chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: FLU4, MNQ, PPV
Symptoms: No therapeutic response, Peripheral swelling, Pyrexia, Sepsis, Septic shock
Clinical narrative: Initial unsolicited report received from a physician on 18 September 2015. This case involves a 57-year-old female patient who was vaccinated with second dose of MENACTRA [batch number: U5172AA, expiry date: 14 January 2017, dose and route of administration were not reported] in left deltoid; fourth dose of FLUZONE QIV (Syringe) [batch number: UI439AA, expiry date: 30 June 2016, dose and route of administration were not reported] in right deltoid and second dose of PNEUMOVAX 23 [manufacturer: Merck, batch number: K021881, expiry date, dose and route of administration were not reported] in left deltoid on 15 September 2015. The patient's illness at the time of vaccination reported as none. The patient's pre-existing physician diagnosed allergies, birth defects, medical conditions reported as head and neck twitching with amitriptyline, MS (Multiple sclerosis), tape, splenectomy. She had a history of getting head and neck twitching from the Amitriptyline. Concomitant medications were not reported. On 15 September 2015, few minutes following the vaccination (reported as immediately after vaccination), the patient had developed fever with head and neck twitching (area of twitching was not specified). On 17 September 2015, the patient was taken to intermediate care center with left arm redness, swelling with lymph involvement, hypotensive and failed to respond to fluid bolus. On the same day, the patient's WBC count was 35,000 and was transferred to hospital with a diagnosis of sepsis, septic shock.  Relevant diagnostic tests included full panel of blood work, lumbar puncture was found negative and CT scans of chest and abdomen showed left arm diffuse swelling with lymph involvement suspicious of cellulitis. The patient had received blood pressure support from fluids and a norepinephrine drip as a corrective treatment. The patient had not recovered from the events. List of documents held by sender: none.
Age: 57.0
Sex: F
Vaccine: FLU4, MNQ, PPV
Symptoms: White blood cell count increased
Clinical narrative: Initial unsolicited report received from a physician on 18 September 2015. This case involves a 57-year-old female patient who was vaccinated with second dose of MENACTRA [batch number: U5172AA, expiry date: 14 January 2017, dose and route of administration were not reported] in left deltoid; fourth dose of FLUZONE QIV (Syringe) [batch number: UI439AA, expiry date: 30 June 2016, dose and route of administration were not reported] in right deltoid and second dose of PNEUMOVAX 23 [manufacturer: Merck, batch number: K021881, expiry date, dose and route of administration were not reported] in left deltoid on 15 September 2015. The patient's illness at the time of vaccination reported as none. The patient's pre-existing physician diagnosed allergies, birth defects, medical conditions reported as head and neck twitching with amitriptyline, MS (Multiple sclerosis), tape, splenectomy. She had a history of getting head and neck twitching from the Amitriptyline. Concomitant medications were not reported. On 15 September 2015, few minutes following the vaccination (reported as immediately after vaccination), the patient had developed fever with head and neck twitching (area of twitching was not specified). On 17 September 2015, the patient was taken to intermediate care center with left arm redness, swelling with lymph involvement, hypotensive and failed to respond to fluid bolus. On the same day, the patient's WBC count was 35,000 and was transferred to hospital with a diagnosis of sepsis, septic shock.  Relevant diagnostic tests included full panel of blood work, lumbar puncture was found negative and CT scans of chest and abdomen showed left arm diffuse swelling with lymph involvement suspicious of cellulitis. The patient had received blood pressure support from fluids and a norepinephrine drip as a corrective treatment. The patient had not recovered from the events. List of documents held by sender: none.
Age: 71.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Abdominal pain upper, Ear pain, Haemorrhage, Headache, Injection site discolouration
Clinical narrative: Initial unsolicited report received from consumer on 15 September 2015. This case involves a 71-year-old female patient who was vaccinated with a first intramuscular dose of ADACEL (batch number was unknown, dose and site of administration was not reported) and also received an intramuscular dose of PREVENAR (Manufacturer Other, batch number, dose, cycle in series and site were not reported) on 3 August 2015. Illness at time of vaccination was reported as none. Pre-existing physician diagnosed allergies, birth defects and medical conditions were reported as unknown. Concomitant medications were not reported. On 3 August 2015, following the vaccination, the patient experienced pain in both arms and they were locking, swelling in both arms and both arms were purple from the injection site to the elbow. The patient went to the physician and the arms were still swollen and itchy. The patient also experienced headaches and tightness in the throat and pain in ears, pain in stomach and some blood when going to the bathroom. The patient required emergency room and physician visit. Laboratory investigation and corrective treatments were not reported. The patient was recovered from the event itchy and not recovered from the other events. Upon internal review, the company decided to consider the event "some blood when going to the bathroom" serious because of important medical event bleeding. List of documents held by sender: none.
