chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse from a pediatricians office (phone call) via PDC (Rocky Mountain Poison and Drug Center) and refers to a 6 month old male patient. The registered nurse reported that the male patient received a 0.5ml dose of VAQTA (Lot number reported as N005273, expiration date reported as 03-APR-2017) (route: intramuscular, frequency: once) on 27-JUN-2017 as the result of an unintended exposure (The indication for the vaccine was reported as unintentional exposure.) as the patient is less than 12 months old. The patients medical history includes being a term infant whose primary care provider was ordering routine immunizations.  The patient has not relevant concomitant medications or laboratory data.  The nurse reported that the patient has not experienced an adverse reaction and no treatments have been provided.  As of 27-JUN-2017, it is unknown if the patient will continue to receive VAQTA and the outcome of the unintended exposure was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Information has been received on 27-JUN-2017 from a registered nurse regarding an unknown number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. The registered nurse reported that an unknown number of patients received a dose of VARIVAX, subcutaneous for prophylaxis an unknown date after 19-JUN-2017 which were stored outside of the recommended temperature range. The registered nurse reported the following lot numbers involved: 14 vials of lot # N001527 expiration 13-JAN-2019, 30 vials of lot # M046924 expiration 28-NOV-2018, 30 vials of lot # M044347 expiration 04-NOV-2018, 10 vials of lot # N014368 expiration 09-MAY-2019 and 12 vials of lot # M037642 expiration 01-SEP-2018. The registered nurse reported that the VARIVAX are stored in the freezer. The freezer got up to -14 degrees Celsius on 19-JUN-2017. The temperature was out of range from 06:40 on 19-JUN-2017 to 05:00 on 20-JUN2017. The patients were vaccinated from doses that were in these storage conditions. The registered nurse was inquiring if the patients needed to be revaccinated. As of 27-JUN-2017, the outcome of receiving VARIVAX that was stored outside of the recommended temperature range is unknown. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant concerning multiple unspecified patients of unknown age and gender. No pertinent medical history, concurrent conditions, concomitant medications or drug allergies were reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (Lot # M004508, Expiry date : 29-JUN-2017, NDC# 0006-4047-41) (Strength, dose and route of administration were not reported) for prophylaxis (incorrect product storage). Other suspect therapies included sterile diluent(MERCK STERILE DILUENT)  as prophylaxis.   There was previous temperature excursions on 23-FEB-2016 to 24-FEB-2016, 27-FEB-2016 to 29-FEB-2016, 01-MAR-2016 to 04-MAR-2016, 08-MAR-2016 to 09-MAR-2016, 15-MAR-2016 to 20-MAR-2016, 23-MAR-2016 to 26-MAR-2016, 30-MAR-2016, 02-APR-201 to 04-APR-2016, 19-APR-2016 to 21-APR-2016 and 23-APR-2016 to 24-APR-2016 for 24 hours each. Data logger was involved.   On 27-APR-2016,12-MAY-2016, 24-OCT-2016, 13-NOV-2016, 06-DEC-2016 and 04-APR-2017 there was temperature excursions of -0.12, -0.46, -0.14, -0.24, +9 and -20.18 to +14 degree Celsius for 1 hour 15 minutes, 1 hour, 30 minutes, 45 minutes, 1 hour and 3 hours 30 minutes respectively. There was no product quality complaint involved. No adverse effects were reported.   This is 1 of 6 reports from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1706USA007802:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant concerning multiple unspecified patients of unknown age and gender. No pertinent medical history, concurrent conditions, concomitant medications or drug allergies were reported. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II (Lot # K021950, Expiry date : 10-NOV-2016, NDC# 0006-4681-00, Expiry date :  23-AUG-2018) (Strength, dose and route of administration were not reported) for prophylaxis (incorrect product storage). Other suspect therapies included sterile diluent (MERCK STERILE DILUENT) as prophylaxis.   There was previous temperature excursions on 23-FEB-2016 to 24-FEB-2016, 27-FEB-2016 to 29-FEB-2016, 01-MAR-2016 to 04-MAR-2016, 08-MAR-2016 to 09-MAR-2016, 15-MAR-2016 to 20-MAR-2016, 23-MAR-2016 to 26-MAR-2016, 30-MAR-2016, 02-APR-201 to 04-APR-2016, 19-APR-2016 to 21-APR-2016 and 23-APR-2016 to 24-APR-2016 for 24 hours each. Data logger was involved.   On 27-APR-2016,12-MAY-2016, 24-OCT-2016, 13-NOV-2016, 06-DEC-2016 and 04-APR-2017 there was temperature excursions of -0.12, -0.46, -0.14, -0.24, +9 and -20.18 to +14 degree Celsius for 1 hour 15 minutes, 1 hour, 30 minutes, 45 minutes, 1 hour and 3 hours 30 minutes respectively. There was no product quality complaint involved. No adverse effects were reported.   This is 1 of 6 reports from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1706USA007802:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant concerning multiple unspecified patients of unknown age and gender. No pertinent medical history, concurrent conditions, concomitant medications or drug allergies were reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (Lot # L004655, Expiry date : 11-FEB-2017, NDC# 0006-4827-00) (Strength, dose and route of administration were not reported) for prophylaxis (incorrect product storage). Other suspect therapies included sterile diluent(MERCK STERILE DILUENT) as prophylaxis. There was previous temperature excursions on 23-FEB-2016 to 24-FEB-2016, 27-FEB-2016 to 29-FEB-2016, 01-MAR-2016 to 04-MAR-2016, 08-MAR-2016 to 09-MAR-2016, 15-MAR-2016 to 20-MAR-2016, 23-MAR-2016 to 26-MAR-2016, 30-MAR-2016, 02-APR-201 to 04-APR-2016, 19-APR-2016 to 21-APR-2016 and 23-APR-2016 to 24-APR-2016 for 24 hours each. Data logger was involved. On 27-APR-2016,12-MAY-2016, 24-OCT-2016, 13-NOV-2016, 06-DEC-2016 and 04-APR-2017 there was temperature excursions of -0.12, -0.46, -0.14, -0.24, +9 and -20.18 to +14 degree Celsius for 1 hour 15 minutes, 1 hour, 30 minutes, 45 minutes, 1 hour and 3 hours 30 minutes respectively. There was no product quality complaint involved. No adverse effects were reported. This is 1 of 6 reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA007802:
