chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain, Activities of daily living impaired, Aphagia, Diarrhoea, Fatigue
Clinical narrative: Extreme exhaustion/fatigue with severe body ache and neck pain onset at approximately 6:00PM, followed by head ache and migraine like symptoms impacting ability to function by 8:00PM. Sleep was attempted starting around 7:30-7:45PM, but not achieved. By this time abdominal pain and nausea were both present. At about 9:00PM patient began vomiting accompanied by diarrhea. Warm compress in combination with noise and light restriction helped with severe neck pain, but nausea and vomiting continued for at least 8 hours. At approximately 1:00 AM patient took an adult dose of diphenylhydramine HCl, generic brand to help with muscle aches and headache, immediately followed by vomiting. Patient has been unable to eat or drink without vomiting. At time of reporting, symptoms are still present. Plans to visit a doctor immediately should they worsen anymore have been made.
Age: 23.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Insomnia, Migraine, Myalgia, Nausea
Clinical narrative: Extreme exhaustion/fatigue with severe body ache and neck pain onset at approximately 6:00PM, followed by head ache and migraine like symptoms impacting ability to function by 8:00PM. Sleep was attempted starting around 7:30-7:45PM, but not achieved. By this time abdominal pain and nausea were both present. At about 9:00PM patient began vomiting accompanied by diarrhea. Warm compress in combination with noise and light restriction helped with severe neck pain, but nausea and vomiting continued for at least 8 hours. At approximately 1:00 AM patient took an adult dose of diphenylhydramine HCl, generic brand to help with muscle aches and headache, immediately followed by vomiting. Patient has been unable to eat or drink without vomiting. At time of reporting, symptoms are still present. Plans to visit a doctor immediately should they worsen anymore have been made.
Age: 23.0
Sex: F
Vaccine: FLUX
Symptoms: Neck pain, Pain, Vomiting
Clinical narrative: Extreme exhaustion/fatigue with severe body ache and neck pain onset at approximately 6:00PM, followed by head ache and migraine like symptoms impacting ability to function by 8:00PM. Sleep was attempted starting around 7:30-7:45PM, but not achieved. By this time abdominal pain and nausea were both present. At about 9:00PM patient began vomiting accompanied by diarrhea. Warm compress in combination with noise and light restriction helped with severe neck pain, but nausea and vomiting continued for at least 8 hours. At approximately 1:00 AM patient took an adult dose of diphenylhydramine HCl, generic brand to help with muscle aches and headache, immediately followed by vomiting. Patient has been unable to eat or drink without vomiting. At time of reporting, symptoms are still present. Plans to visit a doctor immediately should they worsen anymore have been made.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site joint swelling, Injection site mass, Injection site pain
Clinical narrative: Pt. states that left shoulder has swelling and lump is present at injection site. Pt. states she was fine day 0, 1 & 2. Slight tenderness at injection site only.  Symptoms worsened on day 3&4. Called HD on 03/19/2013 to report adverse event. States she is treating symptoms and I advised her to follow up with PCP if symptoms persist or worsen.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Computerised tomogram, Pancreatitis
Clinical narrative: This spontaneous report as received from a nurse practitioner via company representative refers to a 16 year old male patient. On 05-MAR-2013 the patient was vaccinated with his first dose of GARDASIL (lot number not provided). The patient was admitted to the hospital on 14-MAR-2013(no hospital details were provided, length of stay undetermined), and was diagnosed with pancreatitis. Lab diagnostics studies about CT and Cats Scan were performed without result provided. The outcome of pancreatitis was unknown. The relatedness for pancreatitis was unknown for GARDASIL. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Cardiac arrest, Death, Laboratory test normal, Syncope, Vomiting
Clinical narrative: A report was received from a physician via a medical representative concerning a 3 year old female. Her medical history, concurrent diseases, and concomitant medications were not reported. On an unknown date, she received nasal FLUMIST. The medical doctor mentioned that two to three years ago a previously healthy 3 year old female died within three days of receiving FLUMIST in her office. The medical representative was uncertain whether symptoms began shortly after dose or three days later. At an unspecified time period after FLUMIST, the patient started vomiting and collapsed. She was taken to hospital three days after receiving FLUMIST and died. The physician stated that all the tests were negative, and the child was afebrile. The medical representative was uncertain whether an autopsy was performed. She also stated that the doctor thought the death was related to FLUMIST. The official cause of death was cardiac arrest. On an unspecified date, the patient died from the event of cardiac arrest, and at the time of reporting the outcome of the event of collapse and vomiting was unknown. According to the reporter the adverse event of cardiac arrest was considered to be serious with the serious criteria of death and the adverse event of vomiting was considered to be non-serious. According to the company physician the adverse event of collapse was considered to be serious with the serious criteria of important medical event. According to the reporter the adverse events were causally related to the suspect drug of FLUMIST.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Hypophagia, Intussusception, Lethargy, Vomiting
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 3 month old female patient with no drug allergies. The patient's medical history included heart murmur. On 06-MAR-2013 the patient was vaccinated with the first dose of ROTATEQ (lot # reported as 0382AE, EXP 20-OCT-2013).There was no concomitant medication. On 13-MAR-2013, patient developed intussusception. The reporter reported the patient was lethargic, vomited one time and had decreased oral intake on 13-MAR-2013 and was hospitalized on 14-MAR-2013 in the Medical Center. The patient sought medical attention. The outcome of patient developed intussusception was reported as recovering/resolving. Additional information has been requested.
