chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: HEP
Symptoms: Insomnia, Musculoskeletal pain, Pain in extremity, Periarthritis
Clinical narrative: I mentioned at the time that it seemed to hurt more than the other two shots. I took ibuprofen following the shot, again that night and again the next morning. The ibuprofen doesn't seem to be helping and I've developed other symptoms as well. When I move my arm even the slightest amount, I have shooting pains on the outside of my arm as well as on the underside. I feel like my shoulder is frozen and now I have pain on the outside of my shoulder socket? (sorry, I don't know all of the technical/medical terms). I also have troubles sleeping. Perhaps this has to do with the angle of the arm when lying down?
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Crying, Dizziness, Headache, Nausea, Screaming
Clinical narrative: When they left the office, within the hour after eating lunch, the patient started to scream and cry in headache pain. He vomited 2-3x and felt nauseated and lightheaded. They called our office. The mom took the child home and he slept it off. He did not go to the emergency room or need any prescription medicines. We kept in contact with him during the day.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Vomiting
Clinical narrative: When they left the office, within the hour after eating lunch, the patient started to scream and cry in headache pain. He vomited 2-3x and felt nauseated and lightheaded. They called our office. The mom took the child home and he slept it off. He did not go to the emergency room or need any prescription medicines. We kept in contact with him during the day.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Migraine, Muscular weakness, Speech disorder, Tunnel vision, Vomiting
Clinical narrative: Tunnel vision, weak arms & legs, blurry vision, migraine, throwing up, confusion, trouble speaking.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Back pain, Chest pain, Dizziness, Erythema, Grip strength decreased
Clinical narrative: HPV 9 was injected left deltoid and patient was asked to remain in room for 15 minutes after injection. When nurse returned to check patient response to vaccine, patient complained of "cloudy vision and dizziness". Nurse asked patient to lie down and then asked physician to asses patient.  Physician note regarding assesment: Upon entering the room, she was sneezing numerous times and also complained of some scratchiness in her throat. This is similar to the reactions she has had to hand sanitizer and other perfumed items in the past. Felt that perhaps she was actually having a reaction to hand sanitizer used in the office, so gave benadryl 25 mg po x 1.  Approx 5 min later, went to reassess patient and she began complaining of chest pain. Complained of "stabbing" pain in center of chest and radiating through to the back. Chest pain was reproducible with palpation of the costochondral junction. Lungs clear. CV RRR without murmur. Ox Sat 99-100% and HR 72.  Reassurance provided; patient left in quiet room and cool washcloth on chest and reassessed shortly after and said she was feeling better. Still slightly dizzy but vision better (could identify number of fingers being held up, etc). Patient felt comfortable and ready to go home. Decided to have a nurse escort her out of office in wheelchair to ensure she continued to do well with standing, etc, getting into car. Did well getting from bed to wheelchair and seemed more comfortable upon leaving office. Nurse returned to office to retrieve O2 sat monitor and stated patient got into car and began complaining again of chest pain and now also of left arm pain and numbness. Went to reassess in parking lot and patient now complaining she could not move her left arm. Good pulse but left arm pale and upper arm and chest very red. No labored breathing.  Lungs CTAB and CV RRR without murmur. Sat 98%. Asked patient to squeeze my finger with both hands. Did so with right hand but states she is trying with left hand and cannot. Raises left shoulder but cannot bend left arm at wrist or elbow. When I raise the arm at elbow and leg go, she allows it to simply "flop" into the car seat. States she cannot feel anything and does not react to having the arm pinched, etc. Decided to have patient admitted for observation. Spoke with nurse to inform that patient directed to go straight to peds floor and with Dr. regarding observations in office and desire to admit overnight. Appreciate his assistance with patient.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site erythema, Pain in extremity, Pallor
