chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Bronchial hyperreactivity, Chest X-ray abnormal, Computerised tomogram head abnormal, Pregnancy test urine negative, Sinusitis
Clinical narrative: Information has been received from an office administrator via a field representative referring to a 16 year old female patient. No relevant medical history and drug allergy were reported. On 10-FEB-2015 the patient was vaccinated with her first dose of GARDASIL (lot# unknown), 0.5 ml, intramuscularly in the left deltoid. There was no concomitant medication. Prior to receiving the GARDASIL, the patient was in good health. When the dose of GARDASIL was administered to the patient, she felt dizzy or light-headed. Seven minutes later, the patient lost consciousness for approximately 20 minutes. The facility performed the following intervention to prevent serious criteria: they called 911, and the paramedics provided the intravenous fluid as treatment, and they also performed an electrocardiogram (EKG) as a diagnostic test (result unspecified). The patient was transported by the paramedics to an unspecified hospital on 10-FEB-2015. The representative did not know if the patient was observed overnight or admitted to the hospital. On 12-FEB-2015, the patient had an appointment to be examined by a Physician. The physician was reluctant to give her more doses of GARDASIL, so the representative did not know if the GARDASIL series were discontinued. The events of dizzy or light-headed and lost consciousness were reported to be serious as other medical significant. The outcome of feeling dizzy or light-headed was unknown. The relationship of the adverse events and GARDASIL was not reported. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Syncope, Unresponsive to stimuli, Viral infection
Clinical narrative: Information has been received from an office administrator via a field representative referring to a 16 year old female patient. No relevant medical history and drug allergy were reported. On 10-FEB-2015 the patient was vaccinated with her first dose of GARDASIL (lot# unknown), 0.5 ml, intramuscularly in the left deltoid. There was no concomitant medication. Prior to receiving the GARDASIL, the patient was in good health. When the dose of GARDASIL was administered to the patient, she felt dizzy or light-headed. Seven minutes later, the patient lost consciousness for approximately 20 minutes. The facility performed the following intervention to prevent serious criteria: they called 911, and the paramedics provided the intravenous fluid as treatment, and they also performed an electrocardiogram (EKG) as a diagnostic test (result unspecified). The patient was transported by the paramedics to an unspecified hospital on 10-FEB-2015. The representative did not know if the patient was observed overnight or admitted to the hospital. On 12-FEB-2015, the patient had an appointment to be examined by a Physician. The physician was reluctant to give her more doses of GARDASIL, so the representative did not know if the GARDASIL series were discontinued. The events of dizzy or light-headed and lost consciousness were reported to be serious as other medical significant. The outcome of feeling dizzy or light-headed was unknown. The relationship of the adverse events and GARDASIL was not reported. Additional information has been requested.
Age: 1.27
Sex: F
Vaccine: HIBV
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: 101 fever for two days, on and off followed by vomiting within 24 hours. By 2/12/15, daily diarrhea for 4+ days.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Drug administered at inappropriate site, Hypoaesthesia, Immediate post-injection reaction, Joint range of motion decreased
Clinical narrative: Pain at time of inection.  Injection was goven high on shoulder.  Later bruising nodule hot to touch pain radiating through arm and up neck. Numbness in fingers and painful to touch.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Neck pain, Nodule, Pain in extremity, Skin warm, Tenderness
Clinical narrative: Pain at time of inection.  Injection was goven high on shoulder.  Later bruising nodule hot to touch pain radiating through arm and up neck. Numbness in fingers and painful to touch.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Allergy test positive, Anaphylactic reaction, Dizziness, Dyspnoea, Food allergy
Clinical narrative: High fever, nausea, lethargic, loss of consciousness, headache, dizziness, tight throat, trouble breathing, rash/hives, anaphylaxis.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Hypersensitivity, Lethargy, Loss of consciousness, Nausea
Clinical narrative: High fever, nausea, lethargic, loss of consciousness, headache, dizziness, tight throat, trouble breathing, rash/hives, anaphylaxis.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Rash, Throat tightness, Urticaria
Clinical narrative: High fever, nausea, lethargic, loss of consciousness, headache, dizziness, tight throat, trouble breathing, rash/hives, anaphylaxis.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dysphonia, Oedema peripheral, Pain, Pruritus generalised
Clinical narrative: Body aches, itchiness all over body, hoarseness and slight cough, edema on the hands.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a health worker (medical assistant) concerning unspecified patients of unknown age. Since 31-FEB-2014, improperly stored ROTATEQ (strength and dose were not reported) were administered to unspecified patients. No adverse effects were reported. 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 licensed piratical nurse (LPR) refers to unspecified group of patients of unknown age and gender. Information about patients' medical histories were not provided. On an unknown date, the patients were vaccinated with doses of ROTATEQ (dose, frequency, indication and lot # were not provided, route of administration default to oral) which possibly were improperly stored. No adverse effects were noted. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Injury, Nuclear magnetic resonance imaging, X-ray
Clinical narrative: Vaccine was given in right arm at approx. 10:00 am. Positive pain onset 1-2 hours later, in right shoulder and radiating down front of right bicep. KENALOG injections in right shoulder x4, numerous ortho appts, not resolved. Continued pain and ROM. Surgery scheduled.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Upper left arm has pain, unable to lift or move without pain.
