chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV, FLUX, PPV, FLU4, PPV, FLU4, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Injected limb mobility decreased, Myalgia
Clinical narrative: This spontaneous case, initially received on 17-Oct-2016, was reported by a health professional and concerns a 75-year-old female patient. Weight: not provided; Height: not provided. Medical history includes unspecified pain. Concomitant medication includes an unspecified prescription pain medication. Administration of company suspect drug(s): The patient received Influenza Virus Vaccine (INN) for indication not reported from 06-OCT-2016 to 06-OCT-2016. Dose regimen: Not reported, Route of administration: Not reported. Batch number: Not reported. Non-company suspect drugs: On the same day, the patient also received an injection of PNEUMOVAX 23 for indication not reported in the opposite arm to the influenza vaccine. Dose regimen: Not reported, Route of administration: Not reported. Batch number: L038522. Adverse reactions/events and outcomes: On 06-Oct-2016 (also reported as 16-Oct-2016) later on the same day, the patient developed myalgia in the PNEUMOVAX 23 injection arm (outcome: not recovered / not resolved).  On 07-Oct-2016, the patient stated she couldn't move the arm (disability, outcome: not recovered / not resolved). The healthcare professional states that there was no redness, bumps or swelling at the injection site when he inspected the arm. The patient sought medical assistance (pharmacy visit). Treatment was given for the adverse event. No lab diagnostic studies were performed. Reporter comments: The healthcare professional considered the event 'couldn't move the arm' as serious (significant disability or incapacity). Sender's Comments: Company comments: Unlisted: Brand of Influenza vaccine not specified. Assessment according to the CCDS for CSL's Inactivated Influenza Virus Vaccine, inability to move the vaccinated arm is unlisted. Myalgia is listed. Causality: Not related. The events occurred in the arm of pneumococcal vaccine administration and not Influenza vaccination arm, hence causality is considered not related.
Age: 75.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV, FLUX, PPV, FLU4, PPV, FLU4, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Fall, Mobility decreased, Pain, Pain in extremity
Clinical narrative: This spontaneous case, initially received on 17-Oct-2016, was reported by a health professional and concerns a 75-year-old female patient. Weight: not provided; Height: not provided. Medical history includes unspecified pain. Concomitant medication includes an unspecified prescription pain medication. Administration of company suspect drug(s): The patient received Influenza Virus Vaccine (INN) for indication not reported from 06-OCT-2016 to 06-OCT-2016. Dose regimen: Not reported, Route of administration: Not reported. Batch number: Not reported. Non-company suspect drugs: On the same day, the patient also received an injection of PNEUMOVAX 23 for indication not reported in the opposite arm to the influenza vaccine. Dose regimen: Not reported, Route of administration: Not reported. Batch number: L038522. Adverse reactions/events and outcomes: On 06-Oct-2016 (also reported as 16-Oct-2016) later on the same day, the patient developed myalgia in the PNEUMOVAX 23 injection arm (outcome: not recovered / not resolved).  On 07-Oct-2016, the patient stated she couldn't move the arm (disability, outcome: not recovered / not resolved). The healthcare professional states that there was no redness, bumps or swelling at the injection site when he inspected the arm. The patient sought medical assistance (pharmacy visit). Treatment was given for the adverse event. No lab diagnostic studies were performed. Reporter comments: The healthcare professional considered the event 'couldn't move the arm' as serious (significant disability or incapacity). Sender's Comments: Company comments: Unlisted: Brand of Influenza vaccine not specified. Assessment according to the CCDS for CSL's Inactivated Influenza Virus Vaccine, inability to move the vaccinated arm is unlisted. Myalgia is listed. Causality: Not related. The events occurred in the arm of pneumococcal vaccine administration and not Influenza vaccination arm, hence causality is considered not related.