Clinical narrative: HPV 9 was injected left deltoid and patient was asked to remain in room for 15 minutes after injection. When nurse returned to check patient response to vaccine, patient complained of "cloudy vision and dizziness". Nurse asked patient to lie down and then asked physician to asses patient.  Physician note regarding assesment: Upon entering the room, she was sneezing numerous times and also complained of some scratchiness in her throat. This is similar to the reactions she has had to hand sanitizer and other perfumed items in the past. Felt that perhaps she was actually having a reaction to hand sanitizer used in the office, so gave benadryl 25 mg po x 1.  Approx 5 min later, went to reassess patient and she began complaining of chest pain. Complained of "stabbing" pain in center of chest and radiating through to the back. Chest pain was reproducible with palpation of the costochondral junction. Lungs clear. CV RRR without murmur. Ox Sat 99-100% and HR 72.  Reassurance provided; patient left in quiet room and cool washcloth on chest and reassessed shortly after and said she was feeling better. Still slightly dizzy but vision better (could identify number of fingers being held up, etc). Patient felt comfortable and ready to go home. Decided to have a nurse escort her out of office in wheelchair to ensure she continued to do well with standing, etc, getting into car. Did well getting from bed to wheelchair and seemed more comfortable upon leaving office. Nurse returned to office to retrieve O2 sat monitor and stated patient got into car and began complaining again of chest pain and now also of left arm pain and numbness. Went to reassess in parking lot and patient now complaining she could not move her left arm. Good pulse but left arm pale and upper arm and chest very red. No labored breathing.  Lungs CTAB and CV RRR without murmur. Sat 98%. Asked patient to squeeze my finger with both hands. Did so with right hand but states she is trying with left hand and cannot. Raises left shoulder but cannot bend left arm at wrist or elbow. When I raise the arm at elbow and leg go, she allows it to simply "flop" into the car seat. States she cannot feel anything and does not react to having the arm pinched, etc. Decided to have patient admitted for observation. Spoke with nurse to inform that patient directed to go straight to peds floor and with Dr. regarding observations in office and desire to admit overnight. Appreciate his assistance with patient.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Sneezing, Specialist consultation, Throat irritation, Unresponsive to stimuli, Vision blurred
Clinical narrative: HPV 9 was injected left deltoid and patient was asked to remain in room for 15 minutes after injection. When nurse returned to check patient response to vaccine, patient complained of "cloudy vision and dizziness". Nurse asked patient to lie down and then asked physician to asses patient.  Physician note regarding assesment: Upon entering the room, she was sneezing numerous times and also complained of some scratchiness in her throat. This is similar to the reactions she has had to hand sanitizer and other perfumed items in the past. Felt that perhaps she was actually having a reaction to hand sanitizer used in the office, so gave benadryl 25 mg po x 1.  Approx 5 min later, went to reassess patient and she began complaining of chest pain. Complained of "stabbing" pain in center of chest and radiating through to the back. Chest pain was reproducible with palpation of the costochondral junction. Lungs clear. CV RRR without murmur. Ox Sat 99-100% and HR 72.  Reassurance provided; patient left in quiet room and cool washcloth on chest and reassessed shortly after and said she was feeling better. Still slightly dizzy but vision better (could identify number of fingers being held up, etc). Patient felt comfortable and ready to go home. Decided to have a nurse escort her out of office in wheelchair to ensure she continued to do well with standing, etc, getting into car. Did well getting from bed to wheelchair and seemed more comfortable upon leaving office. Nurse returned to office to retrieve O2 sat monitor and stated patient got into car and began complaining again of chest pain and now also of left arm pain and numbness. Went to reassess in parking lot and patient now complaining she could not move her left arm. Good pulse but left arm pale and upper arm and chest very red. No labored breathing.  Lungs CTAB and CV RRR without murmur. Sat 98%. Asked patient to squeeze my finger with both hands. Did so with right hand but states she is trying with left hand and cannot. Raises left shoulder but cannot bend left arm at wrist or elbow. When I raise the arm at elbow and leg go, she allows it to simply "flop" into the car seat. States she cannot feel anything and does not react to having the arm pinched, etc. Decided to have patient admitted for observation. Spoke with nurse to inform that patient directed to go straight to peds floor and with Dr. regarding observations in office and desire to admit overnight. Appreciate his assistance with patient.
Age: 50.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth, Vaccination site swelling
Clinical narrative: Swelling, redness, and itchiness on arm around vaccination site. Swelling has gone down on day 3, but is still red and hot.
Age: 1.0
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Crying, Hypotonia, Immediate post-injection reaction, Muscle twitching, Pain
Clinical narrative: Child immediately starting crying weakly and became limp in my arms within seconds of being vaccinated. His head started twitching to one side only as if he was severely dizzy and couldn't control it. We were at the health department for vaccines so I'm not sure of the attending doctor's name but she glanced at him and said he's just frustrated and exited the room. He stayed limp and continue to twitch his head for about a minute until it ended. He then started crying stronger again and trying to hold me. Within a half hour he had a low fever and unbearable pain to were you couldn't touch him. This lasted about 24 hours and we gave him TYLENOL every 6 hours.
