chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction
Clinical narrative: This spontaneous report was received from a pharmacy employee referring to a female patient of unknown age who was a pharmacist. The patient's concurrent conditions, medical history, drug reactions and allergies were unspecified by the reporter. On approximately 12-MAR-2016 (reported as "about 5 days ago"), the patient was vaccinated with a dose of ZOSTAVAX subcutaneous injection (dose, concentration, dose number, anatomical site of vaccination, lot# and expiration date were not provided). Concomitant therapies were not reported. On the same date and shortly after the vaccination with ZOSTAVAX, the patient experienced an injection site reaction and complained of pain, redness and itching at injection site, which the reporter stated that "lasted about 4 days". No product quality complaint was involved. There was no intervention to prevent serious criteria, the events were not cancer or overdose, the patient did not die, there was no significant disability or incapacity, no hospitalization and the events were not life-threatening. The patient did not seek for medical attention and was unspecified by the reporter if lab tests were performed. At the time of the report, the outcome of the injection site reaction, injection site pruritus, injection site erythema and injection site pain was reported as recovering. The reporter did not assessed a causality assessment between ZOSTAVAX and the events. Additional information is not expected, as no contact details were provided.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain, Chest discomfort, Chest pain, Cough, Dizziness
Clinical narrative: Body ache, pain at the injection site, rash, extreme fatigue, tiredness, extreme redness/swelling upper left arm (felt like arm was going to drop off), swelling of the throat, needing to hold chest due to pain when coughing, dizziness, difficulty breathing, fast heart beat, tightness in the chest, numbness/tingling between fingers and toes.  For months after the shot, continued to feel a dull ache at site of the shot.  Eventually had on-going abdominal pain.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Dyspnoea, Fatigue, Heart rate increased, Hypoaesthesia, Injection site erythema
Clinical narrative: Body ache, pain at the injection site, rash, extreme fatigue, tiredness, extreme redness/swelling upper left arm (felt like arm was going to drop off), swelling of the throat, needing to hold chest due to pain when coughing, dizziness, difficulty breathing, fast heart beat, tightness in the chest, numbness/tingling between fingers and toes.  For months after the shot, continued to feel a dull ache at site of the shot.  Eventually had on-going abdominal pain.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Pain, Pharyngeal oedema, Rash
Clinical narrative: Body ache, pain at the injection site, rash, extreme fatigue, tiredness, extreme redness/swelling upper left arm (felt like arm was going to drop off), swelling of the throat, needing to hold chest due to pain when coughing, dizziness, difficulty breathing, fast heart beat, tightness in the chest, numbness/tingling between fingers and toes.  For months after the shot, continued to feel a dull ache at site of the shot.  Eventually had on-going abdominal pain.
Age: 54.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site pain, Nuclear magnetic resonance imaging abnormal, Rotator cuff repair, Rotator cuff syndrome
Clinical narrative: PCV 13 vaccine administered 5/30/2015 right arm at shoulder level. Immediate pain that increased progressively within hours. Pain severe. Limited ROM. IV NSAIDS steroid (oral) and Rt shoulder joint injection, physical therapy. MRI showed rotator cuff tear. Surgery 4/28/5 on rt shoulder showed sm tear and frozen shoulder. Still in physical therapy.
Age: 54.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site injury, Injection site pain, Injection site reaction
Clinical narrative: PCV 13 vaccine administered 5/30/2015 right arm at shoulder level. Immediate pain that increased progressively within hours. Pain severe. Limited ROM. IV NSAIDS steroid (oral) and Rt shoulder joint injection, physical therapy. MRI showed rotator cuff tear. Surgery 4/28/5 on rt shoulder showed sm tear and frozen shoulder. Still in physical therapy.
Age: 54.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Nuclear magnetic resonance imaging abnormal, Periarthritis, Rotator cuff syndrome, Shoulder operation
Clinical narrative: PCV 13 vaccine administered 5/30/2015 right arm at shoulder level. Immediate pain that increased progressively within hours. Pain severe. Limited ROM. IV NSAIDS steroid (oral) and Rt shoulder joint injection, physical therapy. MRI showed rotator cuff tear. Surgery 4/28/5 on rt shoulder showed sm tear and frozen shoulder. Still in physical therapy.
