chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: Pt reported to the pharmacy approximately 48 hours after injection with warmth, redness, tenderness, pain, and hard lump at injection site. Instructed her to take BENADRYL, TYLENOL, and use cold compress.
Age: 1.35
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Crying, Pyrexia
Clinical narrative: Pt has 1 1/2 hours of crying on evening of vaccination. Next day > 4 hours of inconsolable crying. Low grade fever 100.5.
Age: 21.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 21 year old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 20-AUG-2015 the patient was vaccinated with an improperly stored dose of GARDASIL 9 (Lot# L000610, expiration date 31-JAN-2017) (Strength, dose and route were not provided). Concomitant medication was not reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 15 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 16-JUL-2015, the patient was vaccinated with an improperly stored dose of GARDASIL lot # K11562, expiration date 08-APR-2017 (strength, dose and route of administration were not provided). There were no adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 10.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 10 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 05-AUG-2015, the patient was vaccinated with an improperly stored dose of GARDASIL lot # K11562, expiration date 08-APR-2017 (strength, dose and route of administration were not provided). There were no adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a 11 year old patient of unknown gender. No information  about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 22-SEP-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot # L000610, expiration date 31-JAN-2017) (dose and route were not provided). No adverse effects reported. This is one of several reports 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 medical assistant referring to multiple patients of unknown age and gender. No concurrent or historical conditions were reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL (lot# K007264, expiration date 02-MAR-2017; K007828, expiration date 02-MAR-2017; strength, dose and route unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple patients of unknown age and gender. No concurrent or historical conditions were reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot# K026246, expiration date 28-JAN-2017; L004014, expiration date 04-MAR-2017; L007560, expiration date 15-JUN-2017; L016428, expiration date 30-JUL-2017; strength, dose and route unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with an improperly stored doses of RECOMBIVAX HB (dose and route were not reported, lot # L019298, expiration date 22-JUN-2017). There were no adverse effect reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. Approximately in November 2015, the patient was vaccinated with improperly stored doses of PROQUAD (Merck) (unknown strength and route) lot # L024122 and expiry date of 30-DEC-2016. No adverse effects were reported. There was no product quality complaint involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 10.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 10 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 13-JUL-2015, the patient was vaccinated with an improperly stored dose of GARDASIL lot # K011562, expiration date 08-APR-2017 (strength, dose and route of administration were not provided). On 24-SEP-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # L011846, expiration date 16-JUN-2017 (strength, dose and route of administration were not provided). There were no adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 17.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 17 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 27-JUL-2015, the patient was vaccinated with an improperly stored dose of GARDASIL lot # K011562, expiration date 08-APR-2017 (strength, dose and route of administration were not provided). There were no adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Hypersensitivity, Local reaction
Clinical narrative: This report was received from a physician via Pfizer and was assigned manufacturer report number 2015308608, referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, frequency, route, lot # and expiration date were not reported). No concomitant medications were reported. On an unknown date, the patient experienced a severe local reaction to PNEUMOVAX 23. It was reported that if it would be expected the same type of reaction with a dose of PREVNAR 13 in a patient previously vaccinated with PNEUMOVAX 23. At the time of the report, the outcome of hypersensitivity reaction was unknown. The relatedness between hypersensitivity reaction and PNEUMOVAX 23 was not provided. 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 and refers to one unspecified patient of unknown age and gender. On an unknown date, the patient was vaccinated with improperly stored ZOSTAVAX, dose and frequency unknown (lot # L029482, expiry date 06-NOV-2016). No adverse effects were reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist via a company employee referring to a male patient of unknown age. Patient's concurrent conditions included Alzheimer's disease. On 15-NOV-2015, the patient was vaccinated with ZOSTAVAX (lot number and expiration date not provided) dose, route, and anatomical location were unknown for vaccination. No concomitant medication was reported. On unspecified date in November 2015, the patient experienced a "serious swelling" at the injection site after receipt of the injection, the patient sought for medical attention and spoke with the pharmacy, the treatment included BENADRYL. The outcome of injection site swelling was reported as not recovered/not resolved. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 14 year old patient (gender was not specified). The patient's pertinent medical history or drug allergies/drug reactions were not reported. On 24-SEP-2015, the patient was vaccinated with the first dose of PROQUAD (Merck) (lot # L025204, expiration date 07-JAN-2017) (dose, route of administration and anatomical location were not reported). On 11-NOV-2015, the patient was vaccinated with a second dose of PROQUAD (Merck) (lot # L032759, expiration date 24-FEB-2017) (dose, route of administration and anatomical location were not reported). There was no concomitant medication reported and no product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: FLU4
Symptoms: Bursitis, Musculoskeletal pain, Neuritis, Nuclear magnetic resonance imaging
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shoulder pain in a patient who received FLUARIX QUADRIVALENT (batch number 7994K, expiry date 15th June 2016). On 7th October 2015, 7 days after receiving FLUARIX QUADRIVALENT, the patient experienced shoulder pain. On an unknown date, the patient experienced neuritis and bursitis. On an unknown date, the outcome of the shoulder pain, neuritis and bursitis were unknown. It was unknown if the reporter considered the shoulder pain, neuritis and bursitis to be related to FLUARIX QUADRIVALENT. Additional details were received as follows: This case was reported by a nurse to a pharmacist. There were 5 employees who received FLUARIX QUADRIVALENT, and experienced increasing pain at the shoulder, one week later after vaccination. Among the 5 employees 2 patients were female and the genders of the other 3 patients were unknown. One of the patients was treated at the emergency room. Other patients were seen by their primary care physician and diagnosed with possible bursitis or neuritis. The patients were underwent Nuclear magnetic resonance, but it was unknown that, who amongst 5 patients underwent had the test and what are the outcomes. It was reported that, according to one physician the cause of the events was maladministration, but the nature of maladministration was not certain. The reporter stated that, she provided all the information she had available.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple patients of unknown age and gender. No concurrent or historical conditions were reported. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (lot# K011077, expiration date 30-MAR-2017; K015462, expiration date 10-JUL-2017; K026532, expiration date 07-AUG-2017; L006545, expiration date 16-NOV-2017; L012838, expiration date 10-MAR-2018; strength, dose and route unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker regarding unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. Since 08-AUG-2015, the patients were vaccinated with improperly stored VAQTA lot # K019560, expiration date 02-JUN-2017. No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HBHEPB
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker regarding unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. Since 08-APR-2015, the patients were vaccinated with improperly stored COMVAX lot # J002621, expiration date- 29-NOV-2015, (incorrect product storage). No concomitant medication was reported. No adverse event was reported. 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: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker regarding unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. Since 08-AUG-2015, the patients were vaccinated with improperly stored oral, ROTATEQ, lot number- L004453 expiration date 27-MAY-2016, lot # K023159 expiration date 26-JUL-2016. No concomitant medication was reported. No adverse event was reported. 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: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker regarding unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. Since 08-AUG-2015, the patients were vaccinated with improperly stored PROQUAD (Merck) lot # L014401 expiration date 23-OCT-2016. No concurrent medication was reported. No adverse event was reported. 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: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple patients of unknown age and gender. No concurrent or historical conditions were reported. On unknown dates, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (lot# L004649, expiration date 11-FEB-2017; K021485, expiration date 03-NOV-2016; strength, dose and route unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple patients of unknown age and gender. No concurrent or historical conditions were reported. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II (therapy type: rHA, lot# K014833, expiration date 14-SEP-2016; strength, dose and route unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 10.