chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: FLUN4, FLUX
Symptoms: Influenza
Clinical narrative: A report has been received from a physician concerning an 11 years old female patient. No information regarding the concomitant disease and concomitant drug was provided. Patient had received FLUMIST QUADRIVALENT (intranasal). It was reported that last year the patient received FLUMIST and contracted the flu last year which was confirmed by testing. The patient had received flu vaccine injection three (consecutive) years prior to last year's FLUMIST. The doctor reported the patient contracted the flu despite vaccination in the previous three years. The outcome of the event of influenza was unknown. The reporter assessed the report to be non serious by reporter.
Sex: F
Vaccine: FLUN4
Symptoms: Exposure to vaccinated person, Headache, Nasal congestion, Pyrexia
Clinical narrative: A report has been received from a physician concerning herself who was exposed to a vaccinated person who received FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on 02-Sep-2014. The patient was exposed to vaccinated person and experienced fever, headache and stuffy nose and which started on 05-Sep-2014. The outcome of the event of fever, headache, stuffy nose and exposure to vaccinated person is unknown. The report was considered to be non-serious by the reporter. The event of exposure to vaccinated person was identified by company physician from the source document and it was added as non serious event.
Sex: F
Vaccine: FLUN3
Symptoms: Influenza, Malaise
Clinical narrative: A report has been received from a health professional concerning a (herself) female patient. No information was provided regarding relevant history, concurrent diseases and concomitant medications of the patient. The patient has been received FLUMIST (intranasal), unknown frequency, started on an unknown date for an unknown indication. A female patient received FLUMIST, and a few days after she got very sick with Flu symptoms. The outcome of the event of got very sick with Flu symptoms was unkonwn. The report was considered to be non-serious by reporter. The reporter considered the event of got very sick with Flu symptoms with the suspect drug of FLUMIST to be related.
Sex: U
Vaccine: FLUN3
Symptoms: Ocular hyperaemia
Clinical narrative: A report has been received from a Physician concerning a child, subject of unknown gender, who had been receiving FLUMIST (intranasal). FLUMIST (intranasal) started on an unknown date. The patient experienced RED EYES. The patient recovered from the event of RED EYES on an unspecified date. The report was considered to be non-serious.
Sex: M
Vaccine: FLUN4
Symptoms: Rhinorrhoea, Sinusitis
Clinical narrative: A report has been received from a health professional concerning a male patient, estimated to be in his 40s. The patient had endoscopy at the hospital. The patient had been receiving FLUMIST (intranasal) 0.2 ml on 24-Oct-2014. The patient experienced severe sinusitis and runny nose which started on 24-Oct-2014. The patient took cold medicine for a week. The doctor diagnosed his case as severe sinusitis and put him on antibiotics for a week. Action taken with FLUMIST was unknown. The outcome of the events of sinusitis and runny nose were not recovered. The report was considered to be non-serious by the company physician. Corrected report 18-Nov-2014: Outcome updated. Patient initial, drug start date, intensity and dose added.
Age: 49.0
Sex: F
Vaccine: FLUN4
Symptoms: Headache
Clinical narrative: A report has been received from a physician concerning a 49 year old female patient, enrolled in a study. The patient's concurrent disease(s) included thyroid cancer. Concomitant medications of the patient was not reported. The patient had been received FLUMIST (intranasal) started on 23-Oct-2014. The patient experienced headache which started on 24-Oct-2014. Patient went and came back from ER (emergency room) in hospital on 29-Oct-2014. The outcome of the event of headache was unknown. The reporter considered the event headache to be serious due to important medical event. Based on the information in this report, and awaiting the reporter's assessment, the company physician considered the events of headache be related with the suspect drug of FLUMIST.
Age: 66.0
Sex: M
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Health Professional concerning a Male subject, who had been receiving FLUMIST (intranasal). Concomitant medications included EZETIMIBE. FLUMIST (intranasal) started on an unknown date. It was reported that the patient was inadvertently administered with FLUMIST at an age of 66 years which started on 07-Nov-2014. The outcome of the event of inadvertent administration to a 66 year old patient is unknown. The report was considered to be non-serious. The reporter considered that there was no causal relationship between inadvertent administration to a 68 year old patient and FLUMIST. Reporter and company physician assessed the event inadvertent administration to a 66 year old patient was not related to suspect FLUMIST.
Age: 43.0
Sex: F
Vaccine: FLUN4
Symptoms: Drug administration error, Nasal congestion, Rhinalgia
Clinical narrative: A report had been received from the Pharmacist concerning a 43 year old female patient. No information was provided regarding relevant history, concurrent diseases and concomitant medications of the patient. The patient (who is also the reporter and is a pharmacist) administered FLUMIST (intranasal) full dose into a single nostril on 02-Nov-2014. On 03-Nov-2014 she started feeling a bit of a sore nostril and stuffy nose on one side which has not resolved at this point. Patient has been getting FLUMIST for the last few years. The outcome of the events of sore nostril on which full dose was administered and full dose in single nostril was unknown. The company physician considered the event of sore nostril in which full dose was administered and full dose in single nostril to be non serious. The reporting and company considered the events of sore nostril in which full dose was administered and full dose in single nostril with the suspect drug FLUMIST to be not related.
