chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: HEPA
Symptoms: Computerised tomogram, Guillain-Barre syndrome, Hypoaesthesia, Lumbar puncture, Mechanical ventilation
Clinical narrative: Guillain Barre. 10/25 Numbness, tingling in arms/legs - facial numbness that got worse - ER visit, Dr visit - admitted to hosp. 10/28/15 - got worse - put on vent. until 11/12/15 - then moved to rehab on 11/19/15-12/17/15 - now doing outpt rehab 3 x's week. Prior to 10/25 daughter had been complaining of numbness, tingling for weeks prior.
Age: 14.0
Sex: F
Vaccine: HEPA
Symptoms: Nuclear magnetic resonance imaging, Paraesthesia
Clinical narrative: Guillain Barre. 10/25 Numbness, tingling in arms/legs - facial numbness that got worse - ER visit, Dr visit - admitted to hosp. 10/28/15 - got worse - put on vent. until 11/12/15 - then moved to rehab on 11/19/15-12/17/15 - now doing outpt rehab 3 x's week. Prior to 10/25 daughter had been complaining of numbness, tingling for weeks prior.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 12-MAY-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unspecified dates, the patients received improperly stored doses of (Oka/Merck) VARIVAX lot # L027287 with expiration date 01-JUL-2017 (dose and route of administration were not reported). No adverse effect reported. This is one of two reports received from the same source. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US019328, is an initial spontaneous report received from a health care professional on 24 Sep 2015. This report refers to a 15 year old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with MENVEO, batch number: M14097, expiry date: 31 Dec 2015) on 15 Aug 2015 and the vaccine administered was stored in 34.0 degrees Fahrenheit and 50.2 Fahrenheit for 48-120 hours. No adverse event was reported following this maladministration. Follow-up information received on 25 November 2015: The patient's vaccination status was current. Concomitant products included GARDASIL., received on 15th April 2015. The patient's details (height and weight) were provided. MENVEO was administered intramuscularly on the left deltoid.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US019326, is an initial spontaneous report received from a health care professional on 24 Sep 2015. This report refers to a 16-year-old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with MENVEO, batch number: M14097, expiry date: 31 Dec 2015) on 18 Jun 2015 and vaccine administered was stored in 34.0 degrees Fahrenheit and 50.2 degree Fahrenheit for 48-120 hours. No adverse event was reported following this maladministration. Follow-up information received on 25 November 2015: Previously administered products included MENVEO which was well tolerated. The patient's vaccination status was current. The patient's details (height and weight) were provided. MENVEO batch number was changed to M14070; the vaccine was administered intramuscularly on the right deltoid.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Balance disorder, Fall, Gait disturbance, Hypoaesthesia, Incontinence
Clinical narrative: Numbness starting/worse in feet, extending up legs to chest. Incontinence. Poor balance, unsteady gait, two falls. Treatment w steroids and physical therapy (hosp.).
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Lumbar puncture, Myelitis transverse, Nuclear magnetic resonance imaging
Clinical narrative: Numbness starting/worse in feet, extending up legs to chest. Incontinence. Poor balance, unsteady gait, two falls. Treatment w steroids and physical therapy (hosp.).
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 15-APR-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 8.0
Sex: U
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 8 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 07-JAN-2016, the patient was vaccinated with GARDASIL 9 lot # L028083, expiration date: 03-SEP-2017, which was outside the recommendations per the GARDASIL 9 prescribing information. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 04-JUN-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (medical assistant) and refers to an unspecified number of patients of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (lot # L017143 and expiration date 13-MAY-2017, lot # L025207 and expiration date 07-JUL-2017; exact dose and route of administration were not reported). It was reported that the vaccines were exposed to temperature of 6F during cumulative total of 70 hours. No adverse effect was reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Asthenia, Blood test, Decreased eye contact, Dehydration, Dyskinesia
Clinical narrative: Lethargy weakness sleeping a lot head drops seizure like activity not urinating hypoglycemia low muscle tone no eye contact gasping episodes dehydration jerking right arm and leg stiffening and arching of back spitting up.
