chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to unspecified number of patients of unknown demography. Concurrent conditions and medical history were not reported. On an unknown date, the unspecified number of patients were vaccinated with GARDASIL (dosage regimen, lot # and expiry date were not reported) that was stored improperly. No adverse effects reported. No further information was provided. This case is one of the several reports from 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 to unspecified number of patients of unknown demography. Concurrent conditions and medical history were not reported. On an unknown date, the unspecified number of patients were vaccinated with RECOMBIVAX HB (dosage regimen, lot # and expiration date were not reported) that was stored improperly. No adverse effects reported. No further information was provided. This case is one of several reports from same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 31-JUL-2014, the patient was vaccinated with ZOSTAVAX (dose number was not reported), 0.65 ml, subcutaneous. Co-suspect and concomitant therapies were not reported. The pharmacist reports that on 31-JUL-2014 a ZOSTAVAX that underwent a temperature excursions was administered to five patients. (MARRS 1408USA006489, 1408USA006490, 1408USA006491, 1408USA006492 AND 1408USA001809). This case is one (1) of five (5) reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 01-AUG-2014, the patient was vaccinated with a dose of ZOSTAVAX (dose number was not reported), 0.65 ml, subcutaneous. Co-suspect and concomitant therapies were not reported. The pharmacist reports that on 01-AUG-2014, dose of ZOSTAVAX that underwent a temperature excursion was administered to five patients. (MARRS 1408USA006490, 1408USA006491, 1408USA006492 and 1408USA001809). This case is one (1) of five (5) reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 01-AUG-2014, the patient was vaccinated with dose of ZOSTAVAX (dose number, lot number and expiration date was not reported), 0.65 ml, subcutaneous. Co-suspect and concomitant therapies were not reported. The pharmacist reports that on 01-AUG-2014 a dose ZOSTAVAX that underwent a temperature excursion was administered to five patients. (MARRS 1408USA006489, 1408USA006490, 1408USA006491, 1408USA006492 and 1408USA001809). This case is one (1) of five (5) reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 01-AUG-2014, the patient was vaccinated with ZOSTAVAX (dose number was not reported), 0.65 ml, subcutaneous. Co-suspect and concomitant therapies were not reported. The pharmacist reports that on 01-AUG-2014, a ZOSTAVAX that underwent a temperature excursion was administred to five patients. (MARRS 1408USA006489, 1408USA006490, 1408USA006491, 1408USA006492 and 1408USA001809). This case is one (1) of five (5) reports from the same source. Additional information has been requested.
Age: 46.0
Sex: M
Vaccine: MMR
Symptoms: Malaise, Neck pain, Pyrexia
Clinical narrative: States began having malaise, neck pain, feverish feeling. Symptoms continued 2 days later. States onset of symptoms was about 2-4 hrs after vaccine administered.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness/swelling at site of injection. Improving each day.
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Red area, approx. 5 cm x 5 cm on (R) arm - swollen and warm to touch with pain reported when stretching out his arm. Treatment - OTC pain medication.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling, Mobility decreased
Clinical narrative: Patient said her arm was swollen and she was unable to lift her arm up for 5 days.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Grand mal convulsion, Syncope, Unresponsive to stimuli, Urinary incontinence
Clinical narrative: Syncope, incontinent of urine, tonic/clonic seizure like activity lasting 30-45 sec. Observation, no other treatment provided. Remained unresponsive approx. 2 minutes.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient called on 8-11-14 and said had two red quarter sized circular areas around injection site. She said it started itching on 8-10-14 and found red areas on 8-11-14.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Patient called on 8-11-14 and said had two red quarter sized circular areas around injection site. She said it started itching on 8-10-14 and found red areas on 8-11-14.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This sponanteous report as received from a healthcare worker refers to a patient of unknown age and unknown gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 28-JUL-2014 the patient was vaccinated with (Oka/Merck) VARIVAX (lot # not provided) 0.5 ml, subcutaneous. The (Oka/Merck) VARIVAX was improperly stored which exposed to 8.5F for 20 minutes on multiple occasions to total time of ten hours. No adverse effect was reported. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: HEP, HEPA, IPV, MMR, VARCEL
Symptoms: Syncope
Clinical narrative: Vaccinated 8 yr old - Appeared fine while vaccinated - at cashiers door - fainted on floor. Brought in by aunt.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling, redness at injection site. Swelling 3.25" x 2.5".