Age: 0.51
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Cough, Dyspnoea, Lethargy, Pallor, Respiratory arrest
Clinical narrative: 6 month old female via EMS, mother reports rcvd 6 month immunizations today, ~1 hour PTA had episode of increased lethargy, trouble breathing. Reports EMS had to sternal rub multiple times for baby to stay awake en route here.  Mother reports child had immunizations today.  After returning home she coughed and "stopped breathing" for approximately 2 min.  No seizure activity noted. The father states the child was pale.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician referring to his wife, a 60 year old female patient with asthma and allergy to sulfonamides. The patient's medical history included cytopenia, mild hemolytic anemia and hemochromatosis. On 18-MAR-2016 the patient was vaccinated with a dose of ZOSTAVAX (dose and lot# were unknown) subcutaneously at an unspecified pharmacy. Concomitant therapies included SPIRIVA, SINGULAIR and albuterol. On 24-MAR-2016, the patient called the reporter and her primary physician for medical attention since she experienced dermatomal pain over half of her scalp on the right side. The reporter also stated that on 25-MAR-2016 the patient began having a "small papular eruption" above her right eyebrow. Varicella zoster virus identification program (VZVIP) packet was forwarded to the physician. No treatment was given and no lab test was performed. The outcome of the events was reported as not recovered. Causality was not provided. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain of skin, Rash papular
Clinical narrative: Information has been received from a physician referring to his wife, a 60 year old female patient with asthma and allergy to sulfonamides. The patient's medical history included cytopenia, mild hemolytic anemia and hemochromatosis. On 18-MAR-2016 the patient was vaccinated with a dose of ZOSTAVAX (dose and lot# were unknown) subcutaneously at an unspecified pharmacy. Concomitant therapies included SPIRIVA, SINGULAIR and albuterol. On 24-MAR-2016, the patient called the reporter and her primary physician for medical attention since she experienced dermatomal pain over half of her scalp on the right side. The reporter also stated that on 25-MAR-2016 the patient began having a "small papular eruption" above her right eyebrow. Varicella zoster virus identification program (VZVIP) packet was forwarded to the physician. No treatment was given and no lab test was performed. The outcome of the events was reported as not recovered. Causality was not provided. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Shoulder and upper arm extremely swollen, red, and hot.
Sex: F
Vaccine: RAB
Symptoms: Headache
Clinical narrative: Initial unsolicited report received from a pharmacist on 05 November 2015. This case involves a female (age unknown) patient who was vaccinated with a dose of RABIES VACCINE (RABIES) (batch number, expiry date, route and site of administration were not reported) on an unspecified date (six months ago). Medical history and concomitant medications were not reported. On an unspecified date, six months following the vaccination patient experienced headaches. Laboratory investigation and corrective treatment were not reported. The outcome of event was unknown. List of documents held by sender: none.
Age: 0.73
Sex: F
Vaccine: HIBV, PPV
Symptoms: Pyrexia
Clinical narrative: Only got Hib & PC vaccines.  Fever of 101 @ 7am.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Decreased appetite, Fatigue, Malaise, Pain
Clinical narrative: Information has been received from a nurse referring to an approximately 16 year old female patient via Pfizer and was assigned manufacturer report number 2016150434 for TRUMENBA on 24-MAR-2016. On an unknown date the patient was vaccinated with a dose of GARDASIL (lot#, expiration date and route not reported). The nurse reported that on 09-MAR-2016 the patient was vaccinated with both TRUMENBA and MENACTRA during the same visit. Almost immediately after receiving the vaccines, the patient did not feel well and experienced general body aches, extreme fatigue (did not want to get out of bed) the next morning and loss of appetite. The nurse also reported that according to the patient's mother, in March 2015 (reported as a year ago) the patient experienced the similar symptoms after being vaccinated GARDASIL. The outcome of above events was unknown. The reporter did not provide the causality. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare professional referring to an unspecified number of unspecified patients of unknown age and gender. On unspecified dates since 30-MAR-2016, the patients were vaccinated with improperly stored doses of ROTATEQ (oral, lot # K024700 with expiration date: 30-JUL-2016; lot# L013192 with expiration date: 19-JAN-2017, dose was unknown (50 Fahrenheit (F) for 45 minutes and 32F for 72 hours). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information is not expected as the reporter didn't like to be contacted.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare professional referring to an unspecified number of unspecified patients of unknown age and gender. On unspecified dates since 30-MAR-2016, the patients were vaccinated with improperly stored doses of MMR II (lot # L027591, expiration date: 23-JUL-2017, dose and route were unknown (50 Fahrenheit (F) for 45 minutes and 32F for 72 hours). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information is not expected as the reporter didn't like to be contacted.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Extra dose administered, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse, referring to an 18 year old, male patient. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On unknown dates, the patient was vaccinated with the three dose series of GARDASIL (dose, route, lot # and expiration date were not reported). Then, on 25-AUG-2015, the patient was vaccinated with an additional dose of GARDASIL 9 by intramuscular route in the right arm (reported as RD), lot # L004014 (expiration date was not reported), because a company representative mistakenly told that it was the Centers for Disease Control and Prevention (CDC) recommendation. No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information has been received.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. Information about concurrent condition, medical history and concomitant therapy was not provided. On 28-MAR-2016 the patient was inadvertently administered an expired dose of ROTATEQ (lot # K006456; expiration date: 08-MAR-2016; dose not reported). No adverse effects were reported. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Abnormal behaviour, Asterixis, Hyperacusis, Toe walking
Clinical narrative: Information has been received from a consumer referring to her son, a male patient of unknown age. On an unknown date the patient was vaccinated with a dose of MMR II (dose and expiration date unknown, lot# was reported as K00815, injection). About a week later (date unknown), the patient became very sensitive to certain sounds and started to hit himself in the head when he could hear some of them. The reporter also stated that the patient previously was given a dose of DTaP (unspecified) and he became slightly sensitive to some sounds, but nothing like he was now. The reporter also stated that after the patient was given his 3rd vaccine (the reporter did not know which vaccine it was), he began walking on his toes and flapping his arms. The reporter did not specify if this vaccine was given before or after the DTaP (unspecified). The patient eventually started walking normally again but he still waved one arm when he was nervous. The patient spoke with doctor for medical attention. Sound cancelling headphones were given as the treatment. The patient recovered from walking on his toes on an unknown date. The final outcome of the other events was not reported. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 92.0
Sex: M
Vaccine: PNC13
Symptoms: Fatigue, Headache, Malaise, Myalgia, Peripheral swelling
Clinical narrative: Local swelling upper arm x 5 days. Low grade fever (99-100) with malaise, fatigue, headache, myalgias x 8 days.
