chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: M
Vaccine: PNC13, PPV
Symptoms: Pain in extremity, Skin warm, Tenderness
Clinical narrative: This is a spontaneous report from a contactable registered nurse who reported on behalf of a physician. This is first of two reports. A 49-year-old male patient received while he was in the dialysis clinic, a dose of PREVNAR 13 (Lot J90092; Expiration date May 2016; NDC number 005197105), intramuscular in right arm on 11Nov2014 approximately 7 am at 0.5 ml single. He was diabetic, had high blood pressure, high cholesterol and chronic renal failure. He had a catheter in his left arm for dialysis. Concomitant medication included PNEUMOVAX 23 (lot K007773; expiry date of May2015) administered on 11Nov2014 in right arm, aspirin at 81 mg daily, FLONASE as needed, clopidogrel at 75mg daily, carvedilol at 12.5mg twice a day, lisinopril 20mg daily, pantoprazole 40mg daily, pravastatin 40mg at bedtime, LANTUS on a sliding scale, vancomycin 1g IV for planned shunt placement and VELPHORO 500mg four times a day. On 13Nov2014 patient complained of severe pain during administration of PREVNAR 13 and discomfort. On the same date he experienced cellulitis of arm: cellulitis was above his right elbow and did not require an emergency room visit. Always on 13Nov2014 patient had pain and tenderness in right arm and redness, swelling and warm of right arm. The outcome of discomfort was unknown, the other events recovered on unknown date.
Age: 1.67
Sex: F
Vaccine: DTAP
Symptoms: Apnoea, Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis
Clinical narrative: This is one case out of a cumulative total of 237 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 10 November 2014. These 237 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial report received on 10 November 2014 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 32-month-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot numbers not reported on 06 Apr 2012, on 18 June 2012 and on 28 July 2012 (routes and sites not reported). The subject also received one dose of DAPTACEL, lot number C4431AA on 02 October 2013, (route and site not reported). The subject developed cold-like symptoms on 11 October 2014, approximately 12 months after the last dose. On 14 October 2014, the subject developed a cough and paroxysmal cough on 19 October 2014 without a whoop. The subject experienced posttussive vomiting on an unreported date. The subject did not experience sleep disturbance and apnea. Laboratory testing included positive PCR on 20 October 2014. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 21 October 2014 for 5 days. The subject was not hospitalized. At the time of final contact on 29 October 2014, the subject's cough was still persisting. The duration of the cough was reported at that time as 15 days. According to the investigator, this case was not epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.67
Sex: F
Vaccine: DTAP
Symptoms: Pertussis, Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: This is one case out of a cumulative total of 237 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 10 November 2014. These 237 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial report received on 10 November 2014 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 32-month-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot numbers not reported on 06 Apr 2012, on 18 June 2012 and on 28 July 2012 (routes and sites not reported). The subject also received one dose of DAPTACEL, lot number C4431AA on 02 October 2013, (route and site not reported). The subject developed cold-like symptoms on 11 October 2014, approximately 12 months after the last dose. On 14 October 2014, the subject developed a cough and paroxysmal cough on 19 October 2014 without a whoop. The subject experienced posttussive vomiting on an unreported date. The subject did not experience sleep disturbance and apnea. Laboratory testing included positive PCR on 20 October 2014. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 21 October 2014 for 5 days. The subject was not hospitalized. At the time of final contact on 29 October 2014, the subject's cough was still persisting. The duration of the cough was reported at that time as 15 days. According to the investigator, this case was not epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Chills, Dysstasia, Muscle spasms, Muscle twitching, Nausea
Clinical narrative: Uncontrollable hand and Finger Spasms / Twitching, High Fever (102), Nausea, Heavy Chills unable to stand up.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: Uncontrollable hand and Finger Spasms / Twitching, High Fever (102), Nausea, Heavy Chills unable to stand up.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site reaction, Muscular weakness, Nuclear magnetic resonance imaging
Clinical narrative: Developed pain at injection site, which progressed to weakness in upper arm and shoulder and decreased range of motion. Exam is consistent with rotator cuff pathology - that did not exist before vaccine administration.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Rotator cuff syndrome
Clinical narrative: Developed pain at injection site, which progressed to weakness in upper arm and shoulder and decreased range of motion. Exam is consistent with rotator cuff pathology - that did not exist before vaccine administration.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever, chills, body aches from about 9:30 PM that night through the following night and felt better the morning after (10/1/14).
Age: 41.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Injection site pain, Pain, Pyrexia
Clinical narrative: Fever, chills, body aches for about 24 hours. Pain at injection site for about 72 hours.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Cellulitis to Left Arm/ Pain, Redness, Swelling, Fever. Redness radiated down into wrist. Pt was put on antibiotics for the cellulitis.
