chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: M
Vaccine: FLUX
Symptoms: Body temperature increased, Dizziness, Feeling abnormal, Headache, Pain
Clinical narrative: Started feeling poor at work after receiving flu shot. Felt dizzy, headache, body aches, and warm. When I arrived home, I checked my temperature and it was 102.6.
Age: 28.0
Sex: M
Vaccine: FLUX
Symptoms: Skin warm
Clinical narrative: Started feeling poor at work after receiving flu shot. Felt dizzy, headache, body aches, and warm. When I arrived home, I checked my temperature and it was 102.6.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling, redness distal to the injection site. Pt concerened will go to clinic to follow up.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Peripheral coldness, Pyrexia, Visual impairment
Clinical narrative: Upon administration, pt. reported "seeing spots." Pt. called pharmacy 9/25 complaining of high fever, cold hands and chills. Pt. was referred to her PCP for evaluation and treatment.
Age: 91.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Peripheral swelling, Rash, Skin warm
Clinical narrative: Patients came to pharmacy because right upper hand is red, hot swollen. Patient also complains of rash in the area. This appear today in the morning.
Age: 53.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site irritation, Injection site pruritus
Clinical narrative: Starting day after vaccine, area was "red, irritated and itchy". I recommended a cool compress and Benadryl. *irritation was on RA.
Age: 42.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Blister, Body temperature increased, Eyelid oedema, Injection site warmth, Pruritus
Clinical narrative: The evening after pt. received vaccine she developed puffy eyes; Blisters on face and both arms; heated at injection site. Temp of 99.1; itchy at blister sites pt treated at home with APAP and cold compress and BENADRYL sx lasted about 4 days.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Pyrexia, Tremor
Clinical narrative: Patient came into pharmacy 8 days after vaccine administration (vaccine administered 9/17/150 and told me at 8pm (same day of administration) he had fever chills and shaking. His wife took him to ER and they gave him IV fluids and that he had a fever and left ER and went home after being there for 5 hours.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: A few hours after injection. Injection site slightly red all around about the shape of grapefruit. Circle size not swollen. Warm to touch and sore. Patient took ALLEGRA 180mg and TYLENOL on 9/26/15. Patient's 1st dose of HIGH DOSE. She normally gets regular flu shot.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Patient came in on 9/29/15 5:00 PM with 2 red circles around injection site. First circle 6 cm in diameter second circle 15 cm in diameter. I told patient to take Benadryl 50 mg once, call doctor. She did not have any trouble breathing.
Sex: F
Vaccine: HPV4
Symptoms: Vision blurred
Clinical narrative: This spontaneous report as received from a consumer refers to a female patient of unknown age. No concurrent conditions, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with GARDASIL injection (strength, dose, route and lot number or batch number unspecified). No concomitant medications were reported. On an unknown date, the patient experienced blurred vision after receiving GARDASIL. The outcome of vision blurred was unknown. There was no product quality complaint (PQC) involved. The reporter's causality assessment was not provided. Additional information is not expected, no contact details were provided.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a multiple unspecified patient of unknown age and gender. The patient's concomitant therapies, medical history and concurrent conditions were not provided. On 22-SEP-2015, the patients were vaccinated with improperly stored doses of (Merck) PROQUAD injection, lot # L010143, expiration date 24-SEP-2016 (does and route of administration were not reported). No adverse effects were reported. This is one of the two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a multiple unspecified patient of unknown age and gender. The patients concomitant therapies, medical history and concurrent conditions were not reported. On 22-SEP-2015, the patient were vaccinated with improperly stored doses of VARIVAX (Merck) injection, lot # K021934, expiration date 10-NOV-2016 (dose and route of administration were not reported). No adverse effects were reported. This one of the two reports from the same reporter. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a male patient of unknown age. No relevant medical history or concurrent conditions were reported. On an unknown date, the patient was vaccinated with an improperly stored MMR II (lot # J013431, expiration date 24-OCT-2015, second dose in the series; dose, strength and route of administration were not reported). There was no concomitant medication reported. No adverse effects were reported and the patient declined revaccination. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from the nurse regarding an unspecified patient of unknown age. There was no information about concurrent condition and historical medication. On an unknown date the patient was vaccinated with 1 dose of improperly stored ZOSTAVAX lot # L006380, expiration date 25-MAY-2016. No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 39.0
Sex: M
Vaccine: FLU3, FLU(H1N1)
Symptoms: Dysgeusia, Hemiplegia, Pain in jaw, Tinnitus, VIIth nerve paralysis
Clinical narrative: Case number PHEH2015US018299 is an initial spontaneous report received from a physician on 16 Sep 2015. This report refers to a 45 year old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 98442P1A) intramuscularly in the right deltoid on 16 Nov 2009. On the same day, 5 minutes after vaccination, he had metallic taste in mouth, ringing in right ear, pain in jaw and right side of body and right sided face paralysis with food falling out of side of mouth. It was reported that he had Bell's Palsy after vaccination. He went to emergency room and he was hospitalized. The events outcome was unknown. The causality of the event was not reported.
