chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. Information regarding the patients current condition and medical history was not provided. On an unknown date in March 2016 an unspecified number of patients were vaccinated with improperly stored (temperature excursion-55F) dose of RECOMBIVAX HB lot # L038018, expiry date-13-SEP-2017. No adverse effects were reported. No laboratory tests were reported. No product quality complaint (PCQ) was involved. No further information was provided. Additional information is not expected as the reporter did not wish any further contact.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to unspecified number of unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally (dose, lot # and expiration date were not reported). The vaccine underwent a temperature excursion of maximum 46.9 degrees Fahrenheit for 15 minutes and minimum 34.9 degrees Fahrenheit for 2 hours (6 cycles). It was reported that Digital Data Logger was involved. There were no previous temperature excursions. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 21-MAY-2016, the patient was vaccinated intramuscularly with a 0.5 ml dose of GARDASIL (lot # J006587, expiry date: 04-DEC-2015). No adverse effects were reported. This is one of two 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 certified medical assistant refers to an unspecified patients of unknown age. On an unknown date, the patients were vaccinated with unspecified doses of improperly stored RECOMBIVAX HB 1048236, 31-MAR-2018. No adverse events were reported. Temperature of 49.3 F for 24 hours and there was no previous temperature excursion. This is one of the 4 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 was received from a certified medical assistant refers to an unspecified patients of unknown age. On an unknown date, the patients were vaccinated with unsoecified doses of improperly stored GARDASIL 9, 1024993, 17-OCT-2017. No adverse events were reported. Temperature of 49.3 F for 24 hours and there was no previous temperature excursion. This is one of the 4 reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 21-MAY-2016, the patient was vaccinated intramuscularly with a 0.5 ml expired dose of GARDASIL (lot # J006587, expiry date: 04-DEC-2015). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HEPAB
Symptoms: Fatigue, Hepatic enzyme increased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a adult female patient who received TWINRIX (batch number B457F, expiry date 25th September 2015).  Concomitant products included TWINRIX, TWINRIX, influenza vaccine, and TDAP. On 17th February 2015, the patient received the 3rd dose of TWINRIX. On an unknown date, less than a month after receiving TWINRIX, the patient experienced fatigue and elevated liver enzymes. On an unknown date, the outcome of the fatigue was recovered/resolved and the outcome of the elevated liver enzymes was unknown. It was unknown if the reporter considered the fatigue and elevated liver enzymes to be related to TWINRIX. Additional details were provided as follows: The age at vaccination was not reported. On 8th December 2014, the patient received a dose of Influenza (batch number TS53109, non-GSK vaccine) in an unknown deltoid. On 12th January 2015, the patient received a dose of TDAP (batch number U4870BA, expiry date 3rd October 2016, non-GSK vaccine) in right deltoid. On the same day, the patient received the 1st dose of TWINRIX (batch number B457F, expiry date 25th September 2015) in left deltoid. On 19th January 2015, the patient received the 2nd dose of TWINRIX  (batch number B45TF) in left deltoid. The patient received the 3rd dose of TWINRIX and soon after receiving vaccine, she started feeling fatigue. This feeling of fatigue had lasted for over a year. The dosage amount of the product was unknown and the patient could not locate the information on her paperwork. In addition, the patient had blood work done a year later after receiving the 3rd dose (preparation for a 12 month booster dose) and she was informed she had elevated liver enzymes. The reporter was unable to provide all of the expiration dates. The reported batch number (B45TF and B457) for 2nd and 3rd dose of TWINRIX did not exist and were updated to B457F, according to sales database.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L039660/expiration date- 04-FEB-2018. No adverse event. Excursion temperature was 51.22 F and timeframe was 92 hours. There was no previous temperature excursion. Call was because of the data logger. No concomitant medication 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: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, concomitant medication and medical history were not provided. On unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L043213, 28-AUG-2017, dose, route and dose number were unspecified). No adverse effect was reported. This is one of two reports received from the same source. Additional information is not expected because there was no consent for contact.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local reaction, Peripheral swelling, Pruritus, Rash
