chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Middle insomnia, Pallor, Rash macular, Screaming
Clinical narrative: Yesterday evening just after 7 PM parents called me; Was in for his 4 month well visit today, and received his 4 month vaccines (DTaP-IPV-HIB, PCV-13 and RV-5) - about 6 hours prior. Just then they had given him a bath; after the bath he became very fussy, then started screaming, his eyes opened and closed, and he became very pale. He was afebrile. He was now asleep, his color was normal again - but he had red blotches on his shins. I suggested: Let him sleep a while - then try to feed him (his last bottle was about 1 1/2 hours ago). Call me back if he refuses to feed; becomes febrile; or deviates in any other way from normal. I already discussed with his parents that this is possibly a reaction to the DTaP vaccine - rare, but "serious". Mom tells me now that he slept almost 4 hours after this episode. Reviewing the history again, after the bath mom put on his pajamas - "like a switch, nothing we've heard before, he started screaming". He screamed for 3 minutes (red while screaming) - mom eventually put him down in his crib - he became pale, and his eyes kept opening and closing. No limb movements, no stiffness - just limp. Then - after a few minutes - his color came back, he made some grumbling noises, took his pacifier and fell asleep. Mom has seen him "almost hold his breath" in the past - but "this wasn't like it". He woke up at midnight, took 6 oz, by bottle and went right back to sleep. He was up every hour because he lost his pacifier, went straight back to sleep. Mom doesn't want to be looking for things - but he is making some throat noises, like throwing up in his mouth, and has already taken two naps this morning; but he is making eye contact, smiling, had had wet diapers.
Age: 41.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Local swelling, Lymph node pain, Lymphadenopathy, Malaise, Paraesthesia
Clinical narrative: Pt. received TDaP right delt 5/16/17 C/O swelling right side of neck - noticed swelling 5/17/17 tender to the touch. Tender and swollen lymph node, R supra-clavicular region since the evening of May 16, 2017, following vaccine admin. Noticed tingling to R fingers, denies loss of function in hand, fingers, arm. Sx's peaked on Wednesday, May 17, 2017 approx. 24 hours after admin with mod pain/R lymphadenopathy and generalized feeling of malaise. Sx's improved starting May 18, 2017 and are progressively better today. Still has mild lymphadenopathy R supra-clavicular node. No other Sx's at this time. Pt. denies fever, chills, body aches or other areas of involvement.
Age: 41.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Tenderness
Clinical narrative: Pt. received TDaP right delt 5/16/17 C/O swelling right side of neck - noticed swelling 5/17/17 tender to the touch. Tender and swollen lymph node, R supra-clavicular region since the evening of May 16, 2017, following vaccine admin. Noticed tingling to R fingers, denies loss of function in hand, fingers, arm. Sx's peaked on Wednesday, May 17, 2017 approx. 24 hours after admin with mod pain/R lymphadenopathy and generalized feeling of malaise. Sx's improved starting May 18, 2017 and are progressively better today. Still has mild lymphadenopathy R supra-clavicular node. No other Sx's at this time. Pt. denies fever, chills, body aches or other areas of involvement.
Age: 37.0
Sex: M
Vaccine: HEPAB, TDAP
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Pt. received TDaP and TWINRIX on 5-4-17 returned to clinic on 5-31-17 for unrelated tx. Stated arm was painful and pain went to neck after approx. 15 days. F/u with pt on 6-1-17 pt. states pain resolved.
Age: 7.0
Sex: M
Vaccine: TYP, YF
Symptoms: Ocular hyperaemia, Sensation of foreign body, Urticaria, Wheezing
Clinical narrative: 30 to 45 minutes post yellow fever and TYPHIM VI vaccines child developed bilateral eye redness, sensation of something stuck in throat, hives and wheezing. Vital signs BP - 125/73, Pulse 98-107, Resp. 20, O2 Sat 92-100. Pt. treated in urgent care with 500 ml IV normal saline, 25 mg BENADRYL IV, 40 mg SOLUMEDROL IV, 30 mg ranitidine IV and neb treatment with albuterol 5 mg - observed for 2 hours in UC without return of symptoms - discharged to home. On ORAPRED 1mg PO x 5 day and daily CLARITIN with BENADRYL PRN and to return to clinic if symptoms return.
