chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: FLUX
Symptoms: Influenza like illness, Injected limb mobility decreased, Injection site pain, Malaise
Clinical narrative: Case number PHJHY2015US139418, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 585396) website on 20 OCT 2015. This report refers to a 22 years old female patient. Historical condition and medications at time of vaccination were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly into the left arm on 31 JAN 2015. On the same day, the patient experienced extreme soreness in upper deltoid of left arm where the influenza vaccine was administered and she was unable to lift arm above plane of shoulder. On the following day (01 FEB 2015), the patient became very sick with severe flu like symptoms. It was also reported that events (unspecified) were resolved by the second day of post vaccination. Outcome of the events was reported as complete recovery. Events were reported as non-serious. The causality of the events was not reported.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Eyelid function disorder, Guillain-Barre syndrome, Immunoglobulin therapy, Paraesthesia, Reflexes abnormal
Clinical narrative: Initial unsolicited report received from a physician on 12 July 2015 and 14 July 2015. An 11-year-old male patient, whose medical history and concomitant medications were not reported, had received a dose of MENACTRA and a dose of ADACEL (batch number, route of administration, site of administration were not reported for both the vaccines) on an unspecified date. On an unspecified date after vaccination, the patient had a reaction and hospitalized within 48 hours. The patient was diagnosed with GBS (Guillain-Barre syndrome). Laboratory investigations and corrective treatments were not reported. At the time of this report; the patient was not recovered from the event. Follow up report received from a physician on 10 August 2015. The patient received MENACTRA and ADACEL on 8 July 2015. There was no illness at the time of vaccination and preexisting physician diagnosed allergies, birth defects, medical condition. Any other vaccination within four week prior to 8 July 2015 was reported as none. It was also reported that the patient did not receive any other medication. On 10 July 2015, two days after vaccinations, the patient experienced Guillain-Barre syndrome. The patient required emergency room/physician visit. The patient was hospitalized for unknown number of days. It was reported that the patient was still in inpatient rehabilitation. Follow up information received from a consumer on 1 October 2015. Patient's demographic details were updated (weight: 37 kg or 82 pound) and reported that on 13 July 2015. Vaccination site of MENACTRA and ADACEL vaccine's were reported as left arm. It was reported that the patient was on LYRICA. On 08 July 2015, within 24 hours of receiving the vaccine the patient's feet and hands started tingling and left eye was closing on him. The patient was hospitalized for 5 weeks from 10 July 2015 to 14 August 2015. On 13 July 2015 Guillain Barre syndrome diagnosis confirmed. Patient received IVIG as corrective treatment on 11 July 2015. It was reported that the patient still had problems and physician said it will take a year or more for the patient to be better. Follow-up information received from a physician on 2 November 2015. It was reported that the patient still had poor reflexes. The patient was still receiving physical therapy and was gradually improving and had returned to school. Documents held by sender: none. Follow-up information received from a physician on 30 November 2015. The patient was "off blood pressure medicine" and was continuing to improve gradually. Follow up information received from a physician on 21 December 2015. It was reported that patient showed continuing gradual improvement. No other information was reported.
Sex: U
Vaccine: FLUX, VARZOS
Symptoms: Pruritus
Clinical narrative: Case number PHHY2015US142515, is an initial spontaneous report from a pharmacist via Vaccine Adverse Event Reporting System (VAERS reference number: 586528) received on 23 OCT 2015. This report refers to patient of unknown demographics. Current conditions (not further details provided). The patient was on no other medications. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) and ZOSTAVAX (batch number: not reported) on an unknown date. On an unknown date after vaccination, the patient experienced pruritus that lasted between 2 and 3 months. The outcome of the event was recovered. The event was reported as  non-serious and causality was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Case number PHHY2015US151848, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 587384) website on 23 OCT 2015. The report refers to a female patient of unknown age. Past medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza virus vaccine (manufacturer unknown, batch number: not reported) on an unknown date. After vaccination the patient experienced hives. Outcome of the events was reported as unknown. Event was reported as non serous and causality was not reported.