Age: 39.0
Sex: M
Vaccine: FLU3, FLU(H1N1)
Symptoms: Asthenia, Cognitive disorder, Grip strength decreased, Guillain-Barre syndrome, Neurological examination abnormal
Clinical narrative: Case number PHEH2015US018299 is an initial spontaneous report received from a physician on 16 Sep 2015. This report refers to a 45 year old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 98442P1A) intramuscularly in the right deltoid on 16 Nov 2009. On the same day, 5 minutes after vaccination, he had metallic taste in mouth, ringing in right ear, pain in jaw and right side of body and right sided face paralysis with food falling out of side of mouth. It was reported that he had Bell's Palsy after vaccination. He went to emergency room and he was hospitalized. The events outcome was unknown. The causality of the event was not reported.
Age: 39.0
Sex: M
Vaccine: FLU3, FLU(H1N1)
Symptoms: Pain, Romberg test positive, Toxic encephalopathy, Winged scapula
Clinical narrative: Case number PHEH2015US018299 is an initial spontaneous report received from a physician on 16 Sep 2015. This report refers to a 45 year old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 98442P1A) intramuscularly in the right deltoid on 16 Nov 2009. On the same day, 5 minutes after vaccination, he had metallic taste in mouth, ringing in right ear, pain in jaw and right side of body and right sided face paralysis with food falling out of side of mouth. It was reported that he had Bell's Palsy after vaccination. He went to emergency room and he was hospitalized. The events outcome was unknown. The causality of the event was not reported.
Age: 7.0
Sex: M
Vaccine: FLUX, MMR
Symptoms: Cough, Inappropriate schedule of drug administration, Pneumonia bacterial
Clinical narrative: Case number PHHY2015US116961 is an initial spontaneous report from a nurse via Vaccine Adverse Event Reporting System (VAERS ID 558665) received on 25 Aug 2015. This report refers to a 07-year-old male patient. Medical history included pneumonia. Concomitant medication included albuterol. His vaccine history included previous vaccination with MMR II (other manufacturer, batch number: unknown) on 28 Jan 2009 (dose 1). He was vaccinated with seasonal influenza virus vaccine (manufacturer and batch number: unknown) and MMR II (other manufacturer, batch number: J0005846) on 02 Dec 2011. On an unknown date, reporting nurse stated that she was notified by an unspecified nurse that patient was administered two vaccines too close together and the school was considering the vaccines invalid. On an unknown date, reporting nurse stated that patient had no adverse effects to report as a result of receipt of the two vaccines. The nurse after reading patient's chart, reported that patient had developed bacterial pneumonia, diagnosed on 10 Dec 2011. He had been experiencing cough for unspecified amount of time prior to diagnosis. On an unknown date, patient was treated with amoxicillin and was started on FLOVENT HFA 44, twice a day. Outcome of the events were not reported. No product quality complaint (PQC) was reported. On an unknown day, reporting nurse stated she does not believe these events to be connected.
Age: 82.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Blister, Feeling abnormal, Herpes zoster, Pain, Weight decreased
Clinical narrative: Case number PHHY2015US116969 is an initial spontaneous report from a consumer (patient) via Vaccine Adverse Event Reporting System (VAERS ID 559195) received on 25 Aug 2015. This report refers to a 82-year-old female patient. Medical history was not reported. Concomitant medication included Aspirin. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) and ZOSTAVAX (other manufacturer, batch number: unknown) on 01 Mar 2014. She stated that "she almost died after getting it". In Mar 2014 she developed shingles. She had a few blisters but it was very painful and she lost 20 pounds. She saw her physician who prescribed acyclovir for treatment. She stated that acyclovir was not working out too well. The outcome of the events was reported as not recovered. The seriousness and causality was not reported. Seriousness of "almost died after getting it" and "shingles" was upgraded based on available information in the source document.