Age: 71.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Musculoskeletal stiffness, Pain in extremity, Peripheral swelling, Pruritus, Throat tightness
Clinical narrative: Initial unsolicited report received from consumer on 15 September 2015. This case involves a 71-year-old female patient who was vaccinated with a first intramuscular dose of ADACEL (batch number was unknown, dose and site of administration was not reported) and also received an intramuscular dose of PREVENAR (Manufacturer Other, batch number, dose, cycle in series and site were not reported) on 3 August 2015. Illness at time of vaccination was reported as none. Pre-existing physician diagnosed allergies, birth defects and medical conditions were reported as unknown. Concomitant medications were not reported. On 3 August 2015, following the vaccination, the patient experienced pain in both arms and they were locking, swelling in both arms and both arms were purple from the injection site to the elbow. The patient went to the physician and the arms were still swollen and itchy. The patient also experienced headaches and tightness in the throat and pain in ears, pain in stomach and some blood when going to the bathroom. The patient required emergency room and physician visit. Laboratory investigation and corrective treatments were not reported. The patient was recovered from the event itchy and not recovered from the other events. Upon internal review, the company decided to consider the event "some blood when going to the bathroom" serious because of important medical event bleeding. List of documents held by sender: none.
Age: 51.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Excessive arm soreness and tingling lasting for more than 4 days.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling abnormal, Paraesthesia, Rash erythematous, Rash pruritic
Clinical narrative: Pt states she noticed red itchy bumps on fingers around 4:00pm. She assumed it was nothing big maybe a splinter. She says she then noticed it was spreading to her toes. Pt states she feels tingling and "weird" sensation also noted to soles of feet.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site discolouration, Injection site erythema, Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient reported soreness in her shoulder/upper arm on Saturday 9/26/15, but that had gone away by her follow up call on Monday 9/28/15.  On 9/26 she noted brownish-green discoloration on the upper left arm where the flu vaccine was administered that was smooth and bruise-like.  She also noticed a rose color farther down her arm towards her elbow.  Denies any itching, hives, bumps, or difficulty breathing.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Excessive arm soreness and tingling lasting for more than 4 days.
Age: 79.0
Sex: M
Vaccine: JEVX, JEVX, RAB
Symptoms: Electromyogram, Muscular weakness, Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging spinal, Paraesthesia
Clinical narrative: Patient received Rabies IM and Japanese Encephalitis IM vaccines on 28AUG and 04SEP 2015 on R arm. He reports new distal R hand tingling that has progressed up arm. Endorses gradual progression and new instrinsic R hand mild weakness.
Age: 79.0
Sex: M
Vaccine: JEVX, JEVX, RAB
Symptoms: CSF protein increased, Paraesthesia, Radiculitis brachial
Clinical narrative: Patient received Rabies IM and Japanese Encephalitis IM vaccines on 28AUG and 04SEP 2015 on R arm. He reports new distal R hand tingling that has progressed up arm. Endorses gradual progression and new instrinsic R hand mild weakness.
Age: 75.0
Sex: F
Vaccine: JEV1, PNC13, TYP
Symptoms: Abasia, Blood electrolytes decreased, Blood test, Dysstasia, Guillain-Barre syndrome
Clinical narrative: On 12 August 2015..I went to the Allergy/Immunizations Clinic to see what shots I would need to go on a cruise in October 2015..I was informed that I would need three shots..I took these shots on 12 Aug 2015. Approx the 19th or 20th August I start having pains and weakness in the thigh and legs. Final to the point I could not walk or stand..The 24 August my Doctor sent me to hospital emergency room..I was admitted to the hospital..several test and many blood work was given..my Electrolytes had drop below normal..It was determined that I had a mild case of Guillain Barre. I was in the hospital from Tuesday 24 August until 2 September 2015..My Electrolytes was normal when I was release to Rehab..I stayed in Rehab from 2 September until 15 September..On the 23 September I will start outpatient Physical Therapy. I am still under Doctor's care. If you need more information and correct date..please contact Dr.
Age: 75.0
Sex: F
Vaccine: JEV1, PNC13, TYP
Symptoms: Laboratory test, Muscular weakness, Pain in extremity
Clinical narrative: On 12 August 2015..I went to the Allergy/Immunizations Clinic to see what shots I would need to go on a cruise in October 2015..I was informed that I would need three shots..I took these shots on 12 Aug 2015. Approx the 19th or 20th August I start having pains and weakness in the thigh and legs. Final to the point I could not walk or stand..The 24 August my Doctor sent me to hospital emergency room..I was admitted to the hospital..several test and many blood work was given..my Electrolytes had drop below normal..It was determined that I had a mild case of Guillain Barre. I was in the hospital from Tuesday 24 August until 2 September 2015..My Electrolytes was normal when I was release to Rehab..I stayed in Rehab from 2 September until 15 September..On the 23 September I will start outpatient Physical Therapy. I am still under Doctor's care. If you need more information and correct date..please contact Dr.
Age: 86.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Confusional state, Erythema, Skin warm, Swelling, Vaccination site discolouration
Clinical narrative: Per pts daughter, pt went to ER, had redness, swelling, confusion, "fever in arm", black dot where vaccination was administered.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysphagia, Lip pruritus, Swollen tongue
Clinical narrative: Itchy lips, tongue swelling, given epinephrine she had at home and called ambulance. Went to local ER, treated and released 9/23/15. 9/24/15 presented to ER again w/ trouble swallowing, admitted overnight. Sent home w/ 7 day rx methylprednisone and Benadryl prn.
