chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. No symptoms were reported. Administered doses of vaccines experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. Follow up information has been received on 08-MAY-2016 from the nurse and refers to 6 months old patient of unknown gender. On 09-SEP-2016, the patient received improperly stored dose ROTATEQ. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1608USA012908: US-009507513-1608USA012916: US-009507513-1608USA012794.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. No symptoms were reported. Administered doses of vaccines experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. Follow up information has been received on 08-MAY-2016 from the nurse and refers to 6 months old patient of unknown gender. On 12-SEP-2016, the patient received improperly stored dose ROTATEQ. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1608USA012908: US-009507513-1608USA012916: US-009507513-1608USA012794:
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. No symptoms were reported. Administered doses of vaccines experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. Follow up information has been received on 08-MAY-2016 from the nurse and refers to 10 weeks old patient of unknown gender. On 12-SEP-2016, the patient received improperly stored dose ROTATEQ. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1608USA012908: US-009507513-1608USA012916: US-009507513-1608USA012794:
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 9-week-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 23-SEP-2016, the patient was vaccinated with improperly stored doses of ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. No symptoms were reported. Administered dose of vaccine experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1608USA012908: US-009507513-1608USA012916: US-009507513-1608USA012794:
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 6-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 26-SEP-2016, the patient was vaccinated with improperly stored doses of ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. No symptoms were reported. Administered dose of vaccine experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1608USA012908: US-009507513-1608USA012916.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 11-week-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 26-SEP-2016, the patient was vaccinated with improperly stored doses of ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. No symptoms were reported. Administered dose of vaccine experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1608USA012908: US-009507513-1608USA012916.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 4-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 27-SEP-2016, the patient was vaccinated with improperly stored doses of ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. No symptoms were reported. Administered dose of vaccine experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1608USA012908: US-009507513-1608USA012916.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 9-week-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 27-SEP-2016, the patient was vaccinated with improperly stored doses of ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. No symptoms were reported. Administered dose of vaccine experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1608USA012908: US-009507513-1608USA012916:
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 8-week-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 28-SEP-2016, the patient was vaccinated with improperly stored doses of ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. No symptoms were reported. Administered dose of vaccine experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1608USA012908: US-009507513-1608USA012916.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 8-week-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 30-SEP-2016, the patient was vaccinated with improperly stored doses of ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. No symptoms were reported. Administered dose of vaccine experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1608USA012908: US-009507513-1608USA012916:
Age: 10.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Nausea, Pallor
Clinical narrative: This spontaneous report was received from a immunization specialist concerning a 10 year old male patient. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were unknown by the reporter. On 08-MAY-2017, the patient was vaccinated with a dose of GARDASIL 9 lot # M036059, expiration date: 03-JUN-2019, as prophylaxis (Strength, dose and route were not reported). On 08-MAY-2017, after vaccination the patient laid down for 15 minutes. The patient then got lightheaded (dizziness), pale (pallor) and nausea at which time he laid down again with his legs elevated in the air. The patient was treated with oxygen, dextrose (+) electrolytes (unspecified)(PEDIALYTE) and crackers and felt better after 1 hour. It was unknown if lab diagnostics studies were performed to the patient. Immunization specialist requested lot check for this vaccine. The outcome of pallor, nausea and dizziness was unknown. The reporter did not provide the causality between the events and GARDASIL 9. Upon internal review the events pallor, nausea and dizziness were determined to be medically significant as they were treated with oxygen therapy that is considered medically significant.  Additional information has been requested.
