chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Joint stiffness, Pain
Clinical narrative: Two days after giving birth to my son via caesarean I was given 2 vaccines and informed that I needed them and it would help protect my baby. I was not informed by the hospital of the possible side effects or risks to my newborn, who I was breast feeding, or myself. I was not released from the hospital until later that day and by then I was already starting to feel like I was coming down with the flu. By the next day my all of my joints were in excruciating pain, I had body aches, and my wrists were so stiff I couldn't pick up my baby. I was sleeping under 3 comforters and have never been more tired in my entire life. What was so odd is I didn't run a fever so I know I didn't have the flu. This went on for 2 weeks. I seriously thought I was going to die. My baby has always had trouble sleeping most nights, has had the flu, an ear ache, and had to undergo breathing treatments all in his first 4 months of life.  No one that has just given birth should ever be given a vaccine of any kind! The body is so weak and stressed from the birth already and when there are viruse vaccinations on top of that is deadly for mother and child. I am a super health and fit person too. These vaccines were pushed on to a scared new mother trying to do what best for her baby and self but this could have killed us both!
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Irritability, Swelling, Urticaria
Clinical narrative: Fussy, irritable, swelling on left hand side of face as well as hives which developed quickly. Rushed her to the hospital was administered BENADRYL and monitored for the remainder of the evening.
Age: 27.0
Sex: F
Vaccine: ANTH, HPV4
Symptoms: Dizziness, Fatigue, Lethargy, Pruritus, Rash
Clinical narrative: Patient works nights and it was her night off.  She states that she woke up around 2:00 AM feeling tired, lethargic, lightheaded/dizzy, itching on both arms, and had broken out with a rash/elevated bumps on arms.
Age: 12.0
Sex: F
Vaccine: HPVX
Symptoms: Asthenia, Headache, Immediate post-injection reaction, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Arm vaccine was delivered immediately became so sore the arm could not be moved.  Became very weak and fainted.  5 minutes later patient vomited.  1 hour later patient had a severe headache accompanied by fever of 101 for the following 2 days.
Age: 12.0
Sex: F
Vaccine: HPVX
Symptoms: Pyrexia, Syncope, Vomiting
Clinical narrative: Arm vaccine was delivered immediately became so sore the arm could not be moved.  Became very weak and fainted.  5 minutes later patient vomited.  1 hour later patient had a severe headache accompanied by fever of 101 for the following 2 days.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass
Clinical narrative: Lump at the site of injection that has been there since the injection.
Age: 31.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site discomfort, Injection site erythema, Injection site nodule
Clinical narrative: Pt reports discomfort at injection site along with a "knot" and redness.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Swelling
Clinical narrative: Patient experienced swelling and redness after immunization. Patient stated that these symptoms were uncommon to her. Two days later patient was diagnosed with cellulitis.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness at injection site, swelling, and pain.
Age: 42.0
Sex: M
Vaccine: HEPAB, MMR, UNK
Symptoms: Blood test, Chest X-ray, Chest discomfort, Chest pain, Dyspnoea
Clinical narrative: Began with headaches and nausea. Around 5:30 headache pain escalated still with nausea. Took a 2 hr nap to see if headache would subside. Around 7:30 pm chest pain began, sweating and shortness of breath. 911 was called around 8pm. Firemen arrived first took blood pressure was very high and now was lethargic. Chest pain tightness & shortness of breath was still present upon paramedics arrival. Before heading to hospital paramedics administered oxygen and started IV.
Age: 42.0
Sex: M
Vaccine: HEPAB, MMR, UNK
Symptoms: Electrocardiogram, Headache, Hyperhidrosis, Hypertension, Lethargy
Clinical narrative: Began with headaches and nausea. Around 5:30 headache pain escalated still with nausea. Took a 2 hr nap to see if headache would subside. Around 7:30 pm chest pain began, sweating and shortness of breath. 911 was called around 8pm. Firemen arrived first took blood pressure was very high and now was lethargic. Chest pain tightness & shortness of breath was still present upon paramedics arrival. Before heading to hospital paramedics administered oxygen and started IV.
Age: 42.0
Sex: M
Vaccine: HEPAB, MMR, UNK
Symptoms: Nausea
Clinical narrative: Began with headaches and nausea. Around 5:30 headache pain escalated still with nausea. Took a 2 hr nap to see if headache would subside. Around 7:30 pm chest pain began, sweating and shortness of breath. 911 was called around 8pm. Firemen arrived first took blood pressure was very high and now was lethargic. Chest pain tightness & shortness of breath was still present upon paramedics arrival. Before heading to hospital paramedics administered oxygen and started IV.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Injection site pain
Clinical narrative: Symptom of arm sore at injection site, lasted more than 60 hours. Symptom of chills lasted 3 hours. Symptom of sore joints lasted 3 hours.