Age: 47.0
Sex: F
Vaccine: FLUC3
Symptoms: Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient arm was sore and continued to get worse and go down arm and up over shoulder. Had a few days where couldn't move arm, recovering and doing physical therapy.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site swelling
Clinical narrative: Swelling of right thigh x3 days, after vaccine was admin. of DTaP vaccine.
Age: 68.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site inflammation, Injection site pain, Injection site pruritus
Clinical narrative: Inflammation, pain, itchy around injection site.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Injection site pain
Clinical narrative: Left shoulder pain and chills.
Age: 44.0
Sex: M
Vaccine: TDAP
Symptoms: Angioedema, Cough, Headache, Nasal congestion, Wheezing
Clinical narrative: Headache, angioedema, cough, wheeze and nasal congestion.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Dysphagia, Throat irritation
Clinical narrative: Difficulty swallowing, itching throat.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site urticaria, Injection site warmth
Clinical narrative: Red cellulitis looking welt at site of injection. Site was warm to the touch. Referred to PCP.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Red cellulitis looking welt at site of injection. Site was warm to the touch. Referred to PCP.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Hypoaesthesia
Clinical narrative: Numbness in extremities.
Age: 41.0
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 41 year old patient. On 01-AUG-2014 the patient was vaccinated with an expired dose of M-M-R II, lot# H012572, expiration date: 29-JUN-2014, 0.5 ml, subcutaneous. The reported stated that the dose of M-M-R II had not been exposed to any temperature excursions. The patient had not reported or demonstrated any adverse effects. The outcome of events was unknown. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old male patient. The patient's pertinent medical history and drug reactions/allergies were not reported. On 06-AUG-2014 the patient was vaccinated with a dose of expired ZOSTAVAX (dose and route not reported) lot# H019420 expiration date 23-APR-2014. No adverse effects reported at this time. 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 healthcare worker, office manager, refers to an unknown umber of patients of unknown age and gender. Concomitant medication and pertinent medical history were not provided. On unspecified dates the unknown number of patients were vaccinated with doses of GARDASIL (lot#, dose, route and frequency were not provided), which were exposed to supported temperatures out of range. No adverse effect has been observed or reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown gender aged between 12 months old who on 17-JUL-2014, the patient was vaccinated at the same time with PROQUAD (Merck) (Lot # K007155 expiration date 12-NOV-2015) (dose not provided), subcutaneous and VARIVAX (Merck) (Lot # J014129 expiration date 07-NOV-2015) (dose and route not provided) at the same office visit. No adverse effects reported. No further information is available at this time. This is one of several reports from same source. Additional information has been requested.
Age: 1.01
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown gender aged between 12 months old who on 16-JUL-2014, the patient was vaccinated at the same time with PROQUAD (Merck) (Lot # K007155 expiration date 12-NOV-2015) (dose not provided), subcutaneous and VARIVAX (Merck) (Lot # J014129 expiration date 07-NOV-2015) (dose and route not provided) at the same office visit. No adverse effects reported. No further information is available at this time. This is one of several reports from the same source. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Injection site erythema, Injection site induration
Clinical narrative: This spontaneous report was received from a physician concerning a 65 year old male patient with allergy/drug reaction to non-steroidal anti-inflammatory drug. On 31-JUL-2014, the patient was vaccinated with a dose of PNEUMOVAX23 lot# J007786, expiration date 25-SEP-2014 (also reported as 08-MAR-2015), 0.5 ml, intramuscular. Co-suspect and concomitant therapies were not reported. Physician reported that on 02-AUG-2014, patient experienced induration, erythema at the injection site and temperature of 101.7, after receiving PNEUMOVAX23. At the time of the report, induration and erythema at the injection site has persisted; however, temperature has resolved, in August 2014. Patient received treatment with an ice pack and Tylenol and seek medical attention. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product packaging quantity issue