Age: 2.0
Sex: M
Vaccine: FLUN4
Symptoms: Pyrexia
Clinical narrative: A consumer report has been received. The report concerns a 2 year old, male consumer, who had been receiving FLUMIST (intranasal), 0.2 Millilitres, daily. FLUMIST (intranasal) started on 22-Oct-2014. The patient experienced fever which started on 19-Oct-2014. The outcome of fever is unknown. The report was considered to be non-serious.
Age: 10.0
Sex: M
Vaccine: FLUN4
Symptoms: Diarrhoea, Myalgia, Pyrexia, Vomiting
Clinical narrative: A consumer report has been received. The report concerns a 10 year old, male consumer, who had been receiving FLUMIST (intranasal), 0.2 ML. FLUMIST (intranasal) started on 24-Oct-2014. The patient experienced fever, vomiting, diarrhea and myalgia which started on 24-Oct-2014. The outcome of the event of fever, vomiting, diarrhea and myalgia is unknown. The report was considered to be non-serious. Corrected report 14-Nov-2014: Country of reporter and case were corrected.
Age: 2.0
Sex: F
Vaccine: FLUN4
Symptoms: Contraindication to vaccination
Clinical narrative: A report has been received from a Health Professional concerning a 2 year old, female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). The patient's medical history included asthma. FLUMIST QUADRIVALENT (intranasal) started on 10-Oct-2014. It was reported that patient with history of asthma received FLUMIST QUADRIVALENT on 10-Oct-2014 which started on 10-Oct-2014. The outcome of the event of patient with history of asthma received FLUMIST QUADRIVALENT on 10OCT2014 is unknown. The report was considered to be non-serious.
Sex: F
Vaccine: FLUN4
Symptoms: Drug administration error
Clinical narrative: A consumer report has been received. The report concerns a patient. Female consumer, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on an unknown date. It was reported that while administering FLUMIST QUADRIVALENT, it went into first nostril causing patient to swallow the FLULMIST QUADRIVALENT. The outcome of the event of FLUMIST QUADRIVALENT went into first nostril causing patient to swallow the FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Sex: M
Vaccine: FLUN4
Symptoms: Drug administration error
Clinical narrative: A report has been received from a pharmacy intern concerning a male child above 10 years (exact age unknown). No information regarding relevant history and concomitant medication was provided. The patient received FLUMIST QUADRIVALENT (intranasal), on 15-Oct-2014. It was reported that FLUMIST QUADRIVALENT was administered to a patient and either all the dose went in one nostril or half the dose went into one nostril on 15-Oct-2014. Action taken with FLUMIST was not applicable. The outcome of the event of partial dose or full dose up one nostril was unknown. The report was considered to be non-serious by the reporter.
Age: 13.0
Sex: M
Vaccine: FLUN4
Symptoms: Abdominal pain upper
Clinical narrative: A consumer report has been received. The report concerns a male consumer, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on an unknown date. The patient experienced stomach pain/belly hurt. The outcome of the event of stomach pain/belly hurts is unknown. The report was considered to be non-serious.
Sex: M
Vaccine: FLUN4
Symptoms: Influenza, Influenza virus test positive, Pain, Streptococcus test negative
Clinical narrative: A report has been received from a health professional concerning a child of unknown age and gender. No medical history, concomitant diseases and concomitant medications were reported for consumer. Patient had received FLUMIST QUADRIVALENT (intranasal) started during Oct-2014. A week later of administration of vaccine, patient had come in for a doctor's visit due to having sore throat and aching symptoms, Streptococcus swab/culture result was negative. Influenza swab/culture result was positive. Patient was diagnosed with influenza and received general care instructions to follow up in home. The outcome of the event of child received FLUMIST on October 2014 and then tested positive for influenza with aching symptoms was unknown. The report was considered to be non-serious by reporter.
Age: 11.0
Sex: M
Vaccine: FLUN4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: A report has been received from a Health Professional concerning an 11 year old, male patient. No information regarding the medical history and concomitant drugs were provided. The patient received FLUMIST quadrivalent (intranasal) on 13-Oct-2014. The reporter reported that they inadvertently administered FLUMIST quadrivalent then a Flu shot to a child then one of the physician's in the practice relumed and said that patient not had any adverse events. The outcome of the event of administered FLUMIST quadrivalent then a Flu shot to a child was unknown. The report was considered to be non-serious by reporter.
