chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a  62 year old female patient with no pertinent medical history and no drug reactions or allergies. On 17-SEP-2014, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # K007773, expiration date 01-MAY-2015) in the left deltoid area (dose and route not reported). Concomitant therapies included losartan potassium (manufacturer unknown), vitamin D, VENTOLIN and metoprolol. On 17-SEP-2014, within hours after receiving the injection, the patient experienced swelling the size of a baseball pain, heat and redness at the PNEUMOVAX 23 injection site on her left deltoid. The patient returned to the office the same day and received 25mg BENADRYL intramuscularly (IM) and a prescription for prednisone to address the symptoms. No lab diagnostics studies were performed. The patient recovered from injection site pain and swelling. The outcome of injection site heat and redness was reported as recovering as it was reported: "A call was placed to the patient a few days later and the swelling and pain was gone and she was feeling better". The physician did not want to use the remaining PNEUMOVAX 23 vaccine with this lot number in her office and requested a time sensitive lot check. This is one of several reports from the same source. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: 50 cent size red hot lump at injection site that evening. By morning thigh was red. He was still active and wasn't complaining of it. By today reaction site was improved.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Pain
Clinical narrative: Next day, severe pain-could not even walk, all down right side. Still suffering pain, near 2 years. Shots in shoulder help, pain 3 every 3 months.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Itchy red rash on left and center of neck. Patient states she started BENADRYL Tues 9/23 and hydrocortisone. On 9/26 urgent care doctor told patient to use cetirizine, prednisone and famotidine.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to 2 patients of unknown age and gender. On 20-SEP-2014 those patients were vaccinated with an expired dose of PNEUMOVAX23 (lot # H010515, expiry date: 13-FEB-2014, dose, units, route of administration, anatomical location were not reported). No adverse effects reported. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Blood pressure orthostatic, Cyanosis, Dizziness, Eye movement disorder, Heart rate decreased
Clinical narrative: Lightheaded, dizzy, eyes rolled back, cyanotic mouth, grunt - passed out for roughly 10 seconds. Monitored in office for 1 hr x 2 more episodes "light headed" after passing out hr lower 50's orthostatic by BP.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Loss of consciousness
Clinical narrative: Lightheaded, dizzy, eyes rolled back, cyanotic mouth, grunt - passed out for roughly 10 seconds. Monitored in office for 1 hr x 2 more episodes "light headed" after passing out hr lower 50's orthostatic by BP.
Age: 45.0
Sex: F
Vaccine: TD
Symptoms: Arthralgia, Back pain, Body temperature increased, Chills, Hypoaesthesia
Clinical narrative: Pt states she had a reaction to the TD shot. She states she was achy in all her joints, back, numbness in all extremities, arm was swollen and continues but not as bad, Temp of 101.4 with chills and she has never had a reaction before. Pt still doesn't feel well but is improving.
Age: 45.0
Sex: F
Vaccine: TD
Symptoms: Local swelling
Clinical narrative: Pt states she had a reaction to the TD shot. She states she was achy in all her joints, back, numbness in all extremities, arm was swollen and continues but not as bad, Temp of 101.4 with chills and she has never had a reaction before. Pt still doesn't feel well but is improving.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient c/o pain and swelling in L upper extremity, located at site of PNEUMOVAX, he denies any fever or chills, states swelling started yesterday and has gotten progressively worse. L uppe arm with induration and redness from shoulder to elbow and extending aroudn to medial aspect, warm and tender to palp. Circulation intact to distal aspect of L UE.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site joint movement impairment, Injection site pain, Joint stiffness, Pain, Paraesthesia
Clinical narrative: On 5/5/13 pt calls to report increased left upper arm pain after TDAP 0.5 ml IM given on 4/29/13. She states the injection site is not red and is not swollen. She does report tingling sensation to left had at times, like it's asleep and waking up. Seen by physician on 5/6/13. S: is c/o pain on moving the left shoulder joint and no fall or any injury to the left upper extremity. Left shoulder ROM restricted and also c/o finger ruing is tight. No pain in the hand, forearm or arm on rest. It becomes painful on moving the shoulder. She denies any pain at shot site today. She has applied moist heat at local injection site.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a patient of unknown age and gender. Healthcare worker reported that on 18-SEP-2014, the patient was vaccinated with an expire dose of M-M-R II (lot # reported as H017046, expiration date 17-SEP-2014). No adverse effects reported. Additional information is not expected.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal distension, Local swelling, Pruritus, Swelling face
