chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: HEP, HEPA, TYP
Symptoms: Dizziness, Feeling hot, Tremor
Clinical narrative: Patient was administered typhoid vaccine and subsequnetly hepatitis A vaccine. Shortly afterwards, patient reported feeling dizzy, hot, and wanting to pass. Patient reported symptoms began to subside after approximately 10 minutes and was observed for any additional reactions for approximately 25 minutes. After that time, hepatitis B vaccine was administered and patient began to feel dizzy again and began to shake in arms and legs. Pharmacy called 911 and paramedics arrived 5 minutes later.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, pain, tenderness, redness, heat at injection site - increasing progressively over 2 days to a max of 3 inches in diameter before subsiding. Provided ice pack and homeopathic Arnica for pain relief.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Shingles vaccine was given on 5/23/14. Per pt. on the next day the injection site got itching and swelling. Pt tried oral BENADRYL and topical BENADRYL for 3 days. On 5/27/14, she reported it got better.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Cardiac failure congestive, Oedema peripheral, Pyrexia
Clinical narrative: MD office stated CHF signs, peripheral edema, febrile.
Age: 69.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain, Pain in extremity
Clinical narrative: Pt reported their arm is still sore, especially when he raises arm high pt says it has been this way all along since vaccine.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Injection site discolouration, Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Pt's mother called stating pt had a 3 inch in diameter red raised area with purple spots throughout on R thigh were MMR was given on 6/2/14. Pt placed hydrocortisone cream on rash and it appeared to help. Was instructed to use OTC BENADRYL-childrens as directed on box and call if not resolved in 4-5 days. Child eating, drinking normal. No fever noted by parent.
Age: 48.0
Sex: F
Vaccine: HEPA, TYP, VARCEL
Symptoms: Asthenia, Dizziness, Headache, Urticaria
Clinical narrative: Headache, weakness, dizziness. Severe hives from head to toe. Headache started 5/21. Weakness and hives started 5/23 and lasted for 4 days until 5/26.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient develop swelling and redness on posterior left arm treated with anti-histamines, ice and cephalexan.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Ext. pain lasted 24 hrs. Extreme pain Rt. shoulder and arm elbow to shoulder. - Patient had stroke on 5-13 and fell on rt. shoulder causing soft tissue damage on 5-13- vaccine in same shoulder 5-16.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: His leg swelled up starting the next morning, at least that's when we found it, and lasted 5 days. We gave him the recommended dose of children's Ibuprofen when it hurt him. It caused swelling from the knee to the hip with pain and heat. He also complained of itching.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Pruritus, Throat tightness, Urticaria
Clinical narrative: Experienced hives, itching face and extremities, and throat tightness. Txt = Prednisone and antihistamine per FNP.
Age: 41.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect dose administered, Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a 41 year old patient. On 21-MAY-2014 the patient was vaccinated with MMR II lot # J006955. No other concomitant medications were reported. On 21-MAY-2014, 1 day after onset of therapy the patient experienced patients received MMR II post not supported excursion (doses stored at 17C for 21.5 hours) and Inappropriate schedule of vaccine administered. The outcome of patients received MMR II post not supported excursion (doses stored at 17C for 21.5 hours) and Inappropriate schedule of vaccine administered is unknown. The reporter stated that patients who received MMR II have not expressed any adverse events. The reporter considered patients received MMR II post not supported excursion (doses stored at 17C for 21.5 hours), Inappropriate schedule of vaccine administered and not expressed any adverse events to be not related to MMR II. This case is linked to same reporter linked cases # 1406USA004912 and 1405USA012040. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts, Cryotherapy, Incomplete course of vaccination
Clinical narrative: This spontaneous report as received from a 18 year old female consumer with allergy to "SULFA" refers to herself. No concomitant medication were reported. On 17-DEC-2013 the patient was vaccinated with second shot of GARDASIL lot # J006850, intramuscular for prevention of HPV. On 17-JAN-2014, the patient experienced genital warts. Patient sough medical attention: on unknown date her physician used acid and another unknown substance that freezed the warts for removal. The outcome of genital warts was reported as not recovered. Lab diagnostic studies included pap smear (date and result unknown). The patient did not complete the series of GARDASIL. No adverse effects were reported with first dose of GARDASIL. Relatedness between genital warts and GARDASIL was not reported. Additional information is not expected.
Sex: U
Vaccine: MMRV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to two patients of unknown age and gender. On 29-MAY-2014, the patients were vaccinated with PROQUAD lot # H020851, expiration date 26-MAY-2014, intramuscular. On 29-MAY-2014, 2 patients received expired PROQUAD via the intramuscular route. There was no known adverse effects. It was unknown if the patients sought medical attention. At the time of the report, the patients' status was unknown. Additional information has been requested.
