chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, Sinus tachycardia, Urine analysis normal, White blood cell count increased
Clinical narrative: I experienced numbness and tingling in left arm post injection about 10 minutes after.  About 20 minutes post injection I began to develop tightness in chest, hoarseness in voice, dizziness and weakness.  I then took myself into emergency department.  Arrived at ER at about 11:15am. At this point the tightness in my chest and voice hoarseness had worsened and I had developed a severe headache and neck pain.  I was triaged and immediately taken to a room for IV administration of fluids, Benadryl, Solumedrol, Pepcid.  An EKG was performed and I was found sinus tachycardic.  I was also provided Zofran for my nausea symptoms.  After being monitored for a few hours and my symptoms had improved I was discharged home.  Remaining symptoms were severe headache, neck pain and body weakness.  I was discharged at about 3pm on 11/20/2012.  I returned to ER at about 7:45pm due to return of tightness in chest, hoarseness in voice, increased body weakness and severe head and neck pain as well as neck and upper body stiffness.  An EKG and chest xray were performed as well as a spinal tap.  I was provided IV fluids, Morphine, Zantac, lorazepam, hydromorphone, diazepam and ketorlac.  I was monitored and when symptoms lessened I was discharged home with medications and instructions to return if symptoms worsened.  I was given prescription for Vicodin, Benadryl, prednisone, Zantac.  I was discharged at about 2:00am on 11/21/2012 with medication allergic reaction and possible viral syndrome due to increased WBC.  I returned again to ER on 11/23/2012 at around 10:00am due to increased head and neck pain, body weakness, nausea, fatigue and neck and upper body stiffness.  I was again provided IV fluids, morphine, Valium and Zofran for nausea symptoms.  I was monitored and discharged home with diagnosis of post medication allergic reaction, and spinal headaches. I was provided prescription for Fioricet and Valium and instructed to follow up with primary doctor and return if worsened symptoms.  Follow up with my primary was performed on 11/28/2012.  I am still experiencing the severe head pain, minor neck pain and over fatigue and malaise.
Age: 26.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Injection site erythema, Injection site rash, Injection site swelling, Rash erythematous
Clinical narrative: Horrible rash where the shot was given, red and elevated from the skin, three mosquito bite like dots inside the round rash. Mosquito bite like dots all over my back, neck and ears. My body feels very weak.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea, Vomiting
Clinical narrative: NAUSEA AND VOMITING APROX. 4 HOURS AFTER VACCINATION THAT LASTED THROUGH THE NIGHT. FULL RECOVERY MADE IN 24 HOURS. PROMETHAZINE ADMINISTERED.
Age: 55.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Blood test, Musculoskeletal pain, Pain in extremity
Clinical narrative: I started having pain in my hips, shoulders, hands and feet within a week to 10 days, maybe sooner. I thought it was due to a particular task I was doing at work, but after leaving the job, the pain continued, eventually leading to ER visits & admission.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Decreased appetite, Diarrhoea, Dysgeusia, Nausea, Oedema peripheral
Clinical narrative: This case was received from the health authority on 23-Nov-2012. GB-MHRA-ADR 21922474. This case is not medically confirmed. The primary reporter is a consumer. A 44-year-old female patient received an injection of pneumococcal polysaccharide vaccine (manufacturer unknown; batch no, route, dose and site of administration not reported) on 03-Nov-2012. One day post vaccination, on 04-Nov-2012, she presented with diarrhoea, high temperature, nausea, swelling arm, metallic taste in mouth and weight loss. On an unreported date she also experienced appetite loss and painful arm. The patient's medical history included hypothyroidism and rheumatoid arthritis. Concomitant medications included methotrexate and thyroxine sodium. The patient recovered from diarrhoea, nausea and metallic taste on 06-Nov-2012. The duration was reported as 2 days but the recovery time was reported as 3 days for these reactions. She recovered from high temperature on 07-Nov-2012. The reaction duration was reported as 3 days but the recovery time was reported as 4 days. She recovered from weight loss on 08-Nov-2012. The reaction duration was reported as 4 days but the recovery time was reported as 5 days. On an unreported date, the patient recovered from appetite loss. At the time of reporting she had not recovered from painful arm and swelling arm. The reporter stated that the pneumococcal vaccine was recommended by a rheumatologist. The agency considered this case to be serious as an other medically important condition.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Pyrexia, Weight decreased
Clinical narrative: This case was received from the health authority on 23-Nov-2012. GB-MHRA-ADR 21922474. This case is not medically confirmed. The primary reporter is a consumer. A 44-year-old female patient received an injection of pneumococcal polysaccharide vaccine (manufacturer unknown; batch no, route, dose and site of administration not reported) on 03-Nov-2012. One day post vaccination, on 04-Nov-2012, she presented with diarrhoea, high temperature, nausea, swelling arm, metallic taste in mouth and weight loss. On an unreported date she also experienced appetite loss and painful arm. The patient's medical history included hypothyroidism and rheumatoid arthritis. Concomitant medications included methotrexate and thyroxine sodium. The patient recovered from diarrhoea, nausea and metallic taste on 06-Nov-2012. The duration was reported as 2 days but the recovery time was reported as 3 days for these reactions. She recovered from high temperature on 07-Nov-2012. The reaction duration was reported as 3 days but the recovery time was reported as 4 days. She recovered from weight loss on 08-Nov-2012. The reaction duration was reported as 4 days but the recovery time was reported as 5 days. On an unreported date, the patient recovered from appetite loss. At the time of reporting she had not recovered from painful arm and swelling arm. The reporter stated that the pneumococcal vaccine was recommended by a rheumatologist. The agency considered this case to be serious as an other medically important condition.
