chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and pertinent medical history were not reported. On unknown dates, the patients were vaccinated with GARDASIL 9 (dose, route and site not reported), Lot# L014415 with expiration date on 25-JUL-2017 or Lot# L045711 with expiration date on 08-MAY-2017, that on an unspecified date were improperly stored at -1.7 C during 24 hours. It was reported that the vaccine did not experienced previous temperature excursion. It was unknown if the patients sought medical attention. No product quality complain was involved. This is one of several reports received from the same source. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions and pertinent medical history were not reported. On unknown dates, the patients were vaccinated with RECOMBIVAX HB (dose, route and site reported) Lot # L020157 with expiration date on 12-MAR-2018, Lot # K010216 with expiration date on 17-SEP-2016, that on an unspecified date were improperly stored at -1.7 C during 24 hours. It was reported that the vaccine did not experienced previous temperature excursion. It was unknown if the patient sought medical attention. No product quality complain was involved. This is one of several reports received from the same source. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions and pertinent medical history were not reported. On unknown dates, the patients were vaccinated with PEDVAXHIB (dose, route and site not reported) lot # J010382 with expiration date on 28-MAY-2016, that on an unspecified date was improperly stored at -1.7 C during 24 hours. It was reported that the vaccine did not experienced previous temperature excursion. It was unknown if the patients sought medical attention. No product quality complain was involved. This is one of several reports received from the same source. Additional information is not expected as the reporter did not wish further contact.
Age: 53.0
Sex: F
Vaccine: PNC, VARZOS
Symptoms: Cellulitis, Medication error
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse, via a Pfizer representative (2016046434), referring to a 53 year old female patient. Information about the patient's medical history and concurrent conditions was not provided. On 08-DEC-2015, the patient was vaccinated at a pharmacy, with a dose of ZOSTAVAX, in the deltoid (unsure if left or right arm). At the same time the patient was vaccinated with a dose of PREVNAR in the same deltoid muscle (administration route, lot numbers and expiration dates were not provided for both vaccines). No concomitant therapies were reported. On an unknown date in December 2015, the patient developed cellulitis on the arm that the vaccines were administered in. The cellulitis also went up into her neck. The patient was prescribed an oral antibiotic from the emergency room, as treatment for the cellulitis. The outcome of cellulitis was unknown at the time of this report. The reporter considered cellulitis to be related to ZOSTAVAX. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Erythema, Hyperaesthesia, Pain in extremity, Pruritus, Screaming
Clinical narrative: After being given flu shot (combiant/inactive) (eating regular diet with no other medications) at 1:30 PM...at 8:PM starts Severe itching and burning skin, large hives, whelps all over body beginning on back, stomach, face..quickly spread to all other body parts. Went to ER. Given Benadryl 2tsp every 6 hrs all night. On 03/18/2016 at at 10:00 PM severe itching and painful feet...given 2 tsp Benadryl..feet are completely red on soles and warm to touch. Tried to soak feet but water burns her (warm or cold water has same reaction) and child screams in pain. We dry feet, lay her comfortably with feet propped up for apx 45 min. apply dermisil lotion. Redness fades except for toes, heel and pad under big toe after 2 hours. Still painful to touch. Will go to clinic in AM, 03/21/2016 if nothing else occurs before that requires emergency visit to hospital again.
Age: 6.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Skin burning sensation, Skin warm, Urticaria
Clinical narrative: After being given flu shot (combiant/inactive) (eating regular diet with no other medications) at 1:30 PM...at 8:PM starts Severe itching and burning skin, large hives, whelps all over body beginning on back, stomach, face..quickly spread to all other body parts. Went to ER. Given Benadryl 2tsp every 6 hrs all night. On 03/18/2016 at at 10:00 PM severe itching and painful feet...given 2 tsp Benadryl..feet are completely red on soles and warm to touch. Tried to soak feet but water burns her (warm or cold water has same reaction) and child screams in pain. We dry feet, lay her comfortably with feet propped up for apx 45 min. apply dermisil lotion. Redness fades except for toes, heel and pad under big toe after 2 hours. Still painful to touch. Will go to clinic in AM, 03/21/2016 if nothing else occurs before that requires emergency visit to hospital again.
Age: 6.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Erythema, Pain in extremity, Pruritus, Screaming, Skin burning sensation
Clinical narrative: After being given flu shot (combiant/inactive) (eating regular diet with no other medications) at 1:30 PM...at 8:PM starts Severe itching and burning skin, large hives, whelps all over body beginning on back, stomach, face..quickly spread to all other body parts. Went to ER. Given Benadryl 2tsp every 6 hrs all night. On 03/18/2016 at at 10:00 PM severe itching and painful feet...given 2 tsp Benadryl..feet are completely red on soles and warm to touch. Tried to soak feet but water burns her (warm or cold water has same reaction) and child screams in pain. We dry feet, lay her comfortably with feet propped up for apx 45 min. apply dermisil lotion. Redness fades except for toes, heel and pad under big toe after 2 hours. Still painful to touch. Will go to clinic in AM, 03/21/2016 if nothing else occurs before that requires emergency visit to hospital again.
