chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site reaction
Clinical narrative: Information was received on 07-JUL-2017 from a pharmacist who stated that a 65 year old patient (gender not reported) received ZOSTAVAX 0.65 ml once on 05-JUL-2017 and returned to pharmacy today (07-JUL-2017) with "what appears to be a large mosquito bite (induration) at the injection site". Pharmacist stated the injection site reaction did not resemble a vesicle associated with shingles. Per pharmacist, patient had not been treated and it was not recovered. Per pharmacist, patient takes pravastatin and levothyroxine; medical history unknown. Pharmacist stated patient has a drug allergy to penicillin. Pharmacist provided ZOSTAVAX lot information: N011366, expiration 12-MAR-2018 and diluent information was not available. No further information provided. Additional information has been requested.
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received on 12-JUL-2017 from a licensed practical nurse (LPN) refers to a male patient of unknown age. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. The female LPN reported that the patient was administered a dose of VARIVAX (Dose, route of administration, site of administration, Lot number and expiration date were not reported) for prophylaxis on 01-MAY-2006. The female LPN reported that the patient was administered a dose of M-M-R II (Dose, route of administration, site of administration, Lot number and expiration date were not reported) for prophylaxis on 23-MAY-2006 and 29-JUL-2010. No adverse effects reported.  No further details provided. The outcome of the event of product use issue was unknown. Additional information is not expected as there was no consent for follow-up.
Sex: F
Vaccine: HPV9
Symptoms: Injection site mass
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. No information on the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On an unknown date in June 2017, reported as "approximately one month ago", the patient was vaccinated with a dose of GARDASIL 9 lot # N001533, expiry date 16-OCT-2019 (dose, route of administration were not reported).. On an unknown date in 2017, the patient experienced injection site mass. On 02-JUL-2017, she came to the pharmacy and the reporter palpated a "solid bump under the skin" at the injection site. The patient did not complain of any itchiness or pain at the injection site, and there was no redness at the injection site. There were no lab studies or diagnostics performed. The outcome of injection site mass was unknown. The relatedness between the event and GARDASIL 9 was not reported.  Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site rash
Clinical narrative: This spontaneous report has been received from a pharmacist referring to a 74 year old female patient. The patient was allergic to ciprofloxacin (CIPRO), penicillin (PCN) and computed tomography (CT) contrast dye. Concomitant medication included levothyroxine sodium (SYNTHROID). Pertinent medical history was unknown. On 25-JUL-2017, the patient was vaccinated with PNEUMOVAX 23 (lot#, expiration date and dose not reported), intramuscularly (IM) for prophylaxis. On the same day, later vaccine administration, the patient experienced a rash down the same arm of the injection site. The patient sought medical attention. It was unknown if treatment was given for the event. The outcome of injection site rash was unknown. The causality between the event and PNEUMOVAX 23 was not provided.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician via company representative refers to an unspecified number of patients of unknown ages and genders. On unknown dates, the patients were vaccinated with VAQTA (lot # N005274, expiry date: 03-APR-2017) (route: intramuscular), that was improperly stored. The vaccine was stored at a temperature of 32°F to 35°F (34.8F) for 1 hour and 15 minutes, at 32°F to 35°F (35.4F) for 4 hours and 24 minutes, at 32°F to 35°F (35.4F) for 4 hours and 12 minutes, at 32°F to 35°F (35F) for 4 hours and 36 minutes, at 32°F to 35°F (35F) for 4 hours and 18 minutes, at 32°F to 35°F (35F) for 4 hours and 42 minutes, at 32°F to 35°F (35.4F) for 2 hours and 30 minutes, at 32°F to 35°F (35.4F) for 3 hours and 18 minutes, at 32°F to 35°F (35.2F) for 4 hours and 54 minutes, at 32°F to 35°F (35.2F) for 4 hours and 42 minutes, at 32°F to 35°F (35.2F) for 4 hours, at 32°F to 35°F (35.4F) for 2 hours and 24 minutes, at 32°F to 35°F (35.4F) for 2 hours, at 32°F to 35°F (35F) for 4 hours and 6 minutes, at 32°F to 35°F (35F) for 5 hours and 24 minutes, at 32°F to 35°F (35.2F) for 5 hours and 6 minutes, at 32°F to 35°F (35.2F) for 5 hours and 18 minutes, at 32°F to 35°F (35.4F) for 3 hours. There was no previous temperature excursion. The call was because of a data logger. No adverse symptoms reported. The outcome of the events was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1707USA011555: US-009507513-1707USA011601: US-009507513-1707USA011419:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a other health professional refers to a unspecififed number of patients of unknown age and gender. On 2017 the patients were vaccinated with with the improperly stored doses of VARIVAX for prophylaxis. Concomitant therapies included sterile diluent (STERILE DILUENT).
