chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: F
Vaccine: DTAP, DTAPIPV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Skin tightness
Clinical narrative: LT ARM SWELLING FROM SHOULDER TO ELBOW, BRIGHT RED, HOT, AND TIGHTNESS OF SKIN FROM SWELLING X2 DAYS.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Urticaria
Clinical narrative: Hives to face, chest and upper extremities beginning after receiving vaccination. Patient took Claritin and Benadryl with mild relief in symptoms. Patient was prescribed Prednisone steroid taper: 10mg 3 tablets daily for 5 days. Outcome is undetermined as of todays date as treatment with steroids has not yet be completed.
Age: 46.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Patient has redness at injection site and expanded on arm. We recommended Benadryl and Tylenol/ibuprofen. No improvement so she sought medication attention.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fatigue, Injection site pain, Vomiting
Clinical narrative: Pain at injection site, throwing up, dizziness. Overall fatigue.
Age: 22.0
Sex: M
Vaccine: TYP, YF
Symptoms: Incorrect route of drug administration
Clinical narrative: Typhoid vaccine given subcutaneously instead of intramuscular route.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information was received on 14-JUL-2017 from a physician who reported that an unspecified 20 year old patient (gender unknown) received a dose of ZOSTAVAX (date, dose, lot#/expiration not reported) with diluent (lot#/expiration not reported) instead of VARIVAX. The physician reported that the patient had no history of varicella vaccination. No adverse effects were reported. No additional information was provided. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant concerns an unspecified amount of patients (age and gender unknown). The patients' medical histories, concurrent conditions and concomitant medication use were not provided. On unknown dates the patients were either vaccinated with improperly stored PROQUAD, 1 DF (lot # M043306, expiration date 24-APR-2018 or M044719, expiration date 07-MAY-2018) or VARIVAX, 1 DF, lot# M047660, expiration date 02-DEC-2018 or lot# M041513, expiration date 11-OCT-2018) for prophylaxis. Concomitant therapies included sterile diluent. No adverse event was reported. Temperature -14 degrees Celsius to -10 degrees Celsius, time frame: 5 hours 38 minutes. Previous temperature excursion = yes. The outcome of the event is unknown. Additional information has been requested.
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information was received on 13-JUL-2017 from a pharmacist regarding a male patient (age not reported).  Medical history, concurrent conditions and concomitant medications were not reported.  On 20-JAN-2017, the patient received a dose of VAQTA (lot # L017757, exp 08-APR-2018) (dose, route, and site of administration not reported) for the indication of prophylaxis. The patient received a second dose of VAQTA (lot # L017757, exp 08-APR-2018) one month later, on 21-FEB-2017. No adverse effects reported. No additional information was provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information was received on 11-JUL-2017 from a licensed practical nurse who was reporting on multiple unspecified patients of unknown age and gender. No medical history or concomitant medications were reported. The nurse reported that an unspecified number of patients received on unspecified dates, an unspecified separate number of doses of improperly stored VARIVAX (lot # N012488, expires 20-APR-2019, lot # N001527, expires 13-JAN-2019 and lot # N012134, expires 17-APR-2019). It was also reported that unspecified number of separate patients were administered separate doses of PROQUAD (MARRS# 1707USA009347). The lot numbers of the sterile diluent used to reconstitute the vaccine was unknown. No adverse effects were reported. No other information was provided. The temperature excursion was 6 degrees F. to 14 degrees F. for 8 hours and 52 minutes and 30 seconds. This was due to data logger. Additional information has been requested. This is one of two reports by the same reporter.