Clinical narrative: This spontaneous report has been received from a registered nurse referring to a 68 year old female patient. The patient had neither concurrent condition nor medical history. On 25-MAY-2016 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # L029073, exp data 19-APR-2017, 0.5 ml, dose number and frequency unknown) intramuscularly due to vaccination, post PREVNAR 13. Concomitant therapies included NASONEX, SINGULAIR and XOPENEX. On unknown date in May 2016 "the following day" the patient experienced a localized reaction described as "reddened area that had a rash appearance, and itching" and "following this she also experienced bilateral swelling of arms and hands." The patient seek unspecified medical attention by telephone call to physician office. No lab diagnostic studies were performed. The nurse reported that the patient self administered "some CLARITIN" at home for the localized reaction and the patient experienced "some improvement" in the adverse symptoms of the localized reaction. The outcome of the events were reported as recovering. 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 healthcare worker regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patient was vaccinated with improperly stored LIQUID PEDVAXHIB lot # L042835/expiration date 19-AUG-2018. No adverse event. Excursion temperature was 51.22 F and timeframe was 42 hours. There was no previous temperature excursion. Call was because of the data logger. No concomitant medication was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. 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 nurse and refers to unspecified number of unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (dose, route of administration, lot # and expiration date were not reported). The vaccine underwent a temperature excursion of maximum 46.9 degrees Fahrenheit for 15 minutes and minimum 34.9 degrees Fahrenheit for 2 hours (6 cycles). It was reported Digital Data Logger was involved. There were no previous temperature excursions. No adverse effects were reported. This is one of several reports received 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 nurse and refers to unspecified number of unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (dose, route of administration, lot # and expiration date were not reported). The vaccine underwent a temperature excursion of maximum 46.9 degrees Fahrenheit for 15 minutes and minimum 34.9 degrees Fahrenheit for 2 hours (6 cycles). It was reported that Digital Data Logger was involved. There were no previous temperature excursions. No adverse effects were reported. This is one of several reports received from the same source. 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 registered nurse refers to multiple unspecified patients of unknown ages and genders. The patients' medical history and concurrent conditions were not reported. On unspecified dates, the patients were vaccinated with MMR II (lot #: K005431, expiry date: 15-APR-2017) that had been improperly stored at a temperature of 47 F for a time frame of 74 hours. No adverse effects reported. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of MMR II (dose, route of administration, lot # and expiration date were not reported). The vaccine underwent a temperature excursion of maximum 46.9 degrees Fahrenheit for 15 minutes and minimum 34.9 degrees Fahrenheit for 2 hours (6 cycles). It was reported that Digital Data Logger was involved. There were no previous temperature excursions. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown ages and genders. The patients' medical history and concurrent conditions were not reported. On multiple unspecified dates, the patients were vaccinated with VAQTA (lot #: L023232, expiry date: 25-FEB-2017) that had been improperly stored at a temperature of 47 F for a time frame of 74 hours (incorrect product storage). No adverse effects reported. The outcome of the events was unknown. 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 physician refers to an unspecified number of patients of unknown age and gender. Information regarding the patients current condition and medical history was not provided. On an unknown date in March 2016 an unspecified number of patients were vaccinated with improperly stored (temperature excursion-55F) dose of GARDASIL 9 lot # L043213, expiry date-28-AUG-2017. No adverse effects were reported. No laboratory tests were reported. No product quality complaint (PQC) was involved. No further information was provided. Additional information is not expected as the reporter did not wish any further contact.
