chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; one separate dose of an improperly stored vaccine, PEDVAXHIB was administered to one separate patient.; Information has been received from a medical assistant, referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.    On 22-MAY-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 0.5 milliliter (one dose, lot # R013573, expiration date: 22-MAR-2021, frequency was unknown) intramuscularly for prophylaxis (incorrect product storage). No adverse effect was reported.  The vaccines were exposed to temperature of 34.2 Fahrenheit (F) for 4 hour 54 minutes. The temperature excursion was detected by a data logger. No previous excursions were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; one separate dose of an improperly stored vaccine, PEDVAXHIB was administered to one separate patient.; Information has been received from a medical assistant, referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.    On 23-MAY-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 0.5 milliliter (one dose, lot # R013573, expiration date: 22-MAR-2021, frequency was unknown) intramuscularly for prophylaxis (incorrect product storage). No adverse effect was reported.  The vaccines were exposed to temperature of 34.2 Fahrenheit (F) for 4 hour 54 minutes. The temperature excursion was detected by a data logger. No previous excursions were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; one separate dose of an improperly stored vaccine, PEDVAXHIB was administered to one separate patient.; Information has been received from a medical assistant, referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.    On 23-MAY-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 0.5 milliliter (one dose, lot # R013573, expiration date: 22-MAR-2021, frequency was unknown) intramuscularly for prophylaxis (incorrect product storage). No adverse effect was reported.  The vaccines were exposed to temperature of 34.2 Fahrenheit (F) for 4 hour 54 minutes. The temperature excursion was detected by a data logger. No previous excursions were reported. This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; one separate dose of an improperly stored vaccine, PEDVAXHIB was administered to one separate patient.; Information has been received from a medical assistant, referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.    On 24-MAY-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 0.5 milliliter (one dose, lot # R013573, expiration date: 22-MAR-2021, frequency was unknown) intramuscularly for prophylaxis (incorrect product storage). No adverse effect was reported.  The vaccines were exposed to temperature of 34.2 Fahrenheit (F) for 4 hour 54 minutes. The temperature excursion was detected by a data logger. No previous excursions were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674:
Sex: U
Vaccine: VARZOS
Symptoms: Limb discomfort, Musculoskeletal disorder
Clinical narrative: unable to use arm; This case was reported by a consumer via call center representative and described the occurrence of arm discomfort in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced arm discomfort. On an unknown date, the outcome of the arm discomfort was recovered/resolved.   It was unknown if the reporter considered the arm discomfort to be related to Shingrix.  Additional information was provided as follows: The age group was not reported but was selected as adult as per vaccine indication. The patient received Shingrix and was unable to use arm for 3 days. The reporter was asking if they could give Shingrix in hip instead of arm.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: shingles; rash; This case was reported by a nurse via sales rep and described the occurrence of shingles in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th June 2019, the patient received the 1st dose of Shingrix. In June 2019, less than a month after receiving Shingrix, the patient experienced rash. On 19th June 2019, the patient experienced shingles. On an unknown date, the outcome of the shingles and rash were unknown.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional details were provided as follows: The patient was diagnosed with Shingles 9 days after vaccination. The reporter agreed to follow up from GlaxoSmithKline.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Pain in extremity, Peripheral swelling, Rash erythematous, Skin warm
Clinical narrative: swollen area 6" high 3" wide on right arm in oval shape. started with small red dots progressing to large oval area lasting ten days. warm to the touch, tender  and very sore and swollen, poor mobility.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness, Vaccination complication
Clinical narrative: swollen area 6" high 3" wide on right arm in oval shape. started with small red dots progressing to large oval area lasting ten days. warm to the touch, tender  and very sore and swollen, poor mobility.
