chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Blepharospasm, Brain injury, Cytogenetic analysis normal, Developmental delay, Diarrhoea
Clinical narrative: My daughter start with up normal diarrhea yellow liquid color and rolling her eyes then she start twitched her hand and eyes then she got seizure and brain injury that is make disability for her development until now they destroyed all my family life.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Eye movement disorder, Muscle twitching, Seizure
Clinical narrative: My daughter start with up normal diarrhea yellow liquid color and rolling her eyes then she start twitched her hand and eyes then she got seizure and brain injury that is make disability for her development until now they destroyed all my family life.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Cough, Dizziness, Eye pain, Oropharyngeal pain
Clinical narrative: CHILLS, SORE THROAT, CONGESTED CHEST, COUGH, SORE EYES, DIZZY, RUNNY NOSE.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Respiratory tract congestion, Rhinorrhoea
Clinical narrative: CHILLS, SORE THROAT, CONGESTED CHEST, COUGH, SORE EYES, DIZZY, RUNNY NOSE.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Eyelid oedema, Induration, Injection site erythema, Injection site pain
Clinical narrative: PATIENT STATED APPROX. 15-20 MINUTES AFTER VACCINE PATIENT COMPLAINED OF DIZZINESS, NAUSEA, LEFT ARM, SHOULDER AND NECK PAIN AND EYELIDS AND LIPS SWELLING. LATER IN THE DAY SHE STATES SHE DEVELOPED A RED, HOT, ITCHY 4 INCH AREA AROUND WHERE VACCINE WAS ADMINISTERED. PATIENT CALLED AND REPORTED SYMPTOMS ON MONDAY (10/17/2016) AND STATED ENDURATED AREA WAS IMPROVING, NOT AS RED AND ITCHY.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pruritus, Lip swelling, Nausea, Neck pain, Pain in extremity
Clinical narrative: PATIENT STATED APPROX. 15-20 MINUTES AFTER VACCINE PATIENT COMPLAINED OF DIZZINESS, NAUSEA, LEFT ARM, SHOULDER AND NECK PAIN AND EYELIDS AND LIPS SWELLING. LATER IN THE DAY SHE STATES SHE DEVELOPED A RED, HOT, ITCHY 4 INCH AREA AROUND WHERE VACCINE WAS ADMINISTERED. PATIENT CALLED AND REPORTED SYMPTOMS ON MONDAY (10/17/2016) AND STATED ENDURATED AREA WAS IMPROVING, NOT AS RED AND ITCHY.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Vaccination site warmth
Clinical narrative: PATIENT STATED APPROX. 15-20 MINUTES AFTER VACCINE PATIENT COMPLAINED OF DIZZINESS, NAUSEA, LEFT ARM, SHOULDER AND NECK PAIN AND EYELIDS AND LIPS SWELLING. LATER IN THE DAY SHE STATES SHE DEVELOPED A RED, HOT, ITCHY 4 INCH AREA AROUND WHERE VACCINE WAS ADMINISTERED. PATIENT CALLED AND REPORTED SYMPTOMS ON MONDAY (10/17/2016) AND STATED ENDURATED AREA WAS IMPROVING, NOT AS RED AND ITCHY.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Initial unsolicited report received from an office staff on 05 Oct 2016. This case involves an 8-yeras-old female patient who was vaccinated with Second dose of FLUZONE (manufacturer: Sanofi Pasteur INC.)(Batch number, expiry date, site of administration and Route: unknown) on 05 Oct 2016. Medical history and concomitant medications were not reported. On 05 Oct 2016, the reporter reported that the patient developed rash over fore arm and lower back of body. Laboratory investigation and corrective treatment were not reported. The outcome of the event was not recovered. List of documents held by sender: none.
