chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PNC13
Symptoms: Cellulitis, Erythema, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable nurse through a Pfizer sales representative who reported similar events for two different patients. This is the second of 2 reports. A patient of unspecified age, ethnicity and gender received PREVNAR 13 (lot M35761) on 11Feb2016 at 12:00, at 0.5 ml single. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced a severe reaction with redness, fever and cellulitis, all on an unspecified date in Feb2016, with outcome of unknown. The reporter added that subsequently they just quitted administering any vaccine from that lot.
Age: 78.0
Sex: M
Vaccine: PNC13
Symptoms: Blood count abnormal, Bone marrow failure, Central venous catheterisation, Chemotherapy, Malaise
Clinical narrative: This is a spontaneous report from a contactable female consumer who reported for her father. A 78-year-old male patient received PREVNAR 13, via an unspecified route of administration at 0.5 ml single in Oct2015. The patient medical history was not reported. Concomitant medication included aspirin at 1 DF daily. The patient experienced blood marrow stops making blood in Nov2015 with outcome of not recovered, her father's weight was down to 166, he was 185 before he got sick after taking the shot on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included on unknown date blood count: 7.7; platelet count: 19; weight: 185 lbs; weight: 166 lbs; white blood cell count: 1.9. Therapeutic measures were taken as a result of blood marrow stops making blood included chemotherapy, blood transfusion, platelets, he also need to had this surgery to have a port put in to administer it. She mentioned that he had to have transfusion every week.
Age: 78.0
Sex: M
Vaccine: PNC13
Symptoms: Platelet count decreased, Platelet transfusion, Transfusion, Weight decreased, White blood cell count decreased
Clinical narrative: This is a spontaneous report from a contactable female consumer who reported for her father. A 78-year-old male patient received PREVNAR 13, via an unspecified route of administration at 0.5 ml single in Oct2015. The patient medical history was not reported. Concomitant medication included aspirin at 1 DF daily. The patient experienced blood marrow stops making blood in Nov2015 with outcome of not recovered, her father's weight was down to 166, he was 185 before he got sick after taking the shot on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included on unknown date blood count: 7.7; platelet count: 19; weight: 185 lbs; weight: 166 lbs; white blood cell count: 1.9. Therapeutic measures were taken as a result of blood marrow stops making blood included chemotherapy, blood transfusion, platelets, he also need to had this surgery to have a port put in to administer it. She mentioned that he had to have transfusion every week.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Inflammation, Mobility decreased, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: 5 hours after injection sore arm; 10pm that same night could not move arm.  Saw PCP after Christmas who ordered MRI.  Showed inflammation and patient started physical therapy.  On 2/18/16, patient saw an orthopedic surgeon who evaluated patient and stated no tares, but extreme inflammation of upper arm/rotator cuff area most likely due to flu shot given too high in arm.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Peripheral swelling, Pruritus
Clinical narrative: Swollen arm, redness, pain, itching, streaking to the elbow.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: SWELLING, REDNESS, PAIN AT INJECTION SITE.  DOCTOR INFORMED PATIENT THAT IT WAS CELLULITIS AND TO TAKE BENADRYL AND IBUPROFEN ALONG WITH COLD COMPRESSES.
Age: 17.0
Sex: F
Vaccine: HEP, HPV9, IPV, MNQ, TDAP, VARCEL
Symptoms: Rash
Clinical narrative: Client's mother stated a rash appeared to upper shoulders after receiving vaccines 8/17/15 and rash appeared to back, upper shoulders and chest after receiving vaccines 10/19/15.
Age: 31.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: Spontaneous report received on 29MAY2015 from a nurse practitioner. A 31 year old male received dose 3 of BioThrax vaccine on an unpecified date and experienced a 1 inch area of localized erythema and tenderness at the injection site. On 27MAY2015, he was administered dose 4 'deep intramuscular' in the left arm (Lot FAV440). Approximately 24 hours later, the male called the clinic due to itchiness and redness at the injection site. He was advised to take Benadryl 25mg every 4-6 hours, which helped the itchiness. The following day (48 hours post dose), he was seen at the clinic and observed to have a 4 inch are of mild erythema, induration accompanied by tenderness. The symptoms resolved in several days.
