chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Pt. reported to office after varicella vaccine - rash started on legs and abdomen.
Age: 21.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Skin warm, Swelling
Clinical narrative: Pt was given PNEUMOVAX IM on 7/11/17. She developed swelling in arm on 7/12. She called to report on 7/13. Deltoid area warm and swollen.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No-Adverse Reaction. Expired Immunizations. Please call with any questions.
Age: 16.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Hypoaesthesia oral, Lip swelling, Seizure
Clinical narrative: Convulsions, swelling of lips, numbness around mouth.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Extra dose administered
Clinical narrative: This spontaneous report as received from a nurse via field representative refers to a 4 year old male patient. On 26-SEP-2013 the patient received doses of VARIVAX and M-M-R II. The patient then received a dose of PROQUAD on 14-OCT-2016. On 26-JUN-2017 the patient received extra doses of VARIVAX lot # N000682 and M-M-R II lot# M047302. That same visit the patient also received extra doses of diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid and poliovirus vaccine inactivated (unspecified). The patient experienced no adverse event. The outcome of extra dose administered, no adverse event and inappropriate schedule of drug administration is unknown. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Extra dose administered, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse via field representative refers to a 4 year old male patient. On 26-SEP-2013 the patient received doses of VARIVAX and M-M-R II. The patient then received a dose of PROQUAD on 14-OCT-2016. On 26-JUN-2017 the patient received extra doses of VARIVAX lot # N000682 and M-M-R II lot# M047302. That same visit the patient also received extra doses of diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid and poliovirus vaccine inactivated (unspecified). The patient experienced no adverse event. The outcome of extra dose administered, no adverse event and inappropriate schedule of drug administration is unknown. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Abdominal pain upper, Blood urine present, Dehydration, Dyspnoea, Headache
Clinical narrative: This is a spontaneous report from a contactable consumer reported for her daughter. A 18-year-old female patient received on 06Jul2017 around 10.00 am TRUMENBA, via intramuscular route, in the deltoid left, at 0,5ml single dose for immunization. The patient had no medical history, concomitant medications were unknown. Family history included diabetes for maternal great grandfather and paternal grandfather. On 06Jul2017 at 13.00pm, developed fever of 100.5, headache, stomach ache, nausea, vomiting, blood in urine, weakness, decreased appetite, on 07Jul2017 developed short of breath, on 08Jul2017 protein urine and on unknown date dehydration. Symptoms progressively got worse and she was taken to the ER on 08Jul2017 and admitted until 10Jul2017. The patient recovered from the events fever on 08Jul2017, vomiting on 07Jul2017, short of breath on 08Jul2017, protein urine on 10Jul2017 and the patient recovering from the events headache, stomach ache, nausea, blood in urine, weakness, decreased appetite. The outcome of the event dehydration was unknown. A test for urine was performed on 08Jul2017 with positive result for blood and protein.
Age: 18.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Pyrexia, Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer reported for her daughter. A 18-year-old female patient received on 06Jul2017 around 10.00 am TRUMENBA, via intramuscular route, in the deltoid left, at 0,5ml single dose for immunization. The patient had no medical history, concomitant medications were unknown. Family history included diabetes for maternal great grandfather and paternal grandfather. On 06Jul2017 at 13.00pm, developed fever of 100.5, headache, stomach ache, nausea, vomiting, blood in urine, weakness, decreased appetite, on 07Jul2017 developed short of breath, on 08Jul2017 protein urine and on unknown date dehydration. Symptoms progressively got worse and she was taken to the ER on 08Jul2017 and admitted until 10Jul2017. The patient recovered from the events fever on 08Jul2017, vomiting on 07Jul2017, short of breath on 08Jul2017, protein urine on 10Jul2017 and the patient recovering from the events headache, stomach ache, nausea, blood in urine, weakness, decreased appetite. The outcome of the event dehydration was unknown. A test for urine was performed on 08Jul2017 with positive result for blood and protein.
Age: 18.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Abdominal pain upper, Asthenia, Blood urine present, Decreased appetite, Dehydration
Clinical narrative: This is a spontaneous report from a contactable consumer reported for her daughter. A 18-year-old female patient received on 06Jul2017 around 10.00 am TRUMENBA, via intramuscular route, in the deltoid left, at 0,5ml single dose for immunization. The patient had no medical history, concomitant medications were unknown. Family history included diabetes for maternal great grandfather and paternal grandfather. On 06Jul2017 at 13.00pm, developed fever of 100.5, headache, stomach ache, nausea, vomiting, blood in urine, weakness, decreased appetite, on 07Jul2017 developed short of breath, on 08Jul2017 protein urine and on unknown date dehydration. Symptoms progressively got worse and she was taken to the ER on 08Jul2017 and admitted until 10Jul2017. The patient recovered from the events fever on 08Jul2017, vomiting on 07Jul2017, short of breath on 08Jul2017, protein urine on 10Jul2017 and the patient recovering from the events headache, stomach ache, nausea, blood in urine, weakness, decreased appetite. The outcome of the event dehydration was unknown. A test for urine was performed on 08Jul2017 with positive result for blood and protein.