Age: 1.0
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Pyrexia
Clinical narrative: Child immediately starting crying weakly and became limp in my arms within seconds of being vaccinated. His head started twitching to one side only as if he was severely dizzy and couldn't control it. We were at the health department for vaccines so I'm not sure of the attending doctor's name but she glanced at him and said he's just frustrated and exited the room. He stayed limp and continue to twitch his head for about a minute until it ended. He then started crying stronger again and trying to hold me. Within a half hour he had a low fever and unbearable pain to were you couldn't touch him. This lasted about 24 hours and we gave him TYLENOL every 6 hours.
Age: 0.42
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a consumer (patient's mother) refers to a 5 month and a few days old patient of unknown gender. Information regarding the patient's concurrent conditions, medical history and concomitant medications was not reported. On an unknown date, the patient was vaccinated with ROTATEQ, orally (dose, lot # and expiry date were not reported) for prophylaxis. The patient experienced inappropriate schedule of drug administration. No product quality complaint was reported.
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 a patient of unknown age. On unknown dates, the patients were vaccinated with M-M-R II lot # L011528 (recombinant human albumin) for prophylaxis. Concomitant therapies included sterile diluent (STERILE DILUENT). On unknown dates, the patients experienced incorrect product storage. No adverse event was reported.    The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage to be not related to M-M-R II. The reporter considered no adverse event to be not related to M-M-R II, ROTATEQ, GARDASIL 9, GARDASIL, VARIVAX and VAQTA. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1708USA006858: US-009507513-1708USA006859: US-009507513-1708USA006860: US-009507513-1708USA006861: US-009507513-1708USA006862:
Age: 28.0
Sex: M
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test negative, Rubella antibody negative
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 28 year old male patient. On an unknown date the patient was vaccinated with M-M-R II lot # L009213 for prophylaxis. Concomitant therapies included sterile diluent (STERILE DILUENT). On an unknown date the patient experienced measles antibody negative, rubella antibody negative and mumps antibody test negative. The outcome of measles antibody negative, rubella antibody negative and mumps antibody test negative was reported as not recovered/not resolved. Additional information has been requested.
Age: 9.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, Loss of consciousness
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 9-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 09-AUG-2017, the patient was vaccinated with improperly stored GARDASIL 9 lot # N003703 with an expiration date of 29-OCT-2019 (dose, route of administration and anatomical location were not reported). On 04-AUG-2017, the administered vaccine underwent a temperature excursion of 48.79 degrees Fahrenheit for 38 minutes which was detected by a digital data logger. No previous temperature excursion was reported. On 09-AUG-2017, the patient passed out for an unspecified period of time following administration of GARDASIL 9. The patient was evaluated in a physician's office. No treatment was given for the event. The patient waited a little while then went home. The outcome of the event was considered as unknown. The causality assessment was not provided. Upon internal review, the event of "passed out" was considered to be medically significant. This is one of three reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1708USA005827: US-009507513-1708USA005890: US-009507513-1708USA005891:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional and refers to three patients' of unknown demographics. On unknown date(s), the patients inadvertently administered improperly stored doses of PROQUAD (lot # M042502, expiry date: 17-APR-2018) 0.5 ml for prophylaxis (incorrect product storage). The doses of PROQUAD were reconstituted with properly stored sterile diluent (details not provided). No adverse effects reported. The doses of PROQUAD were exposed to a temperature of -7 degree Centigrade for a time frame of 1 hour 10 minutes (supported). There were no previous temperature excursions. The call was due to a data logger. No Product Quality Complaint (PQC) was involved.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Incorrect route of drug administration, Musculoskeletal chest pain, Rash
Clinical narrative: This spontaneous report as received from a 71 year old female patient and refers to herself. The patient had drug hypersensitivity (epinephrine). The patient's concomitant therapies included estrogens, conjugated, medroxyprogesterone acetate (PREMPRO) and levothyroxine sodium (manufacturer unknown).  The patient had no pertinent medical history. Approximately in 2007 (reported as about 10 years ago), the patient was vaccinated with ZOSTAVAX, one time injection, under the skin, intravenously for shingles prevention (Incorrect route of drug administration). Approximately in 2015 (reported as 8 years later), the patient had an outbreak of shingles that resulted in pain in the rib area and rash (herpes zoster). The patient received pain pills (unspecified) as medical treatment. At the time of this report, the outcome of herpes zoster was unknown. Causality was unknown.