Age: 19.0
Sex: U
Vaccine: HEP, HEPA, HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse regarding a 19 year and 8 months old patient. There was no information about concomitant medication and historical medication. On 28-JAN-2014, the patient was vaccinated with RECOMBIVAX HB lot # L000717 dose 1, on 04-MAR-2014 dose 2 and the patient who was now 19 years and 8 months old received dose 3 on 02-MAR-2016, lot # L000717 and this was outside the recommended per the RECOMBIVAX HB prescribing information. No adverse event was reported. The outcome of the event was unknown. 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 registered nurse refers to multiple unspecified patients of unknown ages and genders. The patients' medical history and concurrent conditions were not reported. On multiple unspecified dates, the patients were vaccinated with RECOMBIVAX HB (lot # L027733, expiry date: 13-SEP-2017; L033343, expiry date 13-SEP-2017) (route of administration: intramuscular) that had been improperly stored at a temperature of 47 F for a time frame of 74 hours. No adverse effects reported. The outcome of the events was unknown. 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 registered nurse refers to multiple unspecified patients of unknown ages and genders. The patients' medical history and concurrent conditions were not reported. On multiple unspecified dates, the patients were vaccinated with GARDASIL 9 (lot #: L048237, expiry date: 08-MAY-2017) that had been improperly stored at a temperature of 47 F for a time frame of 74 hours (incorrect product storage). No adverse effects reported. The outcome of the events was unknown. 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 registered nurse refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medications and drug reactions or allergies was reported. On an unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection, lot # L025735, expiry date 14-AUG-2017 (dose, route of administration and anatomical location were not specified). On an unknown date, the administered doses of RECOMBIVAX HB underwent temperature excursion at 32.4 Fahrenheit degrees for 1 hour. There was no previous temperature excursion. No adverse effects were reported. 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: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional and refers to unspecified number of patients of unknown age or gender. The patients' medical histories and concurrent conditions were not reported. On unspecified dates in 2016, starting on or after 25-FEB-2016, the patients were vaccinated with improperly stored doses of VARIVAX route of administration was not reported (Lot # L034366, expiration date 08-SEP-2017; Lot # L041204, expiration date 20-OCT-2017; Lot # L048462, expiration date 02-DEC-2017). The doses were stored on a temperature of 0.59 degrees C by a time frame of 72 hours and 44 minutes. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medications and drug reactions or allergies was reported. On an unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 injection, lot# L014420, expiry date 23-FEB-2017 (dose, route of administration and anatomical location were not specified). On an unknown date, the administered doses of PNEUMOVAX 23 underwent temperature excursion at 32.4 Fahrenheit degrees for 1 hour. There was no previous temperature excursion. No adverse effects were reported. Product quality complaint (PCQ) was not involved. 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 an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patient was vaccinated with improperly stored VAQTA lot # L023232/expiration date- 25-FEB-2017, (incorrect product storage). No adverse event. Excursion temperature was 51.22 F and timeframe was 42 hours. There was no previous temperature excursion. Call was because of the data logger. No concomitant medication was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. 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 as received from a physician refers to an unspecified number of patients of unknown age and gender. Information regarding the patients current condition and medical history was not provided. On an unknown date in March 2016 an unspecified number of patients were vaccinated with improperly stored (temperature excursion-55F) dose of VAQTA lot # L023936, expiry date- 15-MAR-2017. No adverse effects were reported. No laboratory tests were reported. No product quality complaint (PQC) was involved. No further information was provided. Additional information is not expected as the reporter did not wish any further contact.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medications and drug reactions or allergies was reported. On an unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ oral solution, lot # L013192, expiry date 19-JAN-2017 (dose was not specified). On an unknown date, the administered doses of ROTATEQ underwent temperature excursion at 32.4 Fahrenheit degrees for 1 hour. There was no previous temperature excursion. No adverse affects were reported. 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: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse and refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medications and drug reactions or allergies were reported. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL injection, lot # L031245, expiry date 27-MAY-2017 (dose, route of administration and anatomical location were not specified). On an unknown date, the administered doses of GARDASIL underwent temperature excursion at 32.4 Fahrenheit degrees for 1 hour. There was no previous temperature excursion. No adverse effects were reported. 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: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional and refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # L018503, expiration date: 16-MAR-2017, dose and route were not reported) that was improperly stored (temperature: 50F, time frame: 20 hours). There was no previous excursion. No adverse effect reported. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: DTAP, HEP, MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Mother called clinic regarding her child seen on 5-17-16 that received DTap, Hep B, MMR and Varicella. Mother reports child had fever ranging from 100 to 102 on 5/25th-5/27th. Continued to learn child developed "bumps" on Saturday 5/28th that progressed from face and lower leg to back down to ankles. Mother reported "bumps" non welts on 5/31/16. Mother was advised to take child to pediatrician for evaluation.
