chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent condition, or concomitant medication. On or about 30-OCT-2016, the patient was vaccinated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. The patient began to experience painful symptoms. On or about 07-APR-2015 (note this is prior to vaccination date), the patient was treated by a nurse practitioner for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient has been prescribed ZOVIRAX and hydroxyzine for management of her painful condition. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent condition, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) on or about 20-JUN-2008 at public health department, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 08-FEB-2016, the patient was treated at hospital for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as shingles. The patient was prescribed acyclovir for management of her painful and persistent symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: FLUX
Symptoms: Dizziness
Clinical narrative: Initial unsolicited report received from a consumer on 14-Nov-2017. This case involves a female patient of unknown age who was vaccinated with a dose of INFLUENZA VACCINE (batch number, expiry date, route and site of administration, dose in series was not reported) on an unknown date 20 years ago. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient got dizzy. Lab data and corrective treatment was not reported. The outcome of the event was unknown. List of documents held by sender: none.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Haemorrhage, Scab, Swelling, Wound secretion
Clinical narrative: Red, swollen, scab about 1/2 inch - looks similar to a cut. Bled/oozed x 1 week in that area. Three weeks later still red and some scab.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia
Clinical narrative: Case number PHEH2016US030182 is a spontaneous report initially received from consumer on 15 Nov 2016. This report refers to 76 years old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 1618501) at a dose of 0.5 ml intramuscular on 24 Oct 2016. On 01 Nov 2016, the patient left knee started hurting for the two days and the pain went away. On 03 Nov 2016, the patient left knee hurting was recovered. On 14 Nov 2016 the patient's right knee started hurting. The patient took ibuprofen and her condition was improving. It was reported that, the doctor did not prescribed the vaccine, they did not have any on hand yet. The patient still appearing joint pain in other part of body might be due to old age. The outcome of the events left knee hurting was completely recovered on 03 Nov 2016 and right knee hurting was improving. The seriousness of the events was reported as serious disability. The causality of the events was not reported. Follow up report received from consumer on 13 Dec 2016: Updated reporters comment and event verbatim.
Sex: M
Vaccine: FLUX
Symptoms: Dizziness, Myalgia
Clinical narrative: Case number PHEH2016US033492, is an initial spontaneous report received from a consumer on 15 Dec 2016. This report refers to a male patient. Historical condition included stroke. Current condition included cancer. Concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer unknown, batch number: not reported) on an unknown date. On an unknown date after vaccination, the patient experienced dizziness and muscle aches. The patient went to emergency room on an unknown date. The outcome, seriousness and causality of the events were not reported. Seriousness assessment of the event dizziness was upgraded based on information available in the source document.
Age: 58.0
Sex: F
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Adult was inadvertently given MMR-V that is not authorized for adults.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema
Clinical narrative: Patient experienced redness that went halfway down her arm per mother via telephone. Pt was not seen in the office.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Limb injury, Musculoskeletal pain, Pain
Clinical narrative: Patient got flu shot administered 9/26/17 and is still feeling shoulder pain. Her Neurologist suggested it was SIRVA and told her to ask the pharmacy to file a report. Patient states she still has full mobility and is experiencing pain when she moves her arm. Patient had pain/soreness after the vaccination that never went away.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Diarrhea, vomiting.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Anaphylactic shock
Clinical narrative: Patient had an anaphylactic shock reaction to the vaccine. Patient's wife gave him Epi-pen shot and took him to the Emergency Room. Hospitalization was not required.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Febrile convulsion, Influenza virus test negative, Pyrexia, Streptococcus test negative
Clinical narrative: Spiked fever to 103F on Mon (8-Jan) 0300. Febrile seizure 1745 lasting about 2 minutes. Patient admitted to the ER.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Eosinophil percentage, Erythema, Full blood count, Haematocrit decreased
Clinical narrative: Extreme pain and immobility in arm with eventual swelling and bright redness all the way down past the elbow. Also experienced low grade fever and chills.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Haemoglobin normal, Mobility decreased, Monocyte percentage increased, Pain in extremity, Pyrexia
Clinical narrative: Extreme pain and immobility in arm with eventual swelling and bright redness all the way down past the elbow. Also experienced low grade fever and chills.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Red blood cell count decreased, Swelling, White blood cell count decreased
Clinical narrative: Extreme pain and immobility in arm with eventual swelling and bright redness all the way down past the elbow. Also experienced low grade fever and chills.