Sex: M
Vaccine: HEPA
Symptoms: Cataract, Hypothermia
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to a 7 years old male child. The patient's drug reaction/allergies and current conditions included penicillin hypersensitivity, however he did not have any previous medical history.  On an unknown date, the patient was vaccinated with the first dose of VAQTA injection 25/0.5, (route of administration, lot number and expiration date were not provided) for prevention of Hepatitis A, at another physician office. The patient's concomitant therapy was not reported. On an unknown date, (reported as six months after the vaccine was administered), the patient experienced "a four day episode of hypothermia" and developed juvenile cataracts. Therefore, the patient was hospitalized during 4 days, the patient did receive an unspecified treatment for both events, but no intervention to prevent serious criteria was performed. At the time of the reporting the patient had no recovered from hypothermia and juvenile cataracts, additionally, the causality assessment between VAQTA and the events was unknown. Upon internal review, the event of hypothermia was determined to be medically significant. The reporter considered hypothermia and juvenile cataracts to be life-threatening events. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Burning sensation, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report was received from a 66 years-old female patient, reporting on herself. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 26-APR-2017, the patient was vaccinated with PNEUMOVAX 23 with lot # M043424 (expiration date, strength and dose were not reported), administered intramuscularly in her deltoid muscle by a physician, for prevention of pneumococcal disease. On 27-APR-2017, the patient began to experience swelling of her arm, pain and burning. Subsequently, she sought medical attention and the physician prescribed her prednisone (manufacturer unknown) as treatment. However, on 10-MAY-2017 (reported as "13 days later"), the patient had not recovered and continue to had burning and pain. The relatedness between the peripheral swelling, the pain in extremity and the burning sensation with the vaccine PNEUMOVAX 23 was not reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Pain
Clinical narrative: This is a spontaneous report from a non-contactable pharmacist.  A female elderly patient (age unspecified but more than 65-year-old) of an unspecified race and ethnicity received PREVNAR 13 single dose, on an unknown date, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced sore on one side (at injection site) after the injection and had also pain on different parts of body. The patient did not recover from the event pain (is ongoing at 28 days post dose), while clinical outcome of the other adverse event was unknown at time of this report. No follow-up attempts possible. No further information expected.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Chromosomal deletion, Chromosome analysis abnormal, Decreased eye contact, Dyskinesia, Exaggerated startle response
Clinical narrative: Staring into space, breathing pattern changed, involuntary movements. Sudden seizure attacks->emergency room. Change in personality: no more smiles, giggle, baby babble, regress. Right arm stuck. No more eye contact, acting startled, scared.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Fear, Mobility decreased, Personality change, Regressive behaviour, Respiration abnormal
Clinical narrative: Staring into space, breathing pattern changed, involuntary movements. Sudden seizure attacks->emergency room. Change in personality: no more smiles, giggle, baby babble, regress. Right arm stuck. No more eye contact, acting startled, scared.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Seizure, Staring
Clinical narrative: Staring into space, breathing pattern changed, involuntary movements. Sudden seizure attacks->emergency room. Change in personality: no more smiles, giggle, baby babble, regress. Right arm stuck. No more eye contact, acting startled, scared.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Condition aggravated, Hypoaesthesia, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 4-27-17 Patient noticed redness, tenderness and swelling in (R) bicep area, warm to touch. Followed up with health care provider who felt it may be cellulitis, however not sure if it was related to vaccination since it was in a different area than vaccination site. Patient was prescribed 10 days of KEFLEX. 4-28-17 Patient noticed numbness in left side of body and went to ER. Medical team determined that MS, which had been in remission for 35 years, had reactivated. Patient is now being treated with strong doses of steroids and reports that she is doing better and will continue to follow up with her health care provider.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Laboratory test, Multiple sclerosis
Clinical narrative: 4-27-17 Patient noticed redness, tenderness and swelling in (R) bicep area, warm to touch. Followed up with health care provider who felt it may be cellulitis, however not sure if it was related to vaccination since it was in a different area than vaccination site. Patient was prescribed 10 days of KEFLEX. 4-28-17 Patient noticed numbness in left side of body and went to ER. Medical team determined that MS, which had been in remission for 35 years, had reactivated. Patient is now being treated with strong doses of steroids and reports that she is doing better and will continue to follow up with her health care provider.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: PATIENT REPORTED TO PHARMACY ON 5/16/17 AT 10:00 AM THAT ON SATURDAY 5/13/2017, HE BEGAN TO EXPERIENCE REDNESS, SWELLIN, AND PAIN. HE VISITED HIS PCP ON 5/16/2017, AND TOLD HIM THERE WAS NO SIGN OF INFECTION TO TREAT WITH ICE AND BENADRYL.
