chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 15-APR-2015, the patient was vaccinated with one dose of improperly stored ZOSTAVAX (19400 PFU, dose, route of administration, lot# and expiration date were not reported). The patient's concomitant therapy was not reported. No adverse effects were reported. Product quality complaint was not involved. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional refers to a patient of unknown demographics. On an unknown date the patient was vaccinated with PEDVAXHIB (dose, route, frequency and lot # unspecified). No medical history and concomitant medications were provided. It was reported that the dose administered to the patient on an unknown date was an improperly stored vaccine. But was unsure which ones, may have been MMR II, PEDVAXHIB or GARDASIL. No adverse effects reported at this time. No further details provided. There was no product quality complaint involved. The outcome of incorrect product storage and no adverse event was unknown. This case is linked to: 1505USA014702 and 1505USA004646 (same patient link). Additional information has been requested.
Age: 0.61
Sex: F
Vaccine: FLU3
Symptoms: Rash, Rash macular
Clinical narrative: Noticed splotchy rash on lower portion, legs, some upper thorax and neck. Took to ER 0800, treated w/BENADRYL. Symptoms relieved after 24hrs. No fever, pain, scratchy.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional refers to a patient of unknown demographics. On an unknown date the patient was vaccinated with M-M-R II injection (dose, route, frequency and lot # unspecified). No medical history and concomitant medications were provided. It was reported that the dose administered on an unknown date was an improperly stored vaccine. But was unsure which ones, may have been M-M-R II, LIQUID PEDVAXHIB or GARDASIL. No adverse effects reported at this time. No further details provided. There was no Product Quality Complaint involved. The outcome of incorrect product storage and no adverse event was unknown. This case is linked to 1505USA014703 and 1505USA014702 (same patient link). Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: MMR
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 39 year old female patient. The patient's medical history and concurrent conditions were not reported. On 20-MAY-2015, the patient was vaccinated with a dose of MMR II (0.5 ml, once, lot# L002242, expiration date: 21-JAN-2017) intramuscularly instead of the recommended subcutaneous route. Concurrent conditions were not reported. On the same day, the patient experienced burning and pain at the injection site following the vaccination. No treatment was given for the events and no lab diagnostics studies were performed. The patient did not seek any medical attention. The outcome of the events was unknown. The causal relationship between the events and MMR II was not reported. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to multiple patients of unknown age and gender. The patient's medical histories, concurrent conditions and concomitant medications were not reported. On an unknown date the doses of ROTATEQ (lot # K010221 with expiry date: 12-MAY-2015) were administered post excursion to those multiple patients. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Menorrhagia
Clinical narrative: This spontaneous report was received from a health care worker refers to her daughter, a 17 year old female patient. The patient's concurrent conditions and medical history were not reported. On an unknown date in 2013 (approximated based on 2 years ago) the patient was vaccinated with GARDASIL (Lot #, dose and route of administration were not reported) dose 1. The patient had received first two doses of the vaccine 2 years ago. Concomitant medications were not reported. On an unknown date while on therapy with GARDASIL the patient developed heavy menstrual bleeding. The outcome of the event was unknown. The reporter did not provide the relatedness of heavy menstrual bleeding with GARDASIL. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to multiple patients of unknown age and gender. The patient's medical histories, concurrent conditions and concomitant medications were not reported. On an unknown date the doses of RECOMBIVAX HB (lot # K008334 with expiry date 09-JUN-2016 and lot # K016005 with expiry date 27-AUG-2016) were administered post excursion to those multiple patients. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Urticaria, Vomiting
Clinical narrative: Vomiting and hives 1-2 hours after receiving vaccines. No respiratory distress.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Dyspnoea, Heart rate increased, Wheezing
Clinical narrative: This spontaneous report was received from a consumer regarding her 60 year old husband with no drug reactions or allergies. The patient's medical history included atrial fibrillation. On 22-MAY-2015, the patient was vaccinated with a dose of ZOSTAVAX (dose and route were not provided, lot number was reported as L000448, expiration date 08-MAR-2016). Concomitant therapies included COUMADIN and unspecified cardiac medication. On 23-MAY-2015, the patient developed weakness, difficulty breathing, wheezing and elevated heart rate. The patient sought medication attention, he was evaluated by his unspecified physician on 26-MAY-2015. A chest X-ray was performed but the results were not available. The patient was prescribed unspecified oral steroid medications. At the time of the report, the patient was recovering from the adverse event. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Red, swollen, sore from injection site to elbow, ROM was bad, couldn't lay on that side, shoulder pain.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. The nurse reported that the patient, received the 1st dose of GARDASIL (quadrivalent) (dose, frequency, route, lot # and expiration date were not provided) on an unspecified date. The nurse also reported that the patient was now (18-MAY-2015) in her office about to receive the 2nd dose GARDASIL 9 (dose, frequency, route and lot # were not provided). No concomitant therapies were reported. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Age: 0.7
