chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Urticaria
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of generalized urticaria in a 16-year-old male patient who received BEXSERO (batch number 151501, expiry date unknown). Concomitant products included MENACTRA. On an unknown date, the patient received BEXSERO. On an unknown date, several hours after receiving BEXSERO, the patient experienced generalized urticaria. The patient was treated with CLARITIN, steroids nos and MEDROL dose pack. On an unknown date, the outcome of the generalized urticaria was unknown. It was unknown if the reporter considered the generalized urticaria to be related to BEXSERO. Additional details were provided as follows: The reporter stated that, the patient was administered with a dose of BEXSERO on Friday at 4:00 and 2nd dose of MENACTRA the same day. A few hours later the patient broke out in hives. The patient was treated with CLARITIN and the hives had come and go over the weekend until Sunday, when the patient broke out into hives all over his body. The patient went to emergency room on Sunday and he was given a steroid injection and started on MEDROL dose pack. No further information was provided.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a nurse referring to three unspecified patients of unknown age and genders. Pertinent medical history, rug reactions/allergies and concomitant medications were not reported. The reporter stated that on unspecified dates, the patients were inadvertently vaccinated with improperly stored doses of LIQUID PEDVAXHIB (lot # L038501 with expiration date 16-AUG-2018 or lot # L051122 with expiration date 12-OCT-2018; the dose, route and anatomical location were not reported (the nurse was unable to tell which lot # was administered). The vaccines underwent a temperature of 8.8C during 40 minutes with an "outcome" reported as "supported". No adverse effect was reported and a product quality complaint (PQC) was not involved. It was unknown if the patients sought medical attention. Additional information is not expected as the reporter did not wish further contact.
Age: 0.34
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Registered Nurse referring to a 4 month old male patient. On 25-MAR-2016 at 16:08, the patient was orally vaccinated with his second improperly stored (Temperature: 32F - Time Frame: 5 minutes) dose of ROTATEQ (lot # L013202, dose was unknown). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse (R.N.) refers to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates, the patients were vaccinated with improperly stored M-M-R II (lot # K016154, expiration date 24-SEP-2016; lot # K024824, expiration date 02-DEC-2016; lot # L009214, 17-MAR-2017; dose and route were not reported). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an healthcare worker (also reported as medical assistant) refers to 15 unspecified patients of unknown age. The patient's pertinent medical history, current conditions and concomitant medications were not reported. On an unknown dates the patients were vaccinated with improperly stored GARDASIL 9 (dosing details were not reported) (lot # M004116 expiry date 12-OCT-2017) which was stored at temperature 31.4 F for a total time of 1000 minutes. There was no previous temperature excursion reported. The call was because of data logger (therapy type: digital data logger). No adverse symptoms reported. There was no product quality complaint. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse (R.N.) refers to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 (lot# K026246, expiration date 28-JAN-2017; lot# L007560, expiration date 15-JUN-2017; lot# L017407, 15-AUG-2017; dose and route were not reported). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse (R.N.) refers to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates (prior dates of expiration), the patients were vaccinated with improperly stored PROQUAD (lot # H020137, expiration date 07-MAY-2014; lot# J002933, expiration date 12-SEP-2014; lot# reported as J002930, expiration date 12-SEP-2014; dose and route were not reported). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse (R.N.) refers to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates, the patients were vaccinated with improperly stored GARDASIL (lot# K007828, expiration date 02-MAR-2017; lot# K010574, expiration date 08-APR-2017; dose and route were not reported). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site reaction, Urticaria
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative. The pharmacist was referring to herself, a female patient of unknown age. No pertinent medical history, drug reactions or allergies were reported. The pharmacist stated that on an unknown date she was vaccinated with ZOSTAVAX (lot number, expiration date, dose, route and frequency were unknown). No other suspect therapies or concomitant medications were reported. ON an unknown date after the vaccination with ZOSTAVAX, she developed a welt at the injection site, the welt was several inches in diameter. It was reported that the reaction resolved after 1 week without requiring medical treatment. The reporting pharmacist did not provide a causality between the welt at injection site and ZOSTAVAX. No product quality complaint was reported. Additional information is not expected since the reporter does not want to be contacted.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site reaction, Injection site swelling, Urticaria