Age: 37.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness
Clinical narrative: dizziness -Pt came into the clinic for her 2nd HPV vaccine. -5 to 10 mins after shot Pt felt dizzy while in waiting room
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Lethargy, Peripheral swelling, Pyrexia
Clinical narrative: Per mother, child had fever of 102.8 nine hours after vaccination, then 101.7 two-three hours later, then 100.0.  This was with giving Tylenol every 4 hours.  Mother describes swelling in both legs the size of a golf ball.  Mother felt child was lethargic.
Age: 62.0
Sex: M
Vaccine: RAB
Symptoms: Dizziness, Eyelid rash, Impaired work ability, Petechiae, Rash
Clinical narrative: 06/14/19: Pt received vaccine at approx. 11:00 am.  Approx 20-30 mins later, he noticed a petechiae-type rash of the forehead, eyelids and facial areas. He felt mildly dizzy. He then returned to Employee Health Service. Vital signs were all stable.  A petechiae rash was noted of the forehead, eyelids, facial areas, the posterior pharynx as well as bilateral upper/lower extremities. Benadryl 50 mg PO was given at 11:50 am. His condition was closely monitored over the next hour or so. He was discharged in stable condition at 13:10 from Employee Health Service accompanied by his daughter. He was sent home with Benadryl 25 mg #20 to take as directed (one q 1-2 every 4-6 hours PRN) as well as prescribed Prednisone 40 mg PO daily x 5 days. He was sent home from work. The rash  resolved within 24  hours and he resumed work the next day without difficulty.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Awoke at 3 am the following day with uncontrollable shivering, fever, and chills. The shivering intensified with every exhale and lasted about 30 minutes. The fever and chills lasted longer. Awoke about 6 am with mild fever, body aches, and head ache. Took Tylenol about 6:30 am which helped alleviate the head ache.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Eye irritation, Headache, Influenza like illness, Lethargy
Clinical narrative: Flu-like symptoms.  Swollen lymph glands, muscle & joint pain, mild headache, burning eyes, low-grade fever, lethargy
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Myalgia, Pyrexia
Clinical narrative: Flu-like symptoms.  Swollen lymph glands, muscle & joint pain, mild headache, burning eyes, low-grade fever, lethargy
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Muscle spasms, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Received 2nd dose of Shingrix vaccine 7/2/2019 9:30am (1st dose 3/25/19).  No adverse side effects on 1st dose.  Had side effects on 2nd dose: Took 800 mg ibuprofen when I got home to reduce right arm pain at injection site. Woke up approximately 1-2am with painful stiffening and cramping in both hands and shivering because I was cold.  Took another 800 mg iibuprofen.  Injection site still sore. Woke up 7am ? no hand pain or shivering.  Injection site mildly sore.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Blood glucose normal, Dyspnoea, Electrocardiogram, Injection site pain
Clinical narrative: Nausea, short of breath, lost consciousness at a restaurant.  911 called    Fire trucks  & 3 paramedics responded.   3 MD?s in restaurant:  neurologist (patient?s husband), ER doc &  an ntensivist.   Ambulance & 2 paramedics followed.   Severe pain in right shoulder - now on day 3 - no swelling or redness. Continues to have severe weakness, pain & limited use of arm.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of consciousness, Musculoskeletal disorder, Nausea, Pain
Clinical narrative: Nausea, short of breath, lost consciousness at a restaurant.  911 called    Fire trucks  & 3 paramedics responded.   3 MD?s in restaurant:  neurologist (patient?s husband), ER doc &  an ntensivist.   Ambulance & 2 paramedics followed.   Severe pain in right shoulder - now on day 3 - no swelling or redness. Continues to have severe weakness, pain & limited use of arm.
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; multiple patients were vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant referred to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 28-FEB-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX)(dose and strength were not reported, lot # R019235 and expiry date 04-JUL-2020) via unknown route for prophylaxis and no adverse effects were reported (product storage error and no adverse event). Other suspect therapies included sterile diluent (dose, strength, route, lot # and expiration date were not reported). There was a previous temperature excursion and the time frame and temperature was unknown. Digital data logger was involved. There was no involvement of Product quality complaint (PQC). This is one of the several reports received from the same reporter.
