chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. Information about patient's concurrent conditions and medical history was not reported. "A year prior to 05-NOV-2015", in approximately November 2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot#/expiration date, dose and route not reported). On 05-NOV-2015 the patient was vaccinated with another dose of PNEUMOVAX 23 (dose and route not reported, lot # K009107 with expiration date 21-JAN-2016) (inappropriate schedule of vaccine administered, outside the recommendations for PNEUMOVAX 23). It was reported that the patient received the 2 doses of vaccine after 65 years old. No adverse effects were reported. This is one of two reports received from the same reporter (other linked case # 1512USA005469). Additional information is not expected because the reporter did not want to be contacted.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown ages and genders. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. The reporter stated that on unspecified dates, the patients were administered an unspecified number of improperly stored doses of VAQTA injection (lot # K019560 with expiration date 02-JUN-2017, lot# L002717 with expiration date 02-JUN-2014 and lot# L018499 with expiration date 25-FEB-2017; dose and route were not provided). No adverse effects were reported. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. 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 medical assistant referring to multiple unspecified patients of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On unknown dates the patients were vaccinated with improperly stored PEDVAXHIB (lot # L002867, expiration date 11-NOV-2017, dose and route were not reported). Concomitant drug was not reported. No adverse effect was reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On unknown dates the patient were vaccinated with improperly stored ROTATEQ (lot # L000425, expiration date 21-JUN-2016, dose was not reported) orally. Concomitant drug was not reported. No adverse effect was reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On unknown dates the patient were vaccinated with improperly stored GARDASIL 9 (lot # L014415, expiration date 25-JUL-2017, dose and route were not reported). Concomitant drug was not reported. No adverse effect was reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. Information about patient's concurrent conditions and medical history was not reported. "Greater than 5 years prior to prior to 05-NOV-2015", on an unspecified date the patient was vaccinated with a dose of PNEUMOVAX 23 (lot#/expiration date, dose and route not reported). On 05-NOV-2015 the patient was vaccinated with another dose of PNEUMOVAX 23 (dose and route not reported, lot # K009107 with expiration date 21-JAN-2016) (inappropriate schedule of vaccine administered, outside the recommendations for PNEUMOVAX 23). It was reported that the patient received the 2 doses of vaccine after 65 years old. No adverse effects were reported. This is one of two reports received from the same reporter (other linked case # 1511USA006171). Additional information is not expected because the reporter did not want to be contacted.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to unspecified number of patient of unknown age and gender. Since 11-NOV-2015 unspecified number of patients were vaccinated with PEDVAXHIB (Lot# L002867, Expiry date: 11-NOV-2017, Lot# L030869, Expiry date: 08-JUN-2018, Lot# L014426, Expiry date: 08-MAR-2018, Lot# L012837, Expiry date: 11-MAR-2018) which were exposed to temperatures outside of the recommended range (incorrect product storage). No adverse event were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect product storage, Pain
Clinical narrative: This spontaneous report was received from a pharmacist refers to a male patient of unknown age. On 23-NOV-2015 the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous (lot # 1000448 and exp. 08-MAR-2016). No concomitant medications were reported. Pharmacist reported that an unspecified patient was given an improperly stored dose of ZOSTAVAX, on 23-NOV-2015 and then on 24-NOV-2015 the patient called the pharmacy to say he "felt achy" for an unspecified duration of time. Later on 25-NOV-2015 pharmacist called and provided the lot # for the suspect. The outcome of the event felt achy was unknown. Causality assessment for the event was not reported. 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 healthcare professional refers to unspecified number of patients of unknown age and gender. Since 11-NOV-2015 unspecified number of patients were vaccinated with RECOMBIVAX HB [Lot# K010216, Expiry date: 17-SEP-2016, Lot# K006682, Expiry date: 17-DEC-2015, Lot# L030865, Expiry date: 07-JUN-2018] which were exposed to temperatures outside of the recommended range. No adverse event were reported. This is one of several cases from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site warmth, Nodule
Clinical narrative: This spontaneous report was received from a physician via a field representative regarding a female patient of unknown age. No historical or concurrent conditions were reported. On an unknown date, the patient was vaccinated with a first dose of GARDASIL (lot# unspecified) and there was no adverse reactions. Approximately on an unknown date in October 2015 (reported as a month ago), the patient was vaccinated with the second dose of GARDASIL (lot# unspecified) in the arm. No concomitant medications were reported. Approximately on an unknown date in October 2015 (reported as a month ago), the patient experienced "a warm sensation in arm" at injection site. In addition, the patient had a knot feeling in arm after injection. Furthermore, the patient stated that this was her first day back to the gym for a workout. No Product Quality Complaint (PQC) was reported. Further vaccination with GARDASIL was discontinued. The outcome of the events were not reported. Causality assessment was not provided. No additional information was provided. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. The patient's medical history and concurrent conditions were not reported. On an unspecified date, the patient was vaccinated with RECOMBIVAX HB injection, (dosage, lot number not provided) 3 doses series, when he was a child. On an unspecified date, the antibody titer drawn showed that he failed to seroconvert. The patient was administered with one booster dose of RECOMBIVAX HB about 6 months ago and the reporting pharmacist had questioned if the series of RECOMBIVAX HB can continue. The outcome of the event was unknown. No product quality complaint was involved. The reporter had considered the event to be not related to RECOMBIVAX HB. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist referring to a patient of unknown age and gender. On 02-DEC-2015 the patient was vaccinated with a dose of ZOSTAVAX (dose and route not reported, lot# reported as L028286, expired date: 28-OCT-2016) which was improperly stored (Incorrect product storage). No adverse effects reported. 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 nurse refers to multiple unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored oral, ROTATEQ, lot# L006184, expiry date 13-DEC-2016. No adverse effects reported. No product quality complaint (PQC) was involved. No further information was provided. This is one of four 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 medical assistant refers to an unspecified number of patients of unknown age and gender. Between 09-NOV-2015 and 12-NOV-2015, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # L016959, (dose, route, lot # and expiration date were not provided). No symptoms reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. Between 09-NOV-2015 and 12-NOV-2015, the patients were vaccinated with improperly stored doses of oral, ROTATEQ lot # L008574 exp 22-NOV-2016, (route and dose were not provided). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. Between 09-NOV-2015 and 12-NOV-2015, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot # L014428 with expiration date on 12-MAR-2018, (dose and route were not provided). This is one of several reports received from the same reporter. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: HEP
Symptoms: Injection site induration
Clinical narrative: 2 cm induration at injection site on right deltoid.
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Dry skin, Rash erythematous, Skin exfoliation
Clinical narrative: Not sure of exact onset, pt had red rash which is currently dry and flaky.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Lymphadenopathy, Neck pain
Clinical narrative: Neck pain and swollen left cervical lymph node.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: Erythema at injection site the size of an orange.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Pain at injection site. Pain in the hand. Could not lift or use the arm.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Warmth at site; 3" x 3" swelling and pain at site of injection lasted 5 days.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Developed rash on legs and forearms within a few hours.  Spread to chest within two days.
Age: 49.0
Sex: F
Vaccine: FLUN4
Symptoms: Abdominal pain, Arthralgia, Dysmenorrhoea, Fatigue, Headache
Clinical narrative: That evening 12/08/15 I had congestion, light muscle weakness and sudden, medium fatigue.  That has continued to date. By 12/09/15 morning I also had light headache, sore throat & light nausea.  Continued off and on to date. By evening 12/09/15 I had "Charley horse" cramping of lower right hamstring and aching in both hips (front of body).  That subsided after a few hours. During the night the nausea and muscle weakness increased.  My thighs were incredibly sore, as if I had been weightlifting (although I hadn't exercised at all in a week).  That continues through now. I also have medium abdominal pain but I think that's menstrual cramps.
Age: 49.0
Sex: F
Vaccine: FLUN4
Symptoms: Muscle spasms, Muscular weakness, Nausea, Oropharyngeal pain, Respiratory tract congestion
Clinical narrative: That evening 12/08/15 I had congestion, light muscle weakness and sudden, medium fatigue.  That has continued to date. By 12/09/15 morning I also had light headache, sore throat & light nausea.  Continued off and on to date. By evening 12/09/15 I had "Charley horse" cramping of lower right hamstring and aching in both hips (front of body).  That subsided after a few hours. During the night the nausea and muscle weakness increased.  My thighs were incredibly sore, as if I had been weightlifting (although I hadn't exercised at all in a week).  That continues through now. I also have medium abdominal pain but I think that's menstrual cramps.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Crying, Erythema, Injection site pain, Pain in extremity, Peripheral swelling
Clinical narrative: Seen here yest for 11 yo WCC, rec'd GARDASIL (L arm) and MENACTRA (R). Site started to feel sore last evening; worse on awakening this AM. Went to school but wound up in clinic, crying re. arm pain.  Parents called to pick her up early. Dad states child had a similar reaction, though less severe, to her Tdap in July of this year. The patient is 11 year, 7 month old female who presents with a complaint of skin problems. The onset of the skin problems has been sudden and they have been occurring in an intermittent pattern for 1 day. The course has been increasing. The problem is characterized as a change in skin color. Lesions are described as red. There has been no associated fever (Child received 11yr injections on yesterday (HPV, and MENACTRA vaccine) and is now have returned to office due to Rt arm is red, swollen and hot to touch. Child received the MENACTRA in Rt arm yesterday).