Sex: M
Vaccine: HEP
Symptoms: Dyspnoea, Electroencephalogram, Hypersomnia, Hypoglycaemia, Hypotonia
Clinical narrative: Lethargy weakness sleeping a lot head drops seizure like activity not urinating hypoglycemia low muscle tone no eye contact gasping episodes dehydration jerking right arm and leg stiffening and arching of back spitting up.
Sex: M
Vaccine: HEP
Symptoms: Infantile spitting up, Lethargy, Metabolic function test, Musculoskeletal stiffness, Ophthalmological examination
Clinical narrative: Lethargy weakness sleeping a lot head drops seizure like activity not urinating hypoglycemia low muscle tone no eye contact gasping episodes dehydration jerking right arm and leg stiffening and arching of back spitting up.
Sex: M
Vaccine: HEP
Symptoms: Opisthotonus, Posture abnormal, Seizure like phenomena, Ultrasound kidney, Ultrasound liver
Clinical narrative: Lethargy weakness sleeping a lot head drops seizure like activity not urinating hypoglycemia low muscle tone no eye contact gasping episodes dehydration jerking right arm and leg stiffening and arching of back spitting up.
Sex: M
Vaccine: HEP
Symptoms: Ultrasound skull, Urinary retention, Urine analysis, X-ray
Clinical narrative: Lethargy weakness sleeping a lot head drops seizure like activity not urinating hypoglycemia low muscle tone no eye contact gasping episodes dehydration jerking right arm and leg stiffening and arching of back spitting up.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Type 1 diabetes mellitus
Clinical narrative: Type 1 Diabetes.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB (exact dose, route, lot # and expiration date were not reported). The administered doses experienced a temperature excursion of 34.7 degrees Fahrenheit for 2 hours. There was no previous temperature excursion. The stored vaccines were back in proper temperature range. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On 31-DEC-2015 the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX (dosing details were not reported) lot # L029467 with an expiry date of 06-AUG-2017. No concomitant medications were reported. No adverse symptoms were reported. There was no product quality complaint. This is one of the two reports received from the same reporter. Additional information is not expected as the reporter did not wish further contact.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: ZOSTAVAX immunization shot patient experience rash and itching.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 14-APR-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site pain, Injection site rash, Pain
Clinical narrative: This patient received a ZOSTAVAX immunization in Nov. 2009 and experienced an adverse reaction consisting primarily of significant pain in the area of injection that persistent in the area of injection for ten moths according to the patient. The patient characterized it as carrying a leaden weight. The pain slowly improved and was a non-factor until 12/20/15 when she noticed a dull aching sensation in exactly the same place with progression of a rash that resulted in a clinical diagnosis of shingles on 12/21/15. There was no blistering or itching. The distribution was the C5 dermatome of the left arm. She was treated with acyclovir and otc analgesics. The pain in now only a dull ache and doing well. I have previously reported the first part of this case to Medwatch (no, I don't have a file number).