Age: 6.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Skin warm, Tenderness, Urticaria
Clinical narrative: After being given flu shot (combiant/inactive) (eating regular diet with no other medications) at 1:30 PM...at 8:PM starts Severe itching and burning skin, large hives, whelps all over body beginning on back, stomach, face..quickly spread to all other body parts. Went to ER. Given Benadryl 2tsp every 6 hrs all night. On 03/18/2016 at at 10:00 PM severe itching and painful feet...given 2 tsp Benadryl..feet are completely red on soles and warm to touch. Tried to soak feet but water burns her (warm or cold water has same reaction) and child screams in pain. We dry feet, lay her comfortably with feet propped up for apx 45 min. apply dermisil lotion. Redness fades except for toes, heel and pad under big toe after 2 hours. Still painful to touch. Will go to clinic in AM, 03/21/2016 if nothing else occurs before that requires emergency visit to hospital again.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Patient developed Shingles and was diagnosed as such despite the fact that she had never had Chicken Pox, only the vaccination.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Headache, Nausea, Vomiting
Clinical narrative: Patient is experiencing headache, chills (not sure if feverish), diarrhea, vomiting, and nausea.
Age: 82.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Pruritus
Clinical narrative: Patient says his arm was itchy today so he looked at it and the injection site had a red rind around the area and he said it was a hard knot under the skin.
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Dyskinesia, Electrocardiogram normal, Electroencephalogram normal, Full blood count normal, Metabolic function test normal
Clinical narrative: Seizure, with moving the head side to side. Second seizure occurred on 3/19, with moving the head and arms in rhythmic fashion.
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Seizure
Clinical narrative: Seizure, with moving the head side to side. Second seizure occurred on 3/19, with moving the head and arms in rhythmic fashion.
Age: 1.34
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: High Fever (Tmax 104.1) x 76 hours. Then faint rash to face back and chest.
Age: 75.0
Sex: M
Vaccine: PNC13
Symptoms: Asthenia, Influenza, Influenza virus test negative, Pain
Clinical narrative: Flu symptoms, body aches, no energy.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Insomnia, Mobility decreased, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Arm very stiff.  Increasing stiffness and sharp pain.  Stabbing pain became unbearable until I could no longer sleep nor lift/move my arm.  Went to orthopaedic doctor on 12/30/15.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient noticed next morning the day after receiving vaccine redness,  swelling, warm to touch around injection site and spread down arm but not to elbow. Patient did not take anything for treatment, resolved on its own.
Age: 0.38
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Decreased appetite, Eczema, Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: Very sleepy, lack of nursing, large hard red lump at injection site lasting 6 weeks, patches of eczema behind knee that soon spread to other knee, thighs, stomach, and chest.
Age: 0.38
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Somnolence
Clinical narrative: Very sleepy, lack of nursing, large hard red lump at injection site lasting 6 weeks, patches of eczema behind knee that soon spread to other knee, thighs, stomach, and chest.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Abasia, Abdominal pain upper, Eructation, Fatigue, Gait disturbance
Clinical narrative: Child began to feel nausea, began to projectile vomit. Complained of her feet tingling. Went to sleep, woke up on 1/1/16 very sluggish and fatigued. Fell asleep around 2:00, went to wake her up and she said her whole body was tingling. She attempted to get up and walk and could barely move her legs. Could only shuffle her feet. Tingles were also in her face. Went to local ER where she threw up again and still could not walk. Treated with IV fluids. Was in ER from 6:00 pm till midnight. Now experiencing stomach pain, excessive belching, nausea and being put on acid reflux medications. This was her 2nd shot. In hind sight I now know she reacted to the first one with flu like and bronchitis like symptoms and missed a week of school in August 2015, after the first shot was given.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Nuclear magnetic resonance imaging, Paraesthesia, Sluggishness, Vomiting projectile
Clinical narrative: Child began to feel nausea, began to projectile vomit. Complained of her feet tingling. Went to sleep, woke up on 1/1/16 very sluggish and fatigued. Fell asleep around 2:00, went to wake her up and she said her whole body was tingling. She attempted to get up and walk and could barely move her legs. Could only shuffle her feet. Tingles were also in her face. Went to local ER where she threw up again and still could not walk. Treated with IV fluids. Was in ER from 6:00 pm till midnight. Now experiencing stomach pain, excessive belching, nausea and being put on acid reflux medications. This was her 2nd shot. In hind sight I now know she reacted to the first one with flu like and bronchitis like symptoms and missed a week of school in August 2015, after the first shot was given.