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Skin discolouration, Skin disorder, Skin lesion, Skin warm
Clinical narrative: Seen here yest for 11 yo WCC, rec'd GARDASIL (L arm) and MENACTRA (R). Site started to feel sore last evening; worse on awakening this AM. Went to school but wound up in clinic, crying re. arm pain.  Parents called to pick her up early. Dad states child had a similar reaction, though less severe, to her Tdap in July of this year. The patient is 11 year, 7 month old female who presents with a complaint of skin problems. The onset of the skin problems has been sudden and they have been occurring in an intermittent pattern for 1 day. The course has been increasing. The problem is characterized as a change in skin color. Lesions are described as red. There has been no associated fever (Child received 11yr injections on yesterday (HPV, and MENACTRA vaccine) and is now have returned to office due to Rt arm is red, swollen and hot to touch. Child received the MENACTRA in Rt arm yesterday).
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Pain
Clinical narrative: Achiness 5 days post Tdap.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect route of drug administration
Clinical narrative: Child was given the PROQUAD vaccine intramuscular rather than subcutaneous.
Age: 88.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: 3 days after vaccine arm became swollen, red, and itchy. Called doctor on day 6 and told to use ice and BENADRYL. Saw NP on 7th day. Prescribed antibiotic. Went to walk-in on 9th day and received steroid shot and prescription. Much better on 13th day.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Pt. is still experiencing pain/soreness at the injection site 40 days after the injection. She says it is getting worse, not better.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Injection site erythema, Injection site induration, Injection site pruritus, Pain
Clinical narrative: Area of shot started itching that evening - hard core center surrounded by red. It continued for 2 wks. Redness extended from crook in my rt. arm up to my shoulder. Redness encircled rt. arm almost completely. Arm was hot and swollen. Pain and weakness continues. This is the very first time in 75 yrs, that I've had an adverse event to a shot.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Area of shot started itching that evening - hard core center surrounded by red. It continued for 2 wks. Redness extended from crook in my rt. arm up to my shoulder. Redness encircled rt. arm almost completely. Arm was hot and swollen. Pain and weakness continues. This is the very first time in 75 yrs, that I've had an adverse event to a shot.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Decreased activity, Insomnia, Pain in extremity
Clinical narrative: Per pt 4 weeks after injection pt developed arm pain - restricted activity - prohibited sleep - ADVIL - MOTRIN and heat - symptoms resolved 2 weeks ago.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (C.M.A.) refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 19-NOV-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # L017407, expiration date: 15-AUG-2015 or lot # L016428, expiration date: 30-JUL-2017 (it was not specified by the reporter which lot was administered) (dose, route of administration and location were not reported). No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.74
Sex: M
Vaccine: 6VAX-F
Symptoms: Decreased appetite, Insomnia, Irritability, Pyrexia
Clinical narrative: Irritable, fever, loss of appetite, won't sleep.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Peripheral swelling
Clinical narrative: Swelling in hands and feet, body aches - lasted x 3 days.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Hypoaesthesia, Musculoskeletal pain
Clinical narrative: Continued shoulder pain and hand numbness.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 04-AUG-2015, the patient was vaccinated with the first dose in the three-dose series of GARDASIL intramuscularly (strength, dose, lot # and expiration date were not provided). On 12-OCT-2015, the patient was vaccinated with the second dose in the three-dose series of GARDASIL intramuscularly (strength, dose, lot # and expiration date were not provided). On 08-DEC-2015, the patient was vaccinated with the third dose in the three-dose series of GARDASIL intramuscularly (strength, dose, lot # and expiration date were not provided). This schedule was outside the labeled recommendations in the GARDASIL prescribing information. No adverse effect was reported. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia
Clinical narrative: Patient presented 12/9/15 and stated that she had been experiencing muscle soreness when she lifts her arm ever since she received a Pneumovax vaccination on 10/14/15.
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Induration, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Upper arm became swollen, hard, and warm. Patient reports the area was very painful.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Malaise, Musculoskeletal stiffness, Pain, Pain in extremity
Clinical narrative: Symptoms started with ache in left arm and progressed to severe pain in entire left shoulder area.  Left arm became stiff and unable to lift without pain.  General overall feeling of illness with a 100 degree fever.  Unable to sleep due to pain.  Took aspirin for the fever which diminished the next morning.  Had pain and illness the entire next day with the symptoms relieving the morning of the second day.  Vaccine:  PPSV23.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia, Sleep disorder
Clinical narrative: Symptoms started with ache in left arm and progressed to severe pain in entire left shoulder area.  Left arm became stiff and unable to lift without pain.  General overall feeling of illness with a 100 degree fever.  Unable to sleep due to pain.  Took aspirin for the fever which diminished the next morning.  Had pain and illness the entire next day with the symptoms relieving the morning of the second day.  Vaccine:  PPSV23.
Age: 39.0
Sex: F
Vaccine: FLUC3
Symptoms: Injection site pain, Peripheral swelling, Rash
Clinical narrative: Pain at injection site. Swollen on deltoid/shoulder with rash. May be ADR from vaccine vs cellulitis of overlying area per ID Dr.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Pain, Swelling
Clinical narrative: Swelling, burning, pain.
Age: 4.0
Sex: U
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Seizure
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of seizure in a 4-year-old patient who received KINRIX. Co-suspect products included MMR vaccine and Varicella vaccine. On an unknown date, the patient received KINRIX, MMR vaccine and Varicella vaccine. On an unknown date, less than a day after receiving KINRIX, MMR vaccine and Varicella vaccine, the patient experienced seizure (serious criteria GSK medically significant and other: as per reporter). On an unknown date, the outcome of the seizure was recovered/resolved. It was unknown if the reporter considered the seizure to be related to KINRIX, MMR vaccine and Varicella vaccine. Additional details were provided as follows: The patient had no previous history of seizure activity. The patient began to experience seizure activity within 24 hours after receiving KINRIX, Varicella, and MMR vaccine. The patient was taken to the emergency room, where they were treated and symptoms had resolved. The physician did not think that the vaccines caused the seizure. Further product details and patient identifiers were unknown. No further information was reported regarding the event.
Age: 6.0
Sex: F
Vaccine: FLUN4
Symptoms: Urticaria
Clinical narrative: Hives on face 1 hour after receiving FLUMIST.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Soft tissue swelling
Clinical narrative: Soft tissue swelling/redness that began approx 10-12 hrs after injection. Now starting to itch; now decrease in swelling and redness (site of injection in mid LUE).
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown dates, the patients were administered an unspecified number of improperly stored doses of PNEUMOVAX 23 lot # K020215, expiration date 15-MAY-2016 (dose and route of administration were not reported). No adverse effect reported. This is one of several reports 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 was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown dates, the patients were administered an unspecified number of improperly stored doses of PEDVAXHIB lot # L012835, expiration date 11-MAR-2018 (dose and route of administration were not reported). No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (C.M.A.) refers to unspecified number of unspecified patients of unknown age and gender. The patients concurrent conditions, medical history and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot # L008059, expiration date: 18-DEC-2016 (dose, route of administration and location were not 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: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown dates, the patients were administered an unspecified number of improperly stored doses of ROTATEQ lot # L008574, expiration date 22-NOV-2017 (dose and route of administration were not reported). No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to 37 patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored doses of GARDASIL 9 [lot # L013429, Expiry date: 21-JUL-2017]. No adverse effect were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown dates, the patients were administered an unspecified number of improperly stored doses of GARDASIL 9 lot # L013429, expiration date 21-JUL-2017 (dose and route of administration were not reported). No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional refers to 5 unspecified patients of unknown demographics. On multiple unspecified dates the patients were vaccinated with improperly stored VARIVAX (Merck) (dosing regimen unspecified) (L017145, exp: 05/13/2017). No concomitant medications reported. No adverse effects reported. M-M-R II appears on the product list because stability questions were asked, no doses of improperly stored M-M-R II were administered to patient. No further information was provided. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza
Clinical narrative: This spontaneous report was received from a pharmacist via company representative referring to a male patient of unknown age, whose concurrent conditions and medical history were not provided. On 30-NOV-2015, the patient was vaccinated with ZOSTAVAX, subcutaneous (dose, dose number, site of administration, lot number and duration were not provided). Concomitant therapies were not reported. On 30-NOV-2015, the patient experienced influenza reported as "the flu". On an unknown date, the patient sought for medical attention through an office visit. However, no treatment was given for the adverse event. The outcome of influenza was reported as not recovered. Additional information has been requested.
Age: 0.8
Sex: F
Vaccine: MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 9 month old patient of unknown gender, whom concurrent condition and medical history were not provided. On 24-NOV-2015, the patient was vaccinated with a dose of M-M-R II (concentration, route of administration, dose number, site of administration and duration were not provided). On 28-NOV-2015, the patient was inadvertently vaccinated with a second dose of M-M-R II (concentration, route of administration, dose number, site of administration and duration were not provided). At the time of the report, no adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (C.M.A.) refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 03-NOV-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # L017407, expiration date: 15-AUG-2015 or lot # L016428, expiration date: 30-JUL-2017 (it was not specified by the reporter which lot was administered) (dose, route of administration and location were not 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: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (C.M.A.) refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 19-NOV-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # L017407, expiration date: 15-AUG-2015 or lot # L016428, expiration date: 30-JUl-2017 (it was not specified by the reporter which lot was administered) (dose, route of administration and location were not reported). No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Speech disorder
Clinical narrative: This case was reported by a consumer via patient support programs and described the occurrence of feeling unwell in a 68-year-old female patient who received influenza vaccine unspecified. Co-suspect products fluticasone propionate, ADVAIR inhalation powder (batch number 5ZP9982, expiry date 2016). Concurrent medical conditions included allergy (the patient can hardly talk and thinks that, that was may be from allergies). On 25th November 2015, the patient received influenza vaccine unspecified. In 2015, the patient started ADVAIR at an unknown dose and frequency. In 2015, less than a month after receiving influenza vaccine unspecified and an unknown time after starting ADVIAR, the patient experienced feeling unwell and speech disorder. On an unknown date, the outcome of the feeling unwell and speech disorder were unknown. It was unknown if the reporter considered the feeling unwell and speech disorder to be related to influenza vaccine unspecified and ADVAIR. Additional details were received as follows: This case was received from the healthcare provider vis program for ADVAIR. The patient called for the re-enrollment in the program. After vaccination the patient had not felt well. The patient stated that she could hardly talk and that she thought that may be because of the allergy, which she was having on and off for years. The reporter was unable to provide exact start date of ADVAIR, but was started in early 2015.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to 9 patient of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored doses of M-M-R II (lot # L001336, Expiry date: 13-JAN-2017). No adverse effect were reported. This is one of the several reports 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 as received from a medical assistant refers to multiple unspecified patients. The patients' concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with improperly stored M-M-R II [Lot# K026366 and Expiry date: 15-DEC-2016; Lot# L008684 and Expiry date: 13-MAR-2017; Lot# L023385 and Expiry date: 25-JUN-2017; Lot# L020189 and Expiry date: 03-JUN-2017; Lot# L019989 and Expiry date: 01-JUN-2017; Lot# L009214 and Expiry date: 17-MAR-2017; Lot# K009957 and Expiry date: 14-JUL-2016). 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 medical assistant refers to multiple unspecified patients. The patients' concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with improperly stored RECOMBIVAX HB (confirmed Lot#L016427 and Expiry date 13-APR-2017; Lot#L018501 and Expiry date 22-JUN-2017; Lot#L025738 and Expiry date 04-AUG-2017; Lot#L019298 and Expiry date 22-JUN-2017; Lot#L016427 ane Expiry date 13-APR-2017; Lot#L014417 and Expiry date 13-APR-2017; Lot#K022265 and Expiry date 22-OCT-2016; Lot#K008334 and Expiry date 09-JUN-2016). 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: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to multiple unspecified patients. The patients' concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with improperly stored GARDASIL [Lot# K008931, Expiry date: 04-MAR-2017, Lot# K016966, Expiry date: 10-MAY-2017, Lot# K010215, Expiry date 05-MAY-2017]. No adverse effects reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients. The patients' concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with improperly stored ROTATEQ (Lot# L008996 and Expiry date. 01-DEC-2016; Lot# K022995 and Expiry date. 22-JUL-2016; Lot# K010223 and Expiry date. 13-MAY-2016; Lot# K014826 and Expiry date. 28-MAY-2016; Lot# K009752 and Expiry date. 15-APR-2016; Lot# L000569 and Expiry date. 13-JUL-2016). 