chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Around 11pm, I started getting fever and felt very sore everywhere.  I took two Tylenol and went to bed.  I woke in the night to find that the injection site was swollen to golf ball size.  By morning, it was hot, red, and the size of a softball.  I also had a migraine.  The knot is now the size of a grapefruit and it hurts.  I called the clinic and was told that a reaction is normal.  This is not normal.  The skin is stretched so thin it's almost translucent.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Migraine, Pain, Pyrexia
Clinical narrative: Around 11pm, I started getting fever and felt very sore everywhere.  I took two Tylenol and went to bed.  I woke in the night to find that the injection site was swollen to golf ball size.  By morning, it was hot, red, and the size of a softball.  I also had a migraine.  The knot is now the size of a grapefruit and it hurts.  I called the clinic and was told that a reaction is normal.  This is not normal.  The skin is stretched so thin it's almost translucent.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site pruritus, Injection site reaction, Rash erythematous
Clinical narrative: Patient presented to pharmacy 2 days after receiving Zostavax with erythematous rash with solid borders, appoximately 2 inches in diameter, and pruritis at the site of injection.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site induration, Injection site pain, Injection site reaction, Injection site swelling, Rash macular
Clinical narrative: Large, splotchy, swollen red bump at injection site. Hard and painful to the touch. Used ice to try and calm swelling.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dyspnoea, Pain in extremity
Clinical narrative: Patient called and stated that her arm was hurting and that she was short of breath. Patient stated that daughter was taking her to the emergency room.
Age: 1.92
Sex: M
Vaccine: MMRV
Symptoms: Pyrexia, Rash, Rash erythematous, Rash generalised, Rash morbilliform
Clinical narrative: The next morning when my baby woke up he had a red rash on his chin and jaw line. Within the next 2 weeks he had severe fever and a measles type rash all over his body!
Age: 1.92
Sex: M
Vaccine: MMRV
Symptoms: Vaccination complication
Clinical narrative: The next morning when my baby woke up he had a red rash on his chin and jaw line. Within the next 2 weeks he had severe fever and a measles type rash all over his body!
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Abdominal discomfort, Aphasia, Constipation, Decreased eye contact, Drug hypersensitivity
Clinical narrative: Loss of all expressive verbal language (could no longer speak). Could no longer make eye contact. Overly sensitive to sounds. Would not respond to name (almost appearing to be deaf). Chronic ear infections. Onset of febrile seizure. Sudden allergy to amoxicillin (erythema multiforme). Lost ability to feel pain. GI distress - severe constipation.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Ear infection, Erythema multiforme, Febrile convulsion, Hyperacusis, Language disorder
Clinical narrative: Loss of all expressive verbal language (could no longer speak). Could no longer make eye contact. Overly sensitive to sounds. Would not respond to name (almost appearing to be deaf). Chronic ear infections. Onset of febrile seizure. Sudden allergy to amoxicillin (erythema multiforme). Lost ability to feel pain. GI distress - severe constipation.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Sensory loss, Unresponsive to stimuli
Clinical narrative: Loss of all expressive verbal language (could no longer speak). Could no longer make eye contact. Overly sensitive to sounds. Would not respond to name (almost appearing to be deaf). Chronic ear infections. Onset of febrile seizure. Sudden allergy to amoxicillin (erythema multiforme). Lost ability to feel pain. GI distress - severe constipation.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Eye movement disorder, Loss of consciousness, Musculoskeletal stiffness, Opisthotonus, Pallor
