chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Immediate post-injection reaction, Injection site pain, Musculoskeletal pain
Clinical narrative: This non-serious initial spontaneous case was received from other non-health professional via health authority (VAERS Id: 686300) on 10-Jul-2017, concerning a 31-year-old adult female patient. The patient had no current illness and medical history. On 07-Mar-2017, the patient was administered with INN Flu Vaccine Seasonal "trade name, batch number, expiry date, manufacturer: not reported: (dose route of administration and anatomical location: not reported). Immediately after the vaccination the patient experienced pain in injection site which continued even after 2 weeks and reported that she had shoulder ache for 3 days prior to this report. The outcome of the events was not reported. Reporter's comment: The health authority assessed the events as non-serious.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Myalgia
Clinical narrative: This initial spontaneous case was received via health authority (VAERS ID: 688206) on 10-Jul-2017, concerns a adult female patient. The patient's historical conditions included pernicious anemia and Meniere's disease. The patient had anaphylaxis to an unspecified proton pump inhibitor and was allergic to amoxicillin and sulfur based drugs. The patient had no current illness. On 06-Mar-2017, the patient was administered with INN Flu Vaccine Seasonal (route of administration: intramuscular, anatomical location: left arm, dose, trade name, batch number and manufacture: not reported). On 09-Mar-2017, after 4 days of vaccination, the patient experienced flu like symptoms such as fever, fatigue, muscles aches and pains, headache, tiredness, blocked sinuses and chills. It was reported that, the patient had taken pain and congestion relief and went for sleep. As of 26-Mar-2017, chills, fever and headache were persisting. The outcome of the event was not reported. Reporter's comments: The health authority did not provide the causal relationship between event and influenza vaccine and considered this report as non-serious.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pyrexia, Sinus congestion
Clinical narrative: This initial spontaneous case was received via health authority (VAERS ID: 688206) on 10-Jul-2017, concerns a adult female patient. The patient's historical conditions included pernicious anemia and Meniere's disease. The patient had anaphylaxis to an unspecified proton pump inhibitor and was allergic to amoxicillin and sulfur based drugs. The patient had no current illness. On 06-Mar-2017, the patient was administered with INN Flu Vaccine Seasonal (route of administration: intramuscular, anatomical location: left arm, dose, trade name, batch number and manufacture: not reported). On 09-Mar-2017, after 4 days of vaccination, the patient experienced flu like symptoms such as fever, fatigue, muscles aches and pains, headache, tiredness, blocked sinuses and chills. It was reported that, the patient had taken pain and congestion relief and went for sleep. As of 26-Mar-2017, chills, fever and headache were persisting. The outcome of the event was not reported. Reporter's comments: The health authority did not provide the causal relationship between event and influenza vaccine and considered this report as non-serious.
Age: 66.0
Sex: M
Vaccine: DTAP, FLUX, HEPAB, TD, FLU3, HEPAB, TDAP, DTAP, FLUX, HEPAB, TD
Symptoms: Blood test, Erythema, Peripheral swelling, Pruritus, Skin burning sensation
Clinical narrative: This initial spontaneous case, was received on 10-Jul-2017 and reported by other non-health professional via health authority (VAERS: 688221) concerning a 66-year-old male elderly patient. The patient had no relevant medical history. On 14-Mar-2017, the patient was vaccinated with INN Flu Vaccine Seasonal (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacture name: not reported). On the same day, the patient was also vaccinated with Dtap, Hep A plus Hep B and tetanus Diphtheria (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacture name: not reported). On 15-Mar-2017, next day after the vaccination, the patient had lower left leg swollen up to twice than the normal size, he felt like harsh sunburn and turned to red on lower left leg. On an unspecified date, the patient went urgent care and underwent ultra-scan to check the blood clots and ran blood test and results of the test were not reported. The treatment drugs of the patient included antibiotics, clemdonmiacin (as reported) and KEFLEX and there was no change in the swelling. Moreover, the patient had hives (reported as broke out in hives) all over the body and felt itching crazily (report as itches like crazy). The outcome of the events was not recovered. Reporter's comment: The health authority assessed the report as not serious.
Age: 66.0
Sex: M
Vaccine: DTAP, FLUX, HEPAB, TD, FLU3, HEPAB, TDAP, DTAP, FLUX, HEPAB, TD
Symptoms: Ultrasound scan, Urticaria
Clinical narrative: This initial spontaneous case, was received on 10-Jul-2017 and reported by other non-health professional via health authority (VAERS: 688221) concerning a 66-year-old male elderly patient. The patient had no relevant medical history. On 14-Mar-2017, the patient was vaccinated with INN Flu Vaccine Seasonal (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacture name: not reported). On the same day, the patient was also vaccinated with Dtap, Hep A plus Hep B and tetanus Diphtheria (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacture name: not reported). On 15-Mar-2017, next day after the vaccination, the patient had lower left leg swollen up to twice than the normal size, he felt like harsh sunburn and turned to red on lower left leg. On an unspecified date, the patient went urgent care and underwent ultra-scan to check the blood clots and ran blood test and results of the test were not reported. The treatment drugs of the patient included antibiotics, clemdonmiacin (as reported) and KEFLEX and there was no change in the swelling. Moreover, the patient had hives (reported as broke out in hives) all over the body and felt itching crazily (report as itches like crazy). The outcome of the events was not recovered. Reporter's comment: The health authority assessed the report as not serious.