Age: 49.0
Sex: M
Vaccine: FLU4
Symptoms: Burning sensation, Pain in extremity
Clinical narrative: C/o pain and burning down arm and towards scapular and clavicular area. Saw MD on 11/11. Prescribed a course of prednisone and PRN FLEXERIL. Will be followed up by MD in December.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Blood test, Dehydration, Dizziness, Electrocardiogram normal
Clinical narrative: 10/20/14 PM chills, body aches-continued into 10/21/14. 10/21/14 AM vomiting-coffee ground emesis x1-called PCP-ZOFRAN. (Vomited 3-4 x total) Dizzy. 10/22/14, 10/23/14 Weakness, general body aches persisted, Gatorade for dehydration-persisted. 10/30/14 Saw PCP-lab work ordered EKG WNL.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling cold, Haematemesis, Pain
Clinical narrative: 10/20/14 PM chills, body aches-continued into 10/21/14. 10/21/14 AM vomiting-coffee ground emesis x1-called PCP-ZOFRAN. (Vomited 3-4 x total) Dizzy. 10/22/14, 10/23/14 Weakness, general body aches persisted, Gatorade for dehydration-persisted. 10/30/14 Saw PCP-lab work ordered EKG WNL.
Age: 1.01
Sex: F
Vaccine: FLU4, HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Pyrexia, Rash generalised, Rash papular
Clinical narrative: 10 days after vaccine developed large 4 cm area of erythema and swelling at injection site, fever, one generalized papular rash.
Age: 1.01
Sex: F
Vaccine: FLU4, HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Pyrexia, Rash generalised, Rash papular
Clinical narrative: 10 days after vaccine developed large - 5cm area of erythema and swelling at injection site, fever, and  generalized papular rash.
Age: 9.0
Sex: M
Vaccine: FLUN4
Symptoms: Urticaria
Clinical narrative: Mother called 6 days later to report generalized hives.
Age: 59.0
Sex: F
Vaccine: PNC13, TDAP, VARZOS
Symptoms: Erythema, Injection site swelling, Malaise
Clinical narrative: Pt stated arm swelled up at SubQ injection site and down arm. Pt also states arm was red. Pt states she also felt ill for 3 days. Immunizations were given 11/12/14. Pt presented to clinic 11/17/14 symptoms resolved.
Age: 90.0
Sex: F
Vaccine: FLU3
Symptoms: Insomnia, Neuralgia
Clinical narrative: Patient came into pharmacy about one week after receiving shot. She reported radiating nerve pain that shot down her arm that she received the shot in. She was unable to sleep and went to the local urgent care where she was given a cortisone shot that relieved her pain. Pain lasted for 3 days.
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Erythema, Fatigue, Heart rate increased, Hyperhidrosis
Clinical narrative: Sweating, turned "rosey", SOB, rapid heart beat, nausea w/out vomit, fatigue.
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea
Clinical narrative: Sweating, turned "rosey", SOB, rapid heart beat, nausea w/out vomit, fatigue.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Hypoaesthesia, Injection site pain, Paraesthesia
Clinical narrative: Patient states soreness at site of injection, progressing down arm with numbness and tingling.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site nerve damage, Injection site pain, Muscular weakness, Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient states soreness at site of injection, progressing down arm with numbness and tingling.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Paraesthesia, Peripheral coldness
Clinical narrative: Patient states soreness at site of injection, progressing down arm with numbness and tingling.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Local reaction
Clinical narrative: Red itchy area the size of a palm and bump at the injection site. Bump at not raised or warm. Local reaction only. No fever.
Age: 80.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Anuria, Blood pressure decreased, Diarrhoea, Haematochezia, Intensive care
Clinical narrative: 80 y/o female w/ hx of celiac dx had been well before and after an office visit where she had Pneumovax and HD flu vaccine started to have N/V and profuse watery diarrhea shortly after eating a Chinese dinner that evening.  Diarrhea cont'd into the ED visit progressing to bloody and mucousy stool.  Pt dropped her BP, became anuric and was admitted to the ICU.
Age: 80.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Laboratory test, Mucous stools, Nausea, Vomiting
Clinical narrative: 80 y/o female w/ hx of celiac dx had been well before and after an office visit where she had Pneumovax and HD flu vaccine started to have N/V and profuse watery diarrhea shortly after eating a Chinese dinner that evening.  Diarrhea cont'd into the ED visit progressing to bloody and mucousy stool.  Pt dropped her BP, became anuric and was admitted to the ICU.
Age: 80.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Mucous stools
Clinical narrative: 80 y/o female w/ hx of celiac dx had been well before and after an office visit where she had Pneumovax and HD flu vaccine started to have N/V and profuse watery diarrhea shortly after eating a Chinese dinner that evening.  Diarrhea cont'd into the ED visit progressing to bloody and mucousy stool.  Pt dropped her BP, became anuric and was admitted to the ICU.
