chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: M
Vaccine: FLUN4, MNQ
Symptoms: Injection site erythema, Muscular weakness, Paraesthesia
Clinical narrative: Patient describes a tingling feeling in his left fingers and weakness to his left hand (less strength) also has a red swollen area at site of injection (left deltoid).
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Abdominal X-ray, Explorative laparotomy, Internal hernia, Small intestinal obstruction, Somnolence
Clinical narrative: July 19th-increased sleepiness-vomiting- decreased urine output taken to ER-see attached (1) Abd x-ray-showed multiple dilated bowel loops. US-sign. amt free fluid. Labs-increased WBC. 7/20/15 pt taken to operating room.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Ultrasound abdomen abnormal, Urine output decreased, Vitello-intestinal duct remnant, Vomiting, White blood cell count increased
Clinical narrative: July 19th-increased sleepiness-vomiting- decreased urine output taken to ER-see attached (1) Abd x-ray-showed multiple dilated bowel loops. US-sign. amt free fluid. Labs-increased WBC. 7/20/15 pt taken to operating room.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: X-ray abnormal
Clinical narrative: July 19th-increased sleepiness-vomiting- decreased urine output taken to ER-see attached (1) Abd x-ray-showed multiple dilated bowel loops. US-sign. amt free fluid. Labs-increased WBC. 7/20/15 pt taken to operating room.
Age: 64.0
Sex: M
Vaccine: FLUX
Symptoms: Balance disorder, Chills, Pyrexia, Visual impairment, Vomiting
Clinical narrative: Vision, vomiting, balance, chills, fever 3 1/2 hours after shot, lasted 1 day.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red, swollen, warm to touch area around both injection site on each arm. Shots given 9/22/15 started 9/23/15.
Age: 86.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal pain
Clinical narrative: Pt has been experiencing pain in left shoulder for past year. Has received cortisone shots. Was told by MD that flu shot was given too high on the arm. Pt said shot was given 3-6" from shoulder which seems appropriate.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Rash maculo-papular
Clinical narrative: Localized maculopapular rash spreading to arms, (chest and legs).
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dysphagia, Sensation of foreign body, Throat tightness
Clinical narrative: Throat began to close - felt like a lump growing on left side or something stuck. An hour later felt like a lump growing on right side of throat across from left lump. Swallowing became difficult. Then extreme chills. Took double dose of Benadryl and prepared to go to ER if Benadryl didn't work.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Culture negative, Dry skin, Pruritus, Rash erythematous, Rash pruritic
Clinical narrative: Woke up with a bumpy, itchy, raised red rash all over my anterior and posterior trunk, breasts, both flanks, down both arms and down my legs stopping half-way down my thighs. The rash proceeded to get worse as the day continued, with it spreading up my neck and onto my ears and cheeks by 12:30 PM. I took zyrtec at 03:40 PM, and the rash disappeared by about 25%. I took 50mg Benadryl at bedtime, and I woke up on 09/26/15 with a very limited rash on just my low back, my abdomen, and my neck. The rash has yet to fully resolve. There is no more redness, but I have small patches of sandpaper like skin that itches in two fist-sized areas on both sids of my low back. This is where the rash was the worst at onset.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Streptococcus test negative
Clinical narrative: Woke up with a bumpy, itchy, raised red rash all over my anterior and posterior trunk, breasts, both flanks, down both arms and down my legs stopping half-way down my thighs. The rash proceeded to get worse as the day continued, with it spreading up my neck and onto my ears and cheeks by 12:30 PM. I took zyrtec at 03:40 PM, and the rash disappeared by about 25%. I took 50mg Benadryl at bedtime, and I woke up on 09/26/15 with a very limited rash on just my low back, my abdomen, and my neck. The rash has yet to fully resolve. There is no more redness, but I have small patches of sandpaper like skin that itches in two fist-sized areas on both sids of my low back. This is where the rash was the worst at onset.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Hypoaesthesia, Injection site pain, Pain, Paraesthesia
Clinical narrative: Employee stated she has "always developed a heavy, swollen, numb and reddened arm after flu vaccine. Doesn't matter which arm is used. Today the symptoms are different because she is having pain with small electric shocks and constant burning between her shoulder and elbow of the left arm.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Peripheral swelling
Clinical narrative: Employee stated she has "always developed a heavy, swollen, numb and reddened arm after flu vaccine. Doesn't matter which arm is used. Today the symptoms are different because she is having pain with small electric shocks and constant burning between her shoulder and elbow of the left arm.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Asthenia, Chills, Dizziness, Headache
Clinical narrative: Weak, fever, headache, dizziness, chills, achy joints, achy muscles times 3 days.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia, Pyrexia
Clinical narrative: Weak, fever, headache, dizziness, chills, achy joints, achy muscles times 3 days.
