chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with an unspecified improperly stored dose of ROTATEQ, oral, of one of the following three lots; lot # L006181 and expiration date 13-DEC-2016 as reported, lot # L008996 and expiration date 01-DEC-2016 or lot # K023534 and expiration date 22-MAY-2016. There were no concomitant medications provided. No adverse effects were reported. There was no product quality issue involved. This is one of several cases from the same reporter. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Headache, Rhinorrhoea
Clinical narrative: Head aches, nose running, upset stomach.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Chills, Migraine, Pain, Vomiting
Clinical narrative: On 10/14/1 5- severe body aches, unable to function, having chills, vomiting, severe headache migraine in nature.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling of body temperature change
Clinical narrative: Cold-/hot went to bed early and felt fine in the morning.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea
Clinical narrative: Nauseous.
Age: 2.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse (R.N.) via telephone call on 20-OCT-2015, concerning a 2 year old patient of unknown gender. No concurrent conditions or medical history were reported. On 31-AUG-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot K024825 Expiration date: not reported) (dose, route and anatomical location of administration were not reported). No concomitant therapy was provided. No adverse effects were reported. This is one of several cases from the same reporter. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse (R.N.) via telephone call on 20-OCT-2015, concerning a 5 year old patient of unknown gender. No concurrent conditions or medical history were reported. On 01-SEP-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # L002242 Expiration date: not reported) (dose, route and anatomical location of administration were not reported). No concomitant therapy was provided. No adverse effects were reported. This is one of several cases from the same reporter. Additional information has been requested.
Age: 1.3
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse (R.N.) via telephone call on 20-OCT-2015, concerning a 15 month old patient of unknown gender. No concurrent conditions or medical history were reported. On 01-SEP-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # L002242 Expiration date: not reported) (dose, route and anatomical location of administration were not reported). No concomitant therapy was provided. No adverse effects were reported. This is one of several cases from the same reporter. Additional information has been requested.
Age: 1.02
Sex: U
Vaccine: HEPA, MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse (R.N.) via telephone call on 20-OCT-2015, concerning a 12 month old patient of unknown gender. No concomitant conditions or medical history were reported. On 02-SEP-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # L002242 Expiration date: not reported) and with an improperly stored dose of VAQTA (Lot No. L007559 Expiration date: not reported) (dose, route and anatomical location of administration were not reported). No concomitant therapy was provided. No adverse effects were reported. This is one of several cases from the same reporter. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse (R.N.) via telephone call on 20-OCT-2015, concerning a 5 year old patient of unknown gender. No concurrent conditions or medical history were reported. On 02-SEP-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K024825 Expiration date: not reported) and with an improperly stored dose of VARIVAX (Merck) (Lot No. L005299 Expiration date: not reported) (dose, route and anatomical location of administration were not reported). No concomitant therapy was provided. No adverse effects were reported. This is one of several cases from the same reporter. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse (R.N.) via telephone call on 20-OCT-2015, concerning a 5 year old patient of unknown gender. No concurrent conditions or medical history were reported. On 01-SEP-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) lot # L001333 Expiration date: not reported (dose, route and anatomical location of administration were not reported). No concomitant therapy was provided. No adverse effects were reported. This is one of several cases from the same reporter. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 1 year old patient gender not provided On 20-MAY-2001, the patient was vaccinated with the first dose of RECOMBIVAX HB (dose, route and lot # not reported). On  31-AUG-2001, the patient received the second dose of (dose, route and lot # not reported) and on 13-OCT-2015, the patient received the third dose of RECOMBIVAX HB (dose, route and lot not reported). The pharmacist also reported that the patient also received the first dose of VARIVAX (Merck) (dose, route and lot # not reported) in July 2002 and the second dose of VARIVAX (Merck) (dose, route and lot # not reported) on 13-OCT-2015. No adverse symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse, referring to multiple unspecified patients. The nurse reported that on multiple unspecified dates, multiple different unspecified patients were administered improperly stored VARIVAX (Merck) lot # L02000, expiration date 02-JUN-2017, lot # L013824, expiry date 21-APR-2017. The nurse enquired about the stability of ZOSTAVAX, but none was administered. On 26-OCT-2015, the nurse reported that on multiple unspecified dates, multiple different unspecified patients were administered improperly stored VARIVAX (Merck) lot # L013824, expiry date 21-APR-2017 after the previously reported temperature excursions. No adverse effects were reported. The ZOSTAVAX, lot # L013546, expiration date 17-JUL-2016 and other lot numbers of VARIVAX (Merck) lot # L02000, expiration date 02-JUN-2017 and lot # L026410, expiration date 15-FEB-2017 appeared on the product list, since the stability was enquired about these vaccines. No doses of ZOSTAVAX, was administered. This case is one of the two reports with the same reporter link. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Erythema, Injected limb mobility decreased, Peripheral swelling
Clinical narrative: Had reaction left arm from PNEUMOVAX last eve. Noted 4x6 swelling and redness below injection site. Difficulty raising arm. Swelling less this arm and about 2 area below inj. site with redenned area. Has taken TYLENOL, ALLEGRA and drinking lots of water.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Computerised tomogram abdomen abnormal, Endoscopy, Gallbladder disorder, Hepatobiliary scan abnormal
Clinical narrative: Complained of abdominal pain -rt upper quadrant after getting vaccine. After several months of CT scans, ultrasound, Hida scan and endoscopy - found gallbladder sluggish. Surgical consult.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound abdomen
Clinical narrative: Complained of abdominal pain -rt upper quadrant after getting vaccine. After several months of CT scans, ultrasound, Hida scan and endoscopy - found gallbladder sluggish. Surgical consult.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker concerning a patient of unknown age and gender. No concurrent conditions or medical history were reported. On 28-OCT-2015, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (lot # L003218 Expiration date: 30-APR-2016) (dose, route and anatomical location of administration were not reported). No adverse effect was reported. No Product Quality Complaint (PQC) was involved. Addiitonal information has been requested.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Blood pressure increased, Chills, Cough, Fatigue, Pain
Clinical narrative: This spontaneous report was received from a registered nurse concerning on herself, a 78 year old female patient with high blood pressure, gastrooesophageal reflux disease (GERD), asthma, irritable bowel syndrome (IBS), diverticulosis, penicillin allergy and Guillain-Barre syndrome (diagnosed on an unspecified date, in about 1989 or 1990, after received an unspecified flu vaccine). The patient's medical history included leg weakness and a racing heart (in about 1989 or 1990, after received an unspecified flu vaccine, she recovered a few months later), stomach sickness, chills, fever and rubella rash all over her body (MARRS# 1511USA001618) and a burning sensation up the spine in about 2001 after taking the second dose of ciprofloxacin (manufacturer unknown). On an unspecified date, reported as "in the early 1990's", the patient was vaccinated with an unspecified dose of MERUVAX II, intramuscular injection (anatomical location, lot number and expiration date were not provided). On an unspecified date, in approximately October 2014, reported as "about 1 year ago", the patient was vaccinated with PNEUMOVAX 23, intramuscular injection, (anatomical location, lot number and expiration date were not provided). Concomitant therapies included PRILOSEC, ZANTAC, aspirin, XOPENEX, ALVESCO, atenolol and lisinopril. On an unspecified date, in approximately October 2014, later that the same day that she received the unspecified dose of PNEUMOVAX 23, the patient began to feel achy all over her whole body and tired. She did not seek any medical attention for the tired and achy feeling. She recovered, on an unspecified date, in 2014, 2 days later for the adverse events. On an unspecified date, in June 2015, the patient developed an unspecified viral infection. She also developed fever (temperature unspecified), cough and chills. On an unspecified date, in June 2015, the patient sought medical attention at an unspecified emergency room in an unspecified city and she received 1 dose of erythromycin. On an unspecified date, in 2015, 48 hours after visiting the emergency room, the patient recovered from the viral infection, cough, pyrexia and chills. The reporter did not assess the relatedness of pain, fatigue, viral infection, fever, cough, chills and pyrexia with MERUVAX II and PNEUMOVAX 23. This is one of several cases from the same reporter. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Viral infection