Sex: U
Vaccine: HIBV, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an other health professional refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with improperly stored dose of PEDVAXHIB lot # M036057 or N000238 or with improperly stored dose GARDASIL 9 lot # M032650. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with VAQTA lot # L015460 for prophylaxis.    Concomitant therapies included sterile diluent. On an unknown date the patient experienced incorrect product storage. No adverse effect was reported. 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 VAQTA. Additional information has been requested. Sender's Comments: US-009507513-1708USA005191.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with VARIVAX lot # L012036 for prophylaxis. Concomitant therapies included sterile diluent. On an unknown date the patient experienced incorrect product storage. No adverse event was reported. 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. {Additional information has been requested. / Additional information is not expected.} Sender's Comments: US-009507513-1708USA005191.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL 9 lot # M026306 for prophylaxis. Concomitant therapies included sterile diluent. On an unknown date the patient experienced incorrect product storage. No adverse event was reported. 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. Sender's Comments: US-009507513-1708USA005191.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with ROTATEQ lot # L013204, oral for prophylaxis. Concomitant therapies included sterile diluent. On an unknown date the patient experienced incorrect product storage. No adverse event was reported. 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 ROTATEQ. Additional information has been requested. Sender's Comments: US-009507513-1708USA005191.
Sex: U
Vaccine: HPV4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL lot # L000610 for prophylaxis. Concomitant therapies included sterile diluent. On an unknown date the patient experienced incorrect product storage. No adverse event was reported. 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. Additional information has been requested. Sender's Comments: US-009507513-1708USA005191.
Sex: F
Vaccine: TDAP
Symptoms: Incorrect route of drug administration, Musculoskeletal pain
Clinical narrative: Initial unsolicited case received from a pharmacist on 02-Aug-2017. This case involves a 46-year-old female patient who was vaccinated with a dose ADACEL (Batch number, expiry date, dose, dose in series, were not reported) subcutaneously instead of intramuscular route in the arm on an unknown date. Patient's medical history, pre-existing allergies, medical condition and illness at the time of vaccination was not reported. Any other vaccine within four weeks of vaccination was not reported. On an unknown date, following vaccination patient experienced shoulder soreness. It was also a case of actual medication error due to inappropriate route of vaccination. Laboratory investigations were not reported. Patient used warm compresses to treat soreness. On an unknown date, patient got recovered from the event shoulder pain. It was reported that event got resolved by second day after vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: DTAP
Symptoms: Hypersensitivity, Respiration abnormal
Clinical narrative: Initial unsolicited case received from a pharmacist via Merck (reference number: 00531824) on 03-AUG-2017. This case involves a patient (age and gender not reported) who was vaccinated with a dose of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DTAP) (Batch number, expiry date and dose were unknown, dose in series, route and site of administration were not reported) on an unknown date. The patient is allergic to statins and phenothiazines. Other medical history was not reported. Concomitant medication were not reported. On an unknown date, following the vaccination, the patient experienced super allergic reaction that affected her breathing. Patient other lab tests and corrective treatment was not reported. The outcome of all the events was not reported. List of documents held by sender: none.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Fatigue, Headache, Myalgia, Oropharyngeal pain, Pyrexia
Clinical narrative: Fever, fatigue, sore throat, myalgia, headache, and hives. Started day after immunization and continues at day 7.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Urticaria
Clinical narrative: Fever, fatigue, sore throat, myalgia, headache, and hives. Started day after immunization and continues at day 7.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: Patient presented for immunization--clinic staff gave immunization without knowing patient was going to be getting immunization from Community Health. Community Health then gave patient immunization at which time it was noted she had already received the immunization 15 min prior. No reaction/adverse event noted at this time.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Dyspnoea, Nausea, Tremor, Vomiting