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 12-JUL-2017, the patient was vaccinated with ZOSTAVAX lot # M018593, subcutaneous for prophylaxis. On 12-JUL-2017, 1 day after onset of therapy, the patient experienced expired product administered. On an unknown date, the patient experienced no adverse event. The outcome of expired product administered and no adverse event is unknown.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not provided. On an unspecified date, the patient received an improperly stored dose of VARIVAX Lot # M036293 with an expiration date on 17-AUG-2018 for prophylaxis (strength and route of administration was not reported). The vaccine was stored at a temperature between 15°F to 46°F during 12 hours. No previous temperature excursions were reported and the call was not because of a data logger. Additionally, no adverse effects were reported.
Age: 5.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Information was received on 28-JUN-2017 from a registered nurse who reported that a 12 year old 11 month female patient received VAQTA (lot# M039055, expiration 22-JUL-2018) adult dose of 1.0 ml booster dose in right deltoid on 28-JUN-2017 at medical office, as a second series of shots, with the first shot of VAQTA administered in April 2010 as a 0.5 ml dose for prevention of hepatitis A. The nurse stated that the patient did not have any concomitant medications, laboratory data, and relevant medical history. As of 28-JUN-2017, the outcome of the patient receiving 1.0 ml adult dose of VAQTA is unknown. Additional information has been requested.
Age: 52.0
Sex: M
Vaccine: HEP
Symptoms: Burning sensation, Injection site erythema, Peripheral swelling, Sensory disturbance, Skin exfoliation
Clinical narrative: Patient reports that about 2-3 days after his Hep B shot he saw a red circle around the site of the injection. A few days after that he noted a sensation of his hands and top of feet burning and the skin began to slough. A few days later he noted increased swelling of his legs.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site urticaria, Swelling face
Clinical narrative: Patient's mother stated that patient started with hives around injection site which lead to swelling in face. Mother states reaction started that evening after immunization was given.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Blood test normal, Injection site urticaria
Clinical narrative: Hives on and around injection site. From shoulder injection site to midway to elbow.
Age: 44.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Perspective employee received Varicella for pre-employment on 7/11/17 to L arm and she came to EHSon 7/13/17 stating that L her arm was sore,red and a little swelling at the site. She described sight being painful to touch 3/10. The area measures 70 mm wide and 70 mm long. She denied having any difficulty breathing or swallowing at anytime post vacciantion. She said the site started out with reddness the size of a dime the day of vacciantion and then she showered and the next day it was the size that it is now. Her VS are WNL, she has no fever, and she was given a cool compress to apply to site. She said that she would take something for pain when she return home.She was informed to see medical attention if condition worsens, or return to Employee Health & Safety department.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Arthralgia, Chills, Fatigue, Headache
Clinical narrative: After receiving the dose in the morning, that evening patient developed chills, fatigue and hip/joint pain.  Chills lasted 2-3 days with the onset of headache as well.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 26-JUN-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # M042853, expiration date: 17-JUL-2019 (dose, strength, route of administration was not reported) for prophylaxis. There were no adverse effects reported. The administered dose of vaccine experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 105 hours. Data logger was not involved. There were no previous excursions reported. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Patient received VARIVAX #2 per School requirements on 07/12/2017 at 1437. Patient started noticing a localized reaction 07/13/2017 afternoon/evening. Patient arrived to clinic 07/14/2017 at 0815 for reaction to be assessed. Site was red, circular, slightly raised and warm to the touch with intermittent itchiness. There were no signs or symptoms of respiratory or cardiac distress and Patient had no other complaints. Patient was directed to Primary Care Clinic to be further assessed by Primary Care Physician.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Patient developed a case of shingles the day after vaccination according to the doctor.  Rash developed on patient's side.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Hyperhidrosis, Loss of consciousness, Pallor, Syncope, Vision blurred
Clinical narrative: 10 min after vaccines administered, pt had a syncopal episode while in the waiting room. She "blacked out," had blurry vision and became pale and diaphoretic. Post-episode vitals: BP 98/60, HR 60,  RR 14. Pt was still awake and responsive, she laid down, drank water, and ice packs were applied. Episode resolved after 15min, color returned to baseline, vision returned to normal and diaphoresis resolved. Repeat vitals before leaving: BP 100/60, HR 68, RR 16.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site infection
Clinical narrative: Parent reports "infection on left arm at site of injections".
