chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous
Clinical narrative: Rash on face, chest, back, arms, legs. Erythematous slightly raised round spots 0.2-1 mm diam, no vesicles, papules, scale, or crust.
Age: 11.0
Sex: M
Vaccine: FLUN4
Symptoms: Dyspnoea, Swelling
Clinical narrative: Difficulty breathing through nose.  Took to urgent care facility on 10/25/2015 although should have taken him 10/24/15.  Doctor prescribed oral steroids to decrease swelling from reaction to the nasal vaccine.
Age: 84.0
Sex: M
Vaccine: FLU3
Symptoms: Chronic obstructive pulmonary disease, Constipation, Heart rate irregular, Musculoskeletal pain, Myalgia
Clinical narrative: 10-25/26-15 rapid 150 pulse 10-25 & previously skipping beats but <90 bum. Still running 120-150 after urinating. O2 96-97. No other symptoms. Did not eat well till 1900 corn&shrimp. Just 2 donuts & 8 oz OJ prior. Note: had hot flu shot 10-20 -15 muscle aches neck, back, chest 10-24 relieved w/2 Tylenol ea 6 hrs till 10-25 (total 8 pills). O2 @ 2-3 l/min. Pulse rates @ rest! 7 cups coffee no alcohol past 4 days. Constipated 10-25. No fever, sweating, arm or chest pain, not faint, mentally alert. Pulse returned to 90 bpm @ 0320 when I urinated. Checks @ 0545, 0745, & 0945 were 90 90 87! O2 @98 throughout no pains except modest ache in R anterior trapezius radiating to R  shoulder. All normal @ 1000 Mon 10-26-15. Flu shot reactions? Have had vaccine annually sine 1953 with no reaction.  This was the first time the shot hurt when injected.  It was the "hot" shot for those over 65.  Also prior to this event, I experienced back, chest, and neck muscle aches for 16 hrs 10/24/2015 that were relieved with Tylenol. I have COPD and am on supplemental O2 @ 2 lpm. No breathing problems experience and O2 levels remained at 98-97%. I'm a PhD research microbiologist. I hope this information will be helpful.  As of 11:25 AM Monday 10/26/2015 I am back to normal and eating well.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Patient reported muscle pain/soreness in the arm he got flu shot in. He reported taking Tylenol to alleviate the pain, but that did not help. He did not tell us until 10/26/2015. Patient Primary MD started him on cephalexin on Friday to help alleviate the pain. I left MD a voicemail for pain prescription medication recommendation.
Age: 1.27
Sex: M
Vaccine: DTAP, FLU4, MMR
Symptoms: No adverse event, Vaccination error
Clinical narrative: No adverse reaction to MMR given in error on 10/20/2015. Initial MMR given on 7/13/2014.
Age: 94.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth, Malaise
Clinical narrative: Malaise, warm constant red rash on left upper arm, swollen.
Age: 39.0
Sex: F
Vaccine: FLU3, HEP, TDAP
Symptoms: Abdominal pain upper, Chills, Headache, Injection site induration, Injection site nodule
Clinical narrative: Nausea, vomiting, stomach ache, chills, body aches, headache, fever, left leg swollen at injection site, hard not at injection site, left leg pain. Treatment: Alternate Ibuprofen and Tylenol. Alternate hot and cold packs.
Age: 39.0
Sex: F
Vaccine: FLU3, HEP, TDAP
Symptoms: Injection site pain, Injection site swelling, Nausea, Pain, Pyrexia
Clinical narrative: Nausea, vomiting, stomach ache, chills, body aches, headache, fever, left leg swollen at injection site, hard not at injection site, left leg pain. Treatment: Alternate Ibuprofen and Tylenol. Alternate hot and cold packs.
Age: 39.0
Sex: F
Vaccine: FLU3, HEP, TDAP
Symptoms: Vomiting
Clinical narrative: Nausea, vomiting, stomach ache, chills, body aches, headache, fever, left leg swollen at injection site, hard not at injection site, left leg pain. Treatment: Alternate Ibuprofen and Tylenol. Alternate hot and cold packs.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Aphasia, Autism, Autism spectrum disorder, Developmental delay, Developmental regression
Clinical narrative: Stopped speaking, stopped hitting infant milestones on time. Began developing later and later with each subsequent vaccine received. He now has an autism spectrum diagnosis. The only reason I am choosing to highlight a vaccine administered at 9 months is because it's the first time I feel like he started to regress. I firmly believe that the vaccine I received while pregnant is what compromised his immune system initially... then all the of the subsequent vaccines he received did more harm and more harm with each one, finally harming him to the point of having to be treated for sensory processing disorder (which includes eating disorder) and autism. He had awful acid reflux from day one, which I strongly feel was caused by the flu vaccine (H1N1 - 2009) I received while pregnant.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Eating disorder, Food allergy, Gastrooesophageal reflux disease, Immunodeficiency, Sensorimotor disorder
Clinical narrative: Stopped speaking, stopped hitting infant milestones on time. Began developing later and later with each subsequent vaccine received. He now has an autism spectrum diagnosis. The only reason I am choosing to highlight a vaccine administered at 9 months is because it's the first time I feel like he started to regress. I firmly believe that the vaccine I received while pregnant is what compromised his immune system initially... then all the of the subsequent vaccines he received did more harm and more harm with each one, finally harming him to the point of having to be treated for sensory processing disorder (which includes eating disorder) and autism. He had awful acid reflux from day one, which I strongly feel was caused by the flu vaccine (H1N1 - 2009) I received while pregnant.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pain and swelling at site of injection lasting more than a month. Extreme pain, can't lie on side.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site reaction
Clinical narrative: Patient received a site reaction.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site induration, Pain
Clinical narrative: Pt had a red circular area that became painful the day following the immunization and eventually the site became firm. Pt no longer has pain and no firmness but she still has a red circle. Pt did not seek any treatment.