Age: 29.0
Sex: F
Vaccine: MMR
Symptoms: Rash, Rash erythematous, Rash pruritic, Reaction to preservatives
Clinical narrative: Red raised puritic rash first on palms of hands then spread to chest, abd. and back. PCP dx of Thimerasol rx but the vaccine and diluent are preservative free. Steroid injection and cream RX 5-15-17.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Pain, Pruritus
Clinical narrative: On 5/15/2017, the patient has experienced redness and swelling around the injection site. There was some itching and pain that morning, but this has since gone away. The patient used ibuprofen to help with the swelling. On 05/16/2017 the redness spread farther around the injection site. The patient sought medical advice from her primary doctor and the pharmacist.  Diphenhydramine was suggested to help with the swelling and redness.
Age: 41.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal pain, Abdominal pain upper, Influenza like illness, Injection site pain, Musculoskeletal pain
Clinical narrative: Patient began having airway issues "tightness" "feeling of needing to clear throat frequently," in the evening of 5/12/17. Patient took 25mg Benedryl and within 20-25 minutes noticed so relief. Within a half hour, she noticed the tightness again, and it was necessary to take more benedryl; patient took 50mg. Between 1800 and 1830 hours, the patient noticed she was wheezing and continuing tightness and constriction through dinner. Shortly after dinner, became nauseous, nausea and throat issues lasted through the night. 5/13/17 the patient noticed extreme pain in the shoulders, cramping in the stomach, and flu-like symptoms; she took 800 mg Ibuprofen for aches/pains. Around noon she noticed a stiff neck. She continued with nausea through the day, and noticed an increase in nausea during the night. Continued to take Benedryl 25mg Q4H throughout this day. 5/14/17 the patient began to "vomit profusely;" she took zofran. She continued with abdominal cramping, nausea, vomiting throughout the night. 5/15/17 the patient went to Urgent care at TMO to see Dr. She was given Zofran SL and Prednisone IM. Which provided relief to symptoms. Began a tapering dose of Predinisone. 5/16/17 the patient was able to attend her work this day; she is still experiencing the "need to clear [her] throat." She has instructions to follow-up with Dr. on Wednesday.
Age: 41.0
Sex: M
Vaccine: TDAP
Symptoms: Musculoskeletal stiffness, Nausea, Respiratory disorder, Throat irritation, Throat tightness
Clinical narrative: Patient began having airway issues "tightness" "feeling of needing to clear throat frequently," in the evening of 5/12/17. Patient took 25mg Benedryl and within 20-25 minutes noticed so relief. Within a half hour, she noticed the tightness again, and it was necessary to take more benedryl; patient took 50mg. Between 1800 and 1830 hours, the patient noticed she was wheezing and continuing tightness and constriction through dinner. Shortly after dinner, became nauseous, nausea and throat issues lasted through the night. 5/13/17 the patient noticed extreme pain in the shoulders, cramping in the stomach, and flu-like symptoms; she took 800 mg Ibuprofen for aches/pains. Around noon she noticed a stiff neck. She continued with nausea through the day, and noticed an increase in nausea during the night. Continued to take Benedryl 25mg Q4H throughout this day. 5/14/17 the patient began to "vomit profusely;" she took zofran. She continued with abdominal cramping, nausea, vomiting throughout the night. 5/15/17 the patient went to Urgent care at TMO to see Dr. She was given Zofran SL and Prednisone IM. Which provided relief to symptoms. Began a tapering dose of Predinisone. 5/16/17 the patient was able to attend her work this day; she is still experiencing the "need to clear [her] throat." She has instructions to follow-up with Dr. on Wednesday.
