chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.95
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: This case was reported by a nurse and described the occurrence of expired vaccine used in a child male patient who received INFANRIX (batch number AC14B157CA, expiry date 13th September 2014). In September 2014, the patient received INFANRIX. On an unknown date, an unknown time after receiving INFANRIX, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. It was unknown if the reporter considered the expired vaccine used to be related to INFANRIX. Additional information received on 29 September 2014: An expired dose of INFANRIX was inadvertently administered.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from a physician via a field employee refers to a 68 year old male patient. On 06-FEB-2012, the patient was vaccinated with a dose of ZOSTAVAX (dose and route not reported). On 11-NOV-2014, patient sought medical attention at the office of the physician for a unilateral rash on his right side that started at his back "sort of midline" and came around the front, "consistent with shingle". Unspecified antivirals were given for the adverse event. No lab diagnostics studies performed. The outcome of the event was unknown. Additional information is not expected since the reporter refused to be contacted.
Age: 11.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 11 years old child patient and unknown gender. On 15-JUL-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot H020901, expiration date 05-JUL-2015)(dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received 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 Licensed Practical Nurse refers to a patient of 14 years old adolescent patient and unknown gender. On 29-SEP-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot J015378, expiration date 09-APR-2016(dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 11 years old child patient and unknown gender. On 10-SEP-2014 the patient was vaccinated with an improperly stored GARDASIL (lot J015378, expiration date 09-APR-2016) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported is unknown. 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: HPV4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from an office manager (also reported as healthcare worker) via a company representative refers to unknown number of patients of unknown age and gender without past vaccination records. On an unknown dates, the patients were vaccinated with more than three doses of GARDASIL (dose, lot #, expiration date were not reported). No adverse effects was reported. Additional information has been requested.
Age: 1.03
Sex: F
Vaccine: HEP
Symptoms: Extra dose administered, Wrong drug administered
Clinical narrative: This case was reported by a other health professional and described the occurrence of extra dose of administered in a 12-month-old female patient who received ENGERIX B pediatric (batch number AHBVC190BA, expiry date 31st January 2015). Concomitant products included ENGERIX B pediatric. On 22nd September 2014, the patient received the 4th dose of ENGERIX B pediatric. On 22nd September 2014, an unknown time after receiving ENGERIX B pediatric, the patient experienced extra dose administered and wrong vaccine administered. On an unknown date, the outcome of the extra dose administered and wrong vaccine administered were unknown. It was unknown if the reporter considered the extra dose administered and wrong vaccine administered to be related to ENGERIX B pediatric. Additional information: Medical assistant reported on 22 September 2014, she vaccinated the patient and instead of getting a Hepatitis A vaccine, the patient received an 4th (extra dose) of ENGERIX B. No adverse event was reported.
Age: 14.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 14 years old adolescent patient and unknown gender. On 14-JUL-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot H020901, expiration date 05-JUL-2015) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 11 years old child patient and unknown gender. On 14-JUL-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL 120 Y (lot H020901, expiration date 05-JUL-2015) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse event. No treatment needed.