Sex: M
Vaccine: ANTH
Symptoms: Exposure via direct contact, Eye irrigation, No adverse event, Ophthalmological examination, Syringe issue
Clinical narrative: Spontaneous report received on 17JUL2015. On 17JUL2015, an approximately 20 year old male medical technician was accidentally squirted in the eye with BioThrax vaccine solution while administering vaccine to another serviceman. The reporter stated that the syringe malfunctioned allowing the BioThrax vaccine solution (LOT FAV427A) to project toward the personnel administering the vaccine. Of the 0.5ml dose, it was estimated that approximately a half to a quarter of the solution made contact with the medical technician's eye. He reportedly flushed his eye for 22 minutes immediately following the exposure. He was then seen by a medical professional and also had an eye exam. No adverse reactions were noted at the time of the examinations. On 20JUL2015, he was  doing fine and showed no adverse reactions. No further information was provided. Sender's Comments: Occupational exposure without adverse event; Not assessable.
Age: 45.0
Sex: M
Vaccine: ANTH
Symptoms: Axillary mass, Axillary pain, Blood test, Muscle mass, Myalgia
Clinical narrative: Spontaneous report received on 26OCT2015 and 28OCT2015 from a consumer. The consumer reported that he had received BioThrax (Lot FAV390) intramuscularly in the left arm on 05MAY2015. Five days later, on 10MAY2015 he experienced a large painful lump under his left arm and left pectoral muscle. He reported that he was being seen by a physician who was trying to determine if he was allergic to "some chemical in the anthrax shot". The consumer reported that he had an unspecified blood test (result unknown). No treatments were reported. At the time of report he had not recovered. Concurrent medications and medical history were not reported.
Sex: M
Vaccine: ANTH
Symptoms: Xanthoma
Clinical narrative: Informaton received from a pharmacist on behalf of a physician on 03NOV2015 who inquired whether BioThrax was known to cause cholesterol xanthoma. In approximately 1999-2000, 1-2 weeks after receiving BioThrax (Lot FAV036), a male consumer reported that he experienced cholesterol xanthoma around the eyes. Subsequently, every time the individual received BioThrax the condition worsened. No further information was provided. Sender's Comments: Not assessable.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, Erythema, Fatigue, Feeling abnormal, Fibromyalgia
Clinical narrative: Case Narrative: Based on additional information received on 01 February 2016, this case become medically confirmed. Initial unsolicited report received from a consumer on 21-Dec-2015. This case involves a 67-year-old female patient who was vaccinated with an intramuscular first dose of Fluzone HD (batch number: UI460AA, expiry date: 05-MAY-2016) in right deltoid on 14-Dec-2015. Previous medications included seasonal standard Flu vaccine (unspecified date) and never had a reaction, experinced reaction (swelling from her shoulder to her neck which lasted about 2 week) after tetanus vaccine several years ago on unspecified dates. Illness at time of vaccination was reported not reported and medical conditions of patient included history of fibromyalgia. Concomitant medications were not reported. On 15-Dec-2015, at about 1:30 am one day after vaccination, the patient woke up and could not move head off pillow and could not move her right side. Which lasted for 40 minutes and then she was able to move her right side and turn and get up but was stiff throughout her whole body. The patient also experienced sweating and her nightclothes and bedding was wet. On an unspecified date after vaccination the patient experienced events flare up of fibromyalgia, sore and tiredness and did not feel good for all week and felt nauseaous. She felt her head was too big for her neck and difficult to hold head up. On an unspecified day after vaccination the patient also experienced red knot size of thumb and forefinger together. The patient did not visit physician. No Laboratory investigations were reported. Corrective treatments were not reported. It was reported that on an unspecified day the event red knot size of thumb and forefinger and mobility decreased was resolved. The outcomes of all other events were reported as not recovered. Follow up information received from pharmacist on 01 February 2016. Batch number and expiry date of Fluzone HD was updated as UI427AA and 28 March 2016. On an unknown date, following the vaccination the patient had experienced tender to touch at vaccination site. The patient did not receive any corrective treatment. It was reported that, the knot was on the underside of arm and not on the where the patient received a shot. On an unknown date, the patient recovered from the tender to touch. Documents held by sender: none.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Hyperhidrosis, Mobility decreased, Musculoskeletal stiffness, Nausea, Nodule
