chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.51
Sex: F
Vaccine: DTAP, HIBV, IPV, RV5
Symptoms: Abdominal operation, Intussusception
Clinical narrative: Child presented to our clinic today (04/30/2015) Pediatrician's office was out of Prevnar.  Gathering history from Mom, through interpreter, Mom reported patient had abdominal surgery for twisted bowel 2 weeks ago.  Noted had Rotateq 4-11-15 prior to illness.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Left arm pain, redness and swelling.
Age: 35.0
Sex: F
Vaccine: HPV4
Symptoms: Anger, Anogenital warts, Arthralgia, Back pain, Biopsy site unspecified abnormal
Clinical narrative: In 2008 I got the 3 doses of GARDASIL to prevent HPV, since I had not become sexually active. During that first year, I started to see changes in my vulva, skin growths appeared and began to grow. I had witness the changing process but failed to mentioned to my doctor since, I had not become sexually active. Then I began to have a series of pulmonary illnesses to the point that I was hospitalize twice and given pulmonary therapy and a prolong steroid therapy which caused other health problems, such as weight gain. Also I got gastric and biliary reflux, IBS, began to have problems with hemorrhoids and varicose veins, and joint pain and problems which included severe back pain that needed hospitalization. I began sexually active in 2011, only one partner, one sexual encounter since. In 2015, I got my first pap smear, and the doctor saw the growths. I mentioned those appeared right after I was vaccinated, and he urged me to have them removed. I went through an extremely painful electrocautery. And now after the diagnosis came positive for condylomas; I am undergoing emotional distress, anger and helplessness because the vaccine I thought will prevent an illness actually infected me with it. Now, I have to deal with living with a venereal disease, the insecurity that brings on a possible relationship, or having regular check ups to watch out for more condylomas to appear again, and undergo an extremely painful and costly procedure to have them remove. Also I have to consider a possible transmission to my child if I get pregnant. GARDASIL should be taken out of the market. It is shameful that the FDA permits it to be on the market and Merck can ruin the lives of so many young girls, and women around the world. Take the responsibility!
Age: 35.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Electrocauterisation, Emotional distress, Gastrooesophageal reflux disease, Haemorrhoids
Clinical narrative: In 2008 I got the 3 doses of GARDASIL to prevent HPV, since I had not become sexually active. During that first year, I started to see changes in my vulva, skin growths appeared and began to grow. I had witness the changing process but failed to mentioned to my doctor since, I had not become sexually active. Then I began to have a series of pulmonary illnesses to the point that I was hospitalize twice and given pulmonary therapy and a prolong steroid therapy which caused other health problems, such as weight gain. Also I got gastric and biliary reflux, IBS, began to have problems with hemorrhoids and varicose veins, and joint pain and problems which included severe back pain that needed hospitalization. I began sexually active in 2011, only one partner, one sexual encounter since. In 2015, I got my first pap smear, and the doctor saw the growths. I mentioned those appeared right after I was vaccinated, and he urged me to have them removed. I went through an extremely painful electrocautery. And now after the diagnosis came positive for condylomas; I am undergoing emotional distress, anger and helplessness because the vaccine I thought will prevent an illness actually infected me with it. Now, I have to deal with living with a venereal disease, the insecurity that brings on a possible relationship, or having regular check ups to watch out for more condylomas to appear again, and undergo an extremely painful and costly procedure to have them remove. Also I have to consider a possible transmission to my child if I get pregnant. GARDASIL should be taken out of the market. It is shameful that the FDA permits it to be on the market and Merck can ruin the lives of so many young girls, and women around the world. Take the responsibility!
Age: 35.0
Sex: F
Vaccine: HPV4
Symptoms: Irritable bowel syndrome, Lung disorder, Neoplasm skin, Sexually transmitted disease, Smear cervix normal
Clinical narrative: In 2008 I got the 3 doses of GARDASIL to prevent HPV, since I had not become sexually active. During that first year, I started to see changes in my vulva, skin growths appeared and began to grow. I had witness the changing process but failed to mentioned to my doctor since, I had not become sexually active. Then I began to have a series of pulmonary illnesses to the point that I was hospitalize twice and given pulmonary therapy and a prolong steroid therapy which caused other health problems, such as weight gain. Also I got gastric and biliary reflux, IBS, began to have problems with hemorrhoids and varicose veins, and joint pain and problems which included severe back pain that needed hospitalization. I began sexually active in 2011, only one partner, one sexual encounter since. In 2015, I got my first pap smear, and the doctor saw the growths. I mentioned those appeared right after I was vaccinated, and he urged me to have them removed. I went through an extremely painful electrocautery. And now after the diagnosis came positive for condylomas; I am undergoing emotional distress, anger and helplessness because the vaccine I thought will prevent an illness actually infected me with it. Now, I have to deal with living with a venereal disease, the insecurity that brings on a possible relationship, or having regular check ups to watch out for more condylomas to appear again, and undergo an extremely painful and costly procedure to have them remove. Also I have to consider a possible transmission to my child if I get pregnant. GARDASIL should be taken out of the market. It is shameful that the FDA permits it to be on the market and Merck can ruin the lives of so many young girls, and women around the world. Take the responsibility!
