chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Cough, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Chills, fever, nauseous, headache, coughing, body aches.  Red swollen spot where pneumonia vaccine was given size of a small plate.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Chills, fever, nauseous, headache, coughing, body aches.  Red swollen spot where pneumonia vaccine was given size of a small plate.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: After 2 weeks arm is still sore and having difficulty lifting anything over 5lbs with the left arm.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Injection site erythema, Injection site warmth
Clinical narrative: Pt reported redness and heat around injection site, did not treat, upset stomach as well.
Age: 26.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Injection site reaction, Injection site urticaria, Paraesthesia, Paraesthesia oral, Urticaria
Clinical narrative: Tingling lips, left arm and hand, welts/hives at site of injection (left arm). Patient took Benadryl.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect storage of drug
Clinical narrative: Vaccine was not refrigerated....was sitting on the dirt in a cardboard box.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Dry mouth, Erythema, Heart rate increased, Hypopnoea
Clinical narrative: Hives, Increased Blood Pressure, Increased pulse, Rapid/Shallow Breathing, Dry Mouth, Red & Blotchy Skin.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Rash macular, Respiratory rate increased, Urticaria
Clinical narrative: Hives, Increased Blood Pressure, Increased pulse, Rapid/Shallow Breathing, Dry Mouth, Red & Blotchy Skin.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient came to pharmacy to report/show a red, warm, and tender circle approx, 2 inches in diameter.  Area was located several inches below actual injection site.  We recommended that she seek further attention at her doctor's office/urgent for a second opinion and antibiotics (if deemed necessary).
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Contusion, Local swelling
Clinical narrative: Patient has upper arm swelling and bruising which spread from upper arm to forearm. Patient was instructed by ER staff (by telephone) to ice the area and take Benadryl. Symptoms better at time of reporting to pharmacy.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: NUMBNESS & TINGLING IN ARM.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Upper torso and extremities rash.
Age: 1.06
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Decreased appetite, Erythema, Local swelling, Parotitis, Platelet count decreased
Clinical narrative: 10 days after MMR Fever 102 and decreased appetite, red face and rash on trunk. And evolved to rash of the hands and feet, with swelling of the hands and feet. Fever lasted 2 days Today (9/29/14) patient presents with swollen left jaw. Consistent with parotitis. (Parotitis started 15 days post vaccine). rash has improved
Age: 1.06
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash, Swelling face
Clinical narrative: 10 days after MMR Fever 102 and decreased appetite, red face and rash on trunk. And evolved to rash of the hands and feet, with swelling of the hands and feet. Fever lasted 2 days Today (9/29/14) patient presents with swollen left jaw. Consistent with parotitis. (Parotitis started 15 days post vaccine). rash has improved
Age: 67.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Mobility decreased, Myalgia
Clinical narrative: Extreme muscle pain down to the wrist with eventual non mobility of my arm. Symptoms still exist over a week later but have improved about 95%. I have not sought treatment due to improvement.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: SITE OF INJECTION APPROXIMATELY THE SIZE OF A FIST BECAME RED AND WARM TO TOUCH BY 2ND DAY AFTER INJ. PT SAID FIRST DAY AFTER SHOT SMALL REDNESS AT SITE. WORSE ON 2ND DAY AFTER AND LASTED FOR APPROXIMATELY 1 WEEK.
Age: 74.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site erythema, Injection site swelling, Injection site warmth, Insomnia
Clinical narrative: Low fever, chills, body aches to the extent the patient could not sleep.  Also swelling on inside of left elbow (vaccination arm) the size of his hand that was red and hot.
Age: 74.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain, Pyrexia
Clinical narrative: Low fever, chills, body aches to the extent the patient could not sleep.  Also swelling on inside of left elbow (vaccination arm) the size of his hand that was red and hot.
Age: 0.17
Sex: F
Vaccine: DTAP, HEP, HIBV, RVX
Symptoms: Abdominal discomfort, Abdominal pain upper, Diarrhoea, Diet refusal, Vomiting
Clinical narrative: Vomiting, diarrhea, general upset stomach. Refusing bottle, stomach pain. Lasted for 4 to five days. Doctor said said keep a close eye on baby and continue to report any new symptoms or concerns. Recommend not having any more doses of this vaccine.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Blood potassium decreased, Dizziness, Dyspnoea, Nausea, Pyrexia
Clinical narrative: Fever 105F, shaky, light headed, nausea, trouble breathing.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Tremor
Clinical narrative: Fever 105F, shaky, light headed, nausea, trouble breathing.