Age: 68.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Dizziness, Epistaxis
Clinical narrative: Nosebleed and dizziness starting soon after dosage and continuing on and off for last month.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Abdominal discomfort, Body temperature increased, Diarrhoea, Injection site rash, Irritability
Clinical narrative: Stomach discomfort, diarrhea, slight elevated temperature, irritable, light rash around mouth and torso, behind legs and neck.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Stomach discomfort, diarrhea, slight elevated temperature, irritable, light rash around mouth and torso, behind legs and neck.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Crying, Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling at site, excessive crying.
Age: 7.0
Sex: M
Vaccine: FLUN4
Symptoms: Abnormal behaviour, Activities of daily living impaired, Aggression
Clinical narrative: Pt autistic. After receiving FLUMIST in 2012, 2013, 2014 mom noted pt behavior became more aggressive and out of control from his normal baseline scales. Sx lasted x several weeks - could not attend school. Note as baseline, pls advise if other reports of similar sx.
Age: 0.22
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Emotional distress, Eyelid oedema, Irritability, Mouth swelling, Pyrexia
Clinical narrative: Patient received PEDIARIX, PEDVAXHIB, PCV-13, ROTARIX ON 12/10/2014 - 1 hour after vaccine had marked irritability and way not consolable over 5-6 hours. Fever noted. ER visit. Swelling around mouth and eyes developed at 1 hour after vaccines and was still present in ER at 5-6 hrs. Fussiness x 48h with fever. Fully recovered.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Stridor, Swelling, Urticaria
Clinical narrative: This spontaneous report as received from a physician refers to an approximately 1 year old male patient. The patient pertinent medical history and drug allergies were none. Approximately on an unknown date in 2009 (reported as 6 years ago), the patient was vaccinated with VARIVAX (Merck) (dose, frequency, route and lot # were unspecified) and M-M-R II (dose, frequency, route and lot # were unspecified). Concomitant medications were unspecified. Approximately on an unknown date in 2009, within 10 minutes of vaccination, the patient developed swelling, stridor and diffused hives all over his body. The patient sought medical attention and the physician reported that the patient was administered an EPIPEN after the symptoms developed and was sent home. The outcome of patient developed swelling, stridor and diffused hives all over his body was unknown. The causality of swelling, stridor and diffused hives all over his body was unknown. No product quality complaint (PQC) was reported for VARIVAX (Merck) and M-M-R II. Additional information has been requested. This is a corrected report. Upon internal review, the events of swelling, stridor and diffused hives all over his body were considered to be medically significant as they were treated with EPIPEN and therefore the seriousness criteria for each one of these events was updated accordingly.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Unknown onset of symptoms.  Pt sought attention after 3 weeks of pain in left arm following injection.
Age: 31.0
Sex: F
Vaccine: HEP, HEPA, HIBV, MNQ, PPV, VARCEL
Symptoms: Chills, Fatigue, Headache, Nausea, Neck pain
Clinical narrative: Patient presented to clinic for scheduled appointment for 6 immunizations. Researched by PCP okay to give on same day. Patient waited in clinic past injections for 15 minutes without problem. She contacted office 2 days later. Complained of fever, nausea, chills, severe headache and rash on right arm. She did not come in to be seen until 2/16/2015. She did contact a physician for phone management. she said symptoms were resolving with exception of slight headache, neck pain and fatigue, rash is subsiding, still tender and warm to touch. She is using ibuprofen, Tylenol, and cool compresses.