Clinical narrative: This spontaneous report was received from a registered nurse concerning on herself, a 78 year old female patient with high blood pressure, gastrooesophageal reflux disease (GERD), asthma, irritable bowel syndrome (IBS), diverticulosis, penicillin allergy and Guillain-Barre syndrome (diagnosed on an unspecified date, in about 1989 or 1990, after received an unspecified flu vaccine). The patient's medical history included leg weakness and a racing heart (in about 1989 or 1990, after received an unspecified flu vaccine, she recovered a few months later), stomach sickness, chills, fever and rubella rash all over her body (MARRS# 1511USA001618) and a burning sensation up the spine in about 2001 after taking the second dose of ciprofloxacin (manufacturer unknown). On an unspecified date, reported as "in the early 1990's", the patient was vaccinated with an unspecified dose of MERUVAX II, intramuscular injection (anatomical location, lot number and expiration date were not provided). On an unspecified date, in approximately October 2014, reported as "about 1 year ago", the patient was vaccinated with PNEUMOVAX 23, intramuscular injection, (anatomical location, lot number and expiration date were not provided). Concomitant therapies included PRILOSEC, ZANTAC, aspirin, XOPENEX, ALVESCO, atenolol and lisinopril. On an unspecified date, in approximately October 2014, later that the same day that she received the unspecified dose of PNEUMOVAX 23, the patient began to feel achy all over her whole body and tired. She did not seek any medical attention for the tired and achy feeling. She recovered, on an unspecified date, in 2014, 2 days later for the adverse events. On an unspecified date, in June 2015, the patient developed an unspecified viral infection. She also developed fever (temperature unspecified), cough and chills. On an unspecified date, in June 2015, the patient sought medical attention at an unspecified emergency room in an unspecified city and she received 1 dose of erythromycin. On an unspecified date, in 2015, 48 hours after visiting the emergency room, the patient recovered from the viral infection, cough, pyrexia and chills. The reporter did not assess the relatedness of pain, fatigue, viral infection, fever, cough, chills and pyrexia with MERUVAX II and PNEUMOVAX 23. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant, refers to multiple unspecified patients of unknown age and gender. No medical history and concurrent conditions were reported for the patients. On an unspecified date in 2015, starting from and after 03-AUG-2015, the unspecified patients were vaccinated with improperly stored doses of PNEUMOVAX 23 lot # L003188, expiration date 06-JUL-2016 (dose, frequency and route were not reported). No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. Information about patients' concurrent conditions and medical history was not reported. On unspecified dates the patients were vaccinated with doses of improperly stored PROQUAD (dose and route not reported, lot # L010141 with expiration date 24-SEP-2016). Concomitant medications were not provided. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a healthcare worker (medical assistant) referring to a patient of unknown gender and age. The information of concurrent conditions, medical history and concomitant medications was not provided. On 15-OCT-2015 (reported as "today"), the patient was administered an expired dose of the Pediatric/Adolescent Formulation of VAQTA 25/0.5 (unit not provided) vial (lot # J012768, expired date 25-SEP-2015, dose and frequency were not provided) intramuscularly. This was the first dose of VAQTA this patient had been administered. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. Information about medical history and concurrent conditions were unspecified. The reporter stated that from 25-OCT-2015, ZOSTAVAX (lot number L011533, expiration date 03-JUL-2016) was improperly exposed to 46F for 72 hours. Then on 30-OCT-2015, the patient was vaccinated with the improperly stored dose of ZOSTAVAX (dose unknown, subcutaneous). No known adverse effects were reported. No PQC involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of an unknown age and gender. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, (dose, route, lot # and expiration date were not provided). On an unknown date, after receiving the vaccine, the patient developed swelling, redness, "soreness" and "hot" at the injection site. The outcome of the events was unknown. The causality was not stated. This is one of several reports received from the same reporter. 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 certified medical assistant, refers to multiple unspecified patients of unknown age and gender. No medical history and concurrent conditions were reported for the patients. On an unspecified date in 2015, starting from and after 03-AUG-2015, the unspecified patients were vaccinated with improperly stored doses of ZOSTAVAX lot # L015417, expiration date 01-AUG-2016 (dose, frequency and route were not reported). No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Erythema multiforme, Pain in extremity, Peripheral swelling, Vaccination site induration
Clinical narrative: Erythema multiforme and induration of vaccinated area, (R) arm soreness/swelling. Diphenhydramine, amoxicillin/clavulanate 875 mg BID.