Age: 80.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Diarrhoea, Gastrointestinal disorder, Haematochezia, Hypotension, Intensive care
Clinical narrative: 80 y/o female w/ hx of celiac dx had been well before and after an office visit where she had Pneumovax and HD flu vaccine started to have N/V and profuse watery diarrhea shortly after eating a Chinese dinner that evening.  Diarrhea cont'd into the ED visit progressing to bloody and mucousy stool.  Pt dropped her BP, became anuric and was admitted to the ICU.
Age: 80.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Shock
Clinical narrative: 80 y/o female w/ hx of celiac dx had been well before and after an office visit where she had Pneumovax and HD flu vaccine started to have N/V and profuse watery diarrhea shortly after eating a Chinese dinner that evening.  Diarrhea cont'd into the ED visit progressing to bloody and mucousy stool.  Pt dropped her BP, became anuric and was admitted to the ICU.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Electromyogram, Injection site pain, Middle insomnia, Musculoskeletal pain, Neuralgic amyotrophy
Clinical narrative: I had my flu shot in my left arm on 10/1/2013 and had what I thought was normal aching for a couple of weeks, which then progressed to my lower deltoid region. I asked if people were complaining about the flu shot because my soreness was not going away (She said no or not more than usual). My left arm aching began to get much worse in mid-October. I had been doing some crocheting in early to mid October and I thought this may have played a part in my left arm pain, so I quit doing it. Even though I quit crocheting, the pain got worse in my left arm/shoulder and then progressed to my right shoulder too. This caused me to wake-up multiple times during the night because of the pain. I have had multiple tests done and was diagnosed as having Parsonage-Turner syndrome.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging, Ultrasound scan, X-ray
Clinical narrative: I had my flu shot in my left arm on 10/1/2013 and had what I thought was normal aching for a couple of weeks, which then progressed to my lower deltoid region. I asked if people were complaining about the flu shot because my soreness was not going away (She said no or not more than usual). My left arm aching began to get much worse in mid-October. I had been doing some crocheting in early to mid October and I thought this may have played a part in my left arm pain, so I quit doing it. Even though I quit crocheting, the pain got worse in my left arm/shoulder and then progressed to my right shoulder too. This caused me to wake-up multiple times during the night because of the pain. I have had multiple tests done and was diagnosed as having Parsonage-Turner syndrome.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Arthralgia, Erythema, Induration, Pain, Peripheral swelling
Clinical narrative: Arm swollen from shoulder to elbow. Very red and hot to touch. Entire swollen area is hard. Painful and itching. Joint pain all night in leg, foot, knee and arm. The next day swelling extended to forearm. Hotness, redness, swelling, pain and itching continue. Painful to move or touch arm.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Pruritus, Skin warm, Tenderness
Clinical narrative: Arm swollen from shoulder to elbow. Very red and hot to touch. Entire swollen area is hard. Painful and itching. Joint pain all night in leg, foot, knee and arm. The next day swelling extended to forearm. Hotness, redness, swelling, pain and itching continue. Painful to move or touch arm.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Chills, Injection site erythema, Injection site induration, Injection site swelling, Pyrexia
Clinical narrative: 2" hard raised red swollen area around injection site w/ fever and chills.
Age: 61.0
Sex: M
Vaccine: FLU3, TDAP, VARZOS
Symptoms: Laboratory test normal, Myalgia, Polymerase chain reaction, Rash erythematous, Rash pruritic
Clinical narrative: Pt given ZOSTAVAX on 10/20/14. On approz. 11/5/14 pt. developed prutitic, erythematous rash with myalgia-> positive for chickenpox.
Age: 61.0
Sex: M
Vaccine: FLU3, TDAP, VARZOS
Symptoms: Varicella
Clinical narrative: Pt given ZOSTAVAX on 10/20/14. On approz. 11/5/14 pt. developed prutitic, erythematous rash with myalgia-> positive for chickenpox.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Neuropathy peripheral, Vaccination site reaction
Clinical narrative: Radiating neuropathy in arm vaccinated.