Sex: M
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; inadverent administration of vaccine past its expiry; This spontaneous report as received from nurse practitioner refer to a 4-year-old male patient.  The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 27-JUN-2019, the patient was inadvertently vaccinated with second dose of expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # R011801, expiry date:19-MAY-2019) (therapy type was rha) via subcutaneous route for prophylaxis. No adverse effects were reported.  The outcome of expired product administered and no adverse event was unknown.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Borrelia test, Fatigue, Pain
Clinical narrative: Patient developed rash below the injection site, macular, some scaling noted. Then developed body aches in arms, back, ankles and legs. Today is feeling fatigued.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Rash macular, Skin exfoliation
Clinical narrative: Patient developed rash below the injection site, macular, some scaling noted. Then developed body aches in arms, back, ankles and legs. Today is feeling fatigued.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain, Fatigue, Malaise, Pyrexia
Clinical narrative: Fever 101.0  F; abdominal pain; fatigue; malaise.  Commenced 18 hours after vaccination, resolved completely 40 hours after vaccination.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Arthritis, Gait disturbance, Headache, Joint swelling
Clinical narrative: This was the second injection. My reaction this time was MUCH more extreme than the first. It's now 2 days out and joints are much better, but still very stiff and sore?have tingling sensation in my right hand from elbow down. 1.  Joints became inflamed and swollen?the morning after I couldn't make fists with either hand due to pain and swelling. Knees, elbows, shoulders and neck all extremely inflamed, sore and stiff. Walking was difficult due to knee pain. 2.  Fever 3.  Headache 4.  Overall body aches and discomfort?flu-like symptoms on steroids
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Pain, Paraesthesia, Pyrexia
Clinical narrative: This was the second injection. My reaction this time was MUCH more extreme than the first. It's now 2 days out and joints are much better, but still very stiff and sore?have tingling sensation in my right hand from elbow down. 1.  Joints became inflamed and swollen?the morning after I couldn't make fists with either hand due to pain and swelling. Knees, elbows, shoulders and neck all extremely inflamed, sore and stiff. Walking was difficult due to knee pain. 2.  Fever 3.  Headache 4.  Overall body aches and discomfort?flu-like symptoms on steroids
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Swelling
Clinical narrative: pt has experienced pain in left arm- noticable swellingn and redness today 2 days after immunization
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Clumsiness, Disorientation, Dizziness, Flushing
Clinical narrative: During vaccination felt flushed and dizziness.  Went home and arm was sore as expected.  As night progressed, around 6-8pm, arm got achy and sore.  Took an Epsom salt bath. Went to bed got headache, shivering, and achy.  Did not take any medicine that day.  Today, patient feels nauseous--took nauseous meds--, feverish, achy, and shivering. Patient has bad headache--but has not taken migraine meds--, feels disoriented, and clumsy.   Patient has disability and if she had known the adverse events would be as severe she would have planned better to get help.  She just feels sick, and there is a 3-inch area of redness and swelling at vaccination site. She does not feel like she could even drive right now.   Patient planning to take the 2nd dose since needs to be covered and avoid future shingles outbreaks.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Malaise, Nausea, Pain
Clinical narrative: During vaccination felt flushed and dizziness.  Went home and arm was sore as expected.  As night progressed, around 6-8pm, arm got achy and sore.  Took an Epsom salt bath. Went to bed got headache, shivering, and achy.  Did not take any medicine that day.  Today, patient feels nauseous--took nauseous meds--, feverish, achy, and shivering. Patient has bad headache--but has not taken migraine meds--, feels disoriented, and clumsy.   Patient has disability and if she had known the adverse events would be as severe she would have planned better to get help.  She just feels sick, and there is a 3-inch area of redness and swelling at vaccination site. She does not feel like she could even drive right now.   Patient planning to take the 2nd dose since needs to be covered and avoid future shingles outbreaks.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Vaccination site swelling