Age: 31.0
Sex: F
Vaccine: HEP, HEPA, HIBV, MNQ, PPV, VARCEL
Symptoms: Pyrexia, Rash, Skin warm, Tenderness
Clinical narrative: Patient presented to clinic for scheduled appointment for 6 immunizations. Researched by PCP okay to give on same day. Patient waited in clinic past injections for 15 minutes without problem. She contacted office 2 days later. Complained of fever, nausea, chills, severe headache and rash on right arm. She did not come in to be seen until 2/16/2015. She did contact a physician for phone management. she said symptoms were resolving with exception of slight headache, neck pain and fatigue, rash is subsiding, still tender and warm to touch. She is using ibuprofen, Tylenol, and cool compresses.
Age: 54.0
Sex: F
Vaccine: HEP
Symptoms: Cellulitis, Erythema nodosum, Papule, Rash erythematous, Skin warm
Clinical narrative: Erythema nodosum. Bright red rash about 20x10cm in diameter located at the anterior left lower ext. Warm and tender to touch. Clear demarcated. Redder papula within the rash area. No scratch marks. Most likely cellulitis: start pt on doxycycline, oxycodone for pain, and monitor vitals closely. Affected area is marked. Will f/u tomorrow. DDx is erythema nodosum due to the location, redness, and tenderness of the rash. Pt had hep B vaccine back on Jan 26th. Possible cause of erythema nodosum.
Age: 54.0
Sex: F
Vaccine: HEP
Symptoms: Tenderness
Clinical narrative: Erythema nodosum. Bright red rash about 20x10cm in diameter located at the anterior left lower ext. Warm and tender to touch. Clear demarcated. Redder papula within the rash area. No scratch marks. Most likely cellulitis: start pt on doxycycline, oxycodone for pain, and monitor vitals closely. Affected area is marked. Will f/u tomorrow. DDx is erythema nodosum due to the location, redness, and tenderness of the rash. Pt had hep B vaccine back on Jan 26th. Possible cause of erythema nodosum.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Musculoskeletal pain, Neck pain, Nuclear magnetic resonance imaging normal, Paraesthesia
Clinical narrative: Within 20 minutes of receiving vaccine, noted increasing pain in left shoulder, which radiated to left scapula and back of neck. Within one week of vaccine, noted numbness in left hand and lower arm, as well as pain in shoulder area. Two weeks later, noted numbness in left side of face and throat, as well as some left leg numbness and tingling.  Consults made to Physical Therapy, Pain service and Neurology.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Pruritus generalised, Rash
Clinical narrative: Rash from shoulder to elbow then itching over most of body continuing until today 01/16/2015. No other symptoms.
Age: 42.0
Sex: M
Vaccine: RAB
Symptoms: Musculoskeletal stiffness, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Pain shooting down arm / tingling and shoulder stiffness.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Had one spot of shingles on left temple of face, near hairline.
Sex: U
Vaccine: FLU4
Symptoms: Arthralgia
Clinical narrative: This case was reported by a physician and described the occurrence of arthralgia in a adult patient who received FLUARIX QUADRIVALENT (batch number LY2F5, expiry date 30th June 2015). On an unknown date, the patient received FLUARIX QUADRIVALENT. On an unknown date, unknown after receiving FLUARIX QUADRIVALENT, the patient experienced arthralgia. On an unknown date, the outcome of the arthralgia was unknown. It was unknown if the reporter considered the arthralgia to be related to FLUARIX QUADRIVALENT. Additional information: Physician updated previous report of shoulder arthralgia in 10 patients following vaccination with FLUARIX QIV, with lot number and expiration date info. He was unable to obtain more information on the patients, though he states that they were all adults.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown date, an unspecified number of patients were vaccinated with a dose of ROTATEQ, (strength, dose, frequency, route, anatomical location, lot number and expiration date were not reported), which were improperly stored. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain upper, Diarrhoea, Hyperhidrosis, Influenza like illness, Pyrexia
Clinical narrative: This case was reported by a consumer (subject's son) and described the occurrence of flu like symptoms in an adult female subject who was vaccinated with Influenza vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. The subject's medical history included emphysema and smoker. The subject had none concomitant medications. In February 2012, the subject received unspecified dose of Influenza vaccine (unknown route and injection site; lot number not provided). In February 2012, less than 1 month after vaccination with Influenza vaccine, the subject experienced flu like symptoms, diarrhea, sweating, stomach pain and fever. At the time of reporting the events were resolved. Limited information was provided; during the report the subject's son did not feel comfortable answering any further questions regarding his mother and the report stopped.