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Decreased appetite, Pyrexia, Rash generalised
Clinical narrative: High fever, loss of appetite and rash covering body and face.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV, PPV
Symptoms: Abdominal pain upper, Erythema, Pain in extremity, Pyrexia, Skin warm
Clinical narrative: Woke up Friday morning with pain in right arm, red area and warm, high fever 100+ and pain in stomach.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV, PPV
Symptoms: Vaccination complication
Clinical narrative: Woke up Friday morning with pain in right arm, red area and warm, high fever 100+ and pain in stomach.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV, PPV
Symptoms: Chills, Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Woke up Friday morning with pain in right arm, red area and warm, high fever 100+ and pain in stomach.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV, PPV
Symptoms: Somnolence
Clinical narrative: Woke up Friday morning with pain in right arm, red area and warm, high fever 100+ and pain in stomach.
Age: 80.0
Sex: F
Vaccine: FLUX
Symptoms: Chest X-ray, Chills, Injection site pain, Pyrexia, Scan
Clinical narrative: Uncontrollable chills, shaking, fever of 103, left arm hurt where shot was given.
Age: 80.0
Sex: F
Vaccine: FLUX
Symptoms: Tremor, Urine analysis
Clinical narrative: Uncontrollable chills, shaking, fever of 103, left arm hurt where shot was given.
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Musculoskeletal pain, Pain, Pain in extremity, Tenderness
Clinical narrative: SHOULDER ACHING, THOUGHT HE HAD INJURED IT.  STARTED TRAVELING DOWN ARM AND INTO FINGERS. CONTINUES TO ACHE 2 1/2 WEEKS LATER.  HURTS TO MOVE ARM OR GRAB ANYTHING. PAIN IS INTERMITTENT.  TOUCHING IT OR LAYING ON THAT SIDE AT NIGHT HURTS.
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Alcohol use, Hot flush, Injection site pruritus, Injection site reaction, Skin lesion
Clinical narrative: Pt noticed mild itching over injection site, and removed band aid. Next night, pt's wife noticed pt was hot to touch. Pt notes he had alcohol and was "buzzed." Wife drove pt to ER at 2000 hrs. Temp was 99 degrees F. Pt left w/out being seen due to wait time. Small lesions present under band-aid site. Pt occ gets hot flashes.
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Skin warm
Clinical narrative: Pt noticed mild itching over injection site, and removed band aid. Next night, pt's wife noticed pt was hot to touch. Pt notes he had alcohol and was "buzzed." Wife drove pt to ER at 2000 hrs. Temp was 99 degrees F. Pt left w/out being seen due to wait time. Small lesions present under band-aid site. Pt occ gets hot flashes.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Localized swelling, warmth and erythema no systemic symptoms; T=cold compresses.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Pt left arm is red and swollen. Being seen today 9/28/15 by our dr here at facility.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Blood glucose decreased, Immediate post-injection reaction, Malaise, Peripheral swelling, Presyncope
Clinical narrative: Pt's deltoid immediately swelled 1/2 in x 2 in circle raised lump. Pt stated he did not feel well and had a vasovagal response. EMS came. His blood sugar was 66. Other vitals 118/72, HR= 84, PO: 98%.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Upper extremity mass
Clinical narrative: Pt's deltoid immediately swelled 1/2 in x 2 in circle raised lump. Pt stated he did not feel well and had a vasovagal response. EMS came. His blood sugar was 66. Other vitals 118/72, HR= 84, PO: 98%.
Age: 85.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Patient came to the pharmacy the day after getting a flu shot with a red rash on the arm of the injection that extended to the elbow. I advised him to contact his doctor because I was unsure if it was just a rxn or an infection.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Peripheral swelling, Rash erythematous, Rash generalised, Vision blurred
Clinical narrative: Pt said red bumps all over her body. Sunburn feeling. Swollen legs. Blurry vision.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Fatigue, Pruritus, Skin swelling, Urticaria
Clinical narrative: Starting 1 day after vaccine given-bright red itchy swollen skin, hive under armpit. Fatigue side effects continuing 6+ days.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Drooling, Eyelid pain, Lacrimation increased, Oral pain, Pain
Clinical narrative: Eye lid stinging, whole mouth stinging, drooling, occurred for 4 hrs, excessive eye, saliva, and nasal fluid. Difficult time with pain from 7-1:00 pm, 1 and 1/2 hours after shot.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Rhinorrhoea, Salivary hypersecretion
Clinical narrative: Eye lid stinging, whole mouth stinging, drooling, occurred for 4 hrs, excessive eye, saliva, and nasal fluid. Difficult time with pain from 7-1:00 pm, 1 and 1/2 hours after shot.
Age: 79.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Dyspnoea
Clinical narrative: Patient reported he had difficulty breathing when he laid down the night he got the vaccinations. He could breathe sitting up or standing, but not when lying down.
Age: 64.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Dizziness, Dyspnoea, Fatigue, Heart rate increased
Clinical narrative: Extreme fatigue, wekaness, fast heartrate, dizziness, sore throat, breathing issues (short of breath) high blood pressure, severe bruising t site. ER visit/overnight stay.
