chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient was immunized with Fluzone HD (Lot# UI519AA, Exp 6/30/16) intramuscularly in his left arm on 11/28/15. Patient's wife reports to the pharmacy on 12/15/15 (17 days later) and states her husband is still experiencing soreness and limited range in mobility in his left arm. Patient received the immunization at around 5:10 P.M. and patient's wife states he did not experience any pain at the time of immunization. However, he began experiencing soreness the following evening on 11/29/15. She states there are no signs of redness or swelling, however he is unable to raise his left arm above his head and unable to move his arm too far backwards. She states he has not seen a doctor yet but plans to see his primary care physician soon.
Age: 56.0
Sex: F
Vaccine: PNC13
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient stated that her arm was very sore to the point where she was having a hard time lifting her arm.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Activities of daily living impaired, Diarrhoea, Erythema, Pain, Pruritus
Clinical narrative: Redness size of baseball, pain (8 on scale 0-10, with 10 most severe), itchy. Called Health Center and advised to give 2 Benadryl q4h until resolved.  Mom did so from 12/9 4 pm through 12/10 (2 pills q4h). Gave just a few doses (per mom) 12/11, and was completely resolved by 12/13.  Missed 2 days of school.  Vomit x2 8:30 pm on 12/7 (DOA) and diarrhea x1 after Benadryl on 12/10.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Vomiting
Clinical narrative: Redness size of baseball, pain (8 on scale 0-10, with 10 most severe), itchy. Called Health Center and advised to give 2 Benadryl q4h until resolved.  Mom did so from 12/9 4 pm through 12/10 (2 pills q4h). Gave just a few doses (per mom) 12/11, and was completely resolved by 12/13.  Missed 2 days of school.  Vomit x2 8:30 pm on 12/7 (DOA) and diarrhea x1 after Benadryl on 12/10.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Urticaria, Vaccination complication
Clinical narrative: Patient advised he woke up and had hives all over and itching. By Wednesday the hives had gone down, but the itching was still present. Went to Doctor on 12/16/2015 and was told he had a reaction to the vaccine and was given a steroid shot.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Dry eye, Eye pruritus, Pruritus
Clinical narrative: Pt states that his eyes begin itching and a few hours later his body was itching. He did not notice any rash or hives. He took a Claritin at 6pm and then Benadryl at 10pm. The next morning (12/15/15) he stated it took 50mg of Benadryl at 11am, 2pm and 6pm and took a Claritin sometime that morning. He felt like he was getting better. On 12/16/15 he did not take any medication. He did state his eyes were dry and he had to throw a contact away.
Age: 66.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: DEVELOPED A RED, WARM, HARD AREA AT INJECNTION SITE ON RIGHT ARM.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Hyperaesthesia, Myalgia
Clinical narrative: Patient stated he had severe muscular pain and sensitivity at left shoulder. Symptoms started 2 weeks after receiving flu shot on 9/30/2015.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient noticed redness, soreness at injection site about 7 days after injection. Has lasted for 4 days. Patient ask try oral BENADRYL and contact his primary dr. if no improvement or gets worse.
Age: 50.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Chest X-ray normal, Joint swelling, Pain in extremity, Peripheral swelling
Clinical narrative: Patient states the evening of vaccines she experienced pain in hands and feet. A day or 2 later noticed swelling in hands, feet and ankles. She saw MD 10 days after vaccines and was given prednisone. She says MD thinks it's a reaction to BOOSTRIX or to RITALIN, which she recently began taking. Also noticed increased use of inhaler but chest x-ray clean.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot # L012042, expiration date 18-NOV-2016; lot # L003227, expiration date 13-OCT-2016; prefilled syringe lot # L003189, expiration date 23-JUN-2016; dose and route unknown). No adverse events were reported. Additional information is not expected because there's no consent for follow up.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Injection site pain, Pain in extremity, Paraesthesia, Skin discolouration
Clinical narrative: Information has been received from healthcare worker referring to an 18 year old female patient with none drug reactions/allergies. The patient was vaccinated with her first dose, second dose and third dose of GARDASIL (third dose: lot # K010215, expire date: 05-MAY-2017, dose and route were unknown) on 04-JUN-2015, 06-AUG-2015 and 03-DEC-2015 (also reported as about a week and half ago), respectively. Concomitant therapy included Vitamin D (unspecified). On an unknown date in 2015 the patient developed discoloration and patient's arm and hand were turning purplish color. In December 2015 the patient developed pain at injection site right after administration of her third dose and pain radiated all the way down to her hand from injection site and she was also experiencing tingling and numbness in her arm and hand. The patient was prescribed NSAIDS and hydrocodone (manufacturer unspecified) but non relieved the pain. Patient also tried ice and immobilizing the arm but it did not help with pain either. On or around 09-DEC-2015, the patient went emergency room (ER) after pain became very severe but she was not admitted to hospital and was discharged on the same day. The outcome of the events was reported as not recovered/not resolved. The causality was not reported. 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 physician's assistant refers to a patient of unknown age and gender. On 09-SEP-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # L003855 exp date 05-FEB-2017) (dose and route not reported). The temperature excursion was 53.8 F for 10.75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports received from the same source. Additional information is not expected as all follow up information to complete the case was received.