Age: 75.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV, FLUX, PPV, FLU4, PPV, FLU4, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Fall, Injected limb mobility decreased, Pain in extremity
Clinical narrative: This spontaneous case, initially received on 17-Oct-2016, was reported by a health professional and concerns a 75-year-old female patient. Weight: not provided; Height: not provided. Medical history includes unspecified pain. Concomitant medication includes an unspecified prescription pain medication. Administration of company suspect drug(s): The patient received Influenza Virus Vaccine (INN) for indication not reported from 06-OCT-2016 to 06-OCT-2016. Dose regimen: Not reported, Route of administration: Not reported. Batch number: Not reported. Non-company suspect drugs: On the same day, the patient also received an injection of PNEUMOVAX 23 for indication not reported in the opposite arm to the influenza vaccine. Dose regimen: Not reported, Route of administration: Not reported. Batch number: L038522. Adverse reactions/events and outcomes: On 06-Oct-2016 (also reported as 16-Oct-2016) later on the same day, the patient developed myalgia in the PNEUMOVAX 23 injection arm (outcome: not recovered / not resolved).  On 07-Oct-2016, the patient stated she couldn't move the arm (disability, outcome: not recovered / not resolved). The healthcare professional states that there was no redness, bumps or swelling at the injection site when he inspected the arm. The patient sought medical assistance (pharmacy visit). Treatment was given for the adverse event. No lab diagnostic studies were performed. Reporter comments: The healthcare professional considered the event 'couldn't move the arm' as serious (significant disability or incapacity). Sender's Comments: Company comments: Unlisted: Brand of Influenza vaccine not specified. Assessment according to the CCDS for CSL's Inactivated Influenza Virus Vaccine, inability to move the vaccinated arm is unlisted. Myalgia is listed. Causality: Not related. The events occurred in the arm of pneumococcal vaccine administration and not Influenza vaccination arm, hence causality is considered not related.
Age: 75.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV, FLUX, PPV, FLU4, PPV, FLU4, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Mobility decreased, Myalgia
Clinical narrative: This spontaneous case, initially received on 17-Oct-2016, was reported by a health professional and concerns a 75-year-old female patient. Weight: not provided; Height: not provided. Medical history includes unspecified pain. Concomitant medication includes an unspecified prescription pain medication. Administration of company suspect drug(s): The patient received Influenza Virus Vaccine (INN) for indication not reported from 06-OCT-2016 to 06-OCT-2016. Dose regimen: Not reported, Route of administration: Not reported. Batch number: Not reported. Non-company suspect drugs: On the same day, the patient also received an injection of PNEUMOVAX 23 for indication not reported in the opposite arm to the influenza vaccine. Dose regimen: Not reported, Route of administration: Not reported. Batch number: L038522. Adverse reactions/events and outcomes: On 06-Oct-2016 (also reported as 16-Oct-2016) later on the same day, the patient developed myalgia in the PNEUMOVAX 23 injection arm (outcome: not recovered / not resolved).  On 07-Oct-2016, the patient stated she couldn't move the arm (disability, outcome: not recovered / not resolved). The healthcare professional states that there was no redness, bumps or swelling at the injection site when he inspected the arm. The patient sought medical assistance (pharmacy visit). Treatment was given for the adverse event. No lab diagnostic studies were performed. Reporter comments: The healthcare professional considered the event 'couldn't move the arm' as serious (significant disability or incapacity). Sender's Comments: Company comments: Unlisted: Brand of Influenza vaccine not specified. Assessment according to the CCDS for CSL's Inactivated Influenza Virus Vaccine, inability to move the vaccinated arm is unlisted. Myalgia is listed. Causality: Not related. The events occurred in the arm of pneumococcal vaccine administration and not Influenza vaccination arm, hence causality is considered not related.