Age: 57.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Blood cortisol, Blood test normal, Chest X-ray normal, Fatigue, Headache
Clinical narrative: Initial unsolicited report received from a consumer on 30 March 2015. A 57-year-old female patient, whose medical history and concomitant medications were not reported, had received an expired dose of Tdap once (batch number-unknown, expiry date-09 May 2013, route of administration was not reported) in left arm on 12 December 2014. On 30 March 2015, 108 days after vaccination, the patient experienced bulging at the injection site and injection site was very painful, the pain had never resolved. The patient's pain spread to shoulder blades and then to elbow involving muscles and tendons and then spread to collar bone, and neck, then chest underneath breast and back. It was an expired vaccine used. Laboratory investigations and corrective treatments were not reported. At the time of this report the patient had not recovered from the events. Documents held by sender: none.
Age: 57.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Hypotension, Injection site erythema, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: Initial unsolicited report received from a consumer on 30 March 2015. A 57-year-old female patient, whose medical history and concomitant medications were not reported, had received an expired dose of Tdap once (batch number-unknown, expiry date-09 May 2013, route of administration was not reported) in left arm on 12 December 2014. On 30 March 2015, 108 days after vaccination, the patient experienced bulging at the injection site and injection site was very painful, the pain had never resolved. The patient's pain spread to shoulder blades and then to elbow involving muscles and tendons and then spread to collar bone, and neck, then chest underneath breast and back. It was an expired vaccine used. Laboratory investigations and corrective treatments were not reported. At the time of this report the patient had not recovered from the events. Documents held by sender: none.
Age: 57.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Nuclear magnetic resonance imaging normal, Urine analysis
Clinical narrative: Initial unsolicited report received from a consumer on 30 March 2015. A 57-year-old female patient, whose medical history and concomitant medications were not reported, had received an expired dose of Tdap once (batch number-unknown, expiry date-09 May 2013, route of administration was not reported) in left arm on 12 December 2014. On 30 March 2015, 108 days after vaccination, the patient experienced bulging at the injection site and injection site was very painful, the pain had never resolved. The patient's pain spread to shoulder blades and then to elbow involving muscles and tendons and then spread to collar bone, and neck, then chest underneath breast and back. It was an expired vaccine used. Laboratory investigations and corrective treatments were not reported. At the time of this report the patient had not recovered from the events. Documents held by sender: none.
Age: 57.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Arthralgia, Back pain, Bone pain, Chest pain, Expired product administered
Clinical narrative: Initial unsolicited report received from a consumer on 30 March 2015. A 57-year-old female patient, whose medical history and concomitant medications were not reported, had received an expired dose of Tdap once (batch number-unknown, expiry date-09 May 2013, route of administration was not reported) in left arm on 12 December 2014. On 30 March 2015, 108 days after vaccination, the patient experienced bulging at the injection site and injection site was very painful, the pain had never resolved. The patient's pain spread to shoulder blades and then to elbow involving muscles and tendons and then spread to collar bone, and neck, then chest underneath breast and back. It was an expired vaccine used. Laboratory investigations and corrective treatments were not reported. At the time of this report the patient had not recovered from the events. Documents held by sender: none.
Age: 57.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site pain, Injection site swelling, Musculoskeletal pain, Myalgia, Neck pain
Clinical narrative: Initial unsolicited report received from a consumer on 30 March 2015. A 57-year-old female patient, whose medical history and concomitant medications were not reported, had received an expired dose of Tdap once (batch number-unknown, expiry date-09 May 2013, route of administration was not reported) in left arm on 12 December 2014. On 30 March 2015, 108 days after vaccination, the patient experienced bulging at the injection site and injection site was very painful, the pain had never resolved. The patient's pain spread to shoulder blades and then to elbow involving muscles and tendons and then spread to collar bone, and neck, then chest underneath breast and back. It was an expired vaccine used. Laboratory investigations and corrective treatments were not reported. At the time of this report the patient had not recovered from the events. Documents held by sender: none.
Age: 57.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Tendon pain
Clinical narrative: Initial unsolicited report received from a consumer on 30 March 2015. A 57-year-old female patient, whose medical history and concomitant medications were not reported, had received an expired dose of Tdap once (batch number-unknown, expiry date-09 May 2013, route of administration was not reported) in left arm on 12 December 2014. On 30 March 2015, 108 days after vaccination, the patient experienced bulging at the injection site and injection site was very painful, the pain had never resolved. The patient's pain spread to shoulder blades and then to elbow involving muscles and tendons and then spread to collar bone, and neck, then chest underneath breast and back. It was an expired vaccine used. Laboratory investigations and corrective treatments were not reported. At the time of this report the patient had not recovered from the events. Documents held by sender: none.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Syncope, Tremor, Unresponsive to stimuli
Clinical narrative: Patient lost postural tone and had jerking movements for 10 seconds. Vasovagal syndrome.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dyskinesia, Hypotonia, Presyncope
Clinical narrative: Patient lost postural tone and had jerking movements for 10 seconds. Vasovagal syndrome.