Age: 36.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect dose administered, Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a 36 year old patient. On 21-MAY-2014 the patient was vaccinated with M-M-R II lot # J006955. No other concomitant medications were reported. On 21-MAY-2014, 1 day after onset of therapy the patient experienced patients received m-m-r ii post not supported excursion (doses stored at 17c for 21.5 hours) and inappropriate schedule of vaccine administered. The outcome of patients received m-m-r ii post not supported excursion (doses stored at 17c for 21.5 hours) and inappropriate schedule of vaccine administered is unknown. The reporter stated that patients who received M-M-R II have not expressed any adverse events. The reporter considered patients received m-m-r ii post not supported excursion (doses stored at 17c for 21.5 hours), inappropriate schedule of vaccine administered and not expressed any adverse events to be not related to M-M-R II. This case is linked to same reporter linked cases # 1405USA004911 and # 1405USA012040. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. In approximately May and July 2012, reported as about 2 years ago the patient was vaccinated with the first and the second dose (respectively) of GARDASIL at the proper time interval (0 and 2 months)(dose, route, lot number and expiration date were not reported), but did not received the 3rd dose. On 30-MAY-2014 the patient was presented in the physician's office to receive the 3rd dose of GARDASIL (route, lot# and expiry date were not reported). No adverse effect was reported. No PQC was involved. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Mobility decreased, Musculoskeletal pain, Periarthritis, X-ray normal
Clinical narrative: Patient came into our Pharmacy on 10/16/2013 for her annual Flu shot. This immunization was given by RPh. on 10/16/13 about 11am, using our Standard Immunization protocol: (patient and RPh in sitting position, given IM in Left Arm using standard 1 inch needle and syringe). The immunization and standard protocol for post immunization discussion was given by RPH with patient. No questions and everything seemed to go well and patient left our pharmacy. On May 19th, 2014, the patient contacted RX mgr via phone to report some shoulder issues that she believed were from her Flu immunization back in October 2013. Rx mgr and patient then had a discussion regarding details of the events since immunization on 10/16/2013 and her present symptoms. Patient said that she had some shoulder pain right after injection but that was normal for her. About 1 week after injection she started to experience shoulder pain and mobility issues. Her pain and mobility continued to deteriorate on an ongoing basis despite some physical therapy and massage therapy in early months of 2014. She was always hoping that her symptoms would get better so delayed reporting such issues to the pharmacy. Patient then said that she had a doctors appointment scheduled for early June and it was agreed that Rx mgr would do a follow up phone call once patient had seen doctor and had a diagnosis to report. It was agreed that a VAER form could then be submitted if needed. On June 10th, 2014, Rx mgr has a phone discussion with patient after seeing an orthopaedist on June 5th, 2014. Patient said that Dr. had diagnosed her shoulder issues as a condition called "adhesive capsulitis or Frozen Shoulder". Patient was given a Cortisone injection at time of visit. Pain has improved some but shoulder mobility is still very limited. Patient is to do some physical therapy and follow up with doctor in 1 month. At this time, prognosis is unknown. It was decided that RX mgr would report the incident on VAER form today.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site anaesthesia, Injection site pruritus
Clinical narrative: This spontaneous report as received from a consumer refers to a 80 year old male patient with high blood pressure, high cholesterol and unspecified prostate issues. The patient did not have drug reactions/allergies. On 07-JAN-2014, the patient was vaccinated with ZOSTAVAX, intramuscular in the left arm (lot number, dose and frequency were not reported). Co-suspect therapy was not reported. Concomitant therapy was not reported. The patient reported that he was still having itching and numb like feelings at the injection site in the left arm after receiving ZOSTAVAX in January 2014. The patient did not feel this particular adverse experience on the same day as recieving the ZOSTAVAX vaccine; however, the "itching and numb like feelings at the injection site" started becoming worse gradually. No treatment was given to the patient. No lab diagnostic studies were performed to the patient. The patient spoke with the physician. The outcome of the events was reported as not recovered. Causality beteween the events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: This spontaneous report as received from a patient's daughter refers to a male patient of unknown age. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose and route not reported) and experienced itching afterwards. The outcome of the event was unknown. Causality assessment for the event and therapy was not provided. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Local swelling, Rash
Clinical narrative: Rash under arm, swollen lumps on feet, swelling and redness in left deltoid - was swollen then resolved then returned 2 weeks later. Also, an area noted in (R) inguinal area - circular with central clearing. Here last on 6/5. Called to follow up but have not head back yet.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Nausea, Petechiae, Pyrexia, Vomiting
Clinical narrative: Low grade fever (100.6 orally), petechiae to face (eye area) and neck. Nausea and vomiting.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Expired drug administered
Clinical narrative: DOH recommends revaccination of PREVNAR 13 because dose administered was expired.