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a physician via company representative referring to a 15 year old female patient. The patient was taking unspecified medications for with anemia and low blood pressure. On 27-JUL-2017 the patient was vaccinated with the second dose of GARDASIL 9 (lot#, expiration date, dose and route unspecified) for HPV. The patient passed out five minutes after being vaccination in the waiting room. The physician had the patient lay down. Also, the patient was given juice boes, a Kashi bar and other liquids. The patient was well enough to go home. The causality between the event and GARDASIL 9 was not provided.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 20 year old female patient. On 10-JUL-2017, the patient was vaccinated with RECOMBIVAX HB lot number reported as N009802, expiration date 19-DEC-2019; for prophylaxis. On 10-JUL-2017, a pediatric dose of RECOMBIVAX HB was administered to the patient (drug administered to patient of inappropriate age and under dose). No adverse events were reported.
Sex: U
Vaccine: HPV4
Symptoms: Encephalopathy
Clinical narrative: This spontaneous report has been received from a pharmacist referring to an unspecified patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not reported. On an unknown date, the patient was vaccinated with GARDASIL (dose, route, lot number and expiration date were not reported) for prophylaxis. On an unspecific date in 2016 (reported as within the last year), the patient developed encephalopathy. The outcome of encephalopathy was unknown. The pharmacist reported that a vaccine adverse event reporting system (VAERS) report was already filed regarding this event but no further information was provided. Upon internal review, encephalopathy was determined to be medically significant
Age: 19.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report as received from a nurse refers to a 19 year old patient of unknown gender. On an unknown date (reported as a couple of weeks ago), the patient was inadvertently received one pediatric dose of VAQTA 25/0.5 (unit not reported) (dose, lot #, expiration date and route not reported) instead of one adult dose of VAQTA for prophylaxis. No adverse effects were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Anaphylactic reaction
Clinical narrative: Information has been received from a pharmacist refers to a 52 year old male patient. The patient's medical history, drug history and concomitant medications are all unknown. On 29-JUL-2017 at 13:00, the patient was vaccinated with ZOSTAVAX at unknown dose, once (strength, route, lot#, expiration date were unknown) for prophylaxis. After the patient was weight lifting on 30-JUL-2017 at 10:00 (also reported as on 29-JUL-2017), he began experiencing an anaphylactic reaction at his home. The patient had not eaten nor been exposed to any chemicals. This anaphylactic reaction required the patient's wife to call 911 and have the patient transported to the emergency room. The patient's laboratory data was unknown. As of 30-JUL-2017, it was unknown if the patient would receive ZOSTAVAX in the future and the outcome of the anaphylactic reaction was unknown. Causality between the suspect therapy and the event was not reported. Upon internal review, anaphylactic reaction was determined to be medically significant.
Sex: U
Vaccine: HEP, HEPA, HIBV, HPV9, MMR, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with an improperly stored dose of vaccine (dose, route, lot # and expiration date were unknown) for prophylaxis, but it was not sure which of the vaccines the patient received. Names of vaccines involved M-M-R II, ROTATEQ, VAQTA, RECOMBIVAX HB, GARDASIL 9 and LIQUID PEDVAXHIB. The time frame was one hour. There was no temperature excursion previously. It was call because of a data logger. No adverse effect was reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to 4 patients of unknown age. On an unknown date the patients were vaccinated with improperly stored PROQUAD lot # M044718, expiration date 07-MAY-2018 for prophylaxis. Concomitant therapies included properly stored sterile diluent (MERCK STERILE DILUENT). Administered doses of vaccines experienced the temperature excursion of 32.5 degrees Fahrenheit for 4 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1708USA000794:
Age: 4.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a 4 year old male patient. On 28-JUL-2017 the patient was vaccinated with VAQTA lot # M003618 for prophylaxis. On 28-JUL-2017, the patient experienced drug administered to patient of inappropriate age. On an unknown date the patient experienced no adverse event. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Immunisation, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse refers to a 15 year old female patient. There was no concomitant medication, pertinent medical history or drug reactions/allergies. On 31-JUL-2017 the patient was inadvertently vaccinated with ZOSTAVAX (lot # N014942, expiration date 02-FEB-2018, dose and route unknown) for herpes zoster prevention instead of VARIVAX. The nurse stated the patient was in the office to receive second dose of VARIVAX (dose, route, lot # and expiration date were unknown) (overdose). No adverse effects were reported. The patient was doing fine. No treatment was given for the events.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL 9 for prophylaxis.  On an unknown date the patient experienced inappropriate schedule of drug administration and no adverse event. The outcome of inappropriate schedule of drug administration and no adverse event is unknown. The reporter considered inappropriate schedule of drug administration and no adverse event to be not related to GARDASIL 9.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to 12 patients of unknown age. On an unknown date the patient were vaccinated with improperly stored VARIVAX lot # N002203, expiration date 19-JAN-2019 and lot # N007930, expiration date 18-MAR-2019 for prophylaxis. Concomitant therapies included properly stored sterile diluent (MERCK). Administered doses of vaccines experienced the temperature excursion of 32.5 degrees Fahrenheit for 4 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA000281.