Age: 41.0
Sex: M
Vaccine: TDAP
Symptoms: Vomiting, Wheezing
Clinical narrative: Patient began having airway issues "tightness" "feeling of needing to clear throat frequently," in the evening of 5/12/17. Patient took 25mg Benedryl and within 20-25 minutes noticed so relief. Within a half hour, she noticed the tightness again, and it was necessary to take more benedryl; patient took 50mg. Between 1800 and 1830 hours, the patient noticed she was wheezing and continuing tightness and constriction through dinner. Shortly after dinner, became nauseous, nausea and throat issues lasted through the night. 5/13/17 the patient noticed extreme pain in the shoulders, cramping in the stomach, and flu-like symptoms; she took 800 mg Ibuprofen for aches/pains. Around noon she noticed a stiff neck. She continued with nausea through the day, and noticed an increase in nausea during the night. Continued to take Benedryl 25mg Q4H throughout this day. 5/14/17 the patient began to "vomit profusely;" she took zofran. She continued with abdominal cramping, nausea, vomiting throughout the night. 5/15/17 the patient went to Urgent care at TMO to see Dr. She was given Zofran SL and Prednisone IM. Which provided relief to symptoms. Began a tapering dose of Predinisone. 5/16/17 the patient was able to attend her work this day; she is still experiencing the "need to clear [her] throat." She has instructions to follow-up with Dr. on Wednesday.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Blood test, Electroencephalogram, Seizure
Clinical narrative: First seizure was 1min30 sec and required ambulatory services to ER pediatric unit, Second seizure occurred on 4/12/2017 at 5:20 PM and required a return to ER followed by an overnight visit.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Musculoskeletal pain, Neck pain
Clinical narrative: I continue to have severe pain in my right arm where I receive the shot, my shoulders, neck & shoulder blades also have pain.  I just started physical therapy 05/15/17.  The pain is not getting better!
Age: 1.33
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and erythema of left deltoid started the day after administration of DTap.
Sex: F
Vaccine: HPV9
Symptoms: Inflammation, Insomnia, Malaise, Pain
Clinical narrative: This spontaneous report as received from a consumer refers to herself, a 25 year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. In approximately JAN-2017, (reported as most recent injection about 3 months ago), the patient was vaccinated with GARDASIL 9 (formulation, dose, total number of doses, frequency, route of administration, anatomical location of administration, lot number and expiration date were not reported) for prophylaxis. In approximately JAN-2017, (reported as after getting GARDASIL 9 administered about 3 months ago), she began to experience "a hard time sleeping", "shooting and burning pain all over her body" and "inflammation". The patient also reported that she did "not feel well" and "had to get off the phone now". Treatment for the events was not provided. The outcome of the events was not provided. Causality assessment was not reported.  Additional information has been requested.