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information was received on 11-JUL-2017 from a company employee who learned of an adverse experience from a female patient approximately "in 16 to 18 years of age range" at an unspecified pharmacy. No medical history or concomitant medications were reported. The patient reported that her arm developed "a lot of soreness" (arm unspecified) after her last dose of GARDASIL (lot, expiration and dose not reported)  that she received from an unspecified physician. It was not specified which dose in the series that she developed the soreness. The patient has recovered from the event. No further details are available. Additional information is not expected. No further details available.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or other concomitant medication. On 26-MAY-2017, the patient received an improperly stored dose of VARIVAX, in left thigh subcutaneously, lot # M046005, expiration date 18-NOV-2018. The sterile diluent used to reconstitute the VARIVAX was properly stored.  No adverse effect reported. Temperature was reported as: 15°F to 46°F (22.1°F) Time frame: 50 minutes Previous temperature excursion: No Data logger involved: Yes No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse, concerning an unspecified patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medications were not provided. On an unknown date in 2015, the patient was vaccinated with the first dose of GARDASIL (also reported as GARDASIL 4) and then, on an unknown date in 2016 (reported as administered late), the patient was vaccinated with the second dose of GARDASIL 9 (dose, route of administration, lot number and expiration date were not provided for both vaccines) for prophylaxis. No adverse effects were reported. There was no product quality complaint involved.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to an unspecified patients of unknown age and gender. On 10-JUL-2017 and 11-JUL-2017, the patients were vaccinated with improperly stored doses of M-M-R II (dose, route of administration and were not reported). Data logger was involved (temperature excursion: 47-77  Fahrenheit degrees).      Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other refers to a patient of unknown age. On an unknown date the patient was vaccinated with PROQUAD lot # N001488 for prophylaxis. Concomitant therapies included 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. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA009857.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. The patients' medical history was not reported. On unknown dates, the patient was vaccinated with improperly stored doses of ZOSTAVAX lot # reported as N012615, expiration date reported as 16-MAR-2018 (dose, route and site of administration were not reported) for prophylaxis. ZOSTAVAX underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 1 hour. Data logger was involved. There was no previous temperature excursion. No adverse effects were reported.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received on 11-JUL-2017 from a licensed practical nurse who was reporting on multiple unspecified patients of unknown age and gender. No medical history or concomitant medications were reported. The nurse reported that on unspecified dates, an unspecified number of patients were administered unspecified separate doses of improperly stored doses of PROQUAD (lot # M038229, expires 06-MAR-2018 and N013865, expires 31-OCT-2018) and also an unspecified separate number of patients were administered doses of improperly stored VARIVAX (MARRS# 1707USA004636). The lot numbers of the sterile diluent used to reconstitute the vaccine were unknown. No adverse effects were reported. No other information was provided. The temperature excursion was 6 degrees F. to 14 degrees F. for 8 hours and 52 minutes and 30 seconds. This was due to data logger. Additional information has been requested. This is one of two reports by the same reporter.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The patients' current conditions, medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored (9 °C to 25 °C for 1 hour) (incorrect product storage) ROTATEQ (strength, dose and route of administration were not reported) for prophylaxis. No adverse effects were reported. No previous temperature excursion was reported.The outcome of incorrect product storage and no adverse effect was unknown. This is one of the several reports received from same reporter.; Sender's Comments: US-009507513-1707USA009370: US-009507513-1707USA009369: US-009507513-1707USA006260:
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Musculoskeletal stiffness
Clinical narrative: This spontaneous report as received from a consumer refers to a female patient of unknown age.    On 20-JUL-2017 the patient was vaccinated with ZOSTAVAX, .65 ml, subcutaneous in the left arm for prophylaxis. In July 2017 the patient experienced injection site swelling, injection site pruritus and musculoskeletal stiffness. The outcome of musculoskeletal stiffness, injection site pruritus and injection site swelling was reported as recovering/resolving. The causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other refers to a patient of unknown age. On 21-JUL-2017 the patient was vaccinated with ZOSTAVAX lot # M040145 for prophylaxis. Concomitant therapies included sterile diluent (STERILE DILUENT). On 21-JUL-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date the patient experienced 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 ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL 9 lot # M040412 for prophylaxis. 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 GARDASIL 9. Additional information has been requested.
Age: 0.83
Sex: U
Vaccine: VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a physician via a company representative concerning a 10 month old patient of unknown gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with the first dose of VARIVAX as prophylaxis (Strength, dose, route, lot # and expiration date were not reported). No adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX, 1 DF for prophylaxis. Concomitant therapies included 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 ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other refers to a patient of unknown age. On an unknown date the patient was vaccinated with VARIVAX lot # M041514 for prophylaxis. Concomitant therapies included 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 VARIVAX. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA008109.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. On an unknown date the patient was vaccinated with RECOMBIVAX HB 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 RECOMBIVAX HB.