Sex: U
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: Case number PHHY2015US148029, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 587386) website on 23 OCT 2015. This report refers to patient of unknown age and gender. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with a seasonal influenza vaccine (manufacturer and batch number was not reported) on an unknown date. The patient experienced fever. The outcome, seriousness and causality of the event was not reported.
Age: 62.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Case number PHHY2015US149498, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 587394) web site on 23 Oct 2015. This report refers to a 62-year-old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: not reported) route unknown and ZOSTAVAX (other manufacturer) subcutaneously at a dose of 0.65 ml both vaccine in left arm in October 2014. On an unknown date in 2014, the patient experienced swelling, itching and redness at the injection site. There was no rash. The swelling at the injection site somewhat had decreased. The patient's husband contacted their health care provider who advised them to keep monitoring these events. Outcome of the events were reported as not recovered. Seriousness and causality was not reported.
Sex: U
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Case number PHHY2015US148065, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 587400) website on 23 Oct 2015. This report refers to patient of unknown age and gender. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with a seasonal influenza vaccine (manufacturer and batch number not reported) on an unknown date (many years ago). The patient experienced developed hives after vaccination. The outcome of the event was complete recovery on an unknown date. Seriousness and causality of the event was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Case number PHHY2014US149661, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 587408) website on 23 Oct 2015. This report refers to a female patient of an unknown age (age reported as 71, unit not given). Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: not reported). On an unknown date, the patient experienced high temperatures, chills, fatigue, severe achiness especially in the joints, and all over generalized body pain. The outcome of the events were unknown and seriousness was reported as non-serious and causality was not reported.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Malaise
Clinical narrative: Case number PHHY2015US150831, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 587570) website on 23 Oct 2015. This report refers to a 56 years old female patient. Historical condition was not reported. Current conditions included drug allergy (female patient who had allergies to lovastatin, methylprednisolone, ciprofloxacin, lisinopril, sumatriptan, acetaminophen/codeine, alprazolam, mitoxantrone, trimethoprim/sulfamethoxazole, acetaminophen/oxycodone, interferon beta-1b, interferon beta-1a, glatiramer acetate) and band aids allergy (Band Aids and Tegaderm dressings). Historical medication included PRIVIGEN infusion (immunoglobulin human normal, batch numbers 4323300111 and 4364600037) three days before her influenza vaccine. This polymedicated patient was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date. On an unspecified date, the patient had been sick ever since the flu shot. She also reported being tired. The outcome was unknown. The reporter the case as non-serious and the causality as not assessable.
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Case number PHHY2015US148002, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 587582) website on 23 Oct 2015. This report refers to a female patient of an unknown age. Past medical history and concomitant medications were not reported. The patient was vaccinated with influenza virus vaccine seasonal (manufacturer unknown, batch number: not reported) on an unknown date (6 years ago). After vaccination, the patient experienced hives. Outcome of the event was reported as not reported. Seriousness of the event was reported as non serious and causality was not reported.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Body temperature increased, Fatigue, Influenza like illness, Pain
Clinical narrative: Case number PHHY2015US148196, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 587621) website on 23 Oct 2015. This report refers to a female patient of an unknown age. Medical history included colitis. The patient was allergic to amoxicillin, sulfa, metronidazole, infliximab and azathioprine. Current condition included suppressed immune system. Concomitant medication was not reported. The patient was vaccination history included, administration of flu shot in 2008 and was not tolerated (refer to 2014045212). The patient was vaccinated with influenza virus vaccine seasonal INN (manufacturer unknown, batch number: not reported) in the opposite arm and PNEUMOVAX 23 (batch number: J007059) on an unknown date in 2013. On the second day after vaccination, the patient experienced body aches, 103 degree temperature, fatigue and general flu like symptoms that lasted for about a day. The patient arm was sore for two days. Outcome of the events was reported as recovered. Seriousness of the events was reported as non serious and causality was not reported. The reporter stated that, the patient experienced same symptoms after each PNEUMOVAX 23 injection.
Sex: F
Vaccine: FLUX
Symptoms: Headache
Clinical narrative: Case number PHHY2015US148264, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 587734) website on 23 Oct 2015. This report refers to a female patient of an unknown age. Past medical history and concomitant medications were not reported. The patient was vaccinated with influenza virus vaccine seasonal INN (manufacturer unknown, batch number: not reported) on an unknown date 2013. After vaccination, the patient experienced headache. Outcome of the event was reported. Seriousness of the event was reported as non serious and causality was not reported.