Age: 11.0
Sex: U
Vaccine: HPV4, HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Nurse refers to a patient of 11 years old child patient and unknown gender. On 23-JUL-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot H020901, expiration date 05-JUL-2015) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HPV4, HPV4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Nurse refers to a patient of 11 years old child patient and unknown gender. On 23-JUL-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot H020901, expiration date 05-JUL-2015) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HPV4, HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 11 years old child patient and unknown gender. On 23-JUL-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot H020901, expiration date 05-JUL-2015)(dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HPV4, HPV4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 11 years old child patient and unknown gender. On 23-JUL-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot H020901, expiration date 05-JUL-2015)(dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. In September 2014 the patients were vaccinated with an improperly stored GARDASIL (dose, route, lot number and expiration date not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Follow up information was received from a Licensed Practical Nurse. The nurse stated that she did not have the information (patient identifiers, lot numbers, expiration dates, and date of vaccine administration) available at the reporting time. The nurse also stated she might fax information at a later time. Follow up information has been received from the Licensed Practical Nurse on 28-OCT-2014. The patient identifiers were reported and the patient was 16 years old Adolescent. The patient was vaccinated with GARDASIL on 30-SEP-2014. Lot was reported as J015378, expiration date 09-APR-2016 for the vaccine GARDASIL. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 11 years old child and unknown gender. On 02-SEP-2014 the patient was vaccinated with an improperly stored GARDASIL (lot J015378, expiration date 09-APR-2016) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported is unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 11 years old child patient and unknown gender. On 30-JUL-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot H020901, expiration date 05-JUL-2015) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 11 years old child patient and unknown gender. On 24-SEP-2014 the patient was vaccinated with an improperly stored GARDASIL (lot J015378, expiration date 09-APR-2016) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported is unknown. No product quality complaint was involved. This is one of several reports received from the same source. 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 Licensed Practical Nurse refers to a patient of 17 years old adolescent and unknown gender. On 30-SEP-2014 the patient was vaccinated with an improperly stored GARDASIL (lot J015378, expiration date 09-APR-2016) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported is unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 11 years old child patient and unknown gender. On 18-JUL-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot H020901, expiration date 05-JUL-2015) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unkonwn. No product quality complaint was involved. this is one of several reports received from the same source. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 11 years old child patient and unknown gender. On 16-JUL-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot H020901, expiration date 05-JUL-2015) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HPV4, HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. In July 2014 the patients were vaccinated with an improperly stored GARDASIL (dose, route, lot number and expiration date were not reported). No adverse effect was reported. This is one of several reports received from the same reporter. Follow up information has been received from the Licensed Practical Nurse. The Licensed Practical Nurse stated that she did not have the information (patient identifiers, lot numbers, expiration dates, and dates of vaccine administration) available at this time. No further information was available at this time of report. Follow up information has been received from the Licensed Practical Nurse on 28-OCT-2014. The patient identifiers were reported and the patient was 11 years old child. The patient was vaccinated with GARDASIL on 09-JUL-2014 Lot was reported as H020901, expiration date 05-JUL-2015 for the vaccine GARDASIL. Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 13 years old adolescent patient and unknown gender. On 30-JUL-2014 the patient was vaccinated with a dose of improperly stored GARDASIL 120 Y (lot J009788, expiration date 17-MAR-2016) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 11 years old child patient and unknown gender. On 17-JUL-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot H020901, expiration date 05-JUL-2015) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 11 years old child patient and unknown gender. On 03-SEP-2014 the patient was vaccinated with an improperly stored GARDASIL (lot J015378, expiration date 09-APR-2016) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported is unknown. No product quality complaint was involved. This is one of several reports received from the same source. 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 Licensed Practical Nurse refers to a patient of 12 years old child patient and unknown gender. On 21-JUL-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot H020901, expiration date 05-JUL-2015) (dose, route, were not reported). No adverse effect was reproted. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Incorrect product storage
Clinical narrative: This case was reported by a nurse and described the occurrence of incorrect product storage in a 4-year-old female patient who received KINRIX (batch number EP2A3, expiry date 30th September 2014). On an unknown date, the patient received KINRIX. On an unknown date, an unknown time after receiving KINRIX, the patient experienced incorrect product storage. On an unknown date, the outcome of the incorrect product storage was unknown. It was unknown if the reporter considered the incorrect product storage to be related to KINRIX. Additional information received: KINRIX stored at 0.5 degrees C and administered to the patient.
Sex: M
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: This case was reported by a other health professional and described the occurrence of incorrect product storage in a male patient who received HAVRIX pediatric (batch number AHAVB642CA, expiry date 14th December 2014). On an unknown date, the patient received HAVRIX pediatric. On an unknown date, an unknown time after receiving HAVRIX pediatric, the patient experienced incorrect product storage. On an unknown date, the outcome of the incorrect product storage was unknown. It was unknown if the reporter considered the incorrect product storage to be related to HAVRIX pediatric.
Age: 0.19
Sex: F
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: This case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a 2-month-old female patient who received KINRIX (batch number 2B463 ?, expiry date unknown). On an unknown date, the patient received KINRIX. On an unknown date, an unknown time after receiving KINRIX, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown. It was unknown if the reporter considered the inappropriate age at vaccine administration and wrong vaccine administered to be related to KINRIX. Additional information received: Per HCP, patient received KINRIX at 2 months of age on 23 October 2013 while in the care of another health facility.