Age: 50.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain in extremity
Clinical narrative: SORE ARM.
Age: 50.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Activities of daily living impaired, Adverse drug reaction, Insomnia, Pain, Swelling
Clinical narrative: SORE ARM.
Age: 50.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: X-ray
Clinical narrative: SORE ARM.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Abnormal behaviour, Aphasia, Dysphonia, Inappropriate affect, Oropharyngeal pain
Clinical narrative: Neurologic sx: impaired thinking, difficulty completing sentences, laughing inappropriately, speed of talking was slowed and pitch of voice different, acted like she was "under the influence" of a drug. When asked any question she could only answer "I don't know." She received vaccine on Monday, began acting strange on Tuesday, left work early on Wednesday and felt back to normal when she got up on Thursday. As a side note, she experienced the usual side effects of body aches sore throat and mild congestion.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Respiratory tract congestion, Slow speech, Thinking abnormal
Clinical narrative: Neurologic sx: impaired thinking, difficulty completing sentences, laughing inappropriately, speed of talking was slowed and pitch of voice different, acted like she was "under the influence" of a drug. When asked any question she could only answer "I don't know." She received vaccine on Monday, began acting strange on Tuesday, left work early on Wednesday and felt back to normal when she got up on Thursday. As a side note, she experienced the usual side effects of body aches sore throat and mild congestion.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Pain at site of inject for more than 1 month. Extreme pain. Can't lie on it.
Age: 13.0
Sex: F
Vaccine: FLUN4
Symptoms: Abdominal pain upper, Asthenia, Headache, Mood swings, Nausea
Clinical narrative: Weakness, mood swings, headache, stomach, nausea, body aches.
Age: 13.0
Sex: F
Vaccine: FLUN4
Symptoms: Pain
Clinical narrative: Weakness, mood swings, headache, stomach, nausea, body aches.
Age: 88.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Contusion, Injection site induration, Injection site warmth, Pruritus
Clinical narrative: After a week, pt, reported severe itching, to where she bruised her skin, reddish-purple from elbow to shoulder. Stated it was hard at injection site, and very warm to touch. This was due to PREVNAR - upper left arm affected.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Flushing, Injection site erythema, Injection site swelling, Malaise
Clinical narrative: Left arm where shot given was red and swollen/raised, feeling flushed, feeling feverish, general malaise.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Left arm where shot given was red and swollen/raised, feeling flushed, feeling feverish, general malaise.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Peripheral swelling, Swelling
Clinical narrative: ALL JOINTS ACHING VERY BAD. SWELLING OF HANDS AND MOST OF ENTIRE BODY.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash generalised, Urticaria
Clinical narrative: Patient got hive like rash all over body.
Age: 84.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Death, Multimorbidity
Clinical narrative: Death - pt had co-morbities at the time, poss pneumonia, pneumothorax.  Death occurred on a subsequent admission not the same as Prevnar 13 administration.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Herpes zoster, Influenza like illness
Clinical narrative: Flu like symptoms lasting 12 hours; 20 days later, severe pain in back near left shoulder blade; 2 days later, Shingles developed.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Blood pressure increased, Headache, Injection site erythema, Rash, Vaccination site paraesthesia
Clinical narrative: Noticed a baseball sized red, warm, sensitive area around vaccination site.  In addition, an upper body rash, headache, elevated blood pressure developed.  She sought medical care.  Took some Benadryl on Sunday; noticed an improvement.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Vaccination site warmth
Clinical narrative: Noticed a baseball sized red, warm, sensitive area around vaccination site.  In addition, an upper body rash, headache, elevated blood pressure developed.  She sought medical care.  Took some Benadryl on Sunday; noticed an improvement.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Fatigue, Headache, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Extreme soreness, swelling and heat at injection site, then muscle aches, headache, fatigue, and fever which persisted off and on (used some NSAIDs for pain relief) but mostly on for the next 2-3 days. It's still 10/26/15, so we don't know how this will resolve.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Myalgia, Pyrexia
Clinical narrative: Extreme soreness, swelling and heat at injection site, then muscle aches, headache, fatigue, and fever which persisted off and on (used some NSAIDs for pain relief) but mostly on for the next 2-3 days. It's still 10/26/15, so we don't know how this will resolve.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Skin discolouration
Clinical narrative: DISCOLORED REGION LOCATED 2 INCHES BELOW INJECTION SITE. RASH DEVELOPED BENEATH DISCOLORED REGION, SPREADING ~3INCHES IN AREA. NO TREATMENT SOUGHT.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Immediately following injection of HPV - 9, patient loss consciousness/slumped in chair for approximately 15 seconds. Recovered spontaneously.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: Large red extremely painful swollen knot at the site of injection. Looks like a poisonous spider bite.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Blood glucose decreased, Laboratory test, Loss of consciousness, Syncope, Vertigo
Clinical narrative: On 10/26/15 at 0835 patient was given the flu vaccine. She then walked without incident until her lab draw (fasting). Pt then lost consciousness, fainting in lab chair. Nursing and PCMN notified. Legs were elevated and VS taken. Pt was observed in clinic. Dr. indicated pt. had low blood sugar. OJ and snacks provided. Pt c/o vertigo sx. Rested until left clinic with friend at 1110.