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL (exact dose, route, lot # and expiration date were not reported). The vaccine doses experienced a temperature excursion of 34.7 degrees Fahrenheit for 2 hours. There was no previous temperature excursion. The stored vaccines were back in a proper temperature range. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: HPV9
Symptoms: Axillary mass
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a 10 year old female patient. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On 27-OCT-2015, the patient was vaccinated with second dose of GARDASIL 9 series (dose: 0.5 ml, lot # L007560, expiry date: 15-JUN-2017) as routine vaccine, via intramuscular route. Patient received the first vaccination dose on 10-AUG-2015. Reporting healthcare worker stated that the patient developed a lump in her left arm pit on an unspecified date, after she received the second GARDASIL 9 dose. No lab tests were performed. No treatment was provided for the event. It was unspecified if the patient required medical attention or not. Outcome of the event was unknown. Reporting healthcare worker did not assess the causality of the event with respect to vaccination GARDASIL 9. Additional information has been requested.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Myositis, Pain
Clinical narrative: Pain noted in left deltoid muscle after vaccine. Initially she felt it was normal but did not resolve so was seen in office on 10/26/15. Physician felt was related to muscle inflammation. Provided MEDROL dose pack. Symptoms continue at this time - pain in left deltoid with abduction.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Developed a red rash that has progressed to a bull's eye shape, at injection site. It is raised, red, itching, and warm to the touch. I advised him to seek medical attention. Treated with topical steroid cream.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 08-APR-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of an unknown gender and age. The patients' concurrent conditions, medical history and concomitant therapy were not reported. On unknown dates, the patients were vaccinated with an unspecified number of doses of improperly stored (Oka/Merck) VARIVAX lot#K011082 and expiration date: 08-AUG-2016, lot#L019124 and expiration date: 27-MAY-2017 (dose and route of administration were not reported). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 13-APR-2015, the patient was vaccinated with improperly stored (Oka-Merck) PROQUAD lot # K02766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of an unknown gender and age. The patients' concurrent conditions, medical history and concomitant therapy were not reported. On unknown dates, the patients were vaccinated with an unspecified number of doses of improperly stored ZOSTAVAX lot#L000448 and expiration date: 08-MAR-2016 (dose and route of administration were not reported). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Death
Clinical narrative: This spontaneous report as received via social media from an unspecified reporter, who obtained the information from the articles published on a web page, refers to many female patients of unknown age. The patients' concurrent conditions and medical history were not reported. On unknown dates, the patients were vaccinated  with unknown doses of GARDASIL (lot #, expiry date, route and site of administration were not reported). Concomitant medications were not reported. On unknown dates, many of patients died. The reason of death was not reported. The reporter considered the events to be related to GARDASIL (it was reported that "vaccine which has killed many women"). This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse and refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (exact dose, route, lot # and expiration date were not reported). The administered doses experienced a temperature excursion of 34.7 degrees Fahrenheit for 2 hours. There was no previous temperature excursion. The stored vaccines were back in proper temperature range. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse and refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapy were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (exact dose, route, loot # and expiration date were not reported). The administered doses experienced a temperature excursion of 34.7 degrees Fahrenheit for 2 hours. There was no previous temperature excursion. The stored vaccines were back in proper temperature range. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On 31-DEC-2015 the patient was vaccinated with improperly stored VARIVAX (Merck) (dosing details were not reported) lot # L029467 with an expiry date 06-AUG-2017 (incorrect product storage). No concomitant medications were reported. No adverse symptoms were reported. There was no product quality complaint. This is one of the two reports received from the same reporter. Additional information is not expected as the reporter did not wish further contact.
Age: 61.0
Sex: M
Vaccine: FLU4, FLUX
Symptoms: Injection site pain
Clinical narrative: Shoulder pain from flu shot. Pt will contact Dr for shoulder pain.
Age: 61.0
Sex: M
Vaccine: FLU4, FLUX
Symptoms: Bursitis, Injection site pain
Clinical narrative: Shoulder pain from flu shot. Pt will contact Dr for shoulder pain.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 10-JUN-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766,  expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 17-MAY-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry fate 08-JUN-2015. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 22.0
Sex: U
Vaccine: MMR, MMR, MMR
Symptoms: Dizziness, Dyspnoea, Exercise tolerance decreased, Heart rate increased, Local swelling
Clinical narrative: Per health department, symptoms include: rash, muscle spasms (mostly in torso), cannot lie flat due to facial and neck swelling, trouble breathing, facial migraine, low physical exertion tolerance, increased heart rate, nausea, lightheaded, intolerance to heat.
