chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Extreme upper arm and shoulder pain.  Limited range of motion as a result of flu shot.
Age: 0.25
Sex: F
Vaccine: HIBV, PPV
Symptoms: Gait disturbance, Irritability, Weight bearing difficulty
Clinical narrative: Extreme fussiness, not wanting to walk or bear weight on feet.
Sex: M
Vaccine: MMR
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a nurse refers to a male patient of unknown age. On an unknown date the patient was vaccinated with MMR II via an unknown route of administration for an unknown indication. Past medical history and concomitant medications were not reported. The nurse reported that a patient who may have had the MMR II vaccination on an unspecified date had negative titer's on an unspecified date. Nurse did not want to share any further information. The outcome of negative titer's is unknown. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of an unknown age and gender. On an unknown date the patients were vaccinated with MMR II via an unknown route of administration for an unknown indication. Past medical history and concomitant medications were not reported. On an unknown date the patients received MMR that was exposed to 57 degrees F for 10 hours which is an excursion that is unsupported by in-house stability data. No adverse symptoms reported. The healthcare worker was unable to provide states of administration and lot numbers/expiration dates at the time of this report. The outcome of patients received MMR that was exposed to 57 degrees F for 10 hours is unknown. The reporter considered patients received MMR that was exposed to 57 degrees F for 10 hours to be not related to MMR II. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Hypoaesthesia, Mobility decreased, Monoplegia
Clinical narrative: Information has been received from a 61 year old female patient. The patient's medical history included sore arm in 1993, 1994 and 1995. In 2008, the patient was vaccinated with the first dose of PNEUMOVAX23 (dose, route and lot number were not provided). In 2012, the patient was vaccinated with the second dose of PNEUMOVAX23 (dose, route and lot number were not provided) less than 5 years later. Concomitantly, the patient annually has been administered with FLUVIRIN (manufacturer unknown) (dose, route and lot number were not provided). In 2012, on the same day she received PNEUMOVAX23, her right arm and right leg were numb, felt like they were asleep, could not feel them and could not move them by herself. Nurse described these symptoms as her right arm and leg were paralyzed. All of these events resolved within 6 hours without any treatment. Upon internal review the adverse event of right arm and leg were paralyzed was considered to be medically significant. This is one of several reports from the same patient. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Bone pain, Lymphadenopathy, Middle insomnia, Myalgia
Clinical narrative: This spontaneous report as received from a pediatric oncologist via company representative refers to a 13 and a half years old female patient. Medical history and concurrent conditions were not reported. It was reported that the patient had not had medical care in the past 2 years. On 20-OCT-2013, the patient was vaccinated with GARDASIL (dose, route and lot number were not provided). On 20-OCT-2013, the patient had a complete blood count that showed an elevated white blood cell count. On 25-OCT-2013, the blood test was repeated "5 days later" and the white blood cell count was even higher at that time. On 21-DEC-2013, the physician reported that the patient developed fevers, myalgia, bone pain that wakes her from sleep, weight loss and lymphadenopathy a day after (approximately 24 hours) receiving GARDASIL. The patient was also experiencing abdominal pain. The physician states that the patient was admitted to an unspecified hospital. The physician states that although there has not been a final diagnosis, he was "working up" this patient as if she has a severe disseminated cancer. It was reported that physician suspected that the patient had cancer. At the time of the report, the outcome of the events were reported as not recovered and the patient continued to have these symptoms. Upon internal review, Neoplasm malignant was considered to be an other important medical event. The causality was not reported. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Neoplasm malignant, Pyrexia, Weight decreased, White blood cell count increased
Clinical narrative: This spontaneous report as received from a pediatric oncologist via company representative refers to a 13 and a half years old female patient. Medical history and concurrent conditions were not reported. It was reported that the patient had not had medical care in the past 2 years. On 20-OCT-2013, the patient was vaccinated with GARDASIL (dose, route and lot number were not provided). On 20-OCT-2013, the patient had a complete blood count that showed an elevated white blood cell count. On 25-OCT-2013, the blood test was repeated "5 days later" and the white blood cell count was even higher at that time. On 21-DEC-2013, the physician reported that the patient developed fevers, myalgia, bone pain that wakes her from sleep, weight loss and lymphadenopathy a day after (approximately 24 hours) receiving GARDASIL. The patient was also experiencing abdominal pain. The physician states that the patient was admitted to an unspecified hospital. The physician states that although there has not been a final diagnosis, he was "working up" this patient as if she has a severe disseminated cancer. It was reported that physician suspected that the patient had cancer. At the time of the report, the outcome of the events were reported as not recovered and the patient continued to have these symptoms. Upon internal review, Neoplasm malignant was considered to be an other important medical event. The causality was not reported. Additional information has been requested.