Age: 16.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 16 years old adolescent patient and unknown gender. On 15-SEP-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot J015378, expiration date 09-APR-2016) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received 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 Licensed Practical Nurse refers to a patient of 15 years old adolescent patient and unknown gender. On 15-SEP-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot J015378, expiration date 09-APR-2016) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. In July 2014 the patients were vaccinated with an improperly stored GARDASIL (dose, route, lot number and expiration date were not reported). No adverse effect was reported. This is one of several reports received from the same reporter. Follow up information has been received from the Licensed Practical Nurse. The Licensed Practical Nurse stated that she did not have the information (patient identifiers, lot numbers, expiration dates, and date of vaccine administration) available at this time. No further information was available at this time of reporting. Follow up information has been received from the Licensed Practical Nurse on 28-OCT-2014. The patient identifiers were reported and the patient was 11 years old child. The patient was vaccinated with GARDASIL on 16-JUL-2014. Lot was reported as H020901, expiration date 05-JUL-2015 for the GARDASIL. 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 Licensed Practical Nurse refers to a patient of 17 years old adolescent and unknown gender. On 26-SEP-2014 the patient was vaccinated with an improperly stored GARDASIL (lot J015378, expiration date 09-APR-2016) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported is unknown. No product quality complaint was involved. This is one of several reports received from the same source. 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 Licensed Practical Nurse refers to a patient of 12 years old adolescent patient and unknown gender. On 09-SEP-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot J015378, expiration date 09-APR-2016) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: This case was reported by a other health professional and described the occurrence of expired vaccine used in a male patient who received ENGERIX B (batch number unknown, expiry date 6th September 2014). On 22nd September 2014, the patient received ENGERIX B. On an unknown date, an unknown time after receiving ENGERIX B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. It was unknown if the reporter considered the expired vaccine used to be related to ENGERIX B.
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: Pt states while getting dressed this morning he noticed redness surround the site where he received a pneumonia shot x 9 days ago, he was advised by another MD he saw today for non related issue to come to office and report. Pt denies any symptoms or pain - erythema 3in x 1 3/4" (L) deltoid.
Age: 19.0
Sex: M
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: This case was reported by a other health professional and described the occurrence of underdose in a 19-year-old male patient who received HAVRIX pediatric (batch number N4341, expiry date 19th February 2016). On an unknown date, the patient received HAVRIX pediatric .5 ml. On an unknown date, an unknown time after receiving HAVRIX pediatric, the patient experienced underdose. On an unknown date, the outcome of the underdose was unknown. It was unknown if the reporter considered the underdose to be related to HAVRIX pediatric. Additional informations: This 19 years old was inadvertently given a pediatric dose of HAVRIX.
Age: 47.0
Sex: F
Vaccine: HEP, HEPA, MMR, TDAP
Symptoms: Dizziness, Dry eye, Ear congestion, Neck pain, VIIth nerve paralysis
Clinical narrative: Received shots on 10/9. On the arm of Friday 10/11, patient woke with severe neck pain "like she slept on it funny." Then on Saturday she became dizziness and felt like her ears were plugged. On Sunday she noticed facial drooping on right side of face. Went to clinic on 10/13 and received 6 days valacyclovir and drops for dryness in eyes.
Age: 15.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 15 years old adolescent patient and unknown gender. On 15-SEP-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot J015378, expiation date 09-APR-2016) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Burning sensation, Dyspnoea, Erythema, Pruritus, Swelling
Clinical narrative: 08:32 -> Face neck feel like they are "on fire" - cold rag placed. 09:11 -> Itching in BUE - MD paged twice [shortness of breath, wheeze, swelling, etc]. 09:40-> MD at clinic ordered CLARITIN hydroxyzine. Pt has less redness/itching. 10:00 -> CLARITIN given - hydroxyzine given. Pt has no itching or redness anymore.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Wheezing
Clinical narrative: 08:32 -> Face neck feel like they are "on fire" - cold rag placed. 09:11 -> Itching in BUE - MD paged twice [shortness of breath, wheeze, swelling, etc]. 09:40-> MD at clinic ordered CLARITIN hydroxyzine. Pt has less redness/itching. 10:00 -> CLARITIN given - hydroxyzine given. Pt has no itching or redness anymore.