Age: 22.0
Sex: U
Vaccine: MMR, MMR, MMR
Symptoms: Migraine, Muscle spasms, Nausea, Rash, Swelling face
Clinical narrative: Per health department, symptoms include: rash, muscle spasms (mostly in torso), cannot lie flat due to facial and neck swelling, trouble breathing, facial migraine, low physical exertion tolerance, increased heart rate, nausea, lightheaded, intolerance to heat.
Age: 22.0
Sex: U
Vaccine: MMR, MMR, MMR
Symptoms: Temperature intolerance
Clinical narrative: Per health department, symptoms include: rash, muscle spasms (mostly in torso), cannot lie flat due to facial and neck swelling, trouble breathing, facial migraine, low physical exertion tolerance, increased heart rate, nausea, lightheaded, intolerance to heat.
Age: 22.0
Sex: U
Vaccine: MMR, MMR, MMR
Symptoms: Activities of daily living impaired, Biopsy thyroid gland normal, Computerised tomogram thorax normal, Decreased activity, Dizziness
Clinical narrative: Per health department, symptoms include: rash, muscle spasms (mostly in torso), cannot lie flat due to facial and neck swelling, trouble breathing, facial migraine, low physical exertion tolerance, increased heart rate, nausea, lightheaded, intolerance to heat.
Age: 22.0
Sex: U
Vaccine: MMR, MMR, MMR
Symptoms: Dyspnoea, Exercise tolerance decreased, Eye pain, Facial pain, Fatigue
Clinical narrative: Per health department, symptoms include: rash, muscle spasms (mostly in torso), cannot lie flat due to facial and neck swelling, trouble breathing, facial migraine, low physical exertion tolerance, increased heart rate, nausea, lightheaded, intolerance to heat.
Age: 22.0
Sex: U
Vaccine: MMR, MMR, MMR
Symptoms: Gingival pain, Heart rate increased, Hyperacusis, Muscle spasms, Nausea
Clinical narrative: Per health department, symptoms include: rash, muscle spasms (mostly in torso), cannot lie flat due to facial and neck swelling, trouble breathing, facial migraine, low physical exertion tolerance, increased heart rate, nausea, lightheaded, intolerance to heat.
Age: 22.0
Sex: U
Vaccine: MMR, MMR, MMR
Symptoms: Photophobia, Temperature intolerance, Toothache, Urticaria
Clinical narrative: Per health department, symptoms include: rash, muscle spasms (mostly in torso), cannot lie flat due to facial and neck swelling, trouble breathing, facial migraine, low physical exertion tolerance, increased heart rate, nausea, lightheaded, intolerance to heat.
Age: 22.0
Sex: U
Vaccine: MMR, MMR, MMR
Symptoms: Biopsy thyroid gland normal, Blood cortisol abnormal, Blood pressure fluctuation, Cardiac monitoring, Chest X-ray
Clinical narrative: Per health department, symptoms include: rash, muscle spasms (mostly in torso), cannot lie flat due to facial and neck swelling, trouble breathing, facial migraine, low physical exertion tolerance, increased heart rate, nausea, lightheaded, intolerance to heat.
Age: 22.0
Sex: U
Vaccine: MMR, MMR, MMR
Symptoms: Chest pain, Computerised tomogram head normal, Computerised tomogram normal, Computerised tomogram thorax abnormal, Cough
Clinical narrative: Per health department, symptoms include: rash, muscle spasms (mostly in torso), cannot lie flat due to facial and neck swelling, trouble breathing, facial migraine, low physical exertion tolerance, increased heart rate, nausea, lightheaded, intolerance to heat.
Age: 22.0
Sex: U
Vaccine: MMR, MMR, MMR
Symptoms: Dizziness, Dyspnoea, Echocardiogram normal, Exercise tolerance increased, Fatigue
Clinical narrative: Per health department, symptoms include: rash, muscle spasms (mostly in torso), cannot lie flat due to facial and neck swelling, trouble breathing, facial migraine, low physical exertion tolerance, increased heart rate, nausea, lightheaded, intolerance to heat.