Age: 84.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Abdominal pain, Pain
Clinical narrative: Severe pain started a few hours after injection. Pain is worst with movement - put arm in sling.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Patient still experiencing pain at injection site approx 28 day post injection.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Bacterial test negative, Blood creatine phosphokinase normal, C-reactive protein normal, Ehrlichia test, Full blood count normal
Clinical narrative: Myalgias, worse at the end of the day, better at the beginning of the day, lasting over 2 weeks. Peak symptoms were on days 4-6 of illness.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Malaise, Metabolic function test normal, Myalgia, Red blood cell sedimentation rate normal
Clinical narrative: Myalgias, worse at the end of the day, better at the beginning of the day, lasting over 2 weeks. Peak symptoms were on days 4-6 of illness.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Rash, Varicella
Clinical narrative: Pt has burning pain in L LE & varicella rash in dermatome L5.
Age: 55.0
Sex: F
Vaccine: FLUC3
Symptoms: Incorrect route of drug administration, Injection site pain, Injection site swelling
Clinical narrative: Patient complained of swelling and soreness at injection site.  Patient states the injection was given subcutaneously rather than intramuscularly.
Age: 0.25
Sex: M
Vaccine: HEPA
Symptoms: Wrong drug administered
Clinical narrative: NO SYMPTOMS BUT GIVING THE WRONG VACCINE.  SHOULD HAVE BEEN HEPATITIS B AND INSTEAD WAS HEPATITIS B.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Abdominal pain, Antinuclear antibody negative, Arthralgia, Borrelia test negative, C-reactive protein increased
Clinical narrative: Developed 4 week course of purpuric rash of HSP, polyarthralgia, abd pain and vomiting.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Full blood count normal, Henoch-Schonlein purpura, Proteinuria, Purpura, Red blood cell sedimentation rate increased
Clinical narrative: Developed 4 week course of purpuric rash of HSP, polyarthralgia, abd pain and vomiting.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Vomiting
Clinical narrative: Developed 4 week course of purpuric rash of HSP, polyarthralgia, abd pain and vomiting.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Fall, Syncope
Clinical narrative: Patient fainted after checking out and fell into the exit door.
Age: 41.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Adenovirus test, Coxsackie virus test, Cytomegalovirus test, Eye pain, Mouth ulceration
Clinical narrative: Began having body/muscle aches after having received flu vaaccine on 10/13/2015. Also began having oral ulcerations. Fever of 101.6 on 10/18/2015, body aches worsening. Began having vulvar ulcerations on 10/20/2015. To ER. Sent home same day with pain meds/supportive care. Pain worse on 10/22/15 with fever up to 103. Also c/o of right eye pain on 10/22/15. Admitted to hospital at this time. Given steroids, Flagyl, pain meds and vaginal suppository. Discharged 10/24/15. Discharge diagnosis: Stevens Johnson Syndrome vs. Viral Syndrome.
Age: 41.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Myalgia, Pain, Pyrexia, Stevens-Johnson syndrome, Viral infection
Clinical narrative: Began having body/muscle aches after having received flu vaaccine on 10/13/2015. Also began having oral ulcerations. Fever of 101.6 on 10/18/2015, body aches worsening. Began having vulvar ulcerations on 10/20/2015. To ER. Sent home same day with pain meds/supportive care. Pain worse on 10/22/15 with fever up to 103. Also c/o of right eye pain on 10/22/15. Admitted to hospital at this time. Given steroids, Flagyl, pain meds and vaginal suppository. Discharged 10/24/15. Discharge diagnosis: Stevens Johnson Syndrome vs. Viral Syndrome.
Age: 41.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Vulval ulceration
Clinical narrative: Began having body/muscle aches after having received flu vaaccine on 10/13/2015. Also began having oral ulcerations. Fever of 101.6 on 10/18/2015, body aches worsening. Began having vulvar ulcerations on 10/20/2015. To ER. Sent home same day with pain meds/supportive care. Pain worse on 10/22/15 with fever up to 103. Also c/o of right eye pain on 10/22/15. Admitted to hospital at this time. Given steroids, Flagyl, pain meds and vaginal suppository. Discharged 10/24/15. Discharge diagnosis: Stevens Johnson Syndrome vs. Viral Syndrome.