Age: 45.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Reported MENACTRA vaccine site, right deltoid, became red and swollen. No swelling of face, no other erash, no difficulty breathing, no nausea or vomiting. No constipation or diarrhea. MENACTRA vaccine given IM on 8/25/15 via right deltoid site. Patient reported swelling of right deltoid site with redness. No itching or drainage. Returned to office on 9/2/15 for re-eval where upon the redness and swelling was improving.
Age: 45.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Reported MENACTRA vaccine site, right deltoid, became red and swollen. No swelling of face, no other erash, no difficulty breathing, no nausea or vomiting. No constipation or diarrhea. MENACTRA vaccine given IM on 8/25/15 via right deltoid site. Patient reported swelling of right deltoid site with redness. No itching or drainage. Returned to office on 9/2/15 for re-eval where upon the redness and swelling was improving.
Age: 45.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Back pain, Dysstasia, Gait disturbance, Muscle tightness
Clinical narrative: Patient had pain in his Back. He was diagnosed for muscle spasm by his physician on 09/23/15.
Age: 45.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Back pain, Muscle spasms
Clinical narrative: Patient had pain in his Back. He was diagnosed for muscle spasm by his physician on 09/23/15.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Headache, Myalgia, Nausea
Clinical narrative: Dizzy, headache, N&V, sore throat, fever 101, achy muscles, no energy times 2 days.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Pyrexia, Vomiting
Clinical narrative: Dizzy, headache, N&V, sore throat, fever 101, achy muscles, no energy times 2 days.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Myalgia, Nausea, Pyrexia
Clinical narrative: No energy, fever, achy muscles, nausea, fever times 2 days.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: Severe back muscle aches, times 3 days.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Headache
Clinical narrative: Severe stomach pain and head ache.
Age: 25.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Blood glucose normal, Blood pressure increased, Confusional state, Grip strength decreased, Hemiplegia
Clinical narrative: Administered PREVNAR 13 IM to (L) deltoid followed by FLUZONE to (R) deltoid IM. Within 5 mins of administering meds-pt c/o (R) arm numbness. Had difficulty lifting arm up unable to squeeze with (R) hand. Also c/o (R) thigh numbness. BP increased 150/110, HR 134, BS 84, had difficulty with speech et responding, diaphoretic et confused. Squad arrived et symptoms except for (R) arm hemiplegia began to abate.
Age: 25.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Hyperhidrosis, Hypoaesthesia, Injected limb mobility decreased, Speech disorder
Clinical narrative: Administered PREVNAR 13 IM to (L) deltoid followed by FLUZONE to (R) deltoid IM. Within 5 mins of administering meds-pt c/o (R) arm numbness. Had difficulty lifting arm up unable to squeeze with (R) hand. Also c/o (R) thigh numbness. BP increased 150/110, HR 134, BS 84, had difficulty with speech et responding, diaphoretic et confused. Squad arrived et symptoms except for (R) arm hemiplegia began to abate.
Age: 67.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site joint movement impairment, Injection site joint pain
Clinical narrative: Painful left shoulder joint becoming more painful with limited range of motion on 09/25/2015.  Limited motion in left shoulder with pain continues today, though I have begun doing PT exercises at home.
Age: 67.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site pain, Nuclear magnetic resonance imaging, X-ray
Clinical narrative: Painful left shoulder joint becoming more painful with limited range of motion on 09/25/2015.  Limited motion in left shoulder with pain continues today, though I have begun doing PT exercises at home.
Age: 57.0
Sex: F
Vaccine: FLU4, TDAP, FLU3, TDAP
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Injection site pain
Clinical narrative: I got a flu shot in my left arm and the Tdap in my right arm. Both shots were given very high on my arm close or shoulder socket.  I had no pain at time of either injection but pain became severe about 8 hours after the shot in both shoulders.  The flu shoulder was ok the next day, but the Tdap shoulder has become increasingly more painful each day.  I have limited movement and extreme pain.  I called to the pharmacist to report the problem and he suggested pain killer.  This has not been adequate in restoring motion or alleviating pain.