Age: 6.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product preparation error
Clinical narrative: Information has been received from a pharmacist concerning a 6 year old patient of unknown gender. The patient's medical history, concurrent conditions or concomitant medication were not reported. On 02-MAY-2017, the patient was vaccinated with a dose of M-M-R II (dose number, dose, anatomical location, route of administration, lot number and expiration date were not provided) for prophylaxis, reconstituted with 0.45% normal saline. No adverse effects reported.   Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous prospective pregnancy report was received from a nurse practitioner referring to a 23 year old pregnant female patient. No information about the patient's medical history, concurrent conditions or concomitant medications was provided. On 01-MAY-2017, the pregnant patient with 26 weeks and 6 days (third trimester), was inadvertently vaccinated with a dose of M-M-R II that was reconstituted with sterile diluent,  therapy type HSA, (lot # M027637) for prophylaxis (dose, route, dose number and expiration date were not provided) instead of a dose ADACEL due to human error. No adverse effects were reported and no product quality complaint (PQC) was involved. The patient last menstrual period (LMP) was on 11-OCT-2016 and the estimated delivery date (EDD) was on 18-JUL-2017. At the time of reporting, the pregnancy outcome was pending. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Rash
Clinical narrative: Information had been received on 10-MAY-2017 from a lawyer regarding a case in litigation concerning a male patient (age not reported) who was inoculated with ZOSTAVAX (dosage and lot#/expiration not reported) on or about 03-JUL-2012 at a clinic as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused patient to contract a persistent strain of herpes zoster. On or about 06-JUL-2015, patient was treated by two physicians for a painful rash that was diagnosed as herpes zoster (shingles) with ophthalmic interference (in the eyes). Patient had been prescribed valcyclovir for management of his symptoms and outbreaks. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages.  Upon internal review, ophthalmic interference (in the eyes) was determined to be a medically significant event. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Mobility decreased, Muscle disorder, Neurological examination abnormal, Neuropathy peripheral
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for herself. This 67-year-old female patient received PREVNAR 13, via an unspecified route of administration at 0.5 ml single in the arm (unsure if it was given in the right or left arm) on 07Apr2017 for immunisation. Medical history included ongoing osteoporosis (diagnosed in early 2000 and may before in late 90s), she had surgery on that hand a while ago in 2011, underactive thyroid. Concomitant medication included levothyroxine sodium (SYNTHROID) 75mcL, daily for underactive thyroid (she has been taking for years; maybe started around 2009), sertraline 25 mg daily from 2013 and ongoing for antidepressant, denosumab (PROLIA) injection twice a year for osteoporosis. The patient experienced lost ability to bend right thumb on 08Apr2017 with outcome of not recovered, certain muscle was effected on an unspecified date with outcome of unknown, was neuropathy of a particular nerve on an unspecified date with outcome of unknown. The events were described as follows: she lost the ability to bend her right thumb. She could bend it with her other finger but it does not bend on its own. Her doctor ended up sending her to a Neurologist who she saw two weeks ago and went thru all the shock tests and the pins and they said that a certain muscle was effected. The neurological tests on 27Apr2017, the results said that it was neuropathy of a particular nerve. That there was electrodiagnostic evidence of right anterior interosseous neuropathy. She looked it up and that was the name of the nerve and the name of the muscle that was effected was flexor pollicis longus. The little muscle at the base of the joint that bends it and that muscle is the muscle that controls the upper joint.
Sex: U
Vaccine: PNC13
Symptoms: Hypersensitivity, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: This is a spontaneous report from a contactable medical assistant communicated to a Pfizer sales representative. The medical assistant reported similar events for two patients. This is the first of two reports.  A patient of unknown age, gender and race/ethnicity received a single dose of PREVNAR 13 for immunization on an unknown date at the physician office. Medical history and concomitant medications were not reported. On an unknown date, the patient had allergic reaction, arms were extremely swollen; it was really large and they were hot to the touch and very painful for the patient. Treatment was provided. Outcome was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017210408 different patient, same product, same event.
Sex: U
Vaccine: PNC13
Symptoms: Hypersensitivity, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: This is a spontaneous report from a contactable medical assistant via a Pfizer sales representative. The medical assistant reported similar events for two patients. This is the second of two reports. A patient of unknown age, gender and race/ethnicity received a single dose of PREVNAR 13, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation at the physician's office. Medical history and concomitant medications were not reported. On an unknown date the patient had allergic reaction, arm was extremely swollen; it was really large and hot to the touch and very painful. Treatment was provided. Outcome was unknown. Sender's Comments: Linked Report(s) : US-PFIZER INC-2017210371 different patient, same product, same event.