Sex: U
Vaccine: DTAPHEPBIP, HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to a 7 month old patient of unknown gender. On 19-MAY-2015, the patient received a dose of RECOMBIVAX HB, strength 2.5 mcg/0.5 ml, dose and lot number not provided) and a dose of PEDIARIX (dose and lot number not provided) (overdose). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to a patient of unknown age and gender. Patient medical history and drug allergies were not reported. On an unknown date, an unspecified number of patients received improperly stored (Merck) PROQUAD (Incorrect product storage) lot # K020753, exp date: 30-APR-2016 (dose, strength and route were not reported). No concomitant medications were reported. No adverse effects were reported. Lab tests were reported as unspecified. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. The reporter's causality assessment was not provided. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. The patient's current conditions and medical history were not reported. On an unknown date, the patients were vaccinated with unspecified doses of improperly stored (Oka/Merck) VARIVAX injection (unknown strength and route) (incorrect product storage). No adverse effect was reported. The outcome of the events was unknown. There was no product quality complaint involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a female patient in her 70's via a company employee reporting on herself. Information about concurrent conditions and medical history was not provided. On an unknown date the patient was vaccinated with ZOSTAVAX (lot#, strength, dose, dose #, frequency and route not reported). No information regarding concomitant therapy was provided. ON an unknown date the patient got a mild case of shingles after getting the vaccine. The outcome of the event was reported as recovered/resolved on an unspecified date. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. On 11-NOV-2014, the patients were vaccinated with doses of VARIVAX (Merck) (lot # J012377 exp date 03-OCT-2015 also reported as 08-NOV-2014) (dose not reported) subcutaneously that were improperly exposed to 7 degrees C from 13-MAY-2014 to 11-NOV-2014. No known adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected. All follow ups requested to complete the case were received.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 13-MAY-2015, the patient was vaccinated with an expired dose of (Oka/Merck) VARIVAX (lot # J005724, expiration date 08-MAY-2015) (dose and route of administration were not provided). No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with the third dose of RECOMBIVAX HB, 10 mcg/ml (lot #, dose and route unspecified). The pharmacist not4ed the interval between the patient's second and third doses in the RECOMBIVAX HB series was longer (inappropriate schedule of drug administration) than the recommended time period noted the prescribing information; the time period between the administration of the second and third doses of RECOMBIVAX HB was unspecified. No adverse effect was reported. The outcome of the events was unknown. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: Information has been received from a female patient of unknown age referring to herself. Medical history and drug allergy were not reported. On an unknown date the patient was vaccinated with (Oka/Merck) VARIVAX (dose, strength, route, lot # and expire date were not reported) when she was pregnant. Concomitant drug was not reported. The Last Menstrual Period (LMP) and Estimated Date of Delivery (EDD) were not reported. It was not reported whether the patient sought medical attention. At the time of reporting, the outcome of pregnancy was pending. Additional information is not expected because the reporter declined to participate in answering questions and no contact information was provided.
Age: 34.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Injection site irritation, Rash generalised, Rash papular
Clinical narrative: On 4/21/15 patient was given varicella vaccine and Hep B vaccine. Patient had full body papular rash and a localized irritation at injection site of varicella.
Age: 52.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Headache, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 5/20/15 Received inj that morning. That night began having: Fever (102) chills/headache/body aches/swelling at inj site/red site/warm site. Fever/headache/body aches resolved in about 24 hours. Inj site enlarged, then area resolved by 5/26/15.
Age: 52.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Pyrexia
Clinical narrative: 5/20/15 Received inj that morning. That night began having: Fever (102) chills/headache/body aches/swelling at inj site/red site/warm site. Fever/headache/body aches resolved in about 24 hours. Inj site enlarged, then area resolved by 5/26/15.
Age: 18.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Loss of consciousness
Clinical narrative: Meningo given in (R) deltoid; Hep A given in (L) deltoid after hep A vaccine pt. past out, assisted to floor with feet above heart, cool compress given-this lasted several mins and then assistaed to w/c and monitored for 1/2 hr-given orange juice and mom drove pt. home.