Age: 1.0
Sex: F
Vaccine: FLUX, HEPA, MMR, VARCEL
Symptoms: Rash erythematous
Clinical narrative: Case number PHHY2015US148292, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 587774) website on 23 Oct 2015. This report refers to a one year old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with influenza virus vaccine seasonal INN (manufacturer unknown, batch number: not reported), HAVRIX (batch number: not reported), MMR II (batch number: not reported) and VARIVAX (batch number: not reported) at a dose of 0.5 ml subcutaneously. On 08 Oct 2014 the patient experienced two red raised bumps on her face. On the 09-Oct-2014, the patient developed one raised red bump on her chest. Outcome of the event was reported as condition unchanged. Seriousness of the event was reported as non serious and causality was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Case number# PHHY2015US150081, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 587798) website on 23 Oct 2015. This report refers to a female patient of an unknown age. Past medical history and concomitant medications were not reported. The patient was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date. After vaccination, the patient experienced pain and swelling at the injection site. The patient was doing fine at the time of this report. Outcome of the events was reported. Events were reported as non serious and causality was not reported.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Musculoskeletal stiffness, Pain
Clinical narrative: Initial unsolicited report received from a consumer (patient's parent) on 05-Aug-2015. A 18 years old male patient, had received a dose of MENACTRA in the right deltoid (batch number, expiry date, dose details and route were not provided) on 28-Jul-2015. There was no illness at the time of vaccination and no pre-existing physician diagnosed allergies, birth defects and medical conditions. There were no other vacations done within four weeks prior to the date of vaccination. It was unknown if any previous doses were taken. On 29-Jul-2015, 1 day post-vaccination, the patient developed redness at the injection site which had eventually progressed to stiffness in his shoulder and neck with some pain with movement. The pediatrician advised treatment with ice, rest and over the counter analgesics. The patient was advised to come to the office if it worsened or did not improve after a few days. There were no laboratory investigations performed. At the time of this report, the patient recovered from the above mentioned events on an unspecified date. Documents held by sender: none.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Mobility decreased, Pain
Clinical narrative: Case number PHHY2015US150229, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 589296) website on 23 Oct 2015. This report refers to a 52 year old female patient. Medical history included asthma and arthritis. Current condition included diabetes. Concomitant medications included metformin (manufacturer unknown) and glipizide (manufacturer unknown). The patient was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: not reported) on 22 Oct 2014. On the same day after vaccination, the patient experienced excruciating pain and she could not lift her arm or lift anything such as jug of milk. Magnetic resonance imaging (MRI) done on 01 Jun 2015 had no findings. Outcome of the event was reported as condition unchanged. Event was reported as non serious and causality was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Hypersensitivity
Clinical narrative: Case number PHHY2015US154453, is an initial spontaneous report received fro the Vaccine Adverse Event Reporting System (VAERS reference number 591222) website on 24 Nov 2015. This report refers to a female patient of unknown age. Past medical history and concomitant medication was not reported. The patient was vaccinated seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date. After vaccination, the patient experienced less allergic responses to the vaccine. Outcome of the event was reported as complete recovery. Seriousness and causality of the events were not reported.
Sex: F
Vaccine: FLUX
Symptoms: Cellulitis, Influenza like illness
Clinical narrative: Case number PHHY2015US152241, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 591537) website on 16 Nov 2015. This report refers to a female patient of an unknown age. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date. On an unknown date after vaccination, the patient experienced flu like symptoms. Final outcome, seriousness and causality were not reported. The patient was vaccinated with FLUVIRIN (batch number: 157004) intramuscularly into the right arm on 18 Aug 2015 and experienced cellulitis (see case: PHHY2015US152236).