Clinical narrative: Rash and swelling bil hands, arms, legs and face and abd wall, along with itching.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Mobility decreased, Myalgia, Pain in extremity
Clinical narrative: This spontaneous report as received from a 74 (approximately) year old female patient regarding herself. Patient had penicillin (manufacturer unknown) allergy. Patient never had chickenpox. In 2013, the patient was vaccinated with ZOSTAVAX, 1 single shot, subcutaneously. Concomitant therapies included steroids (dosage/frequency/manufacturer unknown). Approximately in 2013, shortly after vaccination, the patient's left arm began to ache so badly in the muscle and joint that patient could hardly move it. No lab tests were performed. Unspecified gel medication was used for the treatment. The outcome of my left arm began to ache so badly in the muscle and joint that patient could hardly move it was reported as not recovered. It was reported that patient sought medical attention> The causality of the event was not reported. No product quality complaint was involved. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Feeling abnormal, Headache, Malaise
Clinical narrative: Patient felt like passing out 9.30.14 dizzy - 9.30.14. Headache 10-1-14 in am. Not feeling well, foggy 10-1-14 am.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to a 17-year old female patient with a diagnosis of costochondritis (Tietze's Syndrome) who had no known drug allergies and no illness at time of vaccination. This report did not correspond to a patient vaccinated with ROTATEQ. Instead, the reporter informed that this patient was vaccinated with the third dose of GARDASIL (intramuscular injection, batch/lot # J008423, expiration date 21-JAN-2016, in the right arm, route not reported), on 25-FEB-2014 at 2:30 PM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event also reported as 27-FEB-2014 at 10:00 AM). The patient did not repeat vaccination dose. No adverse event was reported for the patient. The outcome was reported by the reporter as recovered on 25-APR-2014. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
Age: 1.56
Sex: M
Vaccine: HIBV, DTAP, HIBV, PNC13
Symptoms: Injection site cellulitis, Injection site nodule
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a 17 month old male patient with no pertinent medical history of drug reactions/allergies. On 11-SEP-2014, the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose number was not reported), 0.5 ml, lot number and expiration date reported as K004540 03-DEC-2016, intramuscular route for immunization. Other suspect therapies included PREVNAR 13. Medical assistant reported that patient was taken to emergency room (ER) (name and location unspecified) on unspecified date for injection site reaction but patient was not admitted. Patient was brought in to office on 17-SEP-2014 (reported as today) and was diagnosed with cellulitis around injection site. Medical assistant also reported that there was a small knot around injection site. At the time of report the outcome was reported as recovering. Patient sought medical attention at the ER and office visit. Patient received ROCEPHIN and unspecified oral antibiotic from the ER. Additional information has been requested.
Age: 1.56
Sex: M
Vaccine: HIBV, DTAP, HIBV, PNC13
Symptoms: Blood test normal, Injection site cellulitis, Injection site nodule, Injection site reaction, Injection site swelling
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a 17 month old male patient with no pertinent medical history of drug reactions/allergies. On 11-SEP-2014, the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose number was not reported), 0.5 ml, lot number and expiration date reported as K004540 03-DEC-2016, intramuscular route for immunization. Other suspect therapies included PREVNAR 13. Medical assistant reported that patient was taken to emergency room (ER) (name and location unspecified) on unspecified date for injection site reaction but patient was not admitted. Patient was brought in to office on 17-SEP-2014 (reported as today) and was diagnosed with cellulitis around injection site. Medical assistant also reported that there was a small knot around injection site. At the time of report the outcome was reported as recovering. Patient sought medical attention at the ER and office visit. Patient received ROCEPHIN and unspecified oral antibiotic from the ER. Additional information has been requested.