Sex: F
Vaccine: TD
Symptoms: Peripheral swelling
Clinical narrative: Initial unsolicited report received from a pharmacist via other company (Pfizer) on 05 Oct 2016. This case involves a female patient age unknown who was vaccinated with a dose of TETANUS/DIPTHERIA (batch number, expiry date of the product, dose, route and site of administration was not reported) on an unknown date (about 15 years ago). The patient's medical history and concomitant medications were not reported. On an unknown date and unspecified duration following the vaccination (about 15 years ago), the patient experienced swelling of the arm. The patient's lab tests and corrective treatment were not reported. The outcome of the event were unknown. List of documents held by sender: none.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site mass
Clinical narrative: Initial unsolicited report received from a pharmacist on 11-Oct- 2016. This case involves a 76-year-old female patient who was vaccinated with a dose of Fluzone HD via intramuscular route (lot number: UI664AA, expiration date: 06-Apr-2017; dose not reported) in right deltoid on 11-Oct-2016. Reporter denied illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions. On 11-Oct-2016, same day after vaccination, the patient experienced a bump at the injection site. Lab data and corrective treatment were not reported. The outcome of the events was reported as unknown. List of the documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis
Clinical narrative: Initial unsolicited case received from a nurse on 11-Oct-2016. This case involves a female patient (age not reported) who was vaccinated with a dose of Fluzone (Batch number, expiry date, route and site of administration: not reported) on an unspecified date (reported as last year). Patient's medical history and concomitant medications were not reported. On an unspecified date, post vaccination, the patient experienced cellulitis. It was reported that, patient also had vaccinated with Fluzone two year ago and developed cellulitis. Patient's lab data was not reported. Corrective treatment received was antibiotics. The outcome of the events was not reported. Upon internal review, the company decided to consider the event serious because of important medical event cellulitis. List of documents held by sender: none. Sender's Comments: Cellulitis is unlisted with INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE. This is poorly documented case. However, investigation results ruling out a concurrent condition and other etiologies would be helpful to further assess this case. More over patient received more than one vaccine hence role of a particular vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Bronchitis
Clinical narrative: Initial unsolicited report received from a consumer via social media on 10 Oct 2016. This case is linked to 2016SA188144, 2016SA188556, 2016SA188803, 2016SA188804, 2016SA188805, 2016SA188806, 2016SA188807, 2016SA188808, 2016SA188809, 2016SA188811, 2016SA188812, 2016SA188813, 2016SA188814, 2016SA188815, 2016SA188816, 2016SA188817, 2016SA188818, 2016SA188819, 2016SA188820, 2016SA188821, 2016SA188822, 2016SA188833, 2016SA188834, 2016SA188835, 2016SA188836, 2016SA188837, 2016SA188838, 2016SA188839, 2016SA188840, 2016SA188841, 2016SA188842, 2016SA188843, 2016SA188844, 2016SA188845, 2016SA188846, 2016SA188847, 2016SA188848, 2016SA188849, 2016SA188850, 2016SA188851 (same site, same vaccine). This case involves a patient (age and gender not reported) who was vaccinated with a dose of Flu Shot (manufacuturer: unknown batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, post vaccination the patient was down with bronchitis. Lab data and corrective treatment was not reported. Outcome of the event was not reported. List of documents held by sender: none.
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Initial unsolicited case received from consumer via social media on 10-Oct-2016. This case is linked to 2016SA188144, 2016SA188556, 2016SA188803, 2016SA188804, 2016SA188805, 2016SA188806, 2016SA188807, 2016SA188808, 2016SA188809, 2016SA188810, 2016SA188811, 2016SA188812, 2016SA188813, 2016SA188814, 2016SA188815, 2016SA188816, 2016SA188817, 2016SA188818, 2016SA188819, 2016SA188820, 2016SA188821, 2016SA188822, 2016SA188833, 2016SA188834, 2016SA188835, 2016SA188836, 2016SA188837, 2016SA188838, 2016SA188839, 2016SA188840, 2016SA188841, 2016SA188842, 2016SA188843, 2016SA188844, 2016SA188845, 2016SA188846, 2016SA188848, 2016SA188849, 2016SA188850, 2016SA188851 (same source, same vaccine). This case involves a male patient (age not reported) who was vaccinated with a dose of FLU SHOT (manufacturer: unknown, batch number, expiry date, route and site of administration: not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, post vaccination, the patient experienced flu. (It was reported that the only time in his life he got the flu was the one year he got a flu shot.) 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: 68.0
Sex: F
Vaccine: FLUX
Symptoms: Pneumonia
Clinical narrative: Initial unsolicited report received from consumer on 10 October 2016. This case is linked to 2016SA188144, 2016SA188556, 2016SA188803, 2016SA188804, 2016SA188805, 2016SA188806, 2016SA188807, 2016SA188808, 2016SA188809, 2016SA188810, 2016SA188811, 2016SA188812, 2016SA188813, 2016SA188814, 2016SA188815, 2016SA188816, 2016SA188817, 2016SA188818, 2016SA188819, 2016SA188820, 2016SA188821, 2016SA188822, 2016SA188833, 2016SA188834, 2016SA188835, 2016SA188836, 2016SA188837, 2016SA188838, 2016SA188839, 2016SA188840, 2016SA188841, 2016SA188842, 2016SA188843, 2016SA188844, 2016SA188845, 2016SA188846, 2016SA188847, 2016SA188848, 2016SA188849 and 2016SA188851. (Same vaccine) This case involves 68-year-old female patient who was vaccinated with first dose of Flu Shot (Batch number, expiration date, dose, route and site of administration were not reported) on an unspecified date. Patient medical history and concomitant medication were not reported. On an unspecified date, following vaccination patient had pneumonia. On an unspecified date patient was hospitalized. Lab data and corrective treatment were not reported. Outcome of event was not reported. List of documents held by sender: none. Sender's Comments: This is poorly documented case as patient take flu shot and had pneumonia. Time to onset is unknown, additional information regarding patient medical history, immune status, past vaccination history and its tolerance are needed to further assess the case. Patient was admitted twice for pneumonia. Based on available information the role of vaccine cannot be assessed.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Malaise, Nausea, Pyrexia, Urticaria
Clinical narrative: Dizzyness, nausea, hives to both arms, fever 101.7, malaise.