Age: 41.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Myalgia, Rash, Stevens-Johnson syndrome
Clinical narrative: Began having body/muscle aches after having received flu vaaccine on 10/13/2015. Also began having oral ulcerations. Fever of 101.6 on 10/18/2015, body aches worsening. Began having vulvar ulcerations on 10/20/2015. To ER. Sent home same day with pain meds/supportive care. Pain worse on 10/22/15 with fever up to 103. Also c/o of right eye pain on 10/22/15. Admitted to hospital at this time. Given steroids, Flagyl, pain meds and vaginal suppository. Discharged 10/24/15. Discharge diagnosis: Stevens Johnson Syndrome vs. Viral Syndrome.
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Death, Pneumonia
Clinical narrative: As per patient spouse, He was admitted in hospital on 10/04/2015 due to pnuemonia and died on 10/12/2015. We don't have hospital report.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Axillary pain, Blood test normal, Bone pain, Dizziness
Clinical narrative: Pain in left collar bone, similar to pleurisy, nauseous, mouth watering, dizzy, shaky, buzzing in ears, ears ringing worse than normal.  Following day pain moved to left armpit.  2 days later, severe vertigo in evening, including vomiting. 3 weeks after vaccination, had another severe vertigo episode, with vomiting, numbness in hands and feet.  Continues to feel low energy, and non-specific ill feeling.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Electrocardiogram normal, Hypoaesthesia, Malaise, Nausea, Salivary hypersecretion
Clinical narrative: Pain in left collar bone, similar to pleurisy, nauseous, mouth watering, dizzy, shaky, buzzing in ears, ears ringing worse than normal.  Following day pain moved to left armpit.  2 days later, severe vertigo in evening, including vomiting. 3 weeks after vaccination, had another severe vertigo episode, with vomiting, numbness in hands and feet.  Continues to feel low energy, and non-specific ill feeling.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Tinnitus, Tremor, Vertigo, Vomiting
Clinical narrative: Pain in left collar bone, similar to pleurisy, nauseous, mouth watering, dizzy, shaky, buzzing in ears, ears ringing worse than normal.  Following day pain moved to left armpit.  2 days later, severe vertigo in evening, including vomiting. 3 weeks after vaccination, had another severe vertigo episode, with vomiting, numbness in hands and feet.  Continues to feel low energy, and non-specific ill feeling.
Age: 1.0
Sex: F
Vaccine: MMR, PPV, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: High fever for 2 days with rashes, treated with moldrin and Tylenol. 2nd reaction 6 days after the vaccines with no fever, but severe rashes lasting 5/6 days, treated with Benadryl for 2 days prescribed by doctor, but no changes.
Age: 53.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Altered state of consciousness, Dizziness, Dyspnoea, Heart rate increased, Impaired driving ability
Clinical narrative: Very dizzy, increased heart rate, heavy breathing. Felt like I was going to pass out.
Age: 53.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Dizziness, Dyspnoea, Flushing
Clinical narrative: Very dizzy, increased heart rate, heavy breathing. Felt like I was going to pass out.
Age: 42.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Erythema, Mass, Skin warm
Clinical narrative: Skin is hot to the touch, there is a lump and a area of redness with a clearly defined border.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site reaction
Clinical narrative: Patient presented to her physcian with injection site reaction. Provider gave her antibiotic (Bactrim) in case there could have been a probable infection.
Age: 31.0
Sex: M
Vaccine: FLU4
Symptoms: Malaise, Myalgia
Clinical narrative: Patient complained of malaise and myalgia and saw his Dr.
Age: 41.0
Sex: F
Vaccine: FLUC3
Symptoms: Headache, Night sweats, Pruritus, Urticaria
Clinical narrative: Headache started on 10/19, then noticed welts on 10/21. Welts are itchy, red and swollen and on forearms, face, back and knee. Headache went away and came back on 10/24/2015. Had night sweats on 10/21-22. Welts finally going down 10/26.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC13, VARZOS
Symptoms: Injection site swelling, Peripheral swelling, Ultrasound scan
Clinical narrative: Swelling of upper and lower right arm.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain upper, Dizziness, Hypoaesthesia, Paraesthesia, Ultrasound scan
Clinical narrative: Stomach pain in upper left abdomen.  Dizziness, blurred vision.  Numbness and tingling in left arm pectoral and jaw.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Vision blurred
Clinical narrative: Stomach pain in upper left abdomen.  Dizziness, blurred vision.  Numbness and tingling in left arm pectoral and jaw.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Nausea
Clinical narrative: Pt's daughter called to report patient was feeling nauseated and slightly dizzy.  These are side effects listed in the literature.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: SWOLLEN ARM AT INJECTION SITE, WARM TO TOUCH & ITCHING.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Mass, Peripheral swelling, Rash generalised
Clinical narrative: Patient called our pharmacy on 10/20/2015 at around 2PM to inform us that she experienced a severe allergic reaction that she thinks is due to a flu shot (Fluzone high dose) that she received at our pharmacy on 10/14/2015. She said that she had a rash all over her body including her hands and knuckles. She said that her feet were swollen; that she had lumps on the palm of her hand/feet and underneath her skin. She claimed that this all happened 2 days after receiving the flu shot. I asked her what her Dr thinks this kind of reaction came from and she said that her Dr doesn't know exactly and prescribed for her Medrol dose pak to treat this condition. She also took Benadryl and it didn't help. I questioned her if she took any new drugs before experiencing the rash to see if it was due to a new drug that she may took and she said no. She stated that she only took her regular medications, which cause no problems in the past. I also asked her if she had the flu shot in prior years and she said yes and that she had no problems with the regular flu shots in the past. She informed me that she started her Medrol dose pak on 10/19 and on 10/20 she did not see improvement and asked me what to do. I told her to give it 1 more day and that if she does not see improvement by 10/21 that she should let her Dr know to see what they recommend. It was her first time getting the high dose flu shot so I think she may develop this allergic reaction from receiving the high dose formulation of the flu shot, which is kind of unusual since she had regular flu shots in the past. Pt was complaining that she had to pay a fortune to see several doctors to get this condition treated.
