chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Nerve conduction studies, Nuclear magnetic resonance imaging
Clinical narrative: I began feeling weak and my legs were like rubber on 11 Oct. On the 12 Oct I had trouble walking and fell down. On 13 Oct I couldn't walk so my husband took me to the ER. While there I lost the feeling in my feet and legs and couldn't move them. I was admitted and treated for Guillain Barre syndrome. I was transferred to a nursing facility for rehabilitation and am still there.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dyskinesia, Eating disorder, Facial paresis, Gait disturbance
Clinical narrative: On 10-11-11, pt experienced sudden weakness in body, left arm and hand paralysis, facial muscular collapse, difficulty walking & talking. Pt was hospitalized, diagnosed Guillain-Barre syndrome. Pt remains in hosp in rehabilitation wing. Pt is unable to close mouth completely, has difficulty speaking, eating, walking. Arm is "dead". Face resembles Bell's palsy.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Monoplegia, Plasmapheresis, Speech disorder
Clinical narrative: On 10-11-11, pt experienced sudden weakness in body, left arm and hand paralysis, facial muscular collapse, difficulty walking & talking. Pt was hospitalized, diagnosed Guillain-Barre syndrome. Pt remains in hosp in rehabilitation wing. Pt is unable to close mouth completely, has difficulty speaking, eating, walking. Arm is "dead". Face resembles Bell's palsy.
Age: 34.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Had vaccines 12-14-11. 12-15-11 Developed redness, swelling and pain. Treatment of BENADRYL as needed. Ibuprofen as needed, ice and elevation of arm, moderate activity.
Age: 62.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Nasopharyngitis, Urticaria
Clinical narrative: Felt like coming down with cold. Hives on abdomen. BENADRYL 50mg PO.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: Pt. received vaccine waited in room for 15-20 minutes after several hours later began to experience rash & itching. Came into pharmacy, BENADRYL was administered, pt. didn't go to ER. Took BENADRYL went home was OK afternoon.
Age: 17.0
Sex: M
Vaccine: FLU3
Symptoms: Agitation, Anticonvulsant drug level, Condition aggravated, Gaze palsy, Laboratory test
Clinical narrative: Had 20 minute generalized partial seizure very agitated, eyes rolled unresponsive.
Age: 17.0
Sex: M
Vaccine: FLU3
Symptoms: Partial seizures, Unresponsive to stimuli
Clinical narrative: Had 20 minute generalized partial seizure very agitated, eyes rolled unresponsive.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site infection, Nuclear magnetic resonance imaging abnormal, Pain in extremity
Clinical narrative: Patient stated that she developed severe arm pain that is still on-going. Attempted treatment with ibuprofen and hot compresses, ultimately going to physician who diagnosed infection at injection site after ordering an MRI. Patient proceeding to see an orthopedist for further treatment.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Headache, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: On 11/21/11: Pt. presented with area 2"x4" on (L) arm on deltoid that was red, swollen and warm. Pt. stated arm started hurting in evening 11/.18/1. On AM 11/19 had headache and arm aching. On 11/19 had shaking, chills, fever and vomiting. Began improving on 11/20 in PM. Took a couple doses of TYLENOL and BENADRYL with little improvement. Saw OB/GYN today and he suggested warm compress. Recommended TYLENOL/BENADRYL TID x 2d and to see MF if no improvement in 1-2 days.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Pyrexia, Tremor, Vomiting
Clinical narrative: On 11/21/11: Pt. presented with area 2"x4" on (L) arm on deltoid that was red, swollen and warm. Pt. stated arm started hurting in evening 11/.18/1. On AM 11/19 had headache and arm aching. On 11/19 had shaking, chills, fever and vomiting. Began improving on 11/20 in PM. Took a couple doses of TYLENOL and BENADRYL with little improvement. Saw OB/GYN today and he suggested warm compress. Recommended TYLENOL/BENADRYL TID x 2d and to see MF if no improvement in 1-2 days.
Age: 16.0
Sex: F
Vaccine: FLU3, HPV4, MNQ
Symptoms: Abdominal pain, Dizziness, Dyskinesia, Headache, Syncope
Clinical narrative: Brief fainting episode w/ "jerking movements", headache, abdominal pain and dizziness. Sent to ER for eval.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: The injection site was swollen to the size of 1/2 dollar. Took BENADRYL and used cold compress. Was gone by Sat 12/17/11.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Urticaria
Clinical narrative: Urticaria & itching.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Onset about 18-19 hrs. after inj. pt. took BENADRYL swelling went down the inj. site was painful & swollen, area approximately 3".
Age: 1.25
Sex: M
Vaccine: PNC
Symptoms: Death, Pneumococcal sepsis
Clinical narrative: This is an initial spontaneous report from a contactable physician communicated to a Pfizer Sales Representative. A 4-year-old patient (gender unknown) received a dose of PREVENAR on an unknown date for an unknown indication (site and time of administration were also unknown). Relevant medical history, concomitant medications, concomitant vaccines or vaccines given within the last four weeks were unknown. On an unknown date, the patient experienced invasive pneumococcal sepsis which resulted in death. Relevant laboratory data was unknown and it was unknown if an autopsy was performed. The cause of death was reported as invasive pneumococcal sepsis.