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 10 year old patient of unknown gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 08-JUL-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (lot # K023432, expiration date 18-JUN-2016) (strength, dose, route and site of administration were not provided). No adverse effects were reported. This is one of several reports 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 registered nurse refers to an unknown number of patients of unknown ages and genders. No medical history or concurrent conditions were reported. Since 18-SEP-2015 an unknown number of patients were vaccinated with oral ROTATEQ (lot # L008054, exp date 30-NOV-2016; lot # L006184, exp date 13-DEC-2016; lot # L008054, exp date 30-NOV-2016; lot # L010128, exp date 24-JAN-2017) (concentration, dosage and frequency were not reported) which were exposed to temperatures outside of the recommended range. No adverse experiences 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: Information has been received from a nurse referring to unknown number of patients of unknown age and gender. No concurrent or historical conditions were reported. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (lot# K012457, expiration, expiration date 04-JUN-2017; lot# L004743, expiration date 01-JUN-2017; lot# K005958, expiration date 09-FEB-2017; strength, dose and route unknown). No adverse effects were reported. This is one several reports received from the same reporter. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Dysphonia, Fatigue, Headache
Clinical narrative: By 3pm sore throat started, hoarse, then headache started, had chills so badly that body was shaking. Had 100.2 fever, body aches (back, neck, knees hurt to the point of weakness), totally fatigued, had a bit of nausea. Put on wet compresses on head at night. The symptoms lasted for 12 hours. The symptoms were very intense by 11pm -> 12am they started to subside. By 2am they were slowing down by everything went away by 6am.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Oropharyngeal pain, Pain, Pyrexia, Tremor
Clinical narrative: By 3pm sore throat started, hoarse, then headache started, had chills so badly that body was shaking. Had 100.2 fever, body aches (back, neck, knees hurt to the point of weakness), totally fatigued, had a bit of nausea. Put on wet compresses on head at night. The symptoms lasted for 12 hours. The symptoms were very intense by 11pm -> 12am they started to subside. By 2am they were slowing down by everything went away by 6am.
Age: 24.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 24 year old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 31-JUL-2015 the patient was vaccinated with an improperly stored dose of GARDASIL 9 (Lot#L000610, expiration date 31-JAN-2017) (Strength, dose and route were not provided). Concomitant medication was not reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 15 year old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 20-AUG-2015 the patient was vaccinated with an improperly stored dose of GARDASIL 9 (Lot#L000610, expiration date 31-JAN-2017) (Strength, dose and route were not provided). Concomitant medication was not reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 2 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 30-NOV-2015, the patient was inadvertently vaccinated with a dose of VAQTA (0.5 ml, lot # L004439, expiration date 15-FEB-2016; route of administration was not reported). No adverse effects were reported. Additional information is not expected as the reporter did not wish to be contacted.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 11 year old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 24-AUG-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (Lot# L000610, expiration date 31-JAN-2017) (Strength, dose and route were not provided). Concomitant medication was not reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to unknown number of patients of unknown age and gender. No concurrent or historical conditions were reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot# L016427, expiration date 13-APR-2017; lot# L004754, expiration date 10-NOV-2016; lot# K020216, expiration date 17-SEP-2016; strength, dose and route unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, VARCEL
Symptoms: Blood glucose normal, Blood test, Dizziness
Clinical narrative: Patient received her first injection of GARDASIL 9 at 12:35 pm, along with three other vaccines. Patient then had her blood work drawn in the our lab. Patient was checking out when she began to feel lightheaded. Patient sat down in a chair, and then was brought back into a room for further evaluation. Patient's blood pressure was taken manually in her left arm while sitting, and was 100/68. Finger stick blood sugar was 73. Patient said that she began to feel better. Mom informed me that the patient was fasting today. Advised mom that patient may have become lightheaded from a combination of the patient not eating, having 4 vaccines, and having blood work drawn. Mom agreed. Patient left the building. Dr. notified.
Age: 22.0
Sex: F
Vaccine: SMALL
Symptoms: Eschar
Clinical narrative: Smallpox vaccination on 9/12/2015. On 11/27/2015 she still had eschar -- decreasing in size from the previous week. Otherwise normal take and asymptomatic after 2 weeks post vaccine.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: 1 inch diameter swelling from PNEUMOVAX IM, received swelling began to decrease after approximately 5 min diphenhydramine 50 mg once.
Age: 59.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Skin warm
Clinical narrative: Vaccine given 5/4/15, reaction noted 5/6; warmth/erythematous about the size of a nickle, observed and on 5/7 noted that reaction area a little worse. Diphenhydramine 25mg oral given and cephalexin 500mg tid x7d.
