chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Musculoskeletal pain, Pyrexia, Sleep disorder
Clinical narrative: "My shoulder was a little sore when I went to bed. I woke up in the middle of the night with intense pain in the shoulder - I couldn't sleep on that side. I also had chills. My teeth were chattering, and I felt feverish, but my temp was normal. I took acetaminophen. The pain subsided enough so I could get back to sleep, and the chills stopped. When I woke up this morning, I had some pain in my shoulder, but no other symptoms. I took another dose of acetaminophen, which is controlling the shoulder pain. The pain seems to be subsiding, so I'm thinking I probably won't need any more analgesics."
Age: 17.0
Sex: M
Vaccine: HPV9, VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: Swelling redness and spreading redness. Steroid given in clinic. Advised OTC BENADRYL and PEPCID at home. If not improved advised to come back to clinic.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a Registered Nurse and refers to a patient of unknown age and gender. Medical history and concomitant medications were not provided. On 02-FEB-2015, the patient was due for a booster for VARIVAX but was given ZOSTAVAX (lot # K009198) instead. No adverse effects were reported. Additional information has been requested.
Age: 84.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received on 14-JUL-2017 from a pharmacist regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date the patient administered one dose of improperly stored ZOSTAVAX lot # N013289, expiration 04-JUL-2018, 1 DF, subcutaneous for prophylaxis that was reconstituted with one dose of sterile diluent (STERILE DILUENT) lot # L035498 expiration 01-MAY-2018. No adverse effects reported. The vaccine and sterile diluent were stored at a temperature range of 15 degrees Fahrenheit to 46 degrees Fahrenheit for the time frame of 24 hours. There was no previous temperature excursion. The call was not because of a data logger. No additional information provided. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report has been received from a midwife referring to a 20 year old female patient. Information about concurrent condition, concomitant medication and medical history was not provided. On 20-FEB-2015, the patient was vaccinated the 1st dose of GARDASIL lot# K009482 with expiration date 06-MAR-2017, (strength, dose and route were not reported) for prophylaxis. On 21-APR-2015, the patient was vaccinated the 2nd dose of GARDASIL, lot # K008931 with expiration date 04-MAR-2017, (strength, dose and route were not reported) for prophylaxis. On 18-JUL-2017, the patient was in the office in order to receive the 3rd dose of series and would be receiving GARDASIL 9 as the 3rd dose (interchange of vaccine products and inappropriate schedule of drug administration); this was outside the recommendations per the GARDASIL prescribing information. No adverse events reported.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse (LPN) and refers to a 4-year-old patient of unknown gender. No information regarding the patient's pertinent medical history and drug reactions or allergies was provided. On 26-JUL-2017, the patient was vaccinated with improperly stored dose of PROQUAD injection (lot # M044718, expiration date: 07-MAY-2018; dose and route of administration were not reported). The dose of the vaccine was reconstituted with properly stored sterile diluent (MERCK) injection. The reporter stated that the administered dose of PROQUAD was stored at temperature between 15 to 46 degrees Fahrenheit (17.8 degrees Fahrenheit) for 2 hours. Data logger was used to detect temperature excursions. There were no previous temperature excursions reported. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 31-JUL-2017, the patient was vaccinated with VARIVAX from lot # L028277 that had expired on 28-JUL-2017 (expired product administered) for prophylaxis (dose, and route unknown). The vaccine was reconstituted with a sterile water diluent (MSD) (Lot # and expiry date unknown) and it was verified to be not expired. No adverse effects were reported. Product quality complaint was not involved.
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain, Nervousness
Clinical narrative: This spontaneous report as received from a other health professional refers to a 15 year old female patient. On 31-JUL-2017 the patient was vaccinated with GARDASIL 9, intramuscular for prophylaxis. On 2017 the patient experienced injection site pain and nervousness. The outcome of nervousness and injection site pain is unknown. {Additional information has been requested. Additional information is not expected.}
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Incorrect route of drug administration, Injection site mass
Clinical narrative: This spontaneous report as received from a other health professional refers to a 24 year old female patient. On 18-JUL-2017 the patient was vaccinated with GARDASIL 9 lot # M016193, subcutaneous in the left deltoid for prophylaxis. On JUL-2017 the patient experienced injection site mass. On 18-JUL-2017 the patient experienced incorrect route of drug administration. The outcome of injection site mass was reported as recovered/resolved. The outcome of incorrect route of drug administration is unknown. The reporter considered incorrect route of drug administration to be not related to GARDASIL 9. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an other health professional refers to a patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL lot # K023432 for prophylaxis. No adverse effects were reported. Data logger was involved. This is one of several reports received from the same reporter. Additional information is not expected. Sender's Comments: US-009507513-1708USA002370: US-009507513-1708USA002371: US-009507513-1708USA002372: US-009507513-1708USA002373: US-009507513-1708USA000870.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L000610 and M041990 for prophylaxis. No adverse effects were reported. Data logger was involved. This is one of several reports received from the same reporter. Additional information is not expected. Sender's Comments: US-009507513-1708USA002369: US-009507513-1708USA002371: US-009507513-1708USA002372: US-009507513-1708USA002373: US-009507513-1708USA000870.