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Arthralgia, Depression, Influenza, Mobility decreased
Clinical narrative: This case was reported by a physician and described the occurrence of influenza in a female subject of unspecified age who was vaccinated with FLUARIX (GlaxoSmithKline). In 2012, the subject received a dose of FLUARIX (unknown route, unknown arm, batch number not provided). 1 week after vaccination with FLUARIX, the subject experienced influenza. After 2 weeks, influenza was resolved. At an unspecified time after vaccination with FLUARIX, the subject experienced other events on injected limb: the arm slowly started freezing, joint was hurting, and the limb mobility decreased (the subject could not put her arm through the sleeves of a jacket and could not move her arm above her hair). In 2013, the subject's shoulder got severely frozen. As a result, the reporter said that she had been through emotional depression and also experienced extreme pain in her arm: she would scream if someone touched her arm. At the time of reporting, the influenza was resolved but the other events were unresolved.
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Periarthritis, Tenderness
Clinical narrative: This case was reported by a physician and described the occurrence of influenza in a female subject of unspecified age who was vaccinated with FLUARIX (GlaxoSmithKline). In 2012, the subject received a dose of FLUARIX (unknown route, unknown arm, batch number not provided). 1 week after vaccination with FLUARIX, the subject experienced influenza. After 2 weeks, influenza was resolved. At an unspecified time after vaccination with FLUARIX, the subject experienced other events on injected limb: the arm slowly started freezing, joint was hurting, and the limb mobility decreased (the subject could not put her arm through the sleeves of a jacket and could not move her arm above her hair). In 2013, the subject's shoulder got severely frozen. As a result, the reporter said that she had been through emotional depression and also experienced extreme pain in her arm: she would scream if someone touched her arm. At the time of reporting, the influenza was resolved but the other events were unresolved.
Sex: F
Vaccine: FLU3
Symptoms: Vaccination complication
Clinical narrative: This case was reported by a consumer and described the occurrence of adverse reaction to vaccine in a female subject of unspecified age who was vaccinated with FLUARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date, the subject received unspecified dose of FLUARIX (unknown route and injection site). At an unspecified time after vaccination with FLUARIX, the subject experienced adverse reaction to vaccine. At the time of reporting, the outcome of the event was unspecified.
Age: 1.5
Sex: M
Vaccine: DTAP, FLU4, HIBV
Symptoms: Local reaction
Clinical narrative: Local vaccine reaction.
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Received vaccine 1/20/15 - developed swelling at injection site and temp to 104 degrees - still febrile at 24 hrs.
Sex: U
Vaccine: FLU4
Symptoms: Arthralgia
Clinical narrative: This case was reported by a physician and described the occurrence of arthralgia in a adult patient who received FLUARIX (batch number LY2F5, expiry date 30th June 2015). On an unknown date, the patient received FLUARIX. On an unknown date, unknown after received FLUARIX, the patient experienced arthralgia. On an unknown date, the outcome of the arthralgia was unknown. It was unknown if the reporter considered the arthralgia to be related to FLUARIX. Additional information: Physician updating previous report of shoulder arthralgia in 10 patients following vaccination with FLUARIX QIV, with lot number and expiration date info. He was unable to obtain more information on the patients, though he states that they were all adults.
Sex: U
Vaccine: FLU4
Symptoms: Arthralgia
Clinical narrative: This case was reported by a physician and described the occurrence of arthralgia in a adult patient who received FLUARIX QUADRIVALENT (batch number LY2F5, expiry date 30th June 2015). On an unknown date, the patient received FLUARIX QUADRIVALENT. On an unknown date, unknown after receiving FLUARIX QUADRIVALENT, the patient experienced arthralgia. On an unknown date, the outcome of the arthralgia was unknown. It was unknown if the reporter considered the arthralgia to be related to FLUARIX QUADRIVALENT. Additional information: Physician updating previous report of shoulder arthralgia in 10 patients following vaccination with FLUARIX QIV, with lot number and expiration date info. He was unable to obtain more information on the patients, though he states that they were all adults.
