chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: DTAP, FLUX, IPV, MMRV, DTAP, FLUX, IPV, MMRV
Symptoms: Pyrexia, Rhinorrhoea, Somnolence, Viral upper respiratory tract infection
Clinical narrative: TIRED, HEADACHE, SLEEPY, COLD, FEVER, EXHAUSTED. DOESN'T WANT TO EAT OR DRINK ANYTHING. COLD AND HOT (KEPT GOING ON AND OFF) AND JUST WANT TO SLEEP. COUGHING, RUNNING NOSES AND REDNESS AROUND THE EYES. HE FELT TENDER AT THE INJECTION SITE RIGHT AFTER THE SHOTS. MMRV, FLU, POLIO, DTAP. VERY EMOTIONAL. JUST TEARS ROLLING DOWN HIS CHEEKS AND DOESN'T WANT TO DO ANYTHING AT ALL.
Age: 19.0
Sex: M
Vaccine: HPV4
Symptoms: Anti-aquaporin-4 antibody positive, Blood test abnormal, Eye pain, Neuromyelitis optica spectrum disorder, Optic neuritis
Clinical narrative: Pain in and around right eye, worsens over time, almost blind by02/09/14.  Patient went to ER. Diagnosed with optic neuritis. Was given infusion of Solumedrol  for 3 days, then started on prednisone and tapered over 2 weeks.  03/10/14 optic neuritis in left eye. Repeat therapy with prednisone taper over 4 weeks. 04/08/14 symptoms reappear in left eye.  Solumedrol given for 5 days, then prednisone taper.  Blood test and spinal tap indicate Neuromyelitis Optica. Diagnosed 04/23/14.  Since then, repeated bouts of optic neuritis and treatment with Rituximab, Cell Cept and prednisone.
Age: 19.0
Sex: M
Vaccine: HPV4
Symptoms: Visual acuity reduced
Clinical narrative: Pain in and around right eye, worsens over time, almost blind by02/09/14.  Patient went to ER. Diagnosed with optic neuritis. Was given infusion of Solumedrol  for 3 days, then started on prednisone and tapered over 2 weeks.  03/10/14 optic neuritis in left eye. Repeat therapy with prednisone taper over 4 weeks. 04/08/14 symptoms reappear in left eye.  Solumedrol given for 5 days, then prednisone taper.  Blood test and spinal tap indicate Neuromyelitis Optica. Diagnosed 04/23/14.  Since then, repeated bouts of optic neuritis and treatment with Rituximab, Cell Cept and prednisone.
Age: 41.0
Sex: F
Vaccine: DTAP
Symptoms: Arthralgia, Dizziness, Fatigue, Injection site pain, Injection site swelling
Clinical narrative: Nausea, fatigue, soreness and swelling in shot site. Took Tylenol. That evening extreme fatigue, migraines, fever, joint pain, dizziness that lasted about a week.
Age: 41.0
Sex: F
Vaccine: DTAP
Symptoms: Migraine, Nausea, Pyrexia
Clinical narrative: Nausea, fatigue, soreness and swelling in shot site. Took Tylenol. That evening extreme fatigue, migraines, fever, joint pain, dizziness that lasted about a week.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Activities of daily living impaired, Blood test abnormal, Gait disturbance, Inflammation, Injected limb mobility decreased
Clinical narrative: Body Stiffness in legs, knees, arms, could not raise arms to comb hair, left leg felt heavy, right leg stiffness, could not bend to pick anything up from floor.  After getting out of chair could not walk immediately, had to stake small steps to get stretched out.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Limb discomfort, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: Body Stiffness in legs, knees, arms, could not raise arms to comb hair, left leg felt heavy, right leg stiffness, could not bend to pick anything up from floor.  After getting out of chair could not walk immediately, had to stake small steps to get stretched out.
Sex: F
Vaccine: FLUX
Symptoms: Contusion, Erythema, Skin discolouration
Clinical narrative: Case number PHEH2016US000708, is an initial spontaneous report received from a physician on 07 Jan 2016. This report refers to an elderly female patient. Historical condition was not reported. Current condition included formaldehyde and lidocaine. Past vaccination history included Flu vaccine (Please see case PHEH2016US001420). Concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) intramuscularly last year (year and date unspecified). The patient whole arm was red and purple with bruising after injection. The outcome of the events was complete recovery. Seriousness of the event was unknown. Causality was not reported.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash. Methylprednisolone 4 mg every day.
Sex: U
Vaccine: FLUC3
Symptoms: Pruritus, Urticaria
Clinical narrative: Case number PHEH2016US026284, is an initial spontaneous report received from a nurse on 07 Oct 2016. This report refers to a patient of an unknown age and an unknown gender. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUCELVAX (unknown whether seasonal or pandemic, manufacturer and batch number: not reported) at a dose of 0.5 ml, intramuscularly on an unknown date. It was reported that, one of the physician patient, that was administered a FLUCELVAX shot and they had an adverse reaction. On an unknown date, the patient became itchy and looked like they had hives from the shot. The outcome of the events was reported as unknown. Seriousness and causality of the events were not reported.