Sex: M
Vaccine: FLUX
Symptoms: Hypersensitivity
Clinical narrative: This initial spontaneous case received from a consumer (patient) on 09-Nov-2017, concerning an elderly male patient of an unknown age. On an unknown date, the patient received flu shot (dose, route, anatomical location, manufacturer, trade name and batch number not reported). On an unknown date, the patient also administered ENTRESTO for an unknown indication. On an unknown date, after receiving vaccine, the patient noticed that he had some sort of allergic reaction, but not sure if it was from shot or from something he came in contact with outside while doing yard work. He also stated that it looked like a bug bite but was concerned as there were a bunch of them.Hes was still taking ENTRESTO. The outcome of the event was not reported.
Age: 68.0
Sex: F
Vaccine: FLUA3
Symptoms: Headache, Injection site indentation, Scar
Clinical narrative: This non-serious initial spontaneous case, was received from a Pharmacist on 23-Oct-2017, concerning an elderly female patient of 68 years. On 30-Aug-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left Deltoid, batch number: 178301, expiry date: Apr-2018). On an unspecified date (between 02-Sep-2017 to 03-Sep-2017), the patient developed "indention" (like a hole) on her arm where injection was given. She had a dimple greater than a quarter dollar coin in the site of the indentation. She went to her physician and he said he had never seen a reaction to a flu vaccine like that and no treatment was recommended for the same. Patient also mentioned that the physician had confirmed the described reaction was from the flu shot. On an unknown date, the patient also experienced headache since she got the vaccine and never had headaches before. It was reported that the patient still had a scar. The indentation had not gone, and the patient kept visiting to the pharmacy to seek advice. The reporter stated that the patient did not receive any treatment measures for the events. At the time of this report, the patient had not yet recovered from the event. The reporter assessed the event as non-serious. Follow up received from the reporter on 14-Nov-2017: Updated age of the patient, added event headache and reporter's comment. Accordingly, updated narrative.
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia
Clinical narrative: This initial non-serious spontaneous case, was received on 19-Oct-2017, from other health professional and concerning a 34-year-2017, adult, female patient. On an unspecified date, the patient was administered with INN (dose, route of administration, batch number, anatomical location, expiry date, trade name, manufacturer: not reported) for an unknown indication. On an unspecified date, 4 hours after vaccination, the patient's arm became numb. It was reported that, the patient was no linger experiencing this symptom.  On an unspecified date, the patient had recovered from the event.
Age: 74.0
Sex: M
Vaccine: FLUA3
Symptoms: Injection site pain, Pain
Clinical narrative: This initial non-serious spontaneous case received on 05-Oct-2017, reported by a pharmacist and concerns 74-year-old elderly male patient. The patient's historical condition included "some kind of large prostate". The patient's current conditions included diabetes, high blood pressure, high blood cholesterol. The patient's concomitant medications included: finasteride, JANUVIA, atorvastatin, metoprolol, DEXILANT. On 15-Sep-2017, the patient received FLUAD (TIV) (dose: 0.5ml, route of administration: intramuscular, anatomical location: deltoid muscle, batch number: 178701 (as reported), expiry date: April-2018). On 22-Sep-2017, 8 days after administration of FLUAD (TIV), the patient had usual aches and pain in the first two days (after the shot). A week after, he felt there was a burning sensation at the site in the muscle, which lasted about a week and went away. The patient had a dull aching pain in the muscle underneath and surrounding the site. It was reported that, as he touched on it then, he felt a little bit of pain. When the shot was given, he felt the liquid might have damaged the muscle (added by the pharmacist). The outcome of the events was not recovered. The reporter assessed this case as non-serious.
Age: 76.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: The initial spontaneous case was received on 11-Oct-2017, concerning a 76-year-old, elderly, female patient. On an unspecified date, the patient was vaccinated with influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacturer: not reported). On an unspecified date, after few days of vaccination, the patient experienced soreness and redness at injection site. The patient stated that, she would continue the flu shot. The outcome of the event was not reported. The reporter assessed this case as non-serious.
Sex: F
Vaccine: FLUX
Symptoms: Exposure during pregnancy
Clinical narrative: This initial spontaneous case was received from other non-health professional on 12-Oct-2017, concerning a female pregnant patient of unspecified age. On 12-Oct-2017, the patient was administered with influenza vaccine (dose, route of administration, batch number, expiry date, anatomical location, manufacture and trade name: not reported). On the same day, the pregnant patient was administered with the vaccine. At the time of this report, the outcome of the event was no reported.