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Fall, Lip injury, Loss of consciousness, Skin abrasion
Clinical narrative: Patient passed out as he went to stand up from the exam table, and fell to the floor face down, he received a small superficial abrasion to his lower lip, he was checked out by one of our doctors, vital signs were normal and he was able to answer questions, we kept him lying on the table for 15-20 minutes until the Dad felt comfortable that he was alright to leave.
Age: 34.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site discomfort, Injection site erythema, Injection site pain, Vaccination site swelling
Clinical narrative: She reported that she received AVA # 6 on 26 Jun in her left arm. Later that evening she developed pain and discomfort in her left shoulder with only mild  local redness and swelling around vaccination site. She reported that the pain and discomfort continues and reports improvement with ibuprofen and use of TENS unit. She stated she has been using cold and hot packs. She denied any previous history of shoulder problems and that the pain in her shoulder will wake her at night. She reports discomfort when she raises her arm and she denied any extensive swelling with her previous AVA but nothing this bad. She denied any other systemic symptoms. She stated that she believes both her and the vaccinator were standing during the immunization process. Pain in left shoulder.
Sex: F
Vaccine: HPV4
Symptoms: Migraine, Myalgia, Pain
Clinical narrative: This spontaneous report as received from a consumer (patient's mother) refers to a female patient of unknown age. On an unspecified date in 2008, the patient was vaccinated with GARDASIL dose 1 (dosing details, lot#, expiration date and route unspecified) for prophylaxis. The patient's mother reported that her daughter had been "living with pain" since receiving the vaccine (approximately since 2008). She also mentioned that her daughter experienced muscle pain and migraines after getting the vaccination (onset dates unspecified). It was unspecified whether the daughter had completed the GARDASIL quadrivalent series in 2008 or if she had only received the first or second dose. The events outcome was not provided. No product quality complaint was involved. Causality assessment was not provided. No additional adverse event details were provided. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Maternal exposure before pregnancy
Clinical narrative: This spontaneous prospective pregnancy report was received from a nurse regarding a 32 year old female patient. Her medical history, concurrent condition and concomitant medication was unknown. The patient's last menstrual period (LMP) was 22-MAY-2017. On 26-MAY-2017, the patient was vaccinated with M-M-R II (lot # L041455, expiration date 22-OCT-2017, subcutaneously) for prevention of measles/mumps/rubella with sterile diluent (subcutaneously, lot number, expiration date and indication unknown) (doses unknown). On 11-JUN-2017, the patient inadvertently became pregnant due to condom breakage during intercourse on the same day (maternal exposure before pregnancy). On an unknown date, the patient visited physician. The estimated date of delivery (EDD) was 26-FEB-2018. The pregnancy outcome was outcome pending. Additional information has been requested.
