per day. In 2012, the patient initially experienced some numbness and tingling in her fingers (numbness in finger and tingling in finger) that made her fingers feel funny. She then was doing okay on Lamotrigine until she started having some light seizures over the last 6 months [2013]. As a result, the physician had just increased her dosase from 2 pills a day to 3 a day but the mother of the patient was not sure if she had actually started the increased dosage. In October 2013 the patient received a dose of Influenza vaccine unspecified (unknown). On the evening of 30 October 2013 the patient collapsed and lost consciousness. The patient never regained consciousness. She was taken to the hospital right away. The patient was hospitalised and it was discovered that the patient was hemorrhaging. She did not have any platelets in her blood (low platelet value) and when she was given platelets, her blood just was not clotting. She had a slight infection in her bowel, which cleared up within one day with antibiotics. The patient was also retaining fluid and was all swelled up and puffy. The patient was put on life support because she was not breathing properly. The patient's kidneys failed on 01 November 2013 and on the 02 November 2013 her brain failed. She was therefore taken off life support on 02 November 2013 and died the same day. The death certificate listed septic shock as the cause of death. The patient's mother reported that the doctors did not know what caused the septic shock but did not think it was medication-related. The patient had received the Influenza vaccine unspecified at work and within 2-3 weeks of the events leading to her death. According to the mother, the Influenza vaccine unspecified "may have triggered all of it." The patient had mentioned after receiving the vaccine that she "felt terrible/awfully bad afterwards" (onset less than 2-3 weeks after vaccination). At the time of reporting, the events were fatal. The patient died on 2 November 2013 from septic shock. It is unknown whether an autopsy was performed.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Syncope
Clinical narrative: This case was reported by a consumer (patient's mother) and described the occurrence of septic shock in a 48-year-old female patient who was vaccinated with Influenza vaccine (unspecified, manufacturer unspecified). A physician or other health care professional has not verified this report. Concurrent medical conditions included seizure. Concurrent medications included Gabapentin and Herbal medication. Co-suspect medication included LAMICTAL. In early 2012, the patient started Lamotrigine (oral) at 100 mg twice per day. In 2012, the patient initially experienced some numbness and tingling in her fingers (numbness in finger and tingling in finger) that made her fingers feel funny. She then was doing okay on Lamotrigine until she started having some light seizures over the last 6 months [2013]. As a result, the physician had just increased her dosase from 2 pills a day to 3 a day but the mother of the patient was not sure if she had actually started the increased dosage. In October 2013 the patient received a dose of Influenza vaccine unspecified (unknown). On the evening of 30 October 2013 the patient collapsed and lost consciousness. The patient never regained consciousness. She was taken to the hospital right away. The patient was hospitalised and it was discovered that the patient was hemorrhaging. She did not have any platelets in her blood (low platelet value) and when she was given platelets, her blood just was not clotting. She had a slight infection in her bowel, which cleared up within one day with antibiotics. The patient was also retaining fluid and was all swelled up and puffy. The patient was put on life support because she was not breathing properly. The patient's kidneys failed on 01 November 2013 and on the 02 November 2013 her brain failed. She was therefore taken off life support on 02 November 2013 and died the same day. The death certificate listed septic shock as the cause of death. The patient's mother reported that the doctors did not know what caused the septic shock but did not think it was medication-related. The patient had received the Influenza vaccine unspecified at work and within 2-3 weeks of the events leading to her death. According to the mother, the Influenza vaccine unspecified "may have triggered all of it." The patient had mentioned after receiving the vaccine that she "felt terrible/awfully bad afterwards" (onset less than 2-3 weeks after vaccination). At the time of reporting, the events were fatal. The patient died on 2 November 2013 from septic shock. It is unknown whether an autopsy was performed.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Limb discomfort, Pain in extremity, Sleep disorder
Clinical narrative: Pt reported pain discomfort in legs and interrupted sleep right after vaccine given. Temp (ear) 102 degrees down to 99 the next am. Pain relieved with OTC NSAID - Symptoms resolved next day 10/24/13.