Clinical narrative: Case Narrative: Based on additional information received on 01 February 2016, this case become medically confirmed. Initial unsolicited report received from a consumer on 21-Dec-2015. This case involves a 67-year-old female patient who was vaccinated with an intramuscular first dose of Fluzone HD (batch number: UI460AA, expiry date: 05-MAY-2016) in right deltoid on 14-Dec-2015. Previous medications included seasonal standard Flu vaccine (unspecified date) and never had a reaction, experinced reaction (swelling from her shoulder to her neck which lasted about 2 week) after tetanus vaccine several years ago on unspecified dates. Illness at time of vaccination was reported not reported and medical conditions of patient included history of fibromyalgia. Concomitant medications were not reported. On 15-Dec-2015, at about 1:30 am one day after vaccination, the patient woke up and could not move head off pillow and could not move her right side. Which lasted for 40 minutes and then she was able to move her right side and turn and get up but was stiff throughout her whole body. The patient also experienced sweating and her nightclothes and bedding was wet. On an unspecified date after vaccination the patient experienced events flare up of fibromyalgia, sore and tiredness and did not feel good for all week and felt nauseaous. She felt her head was too big for her neck and difficult to hold head up. On an unspecified day after vaccination the patient also experienced red knot size of thumb and forefinger together. The patient did not visit physician. No Laboratory investigations were reported. Corrective treatments were not reported. It was reported that on an unspecified day the event red knot size of thumb and forefinger and mobility decreased was resolved. The outcomes of all other events were reported as not recovered. Follow up information received from pharmacist on 01 February 2016. Batch number and expiry date of Fluzone HD was updated as UI427AA and 28 March 2016. On an unknown date, following the vaccination the patient had experienced tender to touch at vaccination site. The patient did not receive any corrective treatment. It was reported that, the knot was on the underside of arm and not on the where the patient received a shot. On an unknown date, the patient recovered from the tender to touch. Documents held by sender: none.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Posture abnormal, Vaccination site pain
Clinical narrative: Case Narrative: Based on additional information received on 01 February 2016, this case become medically confirmed. Initial unsolicited report received from a consumer on 21-Dec-2015. This case involves a 67-year-old female patient who was vaccinated with an intramuscular first dose of Fluzone HD (batch number: UI460AA, expiry date: 05-MAY-2016) in right deltoid on 14-Dec-2015. Previous medications included seasonal standard Flu vaccine (unspecified date) and never had a reaction, experinced reaction (swelling from her shoulder to her neck which lasted about 2 week) after tetanus vaccine several years ago on unspecified dates. Illness at time of vaccination was reported not reported and medical conditions of patient included history of fibromyalgia. Concomitant medications were not reported. On 15-Dec-2015, at about 1:30 am one day after vaccination, the patient woke up and could not move head off pillow and could not move her right side. Which lasted for 40 minutes and then she was able to move her right side and turn and get up but was stiff throughout her whole body. The patient also experienced sweating and her nightclothes and bedding was wet. On an unspecified date after vaccination the patient experienced events flare up of fibromyalgia, sore and tiredness and did not feel good for all week and felt nauseaous. She felt her head was too big for her neck and difficult to hold head up. On an unspecified day after vaccination the patient also experienced red knot size of thumb and forefinger together. The patient did not visit physician. No Laboratory investigations were reported. Corrective treatments were not reported. It was reported that on an unspecified day the event red knot size of thumb and forefinger and mobility decreased was resolved. The outcomes of all other events were reported as not recovered. Follow up information received from pharmacist on 01 February 2016. Batch number and expiry date of Fluzone HD was updated as UI427AA and 28 March 2016. On an unknown date, following the vaccination the patient had experienced tender to touch at vaccination site. The patient did not receive any corrective treatment. It was reported that, the knot was on the underside of arm and not on the where the patient received a shot. On an unknown date, the patient recovered from the tender to touch. Documents held by sender: none.
Age: 66.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Chills, Feeling cold, Pain in extremity, Pyrexia
Clinical narrative: Pt. called into office reporting fever 100.4, no rash, could/chills. sore arm, no appetite or fatigue; pt. refused appt in office 2/19/16.
Age: 66.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Body temperature increased, Decreased appetite, Dizziness, Fatigue, Injection site erythema
Clinical narrative: Pt. called into office reporting fever 100.4, no rash, could/chills. sore arm, no appetite or fatigue; pt. refused appt in office 2/19/16.