Clinical narrative: She went to school and ate breakfast. At 9 am ( 2hrs after the shot) she started having nausea and vomiting and shortness of breath and shaking all over.  She called our office and we sent her to the ER. She went to Hospital.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: On 08/12/2017, mother noticed patient's right bicep was swollen, red, hot, and painful to touch. She initiated ibuprofen and BENADRYL every 4 to 6 hours and hydrocortisone cream. Notified RN at Health Department at 3:15 PM on 08/12/2017. Patient iced right arm off and on for 15 minutes at a time, every few hours over the weekend. Patient reports a headache on 08/12/2017. Mother marked redness and swelling with a marker on 08/12/2017 at 8:45 PM; redness extended from 15.5 cm at acromion and extended down arm, and 14 cm across at widest point. On 08/14/2017, mother brought patient to health department to have arm assessed and VAERS filled out. Patient complains of arm itching and being painful to touch. Redness and swelling have receded from the line marked by mother on 08/12. Right bicep measures 24.5 cm around, 4.5 cm from acromion. Redness extends 12 cm down arm and is 12 cm across at widest point. In comparison, left bicep measures 23.0 cm from acromion.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Pruritus, Tenderness
Clinical narrative: On 08/12/2017, mother noticed patient's right bicep was swollen, red, hot, and painful to touch. She initiated ibuprofen and BENADRYL every 4 to 6 hours and hydrocortisone cream. Notified RN at Health Department at 3:15 PM on 08/12/2017. Patient iced right arm off and on for 15 minutes at a time, every few hours over the weekend. Patient reports a headache on 08/12/2017. Mother marked redness and swelling with a marker on 08/12/2017 at 8:45 PM; redness extended from 15.5 cm at acromion and extended down arm, and 14 cm across at widest point. On 08/14/2017, mother brought patient to health department to have arm assessed and VAERS filled out. Patient complains of arm itching and being painful to touch. Redness and swelling have receded from the line marked by mother on 08/12. Right bicep measures 24.5 cm around, 4.5 cm from acromion. Redness extends 12 cm down arm and is 12 cm across at widest point. In comparison, left bicep measures 23.0 cm from acromion.
Age: 1.0
Sex: U
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Immunizations given and hives developed within 2-3 minutes. BENADRYL given and pt. went to ER. Patient was discharged from ER.
Age: 59.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient c/o still having significant pain, swelling, and redness in a 2 inch diameter at injection site two days after receiving the vaccine.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: Left arm redness and swelling with blistering.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Amniotic cavity infection, Biopsy placenta, Endometritis, Exposure during pregnancy, Pre-eclampsia
Clinical narrative: Due date was August 23, 2017. Premature birth a week after the shot. Placenta tested to have Chorioamniocentesis, which may be a possible reason for premature delivery. Patient had mild preeclampsia, and endometritis accompanied by 102 degrees fever after 72 hours of delivery.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Premature delivery, Pyrexia
Clinical narrative: Due date was August 23, 2017. Premature birth a week after the shot. Placenta tested to have Chorioamniocentesis, which may be a possible reason for premature delivery. Patient had mild preeclampsia, and endometritis accompanied by 102 degrees fever after 72 hours of delivery.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site reaction, Local reaction
Clinical narrative: Local site reaction.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Apnoea, Continuous positive airway pressure, Endotracheal intubation
Clinical narrative: Patient was on room air with a baseline issue of apnea where he had been having 1-2 significant apneic events daily requiring moderate stimulation. Within 14 hours of receiving his 2 month immunizations he had 3 very significant apenic events requiring blow-by oxygen and the 3rd event required PPV and intubationd (approximately 22 hours after immunizations ). He remained intubated for approx 35 hours then weaned to CPAP and finally back to RA on 8/8. He is back to his baseline and finally feeding orally as of 8/9.
Sex: F
Vaccine: VARCEL
Symptoms: Delivery, Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a consumer refers to a 30 year old female patient. On 12-JUL-2017 the patient was vaccinated with VARIVAX, .5 ml for prophylaxis. The patient became pregnant. The LMP and EDD is not known. The patient delivered a {Enter Gender} infant. The pregnancy outcome was outcome pending. On an unknown date the patient experienced exposure during pregnancy. The outcome of exposure during pregnancy is unknown.