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. Medical history was not reported. The reporting pharmacist informed that on an unknown date, dur to an under filled sterile diluent vial, it caused a patient, did not be able to receive a dose of ZOSTAVAX (lot number, expiration date, strength and route were not reported). Concomitant therapy was not reported. No adverse reactions were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a respiratory therapist refers to a three unspecified patients, age and gender were unknown. Medical history was not reported. The respiratory therapist informed that between 01-FEB-2014 through 31-MAY-2014 the patients were vaccinated with GARDASIL injection, (route, strength and dosage were not reported), which was improperly stored. The possible lots involved included: H018755 expiration date 21-MAR-2015; T005679, expiration date: 27-NOV-2015 and T007850, expiration date: 07-APR-2016. Concomitant therapy was 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: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number patients of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. The nurse reported that the patients received doses of (Oka/Merck) VARIVAX INJ (lot numbers, doses, and route not provided), on unspecified dates, that were exposed to temperatures outside of the proper storage range. No adverse effect 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 certified medical assistant refers to unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with 0.5 ml doses of (Oka/Merck) VARIVAX (lot # not reported) subcutaneously that were improperly stored due to temperature excursions. No adverse effects were reported. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a medical assistant refers to an unspecified number of patients of unknown age and gender. On an unknown date the multiple unspecified patients were vaccinated with GARDASIL (lot#, dose, frequency and route unspecified) that was stored improperly. No adverse effects reported. The outcome of the event was unknown. Follow up information has been received from the medical assistant refers to an 11 year old male patient with no illness at time of vaccination and allergy to BENADRYL. On 06-MAY-2014 08:00 AM the patient was vaccinated with his third dose of GARDASIL (lot number reported as J006350), intramuscular in the left deltoid. This one of the several reports received from the same source (linked case # 1406USA010643 and 1408USA006901). Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4, HPV4
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 an unknown date the multiple unspecified patients were vaccinated with GARDASIL (lot#, dose, frequency and route unspecified) that was stored improperly. No adverse effects reported. The outcome of the event was unknown. Follow up information has been received from the medical assistant refers to an 11 year old male patient with no illness at time of vaccination and allergy to BENADRYL. On 06-MAY-2014 08:00 AM the patient was vaccinated with his third dose of GARDASIL (lot number reported as J006350), intramuscular in the left deltoid. This one of the several reports received from the same source (linked case # 1406USA010643 and 1408USA006901). Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a medical assistant refers to an unspecified number of patients of unknown age and gender. On an unknown date the multiple unspecified patients were vaccinated with GARDASIL (lot#, dose, frequency and route unspecified) that was stored improperly. No adverse effects reported. The outcome of the event was unknown. Follow up information has been received from the medical assistant refers to a 12 year old male patient with no known drug allergy and no illness at time of vaccination. On 01-APR-2014 15:00 PM the patient was vaccinated with his first dose of GARDASIL (lot number reported as J006350), intramuscular in the left deltoid. This is one of the several reports received from the same source (linked case # 1406US0106543 and 1408USA006902). Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV4, HPV4
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 an unknown date the multiple unspecified patients were vaccinated with GARDASIL (lot#, dose, frequency and route unspecified) that was stored improperly. No adverse effects reported. The outcome of the event was unknown. Follow up information has been received from the medical assistant refers to a 12 year old male patient with no known drug allergy and no illness at time of vaccination. On 01-APR-2014 15:00 PM the patient was vaccinated with his first dose of GARDASIL (lot number reported as J006350), intramuscular in the left deltoid. This is one of the several reports received from the same source (linked case # 1406US0106543 and 1408USA006902). Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Blood test, Immediate post-injection reaction, Seizure like phenomena, Syncope
Clinical narrative: This spontaneous report has been received from a nurse via a field employee refers to a 16 year old male patient. In approximately June 2014 (About two months ago) the patient was vaccinated with a dose of GARDASIL (dose, strength, lot number and exp date were unknown). During the same visit, patient also received VARIVAX (Merck), VAQTA, MENACTRA (manufacturer not specified) and two other unspecified vaccinations (manufacturer not specified). The nurse reported the patient experienced seizure like symptoms and fainted after receiving the GARDASIL vaccination immediately (in approximately June 2014). Patient sought unspecified medical attention and no treatment was given no treatment for AEs. Blood test was performed but result was unknown. Nurse also reported that patient returned for a follow-up visit (date not specified) and he was fine and no longer had symptoms. Upon internal review, seizure like symptoms was considered to be medically significant. Additional information is not expected.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza B virus test positive
Clinical narrative: Pt. positive for flu type b after flu vaccine.
