chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain, Peripheral swelling, Pruritus, Skin irritation
Clinical narrative: Patient complained of soreness, irritation, and itching starting that evening after the shot and still ongoing. The patient's arm is red, swollen, and the redness has irregular patterns down the arm. The redness is also very warm to the touch.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Skin warm
Clinical narrative: Patient complained of soreness, irritation, and itching starting that evening after the shot and still ongoing. The patient's arm is red, swollen, and the redness has irregular patterns down the arm. The redness is also very warm to the touch.
Sex: U
Vaccine: TDAP
Symptoms: Caesarean section, Exposure during pregnancy, Foetal distress syndrome, Neonatal disorder
Clinical narrative: Patient had uncomplicated pregnancy. Received the Tdap Vaccine at 35 weeks day 6. At 36 weeks and 2 days baby was delivered via emergency C-section due to fetal distress. Infant was transported to a NICU. Infant was diagnosed with...Ascites, Respiratory Insufficiency/Failure, Need for observation and evaluation of newborn for sepsis, Hypoalbuminemia, Proteinuria, Other primary thrombocytopenia, Adrenal Insufficiency, Gross Hematuria, Hepatic injury, Acute renal failure, congenital hypothyroidism.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Serum sickness
Clinical narrative: Redness and swelling of the right upper extremity, soreness. Serum sickness. Treated with ice, rest, BENADRYL and observation. Outcome, good and improving.
Age: 27.0
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy
Clinical narrative: Erroneously administered. approx. 7-8 weeks gestation, outcome unclear.
Age: 25.0
Sex: M
Vaccine: FLU4
Symptoms: Nausea
Clinical narrative: Patient had nausea onset of 2 hours after shot and resolved after 2 days. No treatment was required.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Local injection site pain resolved in normal fashion. After 2 weeks pt had pain radiating down to elbow. After 4 weeks pain was radiating to fingers. Would subside overnight and resume by afternoon, limiting pt ability to use arm. Pt has tried IBU with minimal success.
Age: 3.0
Sex: M
Vaccine: FLU4, MMR, VARCEL
Symptoms: Erythema, Eye swelling, Swelling face, Wheezing
Clinical narrative: Patient given above 3 vaccines @ 10 am on 11/2/17. Patient didn't show any immediate signs of an adverse event. Patient was instructed to wait in clinic for 15 minutes. Patient's mother brought him to get blood drawn @ 10:30 (within health center). Patient's mother noticed facial swelling. RN brought patient into back office where MD odered IM epinepherine 0.3 mg for wheezing and swelling to face and eyes, +erythema. Epi IM 0.3 mg was administered to right thigh at 10:39 am. Patient's symptoms began to improve immediately. 911 was called and ambulance brought patient to emergency department. ED consult note pending.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Musculoskeletal pain, Pain in extremity
Clinical narrative: Shoulder and arm pain lasting several days, weakness lasting several days.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Barium enema, Constipation, X-ray with contrast lower gastrointestinal tract
Clinical narrative: Constipation for 6 months now. Can't poop without mother's help. Nothing has helped her. And she is now receiving x rays because we have tried everything possible. This could be possible intussusception.
Age: 41.0
Sex: M
Vaccine: HEP
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Nausea, vomiting, diarrhea. Unable to hold down any fluids or food, including water, Gatorade, juice.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal tenderness, Cough, Culture negative, Dizziness, Fatigue
Clinical narrative: On 10/28 felt warm at night, coughing. Saturday morning, dizzy, tired, very tired, couldn't get up, very lethargic, fever from 99-101. TYLENOL will bring fever down and then it will go back up after 4 hours. On the 10/31 went to doctor who prescribed Z PACK but did not help much. Fever did not go down, running fever until this morning. Doctor visit on 11/1 who mentioned that it is an upper respiratory viral infection. Swab test came back negative probably to rule out pneumonia. Scheduled to go for a chest x-ray. Prescribed some decongestant on 11/1 to control coughing. Abdomen tender and sore from coughing. So far fever broke, this morning, and decongestant is controlling the coughing. Still a little dizzy and tired - an improvement from the other day. Got the same vax last year with no problems.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling hot, Lethargy, Mobility decreased, Pyrexia, Viral upper respiratory tract infection
Clinical narrative: On 10/28 felt warm at night, coughing. Saturday morning, dizzy, tired, very tired, couldn't get up, very lethargic, fever from 99-101. TYLENOL will bring fever down and then it will go back up after 4 hours. On the 10/31 went to doctor who prescribed Z PACK but did not help much. Fever did not go down, running fever until this morning. Doctor visit on 11/1 who mentioned that it is an upper respiratory viral infection. Swab test came back negative probably to rule out pneumonia. Scheduled to go for a chest x-ray. Prescribed some decongestant on 11/1 to control coughing. Abdomen tender and sore from coughing. So far fever broke, this morning, and decongestant is controlling the coughing. Still a little dizzy and tired - an improvement from the other day. Got the same vax last year with no problems.