Age: 92.0
Sex: M
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: Local swelling upper arm x 5 days. Low grade fever (99-100) with malaise, fatigue, headache, myalgias x 8 days.
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Ophthalmological examination normal
Clinical narrative: This case was reported by a physician via patient support programs and described the occurrence of allergic reaction in a adult female patient who received Seasonal Influenza vaccine. The patient's past medical history included alcohol use (4 beers consumed daily). Concurrent medical conditions included ex-smoker, caffeine consumption (coffee 1 cup a day), arthritis, chronic obstructive pulmonary disease and penicillin allergy. On an unknown date, the patient received Seasonal Influenza vaccine at an unknown dose. On an unknown date, an unknown time after receiving Seasonal Influenza vaccine, the patient experienced allergic reaction. On unknown date, the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction to be related to Seasonal Influenza vaccine.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Pain in jaw
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of jaw pain in a 11-year-old male patient who received BOOSTRIX. In March 2016, the patient received BOOSTRIX. In March 2016, less than a week after receiving BOOSTRIX, the patient experienced jaw pain. On an unknown date, the outcome of the jaw pain was unknown. It was unknown if the reporter considered the jaw pain to be related to BOOSTRIX. Additional details provided were as follows: The medical assistant reported that a patient who received a BOOSTRIX vaccine last week and was now (at time of reporting) complaining of a sore jaw. The reporter did not provide any additional information.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection site became red, swollen, and warm to touch.
Age: 0.53
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Lethargy, Ultrasound abdomen normal, Vomiting projectile
Clinical narrative: Projectile vomiting, lethargy.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Back pain, Chills, Dizziness, Fatigue
Clinical narrative: Extreme fatigue, feeling faint, pain in joints and back, chills, fever of 102.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Extreme fatigue, feeling faint, pain in joints and back, chills, fever of 102.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Cyanosis, Febrile convulsion
Clinical narrative: Pt had a simple febrile seizure with cyanosis, resolved by time they got to ED for further evaluation.  No evidence of infectious etiology to fever at ED evaluation or PCM f/u on 04/07/2016.
Age: 28.0
Sex: M
Vaccine: ANTH
Symptoms: Local swelling, Pyrexia, Rash erythematous
Clinical narrative: Red Rash spreading down left bicep with localized fever and swelling.
Age: 12.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Blister, Contusion, Rash
Clinical narrative: Patient developed rash that progressed to bruising and blisters to (L) arm.
Age: 12.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Injection site bruising, Injection site discolouration, Injection site erythema, Injection site vesicles
Clinical narrative: Patient developed rash that progressed to bruising and blisters to (L) arm.