Age: 63.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Case number PHHY2015US145249, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 593939) website on 02 Nov 2015. This report refers to a 63 year old female patient. Historical condition and current illness was reported as none. The patient was using multiple medications (poly-pharmacy) at time of vaccination. The patient was vaccinated with influenza seasonal vaccine (brand name, manufacturer: unknown, batch number: unknown) and pneumococcal polyvalent vaccine (brand name, manufacturer: unknown, batch number: unknown) intramuscularly into the left arm on 29 Sep 2014. On the same day after vaccination, patient experienced severe pain and was unable to lift arm. Patient was treated with two steroid injections and physical therapy. It was reported that til date of reporting (05 Sep 2015) patient had pain. Outcome of the events was reported as unknown (missing). Events were reported to be non-serious and causality of the events was not reported.
Age: 50.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Injection site pain
Clinical narrative: Initial unsolicited report received from a pharmacist on 11 September 2015. This case involves a 50-year-old female patient who was vaccinated with a dose of MENACTRA [batch number: U5178AA, expiry date: 17 January 2017, route, dose and dose in series were not reported] in left deltoid on 03 August 2015. The patient also received a dose of VAQTA (manufacturer: Merck) and a dose of BOOSTRIX [batch number, expiry date, route, dose and dose in series for both were not reported] both in left deltoid on 3 August 2015. The patient's illness at time of vaccination reported as none. Pre-existing physician diagnosed allergies, birth defects, medical conditions reported as none and no known allergy. Concomitant medications were not reported. On 4 August 2015, one day following the vaccination, the patient had developed pain at the injection site with radiation to the elbow; the pain was burning in nature and pain in her shoulder near the joint. The patient was not sure if all the injections were received in the same arm. The patient required ER/doctor visit. Relevant diagnostic tests/laboratory data reported none. Corrective treatment was not reported. The outcome of the event was unknown. List of documents held by sender: none. Follow-up information received from a pharmacist on 02 November 2015. It was reported that, reviewed no additional information to provide.
Age: 22.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Flushing, Headache, Nausea
Clinical narrative: Case number PHHY2015US154886, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 595558) website on 24 Nov 2015. This report refers to a 22 years old female patient. Past medical history was not reported. Concomitant medication included ORTHO TRI-CYCLEN and folic acid (manufacturer unknown). The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) at a dose of 1 DF intramuscularly on 16 Sep 2015. On the same day after vaccination, the patient experienced nausea, dizziness, headache and flushing of face an hour after vaccination. The patient visited to emergency room on an unknown date. The outcome of the events was reported as complete recovery. Seriousness of the events was reported as non-serious and causality was not reported.
Age: 21.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Rash
Clinical narrative: Case number PHHY2015US153779, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 5595863) website on 24 Nov 2015. This report refers to a 21-year-old female patient. Historical conditions included allergic to penicillin, Sesclor, erythromycin ethylsuccinate; Bactrum; MIRALAX, Toradol; TAMIFLU, and Azithromycin. Concomitant medication was not reported. The patient was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: not reported) on 16 Sep 2015. On 17 Sep 2015 after vaccination, the patient experienced rash and pain. The patient was feeling fine. The outcome of the events were complete recovery. Seriousness and causality was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Diarrhoea, Dizziness, Headache, Nausea
Clinical narrative: Case number PHHY2015US153894, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 596095) website on 24 NOV 2015. This report refers to a 63-year-old female patient. Historical conditions included food allergies and Fentanyl and Versed allergy and past vaccination included influenza vaccine. Concomitant medication included: fluoxetine (manufacturer unknown), B12, D3, Cal citrate, eicosapentaenoic acid (manufacturer unknown), curcumin (manufacturer unknown), Excedrin, Tums. The patient was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: not reported) in left arm on 15 SEP 2015. On 16 SEP 2015 the patient experienced diarrhea, dizziness, headache and nausea. The patient took Excedrin and Tums and went home and slept for 3 hours at abut 12:30 PM. The patient felt well when she woke up. The outcome of the events were complete recovery. Seriousness and causality was not reported.