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative. The pharmacist was referring to herself, a female patient of unknown age. No pertinent medical history, drug reactions or allergies were reported. The pharmacist stated that on an unknown date she was vaccinated with ZOSTAVAX (lot number, expiration date, dose, route and frequency were unknown). No other suspect therapies or concomitant medications were reported. ON an unknown date after the vaccination with ZOSTAVAX, she developed a welt at the injection site, the welt was several inches in diameter. It was reported that the reaction resolved after 1 week without requiring medical treatment. The reporting pharmacist did not provide a causality between the welt at injection site and ZOSTAVAX. No product quality complaint was reported. Additional information is not expected since the reporter does not want to be contacted.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: (RD) and (LD) slight pain, hot, itchy after vaccine given.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (C.M.A.) refers to a patient of unknown age and gender. The patient's medical history, concomitant therapy and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 9 (lot #, dose and route of administration were not reported). The patient received the second dose of GARDASIL 9 (lot #, dose and route of administration were not reported) two months after receiving the first dose (on an unspecified date). Subsequently, on an unknown date (four months after receiving the first dose), the patient received the third dose of GARDASIL 9 (lot #, dose and route of administration were not reported). No symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Guillain-Barre syndrome
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a patient of unknown age and gender. The patient's pertinent medical history was not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 (dosing details were not reported). Concomitant medications were unknown. On an unknown date, the patient experienced Guillain-Barre Syndrome. The outcome of the event Guillain-Barre Syndrome was not reported. The reporter did not provide the causality assessment between the event and the suspect therapy. There were no product quality complaints involved. Upon internal review, Guillain-Barre Syndrome was determined to be medically significant. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Pulmonary granuloma
Clinical narrative: This spontaneous report as received from a physician's assistant refers to a 19 year old female patient. The patient had non allergies or drug reactions in medical history. In approximately 2015 (reported as about year ago), the patient was vaccinated with her first dose of GARDASIL 9 (dose, frequency and route of administration were not reported, lot/expiration date unknown). Concomitant therapy was not reported. On an unknown date, 1 month after vaccination, the patient developed granulomas of the lungs. The physician's assistant stated patient did not report any treatment for the granulomas and still had them (also reported as adverse event improved). Causality assessment was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a multiple, unspecified patients of unknown age and gender. There was no information about the patients concurrent conditions, concomitant therapies or medical history provided. On an unknown dates, the patients "might have been administered" an improperly stored doses of RECOMBIVAX HB (strength, dose, frequency, route of administration, lot # and expiration date were not reported). The storage temperature was 30 Fahrenheit degree for a 84 hours (7 cycles of 12 hours each cycle). There was an data logger. The products were back to range. No adverse effects were reported. 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 physician refers to a multiple, unspecified patients of unknown age and gender. There was no information about the patients concurrent conditions, concomitant therapies or medical history provided. On an unknown dates, the patients "might had been administered" an improperly stored dose of GARDASIL 9 (strength, dose, frequency, route of administration, lot # and expiration date were not reported). The storage temperature was 30 Fahrenheit degree for a 84 hours (7 cycles of 12 hours each cycle). There was an data logger. The products were back to range. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a multiple, unspecified patients of unknown age and gender. There was no information about the patients concurrent conditions, concomitant therapies or medical history provided. On an unknown dates, the patients "might had been administered" an improperly stored doses of VAQTA (strength, dose, frequency, route of administration, lot # and expiration date were not reported). The storage temperature was 30 Fahrenheit degree for a 84 hours (7 cycles of 12 hours each cycle). There was an data logger. The products were back to range. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a provider via a field representative referring to a female patient of unknown age. There was no pertinent medical history, drug reaction or concomitant medication reported. On an unspecified date, in MAY 2016 (reported as "a month ago"), the patient came into the reporter's office for a routine visit and was vaccinated with one dose of ZOSTAVAX injection, (dose, and Lot # not provided) subcutaneously. On an unspecified date, in MAY2016, the patient was vaccinated another dose of ZOSTAVAX at a local pharmacy. After receiving the patient's records, it was realized that the patient had received 2 doses of ZOSTAVAX injection within that month (Accidental Overdose). The patient did not have any complaints or symptoms. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to unspecified number of patients of unknown age and gender. The patients' medical history and concomitant medication were not reported. On unknown dates, the patients were vaccinated unknown doses of improperly stored VAQTA (25/0.5, dose, frequency and route were not reported, data logger was involved), lot # was L041676 with expiration date 15-MAR-2017. The VAQTA was improperly stored at 9 centigrade for 30 hours and then was back in range. No adverse effects reported. There was no previous temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacy referring to unspecified number of patients of unknown age and gender. The patients' medical history and concomitant medication were not reported. On unknown dates, the patients were vaccinated unknown doses of improperly stored ROTATEQ (dose and frequency were not reported, data logger was involved), lot # L035510 with expiration date 13-MAY-2017, orally. The ROTATEQ was improperly stored at 9 centigrade for 30 hours and then was back in range. No adverse effects reported. There was no previous temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to multiple unspecified patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB 10/1.0 microgram/ml injection, lot # L038018 with expiration date 13-SEP-2017 or lot # L048236 with expiration date 31-MAR-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccine experienced a temperature excursion of 31 degrees Fahrenheit for 6 minutes. This is one of two reports received from the same reporter. Additional information is not expected as there was no consent for follow up.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concomitant medication were not reported. On unknown dates, the patients were vaccinated unknown doses of improperly stored GARDASIL 9 (dose, frequency and route were not reported, data logger was involved), lot # was reported as 1024993 with expiration date 17-OCT-2017. The GARDASIL 9 was improperly stored at 9 centigrade for 30 hours and then back in range. No adverse effects were reported. There was no previous temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L048237, expiration date 08-MAY-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 31 degrees Fahrenheit for 6 minutes. This is one of two reports received from the same reporter. Additional information is not expected as there was no consent for follow up.
Age: 1.14
Sex: M
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Registered Nurse referring to a 13 month old (reported as 15 month old) male patient. On 13-APR-2016 at 11:51, the patient was vaccinated with an improperly stored (Temperature: 32F - Time frame: 5 minutes) dose of RECOMBIVAX HB (third dose, lot # K0099553, dose was unknown). No adverse effect was reported. This is one of several reports received form the same reporter. Additional information is not expected as all correspondence was received.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On 13-JUN-2016 the patient received improperly stored PROQUAD 0.5 ml subcutaneously. The nurse could specify improperly stored conditions. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information was received from a nurse referring to a patient who was an adult of unknown age and gender. The patient's medical history and concurrent condition were not reported. On 13-JUN-2016 the patient inadvertently received a pediatric dose of VAQTA (lot # M009377, expired on 17-JUN-2017) 0.5 ml (route unknown). No adverse effect was reported. Additional information is not expected as there was no consent for follow up.
Age: 0.99
Sex: F
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Registered Nurse referring to a 11 month old (reported as 12 month old) female patient. On 17-FEB-2016 at 15:57, the patient was intramuscularly vaccinated with an improperly stored (Temperature: 32F - Time frame: 5 minutes) dose of RECOMBIVAX HB (third dose, lot # K0099553, dose was unknown) in right thigh. No adverse effect was reported. This is one of several reports received form the same reporter. Additional information is not expected as all correspondence was received.
Sex: U
Vaccine: HEP
Symptoms: No therapeutic response
Clinical narrative: This spontaneous report as received from a physician refers to multiple patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with 3 doses in the series of RECOMBIVAX HB (dose, route of administration, lot # and expiration date were not reported). The physician reported that on unknown dates, following the administration of the 3 doses of RECOMBIVAX HB, the patients still did not develop immunity. The outcome of the event and the relatedness between the event and RECOMBIVAX HB were not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. There was no information about the patient's concurrent conditions or medical history provided. In 2010, the patient was vaccinated with a dose of ZOSTAVAX 19400 plaque-forming unit (PFU), subcutaneously (dose, lot # and expiration date were not reported). Concomitant therapies included COREG. On an unknown date, about two weeks later following ZOSTAVAX vaccination, the patient developed mild case of shingles. The patient received unspecified treatment for the event. The outcome of shingles was reported as recovered on an unknown date. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Registered Nurse referring to a 2 year old female patient. On 23-MAR-2016 at 10:52, the patient was intramuscularly vaccinated with an improperly stored (Temperature: 32F - Time frame: 5 minutes) dose of VAQTA (second dose, lot # K012457, dose was unknown) in right deltoid. No adverse effect was reported. This is one of several reports received form the same reporter. Additional information is not expected as all correspondence was received.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a licensed practical nurse referring to an unspecified number of unspecified patients. On unspecified dates the patients were vaccinated with PROQUAD (lot # L044058, expiration date 02-MAY-2017, and lot #L030591, expiration date 10-FEB-2017, dose and route were not reported) which was improperly stored. The vaccine has been stored under temperature of 40 Fahrenheit temperature for 2.5 hours. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant and an office manager referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history were not provided. On an unspecified date, a dose of improperly stored PROQUAD (lot # L051102, exp date 17-JUN-2016) (dose, frequency and route was not provided) had undergone 2 excursions was administered to an unknown patient. The vaccine was stored at 6.5 degree C for 7 hours and 45 minutes and at 4.9 degree C for 4 hours and 45 minutes. Digital data logger was involved. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified number of patients of unknown age and gender. There was no pertinent medical history, concurrent conditions, concomitant medication or drug reaction described. On unspecified dates, in 2016, the patients were vaccinated with PROQUAD Lot # M002053 with expiration date of 11-JUL-2017, M004895 with expiration date of 26-JUL-2017 and Lot # L026723 with expiration date of 15-JAN-2017 (Lot number L026723 is an invalid lot number for the vaccine) (dose and route were not reported), which were stored at 10.7 F for 1 hour. The temperature excursion occurred on 09-MAY-2016, so the doses had been administered since that time to 09-JUN-2016. The vaccines did not have previous temperature excursion. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified number of patients of unknown age and gender. There was no pertinent medical history, concurrent conditions, concomitant medication or drug reaction described. On unspecified dates, in 2016, the patients were vaccinated with VARIVAX Lot # L043620 with expiration date of 02-NOV-2017 and Lot # M000760 with expiration date of 06-JAN-2018 (dose and route were not reported), which were stored at 10.7 F for 1 hour. The temperature excursion occurred on 09-MAY-2016, so the doses had been administered since that time to 09-JUN-2016. The vaccines did not have previous temperature excursion. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. On 27-JUN-2016 the patient was vaccinated with an expired dose of VARIVAX (lot # K008822, expiry date: 19-JUN-2016). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse prescriber referring to more than 23 children of unknown age and gender. Information about concurrent condition, concomitant medication and medical history were not provided. On multiple unspecified dates, multiple doses of improperly stored M-M-R II (lot # L32044, expiry date 24-AUG-2017, dose, frequency and route were not provided) were administered to the patients over two month period. The vaccines were stored at 53.2 F for 9 hours and 25 minutes. There were no previous temperature excursions. Digital data logger was involved. No adverse effect was reported. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Local swelling, No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a pharmacist referring to a 71 year old female patient. The patient's pertinent medical history and drug reactions/allergies were not reported. On an unknown date in 2011 (reported as about 5 years ago) the patient was vaccinated with a dose of ZOSTAVAX (dose, lot# and expiration unknown, subcutaneous). No adverse effects were reported at that time. The pharmacist stated that the patient was scheduled to be administered a dose of PREVNAR 13 on 15-JUN-2016 (reported as about a week ago), but the pharmacist on duty at that time inadvertently administered a second dose of ZOSTAVAX (Lot# was reported as L0355048, expiration date 16-DEC-2016, subcutaneous, dose unknown). It had been confirmed with the pharmacist this was not due to product confusion. The patient was taking multiple unspecified medications concomitantly. The pharmacist reported the patient came back to the pharmacy on 20-JUN-2016 and reported that she had a goose egg on the back of her arm (unknown left or right arm) for a couple of days after the ZOSTAVAX was administered. No lab diagnostics studies were performed and no treatment was given for the events. At the time of this report the patient had been recovered from the goose egg on the back of her arm. Causality between ZOSTAVAX and goose egg on the back of the arm was not reported. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HEP, IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: -Expired Hepatitis B vaccine given to patient (lot # 237PJ - Expiration 5/21/16 name brand ENGERIX-B). - Expired Poliovirus vaccine given to patient (Lot # K13291- - Expiration Jun18, 16 - name brand IPOL.  No adverse reaction reported.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Injection site induration, Lymphadenopathy, Pain in extremity
Clinical narrative: Significant left arm pain that radiated down arm. Had a 2 cm x 2 cm swollen left lymph node and 2 mm induration at injection site.