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Initial report was received from a consumer, who was also the patient's husband, on 20 November 2012. A female patient (age and date of birth not reported) had received an intramuscular injection in the left upper arm near shoulder area of FLUZONE HIGH-DOSE, lot number U4498BA, on 21 October 2012. The next day, on 22 October 2012, the patient's left arm and shoulder was very painful and had limited motion resulting from the injection. A physician referred the patient to a rehabilitation group for treatment. The symptoms persisted at the time of the report and the patient continued to receive physical therapy. The outcome was not recovered (also reported as unknown). Documents held by sender: None.
Age: 21.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Chest discomfort, Dyspnoea, Electrocardiogram abnormal, Troponin normal
Clinical narrative: This study case was received from the investigator on 21 November 2012. A 21-year-old female subject, with no relevant past medical history, had received the following vaccinations on 08 November 2012: ACAM2000 (lot number and route not reported) in the right arm and anthrax vaccine (manufacturer, lot number, route and site not reported). Four days post-vaccination on 12 November 2012, the subject experienced pleuritic chest pressure and shortness of breath. The symptoms were not exacerbated by exercise and the subject was otherwise asymptomatic. On 21 November 2012, the subject's rapid troponin was negative and ECG was abnormal. Symptoms resolved eight days after onset on 20 November 2012. No further information was available at the time of the report. The subject's outcome was recovered. Per the Investigator, this represents a case of potential myopericarditis and was referred to the study's adjudication committee for assessment. Documents held by sender: None.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Local swelling, Oedema peripheral, Pain
Clinical narrative: Pain, localized swelling, boggy edema adjacent to elbow.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site swelling, Oedema peripheral, Pain, Skin warm
Clinical narrative: Swelling at injection site as well as entire arm down to fingers, red, warmth, pain, body aches.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Hives.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Malaise
Clinical narrative: The patient is a 60 year old female who presents for redness swelling and pain involving the left upper arm at site of Pneumovax pt received yesterday.  It has been persistent and present for 1 day.  Additional Comments: pt has fever to 101. Pt also started Augmentin last night for treatment of persistent sinusitis. Despite being on Augmentin she still developed fever, redness swelling, chills. Patient states that when she was sleeping last night her arm was  painful and woke her up from sleep.  When she woke up this morning the arm was swollen but not red. Since then redness has developed and has been extending out  from the site of the Pneumovax injection.  She feels ill and she is having chills.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Middle insomnia, Oedema peripheral, Pain in extremity, Pyrexia
Clinical narrative: The patient is a 60 year old female who presents for redness swelling and pain involving the left upper arm at site of Pneumovax pt received yesterday.  It has been persistent and present for 1 day.  Additional Comments: pt has fever to 101. Pt also started Augmentin last night for treatment of persistent sinusitis. Despite being on Augmentin she still developed fever, redness swelling, chills. Patient states that when she was sleeping last night her arm was  painful and woke her up from sleep.  When she woke up this morning the arm was swollen but not red. Since then redness has developed and has been extending out  from the site of the Pneumovax injection.  She feels ill and she is having chills.
Age: 33.0
Sex: F
Vaccine: HEP, HEPA, MNQ, TYP, YF
Symptoms: Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Pt reports nausea, vomiting, fever and aches.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Abasia, Ataxia, Balance disorder, Condition aggravated, Coordination abnormal
Clinical narrative: Patient became increasingly lethargic, sleeping excessively, having poor balance and coordination/increased ataxic gait and refused to walk starting on 8/16/2012.  On 8/28/12 patient was hospitalized for the complete inability to walk or bear weight.  Partial ability returned in a few days but full ability did not come back for three additional weeks.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Gait disturbance, Hypersomnia, Laboratory test normal, Lethargy, Nuclear magnetic resonance imaging spinal cord normal
Clinical narrative: Patient became increasingly lethargic, sleeping excessively, having poor balance and coordination/increased ataxic gait and refused to walk starting on 8/16/2012.  On 8/28/12 patient was hospitalized for the complete inability to walk or bear weight.  Partial ability returned in a few days but full ability did not come back for three additional weeks.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Weight bearing difficulty
Clinical narrative: Patient became increasingly lethargic, sleeping excessively, having poor balance and coordination/increased ataxic gait and refused to walk starting on 8/16/2012.  On 8/28/12 patient was hospitalized for the complete inability to walk or bear weight.  Partial ability returned in a few days but full ability did not come back for three additional weeks.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphonia, Dyspnoea, Stridor, Throat irritation
Clinical narrative: Voice changes, scratchy throat, difficulty in breathing, stridor.