Age: 30.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Rash generalised
Clinical narrative: GENERALIZED RASH ON CHEST, ABDOMEN, AND BACK.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Joint range of motion decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Sore sholder and upper arm with impaired range of motion 3-20-13 PC from her to lodge a complaint about high dose flu vaccine. She said her arm was sore the next day and just keeps getting more and more sore. Now it is impairing her snow shoveling ability and she wanted to report it. Said it was her first dose of High Dose flu however our records indicate it was her third. She said she mentioned this to her doctor during her regular appointment and was diagnosed with possible tendonitis and physical therapy was recommended. She complained she has no transportation and decided not to go. I strongly recommended she see her doctor and do the PT.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Mobility decreased
Clinical narrative: Shoulder (site of injection) became very sore.  Put ice on it intermittently throughout the evening. By morning it was so sore, I could not raise my arm.  This lasted for 4 days.  When I called the clinic on 03/09, the nurse suggested I come in to be seen, but I didn't want to pay for Urgent Care. She suggested "heat or cold, whichever feels better."
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Dizziness, Hepatitis B antibody positive, Vomiting
Clinical narrative: 9/19/12 dizziness, vomiting, weakness x 2-3 days. No tx given. Pt did report symptoms. 10/17/12 dizziness, vomiting, weakness x 2-3 days. No tx given, pt. did not report symptoms.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Irritability, Pyrexia
Clinical narrative: Fever and irritability for 2 days.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Loss of consciousness
Clinical narrative: Passed out 5 minutes after vaccine given.
Age: 13.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Cough, Dyspnoea, Eye swelling, Swelling face, Urticaria
Clinical narrative: 1 1/2 hours after the vaccination, pt began to have swollen eye, face, hives all over her body, began to have coughing & difficulty breathing. Immediately saw in E.R. was treated with EPIPEN and steroid.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Cough, Dizziness, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Ached all over - myalgias, fatigue, malaise, lethargic, cold, lightheaded, diaphoresis (head), frontal headache, cough. Pain at injection site (L) deltoid. Lasted 4-5 days. Tx - rest, acetaminophen.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Lethargy, Malaise, Myalgia, Nasopharyngitis
Clinical narrative: Ached all over - myalgias, fatigue, malaise, lethargic, cold, lightheaded, diaphoresis (head), frontal headache, cough. Pain at injection site (L) deltoid. Lasted 4-5 days. Tx - rest, acetaminophen.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pain
Clinical narrative: Ached all over - myalgias, fatigue, malaise, lethargic, cold, lightheaded, diaphoresis (head), frontal headache, cough. Pain at injection site (L) deltoid. Lasted 4-5 days. Tx - rest, acetaminophen.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB, MMR
Symptoms: Full blood count normal, Pain in extremity, X-ray limb normal
Clinical narrative: Patient received vaccines in right thigh on 1/25/13. On 1/27/13 she was seen in the ER for left leg pain and sent to another facility for further evaluation of leg pain.
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HEP, PNC13, RV5
Symptoms: Full blood count normal, Pyrexia, Urine analysis normal
Clinical narrative: Hep B (ENGERIX B) given along with PEDIARIX. Pt developed high fever, 105.7 (R) the next am. Taken to ER 3/12/13.
Age: 5.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Arthralgia, Rash maculo-papular
Clinical narrative: Maculopapular rash. Arthralgia of the lower extremities currently with these symptoms. Symptomatic treatment being given at home.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: This spontaneous report was received from a physician refers to a 63 year old female patient. No medical history was reported. On 15-MAR-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot #, route, dose not reported). Concomitant therapies included ACTONEL. On an unknown date in March 2013, the patient had a raised red rash at the site of the injection site. The patient's rash was 3 inches in circumference, erythematous, warm and pruritic. Physician was recommending hydrocortisone cream. No treatment was received for the events. No medical attention was sought by the patient. The outcome of rash which was 3 inches in circumference, erythematous, warm and pruritic was unknown. The relatedness of the events with ZOSTAVAX was unknown. Additional information is not expected.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 year old female patient with no pertinent medical history and no drug reactions/allergies. On 23-FEB-2013 the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously (dose and lot # not reported). Concomitant medication included an unspecified antiviral medication (for an unspecified amount of time, on unspecified dates) at the time that the injection of ZOSTAVAX occurred. The patient developed a rash on 24-FEB-2013 that was larger than normal around the injection site of ZOSTAVAX. The pharmacist reported that the rash went away three days after it appeared. The outcome of rash around the injection site was reported as recovered. The patient sought unspecified medical attention. No treatment was given for the event. No lab diagnostics studies were performed. Additional information is not expected.