Age: 68.0
Sex: F
Vaccine: HEP
Symptoms: Pain in extremity, X-ray limb
Clinical narrative: The same day as the injection pt c/o pain-she stated "arm hurt real bad like the needle hit the bone and when she got home, it hurt up to her neck. The next day, she woke up, the right arm "hurt like the dickens.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Anxiety, Dizziness, Fall, Foaming at mouth, Gaze palsy
Clinical narrative: Patient was getting stickers after shot, Mom said patient didn't respond to her question then patient reported feeling dizzy. Her body became stiff, eyes rolled back, her arms were stiff, foamy mouth and was unresponsive. She fell to the floor. Mom wasn't able to catch her so she hit her head. Dr. arrived to evaluate and patient came to and was interactive and immediately oriented to where she was but anxious. Fam. history of petit mal seizures. Unclear if episode was syncope/vagal response or seizure, although would be very brief and without postictal  phase if seizure. Full exam normal. Reassurance. F/U visit 6/29/16 diagnosed as syncope after vaccination.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Head injury, Musculoskeletal stiffness, Syncope, Unresponsive to stimuli
Clinical narrative: Patient was getting stickers after shot, Mom said patient didn't respond to her question then patient reported feeling dizzy. Her body became stiff, eyes rolled back, her arms were stiff, foamy mouth and was unresponsive. She fell to the floor. Mom wasn't able to catch her so she hit her head. Dr. arrived to evaluate and patient came to and was interactive and immediately oriented to where she was but anxious. Fam. history of petit mal seizures. Unclear if episode was syncope/vagal response or seizure, although would be very brief and without postictal  phase if seizure. Full exam normal. Reassurance. F/U visit 6/29/16 diagnosed as syncope after vaccination.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Cellulitis of upper arm less than 12 hours after injection, treated with cephalexin.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Throat tightness
Clinical narrative: Patient received Tetanus/diphtheria/pertussis toxoid on 6/28/16 at 14:13 pm. C/o at 15:11 pm "itching, throat closing" Dr. notified. Patient brought to ER treatment
Age: 17.0
Sex: F
Vaccine: MENB, TYP, MENB, TYP
Symptoms: Back pain, Fatigue, Feeling abnormal, Hypoaesthesia, Paraesthesia
Clinical narrative: 3-4 hours after receiving vaccines, teen c/o numbness/tingling in arms and legs, feeling of uneasiness, fatigue, pain in lower - mid back 6/28/16.
Age: 17.0
Sex: F
Vaccine: MENB, TYP, MENB, TYP
Symptoms: Back pain, Fatigue, Feeling abnormal, Hypoaesthesia, Limb discomfort
Clinical narrative: 3-4 hours after receiving vaccines, teen c/o numbness/tingling in arms and legs, feeling of uneasiness, fatigue, pain in lower - mid back 6/28/16.
Age: 17.0
Sex: F
Vaccine: MENB, TYP, MENB, TYP
Symptoms: Malaise, Paraesthesia
Clinical narrative: 3-4 hours after receiving vaccines, teen c/o numbness/tingling in arms and legs, feeling of uneasiness, fatigue, pain in lower - mid back 6/28/16.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Nodule, Pruritus, Pyrexia, Rash macular
Clinical narrative: Fever 104, Arm - red splotches, warm, knot size of dime, red face and red, itching.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Fever 104, Arm - red splotches, warm, knot size of dime, red face and red, itching.
Age: 29.0
Sex: M
Vaccine: ANTH
Symptoms: Migraine, Myalgia
Clinical narrative: Developed generalized myalgias and new onset migraine headaches in the period of receiving the 3 ANTHRAX vaccinations. No other vaccines given simultaneously. Symptoms have never resolved.
Age: 15.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Pt was given the wrong vaccine while in office today; she was supposed to get Hep A and not Hep B. No adverse event occurred.
Age: 3.0
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patients arm was swollen, red, warm to the touch. Swollen from left shoulder to her wrist. Twice the size of her right arm. Provider gave BENEDRYL for swelling.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV9, MENB, MNQ
Symptoms: Nausea, Syncope, Vertigo, Vomiting
Clinical narrative: Pt fainted for approx 1-2 minutes. Afterwards vomited. C/O nausea and vertigo.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: 24hr after vaccine, red, painful, swollen, warm to touch.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Headache, Pain
Clinical narrative: Headache localized right frontal area 2 days after MENACTRA was given. Sharp pain lasted for few minutes to an hour about 2-3X per day. Improved after taking Ibuprofen.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Pyrexia
Clinical narrative: Patient woke up last night (6/28/16) with a fever of 103 degrees F. MOC gave TYELONOL and MOTRIN which brought the fever down. Woke up at 10:00 am this morning (6/29/16) with fever of 102 degrees F. MOC gave TYLENOL and brought patient to the office.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Burning sensation, Injection site pain, Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient experienced pain at the injection site and left arm and shoulder. States he cannot lift his arm above his shoulders. There is no swelling at the injection site. There was a burning sensation after the shot in the arm but it went away the next day on 6/28/2016.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Injection site erythema, Irritability
Clinical narrative: Large red area on (L) left from thigh to knee, child fussy.