Age: 75.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV, FLUX, PPV, FLU4, PPV, FLU4, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Disability, Mobility decreased
Clinical narrative: This spontaneous case, initially received on 17-Oct-2016, was reported by a health professional and concerns a 75-year-old female patient. Weight: not provided; Height: not provided. Medical history includes unspecified pain. Concomitant medication includes an unspecified prescription pain medication. Administration of company suspect drug(s): The patient received Influenza Virus Vaccine (INN) for indication not reported from 06-OCT-2016 to 06-OCT-2016. Dose regimen: Not reported, Route of administration: Not reported. Batch number: Not reported. Non-company suspect drugs: On the same day, the patient also received an injection of PNEUMOVAX 23 for indication not reported in the opposite arm to the influenza vaccine. Dose regimen: Not reported, Route of administration: Not reported. Batch number: L038522. Adverse reactions/events and outcomes: On 06-Oct-2016 (also reported as 16-Oct-2016) later on the same day, the patient developed myalgia in the PNEUMOVAX 23 injection arm (outcome: not recovered / not resolved).  On 07-Oct-2016, the patient stated she couldn't move the arm (disability, outcome: not recovered / not resolved). The healthcare professional states that there was no redness, bumps or swelling at the injection site when he inspected the arm. The patient sought medical assistance (pharmacy visit). Treatment was given for the adverse event. No lab diagnostic studies were performed. Reporter comments: The healthcare professional considered the event 'couldn't move the arm' as serious (significant disability or incapacity). Sender's Comments: Company comments: Unlisted: Brand of Influenza vaccine not specified. Assessment according to the CCDS for CSL's Inactivated Influenza Virus Vaccine, inability to move the vaccinated arm is unlisted. Myalgia is listed. Causality: Not related. The events occurred in the arm of pneumococcal vaccine administration and not Influenza vaccination arm, hence causality is considered not related.
Age: 0.33
Sex: F
Vaccine: RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This is a spontaneous report from a contactable physician. This physician reported similar events for 2 patients. This is the first of two reports. A 4-month-old female patient of an unspecified race received the second dose of PREVNAR 13; (lot number M98916, expiration date 30Sep2017), via intramuscular route of administration in the right leg, on 30Aug2016 11:30, at 0.5ml single dose for immunization.  On the same date the patient also received  the second dose of diphtheria vaccine, PENTACEL (Sanofi Pasteur Lot# C0588AA) via intramuscular route in the left leg and the second dose of ROTATEQ (Manufacturer: Merck Lot# M019707) oral. The patient medical history included neonatal Jaundice, nasal congestion ongoing since 26May2016, new born rash ongoing since 26May2016. For the rash the patient had received hydrocortisone but the rash did not improve. The patient received the vaccine after a temperature excursion. The refrigerator temperature went down to 1.3 degree Celsius for about 46 minutes. No event occurred. The patient received the vaccine at the private physician's office. Follow up (18Oct2016): additional information received from the contactable nurse includes route of administration, prescribed dose, time of vaccination and date, anatomical location of the administration of the vaccine, Batch/Lot and patient medical history. Sender's Comments: Linked Report(s): US-PFIZER INC-2016443997 similar report from same reporter.
Age: 0.33
Sex: F
Vaccine: RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Incorrect product storage
Clinical narrative: This is a spontaneous report from a contactable physician. This physician reported similar events for 2 patients. This is the first of two reports. A 4-month-old female patient of an unspecified race received the second dose of PREVNAR 13; (lot number M98916, expiration date 30Sep2017), via intramuscular route of administration in the right leg, on 30Aug2016 11:30, at 0.5ml single dose for immunization.  On the same date the patient also received  the second dose of diphtheria vaccine, PENTACEL (Sanofi Pasteur Lot# C0588AA) via intramuscular route in the left leg and the second dose of ROTATEQ (Manufacturer: Merck Lot# M019707) oral. The patient medical history included neonatal Jaundice, nasal congestion ongoing since 26May2016, new born rash ongoing since 26May2016. For the rash the patient had received hydrocortisone but the rash did not improve. The patient received the vaccine after a temperature excursion. The refrigerator temperature went down to 1.3 degree Celsius for about 46 minutes. No event occurred. The patient received the vaccine at the private physician's office. Follow up (18Oct2016): additional information received from the contactable nurse includes route of administration, prescribed dose, time of vaccination and date, anatomical location of the administration of the vaccine, Batch/Lot and patient medical history. Sender's Comments: Linked Report(s): US-PFIZER INC-2016443997 similar report from same reporter.