Age: 64.0
Sex: F
Vaccine: FLUX
Symptoms: Hypertension, Injection site bruising, Oropharyngeal pain
Clinical narrative: Extreme fatigue, wekaness, fast heartrate, dizziness, sore throat, breathing issues (short of breath) high blood pressure, severe bruising t site. ER visit/overnight stay.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Headache, Nausea
Clinical narrative: Diarrhea, headaches, sick to stomache. This started within 48 hours after vaccination.
Age: 38.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Pain, Peripheral swelling, Vaccination site rash
Clinical narrative: Swelling of left arm, rash from vaccinated site (L deltoid) to down arm approx 7", excruciating pain, still recovering.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Anxiety, Arthralgia, Condition aggravated, Dyspepsia, Incorrect route of drug administration
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of muscle soreness in a 50-year-old female patient who received FLUARIX quadrivalent (batch number 2X5YD, expiry date 30th June 2016). Concurrent medical conditions included anxiety. On 5th September 2015, the patient received FLUARIX quadrivalent (subcutaneous). On 5th September 2015, less than a day after receiving FLUARIX quadrivalent, the patient experienced muscle soreness (serious criteria disability), swelling arm (serious criteria disability) and intramuscular formulation administered by other route. On an unknown date, the patient experienced anxiety aggravated (serious criteria disability), nerve pain (serious criteria disability), digestion impaired (serious criteria disability), joint pain (serious criteria disability) and nausea (serious criteria disability). On an unknown date, the outcome of the muscle soreness and swelling arm were recovered/resolved and the outcome of the anxiety aggravated, nerve pain, digestion impaired, joint pain and nausea were not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown. The reporter considered the muscle soreness, anxiety aggravated, nerve pain, digestion impaired, joint pain, swelling arm and nausea to be possibly related to FLUARIX quadrivalent. Additional details were provided as follows: The patient was a physician's wife. The patient received the vaccine in the left arm, subcutaneously which led to incorrect route of vaccine administration. On 5th September 2015, less than a day after vaccination with FLUARIX quadrivalent, the patient experienced sore muscle and arm swelling. In September 2015, less than a month after vaccination with FLUARIX quadrivalent, the patient experienced increased anxiety, nerve pain, digestive problems, joint pain and nausea. In September 2015, sore muscle and arm swelling had resolved.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Myalgia, Nausea, Neuralgia, Peripheral swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of muscle soreness in a 50-year-old female patient who received FLUARIX quadrivalent (batch number 2X5YD, expiry date 30th June 2016). Concurrent medical conditions included anxiety. On 5th September 2015, the patient received FLUARIX quadrivalent (subcutaneous). On 5th September 2015, less than a day after receiving FLUARIX quadrivalent, the patient experienced muscle soreness (serious criteria disability), swelling arm (serious criteria disability) and intramuscular formulation administered by other route. On an unknown date, the patient experienced anxiety aggravated (serious criteria disability), nerve pain (serious criteria disability), digestion impaired (serious criteria disability), joint pain (serious criteria disability) and nausea (serious criteria disability). On an unknown date, the outcome of the muscle soreness and swelling arm were recovered/resolved and the outcome of the anxiety aggravated, nerve pain, digestion impaired, joint pain and nausea were not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown. The reporter considered the muscle soreness, anxiety aggravated, nerve pain, digestion impaired, joint pain, swelling arm and nausea to be possibly related to FLUARIX quadrivalent. Additional details were provided as follows: The patient was a physician's wife. The patient received the vaccine in the left arm, subcutaneously which led to incorrect route of vaccine administration. On 5th September 2015, less than a day after vaccination with FLUARIX quadrivalent, the patient experienced sore muscle and arm swelling. In September 2015, less than a month after vaccination with FLUARIX quadrivalent, the patient experienced increased anxiety, nerve pain, digestive problems, joint pain and nausea. In September 2015, sore muscle and arm swelling had resolved.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Fatigue, Local reaction, Pain, Pyrexia
Clinical narrative: Vaccine administered late afternoon 9/16. Left arm PREVNAR 13. 9/17 Fever 101.6, body aches, fatigue. 9/18 Seen in office ongoing fatigue, afebrile, 7 cm hot red localized reaction.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Skin warm
Clinical narrative: Vaccine administered late afternoon 9/16. Left arm PREVNAR 13. 9/17 Fever 101.6, body aches, fatigue. 9/18 Seen in office ongoing fatigue, afebrile, 7 cm hot red localized reaction.
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Burning sensation, Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: On 09-10-15 broke out with a burning red rash. 3 spots on each side and back. On 09-11-15 broke out with a itching, burning red spots from shoulders to between my toes this lasted 8 days.
Sex: U
Vaccine: FLU3, PPV
Symptoms: Erythema, Injected limb mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Patients right arm, which is whare PNEUMOVAX 23 was adminstered, swelledm turned red and was painful. Pt also had difficulty moving this arm.