Age: 39.0
Sex: M
Vaccine: HEP, HEPA, TDAP
Symptoms: Injection site vesicles
Clinical narrative: On 6/3 client reported a blister at injection site LD.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Swelling
Clinical narrative: Swelling and pain.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Swelling
Clinical narrative: Swelling and pain.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema
Clinical narrative: Received vaccine 6/4/16. On 6/5/16 noted redness, which increased by 6/6/16 14 x 7 cm. Treated with AUGMENTIN 875 1 po BID. ALLEGRA 180 mg 1 po daily. Cellulitis/Medicine Review.
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a physician referring to an adult patient of unknown gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with PROQUAD. Concomitant therapies were not provided. No adverse events were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a physician referring to an adult patient of unknown gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with PROQUAD (Merck) (strength, dose number, route, anatomical location, lot number and expiration date were not provided). Concomitant therapies were not provided. No adverse events were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist referring to an unspecified number of patients unknown ages and genders. The patients' concurrent conditions and medical histories were not provided. On unknown dates (also reported as "over several years"), the patients were vaccinated with ZOSTAVAX (Lot numbers and expiration dates were not provided) no doses, strengths, anatomical locations were provided. There was not concomitant medication reported. The reporter stated that she heard of patients who have received ZOSTAVAX and were then later diagnosed with the shingles. At the time of the report, the outcome of herpes zoster was unknown. The reporter did not assess the casual relationship between the adverse event and the ZOSTAVAX. 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, referring to an unspecified number of patients of unknown age and genders. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unspecified date (reported as "starting on or after 10-MAR-2016", the patients were vaccinated with a dose of improperly stored PROQUAD (Merck) (which had a lot # of L044058 and an expiration date of 02-MAY-2017, however, dosage number and route of administration were not reported). Nonetheless, no adverse effects were reported. Another batch of stored PROQUAD (Merck) (which had a Lot # L050908 with expiration date on 14-JUN-2017) had also been improperly stored and administered. The vaccines experienced the following temperature excursions on the following dates: 11 F for 15 minutes on or after 10-MAR-2016; reportedly, there had been no previous temperature excursions and the aforementioned ones were identified  due to a data logger. Furthermore, no product quality complaint was involved. This is one of two 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 was received from a healthcare worker, referring to an unspecified number of patients of unknown age and genders. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On an unspecified date (reported as "starting on or after 10-MAR-2016"), the patients were vaccinated with a dose of improperly stored VARIVAX (which had a lot # of L030158 and an expiration date of 11-AUG-2017; however, dosage number and route of administration were not reported). Nonetheless, no adverse effects were reported. Another batch of VARIVAX (which had a lot # of L032395 and an expiration date of 26-AUG-2017; Lot # L038132 and an expiration date of 01-OCT-2017 and Lot # L044527) had also been improperly stored and they had been administered. The vaccines experienced the following temperature excursions on the following dates: 11 F for 15 minutes on or after 10-MAR-2016; reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR, MMRV
Symptoms: Product packaging confusion
Clinical narrative: Information has been received from a Healthcare worker. The healthcare worker stated that their office received box of PROQUAD (lot # L017140 with expiratory date 13-NOV-2016 and lot# L016394 with expiratory date 08-NOV-2016. Due to human error, the PROQUAD that had "same coloring as box of M-M-R II)" was placed in refrigerator for storage. There was no patient affected by this but there was potential confusion based on similar package appearance. 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 physician refers to an unspecified number of patients of unknown age and gender. Information regarding the patients current condition and medical history was not provided. On an unknown date in March 2016 an unspecified number of patients were vaccinated with improperly stored (temperature excursion-55F) dose of ROTATEQ lot # L027076, expiry date-25-MAY-2017, oral. No adverse effects were reported. No laboratory tests were reported. No product quality complaint (PQC) was involved. No further information was provided. Additional information is not expected as the reporter did not wish any further contact.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Dysphemia, Muscle twitching, Seizure
Clinical narrative: Right after administration pt. had 5 second seizure. Normal neuro exam after. Vitals stable. Day after pt. was seen complaint of twitching in arms, stuttered vocabulary, sometimes unable to get words out.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Inflammation, Pain, Pruritus, Skin induration, Skin warm
Clinical narrative: Inflammation (red) about quarter size. Hot to touch and painful for patient. Itchy skin was hard to the touch.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Mobility decreased, Pain, Swelling
Clinical narrative: Friday 6/3/16 arm started to feel hot, red, itchy, started to swell, became painful and pt had difficulty lifting overhead, no difficulty breathing. Pt. applied cold compresses and took ALEVE.