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On 26-JUN-2017, the patient was vaccinated by a nurse with an expired dose of ROTATEQ (lot # L033545, expiration date: 30-MAY-2017) (exact dose, route of administration were not reported) for prophylaxis. No adverse effects was reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from other health professional refers to a patient of unknown age and gender. Medical history, current conditions and concomitant medications were not reported. On an unknown date the patient was vaccinated with improperly stored ROTATEQ (Lot number M040269, Expiry Date 28-APR-2018 and Lot number M035828, Expiry Date 28-MAY-2018), (unknown dose and frequency was not reported) for prophylaxis and no adverse event were reported. It was stated that the timeframe between temperature of 32 degrees Fahrenheit to 35 degrees Fahrenheit for 8 Hours and between 47 degrees Fahrenheit to 77 degrees Fahrenheit for 9 hours. Vaccines underwent a previous temperature excursion of 32 degrees Fahrenheit to 35 degrees Fahrenheit for 9 Hours. Call was because of a "data logger". The outcome of incorrect product storage and no adverse event was unknown. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to unspecified number of patients of unknown demographics. Information on medical history, concurrent condition, concomitant medication and drug allergies/reactions were not provided. On an unknown date, the patients were vaccinated with improperly stored doses of VAQTA (dose, frequency and route of administration were unknown) lot # N005274, expiration date: 03-APR-2018) for prophylaxis. No adverse event reported. Temperature Excursion details were as follows: Temperature and Time frame: Between 32 degree Fahrenheit (F) to 35°F for 8 Hours and between 47 F to 77 F for 9 hours. Previous temperature excursion included 32°F to 35°F for 9 Hours. The call was because of a data logger. No Product Quality Complaint (PQC) was involved. The outcome of incorrect product storage and no adverse event were unknown. No additional information was provided. This case is cross-referenced with 1706USA011420, 1707USA001306, 1707USA001304 and 1707USA001307 (same reporter). Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # M024261 with expiry date: 30-JUL-2018, lot # M031557with expiry date 07-APR-2019, lot# M041990 with expiry date 28-JUN-2019) for prophylaxis (dosing details unspecified). No adverse effects were reported. The vaccines were exposed to a temperature 32 F to 35 F for a time period of 8 hours, 47 F to 77 F for 9 hours. Previous temperature excursions were reported as 32 F to 35 F for a time period of 9 hours. Digital data logger was involved. No additional information was provided. Product quality complaint (PQC) was not reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA001307: US-009507513-1706USA011420: US-009507513-1707USA001304: US-009507513-1707USA001305.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from medical assistant and refers to unspecified number of patients' of unknown demographics. On unknown date(s), the patients' were vaccinated with improperly stored doses of M-M-R II (lot # M034387, expiry date: 19-JUL-2018 and M037096, expiry date: 23-AUG-2018) for prophylaxis. Temperature Excursion details were as follows: Temperature and Time frame: Between 32 degree Fahrenheit (°F) to 35°F for 8 hours and between 47 °F to 77 °F for 9 hours. Previous temperature excursion included 32°F to 35°F for 9 hours. The call was because of a data logger. No adverse effects reported. No Product Quality Complaint (PQC) was involved. This case was cross-referenced with 1706USA011420, 1707USA001306, 1707USA001304 and 1707USA001305 (same reporter). Additional information has been requested.
Age: 1.58
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant via a company representative and refers to a 19 months old female patient. Medical history and concomitant medications were not provided. On 19-JUN-2017, the patient received an expired dose of VAQTA (lot # M011116; expiration 17-JUN-2017). No adverse effects were reported. Additional information has been requested.
Age: 1.25
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Information was received on 28-JUN-2017 from a Licensed Practical Nurse (LPN) who was reporting on a 15 month old female patient. Relevant medical history and drug history included acid reflux treated with omeprazole (manufacturer unknown) (dose, route, frequency and formulation not reported) from  an unknown date. On 27-JUN-2017, the patient received a dose of PROQUAD (lot M046943, expires 27-MAY-2018) (dose and route not reported) and a dose of VARIVAX (lot M043305, expired 26-OCT-2018) (dose and route not reported) by mistake and therefore the varicella was duplicated. The patient will be observed and has had no complications. Additional information has been requested.
Age: 41.0
Sex: M
Vaccine: HEP, TYP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information was received on 28-JUN-2017 from a license practical nurse who was reporting on a 41 year old male patient. Medical history includes Chronic Obstructive Pulmonary Disease (COPD) and there were no relevant concomitant medications. On 27-JUN-2017, the patient received two 1.0 ml doses of RECOMBIVAX HB (lot M046373, expires 04-NOV-2018) in the left deltoid for prophylaxis against Hepatitis B for planned travel. The patient has not had laboratory work in almost one year. The LPN reported that the patient was only supposed to received one dose of RECOMBIVAX HB and that a second 1.0 ml dose was provided in error. The intention was to provide a hepatitis A vaccination in addition to the hepatitis B vaccine. The nurse stated "Due to my lack of paying much attention, the patient received the two doses instead of one each of the Hepatitis A and Hepatitis B." The LPN stated that the patient has not reported any adverse reactions and that no treatments have been provided. As of 28-JUN-2017, it was unknown if the patient will continue on RECOMBIVAX HB and the outcome of receiving two 1.0 ml doses on 27-JUN-2017 is unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: Information was received from a nurse who reported that on an unspecified date, an unspecified patient may have received an improperly stored dose of one of the following vaccines but she is unsure which of the lot numbers the unspecified patient received: ZOSTAVAX (lot # M037655, expiration date 29-NOV-2017); or VARIVAX (lot #M048200, expiration date 07-DEC-2018 or lot #M015731, expiration date 30-MAR-2018) (route of administration not provided). No adverse effect reported. No additional information was provided. Temperature excursion: In the range (-14°C to -10°C), Time frame: 2 hours and 30 minutes, Previous temperature excursion: No, Data logger involved: Yes. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered
Clinical narrative: This spontaneous report was received from a nurse via a company representative and refers to a patient of unknown age and gender. Medical history and concomitant medications were not provided.  On an unspecified date, the patient was given and expired GARDASIL injection (lot # and expiration date not provided). The outcome was unknown. Additional information is not expected as there was no contact information.