Age: 66.0
Sex: M
Vaccine: DTAP, FLUX, HEPAB, TD, FLU3, HEPAB, TDAP, DTAP, FLUX, HEPAB, TD
Symptoms: Blood test, Cellulitis, Myalgia, Ultrasound scan
Clinical narrative: This initial spontaneous case, was received on 10-Jul-2017 and reported by other non-health professional via health authority (VAERS: 688221) concerning a 66-year-old male elderly patient. The patient had no relevant medical history. On 14-Mar-2017, the patient was vaccinated with INN Flu Vaccine Seasonal (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacture name: not reported). On the same day, the patient was also vaccinated with Dtap, Hep A plus Hep B and tetanus Diphtheria (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacture name: not reported). On 15-Mar-2017, next day after the vaccination, the patient had lower left leg swollen up to twice than the normal size, he felt like harsh sunburn and turned to red on lower left leg. On an unspecified date, the patient went urgent care and underwent ultra-scan to check the blood clots and ran blood test and results of the test were not reported. The treatment drugs of the patient included antibiotics, clemdonmiacin (as reported) and KEFLEX and there was no change in the swelling. Moreover, the patient had hives (reported as broke out in hives) all over the body and felt itching crazily (report as itches like crazy). The outcome of the events was not recovered. Reporter's comment: The health authority assessed the report as not serious.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Musculoskeletal pain
Clinical narrative: This initial spontaneous case was received via health authority (VAERS Id: 688224) on 10-Jul-2017, concerning a female patient. The patient did not have any medical history. The patient's current condition included strep throat. On 10-Mar-2017, the patient was administered with INN Flu Vaccine Seasonal "trade name, batch number, manufacturer: not reported" (dose, route of administration and anatomical location: not reported). On the same day, the patient experienced severe pain in upper left shoulder. The outcome of the event was not recovered. Reporter's comment: The health authority did not provide the casual relationship between the event and suspect medicinal product (INN Flu Vaccine Seasonal) and considered the report as non-seriousness.
Age: 72.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Erythema, Induration, Malaise, Pain in extremity
Clinical narrative: This non-serious initial spontaneous case, was received from other non-health professional (consumer) via health authority (VAERS ID: 688269), concerning a 72-year-old female patient. The patient's current conditions included decreased blood sodium, kidney disorder, orthostatic hypotension, palpitations, chest aches and fatigue. On an unspecified date in 2016, the patient underwent CT (computed tomography (due to the palpitations and chest pain, which showed 70 percent of blockage in the LAD (left anterior descending) artery of heart and reported that there was a stent in that area (which was placed in 2014). After 29-Dec-2016, on an unspecified date the patient went to the electrophysiologist who advised her to "wear a monitor for thirty days" but lately the heart palpitations have been intense and she woke up in the morning. It was reported that the palpitations were for a period of several hours which occur about every two or three days and were not always intense. On an unspecified date in Jan-2017, the patient started to have lot of different symptoms and was not feeling well. On 10-Jan-2017, the patient started PRALUENT (batch number: 6F052A, expiry date: 30-Jun-2017) (75 mg. injection, every two weeks) for cholesterol issues and reported at the time of this report that recent injection of PRALUENT was taken on 08-Mar-2017. The patient stated that she has had a total of five injections at the time of this report, with the first injection given into the stomach and the rest of the injections given into the thigh. On 28-Feb-2017, the patient was administered with INN Flu Vaccine (route of administration: SYR (as reported), dose batch number, manufacturer, trade name, anatomical location and indication: not reported). On the same day, the patient was also administered with Pneumococcal vaccine (location: arm, dose, dose in series, batch number, manufacturer, and indication: not reported). On unspecified date, since vaccination, the patient felt sick and the arm with the pneumonia vaccine got so sore, red and round hard spot with sore continued. The patient was referred to her physician for consultation. Corrective treatment was not reported. The outcome of the events was not recovered. Reporter's comment: The health authority assessed the report as non-serious.