Sex: F
Vaccine: MMRV
Symptoms: Accidental exposure to product, Eye pain
Clinical narrative: This spontaneous report was received from a nurse practitioner (over 60 years old) who was reporting on behalf of herself. On 31-OCT-2013 the nurse practitioner stated that as she was preparing to administer PROQUAD, Lot # J007861, expiration date: 28-DEC-2014, to a patient, the syringe was defective and the PROQUAD squirted her in the eye. She stated that she rinsed her eyes out for a few minutes with water. She further stated that her eyes are stinging in the inner canthus of the eye. Past medical history and concomitant medications were not provided. The outcome of eye stinging was reported as not recovered/not resolved. No further information was provided. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: FLU4, HEP, HPV4, TDAP
Symptoms: Syncope, Vomiting
Clinical narrative: After receiving 4 vaccinations client vomited and had multiple syncopal episodes.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: S/S injection site swelled to baseball size is red and warm. Was given Children's Ibuprofen at clinic. Advised to take BENADRYL and ice pack to put on arm at home.
Age: 0.1
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13
Symptoms: No adverse event
Clinical narrative: No adverse events.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Face oedema, Malaise, Pain, Pyrexia, Rash
Clinical narrative: Upper torso rash, facial edema, fever, vomiting, malaise, body aches.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Upper torso rash, facial edema, fever, vomiting, malaise, body aches.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Flank pain, Hypoaesthesia, Skin ulcer, Swelling face
Clinical narrative: After about 15 minutes my left hand was completely numb after I went to bed and wake up my left side was numb and very painful I had sores under my nose and the left side of my face was swollen this lasted for four days pain was on and off.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash, Pruritus
Clinical narrative: Patient presented with wide spread rash around injection site. Treating with cortisone - not terribly troublesome to pt but itching.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Pyrexia
Clinical narrative: Pt. called over office 12/27/13 stating he developed fever and chills last night. T 103. Took BENADRYL feeling better today. Denies rash or SOB.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Skin warm, Swelling face
Clinical narrative: Arm swollen, red, hot, and hard 11/14/13. Face started to swell 11/15/13, 2100. Treated in E.D. with steroid and abx.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Rash on trunk, neck and limbs.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pyrexia, Rash
Clinical narrative: Rash upper torso, fever, body aches.
Age: 0.39
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a physician refers to a 15 week old infant patient of unknown gender. The patient received two doses of ROTATEQ within one week: one on 10-DEC-2013 and another on 16-DEC-2013. The outcome of infant received two doses of ROTATEQ within 1 week was unknown. Additional information has been requested.
Sex: F
Vaccine: FLUR3
Symptoms: Dizziness, Sensation of heaviness
Clinical narrative: Lightheaded, dizzy, heavy arm.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Aptyalism, Dizziness, Dyspnoea, Ear discomfort, Fatigue
Clinical narrative: The patient is a 52 year old female who presents with flu shot reaction. Pt came in yesterday 12/26/2013 9:30 to obtain a flu shot 10 - 12 hrs later she experienced some symptoms like ringing in both ears before going to bed waking up with both ears plugged and still ringing hard time breathing so took ADVAIR, lightheadedness and spacy, neck is stiff and with fatigue. Pt is an engineer and felt she was not able to think and had to stay home today, She describes it only as 'spacy' there is no disorientation or lapse of thought. She does have ADVAIR but it usually only needs it during allergy season. She fel like "I don't have a lot of spit' but not as if she cannot swallow The neck is stiff and muscle ache No headache She has no fever/chills Per pt she has NO allergy to eggs - in fact she used to eat so many she stopped due to her higher cholesterol She denies asthma - inhalers only for seasonal allergies Her primary symptom she would like assist with is - ringing in the ears and a feeling of ear stuffiness 10 yrs ago she had a headache and neck stiffness/nausea -extreme /chills for 4 days after the flu shot that season She swore she would never take the vaccine for influenza again The  is the first time she has taken the flu IZ since that reaction This event was not reported She did not seek ER or PCP provider.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Musculoskeletal stiffness, Myalgia, Tinnitus
Clinical narrative: The patient is a 52 year old female who presents with flu shot reaction. Pt came in yesterday 12/26/2013 9:30 to obtain a flu shot 10 - 12 hrs later she experienced some symptoms like ringing in both ears before going to bed waking up with both ears plugged and still ringing hard time breathing so took ADVAIR, lightheadedness and spacy, neck is stiff and with fatigue. Pt is an engineer and felt she was not able to think and had to stay home today, She describes it only as 'spacy' there is no disorientation or lapse of thought. She does have ADVAIR but it usually only needs it during allergy season. She fel like "I don't have a lot of spit' but not as if she cannot swallow The neck is stiff and muscle ache No headache She has no fever/chills Per pt she has NO allergy to eggs - in fact she used to eat so many she stopped due to her higher cholesterol She denies asthma - inhalers only for seasonal allergies Her primary symptom she would like assist with is - ringing in the ears and a feeling of ear stuffiness 10 yrs ago she had a headache and neck stiffness/nausea -extreme /chills for 4 days after the flu shot that season She swore she would never take the vaccine for influenza again The  is the first time she has taken the flu IZ since that reaction This event was not reported She did not seek ER or PCP provider.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: Pain, itchy, red, swollen.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Hives. Did go to the doctor but Dr. has sent her to see a specialist.