Age: 17.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, TDAP
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Pt. complains of light headed, dizzy, nausea and vomiting x1.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: After receiving TDAP, MCV4, and HPV pt was sitting in lobby and fainted.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: At site of injection redness, hard and painful. S/S radiate down to left elbow. Pt saw MD on Monday (6/9) was given antibiotic shot and course of Duricef Magnesium drainage.
Age: 25.0
Sex: M
Vaccine: RAB
Symptoms: Dizziness, Unresponsive to stimuli
Clinical narrative: Received phone call from patient employer, that he had gone to the ER yesterday 6/9/14 due to dizziness and/or unresponsiveness. Employer unsure of details, but the ER physician was concerned due to history of vaccination. Attempted to call patient, telephone disconnected.
Age: 74.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Local swelling, Pain, Skin warm
Clinical narrative: Patient received vaccine around noon on 6/7/14. That evening she said she felt a little achy and arm was red. Next day the redness/warmth on arm was a lot more noticeable. The area is slightly raised, red, bump and warm to touch, about 6 inches in diameter. Patient states it is getting better though and will not seek medical treatment for it.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Paraesthesia
Clinical narrative: This spontaneous report as received from an office manager, refers to a 73 year old female patient with penicillin allergy. In November 2007, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and frequency were not reported) (Lot # and expiration date were not reported). On an unspecified date, the patient also received a dose of PNEUMOVAX 23 (dose, route and frequency were not reported) (Lot # and expiration date were not reported). On 24-APR-2014, the patient developed prickling feeling on scalp and forehead. On 25-APR-2014, the patient was seen in physician's office and diagnosis of shingles was confirmed. As treatment, physician ordered NEURONTIN, acyclovir and BENADRYL. The office manager reported that as the patient's condition advanced, physician ordered NEURONTIN. Patient's condition has not involved patient's eyes. No lab diagnostics studies were performed. At the time of the report, the patient's outcome of shingles was unknown. Follow up information has been received from the office manager via questionnaire concerning the patient with no illness at time of vaccination. On 16-NOV-2007, the patient was vaccinated with a first dose of ZOSTAVAX (also reported as "previous doses "1") (lot # reported as 14124) (lot # is invalid lot for ZOSTAVAX) in the left upper arm. On 24-APR-2014, the patient experienced lesions on forehead and nose, and a tingling of scalp. There was not a rash at the site of injection or elsewhere within 42 days of vaccination. The dermatome involved was the facial region. The maximum temperature was 98.6 tympanic. The scale of pain was reported as 10. At the time of the report, the patient had not recovered. The pain was still ongoing. Lesions on forehead and nose and a tingling of scalp was considered to be medically significant by the reporter. Additional information is not expected.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Paraesthesia, Skin lesion
Clinical narrative: This spontaneous report as received from an office manager, refers to a 73 year old female patient with penicillin allergy. In November 2007, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and frequency were not reported) (Lot # and expiration date were not reported). On an unspecified date, the patient also received a dose of PNEUMOVAX 23 (dose, route and frequency were not reported) (Lot # and expiration date were not reported). On 24-APR-2014, the patient developed prickling feeling on scalp and forehead. On 25-APR-2014, the patient was seen in physician's office and diagnosis of shingles was confirmed. As treatment, physician ordered NEURONTIN, acyclovir and BENADRYL. The office manager reported that as the patient's condition advanced, physician ordered NEURONTIN. Patient's condition has not involved patient's eyes. No lab diagnostics studies were performed. At the time of the report, the patient's outcome of shingles was unknown. Follow up information has been received from the office manager via questionnaire concerning the patient with no illness at time of vaccination. On 16-NOV-2007, the patient was vaccinated with a first dose of ZOSTAVAX (also reported as "previous doses "1") (lot # reported as 14124) (lot # is invalid lot for ZOSTAVAX) in the left upper arm. On 24-APR-2014, the patient experienced lesions on forehead and nose, and a tingling of scalp. There was not a rash at the site of injection or elsewhere within 42 days of vaccination. The dermatome involved was the facial region. The maximum temperature was 98.6 tympanic. The scale of pain was reported as 10. At the time of the report, the patient had not recovered. The pain was still ongoing. Lesions on forehead and nose and a tingling of scalp was considered to be medically significant by the reporter. Additional information is not expected.
Age: 85.0
Sex: F
Vaccine: TDAP, VARZOS, TDAP, VARZOS
Symptoms: Asthenia, Dizziness, Lethargy, Mental status changes, Somnolence
Clinical narrative: Patient woke late 11:00 am on 5/21/14 seemed lightheaded, weak, trouble walking. Son in law called 911 transported to hospital. Stayed 2 days, went to another hopsital on 26th for increased BP. Followed up with primary MD on 28th. Patient was also confused, but already has dementia. Also developed rash 2 inches.