Sex: F
Vaccine: FLUX
Symptoms: Exposure during pregnancy
Clinical narrative: This initial spontaneous case, was received from other non-health professional on 16-Oct-2017, concerning a female 12 weeks pregnant patient of unspecified age. On an unspecified date, the patient was administered with INN Flu Vaccine (dose, route of administration, batch number, expiry date, anatomical location, manufacture and trade name: not reported). On the same day, the pregnant patient was administered with the vaccine (considered as vaccine exposure during pregnancy). At the time of this report, the outcome of the event was no reported.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Patient developed a rash with redness and  swelling around injection site. Patient took diphenhydramine 25mg and rash improved over 3-4 days. Patient says it's total resolved now.
Age: 18.0
Sex: M
Vaccine: PPV
Symptoms: Dyspnoea, Erythema, Wheelchair user
Clinical narrative: PATIENT IS WHEELCHAIR BOUND AND WHILE WHEELING OUT OF THE PHARMACY, HE TURNED RED, HAD TROUBLE BREATHING, CAME BACK INTO THE PHARMACY ASKING US TO CALL 911. HE SEEMED TO BE CONSCIOUS THE ENTIRE TIME. HE ASKED FOR AND WE GAVE HIM WET PAPER TOWELS AND ICE PACKS. AMBULANCE CAME, CHECKED HIM OUT AND HE LEFT TO GO TO THE HOSPITAL, BUT NOT IN AN AMBULANCE. HE SEEMED TO RECOVER BEFORE LEAVING. THIS WAS PNEUMOVAX, PATIENT HAS HAD PREVNAR BEFORE.
Age: 11.0
Sex: M
Vaccine: MMR, MNQ, TDAP
Symptoms: Seizure like phenomena, Syncope
Clinical narrative: After administration of third shot, patient began to faint. Patient was guided onto exam table and did not completely lose consciousness. Medical Assistant reported the patient had "seizure like activity". Vitals were stable and Pediatrician was immediately on site.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This non-serious initial spontaneous case was received by other-non health professional on 17-Oct-2017, concerns a 41-year-old, female pregnant patient. On 17-Oct-2017, the patient was administered with influenza vaccine (dose, route of administration, anatomical location, batch no., expiry date and manufacturer: not reported). The patient did not experience any adverse events (reported as "no reactions") after administration of influenza vaccine. It was reported that, she did not want to speak with anyone and reported only to notify about the shot and to get on the registry. The reporter did not provide the seriousness assessment.
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain
Clinical narrative: The initial spontaneous case, received on 17-Oct-2017 by other non-health professional (consumer), concerning a female patient of an unspecified age. On an unspecified date, the patient was administered with influenza vaccine (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: expiry date, trade name, manufacturer: not reported). On an unspecified date, after vaccination the patient experienced injection site soreness. On an unspecified date, the patient had recovered from the event. The reporter assessed this case as non-serious.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Exposure during pregnancy, Pain in extremity
Clinical narrative: This initial spontaneous case was received from a consumer on 18-Oct-2017, concerns 30-year-old female pregnant patient. The patient received nadolol and prenatal vitamin prior to pregnancy for an unknown indication. The patient had no medical history, maternal history relevant to pregnancy and paternal medical history included sperm donor, which used in IUI (intrauterine insemination). The patient had no previous pregnancies. The father of the fetus did not receive any medication prior to conception. The patient's concomitant medication included prenatal vitamin for an unknown indication. The patient did not use any contraceptive method. The patient's last menstrual period date was 02-Aug-2017. It was reported as first pregnancy of the patient. There was no any evidence of a defect/adverse finding from a prenatal test. The patient had given the permission to enroll in the pregnancy registry. On 13-Oct-2017, at gestation age of 11 weeks (first trimester), the pregnant patient was administered with INN Flu Vaccine Seasonal (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number, manufacturer, trade name: not reported) (explicitly coded as vaccine exposure during pregnancy). On the same day, the patient developed soreness in arm and no adverse event was reported in the fetus. No treatment was taken for the event. The same day (13-Oct-2017), patient was recovered from the event soreness in arm. The estimated date of delivery was reported as 09-May-2018. The reporter assessed the events as non-serious.
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This initial spontaneous case was received on 25-Oct-2017, reported by other non-health professional, concerning a female patient of unspecified age. The patient's historical drug included Influenza vaccine. The patient's historical conditions included pain, redness and blisters at the injection site. The patient did not receive any concomitant medications. On 25-Oct-2017, the patient was administered with INN Flu Vaccine (dose, route of administration, anatomical location, expiry date, batch number, manufacture and trade name: not reported). On the same day, after administration of vaccine, the patient had a "skin reaction" redness and pain at the injection site. The outcome of the events was not yet recovered. The reporter assessed the events as non-serious.
Sex: F
Vaccine: FLUX
Symptoms: Injection site cellulitis
Clinical narrative: This initial spontaneous case was received on 25-Oct-2017, reported by other non-health professional, concerning a female patient of unspecified age. The patients historical drug included Influenza vaccine. On an unspecified date, the patient was administered with INN Flu Vaccine Seasonal (dose, route of administration, anatomical location, expiry date, batch number, manufacture and trade name: not reported). On unspecified date after administration of vaccine, the patient experienced cellulitis at the injection site. The patient was treated with unspecified antibiotics. The reporter assessed the event non-serious.
Sex: F
Vaccine: FLUX
Symptoms: Exposure during pregnancy
Clinical narrative: This initial non-serious spontaneous case was received on 30-Oct-2017, from a pharmacist, concerning a female pregnant of unspecified age. On an unspecified date, the patient was administered with influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). It was reported that, the pregnant woman was administered with flu vaccine and has enrolled in the flu vaccine registry.
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: This initial non-serious spontaneous case, received on 30-Oct-2017 was reported by a pharmacist and concerns a female patient of unspecified age. It was reported that, the patient has an allergy to latex, ampicillin and buckwheat. On an unspecified date (3 years ago), the patient was administered with INN Flu Vaccine (dose, route of administration, anatomical location, batch number, expiry date: not reported). On an unspecified date (3 years ago) after administration of vaccine, the patient experienced hives. The outcome of the event reported as recovered.
Sex: F
Vaccine: FLUX
Symptoms: Hypersensitivity, Reaction to preservatives
Clinical narrative: This initial spontaneous case initially received on 02-Nov-2017, was reported by other non-health professional, concerns a female patient of unspecified age. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was administered with INN flu vaccine seasonal (dose, route of administration, anatomical location, batch number, expiry date: not reported). On unspecified date, after administration flu vaccine, the patient had allergy because of preservative in it. The outcome of the event was not reported. The reporter assessed the case as non-serious.
Sex: F
Vaccine: FLUX
Symptoms: Mouth swelling, Pharyngeal oedema
Clinical narrative: This initial non-serious spontaneous case was received on 21-Sep-2017 from other non-health professional, concerning a female patient of unspecified age. The patient's medical history and concomitant medications were not reported. On an unspecified date (reported as last year), the patient was administered with influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date, the patient experienced swelling in her throat and mouth after vaccination. It was reported that the reaction was due to the preservative used in vaccine and the patient had recovered from the events.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Adverse event, Exposure during pregnancy
Clinical narrative: This non-serious initial spontaneous case was received from other non-health professional (consumer) on 04-Oct-2017, concerning a 31-year-old adult female pregnant patient. The patient had no relevant medical history. The patient's concomitant medications included metformin and prenatal vitamins for an unknown indication. The patient had no previous pregnancy, maternal medical history relevant to pregnancy and paternal medical history (hereditary disease). The patient was permitted to enroll in the pregnancy registry. The patient's last menstrual period was beginning of September (unspecified date and year) and estimated date of delivery was beginning of June (unspecified date and year). The patient did not use any contraceptive method and no medications received by the father prior to conception. There was no any evidence of a defect/adverse finding from a prenatal test. On an unspecified date, (last week) (as reported), the patient was administered with influenza vaccine (batch number, dose: 0.5 ml, route of administration: intramuscular, batch number, expiry date, manufacturer, trade name, anatomical location: not reported). The patient administered the vaccine during her pregnancy, which was considered as vaccine exposure during pregnancy. It was reported that, and unspecified adverse event was experienced by the patient and no any adverse event was reported in the fetus. The reporter assessed the event as non-serious.
Age: 69.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This non-serious initial spontaneous case, was received from pharmacist on 13-Oct-2017, concerning a 69-year-old female patient. The patient's medical history included unspecified post-transplant complication. The patient concomitant medications included unspecified anti rejection medications post organ transplantation. On 11-Oct-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, batch number: 179402, expiry date: Jun-2018, route of administration: intramuscular, anatomical location: left deltoid). On 12-Oct-2017, after 2 days of vaccination, the patient had dark redness, which was 3 inches in diameter and warmth around the injection site. No treatment was taken for the events. The patient was recovered from the events within 2 to 5 days. Follow up report received on 23-Oct-2017: The outcome of the event from not recovered to recovered within 2-5 days was updated. The reporter confirmed the vaccination date as 11-Oct-2017. The narrative was amended accordingly.
Age: 67.0
Sex: M
Vaccine: FLUA3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This initial spontaneous case was received from other health professional (pharmacist) on 13-Nov-2017, concerning a 67-year-old, elderly, male patient. The patient's historical drug included: received high dose of flu vaccine 1.5 months ago. On 13-Nov-2017, the patient was administered with FLUAD (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch no: 179201 and expiry date: Jun-2018). It was reported that the patient received FLUAD after receiving high dose of flu vaccine 1.5 months ago (explicitly coded as inappropriate schedule of vaccine administered) and no adverse effect was noted. The reporter assessed the events as non-serious.
Age: 65.0
Sex: M
Vaccine: FLUA3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This initial spontaneous case, was received from other health professional on 13-Nov-2017, concerns a 65-year-old male patient. The patient's medical history included mental retardation, high blood pressure, diabetes type II, congenital blindness and concomitant medications included metoprolol, metformin, lisinopril, atorvastatin. On 02-Nov-2017, the patient was administered with FLUAD (dose: 0.5 ml, route of administration, anatomical location: right deltoid, batch no: 179303 and expiry date: 30-Jun-2018). On 13-Nov-2017, the patient accidentally received second shot of FLUAD (explicitly coded as inappropriate schedule of vaccine administered). It was reported that there was no AE after vaccination (explicitly coded as no adverse event). The reporter assessed this case as non-serious.
Sex: F
Vaccine: FLUX
Symptoms: Dysphonia, Laryngitis
Clinical narrative: This initial spontaneous case was received from other non-health care professional on 16-Nov-2017, concerning a female patient of unspecified age. The patient had a current condition of asthma since an unspecified date. The patient was not administered with any concomitant vaccines. On an unspecified date, 4 years ago the patient was administered influenza vaccine (anatomical location: arm, dose: reported as full dose, route of administration, trade name, manufacturer, batch number and expiry date: not reported). On an unspecified date, soon after vaccination, the patient experienced hoarse voice as if one had laryngitis. It was reported as 2 weeks afterward the patient recovered from the events. The reporter considered this report as non-serious.
Sex: M
Vaccine: FLUX
Symptoms: Dysphonia, Laryngitis
Clinical narrative: This non-serious initial spontaneous case, was received from other-non health care professional on 16-Nov-2017, concerning a patient of unspecified age and gender. On an unspecified date, 4 years ago the patient was administered INN Flu Vaccine (dose, route of administration, trade name, manufacturer, batch no, expiry date and anatomical location: not reported). On an unspecified date, the patient experienced hoarse voice as if one had laryngitis. Outcome of the events were not reported. The reporter did not provide the seriousness assessment (reported as unable to assess).
Sex: M
Vaccine: FLUX
Symptoms: Swelling, Vaccination complication
Clinical narrative: This initial non-serious spontaneous case received on 21-Nov-2017 was reported by other non-health professional and concerns a male patient of unspecified age. Patient's medical history and concomitant medications were not reported. On an unspecified date (2-3 years ago), the patient received INN Flu Vaccine Seasonal (dose, batch number, expiry date, route of administration, trade name, manufacturer: not reported). On unspecified date after administration INN Flu Vaccine Seasonal, the patient had a reaction on the right arm and chest was swollen. The outcome of the events was not reported. The reporter assessed the case as non-serious.
Age: 66.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Pt has typical looking injection site reaction. Red slightly raised induration of appx 4". Pt remarked that it was sore, but was not concerned because it was already getting better.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 48 hours after receiving the 4 y/o vaccines, patient had skin swelling, redness, and pain on right thigh around injection site. 72 hours post vaccination Mom brought to our clinic since it worsened. Skin exam: right upper thigh blanchable erythema and swelling approx. 10 cm x 7 cm w/irregular well-demarcated borders. Rx given: BENADRYL Q4 hours and hydrocortisone 25% cream Q8 hrs.
Age: 71.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site extravasation, No adverse event, Underdose
Clinical narrative: This non-serious initial spontaneous case, was received on 11-Oct-2017, from other health professional (pharmacist), concerning a 71-year-old, elderly, female patient. On 09-Oct-2017, the patient was administered with FLUAD (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 179102, expiry date: May-2018). The reporter stated that, the patient was administered with suspect vaccine and during administration, part of the dose leaked out of the injection site. The reporter was unsure whether complete dose was administered (explicitly coded as under-dose and drug administration error). The patient had not experienced any adverse reactions after the vaccination. The outcome of the event was not reported. Significant case correction received 11-OCT-2017: The 'route of administration' was taken as not reported, reporter says site of administration was left deltoid. Left deltoid was updated in the route of administration field and in narrative was amended. The description of the event 'drug administration error was taken incorrect'. The event was removed from the event field.
Sex: M
Vaccine: FLUX
Symptoms: Extra dose administered
Clinical narrative: This non-serious initial spontaneous case, was received from pharmacist on 04-Oct-2017, concerning an elderly male patient of an unspecified age. The patient's current condition included mild dementia (since an unspecified date). The patient's historical drug included unspecified influenza vaccine (was given a month before) (as reported). On an unspecified date, the patient was administered with influenza vaccine (dose, batch number, expiry date, manufacturer, trade name, route of administration and anatomical location: not reported). The patient's wife reported that, her elderly husband was given second flu shot, for that pharmacist checked and found that her husband had mild dementia, and he did not remember that one vaccine was already given to him a month before (explicitly coded as inappropriate schedule of vaccine administered). Also, the patient's record was not checked prior to the latest injection.
Sex: F
Vaccine: FLUX
Symptoms: Vaccination complication
Clinical narrative: This non-serious initial spontaneous case was received from Other Non-Health Professional on 30-Oct-2017, concerning a 54-year-old, adult, female patient. On an unspecified date, the patient was administered with INN Flu Vaccine Seasonal (dose, route of administration, anatomical location, trade name, manufacture: not reported. On an unspecified date, the patient experienced severe reaction and hence she was advised not to take the flu vaccine. The outcome of the event was not reported. The reporter assessed the event as non-serous.
Age: 76.0
Sex: F
Vaccine: FLUA3
Symptoms: Contusion, Rash, Rash erythematous, Skin discolouration
Clinical narrative: This non-serious initial spontaneous case, was received from Other Non-Health Professional on 02-Nov-2017, concerning a 76-year-old female patient. The patient's medical history included: she usually gets some induration on the injection site when she receives the flu shot. The patient's concomitant medication included: Omega 3 started 1 week before the shot, FOSAMAX and unspecified vitamins. On 23-Oct-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number, expiry date: not reported). On the same day, the patient had a pinkish rash across her arm without pain for the first night. After a week her arm turned black and blue then yellow and finally it turned purple. It was reported that the patient's arm was clear on one side but had U shape of a bruise. At the time of this report, the patient had not yet recovered from the events (reported as arm was purple). The reporter assessed the event as non-serious.
Age: 57.0
Sex: M
Vaccine: FLUA3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This non-serious initial spontaneous case was received from other health professional (pharmacist) on 05-Nov-2017, concerning a 57-year-old adult male patient. The patient had no any medical history and concomitant medications. On 05-Nov-2017, the patient was administered with FLUAD (TIV) (dose; 0.5 ml, route of administration: intramuscular, anatomical location: deltoid). The patient received the vaccine under 65 years of age (explicitly coded as inappropriate age at vaccine administration). It was reported that, the patient had not experienced any adverse events or reactions after the vaccination.
Sex: M
Vaccine: FLUX
Symptoms: Abdominal pain upper
Clinical narrative: This non-serious initial spontaneous case was received from Other Non-Health Professional on 02-Nov-2017, concerning a male patient of unspecified age. The patient's medical history and concomitant medications was not reported. On an unspecified date, the patient was administered with INN Flu Vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date, the patient had a bad reaction from the flu shot a few years ago - bad stomach pains. It was unknown if the patient took treatment for the event. At the time of this report, the outcome of the event was not reported.
Age: 55.0
Sex: U
Vaccine: FLUX
Symptoms: Injection site bruising
Clinical narrative: This Spontaneous case, initially received on 03-Nov-2017 was reported by a Other Non Health Professional and concerns a 55 years old patient of an unknown age. On an unspecified date, the patient received influenza vaccine, (dose, route, anatomical location: arm, manufacturer, brand name and batch number not reported). On an unspecified date, the patient also received COSENTYX solution (dose 150 mg route: subcutaneous, once a month) for unknown indication. The patient stated that he had been on the medication for approximately a year, unable to locate an exact date for initial dose for the patient. Earliest recorded interaction with the patient was from late Jun-2016. On an unknown date after flu shot administration, the patient had appeared bruise (reported as 3 to 4 weeks ago before administration of COSENTYX) as if he was slugged in the arm. Patient stated he did not experience bruising problems before taking COSENTYX and that the bruising had begun approximately 4 months ago, but he did not have an exact date. He stated that the bruising has gotten worse and appears at injection site. The outcome of the event was not reported.