Age: 0.33
Sex: M
Vaccine: DTAP
Symptoms: Adenoidal disorder, Crying, Drug administered at inappropriate site, Ear infection, Ear operation
Clinical narrative: Intense screaming and crying; high fever of 105.5* and higher.  Large, purple knot formed at the site of the injection.  Lymph nodes swelled and became hard.
Age: 0.33
Sex: M
Vaccine: DTAP
Symptoms: Eustachian tube obstruction, Hypoacusis, Induration, Injection site nodule, Injection site pain
Clinical narrative: Intense screaming and crying; high fever of 105.5* and higher.  Large, purple knot formed at the site of the injection.  Lymph nodes swelled and became hard.
Age: 0.33
Sex: M
Vaccine: DTAP
Symptoms: Lymphadenopathy, Pyrexia, Screaming, Speech disorder
Clinical narrative: Intense screaming and crying; high fever of 105.5* and higher.  Large, purple knot formed at the site of the injection.  Lymph nodes swelled and became hard.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: Redness and swelling of arm where vaccine was administered. Arm circumference reported to be 1/2 inch larger than unaffected arm.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Rash, Skin warm
Clinical narrative: This spontaneous report as received from a physician refers to a 60 year old female patient. Her concurrent conditions included an unspecified blood pressure disorder and increased level of blood cholesterol. The patient had no known drug reactions or allergies. On 11-OCT-2016, the patient was vaccinated subcutaneously with a dose of ZOSTAVAX injection (dose, lot # and expiration date were not reported). Concomitant medications included an unspecified blood pressure and cholesterol lowering medications. On 12-OCT-2016 (reported as on the following day), the patient developed a hot rash on her left arm and pain. The patient did not develop a fever, denied chills and had not developed any pus at the injection site. The patient sought an unspecified type of medical attention but no treatment was given for the adverse events and no lab diagnostics studies were performed. The outcome of the adverse events was reported as not recovered/not resolved. The relatedness between the adverse events and ZOSTAVAX was not provided. The reporter considered the event of pain to be serious, as it caused a significant disability. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Feeling abnormal, Headache, Injection site erythema, Injection site nodule, Nasal congestion
Clinical narrative: Headache, stuffy nose, nasal congestion, sore throat, general misery. Red circular (2in. in diameter) knot sore to the touch at injection site. Called clinic to follow up. Has had flu shots before with no reaction. Administered nasal wash, asthma maintenance inhalers, OTC cold medicine.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Oropharyngeal pain
Clinical narrative: Headache, stuffy nose, nasal congestion, sore throat, general misery. Red circular (2in. in diameter) knot sore to the touch at injection site. Called clinic to follow up. Has had flu shots before with no reaction. Administered nasal wash, asthma maintenance inhalers, OTC cold medicine.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MEN
Symptoms: Erythema, Local reaction, Pain in extremity, Peripheral swelling
Clinical narrative: Local reaction to right arm with pain, swelling, and redness.