Sex: F
Vaccine: MMR
Symptoms: Idiopathic thrombocytopenic purpura
Clinical narrative: Information has been received from the Freedom of Information Act regarding a female (age not provided) who on 27Jan2010 was vaccinated with MMRII. As the result of this vaccine the patient developed idiopathic thrombocytopenia purpura (no date reported). Outcome of the event was not reported. It was noted the patient's immunization records were sent to CDC on 26May2010. Upon internal medical review, idiopathic thrombocytopenic purpura was considered medically significant. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A pharmacist reported that a 74 year old male consumer started ZOSTAVAX (expiry April 2012), 0.65 ml once, on 09-MAR-2013. The patient's relevant medical history concomitant medications, and past drug history, concomitant medications, and past drug history were unknown. On 09-MAR-2013, he was immunized with an expired dose of ZOSTAVAX, this was administered by a pharmacy student. According to the pharmacist, he was not experiencing any adverse reactions. His relevant laboratory data is unknown. As of 12-MAR-2013, it was unknown if he will continue to received ZOSTAVAX. The outcome of the patient's immunization with an expired dose of ZOSTAVAX was unknown. Additional information has been requested.
Age: 50.0
Sex: M
Vaccine: FLUX
Symptoms: Blood smear test abnormal, Ecchymosis, Evans syndrome, Gingival bleeding, Haemoglobin decreased
Clinical narrative: Case number PHHY2013US025419, is an initial literature report received on 13 Mar 2013. The author reports a case of Evans syndrome following influenza vaccine. This report refers to a 50-year-old male patient. He was vaccinated with influenza virus vaccine (manufacturer and batch number: unknown) on an unspecified date. On unknown date, four days after vaccination he presented to an emergency department (ED) with gum-bleeding and painless discoloration of his right hand for 1 day. Upon examination, he had bilateral petechial lesions on his sclera and multiple petechial lesions on his soft palate. A purpuric rash was noted on his left forearm, and he had ecchymosis on his right thenar eminence. He had a platelet count of less than 5 k/1/4L and a WBC count of 3.6 k/1/4L. In addition, thrombocytopenia was seen with a peripheral blood smear. The patient was admitted and treated with prednisone. However, his platelet count did not improve. He was treated with immune globulin, and his platelet count increased to 70 k/1/4L. He was discharged with a prednisone taper. One week later (unspecified date), he returned to the ED with gum-bleeding. His WBC count and haemoglobin level were 20.6 k/1/4L and 8.7 g/dL, respectively. His platelet count was less than 5 k/1/4L. A peripheral blood smear revealed thrombocytopenia with occasional spherocytes, and he also had a hypercellular marrow with erythroid and megakaryocytic hyperplasia. He was treated with immune globulin and methylprednisolone. His condition improved gradually, and he was discharged on prednisone. At last follow-up, his platelet count had improved to 200 k/1/4L. Causality of the events was not reported. The outcome of the events was not reported.
Age: 50.0
Sex: M
Vaccine: FLUX
Symptoms: Immunoglobulin therapy, Marrow hyperplasia, Megakaryocytes increased, Mouth haemorrhage, Petechiae
Clinical narrative: Case number PHHY2013US025419, is an initial literature report received on 13 Mar 2013. The author reports a case of Evans syndrome following influenza vaccine. This report refers to a 50-year-old male patient. He was vaccinated with influenza virus vaccine (manufacturer and batch number: unknown) on an unspecified date. On unknown date, four days after vaccination he presented to an emergency department (ED) with gum-bleeding and painless discoloration of his right hand for 1 day. Upon examination, he had bilateral petechial lesions on his sclera and multiple petechial lesions on his soft palate. A purpuric rash was noted on his left forearm, and he had ecchymosis on his right thenar eminence. He had a platelet count of less than 5 k/1/4L and a WBC count of 3.6 k/1/4L. In addition, thrombocytopenia was seen with a peripheral blood smear. The patient was admitted and treated with prednisone. However, his platelet count did not improve. He was treated with immune globulin, and his platelet count increased to 70 k/1/4L. He was discharged with a prednisone taper. One week later (unspecified date), he returned to the ED with gum-bleeding. His WBC count and haemoglobin level were 20.6 k/1/4L and 8.7 g/dL, respectively. His platelet count was less than 5 k/1/4L. A peripheral blood smear revealed thrombocytopenia with occasional spherocytes, and he also had a hypercellular marrow with erythroid and megakaryocytic hyperplasia. He was treated with immune globulin and methylprednisolone. His condition improved gradually, and he was discharged on prednisone. At last follow-up, his platelet count had improved to 200 k/1/4L. Causality of the events was not reported. The outcome of the events was not reported.