Sex: F
Vaccine: FLU3
Symptoms: Vaccination complication
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of adverse reaction to vaccine in an adult female subject who was vaccinated with Influenza vaccine (unspecified),  (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of Influenza vaccine (unspecified) (unknown route, injection site and batch number). At an unspecified time after vaccination with Influenza vaccine (unspecified), the subject experienced adverse reaction to vaccine. At the time of reporting, the outcome of the event was unspecified.
Age: 88.0
Sex: M
Vaccine: FLUX
Symptoms: Death, Influenza, Malaise
Clinical narrative: This case was reported by a consumer and described the occurrence of deathly sick in a about 88-year-old male subject who was vaccinated with influenza vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. The subject was healthy but pretty frail and thin. In 2004 or 2005, the subject received unspecified dose of Influenza vaccine (unspecified) (unknown route of administration). Within a couple of days after vaccination with Influenza vaccine (unspecified), the subject was deathly sick and almost died. He got very severe influenza. After an unspecified period of time, the events were resolved. Four or five years later, the subject died just before turning 94. The subject was old, so the death was not related to the flu vaccine.
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer and described the occurrence of arm pain in a female subject of unspecified age who was vaccinated with Influenza vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. In 2013 the subject, received unspecified dose of Influenza vaccine unspecified (unknown route, injection site and batch number). In 2013, at an unspecified time after vaccination with Influenza vaccine unspecified, the subject experienced arm pain. At the time of reporting the event was unresolved.
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: This case was reported by a consumer and described the occurrence of swelling injection site in an adult female subject who was vaccinated with Influenza vaccine (unspecified), manufacturer unspecified). A physician or other health care professional has not verified this report. The subject's medical history included swine influenza (in 1999). Every year, since 1994, the subject received unspecified dose of Influenza vaccine (unspecified) (unknown route and batch number, unknown arm). Since 1994, within hours of vaccination with Influenza vaccine (unspecified), the subject experienced swelling injection site, swelling bump on arm and injection site redness. Over the years she had a variety of local reactions that occurred within a few hours or by the next day. The subject contributed these reactions to vaccines that were from a multi-dose vial, but not necessarily to the preservative. She stated that these may have been due to the technique and potential confirmation from the health care practitioner. Consumer was unable to provide details on the name, lot of vaccine and reported that she did not have any of these issues whenever she received a prefilled syringe flu vaccine. At the time of reporting, the events were resolved.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Eye pruritus, Scar
Clinical narrative: This case was reported by a consumer and described the occurrence of scar tissue in a 53-year-old male subject who was vaccinated with FLUARIX 2012-13 season (GlaxoSmithKline), FLUARIX 2013-14 season. A physician or other health care professional has not verified this report. On 12 October 2012, the subject received a dose of FLUARIX (administration site and route unknown, batch number not provided). On 13 October 2012, 1 day after vaccination with FLUARIX, the subject experienced eye pruritus and erythema around eyes. Some scar tissue remained around eyes. In October 2013, the subject received a dose of FLUARIX (administration site and route unknown, batch number not provided). At an unspecified time after vaccination with FLUARIX, the subject experienced some itchiness about the eyes and some redness but not as bad as after previous dose. The subject was treated with BENADRYL but it didn't help. At the time of reporting, scar tissue was unresolved, eye pruritus and redness around eyes were improved.
Age: 43.0
Sex: M
Vaccine: FLUX
Symptoms: Platelet count decreased
Clinical narrative: This case was reported by a consumer and described the occurrence of drop in platelet count in a 43-year-old male subject who was vaccinated with Influenza vaccine (unspecified) (manufacturer unspecified). A physician or other health care professional has not verified this report. Concurrent medical conditions included ITP since 2007. On 2008, 2009, 2010 and 2011, the subject received a dose of Influenza vaccine (unspecified) (administration site and route unknown, batch number not provided). At an unspecified time after vaccination with each doses of Influenza vaccine (unspecified), the subject experienced drop in platelet count for 6 months. All of these years, his platelet count was above 50000. He believed that he was taking prednisone in 2012 when he received the flu vaccine. At the time of reporting, the event was resolved.