Clinical narrative: During vaccination felt flushed and dizziness.  Went home and arm was sore as expected.  As night progressed, around 6-8pm, arm got achy and sore.  Took an Epsom salt bath. Went to bed got headache, shivering, and achy.  Did not take any medicine that day.  Today, patient feels nauseous--took nauseous meds--, feverish, achy, and shivering. Patient has bad headache--but has not taken migraine meds--, feels disoriented, and clumsy.   Patient has disability and if she had known the adverse events would be as severe she would have planned better to get help.  She just feels sick, and there is a 3-inch area of redness and swelling at vaccination site. She does not feel like she could even drive right now.   Patient planning to take the 2nd dose since needs to be covered and avoid future shingles outbreaks.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Eyelid function disorder, Eyelid rash, Hypoaesthesia
Clinical narrative: My right eye in the lower lash area developed a pox type lesion and the cheek on that side felt numb and I could not fully close my right eye for about 30 hours.  Then it went away.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Lymph node pain, Lymphadenopathy, Pain, Rash
Clinical narrative: Patient experienced body aches and mild headache for about 2 days.  He also developed 2 swollen lymph nodes that was tender to touch.  On the crown of his head, patient developed a dry, bumpy, rash.  Patient was see at the Center and was treated with generic Valtrex.
Age: 18.0
Sex: U
Vaccine: MENB
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient received vaccine on 7/1/19. Presented to office today on 7/3/19 with s/s of tenderness at Injection site and decreased mobility of left arm. Patient assessed by PCP, s/s improving.
Sex: F
Vaccine: HEPA
Symptoms: Exposure via eye contact, Eye irrigation, Eye irritation, Syringe issue
Clinical narrative: Irritation in her eyes; Some of the VAQTA squirted into her eyes; The plastic syringe broke and some of the VAQTA squirted into her eyes; Drew up the VAQTA into a plastic syringe; This spontaneous report was received from a pharmacist concerning herself, a 47 year old female patient. The patient had no concomitant medications or pertinent medical history. The patient's drug reactions/allergies included NSAIDS (nonsteroidal anti-inflammatory drugs), the reaction was welts, hives, throat, tightening, watery eyes, and fever which occurred over 10 years ago.  On an unknown date, the patient was vaccinated with a dose of hepatitis a vaccine, inactivated(VAQTA) lot # S001360 with expiration date of 06-MAR-2020) for prophylaxis (dose, frequency, route of administration and anatomical location were not provided).   On 24-JUN-2019, the pharmacist prepared a dose of hepatitis a vaccine, inactivated(VAQTA) and drew up the hepatitis a vaccine, inactivated(VAQTA) into a plastic syringe. After this, the plastic syringe broke and some of the hepatitis a vaccine, inactivated(VAQTA) squirted into her eyes. She flushed her eyes with water and then went to an unspecified emergency room where her eyes were flushed further. While at the emergency room, she also developed irritation in her eyes, so she was given moxifloxacin (VIGAMOX). No laboratory diagnostics or studies were performed. At the reporting time, she was recovering from eyes irritation. The reporter did not provide any causality assessment between therapy with hepatitis a vaccine, inactivated(VAQTA) and the aforementioned event.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Urticaria
Clinical narrative: On 5/30 around 10:30 AM started having flu like symptoms that continued to get worse throughout the day & night. The next morning woke up with hives up & down her arm. Recovered 2 days later.
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; multiple patients were vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant referred to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 20-FEB-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX)(dose and strength were not reported, lot # R019235 and expiry date 04-JUL-2020) via unknown route for prophylaxis and no adverse effects were reported (product storage error and no adverse event). Other suspect therapies included sterile diluent (dose, strength, route, lot # and expiration date were not reported). There was a previous temperature excursion and the time frame and temperature was unknown. Digital data logger was involved. There was no involvement of Product quality complaint (PQC). This is one of the several reports received from the same reporter.