Age: 7.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Face injury, Fall, Syncope
Clinical narrative: Patient fainted when he got up to walk down the hall. Hit side of cheek on wall when he went down. Got him sitting up and in a chair. Given water and cool towel, assessed by physician.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Fever of 102.2 axillary starting at 1230am and extending throughout the day. On 10/14/16 fever was down to 101.4 axillary and pt started to present with a fine rash over trunk and extremities. On 10/15/16, fever was gone and rash was worse. By 10/17/16 rash was gone.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Sore arm, difficulty with full range of motion in arm.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Oedema, Pain, Peripheral swelling, Pruritus
Clinical narrative: Child told mother next morning arm was swollen, itching and hurting. Mother noted rash from shoulder to neck, arm with increased redness and edema. Warm to touch.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Skin warm
Clinical narrative: Child told mother next morning arm was swollen, itching and hurting. Mother noted rash from shoulder to neck, arm with increased redness and edema. Warm to touch.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Musculoskeletal pain
Clinical narrative: Erythema, induration and severe pain at injection site. Pt also reported pain in shoulder joint as well as at injection site that lasted for 3-4 days.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: 10-10-16 Influenza vaccine administered left deltoid. That night client complained of sore arm, no fever or redness at the site of injection. 10/11/2016 child woke up with fever, sore arm with knot, redness at site that migrated down to antecubital/elbow area. TYLENOL and Ibuprofen given on alternate schedule. MOC states she placed cortisol cream at site of injection. 10/12/2016 Fever continued, swelling (knot), redness still noted per MOC upper arm. TYLENOL and Ibuprofen given on alternate schedule. 10/13/2016 Redness not as evident around antecubital/elbow area but still red and knot present at the injection site. No fever per MOC. 10/15/2016 Child still complaining of sore arm, MOC took child to see pediatrician- Per MOC, pediatrician stated to rub and place heat at site of injection. No further actions needed. 10/16/2016 Slight knot at site, redness gone and no pain per MOC.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: 10-10-16 Influenza vaccine administered left deltoid. That night client complained of sore arm, no fever or redness at the site of injection. 10/11/2016 child woke up with fever, sore arm with knot, redness at site that migrated down to antecubital/elbow area. TYLENOL and Ibuprofen given on alternate schedule. MOC states she placed cortisol cream at site of injection. 10/12/2016 Fever continued, swelling (knot), redness still noted per MOC upper arm. TYLENOL and Ibuprofen given on alternate schedule. 10/13/2016 Redness not as evident around antecubital/elbow area but still red and knot present at the injection site. No fever per MOC. 10/15/2016 Child still complaining of sore arm, MOC took child to see pediatrician- Per MOC, pediatrician stated to rub and place heat at site of injection. No further actions needed. 10/16/2016 Slight knot at site, redness gone and no pain per MOC.
Age: 25.0
Sex: M
Vaccine: HPV9
Symptoms: Myalgia, Pain, Pyrexia
Clinical narrative: First symptom was over-sensitive muscles (an achy "Don't touch me" feeling started around 7:30. Fever started around 11:30 pm and has continued into this morning.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Feeling abnormal, Injected limb mobility decreased, Injection site pain, Insomnia
Clinical narrative: Described previously. Miserable. Fever, chills, tingling hands and feet, sleepy, extreme arm pain. Miserable.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Paraesthesia, Pyrexia, Somnolence
Clinical narrative: Described previously. Miserable. Fever, chills, tingling hands and feet, sleepy, extreme arm pain. Miserable.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Cough, Pyrexia
Clinical narrative: Dad reported coughing and low grade fever (99F-101F) lasting one week. He stated this happens every once in a while.
Sex: M
Vaccine: TTOX
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited report received from a physician via other company (Pfizer) (Manufacturer Report Number: 2016447068) on 05-Oct-2016. This case involves a male patient (age not reported) who was vaccinated with a dose of TETANUS TOXOID (Batch number, expiry date, route and site of administration: not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, patient developed allergy to Tetanus Tox. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Dizziness, Erythema, Headache, Influenza like illness, Pain
Clinical narrative: Initial unsolicited report received from a pharmacist on 06 Oct 2016. This case involves a 50 patients (age and gender not reported) who were vaccinated with a dose of Fluzone Qiv (batch number, expiry date, route and site of administration: not reported) on unspecified dates. Illness at time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as unknown and concomitant medications were not reported. On an unspecified date, after vaccination, the patients reported adverse events varying from soreness, red welts, headaches for days, flu like symptoms, dizziness and fainting. Patient's laboratory data and corrective treatment was not reported. The outcome of the events was not reported. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Syncope, Urticaria
Clinical narrative: Initial unsolicited report received from a pharmacist on 06 Oct 2016. This case involves a 50 patients (age and gender not reported) who were vaccinated with a dose of Fluzone Qiv (batch number, expiry date, route and site of administration: not reported) on unspecified dates. Illness at time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as unknown and concomitant medications were not reported. On an unspecified date, after vaccination, the patients reported adverse events varying from soreness, red welts, headaches for days, flu like symptoms, dizziness and fainting. Patient's laboratory data and corrective treatment was not reported. The outcome of the events was not reported. List of documents held by sender: none.