Age: 50.0
Sex: M
Vaccine: FLUX
Symptoms: Platelet count decreased, Purpura, Red blood cell spherocytes present, Skin discolouration, Thrombocytopenia
Clinical narrative: Case number PHHY2013US025419, is an initial literature report received on 13 Mar 2013. The author reports a case of Evans syndrome following influenza vaccine. This report refers to a 50-year-old male patient. He was vaccinated with influenza virus vaccine (manufacturer and batch number: unknown) on an unspecified date. On unknown date, four days after vaccination he presented to an emergency department (ED) with gum-bleeding and painless discoloration of his right hand for 1 day. Upon examination, he had bilateral petechial lesions on his sclera and multiple petechial lesions on his soft palate. A purpuric rash was noted on his left forearm, and he had ecchymosis on his right thenar eminence. He had a platelet count of less than 5 k/1/4L and a WBC count of 3.6 k/1/4L. In addition, thrombocytopenia was seen with a peripheral blood smear. The patient was admitted and treated with prednisone. However, his platelet count did not improve. He was treated with immune globulin, and his platelet count increased to 70 k/1/4L. He was discharged with a prednisone taper. One week later (unspecified date), he returned to the ED with gum-bleeding. His WBC count and haemoglobin level were 20.6 k/1/4L and 8.7 g/dL, respectively. His platelet count was less than 5 k/1/4L. A peripheral blood smear revealed thrombocytopenia with occasional spherocytes, and he also had a hypercellular marrow with erythroid and megakaryocytic hyperplasia. He was treated with immune globulin and methylprednisolone. His condition improved gradually, and he was discharged on prednisone. At last follow-up, his platelet count had improved to 200 k/1/4L. Causality of the events was not reported. The outcome of the events was not reported.
Age: 50.0
Sex: M
Vaccine: FLUX
Symptoms: White blood cell count decreased, White blood cell count increased
Clinical narrative: Case number PHHY2013US025419, is an initial literature report received on 13 Mar 2013. The author reports a case of Evans syndrome following influenza vaccine. This report refers to a 50-year-old male patient. He was vaccinated with influenza virus vaccine (manufacturer and batch number: unknown) on an unspecified date. On unknown date, four days after vaccination he presented to an emergency department (ED) with gum-bleeding and painless discoloration of his right hand for 1 day. Upon examination, he had bilateral petechial lesions on his sclera and multiple petechial lesions on his soft palate. A purpuric rash was noted on his left forearm, and he had ecchymosis on his right thenar eminence. He had a platelet count of less than 5 k/1/4L and a WBC count of 3.6 k/1/4L. In addition, thrombocytopenia was seen with a peripheral blood smear. The patient was admitted and treated with prednisone. However, his platelet count did not improve. He was treated with immune globulin, and his platelet count increased to 70 k/1/4L. He was discharged with a prednisone taper. One week later (unspecified date), he returned to the ED with gum-bleeding. His WBC count and haemoglobin level were 20.6 k/1/4L and 8.7 g/dL, respectively. His platelet count was less than 5 k/1/4L. A peripheral blood smear revealed thrombocytopenia with occasional spherocytes, and he also had a hypercellular marrow with erythroid and megakaryocytic hyperplasia. He was treated with immune globulin and methylprednisolone. His condition improved gradually, and he was discharged on prednisone. At last follow-up, his platelet count had improved to 200 k/1/4L. Causality of the events was not reported. The outcome of the events was not reported.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site reaction, Rash vesicular, Varicella virus test, Viral test
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse (LPN) refers to a 5 year old female patient with none concomitant medications, pertinent medical history or drug reactions/allergies. The LPN reported that in September 2011 the patient was vaccinated with (merck) VARIVAX (lot # H017440, expiration date 19-SEP-2014), first dose, 0.5 ml, subcutaneous (anatomical location unspecified). On 08-MAR-2013 the patient was vaccinated with (merck) VARIVAX (lot # and expiration date unspecified) dose 2, 0.5ml, subcutaneous (Anatomical location unspecified). The LPN reported that on 10-MAR-2013 the patient developed a varicella-like rash around the injection site. Nurse stated that the lesions were localized to the injection site. The patient was seen by pediatrician on an unknown date. The pediatrician cultured the vesicles at the injection site for Varicella zoster virus (VZV) identification done in the office on an unknown date. No treatment was given. At the time of the report the outcome of varicella-like rash at the injection site was unknown. Additional information is not expected.
Sex: M
Vaccine: MMR
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report was received from a consumer (mother) refers to a male patient of unknown age. On an unknown date the patient was vaccinated with measles, mumps, and rubella virus vaccine, live(manufacturer unknown) (lot#, expiration date and route not reported). Patient's mother called to inquire about monovalent vaccine availability. On an unknown date the patient experienced a bad reaction after a monovalent vaccine meant for either: measles, mumps or rubella. The outcome of the event was unknown. Causality was not reported. Additional information is not expected.