Age: 1.56
Sex: M
Vaccine: HIBV, DTAP, HIBV, PNC13
Symptoms: Pyrexia, Staphylococcal infection, Staphylococcus test negative, Viral infection
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a 17 month old male patient with no pertinent medical history of drug reactions/allergies. On 11-SEP-2014, the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose number was not reported), 0.5 ml, lot number and expiration date reported as K004540 03-DEC-2016, intramuscular route for immunization. Other suspect therapies included PREVNAR 13. Medical assistant reported that patient was taken to emergency room (ER) (name and location unspecified) on unspecified date for injection site reaction but patient was not admitted. Patient was brought in to office on 17-SEP-2014 (reported as today) and was diagnosed with cellulitis around injection site. Medical assistant also reported that there was a small knot around injection site. At the time of report the outcome was reported as recovering. Patient sought medical attention at the ER and office visit. Patient received ROCEPHIN and unspecified oral antibiotic from the ER. 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 refers to a patient of unknown age and gender. On 30-SEP-2014 the patient was vaccinated with ZOSTAVAX, subcutaneous, (lot # J07211 exp date: 20-SEP-2014) dose and frequency not provided. No adverse effects reported. No further information provided. The outcome of Expired vaccine used was unknown. The reporter considered Expired vaccine used to be not related to ZOSTAVAX. Additional information has been requested.
Age: 0.21
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Urticaria
Clinical narrative: Vaccine admin 09/26/14, rash (urticarial) started around 1700 that day.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to a 14-year old female patient, who had no known drug allergies and no illness at time of vaccination. This report did not correspond to a patient vaccinated with ROTATEQ. Instead, the reporter informed that this patient was vaccinated with the third dose of GARDASIL (intramuscular injection, batch/lot # J008423, expiration date 21-JAN-2016, in the right arm, route not reported), on 25-FEB-2014 at 2:20 PM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event also reported as 27-FEB-2014 at 10:00 AM). The patient declined to repeat vaccination. No adverse event was reported for the patient. The outcome was reported by the reporter as recovered on 25-APR-2014. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case was received.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Hypersensitivity, Immediate post-injection reaction, Injection site discolouration
Clinical narrative: This spontaneous report was received from a 59 year old female consumer with anxiety, asthma, blood pressure, chronic obstructive pulmonary disease (COPD), sensitivity to many drugs, allergies, lung disorder and heart condition. On 15-SEP-2014, the patient was vaccinated with ZOSTAVAX (dose number, lot number, expiration date and route were not reported) in the left arm as vaccine. Patient reported she was on unspecified medications for many conditions. On 15-SEP-2014, same evening after vaccination the patient had a pink elongated 2 to 3 inches mark at injection site. The patient also experienced light dizziness, racing heartbeat and nausea right after the injection of ZOSTAVAX at the pharmacy. The patient has since maintained a light headache and nausea and the injection site was raised and itchy. The patient returned to the pharmacy and contacted a physician within the last couple of days for consultation. The patient was told she had allergic reaction and advised to use calamine lotion for the itchiness. Although the prescription was given by her physician the patient had the ZOSTAVAX administered at the pharmacy. Patient returned to the pharmacy that administered the ZOSTAVAX. The pharmacist there believed the 2 to 3 inch mark  at the injection site was now infected. At the time od the report the outcome was reported as not recovered. Patient sought medical attention at the pharmacy and consultation with her physician. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site infection, Injection site pruritus, Injection site swelling, Nausea, Palpitations
Clinical narrative: This spontaneous report was received from a 59 year old female consumer with anxiety, asthma, blood pressure, chronic obstructive pulmonary disease (COPD), sensitivity to many drugs, allergies, lung disorder and heart condition. On 15-SEP-2014, the patient was vaccinated with ZOSTAVAX (dose number, lot number, expiration date and route were not reported) in the left arm as vaccine. Patient reported she was on unspecified medications for many conditions. On 15-SEP-2014, same evening after vaccination the patient had a pink elongated 2 to 3 inches mark at injection site. The patient also experienced light dizziness, racing heartbeat and nausea right after the injection of ZOSTAVAX at the pharmacy. The patient has since maintained a light headache and nausea and the injection site was raised and itchy. The patient returned to the pharmacy and contacted a physician within the last couple of days for consultation. The patient was told she had allergic reaction and advised to use calamine lotion for the itchiness. Although the prescription was given by her physician the patient had the ZOSTAVAX administered at the pharmacy. Patient returned to the pharmacy that administered the ZOSTAVAX. The pharmacist there believed the 2 to 3 inch mark  at the injection site was now infected. At the time od the report the outcome was reported as not recovered. Patient sought medical attention at the pharmacy and consultation with her physician. Additional information has been requested.
