chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Axillary mass, Axillary pain, Oedema, Pain
Clinical narrative: Student reported to school nurse that he started with a painful lump approx 2.5 inches in size anterior axillary, starting approx 12 hrs after receiving MENACTRA vaccine. He states discomfort on raising arm, but no fever or redness. SNT examined but did not feel a nose, just edema. SNT spoke with school MD and suggested parents watch for developing redness or fever, and if this develops over the weekend, or the lump or pain increases then he should be seen by his PCP. SNT relayed message to dad. Symptoms lessened and as of 11/14, 1 week s/p vaccination, the SNT reported to me that he has improved, with swelling and pain just about gone.
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Chapped lips, Lip blister, Lip erythema, Lip pain, Lip swelling
Clinical narrative: About 2 hours after vaccination, started feeling lip tingling, burning and chapped. This got worse throughout the night. Woke up the following day and had swelling, redness, blisters and chapped around the lips. Also complains of pain around lips BENADRYL and DECADRON taken. Completely cleared by 11/14/2017. Denies any use of new products or medications.
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Oral discomfort, Paraesthesia oral
Clinical narrative: About 2 hours after vaccination, started feeling lip tingling, burning and chapped. This got worse throughout the night. Woke up the following day and had swelling, redness, blisters and chapped around the lips. Also complains of pain around lips BENADRYL and DECADRON taken. Completely cleared by 11/14/2017. Denies any use of new products or medications.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Hypoaesthesia, Pain, Peripheral swelling
Clinical narrative: Pt received vaccine on 11/13/17, about 30 mins after administration noticed swelling, redness and pain. Came back to clinic on 11/14/17 area of swelling/redness was 12x12 with numbness from her left hand to her mid forearm. Pt was advised to ice area and was prescribed naproxen.
Age: 74.0
Sex: M
Vaccine: PNC13
Symptoms: Insomnia, Pain in extremity
Clinical narrative: On August 30 visit (33 days after vaccination) was seen in office and he complained of arm pain. He said he could not sleep on side due to pain. Patient was prescribed topical NSAID.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Lip swelling, Rash, Swollen tongue, Vaccination site swelling
Clinical narrative: Pt had lip and tongue swelling as well had rash on her upper body. The patient denied SOB. Patient also had swollen left upper arm at site where vaccine was given. BENADRYL, prednisolone given and follow up next day. Patient is being sent to allergist.
Age: 42.0
Sex: M
Vaccine: FLUC4
Symptoms: Dehydration, Vomiting
Clinical narrative: Vomiting, dehydration.
Age: 79.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Urticaria
Clinical narrative: Patient broke in hives after receiving influenza vaccine. Rash decreased by ~70% within 4 hours. Discharged with medal dosepak on same day.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Electromyogram, Fatigue, Hypoaesthesia oral, Intranasal hypoaesthesia
Clinical narrative: Neurological symptoms: weakness/tired feeling in arms and legs, tiredness in jaw muscles when chewing, stiffness in  facial muscles, nerve pain in hands and in legs, sluggish tongue and resulting biting of tongue, brief period of numbness in upper lip and nose.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle fatigue, Muscular weakness, Musculoskeletal stiffness, Nerve conduction studies, Neuralgia
Clinical narrative: Neurological symptoms: weakness/tired feeling in arms and legs, tiredness in jaw muscles when chewing, stiffness in  facial muscles, nerve pain in hands and in legs, sluggish tongue and resulting biting of tongue, brief period of numbness in upper lip and nose.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Neurological symptom, Nuclear magnetic resonance imaging, Tongue biting, Tongue movement disturbance
Clinical narrative: Neurological symptoms: weakness/tired feeling in arms and legs, tiredness in jaw muscles when chewing, stiffness in  facial muscles, nerve pain in hands and in legs, sluggish tongue and resulting biting of tongue, brief period of numbness in upper lip and nose.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Loss of consciousness
Clinical narrative: Patient passed out after flu vaccination.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Excruciating pain at the site of injection. Could not move arm.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Furuncle, Injection site indentation, Injection site irritation, Injection site reaction, Injection site scar
Clinical narrative: Pt reported she had injection site irritation and blistering. Swelling as well and a boil that stuck out from her arm. Left a scar and "hole" in her arm.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Injection site vesicles
Clinical narrative: Pt reported she had injection site irritation and blistering. Swelling as well and a boil that stuck out from her arm. Left a scar and "hole" in her arm.
Age: 0.58
Sex: F
Vaccine: HIBV
Symptoms: Haemophilus infection, Haemophilus test positive, Human metapneumovirus test positive, Metapneumovirus infection, Pneumonia
Clinical narrative: Patient received all three hib vaccines (4/18/2017, 6/20/2017, 10/3/2017). Was admitted on 11/4/2017 in respiratory distress. Found to have metapneumoviral pneumonia and Haemophilus influenza type B grew from her aerobic and anaerobic blood culture on 11/4. Repeat Cx after 1 day of ceftriaxone was negative.