Age: 66.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site swelling, Nausea, Pruritus, Rash
Clinical narrative: Pt. called into office reporting fever 100.4, no rash, could/chills. sore arm, no appetite or fatigue; pt. refused appt in office 2/19/16.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Asthenia, Joint range of motion decreased, Myalgia, Pain in extremity
Clinical narrative: Chronic muscle aching mid-deltoid, moderate weakness and reduced range of motion in upper arm, dull ache affecting sleep due to pain in upper arm and elbow. Treatment in PT three times a week, beginning Jan 4, 2016 and continuing to date.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Sleep disorder, X-ray abnormal
Clinical narrative: Chronic muscle aching mid-deltoid, moderate weakness and reduced range of motion in upper arm, dull ache affecting sleep due to pain in upper arm and elbow. Treatment in PT three times a week, beginning Jan 4, 2016 and continuing to date.
Age: 8.0
Sex: F
Vaccine: FLUN4
Symptoms: Immunology test, Influenza, Influenza A virus test, Influenza B virus test
Clinical narrative: Pt contracted influenza B one day after receiving FLUMIST.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Apnoea, Blood electrolytes normal, Blood thyroid stimulating hormone increased, Body temperature increased, Chest X-ray normal
Clinical narrative: Received vaccines earlier in day. Became fussy at night. Developed grunting and stopped breathing. Became pale and blue around the lips. Apnea approximately 30 sec. called EMS. Responded when police officer picked her up. One time temp of 100.4. Admitted to hospital.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Cyanosis, Echocardiogram normal, Electrocardiogram normal, Full blood count normal, Grunting
Clinical narrative: Received vaccines earlier in day. Became fussy at night. Developed grunting and stopped breathing. Became pale and blue around the lips. Apnea approximately 30 sec. called EMS. Responded when police officer picked her up. One time temp of 100.4. Admitted to hospital.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Irritability, Pallor, Respiratory arrest, Thyroxine normal, Urine analysis normal
Clinical narrative: Received vaccines earlier in day. Became fussy at night. Developed grunting and stopped breathing. Became pale and blue around the lips. Apnea approximately 30 sec. called EMS. Responded when police officer picked her up. One time temp of 100.4. Admitted to hospital.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Viral test negative
Clinical narrative: Received vaccines earlier in day. Became fussy at night. Developed grunting and stopped breathing. Became pale and blue around the lips. Apnea approximately 30 sec. called EMS. Responded when police officer picked her up. One time temp of 100.4. Admitted to hospital.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Pt reported at 3 days after flu shot she developed a rash on her knees and legs.
Age: 9.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram head normal, Electroencephalogram normal, Eye movement disorder, Foaming at mouth, Musculoskeletal stiffness
Clinical narrative: Patient had the Gardasil series on the following dates: 3/27/14, 7/2/14, and 4/7/15.  On 7/25/15, Mother was awoken on a Saturday to dog barking.  She noted child lying on bed stiff with arms drawn up toward chest, eyes rolling upward and foaming at the mouth with the dog lying on top of the child.  Mother unsure of the length of activity- no loss of bladder or bowel.  Patient was seen over the course of several months for an EEG, sleep study, and had a Head CT done on 7/25/15.  The CT and EEG were essentially normal, and her sleep study showed some sleep apnea, possibly due to enlarged tonsils.  The mother states she has had a total of 4 of these type "seizures", but they have not been witnessed by anyone other than her.  She presented to the clinic today to discuss her concerns with her PCM, as she is concerned that these episodes are related to her receiving the Gardasil series.  It should be noted that on 10/1/2015, she received Menactra and TDaP, and there was nothing said at that time about the mothers concerns to this nurse.
Age: 9.0
Sex: F
Vaccine: HPV4
Symptoms: Seizure, Sleep apnoea syndrome, Sleep study abnormal
Clinical narrative: Patient had the Gardasil series on the following dates: 3/27/14, 7/2/14, and 4/7/15.  On 7/25/15, Mother was awoken on a Saturday to dog barking.  She noted child lying on bed stiff with arms drawn up toward chest, eyes rolling upward and foaming at the mouth with the dog lying on top of the child.  Mother unsure of the length of activity- no loss of bladder or bowel.  Patient was seen over the course of several months for an EEG, sleep study, and had a Head CT done on 7/25/15.  The CT and EEG were essentially normal, and her sleep study showed some sleep apnea, possibly due to enlarged tonsils.  The mother states she has had a total of 4 of these type "seizures", but they have not been witnessed by anyone other than her.  She presented to the clinic today to discuss her concerns with her PCM, as she is concerned that these episodes are related to her receiving the Gardasil series.  It should be noted that on 10/1/2015, she received Menactra and TDaP, and there was nothing said at that time about the mothers concerns to this nurse.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Local swelling
Clinical narrative: Localized swelling and redness, 6"x3".