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Pain in extremity
Clinical narrative: This is a spontaneous report obtained from a contactable nurse through a Pfizer sales representative. A female patient of an unspecified age, race and ethnicity received PREVNAR 13 (Lot. R56671) on an unknown date, in the left arm, at single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced large erythema from elbow to shoulder on left arm with 50 cm induration at site of injection and soreness of arm. No fever was reported. Clinical outcome of the events was unknown at time of this report.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Hypotension, Nausea, Pallor
Clinical narrative: Patient immediately after immunizations had an episode of dizziness, nausea, pallor with hypotension. Blood pressure was 115/46 supine. Was left on supine position, then given water and ate some crackers (had been fasting). Blood pressure 10 minutes after 103/64, dizziness, nausea and pallor resolved. Was observed for another 10 minutes and discharged because the symptoms had resolved.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Anxiety, Fatigue, Feeling abnormal, Headache, Injection site induration
Clinical narrative: Patient calling in stating had injection one week ago and after injection of PREVNAR her arm hurt, fever. No other symptoms till yesterday at the site it is 5 cm in diameter 2 cm deep indurated hot red intensely. She has had this happen with other proteins. She feels funny anxiety kind of shaking, no trouble breathing, no trouble swallowing, no swelling in tongue or mouth, no chest pain, no faintness or dizzy, no changes in vision, no swelling in face or extremities. No fever, a little fatigued and headache minor. Onset: One week ago.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site warmth, Pain in extremity, Pyrexia, Tremor
Clinical narrative: Patient calling in stating had injection one week ago and after injection of PREVNAR her arm hurt, fever. No other symptoms till yesterday at the site it is 5 cm in diameter 2 cm deep indurated hot red intensely. She has had this happen with other proteins. She feels funny anxiety kind of shaking, no trouble breathing, no trouble swallowing, no swelling in tongue or mouth, no chest pain, no faintness or dizzy, no changes in vision, no swelling in face or extremities. No fever, a little fatigued and headache minor. Onset: One week ago.
Age: 48.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site reaction, Pain, Rash erythematous
Clinical narrative: Patient developed a red and itchy rash on her left posterior arm, shoulder felt achy, and she may have had a low grade fever. The itchy rash resolved 1 week later, but shoulder pain worsened to the point that she had difficulty raising her arm over her head, fixing her hair, etc. I saw her yesterday in clinic and pain is improved, but she continues to feel pain with abduction and flexion of shoulder > 90 degrees.
Age: 48.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Rash pruritic
Clinical narrative: Patient developed a red and itchy rash on her left posterior arm, shoulder felt achy, and she may have had a low grade fever. The itchy rash resolved 1 week later, but shoulder pain worsened to the point that she had difficulty raising her arm over her head, fixing her hair, etc. I saw her yesterday in clinic and pain is improved, but she continues to feel pain with abduction and flexion of shoulder > 90 degrees.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site nodule
Clinical narrative: 7/25/17 Hard knot at injection site 7/19/17. Knot went down 7/20/17. Then area turned red. Red area 6 ins. in diameter - by 4 ins. across. Circled area, will recheck. Area checked by FNP - patient on 7/27/17.
Age: 18.0
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site became sore on 7-16-17. On 07/17/17 pt's complained of redness, swelling and itching in arm where both Meningococcal vaccines were given. 8 cm x 5 cm area. Pt. was instructed to use BENADRYL at first of week but it didn't seem to help. Pt treated on 7/21/17 for cellulitis. Started on cephalexin 500 mg one cap every 12 hours and a MEDROL (Pak) 4 mg dosepak. Instructed to monitor for increasing infection including warmth, redness, swelling, fever or pus. Follow up if no improvement or worsening symptoms.
Age: 18.0
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ
Symptoms: Injection site cellulitis, Local reaction
Clinical narrative: Injection site became sore on 7-16-17. On 07/17/17 pt's complained of redness, swelling and itching in arm where both Meningococcal vaccines were given. 8 cm x 5 cm area. Pt. was instructed to use BENADRYL at first of week but it didn't seem to help. Pt treated on 7/21/17 for cellulitis. Started on cephalexin 500 mg one cap every 12 hours and a MEDROL (Pak) 4 mg dosepak. Instructed to monitor for increasing infection including warmth, redness, swelling, fever or pus. Follow up if no improvement or worsening symptoms.
Age: 18.0
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ
Symptoms: Injection site cellulitis
Clinical narrative: Injection site became sore on 7-16-17. On 07/17/17 pt's complained of redness, swelling and itching in arm where both Meningococcal vaccines were given. 8 cm x 5 cm area. Pt. was instructed to use BENADRYL at first of week but it didn't seem to help. Pt treated on 7/21/17 for cellulitis. Started on cephalexin 500 mg one cap every 12 hours and a MEDROL (Pak) 4 mg dosepak. Instructed to monitor for increasing infection including warmth, redness, swelling, fever or pus. Follow up if no improvement or worsening symptoms.