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Malaise, Nausea, Pyrexia, Vomiting
Clinical narrative: Nausea, vomiting, fever, chills lasting 36 hours, malaise lasting 4 days.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Sharp/Shooting Pain down arm, Constant Dull Ache.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Nausea
Clinical narrative: Our policy states to keep the child for the first Gardasil injection for 20 minutes to monitor, this was his second injection and he had no adverse reaction the first time. However after leaving, mom called and said he was nauseous, and felt faint. He had not eaten, and she was going to get him fed.
Age: 0.08
Sex: F
Vaccine: DTAP
Symptoms: No adverse event
Clinical narrative: No signs/symptoms.
Age: 77.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Asthenia, Blood test normal, Dysstasia, Electrocardiogram normal, Fatigue
Clinical narrative: The patient stated he was fine after the shot and went home.  Soon after he was home he became "extremely tired" and "had a hard time getting up from his chair".  He went to the ER and was evaluated with blood work, EKG, and urine analysis that all returned negative, according to the patient.  The patient stated he "was given steroids and IV fluids" and was hospitalized overnight and released the next day with the no specific diagnosis except" reaction to the vaccines".  He had to be catherterized and wife claims he was "paralyzed". He was released fully able to walk, talk, swallow, and eat.  He admits to a "decrease in stamina". He is able to continue with his work.
Age: 77.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Urine analysis normal, Vaccination complication
Clinical narrative: The patient stated he was fine after the shot and went home.  Soon after he was home he became "extremely tired" and "had a hard time getting up from his chair".  He went to the ER and was evaluated with blood work, EKG, and urine analysis that all returned negative, according to the patient.  The patient stated he "was given steroids and IV fluids" and was hospitalized overnight and released the next day with the no specific diagnosis except" reaction to the vaccines".  He had to be catherterized and wife claims he was "paralyzed". He was released fully able to walk, talk, swallow, and eat.  He admits to a "decrease in stamina". He is able to continue with his work.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Skin warm, Tenderness
Clinical narrative: Pt reported waking up with R arm swollen, when came into office, arm was 2-3 x it's usual size. Red, tender to touch. Hot. When f/u on pt on 10/22/2012, pt reported that her arm was still pretty tender but the swelling is down. "Not worried about it now."
Age: 45.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Infection, Oedema peripheral, Skin warm, Vaccination complication
Clinical narrative: "Reaction to her injection at yesterday's office visit. Her arm is swollen 3x it's size and is red and hot."
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Skin warm, Urticaria
Clinical narrative: Red welt, hot to touch and itched.
Age: 1.98
Sex: M
Vaccine: HEPA
Symptoms: Feeling hot, Pyrexia, Vomiting projectile
Clinical narrative: Patient felt warm/fever-like (parents did not take his temp), projectile vomiting, parent reports these symptoms lasted 24 hours.
Age: 1.97
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Vomited 3 times over the course of 45 minutes.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Chest X-ray, Chills, Cough, Fatigue, Full blood count
Clinical narrative: Fever, malaise, chills, muscle aches, extreme fatigue, cough, hives, generalized body edema, airway tightness, facial swelling.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Generalised oedema, Influenza, Malaise, Myalgia, Pertussis
Clinical narrative: Fever, malaise, chills, muscle aches, extreme fatigue, cough, hives, generalized body edema, airway tightness, facial swelling.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Respiratory disorder, Swelling face, Urticaria
Clinical narrative: Fever, malaise, chills, muscle aches, extreme fatigue, cough, hives, generalized body edema, airway tightness, facial swelling.
Age: 77.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Feeling abnormal, Inflammation, Injected limb mobility decreased, Musculoskeletal stiffness, Pain
Clinical narrative: Extreme pain, swelling and stiffness.  Unable to move right arm after given Pneumovax vaccine. Felt as though "something was biting her" and might have hit a nerve. Went to her physician and was given a prescription for Percocet. Advised to ice the area and take ibuprofen 600 mg every 6 hours to help with swelling and inflammation.
Age: 77.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Swelling
Clinical narrative: Extreme pain, swelling and stiffness.  Unable to move right arm after given Pneumovax vaccine. Felt as though "something was biting her" and might have hit a nerve. Went to her physician and was given a prescription for Percocet. Advised to ice the area and take ibuprofen 600 mg every 6 hours to help with swelling and inflammation.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Cough, Dyspnoea, Heart rate increased, Wheezing
Clinical narrative: Coughing, rapid heart beat about 180, temp approx 99+, wheezing, difficulty breathing.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Pt called back and complained of soreness in the arm. Was advised to apply ice to reduce swelling from occuring and to take an anti-inflammatory if able to.