Age: 39.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Within 24 hrs of injection of VARIVAX subcu, pt. developed redness, warmth, mild edema 3.5 x 4.5 cm around injection site on (L) posterior upper arm.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Hyperhidrosis, Local swelling, Mobility decreased
Clinical narrative: Sore arm then chills with intense pain in upper arm. My arm began to increase in size. The redness was like a sunburn. Then about 1:45 AM fever, sweating and worse pain in upper arm. Swelling increased. unable to use my arm at all.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Sore arm then chills with intense pain in upper arm. My arm began to increase in size. The redness was like a sunburn. Then about 1:45 AM fever, sweating and worse pain in upper arm. Swelling increased. unable to use my arm at all.
Age: 17.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Fatigue, Pyrexia
Clinical narrative: Fever of 103.5, fatigue, dizziness lasting 3-4 days.
Age: 18.0
Sex: M
Vaccine: FLU3
Symptoms: Chest X-ray abnormal, Chest discomfort, Chest pain, Dyspnoea, Musculoskeletal discomfort
Clinical narrative: About 20 minutes after receiving the flu shot, pain and discomfort spread from arm across into shoulder front chest above heart to back into side of neck then up neck. It gradually spread across neck and chest to just past mid line on her chest and around her whole neck. Making it feel difficult and tight kind of swollen like when breathing. 2 Benadryl were given in 20 min. intervals per the pharmacists recommendation then the Drs office was called patient then was taken to ER per both the pharmacist and Drs. recommendation. The ER Dr. determined it was a pneumomediastinum and said it was a coincidence it happened at the same time as the vaccine but she had NO SYMPTOMS prior to the shot and the symptoms shoed up 20 minutes after the shot!!!
Age: 18.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: About 20 minutes after receiving the flu shot, pain and discomfort spread from arm across into shoulder front chest above heart to back into side of neck then up neck. It gradually spread across neck and chest to just past mid line on her chest and around her whole neck. Making it feel difficult and tight kind of swollen like when breathing. 2 Benadryl were given in 20 min. intervals per the pharmacists recommendation then the Drs office was called patient then was taken to ER per both the pharmacist and Drs. recommendation. The ER Dr. determined it was a pneumomediastinum and said it was a coincidence it happened at the same time as the vaccine but she had NO SYMPTOMS prior to the shot and the symptoms shoed up 20 minutes after the shot!!!
Age: 1.05
Sex: M
Vaccine: DTPIHI, HEPA, MMRV
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: Skin rash of small red spots over body, most densely populated on hands, cheeks, and ears.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Audiogram abnormal, Deafness bilateral, Deafness neurosensory, Sudden hearing loss
Clinical narrative: Patient developed sudden hearing loss.  Was evaluated by ENT and was found to have moderate sensorineural hearing loss for the right ear and severe to profound hearing loss for the left ear.  This was new.  He did not significantly improve with a course of prednisone.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Crying, Fall, Pain, Screaming, Vomiting
Clinical narrative: CRYING/SCREAMING EVERY 20-30 MIN, FALLING ON FLOOR IN PAIN, VOMITING.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Blood pressure increased, Dizziness, Mobility decreased, Nausea
Clinical narrative: Severe pain in my left arm, the complete arm was in pain and I couldn't even use it. I became very dizzy and felt very weak. It felt like my blood pressure had went up. Then I started to vomit and was nauseated throughout the night. I had a fever of about 103. I have had the flu shot many times before and never had this kind of reaction. It is 6:00 PM on 12/28/2013 and I am feeling alot better.  Only my arm is a little sore now.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Severe pain in my left arm, the complete arm was in pain and I couldn't even use it. I became very dizzy and felt very weak. It felt like my blood pressure had went up. Then I started to vomit and was nauseated throughout the night. I had a fever of about 103. I have had the flu shot many times before and never had this kind of reaction. It is 6:00 PM on 12/28/2013 and I am feeling alot better.  Only my arm is a little sore now.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Middle insomnia, Pruritus
Clinical narrative: Severe itching of extremities that awakened patient, sore joints.