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; multiple patients were vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant referred to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 04-MAR-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX)(dose and strength were not reported, lot # R019235 and expiry date 04-JUL-2020) via unknown route for prophylaxis and no adverse effects were reported (product storage error and no adverse event). Other suspect therapies included sterile diluent (dose, strength, route, lot # and expiration date were not reported). There was a previous temperature excursion and the time frame and temperature was unknown. Digital data logger was involved. There was no involvement of Product quality complaint (PQC). This is one of the several reports received from the same reporter.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; one separate dose of an improperly stored vaccine, PEDVAXHIB was administered to one separate patient.; Information has been received from a medical assistant, referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.    On 28-MAY-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 0.5 milliliter (one dose, lot# R021077, expiration date: 11-JUN-2021, frequency was unknown) intramuscularly for prophylaxis (incorrect product storage). No adverse effect was reported.  The vaccines were exposed to temperature of 34.2 Fahrenheit (F) for 4 hour 54 minutes. The temperature excursion was detected by a data logger. No previous excursions were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; one separate dose of an improperly stored vaccine, PEDVAXHIB was administered to one separate patient.; Information has been received from a medical assistant, referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.    On 30-MAY-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 0.5 milliliter (one dose, lot# R021077, expiration date: 11-JUN-2021, frequency was unknown) intramuscularly for prophylaxis (incorrect product storage). No adverse effect was reported.  The vaccines were exposed to temperature of 34.2 Fahrenheit (F) for 4 hour 54 minutes. The temperature excursion was detected by a data logger. No previous excursions were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; one separate dose of an improperly stored vaccine, PEDVAXHIB was administered to one separate patient.; Information has been received from a medical assistant, referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.    On 04-JUN-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 0.5 milliliter (one dose, lot# R021077, expiration date: 11-JUN-2021, frequency was unknown) intramuscularly for prophylaxis (incorrect product storage). No adverse effect was reported.  The vaccines were exposed to temperature of 34.2 Fahrenheit (F) for 4 hour 54 minutes. The temperature excursion was detected by a data logger. No previous excursions were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; one separate dose of an improperly stored vaccine, PEDVAXHIB was administered to one separate patient.; Information has been received from a medical assistant, referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.    On 05-JUN-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 0.5 milliliter (one dose, lot# R021077, expiration date: 11-JUN-2021, frequency was unknown) intramuscularly for prophylaxis (incorrect product storage). No adverse effect was reported.  The vaccines were exposed to temperature of 34.2 Fahrenheit (F) for 4 hour 54 minutes. The temperature excursion was detected by a data logger. No previous excursions were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; one separate dose of an improperly stored vaccine, PEDVAXHIB was administered to one separate patient.; Information has been received from a medical assistant, referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.    On 10-JUN-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 0.5 milliliter (one dose, lot# R021077, expiration date: 11-JUN-2021, frequency was unknown) intramuscularly for prophylaxis (incorrect product storage). No adverse effect was reported.  The vaccines were exposed to temperature of 34.2 Fahrenheit (F) for 4 hour 54 minutes. The temperature excursion was detected by a data logger. No previous excursions were reported.  This is one of several reports from the same reporter. ; Sender's Comments:  US-009507513-1906USA011674:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; one separate dose of an improperly stored vaccine, PEDVAXHIB was administered to one separate patient.; Information has been received from a medical assistant, referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.    On 10-JUN-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 0.5 milliliter (one dose, lot# R021077, expiration date: 11-JUN-2021, frequency was unknown) intramuscularly for prophylaxis (incorrect product storage). No adverse effect was reported.  