Age: 72.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Injection site erythema, Malaise, Vaccination site induration, Vaccination site pain
Clinical narrative: This non-serious initial spontaneous case, was received from other non-health professional (consumer) via health authority (VAERS ID: 688269), concerning a 72-year-old female patient. The patient's current conditions included decreased blood sodium, kidney disorder, orthostatic hypotension, palpitations, chest aches and fatigue. On an unspecified date in 2016, the patient underwent CT (computed tomography (due to the palpitations and chest pain, which showed 70 percent of blockage in the LAD (left anterior descending) artery of heart and reported that there was a stent in that area (which was placed in 2014). After 29-Dec-2016, on an unspecified date the patient went to the electrophysiologist who advised her to "wear a monitor for thirty days" but lately the heart palpitations have been intense and she woke up in the morning. It was reported that the palpitations were for a period of several hours which occur about every two or three days and were not always intense. On an unspecified date in Jan-2017, the patient started to have lot of different symptoms and was not feeling well. On 10-Jan-2017, the patient started PRALUENT (batch number: 6F052A, expiry date: 30-Jun-2017) (75 mg. injection, every two weeks) for cholesterol issues and reported at the time of this report that recent injection of PRALUENT was taken on 08-Mar-2017. The patient stated that she has had a total of five injections at the time of this report, with the first injection given into the stomach and the rest of the injections given into the thigh. On 28-Feb-2017, the patient was administered with INN Flu Vaccine (route of administration: SYR (as reported), dose batch number, manufacturer, trade name, anatomical location and indication: not reported). On the same day, the patient was also administered with Pneumococcal vaccine (location: arm, dose, dose in series, batch number, manufacturer, and indication: not reported). On unspecified date, since vaccination, the patient felt sick and the arm with the pneumonia vaccine got so sore, red and round hard spot with sore continued. The patient was referred to her physician for consultation. Corrective treatment was not reported. The outcome of the events was not recovered. Reporter's comment: The health authority assessed the report as non-serious.
Sex: M
Vaccine: FLUA3, FLUA3
Symptoms: Injection site pain
Clinical narrative: This initial spontaneous case, was received on 15-Jun-2017, which was reported by other non-health professional via regulatory authority (VAERS ID: 689031) and concerning a 75-year-old male patient. The patient's historical condition included diabetes. On 11-Feb-2017, the patient was administered with FLUAD (dose: 05 ml, route of administration: intramuscular, anatomical location: right arm, batch number: 166001, expiry date: not reported). On 12-Feb-2017, one day after vaccination, the patient experienced sore and ache in arm at the site of injection only. It was reported that, the soreness was not severe like before, but it was persisting as of 31-Mar-2017. The reporter did not provide the causal relationship between the event and vaccine (FLUAD). This report was non-serious.
Age: 28.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Back pain
Clinical narrative: This initial spontaneous case, was received via health authority (VAERS ID: 689033) on 10-Jul-2017, concerning a 28-year-old adult female patient. The patient had no medical history and current illness. The patient's concomitant medications included ZOLOFT for unknown indication. On 29-Mar-2017, the patient was administered with INN Flu Vaccine (route of administration: intramuscular, anatomical location: left arm, batch number, expiry date and indication: not reported). On the same day, after receiving the flu vaccination, patient developed sharp pain in her upper back next to the left shoulder blade and within another half hour it extended to her left lower back. The outcome of the event was not recovered. Reporter's comments: Health authority assessed the report as non-serious. Significant case correction received on 26-Jul-2017: Listedness of the event back pain was corrected.
Age: 27.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injected limb mobility decreased, Injection site reaction, Joint crepitation, Musculoskeletal pain, Nuclear magnetic resonance imaging
Clinical narrative: This non-serious initial spontaneous case, was received from other non-health professional via health authority (VAERS ID: 689146) on 10-Jul-2017, concerning a 27-year-old female patient. The historical conditions of the patient included hyperthyroidism and hypercholesterolemia and the concomitant medications included Atorvastatin and Methimazole. On 04-Oct-2016, the patient was administered with influenza virus vaccine polyvalent, anatomical location: left arm, dose, route of administration, batch number, expiry date, trade name, manufacturer: not reported). On the same day, the patient experienced, limited range of motion in the left shoulder and pain on exertion especially when abducting or pushing down. The patient stated that the pain in the shoulder woke her up at night and audible sounds were heard upon use of left shoulder. On an unspecified date, X-ray and MRI (magnetic resonance imaging) were performed but results were not provided. The health authority preferred term included injection site reaction. The outcome of the events was not recovered. Reporter's comment: The health authority assesses the report as non-serious.
Age: 27.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pain, Sleep disorder, X-ray
Clinical narrative: This non-serious initial spontaneous case, was received from other non-health professional via health authority (VAERS ID: 689146) on 10-Jul-2017, concerning a 27-year-old female patient. The historical conditions of the patient included hyperthyroidism and hypercholesterolemia and the concomitant medications included Atorvastatin and Methimazole. On 04-Oct-2016, the patient was administered with influenza virus vaccine polyvalent, anatomical location: left arm, dose, route of administration, batch number, expiry date, trade name, manufacturer: not reported). On the same day, the patient experienced, limited range of motion in the left shoulder and pain on exertion especially when abducting or pushing down. The patient stated that the pain in the shoulder woke her up at night and audible sounds were heard upon use of left shoulder. On an unspecified date, X-ray and MRI (magnetic resonance imaging) were performed but results were not provided. The health authority preferred term included injection site reaction. The outcome of the events was not recovered. Reporter's comment: The health authority assesses the report as non-serious.