Age: 1.5
Sex: F
Vaccine: FLU3, HIBV, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Irritability
Clinical narrative: Redness around 4-5 inches across, warmth and tenderness developed around bathtime at 9:30 pm on 2/17/2016 at site where ActHib and Prevnar were administered.  Mom administered pain reliever.  Patient was fussy the next morning wanting to be held but beginning mid-day became active and began to play normally.  Redness and tenderness at site have continued since yesterday. Redness has remained the same size though less red and less warm.  Tenderness has continued.  Patient continues active, playful and has been using the leg normally but notices when she bumps the leg against something.
Age: 24.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Chills, Injection site erythema, Injection site reaction, Pyrexia, Urticaria
Clinical narrative: Red welt at sight of injection, low grade fever, and chills.
Age: 24.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pruritus
Clinical narrative: Red welt at sight of injection, low grade fever, and chills.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Red, swollen arm.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Aphasia, Lethargy, Pyrexia, Urinary tract infection, Urine bilirubin increased
Clinical narrative: After vaccines patient's fever gradually went higher throughout the day. I believe it stayed at around 104 but he was acting okay, the next day is when it hit 107 degrees and this is when we went to the hospital immediately. He was completely lethargic and looked like death. After some tests they learned he had bilirubin in his urine and his white blood cell count was very low and he had a UTI. They didn't ever find out what was wrong with him and sent us on our way with antibiotics. Since those vaccines our son has not talked, he was silent for almost a year and it took almost 8 months to get his diet back up to a healthy amount.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: White blood cell count decreased
Clinical narrative: After vaccines patient's fever gradually went higher throughout the day. I believe it stayed at around 104 but he was acting okay, the next day is when it hit 107 degrees and this is when we went to the hospital immediately. He was completely lethargic and looked like death. After some tests they learned he had bilirubin in his urine and his white blood cell count was very low and he had a UTI. They didn't ever find out what was wrong with him and sent us on our way with antibiotics. Since those vaccines our son has not talked, he was silent for almost a year and it took almost 8 months to get his diet back up to a healthy amount.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Injection site pain, Pain, Paraesthesia
Clinical narrative: Pain on lifting left arm, constant pain upper left arm, pain behind left shoulder, pain in shoulder joint, pain in left elbow, tingling in fingers of left hand.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Malaise
Clinical narrative: Arm, at site of injection throbbing. Eventually all deltoid muscle involved as well as in the back. General malaise, feeling of not being well.
Age: 0.19
Sex: M
Vaccine: DTAP
Symptoms: Emotional distress, Haematochezia, Irritability, Vomiting
Clinical narrative: Vomiting, blood in stool, irritable, inconsolable.
Age: 51.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site joint movement impairment, Injection site pain
Clinical narrative: Right shoulder pain progressing to decreased range of motion.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Arthralgia, Cold sweat, Nausea, Pyrexia
Clinical narrative: At about 7:30 AM I started experiencing minor abdominal pain. As the day went on the pain got much worse. By 11:30 AM I could not get out of bed. I developed a fever on top of the abdominal pain and my joints began to ache all right around 11:30 AM. At about 2:00 PM I got very nauseous and had been experiencing cold sweats. I threw up twice and then things slowly calmed down. The fever subsided by 8:00 PM as did the joint pain however on 02/19/2016 at 4:54 PM I am still experiencing minor abdominal pain.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Vomiting
Clinical narrative: At about 7:30 AM I started experiencing minor abdominal pain. As the day went on the pain got much worse. By 11:30 AM I could not get out of bed. I developed a fever on top of the abdominal pain and my joints began to ache all right around 11:30 AM. At about 2:00 PM I got very nauseous and had been experiencing cold sweats. I threw up twice and then things slowly calmed down. The fever subsided by 8:00 PM as did the joint pain however on 02/19/2016 at 4:54 PM I am still experiencing minor abdominal pain.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV4, MNQ, TDAP
Symptoms: Pruritus
Clinical narrative: Pt c/o itching to mother in evening.