Age: 5.0
Sex: F
Vaccine: IPV
Symptoms: Syncope
Clinical narrative: Patient faint about 3 minutes after vaccine. Had patient lay down. Checked B/P, pulse, ox. Had patient remaining laying down. Doctor evaluated her after 15 minutes.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse regarding unspecified number of patients who on an unknown date was vaccinated with GARDASIL. The nurse stated that unspecified number of patients were administered improperly stored doses of the vaccine. The outcome of the events was unknown. This case is linked to 1505USA008498 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse regarding unspecified number of patients who on an unknown date was vaccinated with PNEUMOVAX23. The nurse stated that unspecified number of patients were administered improperly stored doses of the vaccine (incorrect storage and poor quality drug administration). The outcome of the events was unknown. This case is lined to 1505USA014517 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to an unspecified number of patients of unknown age and gender. No information on patients concurrent conditions and medical history was provided. On an unknown dates between the August 2014 and May 2015, the unspecified number of patients was vaccinated with improperly stored GARDASIL (dose, route, frequency, lot # and expiration dates were not provided). No adverse effects were reported. This is the one of the several reports from the same reporter source. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Arthralgia, Blood test normal
Clinical narrative: Information has been received from an unspecified caller and a female patient of unknown age reporting on herself. Information about concurrent conditions and medical history was not provided. In December 2014 the patient was vaccinated with the first 0.5 ml dose of (Oka/Merck) VARIVAX (lot#, strength not provided, route was reported as injection). In April 2015 the patient developed achiness in her joints. The patient further explained she was never vaccinated for chickenpox and never had the virus growing up, so she was administered the vaccine as an adult however had not yet received her second dose (inappropriate schedule of drug administration). The patient sought medical attention via office visit. Blood work was performed on an unspecified date and results were all normal. The outcome of the event was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to an unspecified number of patients of unknown age and gender. No information on patients concurrent conditions and medical history was provided. ON an unknown date between August 2104 and May 2015, the unspecified number of patients was vaccinated with improperly stored M-M-R II (dose, route, frequency, lot # and expiration dates were not provided). No adverse effects were reported. This is one of several reports from the same reporter source.  Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to two patients of unknown age and gender. On 21-MAY-2015 the 2 patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (lot #, expiry date, dose and route not reported). No symptoms were reported. No other details were reported. No PQC (Production Quality Complaint) was involved. Additional information has been requested.
Sex: U
Vaccine: MMR, MMRV, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to an unknown number of patients (age and genders were not reported). On unknown dates, the patients were vaccinated with MMR II, (Merck) PROQUAD and (Merck) VARIVAX (doses, routes of administration and lot numbers were not reported), that had been improperly stored. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 21-APR-2015, the patient was vaccinated with one dose of improperly stored ZOSTAVAX vial (19400 PFU) (plague forming unit(s), dose, route of administration, lot # and expiration date were not reported). The patient's concomitant therapy was not reported. No adverse effects were reported. Product Quality Complaint (PQC) was not involved. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. On 10-SEP-2014, the patients were vaccinated with doses of (Oka/Merck) VARIVAX (lot # J012377 exp date 03-OCT-2015 also reported as 08-NOV-2014) (dose not reported) subcutaneously that were improperly exposed to 7C from  13-MAY-2014 to 10-SEP-2014. No known adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected. All follow ups requested to complete the case were received.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding an unspecified number of patients of an unknown age and gender. The patients medical history or concurrent conditions were not provided. On 27-MAY-2015, the unspecified number of unspecified patients received doses of (Oka/Merck) VARIVAX (dose and route were not provided) (lot numbers involved in the temperature excursion were K010437 expiration date 22-JUL-2016, K009457 expiration date 09-JUL-2016, K021936 expiration date 11-NOV-2016 and L001335 expiration date 13-JAN-2017) (it was unspecified what lot number were administered to patients) that were improperly stored. No adverse experience reported. This is one of two reports from the same source (MARRS#1505USA014912). Additional information has been requested.
