chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: TDAP, YF, YF, YF
Symptoms: Dizziness, Headache, Pyrexia, Syncope
Clinical narrative: Initial unsolicited report received from pharmacist on 12-Jan-2018. This case involves a 39-year-old female (reported as 40 year old) patient who was vaccinated with 0.5 ml dose once of YELLOW FEVER VACCINE - US (YF-VAX) (Batch number, expiration date, dose, and site of administration was not reported) via subcutaneous route on 05 Jan 2018. On an unspecified date, following the vaccination, the patient had syncope, vitals and had fever. On 09 Jan 2017, the patient was seen in the emergency room. It was also reported that, the patient followed up with PCP on 11 Jan 2017. Lab data were normal (unspecified). Corrective treatment was not reported. The patient was recovering from events. Follow up information received from pharmacist on 31-Jan-2018. Patient age was updated as 40-years. It was reported that the patient was vaccinated with 0.5 ml dose of YELLOW FEVER VACCINE - FR (STAMARIL) (Batch number, expiration date, dose, dose in series and site of administration was not reported) via subcutaneous route on 05 Jan 2018, which was initially reported as YF-VAX. On 09-Jan-2018, four days following the vaccination, patient experienced syncope, dizziness, fever and headache. The patient was still recovering from syncope and fever and also the patient had not yet recovered from dizziness and headache at the time of reporting. List of documents held by sender: none.
Age: 40.0
Sex: F
Vaccine: TDAP, YF, YF, YF
Symptoms: Cold sweat, Decreased appetite, Headache, Hypotension, Muscular weakness
Clinical narrative: Initial unsolicited report received from pharmacist on 12-Jan-2018. This case involves a 39-year-old female (reported as 40 year old) patient who was vaccinated with 0.5 ml dose once of YELLOW FEVER VACCINE - US (YF-VAX) (Batch number, expiration date, dose, and site of administration was not reported) via subcutaneous route on 05 Jan 2018. On an unspecified date, following the vaccination, the patient had syncope, vitals and had fever. On 09 Jan 2017, the patient was seen in the emergency room. It was also reported that, the patient followed up with PCP on 11 Jan 2017. Lab data were normal (unspecified). Corrective treatment was not reported. The patient was recovering from events. Follow up information received from pharmacist on 31-Jan-2018. Patient age was updated as 40-years. It was reported that the patient was vaccinated with 0.5 ml dose of YELLOW FEVER VACCINE - FR (STAMARIL) (Batch number, expiration date, dose, dose in series and site of administration was not reported) via subcutaneous route on 05 Jan 2018, which was initially reported as YF-VAX. On 09-Jan-2018, four days following the vaccination, patient experienced syncope, dizziness, fever and headache. The patient was still recovering from syncope and fever and also the patient had not yet recovered from dizziness and headache at the time of reporting. List of documents held by sender: none.
Age: 40.0
Sex: F
Vaccine: TDAP, YF, YF, YF
Symptoms: Nausea, Presyncope, Pyrexia, Sensory disturbance
Clinical narrative: Initial unsolicited report received from pharmacist on 12-Jan-2018. This case involves a 39-year-old female (reported as 40 year old) patient who was vaccinated with 0.5 ml dose once of YELLOW FEVER VACCINE - US (YF-VAX) (Batch number, expiration date, dose, and site of administration was not reported) via subcutaneous route on 05 Jan 2018. On an unspecified date, following the vaccination, the patient had syncope, vitals and had fever. On 09 Jan 2017, the patient was seen in the emergency room. It was also reported that, the patient followed up with PCP on 11 Jan 2017. Lab data were normal (unspecified). Corrective treatment was not reported. The patient was recovering from events. Follow up information received from pharmacist on 31-Jan-2018. Patient age was updated as 40-years. It was reported that the patient was vaccinated with 0.5 ml dose of YELLOW FEVER VACCINE - FR (STAMARIL) (Batch number, expiration date, dose, dose in series and site of administration was not reported) via subcutaneous route on 05 Jan 2018, which was initially reported as YF-VAX. On 09-Jan-2018, four days following the vaccination, patient experienced syncope, dizziness, fever and headache. The patient was still recovering from syncope and fever and also the patient had not yet recovered from dizziness and headache at the time of reporting. List of documents held by sender: none.