Sex: M
Vaccine: HPV9
Symptoms: Laboratory test normal, Tongue ulceration
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a 11 year old male patient. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patient was vaccinated with GARDASIL 9 (dose 1 and 2) (dosing details were not reported) for prophylaxis. On an unknown date in May 2017 the patient was vaccinated with third dose of GARDASIL 9 (dosing details were not reported) for prophylaxis. On an unknown date in June 2017 the patient developed a "white sore on his tongue the size of a dime". On an unknown date in 2017 "the sore resolved on its own". On an unknown date in July 2017 the patient again developed a "white sore on his tongue the size of a dime" which again "resolved on it's own". On an unknown date the patient was seen by an unspecified physician in regards to reaction and had "multiple labs done and all were normal". The reporter stated that "the patient is fine now". Causality assessment was not provided. No product quality complaint was involved.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse refers to unspecified number of patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patients were vaccinated with improperly stored VAQTA lot # N005274, expiry date: 03-APR-2018 (dosing details were unknown) for prophylaxis. It was reported that the vaccine was exposed to a temperature range of 0 C to 1C for 15 Hours and below 0C (-1C) for 47 Hours 30 Minutes. There was no previous temperature excursion. No data logger was involved. No adverse effects were reported. There were no product quality complaints. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA006758: US-009507513-1708USA006759: US-009507513-1708USA006757.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse refers to unspecified number of patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patients were vaccinated with improperly stored RECOMBIVAX HB lot # N002202, expiry date: 04-NOV-2019, (dosing details were unknown) (incorrect product storage) for prophylaxis. It was reported that the vaccine was exposed to a temperature range of 0 C to 1C for 15 Hours and below 0C (-1C) for 47 Hours 30 Minutes. There was no previous temperature excursion. No data logger was involved. No adverse effects were reported. There were no product quality complaints. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA006518.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse refers to unspecified number of patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patients were vaccinated with improperly stored GARDASIL 9 lot # M035486, with expiry date: 05-JUN-2019 and lot#M041990 with expiry date: 28-JUN-2019 (dosing details were unknown) for prophylaxis. It was reported that the vaccines were exposed to a temperature range of 0 C to 1C for 15 Hours and below 0C (-1C) for 47 Hours 30 Minutes. There was no previous temperature excursion for GARDASIL 9 with lot # M035486. Previous temperature excursion included 9C to 25C for a duration of 16 hours for GARDASIL 9 with lot#M041990. No data logger was involved for lot # M035486 but for lot# M041990 data logger was involved. No adverse effects were reported. There were no product quality complaints. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA006518.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse refers to unspecified number of patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patients were vaccinated with improperly stored ROTATEQ lot # M038846 with expiry date: 26-APR-2018 (dosing details were unknown) for prophylaxis. It was reported that the vaccines were exposed to a temperature range of 0 C to 1C for 15 Hours and below 0C (-1C) for 47 Hours 30 Minutes. Previous temperature excursion included 9C to 25C for a duration of 16 hours. Data logger was involved. No adverse effects were reported. There were no product quality complaints. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA006518.
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with PNEUMOVAX 23 for prophylaxis. On an unknown date the patient experienced incorrect product storage. The outcome of incorrect product storage is unknown.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This is a spontaneous report received from a contactable consumer. An 18-year-old female patient received TRUMENBA (lot number: S26962, expiry date 31Jan2019), intramuscular at left deltoid on 07Aug2017 at 0.5 ml, single to prevent meningitis. There were no reported medical history. The patient's concomitant medications were not reported. On 08Aug2017, the patient woke up with redness, swelling and itching at the site of injection. The patient further reported that it was worsening. At the time of the report, the patient was seen by a physician and was prescribed BENADRYL and ALLEGRA to treat them. The outcome of the events was not recovered.
Sex: U
Vaccine: PNC13
Symptoms: Nausea
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. An elderly (age 65 plus) patient of unspecified age ethnicity and gender started to receive PREVNAR 13, via an unspecified route of administration in Aug2017 at single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced nausea and sick to stomach after receiving PREVNAR 13 in Aug2017. The outcome of the events was unknown.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Cellulitis, Peripheral swelling, Pyrexia, Vaccination complication
Clinical narrative: This is a spontaneous report from a contactable medical assistant reporting on behalf of a physician. A 17-years-old female patient received single dose of TRUMENBA, via an unspecified route of administration on 08Aug2017 12:30 at 0.5mL (Lot Number: R94916, Expiry Date: 30Jan2019) in the Right deltoid for against bacterial meningitis. Medical history included heart murmur from 2005 and ongoing, seasonal allergy, acne, familial hyperlipidemia; Family Medical History Relevant included Dad: hypertension, gout, and hyperlipidemia, Mom: low back pain. Prior Vaccinations (within 4 weeks): None. Concomitant medication included MENACTRA Sanofi, Lot: U5823AB, Expiry: 22Feb2019, IM, left deltoid received on 08Aug2017, cetirizine for seasonal allergy, cephalexin capsule for acne. After receiving the vaccination, the patient experienced arm swelling of 10cm x 12cm with fever on 09Aug2017 and the patient was seen in the office on the 10Aug2017. The arm swelling was seen on the 09Aug2017 but was getting better by the time she was seen by the doctor on the 10Aug2017. It measured 10cm wide x 12cm long which is why the doctor felt it was a reaction to the vaccine instead of just cellulitis, because it was just so significant. Treatment for the swelling: Over the counter BENADRYL. The fever was 100.8F on 09Aug2017. It had gotten better with Ibuprofen. Outcome of events was recovering.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 7:30 PM mother concerned because of redness and swollen leg. Patient shows no signs of symptoms or fever. Notified provider Friday afternoon (8/11/17).