Age: 1.27
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Induration, Injection site bruising, Pyrexia, Seizure
Clinical narrative: Rec'd 15 mo shots on 6-01-16 at WCE. Developed fever 6-02-16 (101-103 max). Seizure occurred 6/02 pm while being given bath. 911-transport to local hospital. D/c' d and seen at PCN 6-03-16 for follow-up (+) induration ~ 3x3 cm. Bruising (slight) to (LT) thigh. Seizure info and supportive care discussed with parents.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Pain
Clinical narrative: Patient had new onset of pain disorder spring 2014
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Chest pain, Chills, Decreased appetite, Fatigue, Neck pain
Clinical narrative: The same evening I started to feel very tired; the next day it was exhaustion, no appetite, neck pain, chills, chest pain, low fever, general aching.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Pyrexia
Clinical narrative: The same evening I started to feel very tired; the next day it was exhaustion, no appetite, neck pain, chills, chest pain, low fever, general aching.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema, Skin warm
Clinical narrative: The area is observed red, edema, little bit hot when you touch it, no pain. Patient was evaluated with the doctor. The doctor prescribed SEPTRA DS.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Urticaria
Clinical narrative: 3'x4' oblong, hot, red, raised wheel.
Age: 19.0
Sex: M
Vaccine: HEPA, HPV4, IPV, MENB, MNQ, TDAP
Symptoms: Blood glucose normal, Generalised tonic-clonic seizure
Clinical narrative: Patient had a tonic clonic seizure lasting 20-30 seconds just after receiving immunizations. Postictal was alert and oriented. Denies any hx of seizures or any previous reaction to any immunizations. Sent to ER. MENACTRA and IPV taken from VFC instead of private.
Age: 21.0
Sex: F
Vaccine: HEPA
Symptoms: Syncope
Clinical narrative: Patient had syncope episode after receiving vaccination.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Fatigue, Headache, Injection site mass, Pain
Clinical narrative: 5/24 fever 101, headache, joint pains, fatigue. 5/25 fever 100, joint pain. 5/27 fever 99, body aches, legs restless, fatigue, lump at 3 inch diameter at injection site. 5/31 lump resolving, no temp, body aches improved.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Restless legs syndrome
Clinical narrative: 5/24 fever 101, headache, joint pains, fatigue. 5/25 fever 100, joint pain. 5/27 fever 99, body aches, legs restless, fatigue, lump at 3 inch diameter at injection site. 5/31 lump resolving, no temp, body aches improved.
Age: 1.36
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Accidental exposure to product
Clinical narrative: Accidently gave patient a varicella, MMR and a hepatitis a shot.
Age: 55.0
Sex: F
Vaccine: MMR
Symptoms: Nausea, Pain
Clinical narrative: Nausea and body ache several days. Saw her own PCP (est 4/7/16). Rec'd anti nausea medication. Pt reports all symptoms resolved after est 10 days .
Age: 11.0
Sex: F
Vaccine: HPV9, HPV4
Symptoms: Rash
Clinical narrative: Rash arms and legs.
Age: 11.0
Sex: F
Vaccine: HPV9, HPV4
Symptoms: Rash pruritic
Clinical narrative: Rash arms and legs.