Age: 16.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives covering full body. Diphenhydramine given ay 6:15 pm 11/12/14, pharmacy called by mother approx 6:45 pm. Advised mother to provide another dose at 10:15 pm and to go to urgent care/ER if worsening at second dose. 2nd dose given at 10:15 pm. 11/13 pt was recovered in am, broke out again in evening after shower. 3rd dose given approx 8 pm.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 11-NOV-2014 the patient was inadvertently administered a single dose of ROTATEQ (oral, lot # J004943), that had expired on 05-NOV-2014. No adverse effects were reported. No PQC (product quality complaint) was involved. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Upper arm from elbow up red and swollen on arm of injections starting day after vaccination.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Autoimmune disorder, Back pain, Biopsy skin abnormal, Blood test abnormal, Body temperature increased
Clinical narrative: Received flu vaccine 9/8/14 developed chills, T. 100.2, low backache on 9/15/14 developed rash from knees down bilaterally and pain. Seen at ED on 9/15/14. Seen by PCP 9/16/14 referred to Derm 9/16/14 skin biopsy result vesicular rash. Seen by Rheumatology 9/17/14 blood work positive cryoprotein. Started on Prednisone final Dx autoimmune response to flu vaccine start Rituximab infusion 11/29/14.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Pain, Rash, Rash vesicular
Clinical narrative: Received flu vaccine 9/8/14 developed chills, T. 100.2, low backache on 9/15/14 developed rash from knees down bilaterally and pain. Seen at ED on 9/15/14. Seen by PCP 9/16/14 referred to Derm 9/16/14 skin biopsy result vesicular rash. Seen by Rheumatology 9/17/14 blood work positive cryoprotein. Started on Prednisone final Dx autoimmune response to flu vaccine start Rituximab infusion 11/29/14.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Area of injection has red warm area 8 1/2 x 13 1/2 cm.
Age: 21.0
Sex: F
Vaccine: FLU4, HEPA, PPV
Symptoms: Chest X-ray normal, Cough, Dizziness, Face and mouth X-ray normal, Nausea
Clinical narrative: Nausea, vomiting, body aches-visit 11-10-2014. RX ZOFRAN. Cough, dizziness-persistent URI-sx-evaluated 11-17-2014-R/T vaccinations 11-20-14 - seen for sinus cough persistent cough x-rays neg RX CEFTIN given.
Age: 21.0
Sex: F
Vaccine: FLU4, HEPA, PPV
Symptoms: Neutrophil percentage increased, Pain, Upper respiratory tract infection, Vomiting, White blood cell count increased
Clinical narrative: Nausea, vomiting, body aches-visit 11-10-2014. RX ZOFRAN. Cough, dizziness-persistent URI-sx-evaluated 11-17-2014-R/T vaccinations 11-20-14 - seen for sinus cough persistent cough x-rays neg RX CEFTIN given.
Age: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Gait disturbance, Lethargy, Pallor
Clinical narrative: Approximately 4-5 minutes post flu injection, patient became faint and stumbled into table.  His mother caught him and helped him into a chair.  Nurse provided ice pack to place on the back of his neck.  Patient also layed down on a couch in the office. Patient's BP was 100/56.  After approximately 20 minutes, patient drank some lemonade, regained the color in his face, and said he felt better. 2 days later, patient's mother reported to the writer that patient was lethargic and light-headed for the rest of the evening on the date of the injection but was fine the next day.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: NONE.
Age: 22.0
Sex: F
Vaccine: FLU4, TDAP, VARCEL
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Client reports left arm swelling at injection site sates now size of her palm and "feels hot".
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to unknown number of patients of unknown age and demographics. Patient's current condition and medical history was not reported. On an unknown date (also reported as for the last several months), the patients were vaccinated with ZOSTAVAX subcutaneous injection (strength, dose, route and lot number not reported) which had undergone a supported temperature excursion). No concomitant medication was reported. On an unknown date, the patients experienced no adverse effects. There was no product quality complaint involved. Action taken and the outcome of the events were not provided. Causality was not reported. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: NONE
Age: 44.0
Sex: F
Vaccine: FLUX, FLU4
Symptoms: Burning sensation, Bursitis, Injection site joint movement impairment, Injection site pain, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Flu vaccine was administered very high on my left arm, very close to the shoulder bone. It burned tremendously when it was pushed into the tissue, more than any vaccine I've ever had.  I have received the flu vaccine all of my adult life with zero adverse reaction until this year.  Since the date of injection, I have had a tremendous increase in left shoulder pain, and a marked decrease in range of motion.  It is now 3 weeks post injection and I'm feeling worse than ever.  I had a shoulder MRI and was told I have tendonitis and bursitis.  I was referred to a sports medicine orthopedic doctor, and saw him yesterday.  My left arm is now in a sling, I will be icing my shoulder 4x a day, and I am on a rigorous dosage of Prednisone.  I am hoping and praying that I get some relief, this has been absolutely miserable.
Age: 44.0
Sex: F
Vaccine: FLUX, FLU4
Symptoms: Tendonitis
Clinical narrative: Flu vaccine was administered very high on my left arm, very close to the shoulder bone. It burned tremendously when it was pushed into the tissue, more than any vaccine I've ever had.  I have received the flu vaccine all of my adult life with zero adverse reaction until this year.  Since the date of injection, I have had a tremendous increase in left shoulder pain, and a marked decrease in range of motion.  It is now 3 weeks post injection and I'm feeling worse than ever.  I had a shoulder MRI and was told I have tendonitis and bursitis.  I was referred to a sports medicine orthopedic doctor, and saw him yesterday.  My left arm is now in a sling, I will be icing my shoulder 4x a day, and I am on a rigorous dosage of Prednisone.  I am hoping and praying that I get some relief, this has been absolutely miserable.