Age: 45.0
Sex: F
Vaccine: HEP, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling at inj. site.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 01-APR-2016, the patient was vaccinated with expired dose of PNEUMOVAX 23 (lot # K009874, expiration date: 19-MAR-2016; dose and route were not provided). No adverse effects were reported. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Influenza, Influenza A virus test positive, Pyrexia, Vaccination failure
Clinical narrative: Initial unsolicited report received from a consumer on 25 March 2016. This case was linked to 2016SA062194 (same vaccine). This case involves a 41-year-old female patient who was vaccinated with a dose of INFLUENZA QUADRIVAL A-B VACCINE (FLUZONE QIV) (batch number, expiration date was unknown and did not remember route of administration) in the arm on an unspecified date in September or October 2015. The patient was vaccinated at a family clinic. Pre-existing physician diagnosed allergies included allergy to doxycycline and feathers. Patient had a history of diabetes. She had also received flu vaccine every year for past 30 years. Concomitant medications were not reported. On 24 March 2016, few months following the vaccination, the patient had developed elevated fever of 102.5 Fahrenheit and was diagnosed with flu and had a positive flu test for A strain of Flu. It was a case of suspected vaccination failure. The patient required ER/doctor visit. It was reported that she was seen by health care professional on 24 March 2016. Other laboratory data and corrective treatments were not reported. The outcomes of events were unknown. Upon medical review, the case was considered as serious due to important medical event: flu/positive flu test for A strain of Flu and suspected vaccination failure. List of documents held by sender: none. Sender's Comments: This is a non-medically confirmed case. Reportedly, the patient was tested for Influenza type A approximately 4-5 months after vaccination. As with any vaccine, INFLUENZA QUADRIVAL A-B VACCINE may not protect 100% of vaccinated individuals. Further information including but not limited to patient's medical history, details of symptoms, test results confirming the diagnosis and the strain identified and immune status at the time of vaccination would be needed for complete assessment. Based on the information available, a role of the vaccine cannot be assessed.
Age: 66.0
Sex: M
Vaccine: PNC10
Symptoms: Injection site pain, Sleep disorder
Clinical narrative: Acute soreness in right upper arm; could not sleep on right side. Soreness has diminished but continues to hurt when arm is raised or is in certain positions.
Sex: U
Vaccine: PNC13
Symptoms: Injection site cellulitis
Clinical narrative: This is a spontaneous report from a contactable consumer via a Pfizer sales representative. This consumer reported similar events for 3 patients. This is the 1st of 3 reports. A patient of unspecified age, ethnicity and gender received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at single dose. The patient's medical history and concomitant medications were not reported. The patient experienced significant cellulitis at the point of the shot on an unspecified date with outcome of unknown. The doctor attributed the significant cellulitis to PREVNAR 13.
Age: 82.0
Sex: M
Vaccine: PNC13
Symptoms: Atrial fibrillation, Biopsy bone marrow normal, C-reactive protein normal, Computerised tomogram abdomen normal, Computerised tomogram normal
Clinical narrative: This case has been migrated from another database into the current safety database for processing follow-up information. As a consequence of this migration, the follow-up CIOMS I or MedWatch report may indicate in the appropriate field that it is an initial report. New information was received in test results, event outcome and medical monitor comments. Information regarding Pneumococcal Conjugate Vaccine, 13-Valent (injection) was received from an investigator regarding an 83-year-old male participant in a study who experienced idiopathic thrombocytopenic purpura. The participant received the second dose on 03-Apr-2009. The patient experienced idiopathic thrombocytopenic purpura on 13-Aug-2009. The patient was hospitalized and diagnostic tests were performed (see test results). The patient was treated with steroids and IVIG for 5 days. The platelet count improved and the patient was discharged on 20-Aug-2009. The patient was re-admitted to the hospital on 26-Aug-2009 with symptoms of epistaxis, buccal bruising, petechiae on lower extremities, and a low platelet count of 5000. He was treated with RITUXAN and methylprednisolone. Idiopathic thrombocytopenic purpura (ITP) was considered resolved on 20-Nov-2009. The investigator does not consider that concomitant medications taken prior to this SAE were related to the development of ITP. No additional information was available at the time of this report. The investigator does not consider mild renal failure to have prolonged hospitalization. This is a final report. The investigator considered idiopathic thrombocytopenic purpura possibly related to the study product. The medical monitor considered idiopathic thrombocytopenic purpura not related to the study product. The medical monitor noted that the last dose of any vaccine was 4 months prior to the signs and symptoms of ITP. The subject had serologic evidence of Hepatitis B infection, though onset has not yet been established. Follow-up (24Mar16): This follow up is submitted to notify that the history of the patient has also been published in the literature report. No further information provided.
Age: 82.0
Sex: M
Vaccine: PNC13
Symptoms: Computerised tomogram pelvis, Computerised tomogram thorax normal, Contusion, Echocardiogram abnormal, Ejection fraction decreased
Clinical narrative: This case has been migrated from another database into the current safety database for processing follow-up information. As a consequence of this migration, the follow-up CIOMS I or MedWatch report may indicate in the appropriate field that it is an initial report. New information was received in test results, event outcome and medical monitor comments. Information regarding Pneumococcal Conjugate Vaccine, 13-Valent (injection) was received from an investigator regarding an 83-year-old male participant in a study who experienced idiopathic thrombocytopenic purpura. The participant received the second dose on 03-Apr-2009. The patient experienced idiopathic thrombocytopenic purpura on 13-Aug-2009. The patient was hospitalized and diagnostic tests were performed (see test results). The patient was treated with steroids and IVIG for 5 days. The platelet count improved and the patient was discharged on 20-Aug-2009. The patient was re-admitted to the hospital on 26-Aug-2009 with symptoms of epistaxis, buccal bruising, petechiae on lower extremities, and a low platelet count of 5000. He was treated with RITUXAN and methylprednisolone. Idiopathic thrombocytopenic purpura (ITP) was considered resolved on 20-Nov-2009. The investigator does not consider that concomitant medications taken prior to this SAE were related to the development of ITP. No additional information was available at the time of this report. The investigator does not consider mild renal failure to have prolonged hospitalization. This is a final report. The investigator considered idiopathic thrombocytopenic purpura possibly related to the study product. The medical monitor considered idiopathic thrombocytopenic purpura not related to the study product. The medical monitor noted that the last dose of any vaccine was 4 months prior to the signs and symptoms of ITP. The subject had serologic evidence of Hepatitis B infection, though onset has not yet been established. Follow-up (24Mar16): This follow up is submitted to notify that the history of the patient has also been published in the literature report. No further information provided.
