chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to an adult patient of unknown age and gender who on 10-JUN-2015 was vaccinated with an improperly stored dose of GARDASIL lot #K006960 (exp date, dose and route of administration not provided). According to the reporter the vaccine dose administered underwent a temperature excursion for 63 hours. This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received. Product and narrative were updated.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender who on 25-JUN-2015 the patient was vaccinated with a dose of GARDASIL (lot # K006960)(route and dose were not provided) that was exposed to temperatures outside of the recommended range during 63 hours excursion. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 1.04
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Feeling hot, Rash
Clinical narrative: 12 mo female given MMR, VZV, Hep A #1 7/2. Mom noticed rash few days later on thigh. CC rash starting on thigh and abdomen a few days after varicella and MMR vaccine. It seemed to resolve for 1 day then came back with much more diffuse distribution. Now present on face, torso, back, legs and arms. She is not itching except when she sees her belly, then she'll grab at it. Mom reports that she's felt hot, but she hasn't had a thermometer to take temp.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Local swelling, Pain, Pruritus, Pyrexia
Clinical narrative: Patient had PCV 13 done on 7/8/2015, then has localized swelling, erythema, pain, and itching. Patient had fever with temp 39 degrees C. Improved on 7/11/2015.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Feeling abnormal, Injection site reaction, Local reaction, Loss of consciousness, Pallor
Clinical narrative: Patient stated she did not feel good, the color drained from her face and she almost passed out. She also had a local reaction at injection site.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Anaphylactic reaction, Cough, Urticaria, Wheezing
Clinical narrative: Anaphylaxis - presented 1 hr after vaccines with hives, wheezing, coughing. EPI PEN JR, BENADRYL, albuterol. Improved with treatment.
Age: 8.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Mom called and stated he woke with 1 1/2 inch diameter area surrounding shot injection site that is red and itches.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Mom called and stated he woke with 3-4 inch oblong reddened area at site of injection. Underneath the area is a now circular welt that is swollen beyond the red margin. It is itchy, red and warm to touch.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Urticaria
Clinical narrative: Mom called and stated he woke with 3-4 inch oblong reddened area at site of injection. Underneath the area is a now circular welt that is swollen beyond the red margin. It is itchy, red and warm to touch.
Age: 62.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Product quality issue
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 62-year-old male patient who received BOOSTRIX (batch number B54KE, expiry date 2nd April 2017). This case was associated with a product complaint. On 8th June 2015, the patient received the 1st dose of BOOSTRIX .5 ml. On 9th June 2015, 1 days after receiving BOOSTRIX, the patient experienced injection site pain and injection site swelling. On an unknown date, the patient experienced product complaint. On an unknown date, the outcome of the injection site pain, injection site swelling and product complaint were unknown. It was unknown if the reporter considered the injection site pain and injection site swelling to be related to BOOSTRIX. Additional information provided: The physician suspected a Quality Concern with this vaccine and their office has withheld the rest of this lot number. QA filed UV20150062. This case is one of the 2 cases reported by the same reporter for the same vaccine. QA Results (Complaint number UV20150062) received on 07 July 2015: the review of the safety data reported for batch number B54KE and other associated batches does not highlight a safety issue. It is unlikely that the reported events are related to a product quality issue from manufacturing origin. No investigation is required.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Blood pressure increased, Condition aggravated, Urticaria
Clinical narrative: Patient experienced hives on right arm approximately 15 minutes after receiving PREVNAR vaccination in right arm. She was monitored for about a half hour. At that time the hives seemed to be subsiding. She was given 50 mg of diphenhydramine. Her blood pressure was taken approximately 11:45am and red 224/117. Patient's Dr. (who prescribes her B.P. meds) was contacted and advised she go to ER if BP did not go down. BP was taken again at approximately 1 pm and was still 238/124. Pt. was advised to go to ED but decided on her own to go home. She called back to report that BP was 157/86 at 2:50 pm. Hives were almost gone by the time she left pharmacy at around 1 pm.
Age: 0.67
Sex: M
Vaccine: DTAP, HEP, IPV, PPV
Symptoms: Wrong drug administered
Clinical narrative: Child was given PNEUMOVAX 23 instead of PREVNAR 13.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PPV
Symptoms: Irritability, Skin warm
Clinical narrative: Grandmother states child was fussy after shots, felt warm but did not check temp. States she is fine today.