Age: 5.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 5-year-old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. On 07-OCT-2016, the patient was inadvertently vaccinated with a dose of GARDASIL 9 lot # L036301, expiration date 20-DEC-2017 (route of administration and dose were not reported) instead of influenza virus vaccine. There was no adverse event reported. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 5-year-old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. On 07-OCT-2016, the patient was inadvertently vaccinated with a dose of GARDASIL 9 lot # L036301, expiration date 20-DEC-2017 (route of administration and dose were not reported) instead of influenza virus vaccine. There was no adverse event reported. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Injection site discomfort, Injection site erythema, Injection site warmth
Clinical narrative: Rash. 12 x 10 cm over course 24 hours.
Age: 73.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Rash
Clinical narrative: Rash. 12 x 10 cm over course 24 hours.
Age: 34.0
Sex: M
Vaccine: FLU3, HEPAB, TDAP
Symptoms: Headache, Injection site pain, Injection site reaction, Musculoskeletal stiffness, Oropharyngeal pain
Clinical narrative: ACCORDING TO PATIENT: PATIENT HAS HAVE SYMPTOMS OF SORE THROAT, HEADACHE, PAIN AT INJECTION SITES, SWOLLEN IN THE HANDS, STIFFNESS AT RIGHT SHOULDER AND HAND, PAIN LIKE NEEDLE PINCH, NO FEVER.
Age: 34.0
Sex: M
Vaccine: FLU3, HEPAB, TDAP
Symptoms: Pain, Peripheral swelling
Clinical narrative: ACCORDING TO PATIENT: PATIENT HAS HAVE SYMPTOMS OF SORE THROAT, HEADACHE, PAIN AT INJECTION SITES, SWOLLEN IN THE HANDS, STIFFNESS AT RIGHT SHOULDER AND HAND, PAIN LIKE NEEDLE PINCH, NO FEVER.
Age: 19.0
Sex: F
Vaccine: HPVX
Symptoms: Cold sweat, Computerised tomogram head, Dizziness, Full blood count, Hyperhidrosis
Clinical narrative: Hot and cold sweats, palpitations, dizziness.
Age: 19.0
Sex: F
Vaccine: HPVX
Symptoms: Metabolic function test, Palpitations, Urine analysis
Clinical narrative: Hot and cold sweats, palpitations, dizziness.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Redness/pain/warmth at injection site measuring approximately 5.5cm x 5cm.  Patient 28 weeks pregnant.
Sex: F
Vaccine: FLUX
Symptoms: Ophthalmic herpes zoster
Clinical narrative: This spontaneous case, initially received on 17-Oct-2016, was reported by a company representative and concerns an 18-year-old female patient. Weight: not provided; Height: not provided. Administration of company suspect drug(s): On an unknown date (after NEXPLANON insertion), the patient received Influenza Virus Vaccine (INN) for indication not reported. Dose regimen: Not reported, Route of administration: Not reported. Batch number: Not reported. Non-company suspect drugs: On 07-Sep-2016, the patient received NEXPLANON for the prevention of pregnancy. Dose regimen: Not reported, Route of administration: Intradermal. Batch number: Not reported. Adverse reactions/events and outcomes: On an unspecified date in 2016 following NEXPLANON insertion and subsequent flu vaccination, the patient was diagnosed with shingles in her retina (did not specify which eye) (medically significant, outcome: recovering / resolving). The reporter stated that the patient was already symptomatic during the time of the flu shot with spots on her face and forehead. The patient sought medical attention (office visit). It is unknown whether the patient received treatment or whether lab diagnostic studies were performed. Sender's Comments: Company comments: Listedness: Brand of vaccine not specified. Assessment according to the CCDS for CSL's Inactivated Influenza Virus Vaccine, Herpes ophthalmic is unlisted. Causality: Not Related. Patient was symptomatic with lesion on her face at time of receiving vaccination. Ophthalmic herpes zoster is due to varicella-zoster virus  reactivation involving in the ophthalmic division of the trigeminal nerve; hence not related to Influenza vaccine.