Age: 27.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site joint movement impairment, Injection site pain, Joint crepitation, Middle insomnia, Nuclear magnetic resonance imaging
Clinical narrative: This non-serious initial spontaneous case, was received from other non-health professional via health authority (VAERS ID: 689146) on 10-Jul-2017, concerning a 27-year-old female patient. The historical conditions of the patient included hyperthyroidism and hypercholesterolemia and the concomitant medications included Atorvastatin and Methimazole. On 04-Oct-2016, the patient was administered with influenza virus vaccine polyvalent, anatomical location: left arm, dose, route of administration, batch number, expiry date, trade name, manufacturer: not reported). On the same day, the patient experienced, limited range of motion in the left shoulder and pain on exertion especially when abducting or pushing down. The patient stated that the pain in the shoulder woke her up at night and audible sounds were heard upon use of left shoulder. On an unspecified date, X-ray and MRI (magnetic resonance imaging) were performed but results were not provided. The health authority preferred term included injection site reaction. The outcome of the events was not recovered. Reporter's comment: The health authority assesses the report as non-serious.
Age: 27.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pain, X-ray
Clinical narrative: This non-serious initial spontaneous case, was received from other non-health professional via health authority (VAERS ID: 689146) on 10-Jul-2017, concerning a 27-year-old female patient. The historical conditions of the patient included hyperthyroidism and hypercholesterolemia and the concomitant medications included Atorvastatin and Methimazole. On 04-Oct-2016, the patient was administered with influenza virus vaccine polyvalent, anatomical location: left arm, dose, route of administration, batch number, expiry date, trade name, manufacturer: not reported). On the same day, the patient experienced, limited range of motion in the left shoulder and pain on exertion especially when abducting or pushing down. The patient stated that the pain in the shoulder woke her up at night and audible sounds were heard upon use of left shoulder. On an unspecified date, X-ray and MRI (magnetic resonance imaging) were performed but results were not provided. The health authority preferred term included injection site reaction. The outcome of the events was not recovered. Reporter's comment: The health authority assesses the report as non-serious.
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Blood pressure increased, Heart rate increased
Clinical narrative: This initial spontaneous case was received from other non-health care professional via health authority (VAERS Id: 689216) on 10-Jul-2017, concerning a 39-year-old adult female patient. The patient's medical history included allergies, asthma, thyroid disease and lung disease. The patient did not have blood pressure problems. The patient had no current illness. On 13-Feb-2017, the patient was administered with INN Flu Vaccine Seasonal "trade name, batch number and manufacturer: not reported: (anatomical location: right arm, route of administration: unknown, dose expiry date, and indication: not reported). On 13-Feb-2017, the patient was also administered with Pneumococcal vaccine (anatomical location: left arm, dose, batch number, expiry date, manufacturer, trade name, route of administration and indication: not reported). On the same day, within an hour, the patient experienced rapid heartbeat and elevated blood pressure. The patient's blood pressure was monitored and found 155/95 mmHg. It was reported that, the events were lasted about 8 hours afterwards. The outcome of the events was recovered. Reporter's comment: The health authority considered the case as non-serious and did not provided the causal relationship between the events and suspect medical product (INN Flu Vaccine Seasonal).
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pain in extremity
Clinical narrative: This initial spontaneous case was received via health authority (VAERS Id: 689222) on 10-Jul-2017, concerning a female patient. The patient's history condition included high blood pressure. The patient's current illness was reported as none. On 04-Oct-2016, the patient was administered with INN Flu Vaccine Seasonal "trade name, batch number, manufacturer: not reported" (dose: not reported, route of administration and anatomical location: unknown). On the same day, the patient experienced continuous, chronic pain in right arm since injection. The patient's lab data was not reported. The outcome of the event was not reported. Reporter's comment: The health authority did not provided the causal relationship between the event and suspect medicinal product (INN Flu Vaccine Seasonal) and assessed the events as non-seriousness.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Cough, Headache, Influenza virus test positive, Pain, Pyrexia
Clinical narrative: This serious initial spontaneous case was received on 10-Jul-2017 from other non-healthcare professional via health authority (VAERS: 689233) concerning an 18-year-old male adult patient. The patient's historical condition included allergy to Cefdinir and LACTAID. The patient had no current illness. On 10-Oct-2016, the patient was vaccinated with the INN Flu Vaccine Seasonal "trade name, manufacture name, batch number: not reported" (route of administration: intramuscular, dose: 16 (as reported), anatomical location: unknown). On 27-Mar-2017, after 5 months 12 days of vaccination (162) days, the patient experienced fever with 103, body aches, headache, cough and had rapid flu swab test which revealed positive for flu (explicitly coded: vaccination failure). The outcome of the events was reported as recovered. Reporter's comment: The health authority assessed the report as non-serious.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Cough, Headache, Influenza, Influenza virus test positive, Pain
Clinical narrative: This serious initial spontaneous case was received on 10-Jul-2017 from other non-healthcare professional via health authority (VAERS: 689233) concerning an 18-year-old male adult patient. The patient's historical condition included allergy to Cefdinir and LACTAID. The patient had no current illness. On 10-Oct-2016, the patient was vaccinated with the INN Flu Vaccine Seasonal "trade name, manufacture name, batch number: not reported" (route of administration: intramuscular, dose: 16 (as reported), anatomical location: unknown). On 27-Mar-2017, after 5 months 12 days of vaccination (162) days, the patient experienced fever with 103, body aches, headache, cough and had rapid flu swab test which revealed positive for flu (explicitly coded: vaccination failure). The outcome of the events was reported as recovered. Reporter's comment: The health authority assessed the report as non-serious.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Pyrexia, Vaccination failure
Clinical narrative: This serious initial spontaneous case was received on 10-Jul-2017 from other non-healthcare professional via health authority (VAERS: 689233) concerning an 18-year-old male adult patient. The patient's historical condition included allergy to Cefdinir and LACTAID. The patient had no current illness. On 10-Oct-2016, the patient was vaccinated with the INN Flu Vaccine Seasonal "trade name, manufacture name, batch number: not reported" (route of administration: intramuscular, dose: 16 (as reported), anatomical location: unknown). On 27-Mar-2017, after 5 months 12 days of vaccination (162) days, the patient experienced fever with 103, body aches, headache, cough and had rapid flu swab test which revealed positive for flu (explicitly coded: vaccination failure). The outcome of the events was reported as recovered. Reporter's comment: The health authority assessed the report as non-serious.