Age: 11.0
Sex: F
Vaccine: FLU4, MMR, MNQ, TDAP
Symptoms: Blood glucose decreased, Dizziness, Heart rate decreased, Hyperhidrosis, Hypotension
Clinical narrative: 11 year old, felt dizzy, diaphoretic low blood pressure after MMR given. Heart rate low she did faint but was arousable. BG 77. Placed supine with legs elevated. Given low flow oxygen. Vitals monitored. She recovered. Soda given to increase blood sugar. No S/s of hives, swelling or shortness of breath. No difficulty swallowing.
Age: 11.0
Sex: F
Vaccine: FLU4, MMR, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: 11 year old, felt dizzy, diaphoretic low blood pressure after MMR given. Heart rate low she did faint but was arousable. BG 77. Placed supine with legs elevated. Given low flow oxygen. Vitals monitored. She recovered. Soda given to increase blood sugar. No S/s of hives, swelling or shortness of breath. No difficulty swallowing.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site erythema, Rash
Clinical narrative: 9-17-15 Flu vaccine given 5 pm. 9-17-15 Late evening noticed redness around Band-Aid. 9-18-15 In morning red "band" on arm with raised bumps no fever. 9-22-15 Almost completely resolved.
Sex: U
Vaccine: FLU4
Symptoms: Induration, Injection site induration, Local reaction, Local swelling
Clinical narrative: This case was received by a nurse via call center representative and described the occurrence of induration in a patient who received FLUARIX QUADRIVALENT (batch number 5C2L4, expiry date 18th June 2016). On an unknown date, the patent received FLUARIX QUADRIVALENT. On an unknown date, an unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced induration, injection site induration and neck swelling. On an unknown date, the outcome of the induration, injection site induration and neck swelling were unknown. It was unknown  if the reporter considered the induration, injections site induration and neck swelling to be related to FLUARIX QUADRIVALENT. Additional details were received as follows: The reporter stated that, 70 patients received FLUARIX QUADRIVALENT and 5 patients developed localized reaction. The patients experienced quarter sized induration to a full arm and neck swelling. The reported batch number (5C2LA) for FLUARIX QIV did not exist and was updated to be 5C2L4 as per sales database. No patient information available at the time of reporting. This case was one of the 5 cases reported by same reporter.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Insomnia, Pain in extremity
Clinical narrative: Pt states arm hurts still 9/18/15 can't sleep on left side.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Malaise
Clinical narrative: The day after receiving FLUVIRIN she began having headache, fever, malaise and redness, pain and swelling at the injection site. Two days after vaccine she returned to the pharmacy for symptoms. Injection site was red and raised approx. 5 cm x 3 cm.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: The day after receiving FLUVIRIN she began having headache, fever, malaise and redness, pain and swelling at the injection site. Two days after vaccine she returned to the pharmacy for symptoms. Injection site was red and raised approx. 5 cm x 3 cm.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Dermatitis, Injection site pain, Vaccination complication
Clinical narrative: Pain left upper arm.  Ice pack injection site. Tylenol.  Next night 9/4/2015 pain worse, Pain in shoulder continued and worse at night when lying down.  Saw doctor 9/16/2015 and was told I had reaction to flu shot, skin inflammation.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Feeling abnormal, Palpitations, Tremor
Clinical narrative: Within a very short amount of time, patient reported feeling dizzy with palpitation. Her hands were shaking, and she felt like her blood pressure was decreasing.  We are a pharmacy inside a hospital, so we called for help.  A dozen healthcare professionals (doctors and nurses) rushed to come get her.
Age: 21.0
Sex: F
Vaccine: HPV4, PPV
Symptoms: Activities of daily living impaired, Contusion, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient said vaccine hurt immediately following administration. I told her some soreness was to be expected particularly with the Gardasil vaccine. She came to me on 09/28/2015 stating that her arm hurt so much she couldn't lift it and couldn't even use it to straighten her hair this morning. She also had a softball sized bruise on her arm.
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient called today (9/28/15) to report severe arm pain and limited range of motion at injection site. Said that it had started approximately the day of administration but he waited to report thinking it would go away. Advising patient to ice and NSAIDS to see if he can get symptomatic relief.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Headache, Myalgia, Pain
Clinical narrative: Shooting pain from neck to feet, fever 101, dizzy, headache, sore muscles, no energy, times 2 days.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Shooting pain from neck to feet, fever 101, dizzy, headache, sore muscles, no energy, times 2 days.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pruritus
Clinical narrative: The patient noticed redness that persisted for a week and went away.  She also noticed itching at the injections site.  The itching has persisted after the redness has resolved.  She notes sporadic itching at the injection site a week and a half after the injection was given.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Dysphagia, Headache, Paraesthesia, Paraesthesia oral, Pharyngeal oedema
Clinical narrative: Headache, tingling in lips and legs, difficulty swallowing and throat swelling.
Age: 0.52
Sex: F
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13, RV5
Symptoms: Intussusception, Pyrexia, Vomiting
Clinical narrative: Mother called on call physician in the evening after immunizations were given to report fever and vomiting. Parents were instructed to bring child in to office for evaluation the next morning.
Age: 60.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Feeling abnormal, Malaise, Pain, Pyrexia, Retching
Clinical narrative: She felt sick, sore to the touch, had a fever and cannot relax. She also had to go to the bathroom often because she had dry heaves with her stomach and vomited. She still does not feel good as of 9-27-15.