Age: 57.0
Sex: F
Vaccine: FLU4, TDAP, FLU3, TDAP
Symptoms: Drug administered at inappropriate site, Rotator cuff syndrome, Surgery
Clinical narrative: I got a flu shot in my left arm and the Tdap in my right arm. Both shots were given very high on my arm close or shoulder socket.  I had no pain at time of either injection but pain became severe about 8 hours after the shot in both shoulders.  The flu shoulder was ok the next day, but the Tdap shoulder has become increasingly more painful each day.  I have limited movement and extreme pain.  I called to the pharmacist to report the problem and he suggested pain killer.  This has not been adequate in restoring motion or alleviating pain.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site bruising, Injection site swelling
Clinical narrative: Bruise appeared on shoulder where flu vaccine was administered and a spot/bump appeared on the back of the arm where the shingles vaccine was administered.
Age: 70.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Muscle spasms
Clinical narrative: Severe lower back muscle spasms and weakness when getting off bed. Faded off in 1/2 hr, but returned next day and getting worse.
Age: 79.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: On 9/15 site of injection was red, itching and soreness. On 9/16 noticed arm was red, arm swollen, puffed up, red polka dots and diagonal strip going from site of injection that is bright red. Called doctor who recommended to ice arm. Applied ice and swelling reduced. Also applied Eucerin cream. By night diagonal strip not as red. By 9/18 showed area to NP. By 9/20 mark injection site with marker and redness was already 3 inches from site of injection went to ER. Admitted to short term stay and received intravenous antibiotics. Released on 9/22 with oral antibiotics. Today redness has diminished will follow-up with internist on 9/28.
Age: 79.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Rash erythematous
Clinical narrative: On 9/15 site of injection was red, itching and soreness. On 9/16 noticed arm was red, arm swollen, puffed up, red polka dots and diagonal strip going from site of injection that is bright red. Called doctor who recommended to ice arm. Applied ice and swelling reduced. Also applied Eucerin cream. By night diagonal strip not as red. By 9/18 showed area to NP. By 9/20 mark injection site with marker and redness was already 3 inches from site of injection went to ER. Admitted to short term stay and received intravenous antibiotics. Released on 9/22 with oral antibiotics. Today redness has diminished will follow-up with internist on 9/28.
Sex: U
Vaccine: FLU4
Symptoms: Induration, Injection site induration, Local reaction, Local swelling
Clinical narrative: This case was reported 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 patient 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, injection site induration and neck swelling to be related to FLUARIX QUADRIVALENT. Additional details were received as follows: The reporter stated that, 700 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: Condition aggravated, Supraventricular extrasystoles
Clinical narrative: Episode of PAC's (which patient has prior history of). Patient reports they began day after vaccine (09/23/2015) and continued until 9/24 or 9/25. Patient left a message with my corporate voicemail and with her primary care doctor on 9/25, but did not seek any further treatment.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Lacrimation increased, Oropharyngeal pain, Paranasal sinus hypersecretion, Rhinorrhoea
Clinical narrative: COUGH, SINUS DRAINAGE, WET EYES, NOSE DRIPPING, SORE THROAT, PROBABLE INFLAMED TRACHEA/ AIR-WAY.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Tracheal inflammation
Clinical narrative: COUGH, SINUS DRAINAGE, WET EYES, NOSE DRIPPING, SORE THROAT, PROBABLE INFLAMED TRACHEA/ AIR-WAY.
Age: 47.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient called this morning (9/28/15) to state that his left arm where he received both the Pneumovax and Adacel was red, raised, and painful to the touch and had been as such since the evening of 9/25/15.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Pt had localized redness to injection area.  Injection site itched.
Age: 1.66
Sex: F
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Developed hives on buttocks and hip about 2 hours after receiving Hepatitis A vaccine.  Hives persisted for 8 days.
Age: 51.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cold sweat, Erythema, Inadequate aseptic technique in use of product, Injection site cellulitis, Injection site erythema
Clinical narrative: Notes by provider taken at hospital follow-up cellulitis right arm office visit: (History of Present Illness)  The symptoms began 1 week ago and generally lasts 1 week.  The symptoms are acute and have improved.  Pt received her flu shot 9/15/15, states her arm was not cleaned off prior to injection.  Her arm was sore that night but when she woke up it was very painful and swollen. Later that day she started feeling ill/fever so went to Hospital and was admitted for 4 days for IV antibiotics.  Feeling better and redness, swelling improved. (Assessment and Plan)  Cellulitis of right upper arm (682.3).  Pt left without plan, discussed with pt to continue to use ice and heat on right upper arm, monitor redness and swelling, if starts to get bigger, have a fever, feeling ill again need to call office or go to ER.  Finish all of the antibiotics given in the hospital.  Return to office on Monday 9/28/15 or sooner if needed. Notes when I talked with the pt before she left.  Received IIV4 and PPSV23, both IM in right deltoid on Tuesday, 9/15/15.  States area not prepped before injection.  That evening/night arm was sore.  Wednesday arm extra sore with redness on the deltoid area, hot to touch.  Used ice pack.  Thursday feeling nauseated, clammy, redness on right arm extended down to mid upper arm and anterior mid upper arm.  Went to ED and was admitted for cellulitis.  Given Clindamycin IV.  Discharged Sunday on oral Clindamycin.  Today, Wednesday, 9/23/15 at 4 pm, right deltoid area still sore and tender to touch, no redness or swell.  Still taking oral Clindamycin.