Age: 49.0
Sex: F
Vaccine: RAB
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Lip swelling, Musculoskeletal stiffness
Clinical narrative: Numbness to cheeks and mouth, stiffness to neck, lower lip swelling. Pt. reports S/S after 1st vaccine 5/26/17 and after 2nd 5/29/17. 1st vaccine administered in ER. Did not report to nurse at time of 2nd vaccine.
Age: 19.0
Sex: F
Vaccine: HPV4, MENB
Symptoms: Chills, Dizziness, Syncope, Thyroid function test
Clinical narrative: At 10:25 pt. was administered HPV #2 on right deltoid IM and BEXSERO on left deltoid IM. Did not mention not feeling well therefore taken to lab for thyroid function testing due to history of hypothyroidism. At 10:30 am pt. was at the lab when the lab tech ask for help, feeling lightheaded, fainted. I helped laying her down to the bed and check her BP was 100/60. 15 minutes later her BP was 98/58 and she was shivering. She stayed there for 10 more minutes. Per mom Pt fainted before with blood flow draw 6/9/17.
Age: 16.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Dyspnoea, Headache, Pain, Pyrexia, Rash
Clinical narrative: Received TRUMENBA vaccine on 6/5/2017 at 3 PM, on 6/6/17, woke up with headache, bodyache, low gr fever up to 100.5. Symptoms progressed to 102 fevers, shortness of breathe, bodyache by 6/6/17 evening. 6/7/17 developed rash.
Age: 16.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Dyspnoea, Ear swelling, Erythema, Fatigue, Headache
Clinical narrative: Received TRUMENBA vaccine on 6/5/2017 at 3 PM, on 6/6/17, woke up with headache, bodyache, low gr fever up to 100.5. Symptoms progressed to 102 fevers, shortness of breathe, bodyache by 6/6/17 evening. 6/7/17 developed rash.
Age: 16.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Injection site pain, Pain, Palmar erythema, Pyrexia, Rash
Clinical narrative: Received TRUMENBA vaccine on 6/5/2017 at 3 PM, on 6/6/17, woke up with headache, bodyache, low gr fever up to 100.5. Symptoms progressed to 102 fevers, shortness of breathe, bodyache by 6/6/17 evening. 6/7/17 developed rash.
Age: 16.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Urticaria
Clinical narrative: Received TRUMENBA vaccine on 6/5/2017 at 3 PM, on 6/6/17, woke up with headache, bodyache, low gr fever up to 100.5. Symptoms progressed to 102 fevers, shortness of breathe, bodyache by 6/6/17 evening. 6/7/17 developed rash.
Age: 1.83
Sex: M
Vaccine: PPV
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: 5/26/17 Redness, swelling (R) thigh, also very tenderness. Pt. is bearing weight and otherwise active. Pt. also seen at ED - altogether monitored and Tx'd. Has appt. 6/2/17 and U/S and spclst. notes given to pt. parents 5/26/17.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Localized swelling, redness, and warmth at injection site. Greater than normal reaction. No sickness or breathing difficulty. Treated with antihistamine.