Age: 12.0
Sex: F
Vaccine: FLU3, IPV, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Flushing, Nasal congestion, Pruritus, Pulmonary function test normal, Respiratory tract congestion
Clinical narrative: W/I 15 min after flu shot, pt developed 4+ nasal congestion. RTC: Very congested, body was flushed and he c/o being itchy. MOC states that pt was covered with hives. BP = 104/80 P = 110 R = 20 T = 98.1. He was treated with Epi 0.30 mg IM at 11:10. ZANTAC 75 mg po at 11:10 ZYRTEC 10 mg po H am PFT was normal.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: W/I 15 min after flu shot, pt developed 4+ nasal congestion. RTC: Very congested, body was flushed and he c/o being itchy. MOC states that pt was covered with hives. BP = 104/80 P = 110 R = 20 T = 98.1. He was treated with Epi 0.30 mg IM at 11:10. ZANTAC 75 mg po at 11:10 ZYRTEC 10 mg po H am PFT was normal.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information was received from a pharmacist concerning a 70 year old female patient. On 09-OCT_2013, the patient was vaccinated with PNEUMOVAX 23 (Lot # H022280, expiration 16-JUL-2014), 0.5 ml, intramuscular. On 10-OCT-2013, the patient called the pharmacist to report that her injection site from the PNEUMOVAX 23 was red, hot, swollen and painful. The patient did not report when the injection site reaction was first noticed. The patient stated she has tried placing ice on the injection site to manage the symptoms. The pharmacist reported the injection site, red, hot, swollen and painful was not resolved. No further information is available. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local swelling, Pruritus
Clinical narrative: Information was received from a female consumer of unknown age with asthma, drug hypersensitivity and allergies. The patient's medical history included chemotherapy and reaction to chemotherapy (not specified). Approximately in 2011 the patient was vaccinated with PNEUMOVAX 23. The patient reported that "24 hours after getting the vaccine", she experienced her arm swollen with redness and a minor itch for a "number of days." The patient reported this was her second pneumonia vaccine in 15 years and she had not reaction with the first one. The pt self medicated with BENADRYL and ice. The outcome of arm swollen, minor itch and redness was reported as recovered/resolved. Additional information is not expected.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Insomnia, Muscular weakness, Pain in extremity
Clinical narrative: Since administration of vaccine, patient has had pain in her (R) arm, that radiates into her (R) shoulder to just below the elbow. She has an increased weakness in the arm and difficulty sleeping due to the pain. Symptoms do not seem to be improving.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Fatigue, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 11-15-13 Immunization given. 11-16-13 Red, hot, swollen (L) deltoid, eyes dilated, tired, no energy and a fever. 11-20-13 All symptoms gone except tired and no energy.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Mydriasis, Pyrexia
Clinical narrative: 11-15-13 Immunization given. 11-16-13 Red, hot, swollen (L) deltoid, eyes dilated, tired, no energy and a fever. 11-20-13 All symptoms gone except tired and no energy.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chest pain, Computerised tomogram, Dyspnoea, Electrocardiogram, Headache
Clinical narrative: Patient got vaccines in office, awoke at midnight with chest pain, short of breath, headache, left arm pain went to ER, given pain medication. Had follow up in office, symptoms improving.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity
Clinical narrative: Patient got vaccines in office, awoke at midnight with chest pain, short of breath, headache, left arm pain went to ER, given pain medication. Had follow up in office, symptoms improving.
Age: 20.0
Sex: M
Vaccine: MNQ, PPV
Symptoms: Arthralgia, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Vaccines 11/11/13. C/o painful site, fever, joint pain, swelling at site.
Age: 38.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Chest discomfort, Chills, Nausea, Neck pain, Pain in extremity
Clinical narrative: Vaccines given 11/21/2013, started with sore arm, neck pain, nausea, chills and chest felt heavy. Seen in office 11/22/13.