Clinical narrative: Moments after flu shot, while observing my younger child receive his shot, I turned to notice my daughter unconscious on the floor of the cafeteria where the shot was administered.  Blood was pooling around her face.  Her eyes were rolled back in her head.  She was unconscious and unresponsive.  Her jaw was clamped shut.  Her back was arched with her chest forward.  Her entire body was stiff.  She was white.  She was not breathing.  911 was called.  She was unresponsive for nearly 30 seconds from when it was noticed she was on the ground.  She jumped to her feet.  She didn't know who or where she was.  She was solid white and her pupils hadn't returned.  We then realized that significant damage had been done to her teeth.  The 2 front adult teeth were broken off.  We were not able to find them.  She was transported to Hospital of via paramedic level ambulance.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Pupil fixed, Tooth injury, Trismus, Unresponsive to stimuli
Clinical narrative: Moments after flu shot, while observing my younger child receive his shot, I turned to notice my daughter unconscious on the floor of the cafeteria where the shot was administered.  Blood was pooling around her face.  Her eyes were rolled back in her head.  She was unconscious and unresponsive.  Her jaw was clamped shut.  Her back was arched with her chest forward.  Her entire body was stiff.  She was white.  She was not breathing.  911 was called.  She was unresponsive for nearly 30 seconds from when it was noticed she was on the ground.  She jumped to her feet.  She didn't know who or where she was.  She was solid white and her pupils hadn't returned.  We then realized that significant damage had been done to her teeth.  The 2 front adult teeth were broken off.  We were not able to find them.  She was transported to Hospital of via paramedic level ambulance.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Dyspnoea, Myalgia, Rash, Rhinorrhoea, Sneezing
Clinical narrative: It was started with itchy throat, runny nose, shortness of breath and sneezing. Then I got muscle pain. On Sunday I noticed that I got rashes all over my chest. On Monday it got worse, more prominent.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Throat irritation
Clinical narrative: It was started with itchy throat, runny nose, shortness of breath and sneezing. Then I got muscle pain. On Sunday I noticed that I got rashes all over my chest. On Monday it got worse, more prominent.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Abasia, Joint swelling, Peripheral swelling, Throat tightness, Urticaria
Clinical narrative: Hives on legs, narrowing of throat, inability to walk, swelling of joints and limbs.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Vaccination site inflammation
Clinical narrative: Patient has large red/inflamed area (approximately 3 inches across) in area where vaccine was administered.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Patient presented to pharmacy and requested a flu shot, filled out paperwork, was given the VIS and discussed difference in regular vs hi-dose flu shot for this year. After all questions were answered, regular quad flu shot was administered.  Upon documenting was discovered that pt had already gotten a flu shot during her office visit earlier today.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Enema administration, Intussusception
Clinical narrative: Ileocolic intusussception requiring air enema reduction, no surgery needed.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Crying, Diarrhoea, Enema administration, Haematochezia, Intussusception
Clinical narrative: Ileocolic intusussception requiring air enema reduction, no surgery needed.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Mucous stools, Pyrexia, Ultrasound scan abnormal, Vomiting
Clinical narrative: Ileocolic intusussception requiring air enema reduction, no surgery needed.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Blood gases, Chills, Full blood count, Malaise, Metabolic function test
Clinical narrative: Rigors, chills, myalgia, muscle weakness, malaise.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Myalgia, Urine analysis
Clinical narrative: Rigors, chills, myalgia, muscle weakness, malaise.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Pain left upper arm since receiving Flu shot on 9/20/16.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pyrexia
Clinical narrative: That night she had chills and a fever.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: FLUZONE HIDOSE administered 10/18/16. (L) upper arm became itchy at 7-7:30pm and this continued throughout night. Large area of redness noted on (L) upper arm (underside of arm) Pt. going to see MD today.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Induration
Clinical narrative: Day after vaccine developed large red indurated area approximately 7 x 8 cm. Seen in office 2 days later, area fading.