Age: 4.0
Sex: M
Vaccine: FLUC3
Symptoms: Unevaluable event
Clinical narrative: Case number PHEH2015US027165, is combine initial spontaneous report received from a pharmacist on 23 Dec 2015 and 24 Dec 2015. This report refers to a 04 years old male patient. Past medical history and concomitant medication were not reported. This 04 years old male patient vaccinated with FLUCELVAX (batch number and expiry date: not reported) on an unknown date. No adverse event was reported following this administration error (Inappropriate age at vaccine administration).
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Erythema multiforme
Clinical narrative: Erythema and Multiform.
Age: 64.0
Sex: M
Vaccine: DTP
Symptoms: Dyspnoea, Pruritus, Rash, Urticaria
Clinical narrative: Rash, Urticaria, Pruritus and hives, difficulty breathing.
Age: 94.0
Sex: F
Vaccine: PNC
Symptoms: Cellulitis
Clinical narrative: And Cellulitis.
Sex: F
Vaccine: FLUC3
Symptoms: Hypersensitivity
Clinical narrative: Case number PHEH2015US025834 is an initial spontaneous report received from a consumer (patient's husband) on 07 Dec 2015. This report refers to a female patient whose age was not reported. Past medical history included adverse reactions (unspecified) and her concomitant medications were not reported. The patient was vaccinated with FLUCELVAX (batch number: 173538) intramuscularly on an unknown date. The patient had a mild allergic reaction to FLUCELVAX that was administered by her allergist and this was not the first time she had had an adverse reaction (unspecified). Her allergies stated that FLUCELVAX had the least amount of preservatives and other additives. The event outcome was unknown. The seriousness and causality were not reported.
Age: 82.0
Sex: M
Vaccine: DTP
Symptoms: Rash erythematous
Clinical narrative: Patient presents to the primary care clinic on July 3, 2013 with complaint of rash beginning 2 days after tetanus shot. No pain, no itch, no trouble swallowing and no fever. Rash presented as red flat areas above upper lip, both upper extremities and back and chest area x last few days. Denies having any new medications or food along with no new detergents. Was given prednisone. Rash resolved within a few days.
Sex: U
Vaccine: FLUC4
Symptoms: Food allergy
Clinical narrative: Case PHEH2016US025141 is an initial spontaneous report received from pharmacist on 27 Sep 2016. This report refers to unknown demographics. Medical history and concomitant medication was not reported. The patient was vaccinated with single dose of FLUCELVAX Quadrivalent (batch number and expiry date: not reported) on an unknown date. On an unspecified date, the patient had egg allergy. The outcome, seriousness and causality of event were not reported.
Age: 37.0
Sex: M
Vaccine: DTP
Symptoms: Anaphylactic reaction, Pharyngeal oedema, Rash
Clinical narrative: Anaphylaxis, Skin, Rash and throat swelling.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Inflammation, Injection site pruritus, Injection site reaction, Lip injury
Clinical narrative: RN assessment: 1 inch swollen and discolored area to the back of arm with large circle of inflammation (approximately 3 inches). Patient reports itching not relieved with diphenhydramine. Pt did stated that she felt like her mouth was a little swollen. She bit the inside of her left lower lip (small whitish area on inside of lip). Pt stated that she feels like she has to chew differently. Pt also stated that last night a stabbing pain started on the inside of her lower forehead above her left eye. Resolved after a few days. Patient continued to use diphenhydramine capsules PRN. Rash and Injection site reaction with itching, possible facial swelling.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Local swelling, Mastication disorder, Mouth swelling, Pruritus, Rash
Clinical narrative: RN assessment: 1 inch swollen and discolored area to the back of arm with large circle of inflammation (approximately 3 inches). Patient reports itching not relieved with diphenhydramine. Pt did stated that she felt like her mouth was a little swollen. She bit the inside of her left lower lip (small whitish area on inside of lip). Pt stated that she feels like she has to chew differently. Pt also stated that last night a stabbing pain started on the inside of her lower forehead above her left eye. Resolved after a few days. Patient continued to use diphenhydramine capsules PRN. Rash and Injection site reaction with itching, possible facial swelling.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin discolouration
Clinical narrative: RN assessment: 1 inch swollen and discolored area to the back of arm with large circle of inflammation (approximately 3 inches). Patient reports itching not relieved with diphenhydramine. Pt did stated that she felt like her mouth was a little swollen. She bit the inside of her left lower lip (small whitish area on inside of lip). Pt stated that she feels like she has to chew differently. Pt also stated that last night a stabbing pain started on the inside of her lower forehead above her left eye. Resolved after a few days. Patient continued to use diphenhydramine capsules PRN. Rash and Injection site reaction with itching, possible facial swelling.