Age: 57.0
Sex: M
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Loss of personal independence in daily activities, Mobility decreased, Neck pain, Nuclear magnetic resonance imaging
Clinical narrative: Next day shoulder was hurting, vaccination area hurt, couldn't lift arm, could even put shirt on. Called the hospital the next day and was waiting for doctor to call back on Monday. Went to doctor's office on Monday given a prescription for pain; it did not help. Was referred to specialist in the same facility after a week. Doctor questioned whether there was an on injury, surgery in that area but patient denies any. Doctor prescribed medicine and couldn't take them for too long since got bad side effects. Referred for neck MRI, referred to physical therapy for neck and shoulder. Referred to shoulder MRI. Referred to another doctor, around late May, referred to continue to physical therapy for about a year. Doctor confirmed that it was related to vaccine and no surgery was necessary. Today, has some improvement but still has a lot of pain. In the beginning, after vaccine, couldn't do anything with right arm couldn't do anything at old. Pain from right shoulder to your neck. Couldn't move head backwards or forward; can move forward better. Still has a lot of pain even thought doing better than before and taking painkillers.
Age: 57.0
Sex: M
Vaccine: TDAP
Symptoms: Vaccination site pain
Clinical narrative: Next day shoulder was hurting, vaccination area hurt, couldn't lift arm, could even put shirt on. Called the hospital the next day and was waiting for doctor to call back on Monday. Went to doctor's office on Monday given a prescription for pain; it did not help. Was referred to specialist in the same facility after a week. Doctor questioned whether there was an on injury, surgery in that area but patient denies any. Doctor prescribed medicine and couldn't take them for too long since got bad side effects. Referred for neck MRI, referred to physical therapy for neck and shoulder. Referred to shoulder MRI. Referred to another doctor, around late May, referred to continue to physical therapy for about a year. Doctor confirmed that it was related to vaccine and no surgery was necessary. Today, has some improvement but still has a lot of pain. In the beginning, after vaccine, couldn't do anything with right arm couldn't do anything at old. Pain from right shoulder to your neck. Couldn't move head backwards or forward; can move forward better. Still has a lot of pain even thought doing better than before and taking painkillers.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, Injection site cellulitis, Injection site extravasation, Injection site pustule, Limb injury
Clinical narrative: Pt. had a mild pustular/cellulitis at (B) deltoids. Note that 1st injection on (L) deltoid "leaked" out so she had a second injection of new vaccine/needle in (R) deltoid. "Shoulder injury related to vaccine administration".
Age: 0.75
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Pyrexia
Clinical narrative: Fever 102.
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Blood glucose increased, Diabetic ketoacidosis
Clinical narrative: I was admitted into the hospital for undiagnosed DKA 5 days post injection. I was feeling fine prior to the shot. Blood Glucose > 500 mg/dL. I know it can not cause DKA but I believe it may have been a trigger.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Herpes zoster
Clinical narrative: The patient said that she now has shingles after receiving the flu vaccine and is concerned that the flu vaccine may have been contaminated with the shingles virus.
Age: 82.0
Sex: M
Vaccine: PPV
Symptoms: Adverse reaction, Cellulitis, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Redness and swelling in his left arm that got gradually worse and extended almost to the wrist. Patient's arm was also very sore. Patient did not take any medicine for this before seeing the provider. Per patient's wife the doctor diagnosed it as "violent reaction and cellulitis" Cephalexin 500 mg capsule 1 BID x 7 days. Started on 10/26/17 and still continuing.
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Left arm pain, decreased range of motion, lasting longer than 4 weeks.