Age: 0.58
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Abdominal X-ray, Enema administration, Intussusception, Ultrasound abdomen
Clinical narrative: The patient had rotavirus vaccine #2 on 8/5. On 8/10 - had a documented intussusception that was reduced by an air contrast enema.
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Chest discomfort, Eye swelling, Lip swelling, Sneezing, Swelling face
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 13 year old male patient who was born prematurely. On 06-AUG-2014 the patient was vaccinated with unspecified dose of VARIVAX, (0.5 ml, subcutaneously) (lot # K002912, exp date: 26-FEB-2014). Other suspect vaccines, administered to the patient on 06-AUG-2014, included MENACTRA (dose, frequency, route of administration: unknown) and ADACEL (dose, frequency, route of administration: unknown). On 06-AUG-2014, according to the patient's mother, he experienced sneezing, swelling of the face, eyes and lips and severe chest tightness. The patient sought medical attention. He was treated at the hospital (reported as went emergency room) (date unknown in August 2014) with unspecified intravenous (IV) medication. He was discharged (date unknown in August 2014) on prednisone (manufacturer unknown). Laboratory test were not reported. The outcome of severe chest tightness, swelling of the face, eyes and lips and sneezing was recovered reported as the patient "was fine" on 07-AUG-2014. The relatedness between the events and vaccines was not reported. Upon internal review, severe chest tightness, swelling of the face, eyes and lips and sneezing were considered medically significant, as the events required treatment with unspecified IV medication. Additional information is not expected, as the further contact was denied by the reporter.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Swollen right leg at injection site. Mom reports large swollen and warm.
Age: 3.0
Sex: F
Vaccine: PNC13, VARCEL
Symptoms: Pyrexia, Rash, Rash vesicular
Clinical narrative: RASH ON ARM AND FEVER.  DEVELOPED CHICKEN POX RASH 4 WEEKS AFTER THE IMMUNIZATION.
Age: 92.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Cellulitis, Nausea
Clinical narrative: Injection PNEUMOVAX 23 right deltoid 8/7/14. 8/9/14 pt call concerning nausea. 8/10/14 pt to ER with cellulitis Rt arm (see picture). ED physician started on IV antibiotics admitted to hospital.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swollen, red at injection site.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Local swelling, Nausea, Tenderness, Vomiting
Clinical narrative: Swelling (R) arm, tenderness w/ nausea, vomiting and diarrhea.
Age: 36.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Dizziness, Fatigue, Feeling abnormal, Gait disturbance, Malaise
Clinical narrative: Dizzy, slow speech, altered gait, fatigued, "felt funny" low grade fever malaise.
Age: 36.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Pyrexia, Slow speech
Clinical narrative: Dizzy, slow speech, altered gait, fatigued, "felt funny" low grade fever malaise.
Age: 36.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Disorientation, Dizziness, Fatigue, Gait disturbance, Influenza like illness
Clinical narrative: Dizzy, slow speech, altered gait, fatigued, "felt funny" low grade fever malaise.
Age: 36.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Myalgia, Pain
Clinical narrative: Dizzy, slow speech, altered gait, fatigued, "felt funny" low grade fever malaise.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Fever with a Tmax of 102 F, persisted for one day, afebrile (98.5 F) since 08/06/2014 10 pm.
Age: 49.0
Sex: M
Vaccine: TD
Symptoms: Local swelling, Musculoskeletal pain, Neck pain, Pain in extremity, Skin warm
Clinical narrative: Patient came to clinic complaining of a sore arm, up into neck and shoulder after receiving TD injection on 7/29/14. The arm was slightly swollen and warm. Patient referred to PCP.
Age: 28.0
Sex: M
Vaccine: ANTH
Symptoms: Blister, Neuralgia, Pruritus, Rash
Clinical narrative: Itching on forehead scalp and nerve pain, rash, blister.
Age: 27.0
Sex: M
Vaccine: SMALL
Symptoms: Blister, Chest pain, Neuralgia, Pruritus, Rash
Clinical narrative: Chest pain, itching on forehead, rash, blisters nerve pain.
Age: 24.0
Sex: F
Vaccine: PPV
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: Information has been received regarding a case in litigation for NUVARING (case #1402USA004226) from a physician concerning an approximately 24 year old female, gravida 1. In 2008, the patient was reported to have questionably received a pneumococcal vaccine (unspecified manufacturer) when she was pregnant. The patient subsequently had a spontaneous abortion. No further details of gestation at time of possible vaccination or at the time of the spontaneous abortion were provided. Upon internal review, spontaneous abortion was determined to be medically significant. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Injection site pain, Injection site warmth, Skin lesion
Clinical narrative: Red round lesion "larger than a silver dollar" per mom; pain and warmth at site; pt to crease of elbow.  No numbness or tingling.