Age: 35.0
Sex: F
Vaccine: HPV4
Symptoms: Varicose vein, Vulval disorder, Weight increased
Clinical narrative: In 2008 I got the 3 doses of GARDASIL to prevent HPV, since I had not become sexually active. During that first year, I started to see changes in my vulva, skin growths appeared and began to grow. I had witness the changing process but failed to mentioned to my doctor since, I had not become sexually active. Then I began to have a series of pulmonary illnesses to the point that I was hospitalize twice and given pulmonary therapy and a prolong steroid therapy which caused other health problems, such as weight gain. Also I got gastric and biliary reflux, IBS, began to have problems with hemorrhoids and varicose veins, and joint pain and problems which included severe back pain that needed hospitalization. I began sexually active in 2011, only one partner, one sexual encounter since. In 2015, I got my first pap smear, and the doctor saw the growths. I mentioned those appeared right after I was vaccinated, and he urged me to have them removed. I went through an extremely painful electrocautery. And now after the diagnosis came positive for condylomas; I am undergoing emotional distress, anger and helplessness because the vaccine I thought will prevent an illness actually infected me with it. Now, I have to deal with living with a venereal disease, the insecurity that brings on a possible relationship, or having regular check ups to watch out for more condylomas to appear again, and undergo an extremely painful and costly procedure to have them remove. Also I have to consider a possible transmission to my child if I get pregnant. GARDASIL should be taken out of the market. It is shameful that the FDA permits it to be on the market and Merck can ruin the lives of so many young girls, and women around the world. Take the responsibility!
Age: 0.21
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Pt here at 2-month well-baby check. Rotavirus vaccine was given to pt, followed by immunizations. Pt broke out in hives on legs, torso and face within 10 minutes. No signs of respiratory distress. Pt was monitored here for 30+ minutes, no further complications.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Skin lesion
Clinical narrative: Swelling, redness and itching at the injection site following a zoster vaccine that was placed 4/21/15. Skin lesion located in the back of right arm, measure 4 cm around. No tenderness or soreness.
Age: 32.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: Patient received varicella vaccine on 3/20, during first trimester of pregnancy. Upon receipt of vaccine, neither patient nor provider knew patient was pregnant. Patient had wellness exam 3/10 and had titers drawn showing she was not immune to varicella or hepatitis B. Patient found out shortly after 3/20 visit that she was pregnant. Pregnancy followed by another clinic. Clinic informed us of patient's pregnancy and vaccine error.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Pts leg was very swollen, warm to the touch and had a slight rash near injection site.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Lip swelling, Urticaria
Clinical narrative: This spontaneous report was received from a physician regarding a 15 year old female patient with no pertinent medical history, drug reactions or allergies. On 20-APR-2015, the patient was vaccinated with the first dose of GARDASIL (0.5 ml, intramuscular, lot number was not provided). There was no concomitant medication. On 23-APR-2015, the patient developed upper lip swelling and a few hives on the left forearm and wrist. The patient sought medical attention, at office visit. Subsequently, she was prescribed BENADRYL. Laboratories tests were not performed. It was not known if the patient would continue the GARDASIL series. At the time of the report, the patient's outcome was unknown. Additional information is not expected since the physician did not want to be contacted.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site induration, Injection site warmth, Peripheral swelling, Pruritus
Clinical narrative: 02/09/2015 Addendum status: Completed. Patient calling back to state that when he saw PCP on Wednesday he got a PNU shot in his L arm, states it was a booster shot, patient states that his arm is slightly swollen, red and itching, patient states that it started swelling up. About two 2 days after, states the swelling is not to bad, but the redness and itching is about the size of a small cantaloupe. States he has not ever had a reaction before, he does not c/o of swelling in the mouth, tongue, or any SOB. He is not taking any OTC meds for this. Will forward to PCP to review. Can he come in to nurse clinic to show us the area so we can document if this looks like reaction to PREVNAR 13 shot he got last week? Called patient, he will come to clinic today at 1PM. I saw him briefly in nurse clinic left upper arm has area approx 4-5 inches in widest diameter about the injection from PREVNAR shot last week, center of this area w/induration and midly warm to touch on my review of chart, there is an order in note to administer PREVNAR 13 shot and patient acknowledges it was givwn but i do not see the vaccine status in cprs/will notify lpn.