Age: 42.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Erythema, Muscle rigidity, Peripheral swelling, Skin warm, Sunburn
Clinical narrative: Pt received Anthrax and typhoid vaccines in left deltoid on 5/12/17. pt presented to clinic on 5/15/17 with a red, rigid, hot to the touch swollen upper arm (deltoid and bicep.) Pt states she was sun burnt over the weekend. Anthrax normal rxn seen before. Pt instructed to take Benadryl and use ice packs on the area and to f/u with PCM if not better in a day or two.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Sunday am mom noted rash on left side of neck.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: The patient called into the pharmacy complaining of redness, swelling, and warmth around the injection site on 5/16/17 after waking up.  She had not taken anything for these symptoms at the time of the call.
Age: 83.0
Sex: M
Vaccine: PNC13
Symptoms: Encephalopathy, Meningitis bacterial, Neck pain
Clinical narrative: On 5/4/2017 called complaining of extreme neck pain. Went to ER and was admitted with acute encephalopathy and bacterial meningitis. Patient is currently in the hospital.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Patient developed a red rash that itched.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Patient stated she has swelling the size of an orange and warmth at the injection site. It has decreased in size over the last 24 hours.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Dyspnoea, Vomiting
Clinical narrative: Vomiting, breathing issues.  He was put on O2 and also given 3 doses of Epi.
Age: 1.25
Sex: F
Vaccine: HIBV
Symptoms: Injection site urticaria
Clinical narrative: Hives around vaccine site.
Age: 28.0
Sex: U
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from an employee refers to a 28 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient at 28 years of age was vaccinated with GARDASIL 9 (formulation, dose, frequency, route of administration and anatomical location of administration, lot # and expiration date were not reported) for prophylaxis (considered drug administered to patient of inappropriate age). No adverse effects were reported. Product quality complaint was not involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Rash
Clinical narrative: This spontaneous report was received from a physician via a company representative concerning a 91-year-old female patient. There was no information about the patient's pertinent medical history, concurrent conditions, concomitant medications or drug reactions/allergies. On an unknown date, the patient was vaccinated with ZOSTAVAX and sterile diluent for prophylaxis (dose, route of administration, lot number and expiration date were not reported for both products). On an unknown date, the patient had a shingles outbreak along her face and the patient developed a post-herpetic neuralgia as a result of the shingles. There was no product quality complaint involved and no additional information was given. The outcome of the events and the causal relationship between the events and the vaccine were not reported. Additional information is not expected because there was no consent to contact the physician.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: Information had been received on 10-MAY-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a female patient (age unknown) was inoculated with ZOSTAVAX on or about 20-FEB-2015 at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles (dosage and lot#/expiration not reported). The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. Three days after being inoculated, on or about 23-FEB-2015, patient was treated by physician for a rash that was diagnosed as severe shingles. Patient has been prescribed acetaminophen-codeine and valacyclovir to manage her painful symptoms. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Post herpetic neuralgia, Rash
Clinical narrative: Information had been received on 10-MAY-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a female patient (age unknown) was inoculated with ZOSTAVAX on or about 01-SEP-2011 as logged in the vaccine registry, as recommended for routine adult health maintenance for the prevention of shingles (dosage and lot#/expiration not reported). The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 15-AUG-2013, patient was treated at a clinic for a painful rash that was then diagnosed as shingles. On or about 19-SEP-2013, patient was treated at the same facility for worsening symptoms that were diagnosed as severe shingles. On or about 09-OCT-2013, patient was treated again at the clinic for severe shingles which had developed into postherpetic neuralgia. On or about 15-NOV-2013, patient was treated for ongoing postherpetic neuralgia and chronic pain at the clinic. Patient was prescribed valacyclovir, lidocaine and gabapentin for management of these excrutiating symptoms. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information had been received on 10-MAY-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a female patient (age unknown) was inoculated with ZOSTAVAX on or about 29-SEP-2009 at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles (dosage and lot#/expiration not reported). The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 02-JUL-2016, patient was treated by a physician assistant for a painful rash that was diagnosed as shingles. Patient had been prescribed acyclovir to manage her symptoms and outbreaks. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, 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: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse who reported that on 15-MAY-2017, an unspecified patient (age and gender unknown), was administered an expired dose of VARIVAX (lot # L017143, expiry date 13-MAY-2017) reconstituted with sterile diluent (lot # and expiry date were unknown). No adverse effects were reported. The outcome of expired product administered and no adverse event was unknown. The reporter considered expired product administered to be not related to sterile diluent and VARIVAX. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Abdominal pain, Diarrhoea, Infantile spitting up, Irritability
Clinical narrative: Diarrhea, abdominal pain, fussy, spitting up.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Musculoskeletal pain, Vaccination site pain
Clinical narrative: Arm hurt where vaccine was given after the administration for about 2 weeks.  No pain for a day or two then shoulder pain occurred until seen 4/27/17.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Administration site pain, Administration site swelling, Injection site pruritus
Clinical narrative: Area of administration site is sore, swollen, itchy.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Diarrhoea, Dizziness, Dyspnoea, Fatigue
Clinical narrative: Left arm became more and more numb, headache and warmth came over my body, fatigue and dizziness, heart palpitations and shortness of breath followed, diarrhea and vomiting then occurred. The following day, 5/16/2017, body stiffness, joint pain and stiffness occurred along with headache and malaise. Sore throat worsened and itching of the arms and head/neck occurred.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Feeling hot, Headache, Hypoaesthesia, Malaise, Musculoskeletal stiffness
Clinical narrative: Left arm became more and more numb, headache and warmth came over my body, fatigue and dizziness, heart palpitations and shortness of breath followed, diarrhea and vomiting then occurred. The following day, 5/16/2017, body stiffness, joint pain and stiffness occurred along with headache and malaise. Sore throat worsened and itching of the arms and head/neck occurred.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Oropharyngeal pain, Palpitations, Pruritus, Vomiting
Clinical narrative: Left arm became more and more numb, headache and warmth came over my body, fatigue and dizziness, heart palpitations and shortness of breath followed, diarrhea and vomiting then occurred. The following day, 5/16/2017, body stiffness, joint pain and stiffness occurred along with headache and malaise. Sore throat worsened and itching of the arms and head/neck occurred.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Swelling, redness, warmth to touch.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Swelling
Clinical narrative: Pain and swelling.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Decreased appetite, Drug administered to patient of inappropriate age, Pyrexia
Clinical narrative: Spoke with mom on 05/16/2017 at 4:58 pm and she stated that since getting the vaccines on 05/15/2017, pt has been having fevers, not eating well. Pt received the ROTATEQ vaccine (first time). He should not have gotten it due to age at start of vaccine (over 14 weeks). Provider concerned that pt could have mesenteric adenopathy from getting vaccine out of sequence.  Will watch for sx for 3 days.
Age: 33.0
Sex: M
Vaccine: RAB
Symptoms: Muscle spasms, Muscle twitching, Muscular weakness, Myalgia, Paraesthesia
Clinical narrative: Vaccine was administered IM in left arm. 04/13/2017 PM myalgia, weakness, trembling in left arm. Myalgia in thighs. Thought reaction normal, due to sensitization from initial vaccine sequence administered in fall 2015. 04/17/2017 booster was administered IM in right arm. Since then, as of today (05/16/2017) intermittent myalgia has persisted, especially in arms and legs, as well as neuromuscular signs: skeletal muscle spasms/twitches in arms, legs, hands, abdomen, neck, face. Some days worse than others. Intermittent paresthesia, especially in left foot and hand. No loss of function or loss of sensation to date.
Age: 33.0
Sex: M
Vaccine: RAB
Symptoms: Tremor
Clinical narrative: Vaccine was administered IM in left arm. 04/13/2017 PM myalgia, weakness, trembling in left arm. Myalgia in thighs. Thought reaction normal, due to sensitization from initial vaccine sequence administered in fall 2015. 04/17/2017 booster was administered IM in right arm. Since then, as of today (05/16/2017) intermittent myalgia has persisted, especially in arms and legs, as well as neuromuscular signs: skeletal muscle spasms/twitches in arms, legs, hands, abdomen, neck, face. Some days worse than others. Intermittent paresthesia, especially in left foot and hand. No loss of function or loss of sensation to date.