Age: 0.4
Sex: U
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This case was reported by a other health professional and described the occurrence of inappropriate age at vaccine administration in a 4-month-old unk patient who received KINRIX. On an unknown date, the patient received KINRIX at an unknown dose. On an unknown date, an unknown time after receiving KINRIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. It was unknown if the reporter considered the inappropriate age at vaccine administration to be related to KINRIX.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (healthcare worker) refers to a 12 month old patient of unknown gender. On 11-NOV-2014 the patient was vaccinated with M-M-R II (subcutaneously, 0.5 ml dose, frequency reported as once, lot # reported as J004321) that was expiry dated on 17-OCT-2014. No adverse effects reported. Lot # J004321 is an invalid lot # for M-M-R II. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 75 year old female patient. On 07-NOV-2014 the patient was vaccinated with PNEUMOVAX 23 lot # K007825, intramuscular in one of the arm. No concomitant medications and medical history were reported. At the same time patient had an unspecified high dose flu shot administered on the other arm. On an unspecified date in the year 2014 the patient experienced sore shoulders followed by the administration. No lab diagnostic studies were performed. The patient was advised to treat the soreness with ice as needed. The reporter was requesting a lot check for the PNEUMOVAX 23. Patient sought medical attention through pharmacy call. No product quality complaint was involved. The outcome of event was reported as recovering/resolving. This is one of several reports from the same reporter. The pharmacist requested lot check for the PNEUMOVAX 23. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 14 years old adolescent and unknown gender. On 09-SEP-2014 the patient was vaccinated with an improperly stored GARDASIL (lot J015378, expiration date 09-APR-2016) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported is unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.34
Sex: M
Vaccine: TDAP
Symptoms: Drug administered to patient of inappropriate age, Underdose, Wrong drug administered
Clinical narrative: This case was reported by a other health professional and described the occurrence of inappropriate age at vaccine administration in a 16-month-old male patient who received BOOSTRIX (batch number N2K27, expiry date 1st October 2015). On 24th September 2014, the patient received BOOSTRIX. On 24th September 2014, an unknown time after receiving BOOSTRIX, the patient experienced inappropriate age at vaccine administration, under dosed wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration, under dose and wrong vaccine administered were unknown. It was unknown if the reporter considered the inappropriate age at vaccine administration, under dose and wrong vaccine administered to be related to BOOSTRIX. Additional information: A BOOSTRIX vaccine was accidentally administered to two 16 month old twins. BOOSTRIX was recommended in a patient 10 years of age and older. No adverse event reported.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Pyrexia
Clinical narrative: This spontaneous report as received from a female patient of unknown age and demographics concerns herself. Patient's current condition and medical history was not reported. On 03-OCT-2014, the patient was vaccinated with ZOSTAVAX (strength, dose, route and lot number not reported) subcutaneous injection. No concomitant medication was reported. On 04-NOV-2014, the patient presented with fever as well as pain, redness, itching and burning at the injection site. There was no product quality complaint involved. Action taken and the outcome of the events were not reported. Causality was not reported. Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 16 years old adolescent patient and unknown gender. On 29-AUG-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot J015378, expiration date 09-APR-2016) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 11 years old child patient and unknown gender. On 17-SEP-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot J015378, expiration date 09-APR-2016) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 14 years old adolescent patient and unknown gender. On 16-SEP-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot J015378, expiration date 09-APR-2016) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. 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: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from registered nurse refers to a unspecified number of patients of unknown age and gender. Patient's medical history and current condition were not reported. On an unknown date the patient was vaccinated with VARIVAX (Merck) injection 0.5 ml (dose number, lot number and expiry date unknown). No concomitant medications were reported. On an unknown date the unspecified number of patients received improperly stored VARIVAX (Merck) and no adverse events were reported. Action taken with VARIVAX (Merck) was unknown. The outcome of received improperly stored VARIVAX (Merck) and no adverse event was unknown. The reporter considered received improperly stored VARIVAX and no adverse event to be not related to VARIVAX (Merck). Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. On an unknown date the unspecified amount of clients were vaccinated with improperly stored RECOMBIVAX HB (lot# and expiration date not provided) (dose not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.4
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 4 month old patient. On 11-NOV-2014, the patient was inadvertently vaccinated with a 0.5ml (reported as "pediatric dose") of VAQTA, (lot and route were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site vesicles
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 23-OCT-2014, the patient was vaccinated with ZOSTAVAX (batch/lot#, expiration date, dose and route were not provided). On approximately 02-NOV-2014 (Reported as 2 days ago), the patient experienced blisters on the opposite shoulder from injection site. The outcome of blisters on the opposite shoulder from injection site was unknown. The relatedness between the event and therapy with ZOSTAVAX was not reported. 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 Licensed Practical Nurse refers to a patient of 12 years old adolescent patient and unknown gender. On 21-JUL-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot H020901, expiration date 05-JUL-2015) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 75 year old male patient. On 19-AUG-2013, the patient was vaccinated with ZOSTAVAX (lot # J001005, expiration date 24-APR-2014, dose, frequency not provided), subcutaneous. On 11-NOV-2014, the patient was diagnosed with shingles by the patient's primary care physician. The patient saw primary care physician. The outcome of shingles was reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from nurse refers to unspecified number patiens of unknown age. On an unknown date the patients were vaccinated with GARDASIL (lot# was not reported). Nurse reported the vaccine administered were improperly stored. No adverse events were reported. This is one of the reports from the same reporter. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 11 years old child patient and unknown gender. On 30-SEP-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot H020901, expiration date 05-JUL-2015) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. 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: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (dose, lot #, route unknown). No concomitant medication was reported. On an unknown date one dose of improperly stored GARDASIL was inadvertently administered to patients. No adverse events were reported. Product quality issue was not involved. The outcome of events was unknown. This is one of several reports from the same reporter. Additional information has been requested.
Age: 47.0
Sex: F
Vaccine: HEP, TD
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Pain in extremity
Clinical narrative: On 9/22/14 client c/o right arm decreased ROM that developed shortly after receiving Hepatitis B vaccine on 6/24/14 and progressively worsened over 1 week after receiving vaccination and still continues to have decreased ROM when cleaning, taking off T shirt, etc. and intermittent pain after sleeping on right arm. Referred client on 9/22/14 to f/u with primary care provider for further evaluation and medical clearance for future vaccinations.
Age: 61.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 61 year old patient of unknown gender. On 12-NOV-2014 the patient was vaccinated with a dose of improperly stored ZOSTAVAX (dose, route were not reported, lot # K003597, expiration date 12-MAR-2015). No adverse effects were noted. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 60 year old patient of unknown gender. On 12-NOV-2014 the patient was vaccinated with a dose of improperly stored ZOSTAVAX (dose, route were not reported, lot # K003597, expiration date 12-MAR-2015). No adverse effects were noted. No PQC (product quality complaint) was involved. This is one of several received from the same reporter. Additional information has been requested.