Age: 10.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Burning sensation, Crying, Fall, Loss of consciousness, Pallor
Clinical narrative: Patient was administered Tdap vaccine in (L) deltoid with no complication. Then given HPV #1 into Rt. deltoid, pt. let out a cry due to burning sensation when administered. She immediately tilted to left side of table and fell off exam table. I was at right side, mom was sitting across room. Patient passed out about 10-15 secs. became pale.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Musculoskeletal pain, Myalgia, Pain in extremity
Clinical narrative: Patient's right arm became progressively more painful after vaccination with FLUZONE HIGH DOSE. Says it is increasingly harder to use/lift her arm due to shoulder and muscle pain. She has sought treatment from her PCP.
Sex: U
Vaccine: VARZOS
Symptoms: Drug dose omission, No adverse event, Product quality issue
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown demographics. On an unknown date the patient did not receive ZOSTAVAX vaccination due to product quality complaint (PQC). No adverse effect was reported. Additional information has been requested.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Axillary pain, Back pain, Blood test normal, Electrocardiogram normal
Clinical narrative: Information has been received from a 77 year old male patient concerning himself. The patient had open heart surgery 7 years ago. In approximately 2012 (reported as "between 2 and 3 years ago"), the patient was vaccinated with ZOSTAVAX (dose, strength, lot# and route were not reported) in his physician's office following physician's advice. In approximately February 2015 (reported as "about 4.5 weeks ago") the patient developed sharp pains in his back near spine with itching which went away. But when at an unspecified time shortly afterward the patient stated that he developed pain on left side and under arm pit. The patient also additionally stated that he was feeling pain in his left wrist and jaw. The patient was given unspecified pain killer for treatment and the pain declined with pain killers. The patient also reported he was placed on unspecified medication that reduced inflammation (onset date).. The patient received medical attention in physician's office: an electrocardiogram (EKG) and blood work were performed showing no heart and bone disease and. The symptoms were determined to be related to shingles and nerve involvement with shingles. The patient stated that at the time of reporting, his symptoms were milder and slowly going away. The patient was recovering from the Herpes zoster infection neurological. At the time of reporting, the outcome of "inflammation" was unknown. Causality between both events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Flank pain, Herpes zoster, Herpes zoster infection neurological, Inflammation, Pain in jaw
Clinical narrative: Information has been received from a 77 year old male patient concerning himself. The patient had open heart surgery 7 years ago. In approximately 2012 (reported as "between 2 and 3 years ago"), the patient was vaccinated with ZOSTAVAX (dose, strength, lot# and route were not reported) in his physician's office following physician's advice. In approximately February 2015 (reported as "about 4.5 weeks ago") the patient developed sharp pains in his back near spine with itching which went away. But when at an unspecified time shortly afterward the patient stated that he developed pain on left side and under arm pit. The patient also additionally stated that he was feeling pain in his left wrist and jaw. The patient was given unspecified pain killer for treatment and the pain declined with pain killers. The patient also reported he was placed on unspecified medication that reduced inflammation (onset date).. The patient received medical attention in physician's office: an electrocardiogram (EKG) and blood work were performed showing no heart and bone disease and. The symptoms were determined to be related to shingles and nerve involvement with shingles. The patient stated that at the time of reporting, his symptoms were milder and slowly going away. The patient was recovering from the Herpes zoster infection neurological. At the time of reporting, the outcome of "inflammation" was unknown. Causality between both events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Information has been received from a 77 year old male patient concerning himself. The patient had open heart surgery 7 years ago. In approximately 2012 (reported as "between 2 and 3 years ago"), the patient was vaccinated with ZOSTAVAX (dose, strength, lot# and route were not reported) in his physician's office following physician's advice. In approximately February 2015 (reported as "about 4.5 weeks ago") the patient developed sharp pains in his back near spine with itching which went away. But when at an unspecified time shortly afterward the patient stated that he developed pain on left side and under arm pit. The patient also additionally stated that he was feeling pain in his left wrist and jaw. The patient was given unspecified pain killer for treatment and the pain declined with pain killers. The patient also reported he was placed on unspecified medication that reduced inflammation (onset date).. The patient received medical attention in physician's office: an electrocardiogram (EKG) and blood work were performed showing no heart and bone disease and. The symptoms were determined to be related to shingles and nerve involvement with shingles. The patient stated that at the time of reporting, his symptoms were milder and slowly going away. The patient was recovering from the Herpes zoster infection neurological. At the time of reporting, the outcome of "inflammation" was unknown. Causality between both events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has received from an office manager (also reported as administrator) referring to a male patient of unknown age. On 27-APR-2015 the patient was vaccinated with an expired dose of VARIVAX (Merck) (lot # J005253, expiration date 26-APR-2015; first dose, 0.5 ml) subcutaneously. No adverse effects were reported. This is one of several cases reported from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a pharmacist via a company representative concerning a patient of unknown age and gender. No concurrent or historical conditions were reported. On an unknown date of 2011, the patient was vaccinated with one dose of ZOSTAVAX (strength, route, lot# and expiration unknown). On 23-APR-2015 the patient inadvertently received a second dose of ZOSTAVAX (strength, route, lot# and expiration unknown), which caused extra dose administered. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown ages with no pertinent medical history/drug allergies or drug reactions reported. On an unknown dates, the patients were vaccinated with an improperly storage of VARIVAX (Merck) (subcutaneously), (anatomical location, lot# and expiration date were not reported). There was not concomitant therapy reported. No adverse events reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: TDAP, VARZOS, TDAP, VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Based on the additional information received on 15 April 2015, this case initially considered as non-serious was upgraded to serious due to the event cellulitis of extremity which is an important medical event as per the EMA list. Initial unsolicited report received from a non-healthcare professional on 19 March 2015. A 61-year-old female patient, whose medical history and concomitant medications were not reported, had received an intramuscular dose of ADACEL (Batch number C4695AA, expiry date and dose number was not reported) in left deltoid on an unspecified date. On an unspecified date, the patient had experienced redness, tenderness, swelling at the left deltoid. Laboratory investigations and corrective treatment were not reported. The patient illness at the time of vaccination, and pre-existing diagnosed allergies and birth defects were not reported. At the time of this report, outcome of the event was unknown. List of documents held by sender: none. Follow up information received from a non-healthcare professional on 15 April 2015. It was reported that the patient had received an intramuscular dose of ADACEL in left deltoid and a dose of ZOSTAVAX (batch number K018175, expiry date, dose, dose number and route of administration were not reported) in right deltoid, both the vaccine administered on 16 March 2015 (11:00 hours). It was reported that patient had no known pre-existing allergies. On 17 March 2015, one day after vaccination, patient had experienced redness, tenderness, swelling at the left deltoid and laboratory investigation was reported as cellulitis of extremity. The patient was advised to use warm compresses and prescribed with sulfamethoxazole and this treatment started on 19 March 2015. At the time of this report, the outcome of the event was unknown. Upon internal review, company assessed the event of cellulitis of extremity as serious and important medical event. Documents held by sender: none.
Age: 61.0
Sex: F
Vaccine: TDAP, VARZOS, TDAP, VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Laboratory test abnormal
Clinical narrative: Based on the additional information received on 15 April 2015, this case initially considered as non-serious was upgraded to serious due to the event cellulitis of extremity which is an important medical event as per the EMA list. Initial unsolicited report received from a non-healthcare professional on 19 March 2015. A 61-year-old female patient, whose medical history and concomitant medications were not reported, had received an intramuscular dose of ADACEL (Batch number C4695AA, expiry date and dose number was not reported) in left deltoid on an unspecified date. On an unspecified date, the patient had experienced redness, tenderness, swelling at the left deltoid. Laboratory investigations and corrective treatment were not reported. The patient illness at the time of vaccination, and pre-existing diagnosed allergies and birth defects were not reported. At the time of this report, outcome of the event was unknown. List of documents held by sender: none. Follow up information received from a non-healthcare professional on 15 April 2015. It was reported that the patient had received an intramuscular dose of ADACEL in left deltoid and a dose of ZOSTAVAX (batch number K018175, expiry date, dose, dose number and route of administration were not reported) in right deltoid, both the vaccine administered on 16 March 2015 (11:00 hours). It was reported that patient had no known pre-existing allergies. On 17 March 2015, one day after vaccination, patient had experienced redness, tenderness, swelling at the left deltoid and laboratory investigation was reported as cellulitis of extremity. The patient was advised to use warm compresses and prescribed with sulfamethoxazole and this treatment started on 19 March 2015. At the time of this report, the outcome of the event was unknown. Upon internal review, company assessed the event of cellulitis of extremity as serious and important medical event. Documents held by sender: none.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Mass, Pain in extremity, Pruritus, Skin irritation
Clinical narrative: 1 sore red area 4 cm 1 (not sore) red area 3 cm.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pain
Clinical narrative: 1 sore red area 4 cm 1 (not sore) red area 3 cm.