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Pain, Paraesthesia, Pyrexia, Tremor
Clinical narrative: Tingling all over, aches all over, warm then later got fever chills and shaking rigors but better next day.
Age: 76.0
Sex: M
Vaccine: PNC13
Symptoms: Cough, Pyrexia
Clinical narrative: FEVER TO 102 DEGREES F., COUGH.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Hypoaesthesia, Hyporeflexia, Immunoglobulin therapy, Laboratory test normal, Multiple sclerosis
Clinical narrative: 09/27/15 developed first pain then numbness in bilateral thighs followed by weakness, urinary incontinence and retention. Febrile w/strength 1/5 in bilat quads 0/5 in bilat low extremities. Reflexes 0/5 in achilles/patella. Hosp course: infectious workup was neg MRI showed T2 abnorm at T7, 8 T 11-12 consistent w/transverse myelitis or MS. Received IVIG, steroids; Pt. improving. Still in hosp.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Muscular weakness, Myelitis transverse, Nuclear magnetic resonance imaging spinal abnormal, Pain in extremity, Pyrexia
Clinical narrative: 09/27/15 developed first pain then numbness in bilateral thighs followed by weakness, urinary incontinence and retention. Febrile w/strength 1/5 in bilat quads 0/5 in bilat low extremities. Reflexes 0/5 in achilles/patella. Hosp course: infectious workup was neg MRI showed T2 abnorm at T7, 8 T 11-12 consistent w/transverse myelitis or MS. Received IVIG, steroids; Pt. improving. Still in hosp.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Urinary incontinence, Urinary retention
Clinical narrative: 09/27/15 developed first pain then numbness in bilateral thighs followed by weakness, urinary incontinence and retention. Febrile w/strength 1/5 in bilat quads 0/5 in bilat low extremities. Reflexes 0/5 in achilles/patella. Hosp course: infectious workup was neg MRI showed T2 abnorm at T7, 8 T 11-12 consistent w/transverse myelitis or MS. Received IVIG, steroids; Pt. improving. Still in hosp.
Age: 25.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: This is a spontaneous report obtained from a contactable consumer (lawyer who is the patient). This 25-year-old female patient received, on 29Apr2015, the first dose of TRUMENBA intramuscular in the left upper at 0.5 ml, single. Relevant medical history included heartburn on an unspecified date in Apr2015 and dermatologic urticarial. Concomitant medications included ZANTAC taken as needed for heartburn. On 29Apr2015, the patient experienced lots and severe pain at the injection site and pain in arm. Patient mentioned that she did not receive any treatment for the adverse events. The patient did not recover from sore arm while she recovered from the pain at the injection site. Follow-up (26Jun2015): Follow-up attempts completed. No further information expected. Follow-up (10Jul2015): New information reported from a contactable consumer includes: updated date of vaccination, medical history, concomitant medication, onset date of the event, outcome.
Age: 27.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient has a red circle around the area of injection on her left arm (from the Boostrix).  She said it itches.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Asthma, Cough, Productive cough, Respiratory tract congestion, Wheezing
Clinical narrative: Asthma attack, heavy wheezing and coughing for 2 hours. I took 2 60mg Allegra and 3 puffs of PROAIR-HFA to help me cough up congestion from the phlegm in my chest.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pruritus, Injection site reaction, Rash erythematous
Clinical narrative: Pt c/o itching at injection site after the injection and RN observed fine red rash at the site.  Pt took one Benadryl 25mg PO at home.  RN called pt the next day on 9/25/15 and pt had no additional itching, no swelling or pain.  Pt did not require any additional treatment.
Age: 46.0
Sex: M
Vaccine: FLU3, HEP, MMR, TDAP
Symptoms: Diarrhoea, Nausea, Rash, Vomiting
Clinical narrative: Nausea, vomiting, diarrhea, rash under arms.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Injection site reaction, Pyrexia, Rash, Rash erythematous
Clinical narrative: Red erythematous rash around injection site. Fevers/chlls for 2 days. Rash spread to medial forearm. Rash not apparent anywhere else. No shortness of breath.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Blister, Erythema, Swelling
Clinical narrative: Redness, extreme swelling, and blisters.