Age: 1.0
Sex: F
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Chemotherapy, Neuroblastoma, Polymerase chain reaction positive, Rash generalised, Varicella virus test positive
Clinical narrative: Diagnosed with neuroblastoma on 3/13 and started on chemotherapy on 3/18. Admitted at Hospital. Rash starting near left eye on 3/27 then disseminated to entire body over next 1-2 days. Started on acyclovir on 3/28. Remains on acyclovir because of continued chemotherapy.
Age: 34.0
Sex: F
Vaccine: TD
Symptoms: Cellulitis, Erythema, Peripheral swelling, Skin warm
Clinical narrative: Arm was swollen, hot to the touch, redness. Went to the Dr on 4/6/17 and was diagnosed with Cellulitits. Was given Augmentin.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Swelling
Clinical narrative: PATIENT CAME IN TO PHARMACY FOR A SHINGLE VACCINE ON 4/6/2017. SHE SHOWED NO SIGNS OF REACTION UNTIL THE MORNING OF 4/7/2017. PATIENT WORK UP WITH REDNESS, SWELLING AND HARDEN AND WARM TO  TOUCH AT THE SIGHT OF INJECTION. PATIENT CAME INTO PHARMACY ON 4/9/2017 TO REPORT REACTION. SHE SAID SWELLING RADIATED TO HER UNDER ARM. I ADVISED PATIENT TO SEEK  MEDICAL HELP AS SOON AS POSSIBLE AND TAKE BENADRYL AND USE ICE PAK IN THE MEANTIME.
Age: 11.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Induration, Pain in extremity, Pyrexia, Skin warm
Clinical narrative: Arm was very sore, hard to the touch and very hot. Low grade fever.
Age: 52.0
Sex: U
Vaccine: VARZOS
Symptoms: Body temperature, Injection site erythema, Injection site warmth, Nausea
Clinical narrative: Within 48hours patients left arm developed redness down to elbow, hot skin, temperature, nausea.
Sex: F
Vaccine: HEP, HEPA, HPV9, IPV, MNQ, TDAP, VARCEL
Symptoms: Blood pressure decreased, Computerised tomogram normal, Erythema, Head injury, Ligament sprain
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 591338). This spontaneous report refers to a 15 year old female patient. The patient's historical conditions, concurrent conditions and concomitant medications were not reported. On 20-AUG-2015 the patient was vaccinated with GARDASIL 9 lot # L007560 (intramuscular), VARIVAX lot # L002216 (subcutaneous), VAQTA lot # K008333 (intramuscular) and RECOMBIVAX HB lot # K010535 (intramuscular) in the right arm for prophylaxis. On the same day, the patient was also vaccinated with BOOSTRIX, MENVEO, IPOL in the left arm through intramuscular route. On 20-AUG-2015, the patient's spinal x-ray was normal, skull x-ray was normal, computerised tomogram was normal. On the same day, the patient also experienced blood pressure decreased, vomiting, ligament sprain. The patient became nauseous and stood up. She then had a syncope episode and sustained an injury to right lateral upper side of forehead. The patient had 10x10 mm closed wound with erythema and oedema. She continued to be unconsciousness and unresponsive to stimuli for approximately 2 minutes. Two ammonia inhalants were used and the patient did not respond. Emergency responders were called. Ice pack to forehead was placed and the vitals were within normal limits. Orientated x 3 after she was responsive (approximately two minutes) but stated lack of memory of event. Also she denied HA, nausea, SOB (shortness of breath) and dizziness. EMS (emergency medical services) responded and transferred patient to hospital via ambulance. On 21-AUG-2015, patient's guardian stated that "the patient continued with decreased blood pressure yesterday afternoon". The patient had an emesis episode and after vomiting, she began to feel much better. She was kept at the hospital overnight and was discharged today. CT (computerized tomogram) scan and X-ray of head and neck were normal with in limits but did have a slight neck sprain. The outcome of spinal x-ray normal, skull x-ray normal, computerised tomogram normal, blood pressure decreased, vomiting, ligament sprain, nausea, syncope, head injury, wound, erythema, oedema, loss of consciousness and unresponsive to stimuli was reported as recovered. The causality assessment for all the events with respect to the suspect therapies was not provided by the reporter. The agency considered the case to be serious as the patient was hospitalized due to the events spinal x-ray normal, skull x-ray normal, computerised tomogram normal, blood pressure decreased, vomiting, ligament sprain, nausea, syncope, head injury, wound, erythema, oedema, loss of consciousness and unresponsive to stimuli. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HEP, HEPA, HPV9, IPV, MNQ, TDAP, VARCEL