Age: 68.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pain, Peripheral swelling
Clinical narrative: Swollen arm. Pain.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Peripheral swelling
Clinical narrative: This spontaneous report was received from a doctor of pharmacy referring to a 50 year old male patient. The patient did not have any pertinent medical history, concurrent condition, drug reactions or allergies. On 03-OCT-2016, the patient was subcutaneously vaccinated with an unknown dose number of ZOSTAVAX lot # L046897, expiration date 23-FEB-2017, 0.65 ml. The patient was not taking any concomitant medication. On an unspecified date in October 2016, the patient experienced headache, injection site pain and peripheral swelling. It was unknown if the patient received any treatment or if laboratory diagnostics studies were performed. The outcome of peripheral swelling, injection site pain and headache was unknown. The causal relationship between ZOSTAVAX and adverse events were not reported. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain, Pain in extremity
Clinical narrative: Sharp pain to left arm with internal/external rotation.
Age: 61.0
Sex: F
Vaccine: FLU4, PNC13, VARZOS
Symptoms: Asthenia, Injection site erythema, Injection site swelling, Nausea, Pyrexia
Clinical narrative: Nausea/vomiting/weakness/high fevers. Swelling/redness at inj site. 7x3 cm area on (R) deltoid.
Age: 61.0
Sex: F
Vaccine: FLU4, PNC13, VARZOS
Symptoms: Vomiting
Clinical narrative: Nausea/vomiting/weakness/high fevers. Swelling/redness at inj site. 7x3 cm area on (R) deltoid.
Age: 66.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site x 3 days.
Age: 66.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness and swelling at injection site x 3 days.
Age: 75.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Erythema, Pruritus, Tenderness
Clinical narrative: Tender to touch, erythematous, pruritic.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain, Neck pain
Clinical narrative: Patient called pharmacy to state that she still felt pain in shoulder and neck. She believes from flu vaccine. Reporting for safety.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Fatigue, Swelling
Clinical narrative: Swollen shoulder blade (Left side). Lightheadedness. Fatigue.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Hypoaesthesia, Spinal X-ray
Clinical narrative: Numbness all over the body, improved to (L) arm dermatome numbness.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Erythema, Nodule
Clinical narrative: Got FLUZONE High Dose around 5:00pm on 10/17/16. Patient came in 10/19/16 around 12:45pm showing a major round bruise. She states she noticed the bruise starting around 8:00 pm the night she got the shot. Redness came well below the bruised area and a knot formed. The bruised area is the size of a half dollar. The redness and knot went away by the time she came into us. Pt. got shot in  right arm. Takes Aspirin, but has never had this happen before.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Pain, Pain in extremity
Clinical narrative: Swelling in right eye, sharp pain in hands and feet.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: Muscle still aches - 5 days after shot. when administered no issues - no redness or swelling.
Age: 80.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Discomfort, Dizziness
Clinical narrative: Dizzy, "uncomfortable" feeling, light headed, weak. Pt felt better after taking her ALKASELTZER and sitting for 30 minutes.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site rash, Swelling, Tenderness
Clinical narrative: 2" red circular bump at injection site. Swollen and tender. No fever. Patient contacted PCP and is taking ibuprofen and icing site.