Sex: U
Vaccine: PNC
Symptoms: Death, Pneumococcal infection
Clinical narrative: This is an initial spontaneous report from a contactable reporter. The reporter reported for a consumer (age, gender and race unknown) who received a dose of PREVNAR on and unknown date for an unknown indication. Relevant medical history and relevant concomitant medications were unknown. The reporter mentioned that the child died on an unknown date due to pneumococcal disease after taking PREVNAR. Therapeutic measures taken in response to the events, if any were unknown. Relevant laboratory data was unknown and it was unknown if an autopsy was performed. The reported cause of death was pneumococcal infection.
Age: 50.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt. called after 24 hrs of receiving shot. C/O that elbow to her shoulder swollen & hot to touch, very painful. (R) arm.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: Pt. reported a red, raised, circular (approximately 2 inch in diameter) area of rash with heat and hardness about 2 inches below injection site on left arm. Advised to take BENADRYL & seek medical attention if no improvement.
Age: 0.37
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pt had significant swelling and pain at both thighs where the injection was given.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Axillary pain, Blood test normal, Borrelia test negative, C-reactive protein normal
Clinical narrative: Information has been received from a 24 year old female patient (also a registered nurse) with no pertinent medical history and with azithromycin allergy reporting on herself who on 13-JUL-2011 was vaccinated intramuscularly with a dose of GARDASIL (dose and lot # not reported). There was no concomitant medication. On 13-JUL-2011, the same day about 4 hours after receiving the shot the patient broke out in hives. The hives started on her legs and spread to the rest of her body. One of the patient's eyelids almost swelled shut. The patient also had difficulty breathing. The patient took at CLARITIN and the events resolved. On 15-JUL-2011 the patient developed pain in her left arm pits and her lymph node felt swollen. The patient developed pain in her right knee and hip. On 16-JUL-2011 the patient began taking aspirin and then on 18-JUL-2011 began ibuprofen. On 19-JUL-2011 the patient's arm pit pain resolved. On 25-JUL-2011 the patient had bleeding from two of her fingers. She had blood came out from under nail bed. And the patient had about 15 "petechiae" on her body. On 27-JUL-2011 returned from a trip and went to the emergency room. Blood tests were performed but all her levels were normal. The patient was still having joint pain had had not resolved. The joint pain had now spread to other parts of her body, including her wrists. At the time of reporting, the outcome of blood came out from under nail bed and the patient's 15 "petechiae" on her body and her lymph node felt swollen were unknown. Follow up information had been received from a licensed practical nurse who reported that the first dose of GARDASIL was given on 13-JUL-2011 (lot # 669285/0691AA). No concomitant vaccines were given. Many tests were performed including Lyme, rheumatoid factor (RF) test and C-reactive protein (CRP) test; all were normal. The physician suggested to the patient that she waited about six weeks for symptoms to subside before consulting a rheumatologist; in the meantime, the patient prescribed ALEVE and told to exercise to keep limber. Follow up information has been received from the physician who reported that the patient with a history of rash after azithromycin and no illness at the time of vaccination was vaccinated with a first dose of GARDASIL in the afternoon. It was reported that on 13-JUL-2011, the patient experienced severe joint pain eventually, started as hives and muscle twitches 4 hours post vaccine and lasted 12 hours. On 16-JUL-2011, 3 days after vaccination, joint and axillary pain begun. Labs performed were all normal, the patient had been referred to rheumatologist. It was reported that the events required an emergency room/doctor visit. At the time of reporting the patient had not recovered from axillary pain and severe joint pain. Severe joint pain, hives, muscle twitches and axillary pain were considered to be disabling by the reporter. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Eyelid oedema, Laboratory test normal, Lymphadenopathy, Muscle twitching
Clinical narrative: Information has been received from a 24 year old female patient (also a registered nurse) with no pertinent medical history and with azithromycin allergy reporting on herself who on 13-JUL-2011 was vaccinated intramuscularly with a dose of GARDASIL (dose and lot # not reported). There was no concomitant medication. On 13-JUL-2011, the same day about 4 hours after receiving the shot the patient broke out in hives. The hives started on her legs and spread to the rest of her body. One of the patient's eyelids almost swelled shut. The patient also had difficulty breathing. The patient took at CLARITIN and the events resolved. On 15-JUL-2011 the patient developed pain in her left arm pits and her lymph node felt swollen. The patient developed pain in her right knee and hip. On 16-JUL-2011 the patient began taking aspirin and then on 18-JUL-2011 began ibuprofen. On 19-JUL-2011 the patient's arm pit pain resolved. On 25-JUL-2011 the patient had bleeding from two of her fingers. She had blood came out from under nail bed. And the patient had about 15 "petechiae" on her body. On 27-JUL-2011 returned from a trip and went to the emergency room. Blood tests were performed but all