Age: 3.0
Sex: M
Vaccine: FLUN4
Symptoms: Autopsy, Sudden death
Clinical narrative: Sudden unexplained death during nap; autopsy report pending.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Influenza, Injection site erythema, Injection site swelling, Pain, Pyrexia
Clinical narrative: Pt states the day after the vaccinations she started with fever and bodyaches and flu symptoms. She also had redness and swelling at the site of the Pneumovax on the right deltoid area.
Age: 55.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pain, Pyrexia
Clinical narrative: FEVER; PAIN.
Age: 40.0
Sex: M
Vaccine: FLU4
Symptoms: Pain, Pyrexia
Clinical narrative: FEVER; PAIN.
Age: 67.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Pain, Pyrexia
Clinical narrative: FEVER; PAIN.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Rash generalised, Urticaria
Clinical narrative: She had rashes and hives all over the body for 3 to 4 days. She took some Benadryl and now is all gone.
Age: 52.0
Sex: M
Vaccine: FLU4
Symptoms: Pain, Pyrexia
Clinical narrative: FEVER; PAIN.
Age: 40.0
Sex: M
Vaccine: FLU4, PPV, TDAP
Symptoms: Pain, Pyrexia
Clinical narrative: FEVER; PAIN.
Age: 36.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: FEVER.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood urine present, Dysuria, Headache, Injection site erythema, Injection site pruritus
Clinical narrative: Bad headache, severe nausea, palitations, dysuria and blood on tissue when wiped.  Large red itchy injection site.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Nitrite urine absent, Palpitations, Specific gravity urine normal, Urine leukocyte esterase positive
Clinical narrative: Bad headache, severe nausea, palitations, dysuria and blood on tissue when wiped.  Large red itchy injection site.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Feeling hot, Nausea
Clinical narrative: NAUSEA, WARMNESS, LIGHTHEADEDNESS ALL PRESENTED TO MEDICAL STAFF 2 HOURS LATER. VS 151/75 P 85.
Age: 1.0
Sex: F
Vaccine: FLUX, MMR, VARCEL
Symptoms: Rash generalised
Clinical narrative: Full body rash, including face, trunk, and extremities.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Extreme pain in arm from shoulder to fingers.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Pruritus generalised, Urticaria
Clinical narrative: Full body itching and pain at injection site.  Itching and hives occurred 6 hours after injection of Pneumovax 23. Humira injection was completed Thursday 9-25. Treatment with Benadryl 25mg and Tylenol 1000mg interrupted itching and pain response was diminished.  Doing much better after 20 minutes.
Age: 0.39
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood test normal, Computerised tomogram normal, Purpura, Pyrexia, Rash
Clinical narrative: On the evening of 9/4/2014 at approx 8:30 pm, noticed that my 4 month old daughter felt slightly fevered.  I then gave my daughter some infant tylenol, but she threw up after I gave it to her. Since her pajamas were soiled from her vomit, I went to change her pajamas and noticed what appeared to be a purpura looking rash on her right side lower abdomen.  Concerned, took her to the emergency room.  The emergency room doctor called her rash purpura, and determined she also had a UTI. I informed them that I was concerned she was having a reaction to her vaccinations she had the previous day, but they would not even consider that.  Her symptoms included fever, vomiting and the rash. Hospital admitted her to do some more testing. All labs and tests came back normal. We were not happy with the lack of professional care received at Hospital, so we had her transferred to another Hospital.  She was hospitalized for a total of 6 days and never officially received a diagnosis or explanation of what caused this.  I feel very STRONGLY that this was an adverse affect of one if not all of her vaccines.
Age: 0.39
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Urinary tract infection, Vomiting, X-ray normal, X-ray with contrast
Clinical narrative: On the evening of 9/4/2014 at approx 8:30 pm, noticed that my 4 month old daughter felt slightly fevered.  I then gave my daughter some infant tylenol, but she threw up after I gave it to her. Since her pajamas were soiled from her vomit, I went to change her pajamas and noticed what appeared to be a purpura looking rash on her right side lower abdomen.  Concerned, took her to the emergency room.  The emergency room doctor called her rash purpura, and determined she also had a UTI. I informed them that I was concerned she was having a reaction to her vaccinations she had the previous day, but they would not even consider that.  Her symptoms included fever, vomiting and the rash. Hospital admitted her to do some more testing. All labs and tests came back normal. We were not happy with the lack of professional care received at Hospital, so we had her transferred to another Hospital.  She was hospitalized for a total of 6 days and never officially received a diagnosis or explanation of what caused this.  I feel very STRONGLY that this was an adverse affect of one if not all of her vaccines.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Chills, Injection site discomfort, Injection site erythema, Injection site irritation
Clinical narrative: Chills, felt achy, irritation and discomfort of right deltoid, low grade temperature, redness around injection area.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Pain
Clinical narrative: Chills, felt achy, irritation and discomfort of right deltoid, low grade temperature, redness around injection area.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Swelling face
Clinical narrative: Patient said she had swelling on her left jaw.