Sex: U
Vaccine: PNC13, PPV
Symptoms: Overdose
Clinical narrative: This spontaneous report as received from a healthcare professional, as part of a marketing research program, refers to an unspecified number of immunocompromised patients 65 years or older (gender unknown). On unknown dates, the patients were vaccinated with PNEUMOVAX 23 (lot number, dose and route were not reported) and with PREVNAR 13 (lot number, dose and route were not reported) (overdose). Concomitant therapy was not reported. It was reported that the Advisory Committee on Immunization Practices (ACIP) revised pneumonia vaccine schedule, saying all patients 65 or older who are immunocompromised should received both vaccines. The outcomes of overdose was unknown. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding an unspeicifed number of patients of an unknown age and gender. The patients medical history or concurrent conditions were not provided. On 27-MAY-2015, the unspecified number of unspeciifed patients received doses of PROQUAD (intramuscualr, lot numbers involved in the temperature excursion were K020750 expiration date 30-APR-2016 and lot number reported as L00400 expiration date 15-AUG-2016) (it was unspecified what lot numbers were administered to patients), that were improperly stored. No adverse experiences reported. This is one of two reports from the same source (MARRS # 1505USA015039). Additional infromation has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: RASH DEVELOPED ON LOWER PORTION OF NECK AND BACK, SIMILAR TO THAT OF A ZOSTER INFECTION.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Depression, Fatigue, Headache, Injection site erythema, Injection site swelling
Clinical narrative: extreme discomfort in left arm. Swelling, redness and hot at injection site-- and entire upper arm. Unable to lift arm more than several inches. Headache, fatigue, malaise, depression and sore throat.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Limb discomfort, Malaise, Mobility decreased, Oropharyngeal pain
Clinical narrative: extreme discomfort in left arm. Swelling, redness and hot at injection site-- and entire upper arm. Unable to lift arm more than several inches. Headache, fatigue, malaise, depression and sore throat.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Erythema, swelling, pain.
Age: 0.27
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Injection site urticaria
Clinical narrative: Patient developed hives on the thigh on which the IPV and Hib vaccines were administered.  The hives resolved on their own in about one minute.
Age: 61.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Back pain, Injection site pain, Injection site swelling, Migraine
Clinical narrative: Migraine, severe body ache, painful and swollen injection site, general weakness, pain in lower back.
Age: 61.0
Sex: F
Vaccine: PNC13
Symptoms: Pain
Clinical narrative: Migraine, severe body ache, painful and swollen injection site, general weakness, pain in lower back.
Age: 1.01
Sex: F
Vaccine: MMRV, PNC
Symptoms: Injection site erythema, Pyrexia, Varicella
Clinical narrative: Redness at site if injection, fever, mild case chicken pox.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Wrong drug administered
Clinical narrative: Patient received Pentacel instead of DTap and experienced itchiness, redness and swelling at the site of the injection.  Redness was 14 cm by 9 cm.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Hypersensitivity, Injection site discolouration, Injection site erythema, Injection site pruritus, Injection site reaction
Clinical narrative: Left arm at shot site stared having an allergic reaction, red, swollen, arm, glossy from being so swollen, turned purple lose of circulation in his arm, warm to the touch, and was itchy.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Left arm at shot site stared having an allergic reaction, red, swollen, arm, glossy from being so swollen, turned purple lose of circulation in his arm, warm to the touch, and was itchy.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Alopecia, Amnesia, Amylase normal, Arthralgia
Clinical narrative: Information has been received from a nurse and the patient's mother referring to the 15 year old female patient with asthma. The patient had no drug reactions/allergies. On 27-FEB-2013 the patient was vaccinated with her first dose of GARDASIL (lot#, dose not reported) intramuscularly (indication reported as "Had to have it to go to school"). On 10-APR-2013 the patient was vaccinated with her second dose of GARDASIL (lot#, dose not reported, intramuscular). There was no concomitant medication. The patient's mother reported that on unspecified dates in either April or May of 2013, the patient experienced dizziness, fatigue, weakness, headache, stomach pain, vomiting, joint pain, chest pain, hair loss, appetite loss, insomnia, tremor, shortness of breath, itchy, swelling, rash, aching muscles, pelvis pain and discharge, nerve pain, menstrual cycle pain, fainting, swollen lymph nodes, night sweats, nausea, temporary vision and memory loss, ovarian cyst, cyst in left kidney, and a cyst was in left ear after receiving GARDASIL. The patient was admitted to several different unspecified hospitals on several different unspecified dates. The nurse reported that the patient had been to various unspecified hospitals and had had multiple labs drawn such as: Complete Blood Count (CBC), basic metabolic panel (BMP), amylase and lipase levels (on unspecified date in 2013) since receiving the GARDASIL and experiencing the above noted events. The nurse reported that the patient's laboratory values came back as negative. Unspecified treatment was given for the events. Unspecified lab test and unspecified blood work were performed. It was reported that patient had received her third dose of GARDASIL on 27-AUG-2013 (therapy continued). Outcome of the events was reported as not recovered. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Blindness transient, Chest pain, Cyst, Decreased appetite