Age: 17.0
Sex: M
Vaccine: FLUC3
Symptoms: No adverse event
Clinical narrative: Case number PHEH2016US004000, is a spontaneous report initially received from a nurse on 15 Feb 2016. This report was initially reported as a multiple patient case; upon follow up information, identifiers were reported making this a valid single patient case. The report refers to a 17 year old male patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUCELVAX (batch number: 1740874) intramuscularly on 17 Nov 2015. No adverse event was  reported following this maladministration. Upon follow up it was reported that all safety questions were answered by the reporter. No new information was received. Follow up report received from reporter on 17 Feb 2016: All safety questions answered. No new information received. Follow up information received from the nurse on 05 Apr 2016: Updated report type (other to spontaneous), patient demographics (initials, date of birth, age, gender), batch number of suspect vaccine and vaccination and event onset date.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: And redness/swelling of entire arm. Methylprednisolone 125 mg once, Cefazolin 2 gm once, prednisone as directed every day
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Erythema multiforme, Rash
Clinical narrative: Symptoms: Rash and Erythema Multiform. Treatment: Diphenhydramine 25 mg t.i.d., naproxen 500 mg b.i.d.
Age: 34.0
Sex: M
Vaccine: FLUC4
Symptoms: Dizziness
Clinical narrative: Case number PHEH2016US028667, is an initial spontaneous report received from a nurse on 31 Oct 2016. This report refers to a 34 years old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUCELVAX Quadrivalent (batch number: 185888, expiry date: May 2017) at a dose of 0.5 ml intramuscularly on 31 Oct 2016. On the same day after about 30 mins of vaccination, the patient experienced light headedness. The outcome of the event was unknown. The seriousness of the event was reported as non serious. The causality of the event was not reported.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Chest pain, Erythema, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Patient seen as walk-in prior to his Holter appt with c/o left shoulder/arm/chest edema and pain after receiving his PNEUMOVAX vaccine yesterday, patient reports edema did not start until 1800 last night when his shoulder became quite large and painful, he reports this swelling gradually his chest and upper arm, on inspection left shoulder and upper arm reddened, very warm to touch, painful, slight edematous, BP elevated 177/122, 98 seen by PCP will medication with CATAPRES 0.1 mg po x 1 and BENADRYL 25 mg PO x 1 will perform serial BP checks 144/107, 90, 143/106, 92, 148/99, 108 after one hour, patient feels much better, calmer, rash greatly reduced less red and less edema, patient is liable. Rash, hypertension and shoulder edema and pain. Clonidine 0.1 mg once, diphenhydramine 25 mg once.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth, Oedema, Pain in extremity, Skin warm
Clinical narrative: Patient seen as walk-in prior to his Holter appt with c/o left shoulder/arm/chest edema and pain after receiving his PNEUMOVAX vaccine yesterday, patient reports edema did not start until 1800 last night when his shoulder became quite large and painful, he reports this swelling gradually his chest and upper arm, on inspection left shoulder and upper arm reddened, very warm to touch, painful, slight edematous, BP elevated 177/122, 98 seen by PCP will medication with CATAPRES 0.1 mg po x 1 and BENADRYL 25 mg PO x 1 will perform serial BP checks 144/107, 90, 143/106, 92, 148/99, 108 after one hour, patient feels much better, calmer, rash greatly reduced less red and less edema, patient is liable. Rash, hypertension and shoulder edema and pain. Clonidine 0.1 mg once, diphenhydramine 25 mg once.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Case number PHEH2016US001420, is an initial spontaneous report received from a physician on 07 Jan 2016. This report refers to an elderly female patient. Historical condition was not reported. Concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) intramuscularly 2 years ago (year and date unspecified). The patient experienced redness and pain in upper arm of injection (in unspecified year and date). The outcome of the event, seriousness and causality was not reported.
Age: 56.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US023471, is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 56 years old patient of unknown gender. Past medical history and concomitant medications were not reported. The patient was vaccinated with one single dose of FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml, intramuscularly, into right arm on 12 Jan 2016. On 12 Jan 2016, FLUVIRIN MDV that had been exposed to 8 to 10 temperature excursion was administered to patient. No adverse event was reported following this medication error (incorrect product storage). The case was assessed as non-serious by the nurse.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site urticaria
Clinical narrative: Per nursing note, patient complained of swelling and mild tenderness at site of injection. Urticaria. Pruritus and Swelling/mild tenderness.
Age: 85.0
Sex: M
Vaccine: PNC, TTOX
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Rash and upper left arm red and swollen.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Patient is a 68 year old male who was being seen by his primary care doctor for diabetes and dyslipidemia management. During the visit the patient received a pneumococcal polysaccharide vaccine injection intramuscularly in his right deltoid. Patient called the clinic two days later complaining of generalized right arm swelling, redness and pain and was advised to return to the clinic for examination. The patient was treated with amoxicillin 875/clav K 125mg tab; take 1 tablet by mouth twice a day for 7 days with food, diphenhydramine HCL 25mg cap; take one capsule by mouth three times a day as needed for allergies and prednisone 5mg tab dosepak as prescribed and the swelling and pain resolved within one week. And Generalized right arm swelling, redness and pain. Amoxicillin/Clavulanate tab BID, Diphenhydramine 25 mg TID, Prednisone tab other.