Age: 0.36
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Intussusception, Ultrasound abdomen abnormal, X-ray abnormal
Clinical narrative: INTUSSUSCEPTION TAKEN TO HOSPITAL AND TREATED.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. It was reported that an unspecified number of improperly stored doses of ROTATEQ (lot # K010642, expiration date 14-MAY-2106) were administered to the patients (dose and route were not reported) on unknown dates. No adverse events were reported. Additional information is not expected since the physician asks not to be contacted.
Age: 0.28
Sex: F
Vaccine: PPV
Symptoms: Abdominal pain upper, Chills, Injection site pain, Muscle spasms, Pyrexia
Clinical narrative: After having a regular checkup, my doctor recommended at my age I take the preventative pneumonia shot. I saw no reason not to do so however, following the PCV13 Vaccine, the injection site was very sore and within 3 hours I had a high fever, chills, chest/stomach cramps. Later my chest became congested and I have been in bed for 4 days.  I did  notify my doctor and he indicated it was unusual to have a negative side effect. I have been consuming liquids and resting.
Age: 0.28
Sex: F
Vaccine: PPV
Symptoms: Respiratory tract congestion
Clinical narrative: After having a regular checkup, my doctor recommended at my age I take the preventative pneumonia shot. I saw no reason not to do so however, following the PCV13 Vaccine, the injection site was very sore and within 3 hours I had a high fever, chills, chest/stomach cramps. Later my chest became congested and I have been in bed for 4 days.  I did  notify my doctor and he indicated it was unusual to have a negative side effect. I have been consuming liquids and resting.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, RV1
Symptoms: Lip swelling, Vulvovaginal erythema, Vulvovaginal swelling
Clinical narrative: The day after PENTACEL and ROTARIX vaccines were given patient's labia became red and swollen and that her lower lip became swollen. Both symptoms resolved.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella virus test negative
Clinical narrative: This spontaneous report was received from a physician assistant and refers to a 23 year old female patient with dyslipidaemia and anaemia. No concomitant medications or drug reactions/allergies were reported. On 13-SEP-2013, the patient was vaccinated with the first dose of (Oka/Merck) VARIVAX (lot # J006109, expiration date 21-MAY-2015, dose not provided) administered subcutaneously. On 14-OCT-2013, the patient was vaccinated with th second dose of (Oka/Merck) VARIVAX (lot # J0082289-this lot was confirmed twice with the reporter who stated it may have been documented incorrectly, expiration date 12-JUL-2015, dose not provided), administered subcutanenously. The patient had titers drawn on 14-NOV-2013 and on 31-MAR-2015 and both showed she was negative for immunity to varicella. No treatment was given for the adverse event. No additional information was provided. The outcome of the adverse event was reported as not recovered/not resolved. The relatedness between the adverse event and the suspect vaccine was not provided. Additional information has been requested.