her levels were normal. The patient was still having joint pain had had not resolved. The joint pain had now spread to other parts of her body, including her wrists. At the time of reporting, the outcome of blood came out from under nail bed and the patient's 15 "petechiae" on her body and her lymph node felt swollen were unknown. Follow up information had been received from a licensed practical nurse who reported that the first dose of GARDASIL was given on 13-JUL-2011 (lot # 669285/0691AA). No concomitant vaccines were given. Many tests were performed including Lyme, rheumatoid factor (RF) test and C-reactive protein (CRP) test; all were normal. The physician suggested to the patient that she waited about six weeks for symptoms to subside before consulting a rheumatologist; in the meantime, the patient prescribed ALEVE and told to exercise to keep limber. Follow up information has been received from the physician who reported that the patient with a history of rash after azithromycin and no illness at the time of vaccination was vaccinated with a first dose of GARDASIL in the afternoon. It was reported that on 13-JUL-2011, the patient experienced severe joint pain eventually, started as hives and muscle twitches 4 hours post vaccine and lasted 12 hours. On 16-JUL-2011, 3 days after vaccination, joint and axillary pain begun. Labs performed were all normal, the patient had been referred to rheumatologist. It was reported that the events required an emergency room/doctor visit. At the time of reporting the patient had not recovered from axillary pain and severe joint pain. Severe joint pain, hives, muscle twitches and axillary pain were considered to be disabling by the reporter. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Nail bed bleeding, Petechiae, Rheumatoid factor negative, Urticaria
Clinical narrative: Information has been received from a 24 year old female patient (also a registered nurse) with no pertinent medical history and with azithromycin allergy reporting on herself who on 13-JUL-2011 was vaccinated intramuscularly with a dose of GARDASIL (dose and lot # not reported). There was no concomitant medication. On 13-JUL-2011, the same day about 4 hours after receiving the shot the patient broke out in hives. The hives started on her legs and spread to the rest of her body. One of the patient's eyelids almost swelled shut. The patient also had difficulty breathing. The patient took at CLARITIN and the events resolved. On 15-JUL-2011 the patient developed pain in her left arm pits and her lymph node felt swollen. The patient developed pain in her right knee and hip. On 16-JUL-2011 the patient began taking aspirin and then on 18-JUL-2011 began ibuprofen. On 19-JUL-2011 the patient's arm pit pain resolved. On 25-JUL-2011 the patient had bleeding from two of her fingers. She had blood came out from under nail bed. And the patient had about 15 "petechiae" on her body. On 27-JUL-2011 returned from a trip and went to the emergency room. Blood tests were performed but all her levels were normal. The patient was still having joint pain had had not resolved. The joint pain had now spread to other parts of her body, including her wrists. At the time of reporting, the outcome of blood came out from under nail bed and the patient's 15 "petechiae" on her body and her lymph node felt swollen were unknown. Follow up information had been received from a licensed practical nurse who reported that the first dose of GARDASIL was given on 13-JUL-2011 (lot # 669285/0691AA). No concomitant vaccines were given. Many tests were performed including Lyme, rheumatoid factor (RF) test and C-reactive protein (CRP) test; all were normal. The physician suggested to the patient that she waited about six weeks for symptoms to subside before consulting a rheumatologist; in the meantime, the patient prescribed ALEVE and told to exercise to keep limber. Follow up information has been received from the physician who reported that the patient with a history of rash after azithromycin and no illness at the time of vaccination was vaccinated with a first dose of GARDASIL in the afternoon. It was reported that on 13-JUL-2011, the patient experienced severe joint pain eventually, started as hives and muscle twitches 4 hours post vaccine and lasted 12 hours. On 16-JUL-2011, 3 days after vaccination, joint and axillary pain begun. Labs performed were all normal, the patient had been referred to rheumatologist. It was reported that the events required an emergency room/doctor visit. At the time of reporting the patient had not recovered from axillary pain and severe joint pain. Severe joint pain, hives, muscle twitches and axillary pain were considered to be disabling by the reporter. Additional information has been requested.
Age: 1.03
Sex: F
Vaccine: FLU3, MMR, VARCEL
Symptoms: Abasia, Cerebellar ataxia, Miosis
Clinical narrative: This medically confirmed spontaneous report (initial receipt 13-Dec-2011) concerns a 1-year old female patient, who had no pertinent medical history, drug reactions / allergies or taking any concomitant medication. On 30-Nov-2007 the patient received flu vaccine. On the same day she also received dose 1 of VARIVAX injection and dose 1 of MMR. Ten days later, the patient was unable to walk and had 'pinpointing'. She developed cerebella ataxia and was taken to an ER (Emergency Room) with no significant finding. The ataxia resolved within 5 to 7 days after onset. The event outcome was recovered. The patient has since received a second MMR on 06-Dec-2011 with no problems to report. The reporter considered events to be serious as the events caused significant disability / incapacity.