Age: 1.0
Sex: F
Vaccine: PNC13, VARCEL
Symptoms: Abscess, Incisional drainage, Injection site swelling, Injection site urticaria, Pyrexia
Clinical narrative: Pt received 12 month vaccination on 5/24. She was already running fevers. The ff day was taken to ER for fever and (R) thigh swelling. Notes from ER said they drained swelling but PE didn't say/describe the swelling. DX: Abscess and BACTRIM was started. I saw pt today in the office. No more swelling, pain, redness accdg to mom. There was just a small palpable wheal on (R) mid thigh.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV4, MNQ
Symptoms: Syncope
Clinical narrative: Patient had a syncopal episode after receiving vaccination. Recovered in 15 seconds.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Patient's advocate called to say that patient has a rash and thinks it is from the shingles vaccine. Patient was referred to physician for treatment. Rash is mostly on his back but did not seem painful. Itchiness was mild.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Pain, Vaccination site pain, X-ray
Clinical narrative: Immediately my left arm was sore at the side of the vaccine. It remained sore for a few days, then it continued to be sore and I felt perhaps have damage. After several weeks it was throbbing and I had very little range of motion. I sought medical treatment.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Crying, Fine motor skill dysfunction, Injection site movement impairment, Mobility decreased, Pyrexia
Clinical narrative: Patient reports that the night of the 27th he woke crying and febrile, not moving his legs. Reported that he would not bear weight or roll over for several days. Reported that he lost motor skills and took 1 month to regain them.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Weight bearing difficulty
Clinical narrative: Patient reports that the night of the 27th he woke crying and febrile, not moving his legs. Reported that he would not bear weight or roll over for several days. Reported that he lost motor skills and took 1 month to regain them.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: Patient developed hives which required ER visit, treatment with steroid, hives lasted one week. Hives covered large parts of her body. No respiratory distress.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site rash, Injection site swelling, Oral mucosal eruption, Pyrexia
Clinical narrative: Rash and swelling on (L) upper arm - inj site. Rash around patients mouth, fever since Friday night (3/3/17).
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Exposure during pregnancy
Clinical narrative: Vaccine given to pregnant patient (Men B).
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Had welts, hives, itching, red on 06/06/17.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Injection site erythema, Injection site reaction, Injection site vesicles, Pain
Clinical narrative: Redness, itchiness, pain, ridge blisters. Treatment given by physician prednisone 20mg. The site had looked like shingles.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Skin induration, Tenderness
Clinical narrative: Redness, itchiness, pain, ridge blisters. Treatment given by physician prednisone 20mg. The site had looked like shingles.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Erythema, Injection site reaction, Pain, Pruritus
Clinical narrative: Redness, itchiness, pain, ridge blisters. Treatment given by physician prednisone 20mg. The site had looked like shingles.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash vesicular
Clinical narrative: Redness, itchiness, pain, ridge blisters. Treatment given by physician prednisone 20mg. The site had looked like shingles.
Age: 62.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Eyelid oedema
Clinical narrative: Bacterial infection in both eyes - treatment of Tobramycin/Dexame drops for 1 wk followed with a check-up. Both eyes swelled 1 eye completely shut - the other 1.2 shut.
Age: 62.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Eye infection bacterial, Eye swelling, Eyelid oedema
Clinical narrative: Bacterial infection in both eyes - treatment of Tobramycin/Dexame drops for 1 wk followed with a check-up. Both eyes swelled 1 eye completely shut - the other 1.2 shut.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Dysarthria, Dyspnoea, Hypoaesthesia, Immunoglobulin therapy
Clinical narrative: Symptoms: Numbness, difficulty breathing, paralysis, slurred speech, Treatment: 15 courses of Immunoglobulin and Plasmapheresis.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Lumbar puncture, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging thoracic, Paralysis, Plasmapheresis
Clinical narrative: Symptoms: Numbness, difficulty breathing, paralysis, slurred speech, Treatment: 15 courses of Immunoglobulin and Plasmapheresis.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Ultrasound scan
Clinical narrative: Symptoms: Numbness, difficulty breathing, paralysis, slurred speech, Treatment: 15 courses of Immunoglobulin and Plasmapheresis.
Age: 9.0
Sex: M
Vaccine: TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Just below site of injection arm was red, swollen, firm, warm to touch, painful. low grade fever. But 48 hours arm was still spreading redness at fast rate.  4 inches in diameter. Dx with Celulitis and told given antibiotics.Told to follow up in 2 days.Pictures taken by reporter.