Age: 18.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Dyspnoea, Headache, Nausea, Protein urine present, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer reported for her daughter. A 18-year-old female patient received on 06Jul2017 around 10.00 am TRUMENBA, via intramuscular route, in the deltoid left, at 0,5ml single dose for immunization. The patient had no medical history, concomitant medications were unknown. Family history included diabetes for maternal great grandfather and paternal grandfather. On 06Jul2017 at 13.00pm, developed fever of 100.5, headache, stomach ache, nausea, vomiting, blood in urine, weakness, decreased appetite, on 07Jul2017 developed short of breath, on 08Jul2017 protein urine and on unknown date dehydration. Symptoms progressively got worse and she was taken to the ER on 08Jul2017 and admitted until 10Jul2017. The patient recovered from the events fever on 08Jul2017, vomiting on 07Jul2017, short of breath on 08Jul2017, protein urine on 10Jul2017 and the patient recovering from the events headache, stomach ache, nausea, blood in urine, weakness, decreased appetite. The outcome of the event dehydration was unknown. A test for urine was performed on 08Jul2017 with positive result for blood and protein.
Age: 18.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer reported for her daughter. A 18-year-old female patient received on 06Jul2017 around 10.00 am TRUMENBA, via intramuscular route, in the deltoid left, at 0,5ml single dose for immunization. The patient had no medical history, concomitant medications were unknown. Family history included diabetes for maternal great grandfather and paternal grandfather. On 06Jul2017 at 13.00pm, developed fever of 100.5, headache, stomach ache, nausea, vomiting, blood in urine, weakness, decreased appetite, on 07Jul2017 developed short of breath, on 08Jul2017 protein urine and on unknown date dehydration. Symptoms progressively got worse and she was taken to the ER on 08Jul2017 and admitted until 10Jul2017. The patient recovered from the events fever on 08Jul2017, vomiting on 07Jul2017, short of breath on 08Jul2017, protein urine on 10Jul2017 and the patient recovering from the events headache, stomach ache, nausea, blood in urine, weakness, decreased appetite. The outcome of the event dehydration was unknown. A test for urine was performed on 08Jul2017 with positive result for blood and protein.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: SINCE RECEIVNG THE SHINGLES VACCINE I HAVE BEEN BREAKING OUT WITH RED BUMPS AND HIVES ALL OVER MY BODY SINCE ABOUT 5 HOURS OF RECEIVING THE SHOT. THIS HAS CONTINUED NON-STOP FOR OVER 2 MONTHS. EVERYTIME SOME GO AWAY A FEW MORE WILL COME. THEY ARE ALWAYS  RED. THEY LOOK SIMILAR TO MEASLES OR CHICKENPOX. THEY ARE ON MY BACK, HANDS, LEGS AND FEET. THEY ARE WARM TO THE TOUCH. THEY MAKE MY BODY FEVERISH. THEY ALSO ITCH CONSISTENTLY ALL DAY LONG. SOME ARE SMALL, OTHERS ARE BIG. MOST ARE RED. THEY COME AND GO. WHEN THEY LEAVE THEY LEAVE BLACK MARKS ON MY SKIN. THIS IS NEVER-ENDING. I HAVE TAKEN PREDNISONE AND PREDNISONE SHOTS TO NO AVAIL. MY DOCTOR HAS SAID THERE IS NOTHING ELSE SHE CAN DO FOR ME. I WAS REFERRED TO AN ALLERGIST WHO STATED HE DIDNT KNOW WHAT TO DO. I WAS TOLD BY ONE PERSON THAT I WAS ALLERGIC TO THE THIMEROSAL THAT WAS IN THE VACCINE. ANOTHER DOCTOR SAID IT WAS THE IODINE. NO ONE HAS CONCLUDED WHAT THE ALLERGIC REACTION WAS FROM OTHER THAN THE VACCINE.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hypersensitivity, Rash erythematous, Rash morbilliform, Rash vesicular, Skin discolouration
Clinical narrative: SINCE RECEIVNG THE SHINGLES VACCINE I HAVE BEEN BREAKING OUT WITH RED BUMPS AND HIVES ALL OVER MY BODY SINCE ABOUT 5 HOURS OF RECEIVING THE SHOT. THIS HAS CONTINUED NON-STOP FOR OVER 2 MONTHS. EVERYTIME SOME GO AWAY A FEW MORE WILL COME. THEY ARE ALWAYS  RED. THEY LOOK SIMILAR TO MEASLES OR CHICKENPOX. THEY ARE ON MY BACK, HANDS, LEGS AND FEET. THEY ARE WARM TO THE TOUCH. THEY MAKE MY BODY FEVERISH. THEY ALSO ITCH CONSISTENTLY ALL DAY LONG. SOME ARE SMALL, OTHERS ARE BIG. MOST ARE RED. THEY COME AND GO. WHEN THEY LEAVE THEY LEAVE BLACK MARKS ON MY SKIN. THIS IS NEVER-ENDING. I HAVE TAKEN PREDNISONE AND PREDNISONE SHOTS TO NO AVAIL. MY DOCTOR HAS SAID THERE IS NOTHING ELSE SHE CAN DO FOR ME. I WAS REFERRED TO AN ALLERGIST WHO STATED HE DIDNT KNOW WHAT TO DO. I WAS TOLD BY ONE PERSON THAT I WAS ALLERGIC TO THE THIMEROSAL THAT WAS IN THE VACCINE. ANOTHER DOCTOR SAID IT WAS THE IODINE. NO ONE HAS CONCLUDED WHAT THE ALLERGIC REACTION WAS FROM OTHER THAN THE VACCINE.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Urticaria