Age: 38.0
Sex: M
Vaccine: FLUX
Symptoms: Pruritus, Urticaria
Clinical narrative: Case number PHHY2015US15361, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 596227) website on 24 Nov 2015. This report refers to a 38 year old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 17 Sep 2015. On 18 Sep 2015 after vaccination, the patient experienced hives and itching throughout body, mainly back, head, palms of hands. Patient was treated with BENADRYL. The outcome, seriousness and causality of the events were not reported.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Case number PHHY2015US153785, is an initial spontaneous report received from the Vaccine adverse Event Reporting System (VAERS reference number: 596255) website on 24 Nov 2015. This report refers to a 46 year old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 17 Sep 2015. On 19 Sep 2015, the patient experienced fever, headache, body aches and chills. Outcome of the events was reported as condition unchanged. Events were reported as non serious and causality was not reported.
Age: 72.0
Sex: M
Vaccine: FLUX
Symptoms: Headache, Nausea, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Case number PHHY2015US154168, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 596275) website on 24 Nov 2015. This report refers to a 72 year old male patient. The patient had unspecified preexisting conditions. Concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 17 Sep 2015. On 18 Sep 2015, the patient experienced sore throat, nausea, aching, fever and headache. The outcome of the events was reported as recovered. Seriousness and causality of the events were not reported.
Age: 70.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Body temperature increased, Headache, Pain
Clinical narrative: Case number PHHY2015US153824, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 596559) on 24 Nov 2015. This report refers to a 70 years old female patient. Past medical history and concomitant medication were not reported. The patient vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number expiry date: not reported) on 16 Sep 2015. On the same day after vaccination, the patient started with headache, by 10 PM went to bed with severe headache and all over ache, two degree temp started around 12 PM. The patient laid in bed all day 17 Sep 2015, started feeling better but till ached and weak on the 18 Sep 2015 each day a little better, today 21 Sep 2015 just felt a little weak. The outcome of the events were reported as condition unchanged. The seriousness of events were reported as non-serious and causality not reported.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Case number PHHY2015US153839, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 596572) website on 24 Nov 2015. This report refers to a 32-year-old female patient. Historical condition included had two stroke (2 years ago). Concomitant medication was not reported. The patient was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: not reported) on 14 Sep 2015. On the same day after vaccination, the patient experienced pruritus, erythema and urticarial. The outcome of the events were complete recovery. Seriousness and causality was not reported. Following an internal review for the data received on 24 Nov 2015, Non-significant case correction was performed: erythema labeling changed from unlisted to listed.
Sex: U
Vaccine: FLUX
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Case number PHHY2015US154382, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 597210) website on 24 Nov 2015. This report refers to a patient of an unknown age and gender. Medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) into left leg for prophylaxis on an unknown date. After vaccination the patient developed tenderness and swelling to the left thigh of size of 14.5 cm x 8.5 cm. Outcome of the events was unknown. The case was assessed as non-serious. Causality of the events was not reported.
Age: 72.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Case number PHHY2015US154370, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 597824) website on 24 Nov 2015. This report refers to a 72 year old female patient. Medical history was reported. Current condition included sulfa allergy. Concomitant medications included TOPROL XL. CRESTOR and COZAAR. The patient was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: not reported) in left arm on 28 Sep 2015. On 29 Sep 2015, the patient developed red and swollen arm. Outcome of the events was unknown. Events were reported as non serious. Causality was not reported.
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Case number PHHY2015US154604, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 597878) website on 24 Nov 2015. This report refers to a 26 years old female patient. Past medical history and concomitant medications were not reported. Current condition included seasonal allergies. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) intramuscularly in left arm on 24 Sep 2014. On 24 Sep 2014, the patient felt nausea on drive home between 5:a30 and 6:00 pm, diarrhea at 6:00 pm and vomiting at 6:15 pm. The patient was rehydrated with small glass of water, few ounces of GATORADE and a few crackers. The patient again vomited violently 4 times and diarrhea 5 more times. The patient was treated with one dose of ZOFRAN at 09:30 pm slowly rehydrated with water and Gatorade. Outcome of the events diarrhoea and vomiting was reported as complete recovery and outcome was not reported for nausea. Seriousness of the events was reported as non serious and causality of the events was not reported.