Age: 11.0
Sex: M
Vaccine: DTAP, HEPA, HPV4, MNQ
Symptoms: Abdominal X-ray, Back pain, Blood test, Blood urine present, Cystitis
Clinical narrative: At 3:10 PM, he complained of lower back pain. At 8:30 PM, he urinated blood and at 9:00 PM, was taken to the emergency room. He was diagnosed with a bladder infection.
Age: 11.0
Sex: M
Vaccine: DTAP, HEPA, HPV4, MNQ
Symptoms: Ultrasound kidney
Clinical narrative: At 3:10 PM, he complained of lower back pain. At 8:30 PM, he urinated blood and at 9:00 PM, was taken to the emergency room. He was diagnosed with a bladder infection.
Age: 25.0
Sex: F
Vaccine: FLUC3
Symptoms: Convulsion, Syncope
Clinical narrative: PATIENT FAINTED AND STARTED SEIZING ABOUT 2 MINUTES AFTER RECEIVING HER FLUCELVAX IMMUNIZATION.  SHE SEIZED FOR ABOUT 15 SECONDS.  ONCE THE SEIZURE STOPPED, SHE TOLD ME THAT SHE USUALLY FAINTS AND SEIZES WHEN SHE GETS A SHOT BECAUSE SHE IS SO NERVOUS.  AMBULANCE WAS CALLED.  PATIENT REFUSED CARE.
Age: 1.21
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site rash, Irritability, Malaise, Rash, Rash erythematous
Clinical narrative: Patient woke up not feeling well, acting very cranky. Later that day she developed some rash. By the next morning, rash had spread to include mostly arms and legs, but some on face and trunk as well. Rash was red, raised and a little bit itchy. No other symptoms reported and patient was doing okay. I discussed possibility of varicella like rash from vaccination and for mom to treat symptomatically, refer to PMD as needed. Also discussed need to keep patient home until all rash scabbed over and contact management as a precaution.
Age: 1.21
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Rash pruritic
Clinical narrative: Patient woke up not feeling well, acting very cranky. Later that day she developed some rash. By the next morning, rash had spread to include mostly arms and legs, but some on face and trunk as well. Rash was red, raised and a little bit itchy. No other symptoms reported and patient was doing okay. I discussed possibility of varicella like rash from vaccination and for mom to treat symptomatically, refer to PMD as needed. Also discussed need to keep patient home until all rash scabbed over and contact management as a precaution.
Age: 70.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Guillain-Barre syndrome, Hypoaesthesia, Lumbar puncture, Nasopharyngitis
Clinical narrative: 11/30-12/5/13 cold, fever, cough- 12/3-12/18/13 numbing, tingling - both feet. 12/15/13 ER walk in. Found nothing wrong. 12/17/13 Dr. visit. Diagnosis: Neuropathy. 12/18/13-1/1/14 ER Diagnosis: GBS, Hospitalized and rehab.
Age: 70.0
Sex: F
Vaccine: FLUX
Symptoms: Neuropathy peripheral, Paraesthesia, Pyrexia
Clinical narrative: 11/30-12/5/13 cold, fever, cough- 12/3-12/18/13 numbing, tingling - both feet. 12/15/13 ER walk in. Found nothing wrong. 12/17/13 Dr. visit. Diagnosis: Neuropathy. 12/18/13-1/1/14 ER Diagnosis: GBS, Hospitalized and rehab.
Age: 23.0
Sex: F
Vaccine: YF
Symptoms: Chest discomfort, Palpitations
Clinical narrative: Initial information received on 06 August 2014 from a healthcare professional. A 23 year old female patient received a first dose subcutaneous injection into the left deltoid on 22 July 2014 with YFVAX, batch number UI078AA and 13 days later on 04 August 2014 experienced tightness in her chest, palpitations and no chest pain, off and on and is currently happening. The patient's concomitant medications were not reported. The patient's medical history was reported as NKA, no known allergies and the patient was not ill at the time of vaccination. The patient will be advised to go to emergency or see a physician. No further details were reported. The patient outcome was not recovered. Documents held by sender: None.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse regarding unspecified number of patients of unknown age. Concurrent conditions and medical history were reported. On an unknown dates, the unspecified number of patients were vaccinated with M-M-R II (dosage regimen, lot# and expiration date were not reported) that was stored improperly (inappropriate product storage). No adverse events were reported. No further information was provided. This case is one of several reports from the same reporter. Additional information has been requested.