Age: 41.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Amino acid level, Antiphospholipid antibodies, Biopsy, Blood copper, Blood folate
Clinical narrative: I began to develop a severe tingling/electrical feeling in my left leg on Oct 23rd.  Several days later the same feeling began in my right leg and then by Oct 31, 2015 my arms and legs. In addition pain has developed across all extremities.  Symptoms remain to present day (March 19, 2016). I have been clinically diagnosed with peripheral neuropathy and there appears to be no cure to my current condition.
Age: 41.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Blood test, CSF test, Ceruloplasmin, Electromyogram, Nerve conduction studies
Clinical narrative: I began to develop a severe tingling/electrical feeling in my left leg on Oct 23rd.  Several days later the same feeling began in my right leg and then by Oct 31, 2015 my arms and legs. In addition pain has developed across all extremities.  Symptoms remain to present day (March 19, 2016). I have been clinically diagnosed with peripheral neuropathy and there appears to be no cure to my current condition.
Age: 41.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Neuropathy peripheral, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal, Nuclear magnetic resonance imaging thoracic, Pain in extremity
Clinical narrative: I began to develop a severe tingling/electrical feeling in my left leg on Oct 23rd.  Several days later the same feeling began in my right leg and then by Oct 31, 2015 my arms and legs. In addition pain has developed across all extremities.  Symptoms remain to present day (March 19, 2016). I have been clinically diagnosed with peripheral neuropathy and there appears to be no cure to my current condition.
Age: 41.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Paraesthesia, Vitamin B12
Clinical narrative: I began to develop a severe tingling/electrical feeling in my left leg on Oct 23rd.  Several days later the same feeling began in my right leg and then by Oct 31, 2015 my arms and legs. In addition pain has developed across all extremities.  Symptoms remain to present day (March 19, 2016). I have been clinically diagnosed with peripheral neuropathy and there appears to be no cure to my current condition.
Age: 41.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Antiphospholipid antibodies, Biopsy, Blood copper, Blood folate, Blood test
Clinical narrative: I began to develop a severe tingling/electrical feeling in my left leg on Oct 23rd.  Several days later the same feeling began in my right leg and then by Oct 31, 2015 my arms and legs. In addition pain has developed across all extremities.  Symptoms remain to present day (March 19, 2016). I have been clinically diagnosed with peripheral neuropathy and there appears to be no cure to my current condition.
Age: 41.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: CSF test, Ceruloplasmin, Electromyogram, Laboratory test, Nerve conduction studies
Clinical narrative: I began to develop a severe tingling/electrical feeling in my left leg on Oct 23rd.  Several days later the same feeling began in my right leg and then by Oct 31, 2015 my arms and legs. In addition pain has developed across all extremities.  Symptoms remain to present day (March 19, 2016). I have been clinically diagnosed with peripheral neuropathy and there appears to be no cure to my current condition.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site inflammation, Injection site swelling
Clinical narrative: Inflammation and swelling in area where vaccine was administered, approximately 2 inch diameter. Advised pt to take BENADRYL.
Age: 4.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a pharmacist referring to a 4 year old male patient. The patient's concurrent conditions and medical history were not reported. On 04-MAR-2016 the patient was inadvertently administered a unspecified dose of ZOSTAVAX (lot # L034724 with expiration date 09-DEC-2016, dose and route were unknown) instead of a 0.5ml dose of PROQUAD (Merck). No adverse effects reported. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician referring to a female patient who is currently 34 year old. The patient's concurrent conditions and medical history were not reported. The patient was pregnancy with the date of last menstrual period was 19-AUG-2015 and the estimated date of delivery was 25-MAY-2016. The pregnancy outcome was pending. On 02-MAR-2016, the patient was vaccinated with GARDASIL (dose, frequency and route were unknown) in error. The woman was indicated to received Tdap. The physician stated that the medical assistant who made the error didn't tell her why the error occurred. The physician was not able to provide the lot number and expiration date of the dose of GARDASIL that the patient received at the time of this call. The patient had not experienced ill effects from this event and she was "feeling fine". Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unknown number of patients. The patients' concurrent conditions and medical history were not reported. Since 09-FEB-2016 the patients were vaccinated with GARDASIL 9 (lot # L013429 with expiration date 21-JUL-2017, dose, frequency and route were unknown) which were improperly stored. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a certified medical assistant concerning a patient of unknown age. On 10-MAR-2016 the patient was vaccinated with an expired dose of ZOSTAVAX (lot number was L000461, expiry date 08-MAR-2016) with no known temperature excursions. The reporter was not sure if the dose was administered but it might have been. No adverse effects reported. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Asthenia, Fall, Gait disturbance, Guillain-Barre syndrome, Immunoglobulin therapy
Clinical narrative: Malaise, blood in nose, sinus infection, unsteady gait; 8/19 falling ER visit-low electrolytes; 8/21 totally limp symptoms worsen hospitalized; 8/28 ICU for 1 week specialist determined Guillain-Barre' syndrome; Continuous rehab; progressively getting better per patient.