Sex: U
Vaccine: HEPA, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assisstant refers to a patient of unknown age.    On an unknown date the patient was vaccinated with VAQTA lot # M039202 with expiration date 11-MAR-2018, for prophylaxis. Other suspect therapies included VARIVAX lot # M043582 with expiration date 28-OCT-2018, for prophylaxis. Concomitant therapies included sterile diluent (STERILE DILUENT).  On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage to be not related to VAQTA and VARIVAX. The reporter considered no adverse event to be not related to VARIVAX and VAQTA.
Sex: F
Vaccine: TDAP
Symptoms: Injection site abscess, Injection site warmth, Skin warm
Clinical narrative: Initial unsolicited report received from a nurse (patient) on 26-Jul-2017. This case involves a female patient (age at time of the reaction was not reported) who was vaccinated with an injection of ADACEL (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient had a pretty severe reaction, abscess Developed at site of injection and whole arm got hot. Laboratory investigations and corrective treatment were not reported. The outcome of all the events was reported as unknown. List of documents held by sender: none.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Arthralgia, Injection site irritation, Injection site swelling, Migraine
Clinical narrative: Patient experienced fever, joint pain, gastrointestinal upset, headache (migraine), irritation and swelling of left arm from elbow to shoulder.  She did not specify if she took any medications to help.  After about 2 or 3 days the symptoms started to resolve.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient experienced fever, joint pain, gastrointestinal upset, headache (migraine), irritation and swelling of left arm from elbow to shoulder.  She did not specify if she took any medications to help.  After about 2 or 3 days the symptoms started to resolve.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Large red swelling - hot to touch - last measured at 8cm by 11cm.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dyskinesia, Eye movement disorder, Headache, Lethargy, Muscle rigidity
Clinical narrative: 1445 Post immunizations, patient complained of a headache and was sitting in the waiting room. His mother called to the nurse and I that he is having a seizure. On assessment patient was arching his back in the chair, eyes rolling to the back of the head and was rigidly involuntarily moving arms and legs. His head was supported by his father. EMT called by father. This lasted no greater than 45 sec. Soon patient relaxed and was lethargic and drifting in and out of sleep. Able to speak and state name. Denies chest pain, SOB, headache. Pupils equal and reactive to light. VS done, BP 68/46 Patient lifted and carried to exam table to lay down. HR 77, Temp 97.4 tempanic, O2 sat 99%, BP rechecked 94/68, HR 87, O2sat 98%. Neuro exam done, patient mildly lethargic, Oriented x3, PERRLA, CN II-XII intact, equal hand grasps and equal strong toe bends. 1455 EMT by bedside BS done 125. Neuro exam done by EMT WNL. Patient denies pain, chest pain, or SOB. Parents asked if they would like to go by ambulance to the ER. Patients parents refused and states they will call his pediatrician to see if he would like to see him vs driving to the ER.  1510 Discussed care with Dr the patients pediatrician. He states that this appears to be a adverse reaction to the TDAP vaccine and to report the findings to CDC. When asked where the patient should get evaluated. He states, "watch him for 2 hours, give him water and crackers, and send him home. But I am not responsible and you should call your collaborative MD." 1520 Dr called no answer and left a message. 1530 Reassessed patient, alert and oriented x3, VS stable. Neuro exam normal. Patient denied headache, chest pain, shortness of breath, throat discomfort, weakness, or paralysis. He remembers feeling the headache then the next thing he remembers is being lifted to the exam room. 1542 Dr, the Medical Director called and suggested we send patient to the ER for evaluation and seizure workup. Agreed with plan and discussed with parents. Parents agree and will be evaluated at parents preference ER. Advised parents to let him lay down in the car for the trip to avoid hypotension, monitor him closely and if seizure reoccurs call 911. They are asked to followup here Monday for recheck.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Opisthotonus, Seizure, Somnolence