Age: 0.78
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Crying, Dyskinesia, Head banging
Clinical narrative: 12/19/13 aprox 7:30 pm Sudden onset inconsolable crying for approximately 30 minutes.  12/24/13 another crying episode shorter but the same cry as on 12/19. 12/26/13 I noticed leg jerking during sleep. 12/27/13 baby was repeatedly trying to head butt the wall (and my head) during the day. 12/27/13 baby's arm started jerking violently when laid down to sleep.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Blood culture negative, Blood potassium decreased, Brudzinski's sign, Chest X-ray normal, Convulsion
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 1 year old female patient. On 09-DEC-2013 the patient was vaccinated with PROQUAD (merck) dose 1, subcutaneous. On 19-DEC-2013, the patient experienced 105.5 F fever (hospitalization, disability, medically significant and life threatening) and an altered neurologic status (hospitalization, disability, medically significant and life threatening) after receiving a first dose of PROQUAD and was hospitalized. The nurse mentioned the patient was limp (hospitalization, disability, medically significant and life threatening), unaware of her surroundings (hospitalization, disability, medically significant and life threatening), had a blank stare (hospitalization, disability, medically significant and life threatening) and had positive Kernig and Brudzinski signs (hospitalization, disability, medically significant and life threatening). The nurse further reported that the patient's fever was difficult to control with high doses of anti-pyretic medications (ibuprofen, TYLENOL, IV fluids with potassium) and the patient presented in her office with a heart rate of 203 (hospitalization, disability, medically significant and life threatening), respiratory rate of 48 (hospitalization, disability, medically significant and life threatening), a rectal temperature of 105.5F and had a brief seizure (hospitalization, disability, medically significant and life threatening) when her temperature was taken. The patient was sent to another hospital where she was admitted. The nurse stated that the patient had "signs of meningitis", the patient was dehydrated, and had a low potassium level (seriousness criteria for these events reported to be hospitalization, disability, medically significant and life threatening). On an unknown date in December 2013, the patient had the following lab/diagnostic studies: a glucose test, a urinalysis, CBC blood test, a chest x-ray, blood cultures and was tested for having the flu. The nurse mentioned all tests were negative except the patient's potassium with low. The nurse further stated that the IV fluids which the patient had received prevented the patient from going into metabolic acidosis. The outcome of all the events were reported as recovering/resolving. The relationship between PROQUD (merck) and the events was unknown. Additional information is requested.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Dehydration, Disorientation, Full blood count normal, Glucose tolerance test normal, Hypotonia
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 1 year old female patient. On 09-DEC-2013 the patient was vaccinated with PROQUAD (merck) dose 1, subcutaneous. On 19-DEC-2013, the patient experienced 105.5 F fever (hospitalization, disability, medically significant and life threatening) and an altered neurologic status (hospitalization, disability, medically significant and life threatening) after receiving a first dose of PROQUAD and was hospitalized. The nurse mentioned the patient was limp (hospitalization, disability, medically significant and life threatening), unaware of her surroundings (hospitalization, disability, medically significant and life threatening), had a blank stare (hospitalization, disability, medically significant and life threatening) and had positive Kernig and Brudzinski signs (hospitalization, disability, medically significant and life threatening). The nurse further reported that the patient's fever was difficult to control with high doses of anti-pyretic medications (ibuprofen, TYLENOL, IV fluids with potassium) and the patient presented in her office with a heart rate of 203 (hospitalization, disability, medically significant and life threatening), respiratory rate of 48 (hospitalization, disability, medically significant and life threatening), a rectal temperature of 105.5F and had a brief seizure (hospitalization, disability, medically significant and life threatening) when her temperature was taken. The patient was sent to another hospital where she was admitted. The nurse stated that the patient had "signs of meningitis", the patient was dehydrated, and had a low potassium level (seriousness criteria for these events reported to be hospitalization, disability, medically significant and life threatening). On an unknown date in December 2013, the patient had the following lab/diagnostic studies: a glucose test, a urinalysis, CBC blood test, a chest x-ray, blood cultures and was tested for having the flu. The nurse mentioned all tests were negative except the patient's potassium with low. The nurse further stated that the IV fluids which the patient had received prevented the patient from going into metabolic acidosis. The outcome of all the events were reported as recovering/resolving. The relationship between PROQUD (merck) and the events was unknown. Additional information is requested.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Influenza virus test negative, Kernig's sign, Meningitis, Neurological symptom, Pyrexia