Age: 0.58
Sex: F
Vaccine: HIBV
Symptoms: Respiratory distress
Clinical narrative: Patient received all three hib vaccines (4/18/2017, 6/20/2017, 10/3/2017). Was admitted on 11/4/2017 in respiratory distress. Found to have metapneumoviral pneumonia and Haemophilus influenza type B grew from her aerobic and anaerobic blood culture on 11/4. Repeat Cx after 1 day of ceftriaxone was negative.
Age: 0.58
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Crying, Dyspnoea, Mobility decreased, Ocular hyperaemia, Rash generalised
Clinical narrative: My son started breaking out in a small rash at 10:45pm, and head was a little swollen on top of his head at soft spot, was having problems breathing correctly at the time, taking random big breaths. Screaming violently in random spurts, not wanting to move head or both legs at all, only arms and hands. Cried for 4 hours straight. Took to urgent care the next day at 3:45pm because he broke out in a full body rash including head and a eyes had bloody looking  broken blood vessel.
Age: 0.58
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Screaming, Swelling
Clinical narrative: My son started breaking out in a small rash at 10:45pm, and head was a little swollen on top of his head at soft spot, was having problems breathing correctly at the time, taking random big breaths. Screaming violently in random spurts, not wanting to move head or both legs at all, only arms and hands. Cried for 4 hours straight. Took to urgent care the next day at 3:45pm because he broke out in a full body rash including head and a eyes had bloody looking  broken blood vessel.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness
Clinical narrative: Patient returned to the store today (11/15/17) and stated she had to pull over and give herself an EPIPEN shot because her throat closed. She said she went to Hospital and was given prednisone and BENADRYL.
Age: 23.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis at injection site. Patient went home on oral antibiotics.
Age: 26.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Consciousness fluctuating, Diarrhoea, Feeling abnormal
Clinical narrative: Patient called on 11/14/2017 stating that he "didn't feel right". He stated he had no fever, rash, swelling, no diarrhea, or headache. On 11/15/2017 his wife called stating that he now had diarrhea and seemed to be "going in and out of consciousness".  Since they were now already in the ER waiting to be seen, we asked that they keep us posted with how he was doing.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Inflammation, Injection site erythema, Injection site swelling, Peripheral swelling
Clinical narrative: The vaccination given was the DTap + Polio - unsure of the manufacturer. This was to be the final shot in the series. Approximately 48 hours after injection, the injection site became red and raised. The diameter of the affected area was approximately 4". Additionally, the patient's hand developed what appeared to be large hives across the fingers and knuckles with an additional inflamed area on the right forearm, approximately 1" in diameter. The hives did not itch or hurt but the fingers and knuckles appeared red and swollen. The affected area was warm to the touch. Symptoms continued for 9 days, until oral BENADRYL was administered over the course of 48 hours. The inflammation resolved as of day 12, however the red patches have turned brown and the skin has begun to peel.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Skin discolouration, Skin exfoliation, Skin warm, Urticaria
Clinical narrative: The vaccination given was the DTap + Polio - unsure of the manufacturer. This was to be the final shot in the series. Approximately 48 hours after injection, the injection site became red and raised. The diameter of the affected area was approximately 4". Additionally, the patient's hand developed what appeared to be large hives across the fingers and knuckles with an additional inflamed area on the right forearm, approximately 1" in diameter. The hives did not itch or hurt but the fingers and knuckles appeared red and swollen. The affected area was warm to the touch. Symptoms continued for 9 days, until oral BENADRYL was administered over the course of 48 hours. The inflammation resolved as of day 12, however the red patches have turned brown and the skin has begun to peel.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain
Clinical narrative: I still have pain at injection site on my right shoulder. I have discomfort when raising or rotating right arm. The pain has not subsided or reduced since I have been administered the vaccine on 10/17/17. I have been taking OTC naproxen to alleviate some of the inflammation, however, it has not helped.
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Pruritus, Swelling
Clinical narrative: Patient had severe itching and swelling and ended up going to the ER.
Age: 56.0
Sex: F
Vaccine: UNK
Symptoms: Hypoaesthesia oral, Pruritus generalised, Rash generalised
Clinical narrative: Slow itch starting around 7 pm. Started on both legs. About 7:30 pm legs started itching more but still didn't realize. Between 8-8:30 pm more itching moving up my stomach, arms and back. My husband saw a rash on my body. I called the pharmacist around 8:50 pm. Pharmacist suggested to take BENADRYL or CLARITIN. He also said if I felt worse call 911. My husband went to get CLARITIN. While my husband was gone I felt my lip a little numb feeling. I took a CLARITIN by 9:30 pm and started feeling better. I was mildly itchy the next day. The CLARITIN was a 24 hr dosage.