Clinical narrative: 1445 Post immunizations, patient complained of a headache and was sitting in the waiting room. His mother called to the nurse and I that he is having a seizure. On assessment patient was arching his back in the chair, eyes rolling to the back of the head and was rigidly involuntarily moving arms and legs. His head was supported by his father. EMT called by father. This lasted no greater than 45 sec. Soon patient relaxed and was lethargic and drifting in and out of sleep. Able to speak and state name. Denies chest pain, SOB, headache. Pupils equal and reactive to light. VS done, BP 68/46 Patient lifted and carried to exam table to lay down. HR 77, Temp 97.4 tempanic, O2 sat 99%, BP rechecked 94/68, HR 87, O2sat 98%. Neuro exam done, patient mildly lethargic, Oriented x3, PERRLA, CN II-XII intact, equal hand grasps and equal strong toe bends. 1455 EMT by bedside BS done 125. Neuro exam done by EMT WNL. Patient denies pain, chest pain, or SOB. Parents asked if they would like to go by ambulance to the ER. Patients parents refused and states they will call his pediatrician to see if he would like to see him vs driving to the ER.  1510 Discussed care with Dr the patients pediatrician. He states that this appears to be a adverse reaction to the TDAP vaccine and to report the findings to CDC. When asked where the patient should get evaluated. He states, "watch him for 2 hours, give him water and crackers, and send him home. But I am not responsible and you should call your collaborative MD." 1520 Dr called no answer and left a message. 1530 Reassessed patient, alert and oriented x3, VS stable. Neuro exam normal. Patient denied headache, chest pain, shortness of breath, throat discomfort, weakness, or paralysis. He remembers feeling the headache then the next thing he remembers is being lifted to the exam room. 1542 Dr, the Medical Director called and suggested we send patient to the ER for evaluation and seizure workup. Agreed with plan and discussed with parents. Parents agree and will be evaluated at parents preference ER. Advised parents to let him lay down in the car for the trip to avoid hypotension, monitor him closely and if seizure reoccurs call 911. They are asked to followup here Monday for recheck.
Age: 77.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Inflammation
Clinical narrative: Left arm auxillary become red and inflamed the day after being injected with Pneumovax 23.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Fall, Loss of consciousness, Muscular weakness
Clinical narrative: About 5 minuest after vaccine given, pt went out to meet parent in waiting room. She did not sit again at this time, as parent got up to leave with her. As they were leaving, pt reported to mom that she felt lightheaded and her legs felt a little weak, they kept walking and got into an elevator where the patient passed out/fell to the floor. She came to in less than a minute and felt completely fine in less than 5 minutes. As she was still in the clinic, she was brought to a room via wheelchair where vitals were taken and were normal. Pt and parent walked out of clinic approx 10 minutes after the event, she reported feeling completely normal.
Age: 27.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Axillary pain, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient had large red swollen areas at each injection site (approximately 1.5-2.5 inches in diameter).  Area was raised and warm to touch. Also sore to palpation. Complaint of soreness extending down into axillary region upon all ranges of movement. Patient was advised to apply cold compresses to the area, take diphenhydramine by mouth every 6 hours for the reaction and otc analgesics for the pain. Also, advised patient to follow up with her medical doctor immediately if anything became worse.  Patient stopped by pharmacy 2 days after administration and stated it was looking and feeling a small amount better. Advised patient to continue to monitor and to follow the aforementioned advice.
Age: 27.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Pain
Clinical narrative: Patient had large red swollen areas at each injection site (approximately 1.5-2.5 inches in diameter).  Area was raised and warm to touch. Also sore to palpation. Complaint of soreness extending down into axillary region upon all ranges of movement. Patient was advised to apply cold compresses to the area, take diphenhydramine by mouth every 6 hours for the reaction and otc analgesics for the pain. Also, advised patient to follow up with her medical doctor immediately if anything became worse.  Patient stopped by pharmacy 2 days after administration and stated it was looking and feeling a small amount better. Advised patient to continue to monitor and to follow the aforementioned advice.
Age: 1.17
Sex: M
Vaccine: MMRV
Symptoms: C-reactive protein increased, Computerised tomogram abnormal, Parotitis, Pyrexia
Clinical narrative: Right side parotitis and fever developed 8 days subsequent to vaccine administration.  Required parenteral antibiotic administration and hospitalization.