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 1 year old female patient. On 09-DEC-2013 the patient was vaccinated with PROQUAD (merck) dose 1, subcutaneous. On 19-DEC-2013, the patient experienced 105.5 F fever (hospitalization, disability, medically significant and life threatening) and an altered neurologic status (hospitalization, disability, medically significant and life threatening) after receiving a first dose of PROQUAD and was hospitalized. The nurse mentioned the patient was limp (hospitalization, disability, medically significant and life threatening), unaware of her surroundings (hospitalization, disability, medically significant and life threatening), had a blank stare (hospitalization, disability, medically significant and life threatening) and had positive Kernig and Brudzinski signs (hospitalization, disability, medically significant and life threatening). The nurse further reported that the patient's fever was difficult to control with high doses of anti-pyretic medications (ibuprofen, TYLENOL, IV fluids with potassium) and the patient presented in her office with a heart rate of 203 (hospitalization, disability, medically significant and life threatening), respiratory rate of 48 (hospitalization, disability, medically significant and life threatening), a rectal temperature of 105.5F and had a brief seizure (hospitalization, disability, medically significant and life threatening) when her temperature was taken. The patient was sent to another hospital where she was admitted. The nurse stated that the patient had "signs of meningitis", the patient was dehydrated, and had a low potassium level (seriousness criteria for these events reported to be hospitalization, disability, medically significant and life threatening). On an unknown date in December 2013, the patient had the following lab/diagnostic studies: a glucose test, a urinalysis, CBC blood test, a chest x-ray, blood cultures and was tested for having the flu. The nurse mentioned all tests were negative except the patient's potassium with low. The nurse further stated that the IV fluids which the patient had received prevented the patient from going into metabolic acidosis. The outcome of all the events were reported as recovering/resolving. The relationship between PROQUD (merck) and the events was unknown. Additional information is requested.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Staring, Urine analysis normal
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 1 year old female patient. On 09-DEC-2013 the patient was vaccinated with PROQUAD (merck) dose 1, subcutaneous. On 19-DEC-2013, the patient experienced 105.5 F fever (hospitalization, disability, medically significant and life threatening) and an altered neurologic status (hospitalization, disability, medically significant and life threatening) after receiving a first dose of PROQUAD and was hospitalized. The nurse mentioned the patient was limp (hospitalization, disability, medically significant and life threatening), unaware of her surroundings (hospitalization, disability, medically significant and life threatening), had a blank stare (hospitalization, disability, medically significant and life threatening) and had positive Kernig and Brudzinski signs (hospitalization, disability, medically significant and life threatening). The nurse further reported that the patient's fever was difficult to control with high doses of anti-pyretic medications (ibuprofen, TYLENOL, IV fluids with potassium) and the patient presented in her office with a heart rate of 203 (hospitalization, disability, medically significant and life threatening), respiratory rate of 48 (hospitalization, disability, medically significant and life threatening), a rectal temperature of 105.5F and had a brief seizure (hospitalization, disability, medically significant and life threatening) when her temperature was taken. The patient was sent to another hospital where she was admitted. The nurse stated that the patient had "signs of meningitis", the patient was dehydrated, and had a low potassium level (seriousness criteria for these events reported to be hospitalization, disability, medically significant and life threatening). On an unknown date in December 2013, the patient had the following lab/diagnostic studies: a glucose test, a urinalysis, CBC blood test, a chest x-ray, blood cultures and was tested for having the flu. The nurse mentioned all tests were negative except the patient's potassium with low. The nurse further stated that the IV fluids which the patient had received prevented the patient from going into metabolic acidosis. The outcome of all the events were reported as recovering/resolving. The relationship between PROQUD (merck) and the events was unknown. Additional information is requested.
Age: 58.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Blindness, Blindness unilateral, Blood glucose increased, Blood test
Clinical narrative: This spontaneous report as received from a physician refers to a 58 year old male patient. Current conditions of patient were immunosuppressed, diabetes, anemia, toxoplasmosis and orthostatic hypotension. The patient's medical history included cramping with statins and allergy to certain blood pressure medication (unknown date, manufacturer and drug name were unknown). On 02-DEC-2013 the patient was vaccinated with ZOSTAVAX. Concomitant therapies included BENICAR and cinnamon. On 02-DEC-2013 the patient experienced sharp spike in blood sugar level right after receiving the vaccine, since then the blood sugar level had remained elevated. In December 2013 the patient experienced losing vision in right eye (medically significant). On an unknown date in December 2013 (reported as starting a few days after the ZOSTAVAX injection), the patient experienced headache, sleepiness, and weakness. On an unknown date in December 2013 (unspecified date), after the ZOSTAVAX injection, the patient began to feel that he was "losing vision in the right eye". He also stated that his "right eyelid became puffy and the right eye looked red. On 17-DEC-2013 (reported as about "a week ago"), the patient went to an unspecified HCP who stated it was "an infection". The patient was reported to be legally blind, and stated that his right eye is "pucked up", with bumps on the inside of the eye. In the same eye he has decreased vision, along with brightness in vision. It was also reported that the patient had a reddish tint, a "maybe pink or orange glow" in right eye. It was further reported that the patient may have been immunosuppressed at time of receiving shot since he was anaemic and diabetic. The outcome of all the events were reported to be recovering. The patient sought medical attention (reported as went to see the physician). The relationship between the ZOSTAVAX and the events were not reported. Upon internal review, the event "Blindness unilateral" was considered as medically significant. Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Eye disorder, Eyelid oedema, Headache, Infection, Ocular hyperaemia