Age: 53.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Right upper arm became red and swollen.  Abx given by dr...that's all I know...reported through our internal ADR/med error reporting system.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Redness, swelling, hardness to Left arn at injection site.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Swollen right arm and itchiness.
Age: 33.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Acne, Body temperature increased, Generalised erythema, Pruritus generalised
Clinical narrative: PINK/RAISED/ITCHY, PIMPLE-LIKE AREAS ON SCALP, FACE, ARMS, LEGS, AND TORSO BEGAN ON 11-28-2012 THROUGH 11-30-2012. FOLLOWED UP WITH PRIVATE CLINIC ON 11-29-2012 WITH TEMPERTURE 100.4, WAS ISSUED TOPICAL STEROID CREAM.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Allergy test positive, Asthma, Blood test normal, Bronchospasm, Chest X-ray normal
Clinical narrative: This case was reported by a pharmacist and described the occurrence of asthmatic reaction in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subject received dose of FLUARIX (details unknown). At an unspecified time after vaccination with FLUARIX, the subject experienced asthmatic reaction. At the time of reporting the outcome of the event was unspecified. The pharmacist considered the event was possibly related to vaccination with FLUARIX. The pharmacist reported two subjects had asthmatic reactions to FLUARIX vaccinations (see case id A0999318A for details on the other subject). He did not have any further information. Follow up received from a nurse on 20 November 2012. Concurrent medical conditions included asthma, latex allergy, non smoker and non-drinker. Historic vaccination included seasonal influenza vaccine (non-gsk); non-GSK manufacturer; unknown; unknown given on 10 November 2010 and 8 November 2011 with "no reactions". On 24 October 2012, the subject received a dose of FLUARIX. The nurse reported a 43 year old female subject who experienced asthmatic reaction and bronchospasm less than a day after receiving a dose of FLUARIX (unknown details) on 24 October 2012 and was diagnosed with allergic reaction. The reporter stated that the adverse events had improved (date unknown). The reporter named the suspect product was FLUARIX and believed the event to be serious in nature due to the events being clinically significant or requiring intervention. Relevant diagnostic test results were on 24 October 2012: chest x-ray normal and complete CBC normal. On 26 October 2012, the subject had a blood test for reactivity to latex and eggs which was negative. The subject had a reactive skin test for latex allergy on an unknown date. The reporter indicated that the events could have been associated with the subject's medical history/ concurrent illness of asthma and latex allergy. The subject had received flu shots in the past. The immunization series was not discontinued or delayed.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, Full blood count normal, Hypersensitivity, Metabolic function test normal, Skin test positive
Clinical narrative: This case was reported by a pharmacist and described the occurrence of asthmatic reaction in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subject received dose of FLUARIX (details unknown). At an unspecified time after vaccination with FLUARIX, the subject experienced asthmatic reaction. At the time of reporting the outcome of the event was unspecified. The pharmacist considered the event was possibly related to vaccination with FLUARIX. The pharmacist reported two subjects had asthmatic reactions to FLUARIX vaccinations (see case id A0999318A for details on the other subject). He did not have any further information. Follow up received from a nurse on 20 November 2012. Concurrent medical conditions included asthma, latex allergy, non smoker and non-drinker. Historic vaccination included seasonal influenza vaccine (non-gsk); non-GSK manufacturer; unknown; unknown given on 10 November 2010 and 8 November 2011 with "no reactions". On 24 October 2012, the subject received a dose of FLUARIX. The nurse reported a 43 year old female subject who experienced asthmatic reaction and bronchospasm less than a day after receiving a dose of FLUARIX (unknown details) on 24 October 2012 and was diagnosed with allergic reaction. The reporter stated that the adverse events had improved (date unknown). The reporter named the suspect product was FLUARIX and believed the event to be serious in nature due to the events being clinically significant or requiring intervention. Relevant diagnostic test results were on 24 October 2012: chest x-ray normal and complete CBC normal. On 26 October 2012, the subject had a blood test for reactivity to latex and eggs which was negative. The subject had a reactive skin test for latex allergy on an unknown date. The reporter indicated that the events could have been associated with the subject's medical history/ concurrent illness of asthma and latex allergy. The subject had received flu shots in the past. The immunization series was not discontinued or delayed.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: INTRAFLU - I received the flu intradermal shot and later that evening the site started to itch. There was pain and swelling. The area around the shot site was bright red and itchy as well as hard to the touch. It was also very warm. It is now Nov. 30th and it has not resolved. I did see the doctor and he claimed "You are fine."