Age: 81.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: At the injection site, upper arm, was red, swollen and itching. Called Drs. office and was told to put hydrocortisone 1% and take Benadryl. That did not help so Friday went back to Drs. and was prescribed Zyrtec 10mg. and clobetasol propionate .05%.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Headache, Injection site bruising
Clinical narrative: Fatigue, headache, bruising at injection site.
Age: 44.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injected limb mobility decreased, Insomnia, Musculoskeletal pain
Clinical narrative: The day after flu and Tdap, started to have some soreness at the shoulder and over the course of a week or two, was not able to raise the left arm and could not sleep due to pain.  Now 2/19/16 and still with pain and trouble sleeping.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Vaccination complication
Clinical narrative: The pt received Pneumovax 23 and ended up having adverse reaction to the vaccine. Her upper arm is swollen and red and she has radiating pain in the shoulder on her left arm as well. The pt was informed that the Dr will call her if it is necessary to visit them. She was happy with the fact that we would be reporting this event to VEARS. She was adviced to go to the dr's office if she doesn't feel better in a couple of days.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: Profuse vomiting x 1 week.
Age: 12.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Antinuclear antibody negative, Borrelia test negative, C-reactive protein normal, Differential white blood cell count normal, Electroencephalogram normal
Clinical narrative: Uncontrollable shaking of right hand/ arm- tremors that progressed to leg and shoulder twitching.
Age: 12.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Full blood count normal, Metabolic function test normal, Muscle twitching, Nuclear magnetic resonance imaging brain normal, Streptococcus test negative
Clinical narrative: Uncontrollable shaking of right hand/ arm- tremors that progressed to leg and shoulder twitching.
Age: 12.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Thyroxine free normal, Tremor
Clinical narrative: Uncontrollable shaking of right hand/ arm- tremors that progressed to leg and shoulder twitching.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Injection site swelling, Pyrexia
Clinical narrative: Patient had fever and swelling at injection site.
Age: 12.0
Sex: F
Vaccine: HPVX
Symptoms: Rash
Clinical narrative: Broke out in rash on low-mid back and right leg.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Local reaction, Vaccination site pain, Vaccination site rash
Clinical narrative: Patient had a local reaction to his right arm (site where vaccine was administered) developed redness, rash and pain.
Age: 53.0
Sex: F
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Myalgia, Paralysis
Clinical narrative: Experienced persistent pain in medial deltoid muscles. Paralysis, lack of mobility in left arm, lasting as recovering with severe diminishment 30 days after onset.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Injection site pain, injection site and surrounding area swelling, injection site and surrounding area warmth, mild fever.
Age: 16.0
Sex: M
Vaccine: HEP, HEPA, HPV9
Symptoms: Dizziness
Clinical narrative: Complained of feeling lightheaded.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Rash
Clinical narrative: Rash on both arms.
Age: 0.53
Sex: M
Vaccine: DTAPIPVHIB, FLU4, PNC13, RV5
Symptoms: Cough, Otitis media, Pyrexia, Respiratory rate increased, Rhinorrhoea
Clinical narrative: Temperature that started low grade in afternoon then increased to 102 then 104 degrees. Cough, rhinorrhea and increase in respirations reported to nurse upon arrival to office. Patient was diagnosed with an Otitis Media.
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Wrong vaccine given - as of now, no adverse event reported.
Age: 0.81
Sex: M
Vaccine: DTAPIPVHIB, HEP, PPV
Symptoms: Crying, Pain, Screaming
Clinical narrative: My baby cried inconsolably (screaming, crying hysterically despite the ibuprofen we'd given him two hours prior to help with any pain from the injection) for three and a half hours.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Cough, Decreased appetite, Insomnia, Irritability, Lethargy
Clinical narrative: One week of high fever, temperature over 104 with cough, congestion, bilateral otitis media, irritability, decreased sleep, decreased appetite, and lethargy.  Four office visits.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Otitis media, Pyrexia, Respiratory tract congestion
Clinical narrative: One week of high fever, temperature over 104 with cough, congestion, bilateral otitis media, irritability, decreased sleep, decreased appetite, and lethargy.  Four office visits.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Immediate post-injection reaction, Injection site haemorrhage, Injection site swelling
Clinical narrative: Upon removal of needle there was slight bleeding. Immediately after administration injection site was swollen. Swelling of the area was as big as a quarter. Patient stated he felt fine. Was advised to sit in waiting room. An ice pack was offered but patient refused.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Muscular weakness, Pain in extremity, Tendonitis
Clinical narrative: Arm pain and weakness. Biceps tendonitis. Stretching exercises, ice, NSAIDs.