The vaccines were exposed to temperature of 34.2 Fahrenheit (F) for 4 hour 54 minutes. The temperature excursion was detected by a data logger. No previous excursions were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; one separate dose of an improperly stored vaccine, PEDVAXHIB was administered to one separate patient.; Information has been received from a medical assistant, referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.    On 11-JUN-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 0.5 milliliter (one dose, lot# R021077, expiration date: 11-JUN-2021, frequency was unknown) intramuscularly for prophylaxis (incorrect product storage). No adverse effect was reported.  The vaccines were exposed to temperature of 34.2 Fahrenheit (F) for 4 hour 54 minutes. The temperature excursion was detected by a data logger. No previous excursions were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; one separate dose of an improperly stored vaccine, PEDVAXHIB was administered to one separate patient.; Information has been received from a medical assistant, referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.    On 11-JUN-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 0.5 milliliter (one dose, lot# R021077, expiration date: 11-JUN-2021, frequency was unknown) intramuscularly for prophylaxis (incorrect product storage). No adverse effect was reported.  The vaccines were exposed to temperature of 34.2 Fahrenheit (F) for 4 hour 54 minutes. The temperature excursion was detected by a data logger. No previous excursions were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674:Original Case : 1906USA011674
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; one separate dose of an improperly stored vaccine, PEDVAXHIB was administered to one separate patient.; Information has been received from a medical assistant, referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.    On 13-JUN-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 0.5 milliliter (one dose, lot# R021077, expiration date: 11-JUN-2021, frequency was unknown) intramuscularly for prophylaxis (incorrect product storage). No adverse effect was reported.  The vaccines were exposed to temperature of 34.2 Fahrenheit (F) for 4 hour 54 minutes. The temperature excursion was detected by a data logger. No previous excursions were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674:Original Case : 1906USA011674
Sex: F
Vaccine: VARZOS
Symptoms: Dermatitis contact, Skin reaction
Clinical narrative: Arm Reaction/face reaction; This case was reported by a consumer via call center representative and described the occurrence of skin reaction in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included rhus radicans (Poison Ivy) for an unknown indication.   In June 2019, the patient received Shingrix. On an unknown date, the patient started Poison Ivy at an unknown dose and frequency. In June 2019, less than a month after receiving Shingrix, the patient experienced skin reaction. On an unknown date, the outcome of the skin reaction was not recovered/not resolved.   It was unknown if the reporter considered the skin reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that received Shingrix vaccine and was unsure if reaction was due to vaccine or poison ivy.  The patient reported that her arm had indication of something occurring on her skin and on the side of her face because she sleeps on that same arm.  It was unknown if the reporter considered the skin reaction to be related to Poison ivy as well. The patient declined to provide demographic information including phone number and address.  The patient would not accept case number as a reference.  The patient abruptly disconnected prior to asking for consent. The patient mentioned she would call back call center, but first wanted to visit the vaccination facility for medical advice since GlaxoSmithKline could not provide medical advice.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number 7457P, expiry date 2nd June 2021) for prophylaxis.   On 26th June 2019, the patient received the 2nd dose of Shingrix. On 27th June 2019, 1 days after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional information received were as follows: The pharmacist reported that the patient's body temperature was recorded as 101.0 degree F. No additional details were provided at the time of the call. The reporter consented to follow up.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Fatigue, Feeling abnormal, Pain
Clinical narrative: achiness; tired; felt bad; This case was reported by a consumer via call center representative and described the occurrence of pain in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th April 2019, the patient received the 1st dose of Shingrix. On 20th April 2019, 1 days after receiving Shingrix, the patient experienced pain, tiredness and feeling bad. On 21st April 2019, the outcome of the pain, tiredness and feeling bad were recovered/resolved.   It was unknown if the reporter considered the pain, tiredness and feeling bad to be related to Shingrix.  Additional details were provided as follows: It was reported that the patient  felt badly after receiving 1st dose of Shingrix. The patient felt achy and tired on the day after Shingrix vaccination.  These effects resolved by the 2nd day after the vaccination. This case has been linked with case US2019116903 reported by the same reporter.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Fatigue, Feeling abnormal, Hypersomnia, Pain, Pain in extremity