Age: 64.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Intensive care, Malaise, Nerve conduction studies abnormal
Clinical narrative: Malaise, blood in nose, sinus infection, unsteady gait; 8/19 falling ER visit-low electrolytes; 8/21 totally limp symptoms worsen hospitalized; 8/28 ICU for 1 week specialist determined Guillain-Barre' syndrome; Continuous rehab; progressively getting better per patient.
Age: 64.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Blood electrolytes decreased, Epistaxis, Fall, Gait disturbance, Guillain-Barre syndrome
Clinical narrative: Malaise, blood in nose, sinus infection, unsteady gait; 8/19 falling ER visit-low electrolytes; 8/21 totally limp symptoms worsen hospitalized; 8/28 ICU for 1 week specialist determined Guillain-Barre' syndrome; Continuous rehab; progressively getting better per patient.
Age: 64.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Hypotonia, Intensive care, Malaise, Sinusitis
Clinical narrative: Malaise, blood in nose, sinus infection, unsteady gait; 8/19 falling ER visit-low electrolytes; 8/21 totally limp symptoms worsen hospitalized; 8/28 ICU for 1 week specialist determined Guillain-Barre' syndrome; Continuous rehab; progressively getting better per patient.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to currently a 72 year old female patient. The patient's medical history included Lyme Disease. In approximately January 2016, also reported as 2.5 to 3 months  ago, the patient was vaccinated with ZOSTAVAX (dose, route and site of administration, lot # and expiry date were not reported). Concomitant therapies included a lot of unspecified antibiotics and antiviral medications. In 2016, also reported as  a week or so after receiving ZOSTAVAX, the patient developed a rash towards her elbow. The rash was itchy and annoying and was located right above the elbow. The pharmacist also reported that the patient had excess fat in the back of her arm. She referred the patient to consult her physician, who prescribed ZOSTAVAX for her. The outcome of the event was reported as not recovered. The patient sought medical attention by seeing the pharmacist. The relatedness between the events and ZOSTAVAX was not provided. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash pruritic
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to currently a 72 year old female patient. The patient's medical history included Lyme Disease. In approximately January 2016, also reported as 2.5 to 3 months  ago, the patient was vaccinated with ZOSTAVAX (dose, route and site of administration, lot # and expiry date were not reported). Concomitant therapies included a lot of unspecified antibiotics and antiviral medications. In 2016, also reported as  a week or so after receiving ZOSTAVAX, the patient developed a rash towards her elbow. The rash was itchy and annoying and was located right above the elbow. The pharmacist also reported that the patient had excess fat in the back of her arm. She referred the patient to consult her physician, who prescribed ZOSTAVAX for her. The outcome of the event was reported as not recovered. The patient sought medical attention by seeing the pharmacist. The relatedness between the events and ZOSTAVAX was not provided. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incorrect route of drug administration, Injection site induration
Clinical narrative: Induration 3 to 5 cm; dark red firm wheal. Per patient she has cellulitis w/abscess and was treated w/BACTRIM.
Age: 48.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abscess, Cellulitis, Erythema, Induration, Urticaria
Clinical narrative: Induration 3 to 5 cm; dark red firm wheal. Per patient she has cellulitis w/abscess and was treated w/BACTRIM.
Age: 30.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Back pain, CSF protein increased, CSF white blood cell count negative, Caesarean section, Electromyogram abnormal
Clinical narrative: Patient presented to Labor and Delivery triage the morning of March 11th, 2016 with low back pain and extremity pain.  No motor loss or sensory loss.  Return to triage March 14th with same sxms but now with addition of lower ext greater than upper ext weakness with paresthesias. Stat MRI was WNL, EMG by Neurology confirmed Guillain Barre.  Patient had worsening protection of airway.  STAT LTCS done under general anesthesia.  Patient as of today (3/21/2016) remains on ventilation and in ICU, stable.
Age: 30.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Exposure during pregnancy, Guillain-Barre syndrome, Intensive care, Mechanical ventilation, Muscular weakness
Clinical narrative: Patient presented to Labor and Delivery triage the morning of March 11th, 2016 with low back pain and extremity pain.  No motor loss or sensory loss.  Return to triage March 14th with same sxms but now with addition of lower ext greater than upper ext weakness with paresthesias. Stat MRI was WNL, EMG by Neurology confirmed Guillain Barre.  Patient had worsening protection of airway.  STAT LTCS done under general anesthesia.  Patient as of today (3/21/2016) remains on ventilation and in ICU, stable.