Symptoms: Loss of consciousness, Memory impairment, Nausea, Oedema, Skull X-ray normal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 591338). This spontaneous report refers to a 15 year old female patient. The patient's historical conditions, concurrent conditions and concomitant medications were not reported. On 20-AUG-2015 the patient was vaccinated with GARDASIL 9 lot # L007560 (intramuscular), VARIVAX lot # L002216 (subcutaneous), VAQTA lot # K008333 (intramuscular) and RECOMBIVAX HB lot # K010535 (intramuscular) in the right arm for prophylaxis. On the same day, the patient was also vaccinated with BOOSTRIX, MENVEO, IPOL in the left arm through intramuscular route. On 20-AUG-2015, the patient's spinal x-ray was normal, skull x-ray was normal, computerised tomogram was normal. On the same day, the patient also experienced blood pressure decreased, vomiting, ligament sprain. The patient became nauseous and stood up. She then had a syncope episode and sustained an injury to right lateral upper side of forehead. The patient had 10x10 mm closed wound with erythema and oedema. She continued to be unconsciousness and unresponsive to stimuli for approximately 2 minutes. Two ammonia inhalants were used and the patient did not respond. Emergency responders were called. Ice pack to forehead was placed and the vitals were within normal limits. Orientated x 3 after she was responsive (approximately two minutes) but stated lack of memory of event. Also she denied HA, nausea, SOB (shortness of breath) and dizziness. EMS (emergency medical services) responded and transferred patient to hospital via ambulance. On 21-AUG-2015, patient's guardian stated that "the patient continued with decreased blood pressure yesterday afternoon". The patient had an emesis episode and after vomiting, she began to feel much better. She was kept at the hospital overnight and was discharged today. CT (computerized tomogram) scan and X-ray of head and neck were normal with in limits but did have a slight neck sprain. The outcome of spinal x-ray normal, skull x-ray normal, computerised tomogram normal, blood pressure decreased, vomiting, ligament sprain, nausea, syncope, head injury, wound, erythema, oedema, loss of consciousness and unresponsive to stimuli was reported as recovered. The causality assessment for all the events with respect to the suspect therapies was not provided by the reporter. The agency considered the case to be serious as the patient was hospitalized due to the events spinal x-ray normal, skull x-ray normal, computerised tomogram normal, blood pressure decreased, vomiting, ligament sprain, nausea, syncope, head injury, wound, erythema, oedema, loss of consciousness and unresponsive to stimuli. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HEP, HEPA, HPV9, IPV, MNQ, TDAP, VARCEL
Symptoms: Spinal X-ray normal, Syncope, Unresponsive to stimuli, Vomiting, Wound
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 591338). This spontaneous report refers to a 15 year old female patient. The patient's historical conditions, concurrent conditions and concomitant medications were not reported. On 20-AUG-2015 the patient was vaccinated with GARDASIL 9 lot # L007560 (intramuscular), VARIVAX lot # L002216 (subcutaneous), VAQTA lot # K008333 (intramuscular) and RECOMBIVAX HB lot # K010535 (intramuscular) in the right arm for prophylaxis. On the same day, the patient was also vaccinated with BOOSTRIX, MENVEO, IPOL in the left arm through intramuscular route. On 20-AUG-2015, the patient's spinal x-ray was normal, skull x-ray was normal, computerised tomogram was normal. On the same day, the patient also experienced blood pressure decreased, vomiting, ligament sprain. The patient became nauseous and stood up. She then had a syncope episode and sustained an injury to right lateral upper side of forehead. The patient had 10x10 mm closed wound with erythema and oedema. She continued to be unconsciousness and unresponsive to stimuli for approximately 2 minutes. Two ammonia inhalants were used and the patient did not respond. Emergency responders were called. Ice pack to forehead was placed and the vitals were within normal limits. Orientated x 3 after she was responsive (approximately two minutes) but stated lack of memory of event. Also she denied HA, nausea, SOB (shortness of breath) and dizziness. EMS (emergency medical services) responded and transferred patient to hospital via ambulance. On 21-AUG-2015, patient's guardian stated that "the patient continued with decreased blood pressure yesterday afternoon". The patient had an emesis episode and after vomiting, she began to feel much better. She was kept at the hospital overnight and was discharged today. CT (computerized tomogram) scan and X-ray of head and neck were normal with in limits but did have a slight neck sprain. The outcome of spinal x-ray normal, skull x-ray normal, computerised tomogram normal, blood pressure decreased, vomiting, ligament sprain, nausea, syncope, head injury, wound, erythema, oedema, loss of consciousness and unresponsive to stimuli was reported as recovered. The causality assessment for all the events with respect to the suspect therapies was not provided by the reporter. The agency considered the case to be serious as the patient was hospitalized due to the events spinal x-ray normal, skull x-ray normal, computerised tomogram normal, blood pressure decreased, vomiting, ligament sprain, nausea, syncope, head injury, wound, erythema, oedema, loss of consciousness and unresponsive to stimuli. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 17.0
Sex: M
Vaccine: HEPA, MNQ, VARCEL, HEPA, MNQ, VARCEL
Symptoms: Pyrexia, Rash pruritic, Rash pustular
Clinical narrative: Patient developed fever and rash, seemn in office next day 3/1 and on 3/3 and diagnosed with varicella.