Age: 44.0
Sex: F
Vaccine: FLUX, FLU4
Symptoms: Injection site pain, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: Flu vaccine was administered very high on my left arm, very close to the shoulder bone. It burned tremendously when it was pushed into the tissue, more than any vaccine I've ever had.  I have received the flu vaccine all of my adult life with zero adverse reaction until this year.  Since the date of injection, I have had a tremendous increase in left shoulder pain, and a marked decrease in range of motion.  It is now 3 weeks post injection and I'm feeling worse than ever.  I had a shoulder MRI and was told I have tendonitis and bursitis.  I was referred to a sports medicine orthopedic doctor, and saw him yesterday.  My left arm is now in a sling, I will be icing my shoulder 4x a day, and I am on a rigorous dosage of Prednisone.  I am hoping and praying that I get some relief, this has been absolutely miserable.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Antibody test positive
Clinical narrative: This spontaneous report as received from a physician refers to physician's daughter, a currently 47 year old female patient of unknown age with lupus. Drug reactions or allergies were not reported. On 22-MAY-1995 the patient was vaccinated with VARIVAX (Merck) dose 1, 0.5 ml, subcutaneous (anatomical location, lot number and expiration date were unspecified) and, on 30-JUN-1995, VARIVAX (Merck) dose 2, 0.5 ml, subcutaneous. On an unknown date (also reported as later), her antibody titers were checked and they were negative. On 01 September (year was not reported), the patient was vaccinated with VARIVAX (Merck) dose 3, 0.5 ml, subcutaneous (anatomical location, lot number and expiration date were unspecified). On an unknown date, after receiving dose 3, the antibody titers were still negative. On 21-JUL-2001 the patient was vaccinated with VARIVAX (Merck) dose 4, 0.5 ml, subcutaneous (anatomical location, lot number and expiration date were unspecified). No treatment was given to the patient for the adverse event. On an unknown date in 2006, her titers were checked again and they were positive. The physician's daughter did not get further doses of VARIVAX (Merck). The relatedness between the events and VARIVAX (Merck) was not reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist who was informed by a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot #, expiration date and route were not provided). On an unknown date, the patient developed soreness at the injection site as well as redness at the injection site that went down the patient's arm after receiving PNEUMOVAX 23. It was unknown if the patient sought medical attention. At the time of the report, the patient's status was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 68 year old female patient. On 14-NOV-2014, the patient was vaccinated with 0.5 ml dose of PNEUMOVAX 23 lot # K006681, expiration date 21-OCT-2015, intramuscular. Later that evening, also on 14-NOV-2014, the patient developed soreness at the injection site as well as redness at the injection site that went down the patient's arm after receiving PNEUMOVAX 23. There were no laboratory diagnostics studies performed. On 17-NOV-2014, the patient called into the pharmacy and spoke to the pharmacist who informed the patient to take ibuprofen. The outcome of soreness at the injection site and redness at the injection site was reported as recovering/resolving. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown demographics. On 25-SEP-2014 the patient was vaccinated with PROQUAD (Merck) (lot # K005646 with the expiry date of 17-OCT-2015). Approximately in the year 2014 PROQUAD (Merck), which was involved in supported temperature excursion. No concomitant therapy was reported. No adverse effects were reported. No Product Quality Complaint (PQC) was filed. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. On 28-OCT-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot # K008881, expiration date: 20-SEP-2015), 0.65 ml, subcutaneous. Concomitant therapies included LIALDA. On an unknown date in 2014, after vaccination, the patient experienced unspecified event. The outcome of unspecified event was unknown." The patient sought medical attention and was prescribed amoxicillin and MEDROL pack as a treatment for the event. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On unspecified day in 2013, the patient was vaccinated with ZOSTAVAX (dose, route of administration, anatomical location, lot #, expiration date were not reported). On an unknown date, few days after administration of ZOSTAVAX, the patient developed pain and itching at the injection site. The outcome of the events was not provided. The relatedness between the event and the vaccination with ZOSTAVAX was not provided. Additional information is not expected, as the reporting pharmacist declined to provided any additional information.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to an unspecified number of patients of unkonwn age and gender. On an unknown date those patients were vaccinated with an improperly stored M-M-R II (dose, units, route of administration, anatomical location, lot number was not reported). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to an unspecified number of patients of unknown age and gender. In October 2014 (exact date unspecified, reported as between 08-OCT-2014 and 22-OCT-2014) those patients were vaccinated with an improperly stored at 31F for 10 hours PEDVAXHIB (dose, units, route of administration, anatomical location, lot number was not reported). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: M
Vaccine: FLUX
Symptoms: Biopsy skin abnormal, Blood creatine phosphokinase increased, Blood creatinine increased, Dermatitis, Epidermal necrosis
Clinical narrative: This case was reported in a literature article and described the occurrence of rhabdomyolysis in a 76-year-old male patient who received Influenza vaccine. Concurrent medical conditions included chronic kidney disease and hyperlipidemia. Concomitant products included Atorvastatin. On an unknown date, the patient received influenza vaccine (unknown). On an unknown date, 3 days after receiving Influenza vaccine, the patient experienced rhabdomyolysis (serious criteria hospitalization and GSK medically significant), Stevens-Johnson syndrome (serious criteria hospitalization and GSK medically significant), weeping rash (serious criteria hospitalization) and renal failure (serious criteria hospitalization and GSK medically significant). The patient was treated with medication unknown (Unspecified Treatment), SOLU-MEDROL and diphenhydramine. On an unknown date, the outcome of the rhabdomyolysis, Stevens-Johnson syndrome, weeping rash and renal failure were unknown. It was unknown if the reporter considered the rhabdomyolysis, Stevens-Johnson syndrome, weeping rash and renal failure to be related to Influenza vaccine. Additional information received: This case was reported in a literature article and it described the occurrence of rhabdomyolysis secondary to an Stevens-Johnson syndrome in a 76-year-old male subject who had previously received an unspecified influenza vaccine (manufacturers unknown). The subject's concurrent medical conditions included chronic kidney disease and hyperlipidemia. Concomitant medications included atorvastatin for the hyperlipidemia. His baseline creatinine level was 2.0 mg/dl. No further information on the subject's medical history, concurrent medical conditions or concomitant medication was provided. On an unspecified date, the subject received an unspecified influenza vaccine (dosage, route and administration site unknown; batch number not provided). On an unspecified date, 3 days after receiving the vaccine, the subject presented with a widely distributed and weeping rash. He later required renal replacement therapy and was diagnosed with rhabdomyolysis secondary to Stevens-Johnson syndrome. This is a serious case as the subject required admission to an intensive care unit. Initial blood tests revealed a creatinine level of 4.4 mg/dl and his creatinine kinase levels were found to be elevated at 2610 IU/L. Skin biopsy epidermal revealed sloughing, necrotic keratinocytes and vacuolar interface dermatitis that confirmed the diagnosis of rhabdomyolysis secondary to Stevens-Johnson syndrome. Treatment consisted of renal replacement therapy, SOLU-MEDROL and diphenhydramine. Outcome of the events was unknown at the time of reporting. The authors commented that the possibility of an influenza vaccination triggering rhabdomyolysis is rare. The authors concluded that "rhabdomyolysis triggered by an influenza vaccination is an important complication to be aware of, as early recognition can lead to better outcomes".
Sex: M
Vaccine: FLUX
Symptoms: Intensive care, Rash, Renal failure, Rhabdomyolysis, Skin exfoliation
Clinical narrative: This case was reported in a literature article and described the occurrence of rhabdomyolysis in a 76-year-old male patient who received Influenza vaccine. Concurrent medical conditions included chronic kidney disease and hyperlipidemia. Concomitant products included Atorvastatin. On an unknown date, the patient received influenza vaccine (unknown). On an unknown date, 3 days after receiving Influenza vaccine, the patient experienced rhabdomyolysis (serious criteria hospitalization and GSK medically significant), Stevens-Johnson syndrome (serious criteria hospitalization and GSK medically significant), weeping rash (serious criteria hospitalization) and renal failure (serious criteria hospitalization and GSK medically significant). The patient was treated with medication unknown (Unspecified Treatment), SOLU-MEDROL and diphenhydramine. On an unknown date, the outcome of the rhabdomyolysis, Stevens-Johnson syndrome, weeping rash and renal failure were unknown. It was unknown if the reporter considered the rhabdomyolysis, Stevens-Johnson syndrome, weeping rash and renal failure to be related to Influenza vaccine. Additional information received: This case was reported in a literature article and it described the occurrence of rhabdomyolysis secondary to an Stevens-Johnson syndrome in a 76-year-old male subject who had previously received an unspecified influenza vaccine (manufacturers unknown). The subject's concurrent medical conditions included chronic kidney disease and hyperlipidemia. Concomitant medications included atorvastatin for the hyperlipidemia. His baseline creatinine level was 2.0 mg/dl. No further information on the subject's medical history, concurrent medical conditions or concomitant medication was provided. On an unspecified date, the subject received an unspecified influenza vaccine (dosage, route and administration site unknown; batch number not provided). On an unspecified date, 3 days after receiving the vaccine, the subject presented with a widely distributed and weeping rash. He later required renal replacement therapy and was diagnosed with rhabdomyolysis secondary to Stevens-Johnson syndrome. This is a serious case as the subject required admission to an intensive care unit. Initial blood tests revealed a creatinine level of 4.4 mg/dl and his creatinine kinase levels were found to be elevated at 2610 IU/L. Skin biopsy epidermal revealed sloughing, necrotic keratinocytes and vacuolar interface dermatitis that confirmed the diagnosis of rhabdomyolysis secondary to Stevens-Johnson syndrome. Treatment consisted of renal replacement therapy, SOLU-MEDROL and diphenhydramine. Outcome of the events was unknown at the time of reporting. The authors commented that the possibility of an influenza vaccination triggering rhabdomyolysis is rare. The authors concluded that "rhabdomyolysis triggered by an influenza vaccination is an important complication to be aware of, as early recognition can lead to better outcomes".
Sex: M
Vaccine: FLUX
Symptoms: Stevens-Johnson syndrome
Clinical narrative: This case was reported in a literature article and described the occurrence of rhabdomyolysis in a 76-year-old male patient who received Influenza vaccine. Concurrent medical conditions included chronic kidney disease and hyperlipidemia. Concomitant products included Atorvastatin. On an unknown date, the patient received influenza vaccine (unknown). On an unknown date, 3 days after receiving Influenza vaccine, the patient experienced rhabdomyolysis (serious criteria hospitalization and GSK medically significant), Stevens-Johnson syndrome (serious criteria hospitalization and GSK medically significant), weeping rash (serious criteria hospitalization) and renal failure (serious criteria hospitalization and GSK medically significant). The patient was treated with medication unknown (Unspecified Treatment), SOLU-MEDROL and diphenhydramine. On an unknown date, the outcome of the rhabdomyolysis, Stevens-Johnson syndrome, weeping rash and renal failure were unknown. It was unknown if the reporter considered the rhabdomyolysis, Stevens-Johnson syndrome, weeping rash and renal failure to be related to Influenza vaccine. Additional information received: This case was reported in a literature article and it described the occurrence of rhabdomyolysis secondary to an Stevens-Johnson syndrome in a 76-year-old male subject who had previously received an unspecified influenza vaccine (manufacturers unknown). The subject's concurrent medical conditions included chronic kidney disease and hyperlipidemia. Concomitant medications included atorvastatin for the hyperlipidemia. His baseline creatinine level was 2.0 mg/dl. No further information on the subject's medical history, concurrent medical conditions or concomitant medication was provided. On an unspecified date, the subject received an unspecified influenza vaccine (dosage, route and administration site unknown; batch number not provided). On an unspecified date, 3 days after receiving the vaccine, the subject presented with a widely distributed and weeping rash. He later required renal replacement therapy and was diagnosed with rhabdomyolysis secondary to Stevens-Johnson syndrome. This is a serious case as the subject required admission to an intensive care unit. Initial blood tests revealed a creatinine level of 4.4 mg/dl and his creatinine kinase levels were found to be elevated at 2610 IU/L. Skin biopsy epidermal revealed sloughing, necrotic keratinocytes and vacuolar interface dermatitis that confirmed the diagnosis of rhabdomyolysis secondary to Stevens-Johnson syndrome. Treatment consisted of renal replacement therapy, SOLU-MEDROL and diphenhydramine. Outcome of the events was unknown at the time of reporting. The authors commented that the possibility of an influenza vaccination triggering rhabdomyolysis is rare. The authors concluded that "rhabdomyolysis triggered by an influenza vaccination is an important complication to be aware of, as early recognition can lead to better outcomes".
Age: 32.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Injection site erythema, Injection site reaction, Local swelling, Pyrexia
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a 32 year old female patient. Medical history was not reported. On 22-SEP-2014 the patient was vaccinated with PNEUMOVAX 23 injection, 1 ml, subcutaneous  (strength, lot number and expiration date were not reported) for asthmatic. Concomitant therapies included ADVAIR, SINGULAIR and nortriptyline and TOPOMAX. The physician informed that on 24-SEP-2014, the patient had an injection site reaction. Also informed that the patient complained of a red bump and fever. There was 12 cm by 11 c red spot on the patient's arm located by the injection site. The patient sought medical attention by an office visit. The adverse events were treated with doxycycline. The outcome of the events was recovered on 22-OCT-2014. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis, Erythema, Pain, Pyrexia, Skin warm
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a 32 year old female patient. Medical history was not reported. On 22-SEP-2014 the patient was vaccinated with PNEUMOVAX 23 injection, 1 ml, subcutaneous  (strength, lot number and expiration date were not reported) for asthmatic. Concomitant therapies included ADVAIR, SINGULAIR and nortriptyline and TOPOMAX. The physician informed that on 24-SEP-2014, the patient had an injection site reaction. Also informed that the patient complained of a red bump and fever. There was 12 cm by 11 c red spot on the patient's arm located by the injection site. The patient sought medical attention by an office visit. The adverse events were treated with doxycycline. The outcome of the events was recovered on 22-OCT-2014. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Swelling, Tenderness
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a 32 year old female patient. Medical history was not reported. On 22-SEP-2014 the patient was vaccinated with PNEUMOVAX 23 injection, 1 ml, subcutaneous  (strength, lot number and expiration date were not reported) for asthmatic. Concomitant therapies included ADVAIR, SINGULAIR and nortriptyline and TOPOMAX. The physician informed that on 24-SEP-2014, the patient had an injection site reaction. Also informed that the patient complained of a red bump and fever. There was 12 cm by 11 c red spot on the patient's arm located by the injection site. The patient sought medical attention by an office visit. The adverse events were treated with doxycycline. The outcome of the events was recovered on 22-OCT-2014. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Shoulder operation
Clinical narrative: Severe sholder pain in left arm at flu shot site.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain
Clinical narrative: Muscle where medication administered very sore and tender.  Date 11/21/2014 currently and still exhibiting pain and tenderness.
Age: 22.0
Sex: F
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site reaction, Muscular weakness, Pain in extremity
Clinical narrative: Severe pain in left shoulder around injection site. Limited mobility of left arm, tingling in left hand, weakness and sharp pains throughout arm and left shoulder around deltoid. Damage to rotator cuff on left shoulder.
Age: 22.0
Sex: F
Vaccine: FLUX
Symptoms: Paraesthesia, Rotator cuff syndrome
Clinical narrative: Severe pain in left shoulder around injection site. Limited mobility of left arm, tingling in left hand, weakness and sharp pains throughout arm and left shoulder around deltoid. Damage to rotator cuff on left shoulder.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Pharyngeal oedema, Throat irritation
Clinical narrative: Patient states felt swelling in throat, not interfering with breathing or swallowing. Throat irritation lasting up to 12 hours. Patient also states "ping-pong" size swelling at or near injection site. Deltoid lasting 3 days.
Age: 11.0
Sex: F
Vaccine: HEP, IPV, MMR, TDAP, VARCEL
Symptoms: Dyspnoea, Nausea, Oropharyngeal pain, Pruritus, Rash
Clinical narrative: COMPLAINED OF ITCHING. ON 11/20/14 AT 5 AM SHE HAD RAISED RASH, ITCHING, SORE THROAT. THEN ON 11/20/14 AT 11PM SHE HAD NAUSEA. 11/21/14 HAD SHORTNESS OF BREATH.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Hypoaesthesia, Hypoaesthesia oral, Paraesthesia, VIIth nerve paralysis
Clinical narrative: Numbness, tingling of right arm. Facial drooping on right side. Right upper lip numb. Severe headache.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Dyspnoea
Clinical narrative: Shortly after the vaccine was administered the pt had difficulty breathing, she sat down and started to experience back pain. She used her inhaler, and waited until EMS arrived.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Skin lesion
Clinical narrative: Noted mildly raised, erythematous skin lesion at area of injection site of approximately 2-3 cm.  + significant itching.  No fluctuance.  + improvement of itching with Benadryl. Recommend triamcinolone 0.1% lotion appy 2-3 times per day x 4-5 days.
Age: 9.0
Sex: F
Vaccine: FLU3, HEPA, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Small red area size of nickel on 11/19/14 warm to the touch; 11/20/14 progressed to quarter size red in the middle and had a red ring (bullseye like) by 3:00pm that day it grew in size to the size of silver dollar. It was still warm to the touch. It is 3/4 of her upper arm now. She was taken to urgent care and diagnosed there with cellulitis.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Labour pain, Stillbirth
Clinical narrative: Severe, sharp pain in right side of womb lasting 1.5 minute.  Went into full labor on Nov. 4 and delivered baby stillborn. Doctors believed he died a few days before, likely coinciding with pain I felt. I think pain might have been baby seizing. Doctors had not expected problems with birth due to Aperts.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Vaccination site induration
Clinical narrative: 9cm red induration at vaccine site.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Soreness at site, pain at site with motion.
Age: 64.0
Sex: F
Vaccine: FLUX
Symptoms: Vertigo
Clinical narrative: Vertigo. No treatment except sitting still. BP and pulse were normal.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: No adverse event. Expired flu vaccine. Administered to patient.
Age: 6.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Child complaint of soreness, swelling and hard lump at injection site on 11/20/14 at 3:15pm. Mother applied cool compresses, gave the child Tylenol and used "B&W" onitment which she described as an herbal blend they have used previously.
Age: 4.0
Sex: F
Vaccine: FLUN4
Symptoms: Abnormal behaviour, Diet refusal, Fear, Nausea, Pyrexia
Clinical narrative: Fever 103 lasting two days, still not wanting to eat, nausea and change in behavior, not cooperative and scared of more things.
Age: 29.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Dizziness, Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Fever, vomiting, dizziness for 24 hours and swelling and redness at site of vaccine that was approximately 3"x7" and warm at site.
Age: 29.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Vomiting
Clinical narrative: Fever, vomiting, dizziness for 24 hours and swelling and redness at site of vaccine that was approximately 3"x7" and warm at site.