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site warmth
Clinical narrative: INTRAFLU - I received the flu intradermal shot and later that evening the site started to itch. There was pain and swelling. The area around the shot site was bright red and itchy as well as hard to the touch. It was also very warm. It is now Nov. 30th and it has not resolved. I did see the doctor and he claimed "You are fine."
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect dose administered
Clinical narrative: Patient was mistakenly given high dose flu vaccine instead of regular flu vaccine. State vaccine program was phoned and they contacted CDC. No treatment was needed. Patient was notified.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Pain in extremity, Upper extremity mass
Clinical narrative: She stated that the morning after her shot, she woke up with her arm in severe pain and a lump where the pain was given. The lump has disappeared but she is still complaining of pain and weakness in the right arm.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Feeling very tired and achy all day, around 2:00 PM noticed a low grade fever.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Joint range of motion decreased, X-ray normal
Clinical narrative: Painful at injection site, pain continued for several months until approx. March, 2012.  Shoulder lost much range of motion for approx 6 months.
Age: 52.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Pain at site; progressing within 8 hours to upper arm pain, erythema, edema of posterior and anterior left arm below injection site.
Age: 33.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Activities of daily living impaired, Dizziness, Hypoaesthesia, Injection site urticaria, Malaise
Clinical narrative: I was given PPSV Pneumonia and Flu shot at same time in same arm. No previous reaction to flu shot, first time with PPSV shot. Within one hour dizziness, nausea, tingling and numbness in arm and hand. Next day (11/29) had to stay home from work, very painful to move arm, cannot dress/undress, very limited movement of arm due to pain (even with 800mg ibuprofen) tingling and numbness in arm/hand dissipating. Very pale, dizzy. Day 3 (11/30) woke with similar symptoms and now with welts all around injection site. Still extreme pain in arm, general feeling of sickness feeling like passing out, tingling and numbness in arm/hand returning. Went to facility (11/30) given pain killers and antibiotics, hoping for the best.
Age: 33.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Nausea, Pain, Pain in extremity, Pallor, Paraesthesia
Clinical narrative: I was given PPSV Pneumonia and Flu shot at same time in same arm. No previous reaction to flu shot, first time with PPSV shot. Within one hour dizziness, nausea, tingling and numbness in arm and hand. Next day (11/29) had to stay home from work, very painful to move arm, cannot dress/undress, very limited movement of arm due to pain (even with 800mg ibuprofen) tingling and numbness in arm/hand dissipating. Very pale, dizzy. Day 3 (11/30) woke with similar symptoms and now with welts all around injection site. Still extreme pain in arm, general feeling of sickness feeling like passing out, tingling and numbness in arm/hand returning. Went to facility (11/30) given pain killers and antibiotics, hoping for the best.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Hypoaesthesia, Immediate post-injection reaction, Pallor, Throat tightness
Clinical narrative: Shot given and she felt warm right away. Then throat became tight, became pale and then face ansd neck became numb.
Age: 55.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Arm became red and swollen.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary pain, Back pain, Chest X-ray, Disorientation, Dizziness
Clinical narrative: 24 hours after injection developed pain in back that spread to L arm, under arm and down Left arm. Numbness in Left habd for 5 mins on 2 nites. Had dizziness and disorientation 2 days after injection. Still having pain in arm.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Electrocardiogram, Electromyogram, Hypoaesthesia, Pain in extremity
Clinical narrative: 24 hours after injection developed pain in back that spread to L arm, under arm and down Left arm. Numbness in Left habd for 5 mins on 2 nites. Had dizziness and disorientation 2 days after injection. Still having pain in arm.
Age: 4.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Fever above 102, increasing soreness at injection site.
Age: 56.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site pain, Pain, Pain in extremity
Clinical narrative: Unable to move right arm due to shooting pain from shoulder to wrist - I believe the injection hit a tendon or nerve in upper right shoulder... am having severe pain upon any attempt to move my arm. Will seek physician advice on Monday 12/3/2012.
Age: 11.0
Sex: M
Vaccine: MMR
Symptoms: Loss of consciousness
Clinical narrative: Patient got up immediately following the vaccination and then passed out in the hallway. He was easily revived and seemed okay.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Haemorrhage, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Excessive bleeding after shot given. Redness, swelling, itching, warm to touch at injection site a couple of days after shot given.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Lymphadenopathy
Clinical narrative: Site became very swollen, red, hot, throbbing.  Swollen lymph node in armpit on same side of injection.  Next day rash was larger (over 5 in. diameter).  By 11/30, rash was covering entire upper arm and shoulder, but center was less hot and throbbing.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash
Clinical narrative: Site became very swollen, red, hot, throbbing.  Swollen lymph node in armpit on same side of injection.  Next day rash was larger (over 5 in. diameter).  By 11/30, rash was covering entire upper arm and shoulder, but center was less hot and throbbing.