Age: 17.0
Sex: M
Vaccine: HEPA, MNQ, VARCEL, HEPA, MNQ, VARCEL
Symptoms: Pyrexia, Rash, Varicella post vaccine
Clinical narrative: Patient developed fever and rash, seemn in office next day 3/1 and on 3/3 and diagnosed with varicella.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of an unknown age and gender. There was no information about the patient's pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies. On 16-MAR-2017, the patient was vaccinated with an expired dose of PNEUMOVAX23 lot number: L012215, expiration date: 13-JAN-2017 (strength, dose, frequency, route of administration, and anatomical location were not provided) for prophylaxis. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and office manager referring to five patients of unspecified gender and age.  In February and March 2017, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot number M040270, expiration date 29-APR-2019 or lot number M018958, expiration date 03-MAR-2018 (dose and frequency were not reported). No adverse effects were reported. The doses were stored in temperature between 47 degrees Fahrenheit to 77 degrees Fahrenheit for 61 hours. Data logger was involved. There was no previous excursion reported. This is one of several reports received from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1703USA011636:
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot # M034189, expiration date 23-MAY-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 35.2 degrees Fahrenheit for 3 hours 30 minutes. Data logger was used to capture temperature excursions. There were no previous excursions. No Product Quality Complaint (PQC)was involved. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 30-MAR-2017, the patient was vaccinated with an expired dose of GARDASIL injection (confirmed not GARDASIL 9) with lot # L039066 and expiration date: 30-MAR-2017 (dose and route of administration were not provided). No adverse symptoms were reported. The nurse stated, the dose of GARDASIL did not has any previous temperature excursions. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Swelling
Clinical narrative: Information has been received from a physician via a company representative, referring to a 14 year old female patient not pregnant. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 30-DEC-2016, the patient was vaccinated with the first dose of GARDASIL 9 lot # M034780 with an expiration date in April 2019, intramuscularly (strength, dose and anatomical location were not reported) for prevention of Human papillomavirus (HPV). On 09-JAN-2017 (reported as "11 days after receiving the first dose of the vaccine"), the patient experienced "clavicle enlargement". It was reported that the patient contacted the physician due to the event. The outcome of the "clavicle enlargement" was unknown and the causality between the vaccination with GARDASIL 9 and the event was not reported.  No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 07-FEB-2017 at 08:37, the patient was vaccinated with an improperly stored VARIVAX (lot # M031969) for prophylaxis (expiration date, dose and route of administration were not reported). It was reported that the vaccine underwent previous temperature excursions, but the number of previous excursions, time frames and values of incorrect temperature were unknown. A digital data logger was used. No adverse effects were reported. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA008441: US-009507513-1704USA000389: US-009507513-1704USA000390: US-009507513-1704USA000391: US-009507513-1704USA000392: US-009507513-1704USA000393: US-009507513-1704USA000394: US-009507513-1704USA000395: US-009507513-1704USA000396: US-009507513-1704USA000397: US-009507513-1704USA000398: US-009507513-1704USA000399: US-009507513-1704USA000400: US-009507513-1704USA000401: US-009507513-1704USA000402: US-009507513-1704USA000403: US-009507513-1704USA000404: US-009507513-1704USA000405: US-009507513-1704USA000406: US-009507513-1704USA000407: US-009507513-1704USA000408: US-009507513-1704USA000409: US-009507513-1704USA000410: US-009507513-1704USA000411: US-009507513-1704USA000412: US-009507513-1704USA000413: US-009507513-1704USA000414: US-009507513-1704USA000415: US-009507513-1704USA000416: US-009507513-1704USA000417: US-009507513-1704USA000418: US-009507513-1704USA000419: US-009507513-1704USA000420: US-009507513-1704USA000421: US-009507513-1704USA000422: US-009507513-1704USA000423: US-009507513-1704USA000424: US-009507513-1704USA000425: US-009507513-1704USA000426: US-009507513-1704USA000427: US-009507513-1704USA000428: US-009507513-1704USA000429: US-009507513-1704USA000430: US-009507513-1704USA000431: US-009507513-1704USA000432: US-009507513-1704USA000433: US-009507513-1704USA000434: US-009507513-1704USA000435: US-009507513-1704USA000436: US-009507513-1704USA000437: US-009507513-1704USA000438: US-009507513-1704USA000439: US-009507513-1704USA000440: US-009507513-1704USA000441: US-009507513-1704USA000442: US-009507513-1704USA000443: US-009507513-1704USA000444: US-009507513-1704USA000446: US-009507513-1704USA000447: US-009507513-1704USA000448: US-009507513-1704USA000449: US-009507513-1704USA000450: US-009507513-1704USA000451: US-009507513-1704USA000452: US-009507513-1704USA000453: US-009507513-1704USA000454: US-009507513-1704USA000455: US-009507513-1704USA000456: US-009507513-1704USA000457.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 17-JAN-2017 at 08:46, the patient was vaccinated with an improperly stored VARIVAX (lot # M031969) for prophylaxis (expiration date, dose and route of administration were not reported). It was reported that the vaccine underwent previous temperature excursions, but the number of previous excursions, time frames and values of incorrect temperature were unknown. A digital data logger was used. No adverse effects were reported. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA008441: US-009507513-1704USA000389: US-009507513-1704USA000390: US-009507513-1704USA000391: US-009507513-1704USA000392: US-009507513-1704USA000393: US-009507513-1704USA000394: US-009507513-1704USA000395: US-009507513-1704USA000396: US-009507513-1704USA000397: US-009507513-1704USA000398: US-009507513-1704USA000399: US-009507513-1704USA000400: US-009507513-1704USA000401: US-009507513-1704USA000402: US-009507513-1704USA000403: US-009507513-1704USA000404: US-009507513-1704USA000405: US-009507513-1704USA000406: US-009507513-1704USA000407: US-009507513-1704USA000408: US-009507513-1704USA000409: US-009507513-1704USA000410: US-009507513-1704USA000411: US-009507513-1704USA000412: US-009507513-1704USA000413: US-009507513-1704USA000414: US-009507513-1704USA000415: US-009507513-1704USA000416: US-009507513-1704USA000417: US-009507513-1704USA000418: US-009507513-1704USA000419: US-009507513-1704USA000420: US-009507513-1704USA000421: US-009507513-1704USA000422: US-009507513-1704USA000423: US-009507513-1704USA000424: US-009507513-1704USA000425: US-009507513-1704USA000426: US-009507513-1704USA000427: US-009507513-1704USA000428: US-009507513-1704USA000429: US-009507513-1704USA000430: US-009507513-1704USA000431: US-009507513-1704USA000432: US-009507513-1704USA000433: US-009507513-1704USA000434: US-009507513-1704USA000435: US-009507513-1704USA000436: US-009507513-1704USA000437: US-009507513-1704USA000438: US-009507513-1704USA000439: US-009507513-1704USA000440: US-009507513-1704USA000441: US-009507513-1704USA000442: US-009507513-1704USA000443: US-009507513-1704USA000444: US-009507513-1704USA000445: US-009507513-1704USA000447: US-009507513-1704USA000448: US-009507513-1704USA000449: US-009507513-1704USA000450: US-009507513-1704USA000451: US-009507513-1704USA000452: US-009507513-1704USA000453: US-009507513-1704USA000454: US-009507513-1704USA000455: US-009507513-1704USA000456: US-009507513-1704USA000457.