Age: 0.16
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The reporter stated that, on an unspecified date, and unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share. Follow-up information from the registered nurse who provided patients details. This report refers to a 8 week old infant patient of unknown gender. On 09-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported, lot# J016188, expiration date 02-OCT-2016) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a report as from a registered nurse refers to an unknown number of patients of unknown age and gender. On an unknown date those patients were vaccinated with a dose of VARIVAX (dose, units, route of administration, anatomical location, lot number were not reported) which were improperly stored. No adverse effects reported. Additional information is expected because reporter do not wish to be contacted.
Sex: M
Vaccine: VARCEL, HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a physician refers to a male patient of unknown age. On 03-JUN-2014, the patient was vaccinated with (Oka/Merck) VARIVAX (L) subcutaneously. No concomitant medication was reported. The physician reported that, on 03-JUN-2014, the vaccine that have been administered to the patient that was kept out of range of temperature log. Additional information has been requested.
Sex: M
Vaccine: VARCEL, HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a male patient of unknown age. On 03-JUN-2014, the patient was vaccinated with (Oka/Merck) VARIVAX (L) subcutaneously. No concomitant medication was reported. The physician reported that, on 03-JUN-2014, the vaccine that have been administered to the patient that was kept out of range of temperature log. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a male patient of unknown age. On an unknown date the patient was vaccinated with a dose of GARDASIL (intramuscular, dose, units, anatomical location, lot  number were not reported). On an unknown date the patient almost passed out. The reporter stated that the patient did not technically faint. The patient did not seek medical attention. The outcome of adverse event was not reported. The relatedness between adverse event and GARDASIL was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown demographics. No information about medical history, drug reactions and allergies was specified. The physician reported that on an unknown date in June 2014 an unspecified patient received the 1st dose of ROTATEQ vial (lot#, dose not reported) as well as PREVNAR and PENTACEL "about 2 months ago". No concomitant medications were reported. The unspecified patient then developed severe diarrhea that lasted "about 2 weeks". There was no product quality complaint. The action taken, outcome and causality is unknown. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Chest X-ray normal, Headache, Pyrexia, Rhinorrhoea, Sinusitis
Clinical narrative: This spontaneous report was received from a currently 54 year old female patient with a ragweed and sulfa allergy. The patient's medical history included CVIC (Common Variable Immunodeficiency) and the patient was taking IVIG infusions for a long period of time. The physician took her off the infusions at the end of January 2013. On 13-AUG-2013 the patient was vaccinated with a first does of PNEUMOVAX23 (dose and lot number were not reported) . She did not have any adverse reaction to the first administration of the vaccine. Within 9 months from the first dose, on 30-MAY-2014, the patient was re-vaccinated with a second dose of PNEUMOVAX23 (dose and lot # were not reported). Concomitant therapies included doxycycline. On 02-JUN-2014, the patient experienced low grade temperature which listed for about one month (approximately in July 2014), she developed a headache and sinus infection with large amounts of "snot" and now has gotten into her lungs. The patient sought a medical attention. Her physician took a lung x-ray and said she did not have a pneumonia. There was no treatment give for the adverse events. The outcomes of the headache and sinus infection with large amounts of "snot" and has now gotten into her lungs were reported as not recovered/not resolved. The relationship between the PNEUMOVAX23 and the events was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The pharmacist reported that the patient was vaccinated with a dose of RECOMBIVAX HB injection (10Y) on 14-NOV-2014 and the second dose on 07-AUG-2014. No adverse effects reported. No further information provided. No PQC. Outcome of the event was unknown. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Conjunctivitis infective, Lymphadenopathy, Swelling face, Tonsillitis
