chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash macular
Clinical narrative: About 5 minutes after administration of the Varicella vaccine the patient began complaining of chest and throat pain. He was observed for further reaction and developed a rapidly progressive generalized macular erythematous rash as well as some slight swelling of the bilateral eyelids and lips. At no time did the patient develop wheezing or shortness of breath or any signs of hemodynamic compromise.
Age: 60.0
Sex: M
Vaccine: HEP, HEPA, TYP
Symptoms: Asthenia, Back pain, Coordination abnormal, Fall, Fatigue
Clinical narrative: Patient began noticing weakness, numbness, tingling in extremeties, fatigue.  Fell to ground while traveling.  Came home to follow-up with physician, weakness, numbness, tingling, loss of strength, lack of coordination, decreased sensation.  Diagnosed eventually with Guillan Barre syndrome and treated around 4/14/14.  Pt. has made 85% recovery.  Still states he is wobbly, tingling sensation in extremeties, decreased sensation to face, back pain.
Age: 60.0
Sex: M
Vaccine: HEP, HEPA, TYP
Symptoms: Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia, Laboratory test, Muscular weakness
Clinical narrative: Patient began noticing weakness, numbness, tingling in extremeties, fatigue.  Fell to ground while traveling.  Came home to follow-up with physician, weakness, numbness, tingling, loss of strength, lack of coordination, decreased sensation.  Diagnosed eventually with Guillan Barre syndrome and treated around 4/14/14.  Pt. has made 85% recovery.  Still states he is wobbly, tingling sensation in extremeties, decreased sensation to face, back pain.
Age: 60.0
Sex: M
Vaccine: HEP, HEPA, TYP
Symptoms: Paraesthesia, Sensory loss
Clinical narrative: Patient began noticing weakness, numbness, tingling in extremeties, fatigue.  Fell to ground while traveling.  Came home to follow-up with physician, weakness, numbness, tingling, loss of strength, lack of coordination, decreased sensation.  Diagnosed eventually with Guillan Barre syndrome and treated around 4/14/14.  Pt. has made 85% recovery.  Still states he is wobbly, tingling sensation in extremeties, decreased sensation to face, back pain.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Erythema and moderate swelling to right deltoid, non indurated.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: VIIth nerve paralysis
Clinical narrative: Bells Palsy
Age: 23.0
Sex: M
Vaccine: HEPAB, TDAP, VARCEL
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: No symtoms reported, Local redness and swollen around the vaccination area, noticed around 15 minutes after vaccination, Benadril was prescribed by Dr.
Age: 33.0
Sex: F
Vaccine: MMR
Symptoms: Diarrhoea, Dizziness, Pyrexia, Vomiting
Clinical narrative: High fever, light headed, dizzy, vomiting, diarrhea.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema
Clinical narrative: Redness around injection site > 4 inches diameter
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Saturday slightly red, Sunday patient and family noticed child's arm, 1 1/2 inches from top of shoulder, swelling, redness that extends 3 1/2-4 inches down the arm. No changes at time of report, widest portion being approx 4 inches.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: REDNESS AND SWELLING ON OUTER SHOULDER OF LEFT ARM
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Herpes zoster, Neuralgia
Clinical narrative: Five months after vaccine, patient reported severe pain in the right hip. She started breaking out again with shingles. Patient reports this is the worse case she's experienced (shingles outbreak 6 times in 6 years).  Patient was treated with gabapentin for nerve pain and Valtrex for the virus.
Age: 53.0
Sex: M
Vaccine: YF
Symptoms: Cough, Discomfort, Nasal congestion, Wheezing
Clinical narrative: On evaluation, pt was noted to be in mod discomfort w/ conj/nasal congestion, dry cough but no acute sob. Exam significant for mild diffuse exp wheeze, o/w normal. Patient was referred to Urgent Care for immediate treatment and his primary care physician was notified.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Abdominal distension, Acidosis, Cardiopulmonary failure, Diarrhoea, Endotracheal intubation
Clinical narrative: Diarrhea 6/19, then developing abdominal distension and lethargy 6/20, presented in extremis to emergency room with cardiorespiratory failure, CPR and intubated. Resuscitated in PICU with fluids, dopamine, antibiotics, treated acidosis and hyperkalemia. Found in hospital to have intestinal volvulus and necrotic small bowel at surgery.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Gastrointestinal necrosis, Hyperkalaemia, Intensive care, Lethargy, Resuscitation
Clinical narrative: Diarrhea 6/19, then developing abdominal distension and lethargy 6/20, presented in extremis to emergency room with cardiorespiratory failure, CPR and intubated. Resuscitated in PICU with fluids, dopamine, antibiotics, treated acidosis and hyperkalemia. Found in hospital to have intestinal volvulus and necrotic small bowel at surgery.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Surgery, Volvulus
Clinical narrative: Diarrhea 6/19, then developing abdominal distension and lethargy 6/20, presented in extremis to emergency room with cardiorespiratory failure, CPR and intubated. Resuscitated in PICU with fluids, dopamine, antibiotics, treated acidosis and hyperkalemia. Found in hospital to have intestinal volvulus and necrotic small bowel at surgery.