Age: 88.0
Sex: U
Vaccine: PNC13, VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis developed at PREVNAR 13 injection site (upper left arm). Immunization administered at 11:40 AM, July 8th, 2015. Pt developed symptoms within two days and contacted pharmacy around 10 AM on 7/13/15.
Age: 74.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain, Swelling face
Clinical narrative: Left side of face swollen from ear to chin, real puffy, no redness. Got better/resolved on 6/8 pm. Soreness at injection site.
Age: 0.61
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site erythema, Injection site nodule, Injection site warmth
Clinical narrative: Red knot, quarter size where injection was given. It was warm to the touch. It was on left thigh.
Age: 88.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Patient called in and stated that she was having fever, soreness and swollen at the area of injection at night after PREVNAR 13 shot. Symptoms improved on 6/24/2015.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Discomfort, Erythema, Pain, Skin warm
Clinical narrative: Noticed some discomfort the evening of shot called 7/13/15 said she had 6 x 6 spot warm, red to the touch and painful. Was seen at immediate care 7/13 and given antibiotics for cellulitis.
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Rash maculo-papular
Clinical narrative: Maculopapular rash on legs and trunk.
Age: 72.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Pain, Peripheral swelling, Pyrexia
Clinical narrative: Pt walked in complained of body ache, feverish at the night after vaccination of PREVNAR 13. Temperature 101.5 degrees F. Improved since 7/9/15, but still complained of right UE swelling and redness on 7/14/2015 visit.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (also reported as medical assistant (MA) referring to unspecified number of patients of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. ON unknown dates the patient was vaccinated with doses of improperly stored (Oka-Merck) PROQUAD or (Oka-Merck) VARIVAX (lot # and dose not reported). Information regarding concomitant medications was not reported. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to two patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date GARDASIL (lot # K007264, expiration date: 03-FEB-2017) was improperly exposed to 8.3 Celsius for 9 days. Then, on an unspecified date, the patients were vaccinated with a dose of GARDASIL (lot # K007264, expiration date: 03-FEB-2017) (dose, frequency and route were not reported). No known adverse effects were reported. No concomitant therapies were reported. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, Type 2 diabetes mellitus
Clinical narrative: This spontaneous report as received from a healthcare pharmacy student refers to a 43 year old female patient. The patient may have been administered the first dose of Hepatitis B Vaccine (manufacturer unknown). On 12-MAY-2015, the result of hepatitis B surface antibody test was non reactive. It was also reported that on 27-MAY-2015. The second dose, was administered on 23-JUN-2015 (Lot, route and dose were not reported) which was 27 days after the first dose. (Inappropriate dose of vaccine administered). Concomitant therapies included JANUVIA, CRESTOR, lisinopril (manufacturer unknown), metformin (manufacturer unknown) and NOVOLOG. On 12-MAY-2015, the hepatitis B surface antibody was performed which result was negative. It was reported that the patient was diagnosed with type 2 diabetes on an unspecified date and the pharmacist could not confirm if the patient was diagnosed with Type 2 Diabetes before or after the administration of the first documented dose of the vaccine. The outcome of the events was reported as unknown. The causality between the events and RECOMBIVAX HB were unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Product quality issue, Rash vesicular
Clinical narrative: Information has been received from a pharmacist referring to a female patient of unknown age. The patient's medical history included herpes zoster rashes on the back. As a result, the patient started concomitant therapy acyclovir on 23-FEB-2015 to prevent future herpes zoster rashes. On 22-MAY-2015 the patient was vaccinated with ZOSTAVAX (dose, frequency, lot# and expiration date were unknown) subcutaneously. The pharmacist stated that the vial (the one used) had been leaking, product quality complaint (PQC) involved. The patient received her last dose of acyclovir on 23-MAY-2015. On an unknown date in 2015 the patient experienced shingles-like rash after receiving ZOSTAVAX. The outcome of shingles-like rash was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician via a company representative referring to an unknown number of patients of unknown age and gender. Patients' concurrent and historical conditions were not reported. On an unknown ate the patients were vaccinated with GARDASIL (GARDASIL 9) (dose, frequency, route, lot # and expiration date were unknown). The physician reported that the patients were administered doses of GARDASIL one year apart (inappropriate schedule of vaccine administered). Concomitant therapies were not reported. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Intensive care, Vaccination complication