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pustule, Injection site swelling
Clinical narrative: Pt has swelling, redness, pus had to be drained from site.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Patient is experiencing extreme pain from injection site to below the hand - Claims to be like nerve pain and only relieved w/NORCO.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Tremor
Clinical narrative: This spontaneous report was received from a physician via company representative concerning a 11 year old male patient. The patient's concurrent conditions was not provided and his medical history was reported as none. On 11-OCT-2016, the patient was vaccine with the first dose of GARDASIL 9 0.5 ml, intramuscularly, lot # L040054 with expired date of 26-OCT-2017 (strength was not provided). Other suspect therapies administered concomitantly with GARDASIL 9 included meningococcal vaccine (manufacturer unknown) (start date, dose, strength, route of administration, lot number and expiration date were not provided) and tetanus toxoid (manufacturer unknown) (start date, dose, strength, route of administration, lot number and expiration date were not provided). At the time of the report the patient was taking Albuterol HFA 90 mcg as concomitant medication. The physician stated that about 5 minutes after getting vaccinated the patient was trembling. The medical attention and treatment were lay him down for 15 minutes and gave him cheese and crackers. At the time of the report, it was not known if the patient would complete the series of GARDASIL 9. At the time of the report the patient was recovered on unspecified date in October 2016. The causal relationship between the event and GARDASIL 9 was unknown. There was not intervention to prevent serious criteria and product quality complaint (PQC) involved. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a 69 years old female patient concerning herself. The patient's pertinent medical history included high blood pressure, high cholesterol, anxiety and gastroesophageal reflux disease (GERD). The patient had a drug reaction/allergy to penicillin. On 29-JAN-2014, the patient was vaccinated with ZOSTAVAX injection (dose number, route of administration, lot # and expiration date were unknown). Concomitant therapies included CRESTOR, BYSTOLIC, COUMADIN, XANAX, DEXILANT and EFFIENT. On 17-OCT-2016, the patient was diagnosed with shingles by her physician. She received unspecified treatment for shingles. No laboratory diagnostics were performed and no product quality complaint was involved. At the time of reporting, the patient had not recovered from the herpes zoster. The causality assessment between the herpes zoster and the ZOSTAVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed nurse practitioner refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies were not reported. On 20-SEP-2016, the patient was vaccinated with improperly stored ZOSTAVAX (dose and route were not reported) lot # L038926 and expiry date: 06-JUN-2017. No concomitant medications and no adverse events were reported. The call was due to a data logger. No further information was available. There was no product quality complaint (PQC) involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed nurse practitioner refers to unspecified number patients of unknown age and gender. The patients' pertinent medical history, drug reactions and allergies were not reported. On unspecified dates, the patients were vaccinated with improperly stored PEDVAXHIB (dose and route were not reported) lot # L038502 and expiry date: 16-AUG-2018. The reporter stated that she is unaware of any adverse effects reported. The call was due to a data logger. No further information was available. There was no product quality complaint (PQC) involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed nurse practitioner refers to unspecified number patients of unknown age and gender. The patients' pertinent medical history, drug reactions and allergies were not reported. On unspecified dates, the patients were vaccinated with improperly stored VARIVAX (dose and route were not reported) lot # L017142 and expiry date: 13-MAY-2017. No concomitant medications and no adverse events were reported. The call was due to a data logger. No further information was available. There was no product quality complaint (PQC) involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed nurse practitioner refers to unspecified number patients of unknown age and gender. The patients' pertinent medical history, drug reactions and allergies were not reported. On unspecified dates, the patients were vaccinated with improperly stored RECOMBIVAX HB (dose and route were not reported) lot # L042846 and expiry date: 15-SEP-2017. No concomitant medications and no adverse effects were reported. The call was due to a data logger. No further information was available. There was no product quality complaint (PQC) involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed nurse practitioner refers to unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions and allergies were not reported. On unspecified dates, the patients were vaccinated with improperly stored GARDASIL 9 (route was not reported) lot # M009378 and expiry date: 23-APR-2018, 0.5 ml. The reporter stated that she is unaware of any adverse effects reported. The call was due to a data logger. No further information was available. There was no product quality complaint (PQC) involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed nurse practitioner refers to unspecified number patients of unknown age and gender. The patients' pertinent medical history, drug reactions and allergies were not reported. On unspecified dates, the patients were vaccinated with improperly stored VAQTA (dose and route were not reported) lot # L014265 and expiry date: 28-APR-2017. No concomitant medications and adverse events were reported. The call was due to a data logger. No further information was available. There was no product quality complaint (PQC) involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Local reaction, Skin warm, Swelling