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Angioedema, Electrocardiogram normal, Full blood count normal, Metabolic function test normal, Swelling face
Clinical narrative: Facial swelling, angioedema. Entered emergency room on 8/5/2017 at approximately 1:15 PM.  Treatment included IV administration of dipenhydramine, epinephrine, famotidine IVPB, methylprednisone. Discharged at approximately 8:30 PM. NOTE: Spouse recieved same vaccine on the same day, and is experiencing the same symptoms two days later.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site cellulitis, Pyrexia
Clinical narrative: Low grade fever and 3 in X 3.5 in cellulitis at injection site. Keflex 500mg 3 times a day x 7 days prescribed by NP.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Hemiparesis, Hypoaesthesia
Clinical narrative: Patient described of Numbness on right face, weakness on right.
Age: 1.33
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Diarrhoea, Pyrexia, Rash generalised
Clinical narrative: Pt's mother states 1 week after receiving vaccination the child experienced diarrhea, a fever of 99-100 and a rash beginning at his ears and spreading all over the child's body. Pt's mother state this lasted for 3-4 days.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, RV5
Symptoms: No adverse event, Product preparation error
Clinical narrative: 07/28/2017 patient was in office for routine 2moWECH. Patient was given vaccines at the end of visit.  PENTACEL and Rotavirus. The PENTACEL was given incorrectly. Only the ACTHIB was given with the sterile diluent solution not the DTAP/IPV solution.  Patient only received the ACTHIB portion of the vaccine with the sterile diluent solution.  DTAP/IPV not given.
Age: 73.0
Sex: F
Vaccine: HEP
Symptoms: Neck pain, Pruritus, Rash, Rash erythematous
Clinical narrative: Client stated she received the Hep B vaccination in the health department on 7/18/17. She did not notice any immediate reactions at the time the dose was given. This was the clients 1st shot of the series. However, on 7/19/17 she started experiencing symptoms of itching, pain, and rash. She noted from the VIS that pain at the injection site could be a reaction. However, the pain radiated to her neck and she began to get a rash on the same arm that the injection was given. The client rubbed cortizone cream on the affected areas and also took Benadryl. She stated that both have helped alleviate the symptoms. When reporting adverse event to the health department, a red rash was noted on the inner aspect of the arm. Client reported this event on 7/24/17.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse refers to a three unspecified patients. On an unknown date the patients were vaccinated with improperly stored doses of ROTATEQ lot # M019691 expiration date: 02-FEB-2017, for prophylaxis. ROTATEQ was exposed to a temperature ranges between 47° Fahrenheit  to 77°F (also reported as 51.4°F) during a time frame of 50 minutes, with no previous temperature excursions.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On an unknown date the patient was vaccinated with improperly stored GARDASIL 9 (dosing details were not reported) (lot # N001533, expiry date: 16-OCT-2019) for prophylaxis which was stored at a temperature of 47 degree Fahrenheit to 77 degree Fahrenheit (incorrect product storage). No adverse effects were reported. The call was because of a data logger. No product quality complaint was involved.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA lot # K009506, L023936 and K012457 for prophylaxis. No adverse effects were reported. Data logger was involved. This is one of several reports received from the same reporter. Additional information is not expected. Sender's Comments: US-009507513-1708USA002370: US-009507513-1708USA002371: US-009507513-1708USA002372: US-009507513-1708USA002373: US-009507513-1708USA002369.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to multiple unknown patients of unknown age. On an unknown date the patients were vaccinated with VARIVAX for prophylaxis. On an unknown date the patients experienced incorrect product storage and no adverse event.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a healthcare worker (medical assistant) refers to a patient of unknown age. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No drug reactions or allergies were reported. On 01-AUG-2017 the patient was vaccinated with a dose of VARIVAX (dosing details were not reported) for prophylaxis instead of ZOSTAVAX. No adverse effects were reported. No product quality complaint was involved.