Age: 64.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report as received from a health professional (registered nurse) refers to a patient of unknown age who was administered two doses of RECOMBIVAX HB (to equal one adult dose) (5 mcg/0.5 ml), intramuscular (lot # not reported) on 28-AUg-2012 for the first dose in the series, then only one pediatric dose of RECOMBIVAX HB (5 mcg/0.5 ml), intramuscular (lot # not reported) on 31-OCT-2012 for the second dose in the series, and then two pediatric doses of RECOMBIVAX HB (to equal one adult dose) (5 mcg/0.5 ml), intramuscular (lot # not reported) on 11-MAR-2013 for the third dose in the series. No adverse effect reported. Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: RV5
Symptoms: Productive cough, Vomiting
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to a 4 month old male. Concurrent conditions included cystic fibrosis. On 16-JAN-2013 the patient was vaccinated with dose 1, oral, ROTATEQ (lot #, expiration date and route not reported). Concomitant medications included CREON. Approximately on 30-JAN-2013 (reported as 2 to 3 weeks after receiving the first dose) the patient experienced cough with thick mucus accompanied by some vomiting. The outcome of cough with thick mucus accompanied by some vomiting and vomiting was reported as recovered/resolved on an unknown date in 2013. The patient was treated with steroid and antibiotics for the events. The patient sought medical attention by office visit. The patient was in office at the time of this report, but it was unknown if a second dose of oral, ROTATEQ would be administered. Causality was not reported. Additional information is not expected.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: This spontaneous report as received from a nurse refers to a 74 year old female patient. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (route, dose and lot # were unknown). The patient had pneumonia two times on unspecified dates. The outcome of event was unknown. The relationship between event and PNEUMOVAX 23 was unknown. Additional information has been requested.
Age: 30.0
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 30 years patient. On an unknown date, the physician had prescribed GARDASIL (dose, route, and lot# unknown) to the 30 year old patient and no adverse effects reported. No other co-suspects were reported. No concomitant medications were reported. It was unknown if the patient had sought medical attention. The outcome and action taken were unknown. The reporter did not provide assessment of the relationship of the adverse event to the suspect therapy. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site reaction, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Started with itchy, red, raised rash on upper arms and right lower abdomen.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Bronchospasm, Cough, Lacrimation increased, Rhinorrhoea, Salivary hypersecretion
Clinical narrative: CHILD WAS GIVEN IMMUNIZATIONS [DTAP, IPV, MMR, VARIVAX].  FEW MINUTES AFTER ADMINISTERED VACCINES, DEVELOPED RHINORRHEA, SALIVATION, LACRIMATION, COUGH AND BRONCHIOSPASM.  IMMEDIATELY WAS TREATED WITH ALBUTEROL VIA NEB AND EPINEPHRINE 1:10,000 SC.
Age: 0.55
Sex: M
Vaccine: DTAP, FLU3, HIBV, IPV, PNC
Symptoms: Blepharospasm, Blood test, Dyskinesia, Electroencephalogram
Clinical narrative: Whole body jerking and twitching of eyes.
Age: 20.0
Sex: M
Vaccine: HEPA, MMR
Symptoms: Dyskinesia, Dyspnoea, Hypoaesthesia oral, Joint contracture, Speech disorder
Clinical narrative: Patient is a basic trainee, otherwise in excellent health.  He was immunized with MMR (second immunization, did not have protective titers to rubeola, did have + rubella titer) and Hepatitis A (negative titer prior to immunization).  He was also given prophylactic Bicillin injection as well.  Two hours after getting all three injections, patient noticed "numbness" of the lip, "difficulty controlling body" (difficulty breathing and talking and contracting hands.  Did not loss conciousness.  Did not have congestion, difficulty swallowing or throat itching, no wheezing, no nausea/abdominal cramping, no hives.  Transported to Urgent Care Center by ambulance.  Treated with steroids and antihistamines (not sure about epinephrine) and symptoms resolved.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Cold sweat, Headache, Injection site pain, Injection site pruritus
Clinical narrative: Cold sweat, headache, nausea, stomach ache, pain and itching at injection site x3 days. Rest and fluids.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea
Clinical narrative: Cold sweat, headache, nausea, stomach ache, pain and itching at injection site x3 days. Rest and fluids.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Respiratory tract infection
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a late 60's year old female patient. On an unknown date the patient was vaccinated with ZOSTAVAX (lot #, route and dose unknown) 1 injection for shingles vaccination. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced respiratory infection and fever of 102 degrees post vaccination. The patient had sought medical attention by spoke with the nurse practitioner. No PQC involved. The outcome was reported as recovered/resolved on an unknown date. Action taken was not provided. The reporter did not provide assessment of the relationship of the adverse event to the suspect therapy. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Immediate post-injection reaction, Neck pain, Pain in extremity
Clinical narrative: This spontaneous report as received from a health professional refers to a 25 year old female patient. The patients medical history included car accident with neck whiplash approximately on an unknown date in February 2013 (reported as few weeks before vaccination). On 06-MAR-2013, the patient was vaccinated with a dose of GARDASIL (lot # H017698, expiry date was 02-JUL-2015, route and dose were not reported). On 06-MAR-2013, the patient became light headed immediately after vaccination. Approximately on 10-MAR-2013 (reported as 4-5 days after vaccination), the patient developed a sore arm and pain radiated into her neck. Laboratory tests performed was none. The patient sought medical attention and fluids were given for the event light headedness. In response to the events GARDASIL was discontinued on 06-MAR-2013. Approximately on an unknown date in MARCH 2013, the patient recovered from all the reported events. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Activities of daily living impaired, Chills, Contusion, Erythema, Induration