Sex: F
Vaccine: FLUN4
Symptoms: Influenza virus test positive
Clinical narrative: A report has been received from a pharmacist concerning an adult, female patient. No information regarding relevant history, concomitant disease and concomitant medications were provided. The patient received FLUMIST QUADRIVALENT (intranasal) two weeks ago during 2014. It was reported that recently patient was tested positive for influenza (not sure which strain). Patient was still symptomatic. The reporter considered the event to be non-serious.
Age: 2.0
Sex: F
Vaccine: MMRV
Symptoms: Measles post vaccine, Morbillivirus test positive
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 2 year old female patient. The patient's pertinent medical history, drug reactions or allergies were not reported. On 02-FEB-2015, the patient was vaccinated with PROQUAD (Merck) lot # K020753, expiration date: 30-APR-2016, 0.5 ml, subcutaneous in the left thigh. Other suspect was Merck sterile diluent lot # K011430, expiration date: 30-MAY-2017 which was used to dissolve the vaccine. No information regarding concomitant medication was reported. On an unspecified date in February 2015, the patient experienced measles. The medical assistant reported that, on 16-FEB-2015, the patient was at the hospital laboratory and had blood work performed which confirmed that the patient had measles. The patient was not hospitalized. The patient's parent sought medical attention by contacting physician's office. The outcome of the child has measles was reported as not recovered/not resolved. The relatedness between the event and the vaccination with PROQUAD (Merck) which was dissolve in Merck sterile diluent was not provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event, Syringe issue
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unspecified date, the patient received only a partial dose of ZOSTAVAX subcutaneously (lot# and expiration date not reported) because some of the ZOSTAVAX dose leaked out of the space where the needle connects to the syringe. There was no product quality complaint. There were no known adverse effects. Follow up information has been received from a pharmacist. Pharmacist stated, that it was a syringe malfunction and it was not related to ZOSTAVAX. Additional information is not expected, because all follow up information has been obtained.
Age: 30.0
Sex: M
Vaccine: PPV
Symptoms: Malaise
Clinical narrative: This spontaneous report as received from a researcher via market research agency refers to a 30 year old male patient. Patient medical history and current condition was not reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (dose and frequency not reported). Other co-suspects and concomitant medication was not reported. It was reported that the patient was sick for a month (dates unspecified). The outcome of the event was unknown. Causality assessment was not provided by the reporter. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: Appears to be zoster vaccine rash. Skin rash. FAMICICLOVIR 500 MG TID
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a pharmacist concerning a 66 year old male patient. On 05-FEB-2015 the patient was vaccinated with a dose of ZOSTAVAX, (lot#, expiration date, route and dose not provided) in his right arm. On 06-FEB-2015 the patient developed a rash on the right side of his stomach. The patient called to report this rash to the pharmacist on 17-FEB-2015. The outcome of this event was reported as recovering. The reporter did not assess the causality. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a nurse refers who reported that M-M-R II (lot#, expiry date unspecified) was stored improperly due to product confusion: M-M-R II had been shipped together with sterile water diluent in a box, and another unspecified nurse who unpacked the box did not notice that there were 2 boxes of M-M-R II mixed in with a stack of several boxes of sterile water diluent due to the similar blue-colored label of both products. As a result, the nurse thought the stack contained only sterile water diluent and left it out of refrigerator. No patient was involved and no dose was administered. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician concerning approximately 50 patients of unknown age and gender. Between the dates of 04-JAN-2015 to 17-JAN-2015, these patients were vaccinated with improperly stored GARDASIL (lot#, route and dose not provided). No adverse effect was reported. The physician stated he was considering revaccinating the patients. Additional information is not expected as the physician did not allow to be contacted.
Sex: U
Vaccine: HIBV
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. On unknown dates the patients were vaccinated with doses of PEDVAXHIB, (lot # K007258, expiration date 04-MAR-2017) (dose, route unspecified) which were exposed to 32.5F for 2 hours. This event was considered as incorrect product storage. No adverse effects reported. This is one of several reports received from same source. On 23-FEB-2015, a telephone call was placed to the nurse, nurse was unavailable at the time of the call. A voice message was left requesting a returned phone call. Additional information has been requested. Narrative was updated.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a nurse in a physician's office via a field representative concerning a 74 year old female patient. On 05-NOV-2013 the patient was vaccinated with a single dose of ZOSTAVAX (dose and lot# not provided) subcutaneously. On 25-NOV-2013 the patient developed shingles. The outcome of the event was unknown. The relationship between ZOSTAVAX and the event was unknown. Additional information is not expected as the physician did not allow to be contacted.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Patient had fever on 2/21-2/23; experienced febrile seizure x 2 on 2/23/15. Pt evaluated at ER on 2/23.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness, Fatigue, Lethargy, Syncope
Clinical narrative: Tired and lethargic and dizziness (had syncope after administered).
Age: 28.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling, redness and itchy at site of injection. Swollen about 4 inches long by 3 inches wide.
Age: 53.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of drug administration, Injection site pain
Clinical narrative: Area of injection is sore, "like any shot". No lump or bump, area warm or red. SQ injection given as IM.