Clinical narrative: Information has been received from a nurse and the patient's mother referring to the 15 year old female patient with asthma. The patient had no drug reactions/allergies. On 27-FEB-2013 the patient was vaccinated with her first dose of GARDASIL (lot#, dose not reported) intramuscularly (indication reported as "Had to have it to go to school"). On 10-APR-2013 the patient was vaccinated with her second dose of GARDASIL (lot#, dose not reported, intramuscular). There was no concomitant medication. The patient's mother reported that on unspecified dates in either April or May of 2013, the patient experienced dizziness, fatigue, weakness, headache, stomach pain, vomiting, joint pain, chest pain, hair loss, appetite loss, insomnia, tremor, shortness of breath, itchy, swelling, rash, aching muscles, pelvis pain and discharge, nerve pain, menstrual cycle pain, fainting, swollen lymph nodes, night sweats, nausea, temporary vision and memory loss, ovarian cyst, cyst in left kidney, and a cyst was in left ear after receiving GARDASIL. The patient was admitted to several different unspecified hospitals on several different unspecified dates. The nurse reported that the patient had been to various unspecified hospitals and had had multiple labs drawn such as: Complete Blood Count (CBC), basic metabolic panel (BMP), amylase and lipase levels (on unspecified date in 2013) since receiving the GARDASIL and experiencing the above noted events. The nurse reported that the patient's laboratory values came back as negative. Unspecified treatment was given for the events. Unspecified lab test and unspecified blood work were performed. It was reported that patient had received her third dose of GARDASIL on 27-AUG-2013 (therapy continued). Outcome of the events was reported as not recovered. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Dysmenorrhoea, Dyspnoea, Fatigue, Full blood count normal
Clinical narrative: Information has been received from a nurse and the patient's mother referring to the 15 year old female patient with asthma. The patient had no drug reactions/allergies. On 27-FEB-2013 the patient was vaccinated with her first dose of GARDASIL (lot#, dose not reported) intramuscularly (indication reported as "Had to have it to go to school"). On 10-APR-2013 the patient was vaccinated with her second dose of GARDASIL (lot#, dose not reported, intramuscular). There was no concomitant medication. The patient's mother reported that on unspecified dates in either April or May of 2013, the patient experienced dizziness, fatigue, weakness, headache, stomach pain, vomiting, joint pain, chest pain, hair loss, appetite loss, insomnia, tremor, shortness of breath, itchy, swelling, rash, aching muscles, pelvis pain and discharge, nerve pain, menstrual cycle pain, fainting, swollen lymph nodes, night sweats, nausea, temporary vision and memory loss, ovarian cyst, cyst in left kidney, and a cyst was in left ear after receiving GARDASIL. The patient was admitted to several different unspecified hospitals on several different unspecified dates. The nurse reported that the patient had been to various unspecified hospitals and had had multiple labs drawn such as: Complete Blood Count (CBC), basic metabolic panel (BMP), amylase and lipase levels (on unspecified date in 2013) since receiving the GARDASIL and experiencing the above noted events. The nurse reported that the patient's laboratory values came back as negative. Unspecified treatment was given for the events. Unspecified lab test and unspecified blood work were performed. It was reported that patient had received her third dose of GARDASIL on 27-AUG-2013 (therapy continued). Outcome of the events was reported as not recovered. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Insomnia, Lipase normal, Lymphadenopathy, Metabolic function test normal
Clinical narrative: Information has been received from a nurse and the patient's mother referring to the 15 year old female patient with asthma. The patient had no drug reactions/allergies. On 27-FEB-2013 the patient was vaccinated with her first dose of GARDASIL (lot#, dose not reported) intramuscularly (indication reported as "Had to have it to go to school"). On 10-APR-2013 the patient was vaccinated with her second dose of GARDASIL (lot#, dose not reported, intramuscular). There was no concomitant medication. The patient's mother reported that on unspecified dates in either April or May of 2013, the patient experienced dizziness, fatigue, weakness, headache, stomach pain, vomiting, joint pain, chest pain, hair loss, appetite loss, insomnia, tremor, shortness of breath, itchy, swelling, rash, aching muscles, pelvis pain and discharge, nerve pain, menstrual cycle pain, fainting, swollen lymph nodes, night sweats, nausea, temporary vision and memory loss, ovarian cyst, cyst in left kidney, and a cyst was in left ear after receiving GARDASIL. The patient was admitted to several different unspecified hospitals on several different unspecified dates. The nurse reported that the patient had been to various unspecified hospitals and had had multiple labs drawn such as: Complete Blood Count (CBC), basic metabolic panel (BMP), amylase and lipase levels (on unspecified date in 2013) since receiving the GARDASIL and experiencing the above noted events. The nurse reported that the patient's laboratory values came back as negative. Unspecified treatment was given for the events. Unspecified lab test and unspecified blood work were performed. It was reported that patient had received her third dose of GARDASIL on 27-AUG-2013 (therapy continued). Outcome of the events was reported as not recovered. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Myalgia, Nausea, Neuralgia, Night sweats, Ovarian cyst
Clinical narrative: Information has been received from a nurse and the patient's mother referring to the 15 year old female patient with asthma. The patient had no drug reactions/allergies. On 27-FEB-2013 the patient was vaccinated with her first dose of GARDASIL (lot#, dose not reported) intramuscularly (indication reported as "Had to have it to go to school"). On 10-APR-2013 the patient was vaccinated with her second dose of GARDASIL (lot#, dose not reported, intramuscular). There was no concomitant medication. The patient's mother reported that on unspecified dates in either April or May of 2013, the patient experienced dizziness, fatigue, weakness, headache, stomach pain, vomiting, joint pain, chest pain, hair loss, appetite loss, insomnia, tremor, shortness of breath, itchy, swelling, rash, aching muscles, pelvis pain and discharge, nerve pain, menstrual cycle pain, fainting, swollen lymph nodes, night sweats, nausea, temporary vision and memory loss, ovarian cyst, cyst in left kidney, and a cyst was in left ear after receiving GARDASIL. The patient was admitted to several different unspecified hospitals on several different unspecified dates. The nurse reported that the patient had been to various unspecified hospitals and had had multiple labs drawn such as: Complete Blood Count (CBC), basic metabolic panel (BMP), amylase and lipase levels (on unspecified date in 2013) since receiving the GARDASIL and experiencing the above noted events. The nurse reported that the patient's laboratory values came back as negative. Unspecified treatment was given for the events. Unspecified lab test and unspecified blood work were performed. It was reported that patient had received her third dose of GARDASIL on 27-AUG-2013 (therapy continued). Outcome of the events was reported as not recovered. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Pelvic pain, Pruritus, Rash, Renal cyst, Secretion discharge
Clinical narrative: Information has been received from a nurse and the patient's mother referring to the 15 year old female patient with asthma. The patient had no drug reactions/allergies. On 27-FEB-2013 the patient was vaccinated with her first dose of GARDASIL (lot#, dose not reported) intramuscularly (indication reported as "Had to have it to go to school"). On 10-APR-2013 the patient was vaccinated with her second dose of GARDASIL (lot#, dose not reported, intramuscular). There was no concomitant medication. The patient's mother reported that on unspecified dates in either April or May of 2013, the patient experienced dizziness, fatigue, weakness, headache, stomach pain, vomiting, joint pain, chest pain, hair loss, appetite loss, insomnia, tremor, shortness of breath, itchy, swelling, rash, aching muscles, pelvis pain and discharge, nerve pain, menstrual cycle pain, fainting, swollen lymph nodes, night sweats, nausea, temporary vision and memory loss, ovarian cyst, cyst in left kidney, and a cyst was in left ear after receiving GARDASIL. The patient was admitted to several different unspecified hospitals on several different unspecified dates. The nurse reported that the patient had been to various unspecified hospitals and had had multiple labs drawn such as: Complete Blood Count (CBC), basic metabolic panel (BMP), amylase and lipase levels (on unspecified date in 2013) since receiving the GARDASIL and experiencing the above noted events. The nurse reported that the patient's laboratory values came back as negative. Unspecified treatment was given for the events. Unspecified lab test and unspecified blood work were performed. It was reported that patient had received her third dose of GARDASIL on 27-AUG-2013 (therapy continued). Outcome of the events was reported as not recovered. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Swelling, Syncope, Tremor, Vomiting