Age: 8.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Dysgraphia, Injection site erythema, Injection site swelling, Mobility decreased, Pain
Clinical narrative: School nurse called our office to report pt is c/o not being able to move his arm very well and having a hard time writing. Injection site is red and has a small bump. No fever noted. Mom is aware of reaction and will bring pt in if needed but right now is giving pt Ibuprofen for pain/swelling. At time of this report pt has not come into the office for further evaluation.
Age: 8.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Axillary pain, Injected limb mobility decreased, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: School nurse called our office to report pt is c/o not being able to move his arm very well and having a hard time writing. Injection site is red and has a small bump. No fever noted. Mom is aware of reaction and will bring pt in if needed but right now is giving pt Ibuprofen for pain/swelling. At time of this report pt has not come into the office for further evaluation.
Age: 8.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Pain, Pain in extremity
Clinical narrative: School nurse called our office to report pt is c/o not being able to move his arm very well and having a hard time writing. Injection site is red and has a small bump. No fever noted. Mom is aware of reaction and will bring pt in if needed but right now is giving pt Ibuprofen for pain/swelling. At time of this report pt has not come into the office for further evaluation.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Asthma
Clinical narrative: Asthma exacerbation.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Body temperature increased, Cellulitis, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Patient's mother stated that patient was complaining that his right arm was "hurting" when he arrived home from school. She stated that patient was still complaining of pain in the morning before he went to school. The afternoon of 10/12/17, patient's right arm was red, swollen, and hot. She took him to Urgent Care. She states that his temperature at the physician's office was 99.2. Patient was diagnosed with Cellulitis and was treated with KEFLEX three times daily for seven days. She states that patient has recovered and is "fine" now.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Skin warm
Clinical narrative: Patient's mother stated that patient was complaining that his right arm was "hurting" when he arrived home from school. She stated that patient was still complaining of pain in the morning before he went to school. The afternoon of 10/12/17, patient's right arm was red, swollen, and hot. She took him to Urgent Care. She states that his temperature at the physician's office was 99.2. Patient was diagnosed with Cellulitis and was treated with KEFLEX three times daily for seven days. She states that patient has recovered and is "fine" now.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site reaction, Pruritus generalised, Swelling, Urticaria
Clinical narrative: Initial swelling and erythema that became approxiamately 10cmx10cm. Later that evening I developed hives and itching all over body. Hive lasted 4 days, itching 7 days. Injection site reaction last 2 weeks.
Age: 0.5
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Hives within 5 minutes of administration.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain
Clinical narrative: Red area with soreness appeared by next morning dissipating over the next week.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: The patient developed a red, warm, sore area on the left arm about 4-6 inches below the site of injection.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a License Practical Nurse referring to a 6 year old male patient. The patient's pertinent medical history, concurrent conditions and drug reactions/allergies were not provided. On 29-SEP-2017, the patient was vaccinated with an improperly stored unspecified dose of VARIVAX Lot # M049127, expiration date: 15-DEC-2018 (also reported as Lot #M005695, expiration date: 16-SEP-2018) for prophylaxis (strength, dose and route were not reported). The patient's concomitant therapies included sterile diluent (MERCK STERILE DILUENT) Lot #M005695, expiration date: 16-SEP-2018. The patient did not report adverse effects. The vaccine was stored at a temperature of 13 degrees Fahrenheit during 6 hours. Also, it was reported a previously temperature excursion at 32.36 degrees Fahrenheit during 40 hours and 30 minutes. The call was because of a data logger. Until 18-OCT-2017, the patient's parent was unable to search.
Sex: F
Vaccine: PPV
Symptoms: Injection site movement impairment, Injection site pain, Injection site swelling, Malaise
Clinical narrative: This spontaneous report was received from a pharmacist referring to a female patient of unknown age. No information about the patient's medical history, concurrent conditions or concomitant medications was provided. On 07-OCT-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 dose 1, (Lot # reported as 195223 with an expiration date in April 2018), intramuscular, for prophylaxis (dose was not provided). On 07-OCT-2017, 6 hrs after onset of therapy, the patient experienced swelling from injection site on arm down to elbow, soreness, tightness and felt sick. As a result, on 08-OCT-2017, the patient went to an unspecified urgent care unit and was prescribed with diphenhydramine hydrochloride (BENADRYL) and ice to be applied to the affected area. Furthermore, the patient went to visit her physician on 09-OCT-2017. At the time of reporting, the outcome of pain, malaise, injection site swelling and injection site movement impairment was reported as recovered on 10-OCT-2017. The causal relationship between PNEUMOVAX 23 and the reported events was not provided. Lot number 195223 is an invalid lot number for PNEUMOVAX 23.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse, via a field representative, concerning an approximately 14 year old patient of unknown gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. The nurse stated that on an unknown date, at the age of 13 year old, the patient was vaccinated with a dose of GARDASIL (reported as GARDASIL 4) (dose, dose number, route of administration, anatomical location, lot number and expiration date were not provided) for prophylaxis. It was reported that one year later, on an unknown date, the patient was administered a dose of GARDASIL 9 (dose, dose number, route of administration, anatomical location, lot number and expiration date were not provided) for prophylaxis. It was also reported that the time frame was longer than recommended. No adverse effects were reported.
