chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: MMR
Symptoms: Pruritus, Rash
Clinical narrative: MMR given 9/9/14, 2 days later started with itching to back of legs noted. Rash from then kept getting rash only in evening. On 9-27-14 went to MD, still had rash, was told was a reaction to MMR. was not told was the measles. Per the MD, was told not to received the 2nd dose.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23. Lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. The nurse reported that PNEUMOVAX 23 was stored improperly in the freezer below 5F for 12 hours on an unspecified date. The improperly stored PNEUMOVAX 23 was administered to an unspecified patient on an unspecified date. No adverse effect reported. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Blister, Skin exfoliation, Swelling face
Clinical narrative: Facial swelling, blisters on face, on morning following HPV administreation. Later peeled.
Age: 18.0
Sex: M
Vaccine: FLU4, HEPA, MNQ, PPV
Symptoms: Asthenia, Chills, Hypoaesthesia, Nausea, Pain
Clinical narrative: Pain, nausea, vomiting, chills, weakness and numbness in arm.
Age: 18.0
Sex: M
Vaccine: FLU4, HEPA, MNQ, PPV
Symptoms: Vomiting
Clinical narrative: Pain, nausea, vomiting, chills, weakness and numbness in arm.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain, Pain in extremity
Clinical narrative: At 2:00 am 9/26/14 started with severe body pains generalized. Unable to move. Next day 7 am started to ease off. Pain continue Rt. leg. Next day 11:00 am symptoms started to ease. Continued with body aches less severe but is taking Ibuprofen q 12 hrs 800mg. Will see provider today 9/29/14.
Age: 1.02
Sex: M
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Conjunctivitis, Cough, Measles antibody, Pyrexia, Rash
Clinical narrative: Fever, cough, runny nose, conjunctivitis, rash.
Age: 1.02
Sex: M
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Rhinorrhoea
Clinical narrative: Fever, cough, runny nose, conjunctivitis, rash.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Patient reports severe pain in arm and severe limited range of motion.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site pain, Joint range of motion decreased, Pain
Clinical narrative: Patient reports severe pain in arm and severe limited range of motion.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown age and gender. Since July 2014 the patients were vaccinated with a dose of improperly stored GARDASIL (dose, route of administration and lot # were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Joint range of motion decreased, Pain
Clinical narrative: Vacc 2 wks prior. Pain day after vacc. progressed to reduced range of motion and severe pain with movement day 9. Pain at vacc site, no redness or swelling, decreased ability to lift objects and undress.
Sex: U
Vaccine: FLU3
Symptoms: Arthritis, Inflammation, Musculoskeletal pain, X-ray normal
Clinical narrative: Pt received shoulder pain and had inflammatory arthritis in shoulder.
Age: 7.0
Sex: M
Vaccine: FLUN4
Symptoms: Urticaria
Clinical narrative: About 1 hour after adm the vaccine co school based clinic child presented with hives arms and hand. Denies shortness of breath. School nurse adm. 12.5 mg BENADRYL no further problems.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown age and gender. Since July 2014 the patients were vaccinated with a dose of improperly stored ROTATEQ orally (dose and lot # were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown age and gender. Since July 2014 the patients were vaccinated with a dose of improperly stored VAQTA (dose, route of administration and lot # were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown age and gender. Since July 2014 the patients were vaccinated with a dose of improperly stored RECOMBIVAX HB (dose, route of administration and lot # were reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: MMR
Symptoms: Dizziness, Dysgeusia, Paraesthesia, Paraesthesia oral, Pharyngeal hypoaesthesia
Clinical narrative: Right after vaccination administered patient felt her throat felt "tingly and numb". Lips started to feel tingly. Felt lightheaded and dizzy. Said she tasted "mercury" in her mouth.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling of body temperature change, Hot flush, Mobility decreased, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Vaccine administered on 9/30/14 - vomiting is hot and cold flashes next morning - then noticed arm sore then would not move (hard to move) (stiff).
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Vaccine administered on 9/30/14 - vomiting is hot and cold flashes next morning - then noticed arm sore then would not move (hard to move) (stiff).
Age: 85.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: PE tender L deltoid and erythema AC jt shoulder edematous and pain (patient rated 8/10), redness.