Age: 58.0
Sex: F
Vaccine: FLU4, FLU4, FLU4
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Pain
Clinical narrative: I have been getting the flu shot since it's been around and never had anything more than the normal pain for a few days. This time was different. There was no pain at the time of the vaccine like I usually get. I didn't get the normal pain or swelling that usually follows this vaccine either. A few days later (around 09/11/2015) I started feeling pain in my upper shoulder when I moved my arm backwards. Since then, it has gotten worse and the range of motion of my arm has gotten very limited to the point that I want to cry every time I move it around. I can't reach for things, I can't lift things and I practically can't do anything with this arm without wanting to scream or cry. What's worse is I don't know if my flu shot is even effective.
Age: 58.0
Sex: F
Vaccine: FLU4, FLU4, FLU4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: I have been getting the flu shot since it's been around and never had anything more than the normal pain for a few days. This time was different. There was no pain at the time of the vaccine like I usually get. I didn't get the normal pain or swelling that usually follows this vaccine either. A few days later (around 09/11/2015) I started feeling pain in my upper shoulder when I moved my arm backwards. Since then, it has gotten worse and the range of motion of my arm has gotten very limited to the point that I want to cry every time I move it around. I can't reach for things, I can't lift things and I practically can't do anything with this arm without wanting to scream or cry. What's worse is I don't know if my flu shot is even effective.
Age: 58.0
Sex: F
Vaccine: FLU4, FLU4, FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Wrong technique in product usage process
Clinical narrative: I have been getting the flu shot since it's been around and never had anything more than the normal pain for a few days. This time was different. There was no pain at the time of the vaccine like I usually get. I didn't get the normal pain or swelling that usually follows this vaccine either. A few days later (around 09/11/2015) I started feeling pain in my upper shoulder when I moved my arm backwards. Since then, it has gotten worse and the range of motion of my arm has gotten very limited to the point that I want to cry every time I move it around. I can't reach for things, I can't lift things and I practically can't do anything with this arm without wanting to scream or cry. What's worse is I don't know if my flu shot is even effective.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Dizziness, Hypotension
Clinical narrative: Pt felt like she was going to faint and became hypotensive (84/49, 72/41) pt rested had water and BP came back up after approximately 5 mins to 104/71.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PPV, RVX
Symptoms: Abdominal pain, Crying, Decreased appetite, Flatulence, Irritability
Clinical narrative: Fever 100 degrees 4 hours after vaccination and on following day.  Significant abdominal pain, mucousy stools, vomiting, gas, lethargy, loss of appetite, crying and fussiness for 7 days after.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PPV, RVX
Symptoms: Lethargy, Mucous stools, Pyrexia, Vomiting
Clinical narrative: Fever 100 degrees 4 hours after vaccination and on following day.  Significant abdominal pain, mucousy stools, vomiting, gas, lethargy, loss of appetite, crying and fussiness for 7 days after.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site nodule, Injection site pain, Injection site warmth
Clinical narrative: Developed large softball size knot at shot site. Painful and hot for 7 days.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Fall
Clinical narrative: PATIENT FALL ON THE FLOOR AFTER THE FLU VACCINE ADMINISTRATION. SHE FELT DIZZY FOR MORE THAN 10 MINUTES. CALLED 911.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Bursitis, Immediate post-injection reaction, Injection site pain, Mobility decreased, Pain
Clinical narrative: Point tenderness immediately following injection into left deltoid region. Approximately 2 weeks later a left bursitis with decreased range of motion and pain.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: X-ray normal
Clinical narrative: Point tenderness immediately following injection into left deltoid region. Approximately 2 weeks later a left bursitis with decreased range of motion and pain.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Abdominal pain upper, Crying, Ultrasound abdomen normal
Clinical narrative: Stomach cramping, inconsolable crying requiring ER visit.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient have vaccinated twice. One on 9/30/15 with flu quadrivalent at her doctor's office and one on 10/26/15 with Fluzone high-dose at her pharmacy.  No symptom is reported.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Joint injury, Pain in extremity, Skeletal injury
Clinical narrative: Patient states arm still hurts from shot, went to doctor and was told there was joint/bone damage resulting from shot administration.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Diarrhoea, Pruritus, Swollen tongue, Tremor
Clinical narrative: Tongue swelling itching. Shakes diarrhea stomach pain.