Age: 36.0
Sex: M
Vaccine: HEP
Symptoms: Injection site extravasation
Clinical narrative: At the moment the vaccine was administered to the left arm (deltoid) the liquid was expelled from the patient's injection site. The syringe used was 3ml BD Integra 25Gx1.  I contacted rep and they are going to contact CDC for recommendations, in case the patient needs to repeat the dose.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient presented with redness, itching, swelling, and warmth at site of injection.
Age: 17.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Chills, Dizziness, Tremor, Vomiting
Clinical narrative: After 1-2 hrs, the patients had chills, shakes and felt lightheaded. The mom called our office and the patient vomited. The whole episode lasted about 1.5-2 hrs.
Sex: U
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Heart rate decreased
Clinical narrative: This was patients first HPV. Has never had a vaccine reaction before. Had not had breakfast today. She was sitting on exam table after Tdap, HPV and MENACTRA were administered when she told mother she was feeling faint, mom moved close to her and held her in her arms and nursing staff was alerted,  our office emergency response was activated and a series of vitals sign measurements were made, patient was made to lie down supine, while being observed. Her HR remained less than 60/min, in order to take a repeat BP she was assisted to sit up, HR then returned to normal range. She was observed further in room and discharged home since she continued to be stable.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia, Skin warm
Clinical narrative: Per mother, in the morning on 8/15/17 child was awaken by mother and mother did not notice anything unusual when helping child get dressed. Says child felt warm/feverish but was in a rush and didn't take temperature. Child was given TYLENOL, crackers and water. They went about their day and child never complained and performed normal activities. Around 7 or 8 PM on 8/15/17, mother gave child a bath and that's when she noticed the very large red and swollen area over right deltoid muscle and was warm to touch. Received a call from the mother at 10 AM on 8/16/17 letting me know about the reaction. Mother took the child's temperature and it was low grade of 99.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: Patient said she had a red large circle mark a 2inches in diameter. I suggested ice and ibuprofen. She said it was slightly itchy, and I told her if it was no better on Wednesday 8/17 that I would give her some topical BENADRYL for the itch.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Peripheral swelling
Clinical narrative: Arm is swollen, red, and warm to touch on the inside of the vaccinated arm from bicep to middle of forearm. Patient reports no pain or itching. Suggested that the patient take BENADRYL and we will follow up with her tomorrow to see if symptoms are improving.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Skin warm
Clinical narrative: Arm is swollen, red, and warm to touch on the inside of the vaccinated arm from bicep to middle of forearm. Patient reports no pain or itching. Suggested that the patient take BENADRYL and we will follow up with her tomorrow to see if symptoms are improving.
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP, MMRV
Symptoms: Epistaxis, Fatigue, Rash
Clinical narrative: RASH STARTED 8/14 WITH SEVERE FATIGUE AND BLOODY NOSE. SEEN BY URGENT CARE AND R/T MEASLES VS REACTION TO VACCINE NOTED.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Abdominal pain, Nausea, Vomiting
Clinical narrative: This spontaneous report as received from a physician refers to a 15 year old male patient with anxiety. The patient's medical history included rash. On 09-AUG-2017 the patient was vaccinated with GARDASIL 9, intramuscular for prophylaxis. In August 2017 the patient experienced nausea, abdominal pain and vomiting. The outcome of abdominal pain, vomiting and nausea was reported as not recovered/not resolved.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Death
Clinical narrative: This spontaneous report was received from a physician via a company representative concerning a 12 year old female patient. Medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with a dose GARDASIL 9 (dose, route, lot# and the expiration date were not reported) for prophylaxis. There was no concomitant medication provided. The primary reporter stated one parent of one unspecified patient presented physician with media article stating that " a twelve year old girl died a couple hours after receiving GARDASIL 9, a separate patient was said to have entered premature menopause according to a Pediatrician, and a former company doctor reported that this vaccine was dangerous (unevaluable event)."  The cause of death was not provided by the reporter and it was unknown if the autopsy was performed at the reporting time. The outcome of premature menopause and unevaluable event was unknown. The reporter did not provide the causality between the events: premature menopause and unevaluable event and the suspect therapy. Upon internal review, death was determined to be medically significant.; Reported Cause(s) of Death: unknown cause of death.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a female patient of unknown age regarding herself. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date in 2007 (reported as "about ten years ago"), the patient was vaccinated with ZOSTAVAX (lot#, expiration date, route and dosing details were not reported) for prophylaxis. On an unknown date in 2009 (reported as "about eight years ago"), the patient developed shingles (Herpes zoster). The outcome of the event was unknown. Causality assessment was not reported. Product quality complaint (PQC) was not involved. No other information was provided.