Age: 0.39
Sex: F
Vaccine: DTAPIPV, HIBV, PNC13, RV1
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: Patient came into clinic to update vaccines. Vaccine reviewed by RN and she gave verbal order to give, not realizing that it was Kinrix and thought it was Pediarix on injection tray. RN reviewed vaccines that were prepared by MA prior to vaccinating patient and gave authorization to vaccinate patient. MA immediately went to patients exam room and administered Kinrix. Patient left clinic with father. MA went to input data in CAIR and realized that Kinrix was not supposed to be given to children under 4 years of age. Informed RN of this immediately. RN spoke to pediatric nurse, and called public health nurse for information.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dyspnoea, Eye discharge, Eye irritation, Eye swelling
Clinical narrative: 4 hours after injection started coughing, felt tickle in throat, 1/2 hr. later eyes irritated, then eyes swollen & "oozing", 830 diff. breathing "swollen throat" - took family members inhaler - symptoms resolved.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Pharyngeal oedema, Throat irritation
Clinical narrative: 4 hours after injection started coughing, felt tickle in throat, 1/2 hr. later eyes irritated, then eyes swollen & "oozing", 830 diff. breathing "swollen throat" - took family members inhaler - symptoms resolved.
Age: 17.0
Sex: M
Vaccine: FLU3, HPV4, MNQ
Symptoms: Musculoskeletal stiffness, Pallor, Syncope
Clinical narrative: Within seconds of administering (GARDASIL) vaccine pt. fainted & stiffened and was laid back on table with feet elevated. He was responsive within a few seconds and able to answer questions, but appeared pale. He was given something to drink and blood pressure was taken twice (pt. was alert and oriented upon leaving office).
Age: 1.3
Sex: F
Vaccine: FLU3, MMRV
Symptoms: Rash
Clinical narrative: Rash.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: Pt. with red, warm, indurated pruritic area at injection site.
Age: 3.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Pt had KINRIX imm (L) deltoid on Wednesday yest. Today has large 3x3 inch localized red and warm area on inner aspect of (L) deltoid region.
Age: 20.0
Sex: M
Vaccine: UNK
Symptoms: Dermatitis acneiform, Rash, Rash maculo-papular, Skin lesion
Clinical narrative: Maculopapular / acneiform eruption at trunk, back and arms numbering approx 20 lesions.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Auricular swelling, Differential white blood cell count, Erythema, Full blood count, Rash maculo-papular
Clinical narrative: Macular papular erythema with swelling to face and left/right ears.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Streptococcus test negative, Swelling face
Clinical narrative: Macular papular erythema with swelling to face and left/right ears.
Age: 1.45
Sex: F
Vaccine: FLU3, MMR, VARCEL
Symptoms: Febrile convulsion, Urine analysis normal
Clinical narrative: Febrile seizures 6 days after having vaccines. Seen at hospital given MOTRIN in ER & urine checked, urine normal temp controlled with MOTRIN & TYLENOL.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Dry eye, Ocular hyperaemia, Pain
Clinical narrative: Eyes dried out, became very red for full 48 hours. Pain all over body severe pain, took MOTRIN, had minimal relief.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Movement disorder, Muscle tightness, Swelling face
Clinical narrative: Got shot: face swelled up, joint pain moderate, muscle tight, could hardly move. MOTRIN helped. Lasted 27 hours and went back to normal.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Crying, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Musculoskeletal pain
Clinical narrative: 10/14/2011 Flu shot injection into right shoulder. 10/14/11 to 10/28/11 Right shoulder pain increasingly severe, to point of tears. 10/28/11 Phone call to Dr. with complaint of severe right shoulder pain. 11/10/11 Another call to Dr. with same complaint. I was prescribed Prednisone 5 mg/day for 6 days. 11/11/11 Call to Dr.'s office - pain gone. 11/17/11 Call to Dr. - right shoulder pain is back. Dr prescribed 2nd round on Prednisone, 5 mg/day for 6 days, and physical therapy. 11/23/11 and 11/25/11 PT - pain so intense I could not continue PT. Pain continues, severity varies. 3/5/12 Office visit to Dr. - right shoulder pain has been tolerable, but continuous. She suggested appt with sports orthopedic doctor. 3/30/12 Office visit with Dr. Received steroid injection. Pain relieved for a few weeks, but returns. Enough pain to make another appt with Dr. 10/5/12 Office visit to Dr. - X-ray, suggested MRI. 10/15/12 MRI. 10/19/12 Office visit with Dr. - MRI indicated nerve impingement in right shoulder. Steroid injection given and physical therapy recommended. NOTE: The flu shot was administered at the point of my right shoulder. During the flu shot injection administration, I stated loudly "It feels like you went right in my joint". The injection hurt! She responded by saying "I'm supposed to give it to you that high". After the injection, the pain escalated to the point it was severe enough to make me cry and I could not lift my arm, or sleep on my right shoulder. After a year, I still cannot reach backwards without pain and cannot sleep on my right shoulder without pain waking me.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging abnormal, Rotator cuff syndrome, X-ray
Clinical narrative: 10/14/2011 Flu shot injection into right shoulder. 10/14/11 to 10/28/11 Right shoulder pain increasingly severe, to point of tears. 10/28/11 Phone call to Dr. with complaint of severe right shoulder pain. 11/10/11 Another call to Dr. with same complaint. I was prescribed Prednisone 5 mg/day for 6 days. 11/11/11 Call to Dr.'s office - pain gone. 11/17/11 Call to Dr. - right shoulder pain is back. Dr prescribed 2nd round on Prednisone, 5 mg/day for 6 days, and physical therapy. 11/23/11 and 11/25/11 PT - pain so intense I could not continue PT. Pain continues, severity varies. 3/5/12 Office visit to Dr. - right shoulder pain has been tolerable, but continuous. She suggested appt with sports orthopedic doctor. 3/30/12 Office visit with Dr. Received steroid injection. Pain relieved for a few weeks, but returns. Enough pain to make another appt with Dr. 10/5/12 Office visit to Dr. - X-ray, suggested MRI. 10/15/12 MRI. 10/19/12 Office visit with Dr. - MRI indicated nerve impingement in right shoulder. Steroid injection given and physical therapy recommended. NOTE: The flu shot was administered at the point of my right shoulder. During the flu shot injection administration, I stated loudly "It feels like you went right in my joint". The injection hurt! She responded by saying "I'm supposed to give it to you that high". After the injection, the pain escalated to the point it was severe enough to make me cry and I could not lift my arm, or sleep on my right shoulder. After a year, I still cannot reach backwards without pain and cannot sleep on my right shoulder without pain waking me.
Age: 49.0
Sex: F
Vaccine: MMR
Symptoms: Dizziness, Immediate post-injection reaction, Oedema peripheral, Palpitations, Paraesthesia oral
Clinical narrative: Immediate swelling of face, arms, chest, rash, heart racing, tongue tingling, dizzy.
Age: 49.0
Sex: F
Vaccine: MMR
Symptoms: Rash, Swelling, Swelling face
Clinical narrative: Immediate swelling of face, arms, chest, rash, heart racing, tongue tingling, dizzy.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Injection site joint pain
Clinical narrative: Extreme left shoulder joint pain, went to ER 10/25/12 3:00 pm pain unbearable. Given ULTRAM, and NAPROSYN. Sling for left arm. Continued left shoulder pain 11/7 Dr gave Rx for more ULTRAM and NAPROSYN if pain persist appt. with orthopedics.
Age: 17.0
Sex: M
Vaccine: FLUN3, HPV4
Symptoms: Vomiting
Clinical narrative: Patient had finger stick to check lipids then received GARDASIL injection in (L) arm. Physician walked back in room to find patient vomiting in garbage can. He said he was fine within 10 min back to normal. Vitals at beginning visit 125/72 Pulse 61. Vitals post event 118/71 P 60 O2 97%.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Rash erythematous
Clinical narrative: Began itching lower legs (below knees) with raised red bumps. Legs (below knees) also red. Pt. continues to have sxs. Seen by MD 11-6-12 given SINGULAIR & LOTRISONE Cr. Itching more at night. Better since using meds. Pt states had some sxs after last years flu vaccine. Pt could not remember where he got his flu shot at last year.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Abdominal pain upper, Body temperature increased, Diarrhoea, Feeling hot
Clinical narrative: Last night 11/29/12 client began to experience diarrhea, elevated temperature (not taken but mother reports "he felt really hot") and that his "tummy hurt". The symptoms began approximately 6:00 p.m. He was completely recovered by morning. Hospital was called. Hospital staff encouraged to continue to monitor and call if worsens.
Age: 1.07
Sex: F
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Rash macular, Rash papular
Clinical narrative: Macular, papular rash - trunk, face, arms, upper legs.
Age: 40.0
Sex: F
Vaccine: TTOX
Symptoms: Musculoskeletal pain
Clinical narrative: Increasing pain in shoulder - feels like under bones in the night it worsens; was given VOLTAREN, used x 4 weeks - no improvement; will request MRI at upcoming MD appt.