Age: 36.0
Sex: M
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Pt reports pain, swelling, itchiness, redness and unable to move  left arm at site of injection. Symptoms started 2  after the injection day.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Borrelia test, Full blood count normal, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling and redness from top of arm to elbow are, no cellulitis.  Arm very sore. Patient came into office on 8/1/17 and was also noted to have lyme rash on his abdomen. He was sent to local ED, had labs drawn, tick panel pending.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Lyme disease, Rash
Clinical narrative: Swelling and redness from top of arm to elbow are, no cellulitis.  Arm very sore. Patient came into office on 8/1/17 and was also noted to have lyme rash on his abdomen. He was sent to local ED, had labs drawn, tick panel pending.
Age: 16.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Dizziness, Hot flush, Nausea, Paraesthesia, Syncope
Clinical narrative: 3 hours after vaccines and PPD started with hot flashes, body tingling, syncope. Symptoms reoccurred to include tunnel vision, dizzy, nausea the day following day.
Age: 16.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Tunnel vision
Clinical narrative: 3 hours after vaccines and PPD started with hot flashes, body tingling, syncope. Symptoms reoccurred to include tunnel vision, dizzy, nausea the day following day.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Pruritus, Rash, Vision blurred
Clinical narrative: Patient received vaccines at our office. Then she went home and 2 hours later started with rash on face and itchy. She complained with blurry vision.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, PNC13
Symptoms: Rash
Clinical narrative: Rash on face within minutes of injection and resolved within 20 minutes. Given BENADRYL during the last few minutes of reaction.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Started with quarter size red patch at injection site, 12 hours after shot. After that it started growing during the day, swelling, turning hard, tender to touch, quite warm to touch with the red patch growing to about 4-5 inches in diameter.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Dyspnoea, Injection site rash, Tongue eruption
Clinical narrative: Rash left arm above elbow; breakout on right side of tongue; difficulty breathing.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with PROQUAD lot # N00233 for prophylaxis. Concomitant therapies included sterile diluent(STERILE DILUENT).  On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to PROQUAD.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, or medical history provided. On 31-JUL-2017, the patient was vaccinated with an improperly stored dose of M-M-R II (rHA) lot # M036543, expiration date 15-AUG-2018 (dose and route of administration were not reported). The vaccine was reconstituted with properly stored sterile diluent (lot# M041812, expiration date: 17-MAY-2019). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 24 hours. Data logger was not involved. There were no previous excursions reported.
Sex: F
Vaccine: FLUX
Symptoms: Drug intolerance, Erythema, Mobility decreased, No reaction on previous exposure to drug, Urticaria
Clinical narrative: Initial unsolicited report received from a consumer on 25-JUL-2017. This case involves a 70-year-old female patient who was vaccinated with a dose of INFLUENZA VACCINE (FLU SHOT) (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medications included ALIROCUMAB (praluent) (injections, batch number: 7F076A, expiry date: 30-JUN-2018, dose in series, route and site of administration were not reported) for cardiovascular disorder (reported as 'Patient has taken 6 Praluent injections and had no issues with the first 5, but with the most recent one, experienced a red welt, unable to tolerate statins'). On an unspecified date, following the vaccination, the patient was unable to move her arm for a week. Lab data and corrective treatment were not reported. On an unspecified date, the patient recovered from the event. List of documents held by sender: none.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Musculoskeletal stiffness, Pain
Clinical narrative: Stiffness and severe soreness.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Injection site erythema, Injection site pain
Clinical narrative: REDNESS, SORNESS AROUND INJECTION SITE, DIZZINESS.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Musculoskeletal pain
Clinical narrative: Immediate shoulder pain.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Hallucination, Pyrexia