Clinical narrative: Redness, swelling, hot to touch, localized reaction 8 x 7 cm.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Fibromyalgia, Herpes zoster
Clinical narrative: This spontaneous report was received from a medical assistant concerning a 59 years old female patient. The patient's pertinent medical history included fibromyalgia, diabetes mellitus, high cholesterol and high blood pressure. On an unspecified date in January 2016, the patient was vaccinated with ZOSTAVAX, 19400 PFU (dose number, route of administration, lot # and expiration date were unknown). Concomitant therapies included CYMBALTA. On an unspecified date in 2016 (reported as "a couple of weeks ago"), the patient was seen in an unspecified urgent care clinic because she "broke out with a case of shingles". The patient was prescribed VALTREX to treat the shingles. Additionally, since the shingles outbreak, the patient's fibromyalgia symptoms had increased (fibromyalgia worsened). No product quality complaint was involved. At the time of reporting, the outcome of the herpes zoster and the fibromyalgia worsened was unknown. The causal relationship between the herpes zoster and the fibromyalgia worsened with ZOSTAVAX was not provided. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Feeling hot, Pain, Pruritus, Swelling
Clinical narrative: Redness, soreness, swelling, heat and itching. During a routine check up patient's doctor prescribed KEFLEX and ADVIL. He thought it may lead to cellulitis.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Medical assistant, concerning a multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history and concurrent conditions were not informed. it was reported that on unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # M0118410, expiration date 01-FEB-2018, (doses and therapy routes were not provided). Concomitant therapies were not informed. No adverse effects were reported. Temperature: 52.83 degrees F. Time frame: 12 hours 3 minutes. There was a call because of a data logger. Previous temperature excursion: 54 degrees F for 21 hours 3 minutes. Total time frame of temperature excursion: 33 hours 6 minutes. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unknown number of patients of unknown demographics. Information regarding the patient's concurrent conditions and medical history was not provided. On an unknown dates, reported as "sometimes", the patient were vaccinated with doses of RECOMBIVAX HB which were sit on the counter for a few hours before being administered (dose, route of administration, anatomical location, lot number and expiration date were not reported). There we no concomitant medications provided. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: This spontaneous report was received from a physician via a company representative, referring to a male patient of unknown age. The patient's medical history, concomitant therapies or concurrent conditions were not reported. On an unspecified date, the patient was vaccinated with ZOSTAVAX (dose, administration route, lot number and expiration date were not reported). On an unknown date, the patient experienced joint pain. The patient went to the physician's office, where he was prescribed steroids (unspecified) and an unknown anti inflammatory medication to the patient. These measure did not resolve the joint pain, the reporter stated that "she did not know which joints the anonymous patient was experiencing the pain in." A product quality complaint was not involved. At the time of this report, the patient still had the joint pain. The causality between the event and the therapy with ZOSTAVAX was not reported. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HEPAB, MMR, TDAP
Symptoms: Blood glucose decreased, Nuclear magnetic resonance imaging brain, Seizure, Syncope
Clinical narrative: Pt had syncopal episode and a seizure after administering vaccines. Placed on 2 liters of oxygen and remained in office for an hr to monitor. Checked blood sugar at 99 gave pt water and an apple to eat. Pt discharged to follow up w/provider in 24 hrs.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacy student refers to a patient of unknown gender and age. There was no information regarding the patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapy. Pharmacy student reported that on an unknown date, the patient was inadvertently vaccinated with an expired dose of VARIVAX by an unspecified physician. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapy were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored ROTATEQ lot # M019707, expiration date 25-OCT-2017, orally (dose was not reported). The doses of vaccine had been stored under the lowest temperature 49.3 degrees Fahrenheit for 30 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concomitant therapy and concurrent condition were not provided. On an unknown date, the patient was vaccinated with improperly stored PROQUAD (strength, dose and frequency were unknown; lot # M011664 with expiration date 08-SEP-2017) subcutaneously. No adverse effects were reported. This is one of the ten reports that received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to unknown age and gender patient. No information regarding the patients' medical history, concurrent conditions and concomitant medications were not provided. On 29-JUL-2016 the patient was vaccinates with improperly stored GARDASIL 9 (dose and route of administration were not reported); (lot no. M003659 EXP 20-SEP-2017 or lot no. L025737 EXP 28-JUL-2017). No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concomitant therapy and concurrent condition were not provided. On an unknown date, the patient was vaccinated with improperly stored VARIVAX (strength, dose, frequency and route were unknown; lot # was M008172 with expiration date 16-FEB-2018). No adverse effects were reported. This is one of several reports that received from the same reporter. 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 nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored VARIVAX, subcutaneously, which had lot # M009764, with 23-FEB-2018, lot # L048462 with expiry: 02-DEC-2017 and M012990 with expiry: 14-MAR-2018 (dosing details not reported). No adverse effects reported. No further information reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concomitant therapy and concurrent condition were not provided. On an unknown date, the patient was vaccinated with improperly stored VARIVAX (strength, dose and frequency were unknown; lot # was L048468 with expiration date 02-DEC-2017). No adverse effects were reported. This is one of several reports that received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a 64 year old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot # M014310, expiration date unknown, dose and route of administration were not reported). On an unknown date, the patient and developed a 3 inch to 4 inch area of redness and itching. The pharmacist recommended patient take BENADRYL for the itching and redness and MOTRIN if any pain. The patient did not seek doctor care. On an unknown date, the patient recovered from the events. No product quality complaint (PQC) was involved. No further information was available. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concomitant therapy and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with improperly stored VARIVAX (strength, dose and frequency were unknown; lot # was L048468 with expiration date 02-DEC-2017). No adverse effects were reported. This is one of several reports that received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 03-MAR-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5ml, (lot # K012424, expiration date 05-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 48 hours with the lowest recorded temperature of 32 Fahrenheit degree. The total cumulative excursion time of the second time was 24 hours with the lowest recorded temperature of 33 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 26-FEB-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5ml, (lot # K012424, expiration date 05-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 48 hours with the lowest recorded temperature of 32 Fahrenheit degree.The total cumulative excursion time of the second time was 24 hours with the lowest recorded temperature of 33 Fahrenheit degree. The storage criteria and the type of excursion for this type of vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapy were not reported. On 15-SEP-2016, the patient was vaccinated with an expired dose of PROQUAD (therapy type: human serum albumin), lot # L008353, expiration date 11-SEP-2016 (dose and route of administration were not reported). No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. The patients' medical history, concomitant therapy and concurrent condition were not provided. On an unknown date, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX (strength, dose and frequency were unknown; lot # was L048468 with expiration date 02-DEC-2017). No adverse effects were reported. This is one of several reports that received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concomitant therapy and concurrent condition were not provided. On an unknown date, the patient was vaccinated with improperly stored VARIVAX (strength, dose and frequency were unknown; lot # was  L048468 with expiration date 02-DEC-2017). No adverse effects were reported. This is one of several reports that received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 02-APR-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5ml, (lot # K012424, expiration date 05-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 48 hours with the lowest recorded temperature of 32 Fahrenheit degree. The total cumulative excursion time of the second time was 24 hours with the lowest recorded temperature of 33 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 8-week-old patient (also reported as 7 and a half week old). The patient's medical history and concurrent conditions were not reported. On 19-AUG-2016, the patient was vaccinated with PEDVAXHIB intramuscularly (lot # M001814, expiry date: 15-OCT-2018). No concomitant therapy was reported. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored PNEUMOVAX 23 (lot # L019836, expiration date 24-MAR-2017; lot # M022085, expiration date 09-OCT-2017, dose and route not reported). The doses of vaccine were improperly stored at 1.7 Celsius degree for 32 hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information regarding the patient's medical history and concurrent conditions was provided. On 14-OCT-2016, the patient was vaccinated with an expired dose of M-M-R II, lot # K016154, expiration date: 24-SEP-2016, (dose, route of administration and injection site were not provided). There were no concomitant medications reported. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information about the patient's relevant medical history, drug history and concomitant medications was provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 lot # reported as 36301, expiration date December 2017 (dose and route of administration were not provided) that underwent a temperature excursion and had been exposed to a temperature of 32.1 Fahrenheit degrees for 7 hours. The patient did not experience any adverse events. It was unknown if any relevant tests were done. Lot number 36301 is an invalid lot number for GARDASIL 9. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 09-MAR-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5ml, (lot # K012424, expiration date 05-JUN-2016. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 48 hours with the lowest recorded temperature of 32 Fahrenheit degree. The total cumulative excursion time of the second time was 24 hours with the lowest recorded temperature of 33 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPVX
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test, Ultrasound antenatal screen
Clinical narrative: This spontaneous prospective pregnancy report as received from a nurse refers to a 19 year old female patient. The patient's medical history included blood infection 5 years ago. On 19-SEP-2016, the patient was vaccinated with GARDASIL dose 2, (route: intramuscular) or GARDASIL 9 and later it was revealed that she was 9 weeks and 1 day pregnant as of today (17-OCT-2016). The reporter was unsure if the patient received GARDASIL or GARDASIL 9, because the vaccines were administered at a different physician's office and complete medical records were not available. On an unknown date, patient underwent pregnancy test, 2 ultrasounds, and routine pregnancy blood work (results were not specified). No adverse effects have been observed. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored PEDVAXHIB (lot # L006546, expiration date 27-NOV-2017, dose and route not reported). The doses of vaccine were improperly stored at 1.7 Celsius degree for 32 hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 06-APR-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5ml, (lot # K012424, expiration date 05-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 48 hours with the lowest recorded temperature of 32 Fahrenheit degree. The total cumulative excursion time of the second time was 24 hours with the lowest recorded temperature of 33 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On an unknown date in OCT-2016, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot # L048237 and expiry date 18-MAY-2017) (strength, dosing details, anatomical location were unknown). No adverse effects were reported. The GARDASIL 9 experienced multiple temperature excursions. Currently (unknown date) the vaccine temperature excursion was minimum of 1 degree Celsius and maximum of 5 degree Celsius for time frame of 40 hours. The vaccine had previous temperature excursions on 06-SEP-2016 exposed to 1 degree Celsius for 72 hours and on 07-SEP-2016 exposed to 1 degree Celsius for 17 hours. Data logger was not involved. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product use issue
Clinical narrative: Information has been received from a pharmacy student concerning an adult patient of unknown age and gender with tetanus allergy. Concomitant therapies were not reported. On an unknown date, the patient underwent a splenectomy at an unspecified hospital for an unspecified reason. On an unknown date, post splenectomy, the patient was vaccinated with a dose of PEDVAXHIB (lot # and expiration date were unknown; 0.5 ml), once intramuscularly (product use issue). No adverse effect were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 09-MAR-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5ml, (lot # K012424, expiration date 05-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 48 hours with the lowest recorded temperature of 32 Fahrenheit degree. The total cumulative excursion time of the second time was 24 hours with the lowest recorded temperature of 33 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 11-MAR-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml, (lot # K012424, expiration date 05-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 48 hours with the lowest recorded temperature of 32 Fahrenheit degree. The total cumulative excursion time of the second time was 24 hours with the lowest recorded temperature of 33 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored GARDASIL 9 (lot # M007764, expiration date 30-JAN-2018, dose and route not reported). The doses of vaccine were improperly stored at 1.7 Celsius degree for 32 hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect dose administered, No adverse event, Product quality issue, Syringe issue
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reaction or allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 injection, lot # M027552, expiration date 04-FEB-2018 (route and site of administration were not reported). During the injection, the pharmacist noticed that the syringe was leaking (exact dose administered was considered unknown). Then, he administered "another full dose" (0.5 ml) of PNEUMOVAX 23 to the patient (route and site of administration, lot # and expiration date were not reported). The reporter confirmed that the patient received more than the recommended dose of vaccine (also reported as "single 0.5 ml dose). No adverse effects were reported. Product quality complaint was involved. Additional information has been requested.