Clinical narrative: Information has been received from a healthcare professional (the administrator) via company representative referring to a female patient of unknown age. Information regarding the medical history and concurrent condition was not reported. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX 23, injection, 0.5 ml (lot#, expiration date and route were not reported). On an unknown date the patient experienced an unspecified adverse reaction after receiving the PNEUMOVAX 23, which resulted in the patient being admitted to the Emergency room and ended up in the Intensive Care Unit at an unspecified hospital on an unspecified date (hospitalization). The outcome of adverse event was unknown. The reporter considered the event as life threatening. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Blood test, Constipation, Feeling abnormal, Gastrointestinal infection, Neoplasm skin
Clinical narrative: Information has been received from a 82 years old female patient with high cholesterol, thyroid disorder and hay fever referring to herself. In September 2013, the patient was vaccinated with a single dose of ZOSTAVAX (dose, route and lot # were unspecified). Concomitant medication included high cholesterol medicine and thyroid medicine. In October 2013, the patient experienced post vaccination rashes and marks all over her body. She sought medical attention from her doctor and her doctor referred her to an unspecified dermatologist who prescribed Triamcinolone Acetonide Cream. No lab diagnostics study was performed. At the time of reporting, the patient had not recovered and continued to have rashes and marks all over her body. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Paraesthesia, Prurigo, Pruritus generalised, Rash generalised, Skin hypertrophy
Clinical narrative: Information has been received from a 82 years old female patient with high cholesterol, thyroid disorder and hay fever referring to herself. In September 2013, the patient was vaccinated with a single dose of ZOSTAVAX (dose, route and lot # were unspecified). Concomitant medication included high cholesterol medicine and thyroid medicine. In October 2013, the patient experienced post vaccination rashes and marks all over her body. She sought medical attention from her doctor and her doctor referred her to an unspecified dermatologist who prescribed Triamcinolone Acetonide Cream. No lab diagnostics study was performed. At the time of reporting, the patient had not recovered and continued to have rashes and marks all over her body. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Rash generalised, Skin disorder
Clinical narrative: Information has been received from a 82 years old female patient with high cholesterol, thyroid disorder and hay fever referring to herself. In September 2013, the patient was vaccinated with a single dose of ZOSTAVAX (dose, route and lot # were unspecified). Concomitant medication included high cholesterol medicine and thyroid medicine. In October 2013, the patient experienced post vaccination rashes and marks all over her body. She sought medical attention from her doctor and her doctor referred her to an unspecified dermatologist who prescribed Triamcinolone Acetonide Cream. No lab diagnostics study was performed. At the time of reporting, the patient had not recovered and continued to have rashes and marks all over her body. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Pt states she noticed a "knot" and "redness" at site of shot that seemed to get bigger throughout the day on Friday 07/10/2015 then seemed to be the same on Saturday 07/11/2015 and has started going down in size on Sunday 07/12/2015. Pt states she took Benadryl over the counter off and on, but could not take it & work. Pt states @ the worst it was a knot about 3 inches x 5 inches and the redness went pretty much around her arm. Pt states she works nights and did not call our office till Tuesday 07/15/2015, just to ask if she needed to get the next dose in 28 days? Advised I would consult with Immunization Program Coordinator for Health District and with our Immunization Program Rep.
Age: 26.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Injection site erythema, Injection site nodule
Clinical narrative: Pt states she noticed a "knot" and "redness" at site of shot that seemed to get bigger throughout the day on Friday 07/10/2015 then seemed to be the same on Saturday 07/11/2015 and has started going down in size on Sunday 07/12/2015. Pt states she took Benadryl over the counter off and on, but could not take it & work. Pt states @ the worst it was a knot about 3 inches x 5 inches and the redness went pretty much around her arm. Pt states she works nights and did not call our office till Tuesday 07/15/2015, just to ask if she needed to get the next dose in 28 days? Advised I would consult with Immunization Program Coordinator for Health District and with our Immunization Program Rep.