Age: 82.0
Sex: M
Vaccine: PNC13
Symptoms: Epistaxis, Haematology test normal, Haemoglobin decreased, Heart rate increased, Hepatitis B core antibody positive
Clinical narrative: This case has been migrated from another database into the current safety database for processing follow-up information. As a consequence of this migration, the follow-up CIOMS I or MedWatch report may indicate in the appropriate field that it is an initial report. New information was received in test results, event outcome and medical monitor comments. Information regarding Pneumococcal Conjugate Vaccine, 13-Valent (injection) was received from an investigator regarding an 83-year-old male participant in a study who experienced idiopathic thrombocytopenic purpura. The participant received the second dose on 03-Apr-2009. The patient experienced idiopathic thrombocytopenic purpura on 13-Aug-2009. The patient was hospitalized and diagnostic tests were performed (see test results). The patient was treated with steroids and IVIG for 5 days. The platelet count improved and the patient was discharged on 20-Aug-2009. The patient was re-admitted to the hospital on 26-Aug-2009 with symptoms of epistaxis, buccal bruising, petechiae on lower extremities, and a low platelet count of 5000. He was treated with RITUXAN and methylprednisolone. Idiopathic thrombocytopenic purpura (ITP) was considered resolved on 20-Nov-2009. The investigator does not consider that concomitant medications taken prior to this SAE were related to the development of ITP. No additional information was available at the time of this report. The investigator does not consider mild renal failure to have prolonged hospitalization. This is a final report. The investigator considered idiopathic thrombocytopenic purpura possibly related to the study product. The medical monitor considered idiopathic thrombocytopenic purpura not related to the study product. The medical monitor noted that the last dose of any vaccine was 4 months prior to the signs and symptoms of ITP. The subject had serologic evidence of Hepatitis B infection, though onset has not yet been established. Follow-up (24Mar16): This follow up is submitted to notify that the history of the patient has also been published in the literature report. No further information provided.
Age: 82.0
Sex: M
Vaccine: PNC13
Symptoms: Hepatitis B core antigen positive, Hepatitis B surface antibody positive, Hepatitis B surface antigen positive, Immune thrombocytopenic purpura, Immunoglobulin therapy
Clinical narrative: This case has been migrated from another database into the current safety database for processing follow-up information. As a consequence of this migration, the follow-up CIOMS I or MedWatch report may indicate in the appropriate field that it is an initial report. New information was received in test results, event outcome and medical monitor comments. Information regarding Pneumococcal Conjugate Vaccine, 13-Valent (injection) was received from an investigator regarding an 83-year-old male participant in a study who experienced idiopathic thrombocytopenic purpura. The participant received the second dose on 03-Apr-2009. The patient experienced idiopathic thrombocytopenic purpura on 13-Aug-2009. The patient was hospitalized and diagnostic tests were performed (see test results). The patient was treated with steroids and IVIG for 5 days. The platelet count improved and the patient was discharged on 20-Aug-2009. The patient was re-admitted to the hospital on 26-Aug-2009 with symptoms of epistaxis, buccal bruising, petechiae on lower extremities, and a low platelet count of 5000. He was treated with RITUXAN and methylprednisolone. Idiopathic thrombocytopenic purpura (ITP) was considered resolved on 20-Nov-2009. The investigator does not consider that concomitant medications taken prior to this SAE were related to the development of ITP. No additional information was available at the time of this report. The investigator does not consider mild renal failure to have prolonged hospitalization. This is a final report. The investigator considered idiopathic thrombocytopenic purpura possibly related to the study product. The medical monitor considered idiopathic thrombocytopenic purpura not related to the study product. The medical monitor noted that the last dose of any vaccine was 4 months prior to the signs and symptoms of ITP. The subject had serologic evidence of Hepatitis B infection, though onset has not yet been established. Follow-up (24Mar16): This follow up is submitted to notify that the history of the patient has also been published in the literature report. No further information provided.