Age: 48.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: Redness, Swelling with a large diameter.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injected limb mobility decreased, Injection site pain, Insomnia
Clinical narrative: Shoulder at injection site became extremely sore and couldn't move arm, sleep, etc. because of pain.  Tylenol did not ease the pain.  Pain was severe enough to almost bring tears to my eyes when trying to sleep.  24 hours later, pain has lessened, but still extremely sore with limited movement capability.
Age: 72.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Arm red and swollen.
Age: 27.0
Sex: F
Vaccine: FLUN4
Symptoms: Asthenia, Feeling abnormal, Hyperhidrosis, Palpitations, Pruritus
Clinical narrative: BP 188/113 P107. Itching on chest and upper arms. States feeling weak and feels funny. States feels like have heart palpations. Diaphoretic.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Pain, Peripheral swelling
Clinical narrative: LEFT ARM INITIALLY PAINFUL WITH ROM, NUMBNESS STARTING IN PM ON 27TH, 28TH AM SWELLING STARTED. CURRENTLY ROM IMPROVED, SWELLING OF ARM/HANDS STILL EVIDENT, PAIN PERSISTS AT SAME LEVEL.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Cold sweat, Erythema, Fall, Pallor, Pruritus
Clinical narrative: Patient returned to pharmacy and stated that she was itchy. She took 5ml diphenhydramine and sat down while we called 911. She attempted to stand up and fell to floor. Attending pharmacist stated she felt clammy. Her skin was red at first and then she went pale. She vomited a dozen times.  The ambulance arrived and took her to the hospital.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Patient returned to pharmacy and stated that she was itchy. She took 5ml diphenhydramine and sat down while we called 911. She attempted to stand up and fell to floor. Attending pharmacist stated she felt clammy. Her skin was red at first and then she went pale. She vomited a dozen times.  The ambulance arrived and took her to the hospital.
Age: 1.27
Sex: M
Vaccine: TDAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 20.0
Sex: F
Vaccine: MNQ
Symptoms: Dyspnoea, Erythema, Petechiae, Skin warm, Tenderness
Clinical narrative: Arm was just tender at first but then woke up with 6 x6 in reddened area that was hot to the touch and very tender.  Looked to have petechiae.  Complained of some shortness of breath, but no wheezing and no sign of airway being compromised.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Pain, Pyrexia
Clinical narrative: Patient reported she has redness and swelling at the injection site and by 7pm Friday evening, she had aches, pains and a fever that peaked at 100.9 degrees.  She used ice packs for swelling and Tylenol for the fever.  The fever went down to 97 degrees by Saturday morning at 6:30 am.  She reported she still had some aches and pains but they were getting better and were almost resolved.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Nausea, Neurological examination normal, Peripheral coldness, Vomiting
Clinical narrative: Nausea with vomiting, weakness, cold feeling in arms.  Normal neuro exam.  No visible skin reaction, no wheezing. No specific treatment.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Rash on ankles and lower calves.
Age: 3.0
Sex: F
Vaccine: MMR, PPV
Symptoms: Decreased appetite, Dyskinesia, Headache, Incontinence, Pyrexia
Clinical narrative: 12 HOUR LOW GRADE FEVER OF AROUND 100. HEADACHE AROUND 8 PM. LOSS OF APPETITE, THREE SEPARATE SEIZURES AT 3PM, 6PM AND 8PM ALL HAD STARING SOMETIMES JERKING, AND INCONTINENCE.   RED SPOTS ON FACE AND TRUNK THAT LASTED AROUND 6 HOURS THE NEXT DAY ON 9/27/2015.
Age: 3.0
Sex: F
Vaccine: MMR, PPV
Symptoms: Rash erythematous, Seizure, Staring
Clinical narrative: 12 HOUR LOW GRADE FEVER OF AROUND 100. HEADACHE AROUND 8 PM. LOSS OF APPETITE, THREE SEPARATE SEIZURES AT 3PM, 6PM AND 8PM ALL HAD STARING SOMETIMES JERKING, AND INCONTINENCE.   RED SPOTS ON FACE AND TRUNK THAT LASTED AROUND 6 HOURS THE NEXT DAY ON 9/27/2015.