Age: 1.05
Sex: F
Vaccine: HEP, MMRV
Symptoms: Pyrexia
Clinical narrative: High fever treated with cool cloth to forehead, lukewarm bath, ibuprofen infant drops.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling of right upper arm.
Age: 50.0
Sex: F
Vaccine: TD
Symptoms: Activities of daily living impaired, Arthralgia, Asthenia, Blood pressure increased, Ear pain
Clinical narrative: Severe, debilitating fatigue and weakness and unable to carry out activities of daily living. Not able to work at present time. Have been feeling very shaky when standing, muscle pain and joint pain throughout entire body, tachycardia and increased blood pressure upon standing. Also am having headaches, sensitive to light and sound, feeling foggy and spacy.  Experienced muscle spasm in lower left leg on day two only. Ear pain in left ear on day two only. All of these symptoms developed approximately a half hour after Td vaccine in my left arm and are still present at this time. I had just had a complete check up at my doctors office 3 days prior (EKG, stress test included) to having the vaccine and was feeling in very good physically before having the Td vaccine.
Age: 50.0
Sex: F
Vaccine: TD
Symptoms: Fatigue, Feeling abnormal, Headache, Hyperacusis, Impaired work ability
Clinical narrative: Severe, debilitating fatigue and weakness and unable to carry out activities of daily living. Not able to work at present time. Have been feeling very shaky when standing, muscle pain and joint pain throughout entire body, tachycardia and increased blood pressure upon standing. Also am having headaches, sensitive to light and sound, feeling foggy and spacy.  Experienced muscle spasm in lower left leg on day two only. Ear pain in left ear on day two only. All of these symptoms developed approximately a half hour after Td vaccine in my left arm and are still present at this time. I had just had a complete check up at my doctors office 3 days prior (EKG, stress test included) to having the vaccine and was feeling in very good physically before having the Td vaccine.
Age: 50.0
Sex: F
Vaccine: TD
Symptoms: Muscle spasms, Myalgia, Nervousness, Photophobia, Tachycardia
Clinical narrative: Severe, debilitating fatigue and weakness and unable to carry out activities of daily living. Not able to work at present time. Have been feeling very shaky when standing, muscle pain and joint pain throughout entire body, tachycardia and increased blood pressure upon standing. Also am having headaches, sensitive to light and sound, feeling foggy and spacy.  Experienced muscle spasm in lower left leg on day two only. Ear pain in left ear on day two only. All of these symptoms developed approximately a half hour after Td vaccine in my left arm and are still present at this time. I had just had a complete check up at my doctors office 3 days prior (EKG, stress test included) to having the vaccine and was feeling in very good physically before having the Td vaccine.
Age: 40.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site movement impairment, Injection site pain, Mobility decreased, Pain in extremity
Clinical narrative: Pain and stiffness at the injection site. Over the next two days became difficult to raise my arm over my head.  The pain and stiffness worsened over time, and my arm still hurts two days later.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Generalised erythema, Injection site pruritus, Muscular weakness, Nausea
Clinical narrative: Within 2 hrs after administration, pt had fever, chills, nausea, vomiting, itching at injections site, slightly itchy all over, overall redness, muscle weakness.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus generalised, Pyrexia, Vomiting
Clinical narrative: Within 2 hrs after administration, pt had fever, chills, nausea, vomiting, itching at injections site, slightly itchy all over, overall redness, muscle weakness.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth, Scratch
Clinical narrative: Left upper arm larger, warm, had scratch marks but no other redness. Patient complained of pain, swelling in left upper arm within 3 hours of injection. Went to urgent care 07/03/2015 and treated with antibiotic.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, MMR, RVX
Symptoms: Decreased appetite, Emotional distress, Insomnia, Pyrexia, Screaming
Clinical narrative: High pitched screaming for hours, inconsolable, lack of appetite, when she did fall asleep if we laid her down she would immediately scream, low grade fever (100-101).
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Diarrhoea
Clinical narrative: Per mom, diarrhea every 30 mins-1 hour x 3 days (so far).