Age: 22.0
Sex: U
Vaccine: MMR, MMR, MMR
Symptoms: Fibrin D dimer increased, HIV test negative, Lymphadenopathy, Migraine, Mononucleosis heterophile test negative
Clinical narrative: Per health department, symptoms include: rash, muscle spasms (mostly in torso), cannot lie flat due to facial and neck swelling, trouble breathing, facial migraine, low physical exertion tolerance, increased heart rate, nausea, lightheaded, intolerance to heat.
Age: 22.0
Sex: U
Vaccine: MMR, MMR, MMR
Symptoms: Muscle spasms, Nausea, Nodule, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging normal
Clinical narrative: Per health department, symptoms include: rash, muscle spasms (mostly in torso), cannot lie flat due to facial and neck swelling, trouble breathing, facial migraine, low physical exertion tolerance, increased heart rate, nausea, lightheaded, intolerance to heat.
Age: 22.0
Sex: U
Vaccine: MMR, MMR, MMR
Symptoms: Ophthalmological examination normal, Palpitations, Photophobia, Red blood cell count normal, Sleep disorder
Clinical narrative: Per health department, symptoms include: rash, muscle spasms (mostly in torso), cannot lie flat due to facial and neck swelling, trouble breathing, facial migraine, low physical exertion tolerance, increased heart rate, nausea, lightheaded, intolerance to heat.
Age: 22.0
Sex: U
Vaccine: MMR, MMR, MMR
Symptoms: Swelling, Thyroiditis, Ultrasound thyroid abnormal, Urine analysis normal, Vomiting
Clinical narrative: Per health department, symptoms include: rash, muscle spasms (mostly in torso), cannot lie flat due to facial and neck swelling, trouble breathing, facial migraine, low physical exertion tolerance, increased heart rate, nausea, lightheaded, intolerance to heat.
Age: 22.0
Sex: U
Vaccine: MMR, MMR, MMR
Symptoms: White blood cell count normal
Clinical narrative: Per health department, symptoms include: rash, muscle spasms (mostly in torso), cannot lie flat due to facial and neck swelling, trouble breathing, facial migraine, low physical exertion tolerance, increased heart rate, nausea, lightheaded, intolerance to heat.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 24hrs later pt developed arm soreness and found red swollen area on (R) arm where injection given. Pt. also experienced chills and fever and flu-like symptoms. Redness spread around lower area of arm as well.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: 24hrs later pt developed arm soreness and found red swollen area on (R) arm where injection given. Pt. also experienced chills and fever and flu-like symptoms. Redness spread around lower area of arm as well.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (medical assistant) and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of oral, ROTATEQ (lot # L004466 and expiration date 02-AUG-2016, lot # L008996 and expiration date 01-DEC-2016; exact doses were not reported). It was reported that the vaccines were exposed to temperature of 31.8F during cumulative total of 28 hours. No adverse effect was reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 08-JUN-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Headache, Heart rate increased, Injection site erythema, Mobility decreased
Clinical narrative: In the middle of the night a little more than 24 hours after receiving my pneumonia vaccine, I began to feel even stronger pains than usual. When I woke up on Saturday morning (I had received my vaccine on Thursday evening), I noticed that I had a large, red, swollen mark where my vaccine had been received. In the preceding 48 hours I had increasingly higher fevers and chills (vacillating between 94 and 101), headaches, muscle aches in my neck, shoulders, and back, and I could not move my arm above my head, or put on a shirt without excruciating pain (like a 6 or 7 on a 10-point pain scale). My resting heart rate was between 80 and 110 bpm (it's typically 60-70). The swelling grew in size at about half an inch a day (both deep and wide). I could barely lift anything or bend down either. I began immediately taking Advil and Benadryl, and applying hydrocortisone cream to the site. I also rested, drank a lot of water, and applied hot and cold packs to the site. However, each day it worsened. Finally, on Monday morning I went back to the pharmacist who immunized me - and a physicians assistant at a local clinic - and both seemed alarmed, but told me to wait and keep applying the same treatments I had been doing. The physicians assistant told me to come back on Wednesday to receive antibiotics if conditions did not improve. However, as the conditions kept worsening, on Monday evening, approximately 96 hours after receiving the vaccine, I consulted with my mother (a retired RN nurse) and she recommended I try taking azitromicina (Z-pack) as this seemed particularly severe to her. I did so, and 12 hours after my first dose - as I write this - my fever has been reduced (to about 99) and more importantly the vaccination spot has not grown in size today. I will be completing the Z-pack and updating you with results.