Age: 18.0
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ
Symptoms: Cellulitis, Local reaction
Clinical narrative: Injection site became sore on 7-16-17. On 07/17/17 pt's complained of redness, swelling and itching in arm where both Meningococcal vaccines were given. 8 cm x 5 cm area. Pt. was instructed to use BENADRYL at first of week but it didn't seem to help. Pt treated on 7/21/17 for cellulitis. Started on cephalexin 500 mg one cap every 12 hours and a MEDROL (Pak) 4 mg dosepak. Instructed to monitor for increasing infection including warmth, redness, swelling, fever or pus. Follow up if no improvement or worsening symptoms.
Age: 15.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Dizziness, Pallor, Vomiting
Clinical narrative: Patient turned pale about 2 min. post first HPV-9 vaccine. He became a little dizzy but no syncope, pt. still alert and oriented. Pt vomited x1 then started to feel better - color returned within 5 min. Monitored Pt's vitals, and Pt for another 20 min. Pt doing well today (7-25-17).
Age: 11.0
Sex: F
Vaccine: IPV, MNQ, TDAP
Symptoms: Food allergy, Pharyngitis, Rash generalised, Upper respiratory tract infection, Vaccination complication
Clinical narrative: Given MENACTRA, TDaP and IPV on 6-27-17. Presented to the office on 6-30-17 with URI, pharyngitis, and generalized rash. Dx: viral rash, food allergy vs. reaction to vaccine.
Age: 11.0
Sex: F
Vaccine: IPV, MNQ, TDAP
Symptoms: Viral rash
Clinical narrative: Given MENACTRA, TDaP and IPV on 6-27-17. Presented to the office on 6-30-17 with URI, pharyngitis, and generalized rash. Dx: viral rash, food allergy vs. reaction to vaccine.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Discomfort, Erythema, Hypoaesthesia, Injection site pain, Muscular weakness
Clinical narrative: 47-year-old female presents with painful arm and her injection site from her PNEUMOVAX. Patient was in the office on July 24 for physical and received a PNEUMOVAX 23 immunization due to her asthma history. She states initially she had no discomfort and as the day wore on she had some mild discomfort which was to be expected. During the night the pain increased and the swelling did and she had to put ice on it for her discomfort. This morning she had worsening swollen some redness warmth and some numbness and weakness of her left hand and she presents for evaluation. She has no fevers chills or sweats. No other myalgias other than the left arm. She has not reacted to Immunizations in the past but has never had the PNEUMOVAX immunization. Pain is a 7-8 out of 10 at rest and 10 out of 10 with any movement. Pain is also worse with palpation of the area.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pain in extremity, Skin warm, Swelling
Clinical narrative: 47-year-old female presents with painful arm and her injection site from her PNEUMOVAX. Patient was in the office on July 24 for physical and received a PNEUMOVAX 23 immunization due to her asthma history. She states initially she had no discomfort and as the day wore on she had some mild discomfort which was to be expected. During the night the pain increased and the swelling did and she had to put ice on it for her discomfort. This morning she had worsening swollen some redness warmth and some numbness and weakness of her left hand and she presents for evaluation. She has no fevers chills or sweats. No other myalgias other than the left arm. She has not reacted to Immunizations in the past but has never had the PNEUMOVAX immunization. Pain is a 7-8 out of 10 at rest and 10 out of 10 with any movement. Pain is also worse with palpation of the area.
Age: 6.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Weight bearing difficulty
Clinical narrative: Right thigh pain (non-bearing weight) 3 days post PPSV23 vaccination. Pt sent to ER.
Age: 19.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Redness, swelling at injection site. Rash at injection site. Pain at injection site. Given 5-days of prednisone to use ice and MOTRIN.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Fall, Loss of consciousness
Clinical narrative: Patient fell from exam table right after administration of those 3 vaccines when MA turned to put the syringe away. Brief (few seconds) LOC. Gain back consciousness within few seconds. Rx- Kept patient laid down on the floor for 10-15 minutes, she states feeling normal and transferred to exam table, drunk water. rested for another 15 minutes before d/c home with mom, f/up apt next morning  Pt came back for f/up this morning and doing well, no c/o dizziness or anything else. Ate breakfast. No concern at all today.