Age: 26.0
Sex: M
Vaccine: FLU3
Symptoms: Colitis
Clinical narrative: 2nd episode of colitis like symptoms persisting after influenza vaccination.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Burning sensation, Erythema, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Severe erythema, burning and itching from inj site down the arm. (Also swelling) saw PA and received steroid shot and antibiotic on 9/23, and saw her again on 9/25 and was given a dif. antibiotic. 103 degrees oral temp on 23rd. Much improved on 9/25. 1st antibiotic- BACT SC - 2nd CLEOCIN 300.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pruritus, White blood cell count increased
Clinical narrative: Severe erythema, burning and itching from inj site down the arm. (Also swelling) saw PA and received steroid shot and antibiotic on 9/23, and saw her again on 9/25 and was given a dif. antibiotic. 103 degrees oral temp on 23rd. Much improved on 9/25. 1st antibiotic- BACT SC - 2nd CLEOCIN 300.
Age: 1.0
Sex: M
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Nodule, Rash
Clinical narrative: Knot under injection site and rash. BENADRYL.
Age: 5.0
Sex: M
Vaccine: FLUN4
Symptoms: Headache, Pyrexia, Vomiting
Clinical narrative: As soon as received FLUMIST got HA and 2 hours later started vomiting, fever 9-26-14.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 9-30 - reddened and swollen size of pea, "mosquito bite". 10-1 - size of plum, c/o pain. Location (R) thigh.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Laboratory test, Rash
Clinical narrative: I got a very serious skin rash. The only control for some time was prednisone. Since then I have been taking cyclosporine twice a day. The symptoms are now primarily just on my hands and wrists. my dermatologist does not see a connection.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Contusion, Pain, Pruritus, Swelling
Clinical narrative: Swelling, bruising, pain, itching.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Bronchitis, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Extreme headache, progressed to fever, chills, myalgia, fatigue, strep infection, bronchitis.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Streptococcal infection
Clinical narrative: Extreme headache, progressed to fever, chills, myalgia, fatigue, strep infection, bronchitis.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Cyanosis, Hypotonia, Loss of consciousness, Pallor
Clinical narrative: Patient lost consciousness approximately 5 minutes after receiving vaccine. He was pale, flaccid and blue around his mouth. Sternal rub, oxygen, and ambulance was called. He became conscious again after 5 minutes.
Age: 10.0
Sex: F
Vaccine: FLUN4
Symptoms: Erythema, Oropharyngeal discomfort, Swelling face
Clinical narrative: Patient's mom called, couple hours after FLUMIST had facial redness/swelling, "throat felt funny" given OPAPRED at ER. Couldn't have BENADRYL due to seizure disorder.
Age: 55.0
Sex: U
Vaccine: FLU3, PPV
Symptoms: Body temperature increased, Pain, Rash
Clinical narrative: Had vaccination, had pain, next morning had 102 degree temp and rash, rash got worse pt went to physician got steroid shot Cephalexin and Ibuprofen.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Induration
Clinical narrative: Localized induration after PENTACEL vaccine.
Age: 50.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Eyelid oedema, Oropharyngeal pain, Pruritus, Swelling face, Tachycardia
Clinical narrative: 10-5-14 1:00 pm face swelling esp eyelids/under eyes. 10-6-14 8:00 am itchy face. 10-7-14 8:00 am itchy face, sore throat, sl. tachycardia took 2 BENADRYL at noon OTC; states symptoms have decreased at this time.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Lethargy, Respiratory arrest, Unresponsive to stimuli
Clinical narrative: Patient stopped breathing after PCV13 injection given. Pt unresponsive for 2 min. Pt was stimulated and began to cry, pt was still lethargic. Vitals taken and pt monitored for 1/2 hrs.