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia, Pain, Pyrexia, Vaccination site swelling
Clinical narrative: In the middle of the night a little more than 24 hours after receiving my pneumonia vaccine, I began to feel even stronger pains than usual. When I woke up on Saturday morning (I had received my vaccine on Thursday evening), I noticed that I had a large, red, swollen mark where my vaccine had been received. In the preceding 48 hours I had increasingly higher fevers and chills (vacillating between 94 and 101), headaches, muscle aches in my neck, shoulders, and back, and I could not move my arm above my head, or put on a shirt without excruciating pain (like a 6 or 7 on a 10-point pain scale). My resting heart rate was between 80 and 110 bpm (it's typically 60-70). The swelling grew in size at about half an inch a day (both deep and wide). I could barely lift anything or bend down either. I began immediately taking Advil and Benadryl, and applying hydrocortisone cream to the site. I also rested, drank a lot of water, and applied hot and cold packs to the site. However, each day it worsened. Finally, on Monday morning I went back to the pharmacist who immunized me - and a physicians assistant at a local clinic - and both seemed alarmed, but told me to wait and keep applying the same treatments I had been doing. The physicians assistant told me to come back on Wednesday to receive antibiotics if conditions did not improve. However, as the conditions kept worsening, on Monday evening, approximately 96 hours after receiving the vaccine, I consulted with my mother (a retired RN nurse) and she recommended I try taking azitromicina (Z-pack) as this seemed particularly severe to her. I did so, and 12 hours after my first dose - as I write this - my fever has been reduced (to about 99) and more importantly the vaccination spot has not grown in size today. I will be completing the Z-pack and updating you with results.
Age: 8.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, redness, and pain at injection site.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient in for well check physical. Required 3 immunizations. Tetanus booster 0.5 ml given IM in left deltoid. MENVEO vaccine 0.5 ml given in Lt deltoid. Patient reports redness and swelling from injection site down to lft elbow.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stores doses of PNEUMOVAX 23 (exact dose, route, lot # and expiration date were not reported). The administered doses experienced a temperature excursion of 34.7 degrees Fahrenheit for 2 hours. There was no previous temperature excursion. The stored vaccines were back in proper temperature range. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (medical assistant) and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL (lot # K008931, expiration date 04-MAR-2017, exact doses and route of administration were not reported). It was reported that the vaccines were exposed to temperature of 31.8F during cumulative total of 28 hours. No adverse effect was reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 12-MAY-2015, the patient was vaccinated with improperly stored PROQUAD lot # K025766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site pruritus, Pruritus
Clinical narrative: Needed to take flu shot (was forced by my employer). Allergy (severe to latex) pharmacist gave me the latex free shot within minutes I began itchiness at the site then from my waist up - my hands and neck became very red this lasted 2 days.
Age: 52.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Erythema, Injection site pruritus, Pruritus
Clinical narrative: Needed to take flu shot (was forced by my employer). Allergy (severe to latex) pharmacist gave me the latex free shot within minutes I began itchiness at the site then from my waist up - my hands and neck became very red this lasted 2 days.