Age: 40.0
Sex: F
Vaccine: HEP, MNQ, VARCEL
Symptoms: Dyskinesia, Headache, Hypoaesthesia, Musculoskeletal stiffness, Pain
Clinical narrative: Stiff neck, headache, numbness in right cheek, holds mouth differently.  Went to a chiropractor twice with no relief. On 9/21/15 she came to Public Health office with no relief of symptoms. Advised to see a physician, given info on National Vaccine Injury Compensation Program.  On 9/29/2015 she again came to Public Health, stated that she is "getting worse", C/O pain "in my clavicles", still holding mouth as if she cannot open it fully, stated she is going to the ER.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives.
Age: 72.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Painful injection site. Swollen, red, and warm.
Age: 1.09
Sex: F
Vaccine: DTAPIPVHIB, HEPAB, MMR, VARCEL
Symptoms: Pyrexia, Urticaria
Clinical narrative: High fever on Sat. Hive for now two days. Treatment Benadryl.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Lip swelling, Vertigo
Clinical narrative: Patient developed vertigo and her eyes and lips were swollen. Patient then took Allegra for 3 days until symptoms resolved on 09/22/2015.
Age: 43.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Pain in extremity
Clinical narrative: Patient says his arm is sore and it is still red where he got the injection.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Pruritus
Clinical narrative: Redness and itching.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Grip strength decreased, Muscular weakness, Pain in extremity, Paraesthesia, Sensory disturbance
Clinical narrative: Severe pain through entire left arm. Muscle weakness, unable to grip anything with left hand. Odd sensations of cold water or prickling running down arm.
Age: 28.0
Sex: F
Vaccine: FLUC3
Symptoms: Muscle spasms, Pain in extremity
Clinical narrative: Vaccine was administered in the left arm, but the employee had pain in the right arm of a "8" and had a continuous cramp it felt like the muscle and then none were aching all the way to the finger tips. After a half hour the pain started to dissipated and it was gone in the evening.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Neck pain, Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: Patient stated that she woke up with a sore left arm and was red and swollen. She took Tylenol and put ice on it and went to work. She said the next day, her arm was still sore and swollen and it swelled into a perfect square on her left arm. She continued to take Tylenol and went to work.  Today she came to the pharmacy after work and showed me her arm, no swelling but a little redness still there.  She states that now it is sore into her neck but soreness diminished in her arm.  Slightly tender to the touch.
Age: 2.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Scratch
Clinical narrative: Swelling and redness around the site of the vaccine.  Measured 2 in. x 2.5 in. First noticed at 7:30 PM day after vaccination.  No behavioral changes.  Indication of scratch marks.  Noticeable radiating heat from site of vaccine.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Headache, Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: Red swollen around injection site. Blister at injection site.  Sore arm, fatigue, headache.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Red swollen around injection site. Blister at injection site.  Sore arm, fatigue, headache.
Age: 55.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site reaction, Injection site swelling, Myalgia
Clinical narrative: MUSCLE PAIN, SWELLING AT INJECTION SITE AND RADIATING OUTWARD FROM IT.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Rash and itching at injection site.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Generalised tonic-clonic seizure, Postictal state
Clinical narrative: Code red was sent and when I arrived the pt was on the exam table with generalized tonic clonic seizure last for 30 sec then pt went into a post ictal state for 1 minute.
Age: 25.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Pyrexia, Vaccination site swelling
Clinical narrative: Patient's arm was red and swollen at the site of vaccination. Patient also reported a fever of 103 degrees.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site reaction, Nausea, Pain in extremity, Sensory disturbance
Clinical narrative: Pt reported sensation down entire arm-length of vaccinated arm immediately after vaccine was given. The following day, she was extremely nauseous. Her arm was painful for the following week and was beginning to improve as of 09/28/15.
Age: 12.0
Sex: M
Vaccine: FLUN4, HPV9, MNQ
Symptoms: Dyskinesia, Syncope
Clinical narrative: Approximately 5 minutes after receiving vaccines, walking out of office and had syncopal episode lasting only a few seconds with brief jerking movements.  Rested in office for approx 30 min and given some water and apple juice.
Age: 92.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Contusion, Fatigue, Rash, Skin warm
Clinical narrative: Received Prevnar and Fluzone HD 1: apart in the Right Arm - Sunday morning below the area that the injections were given (right above the elbow) she developed a rash and was extremely tired the whole day.  Still present Monday and started taking Benadry which helped a little, now has heat and a bruise forming.