Sex: U
Vaccine: FLU3
Symptoms: Exposure during breast feeding
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vaccine exposure via breast milk in a unk infant. The parent received the product. Concurrent medical conditions included breastfeeding. On an unknown date, the mother received FLULAVAL at an unknown dose. The mother's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The infant was diagnosed with vaccine exposure via breast milk. On an unknown date, the outcome of the vaccine exposure via breast milk was unknown. It was unknown if the reporter considered the vaccine exposure via breast milk to be related to FLULAVAL. Additional information received: Mother of baby called and said she received a flu vaccine and she is currently nursing. She does not know which Flu vaccine she received, however she knows it was a GSK flu vaccine, it had preservatives in it, and it came from a multi-dose vial. She did not want to do the AE form.
Sex: U
Vaccine: FLU4
Symptoms: Arthralgia
Clinical narrative: This case was reported by a other health professional and described the occurrence of arthralgia in a adult patient who received FLUARIX QUADRIVALENT (batch number LY2F5, expiry date 30th June 2015). On an unknown date, the patient received FLUARIX QUADRIVALENT. On an unknown date, unknown after receiving FLUARIX QUADRIVALENT, the patient experienced arthralgia. On an unknown date, the outcome of the arthralgia was unknown. It was unknown if the reporter considered the arthralgia to be related to FLUARIX QUADRIVALENT. Additional information: Physician updated previous AE report of shoulder arthralgia in 10 patients following vaccination with FLUARIX QIV, with lot number and expiration date info. He was unable to obtain more information on the patients, though he states that they were all adults.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unknown number of patients of unknown age and gender. Since 12-FEB-2014 the patients were vaccinated with PROQUAD (Merck) which was administered subcutaneously and underwent supported temperature excursions on unknown date. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: TDAP
Symptoms: Incorrect product storage
Clinical narrative: ```This case was reported by a nurse and described the occurrence of incorrect storage of drug in a patient who received BOOSTRIX (batch number HM4FY, expiry date 6th December 2016). On an unknown date, the patient received BOOSTRIX. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information: Nurse at this time did not have any other information. Ten patients received BOOSTRIX that was exposed to temperature of 30.4F. Two lot numbers 3P9CL exp 15apr2016 or HM4FY exp 06dec2016.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown date, an unspecified number of patients were vaccinated with a dose of GARDASIL, strength reported as 120 Y, (dose, frequency, route, anatomical location, lot number and expiration date were not reported), which were improperly stored. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 30.0
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a 30 year old patient with unknown gender. No pertinent medical history was reported. On 02-FEB-2015, 30 year old patient was vaccinated with the 1st dose of GARDASIL. No adverse effects reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: Information has been received from a male patient of unknown age concerning himself. On an unknown date the patient was vaccinated with a dose of MMR II (dose, frequency, route and lot# not reported). On an unknown date the patient experienced very high fever for nearly a week. The outcome of the event was not reported. The causality was not provided. Additional information has been requested.
Age: 1.77
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13
Symptoms: Rash
Clinical narrative: Rash to face, chest, abdomen, back, upper extremities, periarea.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to 2 patients of unknown demographics. The pertinent medical history was not reported. On 12-FEB-2015 the patients were vaccinated with an expired dose of ZOSTAVAX (lot # J000853, Expiry date: 23-APR-2014). No adverse effects were reported. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patients of unknown age and gender. Patient's medical history and current conditions were not provided. On an unknown date the patients were vaccinated with a dose of improperly stored PEDVAXHIB (lot #, expiration date, dose and route were not reported). No concomitant medications were reported. Additional information has been requested. This is one of several reports received from the same reporter.