Clinical narrative: Fever started at 0230 on 8/1/17 axillary temp of 102. Mom gave Tylenol at 0230, 0800 and 1300. Mom called health department at 1500 on 8/1/17 to report that pt was having hallucinations and was seeing sheep, a net and perceived that his hands were gigantic. Advised to continue fluids, Tylenol and consider dosing with ibuprofen. RN called at 1730 and Mom reports that pt is better - fever has broken and no hallucinations at that time. On 8/2/17, RN called again and Mom reports that pt had a good night, ate breakfast and was walking around a bit. Again, no hallucinations at this time.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Patient fainted at check out counter about 3 minutes after receiving the GARDASIL Vaccine, patient had no injury.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient came back to pharmacy the morning of 8/02/2017 and reported that her arm around the injection site was red and itchy. Patient was instructed to take on oral antihistamine to help with the possible reaction and to she her doctor if it dosen't resolve.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Peripheral swelling
Clinical narrative: The patients arm swelled up in a large area with blistering in the middle of the swelled area.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. On an unknown date, the patient was administered a dose of incorrectly stored PROQUAD lot # M022399 with expiration date of 01-NOV-2017 or lot# M042498 with expiration date of 17-APR-2018 or with an improperly stored dose of VARIVAX lot # M046926 with expiration date of 21-NOV-2018 or lot# M035140 with expiration date of 03-AUG-2018. The reporter was not sure which vaccine and lot# the patient received. Sterile diluent used to reconstitute vaccines was properly stored. Administered doses of vaccines underwent a temperature excursion from -9 degrees Celsius to 8 degrees Celsius, which lasted for 2 hours. No previous temperature excursion was reported. A digital data logger was involved in recording the excursion. No adverse events were reported. Product quality complaint was not involved. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from an other health professional and refers to a currently 23 year old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 05-APR-2017, the patient was vaccinated with a first dose of GARDASIL 9 lot # M040412, on 05-JUN-2017 he received the second dose and on 01-AUG-2017 the third dose. (Inappropriate schedule of drug administration). No adverse effects were reported. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No Adverse Reaction. No Adverse Reaction after 48 hrs. Pt. was just given an extra dose of DTAP-IPV-MMR-Varicella.
Age: 1.67
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Allergy test negative, Antibody test, C-reactive protein, Decreased activity, Decreased appetite
Clinical narrative: AT 1:30PM ON THE DAY OF THE VACCINE MOM NOTED A FEVER TO 102, ONE EPISODE OF DIARRHEA THAT NIGHT, GASSY, TIRED/LESS ACTIVE, DECREASED APPETITE AND THE AREA WHERE THE PREVNAR VACCINE WAS GIVEN WAS RED AND WARM TO THE TOUCH. ON 7/26/17 SHE CAME TO THE OFFICE AND A 5CM ROUND AREA OF ERYTHEMA WAS NOTED WITH A CENTRAL AND SUPERIOR OF 3CM CIRCULAR INDURATION. ON 7/28/17 SHE RETURNED TO OFFICE WITH DIARRHEA AND STILL HAVING A FEVER. cbc/esr/crp/celiac panel and food allergy panel.
Age: 1.67
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Diarrhoea, Fatigue, Flatulence, Full blood count, Injection site erythema
Clinical narrative: AT 1:30PM ON THE DAY OF THE VACCINE MOM NOTED A FEVER TO 102, ONE EPISODE OF DIARRHEA THAT NIGHT, GASSY, TIRED/LESS ACTIVE, DECREASED APPETITE AND THE AREA WHERE THE PREVNAR VACCINE WAS GIVEN WAS RED AND WARM TO THE TOUCH. ON 7/26/17 SHE CAME TO THE OFFICE AND A 5CM ROUND AREA OF ERYTHEMA WAS NOTED WITH A CENTRAL AND SUPERIOR OF 3CM CIRCULAR INDURATION. ON 7/28/17 SHE RETURNED TO OFFICE WITH DIARRHEA AND STILL HAVING A FEVER. cbc/esr/crp/celiac panel and food allergy panel.
Age: 1.67
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Injection site induration, Pyrexia, Red blood cell sedimentation rate, Vaccination site warmth
Clinical narrative: AT 1:30PM ON THE DAY OF THE VACCINE MOM NOTED A FEVER TO 102, ONE EPISODE OF DIARRHEA THAT NIGHT, GASSY, TIRED/LESS ACTIVE, DECREASED APPETITE AND THE AREA WHERE THE PREVNAR VACCINE WAS GIVEN WAS RED AND WARM TO THE TOUCH. ON 7/26/17 SHE CAME TO THE OFFICE AND A 5CM ROUND AREA OF ERYTHEMA WAS NOTED WITH A CENTRAL AND SUPERIOR OF 3CM CIRCULAR INDURATION. ON 7/28/17 SHE RETURNED TO OFFICE WITH DIARRHEA AND STILL HAVING A FEVER. cbc/esr/crp/celiac panel and food allergy panel.