Age: 18.0
Sex: M
Vaccine: YF
Symptoms: Asthenia, Blood test normal, Chest X-ray, Chills, Cough
Clinical narrative: Started with severe muscle cramps and progressed to fevers, chills, wheezing, cough, weakness, fatigue lasting 3+ weeks (still going on).
Age: 18.0
Sex: M
Vaccine: YF
Symptoms: Fatigue, Muscle spasms, Pyrexia, Wheezing
Clinical narrative: Started with severe muscle cramps and progressed to fevers, chills, wheezing, cough, weakness, fatigue lasting 3+ weeks (still going on).
Sex: F
Vaccine: MNQ
Symptoms: Condition aggravated, Dizziness, Loss of consciousness, Syncope, Urinary incontinence
Clinical narrative: Case number PHEH2014US011889 is an initial report received from a nurse on 11 Jun 2014. This report refers to an adult female patient in her thirties. Her past medical history included fear of needles and her concomitant medications were not reported. She was vaccinated with MENVEO (batch number: not reported) intramuscularly at a dose of 0.5 ml on 29 Jan 2014. On the same day after the vaccination, she got dizzy and passed out for 20-30 seconds. She also urinated and vomited. The reporter stated that the patient had previously experienced the same. The outcome of the events was not reported. The events were assessed as non serious by the reporter but were reassessed as serious upon internal review. The reporter stated that the fear of needles made the patient faint. The causality of other events was not reported.
Sex: F
Vaccine: MNQ
Symptoms: Vomiting
Clinical narrative: Case number PHEH2014US011889 is an initial report received from a nurse on 11 Jun 2014. This report refers to an adult female patient in her thirties. Her past medical history included fear of needles and her concomitant medications were not reported. She was vaccinated with MENVEO (batch number: not reported) intramuscularly at a dose of 0.5 ml on 29 Jan 2014. On the same day after the vaccination, she got dizzy and passed out for 20-30 seconds. She also urinated and vomited. The reporter stated that the patient had previously experienced the same. The outcome of the events was not reported. The events were assessed as non serious by the reporter but were reassessed as serious upon internal review. The reporter stated that the fear of needles made the patient faint. The causality of other events was not reported.
Age: 6.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Immediate post-injection reaction, Injection site cellulitis, Injection site erythema, Injection site pruritus
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site cellulitis in a 6-year-old female subject who was vaccinated with INFANRIX (GlaxoSmithKline). Concurrent vaccination included MMRV vaccine (non-GSK, Merck) given on 17 June 2014; IPV (non-GSK, Sanofi) given on 17 June 2014. The subject had no allergy and no reaction to previous vaccination. On 17 June 2014 the subject received 5th dose of INFANRIX (0.5 ml, intramuscular, right thigh). On 17 June 2014, immediately after vaccination with INFANRIX, the subject experienced injection site redness which progressed over 24 hours to injection site cellulitis. The subject also developed injection site pruritus. The subject was hospitalised and the healthcare professional considered the events were clinically significant (or requiring intervention). The subject was treated with KEFLEX since 19 June 2014 and her mother gave her some BENADRYL for pruritus. At the time of reporting, pruritus decreased but redness and cellulitis were unresolved. This was one of 3 cases reported by the same reporter. The healthcare professional considered the events were probably related to vaccination with INFANRIX.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site cellulitis
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site cellulitis in a 5-year-old male subject who was vaccinated with KINRIX (GlaxoSmithKline). Concurrent vaccination included MMRV (non-GSK, Merck) given on 3 June 2014. The subject had no allergy and no previous reaction to vaccination. On 3 June 2014 the subject received 5th dose of KINRIX (intramuscular, right thigh). On 4 June 2014, 24 hours after vaccination with KINRIX, the subject experienced injection site cellulitis. The healthcare professional considered the event was clinically significant (or requiring intervention). The subject was treated with Bactrim. On 12 June 2014, the event was resolved. This was one of 3 cases reported by the same reporter.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Injection site cellulitis
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site cellulitis in a 5-year-old male subject who was vaccinated with KINRIX (GlaxoSmithKline). The subject had no allergy and no reaction to previous vaccination. Concurrent vaccination included MMR vaccine (non-GSK, Merck) given on 10 June 2014. On 10 June 2014 the subject received 5th dose of KINRIX (intramuscular, left thigh). On 13 June 2014, 3 days after vaccination with KINRIX, the subject experienced injection site cellulitis. The healthcare professional considered the event was clinically significant (or requiring intervention). The subject was treated with AUGMENTIN. At the time of reporting the outcome of the event was unspecified. The healthcare professional considered the event was probably related to vaccination with KINRIX. This was one of 3 cases reported by the same reporter.