Age: 0.25
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to an unknown number of patients of unknown gender and age. Pertinent medical history or concurrent conditions were not reported. Since 30-MAY-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB which had the lot # reported as N00236, expiration date 24-OCT-2019, lot # N000235, expiration date 26-OCT-2019, lot # N003536, expiration date 02-NOV-2019, for prophylaxis (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32° degrees Fahrenheit and the highest was 54° degrees Fahrenheit  or 49 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter. Follow-up information has been received from a physician on 16-OCT-2017 to an unknown number of patients of unknown gender and age. The patients' concomitant medications, pertinent medical history, drug reactions or allergies were not reported. Since 29-APR-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (lot # M046140, expiration date 27-SEP-2019, dosage information and route were not provided) for prophylaxis. Additionally, it was reported that the lowest temperature was 47° degrees Fahrenheit and the highest was 49° degrees Fahrenheit for 16 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. Follow up information was received from the physician on 27-OCT-2017. This report refers to 3 month old patient. On 19-JUN-2017, the patient was vaccinated with vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot# N000235 with expiration date: 24-OCT-2019. This is one case from several cases from the same reporter.; Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765:  US-009507513-1709USA012764: US-009507513-1709USA007325: US-009507513-1709USA012766:
Age: 0.5
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to an unknown number of patients of unknown gender and age. Pertinent medical history or concurrent conditions were not reported. Since 30-MAY-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of PEDVAXHIB which had the lot # reported as N00236, expiration date 24-OCT-2019, lot # N000235, expiration date 26-OCT-2019, lot # N003536, expiration date 02-NOV-2019, for prophylaxis (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32° degrees Fahrenheit and the highest was 54° degrees Fahrenheit for 49 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter. Follow-up information has been received from a physician on 16-OCT-2017 to an unknown number of patients of unknown gender and age. The patients' concomitant medications, pertinent medical history, drug reactions or allergies were not reported. Since 29-APR-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # M046140, expiration date 27-SEP-2019, dosage information and route were not provided) for prophylaxis. Additionally, it was reported that the lowest temperature was 47° degrees Fahrenheit and the highest was 49° degrees Fahrenheit for 16 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. Follow up information was received from the physician on 27-OCT-2017. This report refers to 6 month old patient. On 27-JUN-2017, the patient was vaccinated with improperly stored doses of PEDVAXHIB lot# N000235 with expiration date: 24-OCT-2019. This is one case from several cases from the same reporter. Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA007325: US-009507513-1709USA012766.
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to an unknown number of patients of unknown gender and age. Pertinent medical history or concurrent conditions were not reported. Since 30-MAY-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of PEDVAXHIB which had the lot # reported as N00236, expiration date 24-OCT-2019, lot # N000235, expiration date 26-OCT-2019, lot # N003536, expiration date 02-NOV-2019, for prophylaxis (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32° degrees Fahrenheit and the highest was 54° degrees Fahrenheit for 49 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter. Follow-up information has been received from a physician on 16-OCT-2017 to an unknown number of patients of unknown gender and age. The patients' concomitant medications, pertinent medical history, drug reactions or allergies were not reported. Since 29-APR-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # M046140, expiration date 27-SEP-2019, dosage information and route were not provided) for prophylaxis. Additionally, it was reported that the lowest temperature was 47° degrees Fahrenheit and the highest was 49° degrees Fahrenheit for 16 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. Follow up information was received from the physician on 27-OCT-2017. This report refers to 8 week old patient. On 27-JUN-2017, the patient was vaccinated with improperly stored doses of PEDVAXHIB lot# N000235 with expiration date: 24-OCT-2019. This is one case from several cases from the same reporter. Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA007325: US-009507513-1709USA012766.