Age: 24.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a 24 year old male patient. On 22-APR-2015 the patient was vaccinated with a dose of GARDASIL 9, lot# not reported, 0.5 ml, intramuscularly. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Vocational Nurse referring to an unspecified number of patients of unknown age and gender. Information regarding concurrent conditions and medical history was not provided. On unknown dates the patients were vaccinated with improperly stored doses of GARDASIL for prophylaxis (strength, dose, dose number, lot #, route and application site were not reported. Concomitant therapy was not reported. No adverse events were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. No medical history was reported. On 13-APR-2015, the patient was vaccinated with ROTATEQ (lot # J012525, exp date 09-APR-2015) (2 ml, once, oral). No concomitant therapy was reported. The reported stated that the patient received an expired dose of ROTATEQ. No adverse events were reported. The outcome of the events was unknown. The events were considered to be not related to ROTATEQ. No product quality issue was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 21-APR-2015 the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (dose, lot # and route of administration not reported). There was reported that vaccine was improperly stored. No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Vocational Nurse referring to an unspecified number of patients of unknown age and gender. Information regarding concurrent conditions and medical history was not provided. On unknown dates the patients were vaccinated with improperly stored doses ROTATEQ, orally (strength, dose, dose number, lot # and application site were not reported). Concomitantt therapy was not reported. No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to unspecified patients of unknown age and gender. On 16-APR-2015, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (lot number, dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to unspecified patients of unknown age and gender. On 20-APR-2015, the patients were vaccinated with improperly stored of LIQUID PEDVAXHIB (lot number, dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to unspecified patients of unknown age and gender. On 13-APR-2015, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (lot number, dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to unspecified patients of unknown age and gender. On 21-APR-2015, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (lot number, dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to unspecified patients of unkonwn age and gender. On 09-APR-2015, the patients were vaccinated with improperly stored doses of GARDASIL (lot number, dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via company representative and refers to a 79 year old male patient. No medical history or concurrent conditions were reported. On 01-NOV-2012, the patient was vaccinated with ZOSTAVAX for prevention of shingles. No concomitant medications were reported. On 15-FEB-2015, the patient developed shingles on his upper chest area, the patient sought medical attention with the physician on the same day. The patient received TYLENOL, valacyclovir (manufacturer unknown), hydrocodone (manufacturer unknown), VICODIN and LYRICA as treatment for the adverse event (dates unknown). It was unknown if the patient had a history of shingles. The outcome of the event was unknown. The reporter did not assess the causality of the event with ZOSTAVAX. Additional information has been requested.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain
Clinical narrative: Information has been received from a pharmacist who was the patient's wife, referring to her husband of unknown age who was also a physician. The patient's medical history and concurrent condition were not reported. On 24-MAR-2015 the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot# were not reported). Information regarding concomitant therapy was not reported. On an unspecified date of 2015 the patient developed tenderness at the injection site which lasted "about ten days". It was unspecified if the patient sought any medical attention. This case was one of two cases from same reporter. Additional information has been requested.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash pustular
Clinical narrative: Information has been received from a pharmacist who was the patient's wife, referring to her husband of unknown age who was also a physician. The patient's medical history and concurrent condition were not reported. On 24-MAR-2015 the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot# were not reported). Information regarding concomitant therapy was not reported. On an unspecified date of 2015 the patient developed tenderness at the injection site which lasted "about ten days". It was unspecified if the patient sought any medical attention. This case was one of two cases from same reporter. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Circumstance or information capable of leading to medication error, Incorrect dose administered, No adverse event
Clinical narrative: Information has been received from a Healthcare worker concerning a 24 year old female patient. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 07-APR-2015, the patient was vaccinated with GARDASIL (lot#, expiration date, route and dose not reported). The patient jumped when the needle was inserted into her arm (the patient was scared to needles), and she did not receive the full dose of the vaccine. A full dose of GARDASIL was re-administered at the same office on 07-APR-2015. No adverse effects were reported. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia
Clinical narrative: This spontaneous report as received from a registered nurse (R.N.) refers to a 17 year old female patient who was not pregnant. It was reported that the patient had a history of an unspecified reaction to penicillin (unspecified) prior to the administration of GARDASIL. The patient's medical history was reported as none. On 10-FEB-2015, the patient was vaccinated with a first dose of GARDASIL (0.5 ml, intramuscular, lot# K007264, expiration date 02-MAR-2017). Approximately in 2015, the patient was vaccinated with a second dose of GARDASIL (0.5 ml, intramuscular, lot# and expiration date were not provided). The patient's concomitant medication was reported as none. On 16-APR-2015, after the patient was vaccinated with a second dose of GARDASIL, she experienced intermittent numbness in the left side of her head, her feet and hands. No treatment was given for the adverse event and no laboratory tests were performed. The patient sought medical attention by an unspecified office visit. The outcome of intermittent numbness in the left side of her head, her feet and hands was reported as not recovered. Causality assessment between the event of intermittent numbness in the left side of her head, her feet and hands and the therapy with GARDASIL was not provided. Product quality complaint (PQC) was not involved. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMR, DTAP, IPV, MMRV