Age: 70.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Burning sensation, Immediate post-injection reaction, Injected limb mobility decreased, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous consumer report (initial receipt 16-Dec-2011) concerns a 70 old male patient, who had a medical history of arthritis, acid reflux and sulfa allergy. Concomitant medications included arthritis medication (unspecified) and acid reflux medication (unspecified). In mid Nov-2011 the patient received flu vaccine in his left arm. On the same day he also received PNEUMOVAX 23 injection in right arm. Immediately post vaccination the patient experienced adverse reaction of pain and soreness of the right arm. The right arm injection site reaction progressed to swelling, redness and the soreness continued, so much so, that he could not lift his right arm. A few weeks after the vaccination, the patient started to get a burning sensation under the right arm, in the armpit. The patient went to a doctor last Tuesday. He was diagnosed a possible shingles and prescribed an unspecified shingles medication. The patient did not have a rash or bumps under his right arm and he did not think it was shingles. In addition the patient claimed that the shingles medication was not helping. The burning sensations continued under the right armpit. He would contact his doctor for follow up. The event outcome was not recovered.
Age: 70.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain in extremity
Clinical narrative: This spontaneous consumer report (initial receipt 16-Dec-2011) concerns a 70 old male patient, who had a medical history of arthritis, acid reflux and sulfa allergy. Concomitant medications included arthritis medication (unspecified) and acid reflux medication (unspecified). In mid Nov-2011 the patient received flu vaccine in his left arm. On the same day he also received PNEUMOVAX 23 injection in right arm. Immediately post vaccination the patient experienced adverse reaction of pain and soreness of the right arm. The right arm injection site reaction progressed to swelling, redness and the soreness continued, so much so, that he could not lift his right arm. A few weeks after the vaccination, the patient started to get a burning sensation under the right arm, in the armpit. The patient went to a doctor last Tuesday. He was diagnosed a possible shingles and prescribed an unspecified shingles medication. The patient did not have a rash or bumps under his right arm and he did not think it was shingles. In addition the patient claimed that the shingles medication was not helping. The burning sensations continued under the right armpit. He would contact his doctor for follow up. The event outcome was not recovered.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Herpes zoster, Lip pain, Oral herpes, Oropharyngeal pain, Pharyngitis streptococcal
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 21-Nov-2011) concerns a 58-year old female patient, who had a medical history of sleeplessness and 'nerves'. On 18-Nov-2011 the patient received 0.5 mL of AFLURIA (batch number: N56506A) intramuscularly in LD (left deltoid). On 20-Nov-2011, the patient developed a painful fever blister on her lip, a sore throat and a 3 inch rash on her leg and a 5 inch rash on her stomach. She never had a fever blister before. The patient visited a doctor and was diagnosed with strep throat and shingles. She did not receive any treatment for the event. The event outcome was recovered. The reporter considered 'strep throat' and 'shingles' to be unrelated to AFLURIA. Follow up (16-Dec-2011): suspect drug administration site, additional AE terms, event summary description, event outcome, reporter's causality assessment, company seriousness assessment, upgraded to serious.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 21-Nov-2011) concerns a 58-year old female patient, who had a medical history of sleeplessness and 'nerves'. On 18-Nov-2011 the patient received 0.5 mL of AFLURIA (batch number: N56506A) intramuscularly in LD (left deltoid). On 20-Nov-2011, the patient developed a painful fever blister on her lip, a sore throat and a 3 inch rash on her leg and a 5 inch rash on her stomach. She never had a fever blister before. The patient visited a doctor and was diagnosed with strep throat and shingles. She did not receive any treatment for the event. The event outcome was recovered. The reporter considered 'strep throat' and 'shingles' to be unrelated to AFLURIA. Follow up (16-Dec-2011): suspect drug administration site, additional AE terms, event summary description, event outcome, reporter's causality assessment, company seriousness assessment, upgraded to serious.
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barre Syndrome.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Musculoskeletal pain, Myalgia, Swelling
Clinical narrative: Within 2hrs of receiving vaccine patient experienced soreness and swelling of left scapular area adjacent to site of injection; persistent for 6 wks with swelling, tenderness of muscle.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Ear pain, Malaise, Oropharyngeal pain, Pain
Clinical narrative: Body aches, night fevers, malaise for 1 week. Cough - last week 12/16/11, sore throat, ear ache. Malaise continues.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Body aches, night fevers, malaise for 1 week. Cough - last week 12/16/11, sore throat, ear ache. Malaise continues.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysgeusia, Hypoaesthesia oral, Immediate post-injection reaction
Clinical narrative: Immediately after vaccine administered. pt stood up and c/o metalic taste in mouth and tongue/mouth/lips being numb. Remained alert and able to talk. No difficulty breathing. MD called. Monitored. No further complications and patient recovered and numbness went away within 10 minutes. No edema.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Injected limb mobility decreased, Injection site pain, Joint range of motion decreased, Pain in extremity