Age: 21.0
Sex: M
Vaccine: FLUA3
Symptoms: Drug administered to patient of inappropriate age, Expired product administered, No adverse event
Clinical narrative: This initial spontaneous case was received from other non-health care professional on 09-Nov-2017, concerning a 21-year-old patient. The patient's concomitant medication included meloxicam for unknown indication. On 09-Nov-2017, the patient was administer with FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 166003 (as reported), expiry date: Apr-2017). It was reported that, the patient had no reactions after administration of the vaccine. The reporter assessed the case as non-serious.
Sex: M
Vaccine: FLUA3
Symptoms: Pain in extremity
Clinical narrative: This initial spontaneous case received from other non-health care professional on 10-Nov-2017, concerning a 70-year-old adult male patient. On 13-Oct-2017, patient was administered with FLUAD (TIV) (dose, route of administration, anatomical location, batch number, and expiry date: not reported). On the same day after vaccination, about 15-20 minutes later, the patient experienced pain in the arm. The patient wanted to get recommendations to treat the patient in his arm. At the time of this report, the patient had not recovered from the event. The reporter assessed the event as non-serious.
Sex: F
Vaccine: FLUX
Symptoms: Injection site vesicles
Clinical narrative: This initial spontaneous case was received on 25-Oct-2017, reported by other non-health professional (consumer), concerning a female patient of an unspecified age. The patient's historical drug included influenza vaccine for an unknown indication. The patient's historical condition included cellulitis at the injection site, which required the treatement with unspecified antibiotics. On an unspecified date, the patient was administered with INN Flu Vaccine (dose, route of administration, anatomical location, expiry date, batch number, manufacture and trade name: not reported). On an unspecified date (reported as last year), the patient had small blisters occurred at the injection site. At the time of this report, the outcome of the event was not reported. The reporter assessed the event as non-serious.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Condition aggravated, Hypoaesthesia, Injection site hypoaesthesia, Injection site paraesthesia, Paraesthesia
Clinical narrative: Within 30 hours of shot, numbness and tingling from site of shot down through hand and up through shoulder to neck. Symptoms still present, but improving daily. Psoriasis flare within 8 days of shot. Also improving.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Psoriasis
Clinical narrative: Within 30 hours of shot, numbness and tingling from site of shot down through hand and up through shoulder to neck. Symptoms still present, but improving daily. Psoriasis flare within 8 days of shot. Also improving.
Sex: U
Vaccine: FLUA3
Symptoms: Syringe issue
Clinical narrative: This initial non-serious spontaneous case, received on 24-Oct-2017, reported by a pharmacist and concerns a patient of unspecified age and gender. Patient's medical history and concomitant medications were not reported. On an unspecified date, while trying to administer the vaccine (FLUAD TIV), (dose: full dose (as reported), route, anatomical location, batch number: 179303, expiry date: Jun-2018, PTC number: 1025511) the pharmacist was not able to push at all (explicitly coded as syringe issue). However, the product was administered in full dose to the patient (explicitly coded as drug administration error). It was reported that, the package condition was fine without any damage or open, no blockages were observed. No damage was seen in the syringe tip or to the syringe, either to the rubber plunger stopper. Luer-lock was tried with a different needle (as reported). It was reported that, the patient had an experience with the vaccine. The outcome of the events was not reported.
Age: 62.0
Sex: M
Vaccine: FLUA3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This initial spontaneous case was received on 31-Oct-2017 reported by a pharmacist and concerns a 62-year-old adult male patient. On 30-Oct-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 179523, expiry date: unspecified date in Jun 2018). It was reported that FLUAD was administered to a 62-year-old adult patient and had no reactions reported. The outcome of the events was not reported. The reporter assessed the events as non-serious.
Age: 61.0
Sex: F
Vaccine: FLUA3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This non-serious initial spontaneous case, was received from Other Non-Health Professional on 24-Oct-2017, concerning a 61-year-old adult female patient. The patient had no relevant medical history and concomitant medication was not reported. On 09-Oct-2017, the patient was administered with FLUAD (dose: 0.5 ml, batch number: 179103, expiry date: May-2018, route of administration: intramuscular, anatomical location: left deltoid). The patient received the vaccine under 65 years of age (explicitly coded as inappropriate age at vaccine administration). The reporter assessed the event as non-serious.
Sex: M
Vaccine: FLUA3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This initial spontaneous case was received from other non-health professional on 24-Oct-2017, concerning a 37-year-old adult male patient. The patient had no relevant medical history and concomitant medication was not reported. On 15-Oct-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, batch number: 179103, expiry date: May-2018, route of administration: intramuscular, anatomical location: right deltoid). The patient received the vaccine under 65 years of age. The reporter assessed the event as non-serious.