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Noticed redness, swelling and itching to injection site at 10:00 pm. Pt symptoms improved after about 4 days. Parent gave pt Ibuprofen 400mg.
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Noticed redness, swelling and itching to injection site. Lasted 4 days. No treatment given.
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Dyskinesia, Electroencephalogram
Clinical narrative: 2-5 minute episodes of upper extremities jerking spells.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Blood potassium decreased, Hyperhidrosis, Tremor
Clinical narrative: Patient's wife stated 4 hours after receiving the vaccine he had tremors, sweating, and weakness. Went to ER and was told it might have been from the flu shot. Not sure what he was given at hospital.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Feeling cold, Injection site nodule, Insomnia
Clinical narrative: Tues Sept 8 I received flu shot about 2 pm. THey gave me the HIGH DOSE -> vom 6 pm-8:30 pm I was ice cold and shaked and shook and teeth rattled and hard knot on right side where 9-8-15 About 2 pm received mega dose flu shot for seniors at 5 pm to 8:30 pm had terrible shakes and shingles and teeth rattling so cold fingers my hands and feet got cold. It was awful I thought I would die it felt like my Bells Palsy was coming back it was awful I do not know if I will ever take another one.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Peripheral coldness, Tremor
Clinical narrative: Tues Sept 8 I received flu shot about 2 pm. THey gave me the HIGH DOSE -> vom 6 pm-8:30 pm I was ice cold and shaked and shook and teeth rattled and hard knot on right side where 9-8-15 About 2 pm received mega dose flu shot for seniors at 5 pm to 8:30 pm had terrible shakes and shingles and teeth rattling so cold fingers my hands and feet got cold. It was awful I thought I would die it felt like my Bells Palsy was coming back it was awful I do not know if I will ever take another one.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Patient noticed redness, swelling, and hot to touch to left arm on 9/26/15. Patient did not take any ibuprofen or apply cold packs to arm. On 9/28/15, patient reported reaction to nurse. Patient states her reaction lessened since then, Area was noted to be redenned and slightly swollen only.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Loss of consciousness, Urticaria, Vaccination site haemorrhage, Vaccination site reaction
Clinical narrative: Patient bled from vaccination site, then a small whelt appeared at the vaccination site, then he lost consciousness for approximately a minute.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Peripheral swelling, Skin warm, Swelling
Clinical narrative: Patient received FLUZONE HIGH DOSE on the left arm. Half an hour later, she experienced swelling and pain. Her deltoid and upper arm were swollen and warm to touch. The area that swelled is 6" x 3" on her arm. Two days later, the swelling went down.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Mobility decreased, Nausea, Pain
Clinical narrative: Pt is having trouble lifting arm rotating arm, soreness, nausea, joint ache, chills.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Nausea, Vein disorder
Clinical narrative: Patient described a "vicious headache" upon awakening the following morning that lasted until about suppertime. She said sh felt like she was kicked in the back the head and a vein was pulsing out. She reported nausea for the following 2 days.
Age: 52.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Back pain, Blood blister, Dysstasia, Injection site pain, Myalgia
Clinical narrative: Pt. reports severe muscle and back pain 15-18 hrs after injection "can't stand up straight". Arm of injection painful from inj site to hand. Fever unknown. "Blood blisters" nostrils and back of hands all lasting 6 or more days.
Age: 52.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Pt. reports severe muscle and back pain 15-18 hrs after injection "can't stand up straight". Arm of injection painful from inj site to hand. Fever unknown. "Blood blisters" nostrils and back of hands all lasting 6 or more days.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to 2 patients of unknown age and gender. Information regarding concurrent conditions and medical history was not provided. Between May 2015 to September 2015 the patients were vaccinated with improperly stored ZOSTAVAX lot # L002424, expiration date 23-APR-2016 (dose, dose #, route of application site were not reported). No adverse effects reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 23-SEP-2015, the patient was vaccinated with an improperly stored ZOSTAVAX 0.65 ml, subcutaneous. The reporter state that the patient received one of the following lots: lot # L000450, expiry date 09-MAR-2016 or lot # L012476, expiry date 10-JUL-2016. No adverse effects were reported. Additional information has been requested.
Age: 0.19
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: Small warm red lump on surface of skin adjacent to injection site, improved after 1 day.