Age: 0.33
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to an unknown number of patients of unknown gender and age. Pertinent medical history or concurrent conditions were not reported. Since 30-MAY-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of PEDVAXHIB which had the lot # reported as N00236, expiration date 24-OCT-2019, lot # N000235, expiration date 26-OCT-2019, lot # N003536, expiration date 02-NOV-2019, for prophylaxis (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32° degrees Fahrenheit and the highest was 54° degrees Fahrenheit for 49 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter. Follow-up information has been received from a physician on 16-OCT-2017 to an unknown number of patients of unknown gender and age. The patients' concomitant medications, pertinent medical history, drug reactions or allergies were not reported. Since 29-APR-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # M046140, expiration date 27-SEP-2019, dosage information and route were not provided) for prophylaxis. Additionally, it was reported that the lowest temperature was 47° degrees Fahrenheit and the highest was 49° degrees Fahrenheit for 16 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. Follow up information was received from the physician on 27-OCT-2017. This report refers to 4 month old patient. On 01-JUL-2017, the patient was vaccinated with improperly stored doses of PEDVAXHIB lot# N000235 with expiration date: 24-OCT-2019. This is one case from several cases from the same reporter. Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA007325: US-009507513-1709USA012766.
Age: 0.5
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to an unknown number of patients of unknown gender and age. Pertinent medical history or concurrent conditions were not reported. Since 30-MAY-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of PEDVAXHIB which had the lot # reported as N00236, expiration date 24-OCT-2019, lot # N000235, expiration date 26-OCT-2019, lot # N003536, expiration date 02-NOV-2019, for prophylaxis (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32° degrees Fahrenheit and the highest was 54° degrees Fahrenheit for 49 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter. Follow-up information has been received from a physician on 16-OCT-2017 to an unknown number of patients of unknown gender and age. The patients' concomitant medications, pertinent medical history, drug reactions or allergies were not reported. Since 29-APR-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # M046140, expiration date 27-SEP-2019, dosage information and route were not provided) for prophylaxis. Additionally, it was reported that the lowest temperature was 47° degrees Fahrenheit and the highest was 49° degrees Fahrenheit for 16 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. Follow up information was received from the physician on 27-OCT-2017. This report refers to 6 month old patient. On 03-JUL-2017, the patient was vaccinated with improperly stored doses of PEDVAXHIB lot# N000235 with expiration date: 24-OCT-2019. This is one case from several cases from the same reporter. Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA007325: US-009507513-1709USA012766.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: 1 week post vaccination pt had rash itching and redness in the arm. She will continue to monitor.
Age: 53.0
Sex: F
Vaccine: FLUC4
Symptoms: Urticaria
Clinical narrative: Hives on all extremities and trunk 5 hours after vaccination. Tx: was sought outside this facility-topical corticosteroid cream and antihistamine P.O-full recovery.
Age: 40.0
Sex: M
Vaccine: FLUC4, PPV
Symptoms: Crying, Injection site reaction, Injection site swelling, Injection site warmth, Middle insomnia
Clinical narrative: Pt. returned to pharmacy approximately 12 hours after receiving PNEUMOVAX 23 injection in left deltoid. Pt. complained of severe pain waking him up crying in the middle of night. I observed no redness or visible evidence of exact inj. site, but muscle was warm and swollen. Pt. winced in pain when I had him move his shirt sleeve up. He was wanting to go to doctor to have it evaluated. Stated he believed we had injured his rotator cuff.