Age: 2.0
Sex: U
Vaccine: HEP
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report was received from an administrative coordinator and refers to a 2 years old patient of unknown gender. ON 12-SEP-2014 the patient was vaccinated with expired RECOMBIVAX HB (injection, pediatric dose, route of administration, lot # and expiry date were not reported). Additional information is not expected because there is no reporter's contact information and follow up with the physician was declined.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information has been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographics details for each patient were provided. This report referred to a 17-year-old female patient, who was allergic to amoxapine and amoxicillin and had no illness at time of vaccination. This report did not correspond to a patient vaccinated with ROTATEQ. Instead, the reporter informed that this patient was vaccinated with the third dose of GARDASIL (intramuscular injection, batch/lot # J008423, expiration date 21-JAN-2016, in the left arm, route not reported), on 29-JAN-2014 at 9:00 AM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event also reported as 27-FEB-2014 at 10:00 AM). The patient did not repeat vaccination dose at visit on 18-JUN-2014. No adverse event was reported for the patient. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case was received.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness at site of injection, warmth to touch and mild swelling.
Sex: U
Vaccine: VARZOS
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 29-SEP-2014, the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX (lot # J011212, expiration date 29-AUG-2014) (dose, route and site of administration not provided). No adverse effect reported. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site swelling, Injection site warmth
Clinical narrative: Arm red, swollen and warm at injection site. Suggested she take BENADRYL 50 mg x one, ice and continue ibuprofen.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Headache, Hyperhidrosis, Nausea, Peripheral coldness
Clinical narrative: Pt reported a fever of 105 degrees, chills, cold feet, tremors, headache, nausea, sweating for a 12 hour duration.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Tremor
Clinical narrative: Pt reported a fever of 105 degrees, chills, cold feet, tremors, headache, nausea, sweating for a 12 hour duration.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to 2 patients of unknown age and gender. On an unknown date the patients were vaccinated with ZOSTAVAX (dose, strength and lot # not provided). On an unknown date the patients experienced injection site reactions after administration of ZOSTAVAX. The outcome of injection site reactions was reported as recovered/resolved within four days. Relatedness between injection site reactions and ZOSTAVAX was not reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Erythema, swelling, itching 6 inches x 6 inches at the injection site, occurred within 2  hours of injection. Applied cold packs only. No other treatment reqd. Issue has resolved except a little itching persists.
Age: 22.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Convulsion
Clinical narrative: Pt was fine came for physical determined she needed HPV shot #1. No Hx of GBS or allergies or seizures. Gave shot IM rt deltoid within 5 minutes she fell back on exam table and had 30 second seizure and then was alert again. Sent to ER for further evaluation.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to an unknown number of patients of unknown age and gender. Nurse reported that unknown number of doses of improperly stored ROTATEQ (lot # not reported), had been administered to the patients. No adverse effects reported. This is one of several reports from the same reporter source. 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 registered nurse referring to an unknown number of patients of unknown age and gender. Nurse reported that unknown number of doses of improperly stored RECOMBIVAX HB (lot # not reported), had been administered to the patients. No adverse effects reported. This is one of several reports from the same reporter source. Additional information has been requested.