Age: 14.0
Sex: M
Vaccine: FLUN4
Symptoms: Paraesthesia, VIIth nerve paralysis
Clinical narrative: Pt received FLUMIST and approx 2 hours later felt tingling in face. Next day noted mild facial droop (L), worse next day. ER Dx'd (L) Bell's Palsy. Rx'd oral steroid consulted Ped. neurologist. Recovered uneventfully.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Fever 103, nausea, vomiting, dizziness, generalized body aches.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: White blood cell count normal
Clinical narrative: Fever 103, nausea, vomiting, dizziness, generalized body aches.
Age: 18.0
Sex: M
Vaccine: MEN, TTOX, YF
Symptoms: Chest discomfort, Cough, Hyperhidrosis, Nausea, Presyncope
Clinical narrative: Sweating, severe shaking, coughing, nausea, near fainting, severe tightening of chest.
Age: 18.0
Sex: M
Vaccine: MEN, TTOX, YF
Symptoms: Tremor
Clinical narrative: Sweating, severe shaking, coughing, nausea, near fainting, severe tightening of chest.
Age: 1.34
Sex: M
Vaccine: DTAP, PNC13
Symptoms: Vomiting
Clinical narrative: Vomiting started approx. 2-2 1/2 hours after immunized w/ PREVNAR (#4) DTaP (#4).
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain
Clinical narrative: Patient developed shingles virus a few weeks after administration. Symptoms included blistering and pain.
Age: 0.51
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: Vomiting x12 over 1 hour, 5-6hrs post vaccine given. Pt was observed. Pt had been outside x5 hrs prior.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Eye pruritus, Eye swelling, Herpes zoster, Injection site erythema
Clinical narrative: Pt described red area with blisters at injection site. Dr. diagnosed as shingles 5/28 and prescribed acyclovir - situation resolved. 6/11 Area around both eyes swollen, itchy, red pustules - MEDROL dose pak helping.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site vesicles, Rash pustular
Clinical narrative: Pt described red area with blisters at injection site. Dr. diagnosed as shingles 5/28 and prescribed acyclovir - situation resolved. 6/11 Area around both eyes swollen, itchy, red pustules - MEDROL dose pak helping.
Age: 0.81
Sex: M
Vaccine: PNC13
Symptoms: Otitis media, Pyrexia
Clinical narrative: Persistent fever >5d, with otitis media diagnosed 4d after. Offered amoxicillin but not sure if given.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified amount of patients. Concomitant medication and pertinent medical history were not provided. The healthcare worker reported that the ROTATEQ (lot number, dose, route and frequency were not provided) was exposed to a lowest temperature of 32F for a total of 136 hours over 17 days occurring since 01-JAN-2014. There was also a nurse reported that she was unsure if the ROTATEQ had undergone excursions since 01-JAN-2014 because she stated that they ordered products on a weekly basis. She reported that "some" may have undergone multiple excursions and "others" may have undergone no excursions but she was not exactly sure of which ones. On an unknown dates an unspecified amount of patients were vaccinated with ROTATEQ which were improperly stored. No adverse effect reported. The outcome of the events was unknown. This is one of several reports received from the same source (MARRS# 1406USA006824). Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from an medical assistant refers to a unspecified number of patients (age and gender unknown). On unknown dates the patients were vaccinated with improperly stored VAQTA dose, route of administration and lot# were not reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Decreased appetite, Full blood count normal, Irritability, Nasal discharge discolouration, Pyrexia
Clinical narrative: About 15 hours after vaccines developed fever 102-103, poor feeding, irritability and shaking. ER visit, fluids, defervesced went home. 6/20 developed thick green nasal discharge and continued to have fevers to 103. Last fever 1AM on 6/22. 6/23 doing much better, feeding well.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Tremor, Urine analysis normal
Clinical narrative: About 15 hours after vaccines developed fever 102-103, poor feeding, irritability and shaking. ER visit, fluids, defervesced went home. 6/20 developed thick green nasal discharge and continued to have fevers to 103. Last fever 1AM on 6/22. 6/23 doing much better, feeding well.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site vesicles
Clinical narrative: Mother reported "bubbling up areas" over MMR and Varicella injection sites, appearing like fluid filled sacks. Mother stated they went away quickly. Took child to MD for assessment and areas had no swelling or redness at that time.