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Arthralgia, Heart rate increased
Clinical narrative: I received an adult flu shot (FLUCELVAX QUADRIVALENT INJ) on January 29, 2018 in my left arm. I have not had a flu shot since I was a child, probably 25 years ago. Thirty minutes after receiving the shot, I noticed a very rapid heartbeat. It seemed to go away about 2 hours later. That night I woke up to throbbing joint pain in my right elbow. I've never had joint pain before. Today is 2/6/18 and I continue to have really bad joint pain there. It does not go away, even with 4 Ibuprofen. Today, the back of my neck is really sore.
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Arthralgia, Heart rate increased, Neck pain
Clinical narrative: I received an adult flu shot (FLUCELVAX QUADRIVALENT INJ) on January 29, 2018 in my left arm. I have not had a flu shot since I was a child, probably 25 years ago. Thirty minutes after receiving the shot, I noticed a very rapid heartbeat. It seemed to go away about 2 hours later. That night I woke up to throbbing joint pain in my right elbow. I've never had joint pain before. Today is 2/6/18 and I continue to have really bad joint pain there. It does not go away, even with 4 Ibuprofen. Today, the back of my neck is really sore.
Age: 48.0
Sex: M
Vaccine: FLUC4, FLUC4
Symptoms: Blood test, Computerised tomogram, Hypoaesthesia, Musculoskeletal pain, Neuralgic amyotrophy
Clinical narrative: Patient began to experince pain at injection site, after many tests doctor diagnosed him with parsonage turner syndrome from the flu shot.
Age: 48.0
Sex: M
Vaccine: FLUC4, FLUC4
Symptoms: Nuclear magnetic resonance imaging
Clinical narrative: Patient began to experince pain at injection site, after many tests doctor diagnosed him with parsonage turner syndrome from the flu shot.
Age: 48.0
Sex: M
Vaccine: FLUC4, FLUC4
Symptoms: Injection site pain, Neuralgic amyotrophy
Clinical narrative: Patient began to experince pain at injection site, after many tests doctor diagnosed him with parsonage turner syndrome from the flu shot.
Sex: F
Vaccine: HPV9
Symptoms: Interchange of vaccine products
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. The patient's pertinent medical history, drug reactions and allergies were not reported. Concomitant therapies were not provided. On an unknown date, the patient was at the pharmacy to complete her CERVARIX (dose, anatomical location lot# and expiration date were not reported) dosing series by using GARDASIL 9 intramuscular for prophylaxis (dose, anatomical location lot# and expiration date were not reported).
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse via a company representative, and refers to a 11 year old male patient. No information about the patient's medical history, concurrent conditions and concomitant medications was provided. On 06-FEB-2018, the patient was inadvertently vaccinated with an expired dose of GARDASIL 9 (lot # M007764, expiration date in 30-JAN-18), for prophylaxis, (dose, frequency, route and strength were not provided). Furthermore, it was reported that, the dose of GARDASIL 9 was properly stored. No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On 21-MAY-2012 the patient was vaccinated with ZOSTAVAX, 1 DF, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 11-FEB-2016 the patient was treated for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. 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, pain and suffering, and other damages. Additional information has been requested.
Age: 0.33
Sex: U
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a physician referring to a 4 month old infant patient. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 13-FEB-2018, the patient was vaccinated with a dose of PNEUMOVAX23 intramuscularly, for prophylaxis (lot # and expiration date were not reported). No known adverse effects were reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 07-FEB-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # N020352, expiration date 10-APR-2020 (dose, route of administration and anatomical location were not reported) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion in the range between 47 Fahrenheit degrees (°F) to 77 °F (47°F) for 1 hour and 13 minutes, as recorded by a data logger. The vaccines had a previous temperature excursion in the range between 47 °F to 77 °F for 9 hours. There was no adverse effect reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1802USA007812: US-009507513-1802USA007813.
Age: 1.0
Sex: U
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 1 year old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 16-AUG-2017, the patient, at the age of 1 year old, received a dose of PNEUMOVAX23 lot # M037533, for prophylaxis (strength, route and expiration date were not reported). No adverse effects were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 13-FEB-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ orally, lot # N015136, expiration date 16-FEB-2019 (dose, route of administration and anatomical location were not reported) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion in the range between 47 °F to 77 °F (47°F) for 1 hour and 13 minutes, as recorded by a data logger. The vaccines had a previous temperature excursion in the range between 47 °F to 77 °F for 9 hours. There was no adverse effect reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1802USA007492: US-009507513-1802USA007813.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 12-FEB-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ orally, lot # N015136, expiration date 16-FEB-2019 (dose, route of administration and anatomical location were not reported) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion in the range between 47 Fahrenheit degrees (°F) to 77 °F (47°F) for 1 hour and 13 minutes, as recorded by a data logger. The vaccines had a previous temperature excursion in the range between 47 °F to 77 °F for 9 hours. There was no adverse effect reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1802USA007812: US-009507513-1802USA007492.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling abnormal, Pain in extremity
Clinical narrative: Soreness/redness in arm and feeling "under the weather" for more than 4 days after vaccination. Recommended ADVIL and BENADRYL for symptoms.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at the injection site.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Pain in extremity, Peripheral swelling, Urticaria
Clinical narrative: Patient started with arm pain and swelling following the vaccine administration that evening. She treated with IBU to help resolve the pain and ice for the swelling. The next morning she woke up with hives down her whole arm. On 2/15 contacted me for advice and recommendations. She will continue IBU every 4-6 hours and ice, but will also take BENADRYL in the evening to help with the allergic reaction.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Insomnia, Mobility decreased, Pain, Product administered at inappropriate site
Clinical narrative: Injection was very high in my shoulder. Have been unable to raise arm or sleep due to pain.
Age: 1.25
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Crying, Irritability, Muscle rigidity, Pain, Pyrexia
Clinical narrative: 2/12/18 9:30 PM Patient woke up crying in his crib and was unable to settle himself to bed.I went in to get him out of the crib and rock him. When I picked him up out of his crib his body went rigid and straight, he screamed out until about 10:30 PM as if he were in pain. I administered Tylenol to help with pain. I nursed him. He went back to sleep. 2/13/18 He had increased irritability, fever of 100.3, and rash on his abdomen and back. Tylenol and Ibuprofen were administered throughout the day to manage his irritability and fever. 2/14/18  Fever continued ranging around 100.0 and rash spread on his abdomen and back. Pediatrician was contacted. Irritability continued. Slept through the night. 2/15/18  Pediatrician aware of symptoms. No fever this morning. Rash still present.
Age: 1.25
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Rash, Screaming
Clinical narrative: 2/12/18 9:30 PM Patient woke up crying in his crib and was unable to settle himself to bed.I went in to get him out of the crib and rock him. When I picked him up out of his crib his body went rigid and straight, he screamed out until about 10:30 PM as if he were in pain. I administered Tylenol to help with pain. I nursed him. He went back to sleep. 2/13/18 He had increased irritability, fever of 100.3, and rash on his abdomen and back. Tylenol and Ibuprofen were administered throughout the day to manage his irritability and fever. 2/14/18  Fever continued ranging around 100.0 and rash spread on his abdomen and back. Pediatrician was contacted. Irritability continued. Slept through the night. 2/15/18  Pediatrician aware of symptoms. No fever this morning. Rash still present.
Age: 0.58
Sex: M
Vaccine: FLU4
Symptoms: Crying, Erythema, Swelling face
Clinical narrative: 2/7/18 1241 baby flu 0.25 prefilled given IM lt thigh. 1252 Mom brings baby back noting 4 red, round areas behind lt ear. Rapidly spreads to torso, rt ear and facial swelling. VSS. 1254 Epi 1mg/ml 0.1cc admin. SQ rt thigh. EMS called. 1257 BENADRYL 50mg/ml 0.3cc admin. IM rt thigh. 1303 EMS arrive. VSS, Pt is alert and intermittently crying. Taken to hospital.
Age: 57.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Adverse event, Total lung capacity decreased
Clinical narrative: This spontaneous report was received from a consumer via call center representative refers to a 62 year old female patient. The patient's medical history include tobacco use (the patient had quit smoking 5 years before reporting data). Concomitant therapies included prednisone (Manufacturer unknown), albuterol sulfate, COMBIVENT and SPIRIVA. On an unknown date in 2011, the patient was vaccinated with PNEUMOVAX 23 (dosing information was not reported) for unknown indication. Approximately on 24-OCT-2011, the patient also received an influenza virus vaccine (unspecified). On 02-NOV-2011, she was hospitalized due to an unknown reason. Patient reported that before the administration of flu shot, she informed that she had cold, but was vaccinated anyway. Outcome of hospitalization was unknown. Causality assessment was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. In approximately 2013, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. In or about April 2016, the patient was treated by a physician for the onset of a severe rash, which was diagnosed as herpes zoster or shingles. 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. The outcomes of the events were unknown at the time of reporting. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 11-MAY-2011, the patient was inoculated with ZOSTAVAX at a pharmacy (route and lot # not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 17-MAR-2016, the patient was treated by a physician for the onset of a vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster or shingles. 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. The outcomes of the events were unknown at the time of reporting. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 07-APR-2015, the patient was inoculated with ZOSTAVAX at an internal medicine physician office for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. In or about November 2016, the patient was treated by a physician for the onset of a severe rash, which was diagnosed as herpes zoster or shingles. 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. The outcomes of the events were unknown at the time of reporting. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 20-MAR-2013, the patient was inoculated with ZOSTAVAX at a physician's office as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 01-DEC-2016, the patient was treated at the same physician's office for the onset of vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster or shingles. 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. The outcomes of the events were unknown at the time of reporting. Causality assessment was related. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report received from a pharmacist refers to an unspecified patient of unknown age and gender. On 12-FEB-2018, the patient was vaccinated with an expired dose of ZOSTAVAX (19400 PFU Vial) lot # M038350 and expiration date 31-DEC-2017, via unspecified route for prophylaxis. Both the ZOSTAVAX and the sterile diluent (unspecified lot and expiration) used to reconstitute the ZOSTAVAX were properly stored. No adverse effects noted. No additional information provided. No product quality complaint involved.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Flushing, Intranasal hypoaesthesia, Nasal congestion, Paraesthesia
Clinical narrative: Patient stated that after 1 hour later of getting the SHINGRIX vaccine, she developed facial flushing, nasal numbness and tingling, mucus and swollen of the nostrils, and the right cleared up a day later, but the left one still swollen. Patient did see her doctor for it but doctor doesn't think it's life-threatening.
Age: 20.0
Sex: F
Vaccine: TD
Symptoms: Exposure during pregnancy, No adverse event, Wrong drug administered
Clinical narrative: TD vaccine administered to pregnant woman (EDD 02/19/2018) instead of Tdap vaccine. No adverse reaction to report.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Rash, Urticaria
Clinical narrative: Patient had hives and rash approximately 2 hours after receiving injection. Mother states he had a possible reaction 2 years prior but last year he had the flu shot and did fine. He received Benadryl in the office and a script for prednisolone.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Large urticaria all over body x hrs after flu shot. Taken to ER - RX steroids and BENADRYL.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMR, VARCEL
Symptoms: Neck pain
Clinical narrative: Wry neck pain 24 hours post vaccine administration. It lasted 3 (three) days, and was resolved.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Injection site pruritus, Injection site rash
Clinical narrative: Per Mom, pt. was feeling fine earlier but after stated pt. feeling dizzy and felt like fainting, elbow area of the arm where HPV was given very itchy and rash that looks like mosquito bites.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Standard work was not followed and patient was given 0.5mL instead of 0.25mL.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Fatigue, Injection site erythema, Injection site pain, Malaise, Nasopharyngitis
Clinical narrative: One post injection, pt c/o cold like symptoms of runny nose, easily tired and general malaise. Pt presents in office today post 3 days of injection with painful 3.5"X2.5" erythema to injection site, red patches noted to bilateral upper buttocks, bilateral upper ear lobes and bilateral cheeks. Pt denies itching or pain to areas besides injection site. No streaking or warmth around injection site.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Rash, Rash erythematous, Rhinorrhoea
Clinical narrative: One post injection, pt c/o cold like symptoms of runny nose, easily tired and general malaise. Pt presents in office today post 3 days of injection with painful 3.5"X2.5" erythema to injection site, red patches noted to bilateral upper buttocks, bilateral upper ear lobes and bilateral cheeks. Pt denies itching or pain to areas besides injection site. No streaking or warmth around injection site.
Age: 1.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, HIBV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: PEDIARIX was given instead of PREVNAR 13. Patient had no adverse reaction or side effects from immunizations.
Age: 48.0
Sex: F
Vaccine: DTAP
Symptoms: Loss of personal independence in daily activities, Myalgia, Nausea, Pain
Clinical narrative: Deep muscle pain in shoulder, shoulder blade, upper arm and lower arm. Could not use arm for normal activities. Very painful to move arm. Also had nausea.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Culture stool negative, Diarrhoea, Frequent bowel movements, Pyrexia
Clinical narrative: Mom states that child has been having loose stools since vaccines given; having small/medium stools every time he eats (around 9/day). Denies any blood or mucous in the stools. Had a little fever (99.3 - rectal) on Tuesday, 2/6 - treated with TYLENOL and has been afebrile since.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Depressed mood, Fatigue, Injection site reaction, Mobility decreased, Rash erythematous
Clinical narrative: Pt came to the Pharmacy and informed that she might have had the reaction to PNEUMOVAX 23. Once she got home in couple hours after the shot, she was very down and tired. She could hardly move much. Also the next day she noticed a red rash about 2 inches away from the injection site which went away the following day after 24 hours. She used Vitamin E cream.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, and refers to two unspecified patients of unknown age and gender. The patients' current conditions, medical history and concomitant medications were not reported. On an unknown date, one patient was vaccinated with improperly stored Oka-Merck VARIVAX lot number: M047662 with expiration date: 02-DEC-2018, for prophylaxis (route of administration was not provided). On an unknown date, the other patient was vaccinated with improperly stored Oka-Merck PROQUAD lot number: N021727 with expiration date: 06-FEB-2019, for prophylaxis (route of administration was not provided). On unknown dates, the doses of Oka-Merck VARIVAX and Oka-Merck PROQUAD underwent unspecified temperature excursions (reported as "unspecified out of the range temperature") for an unspecified time out of the range time frame, which were detected by the data logger. There were multiple unspecified previous temperature excursions reported. No adverse symptoms were reported. Follow-up has been received on 13-FEB-2018 from a medical assistant. The medical assistant reported that on an unspecified date, the patient (name was provided) received a improperly stored dose of Oka-Merck VARIVAX reconstituted with properly stored sterile diluent (manufacturer unknown). The second patient received improperly stored dose of Oka-Merck PROQUAD (captured in MARRS # 1802USA007496). The doses of vaccine were stored between 6 degrees Fahrenheit (F) to 14F for 9 hours and 15 minutes. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1802USA007496.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant medications were not reported. On 08-FEB-2018, the patient was vaccinated with an expired dose of ZOSTAVAX lot# M036296, expiry date 14-NOV-2017 (exact dose and route of administration were not reported) for prophylaxis. The lot and expiry of sterile diluent which was used to reconstitute ZOSTAVAX was unknown. There were no adverse effects reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, and refers to two unspecified patients of unknown age and gender. The patients' current conditions, medical history and concomitant medications were not reported. On an unknown date, one patient was vaccinated with improperly stored VARIVAX lot number: M047662 with expiration date: 02-DEC-2018, for prophylaxis (route of administration was not provided). On an unknown date, the other patient was vaccinated with improperly stored PROQUAD lot number: N021727 with expiration date: 06-FEB-2019, for prophylaxis (route of administration was not provided). On unknown dates, the doses of VARIVAX and PROQUAD underwent unspecified temperature excursions for an unspecified time out of the range time frame, which were detected by the data logger. There were multiple unspecified previous temperature excursions reported. No adverse symptoms were reported. Follow-up has been received on 13-FEB-2018 from a medical assistant. The medical assistant reported that on an unspecified date, the patient (name was provided) received a dose of improperly stored PROQUAD reconstituted with properly stored sterile diluent (manufacturer unknown). The second patient received a dose of improperly stored dose of VARIVAX (captured in MARRS # 1801USA001967). The doses of vaccine were stored between 6 degrees Fahrenheit (F) to 14F for 9 hours and 15 minutes. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1801USA001967.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Antinuclear antibody negative, Borrelia test negative, HIV test negative, Multiple sclerosis, Muscular weakness
Clinical narrative: Pt. developed bil leg weakness within 5 days of the vaccine. Diagnosed with MS by MRI of brain on 11/23/17.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging normal, Treponema test negative
Clinical narrative: Pt. developed bil leg weakness within 5 days of the vaccine. Diagnosed with MS by MRI of brain on 11/23/17.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: My left arm is swollen at the injection site, the size of an egg and the skin is bright red in color and is especially tender. I started having flu like symptoms about 12 hours after the shot was administered, with extreme lower back pain and body aches. I was given a steroid today but have been taking BENADRYL & ALEVE since the symptoms began.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Pain
Clinical narrative: My left arm is swollen at the injection site, the size of an egg and the skin is bright red in color and is especially tender. I started having flu like symptoms about 12 hours after the shot was administered, with extreme lower back pain and body aches. I was given a steroid today but have been taking BENADRYL & ALEVE since the symptoms began.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient's HHA noted a red, hot, puffy spot just below her deltoid on the left arm.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Patient developed a non-painful "bump" at the injection site. No other symptoms.
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis, starting at injection site (left deltoid) and going down arm. Began day after immunization. Two days after immunization prescribed BACTRIM DS twice daily for 10 days.
Age: 25.0
Sex: F
Vaccine: PPV
Symptoms: Injection site inflammation, Injection site warmth
Clinical narrative: Inflammation and radiating heat following the lymphatic vessels from the injection site for approximately 3 to 4 inches.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Adverse drug reaction, Headache, Injection site pain, Peripheral swelling, Pruritus
Clinical narrative: PPSV-23 vaccine given 2/13/18 - pt. reports arm started to feel itchy in the late evening after vaccine administered. Pt. reports later in evening arm started to swell and she developed pain at site of injection. Took BENADRYL: - some improvement. Pt. reports headache, no nausea, vomiting, or chills. Recent reaction to clindamycin. Follow up with PCP 2/15/18 started on ZYRTEC 10 mg, ZANTAC 150 mg, and given referral to allergy and immunology.
Age: 1.25
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: 2nd Hep A was administered before due date. Patient was notified before leaving by medical assistant and provider. Provider assured no harm done, no extraordinary reaction anticipated - Hep A will be given again at proper time. VIS  given to parent. Nothing unusual noted about patient condition before leaving appt.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Pt reports that the site was red, hot and the area was approximately 4 in X 7 in, dark red in the center and lighter red to the dimensions and the area was also hard.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Decreased appetite, Disorientation, Injected limb mobility decreased, Injection site pain
Clinical narrative: Started with extreme pain at injection site, swelling, and inability to use my left arm. Then experienced chills, fever, muscle pain, extreme disorientation, total loss of appetite, more swelling of injected arm and red rash on upper portion of the injected arm. I would like it to be noted that I was given the PREVNAR13 injection one year earlier, on Feb 3, 2017.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site reaction, Myalgia, Peripheral swelling, Pyrexia, Rash erythematous
Clinical narrative: Started with extreme pain at injection site, swelling, and inability to use my left arm. Then experienced chills, fever, muscle pain, extreme disorientation, total loss of appetite, more swelling of injected arm and red rash on upper portion of the injected arm. I would like it to be noted that I was given the PREVNAR13 injection one year earlier, on Feb 3, 2017.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Hypotension
Clinical narrative: I woke up lightheaded the following morning which prompted me to take my BP. It was extremely low for me at 109/66. Three hours later it was 101/62 with temp of 99.2. By 2:30 on same day it was up to 127/72 which is still lower than my normal.
Age: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Fall, Syncope
Clinical narrative: Shortly after administering vaccine. Pt started to display fainting symptoms. Pt fell to his knees. Mom held him up and with help from nursing staff, carried him onto the medical bed. Elevated his feet. Charge Nurse was informed and she took his Blood Pressure. Blood Pressure reading was within normal range. Pt was being monitored for 15 minutes. Was able to sit up and converse. Pt was stable and alert. Pt was discharged from clinic @ 11:14am.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Pruritus, Rash erythematous, Skin warm, Swelling
Clinical narrative: Had injection site pain from time of injection. 2 days later notice red rash. At day 5, rash is from elbow to shoulder. Slightly swollen, itchy, and warm to touch.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Had injection site pain from time of injection. 2 days later notice red rash. At day 5, rash is from elbow to shoulder. Slightly swollen, itchy, and warm to touch.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Erythema, Inflammation, Pain
Clinical narrative: 2/14/2018 Developed pain/redness inflammation following a dose of immz. given 2/12/18.
Sex: F
Vaccine: VARZOS
Symptoms: Visual acuity tests abnormal, Visual impairment
Clinical narrative: This spontaneous report was received from a female patient of unknown age regarding herself. The patient's concurrent condition, historical condition, historical medication, drug allergies and concomitant medications were not reported. On an unknown date in May 2017, the patient was vaccinated with ZOSTAVAX (dose, unit, route, frequency not reported) (expiration date and lot number not specified) for shingles prophylaxis. On an unknown date in May 2017 (since administration with ZOSTAVAX, the patient experienced visual impairment. The patient reported that her vision has been declining since being administered ZOSTAVAX. The patient reported that since May 2017, her vision had become progressively worse. The patient reported that her glasses were "not doing anything". The patient had her vision test results showing the decline from May 2017 and January 2018. The patient reported that she did not make a connection between the vision and the ZOSTAVAX until she saw a commercial on television on 07-FEB-2018. The patient did not mention any legal action, even though she saw a legal commercial. The outcome of visual impairment was unknown. The reporter did not assess the causality of the event with suspect therapy.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On 09-JUL-2014 the patient was vaccinated with ZOSTAVAX, 1 DF, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 16-MAR-2016, the patient was treated by a physician for the onset of a vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster or shingles. The patient was prescribed acyclovir and oxycodone and PERCOCET for management of her symptoms and pain. 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, pain and suffering, and other damages. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 71 year old male patient. The patient had not drug reactions/allergies or concomitant medications. The patient's concurrent conditions included high blood pressure. On 11-FEB-2018, the patient was vaccinated with PNEUMOVAX 23 lot # N020502 with expiration date 08-FEB-2019, for prophylaxis (dose and route of administration were not provided). It was reported that after receiving the vaccine his entire right arm was red and swollen. No treatment was given for the events and no laboratory diagnostic test was performed. At the time of reporting, the outcome of the events was unknown. The causality assessment between erythema and peripheral swelling with PNEUMOVAX23 was not provided.
Age: 71.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Adverse reaction, Erythema, Injection site erythema, Injection site swelling, Peripheral swelling
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 71 year old male patient. The patient had not drug reactions/allergies or concomitant medications. The patient's concurrent conditions included high blood pressure. On 11-FEB-2018, the patient was vaccinated with PNEUMOVAX 23 lot # N020502 with expiration date 08-FEB-2019, for prophylaxis (dose and route of administration were not provided). It was reported that after receiving the vaccine his entire right arm was red and swollen. No treatment was given for the events and no laboratory diagnostic test was performed. At the time of reporting, the outcome of the events was unknown. The causality assessment between erythema and peripheral swelling with PNEUMOVAX23 was not provided.
Sex: M
Vaccine: FLU3
Symptoms: Influenza, Vaccination failure
Clinical narrative: Initial unsolicited report received from a consumer (Patient's parent) on 06-Feb-2018. This case involves a male patient (Age was not reported) who was vaccinated with a dose of FLUZONE VACCINE (Batch number, expiry date, dose, dose series route and site of administration were not reported) on an unspecified date at a Sanofi Pasteur clinic last fall. The patient's medical history and concomitant medication was not reported. On 06-Feb-2018, post vaccination the patient was diagnosed with flu (A strain). It was also a case of vaccination failure. Other lab test and corrective treatment were not reported. Outcome of event was not reported. Upon internal review the case was considered as serious because of important medical event: flu (A Strain) (Influenza A virus infection). List of documents held by sender: none.; Sender's Comments: A patient who had received FLUZONE vaccination was diagnosed with Flu (A strain). Time to onset was compatible as there was considerable difference between vaccine admininstration and diagnosis. Based on the available information this is case of suspected vaccination failure. Further, confirmatory laboratory reports and additional information regarding patient's medical history, immune status, concurrent condition and are need to further assess the case. Based on the information available, a role of the vaccine cannot be assessed.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Infection, Varicella virus test positive
Clinical narrative: Infection. Tested positive for shingles.
Age: 12.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: 1 day after vaccine patient was running a fever (phone call). 2 day after vaccine patient still running a fever and site on arm where vaccines given was red, warm and puffy (phone call).  Instructed mom to take patient to PMD for evaluation. Not aware of what happend at that appointment.
Age: 35.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Paraesthesia, Peripheral swelling, Skin warm
Clinical narrative: Swelling to right arm with redness and warm to the touch with main of 4 on 1-10 scale. Patient states that fingers tingled yesterday. But no further tingling felt.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Pain, redness, swelling, warmth 7x6cm right arm. Treatment: Cephalexin 250mg Cap. Take 1 cap po TID, Hydrocortisone 2.5% oint. apply small amt to affected area QID.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Generalized hives, lungs clear, no difficult breathing, no discomfort. Child has epipen at home for peanut allergy. School nurse called doctor's office, sent home child with mom, has doctor's appointment on 2/16/18.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient is a 11 Y female who presents with redness on right arm. Next day after the immunization, patient noticed small, quarter sized red bump at infection sight. Today after picking up from daycare, sight was significantly larger, erythematous and "hot".
Age: 27.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Migraine, Nervousness, Pain in extremity, Skin warm
Clinical narrative: Large red ring on arm, painful, warm to touch, migraine, vomited once, felt shaky.
Age: 27.0
Sex: F
Vaccine: PPV
Symptoms: Vomiting
Clinical narrative: Large red ring on arm, painful, warm to touch, migraine, vomited once, felt shaky.
Age: 13.0
Sex: M
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Crying, Fall, Loss of consciousness
Clinical narrative: Client fell to floor 10 minutes after receiving flu vaccine, appeared to have passed out. Client hit back of head but no injuries found. Client cried immediately after falling and was neurologically intact. Client ambulated independently with family after event.
Age: 63.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: Patient has noticed soreness in the upper arm in which he received the vaccine. Soreness lasted longer than the expected time.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin exfoliation, Swelling face
Clinical narrative: Pt stated she had red face, swollen face and an exfoliating feeling on her face. Resolved itself after 24 hours.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Abdominal pain upper, Asthenia, Blood thyroid stimulating hormone, Borrelia test, Chest X-ray
Clinical narrative: Fatigue, dizziness, migraine, weakness, muscle pain, falling down, lightheadedness, diarrhea, vomiting, loss of appetite, low concentration, chills, night sweats, decreased mobility, pale, increased heart rate, stomach pain, neck pain, ear pain.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Decreased appetite, Diarrhoea, Differential white blood cell count, Disturbance in attention
Clinical narrative: Fatigue, dizziness, migraine, weakness, muscle pain, falling down, lightheadedness, diarrhea, vomiting, loss of appetite, low concentration, chills, night sweats, decreased mobility, pale, increased heart rate, stomach pain, neck pain, ear pain.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Ear pain, Electrocardiogram, Epstein-Barr virus test, Fall
Clinical narrative: Fatigue, dizziness, migraine, weakness, muscle pain, falling down, lightheadedness, diarrhea, vomiting, loss of appetite, low concentration, chills, night sweats, decreased mobility, pale, increased heart rate, stomach pain, neck pain, ear pain.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Fatigue, Full blood count, Heart rate increased, Human chorionic gonadotropin, Influenza virus test
Clinical narrative: Fatigue, dizziness, migraine, weakness, muscle pain, falling down, lightheadedness, diarrhea, vomiting, loss of appetite, low concentration, chills, night sweats, decreased mobility, pale, increased heart rate, stomach pain, neck pain, ear pain.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Metabolic function test, Migraine, Mobility decreased, Mononucleosis heterophile test, Myalgia
Clinical narrative: Fatigue, dizziness, migraine, weakness, muscle pain, falling down, lightheadedness, diarrhea, vomiting, loss of appetite, low concentration, chills, night sweats, decreased mobility, pale, increased heart rate, stomach pain, neck pain, ear pain.