Clinical narrative: This spontaneous report as received from a physician refers to a 58 year old male patient. Current conditions of patient were immunosuppressed, diabetes, anemia, toxoplasmosis and orthostatic hypotension. The patient's medical history included cramping with statins and allergy to certain blood pressure medication (unknown date, manufacturer and drug name were unknown). On 02-DEC-2013 the patient was vaccinated with ZOSTAVAX. Concomitant therapies included BENICAR and cinnamon. On 02-DEC-2013 the patient experienced sharp spike in blood sugar level right after receiving the vaccine, since then the blood sugar level had remained elevated. In December 2013 the patient experienced losing vision in right eye (medically significant). On an unknown date in December 2013 (reported as starting a few days after the ZOSTAVAX injection), the patient experienced headache, sleepiness, and weakness. On an unknown date in December 2013 (unspecified date), after the ZOSTAVAX injection, the patient began to feel that he was "losing vision in the right eye". He also stated that his "right eyelid became puffy and the right eye looked red. On 17-DEC-2013 (reported as about "a week ago"), the patient went to an unspecified HCP who stated it was "an infection". The patient was reported to be legally blind, and stated that his right eye is "pucked up", with bumps on the inside of the eye. In the same eye he has decreased vision, along with brightness in vision. It was also reported that the patient had a reddish tint, a "maybe pink or orange glow" in right eye. It was further reported that the patient may have been immunosuppressed at time of receiving shot since he was anaemic and diabetic. The outcome of all the events were reported to be recovering. The patient sought medical attention (reported as went to see the physician). The relationship between the ZOSTAVAX and the events were not reported. Upon internal review, the event "Blindness unilateral" was considered as medically significant. Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Somnolence, Visual acuity reduced, Visual brightness
Clinical narrative: This spontaneous report as received from a physician refers to a 58 year old male patient. Current conditions of patient were immunosuppressed, diabetes, anemia, toxoplasmosis and orthostatic hypotension. The patient's medical history included cramping with statins and allergy to certain blood pressure medication (unknown date, manufacturer and drug name were unknown). On 02-DEC-2013 the patient was vaccinated with ZOSTAVAX. Concomitant therapies included BENICAR and cinnamon. On 02-DEC-2013 the patient experienced sharp spike in blood sugar level right after receiving the vaccine, since then the blood sugar level had remained elevated. In December 2013 the patient experienced losing vision in right eye (medically significant). On an unknown date in December 2013 (reported as starting a few days after the ZOSTAVAX injection), the patient experienced headache, sleepiness, and weakness. On an unknown date in December 2013 (unspecified date), after the ZOSTAVAX injection, the patient began to feel that he was "losing vision in the right eye". He also stated that his "right eyelid became puffy and the right eye looked red. On 17-DEC-2013 (reported as about "a week ago"), the patient went to an unspecified HCP who stated it was "an infection". The patient was reported to be legally blind, and stated that his right eye is "pucked up", with bumps on the inside of the eye. In the same eye he has decreased vision, along with brightness in vision. It was also reported that the patient had a reddish tint, a "maybe pink or orange glow" in right eye. It was further reported that the patient may have been immunosuppressed at time of receiving shot since he was anaemic and diabetic. The outcome of all the events were reported to be recovering. The patient sought medical attention (reported as went to see the physician). The relationship between the ZOSTAVAX and the events were not reported. Upon internal review, the event "Blindness unilateral" was considered as medically significant. Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Eyelid oedema, Headache, Infection, Ocular hyperaemia, Rash
Clinical narrative: This spontaneous report as received from a physician refers to a 58 year old male patient. Current conditions of patient were immunosuppressed, diabetes, anemia, toxoplasmosis and orthostatic hypotension. The patient's medical history included cramping with statins and allergy to certain blood pressure medication (unknown date, manufacturer and drug name were unknown). On 02-DEC-2013 the patient was vaccinated with ZOSTAVAX. Concomitant therapies included BENICAR and cinnamon. On 02-DEC-2013 the patient experienced sharp spike in blood sugar level right after receiving the vaccine, since then the blood sugar level had remained elevated. In December 2013 the patient experienced losing vision in right eye (medically significant). On an unknown date in December 2013 (reported as starting a few days after the ZOSTAVAX injection), the patient experienced headache, sleepiness, and weakness. On an unknown date in December 2013 (unspecified date), after the ZOSTAVAX injection, the patient began to feel that he was "losing vision in the right eye". He also stated that his "right eyelid became puffy and the right eye looked red. On 17-DEC-2013 (reported as about "a week ago"), the patient went to an unspecified HCP who stated it was "an infection". The patient was reported to be legally blind, and stated that his right eye is "pucked up", with bumps on the inside of the eye. In the same eye he has decreased vision, along with brightness in vision. It was also reported that the patient had a reddish tint, a "maybe pink or orange glow" in right eye. It was further reported that the patient may have been immunosuppressed at time of receiving shot since he was anaemic and diabetic. The outcome of all the events were reported to be recovering. The patient sought medical attention (reported as went to see the physician). The relationship between the ZOSTAVAX and the events were not reported. Upon internal review, the event "Blindness unilateral" was considered as medically significant. Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Blindness, Blindness unilateral, Blood glucose increased, Blood test
Clinical narrative: This spontaneous report as received from a physician refers to a 58 year old male patient. Current conditions of patient were immunosuppressed, diabetes, anemia, toxoplasmosis and orthostatic hypotension. The patient's medical history included cramping with statins and allergy to certain blood pressure medication (unknown date, manufacturer and drug name were unknown). On 02-DEC-2013 the patient was vaccinated with ZOSTAVAX. Concomitant therapies included BENICAR and cinnamon. On 02-DEC-2013 the patient experienced sharp spike in blood sugar level right after receiving the vaccine, since then the blood sugar level had remained elevated. In December 2013 the patient experienced losing vision in right eye (medically significant). On 02-DEC-2013 the patient experienced sharp spike in blood sugar level right after receiving the vaccine, since then the blood sugar level had remained elevated. Since unknown date in December 2013 the patient experienced losing vision in right eye (medically significant). On an unknown date in December 2013 (reported as starting a few days after the ZOSTAVAX injection), the patient experienced headache, sleepiness, and weakness. On an unknown date in December 2013 (unspecified date), after the ZOSTAVAX injection, the patient began to feel that he was "losing vision in the right eye." He also stated that his "right eyelid became puffy and the right eye looked red". On 17-DEC-2013 (reported as about "a week ago"), the patient went to an unspecified HCP who stated it was "an infection." The patient was reported to be legally blind, and stated that his right eye is "pucked up", with bumps on the inside of the eye. In the same eye he has decreased vision, along with brightness in vision. It was also reported that the patient had a reddish tint, a "maybe pink or orange glow" in right eye. It was further reported that the patient may have been immunosuppressed at time of receiving shot since he was anaemic and diabetic. The outcome of all the events were reported to be recovering. The patient sought medical attention (reported as went to see the physician). The relationship between the ZOSTAVAX and the events were not reported. Upon internal review, the event "Blindness unilateral" was considered as medically significant. Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Eye disorder, Eyelid oedema, Headache, Infection, Ocular hyperaemia
Clinical narrative: This spontaneous report as received from a physician refers to a 58 year old male patient. Current conditions of patient were immunosuppressed, diabetes, anemia, toxoplasmosis and orthostatic hypotension. The patient's medical history included cramping with statins and allergy to certain blood pressure medication (unknown date, manufacturer and drug name were unknown). On 02-DEC-2013 the patient was vaccinated with ZOSTAVAX. Concomitant therapies included BENICAR and cinnamon. On 02-DEC-2013 the patient experienced sharp spike in blood sugar level right after receiving the vaccine, since then the blood sugar level had remained elevated. In December 2013 the patient experienced losing vision in right eye (medically significant). On 02-DEC-2013 the patient experienced sharp spike in blood sugar level right after receiving the vaccine, since then the blood sugar level had remained elevated. Since unknown date in December 2013 the patient experienced losing vision in right eye (medically significant). On an unknown date in December 2013 (reported as starting a few days after the ZOSTAVAX injection), the patient experienced headache, sleepiness, and weakness. On an unknown date in December 2013 (unspecified date), after the ZOSTAVAX injection, the patient began to feel that he was "losing vision in the right eye." He also stated that his "right eyelid became puffy and the right eye looked red". On 17-DEC-2013 (reported as about "a week ago"), the patient went to an unspecified HCP who stated it was "an infection." The patient was reported to be legally blind, and stated that his right eye is "pucked up", with bumps on the inside of the eye. In the same eye he has decreased vision, along with brightness in vision. It was also reported that the patient had a reddish tint, a "maybe pink or orange glow" in right eye. It was further reported that the patient may have been immunosuppressed at time of receiving shot since he was anaemic and diabetic. The outcome of all the events were reported to be recovering. The patient sought medical attention (reported as went to see the physician). The relationship between the ZOSTAVAX and the events were not reported. Upon internal review, the event "Blindness unilateral" was considered as medically significant. Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Somnolence, Visual acuity reduced, Visual brightness