Age: 10.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 10 year old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 27-AUG-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (Lot# L000610, expiration date 31-JAN-2017) (Strength, dose and route were not provided). Concomitant medications was not reported. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 16 year old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 27-AUG-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (Lot# L000610, expiration date 31-JAN-2017) (Strength, dose and route were not provided). Concomitant medication was not reported. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse (vaccine coordinator) refers to a 12-month-old patient of unknown gender. No medical history or concurrent conditions were reported. On 02-SEP-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (lot #  L000456, an expire date 06-JAN-2017) (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 11 year old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 26-AUG-2015, the patient was vaccinated with improperly stored dose of GARDASIL 9 (Lot#L000610, expiration date 31-JAN-2017) (Strength, dose and route were not provided). Concomitant medication was not reported. No adverse effects 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: Information has been received from a nurse referring to unknown number of patients of unknown age and gender. No concurrent or historical conditions were reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot# L013429, expiration date 21-JUL-2017; L007560, expiration date 15-JUN-2017; strength, dose and route unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to unknown number of patients of unknown age and gender. No concurrent or historical conditions were reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally (lot # L008574, expiration date 22-NOV-2016; K023157, expiration date 23-JUL-2016; strength and dose unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to unknown number of patients of unknown age and gender. No concurrent or historical conditions were reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL (lot# K010215, expiration date 05-MAY-2017; K008931, expiration date 04-MAR-2017; strength, dose and route unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Local reaction, Pain in extremity, Peripheral swelling
Clinical narrative: Presented to medical support assistant stating he had right arm swelling however left for another appointment on Feb 9th, 2015. Returned same day and was evaluated by nurse as having redness and swelling above right elbow area below what he states is the injection site from his PNEUMOVAX that he received on 2/6/15. States that 2/6/15 PM his right arm was very painful and swollen. Denies respiratory concerns or shortness of breath, or swelling in throat. PCP and PharmD visualized area, localized reaction.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Sleep disorder
Clinical narrative: Redness/edema to left upper arm onset x1 day. Pt says the injection site was very sore that night-> so bad it interfered with his sleep. Saturday pain was not that bad but on Sunday the arm started to feel like it was burning and he noticed redness distal to where he got the shot and that has seemed to spread further down the arm in the past 24 hours. Burns less on day of presentation in fact barely hurts at all unless touched. Pt thinks it is less bright red than yesterday as well. Prednisone 10 mg every day.
Age: 46.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report as received from a 46 years old male consumer as part of a marketing research program. The patient's medical history and concurrent conditions were not reported. On 17-SEP-2015, the patient was vaccinated with PNEUMOVAX23 dose 1, intramuscular (dosage, frequency, lot# not reported). No concomitant medications reported. The patient reported having a sore arm on an unknown date of September-2015 that he did not consider very bothersome after receiving a pneumo vaccine. He was unsure where he received pneumococcal vaccine. The adverse event sore arm was recovered with on 26-SEP-2015, after stopping suspect therapy. The event was not appeared after restarting suspected therapy. The reporter considered sore to be related to PNEUMOVAX23. Additional information is not expected since the reporter did not wish to discuss further.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin warm
Clinical narrative: Pt had reported on 12/1/2015 that her arm had gotten red from shoulder down her arm. Reported she had 2-3 days of it being warm to touch. No induration or shortness of breath, no signs of distress.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to unknown number of patients of unknown age and gender. No concurrent or historical conditions were reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (lot # L001325, expiration date 13-JAN-2017; strength, dose and route unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to unknown number of patients of unknown age and gender. No concurrent or historical conditions were reported. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (lot # L003221, expiration date 30-JUL-2016; strength, dose and route unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Urticaria