Sex: U
Vaccine: MNQ, TDAP
Symptoms: Eye movement disorder, Tremor
Clinical narrative: Initial unsolicited case received from a physician on 12-Oct-2016. This case involves patient who was vaccinated with a dose of ADACEL and a dose of MENACTRA (batch number, expiry date, route and site of administration: not reported for both vaccines) on an unspecified date (reported as in last week). Patient's medical history and concomitant medications were not reported. On an unspecified date, at the same time (of vaccination) and the patients eyes rolled back and they started shaking. Patient's lab data and corrective treatment was not reported. The outcome of the events was not reported. List of documents held by sender: none.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Haematoma, Injection site discolouration, Injection site pain, Local swelling, Swelling face
Clinical narrative: Initial unsolicited case received from a pharmacist 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, 2016SA189835, 2016SA189836, 2016SA189837, 2016SA189838, 2016SA189839, 2016SA189840, 2016SA189841, 2016SA189842, 2016SA189843, 2016SA189844, 2016SA189845, 2016SA189846, 2016SA189847, 2016SA189848. This case involves a patients of unspecified age and gender who was vaccinated with FLUZONE (lot number:UI669AA, Expiration date:30 June 2016, site of administration and dose details were not reported) by intramuscular route on 4th October 2016. The medical history and concomitant medications were not reported. The illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as unknown. On 6 October 2016, two days following vaccination, the patients experienced hematoma, arm still slightly discolored where the shot was given and slight pain, almost feels swollen going up neck on right side of the face (side received shot). The lab test was not reported and the corrective treatment was reported as no. The outcome of the events was reported as unknown. Documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Cough, Productive cough, Respiratory symptom, Rhinorrhoea, Sinus headache
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, 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 reporter, same vaccine, same lot number). This case involves a patient of unknown age and gender, who was vaccinated with a dose of FLUZONE (batch number: UI669AA, expiry date: 30-JUN-2017 and site of administration was not reported) via intramuscularly on 04 October 2016 (also reported as 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. On unspecified date (also reported as over the past month), following vaccination, the patient had upper respiratory issures, like bad sinus headaches, go to bed with ice on head. Abnormal amounts of phlegm in throat, runny nose and cough. It was reported that the patient required emergency room or doctor visit. Lab data was not reported. Corrective treatment was reported as no. It was also reported as patient go to bed with ice on head. The outcome of the events was reported as unknown. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Limb mass, Pain in extremity, Skin warm
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, 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 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 were not reported) in the arm on 04-Oct-2016. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions 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 and duration following the vaccination, the patient developed sore arm with lump that was warm ('war') to touch. Patient required emergency room (ER)/ doctor visit. Laboratory investigations were not reported. Corrective treatment was reported as 'no'.  The outcome of events was reported as unknown. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Axillary pain, Burning sensation, Headache
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, 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 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 pre-existing physician diagnosed allergies, birth defects, medical conditions 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 05-Oct-2016, one day following the vaccination (reported as throughout the night of 05-Oct-2016), the patient developed pain in axillary area, burning and headache. Patient required emergency room (ER)/ doctor visit. Laboratory investigations was not reported. Corrective treatment was reported as 'no'. The outcome of events burning and headache was reported as unknown and the event pain was not recovered at the time of reporting (reported as 'still pain in underarm area'). List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Erythema, Lymphadenopathy, Paraesthesia oral, Speech disorder, Swelling
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, 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 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 04 October 2016 (over the past month) same day following vaccination patient experienced red and swollen. On 06 October 2016, (over the past month) two days following vaccination patient had glands on right side of neck swollen and its pushing on patients tongue (tungue) which making tongue feel weird and speech was hard to from words. 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: F