Age: 79.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient's representative called today (11/15/17) and stated that the patient's left arm was red, swollen, and painful around the injection site. I encouraged her to take the patient to see a Doctor for further evaluation. I later spoke with patient and again encouraged him to seek medical attention. He stated that he may go see his PCP tomorrow if it doesn't improve.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Blood test, Computerised tomogram, Insomnia, Pain
Clinical narrative: Patient had swelling and pain, then developed body aches and a low grade fever. Went to urgent care 4 days later pain in lower back-thought had kidney stone. Given antibiotic. Two days later Monday, Oct 16, 2017) "went to urologist & had a CT, & x-rays. It turns out the customer had no infection, so took customer off antibiotic. Then customer went to her doctor and told him she couldn't sleep and still had severe pain everywhere. They did a complete blood work & customers white count was down, so was put on steroids.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Swelling, White blood cell count decreased, X-ray
Clinical narrative: Patient had swelling and pain, then developed body aches and a low grade fever. Went to urgent care 4 days later pain in lower back-thought had kidney stone. Given antibiotic. Two days later Monday, Oct 16, 2017) "went to urologist & had a CT, & x-rays. It turns out the customer had no infection, so took customer off antibiotic. Then customer went to her doctor and told him she couldn't sleep and still had severe pain everywhere. They did a complete blood work & customers white count was down, so was put on steroids.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Injection site pain, Pain
Clinical narrative: Pt describes initial bruising 1-2 days after vaccine and then very painful upper left arm beginning 1-2+ weeks after vaccine. Currently still experiencing pain, particularly while raising arm.
Age: 30.0
Sex: M
Vaccine: DTAP
Symptoms: Alcohol abuse, Amnesia, Herpes virus infection, Syphilis
Clinical narrative: Had an uncontrollable urge to drink alcohol. Significant memory loss following alcohol consumption, totalling 14 hours. Later diagnosed with herpes and syphilis.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Drug administered at inappropriate site, Joint range of motion decreased, Limb discomfort, Pain
Clinical narrative: Vaccine was administered higher on my arm than usual; first 24 hours/through the night arm was heavy and sore and continued through the next day. Pain settled deep into the shoulder joint. Range of motion restricted and painful--most acutely upon external rotation. Initial assessment by primary physician (10/19/17) dx as "frozen shoulder" and referred to Orthopedist (pending 11/28/17) and physical therapy (11/6; 11/10; 11/16). Two prescriptions of prednisone (20 mgx3; 8 days taper); nightly ice compress. Pain lessens when taking prednisone but otherwise can be excruciating; sleep interrupted by not being able to move without pain.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Periarthritis, Sleep disorder
Clinical narrative: Vaccine was administered higher on my arm than usual; first 24 hours/through the night arm was heavy and sore and continued through the next day. Pain settled deep into the shoulder joint. Range of motion restricted and painful--most acutely upon external rotation. Initial assessment by primary physician (10/19/17) dx as "frozen shoulder" and referred to Orthopedist (pending 11/28/17) and physical therapy (11/6; 11/10; 11/16). Two prescriptions of prednisone (20 mgx3; 8 days taper); nightly ice compress. Pain lessens when taking prednisone but otherwise can be excruciating; sleep interrupted by not being able to move without pain.
Age: 75.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Laboratory test normal
Clinical narrative: Pt came to pharmacy the following morning with upper left arm (deltoid to just above elbow) red, swollen and warm to the touch. I advised an antihistamine and told her I would follow up with her the next day. Rxn progressed over 24 hr to below the elbow so she went to the ER.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site swelling, Tenderness
Clinical narrative: Pt had some bruising and swelling at the injection site. The arm was painful upon palpation. Pt was recommended to use ice compresses and report to an MD if her condition worsens.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site warmth, Insomnia, Malaise
Clinical narrative: THE SAME NIGHT OF BEING VACCINATED MONDAY 11/13/17. AT NIGHT PT FELT VERY SICK & PT COULDN'T SLEEP. THE NEXT MORNING AT WORK PT VISUALLY NOTICED WIDESPREAD REDNESS AT INJECTION SITE (LOCAL). PT NOTICED IT WAS WARM TO THE TOUCH (VERY HOT). BUT PT DID ADMIT LATER WEDNESDAY EVENING THEY FELT MUCH BETTER (NOT FEELING SICK BUT JUST ARM FEELING WARM TO THE TOUCH & RED).