Age: 66.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Patient got Zoster vaccine on 10/5/14. She came by pharmacy on 10/7/14 due to redness and inflammation to site.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt has large red swelling at injection site.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 06-JUN-2014 the patient was vaccinated with MMR II (strength, dosage and route were not reported) lot number: J009706, expiration date: 15-AUG-2015. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the MMR II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was an any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to an unspecified number of patients of unknown age and gender. On unknown date the patients were vaccinated with a dose of improperly stored VAQTA (dose, route of administration and lot # were not reported). This vaccine had been exposed to 32F for 2.5 hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
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 of unkonwn age and gender. Since 16-SEP-2014 the patients had been vaccinated with improperly stored GARDASIL, (dose, route, lot number and expiration dates not reported). No adverse effects reported. This is one of several reports received 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 pharmacist refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 25-SEP-2014, the patient was vaccinated with a expired dose of PNEUMOVAX 23 lot # J009827, expiration date 10-AUG-2014, 0.5 ml, intramuscular. No adverse effects reported. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Headache, Hypoaesthesia, Injection site erythema, Injection site swelling
Clinical narrative: 48 hours - pain in upper arm, numbness lower arm and hand. Red raised site (golf ball) size, red-purple rash on entire upper arm. Headache, joints and body ached.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity, Rash erythematous
Clinical narrative: 48 hours - pain in upper arm, numbness lower arm and hand. Red raised site (golf ball) size, red-purple rash on entire upper arm. Headache, joints and body ached.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site oedema, Injection site reaction, Injection site warmth, Rash macular
Clinical narrative: Red's 0.5 pre-filled quad flu shot at office clinic on 10-01-14. Afternoon of 10-02-13, LA at site with redness, edema, blotchiness; warmth. Afebrile 2-3 other small 'hive-like' spots also to (rt) upper arm, cheek and neck by 10-03-14. Seen for s/s 10-03-14. Tx with KEFLEX (250/5 (8 ml BID x 7d).
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Red's 0.5 pre-filled quad flu shot at office clinic on 10-01-14. Afternoon of 10-02-13, LA at site with redness, edema, blotchiness; warmth. Afebrile 2-3 other small 'hive-like' spots also to (rt) upper arm, cheek and neck by 10-03-14. Seen for s/s 10-03-14. Tx with KEFLEX (250/5 (8 ml BID x 7d).
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 24-APR-2014 the patient was vaccinated with MMR II (strength, dosage and route were not reported) lot number: J009706, expiration date: 15-AUG-2015. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the MMR II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was an any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: FLU4
Symptoms: Injection site anaesthesia, Injection site paraesthesia, Muscular weakness
Clinical narrative: This case reported by a other health professional and described the occurrence of injection site numbness in a 38-year-old female patient who received FLUARIX QUADRIVALENT. On an unknown date, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On an unknown date, an unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced injection site numbness, injection site paraesthesia and weakness in administration arm. On an unknown date, the outcome of the injection site numbness, injection site paraesthesia and weakness in administration arm were recovered/resolved. The reporter considered the injection site numbness, injection site paraesthesia and weakness in administration arm to be possibly related to FLUARIX QUADRIVALENT. Additional details: The patient did not receive other vaccinations on the same day. Concomitant medication was not reported. The patient had no known medical history or past drug therapy. It was unknown if the patient received any other flu shots or if he had previous reactions to vaccination. Medical attention was not required.  It was unknown if the AE were disabling, life threatening, jeopardized the patient or required intervention. The reporter was not sure whether the AE had to do with how the vaccine was administered by the experienced nurse. A VAERS form was already completed. A couple of days later the events resolved. This was one of the 3 reports received from the same reporter.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unkonwn date the patients were vaccinated with PEDVAXHIB. Dose, route, lot number and expiration date were not reported. The health care worker reported that PEDVAXHIB was improperly stored and administered to unspecified number of patients on unspecified dates. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Mobility decreased, Muscle spasms, Neck pain, Seizure like phenomena
Clinical narrative: Patient stated 1.5 hours after receiving vaccine she felt back spasms, pain in back and neck, she could not move, felt like seizures.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Mobility decreased, Neck pain
Clinical narrative: 4-5 hrs after vaccine severe pain in left shoulder shooting into neck - unable to lift arm and more across chest.