Age: 60.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Vomiting
Clinical narrative: She felt sick, sore to the touch, had a fever and cannot relax. She also had to go to the bathroom often because she had dry heaves with her stomach and vomited. She still does not feel good as of 9-27-15.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea exertional
Clinical narrative: Shortness of breath upon exertion.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site warmth, Neck pain, Pain
Clinical narrative: Hot around the injection site, pain up to shoulder neck region, redness-per patient reported.
Age: 4.0
Sex: M
Vaccine: FLU4, MMR, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Pt due for Varivax, MD ordered Varivax, Zostavax was administered.
Age: 83.0
Sex: M
Vaccine: PNC13
Symptoms: Immediate post-injection reaction, Injection site haemorrhage, Injection site nodule, Injection site swelling
Clinical narrative: Patient had swelling immediately after injection. Patient had a little bit of blood and the swelling was localized in a nodule where the immunization was injected.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash, Rash erythematous
Clinical narrative: Approximately 1 hour after administration patient developed a red rash on arm with itching.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Swelling, Urticaria
Clinical narrative: Hives in palms and between fingers on both hands (severe itching, swelling, redness). BENADRYL and anti-itch lotion. (Lasted 24 hrs.). This was my 10th flu shot but my first high-dose.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site discolouration, Injection site pain
Clinical narrative: Diffuse bruising/black and blue surrounding site of injection, tender to touch. Lasted 10 days post-immunization.
Sex: U
Vaccine: FLUX(H1N1)
Symptoms: Dyspnoea, Pharyngeal oedema
Clinical narrative: This medically confirmed spontaneous report (initial receipt 15-Sep-2015) concerns an unknown demographics patient. On an unspecified date "a few years ago", the patient received unspecified H1N1 vaccine (H1N1 Influenza virus vaccine, manufacturer and batch number not provided). On an unspecified date, after receiving the H1N1 vaccine, the patient experienced swelling of the throat and shortness of breath. No further information was provided. The outcome was not provided. Sender's Comments: Seriousness: Serious (Medically significant). Listedness: Unlisted. Assessment according to Assessment according to the CCDS for CSL's H1N1 Influenza vaccine, and the PI for Influenza A (H1N1) 2009 Monovalent Vaccine, swelling of throat and shortness of breath are unlisted. Causality: Unassessable. Insufficient information such as time to onset, event description, investigation, treatment and outcome. Allergic reaction including anaphylaxis is a known adverse event of H1N1 vaccination; however the case did not meet Brighton collaboration case definition for anaphylaxis. Hence causality is unassessable.
Age: 30.0
Sex: M
Vaccine: FLUC3
Symptoms: Abdominal distension, Discomfort, Erythema, Hypoaesthesia, Limb discomfort
Clinical narrative: Deltoid swollen with prominence noted, warm with erythema, reporting numbness, tingling along outer arm at ulna into fingers with throbbing discomfort and difficulty lifting arm.
Age: 30.0
Sex: M
Vaccine: FLUC3
Symptoms: Mobility decreased, Paraesthesia, Skin warm
Clinical narrative: Deltoid swollen with prominence noted, warm with erythema, reporting numbness, tingling along outer arm at ulna into fingers with throbbing discomfort and difficulty lifting arm.
Age: 64.0
Sex: M
Vaccine: FLUX
Symptoms: Abdominal discomfort, Diarrhoea
Clinical narrative: Diarrhea upset stomach.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Injection site vesicles, Myalgia
Clinical narrative: Circular reaction around injection site.  No redness, blisters formed in a circular formation.  Reaction looked similar to ring worm.  No fever, normal muscle soreness resolved next day.
Age: 0.34
Sex: F
Vaccine: DTAP, RV5
Symptoms: Nuclear magnetic resonance imaging normal, Seizure
Clinical narrative: 3 total seizures beginning at 9pm until 2am the following morning, needed oxygen to get through seizures as well as seizure stopping medication. She is now on anti seizure medications for the time being.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Cellulitis, Chills, Pain in extremity, Pruritus, White blood cell count increased
Clinical narrative: Admitted 9/24 with right hand and arm cellulitis and pruritis and possible underlying HSV or VZV vesicles. WBC elevated.  Symptoms improving during treatment with antivirals.  During admission on 9/26, flu shot was given right upper arm.  Pt had chills overnight following injection.  Right arm aching 9/27.  MD unsure if r/t flu shot vs cellulitis.  Chills treated with acetaminophen x 1.  Pain covered with ibuprofen x 2 doses.  Antibiotic added 9/27.  Pt discharged on antiviral and antibiotic.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Antinuclear antibody, Biopsy skin, Dermatomyositis, Rash
Clinical narrative: A rash appeared on arms, chest, upper back and upper legs. It started out as minor and I thought it would go away. When it was still there by December, I contacted my physician. I was seen by a general practitioner twice, an allergist several times, an endocrinologist, and a rheumatologist. The general consensus is that I have developed dermatomyositis, probably as a result of the flu vaccine. I have been on prednisone since January 2015. I am also seeing a nutritionist and have been following a paleo diet and staying away from nightshade foods to reduce inflammation.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: Red rash on left thigh. Warm to the touch.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Pyrexia
Clinical narrative: CHILLS AND 101 FEVER.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Skin warm
Clinical narrative: Big red spot turned red and got warm.