Sex: F
Vaccine: HEP
Symptoms: Injected limb mobility decreased
Clinical narrative: This spontaneous report as received from other refers to a female patient of unknown age (patient's age: 22 (units not specified)). The patient's medical history, concurrent condition and concomitant medications were not reported. On an unknown date the patient was vaccinated with RECOMBIVAX HB from lot # M043422 expiry date 31-JUL-2017 on her right arm. On 18-JUL-2017, the patient stated that she could not move her right arm after the injection. The patient was currently being treated with booster shots. The patient does not have any known allergies and this was the first time being given this. The outcome of hypoaesthesia was unknown. Causality assessment was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to multiple unspecified patients of unknown age and gender. On an unknown date the patients were vaccinated with VARIVAX lot # M042858 with expiration date of 21-OCT-2018 and M042858 with expiration date of 13-JAN-2019 for prophylaxis. On an unknown date, the vaccine was incorrectly stored at a temperature of 6°F to 14°F. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients of unknown age. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On an unknown date the patient was vaccinated with improperly stored GARDASIL 9 (dosing details were not reported) (lot # M037770, expiry date: 01-JAN-2019) (lot # N001533, expiry date: 16-OCT-2019) for prophylaxis, which was stored at a temperature of 35 degree Fahrenheit for a time frame of 24.91 hours. No adverse effects were reported. No previous temperature excursions reported. The call was because of a data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1708USA002833: US-009507513-1708USA002834.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an other health professional refers to a patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot # L008054 and L004466 for prophylaxis. No adverse effects were reported. Data logger was involved. This is one of several reports received from the same reporter. Additional information is not expected. Sender's Comments: US-009507513-1708USA000870: US-009507513-1708USA002369: US-009507513-1708USA002370: US-009507513-1708USA002372: US-009507513-1708USA002373.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an other health professional refers to a patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot # J007096, K026533, L012838 and L004740 for prophylaxis. No adverse effects were reported. Data logger was involved. This is one of several reports received from the same reporter. Additional information is not expected. Sender's Comments: US-009507513-1708USA000870: US-009507513-1708USA002370: US-009507513-1708USA002371: US-009507513-1708USA002373: US-009507513-1708USA002369.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients of unknown age. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On an unknown date the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) (lot # M039061, expiry date: 28-APR-2018) for prophylaxis, which was stored at a temperature of 35 degree Fahrenheit for a time frame of 24.91 hours. No adverse effects were reported. No previous temperature excursions were reported. No product quality complaint was involved. The call was because of a data logger. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1708USA002354.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients of unknown age. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On an unknown date the patient was vaccinated with improperly stored VAQTA (dosing details were not reported) (lot # M009377, expiry date: 17-JUN-2017) (lot # M018644, expiry date: 20-SEP-2017) and (lot # M022924, expiry date: 24-JAN-2018) for prophylaxis, which was stored at a temperature of 35 degree Fahrenheit for a time frame of 24.91 hours (incorrect product storage). No adverse effects were reported. No previous temperature excursions reported. The call was because of a data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1708USA002354.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Cellulitis, Erythema, Induration, Petechiae
Clinical narrative: Patients mother states he developed a large reddened area on Friday, 08/04/17 and she took him to the local ER where she was told it was cellulitis from a vaccine. Was given Bactrim and a steroid cream. The induration has continued to get larger and now has peticchae around the area. Mom is taking child back to ER today.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Injection site rash, Injection site reaction, Rash, Rash papular
Clinical narrative: PATIENT NOTICED A RASH AROUND THE INJECTION SITE SHORTLY AFTER GETTING HOME. PARENT WAS NOT NOTIFIED UNTIL  A LATER DATE. PARENT CONTACTED THE OFFICE AND WAS GIVEN AN APPOINTMENT. PT PRESENTED WITH A PAPULAR RASH AT INJECTION SITE AND IN THE PALM OF THE HAND.
Age: 23.0
Sex: F
Vaccine: HEP, HPV9, MENB, TD, VARCEL
Symptoms: Body temperature increased, Injection site erythema, Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: Patient came to clinic with concern of vaccine reaction. Left arm, site of varicella vaccination from 8/2/17, exhibited signs of infection. Small clustered blisters spread approximately a 1 inch diameter surrounded the injection site. Inflammation with redness, swelling, warmth and approximately 6 inches around the site on the arm. Patient states it is sore. Reports temperature of 100.6 on 8/3/17. Given information on local urgent care clinics and Urgent Care and instructed to have it examined for treatment. Patient denies taking TYLENOL /Ibuprofen or using ice for treatment.
Age: 23.0
Sex: F
Vaccine: HEP, HPV9, MENB, TD, VARCEL
Symptoms: Injection site vesicles, Injection site warmth, Vaccination site infection
Clinical narrative: Patient came to clinic with concern of vaccine reaction. Left arm, site of varicella vaccination from 8/2/17, exhibited signs of infection. Small clustered blisters spread approximately a 1 inch diameter surrounded the injection site. Inflammation with redness, swelling, warmth and approximately 6 inches around the site on the arm. Patient states it is sore. Reports temperature of 100.6 on 8/3/17. Given information on local urgent care clinics and Urgent Care and instructed to have it examined for treatment. Patient denies taking TYLENOL /Ibuprofen or using ice for treatment.