Age: 17.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Chills, Headache, Muscular weakness, Nausea, Pyrexia
Clinical narrative: Symptoms began about 8:00 pm: "screaming" headache (9 of 10)- throbbing, poss. pressure behind eyes/ migraine (personal and family history of migraine present), chills, fever (unmeasured), muscle weakness, nausea (no episodes of emesis). Tylenol give 9:00 pm, helped a bit, but not resolving headache. Tylenol at 4:00 am for fever, Tylenol at 11:00 am (next morning), 2 of 10 headache at 1:45 pm next day, but symptoms not entirely resolved according to mother. NOTE: MENVEO given at approximately 2:00 pm at clinic after departing immunization clinic (due to unavailability of the vaccine on site) July 24, 2017.
Age: 17.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Screaming
Clinical narrative: Symptoms began about 8:00 pm: "screaming" headache (9 of 10)- throbbing, poss. pressure behind eyes/ migraine (personal and family history of migraine present), chills, fever (unmeasured), muscle weakness, nausea (no episodes of emesis). Tylenol give 9:00 pm, helped a bit, but not resolving headache. Tylenol at 4:00 am for fever, Tylenol at 11:00 am (next morning), 2 of 10 headache at 1:45 pm next day, but symptoms not entirely resolved according to mother. NOTE: MENVEO given at approximately 2:00 pm at clinic after departing immunization clinic (due to unavailability of the vaccine on site) July 24, 2017.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Diarrhoea, Discomfort, Fungal infection, Headache
Clinical narrative: I had a TDaP Vaccine on 7/13/17 at around 10 am in the morning. Early on Friday, 7/14/17, I started having issues with my vaginal area and my labia majora, feeling swollen, itchy and tender, very engorged. I just thought it was a yeast infection starting and didn't think it was related to the TDaP. Friday evening around 5 pm in the evening, I became very ill, nausea, vomiting, diarrhea, complete body aches, not just on the right upper arm area. I felt like I had the flu ten times over. My face was a bit swollen and so was my jaw area on the right. I had tingling on the entire right side of the body down to my feet. I could not lay on that side because it was very uncomfortable. At the time, my highest temp was 101.7. However, I started feeling worse, and took Aleve and Zofran for nausea. This helped a little, not much. I developed a headache and continued having such issues until July 18th or July 19th. Tingling in the entire right side of my body down to my feet, not like the "falling asleep sensation", face swelling on the right side-mainly jaw and cheek/lip area, and I also took Benadryl didn't make a difference. I also kept insisting that there was a rash on my arm but my spouse stated there was nothing there. I also ended up with a full-blown yeast infection, which I did some research and it can happen, apparently depending upon the ingredients in the vaccine, it can cause an over production of yeast as an immunity response. I had planned to see my GYN on 7/19 when my wife was having surgery with him and ask him about it. However, I forgot and mentioned it to him on 7/21/17 prior to going into surgery of my own with him. He stated he had never heard of it happening however he would not rule it out, given my history, and also because my body has went through changes, with recently carrying and losing triplets in 2016. I still have upper right arm tenderness, but no discoloration at the sight of injection. I do have an issue with lying on this side still from time to time that I did not have prior to this vaccine.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Influenza like illness, Lip swelling, Malaise, Nausea, Pain
Clinical narrative: I had a TDaP Vaccine on 7/13/17 at around 10 am in the morning. Early on Friday, 7/14/17, I started having issues with my vaginal area and my labia majora, feeling swollen, itchy and tender, very engorged. I just thought it was a yeast infection starting and didn't think it was related to the TDaP. Friday evening around 5 pm in the evening, I became very ill, nausea, vomiting, diarrhea, complete body aches, not just on the right upper arm area. I felt like I had the flu ten times over. My face was a bit swollen and so was my jaw area on the right. I had tingling on the entire right side of the body down to my feet. I could not lay on that side because it was very uncomfortable. At the time, my highest temp was 101.7. However, I started feeling worse, and took Aleve and Zofran for nausea. This helped a little, not much. I developed a headache and continued having such issues until July 18th or July 19th. Tingling in the entire right side of my body down to my feet, not like the "falling asleep sensation", face swelling on the right side-mainly jaw and cheek/lip area, and I also took Benadryl didn't make a difference. I also kept insisting that there was a rash on my arm but my spouse stated there was nothing there. I also ended up with a full-blown yeast infection, which I did some research and it can happen, apparently depending upon the ingredients in the vaccine, it can cause an over production of yeast as an immunity response. I had planned to see my GYN on 7/19 when my wife was having surgery with him and ask him about it. However, I forgot and mentioned it to him on 7/21/17 prior to going into surgery of my own with him. He stated he had never heard of it happening however he would not rule it out, given my history, and also because my body has went through changes, with recently carrying and losing triplets in 2016. I still have upper right arm tenderness, but no discoloration at the sight of injection. I do have an issue with lying on this side still from time to time that I did not have prior to this vaccine.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Paraesthesia, Pruritus, Swelling face, Tenderness, Vaginal disorder