Clinical narrative: This spontaneous report was received from a pharmacist regarding a female patient of unknown age. There was no information about concurrent condition and historical medication. On 17-NOV-2015 the patient was vaccinated with PNEUMOVAX 23. No concomitant medication was reported. On an unknown date in November 2015, the patient experienced soreness in her arm, redness on the top of her shoulder and back of her arm, like welts. It was unknown if there was any lab work. It was stated that as of 18-NOV-2015, it was unknown if the patient continues on PNEUMOVAX 23. The outcome of soreness in her arm, redness on the top of her shoulder and back of her arm, like welts was reported as not resolved. Causality between PNEUMOVAX 23 and soreness in her arm, redness on the top of her shoulder and back of her arm, like welts was unknown. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to unknown number of patients of unknown age and gender. No concurrent or historical conditions were reported. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II (therapy type: rHA, lot# L009214, expiration date 17-MAR-2017; lot# K021152, expiration date 02-JAN-2016; strength, dose and route unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 74.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 74 year old patient of unknown gender. There were no concomitant medications, concurrent conditions and medical history reported. In September 2015 (reported as "between 10-SEP-2015 and 18-SEP-2015"), the patient was vaccinated with improperly stored dose of ZOSTAVAX (dose, frequency and route of vaccination were not reported, lot # L011533 with expiration date: 03-JUL-2016). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 61.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 61 year old patient of unknown gender. There were no concomitant medications, concurrent conditions and medical history reported. In September 2015 (reported as "between 10-SEP-2015 and 18-SEP-2015"), the patient was vaccinated with improperly stored dose of ZOSTAVAX (dose, frequency and route of vaccination were not reported, lot # L011533 with expiration date: 03-JUL-2016). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 62 year old patient of unknown gender. There were no concomitant medications, concurrent conditions and medical history reported. In September 2015 (reported as "between 10-SEP-2015 and 18-SEP-2015"), the patient was vaccinated with improperly stored dose of ZOSTAVAX (dose, frequency and route of vaccination were not reported, lot # L011533 with expiration date: 03-JUL-2016). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a female patient of unknown age. Medical history and concurrent conditions were not reported. On an unspecified date, the patient was administered the first dose of the human papilloma virus (HPV) series with CERVARIX and, on 20-AUG-2015, she was receiving the second dose of the (HPV) series with GARDASIL (4) (drug administration error). Concomitant medications were not reported. No adverse effect was reported. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a 4 year old patient of unknown gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 21-AUG-2015, the patient was vaccinated with an improperly stored PROQUAD (Merck) lot # L010142, expiration date: 24-SEP-2016 (dose, therapy type, route of administration and anatomical location were not reported). There were no adverse effects reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's current conditions. medical history and concomitant medications were not reported. On 13-NOV-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (strength, dose, frequency and route were not reported, lot number 1019996 and expiry date 02-DEC-2016) injection. No adverse effect was reported. Product quality complaint (PQC) was not involved. No further information was provided. Additional information has been requested.
Age: 59.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 59 year old patient of unknown gender. There were no concomitant medications, concurrent conditions and medical history reported. In September 2015 (reported as "between 10-SEP-2015 and 18-SEP-2015"), the patient was vaccinated with improperly stored dose of ZOSTAVAX (dose, frequency and route of vaccination were not reported, lot # L011533 with expiration date: 03-JUL-2016). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash vesicular
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative regarding a female patient of unknown age. No medical history and concurrent conditions were reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot number and expiry date unknown). No concomitant medications were reported. On an unknown date, after vaccination with ZOSTAVAX, the patient developed an unspecified rash that "resembled shingles" at the injection site which traveled down to her unspecified arm. The patient sought medical attention (details unspecified) and received an unspecified antibiotic as treatment. The outcome of the events was unknown. No product quality complaint was reported. Causality assessment was not provided. This is one of the two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site cellulitis, Injection site haematoma
Clinical narrative: This spontaneous report as received from a Registered Nurse via field representative refers to two patients of unknown age and gender. No medical history, concurrent conditions and concomitant medication were reported. On an unknown date, the patients were vaccinated with VARIVAX (Merck) subcutaneously (dose, lot #, expiry date were not provided). Ten days after administration of VARIVAX (Merck), the patients presented with cellulitis and hematoma at the injection site. The outcome of the events and the relatedness between the events and VARIVAX (Merck) were not provided. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 12 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 09-JUL-2015, the patient was vaccinated with an improperly stored dose of GARDASIL lot # K023432, expiration date 18-JUN-2016 (strength, dose and route of administration were not provided). There were no adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a 4 year old patient of unknown gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 25-AUG-2015, the patient was vaccinated with an improperly stored PROQUAD (Merck) lot # L010142, expiration date: 24-SEP-2016 (dose, therapy type, route of administration and anatomical location were not reported). There were no adverse effects reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: This spontaneous report was received from a consumer (the patient's mother) and refers to a 16 year old female patient. No information regarding the patient's pertinent medical history and drug reactions or allergies were reported. On 30-NOV-2015, the patient was vaccinated with her third dose of unidentified Merck HPV vaccine (the reporter could not confirm whether the vaccine was GARDASIL or GARDASIL 9) (strength, dose, route of administration, lot # and expiration date were not provided). Concomitant therapies included ADDERALL 20 mg. On 30-NOV-2015 (after receiving unidentified Merck HPV vaccine), the patient experienced headache, nausea and feeling faint. The outcome of the events was unknown. The relatedness between the events and the suspect vaccine was not reported. Additional information is not expected because the reporter declined to participate in answering questions within this adverse event report.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Hypersensitivity, Peripheral swelling
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of allergic reaction in a 11-year-old female patient who received MENVEO. On 17th November 2015, the patient received the 1st dose of MENVEO. On 17th November 2015, less than a day after receiving MENVEO, the patient experienced allergic reaction and swelling arm. The patient was treated with antihistamine. On an unknown date, the outcome of the allergic reaction and swelling arm were unknown. It was unknown if the reporter considered the allergic reaction and swelling arm to be related to MENVEO. Additional details were provided as follows: The patient experienced swelling of entire forearm after receiving the MENVEO vaccine. It was reported that it is not believed to be cellulitis but just an allergic reaction to the vaccine. On Wednesday, 18th November 2015, the patient was treated with an antihistamine. This was the first dose in series for the patient and at this time further information regarding patient condition is unknown. The patient's date of birth, lot number and expiry date of the vaccine were unknown. No further information was reported regarding the event.
Age: 14.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 14 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 27-JUL-2015, the patient was vaccinated with an improperly stored dose of GARDASIL lot # K011562, expiration date 08-APR-2017 (strength, dose and route of administration were not provided). There were no adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site nodule, Injection site swelling, Respiratory disorder, Sensation of foreign body
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 56 year old nurse female patient who had sensitivity to certain unspecified medications and unspecified medical history, drug reactions or allergies. On 10-NOV-2015, the patient was vaccinated with a dose of ZOSTAVAX, 0.65ml, subcutaneous, lot number L027322, expiration date 21-OCT-2016, (anatomical location was not reported). There was no concomitant medication reported. On 11-NOV-2015, the patient emailed the pharmacist and reported that she developed "respiratory problems, she felt like she had a lump in her throat" and also a "knot and swelling at the injection site". The reporter stated that the patient went to an unspecified hospital, where she worked, on an unknown date and unspecified antihistamines were given to her while she was at the hospital. The patient was not admitted to the hospital. At the time of the report, the outcome of the respiratory problems was reported as recovered on an unspecified date in November 2015. The outcome of the she felt like she had a lump in her throat and a knot at the injection site was unknown. The outcome of the swelling at the injection site had lessened but had not yet resolved. The relatedness between the events and therapy with ZOSTAVAX, was not reported. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 15 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 10-JUL-2015, the patient was vaccinated with an improperly stored dose of GARDASIL lot # K023432, expiration date 18-JUN-2016 (strength, dose and route of administration were not provided). There were no adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Bronchitis
Clinical narrative: This spontaneous report as received from a 69 years old female consumer as part of a marketing research program. The patient's medical history included with chronic obstructive pulmonary disease (COPD) and interstitial cystitis. The patient's concurrent conditions included with history of bronchitis. On an unknown date of October 2014 the patient was vaccinated with PNEUMOVAX 23 dose 1, intramuscular (dosage, frequency, lot# not reported). No concomitant medications reported. The patient reported severe case of bronchitis verging on pneumonia several months after pneumo vaccine. She is unsure the (illegible) vaccine she received. She thought it was related to a strain of pneumococcal potentially post return from another country. At the time of the report the dose was already taken. On 15-JAN-2015, the event bronchitis and pneumonia were recovered with sequelae. The reporter considered bronchitis and pneumonia to be not related to PNEUMOVAX 23. Additional information has been requested.