Clinical narrative: SINCE RECEIVNG THE SHINGLES VACCINE I HAVE BEEN BREAKING OUT WITH RED BUMPS AND HIVES ALL OVER MY BODY SINCE ABOUT 5 HOURS OF RECEIVING THE SHOT. THIS HAS CONTINUED NON-STOP FOR OVER 2 MONTHS. EVERYTIME SOME GO AWAY A FEW MORE WILL COME. THEY ARE ALWAYS  RED. THEY LOOK SIMILAR TO MEASLES OR CHICKENPOX. THEY ARE ON MY BACK, HANDS, LEGS AND FEET. THEY ARE WARM TO THE TOUCH. THEY MAKE MY BODY FEVERISH. THEY ALSO ITCH CONSISTENTLY ALL DAY LONG. SOME ARE SMALL, OTHERS ARE BIG. MOST ARE RED. THEY COME AND GO. WHEN THEY LEAVE THEY LEAVE BLACK MARKS ON MY SKIN. THIS IS NEVER-ENDING. I HAVE TAKEN PREDNISONE AND PREDNISONE SHOTS TO NO AVAIL. MY DOCTOR HAS SAID THERE IS NOTHING ELSE SHE CAN DO FOR ME. I WAS REFERRED TO AN ALLERGIST WHO STATED HE DIDNT KNOW WHAT TO DO. I WAS TOLD BY ONE PERSON THAT I WAS ALLERGIC TO THE THIMEROSAL THAT WAS IN THE VACCINE. ANOTHER DOCTOR SAID IT WAS THE IODINE. NO ONE HAS CONCLUDED WHAT THE ALLERGIC REACTION WAS FROM OTHER THAN THE VACCINE.
Age: 14.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Asthenia, Decreased appetite, Heart rate increased, Hypotension, Loss of consciousness
Clinical narrative: Three days after receiving the GARDASIL 9 vaccine. 14 year old daughter began passing out and having multiple seizures on a daily basis. Loss of bodily functions while loss of unconsciousness. Confusion, memory loss, migraines aches and pains in muscles and joints on a daily basis.
Age: 14.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Loss of personal independence in daily activities, Seizure, Somnolence
Clinical narrative: Three days after receiving the GARDASIL 9 vaccine. 14 year old daughter began passing out and having multiple seizures on a daily basis. Loss of bodily functions while loss of unconsciousness. Confusion, memory loss, migraines aches and pains in muscles and joints on a daily basis.
Age: 14.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Amnesia, Arthralgia, Autonomic nervous system imbalance, Confusional state, Loss of consciousness
Clinical narrative: Three days after receiving the GARDASIL 9 vaccine. 14 year old daughter began passing out and having multiple seizures on a daily basis. Loss of bodily functions while loss of unconsciousness. Confusion, memory loss, migraines aches and pains in muscles and joints on a daily basis.
Age: 14.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Migraine, Myalgia, Postural orthostatic tachycardia syndrome, Seizure, Syncope
Clinical narrative: Three days after receiving the GARDASIL 9 vaccine. 14 year old daughter began passing out and having multiple seizures on a daily basis. Loss of bodily functions while loss of unconsciousness. Confusion, memory loss, migraines aches and pains in muscles and joints on a daily basis.
Age: 14.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Tachycardia
Clinical narrative: Three days after receiving the GARDASIL 9 vaccine. 14 year old daughter began passing out and having multiple seizures on a daily basis. Loss of bodily functions while loss of unconsciousness. Confusion, memory loss, migraines aches and pains in muscles and joints on a daily basis.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Decreased appetite, Eye movement disorder, Febrile convulsion, Hyporesponsive to stimuli, Incoherent
Clinical narrative: I believe patient got the vaccinations sometime in the morning. Even though he never napped, he was very lethargic all afternoon and fell asleep on the couch.  Around 4:00, when my mom and I tried to rouse him, his eyes rolled back into his and he became stiff (arms, legs, and trunk). This only lasted for a few seconds (maybe 5?), but it was scary. He was also not very coherent and not responding well when I talked to him. He did not want any dinner. We put him to bed around 6 pm. After talking to my pediatrician, we woke him up and took him to the pediatric urgent care type office, as per her recommendation. The doctor there examined him.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Lethargy, Musculoskeletal stiffness, Somnolence
Clinical narrative: I believe patient got the vaccinations sometime in the morning. Even though he never napped, he was very lethargic all afternoon and fell asleep on the couch.  Around 4:00, when my mom and I tried to rouse him, his eyes rolled back into his and he became stiff (arms, legs, and trunk). This only lasted for a few seconds (maybe 5?), but it was scary. He was also not very coherent and not responding well when I talked to him. He did not want any dinner. We put him to bed around 6 pm. After talking to my pediatrician, we woke him up and took him to the pediatric urgent care type office, as per her recommendation. The doctor there examined him.