Age: 51.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site pain, Injection site swelling, Malaise, Nausea, Pain in extremity
Clinical narrative: Notes by provider taken at hospital follow-up cellulitis right arm office visit: (History of Present Illness)  The symptoms began 1 week ago and generally lasts 1 week.  The symptoms are acute and have improved.  Pt received her flu shot 9/15/15, states her arm was not cleaned off prior to injection.  Her arm was sore that night but when she woke up it was very painful and swollen. Later that day she started feeling ill/fever so went to Hospital and was admitted for 4 days for IV antibiotics.  Feeling better and redness, swelling improved. (Assessment and Plan)  Cellulitis of right upper arm (682.3).  Pt left without plan, discussed with pt to continue to use ice and heat on right upper arm, monitor redness and swelling, if starts to get bigger, have a fever, feeling ill again need to call office or go to ER.  Finish all of the antibiotics given in the hospital.  Return to office on Monday 9/28/15 or sooner if needed. Notes when I talked with the pt before she left.  Received IIV4 and PPSV23, both IM in right deltoid on Tuesday, 9/15/15.  States area not prepped before injection.  That evening/night arm was sore.  Wednesday arm extra sore with redness on the deltoid area, hot to touch.  Used ice pack.  Thursday feeling nauseated, clammy, redness on right arm extended down to mid upper arm and anterior mid upper arm.  Went to ED and was admitted for cellulitis.  Given Clindamycin IV.  Discharged Sunday on oral Clindamycin.  Today, Wednesday, 9/23/15 at 4 pm, right deltoid area still sore and tender to touch, no redness or swell.  Still taking oral Clindamycin.
Age: 51.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Notes by provider taken at hospital follow-up cellulitis right arm office visit: (History of Present Illness)  The symptoms began 1 week ago and generally lasts 1 week.  The symptoms are acute and have improved.  Pt received her flu shot 9/15/15, states her arm was not cleaned off prior to injection.  Her arm was sore that night but when she woke up it was very painful and swollen. Later that day she started feeling ill/fever so went to Hospital and was admitted for 4 days for IV antibiotics.  Feeling better and redness, swelling improved. (Assessment and Plan)  Cellulitis of right upper arm (682.3).  Pt left without plan, discussed with pt to continue to use ice and heat on right upper arm, monitor redness and swelling, if starts to get bigger, have a fever, feeling ill again need to call office or go to ER.  Finish all of the antibiotics given in the hospital.  Return to office on Monday 9/28/15 or sooner if needed. Notes when I talked with the pt before she left.  Received IIV4 and PPSV23, both IM in right deltoid on Tuesday, 9/15/15.  States area not prepped before injection.  That evening/night arm was sore.  Wednesday arm extra sore with redness on the deltoid area, hot to touch.  Used ice pack.  Thursday feeling nauseated, clammy, redness on right arm extended down to mid upper arm and anterior mid upper arm.  Went to ED and was admitted for cellulitis.  Given Clindamycin IV.  Discharged Sunday on oral Clindamycin.  Today, Wednesday, 9/23/15 at 4 pm, right deltoid area still sore and tender to touch, no redness or swell.  Still taking oral Clindamycin.
Age: 39.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Dysphemia, Fatigue, Seizure
Clinical narrative: I started feeling fatigued and weak. It progressed into convulsions and stuttering.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Dysphagia, Ear pain, Fatigue, Nausea, Oropharyngeal pain
Clinical narrative: Sore throat, ear pain, nausea, inability to swallow mucous, body aches, fatigue.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Pain
Clinical narrative: Sore throat, ear pain, nausea, inability to swallow mucous, body aches, fatigue.
Age: 48.0
Sex: F
Vaccine: FLUC4
Symptoms: Burning sensation, Pruritus, Urticaria
Clinical narrative: Same day of vaccination (9/24/2015), I started with some itching burning hives in both legs, started around 7:30pm, about 10:00pm, I went to the pharmacy and got some Benadryl capsules and anti-itching cream, I got better, when I got up in the morning 7:00am is started in my left arm, so I apply some more cream. I called my PCP and instructed me to keep taking Benadryl every 6 hours and if gets worse go to ER. Last night 09/27/2015 around 8:00pm, it started again in my left knee.