Age: 41.0
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a 41 year old patient of unknown gender. Medical history and concurrent conditions were not reported. In 2004, the patient was vaccinated with PNEUMOVAX 23 dose 1, 0.5 ml. In 07-OCT-2009 the patient received the second dose of PNEUMOVAX 23. Lot number and expiration date were not reported. No adverse experience reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Customer came to pharmacy 2 days later. Stated arm at injection site felt hot to touch was itchy and red, stated on day after injection. customer was counseled to apply cold compress, take BENADRYL and TYLENOL. Pt. will f/u with dr. if need be.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Customer came to pharmacy 2 days later. Stated arm at injection site felt hot to touch was itchy and red, stated on day after injection. customer was counseled to apply cold compress, take BENADRYL and TYLENOL. Pt. will f/u with dr. if need be.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to an unknown number of patients of unknown age and gender. Nurse reported that unknown number of doses of improperly stored GARDASIL (lot # not reported), had been administered to the patients. No adverse effects reported. This is one of several reports from the same reporter source. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographics details for each patient were provided. This report referred to an 11-year old male patient with polycystic kidney, who had no known drug allergy and had no illness at time of vaccination. This report did not correspond to a patient vaccinated with ROTATEQ. Instead, the reporter informed that this patient was vaccinated with the first dose of GARDASIL (intramuscular injection, batch/lot # J008423, expiration date 21-JAN-2016, in the left arm, route not reported), on 25-FEB-2014 at 12:10 PM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event also reported as 27-FEB-2014 at 10:00 AM). The patient did not return call. No adverse event was reported for the patient. The outcome was reported as unknown. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
Age: 56.0
Sex: M
Vaccine: TDAP
Symptoms: Dyspnoea
Clinical narrative: Dyspnea
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Back pain
Clinical narrative: Patient also on oxymorphone for back pain which could have contributed to his weakness.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dyspnoea, Flushing, Injection site pain, Paraesthesia
Clinical narrative: Within 5 minutes of administration, face flushed, spread to ears, neck, arms, chest with tingling sensation/"pins and needles" in B/L arms and hands - lasted approximately 1 hour followed by light SOB and weakness that lasted another hour. Injection site and upper arm sore.
Age: 73.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site rash, Injection site streaking, Injection site swelling
Clinical narrative: Immediately after vaccinations, injection sites were hot and red. This continued and about 3 days ago, a rash like streak appeared w/bumps and swelling. It does not hurt. Primary doctor suggested he put ice on it and notify him if this continues. Rash extended from injection site to elbow.
Age: 73.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Injection site warmth
Clinical narrative: Immediately after vaccinations, injection sites were hot and red. This continued and about 3 days ago, a rash like streak appeared w/bumps and swelling. It does not hurt. Primary doctor suggested he put ice on it and notify him if this continues. Rash extended from injection site to elbow.
Age: 22.0
Sex: M
Vaccine: HEPAB
Symptoms: Dry mouth, Dysphagia, Dyspnoea, Headache
Clinical narrative: TWINRIX admin at 1126. Pt had dry mouth, shortness of breath difficulty swallowing approx. 10 min after. Pt has headache 3hrs after.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Local swelling, Malaise, Pain, Pyrexia
Clinical narrative: Localized swelling, soreness, fever, malaise. TX: TYLENOL, rest, fluids, f/u appt as needed.
Age: 19.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to a 14-year-old male patient, who was allergic to cephalexin and had no illness at time of vaccination. This report did not correspond to a patient vaccinated with ROTATEQ. Instead, the reporter informed that this patient was vaccinated with the first dose of GARDASIL (intramuscular, batch/lot # J008423, expiration date 21-JAN-2016, in the left arm, route not reported, on 06-FEB-2014 at 11:02 AM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event also reported as 27-FEB-2014 at 10:00AM). The patient's parent never called back. No adverse event was reported for the patient. The reporter reported the outcome as unknown. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site rash
Clinical narrative: Slight reaction to DTAP (R) deltoid. (Rash)
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Temp 37.4 degrees. Pulse 88. BP 98/62. Treated with KEFLEX 250/5mL 8 mls 30 day. Ibuprofen 100 mg chew tid prn. Came to see dr for fever and sore arm.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to a 17-year old female patient, who had no known drug allergies and no illness at time of vaccination. This report referred to a 17-year old female patient, who had no known drug allergies and no illness at time of vaccination. This report did not correspond to a patient vaccinated with ROTATEQ. Instead, the reporter informed that this patient was vaccinated with the first dose of GARDASIL (intramuscular injection, batch/lot # J008423, expiration date 21-JAN-2016, in the right arm, route not reported, on 04-FEB-2014 at 12:20 PM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event also reported as 27-FEB-2014 at 10:00 AM). No adverse event was reported for the patient. The outcome was reported by the reporter as unknown. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Pain, Synovitis
Clinical narrative: Transient synovitis Rt hip. Decreased ROM, pain.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Local swelling, Pain in extremity
Clinical narrative: Pain, swelling, and numbness to whole arm shoulder to hands.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Syncope, Tooth fracture
Clinical narrative: HPV #3 given per LPN on 9/23/14. Approximately 5 minutes after getting vaccine she fainted falling on floor and chipping two upper front teeth. Dentist was seen after. Pt will need permanent crowns for teeth.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Arm is red not where shot was given but underneath the arm close to the arm pit. It is swollen under her arm too. They think she may have had an allergic reaction to shot.