Age: 0.42
Sex: F
Vaccine: DTAPIPVHIB, HEP, PPV
Symptoms: Crying, Injection site erythema
Clinical narrative: Initial unsolicited report received from a Nurse on 06 October 2016. This case involves a five-month-old patient (gender not reported) who was vaccinated with a dose PENTACEL (batch number: C5055AB, expiration date: 03 June 2017) intramuscularly in right thigh, a dose of Hep B (manufacturer: Pfizer) intramuscularly in left thigh and a dose of PCV intramuscularly in left thigh (batch number, dose and expiration were not reported for Hep B and PCV) on [date]. Patient's Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions was denied. Concomitant medications were not reported. On 06 October 2016, same day following the vaccination, the patient experienced redness at the injection site (right thigh) and "inconsolable crying". Patient's Lab data was not reported. Corrective treatment included to apply ice at the injection site. Patient was advised to go for consultation if symptom persists. Outcome of the event was reported as unknown. List of documents held by sender: none.
Sex: U
Vaccine: FLU3, PPV
Symptoms: Malaise, Mobility decreased
Clinical narrative: Initial unsolicited case received from consumer via social media on 10-Oct-2016. This case is liked to 2016SA188144, 2016SA188556, 2016SA188803, 2016SA188804, 2016SA188805, 2016SA188806, 2016SA188807, 2016SA188808, 2016SA188809, 2016SA188810, 2016SA188811, 2016SA188812, 2016SA188813, 2016SA188814, 2016SA188815, 2016SA188816, 2016SA188817, 2016SA188818, 2016SA188819, 2016SA188820, 2016SA188821, 2016SA188822, 2016SA188833, 2016SA188834, 2016SA188835, 2016SA188836, 2016SA188837, 2016SA188838, 2016SA188839, 2016SA188840, 2016SA188841, 2016SA188843, 2016SA188844, 2016SA188845, 2016SA188846, 2016SA188847, 2016SA188848, 2016SA188849, 2016SA188850, 2016SA188851(same vaccine). This case involves a patient (age and gender: not reported) who was vaccinated with a dose of INFLUENZA VACCINE (stronger "senior" dose) (manufacturer: unknown) and a dose of Pneumonia Shot (manufacturer: other), (batch number, expiry date, route and site of administration: not reported for both vaccines) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, next day post vaccination, the patient got very sick. On an unspecified date, post vaccination, the patient then could not raise either arm for three months. Patient's lab data and corrective treatment was not reported. On an unspecified date, the patient recovered from the event could not raise either arm. The outcome of the event got very sick was not reported. The case was considered as serious due to seriousness criteria: disability. List of documents held by sender: none. Sender's Comments: This is poorly documented social media case where could not raise either arm for three month was reported after administration of INFLUENZA VACCINE (unknown manufacturer). However, investigation results ruling out a concurrent infection and other etiologies would be helpful to further assess this case.