Clinical narrative: Experienced initial pain with injection of medicine that resolved shortly after;woke two days later with +8-9/10 pain LT deltoid at injection site; intermittent pain radiation to posterior aspect of LT forearm;at no time was there any swelling and/or discoloration;denies any tingling and/ or numbness;decreased ROM and strength of LT arm and cannot raise LT arm above her waist without assistance of other arm; minimal improvement over last three weeks; has done no self treatment e.g. NSAIDS or cold or heat application;feels fatigued and "run down"; pt was referred to her private MD for further evaluation
Age: 12.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: VARICELLA INJECTION SITE LEFT POSTERIOR UPPER ARM 6 CM X 9 CM REDNESS, SWELLING, TENDER, WARM TO THE TOUCH AND ITCHES.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: REDNESS AND ITCHING AT INJECTION SITE FOR 7 DAYS.  NO TREATMENT NEEDED.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Abdominal pain upper, Herpes zoster, Injection site erythema, Injection site pain
Clinical narrative: VACCINE ADMINISTERED 11/10/2011.  WARM REDDENED TENDER AREA DEVELOPED AT INJECTION SITE THE EVENING OF 11/10/2011.  ABDOMINAL PAIN THE FOLLOWING DAY DESCRIBED BY PT AS A PINCHING, ACHING HURT IN HER STOMACH.  ITCHY RASH ON HER BACK DEVELOPED 11/13/2011.  PHYSICIAN VISIT 11/15/2011 - DX SHINGLES.  TREATED WITH ORAL ANTIVIRAL AND PAIN MEDICATION.  AS OF 12/01/2011 IT IS RESOLVING BUT SHE STILL HAS SOME LINGERING ABDOMINAL PAIN.  PHARMACY WAS INFORMED ON 11/30/2011 BY PT. I WAS NOT HERE BUT GAVE HER A CALL THE MORNING OF 12/01/2011 AND PROCEEDED TO GET THE INFORMATION ABOVE.  MERCK NOTIFIED ON 12/01/2011.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Rash pruritic
Clinical narrative: VACCINE ADMINISTERED 11/10/2011.  WARM REDDENED TENDER AREA DEVELOPED AT INJECTION SITE THE EVENING OF 11/10/2011.  ABDOMINAL PAIN THE FOLLOWING DAY DESCRIBED BY PT AS A PINCHING, ACHING HURT IN HER STOMACH.  ITCHY RASH ON HER BACK DEVELOPED 11/13/2011.  PHYSICIAN VISIT 11/15/2011 - DX SHINGLES.  TREATED WITH ORAL ANTIVIRAL AND PAIN MEDICATION.  AS OF 12/01/2011 IT IS RESOLVING BUT SHE STILL HAS SOME LINGERING ABDOMINAL PAIN.  PHARMACY WAS INFORMED ON 11/30/2011 BY PT. I WAS NOT HERE BUT GAVE HER A CALL THE MORNING OF 12/01/2011 AND PROCEEDED TO GET THE INFORMATION ABOVE.  MERCK NOTIFIED ON 12/01/2011.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Aphonia, Back pain, Blood pressure increased, Chest X-ray normal, Chest pain
Clinical narrative: Extreme fatigue and body aches with really sore arm. This lasted for two days. Then noticed a huge red welt the size of my hand about 4 inches below the injection site. Then began developing a harsh dry cough and horseness with sore throat. Eventually lost my voice and began developing chest and back pains.  Returned to doctor on Nov 29 concerned I may be having a heart attack because shortness of breath and dizziness had started 2 days before along with severe chest and back pains. EKG was normal.  Back and chest pains along with bouts of dizziness and shortness of breath continued periodically.  Went to emergency room on Dec 17 for all of the above symptoms along with pains down my left arm (where the shot was given) and I couldn't focus and blood pressure was thru the roof.  I was released with a Non--specific chest pain diagnosis.  Returned to my doctor on Dec 19 with same issues.  That flu shot did something to me where I can't function w/out feeling like I am going to jump out of my skin and I continue to get all of these chest and back pains.  I was in good health prior to it.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Dizziness, Dysphonia, Dyspnoea, Electrocardiogram normal
Clinical narrative: Extreme fatigue and body aches with really sore arm. This lasted for two days. Then noticed a huge red welt the size of my hand about 4 inches below the injection site. Then began developing a harsh dry cough and horseness with sore throat. Eventually lost my voice and began developing chest and back pains.  Returned to doctor on Nov 29 concerned I may be having a heart attack because shortness of breath and dizziness had started 2 days before along with severe chest and back pains. EKG was normal.  Back and chest pains along with bouts of dizziness and shortness of breath continued periodically.  Went to emergency room on Dec 17 for all of the above symptoms along with pains down my left arm (where the shot was given) and I couldn't focus and blood pressure was thru the roof.  I was released with a Non--specific chest pain diagnosis.  Returned to my doctor on Dec 19 with same issues.  That flu shot did something to me where I can't function w/out feeling like I am going to jump out of my skin and I continue to get all of these chest and back pains.  I was in good health prior to it.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Fatigue, Feeling abnormal, Injection site pain, Oropharyngeal pain
Clinical narrative: Extreme fatigue and body aches with really sore arm. This lasted for two days. Then noticed a huge red welt the size of my hand about 4 inches below the injection site. Then began developing a harsh dry cough and horseness with sore throat. Eventually lost my voice and began developing chest and back pains.  Returned to doctor on Nov 29 concerned I may be having a heart attack because shortness of breath and dizziness had started 2 days before along with severe chest and back pains. EKG was normal.  Back and chest pains along with bouts of dizziness and shortness of breath continued periodically.  Went to emergency room on Dec 17 for all of the above symptoms along with pains down my left arm (where the shot was given) and I couldn't focus and blood pressure was thru the roof.  I was released with a Non--specific chest pain diagnosis.  Returned to my doctor on Dec 19 with same issues.  That flu shot did something to me where I can't function w/out feeling like I am going to jump out of my skin and I continue to get all of these chest and back pains.  I was in good health prior to it.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Pain in extremity, Urticaria, Vision blurred