Age: 14.0
Sex: F
Vaccine: FLU3, HEPA, HPV4
Symptoms: Blood glucose normal, Convulsion, Dizziness postural, Musculoskeletal stiffness, Tonic clonic movements
Clinical narrative: Approx 4-5 min post vaccine administration, pt became dizzy while standing; mother assisted her to chair, body stiffened. Pt observed to have symmetric tonic-clonic movement of arms / legs for approx 10 sec. with loc seizure activity observed by ARNP.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site warmth, Malaise, Myalgia
Clinical narrative: 11-27-12 AM Muscle aches fatigue sick feeling redness at injection site. 11-28-12 redness at injection site enlarging 3 1/2 mm deep red 7 mm lite red warm to touch. Treatment: 11-28-12 CEFDINIR 300 mg BID x 7 D.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Fatigue, Injection site swelling, Injection site warmth, Malaise
Clinical narrative: 11-27-12 AM Muscle aches fatigue sick feeling redness at injection site. 11-28-12 redness at injection site enlarging 3 1/2 mm deep red 7 mm lite red warm to touch. Treatment: 11-28-12 CEFDINIR 300 mg BID x 7 D.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain
Clinical narrative: 11-27-12 AM Muscle aches fatigue sick feeling redness at injection site. 11-28-12 redness at injection site enlarging 3 1/2 mm deep red 7 mm lite red warm to touch. Treatment: 11-28-12 CEFDINIR 300 mg BID x 7 D.
Age: 23.0
Sex: M
Vaccine: UNK, FLU3, PPV
Symptoms: Decreased appetite, Injection site cellulitis
Clinical narrative: Injection site cellulitis - (R) arm loss of appetite,
Age: 23.0
Sex: M
Vaccine: UNK, FLU3, PPV
Symptoms: Cellulitis, Injection site reaction, Local reaction
Clinical narrative: Injection site cellulitis - (R) arm loss of appetite,
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Migraine
Clinical narrative: Headache (migraine-like) post shingles vaccination undergoing treatment by physician for headache since 7/2012.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Left arm pain from shoulder to hand. From 11/9 -> present 11/30/12.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Erythema, Skin warm
Clinical narrative: Mom called states red, warm to touch describes as mosquito bite maybe a little larger per PA. Pt to apply cool compress Q20min specifically daily & TYLENOL/Ibu PRN.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient says that the pharmacist poked a bone in arm and requires physical therapy. She is been complaining of arm pain ever since.
Age: 1.34
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: (R) leg received VZV SC. Pt. parents present nickel sized red raised area over injection site with 3 small vesicles appearing to be chicken pox.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Very sore arm for > 4 days.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous
Clinical narrative: Red bumps appeared on patient's chest, back, neck and ears on 11/29/12. Patient has had flu vaccines in the past without any problems.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Burning sensation, Rash erythematous, Rash generalised, Rash pruritic, Urticaria
Clinical narrative: Patient broke out with red bumps all over. They were itching and burning. They looked like hives. Patient's symptoms lasted about a week and a half. Patient was treated with ATARAX 25mg, CLARITIN 10 mg and was sent home with Epi Pen Jr.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Decreased appetite, Fatigue, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to a 17 year old female patient. The patient did not have any pertinent medical history or drug reactions/allergy. On 15-OCT-2012, the patient was vaccinated with a first dose of 0.5 ml (milliliters) GARDASIL, (lot number H010124, expiration date 16-JAN-2015, route- intramuscular on right arm). Other suspect therapies included VARIVAX (Merck) and MENACTRA on 15-OCT-2012. The patient did not take any concomitant medications. On 16-OCT-2012, the patient experienced injection site reaction, nausea, fatigue, anorexia. The site of GARDASIL administration was red, hot and painful and was getting bigger. There were no laboratory diagnostics performed. Treatment rendered for the events were unspecified. The outcome of the events were reported as not recovered at the time of this report. The patient sought medical attention (office visit). Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Nausea
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to a 17 year old female patient. The patient did not have any pertinent medical history or drug reactions/allergy. On 15-OCT-2012, the patient was vaccinated with a first dose of 0.5 ml (milliliters) GARDASIL, (lot number H010124, expiration date 16-JAN-2015, route- intramuscular on right arm). Other suspect therapies included VARIVAX (Merck) and MENACTRA on 15-OCT-2012. The patient did not take any concomitant medications. On 16-OCT-2012, the patient experienced injection site reaction, nausea, fatigue, anorexia. The site of GARDASIL administration was red, hot and painful and was getting bigger. There were no laboratory diagnostics performed. Treatment rendered for the events were unspecified. The outcome of the events were reported as not recovered at the time of this report. The patient sought medical attention (office visit). Additional information has been requested.
Age: 18.0
Sex: U
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 18 years old patient. The patient was vaccinated with GARDASIL (lot # (666595/0992Z), expiration date was 14-OCT-2012, route and dose were unknown) on 26-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. On 26-NOV-2012 the patient received a dose of GARDASIL that expired 14-OCT-2012. No adverse effect had been observed or reported. No treatment information was reported. At the report time the outcome of the event was unknown. It was unknown if the patient sought medical attention. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 09-OCT-2012 04:13, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not provided. Two lot # were involved and the lot # were reported as: 0294AE, expiry date on 06-SEP-2014; and 0395AE, expiry date on 08-NOV-2014. It was unspecified which lot # the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 09-OCt-2012 01:31, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# the patient as administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 08-OCT-2012 17:43, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.