Age: 85.0
Sex: F
Vaccine: TDAP, VARZOS, TDAP, VARZOS
Symptoms: Abasia, Asthenia, Blood pressure increased, Confusional state, Dizziness
Clinical narrative: Patient woke late 11:00 am on 5/21/14 seemed lightheaded, weak, trouble walking. Son in law called 911 transported to hospital. Stayed 2 days, went to another hopsital on 26th for increased BP. Followed up with primary MD on 28th. Patient was also confused, but already has dementia. Also developed rash 2 inches.
Age: 85.0
Sex: F
Vaccine: TDAP, VARZOS, TDAP, VARZOS
Symptoms: Dyspnoea, Rash
Clinical narrative: Patient woke late 11:00 am on 5/21/14 seemed lightheaded, weak, trouble walking. Son in law called 911 transported to hospital. Stayed 2 days, went to another hopsital on 26th for increased BP. Followed up with primary MD on 28th. Patient was also confused, but already has dementia. Also developed rash 2 inches.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Crying, Dizziness, Feeling abnormal, Lethargy, Pyrexia
Clinical narrative: She had her apt at 3:20...at around 4:45 she said she felt "drugged" then, got a slight fever, got very shaking, light headed--lethargic, very dizzy, crying uncontrollably....I made her keep moving...kept her stimulated. made her drink extra water and eat. Gradually started to feel better, dizziness of and on all night--seemed okay in the morning. Did not take her into the ER..Dr office was closed at the time of reaction....Her FNP who gave and insisted on the shot, (I was never notified or asked about this shot prior to it's administration--I have withheld it previously, for precarious reasons) said she would have to have a Pap if she refused--so my kid opted for the shot--she is only 15). The FNP said there would be no adverse reations, said it was very safe--should not even worry about a fever...would not disclose to ME any the reations to look for...when this started going on, I asked my daughter for all the sheets the practitioner gave her regarding her visit...thats when I saw the reactions to be warned about. The dizziness was one of the serious reactions to look for.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Tremor
Clinical narrative: She had her apt at 3:20...at around 4:45 she said she felt "drugged" then, got a slight fever, got very shaking, light headed--lethargic, very dizzy, crying uncontrollably....I made her keep moving...kept her stimulated. made her drink extra water and eat. Gradually started to feel better, dizziness of and on all night--seemed okay in the morning. Did not take her into the ER..Dr office was closed at the time of reaction....Her FNP who gave and insisted on the shot, (I was never notified or asked about this shot prior to it's administration--I have withheld it previously, for precarious reasons) said she would have to have a Pap if she refused--so my kid opted for the shot--she is only 15). The FNP said there would be no adverse reations, said it was very safe--should not even worry about a fever...would not disclose to ME any the reations to look for...when this started going on, I asked my daughter for all the sheets the practitioner gave her regarding her visit...thats when I saw the reactions to be warned about. The dizziness was one of the serious reactions to look for.
Sex: U
Vaccine: PPV
Symptoms: Death
Clinical narrative: Information has been reported in a study. The report includes VAERS reports following PNEUMOVAX 23 or Pneumococcal polysaccharide vaccine (PPSV23) brand unknown after 2002. The report includes reports information from 01-JAN-1990 to 13-JAN-2014. This spontaneous report as received from an other health professional refers to 4 patients. The median age of the patients was 69 years old; range being 23 to 98 years. Between 01-JAN-1990 and 31-DEC-2013 patients were vaccinated with PNEUMOVAX 23. On an unknown date the patients experienced death. The outcome of death was reported as fatal. The cause of death was reported as 'undetermined'. The death of the patients was confirmed with medical records, autopsy reports and/or death certificates. The report has been split into cases according to cause of death. This case is linked to same reporter linked cases # 1406USA003857 (respiratory disorder), 1406USA003863 (Unknown), 1406USA003859 (other non infectious disorder), 1406USA003860 (gastrointestinal), 1406USA003861 (Neurological), 1406USA003862 (Undetermined) and 1406USA003351 (Cardiovascular). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Death, Gastrointestinal disorder
Clinical narrative: Information has been reported in a study. The report concerns death reports in adult ages 19 years and Older following PNEUMOVAX 23. The report includes VAERS reports following PNEUMOVAX 23 or Pneumococcal polysaccharide vaccine (PPSV23) brand unknown after 2002. The report includes reports information from 01-JAN-1990 to 13-JAN-2014. This spontaneous report as received from an other health professional refers to 1 patient. The median age of the patients was 69 years old; range being 23 to 98 years. Between 01-JAN-1990 and 31-DEC-2013 patients were vaccinated with PNEUMOVAX 23. On an unknown date the patients experienced death. The cause of death was reported as gastrointestinal. The death of the patients was confirmed with medical records, autopsy reports and/or death certificates. The report concerns death reports in adult ages 19 and Older following PNEUMOVAX 23. The report has been split into cases according to cause of death. This case is linked to same reporter linked cases # 1406USA003857 (respiratory disorder), # 1406USA003863 (Unknown), # 1406USA003859 (other non infectious disorder), # 1406USA003858 (other infectious), # 1406USA003861 (Neurological), # 1406USA003862 (Undetermined) and # 1406USA003351 (Cardiovascular). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Death