Clinical narrative: achiness; tired; felt bad; This case was reported by a consumer via call center representative and described the occurrence of pain in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th April 2019, the patient received the 1st dose of Shingrix. On 20th April 2019, 1 days after receiving Shingrix, the patient experienced pain, tiredness and feeling bad. On 21st April 2019, the outcome of the pain, tiredness and feeling bad were recovered/resolved.   It was unknown if the reporter considered the pain, tiredness and feeling bad to be related to Shingrix.  Additional details were provided as follows: It was reported that the patient  felt badly after receiving 1st dose of Shingrix. The patient felt achy and tired on the day after Shingrix vaccination.  These effects resolved by the 2nd day after the vaccination. This case has been linked with case US2019116903 reported by the same reporter.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Somnolence
Clinical narrative: achiness; tired; felt bad; This case was reported by a consumer via call center representative and described the occurrence of pain in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th April 2019, the patient received the 1st dose of Shingrix. On 20th April 2019, 1 days after receiving Shingrix, the patient experienced pain, tiredness and feeling bad. On 21st April 2019, the outcome of the pain, tiredness and feeling bad were recovered/resolved.   It was unknown if the reporter considered the pain, tiredness and feeling bad to be related to Shingrix.  Additional details were provided as follows: It was reported that the patient  felt badly after receiving 1st dose of Shingrix. The patient felt achy and tired on the day after Shingrix vaccination.  These effects resolved by the 2nd day after the vaccination. This case has been linked with case US2019116903 reported by the same reporter.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: achiness; tired; felt bad; This case was reported by a consumer via call center representative and described the occurrence of pain in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th April 2019, the patient received the 1st dose of Shingrix. On 20th April 2019, 1 days after receiving Shingrix, the patient experienced pain, tiredness and feeling bad. On 21st April 2019, the outcome of the pain, tiredness and feeling bad were recovered/resolved.   It was unknown if the reporter considered the pain, tiredness and feeling bad to be related to Shingrix.  Additional details were provided as follows: It was reported that the patient  felt badly after receiving 1st dose of Shingrix. The patient felt achy and tired on the day after Shingrix vaccination.  These effects resolved by the 2nd day after the vaccination. This case has been linked with case US2019116903 reported by the same reporter.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Pain in extremity, Pyrexia
Clinical narrative: headache; fever; hands hurts; knee hurts/joint pain all over; This case was reported by a consumer via call center representative and described the occurrence of headache in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th June 2019, the patient received the 1st dose of Shingrix (intramuscular). On 26th June 2019, 1 days after receiving Shingrix, the patient experienced headache, fever, pain in hand and joint pain. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the headache, fever, pain in hand and joint pain were recovering/resolving.   It was unknown if the reporter considered the headache, fever, pain in hand and joint pain to be related to Shingrix.  Additional details were provided as follows: The batch number for Shingrix was not reported. The patient received Shingrix on right arm. The patient experienced headache, fever of 101 degrees, hands hurt, knees hurt, joint pain all over.  The patient contacted their doctor who recommended Tylenol and the patient's symptoms were getting bit better. The reporter did not consent to follow up.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Irritability, Pyrexia
Clinical narrative: Fever + fussiness started the day after vaccination + continued x 4 days when seen due to increased fussiness
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Urticaria
Clinical narrative: 3 days of Hives.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: -swelling, redness, warmth @ right deltoid for approximately 1 week -feverish for multiple days continues soreness/tenderness/slightly raised for a month after
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Urticaria
Clinical narrative: Diffuse allergic urticaria ~ 25 hours after vaccination
Age: 1.5
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Febrile convulsion, Influenza virus test negative, Pyrexia, Respiratory syncytial virus test negative, Streptococcus test negative
Clinical narrative: Parents concern about fever and febrile seizure and seen in ER - had CBC, labs, Rocephin & Cefdinir.