Sex: U
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse regarding an unspecified adult patient of unknown gender. There was no information about concurrent condition and historical medication. On an unknown date, the adult patient was inadvertently administered a pediatric dose of RECOMBIVAX HB 2.5/0.5 (units unknown) (route and lot number was unknown). No concomitant medication was reported. No adverse event was reported. No product quality complaint (PQC) was involved. The outcome of the event was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a female patient of unknown age. Concurrent condition and medical history were not reported. On 24-MAY-2014 the patient was vaccinated with the first dose of GARDASIL (lot#, expiration date, dose and route were unknown). On 12-MAR-2015, the patient was vaccinated with the second dose of GARDASIL (lot#, expiration date, dose and route were unknown). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nursery referring to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. On unknown dates the patients were vaccinated with unspecified doses of improperly RECOMBIVAX HB (dose, route and dose number were not provided) (lot # L008660, expiry date 10-NOV-2016) (lot # L004754, expiry date 10-NOV-2016). No adverse effects was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, concomitant medications and medical history were not provided. On unknown dates the patients were vaccinated with unspecified dose of improperly stored GARDASIL (dose, route and dose number were not provided) (lot # K014191, expiry date 10-MAY-2017) (lot # L010596, expiry date 06-APR-2017). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, concomitant medication and medical history were not provided. On unknown dates the patients were vaccinated with unspecified doses of improperly stored VAQTA (dose, route and dose number were not provided) (lot # K026529, expiry date 02-JUN-2017) (lot# L007559, expiry date 01-JUN-2017). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. On unknown dates the patients were vaccinated with unspecified dose of improperly stored GARDASIL 9 (dose, route and dose number were not provided) (lot# K026247, expiry date 29-JAN-2017). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. On unknown dates the patients were vaccinated with unspecified doses of improperly stored ROTATEQ (oral, dose and dose number were not provided) (lot # L000571, expiry date 26-JUL-2016). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: Information has been received from a pharmacist via a field employee referring to a 65 year old female patient. The patient's pertinent medical history and drug allergies were not reported. On an unknown date of September 20155 (reported as last week) the patient was vaccinated with ZOSTAVAX (dose, strength and route unknown) for prevention of shingles. On an unknown date of September 2015 the patient visited physician and presented with redness and swelling in the shoulder area following the ZOSTAVAX administration. The outcome of the events was unknown. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site mass, Injection site pain, Insomnia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient with pinched nerve that caused nerve pain in her left arm. The patient had no allergies. On 28-AUG-2015, the patient was vaccinated with a single dose of ZOSTAVAX lot # L000448, expiry date 08-MAR-2016, subcutaneous in the left arm (dose was not reported). Concomitant therapies included EFFEXOR, PAXIL; LIPITOR and diclofenac. On an unknown date in 2015, the patient experienced a hard lump and muscle pain at the injection site, on her left arm. She also experienced trouble sleeping due to the muscle pain and had contacted her physician who recommended patient to use TYLENOL to help sleep. No laboratory tests were performed. At the time of the report, on 16-SEP-2015, the patient did nor recovered from the events. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a 30 to 40 patients of unknown age and gender. Since an unknown date in September 2015 (the vaccinations occurred within the past 2 weeks) the patients were vaccinated with improperly stored doses of M-M-R II (therapy type: rHA, dose and frequency were not reported, lot # K024036 with expiration date: 26-NOV-2016). No adverse effects reported. This is one of the several reports received from the same reporter. Additional information is not expected. Reporters did not wish to be contacted.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 16 year old male patient. Medical history and concurrent conditions were none. Illness at the time of vaccination was none. On 24-AUG-2015 at 10:10 am, the patient was vaccinated with a third dose of improperly stored GARDASIL (lot # K011562, expiry date: 08-APR-2017) intramuscular in the left arm. No adverse event was reported. No concomitant therapy was reported. This is one of the six reports received from the same reporter. Additional information is not expected as all correspondence was received.