Age: 10.0
Sex: M
Vaccine: MENB
Symptoms: Culture throat, Injection site swelling, Pyrexia
Clinical narrative: Patient began to have a fever (spiked at 102.6). Fever continued through yesterday night. Localized swelling noted on the injection site.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV9, MENB, MNQ
Symptoms: Blood glucose decreased, Hyperhidrosis, Immediate post-injection reaction, Nausea, Syncope
Clinical narrative: Patient had a brief fainting spell immediately after all the vaccines had been administered, along with complaints of nausea and extreme diaphoresis. EMS called to come to facility to assess patient. EMS found patient to have a blood sugar in the 70's after drinking 6.75 ounces of juice approximately 20 minutes prior. EMS administered IV Dextrose to patient, with immediate verbal response from patient "I feel much better". Patient left facility with parents AAO X 3, with no complaints,
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Headache, Injection site swelling, Pyrexia
Clinical narrative: FEVER, HEADACHE, SWELLING OF INJECTION SITE.
Age: 3.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site rash
Clinical narrative: 10.5cm rash at injection site.
Age: 18.0
Sex: F
Vaccine: TDAP
Symptoms: Anxiety, Bladder dysfunction, Blood glucose normal, Confusional state, Cyanosis
Clinical narrative: 7/27/2017: Clinical Notes: Tdap vaccine updated during travel consultation (previous tdap given in 2010 with no adverse events). Patient reported "arm tingling and lightheaded" post vaccine. Syncopal episode with loss of breathing. Patient was given Epi Pen in left Vastus Lateralis muscle approximately 30 seconds after loss of consciousness, seizure-like activity with loss of bladder function, and blue lips and facial complexion. Patient responded to the Epi Pen and awoke 30-40 seconds later with anxiety, shaking, and confusion most likely from the dose of epinephrine. EMS on scene at that time. Vitals stable and continually monitored for about 30 minutes post episode. Blood Sugar checked by EMS 115 mg/dL. Patient mother reports that her daughter has not been sleeping well and didn't eat anything this morning. Patient recovered quickly but monitored for 1 hour post vaccine. She was given juice and a granola bar to eat, tolerated well. She remained in the clinic until she felt that she was able to go home. Her mother will continue to monitor her at home for the remainder of the day. Education about what to watch for given. Mother to call 911 if patient has difficulty breathing, feels lightheaded, dizzy, faints, or seizes again. Mother verbalized understanding. Patient ambulated to car. 8/1/2017: Telephone Encounter: Patient's mother returned phone call to Health Department today and spoke with Office Specialist. She reported that pt was doing "better" and that they have spoken with pt's PCP. Pt is NOT to have Tdap vaccine or vaccine containing similar components or additives again. If she needs immunizations she is to have them given in an Emergency Room setting where she can be closely monitored during administration and after. In order to have vaccines given pt needs a doctors order for emergency room monitoring. Employee relayed this message to me. Actions Taken for Phone Encounter: Completed VAERS reporting 8/2/17, Updated pt's allergy list in EMR. I plan to meet with Dr. to discuss pt's case and determine if Dr. or her PCP should write an order for her to have remaining immunization given under ER monitoring. Pts mother requested list of ingredients for the Tdap vaccine that pt was given and the Meningitis vaccine that she still needs. I plan to review these ingredients, comparing the Tdap to both the MENVEO and MENACTRA brands of meningitis vaccines. Recommend that she get the vaccine with the least amount of similar ingredients.  RN 8/2/2017 8:05:28 AM.
Age: 18.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Loss of consciousness, Pallor, Paraesthesia, Respiratory arrest
Clinical narrative: 7/27/2017: Clinical Notes: Tdap vaccine updated during travel consultation (previous tdap given in 2010 with no adverse events). Patient reported "arm tingling and lightheaded" post vaccine. Syncopal episode with loss of breathing. Patient was given Epi Pen in left Vastus Lateralis muscle approximately 30 seconds after loss of consciousness, seizure-like activity with loss of bladder function, and blue lips and facial complexion. Patient responded to the Epi Pen and awoke 30-40 seconds later with anxiety, shaking, and confusion most likely from the dose of epinephrine. EMS on scene at that time. Vitals stable and continually monitored for about 30 minutes post episode. Blood Sugar checked by EMS 115 mg/dL. Patient mother reports that her daughter has not been sleeping well and didn't eat anything this morning. Patient recovered quickly but monitored for 1 hour post vaccine. She was given juice and a granola bar to eat, tolerated well. She remained in the clinic until she felt that she was able to go home. Her mother will continue to monitor her at home for the remainder of the day. Education about what to watch for given. Mother to call 911 if patient has difficulty breathing, feels lightheaded, dizzy, faints, or seizes again. Mother verbalized understanding. Patient ambulated to car. 8/1/2017: Telephone Encounter: Patient's mother returned phone call to Health Department today and spoke with Office Specialist. She reported that pt was doing "better" and that they have spoken with pt's PCP. Pt is NOT to have Tdap vaccine or vaccine containing similar components or additives again. If she needs immunizations she is to have them given in an Emergency Room setting where she can be closely monitored during administration and after. In order to have vaccines given pt needs a doctors order for emergency room monitoring. Employee relayed this message to me. Actions Taken for Phone Encounter: Completed VAERS reporting 8/2/17, Updated pt's allergy list in EMR. I plan to meet with Dr. to discuss pt's case and determine if Dr. or her PCP should write an order for her to have remaining immunization given under ER monitoring. Pts mother requested list of ingredients for the Tdap vaccine that pt was given and the Meningitis vaccine that she still needs. I plan to review these ingredients, comparing the Tdap to both the MENVEO and MENACTRA brands of meningitis vaccines. Recommend that she get the vaccine with the least amount of similar ingredients.  RN 8/2/2017 8:05:28 AM.