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Immediate post-injection reaction, Urticaria
Clinical narrative: Mild hives on arms immediately after vaccination. Given BENADRYL, waited 30 min in office - hives starting to go away. Discharged to home. Advised s/s to look for further rxns.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Fatigue, Pallor, Tremor, Vomiting
Clinical narrative: Approximately 5 mins after administration of GARDASIL-9 in right deltoid, patient complained of dizziness and lightheaded. Patient pale in color. Vomit x1 - clear emesis. Patient shaky. Pt. laid on exam table with feet elevated. Water and ice pop given. Monitored x 30 mins. - Symptoms improved. In follow-up that evening patient more tired than usual. Felt "normal" by next morning 6/23/16.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Dizziness, Hyperhidrosis, Pallor
Clinical narrative: Within minutes of giving vaccines, patient became pale, diaphoretic and c/o being "UNM". Noted patient to be close to fainting. Cool cloth applied, use of ammonia inhalant used. States she ate before coming. Mother present. Water given to patient. Mother reports pt. has history of fainting and Dr is aware. No further issues.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Rt thigh 9.5 x 8 cm - red, tender, swollen. Marked, measurement. No non itchy. Shot was given Wed 6/15/2016.
Age: 31.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Rash
Clinical narrative: ANTHRAX #5 on 01 April 16 - on 14 April 16 broke out into rash. Treated with steroids and when steroids stopped, rash reoccurred. Another round of steroids has cleared rash. Dermatologist says rash due to ANTHRAX shot.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Developed shingles lasted well over month.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Injection site mass
Clinical narrative: Developed a lump at admin site.
Age: 17.0
Sex: M
Vaccine: HPV9, MENB, MNQ, HPVX, MEN, MENB
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 17-year-old male patient who received BEXSERO (batch number 151301C, expiry date 31st December 2016). Concomitant products included HPV VACCINE, MENINGOCOCCAL VACCINES (NOS) (MENINGOCOCCAL CONJUGATE VACCINE) and MEFLOQUINE. On 6th June 2016, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. On 7th June 2016, 1 days after receiving BEXSERO, the patient experienced injection site pain (serious criteria other: serious as per reporter) and injected limb mobility decreased. The patient was treated with TYLENOL. On 9th June 2016, the outcome of the injection site pain and injected limb mobility decreased were recovered/resolved. The reporter considered the injection site pain and injected limb mobility decreased to be almost certainly related to BEXSERO. Additional details were provided as follow: The patient received 9-valent HPV9, MCV4 and MEFLOQUINE concomitantly. The patient received BEXSERO in the right arm. The patient experienced sever injection site pain and he could not move his right arm. On 9th June 2016, the patient had a wellness visit with the physician. He was administered TYLENOL and the issue resolved.
Age: 17.0
Sex: M
Vaccine: HPV9, MENB, MNQ, HPVX, MEN, MENB
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 17-year-old male patient who received BEXSERO (batch number 151301C, expiry date 31st December 2016). Concomitant products included HPV VACCINE, MENINGOCOCCAL VACCINES (NOS) (MENINGOCOCCAL CONJUGATE VACCINE) and MEFLOQUINE. On 6th June 2016, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. On 7th June 2016, 1 days after receiving BEXSERO, the patient experienced injection site pain (serious criteria other: serious as per reporter) and injected limb mobility decreased. The patient was treated with TYLENOL. On 9th June 2016, the outcome of the injection site pain and injected limb mobility decreased were recovered/resolved. The reporter considered the injection site pain and injected limb mobility decreased to be almost certainly related to BEXSERO. Additional details were provided as follow: The patient received 9-valent HPV9, MCV4 and MEFLOQUINE concomitantly. The patient received BEXSERO in the right arm. The patient experienced sever injection site pain and he could not move his right arm. On 9th June 2016, the patient had a wellness visit with the physician. He was administered TYLENOL and the issue resolved.