Clinical narrative: Information has been reported in a study. This report concerns death events in adult ages 19 years and Older following PNEUMOVAX 23. The report includes US VAERS reports following PNEUMVOAX 23 or PPSV 23 brand unknown after 2002. The report includes reports information from 01-JAN-1990 to 31-JAN-2014. This spontaneous report as received from a registered nurse refers to 18 patients. The median age of the patients was 69 years old; range between 23 to 98 years. Between 01-JAN-1990 and 31-DEC-2013 patients were vaccinated with PNEUMOVAX 23. ON an unknown date the patients experienced death. The cause of death was reported as unknown. The death of the patients was confirmed with medical records, autopsy reports and/or death certificates. The report concerns death reports in adult ages 19 years and Older following PNEUMVOAX 23. The report has been split into cases according to cause of death. This case is linked to same reporter linked cases # 1406USA003857 (respiratory disorder), # 1406USA003858 (Other Infectious disorder), # 1406USA003859 (other non infectious disorder), # 1406USA003860 (gastrointestinal), # 1406USA003861 (Neurological), # 1406USA003862 (Undetermined) and # 1406USA003351 (Cardiovascular). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Death, Respiratory disorder
Clinical narrative: Information has been reported in a study. The report includes VAERS reports following PNEUMOVAX 23 or Pneumococcal polysaccharide vaccine (PPSV23) brand unknown after 2002. The report includes reports information from 01-JAN-1990 to 13-JAN-2014. This spontaneous report as received from a other health professional refers to 11 patients. The median age of the patients was 69 years old; range being 23 to 98 years. Between 01-JAN-1990 and 31-DEC-2013 patients were vaccinated with PNEUMOVAX 23. On an unknown date the patients experienced death. The outcome of death was reported as fatal. The cause of death was reported as 'Respiratory'. The death of the patients was confirmed with medical records, autopsy reports and/or death certificates. The report has been split into cases according to cause of death. This case is linked to same reporter linked cases 1406USA003351 (Cardiovascular), 1406USA003858 (Other infectious disorder), 1406USA003859 (other non infectious disorder), 1406USA003860 (gastrointestinal), 1406USA003861 (Neurological), 1406USA003862 (Undetermined) and 1406USA003351 (Cardiovascular). Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: ADEN_4_7, FLUC3, HEP, MNQ, TDAP, ADEN_4_7, FLUC3, HEPA, MNQ, TDAP
Symptoms: Pruritus
Clinical narrative: Patient reported right arm, neck, and right face itching at approximately 11:45 AM after receiving immunizations and bicillin injection at 11:15 AM. 25mg Benadryl given IM at 12:00 PM per provider's order. Patient reported improvement in symptoms after 10 minutes and was released at 1245 with resolved symptoms.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Chest discomfort, Hypersensitivity, Hypoaesthesia, Pain, Pruritus
Clinical narrative: Began with red raised bumps on arms and started spreading across body, some itching and pain, compained of pressure in chest when laid on back, feet felt numb and hurt, to ER- was told allergic reaction to HEP B vaccines, was given steroid shot, began over the counter Benadryl, seemed to be improving but upon awakening on 6/11 felt as if rash worsening again.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Rash erythematous, Rash generalised, Vaccination complication
Clinical narrative: Began with red raised bumps on arms and started spreading across body, some itching and pain, compained of pressure in chest when laid on back, feet felt numb and hurt, to ER- was told allergic reaction to HEP B vaccines, was given steroid shot, began over the counter Benadryl, seemed to be improving but upon awakening on 6/11 felt as if rash worsening again.
Age: 6.0
Sex: M
Vaccine: MMR
Symptoms: Incorrect dose administered
Clinical narrative: Just received 3rd MMR injection.  She should have only received 2 MMR injections.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Cough, Erythema, Eyelid oedema, Urticaria
Clinical narrative: Both eyes puffy, face red, coughing hives developed on neck.
Age: 25.0
Sex: M
Vaccine: HPV4
Symptoms: Pruritus generalised, Swelling, Urticaria
Clinical narrative: There were two occasions of reaction, but I didn't figure out the cause until the second shot in the series. Symptoms are hives and itching all over the body, which lasted for several weeks during the first reaction; and swelling and welts on the back of my neck. Symptoms are being treated with prednisone, cetirizine, ranitidine, and Bnadryl.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from the mother of the patient of unknown age and gender. Concomitant medication and pertinent medical history were not provided. On unknown dates the patient was vaccinated with GARDASIL (lot # not reported) for the prevention of HPV. The 1st and 2nd doses (dose and route unspecified) were received on schedule, but the 3rd dose of GARDASIL (0.5 ml, intramuscular) was received 5 weeks late. No adverse effects were reported. The patient did not seek medical attention. The outcome of the events was unknown. Additional information is not expected.