Age: 54.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 54-year-old female patient who received BOOSTRIX. Co-suspect products included Flu Seasonal TIV Dresden (Influenza vaccine unspecified). Concomitant products included hydrocodone. On 30th September 2016, the patient received BOOSTRIX and Influenza vaccine unspecified. On 1st October 2016, 1 days after receiving BOOSTRIX and Influenza vaccine unspecified, the patient experienced fatigue, fever and headache. On an unknown date, the outcome of the fatigue, fever and headache were not recovered/no resolved. The reporter considered the fatigue, fever and headache to be almost certainly related to BOOSTRIX and Influenza vaccine unspecified. Additional de tails were provided as follows: This case was previously reported to a doctor. The patient received influenza vaccine and whooping cough vaccine on the same arm. The patient began to experience fatigue and low grade fever ever since receiving the vaccine. It was hurting her everyday life big time. The events had not improved after one week. The patient appeared not appreciate the advice she received from her pharmacist. The patient was seen by her by her physician and was informed to keep an eye one it and if it gets worse to go to the Emergency Department. Initially the patient had talked to a sales representative about her side effects, but at the time was not sure it was a GSK products. She called the pharmacy she received the vaccine and confirmed it was GSK vaccines. The patient for the most terrible headache that she had experienced ever in her life everyday since 6 days she got a headache that did not go away. The patient was asking whether this symptoms was common.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Eyelid oedema, Lip swelling
Clinical narrative: Patient got flu shot during Employee Health clinic she went home and when she woke up and her lips was swollen and by 10:00 am she was having swollen eyelids and her face was red.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Asthenia, Feeling abnormal, Musculoskeletal pain
Clinical narrative: Weakness, pain in shoulders and hips. Abnormal feeling - could not lay on one side for more than an hour or so. Onset the night of vaccination and resolved by 6pm the following day.
Age: 1.08
Sex: M
Vaccine: PNC13
Symptoms: Urticaria
Clinical narrative: URTICARIAL/EM RASH. ONCE WITH 3RD DOSE IN MAY 2016 AND ONCE WITH 4TH DOSE IN OCT 2016.
Age: 17.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Abnormal behaviour, Stereotypy
Clinical narrative: Mother states child is having unusual behavior, such as rubbing arms on chairs repetitively, repetitively touching and tapping objects.
Age: 31.0
Sex: F
Vaccine: ANTH
Symptoms: Asthenia, Chills, Malaise, Muscle fatigue
Clinical narrative: Chills, muscle fatigue, weakness, general malaise.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Hyperhidrosis, Pyrexia
Clinical narrative: Patient reported experiencing high fever of 104F, achy joints, sweats and chills, about 6 hours after administration of high-dose FLUZONE.
Age: 39.0
Sex: F
Vaccine: YF
Symptoms: Abdominal pain upper, Chest pain, Ear pain, Gastric dilatation, Hypoaesthesia
Clinical narrative: On 9/8/16, I woke up with tingling in my lower lip. Within a few hours the entire lower half of my face was numb, including tongue, teeth, lips, jaw, chin. The strength of the numbness would come and go over the next few days and then on 9/13/16, the numbness began to migrate around my body. It would be in my right ear (deep numbness, not surface/skin), then my left hand and thumb, then my left foot - which also had a stabbing pain and I couldn't move my two small toes, then my kidney area, my stomach, my chest, forehead, etc. I would feel the deep numbness for about 20-30 minutes in one area before it would go somewhere else in my body. It didn't seem to have any rhyme or reason. After a full day's rest the next day, I began to improve, however, the numbness in my tongue never fully went away and some days I would have the migrating numbness. On October 14th, my symptoms began to increase again, however, it was not just one place at a time. I had numbness from the back of my nose, down my throat, to my stomach, and down to between my legs - all at once. By 1:00am the 15th, the numbness in my torso got stronger and was accompanied by intense pain. I felt my stomach was cramping/hardening. It then added my right ear, which was also accompanied by pain. To date October 18th, the numbness has not subsided and is always accompanied by pain.
Age: 39.0
Sex: F
Vaccine: YF
Symptoms: Hypoaesthesia oral, Mobility decreased, Nuclear magnetic resonance imaging brain normal, Pain in extremity, Paraesthesia oral
Clinical narrative: On 9/8/16, I woke up with tingling in my lower lip. Within a few hours the entire lower half of my face was numb, including tongue, teeth, lips, jaw, chin. The strength of the numbness would come and go over the next few days and then on 9/13/16, the numbness began to migrate around my body. It would be in my right ear (deep numbness, not surface/skin), then my left hand and thumb, then my left foot - which also had a stabbing pain and I couldn't move my two small toes, then my kidney area, my stomach, my chest, forehead, etc. I would feel the deep numbness for about 20-30 minutes in one area before it would go somewhere else in my body. It didn't seem to have any rhyme or reason. After a full day's rest the next day, I began to improve, however, the numbness in my tongue never fully went away and some days I would have the migrating numbness. On October 14th, my symptoms began to increase again, however, it was not just one place at a time. I had numbness from the back of my nose, down my throat, to my stomach, and down to between my legs - all at once. By 1:00am the 15th, the numbness in my torso got stronger and was accompanied by intense pain. I felt my stomach was cramping/hardening. It then added my right ear, which was also accompanied by pain. To date October 18th, the numbness has not subsided and is always accompanied by pain.