Age: 87.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient presented to primary care clinic complaining that right upper arm was red and tender. No shortness of breath or chest pain. Diphenhydramine 25 mg once.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL, DTAPIPVHIB, IPV, MMR, VARCEL
Symptoms: Cough, Eyelid oedema, Swelling face, Wheezing
Clinical narrative: Information has been received from an allergist referring to a 4 year old male patient with no pertinent medical history. The patient had no drug allergies previously. On 08-JUL-2015 the patient was vaccinated with a dose of VARIVAX (Merck) (lot #, dose and route were unknown) and a dose of M-M-R II (lot #, dose and route were unknown) at his pediatrician's office. Concomitant vaccines included IPV and PENTACEL on the same day. On 08-JUL-2015, within 15 minutes of receiving the vaccines, the patient had a "full blown anaphylactic reaction". The patient was treated with prednisone, dexamethasone and BENADRYL at the hospital on the same day. It was unspecified if the patient was admitted or treated and released that same day. Since this reaction occurred, the physician had conducted allergy testing to determine the cause of the reaction. The patient has tested negative for allergy to neomycin and gelatin. Allergy testing has not revealed any other allergies. Serology testing showed the patient had immunity to varicella, measles, mumps and rubella. The outcome was reported as recovered on an unknown date of 2015. Causality was not provided. The physician considered the event to be life threatening. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL, DTAPIPVHIB, IPV, MMR, VARCEL
Symptoms: Allergy test negative, Anaphylactic reaction, Antibody test positive, Measles antibody positive, Mumps antibody test positive
Clinical narrative: Information has been received from an allergist referring to a 4 year old male patient with no pertinent medical history. The patient had no drug allergies previously. On 08-JUL-2015 the patient was vaccinated with a dose of VARIVAX (Merck) (lot #, dose and route were unknown) and a dose of M-M-R II (lot #, dose and route were unknown) at his pediatrician's office. Concomitant vaccines included IPV and PENTACEL on the same day. On 08-JUL-2015, within 15 minutes of receiving the vaccines, the patient had a "full blown anaphylactic reaction". The patient was treated with prednisone, dexamethasone and BENADRYL at the hospital on the same day. It was unspecified if the patient was admitted or treated and released that same day. Since this reaction occurred, the physician had conducted allergy testing to determine the cause of the reaction. The patient has tested negative for allergy to neomycin and gelatin. Allergy testing has not revealed any other allergies. Serology testing showed the patient had immunity to varicella, measles, mumps and rubella. The outcome was reported as recovered on an unknown date of 2015. Causality was not provided. The physician considered the event to be life threatening. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL, DTAPIPVHIB, IPV, MMR, VARCEL
Symptoms: Rubella antibody positive
Clinical narrative: Information has been received from an allergist referring to a 4 year old male patient with no pertinent medical history. The patient had no drug allergies previously. On 08-JUL-2015 the patient was vaccinated with a dose of VARIVAX (Merck) (lot #, dose and route were unknown) and a dose of M-M-R II (lot #, dose and route were unknown) at his pediatrician's office. Concomitant vaccines included IPV and PENTACEL on the same day. On 08-JUL-2015, within 15 minutes of receiving the vaccines, the patient had a "full blown anaphylactic reaction". The patient was treated with prednisone, dexamethasone and BENADRYL at the hospital on the same day. It was unspecified if the patient was admitted or treated and released that same day. Since this reaction occurred, the physician had conducted allergy testing to determine the cause of the reaction. The patient has tested negative for allergy to neomycin and gelatin. Allergy testing has not revealed any other allergies. Serology testing showed the patient had immunity to varicella, measles, mumps and rubella. The outcome was reported as recovered on an unknown date of 2015. Causality was not provided. The physician considered the event to be life threatening. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: FLU4, FLU4, FLU4
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 58-year-old female patient who received FLUARIX QUADRIVALENT (batch number 23J79, expiry date 14th June 2016). On 9th September 2015, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On an unknown date, 14 days after receiving FLUARIX QUADRIVALENT, the patient experienced injection site pain (serious criteria disability) and injected limb mobility decreased (serious criteria disability). On an unknown date, the outcome of the injection site pain and injected limb mobility decreased were not recovered/not resolved. It was unknown if the reporter considered the injection site pain and injected limb mobility decreased to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The pharmacist reported that the patient received a FLUARIX QUADRIVALENT injection on 9th September 2015. The patient recently returned to the pharmacy stating that the arm started hurting about 2 weeks after receiving the injection and now approximately one month after vaccination could not move her arm. The patient believed that the vaccine was injected too high, but the pharmacist denied this. The pharmacist stated that the vaccine was properly injected. The pharmacist referred the patient to her health care professional, but the patient did not want to seek medical care. The pharmacist did not think that the pain was related to the injection.