Sex: F
Vaccine: PPV
Symptoms: Malaise
Clinical narrative: This solicited report has been received from a 65 years old female patient, who was enrolled in a Marked Research concerning herself. The patient's medical history, concurrent conditions and concomitant therapies were unknown. On an unknown date the patient was vaccinated with PNEUMOVAX23 (dose, route, lot# and expiration date were not reported) for prophylaxis. On an unknown date the patient reported that it would make her sick when she was not. The outcome of the event was unknown. Causality between PNEUMOVAX23 and the event was not provided. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV9, MEN, HPV9, MNQ
Symptoms: Generalised tonic-clonic seizure, Urinary incontinence
Clinical narrative: This spontaneous report as received from a nurse prescriber refers to a 16 year old non-pregnant female patient. The patient's concurrent conditions and medical history were not reported. On approximately 04-APR-2017, the patient was vaccinated intramuscularly with GARDASIL 9, lot # M043701, expiry date 22-JUN-2019 (dose and site of administration were not provided) to prevent human papillomavirus (HPV). The patient also received meningococcal a polysaccharide vaccine (dose, route and site of administration, lot # and expiry date were not reported). Concomitant therapies included ibuprofen. On 04-APR-2017, after the meningococcal a polysaccharide vaccine was administered, the patient had a tonic-clonic seizure, and lost control of her bladder. She received first aid in the office, was laid down and her vitals were monitored. In April 2017, reported as now, the patient was in a hospital and was going to have an electroencephalogram (EEG). The patient was treated for the event. The outcome of tonic-clonic seizure was reported as recovered on an unspecified date in April 2017. The relatedness between the event and the suspect therapies was not provided. Upon internal review, the event of tonic-clonic seizure was considered to be medically significant. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV9, MEN, HPV9, MNQ
Symptoms: Electroencephalogram, Loss of consciousness, Opisthotonus, Syncope, Tonic clonic movements
Clinical narrative: This spontaneous report as received from a nurse prescriber refers to a 16 year old non-pregnant female patient. The patient's concurrent conditions and medical history were not reported. On approximately 04-APR-2017, the patient was vaccinated intramuscularly with GARDASIL 9, lot # M043701, expiry date 22-JUN-2019 (dose and site of administration were not provided) to prevent human papillomavirus (HPV). The patient also received meningococcal a polysaccharide vaccine (dose, route and site of administration, lot # and expiry date were not reported). Concomitant therapies included ibuprofen. On 04-APR-2017, after the meningococcal a polysaccharide vaccine was administered, the patient had a tonic-clonic seizure, and lost control of her bladder. She received first aid in the office, was laid down and her vitals were monitored. In April 2017, reported as now, the patient was in a hospital and was going to have an electroencephalogram (EEG). The patient was treated for the event. The outcome of tonic-clonic seizure was reported as recovered on an unspecified date in April 2017. The relatedness between the event and the suspect therapies was not provided. Upon internal review, the event of tonic-clonic seizure was considered to be medically significant. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV9, MEN, HPV9, MNQ
Symptoms: Urinary incontinence
Clinical narrative: This spontaneous report as received from a nurse prescriber refers to a 16 year old non-pregnant female patient. The patient's concurrent conditions and medical history were not reported. On approximately 04-APR-2017, the patient was vaccinated intramuscularly with GARDASIL 9, lot # M043701, expiry date 22-JUN-2019 (dose and site of administration were not provided) to prevent human papillomavirus (HPV). The patient also received meningococcal a polysaccharide vaccine (dose, route and site of administration, lot # and expiry date were not reported). Concomitant therapies included ibuprofen. On 04-APR-2017, after the meningococcal a polysaccharide vaccine was administered, the patient had a tonic-clonic seizure, and lost control of her bladder. She received first aid in the office, was laid down and her vitals were monitored. In April 2017, reported as now, the patient was in a hospital and was going to have an electroencephalogram (EEG). The patient was treated for the event. The outcome of tonic-clonic seizure was reported as recovered on an unspecified date in April 2017. The relatedness between the event and the suspect therapies was not provided. Upon internal review, the event of tonic-clonic seizure was considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On 27-MAR-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ, orally, lot # reported as M040271 with expiry date 30-APR-2018 (exact dose was not reported). The dose was exposed to the temperature between 0 and 1 degrees Celsius for 30 minutes and between -6 and 0 degrees Celsius for 3.5 hours (1 cycle). There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA003054: US-009507513-1704USA003052: US-009507513-1704USA003053:
Sex: U
Vaccine: HPV9
Symptoms: Pain