Age: 30.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Nuclear magnetic resonance imaging normal, Obstructive airways disorder, Pain in extremity, Paraesthesia
Clinical narrative: Patient presented to Labor and Delivery triage the morning of March 11th, 2016 with low back pain and extremity pain.  No motor loss or sensory loss.  Return to triage March 14th with same sxms but now with addition of lower ext greater than upper ext weakness with paresthesias. Stat MRI was WNL, EMG by Neurology confirmed Guillain Barre.  Patient had worsening protection of airway.  STAT LTCS done under general anesthesia.  Patient as of today (3/21/2016) remains on ventilation and in ICU, stable.
Age: 30.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Abasia, Activities of daily living impaired, CSF protein increased, Caesarean section, Dysphagia
Clinical narrative: Patient presented to Labor and Delivery triage the morning of March 11th, 2016 with low back pain and extremity pain.  No motor loss or sensory loss.  Return to triage March 14th with same sxms but now with addition of lower ext greater than upper ext weakness with paresthesias. Stat MRI was WNL, EMG by Neurology confirmed Guillain Barre.  Patient had worsening protection of airway.  STAT LTCS done under general anesthesia.  Patient as of today (3/21/2016) remains on ventilation and in ICU, stable.
Age: 30.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Dysstasia, Exposure during pregnancy, Gastrointestinal tube insertion, Guillain-Barre syndrome, Mechanical ventilation
Clinical narrative: Patient presented to Labor and Delivery triage the morning of March 11th, 2016 with low back pain and extremity pain.  No motor loss or sensory loss.  Return to triage March 14th with same sxms but now with addition of lower ext greater than upper ext weakness with paresthesias. Stat MRI was WNL, EMG by Neurology confirmed Guillain Barre.  Patient had worsening protection of airway.  STAT LTCS done under general anesthesia.  Patient as of today (3/21/2016) remains on ventilation and in ICU, stable.
Age: 30.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Muscular weakness, Paraesthesia
Clinical narrative: Patient presented to Labor and Delivery triage the morning of March 11th, 2016 with low back pain and extremity pain.  No motor loss or sensory loss.  Return to triage March 14th with same sxms but now with addition of lower ext greater than upper ext weakness with paresthesias. Stat MRI was WNL, EMG by Neurology confirmed Guillain Barre.  Patient had worsening protection of airway.  STAT LTCS done under general anesthesia.  Patient as of today (3/21/2016) remains on ventilation and in ICU, stable.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Headache, Pallor
Clinical narrative: This spontaneous report as received from a nurse refers to a 11 year old female patient. No concurrent condition or medical history was reported. On 08-JAN-2016, the patient was vaccinated with first dose of GARDASIL 9 (dose 1, lot # L020015, exp. 16-AUG-2017, intramuscular). The patient experienced few symptoms of headache, dizziness and becoming white but did not experience any hearing issues. On 11-MAR-2016, the patient was vaccinated with second dose of GARDASIL 9. The concomitant therapy included unspecified allergy medicine. On 11-MAR-2016, the patient experienced an instant headache, became dizzy and completely white before the nurse had even finished pushing the dose. The nurse lifted the patient's feet applied a cold cloth and monitored the patient for 20 minutes in the office. The patient recovered from the symptoms a few hours later after leaving the office on 11-MAR-2016. The causality assessment was not reported. No product quality issue was involved. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a 60 year-old female patient, who was a medical assistant via a company representative, and refers to herself. The patient's pertinent medical history included osteoporosis and Raynaud's disease. No information about the patient's drug reactions/allergies and concomitant medications was reported. On 16-JUN-2015, the patient was vaccinated with a dose of ZOSTAVAX injection (dose, lot #, expiry date, route of administration and anatomical location were not specified). On 14-JUL-2015, 4 weeks after the vaccination with ZOSTAVAX, the patient experienced mild case of shingles. The patient sought medical attention and visited a doctor. She was prescribed prednisone (manufacturer unknown) and acyclovir as corrective treatment. The outcome of the events was reported as recovered on an unspecified date. The reporter did not provide the causality assessment. Additional information is not expected as there was no consent for further contact.