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapy, drug and allergy history were not provided. The pharmacist reported that on an unknown date, the patient, who was intended to receive ZOSTAVAX, was inadvertently vaccinated with VARIVAX (dose number, route of administration, lot number, expiration date and indication were not reported). It was also mentioned a sterile diluent used (lot number and expiration date were not provided). On an unspecified date, 1 week after administration of the VARIVAX dose; the patient was vaccinated with a dose of ZOSTAVAX (dose number, route of administration, lot number, expiration date and indication were not reported). No adverse effects were reported.
Age: 47.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Information was received 28-JUN-2017 via telephone call from a pharmacist. The pharmacist reported that a 47 year old female patient received a M-M-R II vaccine, 0.5 ml intramuscular (IM) on 31-MAR-2017 because she is a nursing student. (Lot # M017348, expiration date 06-APR-2018). It was noted that IM administration is an off label administration route. The patients medical history, current medical conditions, concomitant medications were not provided. The pharmacist reported that the patient did not report experiencing any issues and the prescribing physician was not contacted. Pharmacist reported that the second M-M-R II vaccine was administered subcutaneously on 27-JUN-2017. As of 28-JUN-2017 it was unknown if the patient would continue to receive the M-M-R II. The pharmacist had reported the typeface is too small to read the directions for determining the route of administration, very small print on box. Product Quality Complaint was filed. The outcome of MMR II vaccine administered IM instead of SQ was unknown. Additional information was requested.
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with a dose of ZOSTAVAX, subcutaneous in the back of the arm or triceps area of the arm for prophylaxis. On unknown dates, the patients experienced drug administered at inappropriate site and no adverse event. The outcome of drug administered at inappropriate site and no adverse event was unknown. The reporter considered drug administered at inappropriate site and no adverse event to be not related to ZOSTAVAX.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information was received on 30-JUN-2017 from a pharmacist regarding a male patient (age not reported). Medical history, concurrent conditions and concomitant medications were not reported. The patient was administered three doses of ZOSTAVAX. The first dose was given on 17-OCT-2014 (lot # K009769, unspecified expiration date); the second dose was given 24-SEP-2015 (lot # L015417, expiration date 01-AUG-2016); and the third dose was given on 04-JAN-2017 (lot # M035695, expiration date 07-NOV-2017). No adverse effects were reported. The outcome of the events were unknown. No further information was provided. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PPV, VARCEL
Symptoms: Fatigue, Injection site pain, Rash generalised, Wrong drug administered
Clinical narrative: This spontaneous report was received from the patient's father referring to her daughter, an approximately 1-year-old female patient, with milk allergy as concurrent condition. The patient had no pertinent medical history or concomitant medications. On an unknown date towards the end of June 2017, the patient was inadvertently vaccinated with a dose of PNEUMOVAX 23 (lot#, expiration date, route of administration and frequency were unspecified) for prophylaxis, along with four other unspecified routine vaccinations during an office visit. On an unknown date in June 2017 (reported as since getting the vaccines administered) the patient had been tired and her leg hurt where she got the vaccines administered (pain in extremity). Additionally, it was reported that she had a body rash on an unspecified date (rash generalized). It was reported that the patient was not hospitalized because of the adverse events. At the time of the report, the outcome of pain in extremity, rash generalized and fatigue was unknown. The relatedness assessment between PNEUMOVAX 23 and pain in extremity, rash generalized and fatigue was not reported.