Sex: U
Vaccine: FLUX, PER, VARZOS
Symptoms: Chills, Injection site erythema, Pyrexia
Clinical narrative: Case number PHHY2015US155454, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 597927) web site on 24 Nov 2015. This report refers to a patient of unknown age and gender. Past medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported), pertussis vaccine (manufacturer unknown and batch number: not reported) and ZOSTAVAX vaccine (varicella zoster vaccine and batch number: not reported) on an unknown date. It was reported that 4 to 5 days after vaccination the patient experienced fever, chills and redness at injection site. The patient sought medical attention by contacting pharmacist. The outcome of the events was reported as unknown. The seriousness of the events was reported as non serious and causality was not reported.
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Headache, Influenza like illness, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Case number PHHY2015US154687, is an initial spontaneous report receive from the Vaccine Adverse Event Reporting System (VAERS reference number: 598006) website on 24 NOV 2015. This report refers to a 63 years old female patient. Past medical history and concomitant medications was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) and Zoster vaccine live (manufacturer unknown and batch number: not reported) on 29 SEP 2015. On the same day after vaccination, the patient experienced flue like aches, fever at a body temperature of 100.3 degree Celsius, sore, redness, hotness and hardness at injection site and a very bad headache. The outcome of fever was reported as complete recovery. Outcome of rest of the events was reported as condition ongoing. Events were reported as non serious. Causality was not reported.
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: Case number PHHY2015US154687, is an initial spontaneous report receive from the Vaccine Adverse Event Reporting System (VAERS reference number: 598006) website on 24 NOV 2015. This report refers to a 63 years old female patient. Past medical history and concomitant medications was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) and Zoster vaccine live (manufacturer unknown and batch number: not reported) on 29 SEP 2015. On the same day after vaccination, the patient experienced flue like aches, fever at a body temperature of 100.3 degree Celsius, sore, redness, hotness and hardness at injection site and a very bad headache. The outcome of fever was reported as complete recovery. Outcome of rest of the events was reported as condition ongoing. Events were reported as non serious. Causality was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Headache, Nausea, Pain, Pyrexia
Clinical narrative: Case number PHHY2015US154466 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 600916) on 24 NOV 2015. This report refers to a 70  year old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 06 OCT 2015. On the same day after vaccination, she experienced fever, body aches, nausea and headache. The outcome of the event was not reported. The events were reported as non-serious. The causality of the events was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Swelling, Urticaria
Clinical narrative: Case number PHHY2015US154339 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 600921) website on 24 NOV 2015. This report refers to a 50 year old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 30 SEP 2015. On the same day, patient developed swelling and hives. Outcome of the events was reported as complete recovery. The events were reported as non-serious and causality was not reported.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHHY2015US154386 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 600957) website on 24 Nov 2015. The report refers to a 41 year old female patient. Past medication included sulfa. Concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) subcutaneously into left arm on 06 Oct 2015. On the same day, patient experienced injection site swelling and itching. It was hot to touch and hard. The outcome of the events was not reported. The events were reported to be non-serious and causality was not reported.
Age: 52.0
Sex: F
Vaccine: FLUC3
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Case number PHHY2016US007056, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 602955) website on 18 Jan 2016. This report refers to a 52 years old female patient. Past medical history was not reported. Concurrent condition included seasonal allergies. Concomitant medications was not reported. The patient was vaccinated with FLUCELVAX (batch number: 1517601) into left arm on 13 Oct 2015. On the same day after vaccination, the patient experienced fever, chills, body aches, scratchy throat, headache and fatigue. Outcome of the events was reported as complete recovery on 16 Oct 2015. Seriousness of the events was reported as non serious. The causality of the events was not reported. Seriousness assessment of scratchy throat, pyrexia, chills, pain, headache and fatigue were upgraded to medically significant based on the information available in the source document. Quality assurance department confirmed that, reported batch number (1517601) was not a valid batch number for FLUCELVAX. Hence, investigations could not be performed. Follow up report received from a Quality Assurance Department on 29 Jan 2016: Updated QA comment.