Age: 58.0
Sex: F
Vaccine: FLU4, FLU4, FLU4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 58-year-old female patient who received FLUARIX QUADRIVALENT (batch number 23J79, expiry date 14th June 2016). On 9th September 2015, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On an unknown date, 14 days after receiving FLUARIX QUADRIVALENT, the patient experienced injection site pain (serious criteria disability) and injected limb mobility decreased (serious criteria disability). On an unknown date, the outcome of the injection site pain and injected limb mobility decreased were not recovered/not resolved. It was unknown if the reporter considered the injection site pain and injected limb mobility decreased to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The pharmacist reported that the patient received a FLUARIX QUADRIVALENT injection on 9th September 2015. The patient recently returned to the pharmacy stating that the arm started hurting about 2 weeks after receiving the injection and now approximately one month after vaccination could not move her arm. The patient believed that the vaccine was injected too high, but the pharmacist denied this. The pharmacist stated that the vaccine was properly injected. The pharmacist referred the patient to her health care professional, but the patient did not want to seek medical care. The pharmacist did not think that the pain was related to the injection.
Age: 58.0
Sex: F
Vaccine: FLU4, FLU4, FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Wrong technique in product usage process
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 58-year-old female patient who received FLUARIX QUADRIVALENT (batch number 23J79, expiry date 14th June 2016). On 9th September 2015, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On an unknown date, 14 days after receiving FLUARIX QUADRIVALENT, the patient experienced injection site pain (serious criteria disability) and injected limb mobility decreased (serious criteria disability). On an unknown date, the outcome of the injection site pain and injected limb mobility decreased were not recovered/not resolved. It was unknown if the reporter considered the injection site pain and injected limb mobility decreased to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The pharmacist reported that the patient received a FLUARIX QUADRIVALENT injection on 9th September 2015. The patient recently returned to the pharmacy stating that the arm started hurting about 2 weeks after receiving the injection and now approximately one month after vaccination could not move her arm. The patient believed that the vaccine was injected too high, but the pharmacist denied this. The pharmacist stated that the vaccine was properly injected. The pharmacist referred the patient to her health care professional, but the patient did not want to seek medical care. The pharmacist did not think that the pain was related to the injection.
Age: 38.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Blood pressure increased, Chest discomfort, Chest pain, Heart rate increased, Urticaria
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of anaphylactic reaction in a 39-year-old female patient who received FLUARIX QUADRIVALENT (batch number M932G, expiry date unknown). Concurrent medical conditions included drug allergy (allergy to thiomersal). On 30th October 2015, the patient received FLUARIX QUADRIVALENT .5 ml. On 30th October 2015, 3 min after receiving FLUARIX QUADRIVALENT, the patient experienced anaphylactic reaction (serious criteria hospitalization, disability, GSK medically significant and life threatening), hives, throat swelling, difficulty breathing and weakness generalized. The patient was treated with BENADRYL. FLUARIX QUADRIVALENT was continued with no change. On an unknown date, the outcome of the anaphylactic reaction, hives, throat swelling, difficulty breathing and weakness generalized were unknown. It was unknown if the reporter considered the anaphylactic reaction, hives, throat swelling, difficulty breathing and weakness generalized to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The health care professional reported that the patient, whom was his wife, received a dose of a GSK flu product and began to have an anaphylactic reaction within a few minutes after getting the shot. The patient had a history of allergy to thiomersal, but the reporter was unsure which GSK flu product was received. The patient experienced chest hives, throat swelling, difficulty breathing and generalized weakness. The patient was admitted to the hospital and had received some BENADRYL but was unsure if any other treatments were given. The reporter stated that no other vaccines were administered at the time of the patient receiving the flu vaccine. The reporter also stated of not having access to product expiration date at this time of reporting as well. No further information was reported regarding the event.
Age: 38.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Anaphylactic reaction, Asthenia, Dyspnoea, Pharyngeal oedema, Urticaria
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of anaphylactic reaction in a 39-year-old female patient who received FLUARIX QUADRIVALENT (batch number M932G, expiry date unknown). Concurrent medical conditions included drug allergy (allergy to thiomersal). On 30th October 2015, the patient received FLUARIX QUADRIVALENT .5 ml. On 30th October 2015, 3 min after receiving FLUARIX QUADRIVALENT, the patient experienced anaphylactic reaction (serious criteria hospitalization, disability, GSK medically significant and life threatening), hives, throat swelling, difficulty breathing and weakness generalized. The patient was treated with BENADRYL. FLUARIX QUADRIVALENT was continued with no change. On an unknown date, the outcome of the anaphylactic reaction, hives, throat swelling, difficulty breathing and weakness generalized were unknown. It was unknown if the reporter considered the anaphylactic reaction, hives, throat swelling, difficulty breathing and weakness generalized to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The health care professional reported that the patient, whom was his wife, received a dose of a GSK flu product and began to have an anaphylactic reaction within a few minutes after getting the shot. The patient had a history of allergy to thiomersal, but the reporter was unsure which GSK flu product was received. The patient experienced chest hives, throat swelling, difficulty breathing and generalized weakness. The patient was admitted to the hospital and had received some BENADRYL but was unsure if any other treatments were given. The reporter stated that no other vaccines were administered at the time of the patient receiving the flu vaccine. The reporter also stated of not having access to product expiration date at this time of reporting as well. No further information was reported regarding the event.