Sex: U
Vaccine: MMR, MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information was received on 29-JUN-2017 from a nurse who reported that a patient (age and gender not reported) was administered an expired M-M-R II (lot# L023386, expiration 25-JUN-2017) on 28-JUN-2017. No adverse effects were reported. No further information provided.  Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a 72 year old female consumer concerning on herself. Medical history and concurrent conditions were not provided. Approximately in 2015 (reported as about 2.5 years ago), the patient was vaccinated with a dose of ZOSTAVAX injection (dose, route, lot# and the expiration date were not reported) for prevention of shingles. Concomitant therapies included two unspecified inhalers budesonide, formoterol fumarate (SYMBICORT) and umeclidinium bromide (INCRUSE ELLIPTA). On 20-JUN-2017, the patient experienced shingles (herpes zoster) for an unspecified reason, had an outpatient visit to the Community Medical Center and received acetaminophen, oxycodone hydrochloride (PERCOCET) and gabapentin (NEURONTIN) as treatments for the event. At the time of reporting, the outcome of herpes zoster was reported as not recovered. The relatedness between the therapy with ZOSTAVAX and the event was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to multiple patients of unknown age. On an unknown date the patients were vaccinated with VARIVAX lot # M048203 for prophylaxis which had been stored incorrectly. It was stored at 6F to 14F for 74 hours and 22 minutes. There was no previous temperature excursion. This was reported due to a data logger. The diluent was stored properly (lot# not specified). No adverse effects were noted. 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 nurse practitioner and refers to an unspecified  number of patients of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On an unknown dates, the patients were vaccinated with an improperly stored dose of VAQTA lot number N003194 with expiration date 28-OCT-2017 (dose, route and anatomical location were not reported) for prophylaxis. The vaccines were exposed to 47 F (Fahrenheit) during 72 hours. There was no previous temperature excursion, digital data logger was filled. No adverse effects were reported in any patients. This is one of several reports from the same source.; Sender's Comments:  US-009507513-1707USA004450: US-009507513-1707USA004449:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to an unspecified number of patients of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On an unknown dates, the patients were vaccinated with an improperly stored dose of ROTATEQ lot number M032636 with expiration date 06-APR-2018 and lot number M040271 with expiration date 30-APR-2018 (dose, route and anatomical location were not reported) for prophylaxis. The vaccines were exposed to 47 F (Fahrenheit) during 72 hours. There was no previous temperature excursion, digital data logger was filled. No adverse effects were reported in any patients. This is one of several reports from the same source.; Sender's Comments: US-009507513-1707USA004450: US-009507513-1707USA004419:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to an unspecified number of patients of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On an unknown dates, the patients were vaccinated with an improperly stored dose of GARDASIL 9 number M036059 with expiration date 03-JUN-2019 and lot number N002720 with expiration date 12-MAY-2019 (dose, route and anatomical location were not reported) for prophylaxis. The vaccines were exposed to 47 F (Fahrenheit) during 72 hours. There was no previous temperature excursion, digital data logger was filled. No adverse effects were reported in any patients. This is one of several reports from the same source. Sender's Comments: US-009507513-1707USA004419: US-009507513-1707USA004449:
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Dizziness, Hyperhidrosis, Pallor
Clinical narrative: Pt developed lightheadedness. Pallor, diaphoretic. Symptoms were completely resolved within about 10 minutes.
Age: 1.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Rash macular, Urticaria
Clinical narrative: Approximately 10 minutes after PREVNAR was given, child developed redness and slight swelling at injection site (5-6 cm and warm to touch). Given Benadryl. Redness improved after 20 minutes. Then soon returned to office with a faint generalized macular rash to face and BLE. She was sleeping without distress. Monitored in office. Rash resolved 40 minutes later except for half dollar size urticaria to left buttock.
Sex: U
Vaccine: RV5
Symptoms: Immediate post-injection reaction, Vomiting
Clinical narrative: Information was received 28-JUN-2017 via a phone call from a nurse. The nurse reported that a 2-6 month old infant of unknown gender was given a dose of ROTATEQ for vaccination on an unknown date. The lot number and expiration date were not provided. Relevant lab data, medical history, medication history and concomitant medications were unknown. The mother of the infant gave the infant formula immediately after receiving ROTATEQ and the baby vomited.  As of 28-JUN-2017 it was unknown if the baby was to be re-vaccinated.  No further information was provided. The outcome of vomiting is unknown. Additional information was requested.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of "other" ethnicity and unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored (in 32-35 degrees Fahrenheit for 12 hours) doses of ROTATEQ (orally, lot # M039067, expiration date 18-APR-2018; dose was not reported) for prophylaxis. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1707USA005222:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant and refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions, drug allergies/reactions, and concomitant therapies were not reported. On 26-JUN-2017, the patient was administered one expired dose of VAQTA (dose, route of administration, and site of administration were not reported), lot # M037096, expiration date 17-JUN-2017; for prophylaxis. No adverse effects were reported. A product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of "other" ethnicity and unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored (in 32-35 degrees Fahrenheit for 12 hours) doses of GARDASIL 9 (lot # M041990, expiration date 28-JUN-2019; dose and route of administration were not reported) for prophylaxis. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA002408.
Sex: M
Vaccine: MEN, MENB, UNK
Symptoms: Body temperature increased
Clinical narrative: This is a spontaneous report from contactable physician via a Pfizer Sales Representative. A 16-17 year old male patient of an unspecified race/ethnicity received TRUMENBA at single dose via an unspecified route on unknown date. Medical history and concomitant medication were unknown. On the same date the patient also received diphtheria vaccine, pertussis vaccine, tetanus vaccine (TDAP IMMUN) and a meningococcal vaccine. On an unknown date the patient experienced a temperature of 103 approximately for 24 hours. The event recovered on an unknown date.