Age: 82.0
Sex: M
Vaccine: PNC13
Symptoms: Arthritis, Injected limb mobility decreased, Injection site pain, Injection site swelling, X-ray limb abnormal
Clinical narrative: (L) upper arm pain, swelling and decrease ROM. Left shoulder began 3 day after injection. Pt has been going to physical therapy.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 0-JUN-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Oxygen saturation decreased, Pyrexia
Clinical narrative: This case, manufacturer control number 2015-0180667, received via company, is a non-serious case of a patient who experienced: drop in oxygen level from 95 to 88%. The initial receipt date was 02 November 2015 and follow up information was received on 25 November 2015 (case remained non-serious). On 07 January 2016, upon medical review, the event of drop in oxygen level from 95 to 88%, was upgraded to medically significant per the safety physician. A full narrative has been generated below. This case, manufacturer control number 2015-0180667 is a report from a solicited Patient Support Program, referring to a 67 year old female patient. The other HCP reported the following event drop in oxygen level from 95 to 88% for this case. Medical history included: Current conditions: Pulmonary arterial hypertension, Asthma. Historical condition: None Reported. Historical drug: None Reported. On 19 October 2015, the patient received Ambrisentan 10 mg, QD (daily) for treatment of Primary pulmonary hypertension. Additional suspect products included: REMODULIN, ADCIRCA, TRACLEER and an Influenza vaccine. Concomitant medications included CYMBALTA, BONIVA, LIPITOR, SYMBICORT, Potassium, Furosemide, ACIPHEX, PLAVIX, SPIRIVA, Calcium + Vit D, XOPENEX, LASIX. On 26 October 2015, the patient's oxygen level dropped from 95% to 88% after switching from Bosentan to ambrisentan. The patient's physician was aware of the event and was monitoring the patient. Relevant laboratory/diagnostic tests included: 26 October 2015: Oxygen saturation: Dropped from 95 to 88%. Ambrisentan was continued. Drop in oxygen level from 95 to 88% was Serious with an outcome of unknown.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Patient immediately complained of pain in lt arm. Pain has continued with movement of arms, and has remained continuous since injection - some redness and swelling at injection site. Tenderness also.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient immediately complained of pain in lt arm. Pain has continued with movement of arms, and has remained continuous since injection - some redness and swelling at injection site. Tenderness also.
Age: 21.0
Sex: F
Vaccine: FLU4, YF
Symptoms: Cold sweat, Dizziness, Immediate post-injection reaction
Clinical narrative: Lightheaded,  dizzy, clammy skin. Immediately after vaccine (Yellow Fever, Influenza). Pt placed in recumbent position and placed cold pack to back of neck. Pt. monitored for additional 20 minutes. Pt. state that she use to faint with shots when she was a young child.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Dizziness, Erythema, Fear, Mobility decreased
Clinical narrative: Severe swelling from shoulder to forearm. Red color flesh shoulder to elbow. Inability to raise arm for 5 days. Extreme pain/tenderness, chills, dizziness, extreme fear by me and my loved ones. I have been previously hospitalized with pneumonia. I have been advised that due to this event my vaccine is less efficacious.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Peripheral swelling, Tenderness
Clinical narrative: Severe swelling from shoulder to forearm. Red color flesh shoulder to elbow. Inability to raise arm for 5 days. Extreme pain/tenderness, chills, dizziness, extreme fear by me and my loved ones. I have been previously hospitalized with pneumonia. I have been advised that due to this event my vaccine is less efficacious.
Age: 69.0
Sex: U
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: Patient stated he started to get muscle pain at local injection area (right arm) a few days after injection and has been more than 5 days. Manufacturer stated average of 2.5 days possible for local injection site muscle pain. He stated it has been getting better but concerned still.