Age: 10.0
Sex: F
Vaccine: FLU3, PPV, FLU4, PPV
Symptoms: Blood test, Chest X-ray, Computerised tomogram head, Seizure
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of seizure in a 10-year-old female patient who received FLUARIX QUADRIVALENT (batch number 2BX4T, expiry date 30th June 2016). Concomitant products included PNEUMOVAX 23. On 27th October 2015, the patient received FLUARIX QUADRIVALENT .5 ml. On 28th October 2015, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced seizure (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the seizure was resolved with sequelae. It was unknown if the reporter considered the seizure to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: Concomitant vaccination included PNEUMOVAX 23, given on 27th October 2015. On 28th October 2015, at 3 o'clock, the patient experienced seizures. The patient had never had a seizure before and remained in the hospital at the time of reporting. The seizures had resolved with sequelae (details not provided).
Age: 10.0
Sex: F
Vaccine: FLU3, PPV, FLU4, PPV
Symptoms: Seizure
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of seizure in a 10-year-old female patient who received FLUARIX QUADRIVALENT (batch number 2BX4T, expiry date 30th June 2016). Concomitant products included PNEUMOVAX 23. On 27th October 2015, the patient received FLUARIX QUADRIVALENT .5 ml. On 28th October 2015, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced seizure (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the seizure was resolved with sequelae. It was unknown if the reporter considered the seizure to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: Concomitant vaccination included PNEUMOVAX 23, given on 27th October 2015. On 28th October 2015, at 3 o'clock, the patient experienced seizures. The patient had never had a seizure before and remained in the hospital at the time of reporting. The seizures had resolved with sequelae (details not provided).
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Computerised tomogram, VIIth nerve paralysis
Clinical narrative: Left side facial paralysis.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Induration, Rash, Skin warm
Clinical narrative: Pt woke up with a rash and hardness of upper arm, about 3-4 inch wide, area was hard and hot. Pt iced the area and took ibuprofen and Benadryl. The following day (day 2) the area is the size of an orange and red. Developing blister in center and little bisters around it.
Age: 28.0
Sex: M
Vaccine: FLUN4, HPV4
Symptoms: Rash, Rash erythematous
Clinical narrative: Little red bumps on patients chest and down his left arm. Patient took Benadryl after talking to physician.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Gait disturbance, Injection site pain, Injection site swelling, Vaccination complication, X-ray limb abnormal
Clinical narrative: Extreme swelling in left leg.  Injection was given on upper left thigh.  Swelling was from knee to mid thigh.  Child was limping and in pain from the major swelling.  Knee was the size of a baseball.
Age: 71.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Bone pain, Myalgia
Clinical narrative: Muscle pain, joint pain, bone pain, worse at joints where you have arthritis.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain, Diarrhoea, Gastrointestinal infection, Inadequate aseptic technique in use of product, Nausea
Clinical narrative: Diarrhea, abdominal cramping, body aches, mild soreness on the right arm, nausea/vomiting, and Temp 99. Could not keep anything down. My husband drove me to see the doctor and informed her of my sign and symptoms. Also, told her that I received the flu vaccine yesterday (Monday). I also told her two years ago when I got the flu vaccine I got sick. She didn't response to my statement made. Diagnosis with GI virus. Took Zofran (Rx MD).  At 2:00pm developed a fever 102 took Tylenol. After 45minutes was able to sips on water and ate couple soda crackers. At 7pm body aches and fever 101 took Motrin. Last episode of diarrhea was approximately 6:30pm. Wednesday, feeling a little bit better not full 100%.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Pain in extremity, Pyrexia, Viral infection, Vomiting
Clinical narrative: Diarrhea, abdominal cramping, body aches, mild soreness on the right arm, nausea/vomiting, and Temp 99. Could not keep anything down. My husband drove me to see the doctor and informed her of my sign and symptoms. Also, told her that I received the flu vaccine yesterday (Monday). I also told her two years ago when I got the flu vaccine I got sick. She didn't response to my statement made. Diagnosis with GI virus. Took Zofran (Rx MD).  At 2:00pm developed a fever 102 took Tylenol. After 45minutes was able to sips on water and ate couple soda crackers. At 7pm body aches and fever 101 took Motrin. Last episode of diarrhea was approximately 6:30pm. Wednesday, feeling a little bit better not full 100%.