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Allergy to vaccine
Clinical narrative: This non-serious initial spontaneous case was received from nurse via health authority (VAERS ID: 689252) on 10-Jul-2017, concerning a 63-year-old adult female patient. The patient was allergic to adhesive tape (dermatitis contact). On an unspecified date, the patient was administered with INN Flu Vaccine Seasonal (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported) and a non-company suspect product, pneumococcal 13 valent conjugate vaccine, diphtheria crm197 protein (dose, route of administration, anatomical location, batch number, expiry date, not reported). On an unspecified date, the subject experienced allergies to "pneumonia vaccines and influenza vaccines". The outcome of the event was not reported. Reporter's comments: The health authority assessed the report as non-serious.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU(H1N1), FLUX, IPV, MMR, VARCEL, DTAP, FLU(H1N1), FLUX, IPV, MMR, VARCEL
Symptoms: Herpes zoster, Nausea, Pyrexia, Rash
Clinical narrative: This initial spontaneous case, was received on 10-Jul-2017, via health authority (VAERS ID: 689293) reported by other non-health professional concerns a 4-year-old female patient. Patient's medical history was not reported. On 19-Feb-2010, the patient was administered with INN Flu Vaccine (dose: 2 (as reported), route of administration, anatomical location, batch number, trade name, manufacturer, indication was not reported). On the same day, the patient was administered with non-company suspect product, DTAP (dose: 4), M-M-R vaccine (dose: 1), polio vaccine (dose: 3), Varicella vaccine (dose: 1) and Influenza A (H1N1) vaccine (batch: UP144AA), (route of administration, anatomical location, batch number, trade name, indication not reported). On 26-Aug-2016, the patient, administered with 2-dose varicella vaccine including other vaccines had painful unilateral rash (which lasted for less than 4 weeks), nausea and fever, which was diagnosed as herpes zoster. No antiviral treatment was given. Outcome of the event herpes zoster was recovered. The health authority assessed this report as non-serious.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Accidental exposure to product, No adverse event
Clinical narrative: Case number PHEH2016US032834, is a non-serious initial spontaneous report received from a pharmacist on 05 Dec 2016. This report refers to a male patient of unknown age. The patient did not have any illness or medical history and concomitant medications were not reported. The patient was vaccinated with influenza vaccine INN (unknown whether seasonal or pandemic, manufacturer unknown, batch number: not reported) on an unknown date. The pharmacist stated that, the vaccine squirted on the husband of a female, sitting beside her and ran down her arm. No adverse event was reported following this administration error (inadvertent exposure to vaccine). Follow up received from Health Authority (VAERS ID: 689318) New event (no adverse event) was added. The narrative was amended accordingly.
Sex: F
Vaccine: DTAP, FLUX, HIBV, MMR, VARCEL, DTAP, FLUX, HIBV, MMR, VARCEL
Symptoms: Blister, Contusion, Haemoglobin increased, Injection site bruising, Injection site swelling
Clinical narrative: This initial non-serious spontaneous case was received on 10-Jul-2017 from other non-health professional via health authority (VAERS ID: 689384) and concerns a 15-month-old female infant. The patient had no medical history and current illness, but had developed fever and hives during previous influenza (seasonal), HIB and pneumococcal vaccine vaccination. On 03-Feb-2017, the patient was administered with INN Flu Vaccine Seasonal (trade name, manufacturer, dose: 1 (as reported), route of administration: intramuscular, anatomical location: leg, batch number, expiry date: not reported. On the same day, the patient was administered with DTAP (dose: 3 (as reported), route of administration: intramuscular, anatomical location: leg, batch number, expiry date: not reported) for an unknown leg, batch number, expiry date: not reported), Measles-mumps-rubella virus vaccine (dose: 0 (as reported), route of administration: intramuscular, anatomical location: leg, batch number, expiry date: not reported) and Varicella zoster vaccine (dose: 0 (as reported), route of administration: intramuscular, anatomical location: leg, batch number, expiry date: not reported). On Feb-2017, after 8 days of vaccination, the patient developed hives on face, back, legs and arms. The patient had fever of temperature 102 Fahrenheit, intense itching and swelling of face. The patient was treated with OTC medications, BENADRYL and TYLENOL. The patient had to visit emergency room as the reaction worsened causing fluid filled blisters, mottling and bruising/swelling on legs and arms where she was prescribed with oral steroids. The lab test, CBC performed on 14-Feb-2017 showed slightly elevated haemoglobin. The patient recovered from the events approximately 8 days later. Reporter's comment: Health authority assessed the case as non-serious.