Age: 61.0
Sex: M
Vaccine: FLUX
Symptoms: Ageusia, Headache, Myalgia
Clinical narrative: Complete loss of sense of taste; severe muscle soreness; headaches.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Capillary fragility, Contusion, Rash erythematous
Clinical narrative: Started as red bumps that turned rash-like while patient experienced burning and then what appears to be bruising/broken capillaries.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Herpes zoster, Hypersensitivity, Pain of skin, Pyrexia
Clinical narrative: Shortly after her 1 year vaccinations, patient had hive like swelling and redness on her body as well as little red bumps and fever. It was dismissed as an allergic reaction. Now at age 13, she has been diagnosed with shingles. The only chicken pox exposure she has had is from the vaccinations. She had pain on her skin with no visible signs, followed a few days later with a painful blistering rash running along a nerve line.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash erythematous, Rash vesicular, Urticaria
Clinical narrative: Shortly after her 1 year vaccinations, patient had hive like swelling and redness on her body as well as little red bumps and fever. It was dismissed as an allergic reaction. Now at age 13, she has been diagnosed with shingles. The only chicken pox exposure she has had is from the vaccinations. She had pain on her skin with no visible signs, followed a few days later with a painful blistering rash running along a nerve line.
Age: 35.0
Sex: F
Vaccine: HEPAB
Symptoms: Dizziness, Injection site pain, Syncope
Clinical narrative: Pt felt light headed and then fainted however, was still responsive. She was breathing normally during the 1-2 minutes then came to normalization within 5 minutes. She stated the inject hurt and that was it. EMT's showed up and an assessment was complete which from what I could tell came back normal.
Age: 40.0
Sex: F
Vaccine: FLUX
Symptoms: Myalgia, Pyrexia
Clinical narrative: Fever (102) muscle aches.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Chest pain, Muscle spasms, Pain, Pyrexia
Clinical narrative: Patient had body aches and fever of 101.9 on urgent care visit.  He had some leg cramps, body aches and intermittent chest pain.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Depressed level of consciousness, Dizziness, Dysarthria, Hyperhidrosis
Clinical narrative: Patient experienced dizziness, slurred speech, near loss of consciousness, and extreme sweat within five minutes of administration of the vaccine.  Patient lay down and the symptoms faded within another five to ten minutes.  A regular dose of an antihistamine was administered when the symptoms were present.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Hyperhidrosis, Pyrexia, Vomiting
Clinical narrative: The patient reports developing chills, sweating and vomiting with a fever of 103 F.  He self admitted to ER and received ketorolac and APAP which resolved the symptoms.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Bacterial test negative, Blood test normal, Borrelia test negative, Disability
Clinical narrative: This spontaneous report was received from a physician referring to a 17 year old female patient who is also her niece. Pertinent medical history and drug allergies were reported as none. On approximately 10-SEP-2014 (reported as about 2 weeks ago) the patient was vaccinated with GARDASIL dose 1 (dose/ route not reported). Concomitant medication was reported as none. On 10-SEP-2014, 15 minutes after vaccination, the patient experienced nausea, muscle weakness and muscle pain. The physician stated that the patient was only able to do 15 minutes of moderate activity (disability), whereas before vaccination she was healthy and energetic. The physician stated that the patient saw an unspecified physician who treated her with unspecified antibiotics for "strept throat" and there was no improvement in symptoms. The physician stated that the patient had a blood test for mono, Lyme disease and a CBC (complete blood count) which she stated was normal. The reporter indicated that the patient had missed 7 or 8 days of school because of fatigue and pain (disability). The patient sought medical attention. There was no intervention required to prevent seriousness criteria. The event was not life-threatening. There was no hospitalization reported. The outcome of the events was reported as not recovered/not resolved. The causality of the events was unspecified. No PQC reported. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Full blood count normal, Mononucleosis heterophile test negative, Muscular weakness, Myalgia