Age: 62.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Headache, Hyperhidrosis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Information was received from a pharmacist regarding a 62 year old female patient with a history of unspecified lung disease. On 28-SEP-2013, the patient was vaccinated with PNEUMOVAX 23 in the arm (dosage and route of administration not provided), lot # H009826, expiration date 11-FEB-2014. FLUVIRIN was given concomitantly in a separate arm. The patient began to experience redness, pain and warmth at the PNEUMOVAX 23 injection site and also headache, body stiffness, and sweating "about 4 to 6 hours" after the administrations. The patient called her physician on an unspecified date due to her symptoms and was treated with ibuprofen (manufacturer unknown) and was advised to rest. The patient was prescribed an unspecified antibiotic for an unspecified reason on 30-SEP-2013. The pharmacist did not know if this was related to her symptoms. The patient recovered about 2 weeks later. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Musculoskeletal stiffness
Clinical narrative: Information was received from a pharmacist regarding a 62 year old female patient with a history of unspecified lung disease. On 28-SEP-2013, the patient was vaccinated with PNEUMOVAX 23 in the arm (dosage and route of administration not provided), lot # H009826, expiration date 11-FEB-2014. FLUVIRIN was given concomitantly in a separate arm. The patient began to experience redness, pain and warmth at the PNEUMOVAX 23 injection site and also headache, body stiffness, and sweating "about 4 to 6 hours" after the administrations. The patient called her physician on an unspecified date due to her symptoms and was treated with ibuprofen (manufacturer unknown) and was advised to rest. The patient was prescribed an unspecified antibiotic for an unspecified reason on 30-SEP-2013. The pharmacist did not know if this was related to her symptoms. The patient recovered about 2 weeks later. Additional information has been requested.
Age: 30.0
Sex: U
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information was received company representative. On an unspecified date, a patient in the 30's with multiple unspecified comorbid diseases received PNEUMOVAX 23. No adverse effect reported. No further information was provided. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain, Paraesthesia, Tenderness
Clinical narrative: Tender arm, difficult/painful to lift, tingle in arm and hand.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Malaise
Clinical narrative: Information was received from a pharmacist who heard second-hand that a female patient (demographics unknown), was vaccinated with PNEUMOVAX23 (date of vaccination, dosage and route of administration not provided). She received concomitantly an unspecified influenza virus vaccine (manufacturer unknown). It was reported that the patient was "sick for a week." Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Pain, Pain in extremity, Skin warm
Clinical narrative: Received immunization on November 14, 2013. By next morning, arm was swollen and painful to touch. By Nov 16, 2013, are was very red, hot, and painful. By November 2013, symptoms had resolved.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Diplegia, Guillain-Barre syndrome, Immunoglobulin therapy, Mechanical ventilation
Clinical narrative: Patient became very weak on 3/06/12 at home.  Presented to ED with paralysis of lower extremities on 3/07.  Neurology diagnosis: Guillain-Barre Syndrome.  Treated with IVIG.  Patient quickly developed respiratory issues and required ventilatory support.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Respiratory disorder
Clinical narrative: Patient became very weak on 3/06/12 at home.  Presented to ED with paralysis of lower extremities on 3/07.  Neurology diagnosis: Guillain-Barre Syndrome.  Treated with IVIG.  Patient quickly developed respiratory issues and required ventilatory support.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Injection site pain, Injection site reaction, Joint range of motion decreased, Musculoskeletal stiffness
Clinical narrative: (Per injury report completed by patient). On Nov 19th 2013 I came up to employee health to get a flu shot, I received my flu shot in my right arm thinking its my dominate arm that is would be better in that one. I felt fine arm a little sore where shot was given normal. Wednesday morning I woke up and felt very stiff in my right shoulder and neck along with my arm still being sore from the shot. Thinking nothing of it thinking maybe I just slept wrong, and I proceeded with my day. As the day proceeded on, it got worse, I have put heat on the area and cold and ibuprofen, neither of any has helped with the situation. I had a friend massage that area, it gave a small amount of relief but it is still going on to the point at times its hard to breathe and turn my neck. It has become quite intolerable.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Crying, Dyspnoea
Clinical narrative: Pt's mother called reported increased crying and shortness of breath. Instructed to take to emergency room immediately.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Hypoaesthesia, Imaging procedure
Clinical narrative: Left facial numbness, hypoesthesia in CN V-1 distribution. Later developed left arm numbness which persisted more than 2 weeks. Saw neurologist and was treated with oseltamivir.