Sex: F
Vaccine: FLUX
Symptoms: Hypersensitivity
Clinical narrative: A report has been received from a Health Professional concerning a Female patient. No information was provided regarding medical history and concurrent disease of the patient. Concomitant medications included pregabalin, irbesartan, fenofibrate, atorvastatin calcium, fludrocortisone, metformin hydrochloride, duloxetine hydrochloride, levothyroxine and insulin lispro. The patient had been receiving unknown Influenza Vaccine (influenza vaccine) and oral CRESTOR which started on an unknown date. The patient experienced allergy. The outcome of the event of allergy was unknown. The report was considered to be non-serious.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Urticaria
Clinical narrative: Pt stated they developed a firm welt and some redness. The welt dissipated in a few days and was not apparent when the patient presented to the pharmacy on 8/14/17.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Hyperhidrosis, Nausea, Pyrexia, Rash erythematous, Rash pruritic
Clinical narrative: Fever of 101.9, itchy red rash, sweated, nausea and vomiting at the night of vaccination. Patient came in today Wednesday, August 16 to inform me about the reactions. She said she had been taking BENADRYL (one capsule every 6-8 hours) but it did not seem to help with the rash. I advised her to take TYLENOL for her low grade fever and change antihistamine chemical to either ALLEGRA or ZYRTEC to see. If not improved, see a doctor. Patient agreed and left.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Fever of 101.9, itchy red rash, sweated, nausea and vomiting at the night of vaccination. Patient came in today Wednesday, August 16 to inform me about the reactions. She said she had been taking BENADRYL (one capsule every 6-8 hours) but it did not seem to help with the rash. I advised her to take TYLENOL for her low grade fever and change antihistamine chemical to either ALLEGRA or ZYRTEC to see. If not improved, see a doctor. Patient agreed and left.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Eye swelling, Headache, Migraine, Nausea
Clinical narrative: Light headache followed by intense migraine and nausea, swollen left eye.
Age: 1.25
Sex: M
Vaccine: HIBV, MMR
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Fever, Tylenol had been administered, Febrile seizure was outcome.
Age: 0.17
Sex: F
Vaccine: RV1
Symptoms: Haematochezia, Vaccination complication
Clinical narrative: Bloody stool, mother took child to hospital where she was told it was an adverse reaction to ROTARIX.
Age: 86.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Large erythematous blanchable patch to left lateral upper arm. No treatment, monitor.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Body temperature increased, Chills, Feeling abnormal, Headache, Myalgia
Clinical narrative: Within hours of vaccination, patient with headache, muscle tenderness in thigh, soreness in legs, temperature 99.5. Chills, overall feeling poor.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: Within hours of vaccination, patient with headache, muscle tenderness in thigh, soreness in legs, temperature 99.5. Chills, overall feeling poor.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Injection site pain, Vomiting
Clinical narrative: Vomiting since midnight 8-14-17. Went to Emergency. His girlfriend is also sick with nausea and vomiting. He did get vaccination for meningitis about 12 hours prior to  symptom onset. Mild pain at the site of the injection. Denies fever or chills .
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Asthenia, Dizziness, Loss of consciousness, Nervousness
Clinical narrative: Patient felt light headed in the car approximately 7-10 minutes after vaccines were administered. Pt stated everything went black and she woke up less than 1 minute later (per mother) and felt shaky and light headed for a few more minutes. 2 hours post event patient feels better but still feels weak. Pt last ate 3.5 hours before vaccines.