Age: 1.25
Sex: F
Vaccine: MMR
Symptoms: Dysphonia, Pyrexia
Clinical narrative: Mother stated pt had a high fever the following day on 102 and had hoarseness.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: There was an excertion on Sunday July 9,2017, where the temps went up to 60.6.  Patient was monitored for 15 minutes with no adverse reactions noted.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Cellulitis, Injection site cellulitis
Clinical narrative: Pt given immunization on 6/28/17 ON 6/30/17, pt presented to ER with cellulitis of right arm, around injection site.
Age: 11.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: Per telephone call with PCP, pt had redness and warmth surrounding area vaccination was received. Pt complained of soreness to area.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Autoimmune disorder, Biopsy skin abnormal, Blister, Hypokinesia, Pustular psoriasis
Clinical narrative: Pustular psoriasis (autoimmune disorder) sores started developing on palms of hands. Eventually leading to completely envelope both hands and feet with blisters and sores. Could not move fingers because there were so many tiny blisters enveloping them. Patient had to take 20mg of Prednisone over the course of weeks to control and minimize symptoms. Currently taking Clobetasol daily since 2015 but minor symptoms are still present.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Skin ulcer
Clinical narrative: Pustular psoriasis (autoimmune disorder) sores started developing on palms of hands. Eventually leading to completely envelope both hands and feet with blisters and sores. Could not move fingers because there were so many tiny blisters enveloping them. Patient had to take 20mg of Prednisone over the course of weeks to control and minimize symptoms. Currently taking Clobetasol daily since 2015 but minor symptoms are still present.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Injection site erythema, Injection site swelling, Pruritus generalised, Pyrexia
Clinical narrative: Patient says she had fever near 101 F for 5 days straight after receiving ZOSTAVAX, itching all over, redness/swelling at injection site. Felt terrible. No treatment given.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage
Clinical narrative: On July 13,2017 the data logs were check and an excertion was noted for July9 at 60.6F for 12.10 hours.
Age: 48.0
Sex: F
Vaccine: HEP, HEPA, TYP
Symptoms: Abdominal X-ray, Abdominal pain, Computerised tomogram abdomen, Computerised tomogram pelvis, Computerised tomogram thorax
Clinical narrative: On 6/20/2017 awoke with nausea, vomiting, diarrhea, mild headache, abdominal pain, hot and cold flashes. Symptoms persisted growing worse. On 6/21/2017 was seen at health Care urgent care mid day, then ER early evening.
Age: 48.0
Sex: F
Vaccine: HEP, HEPA, TYP
Symptoms: Diarrhoea, Differential white blood cell count, Electrocardiogram, Feeling of body temperature change, Fibrin D dimer
Clinical narrative: On 6/20/2017 awoke with nausea, vomiting, diarrhea, mild headache, abdominal pain, hot and cold flashes. Symptoms persisted growing worse. On 6/21/2017 was seen at health Care urgent care mid day, then ER early evening.
Age: 48.0
Sex: F
Vaccine: HEP, HEPA, TYP
Symptoms: Full blood count, Headache, Lipase, Liver function test, Metabolic function test
Clinical narrative: On 6/20/2017 awoke with nausea, vomiting, diarrhea, mild headache, abdominal pain, hot and cold flashes. Symptoms persisted growing worse. On 6/21/2017 was seen at health Care urgent care mid day, then ER early evening.
Age: 48.0
Sex: F
Vaccine: HEP, HEPA, TYP
Symptoms: Nausea, Nuclear magnetic resonance imaging, Scan with contrast, Troponin T, Urine analysis
Clinical narrative: On 6/20/2017 awoke with nausea, vomiting, diarrhea, mild headache, abdominal pain, hot and cold flashes. Symptoms persisted growing worse. On 6/21/2017 was seen at health Care urgent care mid day, then ER early evening.
Age: 48.0
Sex: F
Vaccine: HEP, HEPA, TYP
Symptoms: Vomiting
Clinical narrative: On 6/20/2017 awoke with nausea, vomiting, diarrhea, mild headache, abdominal pain, hot and cold flashes. Symptoms persisted growing worse. On 6/21/2017 was seen at health Care urgent care mid day, then ER early evening.
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage
Clinical narrative: On July 13, 2017 it was discovered that there was an excertion on July 9 at 60.6F for 12.10 hours. Refrigerator went out of range.