Sex: F
Vaccine: MEN, MENB, UNK
Symptoms: Body temperature increased
Clinical narrative: This is a spontaneous report from contactable physician via a Pfizer Sales Representative. A 16-17 year old female patient of an unspecified race/ethnicity received TRUMENBA at single dose via an unspecified route on unknown date. Medical history and concomitant medication were unknown. On the same date the patient also received diphtheria vaccine, pertussis vaccine, tetanus vaccine (TDAP IMMUN) and a meningococcal vaccine. On an unknown date the patient experienced a temperature of 103 approximately for 24 hours. The event recovered on an unknown date.
Sex: F
Vaccine: MENB
Symptoms: Headache, Nausea, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for the daughter. A female patient of an unspecified age and race/ethnicity received the first dose of TRUMENBA on 10Jul2017, at 0.5 ml single, for immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Since 10Jul2017 and on 11Jul2017 throughout the day the patient experienced fever (at 101.5), was very achy all over the body, had nauseous feeling off and on and her head hurt. The events had not yet resolved at the time of report.
Sex: U
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A contactable Clinical Service Manager reporting on behalf of pharmacist that a patient of an unspecified age, gender and ethnicity received PREVNAR 13 for immunization at single dose on unknown date. Medical history and concomitant medication were unknown. The patient experienced sore arm after receiving the vaccine. The outcome of the event was unknown.
Sex: F
Vaccine: MENB
Symptoms: Feeling abnormal, Nausea
Clinical narrative: This is a spontaneous report from a contactable consumer via a Pfizer sales representative. A female patient of an unspecified age and ethnicity received first dose of TRUMENBA (lot number and expiry was unknown), via an unspecified route of administration on an unspecified date at a single dose for prevention of Meningococcal B. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced nausea and just felt off. The outcome of the events was recovered.
Sex: F
Vaccine: MENB
Symptoms: Cellulitis, Erythema, Feeling hot, Rash, Swelling
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of cellulitis in a 18-year-old female patient who received BEXSERO. In June 2017, the patient received the 1st dose of BEXSERO. On an unknown date, 5 days after receiving BEXSERO, the patient experienced cellulitis (serious criteria GSK medically significant), rash, swelling, feeling of warmth and erythema. The patient was treated with antibiotics nos. On an unknown date, the outcome of the cellulitis, rash, swelling, feeling of warmth and erythema were unknown. It was unknown if the reporter considered the cellulitis, rash, swelling, feeling of warmth and erythema to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The adverse event was reported from the physician's office, which happened about a month before the reporting date. One of their patients received their first dose of BEXSERO and about five days after that the patient experienced rash on her whole arm. The patient went to emergency room and was diagnosed with cellulitis, rash, swelling and warm erythema on her right shoulder.
Age: 14.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Blood glucose normal, Confusional state, Musculoskeletal stiffness, Seizure, Syncope
Clinical narrative: Pt given immunizations and had syncopal episode. Pt then stiffened and began convulsing. Tonic clonic activity x approx 15 seconds. Pt then awakened. Mild confusion for a few minutes. Vital signs stable. Pt was referred to the ER and diagnosed with Vasovasal Syncope. Pt also has a neuro appointment on August 14th. Called mother and mother reports pt has had no further episodes.
Age: 14.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Tonic clonic movements
Clinical narrative: Pt given immunizations and had syncopal episode. Pt then stiffened and began convulsing. Tonic clonic activity x approx 15 seconds. Pt then awakened. Mild confusion for a few minutes. Vital signs stable. Pt was referred to the ER and diagnosed with Vasovasal Syncope. Pt also has a neuro appointment on August 14th. Called mother and mother reports pt has had no further episodes.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash pruritic
Clinical narrative: Patient states "Rash with draining spots on back and both legs. Rash is very itchy." Advised patient to go see MD. Voiced understanding. Client works in nursing home she says so is going to MD today.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Loss of consciousness
Clinical narrative: A few moments after the administration patient lost consciousness.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal discomfort, Asthenia, Cardiac stress test normal, Disturbance in attention, Echocardiogram normal
Clinical narrative: Patient received the third vaccine in the GARDASIL 9 series on January 27. On February 15 she began complaining that her "stomach didn't feel right" and she felt strange. She was weak and very tired.  On the morning of February 16, she passed out at home and was taken to the ER. On Febraury 20, she was diagnosed with POTS and has since had the diagnosis confirmed by a cardiologist and  also by a dysautonomia physician who conducted a tilt table test.  Looking back I believe she had symptoms even after the first injection as she began taking naps when she hadn't taken naps since she was 4-years-old, she complained of being tired all the time, and said she just didn't feel good often.  She seemed to be unable to concentrate and had difficulty comprehending and retaining information at school even though she has always been an A student.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Educational problem, Electrocardiogram normal, Fatigue, Feeling abnormal, Laboratory test
Clinical narrative: Patient received the third vaccine in the GARDASIL 9 series on January 27. On February 15 she began complaining that her "stomach didn't feel right" and she felt strange. She was weak and very tired.  On the morning of February 16, she passed out at home and was taken to the ER. On Febraury 20, she was diagnosed with POTS and has since had the diagnosis confirmed by a cardiologist and  also by a dysautonomia physician who conducted a tilt table test.  Looking back I believe she had symptoms even after the first injection as she began taking naps when she hadn't taken naps since she was 4-years-old, she complained of being tired all the time, and said she just didn't feel good often.  She seemed to be unable to concentrate and had difficulty comprehending and retaining information at school even though she has always been an A student.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Loss of consciousness, Postural orthostatic tachycardia syndrome, Sleep disorder, Tilt table test positive
Clinical narrative: Patient received the third vaccine in the GARDASIL 9 series on January 27. On February 15 she began complaining that her "stomach didn't feel right" and she felt strange. She was weak and very tired.  On the morning of February 16, she passed out at home and was taken to the ER. On Febraury 20, she was diagnosed with POTS and has since had the diagnosis confirmed by a cardiologist and  also by a dysautonomia physician who conducted a tilt table test.  Looking back I believe she had symptoms even after the first injection as she began taking naps when she hadn't taken naps since she was 4-years-old, she complained of being tired all the time, and said she just didn't feel good often.  She seemed to be unable to concentrate and had difficulty comprehending and retaining information at school even though she has always been an A student.