Age: 56.0
Sex: M
Vaccine: FLU4, PPV, FLUX, PPV
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Information has been received from a pharmacist referring to her 56 year old male husband with diabetic. On 10-OCT-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, lot number and route not provided) and an unspecified dose of influenza vaccine (manufacturer unknown, dose, lot number and route not provided). On the night of 10-OCT-2015, the patient experienced body aches, chills and a fever of 99.9 F. The outcome of the body aches, chills and fever was not provided. It was also reported the patient died (detail information not reported, estimated onset date October 2015). Additional information has been requested.
Age: 93.0
Sex: F
Vaccine: FLU3, PNC13, FLU3, PNC13, FLU3, PNC13
Symptoms: Asthenia, Cellulitis, Culture, Skin infection, X-ray
Clinical narrative: Infection after receiving the pneumonia vaccine (PCV13). Shot on 10/13/15 went to urgent care 3x was hospitalized on 10/23/15 for skin infection - on antibiotics until Nov. 2 - very weak.
Age: 93.0
Sex: F
Vaccine: FLU3, PNC13, FLU3, PNC13, FLU3, PNC13
Symptoms: Blood lactic acid normal, Cellulitis, Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: Infection after receiving the pneumonia vaccine (PCV13). Shot on 10/13/15 went to urgent care 3x was hospitalized on 10/23/15 for skin infection - on antibiotics until Nov. 2 - very weak.
Age: 93.0
Sex: F
Vaccine: FLU3, PNC13, FLU3, PNC13, FLU3, PNC13
Symptoms: Leukocytosis, Rash
Clinical narrative: Infection after receiving the pneumonia vaccine (PCV13). Shot on 10/13/15 went to urgent care 3x was hospitalized on 10/23/15 for skin infection - on antibiotics until Nov. 2 - very weak.
Age: 93.0
Sex: F
Vaccine: FLU3, PNC13, FLU3, PNC13, FLU3, PNC13
Symptoms: Cellulitis
Clinical narrative: Infection after receiving the pneumonia vaccine (PCV13). Shot on 10/13/15 went to urgent care 3x was hospitalized on 10/23/15 for skin infection - on antibiotics until Nov. 2 - very weak.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Atelectasis, Chest X-ray abnormal, Dyspnoea, White blood cell count increased
Clinical narrative: Flu shot given on 10/15/15. Not allergic to eggs. No hx of Guillain Barre. Patient called on 10/19/15 reporting that he had gone to the hospital 5 hr. after the injection because he could not breath. He found relief after they gave neb tx. Sent home on prednisone and abx. 10/19 reported feeling normal.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Cheilitis, Rash
Clinical narrative: Rash to face and neck,  face: lower cheek bones - chin - lips. Neck: anterior neck only.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Cough, Erythema, Fatigue, Hypersensitivity, Hypoaesthesia
Clinical narrative: This spontaneous report as received from a registered nurse referring to her 11 year old son with prune belly at birth, intestinal function problems, hydronephrosis, polycystic kidney, baby size right kidney and unspecified musculoskeletal conditions. On 21-SEP-2015, the patient was vaccinated with a dose of GARDASIL 9 (dose, Lot #, expiration date and route were not provided) one shot in the arm. Concomitant therapies included COLACE. On 24-SEP-2015, the patient experienced an allergic reaction that included a large lump in his arm, redness, rash, swelling in the top of the shoulder area, fever of 102.6, he could not feel his fingers, could not lift his arm, and felt tired, he had red bumps in the back of his throat and swelling in his throat and a weird cough. On the same date, the patient sought medical attention but was not admitted. So the patient's mother treat the patient with ice and heat off on the arm, TYLENOL and ibuprofen "but it did not work". On 01-OCT-2015, also reported as today, the patient sought medical attention again, at an unspecified location. A quick test strip was taken for Streptococcal throat and the result was negative. There was not a product quality complain involved. At the time of this report, the outcome of the allergic reaction was reported as not recovered. The relatedness between the events and suspect therapy was not provided. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Local swelling, Mobility decreased, Pharyngeal erythema, Pharyngeal oedema, Pyrexia
Clinical narrative: This spontaneous report as received from a registered nurse referring to her 11 year old son with prune belly at birth, intestinal function problems, hydronephrosis, polycystic kidney, baby size right kidney and unspecified musculoskeletal conditions. On 21-SEP-2015, the patient was vaccinated with a dose of GARDASIL 9 (dose, Lot #, expiration date and route were not provided) one shot in the arm. Concomitant therapies included COLACE. On 24-SEP-2015, the patient experienced an allergic reaction that included a large lump in his arm, redness, rash, swelling in the top of the shoulder area, fever of 102.6, he could not feel his fingers, could not lift his arm, and felt tired, he had red bumps in the back of his throat and swelling in his throat and a weird cough. On the same date, the patient sought medical attention but was not admitted. So the patient's mother treat the patient with ice and heat off on the arm, TYLENOL and ibuprofen "but it did not work". On 01-OCT-2015, also reported as today, the patient sought medical attention again, at an unspecified location. A quick test strip was taken for Streptococcal throat and the result was negative. There was not a product quality complain involved. At the time of this report, the outcome of the allergic reaction was reported as not recovered. The relatedness between the events and suspect therapy was not provided. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Rash, Streptococcus test negative, Upper extremity mass
Clinical narrative: This spontaneous report as received from a registered nurse referring to her 11 year old son with prune belly at birth, intestinal function problems, hydronephrosis, polycystic kidney, baby size right kidney and unspecified musculoskeletal conditions. On 21-SEP-2015, the patient was vaccinated with a dose of GARDASIL 9 (dose, Lot #, expiration date and route were not provided) one shot in the arm. Concomitant therapies included COLACE. On 24-SEP-2015, the patient experienced an allergic reaction that included a large lump in his arm, redness, rash, swelling in the top of the shoulder area, fever of 102.6, he could not feel his fingers, could not lift his arm, and felt tired, he had red bumps in the back of his throat and swelling in his throat and a weird cough. On the same date, the patient sought medical attention but was not admitted. So the patient's mother treat the patient with ice and heat off on the arm, TYLENOL and ibuprofen "but it did not work". On 01-OCT-2015, also reported as today, the patient sought medical attention again, at an unspecified location. A quick test strip was taken for Streptococcal throat and the result was negative. There was not a product quality complain involved. At the time of this report, the outcome of the allergic reaction was reported as not recovered. The relatedness between the events and suspect therapy was not provided. Additional information has been requested.