Clinical narrative: Extreme fatigue and body aches with really sore arm. This lasted for two days. Then noticed a huge red welt the size of my hand about 4 inches below the injection site. Then began developing a harsh dry cough and horseness with sore throat. Eventually lost my voice and began developing chest and back pains.  Returned to doctor on Nov 29 concerned I may be having a heart attack because shortness of breath and dizziness had started 2 days before along with severe chest and back pains. EKG was normal.  Back and chest pains along with bouts of dizziness and shortness of breath continued periodically.  Went to emergency room on Dec 17 for all of the above symptoms along with pains down my left arm (where the shot was given) and I couldn't focus and blood pressure was thru the roof.  I was released with a Non--specific chest pain diagnosis.  Returned to my doctor on Dec 19 with same issues.  That flu shot did something to me where I can't function w/out feeling like I am going to jump out of my skin and I continue to get all of these chest and back pains.  I was in good health prior to it.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site dryness, Injection site erythema, Injection site pruritus, Swelling
Clinical narrative: PATIENT DEVELOPED A DRY RED ITCHY SPOT AT SITE OF INJECTION.  PATIENT JUST NOTICED A WEEK TO 10 DAYS AGO WHEN IT STARTED TO ITCH.  SHE RECEIVED THE SHOT OVER A MONTH AGO 10/18/2011 IN THE RIGHT ARM.  SHE DID HAVE A LITTLE SWELLING RIGHT AWAY BUT DID NOT HURT.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Abdominal pain, Dizziness, Dyskinesia, Nausea
Clinical narrative: Patient developed jerky movement on 12/22/2011 after vaccination. He also c/o dizziness, nausea and mild abdominal pain.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Limb discomfort, Pain in extremity
Clinical narrative: Persistant discomfort in left arm where vaccine was administered.  Continues everytime I move this arm and is very painful when pressure is applied and when I bend my arm.  My arm was fine prior to this and these symptoms began as soon as I had the vaccine.  Mentioned it to my doctor on November 15, 2011, November 29, 2011 and again on December 12,2011.  On December 12, 2011 I was informed by my doctor's nurse that this discomfort was entirely not related to the vaccine.  I disagreed with her opinion and told her it was too much of a coincidence since the pain began after I had the vaccine.  I hope this is not a permanent condition in my arm now.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Urticaria
Clinical narrative: A 2 inch across red welt was noticed the morning of 12/18/11.  The welt and redness began to fade on 12/20/11.  As of 12/22/11, the welt had decreased to a faint pink spot.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Eye swelling, Injection site erythema, Injection site pruritus, Lip swelling, Oedema peripheral
Clinical narrative: FLUZONE administered 11/22/11. Redness/itching at injection site x 7-10 days. Random and periodic hives, itching/swollen hands since vaccinated. Came to pharmacy today w/ swollen (R) eye and upper lip. Pt. denies any allergies, or trouble breathing.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: FLUZONE administered 11/22/11. Redness/itching at injection site x 7-10 days. Random and periodic hives, itching/swollen hands since vaccinated. Came to pharmacy today w/ swollen (R) eye and upper lip. Pt. denies any allergies, or trouble breathing.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: An hour later vaccine was administered started having soreness and swelling at the injection site. Instructed to take OTC BENADRYL and apply cool compress to injection site.
Age: 0.35
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Rash
Clinical narrative: Rash on legs, chest, back and face.
Age: 0.51
Sex: F
Vaccine: DTAPHEPBIP, PNC
Symptoms: Pyrexia, Rash
Clinical narrative: This case was reported by a physician and described the occurrence of fever in a 6-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline). Concurrent vaccination included PREVNAR (Pfizer) given on 19 September 2011. Concurrent medications included BENADRYL. On 19 September 2011 at 10:00 the subject received 3rd dose of PEDIARIX at 0.5 ml in the left leg. On 19 September 2011 (14:00), 4 hours after vaccination with PEDIARIX, the subject experienced fever. On the morning of 20 September 2011, one day following vaccination with PEDIARIX the subject developed a rash. The physician considered the events were clinically significant (or requiring intervention). It was noted that the subject required multiple visits to the physician's office. Fever resolved 3 days after onset on 21 September 2011 and rash resolved 3 days after onset on 22 September 2011. Attribution of the events to vaccination with PEDIARIX was not reported.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Pyrexia, Rash
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of fever in a 6-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of PEDIARIX (details unknown). At an unspecified time after vaccination with PEDIARIX, the subject experienced fever and rash. At the time of reporting the outcome of the events was unspecified.