Age: 40.0
Sex: M
Vaccine: FLUC4, PPV
Symptoms: Pain
Clinical narrative: Pt. returned to pharmacy approximately 12 hours after receiving PNEUMOVAX 23 injection in left deltoid. Pt. complained of severe pain waking him up crying in the middle of night. I observed no redness or visible evidence of exact inj. site, but muscle was warm and swollen. Pt. winced in pain when I had him move his shirt sleeve up. He was wanting to go to doctor to have it evaluated. Stated he believed we had injured his rotator cuff.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Soreness and aching in upper arm where administered. NUPRIN, regular dose, still hurting three days after injection.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Sore shoulder lasting 3 weeks. More than just at injection site.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: HPI: Pt reports pain and redness to the upper L arm. Pt was seen 2 days ago for well visit where he received the TRUMENBA vaccine in the left deltoid. This was his 2nd dose of TRUMENBA - he had no adverse reaction to the first dose. PE: 0.9cm x 0.7cm erythematous macular patch on the left deltoid, warm to touch, small area of induration at superior pole. L shoulder abduction strength 4+/5 and symmetric.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Rash macular
Clinical narrative: HPI: Pt reports pain and redness to the upper L arm. Pt was seen 2 days ago for well visit where he received the TRUMENBA vaccine in the left deltoid. This was his 2nd dose of TRUMENBA - he had no adverse reaction to the first dose. PE: 0.9cm x 0.7cm erythematous macular patch on the left deltoid, warm to touch, small area of induration at superior pole. L shoulder abduction strength 4+/5 and symmetric.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Eye movement disorder, Fall, Loss of consciousness, Musculoskeletal stiffness, Seizure like phenomena
Clinical narrative: Administered HPV9, approximate 2 minutes later child fainted and fell to floor. Appearing to have seizure activity, eyes rolling back, stiff body, called 911, patient came to after 10 seconds screaming what happen to me. Child remained lying on floor with Mom and RN until 911 arrived. Patient was examined by paramedics, offered to be transferred to ER, Mom deferred transport to emergency room.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Administered HPV9, approximate 2 minutes later child fainted and fell to floor. Appearing to have seizure activity, eyes rolling back, stiff body, called 911, patient came to after 10 seconds screaming what happen to me. Child remained lying on floor with Mom and RN until 911 arrived. Patient was examined by paramedics, offered to be transferred to ER, Mom deferred transport to emergency room.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Blister, Erythema, Pruritus
Clinical narrative: Patient woke up with red, bubbled itchy areas on the skin on her left hand. Later in the day she noticed she had several red itchy patches up her left arm as well as one near her elbow. They are not painful, oozing, or warm to the touch. No pain in the muscle, fever, headache. No change in feeling or appearance since then.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Pain radiating to elbow X30 min. Resolved spontaneously.
Age: 75.0
Sex: M
Vaccine: PNC13
Symptoms: Headache, Pyrexia
Clinical narrative: Patient started getting a fever and headache 1 day after receiving vaccination. Patient treating fever and headache with over-the-counter acetaminophen which has been helping with both symptoms.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erysipelas, Erythema, Pain in extremity
Clinical narrative: Patient went to the ER two days after the vaccine administration (10/29/2017) due to redness and pain in the left arm. Patient states that she was diagnosed with cellulitis and subsequently filled cephalexin 250mg (take 500mg four times daily for 10 days). Diagnosis on the prescription states erysipelas (diagnosis code A46).
Age: 15.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Dyspnoea, Lip swelling, Nausea, Pharyngeal oedema, Swelling face
Clinical narrative: GIVEN VACCINES IN PEDIATRIC OFFICE. TOLERATED WELL. MOM REPORTS THAT EVENING HE HAD DIFFICULTY BREATHING, THROAT, FACE AND LIP SWELLING, NAUSEA AND VOMITING. MOM TOOK HIM TO THE ER.
Age: 15.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Vomiting
Clinical narrative: GIVEN VACCINES IN PEDIATRIC OFFICE. TOLERATED WELL. MOM REPORTS THAT EVENING HE HAD DIFFICULTY BREATHING, THROAT, FACE AND LIP SWELLING, NAUSEA AND VOMITING. MOM TOOK HIM TO THE ER.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Pain radiating down arm for 1 hour after injection. Went to doctor.
Age: 24.0
Sex: M
Vaccine: FLU4
Symptoms: Decreased appetite, Disturbance in attention, Hypersomnia, Malaise, Sluggishness
Clinical narrative: Began feeling ill within 2-3 hours of shot. Unable to focus on work by 4th hour. Went home and slept for 3 hours. Could barely eat some dry toast. Went to bed around 8 that night (2 hours earlier than usual). Slept until 11 AM the following morning (4 hours longer than usual). Managed to eat toast successfully but appetite was non-existent until following day. Sluggish behavior following two days after recovery.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Allergy to vaccine, Body temperature increased, Chills, Pain, Sepsis
Clinical narrative: Tdap administered on 10/20/2017 (last dose of Td 7/21/2003). That evening, she described aches and chills. Her temperature at approximately 7:00 pm 103.6. She then went to the ER and was admitted 10/20-10/23/17; discharge diagnosis was no known etiology sepsis. Upon follow-up with her primary care provider on 10/27/2017, she was diagnosed with allergy to Tdap.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Blood glucose increased, Hyperhidrosis
Clinical narrative: Sweating and high blood sugar the evening after flu vaccine was given.