Clinical narrative: I had a TDaP Vaccine on 7/13/17 at around 10 am in the morning. Early on Friday, 7/14/17, I started having issues with my vaginal area and my labia majora, feeling swollen, itchy and tender, very engorged. I just thought it was a yeast infection starting and didn't think it was related to the TDaP. Friday evening around 5 pm in the evening, I became very ill, nausea, vomiting, diarrhea, complete body aches, not just on the right upper arm area. I felt like I had the flu ten times over. My face was a bit swollen and so was my jaw area on the right. I had tingling on the entire right side of the body down to my feet. I could not lay on that side because it was very uncomfortable. At the time, my highest temp was 101.7. However, I started feeling worse, and took Aleve and Zofran for nausea. This helped a little, not much. I developed a headache and continued having such issues until July 18th or July 19th. Tingling in the entire right side of my body down to my feet, not like the "falling asleep sensation", face swelling on the right side-mainly jaw and cheek/lip area, and I also took Benadryl didn't make a difference. I also kept insisting that there was a rash on my arm but my spouse stated there was nothing there. I also ended up with a full-blown yeast infection, which I did some research and it can happen, apparently depending upon the ingredients in the vaccine, it can cause an over production of yeast as an immunity response. I had planned to see my GYN on 7/19 when my wife was having surgery with him and ask him about it. However, I forgot and mentioned it to him on 7/21/17 prior to going into surgery of my own with him. He stated he had never heard of it happening however he would not rule it out, given my history, and also because my body has went through changes, with recently carrying and losing triplets in 2016. I still have upper right arm tenderness, but no discoloration at the sight of injection. I do have an issue with lying on this side still from time to time that I did not have prior to this vaccine.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Vomiting, Vulvovaginal swelling
Clinical narrative: I had a TDaP Vaccine on 7/13/17 at around 10 am in the morning. Early on Friday, 7/14/17, I started having issues with my vaginal area and my labia majora, feeling swollen, itchy and tender, very engorged. I just thought it was a yeast infection starting and didn't think it was related to the TDaP. Friday evening around 5 pm in the evening, I became very ill, nausea, vomiting, diarrhea, complete body aches, not just on the right upper arm area. I felt like I had the flu ten times over. My face was a bit swollen and so was my jaw area on the right. I had tingling on the entire right side of the body down to my feet. I could not lay on that side because it was very uncomfortable. At the time, my highest temp was 101.7. However, I started feeling worse, and took Aleve and Zofran for nausea. This helped a little, not much. I developed a headache and continued having such issues until July 18th or July 19th. Tingling in the entire right side of my body down to my feet, not like the "falling asleep sensation", face swelling on the right side-mainly jaw and cheek/lip area, and I also took Benadryl didn't make a difference. I also kept insisting that there was a rash on my arm but my spouse stated there was nothing there. I also ended up with a full-blown yeast infection, which I did some research and it can happen, apparently depending upon the ingredients in the vaccine, it can cause an over production of yeast as an immunity response. I had planned to see my GYN on 7/19 when my wife was having surgery with him and ask him about it. However, I forgot and mentioned it to him on 7/21/17 prior to going into surgery of my own with him. He stated he had never heard of it happening however he would not rule it out, given my history, and also because my body has went through changes, with recently carrying and losing triplets in 2016. I still have upper right arm tenderness, but no discoloration at the sight of injection. I do have an issue with lying on this side still from time to time that I did not have prior to this vaccine.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Pain in extremity
Clinical narrative: Left arm sore, feeling run down, running nose, congestion, headache, fever, chills, fatigue. Called nurse 7/24/17. Did not seek other tx.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Left arm sore, feeling run down, running nose, congestion, headache, fever, chills, fatigue. Called nurse 7/24/17. Did not seek other tx.