Age: 23.0
Sex: M
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: On July 13, 2017, it was noticed that the temps were out of range on July 9 at 60.6 for 12.10 hours.
Age: 1.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Erythema, Local reaction, Mass, Pruritus, Skin warm
Clinical narrative: Local reaction of redness, swelling, and warm to touch about 1/2 baseball size lump. It is itchy. No drainage or fevers. Recommended Ice and BENADRYL cream to site. Continue to monitor.
Age: 1.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Swelling
Clinical narrative: Local reaction of redness, swelling, and warm to touch about 1/2 baseball size lump. It is itchy. No drainage or fevers. Recommended Ice and BENADRYL cream to site. Continue to monitor.
Age: 21.0
Sex: M
Vaccine: MMR, TDAP, VARCEL, MMR, TDAP, VARCEL
Symptoms: Product storage error
Clinical narrative: On July 13, 2017 we noted that the temps were out of range on July 9 (refrigerator-60.6) (freezer-unknown) for 12.10 Hours.
Age: 21.0
Sex: M
Vaccine: MMR, TDAP, VARCEL, MMR, TDAP, VARCEL
Symptoms: Poor quality drug administered, Product storage error
Clinical narrative: On July 13, 2017 we noted that the temps were out of range on July 9 (refrigerator-60.6) (freezer-unknown) for 12.10 Hours.
Age: 25.0
Sex: M
Vaccine: MMR, TDAP, VARCEL, MMR, TDAP, VARCEL, MMR, VARCEL
Symptoms: Product storage error
Clinical narrative: On July 13,2017 we reported a temp spike in the refrigerator 60.6 freezer is unknown on for 12.10 Hours on July9.
Age: 25.0
Sex: M
Vaccine: MMR, TDAP, VARCEL, MMR, TDAP, VARCEL, MMR, VARCEL
Symptoms: Poor quality drug administered, Product storage error
Clinical narrative: On July 13,2017 we reported a temp spike in the refrigerator 60.6 freezer is unknown on for 12.10 Hours on July9.
Age: 25.0
Sex: M
Vaccine: MMR, TDAP, VARCEL, MMR, TDAP, VARCEL, MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: On July 13,2017 we reported a temp spike in the refrigerator 60.6 freezer is unknown on for 12.10 Hours on July9.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Confusional state, Memory impairment
Clinical narrative: On day following the vaccination, my memory was severely impaired. I couldn't recognize the name of the local road vary near my house that connects to the interstate. Some confusion.
Age: 39.0
Sex: M
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Product storage error
Clinical narrative: On July 13, 2017, we reported a spike in temps refrigerator 60.6F and freezer unknown for 12.10 hours on July 9.
Age: 65.0
Sex: U
Vaccine: PNC13
Symptoms: Chills, Hypersensitivity, Mass, Pain, Pruritus
Clinical narrative: Pain, swelling, hard lump, rash, itch, 99.8 degree F temp, chills. Pt went to MD - severe allergic RXN, given prednisone.
Age: 65.0
Sex: U
Vaccine: PNC13
Symptoms: Rash, Swelling
Clinical narrative: Pain, swelling, hard lump, rash, itch, 99.8 degree F temp, chills. Pt went to MD - severe allergic RXN, given prednisone.
Sex: M
Vaccine: HEPA
Symptoms: Decreased appetite, Fatigue, Wrong drug administered
Clinical narrative: This spontaneous report was received from the patient's father and refers to a 4 day old male patient. The patient's medical history, concurrent condition, concomitant medication and drug allergies/reactions were unknown. It was reported that on 26-JUN-2017, the physician's office accidentally gave the patient VAQTA (dose, frequency, lot#, route of administration and indication were not provided) instead of the RECOMBIVAX HB. Afterward (on an unknown date in 2017), the patient seem "more tired" and was not interested in eating. No treatment was provided. The patient sought medical attention and visited physician office. The outcome of fatigue, wrong drug administered and decreased appetite were unknown. Causality assessment for the events fatigue and decreased appetite were not provided. No Product Quality Complaint (PQC) was involved. No further AE information provided. Additional informational is not expected as no contact details have been provided.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from an office manager via field representative and refers to a patient of unknown demographics. The patient's pertinent medical history, concurrent conditions, concomitant medications, past drugs and drug allergies were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (unknown route) (lot#, expiry date and dosing details were not reported) for prophylaxis. On an unknown date, the patient experienced an unspecified reaction to ZOSTAVAX. It was reported as unknown if the patient received treatment for adverse event. At the time of this report, the outcome of adverse event was unknown. The reporter did not provide the causality of adverse event with ZOSTAVAX. Additional information is not expected as no contact details were provided.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information was received via a telephone message left from a Merck representative on 27-JUN-2017 regarding a physician assistant who had reported to him that an unspecified patient had received a dose of GARDASIL 9 on 16-SEP-2016 and received a second dose on 25-APR-2017.  No further information about the patient was provided. Additional information was requested.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: Information was received on 29-JUN-2017 from a nurse regarding a patient (age and gender not reported). Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of VAQTA (lot number M039055, expiration date 22-JUL-2018) (dose, route, site of administration not reported). The nurse reported the medication was improperly stored. Temperature: 47 degrees Fahrenheit to 77 degrees Fahrenheit, Time frame: 10 minutes, Previous excursions: no, Was call due to data logger: yes. No adverse effects were reported. The outcome of the event was unknown. No additional information was provided. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse and refers to a 32 year old female patient. Medical history and concomitant medications were not provided. On 29-JUN-2017, the patient was vaccinated with and expired VAQTA (lot # M009786; expiration 26-MAY-2017). No adverse events were reported. The outcome was unknown. Additional information has been requested.