Clinical narrative: This spontaneous report was received from a physician referring to a 17 year old female patient who is also her niece. Pertinent medical history and drug allergies were reported as none. On approximately 10-SEP-2014 (reported as about 2 weeks ago) the patient was vaccinated with GARDASIL dose 1 (dose/ route not reported). Concomitant medication was reported as none. On 10-SEP-2014, 15 minutes after vaccination, the patient experienced nausea, muscle weakness and muscle pain. The physician stated that the patient was only able to do 15 minutes of moderate activity (disability), whereas before vaccination she was healthy and energetic. The physician stated that the patient saw an unspecified physician who treated her with unspecified antibiotics for "strept throat" and there was no improvement in symptoms. The physician stated that the patient had a blood test for mono, Lyme disease and a CBC (complete blood count) which she stated was normal. The reporter indicated that the patient had missed 7 or 8 days of school because of fatigue and pain (disability). The patient sought medical attention. There was no intervention required to prevent seriousness criteria. The event was not life-threatening. There was no hospitalization reported. The outcome of the events was reported as not recovered/not resolved. The causality of the events was unspecified. No PQC reported. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Pain, Pharyngitis streptococcal
Clinical narrative: This spontaneous report was received from a physician referring to a 17 year old female patient who is also her niece. Pertinent medical history and drug allergies were reported as none. On approximately 10-SEP-2014 (reported as about 2 weeks ago) the patient was vaccinated with GARDASIL dose 1 (dose/ route not reported). Concomitant medication was reported as none. On 10-SEP-2014, 15 minutes after vaccination, the patient experienced nausea, muscle weakness and muscle pain. The physician stated that the patient was only able to do 15 minutes of moderate activity (disability), whereas before vaccination she was healthy and energetic. The physician stated that the patient saw an unspecified physician who treated her with unspecified antibiotics for "strept throat" and there was no improvement in symptoms. The physician stated that the patient had a blood test for mono, Lyme disease and a CBC (complete blood count) which she stated was normal. The reporter indicated that the patient had missed 7 or 8 days of school because of fatigue and pain (disability). The patient sought medical attention. There was no intervention required to prevent seriousness criteria. The event was not life-threatening. There was no hospitalization reported. The outcome of the events was reported as not recovered/not resolved. The causality of the events was unspecified. No PQC reported. Additional information is not expected.
Age: 34.0
Sex: M
Vaccine: HEPAB
Symptoms: Central nervous system inflammation, Hypoaesthesia
Clinical narrative: Pt started to notice numbness in foot 1 to 2 days after vaccination then numbness moved up to waist in 2 days time - pt. went to ER was hospitalized with spinal inflammation.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain
Clinical narrative: Intermittent shoulder pain > 2 weeks post vaccination.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Discomfort, Genital herpes
Clinical narrative: Within a week of receiving shingles vaccination I experienced outbreak of genital herpes that did subside for 10 weeks, despite use of valacyclovir as directed. After outbreak subsided within 3 weeks had new outbreak which again took more than 2 months to clear up. Continuous and weeks long outbreaks continued for 2 years and then began to lessen in frequency and intensity and duration. Because of the location of the herpes blister I was in quite severe discomfort for months at a time. I have never seen this as a reported side effect, but it should be made known to persons considering the vaccine.
Age: 67.0
Sex: F
Vaccine: PPV, FLU3, PPV
Symptoms: Cellulitis, Injection site bruising, Injection site pruritus
Clinical narrative: Patient received PNEUMOVAX in left arm on 9-16-14 on 9-18 patient came back to pharmacy with lots of redness in shoulder extending down to inner elbow. Pt said it itched badly and was very sore. Patient then went to a clinic and received an Rx of cephalexin stating she may have cellulitis. Shoulder was sore the night of shot then by next evening arm was very warm and redness appeared starting to improve.
Age: 67.0
Sex: F
Vaccine: PPV, FLU3, PPV
Symptoms: Erythema, Musculoskeletal pain, Pain in extremity, Pruritus, Skin warm
Clinical narrative: Patient received PNEUMOVAX in left arm on 9-16-14 on 9-18 patient came back to pharmacy with lots of redness in shoulder extending down to inner elbow. Pt said it itched badly and was very sore. Patient then went to a clinic and received an Rx of cephalexin stating she may have cellulitis. Shoulder was sore the night of shot then by next evening arm was very warm and redness appeared starting to improve.
Age: 0.35
Sex: M
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source.  Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful.  Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided.  This report referred to a 6-months old male patient, with no known drug allergies and no illness at time of vaccination. The patient was vaccinated with the second dose of ROTATEQ (oral, batch/lot # J004875, expiration date 17-OCT-2014), on 15-JAN-2014 in the morning. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event also reported as 27-FEB-2014 at 10:00 AM). The parents of the patient never called back and the were going to  consult with physician. No adverse event was reported for the patient. This is one of several reports from the same source.  Additional information is not expected since all follow ups requested to complete the case were received.