Clinical narrative: This spontaneous report as received from a certified registered nurse practitioner (CRNP) referred to a 65 year old male patient Rheumatoid arthritis (RA), vitamin D deficiency and with drug reactions/allergies to Penicillin, prednisone, SEROMYCIN and sulfa. On 28-FEB-2013 at 11:10 AM, the patient was vaccinated with a dose of ZOSTAVAX (lot # H013943, subcutaneous in the left upper arm, dose unspecified). On 28-FEB-2013 at PM the patient experienced burning on injection, which continued with the rest day. Bright red area 5cm X 4cm raised and hard area, felt like a major bruise. Itching and stinging. Chills started through night and continued to last presently. "Can't get washed." Taking BENADRYL for itching and reaction symptom since Friday. The outcome of all events were unknown. Causality were not provided. All the events were considered as other significant medical events (required medical intervention) by reporter. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Local swelling, Pain, Pruritus
Clinical narrative: This spontaneous report as received from a certified registered nurse practitioner (CRNP) referred to a 65 year old male patient Rheumatoid arthritis (RA), vitamin D deficiency and with drug reactions/allergies to Penicillin, prednisone, SEROMYCIN and sulfa. On 28-FEB-2013 at 11:10 AM, the patient was vaccinated with a dose of ZOSTAVAX (lot # H013943, subcutaneous in the left upper arm, dose unspecified). On 28-FEB-2013 at PM the patient experienced burning on injection, which continued with the rest day. Bright red area 5cm X 4cm raised and hard area, felt like a major bruise. Itching and stinging. Chills started through night and continued to last presently. "Can't get washed." Taking BENADRYL for itching and reaction symptom since Friday. The outcome of all events were unknown. Causality were not provided. All the events were considered as other significant medical events (required medical intervention) by reporter. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Diarrhoea, Feeling cold, Hyperhidrosis, Injection site erythema, Injection site swelling
Clinical narrative: Diarrhea & felt cold, shaky, sweating, also redness and swelling around injection site. Cephalexin 500 mg QID.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Nervousness
Clinical narrative: Diarrhea & felt cold, shaky, sweating, also redness and swelling around injection site. Cephalexin 500 mg QID.
Age: 5.0
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician assistant refers to a 5 year old patient of unknown gender. No medical history was reported. On 16-MAR-2013, the 5 year old patient was inadvertently vaccinated with a 0.5 milliliter (ml) dose of GARDASIL (lot #, expiry not reported), intramuscularly. No concomitant medications were reported. No adverse effect reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Dizziness, Pain in extremity
Clinical narrative: Sore arm for almost a month. Lightheadedness transient.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Syncope, Vomiting
Clinical narrative: Pt fainted and started vomiting immediately.
Age: 0.51
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Convulsion, Pyrexia
Clinical narrative: Patient received vaccinations on 3/11/13. In the next 24 hours she developed increased fever associated with an episode of seizures (x 2) that lasted > 15 min. Patient recovered completely (Hospitalized x 2 days).
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Anaemia, Atrial fibrillation, Autoimmune disorder, Chronic obstructive pulmonary disease, Decreased appetite
Clinical narrative: Started w/ rash, swelling of face & neck, numbness in feet & legs. Swelling of tongue followed with difficulty breathing, sores in mouth, permanent A-Fib, anemia from ulcer caused by excessive medications w/ no appetite. Eventually, diagnosed with COPD & A-Fib & autoimmune disorder, yeast infections, fungus on extremities.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Fungal infection, Fungal skin infection, Hypoaesthesia, Local swelling
Clinical narrative: Started w/ rash, swelling of face & neck, numbness in feet & legs. Swelling of tongue followed with difficulty breathing, sores in mouth, permanent A-Fib, anemia from ulcer caused by excessive medications w/ no appetite. Eventually, diagnosed with COPD & A-Fib & autoimmune disorder, yeast infections, fungus on extremities.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Stomatitis, Swelling face, Swollen tongue, Ulcer
Clinical narrative: Started w/ rash, swelling of face & neck, numbness in feet & legs. Swelling of tongue followed with difficulty breathing, sores in mouth, permanent A-Fib, anemia from ulcer caused by excessive medications w/ no appetite. Eventually, diagnosed with COPD & A-Fib & autoimmune disorder, yeast infections, fungus on extremities.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: RASH ON BUTTOCKS, STARTING ON ONE SIDE THEN SPREADING TO OTHER SIDE.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: SORE ARM.
Age: 2.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Febrile convulsion
Clinical narrative: Patients PCP called to advise that child had been seen overnight at the ER for febrile seizures.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Rash erythematous, Rash pruritic, Skin warm
Clinical narrative: After administration of Zostavax, patients left arm turned red and warm. Three hours later, the back of the arm above the right elbow also turned red and warm. Patient was encouraged to go see a doctor. Cephalexin and cetirizine were prescribed for reaction. Day five following immunization, reaction on both arms went away. However, on day eight following immunization, patient noticed five red spots that itched on her right arm in the same spot the initial reaction was reported. Patient reported that reaction had fully resolved by the 10th day.