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: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to multiple unspecified patients. The patients concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with improperly stored VAQTA (Lot#K012457 and Expiry date 04-JUN-2017; Lot#L018499 and Expiry date:25-FEB-2017;Lot#L002717 and Expiry date: 02-JUN-2017). 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: 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. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) lot # K010338, expiration date 22-JUL-2016 or lot # K026385, expiration date 15-DEC-2016 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (C.M.A.) refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 19-NOV-2015, the patient was vaccinated with an improperly stored doses of GARDASIL 9 lot # L017407, expiration date: 15-AUG-2015 or lot # L016428, expiration date: 30-JUL-2017 (it was not specified by the reporter which lot was administered) (dose, route of administration and location were not reported). No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site cellulitis, Wound
Clinical narrative: Message received from PA at urgent care facility. Pt presented Thursday 12/3 for cellulitis. Spoke with nurse at clinic. Reported patient had "softball-sized" cellulitis at the injection site of her Tdap injection from 12/2. Pt given antibiotics and instructed to return to urgent care on 12/5 for reevaluation of wound.
Age: 0.36
Sex: M
Vaccine: HIBV, PNC13, RV5
Symptoms: Incorrect route of drug administration
Clinical narrative: Patient was given Rotarix vaccine intramuscularly instead of orally.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site pain, Injection site swelling, Lymph node pain, Lymphadenopathy
Clinical narrative: Severe swelling and pain of the upper arm and shoulder area of injection. Lymph nodes of the arm pit on same arm swollen and painful as well. Low grade fever and persistent headache.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Severe swelling and pain of the upper arm and shoulder area of injection. Lymph nodes of the arm pit on same arm swollen and painful as well. Low grade fever and persistent headache.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Hallucination, Injection site erythema, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: 1 hour after vaccination pt expierenced swelling (the size of 1/2 of a pingpong ball) at injection site. Hours later redness surrounding site (the size of a hand) & hot- pt attributes this to possibly having a sleeve that was tight above the injection site at time of administration.  That night she experienced a low grade fever (not more than 100) and hallucinations at bedtime along with being nauseous. These symptoms continued until Tuesday 12/08/15. Wednesday she was symptom free.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: 1 hour after vaccination pt expierenced swelling (the size of 1/2 of a pingpong ball) at injection site. Hours later redness surrounding site (the size of a hand) & hot- pt attributes this to possibly having a sleeve that was tight above the injection site at time of administration.  That night she experienced a low grade fever (not more than 100) and hallucinations at bedtime along with being nauseous. These symptoms continued until Tuesday 12/08/15. Wednesday she was symptom free.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Pt had flu shot on 12/9/15 and had a reaction shortly after with redness, swelling from shoulder to elbow.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Throat irritation
Clinical narrative: Recvd vacine around 3 pm, around 9 pm pt. had strange feeling in throat and chest felt heavy like heart arrack-went to ER for observation- pt was fine.
Age: 0.35
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Reported vomiting and diarrhea.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Injection site induration, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: Pt. discovered warm hard lump to (L) deltoid. Evaluation shows a 14 x 17 cm hard, raised, warm area, surrounding injection site, pt. was given 25mg BENADRYL, pt. was monitored, for 30 minutes. Will have patient follow-up 12/10/15 - improved induration decreased to 12x12 cm.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Muscular weakness
Clinical narrative: Lingering muscle weakness around injection site on left arm.
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Diarrhoea, Pyrexia, Vomiting, Weight decreased
Clinical narrative: Vomiting, diarrhea, fever, chills started within 6-8 hrs of receiving vaccine, 5 lb wt loss w/i 24 hrs.