Age: 39.0
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Dizziness
Clinical narrative: Dizziness, pt stated feeling dizziness after vaccines (2 day after) sent to UC/PCP for evaluation.
Age: 46.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site paraesthesia, Injection site swelling
Clinical narrative: Swollen at injection area, red, pain dull ache, tingling - limited range of motion, sore - physical therapy assigned.
Age: 46.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Nuclear magnetic resonance imaging
Clinical narrative: Swollen at injection area, red, pain dull ache, tingling - limited range of motion, sore - physical therapy assigned.
Age: 46.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Mobility decreased, Nuclear magnetic resonance imaging normal
Clinical narrative: Swollen at injection area, red, pain dull ache, tingling - limited range of motion, sore - physical therapy assigned.
Age: 46.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pain, Paraesthesia
Clinical narrative: Swollen at injection area, red, pain dull ache, tingling - limited range of motion, sore - physical therapy assigned.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Neck pain, Pain in extremity, Swelling face, Urticaria
Clinical narrative: Hives and facial swelling, neck and arm pain.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: Right extremity erythema, pain, warmth following ZOSTAVAX administration.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness, itching on site of Tdap shot.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling
Clinical narrative: Pt developed injection site reaction a bump on injection site that kept getting bigger. Advised pt to go get it seen by her Dr. She stated kept growing (dime size and growing).
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Local swelling, Pain, Pyrexia
Clinical narrative: Approximately 3 hr post vacc -> localized erythema, pain, swelling. Approximately 12 hrs post vacc -> diffuse reaction spread to elbow; febrile 101.3 degrees. Definitive diagnosis per MD: cellulitis. Treatment ROCEPHIN 1gm x 1, AUGMENTIN 875 po BID, prednisone.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information about patient's pertinent medical history, concomitant medications, drug reactions or allergies provided. On 06-OCT-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) injection (lot# K010437, expiration date 22-JUL-2016, dose, anatomical location and route of administration were not reported). No adverse events were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Redness, swelling of upper arm x 3 days.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information about patient's pertinent medical history, concomitant medications, drug reactions or allergies provided. On 13-OCT-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) injection (lot# L011083, expiration date, dose, anatomical location and route of administration were not reported). No adverse events were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Diarrhoea, Dizziness, Mobility decreased, Nausea
Clinical narrative: First shot: diarrhea, nausea, vomiting, dizziness, fever w/ chills. 5 hrs after getting the shot. 2nd shot: same as above w/ hives - inability to move her arm.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Pyrexia, Urticaria, Vomiting
Clinical narrative: First shot: diarrhea, nausea, vomiting, dizziness, fever w/ chills. 5 hrs after getting the shot. 2nd shot: same as above w/ hives - inability to move her arm.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Dyspnoea, Swelling face, Urticaria
Clinical narrative: Patient had moderate-severe reaction after administering 4 yr old vaccines including puffy facial features, breathing difficulty and hives. Dr. treated with O2 and BENADRYL.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information about patient's pertinent medical history, concomitant medications, drug reactions or allergies provided. On 19-OCT-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) injection (lot# K010437, expiration date 22-JUL-2016, dose, anatomical location and route of administration were not reported). No adverse events were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: MMR
Symptoms: Tension headache
Clinical narrative: This spontaneous report has been received from a 55 year old female patient, who was also a nurse and who was reporting on herself, via a company representative. No information regarding the patient's medical history or concurrent conditions was provided. On 03-FEB-2016, the patient was vaccinated with a dose of M-M-R II injection (dose, route of administration, lot# and expiry date were not reported). The patient had no concomitant therapies. On an unknown date in February 2016, reported as last couple of days, the patient experienced a tension headache "in the back of her neck". The patent did not seek medical attention and no treatment was given for the event. The outcome of the event was reported as recovering. The relatedness between M-M-R II and the event was not provided. Additional information is not expected as no contact details were provided.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On 12-OCT-2015, the patient was vaccinated with a dose of improperly store (incorrect product storage) RECOMBIVAX HB, lot number L016427, expiration date 13-APR-2017, (dose, route and anatomical location were not reported). No adverse effect was reported. There was no concomitant medication reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 20-OCT-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Lot# L016427; expiration date: 13-APR-2017) (dose and route of administration were not provided). Concomitant therapies were not reported. No adverse effects reported. The pharmacist explained that the RECOMBIVAX HB doses were not involved in a previous temperature excursion and this time the temperature and time frame were: 1.4C for 22 hours 52 minutes and 8.6C for 112 hours 5 minutes. This is one of several reports from the same source (original report 1602USA004808). Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Movement disorder, Myalgia
Clinical narrative: I had the PREVNAR 13 shot in Oct 2015. I usually have no reaction to any immunizations. But the P13 shot was followed by 3 days of excruciating muscle and joint pain. I could hardly sit or stand. In Dec 2015 I had another bout of excruciating joint and muscle pain that lasted 3 days. Again in Feb 2016 I had another bout of the same - again for 3 days. I am concerned that this will continue to recur indefinitely into the future.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On 15-OCT-2015, the patient was vaccinated with a dose of improperly store RECOMBIVAX HB, lot number L004754, expiration date 10-NOV-2016, (dose, route and anatomical location were not reported). No adverse effect was reported. There was no concomitant medication reported. This is one of several reports from the same source. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: HEPAB
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Patient was given an adult dose of TWINRIX vaccine instead of pediatric dose. No adverse side effects.