Age: 1.32
Sex: F
Vaccine: VARCEL
Symptoms: Abdominal pain upper, Allergy test, Food allergy
Clinical narrative: This spontaneous report was received from a healthcare professional concerning a 1 year old female patient with speech delay, mentally delayed and with no drug reaction/allergies. On 12-DEC-2012, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (dose, dose number, lot number, expiration date and route were not reported) for routine. No concomitant therapies were used by the patient at the time of the event. The healthcare worker reported that she was informed by a mother the patient, that patient developed a sensitivity to eating eggs after receiving (Oka/Merck) VARIVAX, since an unknown date. The healthcare worker reported that before receiving the (Oka/Merck) VARIVAX, the child was able to eat eggs fine but after receiving the (Oka/Merck) VARIVAX, patient got stomach pain after she ate eggs. The healthcare worker reported that an allergy lab panel was performed on 11-SEP-2014 (reported as about week ago), on the child and the result of the panel states that the child was not allergic to eggs. At the time of the report the outcome was reported as not recovered. Patient sought medical attention on approximately on 11-SEP-2014 (reported as a week ago). Patient did not received treatment for the adverse event. Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: MMRV
Symptoms: Dermatitis diaper, Injection site erythema, Mouth ulceration, Rash pustular
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 1 year old female patient with no pertinent medical history or drug reactions/allergies. On 08-SEP-2014 the patient was vaccinated with a dose of (Oka-Merck) PROQUAD (dose, dose number, lot number, expiration date and route were not reported). No co-suspect and concomitant therapies were used by the patient at the time of the report. The pharmacist reported the patient developed a severe diaper rash, with pustules, on 11-SEP-2014 (reported as 2-3 days) after administration of (Oka-Merck) PROQUAD. The parents of the patient called the unspecified physician and was prescribed NYSTATIN topical cream. The symptoms did not improve. On 15-SEP-2014, the patient developed redness at the injection site. On 18-SEP-2014, the patient developed a mouth ulcer. At the time of the report the outcome was reported as not recovered. Patient sought medical attention with an unspecified physician and went to the pharmacy. Patient received treatment with Nystatin. Patient did not performed lab diagnostics studies. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to a 15-year old male patient, who was allergic to sulfamide and had no illness at time of vaccination. This report did not correspond to a patient vaccinated with ROTATEQ. Instead, the reporter informed that this patient was vaccinated with the third dose of GARDASIL (intramuscular injection, batch/lot # J008423, expiration date 21-JAN-2016, in the right arm, route not reported), on 21-FEB-2014 at 2:50 PM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event also reported as 27-FEB-2014 at 10:00 AM). The patient's parent did not call back. No adverse event was reported for the patient. The outcome was reported by the reporter as unknown. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to an 18-year-old male patient, who had no known drug allergies and no illness at time of vaccination. This report did not correspond to a patient vaccinated with ROTATEQ. Instead, the reporter informed that this patient was vaccinated with the first dose of GARDASIL (intramuscular injection, batch/lot # J008423, expiration date 21-JAN-2016, in the left arm, route not reported) on 03-FEB-2014 at 4:30 PM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event also reported as 27-FEB-2014 at 10:00 AM). The patient did not repeat vaccination dose at visit on 18-JUN-2014. Parents were going to discuss with physician and declined to repeat vaccination. No adverse event was reported for the patient. The outcome was reported by the reporter as unknown. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to a 12-year old female patient, who had no known drug allergies and no illness at time of vaccination. This report did not correspond to a patient vaccinated with ROTATEQ. Instead, the reporter informed that this patient was vaccinated with the first dose of GARDASIL (intramuscular injection, batch/lot # J008423, expiration date 21-JAN-2016, in the left arm, route not reported) on 24-FEB-2014 at 4:00 PM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event also reported as 27-FEB-2014 at 10:00 AM). The patient declined to repeat vaccine. No adverse event was reported for the patient. The outcome was reported by the reporter as unknown. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Secondary transmission