Clinical narrative: This spontaneous report as received from a consumer via company representative refers to a 15 year old female patient (consumers daughter). On specified date, patient begin her series of GARDASIL injection (120 Y). Approximately on an unknown date in July 2014 (also reported as about 1 month ago), patient received her second injection of GARDASIL. Within 24 hours, patient developed swollen lymph nodes. This progressed to swollen side of face. Patient was seen by her physician and diagnosed with pink eye and tonsillitis (approximately on an unknown date in July 2014). She sought medical attention and received unspecified treatment and issue resolved (approximately on an unknown date in July 2014). No additional information was given by this reporter. There was no PQC. Outcome of the reported events was recovered. Causality of the event was unknown. Additional information is not expected.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from healthcare worker refers to a patient of unknown age. The reporter stated that the patient received a second dose of VAQTA (50/1.0 IU/ML) injection. Healthcare worker stated the patient received VAQTA on 21-MAR-2013 and 16-SEP-2013. No adverse symptoms reported. No further information provided. No product quality complaint issue was reported. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of drug administration, Measles antibody negative, No therapeutic response, Rubella antibody negative, Viral titre increased
Clinical narrative: This spontaneous report as received from a physician refers to a 16 year old female patient. The reporter stated that the patient received M-M-R II (also reported as M-M-M) on 01-JAN-1998 and 12-SEP-2012. No medical conditions and medical history was reported. The physician also stated that patient was healthy with no immunosuppression or immunocompromise. Concomitant medications were not reported.  On 25-JUN-2014 the patient visited physician for revaccination because of an unspecified date titers were performed and the titers were negative for measles and rubella but was barely positive for mumps. ON 25-JUN-2014 the patient was vaccinated with M-M-R II. The vaccine dose was administered intramuscularly. The outcome of the event was unknown. The patient experienced same event while on therapy with VARIVAX (captured in case# 1407USA001603).  Follow up information has been received from the physician. Information about administration of M-M-R II was updated. patient demographics was updated. Patient current condition included allergy to sulfa containing drugs. On 25-JUN-2014 at 10:30 AM, patient received third dose of M-M-R II (dose 3) (lot # J008533, expiry date: 12-JUL-2015) in left deltoid intramuscularly because of non-responder as documented by negative titers after 2 previous vaccine were given intramuscularly instead of subcutaneously. Relevant diagnostic test and laboratory data were reported as none. There was no other adverse event following prior vaccination. Illness at the tine of vaccination was reported as none. Vaccine was purchased with public fund and vaccinated at public health clinic or hospital. 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 physician refers to a patient of unknown age and gender. Medical history and drug reactions or allergies were not specified. On 07-AUG-2014, the patient inadvertently received an expired dose of PNEUMOVAX23 (dose, dose number and route were not reported) batch number H022064, lot number 0291AEm expiration date 25-JAN-2014. No adverse effect was reported. Concomitant medications were not specified. 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 regarding unspecified number of patients of unknown age. Concurrent conditions and medical history were not reported. On an unknown dates, the unspecified number of patients were vaccinated with (Oka/Merck) VARIVAX (dosage regiment, lot # and expiry date were not reported) that was stored improperly (inappropriate product storage). No adverse events were reported. No further information was provided. This case is one of several reports from 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 physician refers to an unspecified number of patients of unknown age. Physician reported that since 21-JUL-2014, an unspecified number of patients had been administered (Oka/Merck) VARIVAX (dose, lot#, expiration date not reported), subcutaneous) that had been improperly stored. This was supported. No adverse effects was reported. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Seizure.
Age: 0.59
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site erythema, Injection site nodule, Injection site reaction, Injection site warmth, Irritability
Clinical narrative: Vaccine given July 28.  The mother noted "knots" on her legs and she was fussy.  Then Aug 6 the mother noted a round lesion and brought her to see her regular primary care provider.  She was treated with a topical antifungal for possible ringworm.  It did not get better, and the mother brought her to see me today, Aug 12.  I noted an oval, red/pink papulovesicular eruption, sharply demarcated, with a small "blister" in the center.  It is not tender and very slightly warm to touch.  It is located on the upper lateral left thigh, consistent with the location of the Prevnar.  Photo was taken.