Age: 0.93
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an 11 month old patient of unknown gender. On 12-NOV-2014 the 11 month old patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (dose, route were not reported, lot # reported as K007451, expiration date reported as 21-NOV-2015). No adverse effects were noted. 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: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified patients. On an unknown date the patients were vaccinated with PEDVAXHIB (dose, lot #, route unknown). No concomitant medication was reported. On an unknown date the patients were inadvertently vaccinated with 3 doses of improperly stored PEDVAXHIB. No adverse events were reported. Product quality complaint was not involved. The outcome of events was unknown. This is one of several reports from the same reporter. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event, Ultrasound antenatal screen normal
Clinical narrative: This spontaneous pregnancy report as received from a physician refers to an 18 year old female patient with no drug reactions/allergies. The patient's medical history included asthma. On 04-SEP-2012 the patient was vaccinated with a dose of VARIVAX (Merck) (lot# not reported) while she was pregnant. The fetal gestational age was 4 week (LMP:07-AUG-2012; due date: 14-MAY-2013) when VARIVAX (Merck) was administered. Gestation was 26 weeks 6 days. No adverse effect reported. The patient sought medical attention by office visit. No treatment was given for the AE. Level 1 fetal ultrasound showed normal growth. Follow up information has been received from a Licensed Practical Nurse. The reporter did not have much information report at this time. On 24-APR-2013, the patient had a live fetus, 37.1 gestation age at birth, 6 pounds 10 ounces. There was no notation of the baby's health at birth or if the patient had any complications during her pregnancy. The reporter also stated she was not showing any information that VARIVAX (Merck) was given during the patient's pregnancy. No further information is available at this time. Additional information has been requested. Patient, event and narrative were updated.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a other health professional refers to a 17 year old female patient. There was no pertinent medical history and drug reactions/allergies. On 08-SEP-2014 the patient was vaccinated with GARDASIL lot # J010668 dose 2, 0.5 ml  (route unknown). No concomitant medication was reported. It was reported that patient was 2 weeks pregnant when she received second dose of GARDASIL. The patient became pregnant with approximately LMP of 24-AUG-2014 and EDD was 31-MAY-2015. Initial exposure to GARDASIL was at 2 week(s). The pregnancy outcome was outcome pending. The healthcare worker did not know the date of first dose administration. The patient has had no complications in her pregnancy. No adverse effects were reported. The patient sought medical attention and contacted the physician by phone. No treatment was given for the events. No lab tests were performed. The outcome of events was unknown. Additional information has been requested.
Age: 1.34
Sex: M
Vaccine: TDAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Underdose, Wrong drug administered
Clinical narrative: This case was reported by a other health professional and described the occurrence of inappropriate age at vaccine administration in a 16-month-old male patient who received BOOSTRIX (batch number N2K27, expiry date 1st October 2015). On 24th September 2014, the patient received BOOSTRIX. On 24th September 2014, an unknown date after receiving BOOSTRIX, the patient experienced inappropriate age at vaccine administration, wrong vaccine administered and underdose. On an unknown date, the outcome of the inappropriate age at vaccine administration, wrong vaccine administered and underdose were unknown. It was unknown if the reporter considered the inappropriate age at vaccine administration, wrong vaccine administered and underdose to be related to BOOSTRIX. Additional information: BOOSTRIX vaccine was accidentally administered to two 16 month old twins. No adverse event reported.
Age: 1.0
Sex: M
Vaccine: TDAP
Symptoms: Drug administered to patient of inappropriate age, Underdose, Wrong drug administered
Clinical narrative: This case was reported by a other health professional and described the occurrence of inappropriate age at vaccine administration in a 12-month-old male patient who received BOOSTRIX (batch number 3HG7R, expiry date unknown). On an unknown date, the patient received BOOSTRIX. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced inappropriate age at vaccine administration, vaccine underdose and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration, vaccine underdose and wrong vaccine administered were unknown. It was unknown if the reporter considered the inappropriate age at vaccine administration, vaccine underdose and wrong vaccine administered to be related to BOOSTRIX. Additional information received on 26 September 2014: The BOOSTRIX dose was administered inadvertently.
Sex: U
Vaccine: DTAPIPV
Symptoms: Extra dose administered
Clinical narrative: This case was reported by an other Health Professional and described the occurrence of extra dose administered in a 5-year-old patient who received KINRIX. Concomitant products included KINRIX. On an unknown date, the patient received the 2nd dose of KINRIX. On an unknown date, an unknown time after receiving KINRIX and KINRIX, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown. It was unknown if the reporter considered the extra dose administered to be related to KINRIX. Additional information received on 29 September 2014: The patient was inadvertently administered KINRIX 4 days after a previous dose of KINRIX.
Age: 19.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: This case was reported by a other health professional and described the occurrence of underdose in a 19-year-old female patient who received HAVRIX pediatric (batch number N4341 ?, expiry date 19 February 2016). On an unknown date, the patient received HAVRIX pediatric .5 ml. On an unknown date, an unknown time after receiving HAVRIX pediatric, the patient experienced underdose. On an unknown date, the outcome of the underdose was unknown. It was unknown if the reporter considered the underdose to be related to HAVRIX pediatric. Additional informations: This 19 years old inadvertently given a pediatric dose of HAVRIX (720 EL.U).
Age: 14.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 14 years old adolescent patient and unknown gender. On 15-SEP-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot J015378, expiration date 09-APR-2016) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.