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Initial unsolicited case received from a consumer (patient daughter) on 19 Oct 2016. This case involves a female patient (age not reported) who was vaccinated with a dose of FLU VACCINE (Batch number, expiry date, route, dose and site of administration was not reported) on an unknown date ten years ago. The patient illness at the time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as not provided and any other vaccinations within four weeks of vaccinations was reported as none. The patient concomitant medications were not reported. On an unknown date, after vaccination the patient experienced with Guillain Barre Syndrome. On an unknown date the patient was hospitalized which resulted in prolonged hospitalization and she spent time in nursing home. The patient corrective treatment was not reported. The patient lab tests were not reported. (Reported as unable to provide information). The outcome of the event was reported as recovered on an unknown date. It was reported that doctor told the patient that event was directly related to a vaccine. List of documents held by sender: none. Sender's Comments: Guillain Barre Syndrome is unlisted with INFLUENZA VACCINE (Unknown manufacturer). This is poorly documented case. However, investigation results ruling out a concurrent condition and other etiologies would be helpful to further assess this case.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a 75 year old male consumer referring to himself. The patient's concurrent condition included chronic obstructive pulmonary disease (COPD), arthritis and many other unspecified conditions he did not want to list. Concomitant therapy included 25-30 different unspecified medications. The patient did not have drug reactions. In approximately 2014 (reported as about two years ago) the patient was vaccinated with ZOSTAVAX (one shot, lot# and expiration date and route were unknown). On approximately 20-AUG-2016 (reported as two months ago) the patient experienced shingles twice "back to back". On 10-OCT-2016 the patient was admitted to a hospital and stayed there for 8 days. The outcome of the event was reported as not recovered. Causality was not provided. Additional information is not expected since there is no consent to contact the physician.
Age: 78.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Erythema, Monoplegia, Peripheral swelling
Clinical narrative: This spontaneous report as received from a licensed nurse practitioner refers to a 78 year old male patient. The patient's pertinent medical history included sleep apnoea syndrome, hypertension, gout, hyperlipidaemia and osteoarthritis. It was reported that the patient did not have any drug reactions and allergies. On 14-OCT-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # M022947 and expiry date: 12-NOV-2017) 0.5 ml, intramuscularly. Concomitant therapies included allopurinol (Manufacturer unknown), losartan (Manufacturer unknown), metoprolol (Manufacturer unknown), NEURONTIN, simvastatin(manufacturer unknown) and aspirin (manufacturer unknown). On 15-OCT-2016, the patient "felt like his arm was paralyzed (monoplegia), his arm was swollen, red and his hand was swollen (unspecified arm and hand). There were no lab tests performed and there was no treatment given for the events. The patient sought medical attention and visited the office on 21-OCT-2016 in regards to the reaction during which the reporter stated that he still had swelling in his hand. The outcome of monoplegia and erythema was unknown and outcome of peripheral swelling was reported as not recovered. The causality was not reported. There was no product quality complaint involved. Upon internal review, the event monoplegia was determined to be medically significant. Additional information has been requested.
Age: 78.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Hypoaesthesia, Injection site erythema, Injection site hypoaesthesia, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a licensed nurse practitioner refers to a 78 year old male patient. The patient's pertinent medical history included sleep apnoea syndrome, hypertension, gout, hyperlipidaemia and osteoarthritis. It was reported that the patient did not have any drug reactions and allergies. On 14-OCT-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # M022947 and expiry date: 12-NOV-2017) 0.5 ml, intramuscularly. Concomitant therapies included allopurinol (Manufacturer unknown), losartan (Manufacturer unknown), metoprolol (Manufacturer unknown), NEURONTIN, simvastatin(manufacturer unknown) and aspirin (manufacturer unknown). On 15-OCT-2016, the patient "felt like his arm was paralyzed (monoplegia), his arm was swollen, red and his hand was swollen (unspecified arm and hand). There were no lab tests performed and there was no treatment given for the events. The patient sought medical attention and visited the office on 21-OCT-2016 in regards to the reaction during which the reporter stated that he still had swelling in his hand. The outcome of monoplegia and erythema was unknown and outcome of peripheral swelling was reported as not recovered. The causality was not reported. There was no product quality complaint involved. Upon internal review, the event monoplegia was determined to be medically significant. Additional information has been requested.
Age: 78.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Swelling
Clinical narrative: This spontaneous report as received from a licensed nurse practitioner refers to a 78 year old male patient. The patient's pertinent medical history included sleep apnoea syndrome, hypertension, gout, hyperlipidaemia and osteoarthritis. It was reported that the patient did not have any drug reactions and allergies. On 14-OCT-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # M022947 and expiry date: 12-NOV-2017) 0.5 ml, intramuscularly. Concomitant therapies included allopurinol (Manufacturer unknown), losartan (Manufacturer unknown), metoprolol (Manufacturer unknown), NEURONTIN, simvastatin(manufacturer unknown) and aspirin (manufacturer unknown). On 15-OCT-2016, the patient "felt like his arm was paralyzed (monoplegia), his arm was swollen, red and his hand was swollen (unspecified arm and hand). There were no lab tests performed and there was no treatment given for the events. The patient sought medical attention and visited the office on 21-OCT-2016 in regards to the reaction during which the reporter stated that he still had swelling in his hand. The outcome of monoplegia and erythema was unknown and outcome of peripheral swelling was reported as not recovered. The causality was not reported. There was no product quality complaint involved. Upon internal review, the event monoplegia was determined to be medically significant. Additional information has been requested.
Age: 84.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Lung infiltration, Pneumonia
Clinical narrative: Patient reported productive chest cough starting same day as influenza vaccine administration; attempted to follow up with primary physician.  After two attempts was seen in ED/UC. Overall well appearing to ED physician; chest x-ray indicated  likely right lower lobe infiltrate consistent with pneumonia. Treated with Doxycycline 100 mg bid for 7 days.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Abasia, Feeling cold, Injection site erythema, Injection site inflammation, Injection site pruritus
Clinical narrative: Chills Fever Bodyache hard to walk and sit, leg aches. Fever started as low grade 99.8. 10/12/2016 fever up to 102.3. Averaged 101 until 10/15, 9:AM. Friday injection site stated to redden and swell, next day worsened, started to ease 1/16/16 2:PM. 10/21/16 first day feeling better. 10/25/16 injection site almost back to normal- still some itch I recieved both the Flu Vaccine and Pneumonia Vaccine. The Pneumonia vaccine appears to be the culprit- that is the arm that got inflamed.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling, Pain, Pain in extremity, Pyrexia
Clinical narrative: Chills Fever Bodyache hard to walk and sit, leg aches. Fever started as low grade 99.8. 10/12/2016 fever up to 102.3. Averaged 101 until 10/15, 9:AM. Friday injection site stated to redden and swell, next day worsened, started to ease 1/16/16 2:PM. 10/21/16 first day feeling better. 10/25/16 injection site almost back to normal- still some itch I recieved both the Flu Vaccine and Pneumonia Vaccine. The Pneumonia vaccine appears to be the culprit- that is the arm that got inflamed.
Age: 6.0
Sex: M
Vaccine: FLU4, FLUX
Symptoms: Anaphylactic reaction, Throat irritation, Urticaria, Wheezing
Clinical narrative: Hives, itchy throat, wheezing, anaphylaxis symptoms. Given epi-pen at home, has other life threatening allergies, taken to ED by family after epi-pen administered.
Age: 6.0
Sex: M
Vaccine: FLU4, FLUX
Symptoms: Cough, Injection site swelling, Throat irritation, Urticaria, Wheezing
Clinical narrative: Hives, itchy throat, wheezing, anaphylaxis symptoms. Given epi-pen at home, has other life threatening allergies, taken to ED by family after epi-pen administered.