Age: 72.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: I, MA, accidentally administered Varicella to the patient but intended to administer Zoster. I did not witness any adverse reaction to the vaccine however.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Swollen, itchy, hot around the injection site.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Hyperhidrosis, Pallor, Syncope, Vision blurred
Clinical narrative: Patient presents blurred vision and fainting 10 minutes after vaccine administration. Patient was pale and diaphoretic. Initial Vital sign BP: 90/50 mmHg, HR:76 bpm, RR: 18 rpm 1 minutes  Vital sign BP : 100/65 mmHg, HR: 74 bpm, RR 16 rpm Patient was under observation 15 minutes after last vital sign check. Patient denies dizziness, blurred vision or headache. Patient and parent was oriented about vaccine adverse reactions and  recommended  further medical evaluation by her primary care physician. Patient and parent refers understand instructions and recommendations. Patient recived all vaccine documentation. Patient was call to follow up primary care physician visit.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Bladder catheterisation, Pyrexia, Urine analysis normal, Vomiting
Clinical narrative: Patient presented to office on 7/16/2017 after vomiting several times  on 7/15/2017; patient with history of GERD. Parent reports patient with  temperature of 100.4 on the morning of 7/16/2017, parent administered tylenol. No fever in office. Cath Urine was preformed in office to rule out UTI. Results were negative. Patient prescribed Zantac and advised to follow up on 7/17/2017. Patient in for follow up on 7/17/2017; symptoms improving.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site reaction, Rash macular
Clinical narrative: Patient reported by phone that she had "red blotches down the arm" from the injection site to the wrist. Reported no fever, pain, swelling or itching. Reported within 4 1/2 hrs of injection.
Age: 20.0
Sex: M
Vaccine: HPV9
Symptoms: Laboratory test, Myalgia, Nausea, Pyrexia
Clinical narrative: Child was feeling nauseated, fever, myalgia after working a twelve hour shift. Call to dr after hours and sent to hospital.
Age: 0.08
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Immediate post-injection reaction, Irritability, Lethargy, Listless
Clinical narrative: Baby became listless and lethargic immediately after vaccine administration. Baby received PENTACEL along with PREVNAR (pneumococcal) and Rotavirus (oral) vaccine. Head was slumped over but baby was able to to be aroused by doctor when doctor shined light in pt eyes. Baby was mostly listless except when stimulated by repeated touch and light for about 15 minutes. Parents took baby home and said she was fussy later in the day, ate fairly normally that night and seemed to be doing better the next day.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Pt with right deltoid swollen, red, and hot at sight. provider advised cold compress and to use benadryl every 8 hours for adverse reaction.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Pain, Pain in extremity
Clinical narrative: R arm pain with abduction. No tenderness on site or induration on exam.
Age: 17.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Crying, Dyspnoea, Irritability, Pruritus
Clinical narrative: Client was fine right after injections, left and went home. Returned to clinic about 30 minutes later and was crying and very upset. Said her palms were itching like crazy, she said she could not stop scratching them, and she felt like she could not breathe. We brought the client back to a room, blood pressures was 112/62, pulse 90. Palms clammy and face red, client crying and very upset. States she could not breathe. We administered 50mg of diphenhydramine (lot # 096330, exp date 9/2018) intramuscular at that time. Nurse remained with patient. Patient stopped crying and was calming down at this point. She was able to take several big, deep breathes and stated that she was feeling better. By 3:45pm, client was breathing without problems and itching had stopped. Client and mother left clinic about 4pm, stating that felt fine and breathing fine and itching had stopped completely. Phone call to patient's mother on 7-18-2017. Mother stated that patient does not feel well today, but no problems breathing. Mother did give patient another BENADRYL pill last night. Mom stated no problems breathing or with itching.