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Condition aggravated, Crying, Discomfort, Injection site cellulitis, Injection site erythema
Clinical narrative: Patient seemed unusually fussy and uncomfortable after the shots. He is nonverbal and is not able to tell us what was bothering him but kept crying. After about 30-40 minutes that the vaccine was administered, patient had two seizures that are unusual for him and that he had never had these type before. The next day, he developed redness and warmth at both of the injection sites. Two days after, he was taken to the ER because the redness spread on the whole thigh on one leg and a large lump formed on another one. Both sites were warm, red, and swollen. ER doctor diagnosed cellulitis and prescribed antibiotics. Patient continued to have seizures for two weeks after the administration of the vaccine. He had seizures a couple times a day which is also very unusual for him because he usually has one a week. He seems constantly in pain and holds on to his head and cries which is also new for him.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site mass, Injection site swelling, Injection site warmth, Irritability, Pain
Clinical narrative: Patient seemed unusually fussy and uncomfortable after the shots. He is nonverbal and is not able to tell us what was bothering him but kept crying. After about 30-40 minutes that the vaccine was administered, patient had two seizures that are unusual for him and that he had never had these type before. The next day, he developed redness and warmth at both of the injection sites. Two days after, he was taken to the ER because the redness spread on the whole thigh on one leg and a large lump formed on another one. Both sites were warm, red, and swollen. ER doctor diagnosed cellulitis and prescribed antibiotics. Patient continued to have seizures for two weeks after the administration of the vaccine. He had seizures a couple times a day which is also very unusual for him because he usually has one a week. He seems constantly in pain and holds on to his head and cries which is also new for him.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Pain in extremity, Seizure
Clinical narrative: Patient seemed unusually fussy and uncomfortable after the shots. He is nonverbal and is not able to tell us what was bothering him but kept crying. After about 30-40 minutes that the vaccine was administered, patient had two seizures that are unusual for him and that he had never had these type before. The next day, he developed redness and warmth at both of the injection sites. Two days after, he was taken to the ER because the redness spread on the whole thigh on one leg and a large lump formed on another one. Both sites were warm, red, and swollen. ER doctor diagnosed cellulitis and prescribed antibiotics. Patient continued to have seizures for two weeks after the administration of the vaccine. He had seizures a couple times a day which is also very unusual for him because he usually has one a week. He seems constantly in pain and holds on to his head and cries which is also new for him.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Blister, Oral discomfort, Swelling
Clinical narrative: Patient woke approximately 2 days later to a burning mouth sensation. They have become blister like and puffy. Pt saw PCP on 11/15/17. Hurts to laf. Tried lysine but was told to see Doctor. Doctor also looking to adverse event upon start of losartan 100mg tablets close to possibly 1 week prior to vaccination. Doctor told patient to continue losartan and to call/be seen if symptoms worsen/continue.
Age: 24.0
Sex: M
Vaccine: ANTH, FLUX, SMALL
Symptoms: Axillary pain, Injection site rash, Lymphadenopathy, Rash
Clinical narrative: Rash on chest, upper abdomen, shoulder above injection site, swollen lymph nodes (R) armpit - achy since afternoon of Nov. 14th.
Age: 60.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Blister, Hyperhidrosis, Neck pain, Pain in extremity, Peripheral swelling
Clinical narrative: Arm and necked had swelled - called pharmacist the evening PREVNAR was administered to discuss reaction. He advised her to call MD. She went to MD that Thurs. or Fri. He thought she may have had shot in rotator cuff and irritated it. He recommended physical therapy. Started therapy once a week then, increased to twice a week. Pt. said she had a bubble in arm that injection was given. She has been having bad sweating events daily. Neck pain radiates down to fingertips. No change in the pain and sometimes worse. The pain is every day.
Age: 60.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Swelling
Clinical narrative: Arm and necked had swelled - called pharmacist the evening PREVNAR was administered to discuss reaction. He advised her to call MD. She went to MD that Thurs. or Fri. He thought she may have had shot in rotator cuff and irritated it. He recommended physical therapy. Started therapy once a week then, increased to twice a week. Pt. said she had a bubble in arm that injection was given. She has been having bad sweating events daily. Neck pain radiates down to fingertips. No change in the pain and sometimes worse. The pain is every day.
Age: 49.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Asthenia, Chills, Headache, Nausea, Palpitations
Clinical narrative: Pt. received BOOSTRIX (LA) and pneumonia/PREVNAR 13 (RA) and minutes after receiving the vaccines she experienced chills, nausea, vomiting, fever, headaches, palpitation and weakness. The ambulance was called and I notified her doctor of what took place and spoke to nurse manager at Dr's office.
Age: 49.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Pyrexia, Vomiting
Clinical narrative: Pt. received BOOSTRIX (LA) and pneumonia/PREVNAR 13 (RA) and minutes after receiving the vaccines she experienced chills, nausea, vomiting, fever, headaches, palpitation and weakness. The ambulance was called and I notified her doctor of what took place and spoke to nurse manager at Dr's office.
Age: 61.0
Sex: F
Vaccine: FLUC4, PPV, VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Patient has a large red rash at injection site that developed after immunization. Rash is on left arm.
Age: 4.0
Sex: U
Vaccine: DTAP, FLU4, IPV, MMR, VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: Redness and swelling.
Age: 94.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Computerised tomogram, Decreased appetite, Fatigue, Muscular weakness
Clinical narrative: Queasy (nauseous), muscle weakness, loss of appetite, (lost 5 lbs.) tired, eyesight, no energy. (No temperature).
Age: 94.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Nuclear magnetic resonance imaging, Visual impairment, Weight decreased
Clinical narrative: Queasy (nauseous), muscle weakness, loss of appetite, (lost 5 lbs.) tired, eyesight, no energy. (No temperature).
Age: 61.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Vaccine administered 10/25/17-Pt woke w/bright red rash around injection site on 10/30/17. Applied hydrocortisone and BENADRYL to site. Rash is resolving but still present on 11/3/17. Pt reported all of this to Rph 11/3/17.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Cough, Dizziness, Dyspnoea, Eye pruritus
Clinical narrative: Headache, itchy eyes. Dizziness and weakness. Difficulty breathing. Itching and coughing.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Pruritus
Clinical narrative: Headache, itchy eyes. Dizziness and weakness. Difficulty breathing. Itching and coughing.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia, Urticaria
Clinical narrative: Per Mom pt. had fever 101-102 the night after the shot. Hive the next day - they lasted for 2-3 days.