Age: 82.0
Sex: M
Vaccine: PNC13
Symptoms: Mean cell volume normal, Myocardial necrosis marker normal, Petechiae, Platelet count decreased, Red blood cell sedimentation rate normal
Clinical narrative: This case has been migrated from another database into the current safety database for processing follow-up information. As a consequence of this migration, the follow-up CIOMS I or MedWatch report may indicate in the appropriate field that it is an initial report. New information was received in test results, event outcome and medical monitor comments. Information regarding Pneumococcal Conjugate Vaccine, 13-Valent (injection) was received from an investigator regarding an 83-year-old male participant in a study who experienced idiopathic thrombocytopenic purpura. The participant received the second dose on 03-Apr-2009. The patient experienced idiopathic thrombocytopenic purpura on 13-Aug-2009. The patient was hospitalized and diagnostic tests were performed (see test results). The patient was treated with steroids and IVIG for 5 days. The platelet count improved and the patient was discharged on 20-Aug-2009. The patient was re-admitted to the hospital on 26-Aug-2009 with symptoms of epistaxis, buccal bruising, petechiae on lower extremities, and a low platelet count of 5000. He was treated with RITUXAN and methylprednisolone. Idiopathic thrombocytopenic purpura (ITP) was considered resolved on 20-Nov-2009. The investigator does not consider that concomitant medications taken prior to this SAE were related to the development of ITP. No additional information was available at the time of this report. The investigator does not consider mild renal failure to have prolonged hospitalization. This is a final report. The investigator considered idiopathic thrombocytopenic purpura possibly related to the study product. The medical monitor considered idiopathic thrombocytopenic purpura not related to the study product. The medical monitor noted that the last dose of any vaccine was 4 months prior to the signs and symptoms of ITP. The subject had serologic evidence of Hepatitis B infection, though onset has not yet been established. Follow-up (24Mar16): This follow up is submitted to notify that the history of the patient has also been published in the literature report. No further information provided.
Age: 82.0
Sex: M
Vaccine: PNC13
Symptoms: Ventricular hypokinesia, White blood cell count increased
Clinical narrative: This case has been migrated from another database into the current safety database for processing follow-up information. As a consequence of this migration, the follow-up CIOMS I or MedWatch report may indicate in the appropriate field that it is an initial report. New information was received in test results, event outcome and medical monitor comments. Information regarding Pneumococcal Conjugate Vaccine, 13-Valent (injection) was received from an investigator regarding an 83-year-old male participant in a study who experienced idiopathic thrombocytopenic purpura. The participant received the second dose on 03-Apr-2009. The patient experienced idiopathic thrombocytopenic purpura on 13-Aug-2009. The patient was hospitalized and diagnostic tests were performed (see test results). The patient was treated with steroids and IVIG for 5 days. The platelet count improved and the patient was discharged on 20-Aug-2009. The patient was re-admitted to the hospital on 26-Aug-2009 with symptoms of epistaxis, buccal bruising, petechiae on lower extremities, and a low platelet count of 5000. He was treated with RITUXAN and methylprednisolone. Idiopathic thrombocytopenic purpura (ITP) was considered resolved on 20-Nov-2009. The investigator does not consider that concomitant medications taken prior to this SAE were related to the development of ITP. No additional information was available at the time of this report. The investigator does not consider mild renal failure to have prolonged hospitalization. This is a final report. The investigator considered idiopathic thrombocytopenic purpura possibly related to the study product. The medical monitor considered idiopathic thrombocytopenic purpura not related to the study product. The medical monitor noted that the last dose of any vaccine was 4 months prior to the signs and symptoms of ITP. The subject had serologic evidence of Hepatitis B infection, though onset has not yet been established. Follow-up (24Mar16): This follow up is submitted to notify that the history of the patient has also been published in the literature report. No further information provided.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Throat irritation, Throat tightness
Clinical narrative: After 5-6 hrs of receiving annual flu vaccine - throat felt like closing coughing - irritation throat -bronch area.
Age: 1.53
Sex: F
Vaccine: MMR
Symptoms: Crying, Feeling abnormal, Injection site reaction, Irritability, Middle ear effusion
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 18 month old female patient. The patient did not have any pertinent medical history, drug reactions or allergies and concomitant medications. On 25-MAR-2016, the patent was vaccinated with a first dose of M-M-R II intramuscularly in the leg (lot # and expiry date were not reported). On 25-MAR-2016 in the evening, the nurse noted that the patient was not quite herself, was fussy and crying and was not able to put any weight on the leg (unspecified which leg) where the M-M-R II was administered. The patient was given TYLENOL the same evening and was able to bear weight on that leg by the next day. The nurse reported that the patient was not herself since the M-M-R II was administered and continued to cry and fuss. She was taken to a physician on 03-APR-2016, and she had fluid in one ear. No lab diagnostics studies were performed. The outcome of the event of not being able to bear weight on the leg was recovered on 26-MAR-2016. The outcome of the events of not being herself, being fussy and crying was reported as recovered at the time of this report. The outcome of the event of fluid in the ear was unknown. The relatedness between the events and the suspect therapy was not provided. Additional information has been requested.