Sex: U
Vaccine: HIBV, HPV9, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple, unspecified patients of unknown age and gender. No information about the patients' medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. The medical assistant reported that multiple doses of improperly stored vaccines of ROTATEQ (Lot # M032636, expiration date 06-APR-2018), GARDASIL 9 (Lot # M036059, Expiration date 03-JUN-2019), and PEDVAXHIB (Lot # M034188, expiration date 20-MAY-2019) were administered (dose, site and route of administration were not reported) to multiple unspecified patients on multiple unspecified dates. The temperature excursion was reported as 47 degrees Fahrenheit  -  77 degrees Fahrenheit for 1 hour. There was no previous temperature excursion. Digital data logger was used. No adverse effects were reported. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a Registered Nurse and refers to a patient of unknown age and gender. Medical history and concomitant medications were not provided. On an unspecified date, the patient received an improperly stored dose of PROQUAD (lot # M033215; expiration 09-JAN-2018). Temperature: 6 degrees F to 14 degrees F (6.8 degrees F). Time frame: one hour. Call was because of a data logger. The diluent used to reconstitute the PROQUAD was properly stored. No adverse effect was reported. Additional information has been requested.
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This initial spontaneous report was received from a Registered Nurse and refers to a female patient of unknown age. Medical history and concomitant medications were not provided. On 27-JUN-2017, the patient was vaccinated with VARIVAX (lot # M049126; expiration 15-DEC-2018) and diphtheria toxoid pertussis acellular vaccine (unspecified) tetanus toxoid (reported as Tdap) (lot # 3457Y; expiration 20-MAY-2019) when she was 15 weeks pregnant. The sterile diluent was unknown by the reporter. The nurse reported that the patient spoke a different language and an interpreter was present for the immunization consent and the patient did not say she was pregnant. No adverse effects were reported. The outcome of the pregnancy was pending. Additional information has been requested.
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received on 29-JUN-2017 from a vaccine coordinator regarding a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 27-JUN-2017 the patient received an improperly stored dose of PEDVAXHIB lot # M032150, expiration 21-APR-2019, intramuscular for prophylaxis. No adverse effects reported. The vaccine was stored between the temperatures of 47 degrees Fahrenheit to 77 degrees Fahrenheit for the time period of 50 hours. There were no previous temperature excursions reported. The call was made because of a data logger. No further information available. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA005466.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a 62 year old female patient referring to herself. Medical history and concomitant medications were not provided. She is allergic to all narcotics. On an unspecified date, the patient received ZOSTAVAX (dose, indication and lot # not provided). On 29-JUN-2017, the patient developed shingles on an unspecified area. She saw her physician and he gave her a "shot" of acyclovir. The outcome of the event was unknown. Additional information is not expected as the patient did not grant consent to follow up.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant regarding unspecified number of patients (ages and genders not provided). Sometime in JUN-2017 the patients were vaccinated with VARIVAX lot # M033211 exp 13-JUL-2018 and lot # N002204 exp 19-JAN-2019, PROQUAD lot# M037011 exp 21-APR-2018 and lot# M044719 exp 07-MAY-2018, and sterile diluent(STERILE DILUENT). It was reported that the products were stored improperly. The sterile diluent was stored properly. PROQUAD and VARIVAX were stored at 6F to 14F for 14 hours and 7 minutes. No previous temperature excursion. Data logger was yes. There were not reported symptoms. Additional information has been requested.
Sex: U
Vaccine: HEP, HEPA, HIBV, HPV9, MMR, PPV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received on 30-JUN-2017 from a medical assistant regarding an unspecified number of patients. Medical history, concurrent conditions and concomitant medications were not reported. On unspecified dates, the patients received improperly stored PNEUMOVAX 23 (lot # M037669, exp date 09-MAY-2018), PEDVAXHIB (lot # N000235, exp date 26-OCT-2019), VAQTA (lot # L017757, exp date 08-APR-2018), ROTATEQ (lot # M041765, exp date 05-MAY-2018; lot # M031807, exp date 02-APR-2018), GARDASIL 9 (lot # N000326, exp date 14-OCT-2019; lot # M43731, exp date 22-JUN-2019; and lot # N002720, exp date 12-MAY-2019), RECOMBIVAX HB 2.5/0.5 (lot # M039642, exp date 03-JUL-2019), and MMR-II (lot # M040558, exp date 03-OCT-2018; lot # M035389, exp date 02-AUG-2018). Temperature and time frame: 36 degrees Fahrenheit to 46 (46.4F) degrees Fahrenheit for 30 minutes. Previous temperature excursion? 22-MAY-2017 47 degrees Fahrenheit to 77 degrees Fahrenheit (55F) for 2 hours and 30 minutes. Was call because of a "data logger"? No. No adverse effects reported. The outcome of the event was unknown. Additional information has been requested.