Age: 18.0
Sex: F
Vaccine: TDAP
Symptoms: Seizure like phenomena, Syncope, Tremor
Clinical narrative: 7/27/2017: Clinical Notes: Tdap vaccine updated during travel consultation (previous tdap given in 2010 with no adverse events). Patient reported "arm tingling and lightheaded" post vaccine. Syncopal episode with loss of breathing. Patient was given Epi Pen in left Vastus Lateralis muscle approximately 30 seconds after loss of consciousness, seizure-like activity with loss of bladder function, and blue lips and facial complexion. Patient responded to the Epi Pen and awoke 30-40 seconds later with anxiety, shaking, and confusion most likely from the dose of epinephrine. EMS on scene at that time. Vitals stable and continually monitored for about 30 minutes post episode. Blood Sugar checked by EMS 115 mg/dL. Patient mother reports that her daughter has not been sleeping well and didn't eat anything this morning. Patient recovered quickly but monitored for 1 hour post vaccine. She was given juice and a granola bar to eat, tolerated well. She remained in the clinic until she felt that she was able to go home. Her mother will continue to monitor her at home for the remainder of the day. Education about what to watch for given. Mother to call 911 if patient has difficulty breathing, feels lightheaded, dizzy, faints, or seizes again. Mother verbalized understanding. Patient ambulated to car. 8/1/2017: Telephone Encounter: Patient's mother returned phone call to Health Department today and spoke with Office Specialist. She reported that pt was doing "better" and that they have spoken with pt's PCP. Pt is NOT to have Tdap vaccine or vaccine containing similar components or additives again. If she needs immunizations she is to have them given in an Emergency Room setting where she can be closely monitored during administration and after. In order to have vaccines given pt needs a doctors order for emergency room monitoring. Employee relayed this message to me. Actions Taken for Phone Encounter: Completed VAERS reporting 8/2/17, Updated pt's allergy list in EMR. I plan to meet with Dr. to discuss pt's case and determine if Dr. or her PCP should write an order for her to have remaining immunization given under ER monitoring. Pts mother requested list of ingredients for the Tdap vaccine that pt was given and the Meningitis vaccine that she still needs. I plan to review these ingredients, comparing the Tdap to both the MENVEO and MENACTRA brands of meningitis vaccines. Recommend that she get the vaccine with the least amount of similar ingredients.  RN 8/2/2017 8:05:28 AM.
Age: 40.0
Sex: M
Vaccine: FLU4, PPV, TDAP
Symptoms: Cellulitis
Clinical narrative: Cellulitis. Amoxicillin/Clavulanate 550/125 mg BID.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient complaining of severe left arm pain states happened day after PNU injection, states cannot move left arm without pain.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial pain, Headache, Inflammation, Skin lesion
Clinical narrative: Client called and states she had a headache before the vaccination and the next day the headache continued. She had pain and inflammation on her left cheek and a lesion on her left eyelid
Age: 0.5
Sex: M
Vaccine: HIBV
Symptoms: Product preparation error
Clinical narrative: I never constituted the HIB vaccination prior to giving, I only administered the saline dilutent.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Dizziness, Hyperhidrosis, Injection site erythema, Injection site warmth
Clinical narrative: One day after administration feel achy, light headed, ill, that night spiked fever with chills, profuse sweating, injection site red, warm 3" x 3" area. Next am temp 100°, shakey, I'll feeling. Next evening went to doctor.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Malaise, Pain, Pyrexia, Tremor
Clinical narrative: One day after administration feel achy, light headed, ill, that night spiked fever with chills, profuse sweating, injection site red, warm 3" x 3" area. Next am temp 100°, shakey, I'll feeling. Next evening went to doctor.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: The injection site became swollen and red. It was roughly the size of a half-dollar. Has reduced in in size. Is still TTP. No fever/chills. No SOB or difficulty breathing.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient's left arm is swollen from the site of the KINRIX about 3 inches in diameter, redness reaches to elbow. Site is hot to the touch. The site affected is the site of the KINRIX.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Hypersensitivity, Injected limb mobility decreased, Injection site pain, Injection site swelling
Clinical narrative: Given in upper right arm, top of muscle. My arm swelled within a few hours, 2xs normal size for 3 days. Ice packs, BENADRYL to counter allergic reaction and aspirin for pain. Nine months later I still have pain in upper right arm, especially when tired. Restricted movement in arm by evening. The pain has never left.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain upper, Diarrhoea, Nausea, Retching
Clinical narrative: Pt developed a stomach ache and nausea about 4 hours after vaccine, dry heaves without vomit, and diarrhea. This continued all through the night and into the next day 8/2/2017 until she was seen by me, so far 22 hours of symptoms.