Sex: F
Vaccine: DTAP, FLUX, HIBV, MMR, VARCEL, DTAP, FLUX, HIBV, MMR, VARCEL
Symptoms: Peripheral swelling, Pruritus, Pyrexia, Skin discolouration, Swelling face
Clinical narrative: This initial non-serious spontaneous case was received on 10-Jul-2017 from other non-health professional via health authority (VAERS ID: 689384) and concerns a 15-month-old female infant. The patient had no medical history and current illness, but had developed fever and hives during previous influenza (seasonal), HIB and pneumococcal vaccine vaccination. On 03-Feb-2017, the patient was administered with INN Flu Vaccine Seasonal (trade name, manufacturer, dose: 1 (as reported), route of administration: intramuscular, anatomical location: leg, batch number, expiry date: not reported. On the same day, the patient was administered with DTAP (dose: 3 (as reported), route of administration: intramuscular, anatomical location: leg, batch number, expiry date: not reported) for an unknown leg, batch number, expiry date: not reported), Measles-mumps-rubella virus vaccine (dose: 0 (as reported), route of administration: intramuscular, anatomical location: leg, batch number, expiry date: not reported) and Varicella zoster vaccine (dose: 0 (as reported), route of administration: intramuscular, anatomical location: leg, batch number, expiry date: not reported). On Feb-2017, after 8 days of vaccination, the patient developed hives on face, back, legs and arms. The patient had fever of temperature 102 Fahrenheit, intense itching and swelling of face. The patient was treated with OTC medications, BENADRYL and TYLENOL. The patient had to visit emergency room as the reaction worsened causing fluid filled blisters, mottling and bruising/swelling on legs and arms where she was prescribed with oral steroids. The lab test, CBC performed on 14-Feb-2017 showed slightly elevated haemoglobin. The patient recovered from the events approximately 8 days later. Reporter's comment: Health authority assessed the case as non-serious.
Sex: F
Vaccine: DTAP, FLUX, HIBV, MMR, VARCEL, DTAP, FLUX, HIBV, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: This initial non-serious spontaneous case was received on 10-Jul-2017 from other non-health professional via health authority (VAERS ID: 689384) and concerns a 15-month-old female infant. The patient had no medical history and current illness, but had developed fever and hives during previous influenza (seasonal), HIB and pneumococcal vaccine vaccination. On 03-Feb-2017, the patient was administered with INN Flu Vaccine Seasonal (trade name, manufacturer, dose: 1 (as reported), route of administration: intramuscular, anatomical location: leg, batch number, expiry date: not reported. On the same day, the patient was administered with DTAP (dose: 3 (as reported), route of administration: intramuscular, anatomical location: leg, batch number, expiry date: not reported) for an unknown leg, batch number, expiry date: not reported), Measles-mumps-rubella virus vaccine (dose: 0 (as reported), route of administration: intramuscular, anatomical location: leg, batch number, expiry date: not reported) and Varicella zoster vaccine (dose: 0 (as reported), route of administration: intramuscular, anatomical location: leg, batch number, expiry date: not reported). On Feb-2017, after 8 days of vaccination, the patient developed hives on face, back, legs and arms. The patient had fever of temperature 102 Fahrenheit, intense itching and swelling of face. The patient was treated with OTC medications, BENADRYL and TYLENOL. The patient had to visit emergency room as the reaction worsened causing fluid filled blisters, mottling and bruising/swelling on legs and arms where she was prescribed with oral steroids. The lab test, CBC performed on 14-Feb-2017 showed slightly elevated haemoglobin. The patient recovered from the events approximately 8 days later. Reporter's comment: Health authority assessed the case as non-serious.