Age: 3.0
Sex: F
Vaccine: FLUN4
Symptoms: Ear swelling, Erythema, Oropharyngeal pain, Urticaria
Clinical narrative: Hive like rash developed over night after vaccine administered. Pt. stated within 15 min of administering throat felt sore. Left ear red and swollen per grandmother (BENADRYL given).
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient had pain when she was getting the Flu shot and the pain never goes away. She can hardly move her arm.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: Pt is having muscle pain (L) arm.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: (R) upper arm severe pain/induration and erythema. Restricted ROM.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician's assistant refers to a patient of unknown age and gender. On 08-SEP-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # L003855 exp date 05-FEB-2017) (dose and route not reported). The temperature excursion was 53.8 F for 10.75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports received from the same source. Additional information is not expected as all follow up information to complete the case was received.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician's assistant refers to a patient of unknown age and gender. On 04-SEP-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # L003855 exp date 05-FEB-2017) (dose and route not reported). The temperature excursion was 53.8 F for 10.75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports received from the same source. Additional information is not expected as all follow up information to complete the case was received.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician's assistant refers to a patient of unknown age and gender. On 02-SEP-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # L003855 exp date 05-FEB-2017) (dose and route not reported). The temperature excursion was 53.8 F for 10.75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports received from the same source. Additional information is not expected as all follow up information to complete the case was received.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician's assistant refers to a patient of unknown age and gender. On 28-AUG-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # L003855 exp date 05-FEB-2017) (dose and route not reported). The temperature excursion was 53.8 F for 10.75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports received from the same source. Additional information is not expected as all follow up information to complete the case was received.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician's assistant refers to a patient of unknown age and gender. On 27-AUG-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # L003855 exp date 05-FEB-2017) (dose and route not reported). The temperature excursion was 53.8 F for 10.75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports received from the same source. Additional information is not expected as all follow up information to complete the case was received.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV4, MNQ, TDAP
Symptoms: Pain, Pyrexia
Clinical narrative: Fever, no itching of the site, pain with lifting, no trouble breathing, wheezing or throat tightness.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 55 year old male patient, without pertinent medical history, drug reactions or allergies. On 03-DEC-2015, the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous, (Lot # L029482, expiration date 06-NOV-2016), (dose number, site of vaccination and concentration were not provided). Concomitant therapies were not reported. On 05-DEC-2015, developed "what looks like chickenpox on his chest torso area". The reporter stated that the patient was unsure if he ever had chickenpox prior to receiving the vaccine. At the time of the report , the outcome of the varicella was reported as not recovered. The patient would seek for medical attention on 08-DEC-2015 regarding the rash vesicular. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Vaccination site pain
Clinical narrative: This spontaneous report was received from a female patient of unknown age reporting on herself. The concurrent conditions and medical history were not provided. On 08-DEC-2015 the patient was vaccinated with ZOSTAVAX (route, dose and indication were not provided). Concomitant therapies were not provided. On 09-DEC-2015, the patient experienced pain around the vaccine area and redness. The outcome of vaccination site pain and erythema was unknown. Additional information is not expected because the caller refused to provide any information.
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction, Syncope
Clinical narrative: This spontaneous report was received from a pharmacist via Pfizer referring to a patient of unknown age and gender. No concurrent or historical conditions were reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (lot number and expiration date were not provided) dose, route and anatomical location were not provided. No concomitant medications were reported. On an unknown date, the patient experienced a severe reaction to PNEUMOVAX 23; a severe injection site reaction and syncope and fainting. At the time of the report, the outcome of injection site reaction, syncope and fainting was unknown. The reporter considered injection site reaction and syncope and fainting were related to PNEUMOVAX 23. Additional information is not expected because there are no request letters.