Age: 67.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Malaise, Nasal congestion, Pyrexia
Clinical narrative: Malaise/low grade fever/stuffiness.
Age: 67.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Extra dose administered, Injection site irritation, Myalgia, Pyrexia, Sinus congestion
Clinical narrative: Malaise/low grade fever/stuffiness.
Age: 59.0
Sex: F
Vaccine: IPV, RAB
Symptoms: Body temperature increased, Nausea, Palpitations, Pruritus, Skin tightness
Clinical narrative: Patient presented at office of Dr. on 10-25-2017, with hives on back of neck, right shoulder and lower back and a few spots on right knee. Does not have any reaction in either site of injection. Has been on MACROBID antibiotic for IC symptoms once a day for the past 12 days as a precaution. Took ½ tablet of plain ZYRTEC earlier and was a bit edgy. Also tried a new fruit yesterday, persimmon and had nausea off and on. Has been caring for husband that is ill with norovirus and has been using bleach and other antiseptic sprays. Has not changed personal hygiene products, except new brand of clothes dryer sheets. Prescribed Ranitidine 150 mg oral tablet, one tablet BID x 14 days, ALLEGRA 24-hour allergy tablet, Triamcinolone 0.5 % topical cream, apply topically BID on affected areas. Stop MACROBID. Hives continued to spread on 10-26-2017, with worsening symptoms, hives continued to spread to larger area on her back, intergluteal area, anterior thighs and neck area. Patient complained of warmth and itching. Administered KENALOG 60 mg IM right buttock Lot # AAR1751 expires 02-28-2019. Prescribed Ranitidine 150 mg oral tablet, one tablet BID x 14 days, ALLEGRA 24-hour allergy tablet, Triamcinolone 0.5 % topical cream, apply topically BID on affected areas. Stop MACROBID. Advised that cannot confirm that this is a reaction to the rabies vaccine since there are other potential exposures and no local reactions occurred. Patient advised to avoid new products and foods. Keep a diary of exposures.  Advised on potential angioedema symptoms and if that is the case will need to go to the ER.  Consider Allergist consultation for evaluation. Patient deferred referral at this time. 10-26-2017 Patient called Dr. again due to concern of heart racing, pulse > 100 bpm, temp of 99.4, lesions still itching and neck warmth and tightness is improving. Patient has been resting. Advised to stay well hydrated and monitor for gastrointestinal symptoms, respiratory distress, mucosal lesions and angioedema. Tachycardia can be side effect of steroids vs. increased temperature from allergic reaction vs. incipient vial infection.
Age: 59.0
Sex: F
Vaccine: IPV, RAB
Symptoms: Skin warm, Urticaria
Clinical narrative: Patient presented at office of Dr. on 10-25-2017, with hives on back of neck, right shoulder and lower back and a few spots on right knee. Does not have any reaction in either site of injection. Has been on MACROBID antibiotic for IC symptoms once a day for the past 12 days as a precaution. Took ½ tablet of plain ZYRTEC earlier and was a bit edgy. Also tried a new fruit yesterday, persimmon and had nausea off and on. Has been caring for husband that is ill with norovirus and has been using bleach and other antiseptic sprays. Has not changed personal hygiene products, except new brand of clothes dryer sheets. Prescribed Ranitidine 150 mg oral tablet, one tablet BID x 14 days, ALLEGRA 24-hour allergy tablet, Triamcinolone 0.5 % topical cream, apply topically BID on affected areas. Stop MACROBID. Hives continued to spread on 10-26-2017, with worsening symptoms, hives continued to spread to larger area on her back, intergluteal area, anterior thighs and neck area. Patient complained of warmth and itching. Administered KENALOG 60 mg IM right buttock Lot # AAR1751 expires 02-28-2019. Prescribed Ranitidine 150 mg oral tablet, one tablet BID x 14 days, ALLEGRA 24-hour allergy tablet, Triamcinolone 0.5 % topical cream, apply topically BID on affected areas. Stop MACROBID. Advised that cannot confirm that this is a reaction to the rabies vaccine since there are other potential exposures and no local reactions occurred. Patient advised to avoid new products and foods. Keep a diary of exposures.  Advised on potential angioedema symptoms and if that is the case will need to go to the ER.  Consider Allergist consultation for evaluation. Patient deferred referral at this time. 10-26-2017 Patient called Dr. again due to concern of heart racing, pulse > 100 bpm, temp of 99.4, lesions still itching and neck warmth and tightness is improving. Patient has been resting. Advised to stay well hydrated and monitor for gastrointestinal symptoms, respiratory distress, mucosal lesions and angioedema. Tachycardia can be side effect of steroids vs. increased temperature from allergic reaction vs. incipient vial infection.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Unevaluable event