Age: 2.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Patient received FLUARIX flu shot that is indicated for patients 3 years - 64 years. No signs, symptoms, adverse reactions noted. No treatment required.
Age: 23.0
Sex: U
Vaccine: VARCEL
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Reddened mildly swollen and tender area at site of vaccine administration.
Age: 27.0
Sex: M
Vaccine: FLUC4
Symptoms: Loss of consciousness
Clinical narrative: Patient passed out for a couple of seconds after the flu injection. He was sitting in a chair and did not sustain any further injury. He was evaluated by the provider and was cleared to leave the clinic.
Age: 70.0
Sex: F
Vaccine: FLUA3
Symptoms: Arthralgia, Fatigue, Headache, Musculoskeletal chest pain, Musculoskeletal pain
Clinical narrative: The vaccine was received Friday, Nov. 10, 2017. I had a sore shoulder as expected then the fever started and pain all over my head, in my jaw, under my neck, down my neck, fever got hotter, every rib seemed to hurt in my rib cage, my chest muscles, my shoulder joints. As Saturday progressed the pain was in my hip joints, my knees, and somewhat in my ankles. Then as the clock ticked past midnight Saturday I began to notice pain and fever leaving my body from my feet up to my head while pain left my body, the pain in my left jaw increased. Then around 3pm Sunday that pain left my jaw, too. Monday Nov. 13 I felt fine, but tired.
Age: 70.0
Sex: F
Vaccine: FLUA3
Symptoms: Neck pain, Pain, Pain in jaw, Pyrexia
Clinical narrative: The vaccine was received Friday, Nov. 10, 2017. I had a sore shoulder as expected then the fever started and pain all over my head, in my jaw, under my neck, down my neck, fever got hotter, every rib seemed to hurt in my rib cage, my chest muscles, my shoulder joints. As Saturday progressed the pain was in my hip joints, my knees, and somewhat in my ankles. Then as the clock ticked past midnight Saturday I began to notice pain and fever leaving my body from my feet up to my head while pain left my body, the pain in my left jaw increased. Then around 3pm Sunday that pain left my jaw, too. Monday Nov. 13 I felt fine, but tired.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site vesicles
Clinical narrative: Patient had blistering, swelling, redness, itchiness and pain at injection site.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity
Clinical narrative: L index and middle finger pain after vaccination. Achiness.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient has redness, warmth, and general pain in the area of the injection site and surrounding area.
Age: 17.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; An unknown number of unspecified patients have been administered doses of vaccines that were improperly stored; This spontaneous report was received from a physician referring to a 17 year old patient of unknown gender. Pertinent medical history or concurrent conditions were not reported.  On 17-MAY-2017, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # M043731, expiration date 22-JUN-2019 (dosage information and route were not informed). Information regarding concomitant medication was not provided.  Additionally, it was reported that the lowest temperature was 32°F and the higher was 54°F for 70 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved.  This is one case from several cases from the same reporter.
Age: 15.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; An unknown number of unspecified patients have been administered doses of vaccines that were improperly stored; This spontaneous report was received from a physician referring to a 15 year old patient of unknown gender. Pertinent medical history or concurrent conditions were not reported.  On 17-MAY-2017, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # M043731, expiration date 22-JUN-2019 (dosage information and route were not informed). Information regarding concomitant medication was not provided.  Additionally, it was reported that the lowest temperature was 32°F and the higher was 54°F for 70 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved.  This is one case from several cases from the same reporter.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Malaise
Clinical narrative: Case number PHHY2017US020130 is an initial spontaneous report received from other healthcare professional via vaccine adverse event reporting system (VAERS number: 655444) website on 23 Jan 2017. This report refers to female patient of unspecified age. Medical history and concomitant medication was not reported. The patient was vaccinated with Influenza virus vaccine INN (unknown whether seasonal or pandemic) and PNEUMOVAX 23 (other manufacturer) on an unknown date. The patient reported that when she was younger, she would get very sick after vaccination with PNEUMOVAX 23 and influenza virus vaccine. The outcome of the event was unknown, seriousness was reported as non serious and causality of the event was not reported.
Age: 72.0
Sex: M
Vaccine: FLUX, TDAP, TDAP
Symptoms: Injection site pain, Muscle spasms, Muscle twitching
Clinical narrative: The patient came in over 1 month after receiving the ADACEL vaccine complaining of muscle pain in the injection site.  He described it as an electric shock that goes from his ear to injection site, and that the pain started after he received the vaccine.
Age: 72.0
Sex: M
Vaccine: FLUX, TDAP, TDAP
Symptoms: Injection site pain, Paraesthesia
Clinical narrative: The patient came in over 1 month after receiving the ADACEL vaccine complaining of muscle pain in the injection site.  He described it as an electric shock that goes from his ear to injection site, and that the pain started after he received the vaccine.
Sex: M
Vaccine: PPV, PPV
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: This initial spontaneous report was received on 15-NOV-2017 from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information regarding medical history, concurrent conditions and concomitant medications were provided. On 15-NOV-2016, the patient was administered PNEUMOVAX 23 at a pharmacy (dose, route and lot # not provided). It was claimed that the patient experienced shoulder injuries as a result of PNEUMOVAX 23. (Onset date not specified). The patient continued to suffer from intense and prolonged pain, weakness, stiffness, and limited range of motion associated with his shoulder injury related to PNEUMOVAX 23 requiring medical treatment (not further specified). The outcome of the events were not recovered/not resolved. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: PPV, PPV
Symptoms: Asthenia, Joint range of motion decreased, Limb injury, Musculoskeletal stiffness, Pain
Clinical narrative: This initial spontaneous report was received on 15-NOV-2017 from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information regarding medical history, concurrent conditions and concomitant medications were provided. On 15-NOV-2016, the patient was administered PNEUMOVAX 23 at a pharmacy (dose, route and lot # not provided). It was claimed that the patient experienced shoulder injuries as a result of PNEUMOVAX 23. (Onset date not specified). The patient continued to suffer from intense and prolonged pain, weakness, stiffness, and limited range of motion associated with his shoulder injury related to PNEUMOVAX 23 requiring medical treatment (not further specified). The outcome of the events were not recovered/not resolved. Causality assessment was related. Additional information has been requested.
Age: 0.58
Sex: F
Vaccine: DTAPIPVHIB, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Computerised tomogram head, Electroencephalogram, Laboratory test, Seizure
Clinical narrative: 8/31/2017 Woke up around 5 am, woke up screaming and crying which was very unusual as she normally wakes up happy. Temp 99.5. Mother was going to give acetaminophen when she arched backwards, hit the back of her head on a cupboard. Her eyes rolled back, she tensed up, was drooling, shaking. Episode lasted 50-30 seconds. Mother called 911 she was evaluated in the ER. Sent home by 6:30 AM, diagnosed with a febrile seizure. About a month later she had another seizure and has continued to have seizures on a regular basis since then. Has been evaluated by Pediatric neurologist. Normal MRI. Now on seizure medication.
Age: 0.58
Sex: F
Vaccine: DTAPIPVHIB, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Body temperature increased, Chest X-ray normal, Crying, Electroencephalogram normal, Eye movement disorder
Clinical narrative: 8/31/2017 Woke up around 5 am, woke up screaming and crying which was very unusual as she normally wakes up happy. Temp 99.5. Mother was going to give acetaminophen when she arched backwards, hit the back of her head on a cupboard. Her eyes rolled back, she tensed up, was drooling, shaking. Episode lasted 50-30 seconds. Mother called 911 she was evaluated in the ER. Sent home by 6:30 AM, diagnosed with a febrile seizure. About a month later she had another seizure and has continued to have seizures on a regular basis since then. Has been evaluated by Pediatric neurologist. Normal MRI. Now on seizure medication.
Age: 0.58
Sex: F
Vaccine: DTAPIPVHIB, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Febrile convulsion, Head injury, Musculoskeletal stiffness, Nuclear magnetic resonance imaging normal, Opisthotonus
Clinical narrative: 8/31/2017 Woke up around 5 am, woke up screaming and crying which was very unusual as she normally wakes up happy. Temp 99.5. Mother was going to give acetaminophen when she arched backwards, hit the back of her head on a cupboard. Her eyes rolled back, she tensed up, was drooling, shaking. Episode lasted 50-30 seconds. Mother called 911 she was evaluated in the ER. Sent home by 6:30 AM, diagnosed with a febrile seizure. About a month later she had another seizure and has continued to have seizures on a regular basis since then. Has been evaluated by Pediatric neurologist. Normal MRI. Now on seizure medication.
Age: 0.58
Sex: F
Vaccine: DTAPIPVHIB, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Screaming, Seizure, Urine analysis
Clinical narrative: 8/31/2017 Woke up around 5 am, woke up screaming and crying which was very unusual as she normally wakes up happy. Temp 99.5. Mother was going to give acetaminophen when she arched backwards, hit the back of her head on a cupboard. Her eyes rolled back, she tensed up, was drooling, shaking. Episode lasted 50-30 seconds. Mother called 911 she was evaluated in the ER. Sent home by 6:30 AM, diagnosed with a febrile seizure. About a month later she had another seizure and has continued to have seizures on a regular basis since then. Has been evaluated by Pediatric neurologist. Normal MRI. Now on seizure medication.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Computerised tomogram normal, Dysgeusia, Eyelid function disorder, Eyelid ptosis, Facial paralysis
Clinical narrative: Initial unsolicited report received from a consumer (patient) on 01-Nov-2017. This case involves a 66-year-old female patient, who was vaccinated once with 0.5 ml FLUZONE HD via intramuscular route (batch number, expiry date, dose in series and site of administration not reported) on 24-Oct-2017. Patient's medical history and concomitant medications were not reported. On 25-Oct-2017, one day following the vaccination, the patient developed "lips fuzzy, taste buds weird, headache" for 3 days. On 28-Oct-2017, four days after the vaccination, patient experienced right eye wouldn't close, ride side of face paralyzed, and had a visit to ER (emergency room), where diagnosed with Bells Palsy. On 30-Oct-2017, six days after the vaccination patient developed blood pressure of 215/100 and returned to ER. It was reported that patient continues to experience Blood pressure variation to 160/100 and Bells Palsy. Other relevant lab test was not reported. Patient received acyclovir, prednisone and clonidine as corrective treatment. Outcome of the events were reported as not recovered. Case was reported as serious because of permanent or significant disability/incapacitating event: Palsy Bells. Documents held by sender: none.; Sender's Comments: In this case patient expereinced Bell's palsy after vaccination with FLUZONE HD. Time to onset is compatible with the role of vaccine. The cause of Bell's palsy is yet unknown. The risk factors include diabetes and a recent upper respiratory tract infection. Further information on medical history, immune status at the time of vaccination, previous vaccination and tolerance, laboratory investigations excluding alternative etiologies (recent infections) would be needed to fully assess this case. ased on available information the role of vaccine cannot be assessed.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Headache, Hypoaesthesia oral, Lip disorder, Muscular weakness, Oral discomfort
Clinical narrative: Initial unsolicited report received from a consumer (patient) on 01-Nov-2017. This case involves a 66-year-old female patient, who was vaccinated once with 0.5 ml FLUZONE HD via intramuscular route (batch number, expiry date, dose in series and site of administration not reported) on 24-Oct-2017. Patient's medical history and concomitant medications were not reported. On 25-Oct-2017, one day following the vaccination, the patient developed "lips fuzzy, taste buds weird, headache" for 3 days. On 28-Oct-2017, four days after the vaccination, patient experienced right eye wouldn't close, ride side of face paralyzed, and had a visit to ER (emergency room), where diagnosed with Bells Palsy. On 30-Oct-2017, six days after the vaccination patient developed blood pressure of 215/100 and returned to ER. It was reported that patient continues to experience Blood pressure variation to 160/100 and Bells Palsy. Other relevant lab test was not reported. Patient received acyclovir, prednisone and clonidine as corrective treatment. Outcome of the events were reported as not recovered. Case was reported as serious because of permanent or significant disability/incapacitating event: Palsy Bells. Documents held by sender: none.; Sender's Comments: In this case patient expereinced Bell's palsy after vaccination with FLUZONE HD. Time to onset is compatible with the role of vaccine. The cause of Bell's palsy is yet unknown. The risk factors include diabetes and a recent upper respiratory tract infection. Further information on medical history, immune status at the time of vaccination, previous vaccination and tolerance, laboratory investigations excluding alternative etiologies (recent infections) would be needed to fully assess this case. ased on available information the role of vaccine cannot be assessed.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood pressure fluctuation, Dysgeusia, Eyelid function disorder, Facial paralysis, Headache
Clinical narrative: Initial unsolicited report received from a consumer (patient) on 01-Nov-2017. This case involves a 66-year-old female patient, who was vaccinated once with 0.5 ml FLUZONE HD via intramuscular route (batch number, expiry date, dose in series and site of administration not reported) on 24-Oct-2017. Patient's medical history and concomitant medications were not reported. On 25-Oct-2017, one day following the vaccination, the patient developed "lips fuzzy, taste buds weird, headache" for 3 days. On 28-Oct-2017, four days after the vaccination, patient experienced right eye wouldn't close, ride side of face paralyzed, and had a visit to ER (emergency room), where diagnosed with Bells Palsy. On 30-Oct-2017, six days after the vaccination patient developed blood pressure of 215/100 and returned to ER. It was reported that patient continues to experience Blood pressure variation to 160/100 and Bells Palsy. Other relevant lab test was not reported. Patient received acyclovir, prednisone and clonidine as corrective treatment. Outcome of the events were reported as not recovered. Case was reported as serious because of permanent or significant disability/incapacitating event: Palsy Bells. Documents held by sender: none.; Sender's Comments: In this case patient expereinced Bell's palsy after vaccination with FLUZONE HD. Time to onset is compatible with the role of vaccine. The cause of Bell's palsy is yet unknown. The risk factors include diabetes and a recent upper respiratory tract infection. Further information on medical history, immune status at the time of vaccination, previous vaccination and tolerance, laboratory investigations excluding alternative etiologies (recent infections) would be needed to fully assess this case. ased on available information the role of vaccine cannot be assessed.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Lip disorder
Clinical narrative: Initial unsolicited report received from a consumer (patient) on 01-Nov-2017. This case involves a 66-year-old female patient, who was vaccinated once with 0.5 ml FLUZONE HD via intramuscular route (batch number, expiry date, dose in series and site of administration not reported) on 24-Oct-2017. Patient's medical history and concomitant medications were not reported. On 25-Oct-2017, one day following the vaccination, the patient developed "lips fuzzy, taste buds weird, headache" for 3 days. On 28-Oct-2017, four days after the vaccination, patient experienced right eye wouldn't close, ride side of face paralyzed, and had a visit to ER (emergency room), where diagnosed with Bells Palsy. On 30-Oct-2017, six days after the vaccination patient developed blood pressure of 215/100 and returned to ER. It was reported that patient continues to experience Blood pressure variation to 160/100 and Bells Palsy. Other relevant lab test was not reported. Patient received acyclovir, prednisone and clonidine as corrective treatment. Outcome of the events were reported as not recovered. Case was reported as serious because of permanent or significant disability/incapacitating event: Palsy Bells. Documents held by sender: none.; Sender's Comments: In this case patient expereinced Bell's palsy after vaccination with FLUZONE HD. Time to onset is compatible with the role of vaccine. The cause of Bell's palsy is yet unknown. The risk factors include diabetes and a recent upper respiratory tract infection. Further information on medical history, immune status at the time of vaccination, previous vaccination and tolerance, laboratory investigations excluding alternative etiologies (recent infections) would be needed to fully assess this case. ased on available information the role of vaccine cannot be assessed.