Age: 31.0
Sex: F
Vaccine: HEP, HEPA, JEV1, TDAP
Symptoms: Injection site pain, Pain
Clinical narrative: Pain and tender to the touch in right upper deltoid where Adacel was administered for several weeks after administration. Patient reported the symptoms to our pharmacy on 2/27/13 after receiving 4 vaccines (Havrix  R lower delt; Engerix B  L lower delt; Ixiaro  L upper delt) on 1/28/13. She had minor pain at injection sites from the other 3 vaccines that resolved after 3-4 days. The pain at the site of Adacel vaccine continues with pain of 3/10 and max of 5/10 when she uses her arm. Pain is worsened when lifts arm to drive, uses arm, or lifts weights. The patient does report that she has been lifting weights daily starting the day of vaccination. She currently has no pain in left arm.
Age: 6.0
Sex: F
Vaccine: FLU3, HEPA, IPV, VARCEL
Symptoms: Erythema, Injection site erythema, Injection site urticaria, Pruritus, Pyrexia
Clinical narrative: Per mom, the pt was first noticed to have an itchy right earlobe 3 days after the vaccines were administered.  This went away and then her cheek got red and itchy.  After that disappeared she has had small welts appear on her right, upper arm and thigh surrounded by red tissue.  The welts and redness are spread in an area of about a dollar bill on her the lateral aspect of her right thigh and the area on her arm was not visible at the time of assessment.  Mom states the pt did have a fever of 101 the night after the imms were given.
Age: 6.0
Sex: F
Vaccine: FLU3, HEPA, IPV, VARCEL
Symptoms: Urticaria
Clinical narrative: Per mom, the pt was first noticed to have an itchy right earlobe 3 days after the vaccines were administered.  This went away and then her cheek got red and itchy.  After that disappeared she has had small welts appear on her right, upper arm and thigh surrounded by red tissue.  The welts and redness are spread in an area of about a dollar bill on her the lateral aspect of her right thigh and the area on her arm was not visible at the time of assessment.  Mom states the pt did have a fever of 101 the night after the imms were given.
Age: 10.0
Sex: M
Vaccine: IPV, MMR, TDAP, VARCEL
Symptoms: Herpes zoster, Injection site dermatitis, Injection site reaction, Paraesthesia, Pyrexia
Clinical narrative: 3/14/13 - patient feverish, started with small dermatitis on upper right arm. Came into clinic 3/15/13 and seen by NP. Discharged with dermatitis diagnosis. 3/20/13 patient returns to clinic still complaining of fever and worsening rash and tingling down right arm. Upon exam, Nurse Practitioner diagnoses Zoster due to very apparent Zoster lesions on upper right arm.
Age: 10.0
Sex: M
Vaccine: IPV, MMR, TDAP, VARCEL
Symptoms: Rash
Clinical narrative: 3/14/13 - patient feverish, started with small dermatitis on upper right arm. Came into clinic 3/15/13 and seen by NP. Discharged with dermatitis diagnosis. 3/20/13 patient returns to clinic still complaining of fever and worsening rash and tingling down right arm. Upon exam, Nurse Practitioner diagnoses Zoster due to very apparent Zoster lesions on upper right arm.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Head injury, Loss of consciousness
Clinical narrative: HPV injection given at 1540. Patient experienced a brief LOC (<10 sec) post injection at 1541. Slumped in chair and hit forehead on medication freezer in the Pediatric Immunization Room.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Injection site erythema, Injection site swelling, Joint swelling, Oedema peripheral
Clinical narrative: Redness & swelling to injection site few hours after delivery. Benadryl taken & swelling improved the next day. That evening (2/5/13) @ 5 PM swelling & pain noted to Left elbow and upper forearm; no fever. Seen 2/6/13: Cephalexin 500mg TID started, along with instructions to ice and elevate arm.  Follow up on 2/7/13 - "SKIN:  decreasing erythema and edema in left UE, decresed central rubor, nontender to touch."
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Redness & swelling to injection site few hours after delivery. Benadryl taken & swelling improved the next day. That evening (2/5/13) @ 5 PM swelling & pain noted to Left elbow and upper forearm; no fever. Seen 2/6/13: Cephalexin 500mg TID started, along with instructions to ice and elevate arm.  Follow up on 2/7/13 - "SKIN:  decreasing erythema and edema in left UE, decresed central rubor, nontender to touch."
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site warmth
Clinical narrative: Hard red lump at injection site, increased from 5 cm up to 7 cm or slightly more over the course of the day. Very warm to the touch, not bumpy, just hard lump.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pyrexia
Clinical narrative: Redness, fever.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: Generalized hives following shingles vaccine. Lasted 1 week. Treated with BENADRYL for itchiness.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain
Clinical narrative: Pt received 2nd Hep B shot (of 3) on 3/10/13. On 3/19/13 pt c/o pain to (L) shoulder area proximal to injection site. No swelling, bruising or deformity noted. Pain non-reproducible with touch. Pain increased with lateral extension & elevation. Pt states pain onset began approximately 2 days from this date (3/17/13) but did not report until 3/19/13.