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. Within the past months (from 13-MAY-2015 to 13-JUL-2015), the patients were vaccinated with improperly stored doses of GARDASIL (lot # K007828, expiration date 02-MAR-2017; lot # 23432, expiration date 18-JUN-2016, 0.5 ml, intramuscularly). No adverse effects were reported. This is one to two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to two patients of unknown age and gender. No concurrent or historical conditions were reported. On unknown dates, two patients were inadvertently administered GARDASIL (strength, dose, route, lot# and expiration date unknown), which had been improperly stored. No adverse events were reported. This is one of two reports received from the same reporter. Additional information is not expected since the reporter would not like to be contacted.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On an unknown date, the patients were vaccinated with doses of GARDASIL (lot # K009482, expiry date 06-MAR-2017 and lot # K011325, expiry date 08-APR-2017; strength, dose, frequency, route of administration were not reported), which were exposed to temperature outside of the recommended range. There were no concomitant therapies reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On an unknown date, the patients were vaccinated with doses of RECOMBIVAX HB (lot # K020216, expiry date 17-SEP-2016; strength, dose, frequency, route of administration were not reported), which were exposed to temperature outside of the recommended range. There were no concomitant therapies reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Drug dose omission, No adverse event, Product quality issue
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information about medical history, concurrent conditions was reported for the patient. On an unknown date the patient missed a dose of VARIVAX (dose strength unspecified) subcutaneously due to a dislodged cap on a vial. No symptoms were reported. The outcome of events reported was unknown. Product quality complaint was filed. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date in January 2015, the patients were vaccinated with GARDASIL (lot # K004204, 0.5 ml, intramuscular). It was reported that the vaccines which was administered were improperly stored. No adverse effects were reported. The outcome of the two reports from same reporter link (1507USA006655). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to a patient of unknown age and gender. There was no pertinent medical history or drug reaction/allergies reported. On 10-JUL-2015 the patient was inadvertently administered with a dose of expired M-M-R II (lot # J007930, expired date 28-JUN-2015, dose and route were unknown). No adverse effects were reported. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema
Clinical narrative: LOCALIZED REDNESS TO DELTOID APPROX 12X8 CM. RECOMMENDED TO TAKE BENADRYL.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No concurrent or medical history was reported. On an unknown date in January 2015, the patients were vaccinated with RECOMBIVAX HB (lot # H014132, dose and route of administration not provided). It was reported that the vaccines which was administered were improperly stored. No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the two reports from the same reporter link (1507USA000660). Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients of unknown age and genders. No medical history, current conditions and concomitant therapies were reported. On multiple unspecified dates, the patients were administered improperly stored doses of ROTATEQ orally (lot #, expiration date, dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a registered nurse via a company representative referring to a female patient of unknown age. No concurrent or historical conditions were reported. On an unknown dates, the patient was separately vaccinated with 3 doses of RECOMBIVAX HB (strength, dose, route, lot# and expiration date unknown). There was no concomitant medication reported. On an unknown date, the patient was performed the lab test of Hepatitis B antibody titers and had been determined to have negative Hepatitis B antibody titers. The patient sought unspecified medical attention and no treatment was performed to her. At the time of reporting, the outcome of the event was unknown. Causality between the event and RECOMBIVAX HB was not reported. Additional information is not expected since the reporter would not like to be contacted.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients of unknown age and genders. No medical history, current conditions and concomitant therapies were reported. On multiple unspecified dates, the patients were administered improperly stored doses of MMR II (lot #, expiration date, dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse regarding unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date in 2015, as reported since 20-APR-2015, the patient was vaccinated with improperly stored VAQTA. No concomitant medication was reported. No adverse event was reported. No product quality complaint (PQC) was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On 13-JAN-2014, the patient was vaccinated with a dose of improperly stored PEDVAXHIB (lot number# J005672, Expiry date: 05-DEC-2015) (dose and route were not reported). No adverse experiences were reported. This is one of several reprots received from the same reporter. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Injection site induration, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Severe joint pain, fever, swollen, hard, painful injection site.