Sex: U
Vaccine: FLUX
Symptoms: Seizure
Clinical narrative: Initial unsolicited report received from the literature on 14 September 2015. This case is linked to 2015SA146043, 2015SA146044, 2015SA146045, 2015SA146046, 2015SA146047, 2015SA146048, 2015SA146049, 2015SA146050, 2015SA146051, 2015SA146052, 2015SA146053, 2015SA146054, 2015SA146055, 2015SA146056, 2015SA146057, 2015SA146058, 2015SA146059, 2015SA146060, 2015SA146061, 2015SA146062, 2015SA146063, 2015SA146064, 2015SA146065, 2015SA146066 and 2015SA146067 (Same literature). The following is verbatim from the article: Background. Reporting of adverse events (AEs) following vaccination can help identify rare or unexpected complications of immunizations and aid in characterizing potential vaccine safety signals. We developed an open-source, generalizable clinical decision support system called Electronic Support for Public Health-Vaccine Adverse Event Reporting System (ESP-VAERS) to assist clinicians with AE detection and reporting. Methods. ESP-VAERS monitors patient's electronic health records for new diagnoses, changes in laboratory values and new allergies following vaccinations. When suggestive events are found, ESP-VAERS sends the patient's clinician a secure electronic message with an invitation to affirm or refute the message, add comments, and submit an automated, prepopulated electronic report to VAERS. High-probability AEs are reported automatically if the clinician does not respond. We implemented ESP-VAERS in December 2012 throughout the System, an integrated healthcare system. We queried the VAERS database to determine system's baseline reporting rates from January 2009 to March 2012 and then assessed changes in reporting rates with ESP-VAERS. Results. In the 8 months following implementation, 91,622 vaccinations were given. ESP-VAERS sent 1385 messages to responsible clinicians describing potential AEs. Clinicians opened 1304 (94.2 percent) messages, responded to 209 (15.1 percent), and confirmed 16 for transmission to VAERS. An additional 16 high-probability AEs were sent automatically. Reported events included seizure, pleural effusion, and lymphocytopenia. The odds of a VAERS report submission during the implementation period were 30.2 (95 percent confidence interval, 9.52-95.5) times greater than the odds during the comparable pre-implementation period. Conclusions: An open-source, electronic health record-based clinical decision support system can increase AE detection and reporting rates in VAERS. Keywords. Vaccine; immunization; adverse reaction; reporting; adverse event. This case involves a patient (age and gender not reported), who was vaccinated with a dose of INFLUENZA VACCINE (IIV) (Manufacturer: unknown, batch number, route, dose in series and site of administration were not reported) on unspecified date. Medical history and concomitant medications were not reported. On unspecified date following the vaccination, the patient experienced seizures. Lab tests and corrective treatments were not reported. Outcome of event was not reported. Upon internal review case was confirmed as serious due to important medical event: seizure. Documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: Leukopenia
Clinical narrative: Initial unsolicited report received from the literature on 14 September 2015. This case is linked to 2015SA146032, 2015SA146043, 2015SA146044, 2015SA146045, 2015SA146046, 2015SA146047, 2015SA146048, 2015SA146049, 2015SA146050, 2015SA146052, 2015SA146053, 2015SA146054, 2015SA146055, 2015SA146056, 2015SA146057, 2015SA146058, 2015SA146059, 2015SA146060, 2015SA146061, 2015SA146062, 2015SA146063, 2015SA146064, 2015SA146065, 2015SA146066 and 2015SA146067 (Same literature). The following is verbatim from the article: Background: Reporting of adverse events (AEs) following vaccination can help identify rare or unexpected complications of immunizations and aid in characterizing potential vaccine safety signals. We developed an open-source, generalized clinical decision support system called Electronic Support for Public Health-Vaccine Adverse Event Reporting System (ESP-VAERS) to assist clinicians with AE detection and reporting. Methods: ESP-VAERS monitors patient's electronic health records for new diagnoses, changes in laboratory values and new allergies following vaccinations. When suggestive events are found, ESP-VAERS sends the patient's clinician a secure electronic message with an invitation to affirm or refute the message, add comments, and submit an automated, prepopulated electronic report to VAERS. High-probability AEs are reported automatically if the clinician does not respond. We implemented ESP-VAERS in December 2012 throughout the System, an integrated healthcare system. We queried the VAERS database to determine System's baseline reporting rates from January 2009 to March 2012 and then assessed changes in reporting rates with ESP-VAERS. Results: In the 8 months following implementation, 91,622 vaccinations were given. ESP-VAERS sent 1385 messages to responsible clinicians describing potential AEs. Clinicians opened 1304 (94.2 percent) messages, responded to 209 (15.1 percent), and confirmed 16 for transmission to VAERS. An additional 16 high-probability AEs were sent automatically. Reported events included seizure, pleural effusion, and lymphocytopenia. The odds of a VAERS report submission during the implementation period were 30.2 (95 percent confidence interval, 9.52-95.5) times greater than the odds during the comparable pre-implementation period. Conclusions: An open-source, electronic health record-based clinical decision support system can increase AE detection and reporting rates in VAERS. This case involves patient (age and gender not reported), who was vaccinated with a dose of TDAP (manufacturer: unknown, batch number, route, dose in series and site of administration were not reported) on an unspecified date. Medical history and concomitant medications were not reported. On unspecified date following the vaccination, the patient experienced leukopenia. Lab tests and corrective treatments were not reported. Outcome of event was not reported. Upon internal review case was considered as serious due to important medical event: leukopenia. Documents held by sender: none.