Age: 73.0
Sex: M
Vaccine: FLUA3
Symptoms: Dizziness, Nausea
Clinical narrative: This initial spontaneous case was received form other health care professional (pharmacist) on 24-Oct-2017, concerning a 73-year-old elderly male patient. The patient's past drug included PNEUMOVAX. The patient felt ill for couple of weeks prior to vaccination. The patient's concomitant medications were not reported. On 12-Oct-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number 178602, expiry date: 20-Apr-2018) for the first time. On the same day, the patient was also administered with PNEUMOVAX (dose, route of administration, batch number, expiry date, anatomical location, manufacturer and trade name: not reported). On 13-Oct-2017, after 2 days of vaccination, the patient experienced dizziness and violent nausea. On 17-Oct-2017, the patient was recovered from the events. The reporter assessed the events as non-serious. Non-significant follow-up report received on 13-Nov-2017: Vaccination date of pneumonia vaccine was confirmed as 12-Oct-2017.
Sex: F
Vaccine: FLUX
Symptoms: Headache, Nausea, Pain
Clinical narrative: This initial spontaneous case, was received from other non-health professional on 18-Oct-2017, concerning a female patient of an unspecified age. The patient medical history and concomitant medications were not reported. On an unspecified date (yesterday) (as reported), the patient was administered with influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number, expiry date, manufacturer and trade name: not reported. On unspecified date, after several hours of vaccination, the patient had headache, queasiness and general body aches. At the time of this report, the outcome of the events was not reported. The reporter assessed the events as non-serious.
Age: 69.0
Sex: F
Vaccine: FLUA3
Symptoms: Blood pressure increased, Condition aggravated, Cough, Erythema, Fatigue
Clinical narrative: This initial spontaneous case, was received on 18-Oct-2017 from other non-health professional, concerning a 69-year-old, elderly, female patient. The patient's medical history included breast cancer and MI (myocardial infarction) since 1990. The patient's current condition included high blood pressure, that has been well controlled for years as status post MI in 1990. The patient's concomitant medications included potassium, PLAVIX, hydrochlorothiazide, pantoprazole, losartan, levothyroxine, atorvastatin, Baby aspirin, AMBIEN, and Multiple vitamins. On 11-Oct-2017, the patient was administered with FLUAD (dose: 0.5 ml, anatomical location: left deltoid, batch number, expiry date, route of administration: intramuscular). On 12-Oct-2017, within 24 hours of vaccination, the patient had hacking cough. The patient also had a headache, congested sinus/nose and felt tired along with rosy cheeks which lasted for 2 days. It was reported that, the patient went to GI and the patient's BP (blood pressure) was found to be 167/97. At the time of this report, the patient was recovering from the events (cough, nasal congestion and hypertension). The causality of the event cough was related. The reporter assessed the events as non-serious. Follow-up report received on 31-Oct-2017: Outcome of the events (cough, hypertension and nasal congestion) were updated from not recovered to recovering. Amended narrative accordingly.
Age: 69.0
Sex: F
Vaccine: FLUA3
Symptoms: Headache, Hypertension, Nasal congestion, Sinus congestion
Clinical narrative: This initial spontaneous case, was received on 18-Oct-2017 from other non-health professional, concerning a 69-year-old, elderly, female patient. The patient's medical history included breast cancer and MI (myocardial infarction) since 1990. The patient's current condition included high blood pressure, that has been well controlled for years as status post MI in 1990. The patient's concomitant medications included potassium, PLAVIX, hydrochlorothiazide, pantoprazole, losartan, levothyroxine, atorvastatin, Baby aspirin, AMBIEN, and Multiple vitamins. On 11-Oct-2017, the patient was administered with FLUAD (dose: 0.5 ml, anatomical location: left deltoid, batch number, expiry date, route of administration: intramuscular). On 12-Oct-2017, within 24 hours of vaccination, the patient had hacking cough. The patient also had a headache, congested sinus/nose and felt tired along with rosy cheeks which lasted for 2 days. It was reported that, the patient went to GI and the patient's BP (blood pressure) was found to be 167/97. At the time of this report, the patient was recovering from the events (cough, nasal congestion and hypertension). The causality of the event cough was related. The reporter assessed the events as non-serious. Follow-up report received on 31-Oct-2017: Outcome of the events (cough, hypertension and nasal congestion) were updated from not recovered to recovering. Amended narrative accordingly.