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. There was no concurrent condition or medical history reported. On unknown dates the unspecified patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (lot # L001325, expiry date 13-JAN-2017) (dosage, strength and route were not reported). There were totally 10 patients administered with 2 incorrectly stored vaccine and the exact number of patients of (Oka/Merck) VARIVAX was unknown. At the time of the report, no adverse effects was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an 18 (also reported as 19) year old male patient. Medical history and concurrent conditions were none. Illness at the time of vaccination was none. On 24-AUG-2015 at 10:04 am, the patient was vaccinated with a second dose of improperly stored GARDASIL (lot # K011562, expiry date 08-APR-2017) intramuscular in the left arm. No adverse effect was reported. No concomitant therapy was reported. This is one of the six reports received from the same reporter. Additional information is not expected as all correspondence was received.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was not reported. On 24-SEP-2015 the patient inadvertently received an expired dose of PNEUMOVAX23 (lot # K004281 with expiration date of 22-MAR-2015, 0.5 ml, once, intramuscular) (expired product administered). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacists concerning a patient of unknown age and gender. Patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On an unknown date in 2009 patient was vaccinated with ZOSTAVAX (strength, dose were not reported). On 24-SEP-2015 the patient was vaccinated with second dose of ZOSTAVAX lot # L011536 with an expiry of 03-JUL-2016, 0.65 ml, subcutaneous. No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of an unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. The patient was vaccinated with ZOSTAVAX on 27-AUG-2014 and 24-SEP-2015. No adverse symptoms were reported. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a certified medical assistant referring to two unspecified patients of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored PROQUAD (lot number L007229, expiration date 03-SEP-2016, dose and route were not reported). There was no concomitant medication reported. No adverse effects were reported. Follow up information was received from the certified medical assistant (C.M.A.) via a phone call on 24-SEP-2015. The C.M.A. reported that one of the patients who received the improperly stored (Oka-Merck) PROQUAD (lot number L007229, expiration date 03-SEP-2016) was a 4 years old patient of unknown gender.  The (Oka-Merck) PROQUAD was used on 10-AUG-2015. This is one of the several reports 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 medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unspecified dates, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX injection (dose, route of administration, lot# and expiry date were not reported). There were no concomitant therapies reported. No adverse effect was reported. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician and certified medical assistant, refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 08-SEP-2011, the patient was vaccination with an initial dose of VAQTA (dose, route of administration, lot# and expiration date were not reported). On 08-MAR-2012, the patient was administered a second dose of VAQTA (dose, route of administration, lot# and expiration date were not reported). Concomitant medications were not provided. On 24-SEP-2015, the patient was inadvertently vaccinated with a third dose of VAQTA (lot # L007559, expiration date 01-JUN-2017, dose and route of administration were not reported). No adverse effect was reported. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 17 year old male patient. Medical history and concurrent conditions were none. Illness at the time of vaccination was none. On 26-AUG-2015 at 07:20 am, the patient was vaccinated with second dose of improperly stored GARDASIL (lot # K011562, expiry date: 08-APR-2017) intramuscular in the left arm. No adverse effect was reported. No concomitant therapy was reported. This is one of the six reports received from the same reporter. Additional information is not expected as all correspondence was received.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: This spontaneous report was received from a physician via e-mail and refers to an adult patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On an unknown date, the patient was vaccinated with the first dose of ZOSTAVAX (strength, dose, route of administration, lot # and expiration date were not provided). On an unknown date (one year after the first dose of ZOSTAVAX), the patient was vaccinated with the second dose of ZOSTAVAX (strength, dose, route of administration, lot # and expiration date were not provided). The reporter queried if there would be any danger to a patient after receiving the second dose of ZOSTAVAX and if there could be any side effects that the patient would have to be warned of. Additional information has bene requested.