Age: 52.0
Sex: F
Vaccine: FLUC3
Symptoms: Throat irritation
Clinical narrative: Case number PHHY2016US007056, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 602955) website on 18 Jan 2016. This report refers to a 52 years old female patient. Past medical history was not reported. Concurrent condition included seasonal allergies. Concomitant medications was not reported. The patient was vaccinated with FLUCELVAX (batch number: 1517601) into left arm on 13 Oct 2015. On the same day after vaccination, the patient experienced fever, chills, body aches, scratchy throat, headache and fatigue. Outcome of the events was reported as complete recovery on 16 Oct 2015. Seriousness of the events was reported as non serious. The causality of the events was not reported. Seriousness assessment of scratchy throat, pyrexia, chills, pain, headache and fatigue were upgraded to medically significant based on the information available in the source document. Quality assurance department confirmed that, reported batch number (1517601) was not a valid batch number for FLUCELVAX. Hence, investigations could not be performed. Follow up report received from a Quality Assurance Department on 29 Jan 2016: Updated QA comment.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness, Dyskinesia, Gait disturbance, Musculoskeletal stiffness, Pallor
Clinical narrative: Initial unsolicited report received from a physician on 07-Oct-2015. This case involves a 11 years old female patient who was vaccinated with a first dose of ADACEL via intramuscular route (manufacturer: Sanofi Pasteur, batch number: U5241AA, expiry date: 13-Jan-2018) in the left deltoid, a first dose of MENACTRA via intramuscular route (manufacturer: Sanofi Pasteur, batch number: U5195BA, expiry date was not reported) in the right deltoid and a dose of GARDASIL (manufacturer: Merck, batch number: L019286, expiry date was not reported) in the right deltoid, all on 08-Sep-2015. The patient had no illness at time of vaccination. There was no known allergy, no birth defects and no medical conditions. Concomitant medications were not reported. On 08-Sep-2015, same day post vaccination, while the patient was in the office, when she stood at the office desk, she felt dizzy and felt as if she was going to pass out. She was pale, exhibited difficulty walking and had mild dyskinesia of both arms and stiffening. There was no loss of consciousness. Laboratory investigations and corrective treatment were not reported. On 08-Sep-2015, within 30 minutes patient was able to sit up and walk and within two hours and was back in school. The patient recovered from the above mentioned events. List of documents held by sender: none.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Cerebrovascular accident, Dyskinesia, VIIth nerve paralysis
Clinical narrative: Case number PHHY2016US007634 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 604003) website on 18 Jan 2016. This report refers to a 42 year old male patient. Medical history was not reported. Concomitant medication included acyclovir (manufacturer unknown). The patient was vaccinated with AGRIFLU (batch number: 145905) intramuscularly in the right arm on 23 Oct 2014. After vaccination, on 21 Oct 2015 the patient experienced dyskinesia and VIIth nerve paralysis. The patient thought that he was having a stroke, he was unable to control mouth movement and right side of face was starting to sag. The patient was taken to an emergency room following day and he was diagnosed with Bell's palsy. Outcome of the events was reported as condition unchanged. Seriousness of the events was reported as disability and causality was not reported. Quality assurance (QA) department confirmed that, the reported batch number 145905 is not a valid batch for AGRIFLU. Hence, investigation could not be performed. Follow up information received from a Quality Assurance (QA) department on 28 Jan 2016: Added QA comment.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Abasia, Hypoaesthesia, Paraesthesia
Clinical narrative: Case number PHHY2016US007480, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 604778) on 18 Jan 2016. This report refers to a 75 years old male patient. Past medical history was not reported. Current condition included cerebrovascular accident/stroke. Concomitant medication was not reported. He was vaccinated with FLUVIRIN (batch number: 15145P) intramuscularly on 14 Oct 2015. On 16 Oct 2015, two days after administration of vaccine, patient had numbness and tingling in his feet, he was unable to walk and was hospitalized on an unknown date. The outcome of the events was reported as condition unchanged. The causality of the events was not reported. As the mentioned batch was not a valid one (15145P), according to the procedures, we will not investigate. In fact, we cannot definitively confirm the correct batch. Follow up information was as received from QA department on 27 Jan 2016. Added comment QA department comment.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea, Glossodynia, Incorrect route of drug administration, Throat tightness