Age: 1.75
Sex: F
Vaccine: DTAP, HEPA, HIBV
Symptoms: Somnolence
Clinical narrative: Initial unsolicited report received from a medical assistant on 07-Jul-2017. This case involves a 21-months-old female patient who was vaccinated with a dose of ACT-HIB (Batch number: UI764AA, expiry date not reported) and HEPATITIS A VACCINE (Batch number: J3K9H7, expiry date not reported), via intramuscular route in right thigh and DTAP (Batch number: YA4MH, expiry date not reported), intramuscularly on 27-Jun-2017. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) reported as none. Any other vaccinations within 4 weeks of vaccinations was not reported. On 27-Jun-2017, same day following the vaccination, the patient became very sleepy. It was reported that the patient would wake up to eat and drink, but would fall back to sleep. No other symptoms reported. The patient required ER/doctor visit. Relevant diagnostic tests/laboratory data reported as none. The patient corrective treatment not reported. On an unknown date the patient's recovered from event (sleep lasted 3 days and then cleared up). List of documents held by sender: none.
Age: 76.0
Sex: M
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Dr. Office called pharmacy on 7/06/2017 to say patient came in on 7/1 with shoulder pain and limited mobility in the left arm. Nurse said patient was given prednisone and was coming back later that day for a follow up appointment.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Chills, Headache, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Swelling and pain in deltoid muscle, Headache, nausea, vomiting. Got HPV9 vaccine yesterday morning at about 10:20 am when she came in for left ankle pain. Later that evening about 19:00 hrs she started feeling pain in her arm, fever chills, headache and nausea with vomiting. Vommited twice last night, and still feels nauseous on exam today. In addition, has frontal throbbing headache denies photo/phonophobia and no pmhx of migraine headaches.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Vaccination site pain, Vaccination site swelling, Vomiting
Clinical narrative: Swelling and pain in deltoid muscle, Headache, nausea, vomiting. Got HPV9 vaccine yesterday morning at about 10:20 am when she came in for left ankle pain. Later that evening about 19:00 hrs she started feeling pain in her arm, fever chills, headache and nausea with vomiting. Vommited twice last night, and still feels nauseous on exam today. In addition, has frontal throbbing headache denies photo/phonophobia and no pmhx of migraine headaches.
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: Patient received the vaccine administered by a pharmacist. About 7 hours later patient started to experience pain and swelling at injection site. She reported to her PCP the following morning at which time she was given a prescription for KEFLEX 500mg and was told to use cold compresses for the swelling. The inflamed portion of her deltoid at injection site appeared red and slightly swollen. Margins measuring approximately 4 inches X 5inches. Pharmacist called PCP to question not prescribing a steroid. PCP did not want to use a steroid due to patient's medical history. Pharmacist recommended to the patient using cold compresses and BENADRYL 25mg OTC every 6-8 hours as needed.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Craniocerebral injury, Fall, Feeling abnormal, Gaze palsy, Loss of consciousness
Clinical narrative: Patient states he felt "strange" after rcving hpv vaccine, got up to go to the restroom, fell to the floor, hit his head on the floor, stiffened, eyes rolled back in his head, LOC at least 10 seconds, then very groggy when he came to. upon leaving the office 30 minutes after getting vaccine, was talking and smiling with a large knot on his head.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Musculoskeletal stiffness, Skin injury, Somnolence
Clinical narrative: Patient states he felt "strange" after rcving hpv vaccine, got up to go to the restroom, fell to the floor, hit his head on the floor, stiffened, eyes rolled back in his head, LOC at least 10 seconds, then very groggy when he came to. upon leaving the office 30 minutes after getting vaccine, was talking and smiling with a large knot on his head.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Blood potassium decreased, Dysphagia, Eyelid ptosis, Facial paralysis, Fatigue
Clinical narrative: Patient woke 7/10/17 feeling very tired. Developed a spot on her tongue that felt numb. This area of numbness increased over the next couple days to affect her airway and swallowing. On 7/11/17, she developed a severe headache, facial and eyelid droop to the left side of her face, difficulty walking and pain to her left arm and leg. Patient went to the local ER the night of 7/11/17. Labs revealed a decreased potassium level according to patients mother. Values unknown. PA in ER told the patient and her mother that she might have dehydration and possible heat stroke. Pt sent home. Symptoms continued to worsen and patient was driven by family to Clinic where she went through the ER early.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Gait disturbance, Headache, Hypoaesthesia oral, Oral pain, Pain in extremity