Age: 17.0
Sex: F
Vaccine: FLU3, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Vaccine positive rechallenge
Clinical narrative: MENVEO given on 9/30/14 to left upper deltoid. Mom called on 10/3/14 c/o sited red, swollen and tender mom states this happen with 1st MCV dose.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No pertinent medical history or  drug reactions/allergies were provided. On an unspecified date in 2008, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not provided), while in physician office. The pharmacist reported that on 23-JUN-2014, inadvertently, the patient received a second dose of ZOSTAVAX (dose, route and lot number not provided, location was unspecified). No adverse effects were reported. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Brain natriuretic peptide, Chest X-ray, Dyspnoea, Echocardiogram, Full blood count
Clinical narrative: Pt. received influenza vaccine in primary care office in AM, went to pharmacy and received ZOSTAVAX vaccine about 2 PM. Noticed swelling and difficulty breathing about 3 PM, rash developed at same time on face and chest. Used inhaler for breathing and came to clinic in AM. Swelling is bilateral to shins. Concerned re CHF/pulmonary edema . ZANTAC and BENADRYL given.
Age: 73.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Metabolic function test, Rash, Swelling
Clinical narrative: Pt. received influenza vaccine in primary care office in AM, went to pharmacy and received ZOSTAVAX vaccine about 2 PM. Noticed swelling and difficulty breathing about 3 PM, rash developed at same time on face and chest. Used inhaler for breathing and came to clinic in AM. Swelling is bilateral to shins. Concerned re CHF/pulmonary edema . ZANTAC and BENADRYL given.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with GARDASIL. Dose, route lot number and expiration date were not reported. The health care worker reported that GARDASIL was improperly stored and administered to unspecified number of patients on unspecified dates. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Area of shot red, hot and itching. No fever. Little headache - may be allergy. No nausea/vomit.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist concerning a 69 year old female patient with no pertinent medical history or drug reactions/allergies. On 24-SEP-2014, the patient was vaccinated with a dose of ZOSTAVAX (dose, dose number, lot number, expiration date and route were not reported). The patient was not on concomitant therapies. Pharmacist reported the redness around the injection site was present on 29-SEP-2014 (reported as today). The pharmacist reported patient's outcome as "she's fine" in 2014. The patient did not seek medical attention or received treatment for the adverse event. No lab diagnostics test were performed. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Tenderness noted at site of injection the night of the injection. Noted redness and swelling at injection site today at about 8:00 am. Redness and swelling continued to increase in size to approximately 1 1/2 inch diameter by 2 1/2 inches.
Age: 0.53
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Register Nurse refers to a 6 month old patient. On 09-SEP-2014 the patient was vaccinated with improperly stored PEDVAXHIB intramuscular injection, 0.5 ml. No adverse effect was reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to an unspecified number of patients of unknown age and gender. On unknown date the patients were vaccinated with a dose of improperly stored RECOMBIVAX HB (dose, route of administration and lot # were not reported). This vaccine had been exposed to 32F for 2.5 hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Medical history and drug reactions/allergies were not reported. On 12-SEP-2014, the patient was vaccinated with ZOSTAVAX (lot, dose and route not reported). Concomitant medication was not reported. On 28-SEP-2014, the patient visited the pharmacy with a painful, red rash at the injection site (start date September 2014). There are no pustules. The outcome of painful, red rash at the injection site was unknown. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discolouration, Injection site haemorrhage, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: Pain on injection - raised - bleeding internally (Black/blue) about 1 inch around injection site started within 24 hour - raised knot at injection site - pain subsided.
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 79 year old male patient. Medical history and drug reactions/allergies were not reported. On 26-SEP-2014, the patient was vaccinated with an expired dose of PNEUMOVAX 23 lot # H022280 expiry date 16-JUL-2014 (dose and route not reported). Concomitant medication was not reported. No adverse effects reported. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Chest pain, Dizziness, Feeling hot, Injection site erythema, Injection site pain
Clinical narrative: Pt presents today for an acute visit. Pt received a influenza vaccine in her right deltoid and a pneumococcal 23 vaccine in her left deltoid on 10/2/14. Pt states that approx 1 hour after the injection she had increasing pain. This morning pt has increased pain radiating to her left neck, left chest wall, and left arm. Pt c/o dizziness, feeling "hot", and nausea. Pt noted to have a baseball sized erythemic area on her left upper arm which is very tender to touch and warm. Pt is unsure if she has had this vaccine in the past.