Age: 54.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site warmth, Joint range of motion decreased, Pain in extremity
Clinical narrative: This health authority case was initially received on 23-Nov-2015. The case report was received from the Health Professional and concerns a 54 year old male patient. The patient had no illness at the time of vaccination. The patient has a medical history of Asthma. The patient received AFLURIA on 23-Sep-2015 -  unknown stop date, Batch no: U56807, Route of administration: Intramuscular, Dose: 0.5 ml, Site: left arm (LA). PNEUMOVAX, Indication: not provided, Site: right arm (RA). On 24-Sep-2015, 2 days after starting treatment with AFLURIA the patient experienced could not lift elbow over shoulder, arm was extremely painful. On 25-Sep-2015, 2 days after starting treatment with AFLURIA the patient experienced large red area near site of injection measures 7 inches long and 3-4 inches wide, Feels hot to touch in that area. VAERS ID: 597378. Reporter's assessment: Non-serious. Case corrections (04-Mar-2016): AE 1 re-coded.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Oropharyngeal pain, Pain
Clinical narrative: This health authority case was initially received on 23-Sep-2015. The case report was received from a Health Professional and concerns a 52 years old female patient. The patient received a first dose of AFLURIA on 16-Sep-2015 - unknown stop date, Batch no: 11049211A reported as '1104921A', Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 16-Sep-2015, 1 day after starting treatment with AFLURIA the patient experienced lightheaded, Achy, Drained of energy, Sore throat. VAERS ID: 597382. Reporter's assessment: Non-serious. Case correction 17-Feb-2016: Key ingredient for suspect drug changed to Fluvax-thiomersal consistent with initial source document.
Age: 61.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Local reaction, Pain in extremity
Clinical narrative: This health authority case was initially received on 23-Nov-2015. The case report was received from a Health Professional and concerns a 61 year old female patient. The patient reported no illness at the time of vaccination. The patient had a medical history of no known drug allergies or pre-existing physician diagnosed allergies. Patient presented to pharmacy and was in good health. For concomitant medication and therapy dates refers to the appropriate report sections. The patient received AFLURIA on 23-Sept-2015 - unknown stop date, Batch no: U57907, Route of administration: Intramuscular, Dose: 0.5 ml. ZOSTAVAX, Route: subcutaneous, Site: left arm (LA). On 25-Sep-2015, 3 days after starting treatment with AFLURIA the patient experienced Arm was swollen, Arm was sore / Just sore / Arm being sore, Arm being tender, Local injection site [reaction, The area on the arm] was warm [and swollen], Local injection site [reaction. The area on her arm] was [warm and] swollen, Local injection site reaction [The area on her arm was warm and swollen], Local reaction. Ibuprofen and ice. VAERS ID: 597448. Reporter's assessment: Non-serious.
Age: 61.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Peripheral swelling
Clinical narrative: This health authority case was initially received on 23-Nov-2015. The case report was received from a Health Professional and concerns a 61 year old female patient. The patient reported no illness at the time of vaccination. The patient had a medical history of no known drug allergies or pre-existing physician diagnosed allergies. Patient presented to pharmacy and was in good health. For concomitant medication and therapy dates refers to the appropriate report sections. The patient received AFLURIA on 23-Sept-2015 - unknown stop date, Batch no: U57907, Route of administration: Intramuscular, Dose: 0.5 ml. ZOSTAVAX, Route: subcutaneous, Site: left arm (LA). On 25-Sep-2015, 3 days after starting treatment with AFLURIA the patient experienced Arm was swollen, Arm was sore / Just sore / Arm being sore, Arm being tender, Local injection site [reaction, The area on the arm] was warm [and swollen], Local injection site [reaction. The area on her arm] was [warm and] swollen, Local injection site reaction [The area on her arm was warm and swollen], Local reaction. Ibuprofen and ice. VAERS ID: 597448. Reporter's assessment: Non-serious.