Age: 52.0
Sex: M
Vaccine: FLUC4
Symptoms: Pruritus generalised
Clinical narrative: Case number PHEH2016US029896 is an initial spontaneous report received from consumer (Novartis employee) on 10 Nov 2016. This case refers to 52 year old male patient. Medical history and concomitant medication was not reported. The patient was vaccinated with single dose of FLUCELVAX Quadrivalent (batch number: 185285, expiry date: Apr 2017) at dose of 0.5 ml intramuscular on 06 Nov 2016. On 08 Nov 2016, the patient experienced itching all over. The outcome of the events was reported as condition improving. The seriousness of the events was reported as non serious by the consumer. The causality of the events was not reported.
Age: 7.0
Sex: M
Vaccine: FLUC3
Symptoms: No adverse event
Clinical narrative: Case number PHEH2015US027166, is combine initial spontaneous report received from a pharmacist on 23 Dec 2015 and 24 Dec 2015. This report refers to a 07 years old male patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUCELVAX (batch number and expiry date: not reported) at a dose of 0.5 ml on an unknown date when he was 07 years old. No adverse event was reported following this medication error (inappropriate age at vaccine administration).
Age: 3.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2015US027168, is a combined initial spontaneous report received from a pharmacist on 23 Dec 2015 and 24 Dec 2015. This report refers to a 03-years-old male patient. Past medical history and concomitant medications were not reported. He was vaccinated with FLUCELVAX (batch number: not reported) on an unknown date, when the patient was at the age if 03. No adverse event was reported following this mal administration (inappropriate age at vaccine administration).
Age: 4.0
Sex: M
Vaccine: FLUC3
Symptoms: Decreased appetite, Pyrexia
Clinical narrative: Case number PHEH2015US025416 is an initial spontaneous report received from a health care professional on 02 Dec 2015. This report refers to a 4 year old male patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUCELVAX (batch number 173252) intramuscularly on an unknown date. On 24 Nov 2015, reported as within one week of receiving vaccine, the patient experienced fever and loss of appetite. The outcome of the events was not reported. Seriousness and causality of the events was not reported.
Age: 64.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Rash, Swelling
Clinical narrative: Case number PHEH2015US026396, is an initial spontaneous report received from a physician on 15 Dec 2015. This report refers to a 64-years-old female patient. Past medical history included sore throat and swelling on eucalyptus oil and Vitamin D3 and angiotensin 2 receptor blocker (unspecified) as historical drug. Current condition included kidney transplant on 13 Oct 1992, drug allergies and codeine allergy. Concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) on an unknown date. She experienced rash and swelling on an unknown date. On 28 May 2015, she received valsartan (manufacturer unknown) at an unknown dose and experienced allergy to red dyes and migraines (please see case# PHEH2015US010768). The outcome, seriousness and causality of the events was not reported.
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema
Clinical narrative: Case number PHEH2016US028508, is an initial spontaneous report received from a health care professional on 26 Oct 2016. This report refers to a female patient of an unknown age. Medical history and concomitant medication was not reported. The patient was vaccinated with one single dose FLUCELVAX (batch number: 185887, expiry Apr 2017) at a dose of 0.5 ml intramuscular on 24 Oct 2016. On 25 Oct 2016 the patient experienced 7 cm patch of erythema around the injection site. It began on 25 Oct 2016. The patient was using cold compresses and ice for the erythema. It was unknown if the erythema was improving. Final outcome of the event was unknown. Seriousness of the event was reported as non-serious. Causality of the event was not reported.
Age: 65.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain
Clinical narrative: Case number PHEH2016US028813, is a spontaneous report initially received from a pharmacist on 01 Nov 2016. This report refers to a 65 year old female patient. Medical history was not reported. Concomitant medication included losartan 100 mg. The patient was vaccinated with single dose (this was first application) of FLUCELVAX QUADRIVALENT (batch number: 185327 and expiry date: Apr 2017) at a dose of 0.5 ml. intramuscularly on 18 Oct 2016. It was also reported that, the patient had tolerated the vaccine in the past. On 19 Oct 2016, the patient had pain at injection site/ muscle soreness at injection site. On 16 Nov 2016, the patient recovered from pain at injection site/ muscle soreness at injection site. The outcome of the event pain at injection site/muscle soreness at injection site  was complete recovery. The seriousness and causality of the event pain at injection site/muscle soreness at injection site were not reported. Follow up information was received from a pharmacist via a fax on 17 Nov 2016: Report media (fax), FLUCELVAX toleration detail, concomitant drug (losartan 100 mg), event verbatim, event coding and event outcome were updated.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Hypoaesthesia, Injection site pain
Clinical narrative: This case was reported by a non-health professional via call center representative and described the occurrence of injection site pain in a 19-year-old female patient who received MENVEO (batch number M16077, expiry date March 2018). On 12th January 2017, the patient received MENVEO .5 ml. On 12th January 2017, less than a day after receiving MENVEO, the patient experienced injection site pain and numbness. On an unknown date, the outcome of the injection site pain and numbness were unknown. It was unknown if the reporter considered the injection site pain and numbness to be related to MENVEO. Additional details were provided as follows: The patient received a dose of MENVEO in her left deltoid and experienced sharp pain at site. No other information was reported.