Age: 0.71
Sex: F
Vaccine: FLU3
Symptoms: Erythema multiforme
Clinical narrative: Erythema multiforme minor.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Diarrhoea, Flushing, Myalgia, Nausea, Peripheral coldness
Clinical narrative: Initial report received from a consumer (patient's parent) who is also a healthcare professional on 09 August 2012. A 17-year-old male patient, who had no known allergies and whose concomitant medications were not reported, received a dose of MENACTRA (lot number U4052AD, route and site of vaccination not reported) on 06 August 2012. 36 hours after vaccination, the patient developed nausea, flushing, burning of skin, myalgia, diarrhea and warm body core with cold extremities. Corrective medications and laboratory investigations were not reported. The patient's outcome was not recovered. List of documents held by sender: None.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Skin burning sensation
Clinical narrative: Initial report received from a consumer (patient's parent) who is also a healthcare professional on 09 August 2012. A 17-year-old male patient, who had no known allergies and whose concomitant medications were not reported, received a dose of MENACTRA (lot number U4052AD, route and site of vaccination not reported) on 06 August 2012. 36 hours after vaccination, the patient developed nausea, flushing, burning of skin, myalgia, diarrhea and warm body core with cold extremities. Corrective medications and laboratory investigations were not reported. The patient's outcome was not recovered. List of documents held by sender: None.
Age: 28.0
Sex: M
Vaccine: MNQ
Symptoms: Induration
Clinical narrative: Induration. Documents held by sender: none.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Body temperature increased, Chills, Laboratory test normal, Malaise, Oropharyngeal pain
Clinical narrative: Initial report received from a health care professional on 07 September 2012. The 18-year-old female patient who was undergoing workup for Crohn's disease and had no reported concomitant medication received third dose of MENACTRA (batch number: U4345AA)intramuscularly in her left deltoid region and Tubersol (Batch number: C4173AA)on her left forearm (route, dose, dose number not reported) on 29 August 2012. The patient previously received two doses of MENACTRA on 19 June 2008 and 08 August 2011. It was reported that , the patient has not felt well since vaccination on 29 August 2012. On 01 September 2012 the patient was seen in URI and on 04 September 2012 she visited ER for the same. On 04 September 2012 the patient was seen for URI, sore throat, chills and temperature 99.4. The patient was treated with nebulizer and the meeting with MD was canceled. The patient's laboratory investigation for blood work was pending. The outcome of the events was reported as not recovered. Documents held by sender: none. Follow-up information was received from a healthcare professional on 10 December 2012. The responsible physicians contact details were updated. The patients laboratory work-up was unremarkable/normal.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Upper respiratory tract infection
Clinical narrative: Initial report received from a health care professional on 07 September 2012. The 18-year-old female patient who was undergoing workup for Crohn's disease and had no reported concomitant medication received third dose of MENACTRA (batch number: U4345AA)intramuscularly in her left deltoid region and Tubersol (Batch number: C4173AA)on her left forearm (route, dose, dose number not reported) on 29 August 2012. The patient previously received two doses of MENACTRA on 19 June 2008 and 08 August 2011. It was reported that , the patient has not felt well since vaccination on 29 August 2012. On 01 September 2012 the patient was seen in URI and on 04 September 2012 she visited ER for the same. On 04 September 2012 the patient was seen for URI, sore throat, chills and temperature 99.4. The patient was treated with nebulizer and the meeting with MD was canceled. The patient's laboratory investigation for blood work was pending. The outcome of the events was reported as not recovered. Documents held by sender: none. Follow-up information was received from a healthcare professional on 10 December 2012. The responsible physicians contact details were updated. The patients laboratory work-up was unremarkable/normal.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Oedema peripheral, Sunburn, Swelling
Clinical narrative: Initial report received from a healthcare professional (Nurse) on 20 August 2012. A male patient, whose medical history was not reported; had received MENACTRA vaccine sanofi pasteur Inc. (batch number U4341AA, route, site of administration, dose, dose number were not reported) on 16 June 2012. The patient had concomitant medication of metacycline. On next day patient was out in the sun and got sunburned. The patient had lot of swelling (head and scalp) and got worse in his legs, some were swollen. Details of lab tests and treatment were not reported. The patient's outcome was not reported. Documents held by sender: None.
Sex: M
Vaccine: HPVX, MNQ, TDAP
Symptoms: Injection site erythema, Injection site haemorrhage
Clinical narrative: Initial report received on from a healthcare professional on 18 May 2012. A male patient, whose age, medical history and concomitant medications were not reported, had received a dose of MENACTRA vaccine (batch number, route of administration were not reported) and HPV on the same arm and a dose of Tdap vaccine (batch number, route and site of administration were not reported) on 17 May 2012. The reporter stated that, after vaccination on 17 May 2012, the patient left office and was fine, no bleeding. Later in the middle of night, the patient woke up bleeding from the site where MENACTRA vaccine was given. There was significant blood which was all over the bathroom and all over the floor. When the patient was seen on 18 May 2012, the bleeding had stopped and there was no bruising however there was a red spot about 2.5 in X 1 in about 2 in below the injection site which does not look like it was scratched. The corrective treatments were not reported. The event of bleeding was stopped (date was not specified) and the outcome of event red spot was not reported. List of documents held by sender: None.