Age: 43.0
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of drug administration, Pain in extremity
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of foot pain in a 43-year-old male patient who received TWINRIX adult (batch number 7C4Z3, expiry date 26th May 2016). Co-suspect products included TWINRIX adult (batch number 797K7, expiry date 26th April 2017). Concurrent medical conditions included sciatica (severe sciatica and other problems). Concomitant products included TWINRIX adult. On 27th June 2015, the patient received the 2nd dose of TWINRIX adult (intramuscular). On 9th March 2016, the patient received the 3rd dose of TWINRIX adult. On 11th December 2015, 167 days after receiving TWINRIX adult and not applicable after receiving TWINRIX adult, the patient experienced foot pain (serious criteria other: Serious as per reporter). On 9th March 2016, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the foot pain was not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown. The reporter considered the foot pain to be unlikely to TWINRIX adult. Additional details were provided as follows: The patient was a firefighter. The injection site reported for 1st and 2 doses of TWINRIX adult was left deltoid. The injection site reported for 3rd dose was right deltoid. After vaccination with 2nd dose of TWINRIX adult, the patient experienced pain in the ball of his right foot. The patient had visited his healthcare provider, but not been to emergency room (ER). On 9th March 2016, the patient received 3rd dose of TWINRIX adult, which led to lengthening of the vaccination schedule. The reported batch number (7C423) for 1st and 2nd doses of TWINRIX adult did not exist and was updated to 7C4Z3 as per sales database.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Ear pain, Exposure during breast feeding, Influenza, Injection site pain, Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of rectal bleeding in a 45-year-old female patient who received FLUARIX QUADRIVALENT (batch number 2XR43, expiry date 30th June 2016). Concomitant products included Prenatal Vitamin. On 3rd March 2016, the patient received FLUARIX QUADRIVALENT (intramuscular). On 4th March 2016, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced injection site pain, sinus congestion, ringing in ears, sinus pain, productive cough, ear pain, feeling unwell and influenza. In March 2016, the patient experienced rectal bleeding (serious criteria GSK medically significant). On an unknown date, the patient experienced breastfeeding. In March 2016, the outcome of the injection site pain was recovered/resolved. On an unknown date, the outcome of the rectal bleeding, sinus congestion, ringing in ears, sinus pain, productive cough and feeling unwell were not recovered/not resolved and the outcome of the ear pain, influenza and breastfeeding were unknown. The reporter considered the rectal bleeding, injection site pain, sinus congestion, ringing in ears, sinus pain, productive cough and ear pain to be related to FLUARIX QUADRIVALENT. It was unknown if the reporter considered the feeling unwell and influenza to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient was breastfeeding at the time of vaccination. The next day after vaccination, the patient experienced pain at the injection site (left arm), but also felt sick like she had the flu. The patient had severe sinus congestion and a heavy productive cough. Her ears hurt and ring. In March 2016, less than a month after vaccination, the patient experienced rectal bleeding, which she felt was due to the violent coughing she was experiencing. At the time of reporting, the patient was experiencing all of these respiratory symptoms.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Productive cough, Rectal haemorrhage, Respiratory disorder, Sinus congestion, Sinus headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of rectal bleeding in a 45-year-old female patient who received FLUARIX QUADRIVALENT (batch number 2XR43, expiry date 30th June 2016). Concomitant products included Prenatal Vitamin. On 3rd March 2016, the patient received FLUARIX QUADRIVALENT (intramuscular). On 4th March 2016, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced injection site pain, sinus congestion, ringing in ears, sinus pain, productive cough, ear pain, feeling unwell and influenza. In March 2016, the patient experienced rectal bleeding (serious criteria GSK medically significant). On an unknown date, the patient experienced breastfeeding. In March 2016, the outcome of the injection site pain was recovered/resolved. On an unknown date, the outcome of the rectal bleeding, sinus congestion, ringing in ears, sinus pain, productive cough and feeling unwell were not recovered/not resolved and the outcome of the ear pain, influenza and breastfeeding were unknown. The reporter considered the rectal bleeding, injection site pain, sinus congestion, ringing in ears, sinus pain, productive cough and ear pain to be related to FLUARIX QUADRIVALENT. It was unknown if the reporter considered the feeling unwell and influenza to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient was breastfeeding at the time of vaccination. The next day after vaccination, the patient experienced pain at the injection site (left arm), but also felt sick like she had the flu. The patient had severe sinus congestion and a heavy productive cough. Her ears hurt and ring. In March 2016, less than a month after vaccination, the patient experienced rectal bleeding, which she felt was due to the violent coughing she was experiencing. At the time of reporting, the patient was experiencing all of these respiratory symptoms.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Tinnitus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of rectal bleeding in a 45-year-old female patient who received FLUARIX QUADRIVALENT (batch number 2XR43, expiry date 30th June 2016). Concomitant products included Prenatal Vitamin. On 3rd March 2016, the patient received FLUARIX QUADRIVALENT (intramuscular). On 4th March 2016, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced injection site pain, sinus congestion, ringing in ears, sinus pain, productive cough, ear pain, feeling unwell and influenza. In March 2016, the patient experienced rectal bleeding (serious criteria GSK medically significant). On an unknown date, the patient experienced breastfeeding. In March 2016, the outcome of the injection site pain was recovered/resolved. On an unknown date, the outcome of the rectal bleeding, sinus congestion, ringing in ears, sinus pain, productive cough and feeling unwell were not recovered/not resolved and the outcome of the ear pain, influenza and breastfeeding were unknown. The reporter considered the rectal bleeding, injection site pain, sinus congestion, ringing in ears, sinus pain, productive cough and ear pain to be related to FLUARIX QUADRIVALENT. It was unknown if the reporter considered the feeling unwell and influenza to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient was breastfeeding at the time of vaccination. The next day after vaccination, the patient experienced pain at the injection site (left arm), but also felt sick like she had the flu. The patient had severe sinus congestion and a heavy productive cough. Her ears hurt and ring. In March 2016, less than a month after vaccination, the patient experienced rectal bleeding, which she felt was due to the violent coughing she was experiencing. At the time of reporting, the patient was experiencing all of these respiratory symptoms.