Age: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Urticarial rash on extremities within 22-24 hours after flu shot.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (C.M.A.) refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 19-NOV-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # L017407, expiration date: 15-AUG-2017 or lot # L016428, expiration date: 30-JUL-2017 (it was not specified by the reporter which lot was administered) (dose, route of administration and location were not reported). No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: FLUN4, HPV9, MMR, MNQ, TDAP, VARCEL
Symptoms: Dyspnoea, Injection site reaction, Injection site urticaria, Rash, Rash erythematous
Clinical narrative: Hives and red rash surrounding injection sites and torso, followed by difficulty breathing.
Age: 13.0
Sex: M
Vaccine: FLUN4, HPV9, MMR, MNQ, TDAP, VARCEL
Symptoms: Urticaria
Clinical narrative: Hives and red rash surrounding injection sites and torso, followed by difficulty breathing.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Skin exfoliation
Clinical narrative: Left arm (injection arm) became itchy and spread across to other arm. A few days later, the skin began to flake off. Some itching down legs but not as bad as the arms.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Mobility decreased, Pain
Clinical narrative: Soreness in arm where vaccine was given. Painful and hard to lift at time. Tried using heat and ibuprofen.
Age: 61.0
Sex: M
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Was supposed to give patient shingles vaccination and instead gave varicella vaccination (from the state supply vaccinations).
Age: 45.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Unable to fully raise arm secondary to pain, limited external and internal rotation secondary to pain.  Only able to lift arm to 45 degrees.
Age: 13.0
Sex: F
Vaccine: FLU3
Symptoms: Imaging procedure, Laboratory test, Nausea, Vomiting
Clinical narrative: Nausea and vomiting.
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Myalgia, Pharyngitis, Pyrexia
Clinical narrative: Myalgias, fever, chills, pharyngitis.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling, Injection site urticaria, Swelling, Urticaria
Clinical narrative: Shortly after vaccine administered patient started to feel swelling and hives which progressed to cover all of upper, lateral left arm.  Patient self treated with Benadryl.
Age: 21.0
Sex: F
Vaccine: FLUN4, HEP, MMR, TDAP, VARCEL
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Erythmatic, painful, swollen arm near injection site--Left Arm.
Age: 74.0
Sex: M
Vaccine: PNC13
Symptoms: Confusional state, Dizziness, Hypoaesthesia, Mental impairment, Visual impairment
Clinical narrative: Patient said he left the pharmacy area and walked across the aisle to the jewelry dept and all of the sudden his legs went numb and he felt dizziness and confusion and lights were affecting his vision (couldn't think straight).
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Skin warm
Clinical narrative: RED CIRCLE, HOT, TRAILING DOWN THE ARM.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Abdominal pain upper, Back pain, Chills, Dysstasia
Clinical narrative: Flu like symptoms, chills, severe body pain in neck and back, nausea, severe stomach cramping, severe headache. Inability to walk/stand. Pain non-responsive to ibuprofen and Tylenol.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Influenza like illness, Nausea, Neck pain, Pain
Clinical narrative: Flu like symptoms, chills, severe body pain in neck and back, nausea, severe stomach cramping, severe headache. Inability to walk/stand. Pain non-responsive to ibuprofen and Tylenol.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Pt states that his right arm has been sore for the last month after the flu shot. The flu shot was in August. Also, from our records, the flu shot was administered on the left arm. Pt is seeing md tomorrow for an unrelated condition, but will mention the arm pain as well.
Age: 29.0
Sex: F
Vaccine: FLU4, YF
Symptoms: Hypoaesthesia, Swelling face
Clinical narrative: Numbness and swelling on R side of face. No other anaphylaxis associated symptoms.
Age: 49.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Malaise, Vomiting
Clinical narrative: Swelling, pain, redness at injection site, vomiting, malaise.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: Lightheaded, diaphoretic.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Swelling
Clinical narrative: Swelling and bruising 6 to 8 hours after injection. On 12/10 was instructed to see MD and MD suggested possible infection and blood vessel hit.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dizziness, Fatigue, Headache, Pain
Clinical narrative: Achy at first and chills.  Headache and dizziness followed with fever of 102.1 by 8:00 PM.  Treatment with Tylenol was not effective.  Advil seemed to alleviate the fever and achiness somewhat.  It is now more than 48 hours later and I am still dizzy and extremely fatigued.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Achy at first and chills.  Headache and dizziness followed with fever of 102.1 by 8:00 PM.  Treatment with Tylenol was not effective.  Advil seemed to alleviate the fever and achiness somewhat.  It is now more than 48 hours later and I am still dizzy and extremely fatigued.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Pain in left shoulder.