Age: 23.0
Sex: F
Vaccine: MEN
Symptoms: Urticaria, Wheezing
Clinical narrative: Initial unsolicited report received from a healthcare professional on 14 January 2015. A 23-year-old female patient, whose concomitant medication were not reported, had received subcutaneously a dose of MENOMUNE, (batch number: UE123AA), (dose of vaccine was not reported) in left arm on 26-Jul-2004. On 26-Jul-2004, patient experienced wheezing and hives. Illness at time of vaccination was reported as none. Pre-existing physician diagnosed allergies were reported as latex allergy sulfa drugs and fish allergies. Corrective treatment and laboratory investigations. were not reported. At the time of this report, the outcome of the patient was reported as recovered. Documents held by sender: none. Follow-up information received from a healthcare professional on 03 April 2015: The patient had received 0.5 ml first dose of MENOMUNE. Follow-up information received from a healthcare professional on 6 April 2015. No new information reported.
Age: 62.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Tendonitis, Tenosynovitis
Clinical narrative: Deep pain in left shoulder/upper arm; loss of mobility. Two rounds of Prednisone in 10/2014 and Tramadol. Cortisone shots in shoulder 10/29/14 and 9/25/15. Physical therapy started 10/6/15.
Age: 62.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site pain, Mobility decreased, Nuclear magnetic resonance imaging
Clinical narrative: Deep pain in left shoulder/upper arm; loss of mobility. Two rounds of Prednisone in 10/2014 and Tramadol. Cortisone shots in shoulder 10/29/14 and 9/25/15. Physical therapy started 10/6/15.
Sex: F
Vaccine: FLUN3, HPV9, FLUN4, HPV4, FLUN3, HPV9
Symptoms: Activities of daily living impaired, Adverse event, Death
Clinical narrative: A report has been received from a physician via Merck medical representative, concerning a female patient. Relevant medical history, concurrent diseases and concomitant medications were not reported. On unspecified date, the patient received FLUMIST (intranasal). Another vaccine was given on same day, quadrivalent HPV. It was unknown if the quadrivalent HPV injection was the first, second, or third in a series of three injections. The patient went back to the doctor's office the same day she received the injection for an unspecified reason. The next day, the patient did not participate in gym class at school for an unspecified reason and died at an unknown time. Cause of death was unspecified. It was unknown whether autopsy was performed. The reporter assessed the case as serious with death criterion.
Sex: F
Vaccine: FLUN3, HPV9, FLUN4, HPV4, FLUN3, HPV9
Symptoms: Activities of daily living impaired, Death
Clinical narrative: A report has been received from a physician via Merck medical representative, concerning a female patient. Relevant medical history, concurrent diseases and concomitant medications were not reported. On unspecified date, the patient received FLUMIST (intranasal). Another vaccine was given on same day, quadrivalent HPV. It was unknown if the quadrivalent HPV injection was the first, second, or third in a series of three injections. The patient went back to the doctor's office the same day she received the injection for an unspecified reason. The next day, the patient did not participate in gym class at school for an unspecified reason and died at an unknown time. Cause of death was unspecified. It was unknown whether autopsy was performed. The reporter assessed the case as serious with death criterion.
Sex: F
Vaccine: FLUN3, HPV9, FLUN4, HPV4, FLUN3, HPV9
Symptoms: Death
Clinical narrative: A report has been received from a physician via Merck medical representative, concerning a female patient. Relevant medical history, concurrent diseases and concomitant medications were not reported. On unspecified date, the patient received FLUMIST (intranasal). Another vaccine was given on same day, quadrivalent HPV. It was unknown if the quadrivalent HPV injection was the first, second, or third in a series of three injections. The patient went back to the doctor's office the same day she received the injection for an unspecified reason. The next day, the patient did not participate in gym class at school for an unspecified reason and died at an unknown time. Cause of death was unspecified. It was unknown whether autopsy was performed. The reporter assessed the case as serious with death criterion.
Age: 0.34
Sex: F
Vaccine: RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Haematochezia, Mucous stools
Clinical narrative: Mucus in stool, increased vomiting, and fussiness.
Age: 0.34
Sex: F
Vaccine: RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Irritability, Mucous stools, Vomiting
Clinical narrative: Mucus in stool, increased vomiting, and fussiness.