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Drug interaction, Hepatic enzyme increased, Liver injury
Clinical narrative: This spontaneous solicited report as received from a healthcare professional and a currently (at the time of reporting) 79 year old male patient refers to himself. The patient's concurrent condition was not reported. The patient's medical history included skin cancer and vertigo. The patient's concomitant therapy included TYLENOL. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route, lot number and expiration date were not reported). Other suspect therapy included IMBRUVICA (capsule, 420 mg, daily, orally) started on 04-JUL-2014, for the treatment of chronic lymphotic leukaemia. On an unknown date, the patient reported that his primary care provider gave him a PNEUMOVAX 23 shot which, when mixed with IMBRUVICA, caused damage to his liver as the patient's liver enzymes were elevated (date unspecified). The patient indicated that his oncologist told him to stop taking IMBRUVICA until he could restart (date unspecified). An unspecified healthcare professional (HCP) at the oncologist's office confirmed that IMBRUVICA was on hold due to elevated liver enzymes and the patient later confirmed this report. The unspecified HCP also reported that the patient had an appointment with a liver specialist in a few days. Treatment for the liver damage was not reported. IMBRUVICA was withdrawn on an unspecified date. The outcome of the liver damage/elevated liver enzymes was not recovered/not resolved and the outcome of drug interaction was unknown. The patient and the unspecified HCP provided no causal assessment between the liver damage/elevated liver enzymes, drug interaction and IMBRUVICA and PNEUMOVAX 23. The reporters considered the events liver damage (elevated liver enzymes) and drug interaction to be medically significant. Additional information has been requested.
Sex: M
Vaccine: MENB
Symptoms: Fatigue, Feeling cold, Seizure like phenomena, Tremor
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A male patient of an unspecified age and ethnicity received TRUMENBA, via an unspecified route of administration, on an unspecified date, at single dose. The patient's medical history and concomitant medications were not reported. The patient had a reaction a few hours after receiving the vaccine. He started shaking uncontrollably for about 45 minutes, similar to a seizure, and was cold but felt it on the inside of his body. After the shaking stopped he was extremely exhausted.
Age: 60.0
Sex: F
Vaccine: FLU3, TDAP, VARZOS
Symptoms: Computerised tomogram, Pain in extremity, X-ray
Clinical narrative: I have been in constant pain with my left arm which has caused me severe limitations.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Hypoaesthesia, Limb discomfort
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old male patient with diabetes and high cholesterol. No drug reactions or allergies were reported. On 14-MAR-2016, the patient was vaccinated with ZOSTAVAX (lot# L032397, expiration date 26-NOV-2016) 0.65 ml, subcutaneously in an unspecified arm. There was no information about the patient's concomitant medications reported. On an unknown date in March 2016, the patient experienced numbness and an intermittent shooting and burning feeling on the left outer thigh. No treatment was given and none lab diagnostics studies were performed. The outcome of the events was reported as not recovered. The patient sought medical attention and spoke with the reporting pharmacist. The relatedness between the events and ZOSTAVAX was not reported. Additional information is not expected, as there was no consent for follow up.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 12-MAR-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ, orally, lot # L037921, expiration date 31-MAY-2017 (strength and dose were not provided). The vaccine was exposed to the temperature of 34.2 Fahrenheit (F) degrees for 30 minutes. There was no previous temperature excursion. No adverse effect was reported. Additional information has been requested.
Age: 0.44
Sex: F
Vaccine: DTAPIPVHIB, IPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: PENTACEL and IPOL administered, thus double doses of polio. No adverse events in patient reported.
Age: 14.0
Sex: F
Vaccine: HPV2
Symptoms: Blood pressure decreased, Heart rate decreased
Clinical narrative: BP prior to visit - 99/64 HR - 68 BPM 20 minutes post vaccination 92/53 HR - 48BPM pt sat out in WR for 10 minutes and drink water. 10 min later BP 86/56 HR 61BPM. Pt to sit in WR 10 more minutes with water. BP 20 min. later 86/56 HR 61 BPM. All BP's done sitting in (L) arm. MD and RN present with pt. Pt denied any concerns.
Age: 16.0
Sex: F
Vaccine: HPV2
Symptoms: Blood pressure increased
Clinical narrative: BP at time of visit - 136/85 HR - 79BPM 20 minutes post vaccination 117/69. Pt sent to drink water and sit in waiting room. 10 min. later BP 139/81. All BP's done sitting in (L) arm. Pt denied any complaints. Dr and RN remained with pt.