Sex: F
Vaccine: DTAP, FLUX, HIBV, MMR, VARCEL, DTAP, FLUX, HIBV, MMR, VARCEL
Symptoms: Blister, Contusion, Full blood count, Haemoglobin increased, Livedo reticularis
Clinical narrative: This initial non-serious spontaneous case was received on 10-Jul-2017 from other non-health professional via health authority (VAERS ID: 689384) and concerns a 15-month-old female infant. The patient had no medical history and current illness, but had developed fever and hives during previous influenza (seasonal), HIB and pneumococcal vaccine vaccination. On 03-Feb-2017, the patient was administered with INN Flu Vaccine Seasonal (trade name, manufacturer, dose: 1 (as reported), route of administration: intramuscular, anatomical location: leg, batch number, expiry date: not reported. On the same day, the patient was administered with DTAP (dose: 3 (as reported), route of administration: intramuscular, anatomical location: leg, batch number, expiry date: not reported) for an unknown leg, batch number, expiry date: not reported), Measles-mumps-rubella virus vaccine (dose: 0 (as reported), route of administration: intramuscular, anatomical location: leg, batch number, expiry date: not reported) and Varicella zoster vaccine (dose: 0 (as reported), route of administration: intramuscular, anatomical location: leg, batch number, expiry date: not reported). On Feb-2017, after 8 days of vaccination, the patient developed hives on face, back, legs and arms. The patient had fever of temperature 102 Fahrenheit, intense itching and swelling of face. The patient was treated with OTC medications, BENADRYL and TYLENOL. The patient had to visit emergency room as the reaction worsened causing fluid filled blisters, mottling and bruising/swelling on legs and arms where she was prescribed with oral steroids. The lab test, CBC performed on 14-Feb-2017 showed slightly elevated haemoglobin. The patient recovered from the events approximately 8 days later. Reporter's comment: Health authority assessed the case as non-serious.
Sex: F
Vaccine: DTAP, FLUX, HIBV, MMR, VARCEL, DTAP, FLUX, HIBV, MMR, VARCEL
Symptoms: Peripheral swelling, Pruritus, Pyrexia, Swelling face, Urticaria
Clinical narrative: This initial non-serious spontaneous case was received on 10-Jul-2017 from other non-health professional via health authority (VAERS ID: 689384) and concerns a 15-month-old female infant. The patient had no medical history and current illness, but had developed fever and hives during previous influenza (seasonal), HIB and pneumococcal vaccine vaccination. On 03-Feb-2017, the patient was administered with INN Flu Vaccine Seasonal (trade name, manufacturer, dose: 1 (as reported), route of administration: intramuscular, anatomical location: leg, batch number, expiry date: not reported. On the same day, the patient was administered with DTAP (dose: 3 (as reported), route of administration: intramuscular, anatomical location: leg, batch number, expiry date: not reported) for an unknown leg, batch number, expiry date: not reported), Measles-mumps-rubella virus vaccine (dose: 0 (as reported), route of administration: intramuscular, anatomical location: leg, batch number, expiry date: not reported) and Varicella zoster vaccine (dose: 0 (as reported), route of administration: intramuscular, anatomical location: leg, batch number, expiry date: not reported). On Feb-2017, after 8 days of vaccination, the patient developed hives on face, back, legs and arms. The patient had fever of temperature 102 Fahrenheit, intense itching and swelling of face. The patient was treated with OTC medications, BENADRYL and TYLENOL. The patient had to visit emergency room as the reaction worsened causing fluid filled blisters, mottling and bruising/swelling on legs and arms where she was prescribed with oral steroids. The lab test, CBC performed on 14-Feb-2017 showed slightly elevated haemoglobin. The patient recovered from the events approximately 8 days later. Reporter's comment: Health authority assessed the case as non-serious.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Electrocardiogram abnormal, Erythema, Headache, Hyperhidrosis, Local reaction
Clinical narrative: This initial spontaneous case, was received from an other health professional (nurse) via health authority (VAERS ID: 689627) on 10-Jul-2017, concerning a female patient of unspecified age. The patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions and illness at the time of vaccination were not reported. Other vaccinations administered within four weeks of suspect product vaccination was not reported. On an unspecified date (reporter as 10 years ago), the patient was administered with influenza virus vaccine polyvalent, dose, route of administration and anatomical location, trade name, batch number, manufacturer: not reported). On an unspecified date (reported as 10 years ago), after the administration of vaccine the patient experienced a large local red reaction, headache and sweating. The patient visited emergency room with systolic BP (blood pressure) in 80s and ECG (Electrocardiogram) showed PVCs (premature ventricular contractions) on a rhythm strip. Laboratory investigations and corrective treatment was not reported. The outcome of the events was not reported. Reporter's comment: The health authority did not provide the causal relationship between the events and suspect product (INN Flu Vaccine Seasonal) and considered the report as non-seriousness.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Ventricular extrasystoles
Clinical narrative: This initial spontaneous case, was received from an other health professional (nurse) via health authority (VAERS ID: 689627) on 10-Jul-2017, concerning a female patient of unspecified age. The patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions and illness at the time of vaccination were not reported. Other vaccinations administered within four weeks of suspect product vaccination was not reported. On an unspecified date (reporter as 10 years ago), the patient was administered with influenza virus vaccine polyvalent, dose, route of administration and anatomical location, trade name, batch number, manufacturer: not reported). On an unspecified date (reported as 10 years ago), after the administration of vaccine the patient experienced a large local red reaction, headache and sweating. The patient visited emergency room with systolic BP (blood pressure) in 80s and ECG (Electrocardiogram) showed PVCs (premature ventricular contractions) on a rhythm strip. Laboratory investigations and corrective treatment was not reported. The outcome of the events was not reported. Reporter's comment: The health authority did not provide the causal relationship between the events and suspect product (INN Flu Vaccine Seasonal) and considered the report as non-seriousness.