Age: 61.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Vomiting
Clinical narrative: Flu shot and ZOSTAVAX given at approximately 9:45 am, about 30 min later patient called and said she threw up when she got back to her house but then felt fine. Upon follow up at 2:15pm pt reported no other problems. Patient was nervous about getting IMZ.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Pt described extreme itchiness in a band under the injection site. She said it was so itchy that not even steroid creams worked on it. It was red and warm to the touch.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect dose administered
Clinical narrative: Child completed 3 doses GARDASIL, last one given 07-24-14 and again yesterday 09-22-14.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Received flu shot on Saturday 9/27 and noticed under left arm 2 different places that were swollen and red. Area is where the arm meets the shoulder. He noticed that area changed on 9/28 and says it is slightly worse today. Advised to keep an eye on it for worsening symptoms and to contact doctor.
Age: 75.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Patient reported redness and inflammation at the site of injection.
Age: 92.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Fatigue, Pain in extremity, Somnolence
Clinical narrative: Entire arm sore. Slept before and after dinner. Slept on and off for 4 more days. Was weak and tired. Next yr. take lo dose instead.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Immediate post-injection reaction, Injection site urticaria, Pruritus
Clinical narrative: Patient experienced extreme itching as soon as ZOSTAVAX vaccine was administered. Patient noticed a large welt at injection site two days later. Patient was instructed to ice the affected arm and take BENADRYL to decrease itching.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Injection site urticaria, Injection site warmth
Clinical narrative: Day after nickel size welt right leg. Warm to touch, next day size of plum, next day size of orange.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site haemorrhage
Clinical narrative: Blood under skin at shot area - continued for 8 weeks - shot area started to fade but continued to bleed until the blood completely covered arm - from shot area to my elbow. At 8 weeks it stopped bleeding.
Age: 1.09
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Injection site reaction, Staphylococcal infection
Clinical narrative: Patient (mother) reports staph infection at injection site (R) thigh. Mother states problem is resolved and was treated by physician.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Chest X-ray abnormal, Chills, Computerised tomogram abnormal, Decreased appetite, Fatigue
Clinical narrative: Woke up on 8/1/14 with sore throat soon after I developed fever, chills, achiness, extreme fatigue and loss of appetite. Sought treatment at urgent care, was put on antibiotics, cough medicine and inhaler and advised not to work. 8/13/14 follow up with regular physician. Blood work and check x-rays taken. bacterial pneumonia revealed in a cat scan w/contrast. Dr recommended a pulmonary consultation. This will take place 10/1/14.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Oropharyngeal pain, Pain, Pneumonia bacterial, Pyrexia
Clinical narrative: Woke up on 8/1/14 with sore throat soon after I developed fever, chills, achiness, extreme fatigue and loss of appetite. Sought treatment at urgent care, was put on antibiotics, cough medicine and inhaler and advised not to work. 8/13/14 follow up with regular physician. Blood work and check x-rays taken. bacterial pneumonia revealed in a cat scan w/contrast. Dr recommended a pulmonary consultation. This will take place 10/1/14.
Age: 1.5
Sex: U
Vaccine: HPV2
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an 18  month old patient of unknown gender. Medical history and drug reactions or allergies were not specified. On 11-SEP-2014, the patient inadvertently received one dose of GARDASIL injection (route and lot number were not reported). No adverse effects were noted. Concomitant medications were not specified. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a three unspecified patients of unknown gender and age in September 2014 (reported as since the temperature event), the patients were vaccinated with a doses of GARDASIL (dose, dose number, route, lot/batch number, expiration date were not reported) that were improperly stored on 08-SEP-2014. No adverse effects were reported. No product quality complaint (PQC) involved.   Follow-up information has been received from the reporting medical assistant, who provided patients' identifiers (age and gender), dates of vaccinations and lot numbers. This report concerns a 48 years old female patient. No information on her medical history, concurrent conditions or concomitant drugs was provided. It was reported that the PNEUMOVAX23 underwent the temperature excursion on 08-AUG-2014. On 22-AUG-2014, the patient received a dose of PNEUMOVAX23 which underwent temperature excursion (dose, site and route of administration unknown; lot # J008799, expiration date 16-APR-2014). This is one of several reports from the same reporter.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. On 26-SEP-2014, the patient was vaccinated inadvertently with an expired dose of PNEUMOVAX23 (lot # J006921, expiration date 08-AUG-2014) 0.5 ml, intramuscular. No adverse events reported. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Headache, Local swelling, Nausea, Pain in extremity, Vomiting
Clinical narrative: Patient states she had pain and swelling in left arm, headache, nausea and vomiting began Wed. morning (9/24/14) and visited P.A. and was prescribed an antibiotic and anti-inflammatory.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Dyspnoea, Loss of consciousness
Clinical narrative: Patient started having symptoms on 9/23/14 at 11pm. First symptom was chills at 11 pm then shortness of breath at 2 am, then patient passed out and woke up at 6 am and had no other problems.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Reported arm - red, swollen and warm at injection site.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Swelling face, Vomiting
Clinical narrative: 2 days after receiving patient was seen for vomiting. Started 24 hrs after vaccine. Today 9/29, he was seen again with swelling on (L) jaw extending under (L) ear.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Mass, Pain, Swelling
Clinical narrative: Had IZ 9/23/14, on 9/24/14 in for noted red, swollen mass - no fever - only painful to touch.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site pruritus, Pruritus, Swelling, Vaccination site pain
Clinical narrative: Patient reports significant itching and pain at the vaccine site given 1 year ago on 10-4-13. Now 1 year later she still has a raised, red somewhat itchy bump approx 3/4 x 1 cm.
Age: 44.0
Sex: M
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site urticaria, Pain in extremity
Clinical narrative: - Arm pain (sore) 19 days - Rash/welt at injection site - Red
Age: 91.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Burning sensation
Clinical narrative: Burning sensation in hip.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Extreme dizziness, nausea, vomiting lasting 4 + days.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Redness, swelling, pruritis
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site pain, Neck pain, Nerve injury
Clinical narrative: Severe pain in arm, down to elbow of administration site. Pain also in back of neck. Numbness in arm. Suspect nerve damage as a result of the IM vaccination.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a three unspecified patients of unknown gender and age in September 2014 (reported as since the temperature event), the patients were vaccinated with a doses of GARDASIL (dose, dose number, route, lot/batch number, expiration date were not reported) that were improperly stored on 08-SEP-2014. No adverse effects were reported.  Follow-up information has been received from he reporting medical assistant, who provided patients' identifiers (age and gender), dates of vaccinations and lot numbers.  This report concerns a 63 years old male patient. No information of his medical history, concurrent conditions or concomitant drugs was provided. It was reported that the PNEUMOVAX23 underwent the temperature excursion on 08-AUG-2014. On 18-AUG-2014, the patient received a dose of PNEUMOVAX23 which underwent temperature excursion (dose, site and route of administration unknown, lot # J008799, expiration date 16-APR-2014). This is one of several reports from the same reporter. Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain
Clinical narrative: Patients left upper arm was red and was sore. Went to doctor and has cellulitis.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug administered at inappropriate site, Injection site pain, Injection site rash, Injection site swelling, Pain
Clinical narrative: Patient received the ZOSTAVAX immunization and afterwards started to experience a large and painful swollen rash in the area. Four days later she went to her physician... the MD told her that the vaccine had been administered too low and that is what probably caused the reaction (vaccine was administered SUBQ above the elbow by a pharmacist). Patient is currently in pain and says she is being treated with antibiotics and prednisone. She says that her MD who is an expert (but did not administer the vaccine) said that he has never seen anything like it and that it is very unusual that she would experience such a reaction or infection from the vaccine and that it is due to administration error. Patient denies any allergies. I am reporting this because the patient is seeking monetary compensation from Walgreens. I have not seen the rash to examine its characteristics.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Dizziness, Fatigue, Nausea, Polymenorrhoea
Clinical narrative: This spontaneous report as received from a medical assistant in physician's office, refers to a patient of 17 years old female patient. No information about medical history, concurrent conditions and concomitant medications were reported. On 17-APR-2014 the patient was vaccinated with first dose of GARDASIL lot # J009788 expiration date 17-MAR-2016 and on 17-JUL-2014 with second dose of GARDASIL lot # K004204 expiration date 12-JAN-2017. Approximately on an unknown date in 2014 (also reported as unable to state when these events started for the patient), the patient experienced nausea, fatigue, stomach pains and frequent periods, dizziness. The outcome of stomach pains, dizziness, fatigue, nausea and frequent periods was reported as not recovered/not resolved. This case is linked to the 1409USA007180, 1409USA013917 cases via same reporter link.  Additional information has been requested.
Age: 36.0
Sex: M
Vaccine: HEP
Symptoms: Diarrhoea, Dizziness, Hypoaesthesia, Paraesthesia, Rash
Clinical narrative: Felt like he was going to pass out. Dizziness. Diarrhea x 5 days. Rash, forehead only. (R) arm numbness. Fingers (R) hand tingling. All started 7-10 days after vaccine was administered each time.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Heart rate increased, Pharyngeal oedema, Pyrexia, Throat irritation
Clinical narrative: I was administered the AFLURIA (NDC 33332-0014-01, 0.5 ml) on 9/24/14 around 2:40 pm. By 7:00 pm I noticed my throat feeling scratching. This worsened to difficulty breathing, elevated heart rate and a fever of about .5 degrees above normal. The inside of my throat felt swollen. The feeling of having more difficulty breathing lasted for hours but did not become bad enough for me to go to the ER. I'm a 29 year old female. It is possible I could be pregnant though I won't know until 10/1 (around when I miss my period if I'm pregnant). I've felt feverish with sensitive skin and a sore injection site in the past for flu vaccine, but never felt difficulty breathing. It was a little scary.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 72 year old male patient. The patient's medical history and current conditions are not reported. On 15-SEP-2014 the patient was vaccinated with PNEUMOVAX 23 of dose 0.5 ml, intramuscular in the left arm (lot # J009827 and expiry date 10-AUG-2014). Other suspect therapy includes AFLURIA in the left arm, different site. It was reported that the patient was vaccinated with expired PNEUMOVAX 23. No adverse effects reported. Product quality complaint was not reported. The outcome of the events is unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 76 year old male patient. The patient's medical history and current conditions are not reported. On 10-SEP-2014 the patient was vaccinated with PNEUMOVAX23  of dose 0.5 ml, intramuscular in the left arm (lot # J009827 and expiry date 10-AUG-2014). Other suspect therapy includes AFLURIA in the left arm, different site. It was reported that the patient was vaccinated with expired PNEUMOVAX23. No adverse effects reported. Product quality complaint was not reported. The outcome of the events is unknown. Additional information has been requested.
Age: 1.9
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 21 month old patient (gender was not reported). On 02-SEP-2014 the patient was vaccinated with improperly stored M-M-R II (lot # J008153 with expiration date: 08-JUL-2015; dose, frequency and indication were not reported). Lot # J008153 with expiration date: 08-JUL-2015. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 78 year old male patient. The patient's medical history and current conditions are not reported. On 10-SEP-2014 the patient was vaccinated with PNEUMOVAX23 of dose 0.5 ml, intramuscular in the left arm (lot # J009827 and expiry date 10-AUG-2014). Other suspect therapy includes AFLURIA in the left arm, different site. It was reported that the patient was vaccinated with expired PNEUMOVAX23. No adverse effects reported. Product quality complaint was not reported. The outcome of the events is unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (dose, route and lot # not reported). The medical assistant reported that on an unknown date, the patient experienced mild case of chickenpox long after the (Oka/Merck) VARIVAX was given. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Headache, Malaise, Pain
Clinical narrative: Malaise - aches - headache, fatigue - lasted 6 days.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Decreased appetite, Musculoskeletal pain, Pain, Pyrexia
Clinical narrative: Pt described local pain after 2 hours, which progressed into shoulder pain. He had fevers and chills the night after the shot followed by no appetite.
Age: 45.0
Sex: M
Vaccine: HEP
Symptoms: Computerised tomogram, Dizziness, Immediate post-injection reaction, Muscular weakness, Myalgia
Clinical narrative: This spontaneous report as received from a 45 male patient refers to himself. There was no pertinent medical history and drug reaction or allergies. On 31-JAN-2014 the patient was vaccinated by his physician with the first dose of RECOMBIVAX HB (injection, strength: 10mcg/l ml, intramuscular, dose: 1 ml, lot#: J006511 expiration date: 26-JAN-2016) for prevention of infection caused by all known subtypes of the hepatitis B virus. On 03-MAR-2014 the patient was vaccinated by his physician with the second dose of RECOMBIVAX HB (injection, strength: 10mcg/1 ml, intramuscular, dose: 1 ml, lot# reported as: J012565, expiration date reported as: 03-FEB-2016) also for prevention of infection caused by all know subtypes of the hepatitis B virus. There was no concomitant medications. On 31-JAN-2014 the patient experienced dizziness for "about a week" (reported also as: starting immediately after the injection). On 06-MAR-2014, the patient experienced muscle pain and weakness throughout his whole body (reported also as beginning "about three days" after the second injection). The patient reported that muscle pain felt like "after heavy workout" describing it as pain was felt more intensely while moving his arms and legs. The patient also stated that "any normal muscle pain would last longer than normal like upwards of a week". There was computered tomography (CAT) scan performed in approximately June 2014 (reported as: "2 to 3 months ago") but the results were not provided. The therapy with RECOMBIVAX HB was discontinued on 03-MAR-2014 and the patient did not recover from the events of muscle pain and weakness throughout his whole body. The patient's condition did not improve. The outcome of he experienced dizziness for about a week starting immediately after the injection was recovered/resolved. There was no treatment given for the reported events. The patient sought medical attention in approximately September 2014 (reported also as "about week ago") by returning to his physician who referred him to the rheumatologist. The relatedness between the events and the therapy with RECOMBIVAX HB was not reported. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received form a Registered Nurse refers to a male patient of 0 day old. On 28-JUN-2014 the patient was vaccinated with improperly stored RECOMBIVAX HB lot # J012520 dose 1, intramuscular. No adverse events were reported. This is one of several reports received from the same source. Additional information is not expected, all follow ups requested to complete the case were received.
Age: 0.7
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source.  Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful.  Follow up information has been received on 23-SEP-2014. Demographic details for each patient were provided.  This report referred to a 7-months old male patient, with no known drug allergies and no illness at time of vaccination. The patient was vaccinated with the third dose of ROTATEQ (oral, batch/lot # J004875, expiration date 17-OCT-2014), on 03-FEB-2014 at 5:02 PM. It was reported that this dose was spoiled since the refrigerator was too cold. The reporter stated that it ws declined to repeat vaccine. No adverse event was reported for the patient.  This is one of several reports from the same source.  Additional information is not expected since all follow ups requested to complete the case were received.
Age: 70.0
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 70 year old patient of unknown gender and demographics. Patient's current condition and medical history was not reported. On 15-SEP-2014, the patient was vaccinated with ZOSTAVAX subcutaneous injection, 0.65 ml, lot # J005721 expiration date: 29-AUG-2014 for an unknown indication. No concomitant medication was reported. On 15-SEP-2014, the patient received an expired dose of ZOSTAVAX intramuscularly in the left deltoid after having transported the dose of ZOSTAVAX from the pharmacy to the physician's office. On 15-SEP-2014, the dose was exposed to an unknown temperature during transport by the patient. On an unknown date in September 2014, no adverse effect was observed or reported by the patient. There was no product quality complaint involved. The outcome of the events was not reported. The causality between ZOSTAVAX and the events was not reported. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a 4 year old patient. On 16-SEP-2014, the 4 year old patient was vaccinated with ZOSTAVAX via, (dosage information unknown) subcutaneously. No concomitant medication was reported. No known adverse effects were reported. A product quality complaint PQC was not involved. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Abdominal pain upper, Fatigue, Nausea, Pain, Pain in extremity
Clinical narrative: This spontaneous report as received from medical assistant in physician's office refers to a 17 year old male patient. No information about medical history, concurrent conditions and concomitant medications were reported. On 20-MAY-2014 the patient was vaccinated with first dose of GARDASIL lot # J015378 expiration date 09-APR-2016. The medical assistant spoke to the patients mother for schedule second vaccination with GARDASIL. On 21-MAY-2014 (Also reported as them other mentioned to the M. A. that the next day after the 1st vaccination with GARDASIL) the patient experienced body aches and sore (vaccination) arm along with the symptoms nausea, fatigue, stomach pains initially reported. The outcome of the events reported was recovered/resolved approximately on 27-MAY-2014 (also reported as the symptoms lasted for a week and the patient recovered). This case is linked to the cases 1409USA007180, 1409USA013915 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients. On 08-SEP-2014 the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (lot #, expiration date, dose and route unspecified). No adverse symptoms reported. The temperature excursion was found to be supported by in-house stability data. This is one of several reports received from same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, Product label confusion
Clinical narrative: This spontaneous report as received from a nursing assistant. No patient is involved. On an unknown date, there was product confusion between the color of the vial of M-M-R II (therapy type unknown) and the color of the diluent that M-M-R II comes with. The colors of the labels were similar. Because of the color confusion the M-M-R II was accidentally left out of temperature range as it was believed to be the diluent. A product quality complaint (PQC) was not identified. Thi sis one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to unspecified number of patients of unknown demographics. On an unknown date the patients were vaccinated with PNEUMOVAX23 (dosing regimen unsecured). No concomitant medications were reported. Approximately on an unknown date in 2014 it was reported that an unspecified number of patients were administered doses of PNEUMOVAX23 on unspecified dates that were improperly stored since 20-AUG-2014. No adverse events were reported. The outcome of improper stored  vaccine were administered to unspecified number of patients is unknown. There was no product quality complaint involved. Additional information has been requested.