Age: 12.0
Sex: F
Vaccine: HPV2
Symptoms: Blood pressure decreased
Clinical narrative: BP checked 20 minutes post vaccination. 107/62. Pre vaccination BP 118/78. Pt sent back to waiting room to drink water. 10 min. later BP 120/6. Pt denied any complaints sent home. RN and MD remained with pt.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Nodule, Pruritus
Clinical narrative: Hard knot, red, itchy. Treatment - ice topically and oral BENADRYL.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Conjunctivitis, Irritability, Ocular hyperaemia, Pyrexia, Scleral oedema
Clinical narrative: Pt. rec'd Hep A vaccine at O.V. on 03-14-16; new onset of fever 24 hours later (101 degrees max). Also presented with mild (Lt) eye erythema and scleral edema. Fussy; increased sleeping. Dx with fever, (Lt) conjunctivitis and URI (viral -vs- allergic) - ? adenovirus. TX with allergy OTC.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Upper respiratory tract infection, Viral upper respiratory tract infection
Clinical narrative: Pt. rec'd Hep A vaccine at O.V. on 03-14-16; new onset of fever 24 hours later (101 degrees max). Also presented with mild (Lt) eye erythema and scleral edema. Fussy; increased sleeping. Dx with fever, (Lt) conjunctivitis and URI (viral -vs- allergic) - ? adenovirus. TX with allergy OTC.
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes, Rash
Clinical narrative: Information has been received from a physician via company representative referring to a female patient of unknown age. Concurrent condition and medical history were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route and lot# not reported). Concomitant therapy was not reported. Subsequently the patient developed cold sores on her lips and a rash on an unknown date. It was unspecified if the patient sought medical attention. The outcome of the events was unknown. The causality was not reported. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HEPA
Symptoms: Abdominal pain upper, Diarrhoea, Nausea, Tremor
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of tremor in a 14-year-old female patient who received HAVRIX pediatric (batch number F3J75, expiry date 18th November 2017). Concurrent medical conditions included stomach virus. On 6th January 2016, the patient received HAVRIX pediatric (intramuscular). On 6th January 2016, 1 hr after receiving HAVRIX pediatric, the patient experienced tremor, diarrhea, stomach pain and nausea. On an unknown date, the outcome of the tremor, diarrhea, stomach pain and nausea were unknown. It was unknown if the reporter considered the tremor, diarrhea, stomach pain and nausea to be related to HAVRIX pediatric. Additional details provided were as follows: The patient received a dose of HAVRIX pediatric vaccine in right deltoid and beginning 1 hour after receiving the vaccine, the patient experienced shakiness, nausea, mild diarrhea, and stomach pain. It was unknown to the healthcare professional if the patient's symptoms were related to the HAVRIX pediatric and were believed to be a stomach virus. Fluids and rest were recommended as treatment and no emergency room or doctor visits was required.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Hemiparesis, Nuclear magnetic resonance imaging normal
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle weakness in a 56-year-old female patient who received BOOSTRIX. On 15th June 2015, the patient received BOOSTRIX. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced muscle weakness and weakness. On an unknown date, the outcome of the muscle weakness and weakness were unknown. It was unknown if the reporter considered the muscle weakness and weakness to be related to BOOSTRIX. Additional details were provided as follows: This case was previously reported to a doctor. This case was reported by the patient herself. The patient received a vaccine and she believed that it was BOOSTRIX. Later that summer, the patient began to experience weakness on her left side which has progressed to include both arms, both legs and her mouth. In December 2015, the patient had an MRI (Nuclear magnetic resonance imaging) performed and the results were negative.
Sex: U
Vaccine: FLU3
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a consumer via other manufacturer and described the occurrence of adverse reaction in a patient who received Seasonal Influenza vaccine. On an unknown date, the patient received Seasonal Influenza vaccine at an unknown dose. On an unknown date, an unknown time after receiving Seasonal Influenza vaccine, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to Seasonal Influenza vaccine. Additional details were provided as follows: The consent for contacting the reporter for further information was provided, but for the patient the consent was not provided.
Age: 81.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain lower, Dysgeusia, Nausea
Clinical narrative: Pt reports left lower quadrant pain, nausea, and metallic taste in mouth one day following the injection. Nausea has resolved, but LLQ pain and metallic taste persists.
Age: 1.35
Sex: F
Vaccine: DTAP
Symptoms: Administration site cellulitis
Clinical narrative: Cellulitis around vaccine administration site.
Age: 41.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Erythema, Mobility decreased, Peripheral swelling
Clinical narrative: Arm Swollen primarily at shoulder but extending into tricep.  Redness to shoulder, arm, forearm.  Difficulty making fist.  Pain 6/10 to all joints in arm to fingers and R hip.