Age: 1.5
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Urine analysis normal, White blood cell count normal
Clinical narrative: Parents concern about fever and febrile seizure and seen in ER - had CBC, labs, Rocephin & Cefdinir.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Injection site haemorrhage, Syncope, Vomiting
Clinical narrative: Seated. Injection by medical assistant - (R) deltoid. Min pain. Turned head to look at injection site. Some bleeding - rapidly light-headed - fainted. Brief - Then vomiting. Allowed to rest supine. Then sitting. Then standing without problem.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Client reported mild tenderness at injection site starting day of vaccination (6/28). Two days (6/30)following vaccination, client reported onset of itchiness and erythema around area of injection. RN assessed injection site (7/1) and appreciated reddened, oval-shaped area was approximately 2" in width and 3" in length. Area felt warm to touch. Client endorsed mild but diminishing tenderness to site. No hives, angioedema, respiratory distress, or other evidence of complication or anaphylaxis noted. Client counseled on monitoring and comfort measures. RN assessed injection site (7/3) and noted erythema mostly resolved. Client denied additional symptoms or complications and reported to be afebrile.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Musculoskeletal pain
Clinical narrative: Severe pain in shoulder muscle where shot was given and around the area and severe pain left shoulder, difficulty raising left arm
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria
Clinical narrative: Patient with skin redness, itching, and large wheal (urticaria) to left upper arm surrounding site of Gardasil injection. First dose of HPV vaccine administered in clinic with parent consent on 7/1/19. Mother of child brought child to clinic with siblings who had appoitnments on 7/3/19 and asked for arm to be looked at by PCP. Patient was scheduled for appointment and seen. Benadryl was administered in clinic and advised continued use every 6-8 hours as needed for 1-2 days or until symptoms resolve. At time of vaccine administration no known allergies to any drugs, foods, or vaccines. Of note, mother of child reports the skin reaction began same day as administration later in the evening after leaving clinic, but was smaller. No medications were given at home and MOC sis not call to reprot because she wasn't sure if it was serious and planned to ask PCP at siblings appoitment 7/3/19. No other associated symptoms.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthritis, Pain, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Achy for 3 days, ran a fever, and his arm hurt. After that he felt like his hands hurt, Claims his hands are swollen and that he now has arthritis from it
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; multiple patients were vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant referring to a patient of an unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 15-APR-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose and route of administration were not reported) (lot # R022117 and expiry date 02-AUG-2020) for prophylaxis (product storage error). Other suspect therapy included sterile diluent (strength, dose and route of administration, lot# and expiry date were not reported). There was no adverse effect reported. There was a previous temperature excursion and the time frame and temperature was unknown. No product quality complaint (PQC) was reported.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; multiple patients were vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant referring to a patient of an unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 24-APR-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose and route of administration were not reported) (lot # R022117 and expiry date 02-AUG-2020) for prophylaxis (product storage error). Other suspect therapy included sterile diluent (strength, dose and route of administration, lot# and expiry date were not reported). There was no adverse effect reported. There was a previous temperature excursion and the time frame and temperature was unknown. No product quality complaint (PQC) was reported.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; one separate dose of an improperly stored vaccine, PEDVAXHIB was administered to one separate patient.; Information has been received from a medical assistant, referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.    On 14-JUN-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 0.5 milliliter (one dose, lot# R021077, expiration date: 11-JUN-2021, frequency was unknown) intramuscularly for prophylaxis (incorrect product storage). No adverse effect was reported.  The vaccines were exposed to temperature of 34.2 Fahrenheit (F) for 4 hour 54 minutes. The temperature excursion was detected by a data logger. No previous excursions were reported.  This is one of several reports from the same reporter. ; Sender's Comments:  US-009507513-1906USA011674:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; one separate dose of an improperly stored vaccine, PEDVAXHIB was administered to one separate patient.; Information has been received from a medical assistant, referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.    On 14-JUN-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 0.5 milliliter (one dose, lot# R021077, expiration date: 11-JUN-2021, frequency was unknown) intramuscularly for prophylaxis (incorrect product storage). No adverse effect was reported.  The vaccines were exposed to temperature of 34.2 Fahrenheit (F) for 4 hour 54 minutes. The temperature excursion was detected by a data logger. No previous excursions were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674: