chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Comminuted fracture, Computerised tomogram head normal, Facial bones fracture, Fall, Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 616885). This spontaneous report refers to a 18 year old male patient. The patient had no concurrent illnesses, other medications and medical history was reported as no pre-existing medical condition and no known drug allergies (NKDA). On 27-JUL-2015 the patient was vaccinated with GARDASIL 9 lot # K026247, intramuscular route (dosage and site of vaccination unspecified) and VAQTA dose 1, lot # L009445, intramuscular route in the right arm (dosage unspecified) for prophylaxis. On 27-JUL-2015, the patient experienced syncope, comminuted fracture, tooth injury, fall, and facial bones fracture, the patient's x-ray was abnormal and computerised tomogram head was normal. The patient had a syncopal episode after receiving immunization (within a few minutes), fell from exam table where the patient was sitting, injured two upper central incisors and sustained a comminuted nasal fracture. CT head scan: without contrast - interpreted as "normal"; nasal bone x-ray showed comminuted nasal bone fracture. The patient required an emergency room visit. The outcome of comminuted fracture, x-ray abnormal, tooth injury, syncope, fall, facial bones fracture and computerised tomogram head normal was unknown. The causality assessment for the events with respect to GARDASIL 9 and VAQTA was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Tooth injury, X-ray abnormal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 616885). This spontaneous report refers to a 18 year old male patient. The patient had no concurrent illnesses, other medications and medical history was reported as no pre-existing medical condition and no known drug allergies (NKDA). On 27-JUL-2015 the patient was vaccinated with GARDASIL 9 lot # K026247, intramuscular route (dosage and site of vaccination unspecified) and VAQTA dose 1, lot # L009445, intramuscular route in the right arm (dosage unspecified) for prophylaxis. On 27-JUL-2015, the patient experienced syncope, comminuted fracture, tooth injury, fall, and facial bones fracture, the patient's x-ray was abnormal and computerised tomogram head was normal. The patient had a syncopal episode after receiving immunization (within a few minutes), fell from exam table where the patient was sitting, injured two upper central incisors and sustained a comminuted nasal fracture. CT head scan: without contrast - interpreted as "normal"; nasal bone x-ray showed comminuted nasal bone fracture. The patient required an emergency room visit. The outcome of comminuted fracture, x-ray abnormal, tooth injury, syncope, fall, facial bones fracture and computerised tomogram head normal was unknown. The causality assessment for the events with respect to GARDASIL 9 and VAQTA was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV9
Symptoms: Blood pressure increased, Body temperature increased, Chills, Feeling of body temperature change, Flushing
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS ID-618393). This spontaneous report refers to a 11 year old female patient. The patient had a history of acne. She had no current illness. Other medications included benzaclin gel and tretinoin cream. On 10-JAN-2016 the patient was vaccinated with GARDASIL 9 lot # L019286 dose 1 (unspecified dosage regimen), intramuscular in the left arm for prophylaxis. Other suspect therapies included AFLURIA given on same day via intramuscular route in the right arm. Approximately 1-2 minutes after vaccination, patient felt hot and then cold. She had shivering, elevated heart rate, increased body temperature (100.2 Fahrenheit), increased blood pressure, flushed face, slight puffiness in cheeks. This lasted approximately for 2 hours. The outcome of blood pressure increased, swelling face, heart rate increased, flushing, feeling cold, feeling hot, chills and body temperature increased was reported as recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV9
Symptoms: Heart rate increased, Swelling face
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS ID-618393). This spontaneous report refers to a 11 year old female patient. The patient had a history of acne. She had no current illness. Other medications included benzaclin gel and tretinoin cream. On 10-JAN-2016 the patient was vaccinated with GARDASIL 9 lot # L019286 dose 1 (unspecified dosage regimen), intramuscular in the left arm for prophylaxis. Other suspect therapies included AFLURIA given on same day via intramuscular route in the right arm. Approximately 1-2 minutes after vaccination, patient felt hot and then cold. She had shivering, elevated heart rate, increased body temperature (100.2 Fahrenheit), increased blood pressure, flushed face, slight puffiness in cheeks. This lasted approximately for 2 hours. The outcome of blood pressure increased, swelling face, heart rate increased, flushing, feeling cold, feeling hot, chills and body temperature increased was reported as recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Inflammation, Injected limb mobility decreased, Insomnia, Neck pain
Clinical narrative: 11/8/16 Influenza vaccine administered on top left arm. Felt immediate sharp needle point high on upper deltoid. Waited for a day for symptoms to subside but after couple days had throbbing, aching arm with warmth. Pain increased each day. Took ibuprofen. 11/30/16 Severe left arm with sharp, throbbing, aching pain and unable to raise arm out or upward. Could not sleep or lie on left side with pain traveling up to shoulder and neck. Went to ER, took x-ray. Referred to orthopedic. 12/5/16 Saw orthopedic and diagnosed with severe inflammation. Took ADVIL and will attend physical therapy.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity, Skin warm, X-ray
Clinical narrative: 11/8/16 Influenza vaccine administered on top left arm. Felt immediate sharp needle point high on upper deltoid. Waited for a day for symptoms to subside but after couple days had throbbing, aching arm with warmth. Pain increased each day. Took ibuprofen. 11/30/16 Severe left arm with sharp, throbbing, aching pain and unable to raise arm out or upward. Could not sleep or lie on left side with pain traveling up to shoulder and neck. Went to ER, took x-ray. Referred to orthopedic. 12/5/16 Saw orthopedic and diagnosed with severe inflammation. Took ADVIL and will attend physical therapy.
Sex: U
Vaccine: RV5
Symptoms: Cough
Clinical narrative: This spontaneous report was received from a medical assistant via a company representative, concerning a patient of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On an unspecified date, the patient was vaccinated with an oral solution of ROTATEQ (dose, frequency, strength, lot # and expiration date were not reported) for prevention of Rotavirus. On an unknown date, after receiving ROTATEQ, the patient experienced "cough." The patient sought medical attention by contacted the medical assistance, and at the time of the report, it was unknown the patient's current status. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assisstant refers to an unspecified number of patients of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 15-MAR-2017, 16-MAR-2017, 20-MAR-2017, 20-MAR-2017, 23-MAR-2017, 23-MAR-2017, and on 30-MAR-2017, the patients were vaccinated with improperly stored doses of VAQTA (lot # M033611, expiration date: 02-MAR-2018; lot# M038572, expiration date: 11-MAR-2018; dose and route of administration were not provided). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion from 32 degrees Fahrenheit to 35 degrees Fahrenheit for 52 hours. Digital data logger was not involved. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA007820:
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report was received from a female patient of an unknown age who is also a registered nurse reporting on herself. The patient did not have medical history, concurrent conditions, concomitant medications, drug reactions or allergies. On 01-APR-2017, the patient was vaccinated ZOSTAVAX (lot #, expiration date, strength, dose, frequency, route of administration and anatomical location were not provided). On 02-APR-2017, she had a red, tender spot at the injection site of the size of a silver dollar. It was stated that the patient would seek treatment if it would not get better. No laboratory diagnostics studies were performed. No further information was provided. At the reporting time, the patient had not recovered from the injection site erythema. The causal relationship between the ZOSTAVAX and the event was not provided. Additional information has been requested.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Ill-defined disorder, Product use in unapproved indication
Clinical narrative: Information has been received from a pharmacist concerning a 50 year old male patient. The patient's concurrent condition, concomitant therapy and medical history and were not provided. On 04-APR-2017, the patient was vaccinated with a dose of ZOSTAVAX (lot # M038864, expiration date: 12-DEC-2017, dose was unknown, subcutaneous) for "shingles" (Product use in unapproved indication). On 06-APR-2017, the patient experienced "symptoms". No treatment was given for the event. The pharmacist could not provide the lot and expiration for the properly stored sterile diluent (manufacturer unknown) used to reconstitute the dose of ZOSTAVAX. At time of the report, the outcome of the event "symptoms" was reported as not recovered. Causality between "symptoms" and ZOSTAVAX and sterile diluent (manufacturer unknown) was not provided. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Lip swelling, Urticaria
Clinical narrative: This spontaneous report has been received from a physician via a company representative and refers to a 15 year old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 31-MAR-2017, the patient was vaccinated with the second dose of GARDASIL 9 dose 0.5 ml (route of administration, lot # and expiration date were not reported). On an unknown date in 2017 (reported as she came back to the office on 05-APR-2017), the patient experienced hives on her face and lips swelling. The treatment was given for the adverse events. No product quality complaint was involved. The outcome of the events was not reported. The relatedness between the event and GARDASIL 9 was not reported. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, Pyrexia
Clinical narrative: Information has been received from the patient's father reporting on his 2 year old daughter. It was reported that the patient did not have concomitant medications, drug reactions, allergies or any pertinent medical history. In late February 2017 the patient was vaccinated with M-M-R II for prophylaxis (route of administration, lot number, expiration date, dose and dose number were not provided). On an unknown date the patient experienced a fever that went away within 24 hours. The patient's father also reported that he learned that the vaccine administered in February 2017 had been expired for eight months at the time of administration. At the time of the reporting the outcome of fever was reported as resolved. The causal relationship between the adverse event and the therapy with M-M-R II was not provided. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to a 13 years and 6 months old patient. The patient's medical history, concurrent conditions, drugs reactions or allergies and concomitant therapies were not provided. On 08-OCT-2014, the patient received first dose intramuscularly of GARDASIL for prophylaxis (dosage, Lot Number, expiration date and anatomical location were not reported) later, on 27-OCT-2015 the patient received a dose of GARDASIL 9 (intramuscularly, lot number L025737 Expiration date 28-JUL-2017; dosage, anatomical location were unknown). No adverse effect was reported. There was not product quality complaints involved. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report has been received from a pharmacist and refers to a 53 year old female patient. There was no information about the patient's concurrent conditions or medical history provided. The patient's concomitant therapies included acetaminophen (+) oxycodone hydrochloride, meloxicam (manufacturer unknown) and zolpidem. The patient did not have any known drug reactions or allergies. On 07-APR-2017, the patient was vaccinated with ZOSTAVAX lot # M032141, expiration date 02-OCT-2017, subcutaneously (dose was not reported). On 07-APR-2017, the patient experienced "severe" local injection site reaction: redness (erythema) that measured 6 to 8 inches. No treatment was given for the adverse events. The patient sought medical attention by visited pharmacy. No product quality complaint was involved. The outcome of the event was reported as not recovered/not resolved. The relatedness between the event and ZOSTAVAX was not reported. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA004604:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant and refers to an unspecified number of 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 GARDASIL 9 lot # reported as M0632650, expiration date 31-MAR-2019 and lot # L038917, expiration date 20-FEB-2018 (dose and route of administration were not reported). Sterile diluent (manufacturer unknown) was used to reconstitute the vaccines. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 34.3 degrees Fahrenheit for 30 minutes. There were previous temperature excursion of 32 to 35 degrees Fahrenheit for 4 hours and 20 minutes. Digital data logger was involved. No product quality complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA004386.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant and refers to an unspecified number of 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 PNEUMOVAX23 lot # M041394, expiration date 23-MAY-2018 (dose and route of administration were not reported). Sterile diluent (manufacturer unknown) was used to reconstitute the vaccines. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 34.3 degrees Fahrenheit for 30 minutes. There were previous temperature excursion of 32 to 35 degrees Fahrenheit for 4 hours and 20 minutes. Digital data logger was involved. No product quality complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA004383:
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Eye pruritus, Headache, Liver function test increased, Malaise
Clinical narrative: Information has been received from a pharmacist concerning a female patient of unknown age. The patient's medical history, concurrent conditions, drugs reactions or allergies and concomitant therapies were not provided. In approximately 2014, ("reported as three years ago") the patient was vaccinated with one dose of ZOSTAVAX for prophylaxis (route of administration, lot number, expiration date, dosage number and anatomical location were not provided). On an unknown date, the patient experienced itching and redness of skin (no site specified), needle-like pain (no site specified), blurry, itchy eyes and headache. The patient also stated that she was generally feeling sick. It was also reported that on approximately 2014 ("reported as over the past three years") the patient experienced liver function test increased (unknown by the patient how much did it increased). Furthermore, it was unknown if the patient had received a treatment for the mentioned events. The outcome of itching and redness of skin, needle-like pain, blurry, itchy eyes, headache, generally feeling sick, and liver function test increased was unknown. The patient stated that she went to see her doctor and he did not think that ZOSTAVAX had anything to do with the events. Additional information is not expected as there was no consent to contact reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pruritus, Vision blurred
Clinical narrative: Information has been received from a pharmacist concerning a female patient of unknown age. The patient's medical history, concurrent conditions, drugs reactions or allergies and concomitant therapies were not provided. In approximately 2014, ("reported as three years ago") the patient was vaccinated with one dose of ZOSTAVAX for prophylaxis (route of administration, lot number, expiration date, dosage number and anatomical location were not provided). On an unknown date, the patient experienced itching and redness of skin (no site specified), needle-like pain (no site specified), blurry, itchy eyes and headache. The patient also stated that she was generally feeling sick. It was also reported that on approximately 2014 ("reported as over the past three years") the patient experienced liver function test increased (unknown by the patient how much did it increased). Furthermore, it was unknown if the patient had received a treatment for the mentioned events. The outcome of itching and redness of skin, needle-like pain, blurry, itchy eyes, headache, generally feeling sick, and liver function test increased was unknown. The patient stated that she went to see her doctor and he did not think that ZOSTAVAX had anything to do with the events. Additional information is not expected as there was no consent to contact reporter.
Sex: F
Vaccine: HPV9
Symptoms: Haemolysis, Immune thrombocytopenic purpura, Mouth haemorrhage, Platelet count decreased, Platelet transfusion
Clinical narrative: This spontaneous report was received from an office worker and refers to a 17-year-old female patient with a tree nut allergy. The patient had no pertinent medical history and did not receive any concomitant medications. On 17-JAN-2017, the patient was vaccinated with a dose of GARDASIL 9, intramuscularly (lot# M030380, expiration date: 01-FEB-2019) (dose and anatomical location were not provided) for prophylaxis. On an unspecified date in 2017, the patient developed rash over body, blood-filled taste buds on tongue and petechiae in mouth. The patient sought medical attention by seeing a physician, on 08-MAR-2017 and was admitted to the hospital, on the same day, where she was diagnosed with immune thrombocytopenia (ITP). The patient received unspecified studies and received platelets and prednisone (manufacturer unknown) on an unknown date in 2017. The patient was discharged on 13-MAR-2017. On an unknown date in March 2017, the patient had low platelet count and a new hemolysis and was readmitted to the same hospital on 16-MAR-2017. The patient received an unspecified treatment and was discharged on 21-MAR-2017. No Product Quality Complaint (PQC) was involved. The outcome of reported adverse events was unknown. The relatedness between reported adverse events and GARDASIL 9 was not reported. Upon internal review, the events of hemolysis and immune thrombocytopenia were considered to be medically significant. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Rash generalised, Tongue haemorrhage
Clinical narrative: This spontaneous report was received from an office worker and refers to a 17-year-old female patient with a tree nut allergy. The patient had no pertinent medical history and did not receive any concomitant medications. On 17-JAN-2017, the patient was vaccinated with a dose of GARDASIL 9, intramuscularly (lot# M030380, expiration date: 01-FEB-2019) (dose and anatomical location were not provided) for prophylaxis. On an unspecified date in 2017, the patient developed rash over body, blood-filled taste buds on tongue and petechiae in mouth. The patient sought medical attention by seeing a physician, on 08-MAR-2017 and was admitted to the hospital, on the same day, where she was diagnosed with immune thrombocytopenia (ITP). The patient received unspecified studies and received platelets and prednisone (manufacturer unknown) on an unknown date in 2017. The patient was discharged on 13-MAR-2017. On an unknown date in March 2017, the patient had low platelet count and a new hemolysis and was readmitted to the same hospital on 16-MAR-2017. The patient received an unspecified treatment and was discharged on 21-MAR-2017. No Product Quality Complaint (PQC) was involved. The outcome of reported adverse events was unknown. The relatedness between reported adverse events and GARDASIL 9 was not reported. Upon internal review, the events of hemolysis and immune thrombocytopenia were considered to be medically significant. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a 8 weeks old female patient. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported.  On 07-DEC-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ dose 1, lot # L029617, orally, as prophylaxis (Strength, dose and expiration date were not reported), which experienced a temperature excursion (temperature and timeframe were no reported). It was not reported if there were previous temperature excursions. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA006956: US-009507513-1704USA006957: US-009507513-1704USA006958: US-009507513-1701USA005974: US-009507513-1704USA007655: US-009507513-1704USA007664: US-009507513-1704USA007665: US-009507513-1704USA007666: US-009507513-1704USA007668: US-009507513-1704USA007669: US-009507513-1704USA007670: US-009507513-1704USA007671: US-009507513-1704USA007672: US-009507513-1704USA007673:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assisstant refers to an unspecified number of patients of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 15-MAR-2017, 16-MAR-2017, 20-MAR-2017, 20-MAR-2017, 23-MAR-2017, 23-MAR-2017, and on 30-MAR-2017, the patients were vaccinated with improperly stored doses of ROTATEQ (orally; lot # M040269, expiration date: 28-APR-2018; dose was not provided). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion from 32 degrees Fahrenheit to 35 degrees Fahrenheit for 52 hours. Digital data logger was not involved. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA000955:
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain upper, Blood test, Dizziness, Headache, Malaise
Clinical narrative: My daughter took the first dose of the HPV-9 vaccine on April 10, 2017. On April 12, she experienced dizziness. On April 13, her dizziness got worse and she had severe stomach pains, high fever (>103), and headaches. We gave her fever-reducing meds but she still had temperatures of above 101. On April 14, she continued experiencing severe stomach pains, dizziness, and headaches so we took her to the doctor. The doctor's office didn't seem to think her symptoms were due to the vaccine itself because they were too severe and they suggested a virus infection. The doctor told us to give her Motrin to help with the fever. On April 15, she still had dizziness, a moderate temperate and headaches, but the symptoms weren't as severe compared to April 13 or 14. She finally recovered on April 16. Throughout the several days that she was sick, she only exhibited the symptoms mentioned above. As a parent, I disagree highly with the doctor's conclusion that my daughter had a viral infection. She clearly had bad reactions to the vaccine and the doctor's office denied it. We refuse to give her the next dose of this vaccine and need an outlet to voice concerns about this vaccine.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Pyrexia, Viral infection
Clinical narrative: My daughter took the first dose of the HPV-9 vaccine on April 10, 2017. On April 12, she experienced dizziness. On April 13, her dizziness got worse and she had severe stomach pains, high fever (>103), and headaches. We gave her fever-reducing meds but she still had temperatures of above 101. On April 14, she continued experiencing severe stomach pains, dizziness, and headaches so we took her to the doctor. The doctor's office didn't seem to think her symptoms were due to the vaccine itself because they were too severe and they suggested a virus infection. The doctor told us to give her Motrin to help with the fever. On April 15, she still had dizziness, a moderate temperate and headaches, but the symptoms weren't as severe compared to April 13 or 14. She finally recovered on April 16. Throughout the several days that she was sick, she only exhibited the symptoms mentioned above. As a parent, I disagree highly with the doctor's conclusion that my daughter had a viral infection. She clearly had bad reactions to the vaccine and the doctor's office denied it. We refuse to give her the next dose of this vaccine and need an outlet to voice concerns about this vaccine.
Age: 24.0
Sex: F
Vaccine: FLU4, RAB
Symptoms: Chest pain, Cough, Dehydration, Diarrhoea, Differential white blood cell count normal
Clinical narrative: Visited doctor to request Rabies vaccine series necessary for work with animals. Had previous reaction to Tdap (pruritis) twenty years ago and had not received vaccines since except for influenza vaccines with no incidence. Received Rabies and Influenza vaccine on 4/11/17. Went shopping developed fleeting chest pain and cough. Began swelling in bilateral upper arms, some bruising, felt like knees were swelling, also possibly sore throat and swelling. Vomited 3 times that night, had watery diarrhea but no bleeding, Had unproductive cough that kept her up. Said she was congested and it hurt to touch her face. Body aches. Felt hot to touch but didn't take temperature. Returned to health services clinic to see healthcare provider as advised during visit. Saw Dr. Noted during exam: had rash at site of injection of flu shot, bruising at site of rabies shot (1.5cm). Felt dehydrated and unable to drink. Patient questioned whether she was just sick or having reaction to vaccines. Exam that day: 1.5cm bruise at site of rabies vaccine in upper left arm. No rash on right arm or any other area. Speaking in full sentences. Nasal congestion, normal oropharynx, no lip or tongue swelling. No joint erythmia or swelling. Nausea with vomiting. Basic lab panel normal, negative test for flu A or B. At clinic treated with IV fluids (1 liter normal saline over 30 min). Given prescription for Zofran rapid dissolve tablets. Given referral to allergist for further treatment, immunizations.
Age: 24.0
Sex: F
Vaccine: FLU4, RAB
Symptoms: Facial pain, Feeling hot, Full blood count normal, Influenza A virus test negative, Influenza B virus test
Clinical narrative: Visited doctor to request Rabies vaccine series necessary for work with animals. Had previous reaction to Tdap (pruritis) twenty years ago and had not received vaccines since except for influenza vaccines with no incidence. Received Rabies and Influenza vaccine on 4/11/17. Went shopping developed fleeting chest pain and cough. Began swelling in bilateral upper arms, some bruising, felt like knees were swelling, also possibly sore throat and swelling. Vomited 3 times that night, had watery diarrhea but no bleeding, Had unproductive cough that kept her up. Said she was congested and it hurt to touch her face. Body aches. Felt hot to touch but didn't take temperature. Returned to health services clinic to see healthcare provider as advised during visit. Saw Dr. Noted during exam: had rash at site of injection of flu shot, bruising at site of rabies shot (1.5cm). Felt dehydrated and unable to drink. Patient questioned whether she was just sick or having reaction to vaccines. Exam that day: 1.5cm bruise at site of rabies vaccine in upper left arm. No rash on right arm or any other area. Speaking in full sentences. Nasal congestion, normal oropharynx, no lip or tongue swelling. No joint erythmia or swelling. Nausea with vomiting. Basic lab panel normal, negative test for flu A or B. At clinic treated with IV fluids (1 liter normal saline over 30 min). Given prescription for Zofran rapid dissolve tablets. Given referral to allergist for further treatment, immunizations.
Age: 24.0
Sex: F
Vaccine: FLU4, RAB
Symptoms: Influenza virus test negative, Injection site bruising, Injection site rash, Injection site swelling, Joint swelling
Clinical narrative: Visited doctor to request Rabies vaccine series necessary for work with animals. Had previous reaction to Tdap (pruritis) twenty years ago and had not received vaccines since except for influenza vaccines with no incidence. Received Rabies and Influenza vaccine on 4/11/17. Went shopping developed fleeting chest pain and cough. Began swelling in bilateral upper arms, some bruising, felt like knees were swelling, also possibly sore throat and swelling. Vomited 3 times that night, had watery diarrhea but no bleeding, Had unproductive cough that kept her up. Said she was congested and it hurt to touch her face. Body aches. Felt hot to touch but didn't take temperature. Returned to health services clinic to see healthcare provider as advised during visit. Saw Dr. Noted during exam: had rash at site of injection of flu shot, bruising at site of rabies shot (1.5cm). Felt dehydrated and unable to drink. Patient questioned whether she was just sick or having reaction to vaccines. Exam that day: 1.5cm bruise at site of rabies vaccine in upper left arm. No rash on right arm or any other area. Speaking in full sentences. Nasal congestion, normal oropharynx, no lip or tongue swelling. No joint erythmia or swelling. Nausea with vomiting. Basic lab panel normal, negative test for flu A or B. At clinic treated with IV fluids (1 liter normal saline over 30 min). Given prescription for Zofran rapid dissolve tablets. Given referral to allergist for further treatment, immunizations.
Age: 24.0
Sex: F
Vaccine: FLU4, RAB
Symptoms: Nasal congestion, Nausea, Pain, Respiratory tract congestion, Vomiting
Clinical narrative: Visited doctor to request Rabies vaccine series necessary for work with animals. Had previous reaction to Tdap (pruritis) twenty years ago and had not received vaccines since except for influenza vaccines with no incidence. Received Rabies and Influenza vaccine on 4/11/17. Went shopping developed fleeting chest pain and cough. Began swelling in bilateral upper arms, some bruising, felt like knees were swelling, also possibly sore throat and swelling. Vomited 3 times that night, had watery diarrhea but no bleeding, Had unproductive cough that kept her up. Said she was congested and it hurt to touch her face. Body aches. Felt hot to touch but didn't take temperature. Returned to health services clinic to see healthcare provider as advised during visit. Saw Dr. Noted during exam: had rash at site of injection of flu shot, bruising at site of rabies shot (1.5cm). Felt dehydrated and unable to drink. Patient questioned whether she was just sick or having reaction to vaccines. Exam that day: 1.5cm bruise at site of rabies vaccine in upper left arm. No rash on right arm or any other area. Speaking in full sentences. Nasal congestion, normal oropharynx, no lip or tongue swelling. No joint erythmia or swelling. Nausea with vomiting. Basic lab panel normal, negative test for flu A or B. At clinic treated with IV fluids (1 liter normal saline over 30 min). Given prescription for Zofran rapid dissolve tablets. Given referral to allergist for further treatment, immunizations.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site inflammation, Injection site pain, Loss of personal independence in daily activities
Clinical narrative: On 9/12/16 was given flu shot in my left arm at clinic during employee event. My arm had a big red inflammation around the site for over a month. It was also painful to touch. Also immediately, I was unable to use my left arm to put my seatbelt on in the car or use my usual arm exercises at the gym. Saw PCP on 1/13/17 and treated with steroids with temporary improvement. Continued to have intermittent pain that has worsened and is now affecting activities of daily living.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal disorder
Clinical narrative: On 9/12/16 was given flu shot in my left arm at clinic during employee event. My arm had a big red inflammation around the site for over a month. It was also painful to touch. Also immediately, I was unable to use my left arm to put my seatbelt on in the car or use my usual arm exercises at the gym. Saw PCP on 1/13/17 and treated with steroids with temporary improvement. Continued to have intermittent pain that has worsened and is now affecting activities of daily living.
Age: 29.0
Sex: M
Vaccine: SMALL
Symptoms: Rash
Clinical narrative: Rash, Bilateral arm and L knee.
Age: 25.0
Sex: F
Vaccine: SMALL
Symptoms: Headache, Rash, Swelling
Clinical narrative: Headache, swelling under the armpit, rash from the bandage started on 17 April 2017. Visited clinic on 19 April 2017, prescribed Codeine and given Quarters x 1 day.
Age: 11.0
Sex: F
Vaccine: DTAP, HPV9, MNQ
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: Patient came in for WCC and 11 yr vaccines. Patient was given a Dtap instead of the Tdap that was due. No symptoms, signs or treatments needed. MA notified patient. Does not need extra dose per Immunization Coordinator.
Age: 0.25
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Abdominal tenderness, Barium enema abnormal, Crying, Intussusception
Clinical narrative: Inconsolable crying x 4 hours, prompting ER visit.  LLQ tenderness on exam.  Suspected intussusception.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Skin warm, Urticaria
Clinical narrative: Urticarial with erythema and warmth.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Adverse reaction, Diarrhoea, Enlarged uvula, Hypersensitivity, Pharyngeal oedema
Clinical narrative: This case was reported by a consumer via patient support programs and described the occurrence of throat swelling in a 56-year-old female patient who received BENLYSTA powder for infusion for systemic lupus erythematosus. On an unknown date, the patient started BENLYSTA at an unknown dose at unknown dosing. On 5th October 2016, an unknown time after starting BENLYSTA, the patient experienced throat swelling, uvula swelling and adverse reaction. The action taken with BENLYSTA was unknown. On an unknown date, the outcome of the throat swelling, uvula swelling and adverse reaction were unknown. It was unknown if the reporter considered the throat swelling, uvula swelling and adverse reaction to be related to BENLYSTA. Additional details included that the reporter was the patient who reported the information via Patient Assistance Program. The patient reported that she took BENLYSTA "Tuesday and on Wednesday had a reaction and had to go to the hospital." The patient did not specify the reaction other than to say that her throat and uvula were massively swollen. The patient reported the use of other unspecified medications and reported that she did not know if it was due to the combination of them all. Follow up information was received on 03 November 2016 from the patient via a returned Authorization to Contact Physician form. The patient provided the BENLYSTA lot numbers of J295 and J286 (expiry dates unknown). The patient provided permission to contact her healthcare provider. Follow up information was received from the patient via GSK Response Center on 12th April 2017: The patient reported that she started BENLYSTA in June of 2016 and less than a month after receiving BENLYSTA she experienced a sinus infection which was treated with antibiotics. She resumed her BENLYSTA sometime after the infection was resolved. On 4th October 2016, Tuesday, the patient again received BENLYSTA infusion. The patient added that she had taken a flu shot that same week. On 5th October 2016, Wednesday, 1 day after BENLYSTA and less than a week after flu shot, the patient experienced throat swelling and was treated with BENADRYL, taken to the emergency department and admitted into the hospital, overnight for what she stated was an allergic reaction. The patient reported that she was taken off BENLYSTA at that time. The patient stated that she resumed the BENLYSTA infusions on Friday, 31st March 2017. On 11th April 2017, less than a month after BENLYSTA and less than a year after Flu vaccine the patient reported diarrhea which lasted until the morning of 12th April 2017. The patient stated that she had previously reported the allergic reaction from October 2016, but could not find any record of her contact information or a camel report. The patient's rheumatologist contact information was also provided.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Sinusitis
Clinical narrative: This case was reported by a consumer via patient support programs and described the occurrence of throat swelling in a 56-year-old female patient who received BENLYSTA powder for infusion for systemic lupus erythematosus. On an unknown date, the patient started BENLYSTA at an unknown dose at unknown dosing. On 5th October 2016, an unknown time after starting BENLYSTA, the patient experienced throat swelling, uvula swelling and adverse reaction. The action taken with BENLYSTA was unknown. On an unknown date, the outcome of the throat swelling, uvula swelling and adverse reaction were unknown. It was unknown if the reporter considered the throat swelling, uvula swelling and adverse reaction to be related to BENLYSTA. Additional details included that the reporter was the patient who reported the information via Patient Assistance Program. The patient reported that she took BENLYSTA "Tuesday and on Wednesday had a reaction and had to go to the hospital." The patient did not specify the reaction other than to say that her throat and uvula were massively swollen. The patient reported the use of other unspecified medications and reported that she did not know if it was due to the combination of them all. Follow up information was received on 03 November 2016 from the patient via a returned Authorization to Contact Physician form. The patient provided the BENLYSTA lot numbers of J295 and J286 (expiry dates unknown). The patient provided permission to contact her healthcare provider. Follow up information was received from the patient via GSK Response Center on 12th April 2017: The patient reported that she started BENLYSTA in June of 2016 and less than a month after receiving BENLYSTA she experienced a sinus infection which was treated with antibiotics. She resumed her BENLYSTA sometime after the infection was resolved. On 4th October 2016, Tuesday, the patient again received BENLYSTA infusion. The patient added that she had taken a flu shot that same week. On 5th October 2016, Wednesday, 1 day after BENLYSTA and less than a week after flu shot, the patient experienced throat swelling and was treated with BENADRYL, taken to the emergency department and admitted into the hospital, overnight for what she stated was an allergic reaction. The patient reported that she was taken off BENLYSTA at that time. The patient stated that she resumed the BENLYSTA infusions on Friday, 31st March 2017. On 11th April 2017, less than a month after BENLYSTA and less than a year after Flu vaccine the patient reported diarrhea which lasted until the morning of 12th April 2017. The patient stated that she had previously reported the allergic reaction from October 2016, but could not find any record of her contact information or a camel report. The patient's rheumatologist contact information was also provided.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Malaise
Clinical narrative: Patient stated got sicker than a dog the day after receiving vaccine. Patient prescribed TESSALON PERLES and SKELAXIN.
Age: 11.0
Sex: F
Vaccine: MENB
Symptoms: Syncope, Wrong drug administered
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of fainting in a 11-year-old female patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced fainting and wrong drug administered. On an unknown date, the outcome of the fainting and wrong drug administered were unknown. It was unknown if the reporter considered the fainting to be related to BEXSERO. Additional details were reported as follows: It was reported that the health care professional should have given a MENVEO to the patient but gave a BEXSERO, which led to wrong drug administered. The reporter had limited information and had no product information.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Erythema, Influenza like illness, Nasal congestion, Pain in extremity
Clinical narrative: Extreme Pain in arm which continued to escalate through the night into the following day, swelling and redness in upper arm, had chills and shaking overnight, stuffy nose, flu like feeling.  Finally felt better 04/19/2017 but still have swelling and some pain in upper arm area.   Treated with Advil and ice pack on arm.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling, Tremor
Clinical narrative: Extreme Pain in arm which continued to escalate through the night into the following day, swelling and redness in upper arm, had chills and shaking overnight, stuffy nose, flu like feeling.  Finally felt better 04/19/2017 but still have swelling and some pain in upper arm area.   Treated with Advil and ice pack on arm.
Age: 0.83
Sex: M
Vaccine: FLU4
Symptoms: Ear pain, Eye swelling, Generalised erythema, Headache, Mouth swelling
Clinical narrative: Face swelling, eyes swollen, mouth and tongue swollen. Severe redness over entire body, child screaming and clawing at head and ears.
Age: 0.83
Sex: M
Vaccine: FLU4
Symptoms: Screaming, Swelling face, Swollen tongue
Clinical narrative: Face swelling, eyes swollen, mouth and tongue swollen. Severe redness over entire body, child screaming and clawing at head and ears.
Age: 20.0
Sex: M
Vaccine: ANTH, JEV1, SMALL, TYP
Symptoms: Headache, Injection site erythema, Vomiting
Clinical narrative: Local redness at Smallpox vaccination site, headache, unable to hold food down for 3 days. Taken Ibuprofin (2 tablets for a total of 800mg) Visited Emergency room, quarters for one day as per ER.
Sex: F
Vaccine: HPVX
Symptoms: Abasia, Pain
Clinical narrative: This spontaneous non-valid report was received from a consumer via social media and refers to a female patient of unknown age (the reporter stated that she knew personally someone's daughter). The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with an unspecified human papillomavirus vaccine (manufacturer unknown) (dose, route, frequency, lot number and expiration date were not reported) for prophylaxis. Information regarding concomitant medications was not reported. On an unknown date, after vaccination, the patient experienced "the worst pain in her life" and couldn't even walk for weeks, after receiving the unspecified human papillomavirus vaccine (manufacturer unknown). No product quality complaint (PQC) was involved. At the reporting time, the outcome of abasia and severe pain was not reported. The reporter considered the events to be related to the unspecified human papillomavirus vaccine (manufacturer unknown). Upon internal review, the event abasia was considered to be a medically significant event and also serious due to consequent disability. Additionally, the reporter stated that she knew about some "devastating effects" after receiving the unspecified human papillomavirus vaccine (manufacturer unknown) (Captured in MARRS #: 1701USA008604) This is one of two reports received from the same reporter. Additional information is not expected, because the reporter could not be contacted.; Sender's Comments:  US-009507513-1701USA008604:
Sex: F
Vaccine: HPV4
Symptoms: Vaccination complication
Clinical narrative: Information was received from a consumer referring to his/her daughter of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On an unknown date, the patient was vaccinated with GARDASIL (lot#, expiration date, route, dose and frequency were unknown) for prophylaxis. After 3 weeks, the patient had some severe reactions. The reported said he/she meant just saying that the adverse reactions were not real, because these reactions were so vague and could mask as the glue that most doctors dismissed them, and did not actually know which tests to run to confirm these strange symptoms. The outcome of the severe reactions was unknown. The reporter knew the reactions were from the vaccine but few doctors would go to bat for his/her. Additional information is not expected, because there is no contact details.