Age: 30.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site warmth, Nausea, Neck pain, Pain in extremity
Clinical narrative: Pt presents today for an acute visit. Pt received a influenza vaccine in her right deltoid and a pneumococcal 23 vaccine in her left deltoid on 10/2/14. Pt states that approx 1 hour after the injection she had increasing pain. This morning pt has increased pain radiating to her left neck, left chest wall, and left arm. Pt c/o dizziness, feeling "hot", and nausea. Pt noted to have a baseball sized erythemic area on her left upper arm which is very tender to touch and warm. Pt is unsure if she has had this vaccine in the past.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 21-APR-2014 the patient was vaccinated with MMR II (strength, dosage and route were not reported) lot number: J009706, expiration date: 15-AUG-2015. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the MMR II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was an any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with ROTATEQ. Dose, route, lot number and expiration date were not reported. The health care worker reported that ROTATEQ was improperly stored and administered to unspecified number of patients on unspecified dates. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 year old female patient with penicillin and sulfa allergy. On 19-SEP-2014 the patient was vaccinated with ZOSTAVAX lot # K008079, expiration date 03-SEP-2015, subcutaneous, in the deltoid region of the arm. On 23-SEP-2014, the patient experienced the area around her ZOSTAVAX injection was painful to the touch, red, raised and about the size of a half dollar. Patient sought medical attention. No lab diagnostics were performed. The pharmacist recommended oral BENADRYL. At the time of the report the outcome of the events was reported as not recovered. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with RECOMBIVAX HB. Dose, route, lot number and expiration date were not reported. The health care worker reported that RECOMBIVAX HB was improperly stored and administered to unspecified number of patients on unspecified dates. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAP, FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Shot given 9/29/14. Noticed redness, left thigh swollen an warm on 10/1/14. Child seen in office on 10/2/14 because area gotten larger. Treated with ORAPRED. F/u on 10/3/14 child doing better -getting smaller.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: Pt. rec'd 5 yr imm. at WCE 10/01/14. Developed (R.A.) 6 cm x 7.5 cm area erythema, warmth and pain 10/03/14. Afebrile. Seen in office 10/03/14 and tx'd with ice, ibuprofen.
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous, Wheezing
Clinical narrative: Flu vaccine approved to give patient by Dr - mom stated she eats eggs with no problem. Patient developed red patchy rash and a few red bumps. Slight wheeze. Given 10ml BENADRYL and Albuterol 2.5mg/3m - neb. with good response.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Malaise
Clinical narrative: Vaccine received vaccine 9-19-14 at 8:20 pm. At 3 am she got shivers and headache and felt unwell.
Age: 4.0
Sex: F
Vaccine: FLUN4
Symptoms: Dyspnoea
Clinical narrative: FLUMIST administered at 20:15 on 9/25/14, at office visit for allergic rhinitis. Difficulty breathing reported by parents to have started the evening of 9/28/14. She was seen at Urgent Care at 2230. Received albuterol nebulizer and ORAPRED. Pulse ox at 93% RA post treatment. Sent to ED by car upon arrival sx were resolved.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharm technician, concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 01-OCT-2014, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, dose number and route were not reported) lot # J004332, expiration date 26-SEP-2014. Co-suspect and concomitant therapies were not reported. The pharm technician reported the patient received an expired dose of PNEUMOVAX 23 on 01-OCT-2014. The PNEUMOVAX 23 did not have any previous temperature excursions and was supported with post-expiry in-house stability data. No adverse symptoms reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Rash erythematous, Rash vesicular, Sinusitis
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. On an unspecified date in September 2011, "three years ago", the patient was vaccinated with a dose of ZOSTAVAX (route, dose and lot # not reported). The physician reported that on an unknown date, the patient experienced what it appeared like to be shingles, had a red, burning rash and eyelid on the left side of her body. The physician also reported that he thought the patient had sinusitis. The patient received anti-viral treatment. At the time of the report, the patient was recovering. Additional information has been requested.