Sex: U
Vaccine: FLUX
Symptoms: Anaphylactic reaction, Angioedema, Chest pain, Cough, Dyspnoea
Clinical narrative: The case was considered as serious due to important medical event. Initial unsolicited report received from literature on 17-Sep-2015. Abstract: On February 4, 2010 the CDC's Advisory Committee on Immunization Practices voted for universal flu vaccination to expand protection against the flu. In addition to this administration expansion, six new influenza vaccines have been introduced into the market possibly introducing new allergenic potentials. We report two cases of delayed anaphylaxis to the flu vaccine. Drug Terms Acetylsalicylic acid, diphenhydramine, influenza vaccine, methylprednisolone, raloxifene. Disease Terms: anaphylaxis, angioneurotic edema, coughing, dyspnea, heart palpitation, influenza, thorax pain. Other terms: adult, aged, article, case report, drug marketing, drug megadose, female, flushing, human, influenza vaccination, skin test. This case involves 2 patients who had received a doses of Flu Vaccine (Manufacturer: unknown, batch number, route and site of administration were not reported) on unspecified dates. Medical history and concomitant medications were not reported. On unspecified dates, patients had experienced delayed anaphylaxis, angioneurotic edema, coughing, dyspnea, heart palpitation, influenza, thorax pain. Lab tests and corrective treatments were not  reported. Outcome of the events were not reported. Upon medical review, the case was considered as serious due to important medical event: anaphylaxis, angioneurotic edema, coughing, dyspnea, heart palpitation and flushing. Documents held by sender: none.
Sex: U
Vaccine: FLUX
Symptoms: Flushing, Influenza, Palpitations
Clinical narrative: The case was considered as serious due to important medical event. Initial unsolicited report received from literature on 17-Sep-2015. Abstract: On February 4, 2010 the CDC's Advisory Committee on Immunization Practices voted for universal flu vaccination to expand protection against the flu. In addition to this administration expansion, six new influenza vaccines have been introduced into the market possibly introducing new allergenic potentials. We report two cases of delayed anaphylaxis to the flu vaccine. Drug Terms Acetylsalicylic acid, diphenhydramine, influenza vaccine, methylprednisolone, raloxifene. Disease Terms: anaphylaxis, angioneurotic edema, coughing, dyspnea, heart palpitation, influenza, thorax pain. Other terms: adult, aged, article, case report, drug marketing, drug megadose, female, flushing, human, influenza vaccination, skin test. This case involves 2 patients who had received a doses of Flu Vaccine (Manufacturer: unknown, batch number, route and site of administration were not reported) on unspecified dates. Medical history and concomitant medications were not reported. On unspecified dates, patients had experienced delayed anaphylaxis, angioneurotic edema, coughing, dyspnea, heart palpitation, influenza, thorax pain. Lab tests and corrective treatments were not  reported. Outcome of the events were not reported. Upon medical review, the case was considered as serious due to important medical event: anaphylaxis, angioneurotic edema, coughing, dyspnea, heart palpitation and flushing. Documents held by sender: none.
Age: 57.0
Sex: F
Vaccine: FLU4, MNQ, PPV
Symptoms: Cellulitis, Computerised tomogram abdomen abnormal, Computerised tomogram abnormal, Computerised tomogram thorax abnormal, Erythema
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: Full blood count normal, Hypotension, Lumbar puncture normal, Lymphadenopathy, Muscle twitching
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.