Age: 43.0
Sex: M
Vaccine: FLUC3
Symptoms: Dizziness, Eye discharge, Hypoaesthesia, Somnolence, VIIth nerve paralysis
Clinical narrative: Dizzy, groggy, left side of face and left arm numbness; left eye draining for several hours.  Numbness subsided; left eye draining persists after 3 days.
Age: 22.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Feeling hot, Hypersomnia, Injection site pain, Malaise, Pyrexia
Clinical narrative: Patient reports waking up around 5AM feeling very warm, and reports malaise, reports temperature the day after 101.3F, fever resolved later that day. Reports she slept the entire day. Patient also complains of soreness at injection site after administration. Symptoms resolved without medication.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Pain in arm; unable to lift arm at all.  Ice, acetaminophen.  Still taking acetaminophen 09/27/15 & still unable to lift arm over her head.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Biopsy, Burning sensation, Erythema, Peripheral swelling, Skin atrophy
Clinical narrative: Arm turned red and swollen then had a black and blue mark that eventually became ulcerated creating burning and fiery nerve endings. Deep crevice still on arm that doctor says might be permanent.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Skin discolouration, Skin ulcer
Clinical narrative: Arm turned red and swollen then had a black and blue mark that eventually became ulcerated creating burning and fiery nerve endings. Deep crevice still on arm that doctor says might be permanent.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Blood test, Induration, Influenza like illness, Injection site discolouration, Injection site erythema
Clinical narrative: Arm turned red and swollen then had a black and blue mark that eventually became ulcerated creating burning and fiery nerve endings. Deep crevice still on arm that doctor says might be permanent.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site pruritus, Injection site scab, Injection site swelling, Injection site warmth, Nodule
Clinical narrative: Arm turned red and swollen then had a black and blue mark that eventually became ulcerated creating burning and fiery nerve endings. Deep crevice still on arm that doctor says might be permanent.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pain, Paraesthesia, Skin warm, Ulcer
Clinical narrative: Arm turned red and swollen then had a black and blue mark that eventually became ulcerated creating burning and fiery nerve endings. Deep crevice still on arm that doctor says might be permanent.
Age: 73.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Dizziness, Nausea
Clinical narrative: PT COMPLAINED THEY FELT VERY DIZZY AND SICK TO THEIR STOMACH WHEN THEY WENT TO BED THE NIGHT THEY RECEIVED THEIR FLU SHOT.  HE SAID THE SYMPTOMS LASTED ABOUT 48 HOURS.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site irritation, Injection site swelling
Clinical narrative: Patients says she experienced small bump at site of injection. She says bump was red irritated expanded to "grape size bump" 2 days later. She seeked medical treatment with local physician.
Age: 72.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site swelling, Subcutaneous haematoma
Clinical narrative: SWELLING AT INJECTION SITE WITH BLOOD UNDER THE SKIN.
Age: 72.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Haemorrhage, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: SWELLING AT INJECTION SITE WITH BLOOD UNDER THE SKIN.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Acne, Erythema, Pruritus, Rash
Clinical narrative: Per patient's wife on Wednesday evening 9/23/15 he began to develop a rash around his neck which spread down his arms.  It looked like little red pimples and was itchy.  She said it got progressively worse until Saturday evening 9/26/15 it was so itcy he could barely stand it and was dark red.  He went to seek advice from a relative who is a nurse.  She advised that he take some Benadryl.  When she called me Sunday morning 9/27/15 he had taken 3 doses of Benadryl.  She said that it was looking a little better but was still red and itchy.  They were concerned that it could possibly be a reaction to the injection he had about 2 1/2 weeks ago on 9/9/15.  She denied that any new medications, soaps, etc. were being used.  The only change besides the vaccine was some fudge his son had brougt back from a trip.  I paged his doctor who said it was unlikely to be a reaction this far from the administration and side effects from the shingles vaccine were rare anyway, but if he were uncomfortable or getting worse he should go to the urgent care in town.  I advised patient of this.  I followed up with him this morning 9/28/15.  He said his rash was not itchy this morning and not as red, so he did not visit the center last evening.  He said that if he started to feel worse again he would call his doctor for an appointment.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, PNC13, RV5
Symptoms: Crying, Decreased appetite, Encephalitis, Fontanelle bulging, Lethargy
Clinical narrative: Patient had fever of 102.2 for 16 hours, crying non-stop for 12 hours, was exhibiting signs of encephalitis such as stiff neck, bulging fontanel, crying when picked up, etc.  Was very lethargic, somewhat decreased appetite.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, PNC13, RV5
Symptoms: Musculoskeletal stiffness, Pyrexia
Clinical narrative: Patient had fever of 102.2 for 16 hours, crying non-stop for 12 hours, was exhibiting signs of encephalitis such as stiff neck, bulging fontanel, crying when picked up, etc.  Was very lethargic, somewhat decreased appetite.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Redness, minor pain, warmth at site of injection.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, Injection site hypoaesthesia
Clinical narrative: The patient (employee) came back to the pharmacy and said that it was mainly her upper left arm that had gone numb.  She also said that the feeling seemed to be coming back.  Her ob-gyn was contacted who had told her to get the vaccination (she is 5 months pregnant).  He saw no need for her to go to emergency room but told her to go if she got dizzy or faint.  Her vaccination was done under a standing order from Dr.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Blindness, Cerebrovascular accident, Cold sweat, Depressed level of consciousness
Clinical narrative: Weakness, fainting, loss of vision, clammy, seizures, Psychotic break, signs of strokes, slurring of speech, borderline unconscious.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Dysarthria, Psychotic disorder, Seizure, Syncope
Clinical narrative: Weakness, fainting, loss of vision, clammy, seizures, Psychotic break, signs of strokes, slurring of speech, borderline unconscious.