Age: 79.0
Sex: U
Vaccine: FLU3
Symptoms: Chills, Vomiting
Clinical narrative: As per protocol, patient was given a FLUZONE high dose. No reaction. Approx 8 hours later wife called and said he was vomiting and chills. Advised to go to emergency room.
Age: 0.79
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Swelling face
Clinical narrative: Facial swelling and redness, Mom noticed 5-10 minutes after receiving flu vaccine. Monitored in office by RN and MD until resolved. Resolved on it's own without intervention.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain in extremity, Paraesthesia
Clinical narrative: Received Influenza Vaccine on 9/23/15, via IM injection in the left shoulder. The vaccine was administered high on the shoulder, close to the deltoid muscle region. Patient has had pain the area, radiating down the left arm towards the back ever since  . Also left finger tingling.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Breast swelling, Erythema, Injection site erythema, Injection site swelling, Lymphadenopathy
Clinical narrative: Swelling and redness around left shoulder into upper biceps, lymph node and right breast.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site joint movement impairment, Muscular weakness, Pain in extremity
Clinical narrative: Patient received PREVNAR vaccine 9/28/15. Had pain and weakness in RUE, decreased R shoulder ROM.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Type III immune complex mediated reaction
Clinical narrative: Soreness at injection site, artnusr reaction.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Pain, Pyrexia, Vomiting
Clinical narrative: Vomiting; Diarrhea; Fever; Bodyaches.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Mass, Pruritus, Rash, Swelling
Clinical narrative: Rash lump swollen very itchy.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Body temperature increased, Feeling cold, Injection site erythema, Injection site haemorrhage, Injection site pain
Clinical narrative: Pt indicates that had a vaccine earlier in day 10/24/15 and bleed where vaccine was administered. He went home and about 4 hrs post vaccine felt cold/shaking and had a temp 104F. Today he presented with a 3x2 erythema at the site of injection and injection site is still tender, but fever/cold/shaking has resolved.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: Pt indicates that had a vaccine earlier in day 10/24/15 and bleed where vaccine was administered. He went home and about 4 hrs post vaccine felt cold/shaking and had a temp 104F. Today he presented with a 3x2 erythema at the site of injection and injection site is still tender, but fever/cold/shaking has resolved.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Extreme pan at the site of injection. Could not life arm  up and down or side to side after 3 weeks post shot.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 40-year-old female patient who received Influenza vaccine. On an unknown date, the patient received Influenza vaccine. On an unknown date, an unknown time after receiving Influenza vaccine, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to Influenza vaccine. Additional details were provided as follows: This case was not previously reported to anyone. The patient was a pharmacy technician. The patient experienced injection site pain after receiving the flu shot. For tolerance to next vaccination, refer case US2015148969.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Central nervous system inflammation, Electromyogram abnormal, Neuropathy peripheral
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of neuropathy in a 35-year-old female patient who received FLUARIX QUADRIVALENT. On 24th September 2015, the patient received FLUARIX QUADRIVALENT .5 ml. On 24th September 2015, 2 hrs after receiving FLUARIX QUADRIVALENT, the patient experienced neuropathy. On an unknown date, the outcome of the neuropathy was recovering/resolving. The reporter considered the neuropathy to be almost certainly related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was reported by a healthcare professional, who herself was the patient. The reporter had extremely limited information. After 2 hours of the vaccination, the patient developed neuropathy of the right arm (injection site). The patient went to the Employee health clinic, but they did not do anything for her. The patient then went to her own physician who sent her to a neurologist. The neurologist completed an Electromyogram (EMG) for the patient but did not follow through with any recommendations. The patient then submitted a workman's complaint case to her employer. They sent her to another neurologist and he did another Electromyogram (EMG). The neurologist stated that the nerves were not damaged just inflamed. He also said that the patient had post viral neuropathy. The reporter stated that the symptoms were reoccurring which has not totally resolved till the time of reporting. The reporter did not have lot number and expiry date of the vaccine.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 40-year-old female patient who received FLUARIX quadrivalent (batch number 2F5P4, expiry date 30th June 2016). Previously administered products included Flu vaccine with an associated reaction of injection site pain (previous vaccination, refer case US2015GSK152650). On 15th October 2015, the patient received FLUARIX quadrivalent .5 ml. On 15 October 2015, less than a day after received FLUARIX quadrivalent, the patient experienced pain in arm. On an unknown date, the patient experienced injection site pain. On 15th October 2015, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the pain in arm and injection site pain to be related to FLUARIX quadrivalent. Additional details were provided as follows: This case was not previously reported to anyone. The patient was a pharmacy technician. The healthcare professional stated that the day after receiving the vaccine, the patient reported that her arm was hurting. The arm that was hurting was not the one in which the vaccine was administered. In October 2015, less than a week after receiving the vaccine, the patient experienced injection site pain which was more severe than she had ever experienced before with the flu shot.