Clinical narrative: This spontaneous report as received from a pharmacist via Field Representative refers to a male patient of unkonwn age. On an unknown date (within the last week), a pharmacist was somehow exposed to the ZOSTAVAX vaccine, while administering it to a patient (exact route of exposure and dose was unspecified). The Field representative was speaking to his brother who is a pharmacist, the pharmacist, reported to the field representative that another pharmacist, experienced a rash while administering ZOSTAVAX to a patient. On an unknown date (within the last week), a pharmacist, administered ZOSTAVAX to a patient and has experienced shingles himself. The pharmacist got a rash on his elbow. The pharmacist was somehow exposed to the ZOSTAVAX vaccine while administering it to a patient (exact route of exposure was unspecified). The pharmacist then developed a shingles like rash afterwards. The field representative was unable to clarify the exact date or time frame in which that rash was noticed by the Pharmacist nor did he clarify if the rash was diagnosed as shingles specifically. No further AE information was provided. The outcome of the pharmacist then developed a shingles like rash afterwards and the pharmacist was somehow exposed to the ZOSTAVAX vaccine while administering it to a patient (exact route of exposure was unspecified) was unknown. Relatedness between adverse events and ZOSTAVAX was unknown. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to a 13-year old male patient, who had no known drug allergies and no illness at time of vaccination. This report did not correspond to a patient with ROTATEQ. Instead, the reporter informed that this patient was vaccinated with the third dose of GARDASIL (intramuscular injection, batch/lot # J008423, expiration date 21-JAN-2016, in the left arm, route not reported) on 20-JAN-2014 at 10:20 AM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event also reported as 27-FEB-2014 at 10:00 AM). Parent were going to consult physician and declined to repeat vaccination. No adverse event was reported for the patient. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Injection site erythema, Injection site reaction
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 year old female patient with diabetes and penicillin allergy. On 13-SEP-2014 the patient was vaccinated with ZOSTAVAX (dose and route not provided). Concomitant therapies included BENADRYL. The pharmacist reported that on 13-SEP-2014, patient had a site reaction and a red marking where she received the ZOSTAVAX. Pharmacist reported patient had a small grade of shingles and broke out in blisters on the top part of her chest and shoulders and site reaction and a red "marking" where she received the ZOSTAVAX was reported as not recovered/not resolved. Relatedness between adverse events and ZOSTAVAX was unknown. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to a 16-year old male patient, who had no known drug allergies and no illness at time of vaccination. This report did not correspond to a patient vaccination with ROTATEQ. Instead, the reporter informed that this patient was vaccinated with the third dose of GARDASIL (intramuscular injection, batch/lot # J008423, expiration date 21-JAN-2016, in the left arm, route not reported), on 20-JAN-2014 at 10:10 AM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event also reported as 27-FEB-2014 at 10:00 AM). The parents were going to consult with physician and declined to repeat vaccination. No adverse event was reported for the patient. The outcome was reported by the reporter as unknown. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
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 02-JUN-2014 the patient was vaccinated with M-M-R II (strength, dosage and route were not reported) lot number: J006138, expiration date: 17-APR-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 M-M-R II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at 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: 51.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Pyrexia
Clinical narrative: 3 cm erythema induration tenderness over deltoid injection site. Fever started 24 hrs after inject resolved after 5dys tx's w/ZYRTEC.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Red, swollen, hot injection site. Itchy later. Symptoms resolved in 3-4 days.