Age: 1.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Malaise, Mumps, Pyrexia, Rash
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 12 months old patient of unknown gender. In approximately 2014 (within the last 6 months) the patient was vaccinated with first single dose MMR II (injection, route of administration, lot#, expiry date were not reported). Concomitant therapy included VARIVAX. In approximately 2014 (within the last 6 months) the patient developed malaise, rash and fever thought to be consistent with mumps. The outcome of malaise, rash and fever was unknown. The relatedness between malaise, rash and fever and MMR II was unknown. This is one of three reports from the same reporter. Additional information is not expected.
Sex: U
Vaccine: TDAP
Symptoms: Pertussis
Clinical narrative: Initial report was received on 08 June 2014 from a consumer. An unidentified High School student patient, gender and date of birth not reported, was vaccinated on an unknown date with TDAP, manufacturer unknown and was diagnosed on 05 June 2014 with Whooping cough. The patient's medical history, concomitant medications and vaccination history were not reported. Laboratory tests were not reported. Treatments were not reported. The patient outcome was not reported. No further details were available at the time of this report. Documents held by sender: None.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: SWELLING, REDNESS AND ITCHING AT SITE OF SHOT.  ICE PACK, IBUPROFEN.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 12 month old patient. The patient's pertinent medical history was not reported. On 28-MAY-2014 the patient was vaccinated with PROQUAD (Merck). Concomitant medications were not reported. Other suspect therapies included VARIVAX (Merck). On 28-MAY-2014, patient was inadvertently administered both VARIVAX (Merck) and PROQUAD (Merck) at the same office visit, in different anatomical locations. No adverse effects were reported. The outcome of inadvertently administered both VARIVAX (Merck) and PROQUAD (Merck) at the same office visit and no adverse effects was unknown. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: MMR, PPV
Symptoms: Induration, Local swelling, Muscle oedema, Pain in extremity, Pyrexia
Clinical narrative: This spontaneous report as received from a physician refers to a 26 year old female patient who no drug allergies. The patient's pertinent medical history was none. On 29-MAY-2014 the patient was vaccinated with PNEUMOVAX 23 (lot # K003074, expiry date: 13-MAR-2015) intramuscularly. Concomitant medications were none. On 29-MAY-2014, the patient also received MMR II and ADACEL. On 30-MAY-2014 the patient developed fever of 38.6 degree Celsius (C) and pain in the left deltoid area. The patient took TYLENOL and ADVIL which helped the fever of 100.8 Fahrenheit (F). Her left deltoid was swollen and indurated but not red. She received IV fluids. BENADRYL and TYLENOL (manufacturers unspecified), and was sent home. On 02-JUN-2014, she still had a fever and her left deltoid was still painful. The patient then received an ultrasound of the left deltoid area. Edema was found in the left deltoid muscle. The patient also had "2 ill define, erythematous, blotchy areas on the skin slightly inferomedial to the left deltoid muscle. The left deltoid was found to be enlarged compared to the right deltoid muscle. There was no abscess in the left deltoid area." The patient was given cephalexin (manufacturer unknown) and hydrocodone (manufacturer unknown). The outcome of the events was unknown (reported as unspecified). The causality was not reported. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: MMR, PPV
Symptoms: Rash macular, Ultrasound scan abnormal
Clinical narrative: This spontaneous report as received from a physician refers to a 26 year old female patient who no drug allergies. The patient's pertinent medical history was none. On 29-MAY-2014 the patient was vaccinated with PNEUMOVAX 23 (lot # K003074, expiry date: 13-MAR-2015) intramuscularly. Concomitant medications were none. On 29-MAY-2014, the patient also received MMR II and ADACEL. On 30-MAY-2014 the patient developed fever of 38.6 degree Celsius (C) and pain in the left deltoid area. The patient took TYLENOL and ADVIL which helped the fever of 100.8 Fahrenheit (F). Her left deltoid was swollen and indurated but not red. She received IV fluids. BENADRYL and TYLENOL (manufacturers unspecified), and was sent home. On 02-JUN-2014, she still had a fever and her left deltoid was still painful. The patient then received an ultrasound of the left deltoid area. Edema was found in the left deltoid muscle. The patient also had "2 ill define, erythematous, blotchy areas on the skin slightly inferomedial to the left deltoid muscle. The left deltoid was found to be enlarged compared to the right deltoid muscle. There was no abscess in the left deltoid area." The patient was given cephalexin (manufacturer unknown) and hydrocodone (manufacturer unknown). The outcome of the events was unknown (reported as unspecified). The causality was not reported. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: RV5
Symptoms: Abnormal behaviour, Chills, Diarrhoea, Headache, Vomiting
Clinical narrative: This spontaneous report as received from a nurse concerning a 49 year old other healthcare worker with no history of drug reactions or allergies. The reporter stated, that on 22-MAY-2014, an unspecified patient received a complete dose of ROTATEQ (lot #, exp date: not provided) and a short time later he/she blew bubbles/spit on the face of staff member (healthcare worker), who on about 23-MAY-2014 developed chills, diarrhea, and headache. She did not seek medical attention. No lab diagnostic studies were performed. The outcome of developed chills, vomiting, diarrhea, and headache was reported as recovered/resolved. Relatedness between adverse events and ROTATEQ was not reported. This report is linked with MARRS # 1406USA004410 (Same Reporter Link). 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 registered nurse refers to an unspecified number of patients of unknown ages and gender. On an unknown dates the patients were vaccinated with a dose of ROTATEQ (dose, route, and lot number not provided) that was improperly stored and exposed to temperatures outside the storage range in the prescribing information. No adverse effect were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