Clinical narrative: Case number PHHY2016US008071, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS ID: 605108) website on 18 Jan 2016. This report refers to a 29-year-old female patient. Historical condition was not reported. Past medications included erythromycin and doxycycline (both medications taken at same time, did not know which caused chest pain). Current condition included allergic to erythromycin (manufacturer unknown) and doxycycline (manufacturer unknown). Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 6849077-1462) into left arm intradermally instead of intramuscularly on 26 Oct 2015. On same day after vaccination, the patient was talking and started to feel like had burned tongue on something hot and then started to feel the blisters forming on tongue and then about 15 minutes later throat started to tighten. The patient went to doctor to seek help and they informed her there were seven people ahead of her and she would need to wait, but the patient ended up leaving because she was having more trouble breathing and dizzy. The patient got herself some BENADRYL. The final outcome of the events was reported as complete recovery. Seriousness of the events was reported as non serious and causality not reported. Seriousness of the events "glossodynia, tongue blistering, throat tightness and dyspnoea" was upgraded based on the available information in the source document. Quality assurance (QA) department confirmed that, reported batch number (6849077-1462) was not a valid batch number. Hence, investigation could not be performed by QA. Follow up information was received from Quality assurance department on 27 Jan 2016. Added Quality assurance (QA) comment.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Tongue blistering
Clinical narrative: Case number PHHY2016US008071, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS ID: 605108) website on 18 Jan 2016. This report refers to a 29-year-old female patient. Historical condition was not reported. Past medications included erythromycin and doxycycline (both medications taken at same time, did not know which caused chest pain). Current condition included allergic to erythromycin (manufacturer unknown) and doxycycline (manufacturer unknown). Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 6849077-1462) into left arm intradermally instead of intramuscularly on 26 Oct 2015. On same day after vaccination, the patient was talking and started to feel like had burned tongue on something hot and then started to feel the blisters forming on tongue and then about 15 minutes later throat started to tighten. The patient went to doctor to seek help and they informed her there were seven people ahead of her and she would need to wait, but the patient ended up leaving because she was having more trouble breathing and dizzy. The patient got herself some BENADRYL. The final outcome of the events was reported as complete recovery. Seriousness of the events was reported as non serious and causality not reported. Seriousness of the events "glossodynia, tongue blistering, throat tightness and dyspnoea" was upgraded based on the available information in the source document. Quality assurance (QA) department confirmed that, reported batch number (6849077-1462) was not a valid batch number. Hence, investigation could not be performed by QA. Follow up information was received from Quality assurance department on 27 Jan 2016. Added Quality assurance (QA) comment.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Abasia, Asthenia, Back pain, Cough, Malaise
Clinical narrative: Case number PHHY2016US007687, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 606641) website on 18 Jan 2016. This report refers to a 58 years old male patient. Past medical history was not reported. Concomitant medications included losartan potassium (manufacturer unknown). He was vaccinated with AGRIFLU (batch number: 1517701) intramuscularly in left arm on 21 Oct 2015. On the same date, he reported did not feel well, lower back pain and dry cough. On 22 Oct 2015, he reported could not walk or lie down, pain became debilitating and could not put arms and hands together up to face or behind back. The outcome of the events was reported as condition unchanged. The seriousness of the events was reported as serious (reported as permanent disability). The causality of the events was not reported. The quality assurance department reported that, this was not a valid batch number for AGRIFLU, in accordance with the procedure for standard requests, quality assurance department would not further investigate. Follow up report received from quality assurance department on 29 Jan 2016: Updated batch review report.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Pain
Clinical narrative: Case number PHHY2016US007687, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 606641) website on 18 Jan 2016. This report refers to a 58 years old male patient. Past medical history was not reported. Concomitant medications included losartan potassium (manufacturer unknown). He was vaccinated with AGRIFLU (batch number: 1517701) intramuscularly in left arm on 21 Oct 2015. On the same date, he reported did not feel well, lower back pain and dry cough. On 22 Oct 2015, he reported could not walk or lie down, pain became debilitating and could not put arms and hands together up to face or behind back. The outcome of the events was reported as condition unchanged. The seriousness of the events was reported as serious (reported as permanent disability). The causality of the events was not reported. The quality assurance department reported that, this was not a valid batch number for AGRIFLU, in accordance with the procedure for standard requests, quality assurance department would not further investigate. Follow up report received from quality assurance department on 29 Jan 2016: Updated batch review report.