Age: 1.53
Sex: F
Vaccine: MMR
Symptoms: Weight bearing difficulty
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 18 month old female patient. The patient did not have any pertinent medical history, drug reactions or allergies and concomitant medications. On 25-MAR-2016, the patent was vaccinated with a first dose of M-M-R II intramuscularly in the leg (lot # and expiry date were not reported). On 25-MAR-2016 in the evening, the nurse noted that the patient was not quite herself, was fussy and crying and was not able to put any weight on the leg (unspecified which leg) where the M-M-R II was administered. The patient was given TYLENOL the same evening and was able to bear weight on that leg by the next day. The nurse reported that the patient was not herself since the M-M-R II was administered and continued to cry and fuss. She was taken to a physician on 03-APR-2016, and she had fluid in one ear. No lab diagnostics studies were performed. The outcome of the event of not being able to bear weight on the leg was recovered on 26-MAR-2016. The outcome of the events of not being herself, being fussy and crying was reported as recovered at the time of this report. The outcome of the event of fluid in the ear was unknown. The relatedness between the events and the suspect therapy was not provided. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Maternal exposure before pregnancy, Prenatal care, Urine analysis
Clinical narrative: This spontaneous prospective pregnancy report was received from a nurse and refers to a currently 24 year old female patient. The patient did not have any pertinent medical history, drug reactions or allergies and did not receive any concomitant medications. On 28-JUL-2015 and on 25-SEP-2015, the patient was vaccinated with the first and the second dose of GARDASIL (exact dose and route of administration were not reported, lot # K016966, expiration date 10-MAY-2017). The patient became pregnant with last menstrual period (LMP) of 17-OCT-2015 and estimated delivery date (EDD) of 23-JUL-2016. The nurse reported that on 20-JAN-2016, the patient was seen in the clinic for a prenatal office. The patient received standard prenatal care and had standard blood and urine labs performed. The pregnancy outcome was pending. The fetal outcome was unknown. Additional information has been requested.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Diarrhoea, Faeces discoloured, Haematochezia
Clinical narrative: Onset of green, mucousy, diarrhea, which has not resolved as of today (07APR2016). Occasionally has 'coffee ground' blood in stool along with green mucous.
Age: 0.6
Sex: M
Vaccine: DTAPHEPBIP, RV1
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Local site swelling and erythema.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Incomplete course of vaccination, Seizure
Clinical narrative: This spontaneous report as received from a licensed practical nurse via a company representative refers to a 15 year old, non-pregnant female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a first dose of GARDASIL, intramuscularly (site of administration, lot # and expiry date were not reported). In 2012 (also reported as after receiving the dose of GARDASIL,), the patient experienced unspecified seizure. The patient did not receive the second or the third dose of GARDASIL. The outcome of seizure was unknown. The patient sought medical attention via contacting the nurse. The relatedness between the event and the suspect therapy was not provided. Upon internal review the event of seizure was considered medically significant. Additional information has been requested.
Age: 1.5
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Rash, Rash erythematous, Urticaria
Clinical narrative: Red circular rash on trunk, arms, face, initially looked like hives. Then became raised with a target-like appearance. Worsened over 48 hours, started to improve by 72 hours. Mom tried Benadryl, then Zyrtec.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV9, MNQ
Symptoms: Dizziness, Tinnitus
Clinical narrative: Patient complain of dizziness and ringing of the ears.