Clinical narrative: Information has been received from a nurse and the patient's mother referring to the 15 year old female patient with asthma. The patient had no drug reactions/allergies. On 27-FEB-2013 the patient was vaccinated with her first dose of GARDASIL (lot#, dose not reported) intramuscularly (indication reported as "Had to have it to go to school"). On 10-APR-2013 the patient was vaccinated with her second dose of GARDASIL (lot#, dose not reported, intramuscular). There was no concomitant medication. The patient's mother reported that on unspecified dates in either April or May of 2013, the patient experienced dizziness, fatigue, weakness, headache, stomach pain, vomiting, joint pain, chest pain, hair loss, appetite loss, insomnia, tremor, shortness of breath, itchy, swelling, rash, aching muscles, pelvis pain and discharge, nerve pain, menstrual cycle pain, fainting, swollen lymph nodes, night sweats, nausea, temporary vision and memory loss, ovarian cyst, cyst in left kidney, and a cyst was in left ear after receiving GARDASIL. The patient was admitted to several different unspecified hospitals on several different unspecified dates. The nurse reported that the patient had been to various unspecified hospitals and had had multiple labs drawn such as: Complete Blood Count (CBC), basic metabolic panel (BMP), amylase and lipase levels (on unspecified date in 2013) since receiving the GARDASIL and experiencing the above noted events. The nurse reported that the patient's laboratory values came back as negative. Unspecified treatment was given for the events. Unspecified lab test and unspecified blood work were performed. It was reported that patient had received her third dose of GARDASIL on 27-AUG-2013 (therapy continued). Outcome of the events was reported as not recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Fall, Head injury, Presyncope, Suture insertion
Clinical narrative: This unconfirmed spontaneous report as received from a physician via company representative refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with the first dose of GARDASIL (dose reported as one vial, route of administration and lot # not provided). The field representative was told by the physician, who was told by a neighbor that a friend's daughter had a vagal response when she received GARDASIL, fell and bumped her head on the table and had to go to an Emergency Facility, where she received a couple of stitches in her head. The patient's outcome was not reported. The relatedness between events and GARDASIL was not reported. Additional information is not expected, because there is no consent for follow-up.
Sex: U
Vaccine: HEP
Symptoms: Death
Clinical narrative: This unconfirmed spontaneous report was received from a consumer and refers to two patients (children) (unspecified) of unknown age and gender. The consumer read in some publication or article, that on an unknown date, a couple of the children were vaccinated with Hepatitis B vaccine (manufacturer unknown) or a couple of other (unspecified) vaccines (route of administration, doses, lot number and expiry dates were not reported). On an unknown dates, after the vaccination, an unspecified number of the patients died. The cause of death was not reported. The relatedness between the vaccinations and death was not reported. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Acute disseminated encephalomyelitis, Ataxia, Cerebellar syndrome, Dysarthria, Hypoaesthesia
Clinical narrative: Acute disseminated encephalomyelitis - numbness in extremities, dysarthria, dysmetria, truncal ataxia.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Blood glucose normal, Blood lactate dehydrogenase normal, C-reactive protein normal, Culture, Culture negative
Clinical narrative: Pericardial effusion noted on follow up Echo s/p Kawasaki disease, admitted to hospital, noted to be enlarging so had pericardiocentesis and drain placed 5/22/15.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Fibrin D dimer increased, Haematocrit decreased, Haemoglobin normal, Laboratory test normal, Lymphocyte percentage decreased
Clinical narrative: Pericardial effusion noted on follow up Echo s/p Kawasaki disease, admitted to hospital, noted to be enlarging so had pericardiocentesis and drain placed 5/22/15.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Neutrophil percentage, Pericardial drainage, Pericardial effusion, Platelet count normal, Pleural fluid analysis
Clinical narrative: Pericardial effusion noted on follow up Echo s/p Kawasaki disease, admitted to hospital, noted to be enlarging so had pericardiocentesis and drain placed 5/22/15.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Protein total decreased, Red blood cell sedimentation rate increased, Respiratory viral panel, Serum ferritin decreased, Viral test negative
Clinical narrative: Pericardial effusion noted on follow up Echo s/p Kawasaki disease, admitted to hospital, noted to be enlarging so had pericardiocentesis and drain placed 5/22/15.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: White blood cell count decreased
Clinical narrative: Pericardial effusion noted on follow up Echo s/p Kawasaki disease, admitted to hospital, noted to be enlarging so had pericardiocentesis and drain placed 5/22/15.
Sex: F
Vaccine: HPV2
Symptoms: Blood aluminium increased, Hypercoagulation, Necrosis
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of necrosis in a female patient who received CERVARIX. On an unknown date, the patient received CERVARIX at an unknown dose. On an unknown date, unknown after receiving CERVARIX, the patient experienced necrosis (serious criteria GSK medically significant) and hypercoagulation. On an unknown date, the outcome of the necrosis and hypercoagulation were unknown. It was unknown if the reporter considered the necrosis and hypercoagulation to be related to CERVARIX. Additional details provided as follows: The reporter said that one of her patient's was told at the hospital by top doctors that HPV vaccine caused hypercoagulation causing her to have a necrosed foot. They said it could be that the vaccine caused her to have aluminum toxicity.