Age: 9.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: Just below site of injection arm was red, swollen, firm, warm to touch, painful. low grade fever. But 48 hours arm was still spreading redness at fast rate.  4 inches in diameter. Dx with Celulitis and told given antibiotics.Told to follow up in 2 days.Pictures taken by reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Malaise
Clinical narrative: This spontaneous report has been received from a male consumer of an unknown age via a company representative reporting on himself. The patient's relevant medical history, concurrent conditions, and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX subcutaneously (strength, dose, frequency, lot number and expiration date were not reported) for prevention of shingles. Subsequently, on an unknown date, the patient felt a "bit funny" and he was not his usual self (feeling abnormal), he also was tired and sick. At the time of this report, the outcome of feeling abnormal, fatigue, and malaise was unknown. The causality assessment between feeling abnormal, fatigue, and malaise with Zoster Vaccine Live (ZOSTAVAX) was not reported. Additional information is not expected as there was no contact consent provided.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist and referred to an unknown number of patients of unknown ages and genders.  The patients' relevant medical history, concurrent conditions, and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of ZOSTAVAX (strength, dose, frequency, and route of administration were not reported; lot number M018593 with an expiration date 28-JUN-2017) for prophylaxis. The vaccine data logger measured a temperature of 15°F for a total time frame of 2 hours. There was no previous temperature excursion. No adverse effects were reported. This is one of two reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA007898:
Sex: U
Vaccine: HPV9
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report has been received from a physician via a company representative, concerning to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On approximately 10-MAY-2017 (reported as about 2 weeks ago), the patient was vaccinated with a dose of with GARDASIL 9 injection (dose, frequency, route of administration, lot# and expiration date were not provided) for prevent human papilloma virus (HPV). It was unknown which .5 ml dose in the GARDASIL 9 series the patient was given and if the patient was going to complete the series or not. It was stated that, the patient's mother called the physician's office, as a way of seeking medical attention for the patient, who was experiencing swelling and pain at the injection site after receiving the dose of GARDASIL 9. It was unknown if the patient received any treatment or if diagnostic laboratories were performed. At the time of the report, the outcome of the patient was unknown. The causal relationship between the therapy with GARDASIL 9 and the events of swelling and pain at the injection site was unknown. There was no product quality complaint involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Incorrect product storage
Clinical narrative: Information has been received from a pharmacist, on behalf of a consumer, concerning the consumer's wife, a female patient of an unknown age.  The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of ZOSTAVAX 19400 PFU (strength, dosage schedule, anatomical location, route of administration, lot number and expiration date were not provided) reconstituted with a sterile water diluent (DILUENT MRK) for prophylaxis, the patient thought that the dose was exposed to an unknown warmer temperatures prior to it being administered to her for 1 hour and 30 minutes (no digital data logger) and the reporter did not known if there was any previous temperature excursion. It was reported that this occurred because the patient transported the ZOSTAVAX from an unknown pharmacy, where it was dispensed, to an unspecified physician's office. It was unknown how the sterile water diluent (DILUENT MRK) was stored. On an unspecified date (reported as "later"), the patient developed shingles. At the time of the report, the outcome of the patient regarding the shingles and the causal relationship between the shingles and the vaccination with ZOSTAVAX reconstituted with a sterile water diluent (DILUENT MRK)) were not reported. Additional information is not expected since the reporter did not consent for further follow up.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pain, Pyrexia
Clinical narrative: This spontaneous report was received from a 73 year old female patient regarding herself. The patienti's concurrent conditions included osteopenia and arthritis. The patient's medical history included allergic reactions after previous use of penicillin and amoxicillin (+) clavulanate potassium (AUGMENTIN). On 01-JUN-2017, the patient was vaccinated with ZOSTAVAX subcutaneous injection, on an unspecified arm (dose, lot number and expiry date were not reported) for prophylaxis. Concomitant therapies included diclofenac, methocarbamol (ROBAXIN) and raloxifene (RALOXIFENE). On 02-JUN-2017, the patient experienced swelling and redness at the injection site, low grade fever and severe pain. On 03-JUN-2017, the patient sought medical attention at an emergency room and received treatment with mupirocin (BACTROBAN) and sulfamethoxazole (+) trimethoprim (BACTRIM). Also, it was reported that the patient contacted a pharmacy. No laboratory diagnostic studies were performed. additionally, the patient was scheduled to see a healthcare professional "this week." No product quality complaint (PQC) was involved. At the reporting time, the patient did not recover from the events, the reporter did not provide a causality assessment between the events and the ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD (strength, dose and route were unknown) lot # M043310, expiration date 24-APR-2018 for prophylaxis which had a temperature excursion of 10.6°F for 2 hours that was detected by a data logger. The vaccine had no previous temperature excursions. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a nurse concerning multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On unknown dates, the patients were vaccinated with M-M-R II (dose, strength, frequency, route of administration, anatomical location, lot # and expiration date were not reported), for prophylaxis. The administered vaccines were improperly stored at temperature greater than 9°C but less than 25°C for 1 hour and 13 minutes without any previous temperature excursion; this information was registered in a digital data logger. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA002917: US-009507513-1706USA002916: US-009507513-1706USA002914: US-009507513-1706USA002915:
Sex: F
Vaccine: HPV9, MENB
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a physician via a company representative concerning a currently 20 year old female patient. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On an unknown date, the patient received the third dose of GARDASIL 9 intramuscularly (dose, lot number and expiration date were not reported) for prevention of human papillomavirus (prophylaxis). Another suspect therapy included TRUMENBA. On an unknown date, the patient fainted. On an unspecified date, the patient sought medical attention. At the time of reporting, the outcome of the event was recovered. The causal relationship between the event and GARDASIL 9 was not reported. This is one of two reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1706USA002569.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a vaccine coordinator, concerning unspecified number of patients of unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On unspecified dates, the patients were orally vaccinated with an improperly stored dose of ROTATEQ (dose, frequency, lot # and expiration date were not reported) for prophylaxis. The temperature of the ROTATEQ was between 9 °C and 22°C for a time frame of 25 hours and 48 minutes (reported as "25.8 hours") and between 0 °C and 1 °C for a time frame of 25 hours and 48 minutes (reported as "25.8 hours"). No previous temperature excursion occurred, and data logger was involved. No adverse effects were reported. This is one of three reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1706USA002899: US-009507513-1706USA002898:
Age: 1.5
Sex: U
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 18 month old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 06-JUN-2017, the patient was vaccinated with a dose of GARDASIL 9 with lot # M041212 and expiration date of 21-JUN-2019 (strength, dose and route of administration were unknown) for prophylaxis. 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 was received from a vaccine coordinator, concerning unspecified number of patients of unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On unspecified dates, the patients were vaccinated with an improperly stored dose of VAQTA (dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. The temperature of the VAQTA was between 9 °C and 22 °C for a time frame of 25 hours and 48 minutes (reported as "25.8 hours") and between 0 °C and 1 °C for a time frame of 25 hours and 48 minutes (reported as "25.8 hours"). No previous temperature excursion occurred, and data logger was involved. No adverse effects were reported. This is one of three reports received from the same source.  Additional information has been requested.; Sender's Comments:  US-009507513-1706USA002794: US-009507513-1706USA002899:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a vaccine coordinator, concerning unspecified number of patients of unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On unspecified dates, the patients were vaccinated with an improperly stored dose of GARDASIL 9 (dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. The temperature of the GARDASIL 9 was between 9°C and 22°C for a time frame of 25 hours and 48 minutes (reported as "25.8 hours") and between 0°C and 1°C for a time frame of 25 hours and 48 minutes (reported as "25.8 hours"). No previous temperature excursion occurred, and data logger was involved. No adverse effects were reported. This is one of three reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1706USA002794: US-009507513-1706USA002898.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a nurse concerning multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On unknown dates, the patients were vaccinated with RECOMBIVAX HB (dose, strength, frequency, route of administration, anatomical location, lot # and expiration date were not reported), for prophylaxis. Concomitant therapies included properly stored sterile diluent (STERILE DILUENT). The administered vaccines were improperly stored at temperature greater than 9°C but less than 25°C for 1 hour and 13 minutes without any previous temperature excursion; this information was registered in a digital data logger. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA002314: US-009507513-1706USA002915: US-009507513-1706USA002916: US-009507513-1706USA002917:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a nurse concerning multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On unknown dates, the patients were vaccinated with GARDASIL 9 (dose, strength, frequency, route of administration, anatomical location, lot # and expiration date were not reported), for prophylaxis. Concomitant therapies included properly stored STERILE DILUENT. The administered vaccines were improperly stored at temperature greater than 9°C but less than 25°C for 1 hour and 13 minutes without any previous temperature excursion; this information was registered in a digital data logger. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA002314: US-009507513-1706USA002914: US-009507513-1706USA002916: US-009507513-1706USA002917.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a nurse concerning multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On unknown dates, the patients were vaccinated with ROTATEQ oral liquid (dose, strength, frequency, lot # and expiration date were not reported), for prophylaxis. Concomitant therapies included properly stored sterile diluent (STERILE DILUENT). The administered vaccines were improperly stored at temperature greater than 9°C but less than 25°C for 1 hour and 13 minutes without any previous temperature excursion; this information was registered in a digital data logger. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA002917: US-009507513-1706USA002314: US-009507513-1706USA002914: US-009507513-1706USA002915:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a nurse concerning multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On unknown dates, the patients were vaccinated with VAQTA (dose, strength, frequency, route of administration, anatomical location, lot # and expiration date were not reported), for prophylaxis. Concomitant therapies included properly stored sterile diluent (STERILE DILUENT). The administered vaccines were improperly stored at temperature greater than 9°C but less than 25°C for 1 hour and 13 minutes without any previous temperature excursion; this information was registered in a digital data logger.  This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1706USA002314: US-009507513-1706USA002916: US-009507513-1706USA002914: US-009507513-1706USA002915:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to 4 patients of unknown age and gender.  The patients' medical history, concurrent conditions, and allergies were not reported. Concomitant therapies included sterile diluent (manufacturer unknown). On 16-MAY-2017, one patient was vaccinated with an improperly stored dose of VARIVAX and on 19-MAY-2017, three patients were vaccinated with improperly stored doses of VARIVAX, all for prophylaxis (doses and routes of administration were not reported). It was unknown by the nurse which specific vaccine lot numbers were administered on each specific date of administration. Lot # M048200 with expiration date 07-DEC-2018 (which was reconstituted with sterile diluent (manufacturer unknown) L025375 with expiration date 14-MAR-2018) and Lot # M045204 with expiration date 11-NOV-2018 (which was reconstituted with sterile diluent (manufacturer unknown) N007760 with expiration date 31-MAY-2018). The sterile diluent (manufacturer unknown) used to reconstitute the vaccine was properly stored. No symptoms were reported. The doses of the vaccine were exposed to a temperature of 8.8 degree Celsius Fahrenheit (°F) for a time frame of 30 minutes. There were no previous temperature excursions. A digital data logger was involved. Furthermore, No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA015777:
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Computerised tomogram normal, Diarrhoea, Electrocardiogram normal, Headache, Mental status changes
Clinical narrative: Patient presented to ER at the Medical Center with nausea vomiting and diarrhea and headache with altered mental status. She had low grade fever with highest being 101.7 F. She was then life flighted to hospital for more specialized care on 6/8/2017 around 4am. She had completed her sports physical in our office that day. Her urine was within normal limits and EKG was within normal limits. Upon admission to ER she had test ran in which urinalysis was abnormal. CT was WNL, monospot was WNL.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Mononucleosis heterophile test negative, Nausea, Pyrexia, Urine analysis abnormal, Vomiting
Clinical narrative: Patient presented to ER at the Medical Center with nausea vomiting and diarrhea and headache with altered mental status. She had low grade fever with highest being 101.7 F. She was then life flighted to hospital for more specialized care on 6/8/2017 around 4am. She had completed her sports physical in our office that day. Her urine was within normal limits and EKG was within normal limits. Upon admission to ER she had test ran in which urinalysis was abnormal. CT was WNL, monospot was WNL.
Age: 14.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain upper, Headache, Pruritus, Rash, Vomiting
Clinical narrative: Rash started a few hours after first pill of VIVOTIF. Rash, with itch worsened. Had headache also. On 6/7, started having stomach pain and vomiting.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site nodule, Injection site rash, Injection site warmth
Clinical narrative: Patient had a gulf ball size rash that was hot to touch. The patient's rash was also "knot like". The patient's doctors has sent over a Medrol Dose pak for control of her symptoms. Patient states that the symptoms appeared shortly after the vaccine. It is at the same site she was administered the vaccine. Patient once had a reaction to the pneumonia shot, and got cellulitis. Before administering the vaccine, I compared the ingredients of both vaccines, which were different. At the point, I felt comfortable administering the shot.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Decreased appetite, Mood altered, Rash, Vomiting
Clinical narrative: Moody, vomiting, loss of appetite, rash, possible febrile seizure.