Age: 36.0
Sex: F
Vaccine: HEPAB
Symptoms: Feeling hot, Rash erythematous
Clinical narrative: Patient reported feeling warm all over and developed a red rash.  No difficulty breathing or swallowing noted.
Age: 52.0
Sex: M
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Neck pain, Pain in extremity
Clinical narrative: Pain in left arm, hard to lift arm up, pain into left side of neck.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying, Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: Unconsolable high-pitched cry x3 hrs.  Also, 60x70 mm area of warm, red inflammation over right anterior mid thigh surrounding injection site of Pentacel vaccine.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Hypersensitivity, Rash
Clinical narrative: Patient seen in office on 6/28/16 and mom reports that following vaccines on 3/22/16, patient had developed a rash that she believes was an allergic reaction.
Age: 1.72
Sex: M
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Rash vesicular
Clinical narrative: Started breaking out in rash similar to chicken pox--2/30/16-now has over 60 vesicular rash spots.
Age: 67.0
Sex: F
Vaccine: TDAP
Symptoms: Muscular weakness, Myalgia
Clinical narrative: Patient notified office of muscle pain and weakness in arm injection was given; Recommended warm compresses and OTC Aleve; pt instructed to call if symptoms worsen or no improvement.  Patient contacted office on 6/22/16 reporting same symptoms. Patient was seen in office and prescribed Prednisone 20mg, 2 PO twice daily for 5 days.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Erythema, Rash
Clinical narrative: Client alleges she started with a rash and eryhtema in arms, legs, chest, and neck over 24hrs after vaccine administration.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, PNC13, VARCEL
Symptoms: Injection site reaction, Rash erythematous, Skin exfoliation
Clinical narrative: ABNORMAL ERYTHEMATOUS SCALING RASH RIGHT LEG WHERE PREVNAR WAS GIVEN.  PRESCRIBED TRIAMCINOLONE ACETONIDE 0.1% CREAM 1 RIBBON APPLIED TO AFFECTED AREA TWICE A DAY.  PREDNISOLONE SODIUM PHOSPHATE 15 MG/5ML SOLN, 1 TEASPOON DAILY X 3 DAYS.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary pain, Diarrhoea, Lymph node pain, Lymphadenopathy, Nausea
Clinical narrative: Nausea, Diarrhea, Pain in arm, Pain & Tenderness in armpit, swollen armpit, swollen & tender lymphnodes in armpit.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: Nausea, Diarrhea, Pain in arm, Pain & Tenderness in armpit, swollen armpit, swollen & tender lymphnodes in armpit.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Adverse reaction, Headache, Lethargy, Malaise, Wheezing
Clinical narrative: Tight wheezing lungs, headache, overall lethargy like a mild illness.  Will never take this again.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Death
Clinical narrative: Death
Age: 16.0
Sex: F
Vaccine: MENB, MNQ, TDAP
Symptoms: Blood glucose normal, Cold sweat, Hypotension, Loss of consciousness, Mydriasis
Clinical narrative: Pale, clammy, loss of consciousness, unresponsive, BP low, good blood sugar levels, pupils dilated. Had to call 911.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ, TDAP
Symptoms: Pallor, Unresponsive to stimuli
Clinical narrative: Pale, clammy, loss of consciousness, unresponsive, BP low, good blood sugar levels, pupils dilated. Had to call 911.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Irritability, Rash
Clinical narrative: Mom states child developed a rash and cried, fussy for 2 weeks following shots.
Age: 24.0
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Limb discomfort, Lip swelling, Paraesthesia oral, Peripheral swelling
Clinical narrative: Initially had arm swelling and discomfort. Two days later progressed to lip and throat tingling and swelling resulting in ED evaluation for serious allergic reaction.
Age: 24.0
Sex: F
Vaccine: PPV
Symptoms: Pharyngeal oedema, Pharyngeal paraesthesia
Clinical narrative: Initially had arm swelling and discomfort. Two days later progressed to lip and throat tingling and swelling resulting in ED evaluation for serious allergic reaction.
Age: 68.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient came into pharmacy on 6/29/2016 at 8:30pm. She had a Large Red Area on her arm at the sight of the I.M. Injection on 6/24, reported it had been there since Saturday 6/25, and had seemingly gotten a little larger and itchier.  She asked if she should see her primary care physician, she was told that that would be a good idea, and she should probly take some Benadryl.