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a clinical medical assistant refers to an unspecified number of patients of unknown age and gender. No information on patients' medical history or concurrent conditions was provided. On 01-MAY-2015, 05-MAY-2015, 11-MAY-2015, 19-MAY-2015, 22-MAY-2015, 26-MAY-2015, 03-JUN-2015, 08-JUN-2015, 09-JUN-2015, 12-JUN-2015, 16-JUN-2015, 17-JUN-2015, 22-JUN-2015, 25-JUN-2015 and 01-JUL-2015, the patients were vaccinated with improperly stored doses of GARDASIL (strength, dose, route of administration, lot# and expiration date were not reported). No information on patients' concomitant medication was provided. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a consumer (mother of the patient) refers to her daughter, a female patient of unknown age. No information regarding the patient's medical history or concurrent conditions was provided. On an unknown date, the patient missed her second dose of GARDASIL (strength, dose, frequency, route of administration, lot # and expiry date were not reported). It was reported that the second dose of GARDASIL was scheduled at a later unspecified date. There were no concomitant therapies reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age. The patient's pertinent medical history and concomitant medications were not reported. On 23-APR-2015, the patient was vaccinated with an improperly stored doses of GARDASIL (dose and route were not reported; lot ;# K006191, expiration date 02-FEB-2017). There were no adverse experiences 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: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 25-MAR-2014, the patient was vaccinated with an improperly stored dose of GARDASIL (lot # J006236, expiration date: 25-FEB-2016) dose and route were not reported. No adverse experiences were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous reprot as received from a clinical medical assistant refers to an unspecified number of patients of unknown age and gender. No information on patients medical history or concurrent conditions was provided. On 01-MAY-2015, 05-MAY-2015, 11-MAY-2015, 21-MAY-2015, 22-MAY-2015, 26-MAY-2015, 27-MAY-2015, 02-JUN-2015, 03-JUN-2015, 08-JUN-2015, 09-JUN-2015, 15-JUN-2015, 16-JUN-2015, 17-JUN-2015, 22-JUN-2015, 26-JUN-2015 and 01-JUL-2015, the patients were vaccinated with improperly stored doses of VAQTA (strength, dose, route of administration, lot# and expiration date were not reported). No information on patients concomitant medications was provided. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a clinical medical assistant refers to an unspecified number of patients of unknown age and gender. No information on patients medical history or concurrent conditions was provided. On an unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX23 injection (strength, dose, route of administration, lot# and expiration date were not reported). No information on patients concomitant medications was provided. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports from the same reporter. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Blood creatine phosphokinase increased, Muscular weakness, Weight decreased
Clinical narrative: Pt had vaccine 3/30/15. Has had increased muscle weakness, severe elevation of CPK level since weight loss (11 lb wt loss since 3/30/15).
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On 14-FEB-2014, the patient was vaccinated with a dose of improperly stored PEDVAXHIB lot # reported as J005672, expiration date reported as 05-DEC-2015 (dose and route were not reported). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to two unspecified patients of unknown age and gender. There was no concurrent conditions, medical history and concomitant medications reported. On an unknown date, the two patients were vaccinated with improperly stored doses of ZOSTAVAX (dose, route of administration, lot#, expiration date were not reported). No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of an unknown age and gender. The patient's medical history or concurrent conditions were not provided. On 09-JUL-2015, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (dose, route and lot number were not provided). Concomitant medication was not provided. No adverse effects were reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age with a present case of shingles. No information regarding the patient's medical history was provided. On 08-JUL-2015, the patient who at this time already had shingles, was vaccinated with a dose of ZOSTAVAX (strength, dose, route of administration, lot# and expiry date were not reported). There were no concomitant therapies reported. The pharmacist was not aware that the patient had a present care of shingles when she administered the vaccine. It wasn't until after she administered ZOSTAVAX that the patient mentioned he currently had shingles. The patient said the shingles developed prior to receiving ZOSTAVAX and he had "two shingles spots" on his body at the time of vaccination. He was supposed to take VALTREX to treat his shingles but he did not start the treatment. It was unspecified why did the patient request ZOSTAVAX. No adverse symptoms were reported with ZOSTAVAX administration. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On 27-JAN-2014, the patient was vaccinated with a dose of improperly stored PEDVAXHIB lot # reported as J005672, expiration date reported as 05-DE3C-2015 (dose and route were not reported). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Pain