Age: 6.0
Sex: F
Vaccine: HEPA
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Left arm swelling and pain.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: Information was received on 17-JUL-2017 from a health care worker concerning a patient of unknown age and gender. No medical history or concomitant medications were reported. The healthcare worker reported that on 14-JUL-2017, the patient was inadvertently administered a dose of properly stored ZOSTAVAX (Lot # N009777, expires 04-MAR-2018), given for prophylaxis, that was reconstituted with improperly stored sterile water diluent (lot N006322, expires 11-JUL-2019). No adverse effects reported. The temperature was out of range at 31 degrees F. or colder (0 degrees F.) for a period of 5 days. There was no previous temperature excursion. Call was due to a data logger. No other details were provided. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 17-JUL-2017 the patient was vaccinated with PROQUAD, (lot# and expiration date not reported) for prophylaxis and also vaccinated with VARIVAX (lot# and expiration date not reported) for prophylaxis. No adverse events reported.  No additional information provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received on 12-JUL-2017 from a pediatric physician and refers to an unspecified patient of unknown age and gender. The physician reported that the patient received an improperly stored dose of VARIVAX (Lot number M042496, expiration date 19-OCT-2018) (Dose, route, site of administration not reported) and properly stored sterile diluent (M029027, expiration date 14-MAR-2019) for prophylaxis on 11-JUL-2017. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. The VARIVAX (Lot number M042496, expiration date 19-OCT-2018) had the following temperature excursion reported: The temperature was reported as 6 degrees Fahrenheit (F) to 14 degrees Fahrenheit (F) for the time frame of 1 hour. It was administered. There was no previous temperature excursion. The call was because of a "data logger". Product quality complaint was not involved. No adverse effects reported. No additional information was provided. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant via company representative and refers to a 14 year old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 01-JUL-2014 (at the age of 12 years), the patient was vaccinated with first dose GARDASIL prophylaxis. On 26-JUL-2016 (at the age of 14 years), the patient was vaccinated with second dose of GARDASIL 9 for prophylaxis (Interchange of vaccine products, Inappropriate schedule of vaccine administered). No adverse events were reported.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Diarrhoea, Faeces discoloured
Clinical narrative: 7/24/17 returned to clinic-c/o diarrhea, watery, green at least 8x/day) since receiving vaccines on 7/18/17. Pt had f/u visit on 7/28/17 at which time diarrhea had resolved. Prolonged diarrhea of 9 days, presumably from the Rotavirus vaccination.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Heart rate increased, Hypotension, Loss of consciousness, Musculoskeletal stiffness, Unresponsive to stimuli
Clinical narrative: Patient passed out in private car before leaving parking lot. Dad states she was stiff and unresponsive in car for about 2 minutes. Patient had increased heart rate and low blood pressure on exam.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema
Clinical narrative: Redness of the left arm.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Headache. Chills, achiness, highest fever 101.2 on 7/28/17. At site of injection, red, sore, swollen, itchy. Symptoms began on 7/27/17 pm with headache and then chills/fever. The next day the site was red, swollen, sore and itchy. These symptoms lasted through the morning of 7/31/17.  The site was finally getting better on 8/2/17. I purchased and started taking L-Lysine on my own on 7/29/17 one or two times a day and Vitamin C also.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Pain, Pyrexia
Clinical narrative: Headache. Chills, achiness, highest fever 101.2 on 7/28/17. At site of injection, red, sore, swollen, itchy. Symptoms began on 7/27/17 pm with headache and then chills/fever. The next day the site was red, swollen, sore and itchy. These symptoms lasted through the morning of 7/31/17.  The site was finally getting better on 8/2/17. I purchased and started taking L-Lysine on my own on 7/29/17 one or two times a day and Vitamin C also.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Localized reaction at site of injection with increasing swelling, tenderness and warmth to dermis. This continued onto date of notification of 8/2/2017.