Age: 5.0
Sex: F
Vaccine: DTAP, UNK
Symptoms: Arthralgia, Discomfort, Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Immunization Date: Wed 7/19/2017; Immunization: Tetanus; Injection Site: Left Upper Leg (thigh) Pictures available upon request; Thursday the injection site was raised, red and appearing like a small hive Friday morning the injection site was red and spreading by Friday evening the injection site was red, raised and extremely warm to the touch (could feel heat through her shorts). By Saturday afternoon the injection site was extremely red, raised and growing. Friday evening I had marked the parameter of the rash and by Sunday it had surpassed the marked outline. Sunday the redness was dissipating, and by Monday morning, the rash was barely visible. During the weekend, my daughter was in extreme discomfort, she mentioned that her shoulder and hips hurt as well as her leg I had reached out to the RN at Dr.'s office on Friday and they instructed me to give her antihistamine, ice & warm when tolerated. I was using Claritin & Benadryl. I went to the office on Monday to show them the pictures of the reaction, I was instructed to continue the above instructions. A few hours later, the RN called back and said that Dr. wanted to discontinue the Claritin & Benadryl and put her on Allegra 2x's a day for the remaining week.
Age: 5.0
Sex: F
Vaccine: DTAP, UNK
Symptoms: Injection site urticaria, Injection site warmth, Musculoskeletal pain
Clinical narrative: Immunization Date: Wed 7/19/2017; Immunization: Tetanus; Injection Site: Left Upper Leg (thigh) Pictures available upon request; Thursday the injection site was raised, red and appearing like a small hive Friday morning the injection site was red and spreading by Friday evening the injection site was red, raised and extremely warm to the touch (could feel heat through her shorts). By Saturday afternoon the injection site was extremely red, raised and growing. Friday evening I had marked the parameter of the rash and by Sunday it had surpassed the marked outline. Sunday the redness was dissipating, and by Monday morning, the rash was barely visible. During the weekend, my daughter was in extreme discomfort, she mentioned that her shoulder and hips hurt as well as her leg I had reached out to the RN at Dr.'s office on Friday and they instructed me to give her antihistamine, ice & warm when tolerated. I was using Claritin & Benadryl. I went to the office on Monday to show them the pictures of the reaction, I was instructed to continue the above instructions. A few hours later, the RN called back and said that Dr. wanted to discontinue the Claritin & Benadryl and put her on Allegra 2x's a day for the remaining week.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Alopecia, Antiphospholipid antibodies negative, Arthralgia, Fatigue, Thyroid function test normal
Clinical narrative: 1) Hair Loss. 2) Pain in knee joints. 3) Fatigue.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Chills, Discomfort, Dizziness, Musculoskeletal stiffness, Myalgia
Clinical narrative: The morning after receiving the MENVEO vaccine (received at 4:30 pm) she awoke with a fever which increased throughout the day. Max temp was 102 orally. Was accompanied by chills,  generalized myalgia, and light headedness. Also mentioned neck stiffness and discomfort but was able to touch chin to chest. Fever and these associated symptoms continued for total of 2 days. On 3rd day after vaccination, symptoms gradually resolved and she became symptom free.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Pyrexia
Clinical narrative: The morning after receiving the MENVEO vaccine (received at 4:30 pm) she awoke with a fever which increased throughout the day. Max temp was 102 orally. Was accompanied by chills,  generalized myalgia, and light headedness. Also mentioned neck stiffness and discomfort but was able to touch chin to chest. Fever and these associated symptoms continued for total of 2 days. On 3rd day after vaccination, symptoms gradually resolved and she became symptom free.
Age: 33.0
Sex: M
Vaccine: ANTH, MNQ
Symptoms: Chills, Malaise, Myalgia, Pyrexia
Clinical narrative: Severe chills, fever up to 102, malaise, myalgias. Onset about 12 hours after receipt of anthrax #9 & Meningococcal conjugate #2. Treatment acetaminophen (unable to take NSAID), and supportive care fluids, rest etc.