Age: 75.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site reaction, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Pt developed a red, raised itchy rash at the injection site and on his back, chest, and shoulders.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Explorative laparotomy, Intussusception
Clinical narrative: Intussusception requiring Exploratory Laparotomy.
Age: 16.0
Sex: M
Vaccine: MMR
Symptoms: Headache, Photophobia, Pyrexia
Clinical narrative: Fever for 2 days, severe headache and sensativity to light for 10 days.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Local reaction at injection site, onset 3-5 hours post injection, large red area at injection site, swelling, warm to touch.  Ice / cool compresses applied with slight improvement next morning.  Same treatment continued with slight improvement 24 hours post injection.
Age: 0.25
Sex: F
Vaccine: RV1
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: No adverse event noted. Rotavirus vaccine initiated after 14 weeks 6 days. CDC recommendation is to initiate prior to this age.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant (also an office manager) and refers to a patient of unknown age and gender. There was no information about the patient's concomitant therapies, medical history and drug reactions or allergies provided. On 10-APR-2017, the patient was vaccinated with improperly stored dose of VARIVAX 0.5 ml, once, subcutaneously, lot# M038857, expiration date: 14-SEP-2018 (site of administration was not reported). Sterile diluent, lot#: M033585, expiration date: 21-APR-2019, subcutaneously, was used to reconstitute the dose of improperly stored VARIVAX received by the patient. No temperature excursion was identified for the sterile diluent. No adverse effects were reported. Administered dose of vaccine was stored in temperature between 15 degrees Fahrenheit to 46 degrees Fahrenheit (the range was 35.5 degrees Fahrenheit) for 3 hours. Digital data logger was used to capture the temperature excursion. There were no previous temperature excursions. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA015679: US-009507513-1705USA015680: US-009507513-1705USA015681: US-009507513-1705USA015682: US-009507513-1705USA015683:
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site urticaria, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 64-year-old female patient. The patient had no pertinent medical history, drug reactions or allergies nor concomitant therapies. On 15-MAY-2017, the patient was vaccinated with PNEUMOVAX23 (lot # L040178, expiration date: 18-AUG-2017), dose and route of administration were not reported), in the left arm as vaccination. On 16-MAY-2017, she developed warmth and tenderness at the injection site and a raised welt 8 inches, from where the vaccine was administered. Lab diagnostic studied were not preformed. An unspecified treatment was given for the adverse events. The outcome of the events was reported as not recovered. The relatedness between the events and PNEUMOVAX23 was not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown demographics. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unspecified dates, the patients were vaccinated with doses of improperly stored VARIVAX lot # L048463 with expiration date on 02-DEC-2017 (dose and route of administration were not reported). The vaccine underwent a temperature excursion of -9 to 8 degrees Celsius for 27 hours. Digital data logger was used to record the excursion. There was no previous temperature excursions reported. A properly stored sterile diluent (lot number and expiration date were not reported) was used to reconstitute the doses of VARIVAX. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On multiple unspecified dates, the patients were vaccinated with doses of improperly stored LIQUID PEDVAXHIB lot # reported as M046140 with expiration date on 27-SEP-2019 (dose and route of administration were not reported). The vaccine underwent a temperature excursion of 9 to 25 degrees Celsius for 32 minutes. Digital data logger was used to record the excursion. The vaccine did not undergo any previous temperature excursions. No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1705USA006315:
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history and drug reactions or allergies was provided. On 22-MAY-2017, the patient was vaccinated subcutaneously in the left arm with an expired dose of VARIVAX injection (lot # L017145, expiry date: 13-MAY-2017; the dose was not specified). The concomitant medication included sterile diluent injection. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age (also reported as "0") and gender. No information about the patient's pertinent medical history, concomitant medications and concurrent conditions was provided. On 26-APR-2017, the patient was vaccinated with an improperly stored dose of  ROTATEQ oral solution, lot # M041181 (dose, and expiry date were not specified) for prophylaxis. The administered dose of ROTATEQ underwent a temperature excursion of 48 Fahrenheit degrees for 30 minutes. There was no Digital Data Logger involved. No previous temperature excursion was reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all available information has been received.; Sender's Comments:  US-009507513-1704USA000587: US-009507513-1704USA001660: US-009507513-1704USA001661:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age (also reported as "0") and gender. No information about the patient's pertinent medical history, concomitant medications and concurrent conditions was provided. On 02-MAY-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ oral solution, lot # M041181 (dose, and expiry date were not specified) for prophylaxis. The administered dose of ROTATEQ underwent a temperature excursion of 48 Fahrenheit degrees for 30 minutes. No previous temperature excursion was reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all available information has been received.; Sender's Comments: US-009507513-1704USA000587: US-009507513-1704USA001660: US-009507513-1704USA001661:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age (also reported as "0") and gender. No information about the patient's pertinent medical history, concomitant medications and concurrent conditions was provided. On 21-APR-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ oral solution, lot # M041181 (dose, and expiry date were not specified) for prophylaxis. The administered dose of ROTATEQ underwent a temperature excursion of 48 Fahrenheit degrees for 30 minutes. No previous temperature excursion was reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all available information has been received.; Sender's Comments: US-009507513-1704USA000587: US-009507513-1704USA001660: US-009507513-1704USA001661:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age (also reported as "0") and gender. No information about the patient's pertinent medical history, concomitant medications and concurrent conditions was provided. On 04-MAY-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ oral solution, lot # M041181 (dose, and expiry date were not specified) for prophylaxis. The administered dose of ROTATEQ underwent a temperature excursion of 48 Fahrenheit degrees for 30 minutes. No previous temperature excursion was reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all available information has been received.; Sender's Comments: US-009507513-1704USA000587: US-009507513-1704USA001660: US-009507513-1704USA001661:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age (also reported as "0") and gender. No information about the patient's pertinent medical On 27-APR-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ oral solution, lot # M041181 (dose, and expiry date were not specified) for prophylaxis. The administered dose of ROTATEQ underwent a temperature excursion of 48 Fahrenheit degrees for 30 minutes. No previous temperature excursion was reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all available information has been received.; Sender's Comments: US-009507513-1704USA000587: US-009507513-1704USA001660: US-009507513-1704USA001661:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age (also reported as "0") and gender. No information about the patient's pertinent medical history, concomitant medications and concurrent conditions was provided. On 27-APR-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ oral solution, lot # M041181 (dose, and expiry date were not specified) for prophylaxis. The administered dose of ROTATEQ underwent a temperature excursion of 48 Fahrenheit degrees for 30 minutes. No previous temperature excursion was reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all available information has been received.; Sender's Comments: US-009507513-1704USA000587: US-009507513-1704USA001660: US-009507513-1704USA001661:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age (also reported as "0") and gender. No information about the patient's pertinent medical history, concomitant medications and concurrent conditions was provided. On 05-MAY-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ oral solution, lot # M041181 (dose, and expiry date were not specified) for prophylaxis. The administered dose of ROTATEQ underwent a temperature excursion of 48 Fahrenheit degrees for 30 minutes. No previous temperature excursion was reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all available information has been received.; Sender's Comments: US-009507513-1704USA000587: US-009507513-1704USA001660: US-009507513-1704USA001661:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age (also reported as "0") and gender. No information about the patient's pertinent medical history, concomitant medications and concurrent conditions was provided. On 28-APR-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ oral solution, lot # M041181 (dose, and expiry date were not specified) for prophylaxis. The administered dose of ROTATEQ underwent a temperature excursion of 48 Fahrenheit degrees for 30 minutes. No previous temperature excursion was reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all available information has been received.; Sender's Comments: US-009507513-1704USA000587:  US-009507513-1704USA001660: US-009507513-1704USA001661: