chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Pallor
Clinical narrative: Initial unsolicited report received from a physician on 13 October 2016. This case involves a 11 years old male patient who was vaccinated with a dose of ADACEL (batch number U5288AA, expiration date, dose in series, route of administration was not reported) at left arm, with a dose of MENACTRA (batch number U5187AA, expiry date 16 March 2017, dose in series, route of administration was not reported) at right arm and with a dose of GARDASIL 9 (manufacturer other, batch number M011117, dose in series, route of administration was not reported) at left arm on 10 October 2016 on 11:15 AM. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none. Concomitant medications were not reported. On 10 October 2016 at 11:15 AM, immediately following the vaccination, patient got dizzy, stiff, pale, rolled his eyes, fell on exam table, scared and experienced hyperventilation. It was also reported that patient was healthy and seen for check up. Lab data and corrective treatment was not reported. On 10 October 2016, after 30 minutes of rest, patient recovered (got better) from events. List of documents held by sender: none.
Age: 43.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Impaired work ability, Injection site pain, Musculoskeletal stiffness, Pain, X-ray
Clinical narrative: 10/6/16 Patient administered 0.5 ml FLUARIX QUADRIVALENT Prefilled Syringe IM Deltoid. 10/19/16 Patient returned and reported continued pain, tightness, soreness, affecting mobility in that arm and near the sight of the injection.
Age: 43.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Joint stiffness, Mobility decreased, Pain in extremity
Clinical narrative: 10/6/16 Patient administered 0.5 ml FLUARIX QUADRIVALENT Prefilled Syringe IM Deltoid. 10/19/16 Patient returned and reported continued pain, tightness, soreness, affecting mobility in that arm and near the sight of the injection.
Age: 73.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain in extremity
Clinical narrative: Severe pain in Left shoulder continues more than six weeks interfering with daily activities.
Age: 73.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Activities of daily living impaired, Musculoskeletal pain
Clinical narrative: Severe pain in Left shoulder continues more than six weeks interfering with daily activities.
Age: 34.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Abasia, Central nervous system inflammation, Hypoaesthesia, Muscular weakness, Musculoskeletal disorder
Clinical narrative: Started with tingling and numbness in 2 fingers in both hands, then gradually developed weakness in both arms and hands and both legs. Eventually totally paralyzed, no walking and using hands. Hospitalized received intra vain high dose Steroids. Discharged, then hospitalized to another hospital. Received intra vain Steroids and plasmapheresis for 7 days. Then inpatient rehabilitation for 3 weeks. Still currently is not able to walk or use his hands.
Age: 34.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Myelitis transverse, Nuclear magnetic resonance imaging spinal abnormal, Paraesthesia, Paralysis, Plasmapheresis
Clinical narrative: Started with tingling and numbness in 2 fingers in both hands, then gradually developed weakness in both arms and hands and both legs. Eventually totally paralyzed, no walking and using hands. Hospitalized received intra vain high dose Steroids. Discharged, then hospitalized to another hospital. Received intra vain Steroids and plasmapheresis for 7 days. Then inpatient rehabilitation for 3 weeks. Still currently is not able to walk or use his hands.
Sex: U
Vaccine: FLU4
Symptoms: Balance disorder, Dizziness, Nausea
Clinical narrative: Initial unsolicited report received from a pharmacist on 12 October 2016. This case is linked with cases 2016SA189772, 2016SA189781, 2016SA189791, 2016SA189792, 2016SA189793, 2016SA189794, 2016SA189795, 2016SA189796, 2016SA189797, 2016SA189798, 2016SA189799, 2016SA189800, 2016SA189801, 2016SA189802, 2016SA189803, 2016SA189805, 2016SA189806, 2016SA189807, 2016SA189808, 2016SA189809, 2016SA189810, 2016SA189811, 2016SA189812, 2016SA189813, 2016SA189814, 2016SA189815, 2016SA189816, 2016SA189817, 2016SA189818, 2016SA189819, 2016SA189820, 2016SA189821, 2016SA189822, 2016SA189823, 2016SA189824, 2016SA189825, 2016SA189826, 2016SA189827, 2016SA189828, 2016SA189829, 2016SA189830, 2016SA189831, 2016SA189832, 2016SA189833, 2016SA189834, 2016SA189835, 2016SA189836, 2016SA189837, 2016SA189838, 2016SA189839, 2016SA189840, 2016SA189841, 2016SA189842, 2016SA189843, 2016SA189844, 2016SA189845, 2016SA189846, 2016SA189847, 2016SA189848. This case involves a patient (gender and age not reported) who was vaccinated with a dose of FLUZONE via intramuscular route (Batch number: UI669AA, expiry date: 30-Jun-2017, dose, dose in series and site of administration were not reported) on 04-Oct-2016. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was unknown. Illness at the time of vaccination was also reported as unknown. No further information regarding medical history was available. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On an unspecified date, 3 hours following the vaccination, the patient experienced balance disorder, nausea and dizziness. It was reported that the patient required emergency room doctor visit. The patient's laboratory data was reported as unknown. The patient had not received any corrective treatment. The patient's outcome was unknown. List of documents held by sender: none.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Fatigue, Mass, Pain in extremity, Skin warm
Clinical narrative: Initial unsolicited report received from a pharmacist (Director of Pharmacy) on 12 October 2016. This case is linked with 2016SA189772, 2016SA189781, 2016SA189791, 2016SA189792, 2016SA189793, 2016SA189794, 2016SA189795, 2016SA189796, 2016SA189797, 2016SA189798, 2016SA189799, 2016SA189800, 2016SA189801, 2016SA189802, 2016SA189803, 2016SA189804, 2016SA189805, 2016SA189806, 2016SA189807, 2016SA189808, 2016SA189810, 2016SA189811, 2016SA189812, 2016SA189813, 2016SA189814, 2016SA189815, 2016SA189816, 2016SA189817, 2016SA189818, 2016SA189819, 2016SA189820, 2016SA189821, 2016SA189822, 2016SA189823, 2016SA189824, 2016SA189825, 2016SA189826, 2016SA189827, 2016SA189828, 2016SA189829, 2016SA189830, 2016SA189831, 2016SA189832, 2016SA189833, 2016SA189834, 2016SA189835, 2016SA189836, 2016SA189837, 2016SA189838, 2016SA189839, 2016SA189840, 2016SA189841, 2016SA189842, 2016SA189843, 2016SA189844, 2016SA189845, 2016SA189846, 2016SA189847, 2016SA189848. (Same vaccine, same reporter) This case involves a patient (age and gender not reported) who was vaccinated with a dose of FLUZONE (batch number: UI669AA, expiration date: 30 June 2017 and site of administration was not reported) intramuscularly, 04 October 2016 (over the past month). Patient's Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as unknown. Concomitant medication was not reported. On 06 October 2016 (over the past month) two days following vaccination patient experienced abnormally large lump, area of redness and hot and painful arm seems bit bitter tired. Lab data and corrective treatment were not reported. Patient did not received any seek treatment. The outcome of the events was reported as unknown. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Chills, Fatigue, Hyperhidrosis
Clinical narrative: Initial unsolicited report received from a pharmacist on 12-Oct-2016. This case was linked with cases 2016SA189772, 2016SA189781, 2016SA189791, 2016SA189792, 2016SA189793, 2016SA189794, 2016SA189795, 2016SA189796, 2016SA189797, 2016SA189798, 2016SA189799, 2016SA189800, 2016SA189801, 2016SA189802, 2016SA189803, 2016SA189804, 2016SA189805, 2016SA189806, 2016SA189807, 2016SA189808, 2016SA189809, 2016SA189810, 2016SA189812, 2016SA189813, 2016SA189814, 2016SA189815, 2016SA189816, 2016SA189817, 2016SA189818, 2016SA189819, 2016SA189820, 2016SA189821, 2016SA189822, 2016SA189823, 2016SA189824, 2016SA189825, 2016SA189826, 2016SA189827, 2016SA189828, 2016SA189829, 2016SA189830, 2016SA189831, 2016SA189832, 2016SA189833, 2016SA189834, 2016SA189835, 2016SA189836, 2016SA189837, 2016SA189838, 2016SA189839, 2016SA189840, 2016SA189841, 2016SA189842, 2016SA189843, 2016SA189844, 2016SA189845, 2016SA189846, 2016SA189847, 2016SA189848 (Same reporter). This case involves a patient (gender and age not reported) who was vaccinated with a dose of Fluzone Quadrivalent via intramuscular route (Batch number: UI669AA, expiry date: 30-Jun-2017, dose, dose in series and site of administration were not reported) on 04-Oct-2016. Patient's medical history was reported that pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was unknown. Illness at the time of vaccination was also reported as unknown. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On 06-OCT-2016, two days, following the vaccination, the patient reported Chills, hyperhidrosis and fatigue. Patient required emergency room (ER)/ doctor visit. Laboratory investigations and corrective treatment were not reported. The outcome of event was reported as unknown. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Peripheral swelling
Clinical narrative: Initial unsolicited report received from a pharmacist (director of pharmacy) on 12 Oct 2016. This case was linked to 2016SA189772, 2016SA189781, 2016SA189791, 2016SA189792, 2016SA189793, 2016SA189794, 2016SA189795, 2016SA189796, 2016SA189797, 2016SA189798, 2016SA189799, 2016SA189800, 2016SA189801, 2016SA189802, 2016SA189803, 2016SA189804, 2016SA189805, 2016SA189806, 2016SA189807, 2016SA189808, 2016SA189809, 2016SA189810, 2016SA189811, 2016SA189812, 2016SA189814, 2016SA189815, 2016SA189816, 2016SA189817, 2016SA189818, 2016SA189819, 2016SA189820, 2016SA189821, 2016SA189822, 2016SA189823, 2016SA189824, 2016SA189825, 2016SA189826, 2016SA189827, 2016SA189828, 2016SA189829, 2016SA189830, 2016SA189831, 2016SA189832, 2016SA189833, 2016SA189834, 2016SA189835, 2016SA189836, 2016SA189837, 2016SA189838, 2016SA189839, 2016SA189840, 2016SA189841, 2016SA189842, 2016SA189843, 2016SA189844, 2016SA189845, 2016SA189846, 2016SA189847, 2016SA189848. This case involves a patient (age, gender unknown) who was vaccinated with a dose of Fluzone Quadrivalent (batch number- UI669AA, expiry date: 30 Jun 2017, dose and site of administration was not reported) by intramuscular route on 04 Oct 2016. Illness at time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical conditions and concomitant medications were not reported. On an unspecified date, following the vaccination the patient had swollen arm. The patient's lab tests and corrective treatment was not reported. The outcome of the event was reported as unknown. List of documents held by sender: none.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Breast tenderness, Paraesthesia, Tenderness
Clinical narrative: Initial unsolicited report received from a pharmacist on 12-Oct-2016. This case was linked with cases 2016SA189772, 2016SA189781, 2016SA189791, 2016SA189792, 2016SA189793, 2016SA189794, 2016SA189795, 2016SA189796, 2016SA189797, 2016SA189798, 2016SA189799, 2016SA189800, 2016SA189801, 2016SA189802, 2016SA189803, 2016SA189804, 2016SA189805, 2016SA189806, 2016SA189807, 2016SA189808, 2016SA189809, 2016SA189810, 2016SA189811, 2016SA189812, 2016SA189813, 2016SA189814, 2016SA189816, 2016SA189817, 2016SA189818, 2016SA189819, 2016SA189820, 2016SA189821, 2016SA189822, 2016SA189823, 2016SA189824, 2016SA189825, 2016SA189826, 2016SA189827, 2016SA189828, 2016SA189829, 2016SA189830, 2016SA189831, 2016SA189832, 2016SA189833, 2016SA189834, 2016SA189835, 2016SA189836, 2016SA189837, 2016SA189838, 2016SA189839, 2016SA189840, 2016SA189841, 2016SA189842, 2016SA189843, 2016SA189844, 2016SA189845, 2016SA189846, 2016SA189847, 2016SA189848 (Same vaccine). This case involves a patient (gender and age not reported) who was vaccinated with a dose of FLUZONE via intramuscular route (Batch number: UI669AA, expiry date: 30-Jun-2017, dose, dose in series and site of administration were not reported) on 04-Oct-2016. Patient's medical history was reported that Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was unknown. Illness at the time of vaccination was also reported as unknown. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On an unknown date, unspecified timeframe following the vaccination, the patient developed severe tenderness to entire left breast and axillary area, some swelling to the skin between my arm and upper breast, Small red area and deltoid tingly. Patient required emergency room (ER)/ doctor visit. Laboratory investigations and corrective treatment were not reported. The outcome of events was reported as unknown. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Gastrointestinal disorder
Clinical narrative: Initial unsolicited report received from a pharmacist on 12 Oct 2016. This case is linked with 2016SA189772, 2016SA189781, 2016SA189791, 2016SA189792, 2016SA189793, 2016SA189794, 2016SA189795, 2016SA189796, 2016SA189797, 2016SA189798, 2016SA189799, 2016SA189800, 2016SA189801, 2016SA189802, 2016SA189803, 2016SA189804, 2016SA189805, 2016SA189806, 2016SA189807, 2016SA189808, 2016SA189809, 2016SA189810, 2016SA189811, 2016SA189812, 2016SA189813, 2016SA189814, 2016SA189815, 2016SA189816, 2016SA189817, 2016SA189818, 2016SA189819, 2016SA189820, 2016SA189821, 2016SA189822, 2016SA189823, 2016SA189824, 2016SA189825, 2016SA189826, 2016SA189827, 2016SA189828, 2016SA189829, 2016SA189830, 2016SA189831, 2016SA189832, 2016SA189833, 2016SA189834, 2016SA189835, 2016SA189836, 2016SA189837, 2016SA189838, 2016SA189839, 2016SA189840, 2016SA189841, 2016SA189842, 2016SA189843, 2016SA189844, 2016SA189845, 2016SA189846, 2016SA189847, 2016SA189848. (same lot number). This case involves a 60 patients (age and gender not reported) who was vaccinated with a dose of FLUZONE QIV (batch number: UI669AA, expiry date: 30 Jun 2017, dose and site was not reported) via intramuscular route on 04 Oct 2016 (also reported as over the past month). Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) and illness at time of vaccination was unknown. Concomitant medications were not reported. On an unspecified date (reported as over the past month), following the vaccination, the patients had experienced gastrointestinal symptoms. It was reported that, patient do not require ER/ doctor visit. Lab data was not reported. Corrective treatment was reported as no (none). The patient's event outcome was reported as unknown. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Erythema, Grip strength decreased, Induration, Mobility decreased, Musculoskeletal pain
Clinical narrative: Initial unsolicited case received from a Pharmacist on 12 Oct 2016. this case is linked with 2016SA189772, 2016SA189781, 2016SA189791, 2016SA189792, 2016SA189793, 2016SA189794, 2016SA189795, 2016SA189796, 2016SA189797, 2016SA189798, 2016SA189799, 2016SA189800, 2016SA189801, 2016SA189802, 2016SA189803, 2016SA189804, 2016SA189805, 2016SA189806, 2016SA189807, 2016SA189808, 2016SA189809, 2016SA189810, 2016SA189811, 2016SA189812, 2016SA189813, 2016SA189814, 2016SA189815, 2016SA189816, 2016SA189817, 2016SA189818, 2016SA189819, 2016SA189820, 2016SA189821, 2016SA189823, 2016SA189824, 2016SA189825, 2016SA189826, 2016SA189827, 2016SA189828, 2016SA189829, 2016SA189830, 2016SA189831, 2016SA189832, 2016SA189833, 2016SA189834, 2016SA189835, 2016SA189836, 2016SA189837, 2016SA189838, 2016SA189839, 2016SA189840, 2016SA189841, 2016SA189842, 2016SA189843, 2016SA189844, 2016SA189845, 2016SA189846, 2016SA189847.2016SA189848 . This case involves a patient (age and gender not reported) who was vaccinated with a dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (Batch number: UI669AA, Expiry date: 30 Jun 2017 dose and site of administration was not reported) intramuscularly on 03 Oct 2016. The patient medical history Illness at time of vaccination, Pre-existing physician diagnosed allergies, birth defects, medical conditions and any other vaccinations within four weeks of vaccination was reported as unknown. The patient concomitant medications were not reported. On 04 Oct 2016, one day after vaccination the patient shoulder swollen, red, firm and hot to touch with pain affecting my ability to grip tightly with my left hand and raise may left arm above my shoulder. Size of indurations 6.5 cm x 5 cm. And on an unknown date the patient felt occasionally achy when lift arm above shoulder. (Grip strength decreased, Injected limb mobility decreased, Induration, Inflammations, pain and Vaccination site reaction). The patient required emergency room (ER) visit. The patient lab tests and corrective treatment was not reported. The outcome of the event was reported as unknown at the time of this report. (It was also reported as on 07 Oct 2016 redness significantly subsided and sight is warm, not hot). List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Pain, Skin warm, Swelling
Clinical narrative: Initial unsolicited case received from a Pharmacist on 12 Oct 2016. this case is linked with 2016SA189772, 2016SA189781, 2016SA189791, 2016SA189792, 2016SA189793, 2016SA189794, 2016SA189795, 2016SA189796, 2016SA189797, 2016SA189798, 2016SA189799, 2016SA189800, 2016SA189801, 2016SA189802, 2016SA189803, 2016SA189804, 2016SA189805, 2016SA189806, 2016SA189807, 2016SA189808, 2016SA189809, 2016SA189810, 2016SA189811, 2016SA189812, 2016SA189813, 2016SA189814, 2016SA189815, 2016SA189816, 2016SA189817, 2016SA189818, 2016SA189819, 2016SA189820, 2016SA189821, 2016SA189823, 2016SA189824, 2016SA189825, 2016SA189826, 2016SA189827, 2016SA189828, 2016SA189829, 2016SA189830, 2016SA189831, 2016SA189832, 2016SA189833, 2016SA189834, 2016SA189835, 2016SA189836, 2016SA189837, 2016SA189838, 2016SA189839, 2016SA189840, 2016SA189841, 2016SA189842, 2016SA189843, 2016SA189844, 2016SA189845, 2016SA189846, 2016SA189847.2016SA189848 . This case involves a patient (age and gender not reported) who was vaccinated with a dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (Batch number: UI669AA, Expiry date: 30 Jun 2017 dose and site of administration was not reported) intramuscularly on 03 Oct 2016. The patient medical history Illness at time of vaccination, Pre-existing physician diagnosed allergies, birth defects, medical conditions and any other vaccinations within four weeks of vaccination was reported as unknown. The patient concomitant medications were not reported. On 04 Oct 2016, one day after vaccination the patient shoulder swollen, red, firm and hot to touch with pain affecting my ability to grip tightly with my left hand and raise may left arm above my shoulder. Size of indurations 6.5 cm x 5 cm. And on an unknown date the patient felt occasionally achy when lift arm above shoulder. (Grip strength decreased, Injected limb mobility decreased, Induration, Inflammations, pain and Vaccination site reaction). The patient required emergency room (ER) visit. The patient lab tests and corrective treatment was not reported. The outcome of the event was reported as unknown at the time of this report. (It was also reported as on 07 Oct 2016 redness significantly subsided and sight is warm, not hot). List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Cough, Erythema, Fatigue, Headache, Local reaction
Clinical narrative: Initial unsolicited report received from a pharmacist (Director of Pharmacy) on 12-OCT-2016. This case is linked with 2016SA189772, 2016SA189781, 2016SA189791, 2016SA189792, 2016SA189793, 2016SA189794, 2016SA189795, 2016SA189796, 2016SA189797, 2016SA189798, 2016SA189799, 2016SA189800, 2016SA189801, 2016SA189802, 2016SA189803, 2016SA189804, 2016SA189805, 2016SA189806, 2016SA189807, 2016SA189808, 2016SA189809, 2016SA189810, 2016SA189811, 2016SA189812, 2016SA189813, 2016SA189814, 2016SA189815, 2016SA189816, 2016SA189817, 2016SA189818, 2016SA189819, 2016SA189820, 2016SA189821, 2016SA189822, 2016SA189823, 2016SA189824, 2016SA189825, 2016SA189826, 2016SA189828, 2016SA189829, 2016SA189830, 2016SA189831, 2016SA189832, 2016SA189833, 2016SA189834, 2016SA189835, 2016SA189836, 2016SA189837, 2016SA189838, 2016SA189839, 2016SA189840, 2016SA189841, 2016SA189842, 2016SA189843, 2016SA189844, 2016SA189845, 2016SA189846, 2016SA189847, 2016SA189848. This case involves a patient (age and gender not reported) who was vaccinated with a dose of FLUZONE QUADRIVALENT batch number: UI669AA, expiration date: 30-JUN-17, intramuscularly, on 04-OCT-2016. Patient's Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as unknown. Concomitant medications were not reported. On an unspecified date (over the past month), following the vaccination, the patient experienced local reaction: looks like bee sting, raised red dot, sore, systemic reaction: sore throat, headache he, feel tired and cough. It was reported that the patient required emergency room/doctor visit. Lab data and corrective treatment were not reported. The outcome of the events was reported as unknown. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Oropharyngeal pain, Pain, Swelling
Clinical narrative: Initial unsolicited report received from a pharmacist (Director of Pharmacy) on 12-OCT-2016. This case is linked with 2016SA189772, 2016SA189781, 2016SA189791, 2016SA189792, 2016SA189793, 2016SA189794, 2016SA189795, 2016SA189796, 2016SA189797, 2016SA189798, 2016SA189799, 2016SA189800, 2016SA189801, 2016SA189802, 2016SA189803, 2016SA189804, 2016SA189805, 2016SA189806, 2016SA189807, 2016SA189808, 2016SA189809, 2016SA189810, 2016SA189811, 2016SA189812, 2016SA189813, 2016SA189814, 2016SA189815, 2016SA189816, 2016SA189817, 2016SA189818, 2016SA189819, 2016SA189820, 2016SA189821, 2016SA189822, 2016SA189823, 2016SA189824, 2016SA189825, 2016SA189826, 2016SA189828, 2016SA189829, 2016SA189830, 2016SA189831, 2016SA189832, 2016SA189833, 2016SA189834, 2016SA189835, 2016SA189836, 2016SA189837, 2016SA189838, 2016SA189839, 2016SA189840, 2016SA189841, 2016SA189842, 2016SA189843, 2016SA189844, 2016SA189845, 2016SA189846, 2016SA189847, 2016SA189848. This case involves a patient (age and gender not reported) who was vaccinated with a dose of FLUZONE QUADRIVALENT batch number: UI669AA, expiration date: 30-JUN-17, intramuscularly, on 04-OCT-2016. Patient's Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as unknown. Concomitant medications were not reported. On an unspecified date (over the past month), following the vaccination, the patient experienced local reaction: looks like bee sting, raised red dot, sore, systemic reaction: sore throat, headache he, feel tired and cough. It was reported that the patient required emergency room/doctor visit. Lab data and corrective treatment were not reported. The outcome of the events was reported as unknown. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Asthenia, Fatigue, Headache, Nausea
Clinical narrative: Initial unsolicited report received from a pharmacist on 12 Oct 2016. THIS CASE IS LINKED WITH 2016SA189772, 2016SA189781, 2016SA189791, 2016SA189792, 2016SA189793, 2016SA189794, 2016SA189795, 2016SA189796, 2016SA189797, 2016SA189798, 2016SA189799, 2016SA189800, 2016SA189801, 2016SA189802, 2016SA189803, 2016SA189804, 2016SA189805, 2016SA189806, 2016SA189807, 2016SA189808, 2016SA189809, 2016SA189810, 2016SA189811, 2016SA189812, 2016SA189813, 2016SA189814, 2016SA189815, 2016SA189816, 2016SA189817, 2016SA189818, 2016SA189819, 2016SA189820, 2016SA189821, 2016SA189822, 2016SA189823, 2016SA189824, 2016SA189825, 2016SA189826, 2016SA189827, 2016SA189828, 2016SA189829, 2016SA189830, 2016SA189831, 2016SA189832, 2016SA189833, 2016SA189834, 2016SA189835, 2016SA189836, 2016SA189837, 2016SA189838, 2016SA189839, 2016SA189840, 2016SA189841, 2016SA189842, 2016SA189843, 2016SA189844, 2016SA189846, 2016SA189847, 2016SA189848 (same lot number). This case involves a patient (gender and age not reported) who was vaccinated with a dose of FLUZONE QUADRIVALENT (batch number: UI669AA, expiry date: 30 June 2017, dose, dose in series, route and site of administration were not reported) intramuscularly on 03 Oct 2016 (over the past month). Illness at the time of vaccination was reported as and pre-existing physician diagnosed allergies, birth defects, medical conditions was unknown. Concomitant medications were not reported. On an unknown date (over the past month), following the vaccination, the patient had developed headache, nausea, body weakness and fatigue (systemic reaction). The patient's laboratory data was not reported. The patient required ER visit. The patient did not take any treatment. The outcome of events was unknown. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Initial unsolicited report received from a pharmacist on 12-Oct-2016. This case was linked with cases 2016SA189772, 2016SA189781, 2016SA189791, 2016SA189792, 2016SA189793, 2016SA189794, 2016SA189795, 2016SA189796, 2016SA189797, 2016SA189798, 2016SA189799, 2016SA189800, 2016SA189801, 2016SA189802, 2016SA189803, 2016SA189804, 2016SA189805, 2016SA189806, 2016SA189807, 2016SA189808, 2016SA189809, 2016SA189810, 2016SA189811, 2016SA189812, 2016SA189813, 2016SA189814, 2016SA189815, 2016SA189816, 2016SA189817, 2016SA189818, 2016SA189819, 2016SA189820, 2016SA189821, 2016SA189822, 2016SA189823, 2016SA189824, 2016SA189825, 2016SA189826, 2016SA189827, 2016SA189828, 2016SA189829, 2016SA189830, 2016SA189831, 2016SA189832, 2016SA189833, 2016SA189834, 2016SA189835, 2016SA189836, 2016SA189837, 2016SA189838, 2016SA189839, 2016SA189840, 2016SA189841, 2016SA189842, 2016SA189843, 2016SA189844, 2016SA189845, 2016SA189846, 2016SA189847 (Same vaccine). This case involves a patient (gender and age not reported) who was vaccinated with a dose of Fluzone Quadrivalent via intramuscular route (Batch number: UI669AA, expiry date: 30-Jun-2017, dose, dose in series and site of administration were not reported) on 04-Oct-2016. Patient's medical history was reported that Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was unknown. Illness at the time of vaccination was also reported as unknown. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On an unknown date, unspecified timeframe following the vaccination, the patient reported that actual injection hurt more than in past, plus my arm was definitely more sore than usual following the injection. Small area about size of quarter at injection site, reddened, raised and warm to touch. Patient required emergency room (ER)/ doctor visit. Laboratory investigations and corrective treatment were not reported. The patient recovered from the events on 07-Oct-2016 (reported as each day it was continually improved and as 06-Oct-2016 the injection site was just light pink and as on 07-Oct-2016, appeared completely gone). List of documents held by sender: none.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Malaise
Clinical narrative: Initial unsolicited report received from pharmacist on 14 October 2016. This case involves 82- year-old female patient who was vaccinated with dose of Fluzone HD (Batch number: UI725AA, expiration date 28 May 2017, dose was not reported) intramuscularly in right deltoid on an 12 October 2016. Patient Illness at time of vaccination reported as patient was on continuous oxygen therapy and pre-existing physician diagnosed allergies, birth defects and medical conditions include Chronic Obstructive Pulmonary Disease (COPD), Diabetic, CVD (Cardiovascular disease). Concomitant medication was not reported. On 14 October 2016, two days following vaccination patient had a large area of redness at the injection site and her arm felt funny like it had malaise. Lab data and corrective treatment was not reported. Outcome of events was reported as unknown. List of documents held by sender: none.
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Formication, Injection site reaction
Clinical narrative: Initial unsolicited report received from a pharmacist on 14 October 2016. This case involves a 57 years old male patient who was vaccinated with a dose of FLUZONE (batch number, expiry date, dose, dose in series were not reported) via intramuscularly route at left deltoid on 03 October 2016. The patient's medical history reported as unknown Concomitant medications were not reported. On 05 October 2016, two day following the vaccination, the patient felt like there was a spider walking, running around on his arm half inch from the injection site. It felt like the spider was down near his wrist also The patient's laboratory data and corrective treatment was not reported. THe outcome of event was reported as not recovered. List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Pruritus, Rash
Clinical narrative: Initial unsolicited report received from nurse on 14 October 2016. This case involves female patient (age no reported) who was vaccinated with dose of FLUZONE INTRADERMAL (Batch number, expiration date, dose site and route of administration was not reported) on an unspecified date. Medical history and concomitant medication were not reported. On an unspecified date, following vaccination patient experienced Itching, burning and bigger rash than expected (softball size). Lab data and corrective treatment was not reported. Outcome of events was not reported. List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Local swelling, Pruritus, Rash
Clinical narrative: Initial unsolicited report received from a Nurseon 14 October 2016. This case involves a female patient (age not reported) who was vaccinated with a dose FLUZONE INTRADERMAL (batch number, expiration date, dose, site and route of reaction were not reported) on an unknown date. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient developed local rash, itching, burning and swelling. Lab data and corrective treatment were not reported. Outcome of the event was not reported. List of documents held by sender: none.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Nausea
Clinical narrative: Initial unsolicited report received from a non-health care professional on 13 Oct 2016. This case involves a female patient (age not reported) who was vaccinated with a dose of Flu shot (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on 13 Oct 2016. Patient's medical history as Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was not reported. Illness at the time of vaccination was also not reported. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On 13 Oct 2016, six hours following the vaccination, the patient had experienced shivering and nausea. It was reported that patient received Flu shot previously in yearly basis. Laboratory investigations and corrective treatment were not reported. The outcome of the event was reported as unknown. List of documents held by sender: none.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity, Sleep disorder
Clinical narrative: As she gave me the shot I felt a strong pain in my arm.
Age: 42.0
Sex: M
Vaccine: TD
Symptoms: Immediate post-injection reaction, Limb injury, Nuclear magnetic resonance imaging abnormal, Pain
Clinical narrative: Immediate severe pain after shot administered. Pain has continued to present day from April 22, 2016 until now. Many weeks of physical therapy and steroid injection.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Malaise, Myocardial infarction
Clinical narrative: Patient started not feeling well. Thought it was from flu shot. Had heart attack later in evening.
Sex: F
Vaccine: VARZOS
Symptoms: Skin cancer
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. Patient's pertinent medical history, concurrent conditions and concomitant medications were not known. On an unknown date, the patient was vaccinated with ZOSTAVAX (dosage, lot and expiry date unspecified). A week ago, in approximately 14-OCT-2016, the patient was diagnosed with skin cancer. The pharmacist could not confirm if skin cancer was present prior to administration of ZOSTAVAX. Patient was treated for the event. The outcome of skin cancer was unknown. Causality assessment was not provided by the reporter. No Product Quality Complaint (PQC) was involved. Upon internal review, the event of skin cancer was considered to be medically significant. Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Cardiac disorder, Catheterisation cardiac, Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 75 year old male patient. The patient's relevant medical history included "huge cardiac history" (details were not provided). The patient did not have any drug reactions or allergies. On 17-OCT-2016, the patient was vaccinated with a dose of ZOSTAVAX injection (route and site of administration, dose, lot number and expiration date were not reported). The patient's concomitant medications were unknown. On 18-OCT-2016, the patient came into the emergency department of the reporter's hospital and was diagnosed with shingles. He was released from the hospital on the same day without being admitted. The reporter did not know if any treatment was provided or suggested to the patient for this event. On 19-OCT-2016, the patient returned to the same emergency department because of a "cardiac issue". He was admitted to the hospital and he needed to have an "interventional cath procedure" completed. It was unknown if any lab diagnostic studies were performed. Product quality complaint was not involved. The reporter was interested in Varicella Zoster Virus (VZV) analysis by polymerase chain reaction (PCR) and wanted to send the viral isolates. At the time of reporting, the pharmacist did not have any information regarding the outcome of the events of shingles and "cardiac issue". The relatedness between these events and the therapy with ZOSTAVAX was not reported. The reporting pharmacist considered the event of "cardiac issue" to be life-threatening and medically significant as "interventional cath procedure" was considered to be an intervention to prevent serious criteria. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Soreness and pain radiating to hand of left arm from vaccine.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Skin reaction, Skin warm, Underdose
Clinical narrative: Within 1 hour of receiving the vaccine. I started to get a large, hot, red area on my arm. It has gotten worse overnight and is now about 4 inches in diameter. I only received a half dose by my employers health nurse. I was advised today to apply ice to the area and take Tylenol and to report this to your website.
Age: 72.0
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal pain
Clinical narrative: Pain in left should.
Age: 86.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Pain
Clinical narrative: Some discomfort after flu injection but, pain continued to worsen, to the point it is very painful to lift the arm, at all, now.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain
Clinical narrative: Received Flu vaccine in R delt 10/21/16 @ 5PM. Woke up from sleep at 2AM 10/24/16 with pain from R delt rated 5-8/10. Pain increases with movement. Vaccine administered in deltoid approx. 3 inches distal from acromion.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Headache, Skin warm, Swelling
Clinical narrative: Initial unsolicited report received from a pharmacist (Director of Pharmacy) on 12-OCT-2016. This case is linked with 2016SA189772, 2016SA189781, 2016SA189791, 2016SA189792, 2016SA189793, 2016SA189794, 2016SA189795, 2016SA189796, 2016SA189797, 2016SA189798, 2016SA189799, 2016SA189800, 2016SA189802, 2016SA189803, 2016SA189804, 2016SA189805, 2016SA189806, 2016SA189807, 2016SA189808, 2016SA189809, 2016SA189810, 2016SA189811, 2016SA189812, 2016SA189813, 2016SA189814, 2016SA189815, 2016SA189816, 2016SA189817, 2016SA189818, 2016SA189819, 2016SA189820, 2016SA189821, 2016SA189822, 2016SA189823, 2016SA189824, 2016SA189825, 2016SA189826, 2016SA189827, 2016SA189828, 2016SA189829, 2016SA189830, 2016SA189831, 2016SA189832, 2016SA189833, 2016SA189834, 2016SA189835, 2016SA189836, 2016SA189837, 2016SA189838, 2016SA189839, 2016SA189840, 2016SA189841, 2016SA189842, 2016SA189843, 2016SA189844, 2016SA189845, 2016SA189846, 2016SA189847, 2016SA189848. This case involves a patient (age and gender not reported) who was vaccinated with a dose of FLUZONE QUADRIVALENT batch number: UI669AA, expiration date: 30-JUN-17, intramuscularly, on an unspecified date (over the past month). Patient's Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as unknown. Concomitant medications were not reported. On an unspecified date (over the past month), following the vaccination, the patient had some swelling, warmth, cellulitis area 2 x 2 (unit not reported) and headache. It was reported that the patient required emergency room/doctor visit. Lab data and corrective treatment were not reported. The outcome of the events was reported as unknown. List of documents held by sender: none. Sender's Comments: This case concerns a patient (age and gender not reported) who reportedly experienced headache and some swelling, warmth, cellulitis area 2 x 2 post vaccination of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. Details regarding latency from vaccination, medical history of the patient, vaccination history, concomitant medications, past vaccination history and its tolerance are needed to assess the case. based on available information the role of vaccine cannot be assessed.
Age: 33.0
Sex: M
Vaccine: FLU4
Symptoms: Limb discomfort, Pyrexia
Clinical narrative: Initial unsolicited case received from a pharmacist on 12 Oct 2016. This case is linked with 2016SA189772, 2016SA189781, 2016SA189791, 2016SA189792, 2016SA189793, 2016SA189794, 2016SA189795, 2016SA189796, 2016SA189797, 2016SA189798, 2016SA189799, 2016SA189800, 2016SA189801, 2016SA189802, 2016SA189803, 2016SA189804, 2016SA189805, 2016SA189806, 2016SA189807, 2016SA189808, 2016SA189809, 2016SA189810, 2016SA189811, 2016SA189812, 2016SA189813, 2016SA189814, 2016SA189815, 2016SA189816, 2016SA189817, 2016SA189818, 2016SA189819, 2016SA189820, 2016SA189821, 2016SA189822, 2016SA189824, 2016SA189825, 2016SA189826, 2016SA189827, 2016SA189828, 2016SA189829, 2016SA189830, 2016SA189831, 2016SA189832, 2016SA189833, 2016SA189834, 2016SA189835, 2016SA189836, 2016SA189837, 2016SA189838, 2016SA189839, 2016SA189840, 2016SA189841, 2016SA189842, 2016SA189843, 2016SA189844, 2016SA189845, 2016SA189846, 2016SA189847.2016SA189848. This case involves a patient (age and gender not reported) who was vaccinated with a dose of FLUZONE QUADRIVALENT (Batch number: UI669AA Expiry date: 30 Jun 2017 dose and site of administration was not reported) intramuscularly on 04 Oct 2016. The patient medical history illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as unknown. And any other vaccinations within four weeks of vaccination was not reported. The patient concomitant medications were not reported. On an unknown date and time frame after the vaccination the patient right arm bothered and little fever. The patient required emergency room (ER) visit. The patient lab tests and corrective treatment was not reported. The outcome of the events were unknown at the time of this report. List of documents held by sender: none.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Erythema, Headache, Local reaction, Pain
Clinical narrative: Initial unsolicited report received from a pharmacist (Director of pharmacy) on 12 Oct 2016. This case is linked with 2016SA189772, 2016SA189781, 2016SA189791, 2016SA189792, 2016SA189793, 2016SA189794, 2016SA189795, 2016SA189796, 2016SA189797, 2016SA189798, 2016SA189799, 2016SA189800, 2016SA189801, 2016SA189802, 2016SA189803, 2016SA189804, 2016SA189805, 2016SA189806, 2016SA189807, 2016SA189808, 2016SA189809, 2016SA189810, 2016SA189811, 2016SA189812, 2016SA189813, 2016SA189814, 2016SA189815, 2016SA189816, 2016SA189817, 2016SA189818, 2016SA189819, 2016SA189820, 2016SA189821, 2016SA189822, 2016SA189823, 2016SA189824, , 2016SA189826, 2016SA189827, 2016SA189828, 2016SA189829, 2016SA189830, 2016SA189831, 2016SA189832, 2016SA189833, 2016SA189834, 2016SA189835, 2016SA189836, 2016SA189837, 2016SA189838, 2016SA189839, 2016SA189840, 2016SA189841, 2016SA189842, 2016SA189843, 2016SA189844, 2016SA189846, 2016SA189846, 2016SA189847, 2016SA189848 (same batch number). This case involves a patient (gender and age not reported) who was vaccinated with a dose of FLUZONE QUADRIVALENT (batch number: UI669AA, expiry date: 30 June 2017, dose, dose in series, route and site of administration were not reported) intramuscularly on 04 Oct 2016 (over the past month). Illness at the time of vaccination was reported as and pre-existing physician diagnosed allergies, birth defects, medical conditions was unknown. Concomitant medications were not reported. On an unknown date (over the past month), following the vaccination, the patient had developed Aches, chills, pounding headache past 2 days (systemic reaction) and big red welt on left arm, warm to touch (local reaction). The patient required ER/doctor (Pharmacy department) visit. The patient's laboratory data was not reported. The patient did not take any treatment. The outcome of events was unknown. List of documents held by sender: none.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Skin warm, Urticaria
Clinical narrative: Initial unsolicited report received from a pharmacist (Director of pharmacy) on 12 Oct 2016. This case is linked with 2016SA189772, 2016SA189781, 2016SA189791, 2016SA189792, 2016SA189793, 2016SA189794, 2016SA189795, 2016SA189796, 2016SA189797, 2016SA189798, 2016SA189799, 2016SA189800, 2016SA189801, 2016SA189802, 2016SA189803, 2016SA189804, 2016SA189805, 2016SA189806, 2016SA189807, 2016SA189808, 2016SA189809, 2016SA189810, 2016SA189811, 2016SA189812, 2016SA189813, 2016SA189814, 2016SA189815, 2016SA189816, 2016SA189817, 2016SA189818, 2016SA189819, 2016SA189820, 2016SA189821, 2016SA189822, 2016SA189823, 2016SA189824, , 2016SA189826, 2016SA189827, 2016SA189828, 2016SA189829, 2016SA189830, 2016SA189831, 2016SA189832, 2016SA189833, 2016SA189834, 2016SA189835, 2016SA189836, 2016SA189837, 2016SA189838, 2016SA189839, 2016SA189840, 2016SA189841, 2016SA189842, 2016SA189843, 2016SA189844, 2016SA189846, 2016SA189846, 2016SA189847, 2016SA189848 (same batch number). This case involves a patient (gender and age not reported) who was vaccinated with a dose of FLUZONE QUADRIVALENT (batch number: UI669AA, expiry date: 30 June 2017, dose, dose in series, route and site of administration were not reported) intramuscularly on 04 Oct 2016 (over the past month). Illness at the time of vaccination was reported as and pre-existing physician diagnosed allergies, birth defects, medical conditions was unknown. Concomitant medications were not reported. On an unknown date (over the past month), following the vaccination, the patient had developed Aches, chills, pounding headache past 2 days (systemic reaction) and big red welt on left arm, warm to touch (local reaction). The patient required ER/doctor (Pharmacy department) visit. The patient's laboratory data was not reported. The patient did not take any treatment. The outcome of events was unknown. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Headache, Nausea, Pain in extremity, Paraesthesia
Clinical narrative: Initial unsolicited report received from a pharmacist on 12-Oct-2016. This case was linked with cases 2016SA189772, 2016SA189781, 2016SA189791, 2016SA189792, 2016SA189793, 2016SA189794, 2016SA189795, 2016SA189796, 2016SA189797, 2016SA189798, 2016SA189799, 2016SA189800, 2016SA189801, 2016SA189802, 2016SA189803, 2016SA189804, 2016SA189805, 2016SA189806, 2016SA189807, 2016SA189808, 2016SA189809, 2016SA189810, 2016SA189811, 2016SA189812, 2016SA189813, 2016SA189814, 2016SA189815, 2016SA189816, 2016SA189817, 2016SA189818, 2016SA189819, 2016SA189820, 2016SA189821, 2016SA189822, 2016SA189823, 2016SA189824, 2016SA189825, 2016SA189826, 2016SA189827, 2016SA189829, 2016SA189830, 2016SA189831, 2016SA189832, 2016SA189833, 2016SA189834, 2016SA189835, 2016SA189836, 2016SA189837, 2016SA189838, 2016SA189839, 2016SA189840, 2016SA189841, 2016SA189842, 2016SA189843, 2016SA189844, 2016SA189845, 2016SA189846, 2016SA189847, 2016SA189848 (Same vaccine). This case involves a patient (gender and age not reported) who was vaccinated with a dose of Fluzone Quadrivalent via intramuscular route (Batch number: UI669AA, expiry date: 30-Jun-2017, dose, dose in series and site of administration were not reported) on 04-Oct-2016. Patient's medical history was reported that pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was unknown. Illness at the time of vaccination was also reported as unknown. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On an unknown date, unspecified timeframe following the vaccination, the patient experienced arm pain, tingling in hands/fingers, nausea and headache. Patient required emergency room (ER)/ doctor visit. Laboratory investigations and corrective treatment were not reported. The outcome of the event was reported as unknown. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Initial unsolicited report received from a pharmacist (Director of Pharmacy) on 12 October 2016. This case is linked with 2016SA189772, 2016SA189781, 2016SA189791, 2016SA189792, 2016SA189793, 2016SA189794, 2016SA189795, 2016SA189796, 2016SA189797, 2016SA189798, 2016SA189799, 2016SA189800, 2016SA189801, 2016SA189802, 2016SA189803, 2016SA189804, 2016SA189805, 2016SA189806, 2016SA189807, 2016SA189808, 2016SA189809, 2016SA189810, 2016SA189811, 2016SA189812, 2016SA189813, 2016SA189814, 2016SA189815, 2016SA189816, 2016SA189817, 2016SA189818, 2016SA189819, 2016SA189820, 2016SA189821, 2016SA189822, 2016SA189823, 2016SA189824, 2016SA189825, 2016SA189826, 2016SA189827, 2016SA189828, 2016SA189829, 2016SA189830, 2016SA189831, 2016SA189832, 2016SA189833, 2016SA189834, 2016SA189836, 2016SA189837, 2016SA189838, 2016SA189839, 2016SA189840, 2016SA189841, 2016SA189842, 2016SA189843, 2016SA189844, 2016SA189845, 2016SA189846, 2016SA189847, 2016SA189848. This case involves a patient (age and gender not reported) who was vaccinated with a dose of FLUZONE QUADRIVALENT (batch number: UI669AA, expiration date: 30 June 2017 and site of administration was not reported) intramuscularly, 04 October 2016 (over the past month). Patient's Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as unknown. Concomitant medication was not reported. On an unspecified date, (over the past month), following the vaccination patient experienced injections site red, warm to touch and small hard raised bump. It was reported that the patient required emergency room or doctor visit. Lab data and corrective treatment were not reported. Sought out treatment was reported as none. The outcome of the events was reported as unknown. List of documents held by sender: none.