Age: 0.75
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Body temperature increased, Cyanosis, Respiratory arrest
Clinical narrative: Mother states 7/17/17 patient had axillary temp of 103.2 F. Patient stopped breathing, turned blue and may have had a seizure. Mother reported this 7/19/17 after patient had already recovered from the event. Did not call 911. F/U by MD 7/19/17.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or other concomitant medication. On 07-JUL-2017, the patient received an improperly stored dose of VARIVAX, lot # M046005, expiration date 18-NOV-2018 (route not reported). The sterile diluent used to reconstitute the VARIVAX was properly stored. No adverse effect reported. Temperature was reported as: 15°F to 46°F. Time frame: 1 hour 17 minutes. Previous temperature excursion: No. Data logger involved: Yes. No further information was provided.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information was received 30-JUN-2017 via a phone call from a licensed practical nurse who reported that a patient (age and gender not specified) was administered an improperly stored dose of PNEUMOVAX 23 on an unspecified date. Lot number and expiration date were not provided. No adverse effects were reported. No additional information was provided. This is one of several cases from the same reporter. Additional information was requested. Sender's Comments: US-009507513-1707USA009867: US-009507513-1707USA009868: US-009507513-1707USA009869.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a male patient of unknown age via company representative regarding himself. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date in 2012, the patient was vaccinated with ZOSTAVAX (lot #, expiration date, dose and route were not reported) for prophylaxis. On an unknown date in 2012, the patient experienced shingles (herpes zoster). The outcome of herpes zoster was unknown. Causality assessment was not provided by the reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 18-JUL-2017, the patient was vaccinated with an expired dose of GARDASIL intramuscularly, lot # M014929, expiry date 27-MAY-2017. No adverse effects were reported. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 21-JUL-2017 the patient was vaccinated with ZOSTAVAX lot # M020902 expiration date 18-JUL-2017 for prophylaxis. Concomitant therapies included sterile diluent. On 21-JUL-2017, 1 day after onset of therapy the patient experienced expired product administered. On an unknown date the patient experienced no adverse event.
Sex: F
Vaccine: MMR
Symptoms: Rubella antibody negative
Clinical narrative: This spontaneous report was received from a pharmacist refers to a female patient (pharmacist's daughter) of currently 22 years of age. Pertinent medical history, drug reactions/allergies and concomitant medications were unknown. The patient was administered 2 doses of an unknown M-M-R vaccine (lot/expiration date, and manufacturer was unknown) on unknown dates, "when she was younger". The patient had unknown blood work done on an unknown date, which showed the patient's "titer for rubella was low". The outcome of rubella antibody negative was unknown. Causality assessment was not provided. No product quality complaint was filed.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information was received 30-JUN-2017 via a phone call from a licensed practical nurse who reported that a patient (age and gender not specified) was administered an improperly stored dose of PNEUMOVAX 23 on an unspecified date. Lot number and expiration date were not provided. No adverse effects were reported. No additional information was provided. This is one of several cases from the same reporter. Additional information was requested. Sender's Comments: US-009507513-1707USA009867: US-009507513-1707USA009868: US-009507513-1707USA009869: US-009507513-1707USA005581.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information was received 30-JUN-2017 via a phone call from a licensed practical nurse who reported that a patient (age and gender not specified) was administered an improperly stored dose of PNEUMOVAX 23 on an unspecified date. Lot number and expiration date were not provided. No adverse effects were reported. No additional information was provided. This is one of several cases from the same reporter. Additional information was requested. Sender's Comments: US-009507513-1707USA009865: US-009507513-1707USA009867: US-009507513-1707USA009868: US-009507513-1707USA009869: US-009507513-1707USA005581.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information was received 30-JUN-2017 via a phone call from a licensed practical nurse who reported that a patient (age and gender not specified) was administered an improperly stored dose of PNEUMOVAX 23 on an unspecified date. Lot number and expiration date were not provided. No adverse effects were reported. No additional information was provided. This is one of several cases from the same reporter. Additional information was requested. Sender's Comments: US-009507513-1707USA009866: US-009507513-1707USA009865: US-009507513-1707USA005581: US-009507513-1707USA009868: US-009507513-1707USA009869.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information was received 30-JUN-2017 via a phone call from a licensed practical nurse who reported that a patient (age and gender not specified) was administered an improperly stored dose of PNEUMOVAX 23 on an unspecified date. Lot number and expiration date were not provided. No adverse effects were reported. No additional information was provided. This is one of several cases from the same reporter. Additional information was requested. Sender's Comments: US-009507513-1707USA005581: US-009507513-1707USA009865: US-009507513-1707USA009866: US-009507513-1707USA009867: US-009507513-1707USA009869.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information was received 30-JUN-2017 via a phone call from a licensed practical nurse who reported that a patient (age and gender not specified) was administered an improperly stored dose of PNEUMOVAX 23 on an unspecified date. Lot number and expiration date were not provided. No adverse effects were reported. No additional information was provided. This is one of several cases from the same reporter. Additional information was requested. Sender's Comments: US-009507513-1707USA009868: US-009507513-1707USA009866: US-009507513-1707USA009867: US-009507513-1707USA005581: US-009507513-1707USA009865.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a other refers to a patient of unknown age. On 24-JUL-2017 the patient was vaccinated with ROTATEQ lot # M002252, oral for prophylaxis. On 24-JUL-2017, 1 day after onset of therapy the patient experienced expired product administered. On an unknown date the patient experienced no adverse event.