Sex: U
Vaccine: HEP, HEPA, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received on 17-JUL-2017 from a licensed practical nurse (LPN) referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored GARDASIL 9 (Lot # M034780, expiration date 15-APR-2019) or RECOMBIVAX HB (Lot # M044032, expiration date 03-JUL-2019) or VAQTA (Lot # N005274, expiration date 03-APR-2018) for prophylaxis. (The doses, routes of administration and sites of administration were not reported.) The excursion information was reported as: The temperature was reported as 9 degrees Celsius (C) to 25 degrees Celsius (C) for the time frame of 13 hours and 47 minutes. There was a previous temperature excursion of 9 degrees Celsius (C) to 25 degrees Celsius (C) for 42 hours 5 minutes. (No dates for the temperatures excursions were reported.) The call was because of a "data logger". Product quality complaint was not involved. No adverse effects reported. No additional information was provided. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Left arm swelling (bicep area), redness, tenderness, and warm to touch. 3 day time course and totally gone 1 week later.
Age: 52.0
Sex: M
Vaccine: TYP
Symptoms: Rash
Clinical narrative: Rash on torso- no itching associated.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness at injection site.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Erythema, Mass, Swelling
Clinical narrative: Significant swelling and redness, large lump.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Chest X-ray normal, Electrocardiogram normal, Full blood count normal, Glomerular filtration rate normal, Hallucination
Clinical narrative: Hallucination, on 06/09/2017, Recurrent palpitation (tachycardia) on/off since the day of the vaccination. She has been to the Emergency Room since then and EKG was normal. She only reported the event to me today, she has been evaluated, all was normal. She has been referred to a pediatric cardiologist for further evaluation and meantime blood has been drawn for thyroid function tests.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Metabolic function test normal, Palpitations, Tachycardia, Thyroid function test
Clinical narrative: Hallucination, on 06/09/2017, Recurrent palpitation (tachycardia) on/off since the day of the vaccination. She has been to the Emergency Room since then and EKG was normal. She only reported the event to me today, she has been evaluated, all was normal. She has been referred to a pediatric cardiologist for further evaluation and meantime blood has been drawn for thyroid function tests.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Cellulitis
Clinical narrative: Cellulitis.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient developed red area around injection site about 6-7 cm in diameter and minor swelling.  Area is warm to touch and does not itch. Area is sore. Patient was instructed to use cold compresses, NSAIDS, and diphenydramine. If no improvement seen in 24 hours, patient was told to see physician who prescribed the vaccination.
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Erythema, Fatigue
Clinical narrative: Localized redness, fatigue and chest tightness.
Age: 26.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Back pain, Dyspnoea, Erythema, Headache, Nausea
Clinical narrative: Patient received Pneumovax and flu shot on 8/3/17. She went home and had complaints of nausea, fever, vomiting, upper back pain, headache, redness in arm, shortness of breath later on and was rushed to the hospital. While at the hospital it was discovered she had a urinary tract infection for which she was treated for. She came back to the pharmacy was angry and complained hospital said she should not have gotten pneumonia vaccine because she is too young. I assured her because she is a diabetic, she is at risk and needs one. She also showed me her arm which was red all over. I told the patient some of her symptoms could have been attributed by her urinary infection and the redness in her arm is a side effect and should go away within a few days.
Age: 26.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pyrexia, Vomiting
Clinical narrative: Patient received Pneumovax and flu shot on 8/3/17. She went home and had complaints of nausea, fever, vomiting, upper back pain, headache, redness in arm, shortness of breath later on and was rushed to the hospital. While at the hospital it was discovered she had a urinary tract infection for which she was treated for. She came back to the pharmacy was angry and complained hospital said she should not have gotten pneumonia vaccine because she is too young. I assured her because she is a diabetic, she is at risk and needs one. She also showed me her arm which was red all over. I told the patient some of her symptoms could have been attributed by her urinary infection and the redness in her arm is a side effect and should go away within a few days.