Clinical narrative: This spontaneous report as received from a physician refers to a 58 year old male patient. Current conditions of patient were immunosuppressed, diabetes, anemia, toxoplasmosis and orthostatic hypotension. The patient's medical history included cramping with statins and allergy to certain blood pressure medication (unknown date, manufacturer and drug name were unknown). On 02-DEC-2013 the patient was vaccinated with ZOSTAVAX. Concomitant therapies included BENICAR and cinnamon. On 02-DEC-2013 the patient experienced sharp spike in blood sugar level right after receiving the vaccine, since then the blood sugar level had remained elevated. In December 2013 the patient experienced losing vision in right eye (medically significant). On 02-DEC-2013 the patient experienced sharp spike in blood sugar level right after receiving the vaccine, since then the blood sugar level had remained elevated. Since unknown date in December 2013 the patient experienced losing vision in right eye (medically significant). On an unknown date in December 2013 (reported as starting a few days after the ZOSTAVAX injection), the patient experienced headache, sleepiness, and weakness. On an unknown date in December 2013 (unspecified date), after the ZOSTAVAX injection, the patient began to feel that he was "losing vision in the right eye." He also stated that his "right eyelid became puffy and the right eye looked red". On 17-DEC-2013 (reported as about "a week ago"), the patient went to an unspecified HCP who stated it was "an infection." The patient was reported to be legally blind, and stated that his right eye is "pucked up", with bumps on the inside of the eye. In the same eye he has decreased vision, along with brightness in vision. It was also reported that the patient had a reddish tint, a "maybe pink or orange glow" in right eye. It was further reported that the patient may have been immunosuppressed at time of receiving shot since he was anaemic and diabetic. The outcome of all the events were reported to be recovering. The patient sought medical attention (reported as went to see the physician). The relationship between the ZOSTAVAX and the events were not reported. Upon internal review, the event "Blindness unilateral" was considered as medically significant. Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Eyelid oedema, Headache, Infection, Ocular hyperaemia, Rash
Clinical narrative: This spontaneous report as received from a physician refers to a 58 year old male patient. Current conditions of patient were immunosuppressed, diabetes, anemia, toxoplasmosis and orthostatic hypotension. The patient's medical history included cramping with statins and allergy to certain blood pressure medication (unknown date, manufacturer and drug name were unknown). On 02-DEC-2013 the patient was vaccinated with ZOSTAVAX. Concomitant therapies included BENICAR and cinnamon. On 02-DEC-2013 the patient experienced sharp spike in blood sugar level right after receiving the vaccine, since then the blood sugar level had remained elevated. In December 2013 the patient experienced losing vision in right eye (medically significant). On 02-DEC-2013 the patient experienced sharp spike in blood sugar level right after receiving the vaccine, since then the blood sugar level had remained elevated. Since unknown date in December 2013 the patient experienced losing vision in right eye (medically significant). On an unknown date in December 2013 (reported as starting a few days after the ZOSTAVAX injection), the patient experienced headache, sleepiness, and weakness. On an unknown date in December 2013 (unspecified date), after the ZOSTAVAX injection, the patient began to feel that he was "losing vision in the right eye." He also stated that his "right eyelid became puffy and the right eye looked red". On 17-DEC-2013 (reported as about "a week ago"), the patient went to an unspecified HCP who stated it was "an infection." The patient was reported to be legally blind, and stated that his right eye is "pucked up", with bumps on the inside of the eye. In the same eye he has decreased vision, along with brightness in vision. It was also reported that the patient had a reddish tint, a "maybe pink or orange glow" in right eye. It was further reported that the patient may have been immunosuppressed at time of receiving shot since he was anaemic and diabetic. The outcome of all the events were reported to be recovering. The patient sought medical attention (reported as went to see the physician). The relationship between the ZOSTAVAX and the events were not reported. Upon internal review, the event "Blindness unilateral" was considered as medically significant. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Patient has had muscle ache pain in his right arm since the PNEUMOVAX vaccine given on 11/14/13. He has had pain in his arm for 6 weeks. He reported his symptoms to his doctor. He also got a flu shot that day in the left arm, which did not have pain.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus
Clinical narrative: Patient described the area around the vaccination as itchy.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site inflammation
Clinical narrative: Cellulitis at injection site with radial inflammation 6 inches in circumference. Requiring ABX.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphonia, Eye discharge, Throat irritation
Clinical narrative: Pt had a scratchy itchy throat and eyes mattering. She also states a hoarseness in her throat.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal discomfort, Arthralgia, Decreased appetite, Dizziness, Headache
Clinical narrative: Patient developed a swollen ball (soft ball size per report) on the bottom (tricep) area of the arm, pain in elbow, stiffness of the arm, stomach upset, headache, dizziness, sweating, loss of appetite, fever, itching. Referred patient to EMS, was on his way to urgent care.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Hyperhidrosis, Local swelling, Musculoskeletal stiffness, Pruritus, Pyrexia
Clinical narrative: Patient developed a swollen ball (soft ball size per report) on the bottom (tricep) area of the arm, pain in elbow, stiffness of the arm, stomach upset, headache, dizziness, sweating, loss of appetite, fever, itching. Referred patient to EMS, was on his way to urgent care.