Clinical narrative: Patient woke 7/10/17 feeling very tired. Developed a spot on her tongue that felt numb. This area of numbness increased over the next couple days to affect her airway and swallowing. On 7/11/17, she developed a severe headache, facial and eyelid droop to the left side of her face, difficulty walking and pain to her left arm and leg. Patient went to the local ER the night of 7/11/17. Labs revealed a decreased potassium level according to patients mother. Values unknown. PA in ER told the patient and her mother that she might have dehydration and possible heat stroke. Pt sent home. Symptoms continued to worsen and patient was driven by family to Clinic where she went through the ER early.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Paraesthesia oral, Pharyngeal hypoaesthesia, Pharyngeal paraesthesia
Clinical narrative: Patient woke 7/10/17 feeling very tired. Developed a spot on her tongue that felt numb. This area of numbness increased over the next couple days to affect her airway and swallowing. On 7/11/17, she developed a severe headache, facial and eyelid droop to the left side of her face, difficulty walking and pain to her left arm and leg. Patient went to the local ER the night of 7/11/17. Labs revealed a decreased potassium level according to patients mother. Values unknown. PA in ER told the patient and her mother that she might have dehydration and possible heat stroke. Pt sent home. Symptoms continued to worsen and patient was driven by family to Clinic where she went through the ER early.
Age: 8.0
Sex: M
Vaccine: HEP
Symptoms: Immunisation, No adverse event
Clinical narrative: 7/10/17 An 8 year old male patient received an adult dose of GSK Engerix B vaccine in his right deltoid. This was a repeat 3rd dose due because the 3rd dose was given too soon after the 2nd dose by another health care facility. 7/13/17 Nurse called dad and informed him of vaccine error and what he may expect and to watch for. Dad said patient, ?Is doing well.? Dad had no questions or concerns. He was told to call if any concerns arise which he voiced understanding. No adverse event at this time, reporting wrong dose (1.0 ml vs. 0.5 ml).
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Tenderness
Clinical narrative: ORIGINALLY HAD PNEUMOVAX IN 2006, PREVNAR 13 IN 2016 WITHOUT INCIDENT. PATIENT HAD PNEUMOVAX ON 7/7/17 AND LATER THAT EVENING NOTED LEFT MEDIAL ARM  SWELLING, TENDERNESS, AND REDNESS. SEEN FOR EVALUATION IN DR'S OFFICE ON 7/10/17.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a Licensed Vocational Nurse referring to a patient of unknown age and gender. Medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored ROTATEQ (dose and route of administration were not reported) for prophylaxis. The doses were stored at temperatures 47-77 degrees Fahrenheit for a total time of 1 hour as identified by a digital data logger. It was reported that there were no previous temperature excursions. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unspecified date, the patient was vaccinated with an expired dose of PNEUMOVAX 23, lot # M003027, expiration date: 28-JUN-2017 (dose and route of administration was not reported) for prophylaxis. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored VARIVAX (dose and route of administration were not reported) lot # L035129, expiration date: 14-SEP-2017, for prophylaxis. The dose was stored at temperatures -14 degrees Celsius to -10 degrees Celsius for a total time of 2 hours. A digital data logger was not involved. A previous temperature excursion was reported at -9 degrees Celsius to 8 degrees Celsius for a total time of 7 hours and 45 minutes. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA, HIBV, HPV9, MMR, PPV, RV5, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant and refers to a multiple patient of unknown ages and gender. Medical history and concomitant medications were not provided. Improperly stored vaccines which were reconstituted with properly stored diluent were administered to multiple patients on various unspecified dates. The vaccines involved were: VAQTA (lot # M005274; expiration 03-APR-2018), GARDASIL 9, (lot # M041990; expiration 28-JUN-2019), MMR-II (lot # M040624; expiration 03-OCT-2018), PEDVAXHIB (lot # M036612; expiration 19-MAY-2019), PNEUMOVAX 23 (lot # M041990; expiration 10-JUN-2018), ROTATEQ (lot # M041184; expiration 31-MAY-2018), and VARIVAX (lot # N001530; expiration 13-JAN-2019). Temperature: 47-77 degrees F (50 degrees F) for 24 hours, 6-14 degrees F (7 degrees F) for 12 hours, 6-14 degrees F (10 degrees F) for 12 hours. Previous temperature excursion: No. Was call because of a data logger: yes. No adverse effects were reported. Additional information has been requested.