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. On an unknown date the patients were vaccinated with a dose of PROQUAD (Merck), (dose, route, and lot number not provided) that was improperly stored and exposed to temperatures outside the storage range in the prescribing information. No adverse effects were reported. This is one of several reports from the same source. 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 of patients of unknown ages and gender. On an unknown dates the patients were vaccinated with a dose of (Oka/Merck) VARIVAX (dose, route, and lot number not provided) that was improperly stored and exposed to temperatures outside the storage range in the prescribing information. No adverse effects were reported. This is one of several reports from the same source. 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 registered nurse refers to an unspecified number of patients of unknown ages and gender. On an unknown dates the patients were vaccinated with a dose of GARDASIL (dose, route, and lot number not provided) that was improperly stored and exposed to temperatures outside the storage range in the prescribing information. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a female consumer of unknown age refers to herself with allergy to REGLAN. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (strength and dosage unknown, injection for the prevention of shingle). There was no concomitant therapy. The patient stated on unknown date she was diagnosed with shingles before and after she received ZOSTAVAX. There were no treatment, lab diagnostics, studies were not performs. The outcome of the event was reported as not recovered. The causality of the event and therapy with ZOSTAVAX was unknown. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Cystitis, Genital herpes, Herpes zoster, Pain, Pruritus
Clinical narrative: This spontaneous report as received from a 68 years old female patient with medical of diabetes. On an unknown date in May 2012 also reported as on an unspecified date about 2 years ago, the patient was vaccinated with ZOSTAVAX (dose, frequency, route of administration and anatomical location: not provided) (lot #, exp. date: unknown) for the prevention of shingles. On an unknown date in May 2013 also reported as on an unspecified date about one year ago, the patient developed bladder infection and shingles after receiving ZOSTAVAX. On an unknown date, the patient developed also genital herpes after receiving the ZOSTAVAX. The patient sought medical attendance. She has been using DERMOPLAST (dosage, frequency and manufacturer: unspecified) to relieve her pain and itch and it was working great. The patient did not undergo any diagnostic studies. The shingles rash was on her "butt" at the time of the report. The outcome of developed shingles was reported as not recovered/not resolved. The outcome of developed a bladder infection and developed genital herpes was not reported. This report is linked with MARRS # 1406USA001041 (Same Patient Link). Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Local swelling
Clinical narrative: Left arm began to swell and redness at the injection site.  Increased the next day of 4-5 inches of swelling with borders, all upper arm is swollen with redness and very warm to touch.  Complaining of some pain in shoulder and left thumb from swelling.
Age: 39.0
Sex: F
Vaccine: VARCEL
Symptoms: Pain in extremity
Clinical narrative: Left arm began to swell and redness at the injection site.  Increased the next day of 4-5 inches of swelling with borders, all upper arm is swollen with redness and very warm to touch.  Complaining of some pain in shoulder and left thumb from swelling.
Age: 10.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Blister, Erythema, Pain, Rash pustular, Swelling
Clinical narrative: Developed redness initially and small pustules the night after the vaccine was given, then progressed to blisters with continuing redness, pain and swelling.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site warmth, Pain in extremity
Clinical narrative: Pt. was given vaccine (MENVEO) at approx. 4:45 PM on 6/06/14. When pt. awoke on 6/07/14 he reported to his mom that his arm was sore. Mom states the (L) upper arm was red and warm to touch. Pt. c/o arm being sore. Spoke with mom on 6/10 and she stated that pt's arm is better except for slight redness.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to 2 patients of unknown age. No concomitants were reported. On 23-MAY-2014, patients were vaccinated with PEDVAXHIB (dose, frequency, route of administration and indication were not provided) lot J016188, expiration date 02-OCT-2016 that was exposed to 8.8C for 10 days. No adverse effects reported. No product quality complaint (PQC) was involved. The outcome of events was unknown. No further information provided. On 02-JUN-2014 a phone call was placed to reporter. The receptionist stated they do not have anyone by that name employed at this facility. No further information is available at this time. This report is linked to 1405USA013338, 1405USA013916, 1405USA013915, 1406USA004906, 1406USA004908, 1406USA004909, 1406USA004913, 1406USA004914, 1406USA004863, 1406USA004874, 1406USA004881, 1406USA004891, 1406USA004896, 1406USA004897, 1406USA004900, 1406USA004901, 1406USA004814, 1406USA004830, 1406USA004831, 1406USA004832, 1406USA004833, 1406USA004835, 1406USA004837 by the same reporter link.