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling drunk, Hot flush, Injection site pruritus, Injection site reaction, Skin lesion
Clinical narrative: This health authority case was initially received on 23-Nov-2015. The case report was received from a Health Professional concerns a 32 year old male patient. The patient had no illness, no known drug allergies and no medical history at the time of vaccination. Suspect drug (s), timing and conditions surrounding the onset of reaction (s) / event (s): The patient received AFLURIA for indication not reported on 24-Sep-2015 unknown date, Batch no: U56106, Route of administration: Intramuscular, Dose: 0.5 ml, Site: left arm (LA). No additional drugs suspected. On 24-Sep-2015, 1 day after starting / treatment with AFLURIA the patient experienced Pt occ gets hot flashes, hot to touch, Pt was "buzzed", small lesions present under Band-Aid site, mild itching over injection site, Pt notes he had alcohol (and was "buzzed"), Injection site reaction. VAERS ID: 597580. Reporter's assessment: Non serious. The health authority coded additional term injection site reaction. Case corrections (18-Mar-2016): AE 3 (Pt notes he had alcohol and was "buzzed") re-coded to 'feeling drunk'. Case correction 12-Apr-2016: Causality for AE 3 'Pt (noted he had alcohol and was "buzzed") changed to unrelated.
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Skin warm
Clinical narrative: This health authority case was initially received on 23-Nov-2015. The case report was received from a Health Professional concerns a 32 year old male patient. The patient had no illness, no known drug allergies and no medical history at the time of vaccination. Suspect drug (s), timing and conditions surrounding the onset of reaction (s) / event (s): The patient received AFLURIA for indication not reported on 24-Sep-2015 unknown date, Batch no: U56106, Route of administration: Intramuscular, Dose: 0.5 ml, Site: left arm (LA). No additional drugs suspected. On 24-Sep-2015, 1 day after starting / treatment with AFLURIA the patient experienced Pt occ gets hot flashes, hot to touch, Pt was "buzzed", small lesions present under Band-Aid site, mild itching over injection site, Pt notes he had alcohol (and was "buzzed"), Injection site reaction. VAERS ID: 597580. Reporter's assessment: Non serious. The health authority coded additional term injection site reaction. Case corrections (18-Mar-2016): AE 3 (Pt notes he had alcohol and was "buzzed") re-coded to 'feeling drunk'. Case correction 12-Apr-2016: Causality for AE 3 'Pt (noted he had alcohol and was "buzzed") changed to unrelated.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Nausea, Vomiting
Clinical narrative: Source of report and patient demography: This health authority case was initially received on 23-Nov-2015. The case report was received from a Health Professional and concern a 28 year old female patient. The patient had no illness at the time of vaccination and no medical history. Suspect drug(s), timing and conditions surrounding the  onset of reaction(s)/event(s): The patient received AFLURIA for indication Indication not reported on 27-Sep-2015 - unknown stop date, Batch no: U56807, Route of administration: Intramuscular, Dose: 0.5 ml. Site: left arm (LA). Additional suspect drug(s): No additional drugs suspected. Reaction(s) / event (s) and outcome: On 27-Sep-2015, 1 day after starting / treatment with AFLURIA the patient experienced Headache, Chills, Vomiting, Nausea. VAERS ID: 597666. Reporter's assessment: Non-serious.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Burning sensation, Joint range of motion decreased, Musculoskeletal discomfort, Pain
Clinical narrative: This health authority case was initially received on 23-Nov-2015. The case report was received from a Health Professional and concerns a 42 year old female patient. Concurrent medical condition()s, medical and drug history: The patient had no illness at the time of vaccination. The patient has a medical history of ASA allergy. The following drug history information was reported: ASA (Indication:-, Reaction: Allergy). The patient received AFLURIA for indication not reported on 10-Sep-2015-unknown stop date, Batch no: U54506, Route of administration: Unknown, Dose: 0.5 ml, Site: left arm (LA). No additional drugs suspected. On 11-Sep-2015, 2 days after starting/treatment with AFLURIA the patient experienced burning sensation in shoulder, extending toward elbow, extreme pain, discomfort in shoulder, shoulder with decreased mobility, shoulder with decreased strength. VID: 597692. Reporter's assessment: Non-serious.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Rash maculo-papular
Clinical narrative: Concerns a 25 year old female patient. The patient had no illness, concomitant medications or medical history at the time of vaccination. Suspect drug(s), timing and conditions surrounding the onset of reaction (s)/event (s): The patient received AFLURIA for indication not reported on 10-Sep-2015 - unknown stop date, Batch no: U54405, Route of administration: Unknown, Dose: 0.5 ml, Site: left arm (LA). Additional suspect drug(s): No additional drugs suspected. Reaction (s) / event(s) and outcome: On 12-Sep-2015, 3 days after starting / treatment with AFLURIA the patient experienced localized maculopapular rash spreading to arms, (chest and legs). VAERS ID: 597776. Reporter's assessment: Non-serious.