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Pt was administered a dose of influenza high dose vaccine.
Age: 0.64
Sex: F
Vaccine: DTAPHEPBIP, FLU4, MNQ, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Pt was administered a full dose (0.5mL) of influenza vaccine and a dose of Menactra.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Blood electrolytes normal, Blood magnesium normal, Blood thyroid stimulating hormone normal, Chest pain
Clinical narrative: Sudden onset of abdominal cramping, nausea, chest pain and numbness and tingling of her lips and palpitations. Went to the emergency department with diagnosis of Allergic reaction-Vasovagal.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Differential white blood cell count normal, Full blood count normal, Hypersensitivity, Hypoaesthesia oral, Nausea
Clinical narrative: Sudden onset of abdominal cramping, nausea, chest pain and numbness and tingling of her lips and palpitations. Went to the emergency department with diagnosis of Allergic reaction-Vasovagal.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Palpitations, Paraesthesia oral, Presyncope, Thyroxine normal, Tri-iodothyronine normal
Clinical narrative: Sudden onset of abdominal cramping, nausea, chest pain and numbness and tingling of her lips and palpitations. Went to the emergency department with diagnosis of Allergic reaction-Vasovagal.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Troponin I normal
Clinical narrative: Sudden onset of abdominal cramping, nausea, chest pain and numbness and tingling of her lips and palpitations. Went to the emergency department with diagnosis of Allergic reaction-Vasovagal.
Age: 35.0
Sex: F
Vaccine: FLU3, HEPAB, MMR
Symptoms: Maternal exposure before pregnancy
Clinical narrative: Patient received a live virus vaccine (MMR) on 10/6/15. She presented today for a pregnancy test which was positive. Had signed consent not pregnant and agreed to not become pregnant within 4 weeks of vaccination. Based on LMP, probable conception was the day after receiving the MMR vaccine. Report is precautionary.
Age: 0.64
Sex: M
Vaccine: HIBV
Symptoms: Crying, Decreased appetite, Erythema, Urticaria
Clinical narrative: Red hives on top of head, forehead, back of head and neck, unusual crying for hours can't be consoled, loss of appetite.
Age: 7.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Urticaria
Clinical narrative: Patient broke out in hives at school.  She was sent home.  We called the doctor and was told to give her Benadryl.
Age: 65.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Redness, swelling, pain.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: "I received my flu shot during the October clinic and my right arm still hurts. I told the nurse after he administered the shot that it hurt pretty bad.  He said he thought he hit a nerve.  It hurts to rasie my arm above my head.  I will continue to stretch my shoulder out and see if that works."
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site urticaria
Clinical narrative: Within 30 seconds hives developed at injection site. 4 teaspoons diphenhydramine HCl liquid 12.5 mg/5 ml administered. Observed for 45 minutes. Condition improved. No respiratory signs and symptoms.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as recovered from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 23-OCT-2015, the patient was vaccinated with an expired dose of VAQTA (lot # K008984, expiration date 21-OCT-2015, 1 ml, intramuscularly). No adverse effects were reported. Additional information has been requested.
Age: 0.52
Sex: M
Vaccine: DTAPHEPBIP, FLU4, PNC13, RV5
Symptoms: Constipation, Eye swelling, Haematochezia, Pyrexia, Respiratory syncytial virus infection
Clinical narrative: RVS. S and S started week of June 15, 2015. Vomiting, unable to stool, fever, eyes swollen, bloody stools.