Sex: M
Vaccine: VARZOS
Symptoms: Adverse event, Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: This spontaneous report as received from a male patient of unknown age reporting on himself. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 11-MAR-2016, the patient was vaccinated with ZOSTAVAX (refrigerated vial 19400 PFU) (strength, lot#, dose#, dosage and route unspecified). The patient reported that he had experienced following adverse events after receiving the ZOSTAVAX vaccine: redness, an unspecified rash and swelling around the injection site and down to the elbow; heat, itchiness and warmth where the redness was; the glands under the armpit hurt. The outcome of the events was unknown. Product quality complaint (PQC) was not involved. No further information was provided. The reporter did not provide the causality between the events and the suspect therapy ZOSTAVAX. Additional information is not expected as reporter's contact details was not provided.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site warmth, Lymph node pain
Clinical narrative: This spontaneous report as received from a male patient of unknown age reporting on himself. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 11-MAR-2016, the patient was vaccinated with ZOSTAVAX (refrigerated vial 19400 PFU) (strength, lot#, dose#, dosage and route unspecified). The patient reported that he had experienced following adverse events after receiving the ZOSTAVAX vaccine: redness, an unspecified rash and swelling around the injection site and down to the elbow; heat, itchiness and warmth where the redness was; the glands under the armpit hurt. The outcome of the events was unknown. Product quality complaint (PQC) was not involved. No further information was provided. The reporter did not provide the causality between the events and the suspect therapy ZOSTAVAX. Additional information is not expected as reporter's contact details was not provided.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Bilevel positive airway pressure, Blood lactic acid increased, Chest X-ray abnormal, Chills, Dyspnoea
Clinical narrative: Patient stated he started to feel sick the day after he received his vaccination with chills and fever. Patient got progressively worse with sob, coughing up yellow phlegm. He went to the ED with worsening SOB. Preliminary eval in ED documented extensive pulmonary interstitial lung changes suggesting possible early ARDS vs pulmonary edema. Pt admitted to ICU with acute on likely chronic respiratory distress with associated hypoxia. He does not present with hypotension, fever despite findings of leukocytosis and increased lactic acid. BIPAP, breathing treatments, systemic steroids, empiric antibiotic treatment.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Hypotension, Hypoxia, Intensive care, Interstitial lung disease, Leukocytosis
Clinical narrative: Patient stated he started to feel sick the day after he received his vaccination with chills and fever. Patient got progressively worse with sob, coughing up yellow phlegm. He went to the ED with worsening SOB. Preliminary eval in ED documented extensive pulmonary interstitial lung changes suggesting possible early ARDS vs pulmonary edema. Pt admitted to ICU with acute on likely chronic respiratory distress with associated hypoxia. He does not present with hypotension, fever despite findings of leukocytosis and increased lactic acid. BIPAP, breathing treatments, systemic steroids, empiric antibiotic treatment.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Malaise, Productive cough, Pyrexia, Respiratory distress, White blood cell count increased
Clinical narrative: Patient stated he started to feel sick the day after he received his vaccination with chills and fever. Patient got progressively worse with sob, coughing up yellow phlegm. He went to the ED with worsening SOB. Preliminary eval in ED documented extensive pulmonary interstitial lung changes suggesting possible early ARDS vs pulmonary edema. Pt admitted to ICU with acute on likely chronic respiratory distress with associated hypoxia. He does not present with hypotension, fever despite findings of leukocytosis and increased lactic acid. BIPAP, breathing treatments, systemic steroids, empiric antibiotic treatment.
Age: 1.3
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Asthenia, Diarrhoea, Heart rate increased, Pallor, Vomiting
Clinical narrative: Vomiting, diarrhea, paleness, weakness, fast heart beat.
Age: 16.0
Sex: F
Vaccine: FLU3, HEPA, HPV9, MNQ
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: No adverse event noted, vaccine given is not recommended in pregnant women.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus
Clinical narrative: Kinrix vaccine in L deltoid: Mild erythema, pruritus, inflammation surrounding injection sight.
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Asthenia, Chills, Muscular weakness, Pyrexia
Clinical narrative: Initial unsolicited report received from a consumer on 22 March 2016. This case involves a (age and gender not reported) patient who was vaccinated with a dose of INFLUENZA QUADRIVAL A-B VACCINE (INFLUENZA QUADRIVALENT) (batch number, expiry date, site of administration were not reported) on 29 October 2015. Medical history and concomitant medications were not reported. On an unspecified date, following the vaccination patient had experienced hip pain, fever, chills, muscle weakness and general weakness. Laboratory investigation and corrective treatment were not reported. The outcome of events was not reported. List of documents held by sender: none.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Asthenia, Blood test abnormal, Chronic inflammatory demyelinating polyradiculoneuropathy, Dyspnoea
Clinical narrative: Shortness of breath, leg weakness (within 2 months of shot) feet and hand tingling. Blood work went crazy. Loss of hand strength. Was unable to walk. Hurt all the time. Lost 25 pounds in one month (or less time). They put me thru all sorts of tests finally sent me to a neurologist - spinal tap confirmed Guillain-Barre - 6 day treatments 7-wks total treatments were given. CIDP now.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Lumbar puncture abnormal, Muscular weakness, Pain, Paraesthesia
Clinical narrative: Shortness of breath, leg weakness (within 2 months of shot) feet and hand tingling. Blood work went crazy. Loss of hand strength. Was unable to walk. Hurt all the time. Lost 25 pounds in one month (or less time). They put me thru all sorts of tests finally sent me to a neurologist - spinal tap confirmed Guillain-Barre - 6 day treatments 7-wks total treatments were given. CIDP now.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Weight decreased
Clinical narrative: Shortness of breath, leg weakness (within 2 months of shot) feet and hand tingling. Blood work went crazy. Loss of hand strength. Was unable to walk. Hurt all the time. Lost 25 pounds in one month (or less time). They put me thru all sorts of tests finally sent me to a neurologist - spinal tap confirmed Guillain-Barre - 6 day treatments 7-wks total treatments were given. CIDP now.