Sex: U
Vaccine: TDAP
Symptoms: Anaphylactic reaction
Clinical narrative: This case was reported by a nurse via other and described the occurrence of anaphylactic reaction in a patient who received DTPA vaccine. On an unknown date, the patient received DTPA vaccine at an unknown dose. On an unknown date, an unknown time after receiving DTPA vaccine, the patient experienced anaphylactic reaction (serious criteria GSK medically significant and life threatening). On an unknown date, the outcome of the anaphylactic reaction was unknown. It was unknown if the reporter considered the anaphylactic reaction to be related to DTPA vaccine. Additional details were provided as follows: The nurse reported that a patient had an anaphylactic reaction after receiving DTPA vaccine. This case was not reported to the FDA. No further information was provided.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 07-APR-2015, the patient was vaccinated with improperly stored PROQUAD lot # K025766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: This spontaneous report was received from a pharmacist and refers to an elderly male patient. It was reported that the patient had no drug reactions or allergies. Concomitant therapies included furosemide (manufacturer unknown), pravastatin and isosorbide mononitrate (manufacturer unknown). On 03-FEB-2015, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, exact dose and route of administration were not reported) to prevent shingles. On unknown dates, the patient developed 3 cases of shingles after being vaccinated with ZOSTAVAX. In approximately 2015, the patient experienced pain. It was reported that the patient sought medical attention, he contacted the pharmacist. In August 2015, the patient was prescribed hydrocodone and tramadol for pain, but the reporter could not confirm if the patient was taking these medications for shingles related pain. No PQC (product quality complaint) was involved. The outcome of the events was reported as not recovered. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse and refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9. The administered doses experienced a temperature excursion of 34.7 degrees Fahrenheit for 2 hours. There was no previous temperature excursion. The stored vaccines were back in proper temperature range. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of an unknown gender and age. The patients' concurrent conditions, medical history and concomitant therapy were not reported. On unknown dates since 24-NOV-2015, the patients were vaccinated with an unspecified number of doses of improperly stored PROQUAD therapy type: (recombinant human albumin (rHA), lot#L030586 and expiration date: 10-FEB-2017, lot# L033692 and expiration date: 28-FEB-2017 and PROQUAD therapy type: human serum albumin (HSA), lot#L004006 and expiration date: 05-AUG-2016, lot#K020747 and expiration date: 30-APR-2016 (dose and route of administration were not reported). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse and refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reaction or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (orally, exact dose, lot # and expiration date were not reported). The administered doses experienced a temperature excursion of 34.7 degrees Fahrenheit for 2 hours. There was no previous temperature excursion. The stored vaccines were back in proper temperature range. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: RAB
Symptoms: Feeling abnormal, Headache, Inappropriate schedule of drug administration, Incorrect dose administered, Influenza like illness
Clinical narrative: Case number PHEH2015US019971, is an initial spontaneous report from a consumer (patient) received on 30 Sep 2015. This report refers to 68 years old female patient. Medical history was not reported. Concomitant medications included B12 injection and other unspecified medications. The patient was bitten by a bat on the left foot. The patient was started with post exposure prophylaxis of RABAVERT (batch number: 556011A, expiry date: Feb 2018) into left arm on 25 Sep 2015. The vaccination did not hurt and it was not thick. On the same day the patient also received HRIG (batch number: unknown, other manufacturer) into left deltoid. As per the patient the HRIG was very thick and syrupy and it "liked to kill" her because it was very painful. The patient reported that it took about 15 seconds for the nurse to administer the full dose and she felt it all the way down her arm to her thumb nails and through her whole body. The patient stated that the nurse even at one point mentioned that she "thinks she did it backwards". The patient stated that the pain continued for some time and throughout the day. The arm pain was so bad that she thought that she was having a heart attack. On 26 Sep 2015 the patient began having flu-like symptoms described as aches and headache which progressively got better but still occurs. The patient stated that currently she does not feel great but is "functional". No hospitalization or ER/doctor visits were necessary. The patient went back for her next dose of RABAVERT on 28 Sep 2015 and that was when she really realized that her original dosing was incorrect. Outcome of vaccination site pain was recovered on 25 Sep 2015. Outcome of aches and headache was improving. Causality of the events of vaccination site pain, aches and headache was reported as almost certain. The outcome and causality of flu like symptoms was not reported. Seriousness criteria were not reported. Seriousness assessment of vaccination site pain was upgraded based on information in the source document.