Age: 17.0
Sex: F
Vaccine: IPV, VARCEL, VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: AFTER ADMINISTRATION OF IPV AND VARICELLA PATIENT STATED THAT SHE HAD TAKEN 2 POSITIVE PREGNANCY TESTS AT HOME THE NIGHT BEFORE.
Age: 17.0
Sex: F
Vaccine: IPV, VARCEL, VARCEL
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test urine positive
Clinical narrative: AFTER ADMINISTRATION OF IPV AND VARICELLA PATIENT STATED THAT SHE HAD TAKEN 2 POSITIVE PREGNANCY TESTS AT HOME THE NIGHT BEFORE.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Syncope episode while sitting after patient given influenza vaccination, patient given ice pack to put on neck and remained sitting until able to ambulate.
Age: 74.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Injection site reaction, Injection site warmth, Rash pruritic
Clinical narrative: Rash on the inner side of left arm below the administered site.  Pt has no fever, rash is itchy slightly warm to touch.  Rash continued but not spread as of 9/25/15 with OTC hydrocortisone topical.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site discomfort, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Swelling, mild discomfort and tenderness of underarm where vaccine was given as well as soreness of arm in general. Symptoms gradually disappeared over about 5-7 days.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Oropharyngeal pain, Pyrexia
Clinical narrative: Dizziness, fever, sore throat.
Age: 94.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Discomfort, Erythema, Skin warm
Clinical narrative: Initially uncomfortable red area warm to the touch which developed into cellulitis per ED at local hospital by that evening/night.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Anxiety, Condition aggravated, Dizziness, Electrocardiogram, Palpitations
Clinical narrative: After receiving the Vaccine, patient waited 15minutes in Immunization section. Upon standing became light headed-dizzy, increase anxiety and Palpitations. Patient denied any SOB, nausea vomiting, tingling in his throat. Disclosed medical history of hypothyroid and mild anxiety. Upon assessment patient wasn't diaphoretic pulse 77 normal RR. ER staff escorted patient to ER for evaluation.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Activities of daily living impaired, Bronchitis, Chest X-ray abnormal, Cough, Ecchymosis
Clinical narrative: Received 2 injections MMR and varicella. 1 injected in each arm. I questioned why in arm as patient's extremities were very thin. Nurse said it was ok due to little needle and given SQ. 2 days later patient started with lowgrade fever and upper respiratory symptoms. Coughing. She missed school Mon & Tuesday. On Wed she went to her reg GI Dr. She had 103 fever and still coughing. Recommended back to ped. Returned to ped on Fri. Her reg Dr wasn't in. They did a CBC which was ok but low Hgb which is her norm. O2 sat was ranging from 80 - 92. They were unsure if it worked. Dr recommended going to ER. Took her to ER. She had only 1 other complaint of rt arm hurt. They did chest xray and diagnosed bronchitis. Sent home on Zithromax, prednisone & breathing treatment. Sunday morning she woke up with left cheek swollen like mumps and a red ecchymotic area under her arm by chest. While getting her ready to go to hospital she took last breath. CPR started immediately and 911 called. Breaths did not seem to be going in. EMT took over CPR. Taken to hospital where they did get a heartbeat for less than a minute.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Full blood count normal, Haemoglobin decreased, Injection site pain, Mumps
Clinical narrative: Received 2 injections MMR and varicella. 1 injected in each arm. I questioned why in arm as patient's extremities were very thin. Nurse said it was ok due to little needle and given SQ. 2 days later patient started with lowgrade fever and upper respiratory symptoms. Coughing. She missed school Mon & Tuesday. On Wed she went to her reg GI Dr. She had 103 fever and still coughing. Recommended back to ped. Returned to ped on Fri. Her reg Dr wasn't in. They did a CBC which was ok but low Hgb which is her norm. O2 sat was ranging from 80 - 92. They were unsure if it worked. Dr recommended going to ER. Took her to ER. She had only 1 other complaint of rt arm hurt. They did chest xray and diagnosed bronchitis. Sent home on Zithromax, prednisone & breathing treatment. Sunday morning she woke up with left cheek swollen like mumps and a red ecchymotic area under her arm by chest. While getting her ready to go to hospital she took last breath. CPR started immediately and 911 called. Breaths did not seem to be going in. EMT took over CPR. Taken to hospital where they did get a heartbeat for less than a minute.