Sex: U
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: This spontaneous report as received from a physician and a health care worker refers to a 15 month old patient of unknown gender. The patient's concurrent conditions or  medical history were not reported. On 26-JAN-2015 the patient was vaccinated with the first dose of MMR II (dose, route, anatomical location, lot number and expiration date were not reported) and on 07-FEB-2015, developed an unspecified rash and pyrexia. The patient was seen in the emergency department that same day and was released without being admitted (on the same day), with a prescription for unspecified antibiotics. On 09-FEB-2015, the patient presented to the physician's office, the patient's mother reported that the rash had worsened but the fever however had subsided. The physician reported that the rash might be measles but he was unable to make a determination at the time of the report. The health care worker inquired how long after administration can titers be drawn to determine measles immunity and if measles immunity created an IgG or IgM response. No lab diagnostics were performed. 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 register nurse refers to unspecified number of patients of unknown age and gender, who were administered improperly stored doses of (Oka/Merck) VARIVAX since 10-DEC-2014. No adverse events were reported. This is one of two reports received from the same source. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Erythema, Injection site erythema, Pain in extremity, Rash
Clinical narrative: This spontaneous report as received from a 75 year old female consumer with high cholesterol and hypertension and no drug reactions or allergies reporting on herself. The patient's medical history included shingles. On 28-JAN-2015, the patient was vaccinated with a dose of ZOSTAVAX (route, dose and lot # not reported). Concomitant therapies included simvastatin (manufacturer unknown), lisinopril (manufacturer unknown), bisoprolol and hydrochlorothiazide (manufacturer unknown). The consumer reported that on 29-JAN-2015, she experienced injection site erythema, rash, rash papular and pain in extremity reported as redness at the injection site and irregular shaped red patch four inches long and three inches wide after being administered ZOSTAVAX. There were also red pimples inside the red area. The patient stated her arm was sore as well. The patient did not seek medical attention. The patient did not receive treatment for the adverse events. There were no lab diagnostics or studies performed. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash papular
Clinical narrative: This spontaneous report as received from a 75 year old female consumer with high cholesterol and hypertension and no drug reactions or allergies reporting on herself. The patient's medical history included shingles. On 28-JAN-2015, the patient was vaccinated with a dose of ZOSTAVAX (route, dose and lot # not reported). Concomitant therapies included simvastatin (manufacturer unknown), lisinopril (manufacturer unknown), bisoprolol and hydrochlorothiazide (manufacturer unknown). The consumer reported that on 29-JAN-2015, she experienced injection site erythema, rash, rash papular and pain in extremity reported as redness at the injection site and irregular shaped red patch four inches long and three inches wide after being administered ZOSTAVAX. There were also red pimples inside the red area. The patient stated her arm was sore as well. The patient did not seek medical attention. The patient did not receive treatment for the adverse events. There were no lab diagnostics or studies performed. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (immunization administrator) concerning unspecified patients (demographics unknown). The healthcare worker reported that doses of GARDASIL (Lot # not provided) which were exposed a supported temperature excursion, continued to be administered to unspecified patients on unspecified dates since 07-AUG-2014. No adverse effect had been reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker concerning unspecified patients (demographics unknown). The healthcare worker reported that doses of RECOMBIVAX HB (Lot # not provided) which were exposed a supported temperature excursion, continued to be administered to unspecified patients on unspecified dates since 07-AUG-2014. No adverse effect had been reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker concerning unspecified patients (demographics unknown). The healthcare worker reported that doses of VAQTA (Lot # not reported) which were exposed a supported temperature excursion, continued to be administered to unspecified patients on unspecified dates since 07-AUG-2014. No adverse effect had been reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a health professional (licensed practical nurse) refers to an 18 month old female patient. Patients pertinent medical history and drug allergies were not reported. On 04-FEB-2015 the patient was inadvertently administered with two doses of MMR II (lot # J013131, expiration date: 17-OCT-2015). Concomitant medications were not reported. No adverse effects were reported. Outcome of the events were unknown. The reporter considered the event to be not related to MMR II. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Induration, Joint range of motion decreased, Muscular weakness, Pain in extremity