Sex: U
Vaccine: RV5
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 of unkonwn age and gender. Since 16-SEP-2014 the patients had been vaccinated with improperly stored ROTATEQ, (dose, route, lot number and expiration dates not reported). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash erythematous, Swelling
Clinical narrative: The morning after Flu vaccine patient noticed swelling below injection site and red rash down arm to elbow area. The rash wrapped half way around arm. Itched some and resolved in about 4 days.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 30-SEP-2014, the patient was vaccinated with a dose of ZOSTAVAX, (dose and lot number not provided) subcutaneous. On 01-OCT-2014, the patient experienced a red ring around the site of ZOSTAVAX injection. No treatment was given for this event. The patient had not recovered/not resolved. The patient went to see the pharmacist for seeking medical attention. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 29-AUG-2014 the patient was vaccinated with MMR II (strength, dosage and route were not reported) lot number: K001231, expiration date: 27-JAN-2016. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the MMR II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was an any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. 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 certified medical assistant refers to unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with doses of (Merck) VARIVAX (lot # not reported) that were exposed to a supported temperature excursion on 15-AUG-2014. No adverse events were reported. 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 of unknown age and gender. Unknown number of improperly stored (Merck) VARIVAX (dose, route, lot # not reported) were administered to patients. No adverse effects were reported. This is one of several reports from the same source. Follow up information was received from the nurse on 26-SEP-2014. The excursion reported for (Merck) VARIVAX exposed to -12.1 centigrade for 21 hours (20 hours and 45 minutes). The nurse stated that she believed at least one or two individuals have received these various vaccines, but does not have specific data. She had not received any reports of adverse effects to patients post vaccination. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Redness, itchiness, swelling at site of injection (4" diameter spot at injection site). Skin is warm to the touch - took BENADRYL tablets po - applied hydrocortisone cream to affected skin.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV, TDAP, VARZOS
Symptoms: Aphagia, Asthenia, Burning sensation, Local swelling, Malaise
Clinical narrative: Pt got 4 shots Sunday - on Monday he was sick had fever was weak and couldn't eat and had swollen left arm with itchy burning rash. Rash was worse on Tuesday but he was feeling better and could eat.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV, TDAP, VARZOS
Symptoms: Pyrexia, Rash pruritic
Clinical narrative: Pt got 4 shots Sunday - on Monday he was sick had fever was weak and couldn't eat and had swollen left arm with itchy burning rash. Rash was worse on Tuesday but he was feeling better and could eat.
Age: 33.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site rash, Pyrexia
Clinical narrative: Rash at site started after 11:00 PM on 9/24/14. Rash resolved 10/1/14. Fever.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Blood glucose normal, Cardiac monitoring normal, Dizziness, Head injury, Syncope
Clinical narrative: Pt received flu vaccine at her employer and within 20-30 minutes felt lightheaded and fainted hitting her head on the floor. When pharmacist arrived she was conscious, alert, aware. BP was normal, no sign of allergic reaction. 911 had been called and arrived.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chapped lips, Eye pruritus, Flushing, Oropharyngeal pain, Urticaria
Clinical narrative: Flushed. full, chapped lips, sore throat, itchy eyes. hives on chest and torso. 10/7/14 resolved slowly over the course of the week.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Pharyngeal oedema, Pleural effusion
Clinical narrative: Patient states his throat started to close up and his lungs "filled with fluid" and he couldn't breath. He used an Epipen and recovered fully.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site warmth, Skin warm, Swelling, Tenderness
Clinical narrative: About 12 hours after receiving pneumonia vaccine, patient experience some swelling, very tender to the touch, area felt hot to touch. Swelling has reduced, site still warm, but patient feels it is dissipating. Ice has been intermittently applied.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with PNEUMOVAX 23. Dose, route, lot number and expiration date were not reported. The health care worker reported that PNEUMOVAX 23 was improperly stored and administered to unspecified number of patients on unspecified dates. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. In July 2013 the patient was vaccinated with the first dose of GARDASIL (dose, route, lot number and expiration date not reported). On an unspecified date in 2013, the patient was vaccinated with the second dose of GARDASIL (dose, route, lot number and expiration date not reported). On 26-SEP-2014, the patient was scheduled to be vaccinated with the third dose of GARDASIL (dose, route, lot number and expiration date not reported). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 06-MAY-2014 the patient was vaccinated with MMR II (strength, dosage and route were not reported) lot number: J009706, expiration date: 15-AUG-2015. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the MMR II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was an any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age. On unspecified dates, the patients were vaccinated with PROQUAD (Merck) which was exposed to unknown temperatures out of the recommended range for an unknown period of time (dose, route, lot number and expiration date unknown). No adverse effect had been reported. All telephone attempts to obtain follow-up information have been unsuccessful. Follow up information has been received from a physician and a licensed practical nurse (LPN) regarding a 5 year old male patient. On 16-JUL-2014 at 12:46 pm, the patient might have been immunized with a dose of PROQUAD (Merck) lot number J015596, expiration date 05-JUN-2015, in the left thigh (dose number, route and dose were not reported) which was not stored at the appropriate temperature (not further specified). Concomitant medications were not specified. The outcome of the event was reported as unknown. This is one of several reports received from the same source. Additional information is not expected because follow up has been obtained.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 11-APR-2014 the patient was vaccinated with MMR II (strength, dosage and route were not reported) lot number: J009730, expiration date: 28-JUN-2015. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the MMR II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was an any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Lot number J009730 is an invalid lot number for MMR II, upon internal review the lot was valid for (Merck) VARIVAX. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 30-SEP-2014 the patient was vaccinated with an expired dose of VARIVAX (Merck), (0.5 ml, subcutaneous, lot # reported as H010148, expiration date 17-MAY-2014). Concomitant medications were not reported. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 25-APR-2014 the patient was vaccinated with MMR II (strength, dosage and route were not reported) lot number: J009706, expiration date: 15-AUG-2015. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the MMR II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was an any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Erythema, Rash pruritic, Swelling
Clinical narrative: Pt. states after receiving flu shot - pt. developed a dime size bright red swollen blister a few hours after receiving. 24-48 hours after - the blister has gotten smaller but now an itchy rash. Pt took BENADRYL and applied ice.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Paraesthesia, Pruritus generalised
Clinical narrative: This spontaneous report as received from a physician refers to a 13 year old female patient. On 03-JUL-2014 the patient was vaccinated with GARDASIL dose 1, 0.5 ml. On 05-JUL-2014 the patient developed a diffused itchiness and tingling all over the body after receiving GARDASIL. Caller further explained later the itchiness and tingling was localized to the back and abdomen. There was no treatment given for AEs. Patient called office on 15-JUL-2014. Therapy with GARDASIL was discontinued on 15-JUL-2014 and was not reintroduced. The outcome of events was unknown. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: FLUX, HPV4, HPV4
Symptoms: Exposure during pregnancy, Wrong drug administered
Clinical narrative: This spontaneous prospective pregnancy report as received from a 24 year old female patient with Last Menstrual Period (LMP) of 22-MAR-2014 and Estimated Date of Delivery (EDD) of 27-DEC-2014. Allergies included CECLOR. On 20-SEP-2014 (also reported as "30-SEP-2014 AE onset date"), while patient was 26 weeks pregnant, the patient was vaccinated with GARDASIL, intramuscular in the left arm (dose, lot number and expiration date not reported) instead of Tdap due to product confusion. The patient did not seek medical attention and no treatment was given for the event. At the time of the report the pregnancy outcome was pending. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: FLUX, HPV4, HPV4
Symptoms: Exposure during pregnancy, Product name confusion, Wrong drug administered
Clinical narrative: This spontaneous prospective pregnancy report as received from a 24 year old female patient with Last Menstrual Period (LMP) of 22-MAR-2014 and Estimated Date of Delivery (EDD) of 27-DEC-2014. Allergies included CECLOR. On 20-SEP-2014 (also reported as "30-SEP-2014 AE onset date"), while patient was 26 weeks pregnant, the patient was vaccinated with GARDASIL, intramuscular in the left arm (dose, lot number and expiration date not reported) instead of Tdap due to product confusion. The patient did not seek medical attention and no treatment was given for the event. At the time of the report the pregnancy outcome was pending. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Pain in extremity
Clinical narrative: Could not lift my arm.  My husband is a RN and he says the shot was given too high.  It was given in the top of my left arm in the joint
Age: 48.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Drug administered at inappropriate site, Injury, Mobility decreased
Clinical narrative: Could not lift my arm.  My husband is a RN and he says the shot was given too high.  It was given in the top of my left arm in the joint