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia, Limb discomfort, Peripheral swelling
Clinical narrative: This health authority case was initially received on 23-Nov-2015. The case report was received from a Health Professional and concerns an adult female patient. Suspect drug(s), timing and conditions surrounding the onset of reaction(s) / events(s): The patient received Flu vaccine (brand and batch number unknown) for indication not reported. Additional suspect drug(s): No additional drugs suspected. Reaction(s) / event(s) and outcome: On an unknown date, after starting / treatment with Flu vaccine the patient experienced Numb arm, Swollen arm, Heavy arm, Reddened arm. VAERS ID: 597781. Reporter's assessment: Non-serious.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Dizziness, Myalgia, Pyrexia, Urticaria
Clinical narrative: This health authority case was initially received on 23-Nov-2015. The case report was received from a Health Professional and concerns a 42 year old male patient. The patient received AFLURIA for indication not reported on 23-Sep-2015-unknown stop date, Batch no:11049211A, Route of administration: Intramuscular, Site: left arm (LA). No additional drugs suspected. On 23-Sep-2013, 1 day after starting/treatment with AFLURIA the patient experienced achy joints, dizziness, weal, achy muscles, fever. VAERS ID: 597782. Reporter's assessment: Non-serious.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: This health authority case was initially received on 23-Nov-2015. The case report was received from a Health Professional and concerns a 33 year old female patient.  The patient had no illness at the time of vaccination. The patient had a medical history of 'PCN' and concomitant medication included 'BCP'. Suspect drug(s), timing and conditions surrounding the onset of reaction(s) / event (s): The patient received a 12th dose of AFLURIA for indication not reported on 24-Sep-2015 unknown stop date, Batch no: U56506, Route of administration: Intramuscular, Dose: 0.5 ml, Site: left arm. Additional suspect drug(s): No additional drugs suspected. Reaction(s) / event (s) and outcome: On 26-Sep-2015, 3 days after starting / treatment with AFLURIA the patient experienced Left arm initially painful with ROM / Pain persists at same level, Currently ROM improved. On 27-Sep-2015, 4 days after starting / treatment with AFLURIA the patient experienced Numbness. On 28-Sep-2015, 5 days after starting / treatment with AFLURIA the patient experienced Swelling started / Swelling of arms/hands still evident. Lab data: None at this time. VAERS ID: 597826. Reporter's assessment: Non-serious.
Age: 72.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: The case report was received from a Health Professional and concerns a 72 year old female patient. The patient had no illness at the time of vaccination and no medical history. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA for indication not reported on 23-Sep-2015 unknown stop date, Batch no: U59208, Route of administration: Intramuscular, Dose: 0.5 ml. Site: right arm (RA). PREVNAR 13, Indication: not provided, Site: right arm (AR). On 23-Sep-2015, 1 day after starting / treatment of AFLURIA the patient experienced (painful) injection site. Swollen, red and warm, Painful injection site. Painful injection site. Swollen, red and warm. Painful injection site. Swollen, red and warm. Event treatment: Went to see regular doctor and received rx for CEPHALEXIN. VAERS ID: 597836. Reporter's assessment: Non-serious (emergency room visit). Case Correction (04-Mar-2016): Listedness for AE 1 changed to listed.