Age: 60.0
Sex: F
Vaccine: FLUC4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US029299, is an initial spontaneous report received from a nurse on 07 Nov 2016. This report refers to a 60 years old female patient. Past medical history and concomitant medications were not reported. The nurse stated that first temperature excursion of FLUCELVAX Quadrivalent at 52F for 1 hour occurred on 18 Oct 2016. The patient was vaccinated with FLUCELVAX Quadrivalent (batch number: not reported) at a dose of 0.5 ml intramuscularly on 20 Oct 2016. Second temperature excursion occurred on 23 Oct 2016, dropped low 06 times to 34F and lasted 30 minutes each time. Third temperature excursion occurred on 02 Nov 2016, down to 32.2F three times over the course of 12 hours. Vaccine had been administered. It was unknown if vaccine was frozen. Nurse did not know which lot was given to which patient. No adverse event was reported following this administration error (incorrect product storage).
Age: 20.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US023463, is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 19-year-old patient of an unknown gender. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701, expiry date: not reported) at a dose of 0.5 ml intramuscular into left arm on 16 Feb 2016. It was reported that, the patient received FLUVIRIN MDV that had been exposed to 8 to 10 temperature excursion and it was administered to unknown number of patients. No adverse event was reported following this medication error (incorrect product storage).
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Injection site nodule, Paraesthesia
Clinical narrative: Small nodule at injection site C/O numbness/tingling in arm that has continued.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal pain, Asthenia, Culture throat negative, Decreased appetite, Delirium
Clinical narrative: Approximately 2 hrs after injection, had fever of 104.5, pallor, abd pain, vomiting, some delirium. Seen in office 01-25-2017 with persistent fever, pallor, decreased energy, appetite. Fever. Maximum temperature is 104.50 F. Relieving factors include acetaminophen. Associated symptoms include nausea and vomiting. Pertinent negatives include cough, diarrhea and rash. Additional information: Patient had bad reaction to Flu shot which he received 1/24/2017. Patient had glossy eyes, pale skin and was seeing things that weren't there. HA and abd pain and fever. Had flu shot yesterday am and felt sick shortly after that. Fever 104.5. TYLNEOL helped vomited x 2 last night. Perioral rash. Rash around mouth for months tried mupirocin with not much help. Now using Hydrocortisone and Aquaphor. Has not been truly compliant with anything.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Glassy eyes, Influenza virus test negative, Malaise, Nausea, Oral mucosal eruption
Clinical narrative: Approximately 2 hrs after injection, had fever of 104.5, pallor, abd pain, vomiting, some delirium. Seen in office 01-25-2017 with persistent fever, pallor, decreased energy, appetite. Fever. Maximum temperature is 104.50 F. Relieving factors include acetaminophen. Associated symptoms include nausea and vomiting. Pertinent negatives include cough, diarrhea and rash. Additional information: Patient had bad reaction to Flu shot which he received 1/24/2017. Patient had glossy eyes, pale skin and was seeing things that weren't there. HA and abd pain and fever. Had flu shot yesterday am and felt sick shortly after that. Fever 104.5. TYLNEOL helped vomited x 2 last night. Perioral rash. Rash around mouth for months tried mupirocin with not much help. Now using Hydrocortisone and Aquaphor. Has not been truly compliant with anything.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Pallor, Pyrexia, Streptococcus test negative, Vomiting
Clinical narrative: Approximately 2 hrs after injection, had fever of 104.5, pallor, abd pain, vomiting, some delirium. Seen in office 01-25-2017 with persistent fever, pallor, decreased energy, appetite. Fever. Maximum temperature is 104.50 F. Relieving factors include acetaminophen. Associated symptoms include nausea and vomiting. Pertinent negatives include cough, diarrhea and rash. Additional information: Patient had bad reaction to Flu shot which he received 1/24/2017. Patient had glossy eyes, pale skin and was seeing things that weren't there. HA and abd pain and fever. Had flu shot yesterday am and felt sick shortly after that. Fever 104.5. TYLNEOL helped vomited x 2 last night. Perioral rash. Rash around mouth for months tried mupirocin with not much help. Now using Hydrocortisone and Aquaphor. Has not been truly compliant with anything.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus generalised, Rash generalised
Clinical narrative: Rash and itching all over her body.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Few minutes after injection rash appeared-around 4-5 cm around injection site. Pink not warm not blanching, non tender, slightly raised ice pack to arm in office, BENADRYL at home.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient seen in office 1/25/17. Presented with (L) arm redness and some swelling around injection site. Otherwise patient looked well.
Age: 3.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event
Clinical narrative: Case PHEH2016US026616 is an initial spontaneous report received from a nurse on 11 Oct 2016. This report refers to a 3 year old male patient (of label use). Medical history and concomitant medication was not reported. The patient was vaccinated with single dose of FLUCELVAX Quadrivalent (batch number and expiry date not reported) at a dose of 0.5 ml intramuscular on 09 Oct 2016. No adverse event was reported following this medication error (inappropriate age at vaccine administration). The seriousness of the event was reported as non serious.
Age: 1.0
Sex: F
Vaccine: FLU4, MMR, VARCEL
Symptoms: Erythema, Injection site rash, Rash, Rash pustular, Rash vesicular
Clinical narrative: Varicella vaccine received 1/16/17. 1/22/2017 skin erythematous, pustular/vesicular rash to face, trunk, legs.
Age: 15.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Concussion, Fall, Head injury, Loss of consciousness
Clinical narrative: After inoculation. Patient passed out and fell backward. She hit her head on the floor. She received concussion.
Age: 13.0
Sex: M
Vaccine: MENB
Symptoms: Hypoaesthesia, Injection site pain
Clinical narrative: This case was reported by a non-health professional via call center representative and described the occurrence of injection site pain in a 13-year-old male patient who received MENVEO (batch number M16077, expiry date March 2018). On 12th January 2017, the patient received MENVEO 0.5 ml. On 12th January 2017, less than a day after receiving MENVEO, the patient experienced injection site pain and numbness. On an unknown date, the outcome of the injection site pain and numbness were unknown. It was unknown if the reporter considered the injection site pain and numbness to be related to MENVEO. Additional details were provided as follows: The patient received MENVEO in his right deltoid and experienced sharp pain at site. No other information was reported.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, PNC13, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Doing 12 month shots, I gave a varicella and I grabbed a PROQUAD instead of MMR.
Age: 64.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Resident was given PREVNAR 13 on 4/8/2016. A red rash started at injection site and grew to 10x12cm by 4/18/2016.
Age: 3.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2016US008638, is an initial spontaneous report received from a nurse on 05 Apr 2016. This report refers to a 3 years old female patient. Past medical history and concomitant medications were not reported. This patient under the age of 18 was vaccinated with FLUCELVAX (batch number: 174087A) intramuscularly on 04 Dec 2015, instead of FLUARIX (manufacturer: unknown, batch number: 9JX2N, expiry date: 16 Jun 2016) on an unknown date. No adverse event was reported following this maladministration (wrong vaccine administered). Follow up information received from nurse on 22 Jun 2016: Added new suspect drug FLUARIX and its details (lot number and expiry date), added new event (wrong vaccine administered), deleted the event inappropriate age at vaccine administration and updated narrative accordingly.
Age: 17.0
Sex: M
Vaccine: FLUC3
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Case number PHEH2016US008637, is an initial spontaneous report received from a nurse on 05 Apr 2016. This report refers to a 17 years old male patient. Past medical history and concomitant medications were not reported. This patient under the age of 18 was vaccinated with FLUCELVAX (batch number: 174087A) intramuscularly on 15 Oct 2015 instead of FLUARIX (batch number: 9JX2N, expiry date: 16 Jun 2016). No adverse event was reported following this maladministration. Follow up report from nurse received on 22 Jun 2016: Suspect drug FLUARIX and its details (dose and route) updated event coding as (wrong vaccine administered) from inappropriate age at vaccine administration.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Formication, Hypoaesthesia, Nausea, Paraesthesia, Pyrexia
Clinical narrative: Swelling, nausea, fever and left arm, left hips, left shoulders feel tingling, crawling and also numbness in shoulders areas. Everything is getting better.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Swelling, nausea, fever and left arm, left hips, left shoulders feel tingling, crawling and also numbness in shoulders areas. Everything is getting better.
Age: 66.0
Sex: U
Vaccine: PPV
Symptoms: Oedema peripheral, Peripheral swelling
Clinical narrative: Patient had breast cancer (Right) gave PNEUMOVAX 23 in left deltoid. Patient arm to bicep is swollen - Req. also under DR arm pit - has Dr. appt. 1/26/17.
Age: 1.33
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: No adverse symptoms or events; given DTaP with Polio instead of just DTaP at 15 mo WCC.
Age: 78.0
Sex: F
Vaccine: HEPA, PNC13, TDAP
Symptoms: Cellulitis, Erythema, Inflammation, Swelling
Clinical narrative: Patient requested 3 vaccines on 01/02/2017, HAVRIX, BOOSTRIX and PREVNAR. Patient was unable to use both arms for vaccines b/c patient had a mastectomy (or some other issue). Pt. suffered severe cellulitis in her arm. Redness, swelling, inflammation.
Age: 75.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: Pt. stated that rash began on torso 7 days after receiving shingles vaccine. Pt. also complained of being itchy at site of rash. Pt. denied any HX of shingles.
Age: 75.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Pt. stated that redness and swelling at injection site of Td vaccine on L deltoid started on 1/25/17. Pt. seen in clinic There was redness and swelling at injection site. Pt. stated that left arm was in pain from injection site to palm of hand.
Age: 28.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Hepatitis B antibody, Malaise, Measles antibody, Mouth swelling
Clinical narrative: Per mother pt. awoke this morning not feeling well. Since then he has begun vomiting and feeling itchy all over. He has redness and swelling under both arms and in his throat. He states his nasal passages and mouth feel swollen. He took BENADRYL and relief. Referred to ER STAT. Pt had previous allergic RXN to something he drank in high school. No temperature was taken today.
Age: 28.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Mumps antibody test, Nasal congestion, Pharyngeal erythema, Pharyngeal oedema, Pruritus generalised
Clinical narrative: Per mother pt. awoke this morning not feeling well. Since then he has begun vomiting and feeling itchy all over. He has redness and swelling under both arms and in his throat. He states his nasal passages and mouth feel swollen. He took BENADRYL and relief. Referred to ER STAT. Pt had previous allergic RXN to something he drank in high school. No temperature was taken today.
Age: 28.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Rubella antibody test, Swelling, Viral titre, Vomiting
Clinical narrative: Per mother pt. awoke this morning not feeling well. Since then he has begun vomiting and feeling itchy all over. He has redness and swelling under both arms and in his throat. He states his nasal passages and mouth feel swollen. He took BENADRYL and relief. Referred to ER STAT. Pt had previous allergic RXN to something he drank in high school. No temperature was taken today.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left arm slightly swollen and red. Warm to touch. No fever or discomfort.
Age: 67.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Injected limb mobility decreased, Injection site erythema, Injection site swelling, Night sweats
Clinical narrative: 1/17 2 hrs post administration Rt. arm pain, could not lift it, broke out in a sweat and chilled during the night. Could not get out of bed throughout night at 6AM 1/18 rt. shoulder to elbow and around back under arm swelled up and red.
Age: 67.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain in extremity
Clinical narrative: 1/17 2 hrs post administration Rt. arm pain, could not lift it, broke out in a sweat and chilled during the night. Could not get out of bed throughout night at 6AM 1/18 rt. shoulder to elbow and around back under arm swelled up and red.
Sex: U
Vaccine: RV1
Symptoms: Serum sickness
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of serum sickness in a infant patient who received ROTARIX. On an unknown date, the patient received ROTARIX (oral). On an unknown date, an unknown time after receiving ROTARIX, the patient experienced serum sickness. On an unknown date, the outcome of the serum sickness was unknown. It was unknown if the reporter considered the serum sickness to be related to ROTARIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that the patient received 4 vaccines at the same time. ROTARIX was one of those vaccines, but the other 3 vaccines were not known at the time of the call. No further information was provided.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Diffuse swelling, erythema (L) thigh.
Age: 1.0
Sex: F
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Rash erythematous, Rash maculo-papular
Clinical narrative: Patient had an erythematous maculopapular rash develop six days after receiving her vaccination. Rash is present on her trunk, thighs, and face with the rash coalescing on her back. No other notable symptoms.
Age: 17.0
Sex: F
Vaccine: FLUC3
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Case number PHEH2016US008633, is a spontaneous report initially received from a nurse on 05 Apr 2016. This report refers to a 17 years old female patient. Medical history and concomitant medication were not reported. The patient (under the age of 18) was vaccinated with FLUCELVAX (batch number: 174087A) on 10 Oct 2015, intramuscularly instead of FLUARIX (batch number: 9JX2N, expiration date: 16 Jun 3016) as the patient was supposed to receive FLUARIX. No adverse event was reported following this mal administration. Follow up report received from a nurse via fax on 22 Jun 2016: Added co suspect vaccine (FLUARIX, batch number and expiry date), event wrong drug administered and deleted the event inappropriate age at the time of vaccination.
Age: 3.0
Sex: F
Vaccine: FLUC3
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Case number PHEH2016US008632, is an initial spontaneous report received from a nurse on 05 Apr 2016. This report refers to a 3 years old female patient. Past medical history and concomitant medications were not reported. This patient under the age of 18 was vaccinated with FLUCELVAX (batch number: 174087A) intramuscularly on 02 Dec 2015 instead of FLUARIX (lot number: 9JX2N, expiry date: 16 Jun 2016). No adverse event was reported following this maladministration. Follow up report from nurse received on 22 Jun 2016: Suspect drug FLUARIX and its details (dose and route) updated event coding as (wrong vaccine administered) from inappropriate age at vaccine administration.
Age: 17.0
Sex: F
Vaccine: FLUC3
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Case number PHEH2016US008630, is a spontaneous report initially received from a nurse on 05 Apr 2016. This report refers to a17 years old female patient. Medical history and concomitant medication were not reported. The patient (under the age of 18) was vaccinated with FLUCELVAX (batch number: 174087A) on 01 Dec 2015, intramuscularly instead of FLUARIX (batch number: 9JX2N, expiration date: 16 Jun 2016) as the patient was supposed to receive FLUARIX. No adverse event was reported following this maladministration. Follow up report received from a nurse via fax on 22 Jun 2016: Added to co suspect vaccine (FLUARIX), added new event wrong vaccine administered and deleted the event inappropriate age at vaccine administration.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Femoral nerve palsy, Ultrasound joint, Ultrasound scan normal
Clinical narrative: Femoral nerve palsy of (R) hip/thigh.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Hypoaesthesia, Injection site pain
Clinical narrative: This case was reported by a non-health professional via call center representative and described the occurrence of injection site pain in a 12-year-old male patient who received MENVEO (batch number M16077, expiry date March 2018). On 12th January 2017, the patient received MENVEO .5 ml. On 12th January 2017, less than a day after receiving MENVEO, the patient experienced injection site pain and numbness. On an unknown date, the outcome of the injection site pain and numbness were unknown. It was unknown if the reporter considered the injection site pain and numbness to be related to MENVEO. Additional details were provided as follows: The patient received a dose of MENVEO in his left deltoid and experienced sharp pain at site. No other information was reported.
Age: 6.0
Sex: F
Vaccine: FLUC3
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Case number PHEH2016US008627, is an initial spontaneous report received from a nurse on 05 Apr 2016. This report refers to a 6 year old female patient. Medical history and concomitant medication were not reported. This patient under the age of 18 was vaccinated FLUCELVAX (batch number: 174087A) intramuscularly on 01 Dec 0215 instead of FLURIX (manufacturer: unknown, batch number: 9JX2N, expiry date: 16 Jun 2016) on an unknown date. No adverse event was reported following this maladministration (wrong drug administered). Follow up information received from nurse on 22 Jun 2016: Added new suspect drug FLUARIX and its details (lot number and expiry date), added new event (wrong drug administered), deleted the event inappropriate age at vaccine administration and update narrative accordingly.
Sex: F
Vaccine: FLUC4
Symptoms: Incorrect route of drug administration, Injection site erythema
Clinical narrative: Case number PHEH2016US028522, is an initial spontaneous report received from a healthcare professional on 26 Oct 2016. This report refers to a female patient of unknown age. Medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUCELVAX (batch number: 185887, expiry date: Apr 2017) at a dose of 0.5 ml subcutaneously on 24 Oct 2016. The pharmacist stated that, a female patient received FLUCELVAX via subcutaneous route and experienced 7 inch patch of erythema around the injection site on 25 Oct 2016. The patient used cold compress and ice for the erythema. The outcome of the event incorrect route of drug administration was unknown and of the other event was not reported. The seriousness of the event incorrect route of drug administration was reported as non serious and of other event was not reported. The causality of the events was not reported.
Age: 22.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US023416 is an initial spontaneous report received from a nurse on 13 Sep 2106. This report refers to a 22 year old patient whose gender was not specified. The patient's medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml intramuscularly in the left arm on 31 Mar 2016. It was reported that the patient received FLUVIRIN multi dose vial (MDV) that been exposed to 8 to 10 temperature excursion. The patient did not experience any adverse events following vaccination.
Age: 37.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US023421 is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 37 year old patient whose gender was not specified. The patient's medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml intramuscularly in the left arm on 19 Mar 2016. It was reported that the patient received FLUVIRIN multi dose vial (MDV) that had been exposed to 8 to 10 temperature excursion. The patient did not experience any adverse events following vaccination.
Age: 42.0
Sex: F
Vaccine: FLUC4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US027024, is an initial spontaneous report from a nurse received on 17 Oct 2016. This report refers to a 42 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUCELVAX Quadrivalent (batch number: 185888) at a dose of 0.5 ml, intramuscularly on 17 Oct 2016. It was reported that, a temperature excursion occurred with FLUCELVAX Pre-filled syringe in a closed refrigerator, vaccines were cool to touch upon discovery. The patient estimates the time of excursion was 02 to 03 days and max temperature was estimated to be less than 77 degrees Fahrenheit. This was the first temperature excursion. It was stated that, vaccine has been given to 07 people this morning on 17 Oct 2016. No adverse event was reported following this medication error.
Age: 56.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US023425, is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 56 years old patient of unknown gender. Past medical history and concomitant medications were not reported. The patient was vaccinated with one single dose of FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml, intramuscularly into left arm on 29 Feb 2016. On 29 Feb 2016, FLUVIRIN MDV that had been exposed to 8 to 10 temperature excursion was administered to patient. No adverse event was reported following this medication error (incorrect product storage). The case was assessed as non-serious by the nurse.
Age: 3.0
Sex: F
Vaccine: FLUC4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2016US027568, is an initial spontaneous report received from a nurse on 20 Oct 2016. This report refers to a 03 year old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUCELVAX Quadrivalent (batch number: 186685) at a dose of 0.5 ml intramuscularly on 19 Oct 2016, when she was at the age of 03 years old. No adverse event was reported following this administration error (drug administered to patient of inappropriate age).