Age: 0.52
Sex: M
Vaccine: DTAPHEPBIP, FLU4, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: RVS. S and S started week of June 15, 2015. Vomiting, unable to stool, fever, eyes swollen, bloody stools.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Rash pustular, Swelling
Clinical narrative: Swelling, redness, small pustules.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Swelling
Clinical narrative: Swelling, redness.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site reaction, Neck pain, Pain in extremity, Swelling
Clinical narrative: Patient reported neck and arm pain for 5 days following vaccination. Has never had reaction like this before. Some puffiness at site.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Rash started 10-29-15 in the evening. Rash on both arms, neck, feet. Took OTC BENADRYL daily -> some improvement.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Infection, Influenza virus test negative, Injection site reaction, Pyrexia
Clinical narrative: This spontaneous report as received from a patient's daughter, refers to a 58 year old female patient. The patient's concurrent conditions included arthritis, high blood pressure, high cholesterol, unspecified ear and throat disorder (reported as 'ears and throat was bothering her') and allergy to sulfur. The patient went to her physician's office on 27-OCT-2015 for administration of PNEUMOVAX 23 in advance of a planned back surgery which would require an extended stay in the hospital. The patient's ears and her throat were "bothering her" so the physician prescribed oral antibiotics for her. No tests were done during the visit to determine if she had an infection. The patient was administered PNEUMOVAX 23 (lot # L012215, expiration date: January 2017, dose and route were not reported) on 27-OCT-2015, because she was not running a fever and the physician determined it was safe to administer. Concomitant medications included unspecified antibiotics, "something for nausea" and "something for pain/headache", unspecified blood pressure medication and unspecified cholesterol medication. After the visit, on an unspecified date in October 2015, the patient developed a very large welt at the injection site, her head was "killing her" and she had a fever climbing over 102 (units not provided) and she couldn't stop vomiting. She was taken to the emergency room (ER) in the evening of 29-OCT-2015 and kept for observation. The tests for flu and strep performed on the same day came back negative. Based on the test results, the ER physicians believed the patient was infected by PNEUMOVAX 23. At the time of reporting, the patient was on unspecified intravenous (IV) antibiotics. The physicians were not sure if the infection has spread to her muscles or not. The welt has not improved. They might have to cut into the welt to drain the infection from her muscle. The outcome of all the events was reported as not recovered/not resolved. The reporter did not assess the relatedness between the events and PNEUMOVAX 23. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Streptococcus test negative, Urticaria, Vomiting
Clinical narrative: This spontaneous report as received from a patient's daughter, refers to a 58 year old female patient. The patient's concurrent conditions included arthritis, high blood pressure, high cholesterol, unspecified ear and throat disorder (reported as 'ears and throat was bothering her') and allergy to sulfur. The patient went to her physician's office on 27-OCT-2015 for administration of PNEUMOVAX 23 in advance of a planned back surgery which would require an extended stay in the hospital. The patient's ears and her throat were "bothering her" so the physician prescribed oral antibiotics for her. No tests were done during the visit to determine if she had an infection. The patient was administered PNEUMOVAX 23 (lot # L012215, expiration date: January 2017, dose and route were not reported) on 27-OCT-2015, because she was not running a fever and the physician determined it was safe to administer. Concomitant medications included unspecified antibiotics, "something for nausea" and "something for pain/headache", unspecified blood pressure medication and unspecified cholesterol medication. After the visit, on an unspecified date in October 2015, the patient developed a very large welt at the injection site, her head was "killing her" and she had a fever climbing over 102 (units not provided) and she couldn't stop vomiting. She was taken to the emergency room (ER) in the evening of 29-OCT-2015 and kept for observation. The tests for flu and strep performed on the same day came back negative. Based on the test results, the ER physicians believed the patient was infected by PNEUMOVAX 23. At the time of reporting, the patient was on unspecified intravenous (IV) antibiotics. The physicians were not sure if the infection has spread to her muscles or not. The welt has not improved. They might have to cut into the welt to drain the infection from her muscle. The outcome of all the events was reported as not recovered/not resolved. The reporter did not assess the relatedness between the events and PNEUMOVAX 23. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Abnormal behaviour, Aggression, Autism, Decreased appetite, Depressed level of consciousness
Clinical narrative: Pt became extremely irritable, decreased awareness, had behavior change, not cooperative, eating was a challenge, personality change, "autistic like behavior per mom", aggressive behv - lasted for 9 days.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Irritability, Personality change
Clinical narrative: Pt became extremely irritable, decreased awareness, had behavior change, not cooperative, eating was a challenge, personality change, "autistic like behavior per mom", aggressive behv - lasted for 9 days.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Pt had Tdap 10-29-15 states her arm started swelling and had redness the day after.  Stated it continued to swell for the next couple of days but is getting better now.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Injection site induration, Injection site inflammation, Injection site pain, Injection site warmth
Clinical narrative: 8cm area of inflammation on left lateral thigh. Hard and warm/tender to touch.