Age: 0.53
Sex: F
Vaccine: DTAPHEPBIP, HIBV, RVX, UNK
Symptoms: Crying, Decreased appetite, Pyrexia, Vomiting
Clinical narrative: This case was reported by the mother of a consumer and described the occurrence of fever in a 6-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline). Previous vaccination included an unspecified brand (other than PEDIARIX) of DTAP/POLIO/Hib/ Hepatitis B (PENTAOL ?) given at 4 months of age. Concurrent vaccination included HIB PRPT (manufacturer unspecified), live attenuated human rotavirus vaccine (manufacturer unspecified) and unspecified vaccine (PNUCN 13?, manufacturer unknown) all given on 5 July 2011. A concurrent medication of RENATABEAN (?) was reported. On 5 July 2011 the subject received 3rd dose of PEDIARIX (unknown). On 5 July 2011, 12 hours after vaccination with PEDIARIX, the subject experienced fever to 101 degrees, vomiting, loss of appetite and crying. The events were resolved 48 hours after onset. No additional information was provided.
Age: 0.8
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Pyrexia
Clinical narrative: This case was reported by a physician and described the occurrence of high fever in a 9-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline). Concurrent medical conditions included environmental allergy (not to medications). On an unspecified date in January 2010 the subject received 3rd dose of PEDIARIX (.5 ml, unknown route, left thigh). On an unspecified date in January 2010, 6 to 10 hours after vaccination with PEDIARIX, the subject experienced high fever of 102 degrees Fahrenheit. The subject was treated with TYLENOL. At the time of reporting the event was resolved after 48 hours. The physician considered the event was possibly related to vaccination with PEDIARIX.
Age: 0.54
Sex: F
Vaccine: DTAPHEPBIP, UNK
Symptoms: Diarrhoea, Incorrect storage of drug
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of diarrhea in a 7-month-old female subject who was vaccinated with PEDIARIX. Previous and/or concurrent vaccination included two unspecified vaccines given on 19 May 2011. There were no concurrent medications. The subject had no known relevant medical history. On 19 May 2011 at 11:30 the subject received unspecified dose of PEDIARIX (unknown, unknown thigh) that was stored at incorrect temperature conditions. The physician's office told the reporter that due to a recent power outage, the vaccine was "compromised and not kept in proper temperature conditions". The vaccine was then inadvertently administered to the subject. On 20 May 2011, one day after vaccination with PEDIARIX, the subject experienced diarrhea. At the time of reporting the diarrhea was improved.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, RVX
Symptoms: Incorrect dose administered, Injection site mass, Pyrexia
Clinical narrative: This case was reported by the mother of a consumer and described the occurrence of fever in an infant male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), Rotavirus vaccine. A physician or other health care professional has not verified this report. There were no concurrent medications. On 25 March 2011, the subject inadvertently received an extra dose of PEDIARIX and an extra dose of unspecified rotavirus vaccine. It was additionally reported that the subject had received an extra dose of unspecified rotavirus vaccine at 5 months of age. Four total doses of each PEDIARIX and rotavirus vaccine had been administered to the subject. Rotavirus vaccine at 3, 4, 5 and 6 months and PEDIARIX in November 2010, December 2010, February 2011 and again on the day of reporting, 25 March 2011. The mother additionally reported that her son experienced fever following every vaccine administered. No specific details were provided. At the time of reporting the outcome of the events was unspecified. No additional events were reported. The mother stated that she believed her son was supposed to have gotten Hib and pneumococcal vaccine on 25 March 2011, but he did not. Follow-up information was received via physician who reported that the mother of the subject denied any adverse reaction. The subject "had a tiny subcutaneous bump on the site of injection which disappeared in two days".
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Decreased appetite, Pyrexia
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of crying uncontrollably in a 2-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline). Concurrent vaccination included PREVNAR (Pfizer) and ROTATEQ (Merck) both given on 12 April 2011. There were no concurrent medications. On 12 April 2011 at 16:30, the 5 month old subject received 2nd dose of PEDIARIX at 0.5 ml in an unknown leg. On 12 April 2011, less than one day after vaccination with PEDIARIX, the subject experienced crying uncontrollably. A day later, on 13 April 2011, at 01:00, the subject developed a fever (101.5 degrees F). Loss of appetite was also reported with onset 13 April 2011. Fever remained unresolved at the time of reporting. Outcome for uncontrollable crying and loss of appetite was unknown. It was additionally reported that the subject experienced the same events of uncontrollable crying, fever and loss of appetite following the 1st administration of PEDIARIX at the subjects two month old check up. Dates of administrations, onset of events and outcome was not indicated. Follow-up information was received on 13 April 2011. Concurrent vaccination included pediatric Hib vaccine given on 12 April 2011.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Pyrexia
Clinical narrative: This case was reported by a physician via sales representative and described the occurrence of fever post vaccination in an unspecified number of infant subjects of unspecified gender who were vaccinated with PEDIARIX (GlaxoSmithKline). On unspecified dates the subjects received unspecified doses of PEDIARIX (unknown). At unspecified times after vaccination with PEDIARIX, the subjects experienced fever post vaccination. The physician indicated to the sales representative that PEDIARIX was discontinued in her practice "due to parents reports of fevers post vaccinations at 2, 4, and 6 months of ages; was determined by the physician to be vaccine fever and cause her to stop using PEDIARIX in her practice". At the time of the report, no other information of time intervals or lot number was available. At the time of reporting the outcome of the fever post vaccination was unspecified.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Expired drug administered, Vomiting
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of vomiting in a 2-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline), ROTARIX. Concurrent vaccination included ACTHIB (Sanofi Pasteur MSD) and PREVNAR 13 (Wyeth) both given on 22 November 2010. On 22 November 2010 at 14:10 the subject inadvertently received an expired 1st dose of PEDIARIX at 0.5 ml in the right thigh and an expired 1st dose of ROTARIX (unknown). Two days later, on 24 November 2010, the subject experienced vomiting which resolved the same day. The reporter felt that the vomiting was due to the ROTARIX. Attribution to PEDIARIX was not provided. Follow-up information was received on 03 January 2011. It was reported that the subject experienced vomiting on 23 November 2010 which resolved the same day. The event was considered possibly related to treatment with GlaxoSmithKline vaccine and it was noted that the event could have been the result of more than one vaccine given on the same day.