Age: 6.0
Sex: M
Vaccine: FLU4, FLUX
Symptoms: Anaphylactic reaction, Throat irritation, Urticaria, Wheezing
Clinical narrative: Itchy throat, cough, wheezing, hives, swollen R arm where flu shot was administered.  He was given Allegra and epinephrine 0.15mg IM and observed in the ER.  Itchy throat, cough, and wheezing subsided after Epi was given.  Hives resolved 10 hours later.
Age: 6.0
Sex: M
Vaccine: FLU4, FLUX
Symptoms: Cough, Injection site swelling, Throat irritation, Urticaria, Wheezing
Clinical narrative: Itchy throat, cough, wheezing, hives, swollen R arm where flu shot was administered.  He was given Allegra and epinephrine 0.15mg IM and observed in the ER.  Itchy throat, cough, and wheezing subsided after Epi was given.  Hives resolved 10 hours later.
Age: 16.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site warmth, Urticaria
Clinical narrative: Site of injection was red, hot and inflamed. Also patient said it was painful to the touch and broke in hives.
Sex: U
Vaccine: FLU4
Symptoms: Induration, Local reaction, Mass, Pruritus
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, 2016SA189827, 2016SA189828, 2016SA189829, 2016SA189830, 2016SA189831, 2016SA189832, 2016SA189833, 2016SA189834, 2016SA189835, 2016SA189836, 2016SA189837, 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 (FLUZONE) batch number: UI669AA, expiration date: 30-JUN-2017, 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: hard, itchy lump. 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: Erythema, Pain in extremity, Peripheral swelling, 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, 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, 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 (batch number: UI669AA, expiration date: 30 June 2017) via intramuscular route (dose in series, dose and site of administration was not reported), on 04 October 2016. Patient's medical history and concomitant medication were not reported. On an unspecified date, (it was reported as Over the past month ) following the vaccination, the patient had experienced sore arm, redness, warm to touch and raised area approximately 2 x 3 inches. Relevant laboratory data was not reported. Ongoing Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as unknown. Corrective treatment was not reported. The outcome of the events was reported as unknown. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Headache, Injection site pruritus, Injection site warmth, Nausea, Peripheral swelling
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, 2016SA189835, 2016SA189836, 2016SA189837, 2016SA189838, 2016SA189839, 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 (batch number: UI669AA, expiration date: 30 June 2017) via intramuscular route (dose in series, dose and site of administration was not reported), on 04 October 2016. Patient's medical history and concomitant medication were not reported. On an unspecified date,(It was reported as Over the past month ) following the vaccination, the patient had experienced arm swelling (size of baseball), real itchy, hot to touch at site, headache and nausea for 32 hours. Relevant laboratory data was not reported. Ongoing Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as unknown. Corrective treatment was not reported. On an unspecified date the patient was recovered from the event nausea and the outcome for other event was unknown. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Inflammation, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Initial unsolicited report received from a pharmacist 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, 2016SA189835, 2016SA189836, 2016SA189837, 2016SA189838, 2016SA189839, 2016SA189840, 2016SA189841, 2016SA189843, 2016SA189844, 2016SA189845, 2016SA189846, 2016SA189847, 2016SA189848. (Same vaccine). This case involves a patient of unknown age and gender, who was vaccinated with FLUZONE intramuscularly (batch number: UI669AA, expiry date: 30 June 2017 (dose, dose in series were not reported) in the left arm on 04 October 2016. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions 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 unspecified date and duration following vaccination, the patient developed left arm, red, swollen down not elbow and raised area approximately 7cm by 6 cm ('6 em'), warm to touch, hurt at injection site. On 05 October 2016, one day post vaccination the patient felt ill. The patient needed ER visit. Laboratory data was not reported. Corrective treatment was reported as 'no'. The outcome of the events inflammation localized and vaccination site reaction was reported as unknown and on 06 October 2016 the patient recovered from illness. List of documents held by sender: none.