Age: 34.0
Sex: M
Vaccine: MEN, YF
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Hives around injection site (right arm) spread to chest and underarm.
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Blister, Erythema, Fatigue, Swelling
Clinical narrative: Redness, swelling, raised welt. Weeping blisters, weakness, fatigue, by 12/22/2013. Started to get better 11/23/2013 AM.
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Redness, swelling, raised welt. Weeping blisters, weakness, fatigue, by 12/22/2013. Started to get better 11/23/2013 AM.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives lasting 5 days.
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Limb discomfort, Skin warm
Clinical narrative: Her arm turned red in about a four inch circle. It was also hot and very uncomfortable. I gave her Tylenol and Benadryl. Influenza Vaccine: Sanofi Fluzone 2013-2014 5ml Multidose Lot# UH907AB Left deltoid.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Patient reports minor pain day of shot which became progressively worse over the following days. Pain is sharp and radiates upwards.
Age: 0.75
Sex: M
Vaccine: FLUX
Symptoms: Decreased appetite, Hypersomnia, Irritability, Pyrexia, Rash
Clinical narrative: High fever, 104 degrees +. Didn't go under 101 degrees even with Tylenol and/or Motrin for three days. Fever finally broke after almost 18 hours straight sleep on 11/24/13. Bumpy rash appeared morning of 11/25/13. Baby is fussy, lack of appetite.
Age: 12.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Limb discomfort, Skin warm
Clinical narrative: His arm turned red in about a four inch circle. It was also hot and very uncomfortable. I gave her Tylenol and Benadryl. Influenza Vaccine: Sanofi Fluzone 2013-2014 5ml Multidose Lot# UH907AB Left deltoid.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Musculoskeletal pain
Clinical narrative: Light pain starting at shoulder and radiating to elbow.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Redness and induration at site of injection.
Age: 0.76
Sex: M
Vaccine: DTAPH
Symptoms: Injection site pain
Clinical narrative: Baby couldn't put any pressure on the leg the shot was given in without crying.  After speaking with the nurses at the pediatrician's office we gave Motrin and put a warm compress  on the shot area,  as well as massaged the area.  After about an hour baby was able to crawl with less pain. After about 30 more minutes, baby was able to crawl without any pain.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Axillary pain, Musculoskeletal disorder, Musculoskeletal pain
Clinical narrative: Severe shoulder and under arm pain. It is difficult to use it or get dressed with out pain.  I wii see my Doctor on December 3rd to address issue.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Lymph node pain, Lymphadenopathy, Oropharyngeal pain
Clinical narrative: Sore throat and swollen and sore lymph nodes on left side of neck/collar bone area.  Injection was given in left arm.
Age: 58.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: Patient began having redness and tenderness at vaccine site 24 November in a.m. Described as being quarter sized. On A.M. of 25 November patient had significant increase in redness, tenderness and heat to the area.
Age: 32.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Chills, Dizziness, Pyrexia, Tremor
Clinical narrative: High Fever (103 F), intense shaking, chills, dizziness, weakness.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Autopsy, Biopsy, Blindness
Clinical narrative: Loss of vision. Admitted to Medical Center @ 7:00 AM.
Age: 17.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Syncope
Clinical narrative: Patient was given GARDASIL on left - arm, subsequently, given MCV4 on right arm. Patient was fine. I stepped out and 10 seconds later Mom yelled patient had fainted. He quickly recovered. Dr immediately evaluated, was given ice pack and watched over a period of 15 mins. Orthostatics were taken and was discharged by Dr.