Age: 1.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Lymphadenopathy
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swollen lymph nodes of the neck in a 1-year-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline). There were no concurrent medications. On an unspecified date about one month prior to reporting the subject received unspecified dose of PEDIARIX (unknown). One day after vaccination with PEDIARIX, the subject experienced swollen lymph nodes of the neck. It was reported that the symptom lasted for about a month, but it was also stated that the event was on-going. The subject returned to the physician for a round of antibiotics. It was noted that the physician stated that if the swelling still exists the following week, a biopsy would be planned. No further information was provided.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Injection site nodule, Injection site pain, Oedema peripheral, Product quality issue
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of limb swelling in an infant subject of unspecified gender who was vaccinated with PEDIARIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of PEDIARIX (unknown). At an unspecified time after vaccination with PEDIARIX, the subject experienced limb swelling, nodule at injection site, pain and pharmaceutical product complaint. Sales representative was notified that the practice recently ordered 100 prefilled syringes of PEDIARIX and was concerned that there is a quality issue with this lot, lot number was not available. At the time of the report, the practice stopped administering PEDIARIX. At the time of reporting the outcome of the limb swelling, nodule at injection site and pain were unspecified. The healthcare professional considered the events were probably related to vaccination with PEDIARIX. A total of nine subjects were reported to have adverse events after vaccination with PEDIARIX, patient identifiers were not provided. For the other eight cases see A0890713A-A0890720A. Follow-up information was received from QA Product Complaints on 05 November 2010: A representative from QA Product Complaints followed up with the reporting healthcare professional. The healthcare professional reported that she did not have the lot number and was still trying to obtain it. Additionally, she stated that after some investigation, she found out that the original number of affected patients reported (9) was incorrect. She indicated that it appeared that only one patient was involved. Since only one patient was involved, the eight case ids A0890713A through A0890720A have been voided. Case id A0890710A will be retained as the case of reference. Follow-up information was received on 01 February 2011 via Quality Assurance, who reported no sample was returned and no lot number was provided, therefore no further investigation could be performed. This complaint was changed from inconclusive to unsubstantiated.
Age: 0.86
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Injection site nodule, Rash
Clinical narrative: This case was reported by a physician and described the occurrence of nodule injection site in a 10-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline). Concurrent medical conditions included eczema. Concurrent vaccination included ACTHIB (Sanofi) and PREVNAR (Wyeth Labs) both given on 1 December 2010. There were no concurrent medications. On 1 December 2010 at 17:00 the subject received 3rd dose of PEDIARIX at 0.5 ml in the left thigh. On 1 December 2010, immediately after vaccination with PEDIARIX, the subject developed a nodule at the injection site and a rash on the skin. The parents of the subject sought medical attention after the nodule persisted for one week. At the time of reporting the events were improved. The physician considered the nodule probably related to vaccination with PEDIARIX and stated that since the subject has a history of eczema, she was not certain that the rash was related to PEDIARIX although she said it was possible.
Age: 0.2
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Irritability, Pyrexia
Clinical narrative: This case was reported by a physician via sales representative and described the occurrence of fever in a 6-week-old subject of unspecified gender who was vaccinated with PEDIARIX (GlaxoSmithKline), PREVNAR (non-gsk), ACTHIB (non-gsk) and ROTATEQ (non-gsk). On approximately 25 August 2011 the subject received 1st dose of PEDIARIX (.5 ml, unknown, unknown thigh), 1st dose of PREVNAR (unknown, unknown thigh), 1st dose of ACTHIB (unknown, unknown thigh), and 1st dose of ROTATEQ (unknown). On 25 August 2011, within 24 hours of vaccination with PEDIARIX, ACTHIB, PREVNAR and ROTATEQ, the subject experienced fever of 100.5 or 102 degrees Fahrenheit and fussiness. The subject was hospitalized for two days; discharged no sequelae according to hospital protocol and no sepsis. On 26 August 2011, the fever and fussiness were resolved. The physician considered the fever and fussiness possibly related to vaccination with PEDIARIX. Another case was reported please see A0945514A.