Age: 1.03
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Rash, Skin warm
Clinical narrative: Redness, warm to touch, raised spot on left leg.
Age: 10.0
Sex: M
Vaccine: MMR
Symptoms: Abdominal pain upper, Rash, Swelling face
Clinical narrative: Developed rash to face within 4 hours of receiving MMR injection. Following morning woke with swollen face/rash to face, stomach pains.
Age: 0.27
Sex: F
Vaccine: DTAP
Symptoms: Crying
Clinical narrative: S/P DAPTACEL -> "cried all night" (parents) no fever cranky next day - told of this on 2/24/15.
Age: 50.0
Sex: F
Vaccine: MMR
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Day 11 - Red, pin point rash on arms, legs, and stomach - itchy.
Age: 32.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Fatigue, Injection site pain
Clinical narrative: Client c/o soreness 6 sites of injection R + L deltoid and fatigue, Temp 97.7.
Sex: M
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Health Professional concerning a male patient. On unknown date, the patient had received FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT was inadvertently administered to a 61 year old patient. The outcome of the event of inadvertently administered FLUMIST QUADRIVALENT to a 61 year old patient was unknown. The report was considered to be non-serious by reporter.
Age: 41.0
Sex: F
Vaccine: FLUN4
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: A report has been received from a Health Professional concerning a 41 year old, female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). The patient's medical history included anaphylaxis to antibiotics. FLUMIST QUADRIVALENT (intranasal) started during 2009. The patient experienced facial numbness and facial tingling which started on 22-Oct-2014. The outcome of the event of facial numbness and facial tingling is unknown. The report was considered to be non-serious.
Age: 1.6
Sex: F
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Health Professional concerning a 1 year old, female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on an unknown date. It was reported that the patient was inadvertently administered with FLUMIST QUADRIVALENT at age of 19 months which started on 22-Oct-2014. The outcome of the event of inadvertent administration of FLUMIST QUADRIVALENT to a 19 month old child is unknown. The report was considered to be non-serious.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 28-year-old female patient who received FLUARIX (batch number 45HX7, expiry date 30th June 2015). The patient's past medical history included flu vaccination (no reactions). Concurrent medical conditions included body mass index (within normal limits). On 3rd November 2014, the patient received FLUARIX (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. On 3rd November 2014, less than a day after receiving FLUARIX, the patient experienced pain in arm. On 10th November 2014, the patient experienced pain in hand. On 18th November 2014, the patient experienced pain in arm. In November 2014, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the pain in hand and pain in arm were not recovered/not resolved. It was unknown if the reporter considered the pain in arm and pain in hand to be related to FLUARIX. Additional information: This patient reported to the nurse that her arm was extremely sore on the day of her shot but the pain decreased over next few days. Approximately 1 week later, the pain in her left hand and arm began to intensify. Her pain in hand and arm is still present and markedly worse than a week ago. She stated that on a scale of 1-10, the pain was a 7.
Age: 11.0
Sex: M
Vaccine: FLUN4, MNQ
Symptoms: Aphasia, Computerised tomogram normal, Confusional state, Dysstasia, Electrocardiogram normal
Clinical narrative: Became dazed and confused and progressed to tremors and couldn't speak or stand on his own. Called 911 and brought to ER. After a few hours he felt normal again. Same events happened next day and a few weeks later.
Age: 11.0
Sex: M
Vaccine: FLUN4, MNQ
Symptoms: Electroencephalogram normal, Feeling abnormal, Nuclear magnetic resonance imaging normal, Tremor
Clinical narrative: Became dazed and confused and progressed to tremors and couldn't speak or stand on his own. Called 911 and brought to ER. After a few hours he felt normal again. Same events happened next day and a few weeks later.
Age: 54.0
Sex: F
Vaccine: VARZOS, PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Redness and slight swelling at injection site. Swelling traveled down patients arm, was not hot to the touch. was painful to the touch. Dr recommended antihistamine, which patient is unable to take because of side effects. Pharmacy recommended hydrocortisone topically and cold compresses.
Age: 54.0
Sex: F
Vaccine: VARZOS, PPV
Symptoms: Injection site erythema, Injection site swelling, Peripheral swelling, Tenderness
Clinical narrative: Redness and slight swelling at injection site. Swelling traveled down patients arm, was not hot to the touch. was painful to the touch. Dr recommended antihistamine, which patient is unable to take because of side effects. Pharmacy recommended hydrocortisone topically and cold compresses.
Age: 1.08
Sex: M
Vaccine: VARCEL
Symptoms: Unevaluable event
Clinical narrative: Both parents of the child that received the varicella vaccine were diagnosed with shingles a little over a week after the child was given the vaccine. Onset began as mild pain and itching, which yielded patches of tiny blisters that were confirmed to be shingles. Both parents were treated with Valtrex. Both parents did have chicken pox as children.