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of injection site induration in a female patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site induration and injection site erythema. On an unknown date, the outcome of the injection site induration and injection site erythema were unknown. It was unknown if the reporter considered the injection site induration and injection site erythema to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. At the time of the call, patient specifics and lot number were not available. The female patient experienced a quarter-sized induration and erythema. GlaxoSmithKline representative was given info from the medical assistant, who would give a call early next week to provide specific information about patients and vaccine lot. She told the representative that she felt that the female and the male with the more mild adverse events aligned with what was in the patient information. This was one of 3 cases reported by same reporter.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Local reaction, Oedema, Pain, Purpura
Clinical narrative: Erythema and pain with raised edema localized reaction. 2x1 inch in size, normal puerperal Purpura and normal range of motion.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Pyrexia, Rash erythematous, Rash pruritic
Clinical narrative: I got the ZOSTAVAX vaccine and had a bad reaction. The second day I got a large lump at the site which is normal but on the third day I broke out in a terribly itchy red rash all over my chest and neck. I felt feverish. It continued getting worse the fourth, fifth, and sixth days. I took BENADRYL and used cortisone cream which didn't help very much. Today is the seventh day and it has spread to my legs and arms but is less itchy. I hope it won't leave scarring or discoloring when it passes.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Culture throat negative, Erythema, Joint swelling, Limb discomfort, Rash generalised
Clinical narrative: Rash all over her body and discomfort in hands and feet since 07/29/17. On exam: Bilateral arms and thighs w/scattered erythematous raised urticaria lesions that are symmetric in their distribution. Swelling of joints. (R) and (L) arms, thighs, hands and feet. ROM none. Possible reaction to GARDASIL 9 vaccine. Patient's symptoms improved with use of CLARITIN and topical lotion.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Streptococcus test negative, Urticaria
Clinical narrative: Rash all over her body and discomfort in hands and feet since 07/29/17. On exam: Bilateral arms and thighs w/scattered erythematous raised urticaria lesions that are symmetric in their distribution. Swelling of joints. (R) and (L) arms, thighs, hands and feet. ROM none. Possible reaction to GARDASIL 9 vaccine. Patient's symptoms improved with use of CLARITIN and topical lotion.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Photophobia
Clinical narrative: Daily headaches since second HPV-9 vaccine. Happens at various times of the day for various amounts of time. Described as being the whole head, sometimes throbbing. Some light sensitivity. No nausea. No blurry vision. Some improvement with ibuprofen. Had 48 hours of headaches noted after first HPV-9 vaccine.
Sex: M
Vaccine: MENB
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site induration in a male patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site induration and injection site erythema. On an unknown date, the outcome of the injection site induration and injection site erythema were unknown. It was unknown if the reporter considered the injection site induration and injection site erythema to be related to BEXSERO. Additional details were provided as follows: This case was 1 of the 3 cases belonging to the patients who received the same lot of BEXSERO and had injection site reactions. The age at vaccination of the patient concerned in this case was not reported. The patient's age was between 16 to 18 years old. The healthcare professional reported that the patient had injection site reactions which included a quarter-sized induration and erythema. At the time of the reporting, the patient specifies and lot number were not available. The medical assistant provided the above information to sales representative. She would likely call in early next week to provide specific information about the patient and vaccine lot.
Age: 3.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site induration, Injection site rash
Clinical narrative: Firm induration and rash at sites of both vaccines one week after administration.
Age: 11.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Blood glucose normal, Dizziness, Hyperhidrosis, Pallor
Clinical narrative: Patient was administered HPV and Tdap vaccines IM. Patient got off of exam table and walked over to a chair in the room. I began to inform pt and mother of precaution to wait after HPV vaccine to watch for reaction when mother looked over and asked pt if she was ok? Pt was noticed to be pale and sweating profusely. I went over to her and held her and asked mother to open door and ask for help. MA got Dr. to come in for further assistance. Pt was laid down and vitaled 11:08 am BP 83/52 Pulse 67 O2 98 Fb 86.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Diarrhoea, Injection site inflammation, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Both (R) and (L) deltoids swollen and inflamed, tender to touch. Less "tight" than 2 days before, loose stools today, fever today - T-100 yest. TYLENOL with relief. Cold compresses with relief.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Pyrexia, Skin tightness
Clinical narrative: Both (R) and (L) deltoids swollen and inflamed, tender to touch. Less "tight" than 2 days before, loose stools today, fever today - T-100 yest. TYLENOL with relief. Cold compresses with relief.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain
Clinical narrative: Abdominal cramping started day after injection lasted one day.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Bursitis, Periarthritis
Clinical narrative: Frozen shoulder 12/2015. Bursitis 12/2015. 12/21/15 Adverse effect of vaccines and Biological substances. Physical therapy 1/2016. Adhesive capsulitis 12/21/15.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Dyspnoea, Erythema, Hyperhidrosis, Pain, Swelling
Clinical narrative: Pt got PREVNAR 13 injection on 7/27/17 and on 8/1/17 got arm left sided pain redness and swelling started getting short of breathe and excessive sweating on 8/7/17.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Localized swelling/redness (L) deltoid area. No fever. Monitor clinically, TYLENOL.
Age: 19.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Grip strength decreased, Hypoaesthesia, Tremor
Clinical narrative: Severe joint pain in elbows, knees, and shoulders. Hands are becoming numb has difficulty in gripping or making a fist. Shaking in hands began today. Elbows painful to touch. Injection site unremarkable.