Age: 34.0
Sex: F
Vaccine: FLUX, MUR, FLUX, MU, RUB
Symptoms: Chest pain, Dizziness, Fatigue, Respiratory rate increased
Clinical narrative: This initial spontaneous case, was received on 10-Jul-2017 was reported via health authority (VAERS: 689893) concerning a 34-year-old female adult patient. The patient's medical history was not reported. On 27-Mar-2017, the patient was vaccinated with the influenza virus vaccine polyvalent (route of administration: intramuscular, anatomical location: right arm, dose, batch number, expiry date, trade name, manufacture name: not reported). On the same day, the patient was also administered with mumps vaccine, rubella vaccine (route of administration: intramuscular, anatomical location: right arm, dose, batch number, expiry date, trade name, manufacture name: not reported). On the same day, after vaccination, the patient experienced chest pain, tiredness, fast breathing and sometimes the patient felt like she was about to faint. The outcome of the events was not reported. Reporter's comment: The reporter assessed the report as not serious. Significant case correction received on 19-Jul-2017: Listedness for all the events was corrected from unlisted to listed.
Age: 87.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Musculoskeletal pain, Myalgia, Neck pain, Rash
Clinical narrative: This initial spontaneous case was received other non-health professional via health authority (VAERS ID: 689996) on 10-Jul-2017 and concerning an 88-year-old female patient. Patient's medical history included Influenza seasonal vaccine and concomitant medications were not reported. On 01-Oct-2016, at 09:00 hrs, the patient was INN Flu Vaccine Seasonal (trade name, manufacture, dose, route of administration, anatomical location, batch number, expiry date: not reported). On an unspecified date, following the vaccination the patient experienced muscle pain, rash, neck pain and shoulder pain, which required emergency room visit by her family doctor. Lab test and corrective treatment was not reported. The patient recovered from the events on an unspecified date (duration reported as 2 months). Reporter's comment: Health authority assessed the events as non-serious.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Allergy to vaccine
Clinical narrative: This non-serious initial spontaneous case was received on 10-Jul-2017, from other non-health professional via health authority (VAERS ID: 690122), concerning 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 (route of administration: SYR (as reported), dose, trade name, anatomical location, manufacturer, batch number, expiry date and indication: not reported). On an unspecified date, after administration of INN Flu Vaccine Seasonal, the patient developed an allergy to flu shot. Lab data and corrective treatment were not reported. The outcome of the events was not reported. Reporter's comment: The health authority assessed this case as non-serious.
Sex: F
Vaccine: FLUX, MMR, PNC13, VARCEL, FLUX, MMR, PNC13, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This initial spontaneous case received on 09-Aug-2017, via regulatory authority (VAERS ID: 690460) from other non-healthcare professional, concerning a 1-year-old female patient. The patient medical history and concurrent conditions were not reported. On 23 Jan-2017, at 11:20 hours, the patient had received INN Flu Vaccine Seasonal (anatomical location: right lateral thigh, dose, route of administration, batch number, expiry date, trade name, manufacturer: not reported). On the same day, at the same time, the patient also had received VARIVAX (anatomical location: right lateral thigh, batch number: M004662, manufacturer: Merck & Co. Inc., dose, route of administration, expiry date: not reported, the patient also had received MMR II (anatomical location: left lateral thigh, batch number: M007464, manufacturer: Merck & Co. Inc., dose, route of administration, expiry date: not reported) and PREVENAR 13 (anatomical location: left lateral thigh, batch number: M60994, manufacturer: Pfizer\Wyeth, dose, route of administration, expiry date: not reported). It was reported that, the patient was administered with extra dose of VARIVAX. The patient's parents verified that the patient did not show any adverse reactions. The outcome of the events was not reported. The health authority assessed the case as non-serious.
Age: 54.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Pain, Peripheral swelling, Pyrexia, Rash
Clinical narrative: This initial spontaneous case, was received from an-other non-health professional via health authority (VAERS 690805) on 10-Jul-2017, concerning a 54-year-old female patient. On 03-Mar-2017, the patient was administered with INN (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported) for an unknown indication. On the same day patient also received Pneumococcal vaccine polyvalent (dose, route of administration, anatomical location, batch number, expiry date, not reported) for an unknown indication. On 04-Mar-2017, after two days of vaccine administration, the patient developed fever, swollen arm, rash and pain. The recovered from the events on an unspecified date. Reporter's comment: Health authority assessed the case as non -serious.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site mass, Injection site pain
Clinical narrative: This non-serious initial spontaneous case was received from other non-health professional via health authority (VAERS ID: 690830) on 10-Jul-2017, concerning a 49-year-old adult female patient. The patient had no current illness and medical history. On 14-Jan-2017, the patient was administered with INN Flu Vaccine Seasonal (anatomical location: left arm, dose, route of administration, trade name, batch number, manufacturer: not reported). On the same day, the patient developed soreness at injection site in the left upper arm. It was reported that, still 17-Apr-2017 soreness existed with lump. The outcome of the events was not recovered. Reporter's comment: The health authority assessed the events as non-serious.