Age: 12.0
Sex: M
Vaccine: HPVX
Symptoms: Blindness unilateral, Headache, Migraine, Nuclear magnetic resonance imaging normal
Clinical narrative: School nurse called informing me of a headache he had. An hour later she called alarmed. His headache has turned into a massive migraine and he lost vision in his left eye. Went to Pediatrician right away who sent us to the ER. Had an MRI to rule out any tumors. We left without a reason why this was happening.
Age: 32.0
Sex: F
Vaccine: ANTH
Symptoms: Feeling hot, Local swelling, Pain, Pruritus, Rash
Clinical narrative: Itching and hives on chest and abdomen: developed the day after receiving the shot and is spreading in distribution, but severity of rash is improving. I am giving her Benadryl for sx's and recommending against any further vaccinations with the anthrax vaccine in the future. She reports no other allergies to foods, drugs or latex that she is aware of.  I have contradictory recommendations from the patient info pamphlet (hives considered serious reaction and contraindication to further vacc) and from the vaccine packaging insert (anaphylactic or anaphylactic like reactions are contraindications). Localized swelling, warmth and pain: common reaction, but the warmth concerns me a little so she agreed to follow up in the morning for reevaluation. I rx'd ibuprofen for these sx's for now. Skin is otherwise intact, non-fluctuant. I expect it to improve quickly.
Age: 32.0
Sex: F
Vaccine: ANTH
Symptoms: Urticaria
Clinical narrative: Itching and hives on chest and abdomen: developed the day after receiving the shot and is spreading in distribution, but severity of rash is improving. I am giving her Benadryl for sx's and recommending against any further vaccinations with the anthrax vaccine in the future. She reports no other allergies to foods, drugs or latex that she is aware of.  I have contradictory recommendations from the patient info pamphlet (hives considered serious reaction and contraindication to further vacc) and from the vaccine packaging insert (anaphylactic or anaphylactic like reactions are contraindications). Localized swelling, warmth and pain: common reaction, but the warmth concerns me a little so she agreed to follow up in the morning for reevaluation. I rx'd ibuprofen for these sx's for now. Skin is otherwise intact, non-fluctuant. I expect it to improve quickly.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Nausea
Clinical narrative: Nausea, headache lasting through next day (02/22/2015) subsiding next day (02/23/2015).
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Area below inject site was sore, red, raised and warm to touch. Dx: cellulitis.
Age: 7.0
Sex: M
Vaccine: FLUN4
Symptoms: Incorrect dose administered
Clinical narrative: A report has been received from a Health Professional concerning a patient, male subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on an unknown date. It was reported that several patients received only a half dose of FLUMIST QUADRIVALENT. The outcome of the event of multiple patients received a half dose of FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Ear swelling, Pruritus, Rash generalised, Swelling face, Varicella virus test
Clinical narrative: Woke up and noticed itchy spots on arms and swollen face and ears; applied topical Benadryl; later on noticed rashes to neck, face, upper back, knees, arms/elbows.
Age: 80.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Feeling abnormal, Injection site pain, Joint swelling, Mobility decreased
Clinical narrative: Patient called HD on 02/19/15 AM to report concerns that his Lt hand was hurting him through the night. When he woke up, his Lt middle finger knuckle was swollen and red and difficult to move his hand due to the pain. He reported swelling at knuckle about the size of a "nickel". Denies any fever this morning or other symptoms. No swelling, redness or pain in any other fingers, hand or shoulder. He states last night his upper arm was a little tender at injection site and he thinks he might have had a mild fever but those have resolved now. I encouraged him to take some NSAIDS and monitor closely. If any swelling, redness or pain moves further into hand or other fingers, he will need to see his doctor. I attempted to follow up with him that afternoon but he did not answer phone as "he was out all day". I spoke with him the next day and he said his finger was doing better. Still a little swollen with very little redness and no more pain but just "felt a little funny due to swelling". He denied any spread of symptoms into other hand or fingers and he was able to move his hand and fingers today without problem. We discussed some education on vaccinations and possible reactions. I encouraged him to continue at least a daily dose of NSAIDS until fully resolved and again to call ASAP and/or see doctor if any symptoms worsened. I was not able to follow up with client any further as he did not answer the phone after several daily attempts over the next 4-5 days and unable to leave a message. He had been given my information to call if further concerns at last conversation.
Age: 80.0
Sex: M
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: Patient called HD on 02/19/15 AM to report concerns that his Lt hand was hurting him through the night. When he woke up, his Lt middle finger knuckle was swollen and red and difficult to move his hand due to the pain. He reported swelling at knuckle about the size of a "nickel". Denies any fever this morning or other symptoms. No swelling, redness or pain in any other fingers, hand or shoulder. He states last night his upper arm was a little tender at injection site and he thinks he might have had a mild fever but those have resolved now. I encouraged him to take some NSAIDS and monitor closely. If any swelling, redness or pain moves further into hand or other fingers, he will need to see his doctor. I attempted to follow up with him that afternoon but he did not answer phone as "he was out all day". I spoke with him the next day and he said his finger was doing better. Still a little swollen with very little redness and no more pain but just "felt a little funny due to swelling". He denied any spread of symptoms into other hand or fingers and he was able to move his hand and fingers today without problem. We discussed some education on vaccinations and possible reactions. I encouraged him to continue at least a daily dose of NSAIDS until fully resolved and again to call ASAP and/or see doctor if any symptoms worsened. I was not able to follow up with client any further as he did not answer the phone after several daily attempts over the next 4-5 days and unable to leave a message. He had been given my information to call if further concerns at last conversation.
Age: 2.0
Sex: U
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old unk patient who received FLUARIX QUADRIVALENT (batch number 3227Z, expiry date 30th June 2015). On 6th January 2015, the patient received FLUARIX QUADRIVALENT .5 ml. On an unknown date, the dose was an unknown dose. On an unknown date, an unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. Additional information received: FLUARIX QIV mistakenly administered to a 2yo (full 0.5 ml dose) instead of a pediatric flu vaccine that is approved for this age group.
Age: 25.0
Sex: M
Vaccine: FLU3, HEP, FLUC3, HEP
Symptoms: Blood test, Computerised tomogram, Coordination abnormal, Electromyogram abnormal, Fall
Clinical narrative: One week after shots started feeling tired. A week later feeling fatigue and tired. On October 30 started tingling on tongue, fingertips, toes Nov 8th at Roller Derby had lack of coordination and falling. Nov 12 numbness in leg to groin. Nov 14 went to Local ER. Nov 17 admitted to Hospital.
Age: 25.0
Sex: M
Vaccine: FLU3, HEP, FLUC3, HEP
Symptoms: Fatigue, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Lumbar puncture
Clinical narrative: One week after shots started feeling tired. A week later feeling fatigue and tired. On October 30 started tingling on tongue, fingertips, toes Nov 8th at Roller Derby had lack of coordination and falling. Nov 12 numbness in leg to groin. Nov 14 went to Local ER. Nov 17 admitted to Hospital.
Age: 25.0
Sex: M
Vaccine: FLU3, HEP, FLUC3, HEP
Symptoms: Nuclear magnetic resonance imaging, Paraesthesia, Paraesthesia oral
Clinical narrative: One week after shots started feeling tired. A week later feeling fatigue and tired. On October 30 started tingling on tongue, fingertips, toes Nov 8th at Roller Derby had lack of coordination and falling. Nov 12 numbness in leg to groin. Nov 14 went to Local ER. Nov 17 admitted to Hospital.
Age: 10.0
Sex: M
Vaccine: HEP, MMRV
Symptoms: Body temperature increased, Decreased appetite, Dizziness, Lethargy
Clinical narrative: Parent reports that child felt "woozy" and was unable to eat lunch.  Child was in school and reported to the nurses office and had a temperature of 101 degrees.  Later in the day temperature rose to 102 degrees.  Dad called PHN the next day and reported that the childs temperature went up to as high as 103 degrees overnight. No other symptoms besides lack of appetite and lethargy.
Age: 22.0
Sex: F
Vaccine: IPV, MMR, TDAP, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: Given MMR vaccine on 2/10/15 and since discovered is pregnant.  Seen OB today and is 6 to 8 weeks pregnant.  OB referred patient to high risk doctor.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site rash
Clinical narrative: Injection site was red and hard, then rash the size of a baseball appeared.  Is now getting better.
Age: 2.0
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Crying, Dysphemia, Frustration, Pressure of speech
Clinical narrative: Onset of severe stuttering, holding his face in his arm and using a large amount of diaphragmatic force/exertion to complete a word.  Jumping up and down during occasionally to get a word out. Frustration was evident and this has continued for the last two weeks. Usually worse during times of excitement, nervousness.  He has begun crying now during these episodes, stating "I can't talk".  No treatment has occurred yet but referral has been made by our pediatrician to speech pathologist.
Age: 58.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Pruritus generalised
Clinical narrative: States had "itchy feeling all over" after receiving Varicella vaccine.  No c/o SOB, no visible redness/rash.
Age: 74.0
Sex: M
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Health Professional concerning a 74 year old, male subject, who had been receiving FLUMIST QUADRIVALENT (Intranasal). FLUMIST QUADRIVALENT (intranasal) started on 28-Oct-2014. It was reported that the FLUMIST was administered to wrong patient population which started on 28-Oct-2014. The outcome of the event of administration to wrong patient population is unknown. The reporter's description of the event(s) was as follows: Not provided. The report was considered to be non-serious.
Age: 53.0
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Expired product administered
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 53-year-old male patient who received HAVRIX adult (batch number AHAVB642GA, expiry date 14th December 2014). The patient's past medical history included blood pressure high and alcohol abuse. Concomitant products included FLULAVAL QUADRIVALENT and Blood Pressure Med. On 5th January 2015 11:00, the patient received the 1st dose of HAVRIX adult (intramuscular). On an unknown date, the dose was an unknown dose. On 5th January 2015, an unknown time after receiving HAVRIX adult, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional information received: A pharmacist reports that a 53 year old male patient received a dose of HAVRIX which was expired.
Age: 3.0
Sex: F
Vaccine: FLUN4
Symptoms: Condition aggravated, Epistaxis
Clinical narrative: A report has been received from health professional concerning a 3 year old female patient. The patient's medical history included nose bleeds. The patient's concurrent disease included seasonal allergies. The patient has been receiving FLUMIST quadrivalent (intranasal) started on 03-Nov-2014. On 03-Nov-2014, the patient developed a nose bleed after receiving FLUMIST quad. right after the administration, the patient's nose began to bleed. Pressure was applied and the bleeding stopped in about two minutes. The parent said that the patient was prone to nosebleeds. There was no significant medical history; the patient was healthy. The report was considered to be non-serious by reporter.
Sex: U
Vaccine: FLUN4
Symptoms: Croup infectious
Clinical narrative: A report has been received from a Health Professional according a subject of unknown gender, who had been receiving FLUMIST (INTRANASAL).FLUMIST (INTRANASAL) started on an unknown date. The patient experienced CROUP. The outcome of the event of CROUP is unknown. The report was considered to be non-serious.
Age: 18.0
Sex: F
Vaccine: FLUN4
Symptoms: Incorrect dose administered
Clinical narrative: A report has been received from a Health Professional concerning an 18 year old, female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on an unknown date. The patient reported multiple patients received a half a dose of FLUMIST QUADRIVALENT which started on 28-OCT-2014. The outcome of the event of multiple patients received a half dose of FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Peripheral swelling, Pruritus generalised, Throat tightness
Clinical narrative: 02/24/2015 - itching all over/ no rash. 02/25/2015- continued itching, took Benadryl at 14:00; woke at 23;00 and felt throat tightening and left hand swelling. 02/24/2015- no itching but has left hand / thumb pain and swelling. Treated with Medrol dose pack.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Asthma, Dyspnoea, Headache, Heart rate increased, Hyperhidrosis
Clinical narrative: Difficulty breathing, asthma like response.  Shortness of Breath, called 911.  Increased HR, felt like I was running.  Went to clinic, was given anti-allergy medication.  Went home. In bed for 5 days with fever of 103-104.  HR 170 when lying in bed.  Profuse sweating, headache, and difficulty breathing.  Monitored by family and many calls made to Dr. to make sure fever and breathing was within manageable range, not needing ER treatment.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Difficulty breathing, asthma like response.  Shortness of Breath, called 911.  Increased HR, felt like I was running.  Went to clinic, was given anti-allergy medication.  Went home. In bed for 5 days with fever of 103-104.  HR 170 when lying in bed.  Profuse sweating, headache, and difficulty breathing.  Monitored by family and many calls made to Dr. to make sure fever and breathing was within manageable range, not needing ER treatment.
Sex: F
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Health Professional concerning a patient born on 30-Jun-1951, Female subject, who had been receiving Nasal FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on 22-Oct-2014. It was reported that a FLUMIST vaccine was dispensed to the wrong patient population. The outcome of the event of ADMINISTRATION TO WRONG PATIENT POPULATION is unknown. The reporter's description of the event (s) was as follows: Not provided. The report was considered to be non-serious.
Age: 60.0
Sex: F
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Health Professional concerning a 60 year old, female subject, who had been receiving FLUMIST QUADRIVALENT (Intranasal). FLUMIST QUADRIVALENT (Intranasal) started on 21-Oct-2014. It was reported that there vaccine was administered to wrong patient population which started on 21-Oct-2014. The outcome of the event of administration to wrong patient population is unknown. The reporter's description of the event(s) was as follows: Not provided. The report was considered to be non-serious.
Sex: M
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Health Professional concerning a patient born on 29-Sep-2013, Male subject, who had been receiving Nasal FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on an unknown date. It was reported that a patient dispensed FLUMIST vaccine to the wrong patient population. The outcome of the event of ADMINISTRATION TO WRONG PATIENT POPULATION is unknown. The reporter's description of the event (s) was as follows: Not provided. The report was considered to be non-serious.
Age: 24.0
Sex: F
Vaccine: RAB
Symptoms: Viral titre decreased
Clinical narrative: Follow-up was received from a healthcare provider (nurse) on August 2013. The additional information provided includes patient identifiers for two cases. This case now pertains to one of the thirteen patients. Information for the other patients is captured in case number 2013-08317 and 2013-06998. This case involved one of a cluster of thirteen unidentified patients who had received intramuscular injections of IMOVAX Rabies, lot number D1177-1. This 24 year old female patient was vaccinated intramuscularly three times with IMOVAX Rabies Lot # D1177-1 into the right deltoid. Dates of administration were not reported for this patient. Titers were checked on 14 May 2013 and 15 May 2013 and were low. Laboratory test results were not reported. The patient's other medications were reported as SPRINTEC, EPIDUO and BACTRIM. Dose, route, dates and indication were not reported. The patients pre-existing allergies and medical conditions were reported as no known drug allergies, reported as NKDA. No further information was available at the time of this report. The patient outcome was reported as unknown. Document held by sender: None.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Crying, Eye movement disorder, Fall, Syncope
Clinical narrative: Patient's eyes rolled back and she collapsed. Started crying after she fell.
Age: 81.0
Sex: M
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: A report has been received from a pharmacist concerning an 81 year old male patient. Relevant medical history or concomitant medication was not reported. On 26-Sep-2014 the patient started therapy with FLUMIST QUADRIVALENT (intranasal). The patient was over the age of 49 years and has been administered FLUMIST QUADRIVALENT. No adverse effects were observed. The action taken of FLUMIST QUADRIVALENT was unknown. The outcome of the event of inadvertent administration was unknown. The report was considered to be non-serious by the reporter.
Age: 32.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Health Professional concerning a 32 year old, female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on an unknown date. Health Professional reported that two female patients had been administered expired FLUMIST which started on 10-Oct-2014. The outcome of the event of administered expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Age: 5.0
Sex: M
Vaccine: FLUN4
Symptoms: Circumstance or information capable of leading to medication error, Exposure via direct contact
Clinical narrative: A report has been received from a Health Professional concerning a 5 year old, Male subject, who had been receiving Nasal FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on 13-oct-2014. It was reported that the patient moved and was inadvertently sprayed in the eye with FLUMIST which started on 13-Oct-2014. The outcome of the event of PATIENT MOVED AND WAS INADVERTENTLY SPRAYED IN THE EYE WITH FLUMIST is unknown. The report was considered to be non-serious.
Sex: M
Vaccine: PPV
Symptoms: Splenectomy
Clinical narrative: This spontaneous report was received from Pfizer and was assigned manufacturer report number 2015049186 for PREVNAR 13. On an unspecified date in November 2014, the patient was vaccinated with a dose of pneumococcal vaccine (manufacturer unknown) (route, lot# and expiration date were not provided) since then he has had a splenectomy. The outcome of splenectomy was unknown. This was originally reported by a pharmacist. Upon internal review, splenectomy was determined to be medically significant. Additional information is not expected because the patient decline to provide information.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: Information has been received from a 47 year old female patient who was participated in a Market research program. Concurrent condition and medical history were not reported. On an unknown date the patient was vaccinated with a dose of pneumococcal vaccine ((reported as "Pneumonia/pneumococcal (disease) vaccine, manufacturer unknown)) (lot#, expiration date, route and dose were unknown). Concomitant therapies were not reported. It was reported that the patient "previously ended up hospitalized with pneumonia after having the vaccine". The outcome of the event was unknown. Additional information has been requested.
Age: 0.24
Sex: M
Vaccine: DTAP, MEN, DTAP, MNQ
Symptoms: Injection site mass, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: High fever 103.7 with Tylenol 2.5 mg. Large painful swollen lump on leg.  Hospital visit for fever reduction.
Age: 0.24
Sex: M
Vaccine: DTAP, MEN, DTAP, MNQ
Symptoms: Injection site mass, Injection site swelling, Pyrexia
Clinical narrative: High fever 103.7 with Tylenol 2.5 mg. Large painful swollen lump on leg.  Hospital visit for fever reduction.
Age: 1.76
Sex: F
Vaccine: DTAP, HIBV, PPV
Symptoms: Mobility decreased
Clinical narrative: Child was no longer able to use the lower part of her body, could not sit up, lean forward, or use her legs.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Soreness, redness, and swelling of left arm / shoulder.
Age: 45.0
Sex: F
Vaccine: MMR
Symptoms: Induration, Injection site bruising, Injection site pain, Skin discolouration, Swelling
Clinical narrative: On 02/12/15, patient called stating bruises at 3 sites on left arm (MMR vaccine given on back of left arm SQ): axillary, site of injection and back of her arm near the elbow. Patient stated tenderness at the site of the injection. Patient denied achiness, fever, tiredness or problems breathing. Follow-up phone call at 4:45 PM with patient who states her PCP says that the bruising is fine and no follow up care is needed. Patient again denied achiness, fever, tiredness or problems breathing. On 2/16/15 patient called to say the bruises were resolved but now has  hard raised one inch long skin color area an inch below the axilla. Patient denied having a fever, chills, n/v, or erythema at injection site. Patient denies previous reaction to MMR, fever, hives, difficulty breathing, facial swelling or rapid heartbeat. Per voicemail on 2/26/15, patient states everything has resolved.