Symptoms: Measles, Pyrexia
Clinical narrative: Information has been received from a patient's mother referring to her 5 year old daughter without pertinent medical history. On 23-APR-2015 the patient was vaccinated with a dose of M-M-R II (lot# reported as L003221, injection, route and strength and expiration date were unknown). There was no concomitant medication. On 25-APR-2015 the patient developed a 102.8 fever at 17:00 that lasted until 09:00 the next morning. And during this time of the fever, the patient broke out into "full blown measles all over her body." The mother took the patient back to the physician's office (date unspecified) and the patient was seen by two physicians one was the physician who administered the vaccine and other was the senior physician of the practice, both stated that this was a "severe, very severe case of measles" and the senior partner stated "the worse case I have seen in years." The patient was treated with calamine lotion, TYLENOL, NEOSPORIN AF and BENADRYL. At the time of this report, the outcome of the event was not resolved. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMR, DTAP, IPV, MMRV
Symptoms: Measles, Nasal congestion, Pharyngitis, Pyrexia, Rash generalised
Clinical narrative: Information has been received from a patient's mother referring to her 5 year old daughter without pertinent medical history. On 23-APR-2015 the patient was vaccinated with a dose of M-M-R II (lot# reported as L003221, injection, route and strength and expiration date were unknown). There was no concomitant medication. On 25-APR-2015 the patient developed a 102.8 fever at 17:00 that lasted until 09:00 the next morning. And during this time of the fever, the patient broke out into "full blown measles all over her body." The mother took the patient back to the physician's office (date unspecified) and the patient was seen by two physicians one was the physician who administered the vaccine and other was the senior physician of the practice, both stated that this was a "severe, very severe case of measles" and the senior partner stated "the worse case I have seen in years." The patient was treated with calamine lotion, TYLENOL, NEOSPORIN AF and BENADRYL. At the time of this report, the outcome of the event was not resolved. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMR, DTAP, IPV, MMRV
Symptoms: Rash morbilliform, Rash papular, Rash pruritic
Clinical narrative: Information has been received from a patient's mother referring to her 5 year old daughter without pertinent medical history. On 23-APR-2015 the patient was vaccinated with a dose of M-M-R II (lot# reported as L003221, injection, route and strength and expiration date were unknown). There was no concomitant medication. On 25-APR-2015 the patient developed a 102.8 fever at 17:00 that lasted until 09:00 the next morning. And during this time of the fever, the patient broke out into "full blown measles all over her body." The mother took the patient back to the physician's office (date unspecified) and the patient was seen by two physicians one was the physician who administered the vaccine and other was the senior physician of the practice, both stated that this was a "severe, very severe case of measles" and the senior partner stated "the worse case I have seen in years." The patient was treated with calamine lotion, TYLENOL, NEOSPORIN AF and BENADRYL. At the time of this report, the outcome of the event was not resolved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a nurse referring to unspecified patients of unknown age and gender. On 27-APR-2015 the patients were vaccinated with improperly stored (Merck) PROQUAD (lot # K022448, 13-MAY-2016)(dose and route unspecified). This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a licensed practical nurse referring to an unspecified number of patients of unknown age and gender with egg allergy. On unknown dates the patients was vaccinated with doses of M-M-R II, subcutaneously (dose and lot# unknown). On unknown dates the patients experienced a reaction that consisted of redness, and swelling at the injection site following the administration of M-M-R II. The nurse stated the reaction was due to an egg allergy. Some of those patients might have received less than a full dose (less than 0.5ml) (Underdose) of M-M-R II due to an unspecified error during administration (medication error). No PQC (product quality complaint). The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a nurse referring to unspecified patients of unknown age and gender. On 27-APR-2015 the patients were vaccinated with improperly stored VARIVAX (Merck) (lot # K003410, 06-MAR-2016) (dose and route unspecified). This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to 50 patients of unknown age and gender. Information about concurrent conditions and medical history were not provided. The nurse practitioner was reporting that the 50 patients were administered with VARIVAX (Merck) (lot # K007980, expiration date 03-JUN-2016, dose and route not reported) on unspecified dates, that had been improperly stored (incorrect product storage). No information regarding concomitant therapy was provided. No adverse effects reported. The outcome of the event was not reported. Additional information is not expected as there was no consent for follow up contact.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning a patient of unknown age and gender. No current or historical conditions were reported. On 20-APR-2015 the patient was vaccinated with M-M-R II (strength, dose, route and lot# unknown, expiration date is 22-MAR-2015) after the expiration date. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has received from an office manager (also reported as administrator) referring to a female patient of unknown age. On 09-JAN-2012, the patient was vaccinated with a first dose of VARIVAX (Merck) (lot#, expire date were unspecified, 0.5 ml) subcutaneously. On 27-APR-2015 the patient was vaccinated with an expired dose of VARIVAX (Merck) (lot # J005253, expiration date 26-APR-2015; second dose, 0.5 ml) subcutaneously. No adverse effects were reported. This is one of several cases reported from the same reproter. Additional information has been requested.