Age: 1.28
Sex: F
Vaccine: DTAP, HIBV, MMR
Symptoms: Pyrexia
Clinical narrative: Vaccinated 5/27/15. Fever started following day. Temp max 104.2.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, DTAP, IPV
Symptoms: Cough, Erythema of eyelid, Eyelid oedema, Hypersensitivity, Tongue pruritus
Clinical narrative: Bilateral eye lid swelling and redness, tongue, itching and dry hacking cough.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, DTAP, IPV
Symptoms: Cough, Eye swelling, Glossodynia, Immediate post-injection reaction, Injection site erythema
Clinical narrative: Bilateral eye lid swelling and redness, tongue, itching and dry hacking cough.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, DTAP, IPV
Symptoms: Injection site swelling, Rhinorrhoea
Clinical narrative: Bilateral eye lid swelling and redness, tongue, itching and dry hacking cough.
Age: 0.21
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Diarrhoea, Full blood count normal, Pyrexia
Clinical narrative: Fever, diarrhea after rotavirus immunization fever up to 101 degree F, diarrhea-non bloody, non mucousy.
Age: 47.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site erythema, Injection site nodule, Injection site pustule
Clinical narrative: Patient received vaccine 5/23; by 5/25 had red knot at injection site. On 5/26 patient had nodule of pus in arms and started antibiotics. On 5/28, patient is recovering.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Circulatory collapse, Dizziness, Dyspnoea, Hyperhidrosis
Clinical narrative: Sweating, feeling faint, trouble breathing, collapsed to floor.
Age: 28.0
Sex: M
Vaccine: ANTH, RAB, TYP
Symptoms: Pyrexia, Vaccine positive rechallenge
Clinical narrative: Received anthrax, typhoid fever, and rabies on 27 May 15. Eight hours later, developed fever up to 102.3. This is the 2nd time this has happened, suspect reaction was either from rabies or anthrax. Same reaction (12 days of fevers) last time he received them simultaneously.
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Body temperature increased, Fatigue, Pain in extremity, Vomiting
Clinical narrative: Right arm soreness, vomitting, has been very fatigue, low grade temp 100.00
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Local reaction
Clinical narrative: 8 x 7 cm localized rxn.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash erythematous, Rash generalised
Clinical narrative: Started with red spots and itching the evening the day the flu shot was given. Redness scattered all over my body (red spots). Applied anti itch cream.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Fatigue, Flat affect, Staring, Tremor, Vomiting projectile
Clinical narrative: Vaccines given between 10 and 11 AM at 2 month well check-up. Husband and I were both present. Baby seemed exhausted but healthy until 3PM. Father witnessed babies body shaking (arms and legs simultaneously). Our baby didn't cry during the episode. He ask me if it was normal. Not having witnessed the first episode I said "yes, newborns do odd things." At about 5 PM I fed baby his bottle and he projectile vomited the entire feeding. I proceeded to take his temperature and he didn't have a fever. I handed our baby to my husband while I grabbed new clothes for him. On returning to our office I witnessed the second episode of trembling, blank stares and no crying. At that time I made a phone call to the pediatrician on-call. Dr's response after hearing our explanation was "if it happens a third time take him to the ER." He never had another episode. By 7 o'clock that evening our baby was exhausted not smiling or showing expression. By morning he seemed to be his normal self. I trust Dr. as a professional. She had been my daughters pediatrician until just recently. I do not believe she would have put my son in danger. We are waiting for a pediatric neurology appointment. We have left the practice for another office. My daughter, his biological sister, is fully vaccinated.
Age: 25.0
Sex: M
Vaccine: PNC13
Symptoms: Decreased appetite, Fatigue, Heart rate increased, Irritability, Pyrexia
Clinical narrative: Loss of appetite, fever 102.5, irritable, rapid heart beat, fatigue.
Age: 58.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site pain, Pain, Tenderness
Clinical narrative: Besides the typical symptoms; general tenderness/soreness, I did feel that it had an extra cringe to it. After the next 3 days, noticed that the pain was still lingering and in fact, noticed to that it also was painful to stretch out or up my arm along with a needling pain at the site as well still.
Age: 34.0
Sex: M
Vaccine: ANTH, TDAP
Symptoms: Headache, Pain, Petechiae, Pyrexia
Clinical narrative: Patient states he felt feverish, with body aches, and head ache. Patient presented to clinic with petechial rash on upper arms, upper chest, upper back, anterior groin, and anterior upper thighs bilat.