Age: 7.0
Sex: F
Vaccine: IPV, TDAP
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: Nausea, vomiting, headache.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth, Pain
Clinical narrative: Redness, inflammation, and warmth at injection site (L) deltoid) mom states it presented on 6/21/14. Pt complains of soreness. Pt is a febrile. Mom has been using cold compress and elevating pt's arm.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site vesicles
Clinical narrative: 24 hours-36 hours after injection, developed redness, blisters and pain at inj. site and up into shoulder. Pain, redness and rash (blisters) are still present 72 hr. later with redness 50 x 100mm and rash area 30 x 50mm. Seen by physician - Rx'd with Acyclovir.
Age: 6.0
Sex: M
Vaccine: MMR
Symptoms: Lymphadenopathy, Mumps antibody test negative, Neck mass
Clinical narrative: Lumps on front and back of neck. Dx: Lymphadenopathy. Amoxicillin 40 mg/5 ml take 10 ml BID. *Pt was seen at express care.
Age: 1.25
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Cyanosis, Full blood count, Musculoskeletal stiffness, Pyrexia, Staring
Clinical narrative: Patient had fever 102.0, gave TYLENOL (mom) and placed in tepid bath. Pt.'s arms and legs became stiff purplish blue, eyes staring lasted about 10-15 sec.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: At site of administration, raised, red, painful. Seen at clinic 6/23, diagnosis is acute cellulitis. Treated with doxycycline 100mg BID x 10 days, BACTRIM 800/160mg BID x 10 days, hydroxyzine 10 mg 2 8H for itching.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Patient received inj. at 2:50 PM on June 19, 2014. She called pharmacy at 5:35 PM stating her upper Rt arm was very swollen. She then went to local emergency room and was treated with ice, Ibuprofen, BENADRYL.
Age: 33.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Medication error, Nausea
Clinical narrative: Nausea, Light headed, Dizziness. MD office gave him another Tdap shot on 6/19 by mistake.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Blood pressure decreased, Dizziness, Nausea, Vomiting
Clinical narrative: One minute after receiving the GARDASIL vaccine, the patient developed dizziness, nausea and abdominal cramps. T 98 BP decreased/cannot be determined - patient subsequently vomited. After 10 mins BP improved, 103/76.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to an unspecified number of patients of unknown ages and genders. On unknown dates the patients were administered with ROTATEQ (lot# and dose not reported) that were stored improperly. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye haemorrhage
Clinical narrative: Bleed in white of left eye on 6/22/14. Not sure if related, but never had this happen before.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. On 06-JUN-2014 the patient was vaccinated with improperly stored PNEUMOVAX 23 (lot # J005067, expiration date 17-JAN-2015) (dose and route unspecified) that was exposed to 63F for 48 hours and then exposed to 66F for 22.5 hours. PNEUMOVAX 23 was found to be unsupported by in-house stability data. No adverse symptoms reported. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Blister, Pyrexia, Rash generalised, Rash vesicular, Scab
Clinical narrative: Case number PHHY2012US099150 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 463531) web site on 01 Nov 2012, with a follow-up information received from Quality Assurance Department (reference number: 302323) on 13 Jun 2014. This report refers to 12 year old male patient. Child's mother had lupus. The patient's medical history and concomitant medications were not reported. On 30 July 2012, he was vaccinated with MENVEO (batch number: M11054A and expiry date: Jan 2013) IM into right arm, BOOSTRIX (batch number: AC52B073CA), IM into left arm, VARIVAX (batch number: 1798AA) subcutaneous into right arm. On 13 Aug 2012, the child had a fever of 101 F and over 100 chickenpox like spots all over body that blistered, dried and crusted. Spots lasted a couple days according to the mother. This all happened 2 weeks post vaccination. The outcome of the events was recovered. Seriousness and causality assessment was not reported. Based on the investigation performed, the QA department stated that, MENVEO vaccine (batch number: M11054A) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow up information received from the Quality Assurance Department (reference number: 302323) on 13 Jun 2014: Updated batch review report.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Adnexa uteri cyst, Antiphospholipid antibodies negative, Blood folate normal, Blood zinc decreased, Borrelia test negative