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative and refers to multiple patients of unknown ages and genders. The patients' concurrent conditions and medical histories were not reported. On unknown dates, the patients were vaccinated with GARDASIL 9 (dose, route lot number and expiry date were not reported) for prophylaxis. Information regarding concomitant medications was not reported. The reporter stated that, on unknown dates, multiple patients experienced pain after receiving vaccination with GARDASIL 9. The anatomical location of the pain was unknown At the reporting time, the outcome of pain was unknown. The reporter did not provide a causality assessment between the pain and the GARDASIL 9. Additional information is not expected, because the reporter did not allow further contact for follow up.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a Registered Nurse and refers to a unknown patients of unknown age and gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On unknown dates, the patients were vaccinated with improperly stored unspecified doses of M-M-R II for prophylaxis (lot number M011667, with an expiration date of 08-MAR-2018) (strength, dose and frequency were not reported). No concomitant medications were provided. The doses of the vaccine experienced a temperature excursion from 32 degrees Fahrenheit (F) to 35 degrees F for 228 hours and from 47 degrees F to 77 degrees F for 18 hours and 20 minutes. The aforementioned temperature was identified due to a data logger. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA003224: US-009507513-1704USA003225: US-009507513-1704USA003227: US-009507513-1704USA003228: US-009507513-1704USA003223: US-009507513-1704USA003226:
Sex: U
Vaccine: MMR
Symptoms: Mumps, Vaccination failure
Clinical narrative: This spontaneous report was received from a public health practitioner referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of M-M-R II (dose, route, anatomical location, lot number and expiration date were not provided), for prophylaxis. It was reported that in August 2016, an outbreak of mumps began (many of the people are children). Since then, there had been nearly 3000 cases of the disease across 33 counties in the state.  The reporter stated that M-M-R II was given in two doses, but, even with both doses, the vaccine was imperfect. Additionally, the reporter's study indicated that MMR vaccination in communities affected by the 2016 mumps outbreak was suboptimal. It was reported that one out of every 10 individuals who received the M-M-R II, remained susceptible to the mumps virus. In addition, in the event of a mumps outbreak, some people who got sick would be people who were vaccinated. It was reported that the average two dose vaccination rate in communities affected by the outbreak was likely no higher than 89% and might have been as low as 70%. At the time of reporting, the outcome of the vaccination failure and the mumps, and the causal relationship between the events with the M-M-R II, were not reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On 27-MAR-2017, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB, lot # M036056 with expiry date 18-MAY-2019 (exact dose and route of administration were not reported). The dose was exposed to the temperature between -3 and 0 degrees Celsius for 4 hours. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA003053: US-009507513-1704USA003054: US-009507513-1704USA002166:
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On 30-MAR-2017, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB, lot # M036056 with expiry date 18-MAY-2019 (exact dose and route of administration were not reported). The dose was exposed to the temperature between -3 and 0 degrees Celsius for 4 hours. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA002166: US-009507513-1704USA003054: US-009507513-1704USA003052:
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On 30-MAR-2017, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB, lot # M036056 with expiry date 18-MAY-2019 (exact dose and route of administration were not reported). The dose was exposed to the temperature between -3 and 0 degrees Celsius for 4 hours. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA003053: US-009507513-1704USA002166: US-009507513-1704USA003052:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a Registered Nurse and refers to a unknown patients of unknown age and gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On unknown dates, the patients were vaccinated with improperly stored unspecified doses of GARDASIL 9  for prophylaxis (lot number M036059, with an expiration date of 03-JUN-2019) (strength, dose and frequency were not reported). No concomitant medications were provided. The doses of the vaccine experienced a temperature excursion from 32 degrees Fahrenheit (F) to 35 degrees F for 228 hours and from 47 degrees F to 77 degrees F for 18 hours and 20 minutes. The aforementioned temperature was identified due to a data logger. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA003014: US-009507513-1704USA003224: US-009507513-1704USA003228: US-009507513-1704USA003226: US-009507513-1704USA003227: US-009507513-1704USA003225.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a Registered Nurse and refers to a unknown patients of unknown age and gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On unknown dates, the patients were vaccinated with improperly stored unspecified doses of PEDVAXHIB for prophylaxis (lot number L002867, with an expiration date of 11-NOV-2017; lot number M001813, with an expiration date of 14-OCT-2018 and lot number M020100, with an expiration date of 03-JUN-2019) (strength, dose and frequency were not reported). No concomitant medications were provided. The doses of the vaccine experienced a temperature excursion from 32 degrees Fahrenheit (F) to 35 degrees F for 228 hours and from 47 degrees F to 77 degrees F for 18 hours and 20 minutes. The aforementioned temperature was identified due to a data logger. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA003014: US-009507513-1704USA003228: US-009507513-1704USA003226: US-009507513-1704USA003227: US-009507513-1704USA003223: US-009507513-1704USA003225.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a Registered Nurse and refers to a unknown patients of unknown age and gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On unknown dates, the patients were vaccinated with improperly stored unspecified doses of PNEUMOVAX23 for prophylaxis (lot number  reported as M039201, with an expiration date of 20-MAY-2018) (strength, dose and frequency were not reported). No concomitant medications were provided. The doses of the vaccine experienced a temperature excursion from 32 degrees Fahrenheit (F) to 35 degrees F for 228 hours and from 47 degrees F to 77 degrees F for 18 hours and 20 minutes. The aforementioned temperature was identified due to a data logger. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA003224: US-009507513-1704USA003228: US-009507513-1704USA003226: US-009507513-1704USA003227: US-009507513-1704USA003223: US-009507513-1704USA003014:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a Registered Nurse and refers to a unknown patients of unknown age and gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On unknown dates, the patients were vaccinated with improperly stored unspecified doses of RECOMBIVAX HB  for prophylaxis (lot number M039201, with an expiration date of 04-NOV-2018 and lot number L016959, with an expiration date of  12-MAR-2018) (strength, dose and frequency were not reported). No concomitant medications were provided. The doses of the vaccine experienced a temperature excursion from 32 degrees Fahrenheit (F) to 35 degrees F for 228 hours and from 47 degrees F to 77 degrees F for 18 hours and 20 minutes. The aforementioned temperature was identified due to a data logger. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. ; Sender's Comments: US-009507513-1704USA003224: US-009507513-1704USA003228: US-009507513-1704USA003014: US-009507513-1704USA003227: US-009507513-1704USA003223: US-009507513-1704USA003225:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a Registered Nurse and refers to a unknown patients of unknown age and gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On unknown dates, the patients were vaccinated with improperly stored unspecified doses of VAQTA for prophylaxis (lot number reported as M002921, with an expiration date of 08-APR-2018 (strength, dose and frequency were not reported). No concomitant medications were provided. The doses of the vaccine experienced a temperature excursion from 32 degrees Fahrenheit (F) to 35 degrees F for 228 hours and from 47 degrees F to 77 degrees F for 18 hours and 20 minutes. The aforementioned temperature was identified due to a data logger. There were no previous temperature excursions reported.  This is one of several reports received from the same reporter. Additional information has been requested. ; Sender's Comments:  US-009507513-1704USA003224: US-009507513-1704USA003228: US-009507513-1704USA003226: US-009507513-1704USA003014: US-009507513-1704USA003223: US-009507513-1704USA003225:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a Registered Nurse and refers to a unknown patients of unknown age and gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On unknown dates, the patients were vaccinated with improperly stored unspecified doses of ROTATEQ orally for prophylaxis (lot number M016238, with an expiration date of 07-DEC-2017) (strength, dose and frequency were not reported). No concomitant medications were provided. The doses of the vaccine experienced a temperature excursion from 32 degrees Fahrenheit (F) to 35 degrees F for 228 hours and from 47 degrees F to 77 degrees F for 18 hours and 20 minutes. The aforementioned temperature was identified due to a data logger. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA003224: US-009507513-1704USA003014: US-009507513-1704USA003226: US-009507513-1704USA003227: US-009507513-1704USA003223: US-009507513-1704USA003225.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 02-NOV-2016, the patient was vaccinated with a dose of improperly stored VARIVAX (incorrect product storage) (lot # M005971, expiry date: 02-FEB-2018) (dosing regimen and route of administration unknown) for prophylaxis. No concomitant medications were reported. No adverse effects were reported. On an unknown date, the vaccine was exposed to temperature of 48.2 Fahrenheit (F) for 21 hours 57 minutes. Previous temperature excursion was reported on an unknown date, at a temperature of 57.6 F, for a duration of 20 hours 27 minutes. This case was reported because of a data logger. No product quality complaint (PQC) was reported. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEPA, MMR, PNC13, VARCEL
Symptoms: Immune thrombocytopenic purpura, Platelet count decreased
Clinical narrative: Idiopathic Thrombocytopenic Purpura.
Age: 55.0
Sex: F
Vaccine: HEP, IPV
Symptoms: Injection site pain, X-ray limb
Clinical narrative: Awoke am of 03/31/2017 with pain in the left shoulder region. Seen by PMD on 04/01/17 prescribed Ibuprofen 600 mg.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, PPV
Symptoms: Crying, Feeling abnormal, Injection site induration, Injection site swelling, Irritability
Clinical narrative: Extreme fussiness, uncontrollable crying, arching back, just plain miserable. My usual perfect, happy, bubbly baby has not been the same since her recent vaccinations. She has a bump on her leg where the vaccination was received that is raised and is hard as a rock.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, PPV
Symptoms: Opisthotonus
Clinical narrative: Extreme fussiness, uncontrollable crying, arching back, just plain miserable. My usual perfect, happy, bubbly baby has not been the same since her recent vaccinations. She has a bump on her leg where the vaccination was received that is raised and is hard as a rock.