Age: 0.59
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Rash papular, Skin lesion
Clinical narrative: Vaccine given July 28.  The mother noted "knots" on her legs and she was fussy.  Then Aug 6 the mother noted a round lesion and brought her to see her regular primary care provider.  She was treated with a topical antifungal for possible ringworm.  It did not get better, and the mother brought her to see me today, Aug 12.  I noted an oval, red/pink papulovesicular eruption, sharply demarcated, with a small "blister" in the center.  It is not tender and very slightly warm to touch.  It is located on the upper lateral left thigh, consistent with the location of the Prevnar.  Photo was taken.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Feeling hot, Rash, Swelling
Clinical narrative: REDNESS, HOT, RASH APPEARANCE AND SWELLING, WAS GIVEN ANTI-BIOTIC.
Age: 4.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Injection site rash
Clinical narrative: Rash all around injection site within ten minutes.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Dysgeusia, Paraesthesia oral
Clinical narrative: Metallic tast in mouth and upper lip tingling.
Age: 48.0
Sex: F
Vaccine: TD
Symptoms: Local swelling, Rash
Clinical narrative: Came in with a rash and bump on her arm.
Age: 8.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Feeling hot, Rash, Swelling
Clinical narrative: RED, BUMPY, SWOLLEN, HOT.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Feeling hot, Rash, Swelling
Clinical narrative: RED, BUMPY, HOT, SWOLLEN.
Age: 1.52
Sex: F
Vaccine: DTAP, HEPA, PNC
Symptoms: Hyperhidrosis, Pyrexia
Clinical narrative: Went down for a nap at 4 PM. Woke up with soaked shirt from sweat. Fever of 104. Fever continued for over 24 hours, never going below 102 degrees F.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Dyskinesia, Excessive eye blinking, Gaze palsy, Respiration abnormal, Tic
Clinical narrative: Sudden onset of his face making abnormal movements, similar to tics.  Extra blinking of eyes, squinching of his nose (like a bunny), looking downward with eyes only and occasional gulping sound heard from mouth/deep sigh.  No particular order of the symptoms noted yet, no prior hx of these symptoms.  Patient denies his eyes hurting, or itchy.  When asked if there is anything wrong and why he is doing it he told me today that "my face just does it." I was advised on 08/01/2014, that day at this physical that all his exams and studies were normal, by his MD, just prior to his IZ injected.  His vision and hearing were checked that day also. His symptoms appear to be increasing in how often it is occurring.  Otherwise, he is playful, talkative and acting age appropriate.
Age: 1.25
Sex: M
Vaccine: HIBV, MMR
Symptoms: Convulsion
Clinical narrative: Seizure lasting <1 minute.
Age: 12.0
Sex: M
Vaccine: HPV4, MEN
Symptoms: Erythema, Induration, Pain in extremity
Clinical narrative: Pain and large (3 inches diameter), hard, red circle on arm lasting for two days so far.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse regarding unspecified number of patients of unknown age. Concurrent conditions and medical history were not reported. On an unknown dates, the unspecified number of patients were vaccinated with PNEUMOVAX23 (dosage regimen, lot # and expiry date were not reported) that was stored improperly  (inappropriate product storage). No adverse events were reported No further information was provided. This case is one of several reports from 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 nurse regarding unspecified number of patients of unknown age. Concurrent conditions and medical history were not reported. On an unknown dates, the unspecified number of patients were vaccinated with ROTATEQ (dosage regimen, lot # and expiry date were not reported) that was stored improperly (inappropriate product storage). No adverse events were reported. No further information was provided. This case is one of the several reports from same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist to a patient of unknown age and gender. On 14-JUL-2014 the patient was vaccinated in error with a dose of expired ZOSTAVAX (dose not reported) subcutaneously, lot# H013940, expiration date: 25-OCT-2013. No known adverse effects reported. 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 healthcare refers to an unspecified amount of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates, an unspecified amount of patients were vaccinated with doses of GARDASIL (lot number, dose and route were not reported) that underwent a temperature excursion. Concomitant therapies were not reported. No adverse effect was reported. Follow up has been received from a registered nurse, who provided the lot numbers for the GARDASIL that experienced temperature excursion. The following lot numbers were reported: lot number reported as J0105378 (expiration date 09-APR-2016) (captured in this report) and lot number J006850 (expiration date 31-MAR-2016) (captured in MARRS# 1406USA011141). Lot number J0105378 is an invalid lot number for GARDASIL. 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 nurse refers to an unspecified number of patients. On an unknown date the patients were vaccinated with ROTAEQ which were improperly stored (lot#, strength and dosage unknown) orally. No adverse effects reported. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.