Age: 43.0
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 43-year-old patient of unknown gender. The patient's medical history and concurrent condition were not reported. On 18-SEP-2015, the patient was vaccinated with a dose of ZOSTAVAX (inappropriate schedule of drug administration). No adverse effects were reported. No product quality complaint (PQC) was filed for ZOSTAVAX. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: This spontaneous report has been received from a pharmacist concerning a female patient of approximately 75 years old. Patient's pertinent medical history and concurrent conditions were unspecified by the reporter. No previous drug reactions or allergies were reported. On 09-JUN-2015 the patient was vaccinated with ZOSTAVAX (0.65 mL, subcutaneously, left deltoid0 lot # K018176 with an expiry date of 10-JAN-2016. No concomitant medications were reported. On an unknown date in June 2015 the patient experienced shingles. The patient filled a prescription at the pharmacy on 22-JUN-2015 for gabapentin 100 mg two capsules twice a day as needed for shingles pain and acyclovir 800 mg three times a day for 10 days. THe pharmacist states that she does not know when the patient began to experience shingles. The patient filled another prescription on an unspecified date after 22-JUN-2015 for gabapentin for shingles pain, and the patient reports that she is still experiencing post herpetic neuralgia. The pharmacist believes that the patient's lesions are healing. The outcome of the events shingles and post herpetic neuralgia were reported as recovering. The reporter did not provide the causality between the events and the suspect therapy. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HEPA, HIBV, MMR, MMRV
Symptoms: Asthenia, Ear infection, Flat affect, Insomnia, Weight increased
Clinical narrative: On 20-APR-2015, the patient was vaccinated with a doses of MMR II (lot #, expiration date, dose and route were not reported), LIQUID PEDVAXHIB (lot #, expiration date, dose and route were not reported), (Oka-Merck) PROQUAD (lot #, expiration date, dose and route were not reported), RECOMBIVAX HB (lot #, expiration date, dose and route were not reported), VAQTA (lot #, expiration date, dose and route were not reported), (Oka/Merck) VARIVAX and GARDASIL 9 (lot #, expiration date, dose and route were not reported) as well as 5 other unspecified vaccines (non Merck manufactured) all in one visit. On 22-AUG-2015, the patient experienced severe ear infections, weight gain, lack of energy, sleeplessness, dragging along at school, her eyes were hollow, she was showing no signs of emotion anymore. The mother reported that her daughter looked like she had been poisoned. There was no labs diagnostics studies performed. The patient was treated with ibuprofen, ofloxacin and amoxicillin. The outcome adverse events was reported as not recovered. The patient sought medical attention via visiting her doctor. The relatedness between adverse events and suspected therapies was not reported. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a 63 year old male physician via a field employee refers to himself. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not specified by the reporter. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX vial (dose, route of administration, lot# and expiration date were not reported) as a shingles vaccination. On an unknown date (reported as two weeks after receiving the dose of ZOSTAVAX, the patient developed a case of shingles (considered by the field employee as likely self-diagnosed by the physician). No treatment was given for the adverse event. The outcome of shingles was reported as recovered on an unspecified date. Causality assessment between ZOSTAVAX and the adverse event was not provided. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: ZOSTAVAX administered pursuant to Rx from MD on 9/17/15. Pt diagnosed with shingles on back on 9/29/15.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient reports left arm redness, swelling, warm to touch, joint pain on left side. Taking ibuprofen every 4 hours and BENADRYL was ineffective. x 2 weeks.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Hypoaesthesia, Throat tightness
Clinical narrative: Patient experienced allergic reaction after she was home. Her throat was closing and face was numb. She took BENADRYL and symptoms resolved.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning to a patient of unknown age and gender. The patient's concurrent conditions, medical history or allergy/drug reactions were not reported. On an unspecified date in 2014, reported as one year ago, the patient was vaccinated with a dose of ZOSTAVAX (strength, dose, frequency and lot No. not specified) subcutaneously. Then, on 22-SEP-2015 the patient received a second dose of ZOSTAVAX (lot No. not informed) 0.65 ml, subcutaneously. No adverse effect nor product quality issue were informed. Additional information has been requested.
Age: 1.05
Sex: M
Vaccine: HIBV, MMR
Symptoms: Chills, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Fever of 103.0 x 1 episode. Stiff for a few seconds. Chills.
Age: 56.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Arm hurting, complained about can't hold his arm up.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Injection site reaction. Redness, swelling, warm, slight pain. Pt received prescription for KEFLEX 500 qid x 10 days to start if symptoms don't resolve in 48 hrs.
Age: 67.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site reaction, Rash pruritic
Clinical narrative: Raised itchy rash on upper right arm. Primary Dr. ordered ZOSTAVAX, PREVNAR - protocol Dr.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient presented to pharmacy less than 24 hours after vaccination with PNEUMOVAX on left arm. Arm was red and swollen the entire upper arm to the elbow with pain.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 15-SEP-2015, the patient was vaccinated with an expired dose of MMR II (Lot # JJ006995, expiration date 14-JUN-2015 (also reported) 12-JUL-2015) (dose and route not provided). Later, on the same day, the patient was vaccinated with another dose of MMR II (dose, route, lot No. were not provided). The reason was because they thought the expired dose would not count. Concomitant medications were not informed. No adverse event and product quality issue were involved it was unknown if the patient sought medical attention. Additional information has been requested.