Age: 81.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Asthenia, Drug administered at inappropriate site, Dyspnoea, Fatigue, Productive cough
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of productive cough in a 81-year-old female patient who received BOOSTRIX. Co-suspect products FLUZONE HIGH DOSE. Concurrent medical conditions included blood pressure high abd diabetes. Concomitant products included antihypertensive nos, insulin nos and diuretics nos. On 2nd October 2015, the patient received BOOSTRIX and FLUZONE HIGH DOSE. On 2nd October 2015, an unknown time after receiving BOOSTRIX, the patient experienced vaccine administered at inappropriate site. On 11th October 2015, the patient experienced productive cough. On an unknown date, the patient experienced feelings of weakness, tiredness and shortness of breath. The patient was treated with MUCINEX. On an unknown date, the outcome of the productive cough was not recovered/not resolved and the outcome of the feelings of weakness, tiredness, shortness of breath and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the productive cough, feelings of weakness, tiredness and shortness of breath to be related to BOOSTRIX. Additional details were provided as follows: This case was reported to a doctor. This case was reported by the patient's daughter. Concomitant medications included heart medicine, high blood pressure medicine, insulin and water pills. The reporter stated that the patient was not feeling well prior to receiving BOOSTRIX and FLUZONE HIGH DOSE. The reporter tried to get her mother to wait a couple of days before going to the pharmacy. On 2nd October 2014, at 11:30, the patient received BOOSTRIX in gluteal region of deltoid region, which led administration of vaccine at an inappropriate site. On the same day, the patient received FLUZONE HIGH DOSE vaccine. On 11th October 2015, 9 days after receiving the BOOSTRIX and FLUZONE HIGH DOSE vaccine, the patient was coughing up a lot of mucus (productive cough). In October 2015, less than a month after receiving BOOSTRIX and FLUZONE HIGH DOSE vaccine, the patient was feeling weak, tired and had shortness of breath. The healthcare professional was contacted and the patient was instructed to go to the emergency department if she continues to feel bad. The reporter was not sure if the symptoms which her mother was experiencing was due to taking BOOSTRIX or FLUZONE. The patient seems to feel that taking BOOSTRIX gave her the whooping cough instead of preventing it.
Age: 0.59
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEPA, PNC13
Symptoms: Drug administered to patient of inappropriate age, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 7-month-old male patient who received HAVRIX pediatric (batch number PN7GD, expiry date 17th November 2017). Concurrent medical conditions included sickness. Concomitant products included FLUZONE, PENTACEL and PREVNAR. On 15th October 2015, the patient received HAVRIX pediatric (intramuscular) .5 ml. On an unknown date, less than a week after receiving HAVRIX pediatric, the patient experienced fever, and inappropriate age at vaccine administration. On an unknown date, the outcome of the fever was recovering/resolving and the outcome of the inappropriate age at vaccine administration was unknown. The reporter considered the fever to be possibly related to HAVRIX pediatric. Additional details provided were as follows: This case was reported by the patient's mother. On 15th October 2015, at 11:00, the patient received a dose of HAVRIX pediatric at an age of 7 months in left leg. This led to an inappropriate age at vaccination. The patient was sick prior vaccination and then became more sick after receiving the vaccine. Specifically the patient experienced fever. The reporter thought that, the patient might be fighting the flu. The reported batch number (PMGD) for HAVRIX pediatric vaccine did not exist and was updated to PN7GD according to the sales database.
Age: 0.31
Sex: F
Vaccine: HEPA, PPV, HEPA, PPV
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 3 month old female patient. On 28-AUG-2015 the patient was vaccinated with VAQTA (K026529, expiry date 28-AUG-2016) and PNEUMOVAX 23 (K005402, expiry date 28-AUG-2016). When the error occurred, the patient did not have RECOMBIVAX HB, for which the patient was indicated. At this time of report the patient had no adverse event. Additional information has been requested.