Age: 24.0
Sex: F
Vaccine: HEPAB, HPV9, MMR, MNQ, PPV, TDAP
Symptoms: Chills, Feeling cold, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Muscle aches, injection site soreness, fever, chills, feeling cold started after vaccination and continued at least until 5/12/17. Pt made an appointment to see her PCP on 5/16/17. Pt also reported several symptoms that began before vaccination including but not limited to nausea and syncope.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Redness - swelling itching (L) outer arm extending to forearm.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Asthenia, Erythema, Joint range of motion decreased, Pain in extremity
Clinical narrative: (L) arm pain/swelling red some weakness joint pain fever-101. Supportive care -ice, NSAIDS. Decrease ROM. F/U 1 week.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Swelling
Clinical narrative: (L) arm pain/swelling red some weakness joint pain fever-101. Supportive care -ice, NSAIDS. Decrease ROM. F/U 1 week.
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: (R) upper arm red and warm to touch. Area slightly swollen. Started evening of 5/15/17. No pain. Arrived at clinic 5/16/17 at 10:20.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired vaccine (TDaP) administered to patient. Patient has been contacted and no reaction occurred. Will re-vaccinate patient.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Drug administered at inappropriate site, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Give in wrong site. Swollen, red and hot. On right arm. Treatment was cephalexin. We talk to nurse and give her paper with what site to give shots in.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Vaccination site rash
Clinical narrative: Rash right thigh at site of vaccine.
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Electromyogram abnormal, Injected limb mobility decreased, Nerve root injury cervical, Radiculitis brachial, Vaccination complication
Clinical narrative: Left sided brachial neuritis. Can not raise her (L) arm-continuous to date- Neurologist states it is a flu vaccine reaction. Still in physical therapy.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site erythema, Injection site pruritus, Injection site swelling, Vaccination site warmth
Clinical narrative: Pt. experienced redness day of vaccine at site, itching, hot to touch, uncomfortable. Continued to swell thru day 5, then reducing in size, but all symptoms still present day 6. Pt. to ice, treat w/BENADRYL itch cream or hydrocortisone.
Age: 61.0
Sex: M
Vaccine: HEP
Symptoms: Chills, Differential white blood cell count, Full blood count, Injection site pain, Nausea
Clinical narrative: Severe nausea, vertigo, chills, vomiting soreness at injection site.
Age: 61.0
Sex: M
Vaccine: HEP
Symptoms: Vertigo, Vomiting
Clinical narrative: Severe nausea, vertigo, chills, vomiting soreness at injection site.
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site discomfort, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, "hot", discomfort, very tender - hardness at injection site - Left lateral thigh 4" x 4".
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site warmth
Clinical narrative: Redness, swelling, "hot", discomfort, very tender - hardness at injection site - Left lateral thigh 4" x 4".
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Vaccines given above by mistake. Original TDaP and MCV4 given on 4/5/07. Patient had no adverse reactions/symptoms from above.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient described as a red ring around injection site. She did apply ice packs. Now presents with redness and swelling starting half way down upper arm extending to elbow.
Age: 40.0
Sex: F
Vaccine: HEPA, MNQ, TYP, YF
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: No adverse events noted, but yellow fever was given on 2/16/17, before the patient knew she was pregnant. LMP was 1/31/17.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Hypersensitivity, Lip swelling, Swelling face, Urticaria
Clinical narrative: Mother called 4/11/17 stating child developed hives evening of 4/10/17. Was taken to PCP 4-11-17. At this time had developed swelling of lips/face. PCP instructed mother to go back to Health Dept. where imm. was received. Talked with mother on phone - instructed to take child to Emer. Room ASAP.