Age: 18.0
Sex: F
Vaccine: HEPA, IPV, MMRV, MNQ, TDAP
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: Patient presented to have catch up on vaccines. PROQUAD was given instead of MMR, Varicella separately. Patient is 18 years of age, should not have received PROQUAD.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth, Insomnia
Clinical narrative: PATIENT COMPLAINED DIFFICULTY OF SLEEPING, SWOLLEN AT THE SITE OF INJECTION, WARM AT THE AREA OF INJECTION, BUT NO FEVER. WE GIVE PATIENT ONE BOTTLE OF BENADRYL 25MG AND SUGGEST THE PATIENT TO TAKE 25MG EVERY 6 HOURS IF NEEDED. AND IF THE SYMPTOMS GET WORSE RECOMMENDED PATIENT TO SEEK A DOCTOR.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Burning sensation, Chest pain, Cold sweat, Dizziness, Excessive eye blinking
Clinical narrative: Prior to administration of Hepatitis A and HPV, Mother of pt asked if there was something for patient to eat, since she hadn't eaten that day. Pt was given a granola bar. (NKA)  Nurse administered Hepatitis A vaccine. Patient immediately felt light headed and woozy. Pt lay down on exam table with application of a cool compress on her forehead. She recovered and was administered HPV vaccine. Again felt light headed, was very pale, had clammy skin and fluttering eyelids. She was examined by Dr.  who reassured Mom and pt.  After 15 minutes patient was able to walk (with  a steady gait) out of the office with her mother. Mom later reported that patient complained of a burning sensation in her arm and chest. She developed a headache and then spasms in her back. All signs and symptoms have resolved with the exception of pain at the  HPV injection site.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Headache, Immediate post-injection reaction, Injection site pain, Muscle spasms, Pallor
Clinical narrative: Prior to administration of Hepatitis A and HPV, Mother of pt asked if there was something for patient to eat, since she hadn't eaten that day. Pt was given a granola bar. (NKA)  Nurse administered Hepatitis A vaccine. Patient immediately felt light headed and woozy. Pt lay down on exam table with application of a cool compress on her forehead. She recovered and was administered HPV vaccine. Again felt light headed, was very pale, had clammy skin and fluttering eyelids. She was examined by Dr.  who reassured Mom and pt.  After 15 minutes patient was able to walk (with  a steady gait) out of the office with her mother. Mom later reported that patient complained of a burning sensation in her arm and chest. She developed a headache and then spasms in her back. All signs and symptoms have resolved with the exception of pain at the  HPV injection site.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Injected limb mobility decreased, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: Severe left shoulder pain for 24 hours. Could not raise arm to wall light switch or reach forward very far by evening. Could not lay on left shoulder without significant pain. At peak of pain arm was swollen at injection site and muscles were sore down to wrist. Also had chills that evening from 9:00p to 4:00a next day. After 24 hours have better mobility but still sore around injection site only. The PPSV Vaccine information sheet indicated less than 1 out of 100 have this reaction so this is the reason for reporting.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Burning sensation, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Patient visited the doctor's office one week after the vaccination (8/2/17), reported a red, itching, burning rash from the top of her shoulder to mid arm. Doctor wrote a prescription for Triamcinolone 0.5% Cream and pt picked it up 8/2/17.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Cough, Pruritus, Rash, Rash vesicular, Respiratory symptom
Clinical narrative: He rash has developed over the last couple of days and seems to be spreading particularly around her feet and ankles and hands and wrists. The lesions are blister like in nature. They have been itchy. They are in various stages of evolution. There is no obvious bite marks. There is no known bite exposures. No one else has similar rash at home. She has never had a rash like this previously. Over the last couple of days, she has had respiratory symptoms and this morning a mild cough. She is taking no medications.
Age: 1.33
Sex: M
Vaccine: DTAP
Symptoms: Hypersensitivity, Rash generalised, Skin test positive, Urticaria, Vaccination complication
Clinical narrative: 3-6 hours after injection, developed body rash I believe is consistent with hives.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Tenderness
Clinical narrative: Rash on trunk and extremities. Area tender and itchy.
Age: 1.42
Sex: F
Vaccine: HEPA
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Severe localized reaction to vaccine. Entire anterior right thigh swollen, erythematous, warm, and tender. Started 24 hours after vaccine. No fever or other symptoms.
Age: 1.42
Sex: F
Vaccine: HEPA
Symptoms: Vaccination complication
Clinical narrative: Severe localized reaction to vaccine. Entire anterior right thigh swollen, erythematous, warm, and tender. Started 24 hours after vaccine. No fever or other symptoms.
Sex: U
Vaccine: HPV9, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On an unspecified date, unspecified number of patients were administered improperly stored GARDASIL 9 lot # M044717, expiration 19-JUL-2019 for prophylaxis and unspecified number of patients were administered improperly stored ROTATEQ lot# M045546, expiration 12-JUN-2018. No adverse effects reported. Temperature between 9 degrees Celsius (°C) to 25°C (14.5C). Time frame 1 Hour. No previous temperature excursion. Digital Data logger report was not involved. Additional information has been requested.