Age: 23.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 23 year old female patient. There were no patient's concurrent conditions, medical history or illness at time of vaccination. Concomitant therapies were not reported. On 30-OCT-2017, the patient was vaccinated with an expired first dose of GARDASIL 9 with lot # L043214 and expiration date of 30-AUG-2017 (strength and dose were unknown) intramuscularly for prophylaxis. There were no adverse events reported.
Age: 79.0
Sex: M
Vaccine: PPV, FLU3, PPV
Symptoms: Cellulitis, Erythema, Full blood count, Oedema, Skin warm
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 79-year-old male patient. The patient's concurrent conditions included reflux, elevated prostate-specific antigen (PSA) and elevated cholesterol. The patient's concomitant medications were not provided. The patient had no drug reactions or allergies. The patient had a pneumococcal shot in the past, but not specified as PREVNAR 13 or PNEUMOVAX 23. On 31-OCT-2017, the patient received from an unspecified local pharmacy a dose of PNEUMOVAX 23, lot # N013521 with expiration date on 23-JAN-2019 (dose and route of administration were not reported). At the same time when the PNEUMOVAX 23 was administered, the patient received high dose FLUZONE (exact dose, route of administration, lot # and expiration date were not reported). On an unknown date in 2017, the patient experienced a cellulitis type reaction: extremely red that was streaking down arm below injection site, swollen, hot to touch. On 02-NOV-2017 (reported as "today"), the patient came to urgent care. At the time of this report, no treatment was given for the events. The reporter stated she planned to treat the events with warm compresses and unspecified antibiotics. On an unknown date, a complete blood count (CBC) was completed. The outcome of the events was reported as not recovered at the time of this report. The relatedness between the events, PNEUMOVAX 23 and FLUZONE was not assessed by the reporter.
Age: 79.0
Sex: M
Vaccine: PPV, FLU3, PPV
Symptoms: Swelling
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 79-year-old male patient. The patient's concurrent conditions included reflux, elevated prostate-specific antigen (PSA) and elevated cholesterol. The patient's concomitant medications were not provided. The patient had no drug reactions or allergies. The patient had a pneumococcal shot in the past, but not specified as PREVNAR 13 or PNEUMOVAX 23. On 31-OCT-2017, the patient received from an unspecified local pharmacy a dose of PNEUMOVAX 23, lot # N013521 with expiration date on 23-JAN-2019 (dose and route of administration were not reported). At the same time when the PNEUMOVAX 23 was administered, the patient received high dose FLUZONE (exact dose, route of administration, lot # and expiration date were not reported). On an unknown date in 2017, the patient experienced a cellulitis type reaction: extremely red that was streaking down arm below injection site, swollen, hot to touch. On 02-NOV-2017 (reported as "today"), the patient came to urgent care. At the time of this report, no treatment was given for the events. The reporter stated she planned to treat the events with warm compresses and unspecified antibiotics. On an unknown date, a complete blood count (CBC) was completed. The outcome of the events was reported as not recovered at the time of this report. The relatedness between the events, PNEUMOVAX 23 and FLUZONE was not assessed by the reporter.
Age: 79.0
Sex: M
Vaccine: PPV, FLU3, PPV
Symptoms: Full blood count, Injection site cellulitis, Injection site erythema, Injection site streaking, Injection site swelling
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 79-year-old male patient. The patient's concurrent conditions included reflux, elevated prostate-specific antigen (PSA) and elevated cholesterol. The patient's concomitant medications were not provided. The patient had no drug reactions or allergies. The patient had a pneumococcal shot in the past, but not specified as PREVNAR 13 or PNEUMOVAX 23. On 31-OCT-2017, the patient received from an unspecified local pharmacy a dose of PNEUMOVAX 23, lot # N013521 with expiration date on 23-JAN-2019 (dose and route of administration were not reported). At the same time when the PNEUMOVAX 23 was administered, the patient received high dose FLUZONE (exact dose, route of administration, lot # and expiration date were not reported). On an unknown date in 2017, the patient experienced a cellulitis type reaction: extremely red that was streaking down arm below injection site, swollen, hot to touch. On 02-NOV-2017 (reported as "today"), the patient came to urgent care. At the time of this report, no treatment was given for the events. The reporter stated she planned to treat the events with warm compresses and unspecified antibiotics. On an unknown date, a complete blood count (CBC) was completed. The outcome of the events was reported as not recovered at the time of this report. The relatedness between the events, PNEUMOVAX 23 and FLUZONE was not assessed by the reporter.