Age: 9.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Left upper arm with 5 cm area of redness and induration, warm to touch. Treatment: hydrocortisone cream topically, ibuprofen, ice packs, if worsening may start steroid on 7/23/17.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Fall, Headache
Clinical narrative: Pt. received MCV4 vaccine at 0830 AM on 7/25/17, at 0832 I was completing vaccine record paperwork and heard a loud thump and turned around to find patient laying on the floor. Pt. stated 2 pain to back of head, no visible deformities, BP 100/62 at that time. Pt. helped to a chair and given ice pack for her head. BP at 0842 128/82, BP at 0848 122/82 and pt. denies pain at this time. Pt. advised to go to urgent care if anything changes.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: Redness and itching; red erythema area on left arm measured 5inches in diameter.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Crying, Injection site erythema
Clinical narrative: Redness around the injection site on both thighs. Uncontrollable crying for 3 consecutive nights after injections.
Sex: U
Vaccine: MENB
Symptoms: Pruritus, Swelling face, Urticaria
Clinical narrative: Hives, itchy, face swollen.
Age: 58.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain, Rash erythematous
Clinical narrative: Patient requesting a vaccine adverse reaction report following receipt of 6/28/2017 PPSV23 vaccine to her left arm. She advised it was recommended by her HCP due to her diabetes. She stated 24 hours after receipt of the vaccine the site was red, some swelling and sore to touch/move arm around. Over the next few days, she noted 2 other red spots further down her arm directly under the vaccine site. She sent a picture for review. She denied it itching, no trauma and not ointments/lotions or change in detergents/soaps/et al. She advised the reaction resolved on it's own in 4 days. She has had no further reoccurance. No site reaction with concurrent right arm Tdap vaccination.  Symptoms: RASH & OTH NONSPEC.
Age: 58.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Vaccination site reaction
Clinical narrative: Patient requesting a vaccine adverse reaction report following receipt of 6/28/2017 PPSV23 vaccine to her left arm. She advised it was recommended by her HCP due to her diabetes. She stated 24 hours after receipt of the vaccine the site was red, some swelling and sore to touch/move arm around. Over the next few days, she noted 2 other red spots further down her arm directly under the vaccine site. She sent a picture for review. She denied it itching, no trauma and not ointments/lotions or change in detergents/soaps/et al. She advised the reaction resolved on it's own in 4 days. She has had no further reoccurance. No site reaction with concurrent right arm Tdap vaccination.  Symptoms: RASH & OTH NONSPEC.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HIBV, PNC13, RV5
Symptoms: Extra dose administered, No adverse event, Wrong drug administered
Clinical narrative: No adverse reaction, however patient received 4th dose of HIB in error, should have received 3rd dose of Hep B vaccine. No harm to patient.
Age: 1.08
Sex: M
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: There were no patient adverse reactions to the injection site or health of the patient. Noted and reported due to the administration of expired vaccine.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA
Symptoms: Extra dose administered
Clinical narrative: None stated.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Mom states that she noticed the reaction on the morning of 7/18. Mom states that she did 2 days of Benadryl and hydrocortisone cream. Still red and swollen,  it's itchy.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: MOTHER STATED CLIENT FAINTED AFTER RECEIVING VACCINES. EMT EVALUATED CLIENT AND DECLARED CLIENT RECOVERED. MOTHER STATED CLIENT HAD NOT EATEN PRIOR TO VACCINES.