Age: 1.28
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Decreased appetite, Diarrhoea, Lethargy, Vomiting
Clinical narrative: Lethargic, no appetite, diarrhea, vomiting.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information about patient's pertinent medical history, concomitant medications, drug reactions or allergies provided. On 20-OCT-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) injection (lot# K010437, expiration date 22-JUL-2016, dose, anatomical location and route of administration were not reported). No adverse events were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Received Tdap, MENACTRA at 0845. Client then went back to class (P.E.) and had a syncopal episode at 0910. Per school district protocol client was taken to Emergency Room via EMS.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker, refers to a patient of unknown age and gender. On 29-JUN-2015 the patient was vaccinated with the first dose of GARDASIL 9 (dose and lot# not reported). On 30-JUL-2015 the patient was vaccinated with the second dose and on 12-OCT-2015 the third dose of GARDASIL 9 (doses and lot# not reported). No adverse effects reported. Additional information is not expected, due to no permission to contact with physician.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 21-OCT-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Lot# L016427; expiration date: 13-APR-2017) (dose and route of administration were not provided). Concomitant therapies were not reported. No adverse effects reported. The pharmacist explained that the RECOMBIVAX HB doses were not involved in a previous temperature excursion and this time the temperature and time frame were: 1.4C for 22 hours 52 minutes and 8.6C for 112 hours 5 minutes. This is one of several reports from the same source (original report 1602USA004808). Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about patients' pertinent medical histories, concomitant medications, drug reactions or allergies reported. On an unknown dates in 2016, the patients were vaccinated with an improperly stored doses of ROTATEQ (lot #L008057, expiration date 01-DEC-2016; lot# reported as L023870, expiration date 20-APR-2017, dose was not reported; orally). No adverse events were reported. The reporting nurse suspected, that some doses were administered as excursion, which occurred on 29-JAN-2016. Time frame 2 hours and 4 minutes, temperature 10.3 Celsius degree. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On 14-OCT-2015, the patient was vaccinated with a dose of improperly store (incorrect product storage) RECOMBIVAX HB, lot number L016427, expiration date 13-APR-2017, (dose, route and anatomical location were not reported). No adverse effect was reported. There was no concomitant medication reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 20-OCT-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot # L016427, expiration date; 13-APR-2017) (dose and route of administration were not provided). Concomitant therapies were not reported. No adverse effects reported. The pharmacist explained that the RECOMBIVAX HB doses were not involved in a previous temperature excursion and this time the temperature and time frame were: 1.4 C for 22 hours 52 minutes and 8.6C for 112 hours 5 minutes. This is one of several reports from the same source (original report 1602USA004808). Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On 16-OCT-2015, the patient was vaccinated with a dose of improperly store (incorrect product storage) RECOMBIVAX HB, lot number L016427, expiration date 13-APR-2017, (dose, route and anatomical location were not reported). No adverse effect was reported. There was no concomitant medication reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On 14-OCT-2015, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB, lot number L016427, expiration date 13-APR-2017, (dose, route and anatomical location were not reported). No adverse effect was reported. There was no concomitant medication reported. This is one of several reports from the same source. Additional information has been requested.