Age: 3.0
Sex: F
Vaccine: HEP, HEPA, PNC13, VARCEL
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling, Injection site warmth, Wheezing
Clinical narrative: The morning after vaccines the Parent noted a large 70mmX70mm area on her Right deltoid that was red, warm and  swollen. Parent denies child had fever, itching, pain or difficulty breathing at any moment. He admits child had wheezing the night of vaccines due to environmental allergens. Child used inhaler. He does not know exact medication in the inhaler.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site.
Age: 0.42
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying, Rash
Clinical narrative: Mom states child developed a rash and cried for 2 weeks.
Age: 33.0
Sex: F
Vaccine: MMR
Symptoms: Glossodynia, Speech disorder
Clinical narrative: Employee reports that she was unable to talk properly.  Reported tongue pain, although unsure of swelling.  Reports lasted past her bedtime and was resolved by the time she woke up.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Eye swelling, Hypersensitivity, Lip swelling, Rash, Swelling face
Clinical narrative: AT FIRST PT SHOWED SOME RASH, LEFT SIDE OF FACE RASH AND SWELLING OF LIP.  THAT WAS ON 6/20/2016. I RECOMMENDED BENADRYL AND CONTINUED MONITORING. PT REPORTED THAT SHE DID WELL ON THE BENADRYL BUT BY MID DAY ON 6/21/2016, PT REPORTED EYE SWELLING, HIP/WAIST RASH. I RECOMMENDED SEEING HER DR AND KEEPING AN EYE ON THE SWELLING IF IT EFFECTED HER THROAT OR BREATHING.  BY 6/23, I SPOKE WITH HER HUSBAND WHO TOLD ME THEY HAD TO GO TO THE ER TO GET TREATMENT FOR SWELLING OF THE FACE, RASH ON SIDES, BACK AND NECK.  PT RECVD PREDNISONE AND CLARITIN FOR THE ALLERGIC REACTION.  TALKED TO PT ON 6/25, SHE SAID ALL OF THE REACTION WAS, FOR THE MOST PART ALL OVER. AGAIN TALKED TO THE PT ON 6/29 AND SHE REPORTED THAT SHE WAS AS GOOD AS NEW.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Headache, Pyrexia
Clinical narrative: Patient experienced a fever 6 hours after vaccine and has had a headache for the past 3 days.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Anger, Injection site pain, Injection site swelling
Clinical narrative: Pt contacted rph on duty on 6/30/16 stating she experienced swelling and pain at the injection site starting day she received vaccine and it has persisted thus far, states she has iced with no relief, she is concerned about infection, she was counseled to seek evaluation by physician for concerns of infection and advised this is a typical site reaction to vaccination.
Age: 63.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Arthralgia, Body temperature decreased, Body temperature increased, Feeling cold, Feeling hot
Clinical narrative: Extremely cold (while city was in a heat wave!) for 2-3 hours then extremely hot (no temp taken) for next 12 hours; extreme lethargy, muscle and joint pain, injections site pain/itching--all for next 72 hours; temp taken at 36 hours was 102.5f; then at 48 hours temp was 101.9f; then at 56 hours temp was 96.8f.
Age: 63.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Injection site pain, Injection site pruritus, Lethargy, Myalgia
Clinical narrative: Extremely cold (while city was in a heat wave!) for 2-3 hours then extremely hot (no temp taken) for next 12 hours; extreme lethargy, muscle and joint pain, injections site pain/itching--all for next 72 hours; temp taken at 36 hours was 102.5f; then at 48 hours temp was 101.9f; then at 56 hours temp was 96.8f.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness postural, Fall, Head injury
Clinical narrative: RECEIVED GARDASIL 9, TDAP AND MENVEO THEN STOOD UP, BECAME DIZZY, FELL AND BUMPED LEFT TEMPLE ON WALL IN EXAM ROOM
Age: 1.05
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Injection site pain, Injection site reaction, Rash erythematous
Clinical narrative: Localized erythematous rash around injection site, measuring 9.5 X 5.5cm, mildly tender, no fever no abscess.
Age: 1.05
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Bacterial infection, Injection site hypersensitivity, Injection site reaction
Clinical narrative: Localized erythematous rash around injection site, measuring 9.5 X 5.5cm, mildly tender, no fever no abscess.