Clinical narrative: PT states her whole arm became "Hard as stone" and she was unable to bend her elbow or flex her wrist. Her arm was extremely painful all night long like a "cold burn." The next morning the muscles felt weak and fatigued but "she did have some joint movement. Was seen in off and prescribed prednisone.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from the health worker refers to an unspecified number of patients of unknown age and gender. On an unspecified day, RECOMBIVAX HB underwent an excursion and the excursion was supported. On an unspecified dates, unspecified number of patients were administered with post excursion supported RECOMBIVAX HB (Strength, dose, route and lot number were not reported) for an unknown indication. No adverse effects had been reported by any patients. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from the health worker refers to an unspecified number of patients of unknown age and gender. On an unspecified day, VAQTA underwent an excursion and the excursion was supported. On an unspecified dates, unspecified number of patients were administered with post excursion supported VAQTA (Strength, dose, route and lot number were not reported) for an unknown indication. No adverse effects had been reported by any patients. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from the health worker refers to an unspecified number of patients of unknown age and gender. On an unspecified day, GARDASIL underwent an excursion and the excursion was supported. On unspecified dates, unspecified number of patients were administered with post excursion supported GARDASIL (Strength, dose, route and lot number were not reported) for an unknown indication. No adverse effects had been reported by any patients. This is one of the several reports 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 was received from the health worker refers to an unspecified number of patients of unknown age and gender. On an unspecified day, the patient were vaccinated with improperly stored (Oka/Merck) VARIVAX (Strength, dose, route and lot number were not reported) for an unknown indication. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Injection site mass, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: About 1 hour after vaccine was injected a lump started forming just below the puncture, it grew to size of an egg and became very painful and hot. I called Dr he said I should go to the E.R. because he was too busy to me. Instead I took ibuprofen for 5-6 days as recommended by my pharmacist until the lump dropped down to my elbow and disappeared.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Computerised tomogram, Laboratory test, Local swelling
Clinical narrative: Swollen area noted to (R) frontal area-denies injury-denies pain with palpation.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Hypersensitivity, Laboratory test, Muscle strain, Myalgia
Clinical narrative: Allergic reaction, cervical strain, acute muscle pain on encounter. Treatment: FLEXERIL10 mg, DELTASONE 60 mg.
Age: 15.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Erythema, Inflammation, Pain in extremity, Tenderness
Clinical narrative: Right arm with redness, mild pain and tender to touch, inflamed treated with KEFLEX 500mg 3 daily for 5 days, warm compresses.
Age: 1.26
Sex: M
Vaccine: DTAPIPVHIB, MMR, PNC13, VARCEL
Symptoms: Rash, Rash vesicular
Clinical narrative: Went to physician with vesicular rash on upper trunk. <50. Dr treated pt. with acyclovir.
Age: 3.0
Sex: F
Vaccine: HEP
Symptoms: Abnormal behaviour, Irritability, Personality change
Clinical narrative: Woke evening after the shot with personality change. Not in pain. Lasted about 1 hour. Seemed fine the next morning until after a nap woke with similar personality change but did not last as long. No fever or rash or GI symptoms. Just extremely fussy and behavior not usual. Almost angry.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to unspecified group of unknown age and gender. Information about patients' medical histories were not provided. On an unknown date, the patients were vaccinated with doses of GARDASIL (dose, frequency, route of administration, indication and lot # were not provided) which possibly were improperly stored. No adverse effects were noted. No product quality complaint (PQC) was involved. This is one of several 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 Licensed Practical Nurse refers to unspecified group of patients of unknown age and gender. Information about patients' medical histories were not provided. On an unknown date, the patients were vaccinated with doses of VARIVAX (Merck) (dose, frequency, route of administration, indication and lot # were not provided) which possibly were improperly stored. No adverse effects were noted. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, Viral titre decreased
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 38 year old female patient. Patient medical history and current condition was not reported. On an unknown date the patient was vaccinated with MMR II for immunization as a child. Also reported that the patient was unsure if she had one or two doses of MMR II, live as a child. Reporter stated that on an unknown date and month in 2013 the patient has unspecified titers done, and the titers were negative. Pharmacist also reported that on an unknown date in SEPTEMBER-2013 the patient had one dose (unspecified) of MMR II, live cancer and overdose was not reported. The outcome of the events was unknown. Causality for the event 'titers were negative' was unknown. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. Pertinent medical history was unknown. On 10-FEB-2015 the patient was vaccinated with PROQUAD (Merck) (0.5 ml, subcutaneous, anatomical location was unknown) that expired on 14-DEC-2014. Concomitant medications were unspecified by reporter. No adverse experience reported. The outcome of the events was unknown. No further information provided. 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 worker (medical assistant) refers to a patient of unknown demographics. No concurrent conditions or medical history were provided. On 12-FEB-2015, the patient was vaccinated with the second dose of PROQUAD injection 0.5 ml administered subcutaneously (lot # K008158 with expiry date: 12-NOV-2015; strength unspecified) after it was improperly stored. No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.