Clinical narrative: BENADRYL and Antibiotics.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Balance disorder, Nausea, Vomiting
Clinical narrative: Patient reports that she woke up with extreme nausea during the early morning on October 19th. She had difficulty balancing, but made it to her bathroom where she proceeded to have an episode of vomiting. She felt better by midday.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Patient came in on 11/2 with a raised red lump on her arm where she was given the PREVNAR injection. She said that it was much larger the day before but it had started to decrease in size. Patient had been taking ibuprofen and diphenhydramine to help relieve her symptoms. Patient was told to continue to monitor the red area on her arm and if it did not improve in the coming days to be seen by her doctor.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse concerning a currently 16 months old patient of unknown gender. The patient's pertinent medical history, concomitant medication and drug allergies/reactions were not provided. On an unspecified date, the patient was vaccinated with an improperly stored doses of PEDVAXHIB lot# reported as: M047666, expiration date: 24-OCT-2019 for prophylaxis (dose, frequency, route of administration were not reported). The administered dose of the vaccine experienced a temperature excursion 32 degree Fahrenheit to 35 degree Fahrenheit for 6 hours. There were no adverse effects reported. There was no previous temperature excursion. Data logger was involved. The outcome were unknown. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA010758.
Sex: U
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Discomfort, Herpes zoster, Nervous system disorder, Pain
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 11-AUG-2014, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 13-SEP-2016, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. On or about 03-OCT-2016, she was treated again for ongoing and uncontrolled pain and worsening herpes zoster outbreaks. On or about 29-MAR-2017 the patient received treatment for worsening symptoms and extreme discomfort which was then diagnosed as post-herpetic nervous system involvement and post-herpetic neuralgia, which are chronic conditions of residual pain and nerve damage caused secondary to zoster infections. On or about 24-APR-2017, she was treated for uncontrolled and increasing post-herpetic pain. On or about 23-MAY-2017 she received treatment for post herpetic neuralgia with increasing nervous system involvement. On or about 23-JUN-2017 she sought treatment for her post herpetic neuralgia at which time she was diagnosed with chronic pain syndrome. The patient continues to experience uncontrolled symptoms and excruciating daily pain which has not been successfully eased or resolved by medication or pain management therapies. The patient has been prescribed ZORIVAX, PERCOCET, fentanyl patches, DURAGESIC patches and oxycodone for management of her persistent and painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Post herpetic neuralgia, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 11-AUG-2014, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 13-SEP-2016, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. On or about 03-OCT-2016, she was treated again for ongoing and uncontrolled pain and worsening herpes zoster outbreaks. On or about 29-MAR-2017 the patient received treatment for worsening symptoms and extreme discomfort which was then diagnosed as post-herpetic nervous system involvement and post-herpetic neuralgia, which are chronic conditions of residual pain and nerve damage caused secondary to zoster infections. On or about 24-APR-2017, she was treated for uncontrolled and increasing post-herpetic pain. On or about 23-MAY-2017 she received treatment for post herpetic neuralgia with increasing nervous system involvement. On or about 23-JUN-2017 she sought treatment for her post herpetic neuralgia at which time she was diagnosed with chronic pain syndrome. The patient continues to experience uncontrolled symptoms and excruciating daily pain which has not been successfully eased or resolved by medication or pain management therapies. The patient has been prescribed ZORIVAX, PERCOCET, fentanyl patches, DURAGESIC patches and oxycodone for management of her persistent and painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.