Clinical narrative: Case number PHHY2013US012449 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 474297) on 08 Feb 2013, with a follow-up information received from Quality Assurance Department (reference number: 211649) on 23 Jun 2014: This report refers to a 67-year-old female patient. Her medical history included hypertension, hyperlipidemia, asthma and scoliosis. Her concomitant medication included Aspirin 81 mg oral daily and Cozaar 50 mg oral daily. She was vaccinated with FLUVIRIN (batch number: 1206101 and expiry date: Jun 2013) intramuscularly in to the left arm along with PNEUMOVAX (other manufacturer, batch number: H013581) intramuscularly in to right arm on 22 Oct 2012. On 31 Oct 2012, she experienced acute onset of chest pain followed by paraplegia and left arm weakness. She was treated with plasmapheresis in Nov 2012. Some arm function was recovered, but she had loss of use of both legs and no sensation from mid-back down. She was discharged to rehab after hospitalization for two weeks. Diagnostic laboratory test done on unspecified date revealed the following: bleed, infarct, hematoma in left sphenoid, ethmoid and frontal sinus disease. Computed tomography (CT, c/a/ p) revealed no evidence of aortic dissection or aneurysm. Large left pelvic was seen; possibly adnexal cyst in a postmenopausal female that raised concern for ovarian malignancy. Non-emergent pelvic sonography advised for further evaluation. No gastrointestinal or gastro-urinal tract obstruction, cholelithiasis and hepatic cysts were observed. Magnetic resonance imaging (MRI) revealed hyperintense T2 signal within spinal cord at C 4-7, which may represent contusion of myelomalacia. Chest X-ray showed clear lungs. There were no magnetic resonance angiography (MRA) and computed tomographic angiography (CTA) done as per the neuroradiology. Ultrasound of the pelvic region showed adnexal cyst with loculation. Vitamin B12 was 486, folate was 12.9, erythrocyte sedimentation rate (ESR) was 32, lyme test was negative, comprehensive antiphospholipid screening and hepatic panel negative was negative, cerebrospinal fluid (CSF) test revealed oligoclonal B, myelin basic protein (MBP) was negative, zinc was 58 and neuromyelitis optica (NMO) was negative. The normal ranges and units for these tests were not reported. Final outcome was reported as condition unchanged as on 15 Nov 2012. No further information about causality and seriousness was provided. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 1206101) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow up information received from the Quality Assurance Department (reference number: 211649) on 23 Jun 2014: Updated batch review report.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: CSF myelin basic protein normal, CSF oligoclonal band present, Chest X-ray normal, Chest pain, Computerised tomogram abnormal
Clinical narrative: Case number PHHY2013US012449 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 474297) on 08 Feb 2013, with a follow-up information received from Quality Assurance Department (reference number: 211649) on 23 Jun 2014: This report refers to a 67-year-old female patient. Her medical history included hypertension, hyperlipidemia, asthma and scoliosis. Her concomitant medication included Aspirin 81 mg oral daily and Cozaar 50 mg oral daily. She was vaccinated with FLUVIRIN (batch number: 1206101 and expiry date: Jun 2013) intramuscularly in to the left arm along with PNEUMOVAX (other manufacturer, batch number: H013581) intramuscularly in to right arm on 22 Oct 2012. On 31 Oct 2012, she experienced acute onset of chest pain followed by paraplegia and left arm weakness. She was treated with plasmapheresis in Nov 2012. Some arm function was recovered, but she had loss of use of both legs and no sensation from mid-back down. She was discharged to rehab after hospitalization for two weeks. Diagnostic laboratory test done on unspecified date revealed the following: bleed, infarct, hematoma in left sphenoid, ethmoid and frontal sinus disease. Computed tomography (CT, c/a/ p) revealed no evidence of aortic dissection or aneurysm. Large left pelvic was seen; possibly adnexal cyst in a postmenopausal female that raised concern for ovarian malignancy. Non-emergent pelvic sonography advised for further evaluation. No gastrointestinal or gastro-urinal tract obstruction, cholelithiasis and hepatic cysts were observed. Magnetic resonance imaging (MRI) revealed hyperintense T2 signal within spinal cord at C 4-7, which may represent contusion of myelomalacia. Chest X-ray showed clear lungs. There were no magnetic resonance angiography (MRA) and computed tomographic angiography (CTA) done as per the neuroradiology. Ultrasound of the pelvic region showed adnexal cyst with loculation. Vitamin B12 was 486, folate was 12.9, erythrocyte sedimentation rate (ESR) was 32, lyme test was negative, comprehensive antiphospholipid screening and hepatic panel negative was negative, cerebrospinal fluid (CSF) test revealed oligoclonal B, myelin basic protein (MBP) was negative, zinc was 58 and neuromyelitis optica (NMO) was negative. The normal ranges and units for these tests were not reported. Final outcome was reported as condition unchanged as on 15 Nov 2012. No further information about causality and seriousness was provided. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 1206101) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow up information received from the Quality Assurance Department (reference number: 211649) on 23 Jun 2014: Updated batch review report.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Haemorrhage, Infarction, Injected limb mobility decreased, Liver function test normal, Muscular weakness
Clinical narrative: Case number PHHY2013US012449 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 474297) on 08 Feb 2013, with a follow-up information received from Quality Assurance Department (reference number: 211649) on 23 Jun 2014: This report refers to a 67-year-old female patient. Her medical history included hypertension, hyperlipidemia, asthma and scoliosis. Her concomitant medication included Aspirin 81 mg oral daily and Cozaar 50 mg oral daily. She was vaccinated with FLUVIRIN (batch number: 1206101 and expiry date: Jun 2013) intramuscularly in to the left arm along with PNEUMOVAX (other manufacturer, batch number: H013581) intramuscularly in to right arm on 22 Oct 2012. On 31 Oct 2012, she experienced acute onset of chest pain followed by paraplegia and left arm weakness. She was treated with plasmapheresis in Nov 2012. Some arm function was recovered, but she had loss of use of both legs and no sensation from mid-back down. She was discharged to rehab after hospitalization for two weeks. Diagnostic laboratory test done on unspecified date revealed the following: bleed, infarct, hematoma in left sphenoid, ethmoid and frontal sinus disease. Computed tomography (CT, c/a/ p) revealed no evidence of aortic dissection or aneurysm. Large left pelvic was seen; possibly adnexal cyst in a postmenopausal female that raised concern for ovarian malignancy. Non-emergent pelvic sonography advised for further evaluation. No gastrointestinal or gastro-urinal tract obstruction, cholelithiasis and hepatic cysts were observed. Magnetic resonance imaging (MRI) revealed hyperintense T2 signal within spinal cord at C 4-7, which may represent contusion of myelomalacia. Chest X-ray showed clear lungs. There were no magnetic resonance angiography (MRA) and computed tomographic angiography (CTA) done as per the neuroradiology. Ultrasound of the pelvic region showed adnexal cyst with loculation. Vitamin B12 was 486, folate was 12.9, erythrocyte sedimentation rate (ESR) was 32, lyme test was negative, comprehensive antiphospholipid screening and hepatic panel negative was negative, cerebrospinal fluid (CSF) test revealed oligoclonal B, myelin basic protein (MBP) was negative, zinc was 58 and neuromyelitis optica (NMO) was negative. The normal ranges and units for these tests were not reported. Final outcome was reported as condition unchanged as on 15 Nov 2012. No further information about causality and seriousness was provided. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 1206101) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow up information received from the Quality Assurance Department (reference number: 211649) on 23 Jun 2014: Updated batch review report.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Nuclear magnetic resonance imaging spinal abnormal, Paranasal sinus haematoma, Paraplegia, Plasmapheresis, Red blood cell sedimentation rate increased
Clinical narrative: Case number PHHY2013US012449 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 474297) on 08 Feb 2013, with a follow-up information received from Quality Assurance Department (reference number: 211649) on 23 Jun 2014: This report refers to a 67-year-old female patient. Her medical history included hypertension, hyperlipidemia, asthma and scoliosis. Her concomitant medication included Aspirin 81 mg oral daily and Cozaar 50 mg oral daily. She was vaccinated with FLUVIRIN (batch number: 1206101 and expiry date: Jun 2013) intramuscularly in to the left arm along with PNEUMOVAX (other manufacturer, batch number: H013581) intramuscularly in to right arm on 22 Oct 2012. On 31 Oct 2012, she experienced acute onset of chest pain followed by paraplegia and left arm weakness. She was treated with plasmapheresis in Nov 2012. Some arm function was recovered, but she had loss of use of both legs and no sensation from mid-back down. She was discharged to rehab after hospitalization for two weeks. Diagnostic laboratory test done on unspecified date revealed the following: bleed, infarct, hematoma in left sphenoid, ethmoid and frontal sinus disease. Computed tomography (CT, c/a/ p) revealed no evidence of aortic dissection or aneurysm. Large left pelvic was seen; possibly adnexal cyst in a postmenopausal female that raised concern for ovarian malignancy. Non-emergent pelvic sonography advised for further evaluation. No gastrointestinal or gastro-urinal tract obstruction, cholelithiasis and hepatic cysts were observed. Magnetic resonance imaging (MRI) revealed hyperintense T2 signal within spinal cord at C 4-7, which may represent contusion of myelomalacia. Chest X-ray showed clear lungs. There were no magnetic resonance angiography (MRA) and computed tomographic angiography (CTA) done as per the neuroradiology. Ultrasound of the pelvic region showed adnexal cyst with loculation. Vitamin B12 was 486, folate was 12.9, erythrocyte sedimentation rate (ESR) was 32, lyme test was negative, comprehensive antiphospholipid screening and hepatic panel negative was negative, cerebrospinal fluid (CSF) test revealed oligoclonal B, myelin basic protein (MBP) was negative, zinc was 58 and neuromyelitis optica (NMO) was negative. The normal ranges and units for these tests were not reported. Final outcome was reported as condition unchanged as on 15 Nov 2012. No further information about causality and seriousness was provided. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 1206101) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow up information received from the Quality Assurance Department (reference number: 211649) on 23 Jun 2014: Updated batch review report.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Sensory loss, Sinus disorder, Ultrasound pelvis abnormal, Vitamin B12 normal
Clinical narrative: Case number PHHY2013US012449 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 474297) on 08 Feb 2013, with a follow-up information received from Quality Assurance Department (reference number: 211649) on 23 Jun 2014: This report refers to a 67-year-old female patient. Her medical history included hypertension, hyperlipidemia, asthma and scoliosis. Her concomitant medication included Aspirin 81 mg oral daily and Cozaar 50 mg oral daily. She was vaccinated with FLUVIRIN (batch number: 1206101 and expiry date: Jun 2013) intramuscularly in to the left arm along with PNEUMOVAX (other manufacturer, batch number: H013581) intramuscularly in to right arm on 22 Oct 2012. On 31 Oct 2012, she experienced acute onset of chest pain followed by paraplegia and left arm weakness. She was treated with plasmapheresis in Nov 2012. Some arm function was recovered, but she had loss of use of both legs and no sensation from mid-back down. She was discharged to rehab after hospitalization for two weeks. Diagnostic laboratory test done on unspecified date revealed the following: bleed, infarct, hematoma in left sphenoid, ethmoid and frontal sinus disease. Computed tomography (CT, c/a/ p) revealed no evidence of aortic dissection or aneurysm. Large left pelvic was seen; possibly adnexal cyst in a postmenopausal female that raised concern for ovarian malignancy. Non-emergent pelvic sonography advised for further evaluation. No gastrointestinal or gastro-urinal tract obstruction, cholelithiasis and hepatic cysts were observed. Magnetic resonance imaging (MRI) revealed hyperintense T2 signal within spinal cord at C 4-7, which may represent contusion of myelomalacia. Chest X-ray showed clear lungs. There were no magnetic resonance angiography (MRA) and computed tomographic angiography (CTA) done as per the neuroradiology. Ultrasound of the pelvic region showed adnexal cyst with loculation. Vitamin B12 was 486, folate was 12.9, erythrocyte sedimentation rate (ESR) was 32, lyme test was negative, comprehensive antiphospholipid screening and hepatic panel negative was negative, cerebrospinal fluid (CSF) test revealed oligoclonal B, myelin basic protein (MBP) was negative, zinc was 58 and neuromyelitis optica (NMO) was negative. The normal ranges and units for these tests were not reported. Final outcome was reported as condition unchanged as on 15 Nov 2012. No further information about causality and seriousness was provided. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 1206101) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow up information received from the Quality Assurance Department (reference number: 211649) on 23 Jun 2014: Updated batch review report.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Angina pectoris, Chest pain, Dizziness, Nausea, Vomiting
Clinical narrative: Case number PHHY2013US012023 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 474469) website on 08 Feb 2013 with a follow up information received from the quality assurance department (QA reference number: 210460) on 22 Jun 2014. This report refers to a 46-year-old male patient. His medical history included allergy to morphine, hypertension, diabetes mellitus, end stage renal disease (ESRD), secondary to Autosomal Dominant Polycystic Kidney Disease (ADPKD) and kidney transplantation in 2008 for which he was receiving immunosuppressive tacrolimus and Cellcept. He was vaccinated with FLUVIRIN (batch number: 1205801, expiry date: 30 Jun 2013) into right arm on 05 Nov 2012. It was reported that about 15 minutes after vaccination, he had nausea/vomiting, dizziness and chest pain (anginal pain). He visited the emergency room for these events. The outcome of the events was reported as recovered as of unspecified date. The seriousness and causality of the events were not reported. Upon follow up information received from the quality assurance department (QA reference number: 210460) on 22 Jun 2014, it was reported that based on the document review it was concluded that FLUVIRIN batch number 1205801 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. No other information was available. Follow up information received from the quality assurance department on 22 Jun 2014: Batch summary and expiry date updated.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram head normal, Dysarthria
Clinical narrative: Case number PHHY2013US012134 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 474586) web site on 08 Feb 2013, with a follow-up information from Quality Assurance Department (reference number: 210535) on 22 Jun 2014. This report refers to a 38-year-old female patient. Her current conditions included migraine headaches and upper respiratory infection. Her concomitant medications included Maxalt used for migraine and Motrin for headaches. Her vaccination history included administration of seasonal influenza vaccine (manufacturer and batch number: not reported) which were well tolerated. She was vaccinated with FLUVIRIN (batch number: 12254P and expiry date: 31 May 2013) intramuscularly on to right arm on 03 Oct 2012. On the same day, approximately 2 hours after vaccination, she developed gradual onset of dysarthria. She did not have headache or facial drop. She was evaluated by doctor in occupational health and was sent to emergency room to rule out possible transient ischemic attack (TIA). Computerised Tomography (CT) scan of head was performed on 03 Oct 2012 and no acute pathology was reported. She was treated with Benadryl 25 mg. It was reported that the symptoms resolved within 2 hours. The outcome of the events was reported as complete recovery. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 12254P) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow up information received from the Quality Assurance Department (reference number: 210535) on 22 Jun 2014: Updated batch review report.
Age: 74.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Thrombosis, Upper extremity mass
Clinical narrative: Case number PHHY2013US012066 is an initial spontaneous report received from vaccine adverse event reporting system website (VAERS reference number: 475003) on 08 Feb 2013 with a follow up information received from the quality assurance department (QA reference number: 211114) on 22 Jun 2014. This case refers to a 74-year-old male patient. His concomitant medication included of lisinopril. He was vaccinated with FLUVIRIN (batch number: 1205101, expiry date: 30 Jun 2013) intramuscularly in his right arm on 30 Oct 2012. On the same day, he was also vaccinated with PNEUMOVAX (other manufacturer, batch number: 1706AA) intramuscularly in left arm. A couple of days after vaccination he noticed a "lump/clot in other part of arm". He visited his primary care physician due to these events. The physician told the patient to apply heat on the bump thrice daily. As of 19 Nov 2012 the events were ongoing. The seriousness and causality were not reported. Upon follow up information received from the quality assurance department (QA reference number: 211114) on 22 Jun 2014 it was reported that based on the document review, it was concluded that FLUVIRIN batch number 1205101 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. No other information was available. Follow up information received from the quality assurance department (QA reference number: 211114) on 22 Jun 2014: Batch summary and expiry date updated.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site joint movement impairment, Injection site pain, Musculoskeletal pain, Nuclear magnetic resonance imaging, Tendonitis
Clinical narrative: Case number PHHY2013US012122 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 475087) web site on 08 Feb 2013, with a follow-up information received from Quality Assurance Department (reference number: 210429) on 22 Jun 2014. This report refers to a 38-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1205301 and expiry date: Jun 2013) intramuscularly on to left arm on 01 Nov 2012. On the same day, she had stabbing pain in the posterior left shoulder and decreased range of motion which lasted for two and a half weeks. She did not have fever and erythema. She went to physician and was sent for a magnetic resonance imaging (MRI) of the left shoulder. She was diagnosed with tendonitis which was reported as reaction to flu vaccination. The outcome of the events was reported as condition unchanged. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 1205301) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow up information received from the Quality Assurance Department (reference number: 210429) on 22 Jun 2014: Updated batch review report.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccination complication
Clinical narrative: Case number PHHY2013US012122 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 475087) web site on 08 Feb 2013, with a follow-up information received from Quality Assurance Department (reference number: 210429) on 22 Jun 2014. This report refers to a 38-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1205301 and expiry date: Jun 2013) intramuscularly on to left arm on 01 Nov 2012. On the same day, she had stabbing pain in the posterior left shoulder and decreased range of motion which lasted for two and a half weeks. She did not have fever and erythema. She went to physician and was sent for a magnetic resonance imaging (MRI) of the left shoulder. She was diagnosed with tendonitis which was reported as reaction to flu vaccination. The outcome of the events was reported as condition unchanged. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 1205301) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow up information received from the Quality Assurance Department (reference number: 210429) on 22 Jun 2014: Updated batch review report.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Body temperature increased, Chills, Dizziness, Full blood count normal
Clinical narrative: Case number PHHY2013US012148 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 475134) web site on 08 Feb 2013, with a follow-up information received from Quality Assurance Department (reference number: 211584) on 22 Jun 2014. This report refers to a 45-year-old female patient. Her medical history was not reported and concomitant medications included SYNTHROID, gabapentin and VIVELLE DOT. She was vaccinated with FLUVIRIN (batch number: 1205301 and expiry date: Jun 2013) intramuscularly on to right limb on 26 Oct 2012. On the same day, approximately 2 hours after the shot, she began to get very dizzy. She was unable to walk. She was lying down with her eyes closed as she was feeling dizzy. She was taken to her family doctor where they checked her. While she was there, she began having severe tremors or what they called rigors. It was reported that her blood pressure was measured as 96/60 (units unspecified) by a nurse initially. It was reported that her blood pressure and body temperature were usually quite low. Later at the doctor's office, her heart rate went up to 140 (normal values and units not reported). Her temperature was initially measured as 97 degrees and after the rigors it was 100 degrees. She had a blood test done and her complete blood count was normal. She was watched for a while and by the time she left, her blood pressure and temperature became normal. It was reported that the dizziness continued for the rest of the day, but everything else stopped. She became normal the next day. The final outcome of the events was reported as complete recovery. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 1205301) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow up information received from the Quality Assurance Department (reference number: 211584) on 22 Jun 2014: Updated batch review report.