Age: 44.0
Sex: M
Vaccine: ANTH
Symptoms: Influenza like illness, Injection site swelling, Pruritus
Clinical narrative: Pruritus, R shoulder swelling, flu-like symptoms.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Pt requested FLUZONE HD and PNEUMOVAX 23 vaccines in same arm on 12/14/15. The vaccines were administered approximately 1 inch apart in left deltoid. Pt complained on 12/16/15 warm area and puffy red area. She went to PCP on 12/16/15 MD thinks maybe area of cellulitis treating w/penicillin.
Sex: U
Vaccine: HPV9, MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 09-NOV-2015, the patient was either vaccinated with improperly stored M-M-R II (lot # L009214, expiry date 17-MAR-2017) or GARDASIL 9 (lot no# L013429, expiry date: 21-JUL-2017) (incorrect product storage). Concomitant medication of the patient was unknown. No other adverse effects were reported. The outcome of the incorrect product storage was unknown. No product quality complaint was reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9, MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 09-NOV-2015, the patient was either vaccinated with improperly stored M-M-R II (lot # L009214, expiry date 17-MAR-2017) or  GARDASIL 9  (Lot no # L013429, expiry date: 21-JUL-2017) (incorrect product storage). Concomitant medication of the patient was unknown. No other adverse effects were reported. The outcome of the incorrect product storage was unknown. No product quality complaint was reported. The is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9, MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 09-NOV-2015, the patient was either vaccinated with improperly stored MMR II (lot# L009214, expiry date 17-MAR-2017) or GARDASIL 9 (Lot no # L013429, expiry date: 21-JUL-2017). Concomitant medication of the patient was unknown. No other adverse effects were reported. The outcome of the incorrect product storage was unknown. No product quality complaint was reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Injection site discomfort, Injection site pain
Clinical narrative: This spontaneous report as received from a physician refers to 4 unspecified patients of unknown age and gender. No information about medical history, concurrent conditions and concomitant medication was reported. The physician reported that four unspecified patients, who had previously received doses of GARDASIL (dose, route, lot # and expiry date were not specified) on an unspecified dates, experienced severe pain at the injection site after receiving GARDASIL 9 intramuscularly (dose, lot # and expiry date were not provided), on an unspecified dates. It was stated that duration of injection site pain and discomfort lasted ten days to two weeks, after receiving GARDASIL 9. The patients had no other symptoms and on examination, they had normal strength and perfusion, with tenderness over the injection site. The patient s were treated with rest, cool compress, ibuprofen and they were instructed to follow-up, if the experienced any swelling and inflammation. The outcome of the events and causality assessment were not provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous case report was received from a certified medical assistant regarding 2 unspecified patients of unknown age and unknown gender. On an unknown date, the patient was vaccinated with improperly stored GARDASIL (lot number # K010215 and expiry date 05-MAY-2017). No adverse effects were reported. No product quality complaint was reported. This is one of the two cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No information on patients' medical history or concurrent conditions was provided. On an unspecified dates since 30-NOV-2015, doses of GARDASIL 9 (lot # L019286, expiration date 14-SEP-2015) (dose and route were not provided) which were exposed to temperatures outside the recommended range, were administered to unspecified patients. No adverse experience was reported. This is one of the several reports from the same reporter source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous case report was received from a certified medical assistant regarding a 28 unspecified patients of unknown age and unknown gender. No medical history and concurrent conditions were reported. on an unknown date, the patients were vaccinated with improperly stored oral ROTATEQ (lot number # L013192 and expiry date: 19-JAN-2017). No adverse effect was reported. No product quality complaint (PQC) was reported. This is one of the two cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No information on patient's medical history or concurrent conditions was provided. On an unspecified dates since 30-NOV-2015, doses ROTATEQ (lot # L002042, expiration date 28-JUL-2016) (dose was not provided) which were exposed to temperatures outside the recommended rage, were orally administered to unspecified patients. No adverse experience was reported. This is the one of the several reports from the same reporter source. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a nurse refers to a 59 year old female patient. No medical history or drug allergies were reported. No concurrent medications were reported. In November 2015 (reported as either on 16-NOV-2015 or 17-NOV-2015), the patient was vaccinated with ZOSTAVAX (Lot # and expiration date were not provided)(0.65 ml) intramuscularly instead of subcutaneously, in November 2015, after vaccine administration the patient experienced soreness around injection site. There was no treatment given for soreness around injection site. The patient did not seek medical attention. The outcome of injection site pain was unknown. The relatedness between injection site pain and ZOSTAVAX was not reported. Product quality complaint was not involved. 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 an unspecified number of patients of unknown age and gender. No information on patients' medical history or concurrent condition was provided. From 02-DEC-2015 to the time of this report, unspecified number of improperly stored doses of RECOMBIVAX HB (route, dose, lot # and expiration date were not provided) were administered to unspecified number of patients. No adverse effects were reported. This is the one of the several reports from the same reporter source. Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia
Clinical narrative: This spontaneous report was received from an 84-year old female patient reporting on herself. The patient's concurrent condition included high blood pressure. No drug reactions or allergies were reported. Concomitant therapies included DIOVAN. On 15-JAN-2011, the patient was vaccinated with ZOSTAVAX in the right arm (strength, dose, route of administration, lot# and expiry date were not reported). On 24-JUL-2015, the patient was diagnosed with shingles. At the time of the report, patient was still experiencing nerve pain in back, right breast area and in her arm from elbow to shoulders. The patient received treatment with gabapentin. The patient's initial reason for the call was to obtain reimbursement for her cost. The outcome of herpes zoster was reported as not recovered at the time of the report. The causality assessment between adverse event and suspect therapy was not provided. 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 an unspecified number of patients of unknown age and gender. No information on patients' medical history or concurrent condition was provided. From 02-DEC-2015 to the time of this report, unspecified number of improperly stored doses of VAQTA (route, dose lot # and expiration date were not provided) were administered to unspecified number of patients. No adverse effects were reported. This is the one of the several reports from the same reporter source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report has been received from a healthcare professional concerning an unspecified number of patients of unknown age and gender. Since January 2015, the unspecified number of patients was vaccinated with doses of GARDASIL 9 (Lot number: L000610, expiration date: 31-JAN-2017 and Lot number: L011846, expiration date: 16-JUN-2017) (dosage schedules were not reported) which underwent temperature excursions. This report is one of the reports from the same reporter. Follow up information has been received from a Medical Assistant (M.A) during a phone call on 25-NOV-2015. She stated that information on patients was not available over the phone and asked to send her a written request. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 61 year old male patient who was a physician. He did not have any pertinent medical history, drug reactions or allergies. On approximately 11-NOV-2015 (reported as "one month ago"), the patient was vaccinated with one dose of ZOSTAVAX lot # L017165 (dose, route of administration and expiration date were not reported). The patient did not take any concomitant medications. On 11-DEC-2015 (also reported as "approximately one month after ZOSTAVAX administration"), the patient experienced right sided abdominal pain. The patient sought medical attention. He was seen in the emergency room (ER) on 11-DEC-2015 and had an unspecified lab test performed (results not provided). The outcome of right sided abdominal pain was not reported. The relatedness between the event and ZOSTAVAX was not provided. Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from healthcare worker regarding an 8 year old female patient. No historical or concurrent conditions were reported. On 29-OCT-2015, before her ninth birthday, the patient was vaccinated with her first dose of GARDASIL lot # K010215 (expiry date: May 2017). The patient did not experience any adverse effects. No Product Quality Complaint (PQC) was reported. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a currently 64 year old female patient referring to herself. No pertinent or historical conditions were reported. On an unknown date in 2009 (reported as when the patient was 58 year old), the patient was vaccinated with ZOSTAVAX (strength, dose and route unknown), she was given the vaccine before it was indicated for people less than 60 years of age (Inappropriate Schedule of Drug Administration). There was no concomitant medication reported. No adverse event was reported. Additional information is not expected.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site inflammation, Injection site swelling, Injection site warmth
Clinical narrative: Pt received PNEUMOVAX vaccine on 9/4/24, after which he developed LUE swelling, redness, inflammation at injection site and reaching to elbow area. Pt presented for urgent care visit, was treated for cellulitis with cephalexin 500mg QID x 10 days. Subjective fever at injection site.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (medical assistant) refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 11-DEC-2015, the patient was vaccinated with an expired dose of ZOSTAVAX vial, lot# K01096, expiry date 06-NOV-2015, 0.65 milliliter, subcutaneously. No adverse effects were reported. No product quality complaint (PQC) was involved. No further information was provided. 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 an unspecified number of patients of unknown age and gender. No information on patients' medical history or concurrent condition was provided. From 02-DEC-2015 to the time of this report, unspecified number of improperly stored doses of GARDASIL 9 (route, lot # and expiration date were not provided) were administered to unspecified number of patients. No adverse effects were reported. This is the one of the several reports from the same reporter source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On unspecified dates on or after 23-NOV-2015, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (lot # L026410, expiration date 15-FEB-2017, strength, dose, dose# and route unknown). No adverse effects was reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, Measles antibody negative
Clinical narrative: This spontaneous report as received from a physician assistant refers to a currently 34 year old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. The patient had no known drug allergies or reactions. On an unknown date (reported as "when she was younger"), the patient was vaccinated with her first dose of MMR II, human serum albumin (HSA) (strength, dose, route of administration, lot # and expiration date were not reported). In June 1999, the patient was vaccinated with her second dose of MMR II (strength, dose, route of administration, lot # and expiration date were not reported) as routine vaccination. On an unknown date (reported as "a couple months ago"), the patient had "titers drawn" with a result "low for measles". The patient sought medical attention and was seen at unspecified facility. The outcome of the event was unknown. The relatedness between the adverse event and MMR II was not reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with doses of improperly stored VAQTA lot # L018499, expiration date 25-FEB-2017, (dose, dose #, route and application site were not reported). No symptoms reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No information on patient's medical history or concurrent condition was provided. From 02-DEC-2015 to the time of this report, unspecified number of improperly stored doses of ROTATEQ (dose, lot # and expiration date were not provided) were orally administered to unspecified number of patients. No adverse  effects were reported. This is one of the several reports from the same reporter source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with doses of improperly stored RECOMBIVAX HB lot # L010595, expiration date 12-NOV-2016 (dose, dose #, route and application site were not reported). No symptoms reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.4
Sex: M
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an approximately 18 week old male infant. The patient's concurrent condition and medical history were not reported. On 22-OCT-2015 the patient was vaccinated with the first dose of ROTATEQ (Lot# L004453; Expiry date: 27-MAY-2016) orally when he was 17-18 weeks old. This was outside the label recommendations in the prescribing information. This was the only dose of ROTATEQ that the patient received. No adverse reactions were reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Diarrhoea, Fatigue, Headache, Memory impairment
Clinical narrative: Information has been received from a consumer referring to her daughter, a female teenager of unknown age. There was no medical history or concurrent condition reported. On 16-OCT-2014 the patient was vaccinated with the first dose of GARDASIL (dose, lot# and route were unknown). After administration, on an unknown date in 2014, the patient experienced multiple adverse events including headache, fatigue, muscle aches and pains, extreme changes in her vision, stomach pains, memory and speech problems, fevers, vomiting and diarrhea. The headaches and muscle pain were constant and other events developed "about every two months". On 05-JAN-2015, the patient was administered the second dose of the vaccine, after which the adverse experiences increased in frequency, occurring every month. Then the patient was administered her third dose of the vaccine on 10-SEP-2015 and was now sick all of the time. The reporter gave permission to contact her by phone. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Myalgia, Pyrexia, Speech disorder, Visual impairment, Vomiting
Clinical narrative: Information has been received from a consumer referring to her daughter, a female teenager of unknown age. There was no medical history or concurrent condition reported. On 16-OCT-2014 the patient was vaccinated with the first dose of GARDASIL (dose, lot# and route were unknown). After administration, on an unknown date in 2014, the patient experienced multiple adverse events including headache, fatigue, muscle aches and pains, extreme changes in her vision, stomach pains, memory and speech problems, fevers, vomiting and diarrhea. The headaches and muscle pain were constant and other events developed "about every two months". On 05-JAN-2015, the patient was administered the second dose of the vaccine, after which the adverse experiences increased in frequency, occurring every month. Then the patient was administered her third dose of the vaccine on 10-SEP-2015 and was now sick all of the time. The reporter gave permission to contact her by phone. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to unspecified number of patients of unknown age and gender. The patient's concurrent condition and medical history were not reported. Since 01-DEC-2015 the patients were vaccinated with (Oka/Merck) VARIVAX [lot # K011188, Expiry date: 12-AUG-2016] which were exposed to temperatures outside of the recommended age. No product quality has been filed. No adverse events were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Redness at the site of the vaccination.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Redness, itching and rash at injection site at distal left forearm. No pain, no fever, no streaks and no swelling. Seen ED 12/16/15 and treated with Benadryl.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis
Clinical narrative: Cellulitis in vaccinated arm.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to unspecified numbers of patients with unknown age and gender. There was no information about the patients' medical history and concurrent condition. On unknown dates, the patients were vaccinated with improperly stored ROTATEQ (dose, lot# unknown) orally. There was no information about concomitant therapy. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 41.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Pain, Pyrexia
Clinical narrative: This spontaneous report was received from a physician assistant refers to a 41 year old male patient with asthma. On 13-NOV-2015, the patient was vaccinated with PNEUMOVAX 23 lot # L027732. On 14-NOV-2015, the patient had a fever of 102F, was achy with the injection site unspecified deltoid swollen and tender from deltoid to elbow. The reporter stated that on 15-NOV-2015, the patient went to the local unspecified emergency room for the events and was prescribed unspecified steroids, unspecified anti-inflammatory medication, and unspecified antihistamine. The reporter stated on 17-NOV-2015 she ordered the patient AUGMENTIN (manufacturer unspecified) for an unspecified reason. The outcome of the events were reported as recovered/resolved. The patient sought medical attention. This is one of two reports from the same reporter. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling cold, Inflammation, Injection site erythema, Pain
Clinical narrative: Information has been received from a registered nurse via a company representative referring to a 67 year old female patient. The patient had no drug reactions/allergies. On 20-NOV-2015 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # L011531 with expired date 07-JAN-2017, dose and route were unknown). No concomitant medication was reported. On the same date, the patient experienced chills, possibly a fever, soreness, inflammation, and red "wales" that localized at the injection site and then streaked down the patient's arm. The patient emailed a physician's office for medical attention. No treatment was given and no lab test was performed. The events lasted 3 days and the patient was fully recovered on 23-NOV-2015. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: Information has been received from a pharmacist referring to a 63 year old female patient with no pertinent medical history or drug allergies/reactions. On 10-DEC-2015 the patient was vaccinated with ZOSTAVAX (lot # L028285, expiration date 28-OCT-2016, 0.65 ml/once, subcutaneous) to prevent shingles. On unknown dates in December 2015 the patient developed itching, redness, soreness and a "hard bump or hard area" at the injection. The patient called in to the pharmacy on 12-DEC-2015 to seek medical attention. No lab diagnostic studies were performed and no treatment was given for the events. The outcome of the events and causality assessment were not reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 03-NOV_2015, the patient was vaccinated with a dose of improperly stored PROQUAD lot # L011080, expiry date 01-OCT-2016, (dose, strength, route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Influenza like illness, Oral herpes, Pain, Rash macular
Clinical narrative: This spontaneous report was received from a female patient of unknown age reporting on herself. Concomitant medications included acyclovir. The patient's medical history included shingles before receiving ZOSTAVAX. On an unknown date, the patient was vaccinated with ZOSTAVAX (dosage schedule, lot# and expiration date were not provided). On an unknown date, the patient experienced flu like feeling, joint pain, feeling aching, blotchy skin and a cold sore from her lip to her nose. The outcome of patients events was not reported. The relatedness between the events and ZOSTAVAX was not provided. Additional information is not expected as there is no contact information available.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with doses of improperly stored ROTATEQ lot # L008053, expiration date 30-NOV-2016, orally (dose and dose # were not reported). No symptoms 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: Information has been received from a licensed practical nurse referring to an unspecified patient of unknown age and gender. Concurrent condition and medical history were not reported. On an unknown date the patient was vaccinated with improperly stored GARDASIL 9 (lot# was reported as L014239, expiration date 21-JUL-2017, dose and route were unknown). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to unspecified numbers of patients with unknown age and gender. There was no information about the patients' medical history and concurrent condition. On unknown dates, the patients were vaccinated with improperly stored RECOMBIVAX HB (dose, lot#, therapy type and route unknown). There was no information about concomitant therapy. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to unspecified number of patients of unknown age and gender. The patent's concurrent condition and medical history were not reported. Since 01-DEC-2015 the patients were vaccinated with PROQUAD (Merck) [lot # L027634, Expiry date: 21-JAN-2017] which were exposed to temperatures outside of the recommended range. No product quality complaint has been filed. No adverse events were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to unspecified numbers of patients with unknown age and gender. There was no information about the patients' medical history and concurrent condition. On unknown dates, the patients were vaccinated with improperly stored VAQTA (dose, lot# and route unknown). There was no information about concomitant therapy. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.