Age: 33.0
Sex: M
Vaccine: TYP
Symptoms: Rash pruritic
Clinical narrative: Last night a pruritic rash began on his shoulders and back and is present today when he came for treatment.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Erythema, Mobility decreased, Peripheral swelling, Pyrexia
Clinical narrative: The patient reported that he developed a fever in the evening (approximately 8 hours after receiving vaccine) and also had chills.  His arm was red and swollen in a very large area (up and down his arm).  He reported a sensation that his arm felt like "I got stung by 10 bees".  He felt that this limited his mobility.  He did not seek treatment with his physician nor call the pharmacy till a few days later.  He only self-treating with ibuprofen (Advil).  At the fifth day, he reported that the reaction had pretty much completely cleared.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Sensory disturbance
Clinical narrative: The patient reported that he developed a fever in the evening (approximately 8 hours after receiving vaccine) and also had chills.  His arm was red and swollen in a very large area (up and down his arm).  He reported a sensation that his arm felt like "I got stung by 10 bees".  He felt that this limited his mobility.  He did not seek treatment with his physician nor call the pharmacy till a few days later.  He only self-treating with ibuprofen (Advil).  At the fifth day, he reported that the reaction had pretty much completely cleared.
Age: 19.0
Sex: F
Vaccine: HEPA
Symptoms: Blood glucose normal, Immediate post-injection reaction, Nausea, Oropharyngeal pain, Peripheral coldness
Clinical narrative: Client received one vaccine Vaqta IM Left deltoid, felt nauseated immediately after vaccine was given, (9:10 AM BP 50/0 radial pulse undetectable, able to hear, 9:15 AM BP 88/0, 9:20 AM BP 102/52, transferred to a reclining chair with legs elevated, legs and arms felt like cement. 911 called and EMS arrived and Blood glucose: 116.  Refused to go to hospital. 10:00 AM head elevated and able to drink juice, eat a banana and crackers. Client said right side of throat hurt while drinking juice.  10:15AM arms and legs felt cold. Husband arrived 10:10 AM and 10:30 AM client able to sit up, stand, walk, left walking with husband to go home.
Age: 19.0
Sex: F
Vaccine: HEPA
Symptoms: Sensory disturbance
Clinical narrative: Client received one vaccine Vaqta IM Left deltoid, felt nauseated immediately after vaccine was given, (9:10 AM BP 50/0 radial pulse undetectable, able to hear, 9:15 AM BP 88/0, 9:20 AM BP 102/52, transferred to a reclining chair with legs elevated, legs and arms felt like cement. 911 called and EMS arrived and Blood glucose: 116.  Refused to go to hospital. 10:00 AM head elevated and able to drink juice, eat a banana and crackers. Client said right side of throat hurt while drinking juice.  10:15AM arms and legs felt cold. Husband arrived 10:10 AM and 10:30 AM client able to sit up, stand, walk, left walking with husband to go home.
Age: 56.0
Sex: F
Vaccine: HEP
Symptoms: Nasopharyngitis, Rash erythematous, Rash pruritic
Clinical narrative: Red, raised, pruritic, systemic rash.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness and warmth around injection site on right leg.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Pyrexia
Clinical narrative: Patient developed fever 103 degrees. No other adverse symptoms.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache
Clinical narrative: Polyarthralgias and headache which lasted 4-5 days. Symptoms have resolved without treatment.
Age: 1.35
Sex: F
Vaccine: DTAPIPVHIB, VARCEL
Symptoms: Rash generalised
Clinical narrative: Rash - chest to scalp.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Wheezing
Clinical narrative: Administered PREVNAR 4/28/15-to current 5/1/15. Pt has rash bilateral arms and torso and back. Red raised local reaction to injections site. Headache, cough and wheezing. Temp 99.3 orally.