Clinical narrative: Patient got the PREVNAR 13 vaccine on 06/30/15, complained of pain after vaccination. Took TYLENOL for pain. And also complained of redness and swelling around the injection site. Felt better after two days.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified patient of unknown age and gender. The patient's pertinent medical history and concomitant medications were not reported. On 23-MAR-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (dose and route were not reported, lot # K006191, expiration date 02-FEB-2017). There were no adverse experiences reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Injection site was bright red circular in shape.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous reprot as received from a medical assistant refers to a patient of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On 09-JAN-2014, the patient was vaccinated with a dose of improperly stored PEDVAXHIB (lot number reported as J005672, Expiry date: 05-DEC-2015) (dose and route were not reported). No adverse experiences were reported. This is one of several reprots received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients of unknown age and genders. No medical history, current conditions and concomitant therapies were reported. On multtiple unspecified dates, the patients were administered improperly stored doses of GARDASIL (lot #, expiration date, dose and route of administration were not reported). No adverse effects were reproted. This is one of several reports received from the same reporter. Additional informmation has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On 19-MAR-2014, the patient was vaccinated with a dose of improperly stored LIQUID PEDVAXHIB lot # reported as J005672, expiration date reported on 05-DEC-2015 (dose and route were not reported). No adverse experiences 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: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age. The patient's pertinent medical history and concomitant medications were not reported. On 03-APR-2015, the patient was vaccinated with an improperly stored doses of GARDASIL (dose and route were not reported;lot # K006191, expiration date 02-FEB-2017). There were no adverse experiences reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse regarding unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date in 2015, as reported since 20-APR-2015, the patient was vaccinated with improperly stored M-M-R II. No concomitant medication was reported. No adverse event was reported. No product quality complaint (PQC) was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 27-MAR-2014, the patient was vaccinated, with an improperly stored dose of GARDASIL (lot # H020901, expiration date: 05-JUL-2015), dose and route were not reported. No adverse experiences 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: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On 03-MAR-2014, the patient was vaccinated with a dose of improperly stored PEDVAXHIB lot # reported as J005672, expiration date reported as 05-DEC-2015 (dose and route were not reported). No adverse experiences 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: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On 10-JAN-2014, the patient was vaccinated with a dose of improperly stored PEDVAXHIB (lot number # J005672, Expiry date: 05-DEC-2015) (dose and route were not reported). No adverse experiences 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: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 03-MAR-2014, the patient was vaccinated with an improperly stored dose of GARDASIL (lot # J006236, expiration date: 25-FEB-2016), dose and route were not reported. No adverse experiences 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: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On 03-APR-2015, the patient was vaccinated with a dose of improperly stored PEDVAXHIB (lot number reported as K001124, Expiry date: 16-OCT-2016) (dose and route were not reported). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 32.0
Sex: M
Vaccine: MMR, TDAP, VARCEL
Symptoms: Erythema, Injection site erythema, Injection site swelling, Oedema peripheral
Clinical narrative: 10-11" raised red circle which traveled around arm into axillary area and down almost to elbow on her R arm.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse regarding unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date in 2015, as reported since 20-APR-2015, the patient was vaccinated with improperly stored ROTATEQ, oral. No concomitant medication was reported. No adverse event was reported. No product quality complaint (PQC) was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: VARCEL
Symptoms: Asthenia, Depressed level of consciousness, Diarrhoea, Impaired driving ability, Nausea
Clinical narrative: C/o nausea and diarrhea over the weekend. Appeared at clinic on 7/14/15 with complaints of fever, nausea and feeling weak and going to "pass out" temp 992 b/p 140/90. Refused to go to the local ER or her MD. Pt unable to leave by self. Husband escorted pt home unable to drive.
Age: 38.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia
Clinical narrative: C/o nausea and diarrhea over the weekend. Appeared at clinic on 7/14/15 with complaints of fever, nausea and feeling weak and going to "pass out" temp 992 b/p 140/90. Refused to go to the local ER or her MD. Pt unable to leave by self. Husband escorted pt home unable to drive.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Loss of consciousness, Road traffic accident
Clinical narrative: The patient was held in the office 15-30 mins post immunization. He was at his baseline when he left. His mother called at 2:35 to report that he passed out on his way home and had a minor vehicle accident- crashed into a parked car.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL, DTAPIPVHIB, IPV, MMR, VARCEL
Symptoms: Cough, Eyelid oedema, Swelling face, Wheezing
Clinical narrative: Eyelids and facial swelling, cough, wheezing.