Age: 0.37
Sex: M
Vaccine: DTAPHEPBIP, HIBV, RV5
Symptoms: Intussusception, Vomiting, X-ray
Clinical narrative: Bilious vomiting x5 since AM at ER. U.S. done in ER: ileal cecal intussusception. Transferred to another hospital and observed x24 hours - resolved.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. On 02-JUN-2014, the patient was vaccinated with ZOSTAVAX VIAL 19400 PFU (lot number not provided). It was reported that the dose and route were administered according to the prescribing information for ZOSTAVAX. No co-suspect or concomitant therapies were reported. The pharmacist reported that on 02-JUN-2014, a patient was administered a dose of ZOSTAVAX that was improperly stored. No adverse effects were reported. Additional information has been reported.
Sex: U
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to three patients of unknown age and gender. On an unknown date the patients were vaccinated with ZOSTAVAX (dose, route, lot number and expiration date not reported). There was no concomitant medication reported. Pharmacist reported that there were "3 cases of cellulosis" that developed over the last few weeks "(on an unknown date in approximately 2014) after patients received ZOSTAVAX. The outcomes of the events were unknown. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Left arm shingles vaccine, red circular area around site and warm to touch.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to 2 patients of unknown age. No concomitants were reported. On 22-MAY-2014, patients were vaccinated with LIQUID PEDVAXHIB (dose, frequency, route of administration and indication were not provided) lot # J016188, expiration date 02-OCT-2016 that was exposed to 8.8C for 10 days. No adverse effects reported. No product quality complaint (PQC) was involved. The outcome of events was unknown. No further information provided. On 02-JUN-2014 a phone call was placed to reporter. The receptionist stated they do not have any one by that name employed at this facility. No further information is available at this time. This report is linked to 1405USA013338, 1405USA013916, 1405USA013915, 1406USA004906, 1406USA004908, 1406USA004909, 1406USA004913, 1406USA004915, 1406USA004863, 1406USA004874, 1406USA004881, 1406USA004891, 1406USA004896, 1406USA004897, 1406USA004900, 1406USA4901, 1406USA004814, 1406USA004830, 1406USA004831, 1406USA004832, 1406USA004833, 1406USA004835, 1406USA004837 by the same reporter link. Additional information is not expected.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Body temperature increased
Clinical narrative: Mom as historian - states patient had a rectal temp of 104 the day of vaccines. Gave TYLENOL, no recurrence. No other sx noted.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to 2 patients of unknown age. No concomitants were reported. On 21-MAY-2014, patients were vaccinated with LIQUID PEDVAXHIB (dose, frequency, route of administration and indication were not provided) Lot# J016188, expiration date 02-OCT-2016 that was exposed to 8.8C for 10 days. No adverse effects reported. No product quality complaint (PQC) was involved. The outcome of events was unknown. No further information provided. On 02-JUN-2014 a phone call was placed to reporter. The receptionist stated they do not have any one by that name employed at this facility. No further information is available at this time. This report is linked to 1405USA013338 and 1405USA013916 by the same reporter link. Additional information is not expected.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to 7 patients of unknown age. No concomitants were reported. On 20-MAY-2014, patients were vaccinated with PEDVAXHIB (dose, frequency, route of administration and indication were not provided) lot# J016188, expiration date 02-OCT-2016 that was exposed to 8.8C for 10 days. No adverse effects reported. No product quality complaint (PQC) was involved. The outcome of events was unknown. No further information provided. On 02-JUN-2014 a phone call was placed to reporter. The receptionist stated they do not have anyone by that name employed at this facility. No further information is available at this time. This report is linked to 1405USA013338, 1405USA013916, 1405USA013915, 1406USA004906, 1406USA004908, 1406USA004913, 1406USA004914, 1406USA004915, 1406USA004863, 1406USA004874, 1406USA004881, 1406USA004891, 1406USA004896, 1406USA004897, 1406USA004900, 1406USA004901, 1406USA004814, 1406USA004830, 1406USA004831, 1406USA004832, 1406USA004833, 1406USA004835, 1406USA004837 by the same reporter link.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site swelling, Pain
Clinical narrative: Right arm swelling - started the morning after vaccines given and worsened throughout the day. Moderate swelling and mild pain at time of exam that evening.