Age: 39.0
Sex: F
Vaccine: YF
Symptoms: Pharyngeal hypoaesthesia
Clinical narrative: On 9/8/16, I woke up with tingling in my lower lip. Within a few hours the entire lower half of my face was numb, including tongue, teeth, lips, jaw, chin. The strength of the numbness would come and go over the next few days and then on 9/13/16, the numbness began to migrate around my body. It would be in my right ear (deep numbness, not surface/skin), then my left hand and thumb, then my left foot - which also had a stabbing pain and I couldn't move my two small toes, then my kidney area, my stomach, my chest, forehead, etc. I would feel the deep numbness for about 20-30 minutes in one area before it would go somewhere else in my body. It didn't seem to have any rhyme or reason. After a full day's rest the next day, I began to improve, however, the numbness in my tongue never fully went away and some days I would have the migrating numbness. On October 14th, my symptoms began to increase again, however, it was not just one place at a time. I had numbness from the back of my nose, down my throat, to my stomach, and down to between my legs - all at once. By 1:00am the 15th, the numbness in my torso got stronger and was accompanied by intense pain. I felt my stomach was cramping/hardening. It then added my right ear, which was also accompanied by pain. To date October 18th, the numbness has not subsided and is always accompanied by pain.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test normal, Computerised tomogram normal, Diplopia, Nuclear magnetic resonance imaging normal, Scan with contrast normal
Clinical narrative: Vision problems, seeing double, starting on Thursday 10/13/16. Hoping it would clear up waited until Sunday 10/17/16 to go to ER where it was diagnosed as Sixth Cell Palsy. I have never had anything like this before. All tests were normal. I still have this and was advised it could be viral but is unknown. May or may not clear up in 6 weeks. If not will need to see neurologist.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: VIth nerve paralysis, Visual impairment
Clinical narrative: Vision problems, seeing double, starting on Thursday 10/13/16. Hoping it would clear up waited until Sunday 10/17/16 to go to ER where it was diagnosed as Sixth Cell Palsy. I have never had anything like this before. All tests were normal. I still have this and was advised it could be viral but is unknown. May or may not clear up in 6 weeks. If not will need to see neurologist.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain, Skin warm, Swelling, Tenderness
Clinical narrative: STARTED TO NOTICE A LITTLE BUMP ON HER SHOULDER AND BY THE END OF THE DAY IT WAS THE SIZE OF A QUARTER. REPORTS THAT IT IS WARM, RED AND HURTS WHEN MOVING ARM AROUND OR TOUCHING SHOULDER AREA.
Age: 14.0
Sex: F
Vaccine: FLU4, HEPA, HPV9, MNQ, TDAP, VARCEL
Symptoms: Incorrect route of drug administration
Clinical narrative: Varicella was given IM instead of SubQ.
Age: 1.58
Sex: M
Vaccine: TDAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Asthenia, Diarrhoea, Faeces discoloured, Intussusception, Lethargy
Clinical narrative: Yellow/Green vomit, black diarrhea, weak and lethargic.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Surgery, Ultrasound abdomen abnormal, Vomiting, X-ray abnormal
Clinical narrative: Yellow/Green vomit, black diarrhea, weak and lethargic.
Age: 21.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Left upper arm became very itchy and red several hours after getting flu shot. No SOB, wheezing, throat tightening. Pt. reported this to me at a follow-up visit one week later. It resolved with no problems and she did not need to seek medical attention.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Bone pain, Chills, Dizziness, Fatigue
Clinical narrative: Patient/Employee reported a "flu shot response" via email 10/13/2016 upon returning to work the next day. The following information has been copied from her email. "I mentioned this to person, and she said I should tell Employee Health so you can document reactions. I had a pretty severe reaction to the flu shot last night, worse than your typical immune response. Severe muscle, nerve, and joint pain all over my body, and my organs & bones actually hurt (bizarre feeling). Bad flu-like kind of headache w/dizziness, which I still have (dizziness has improved). I had a high fever I could tell (didn't take temperature because I couldn't move); was drenched in sweat but had severe chills. Very red eyes and fatigue. Nausea all day yesterday. I couldn't move my arm without significant pain all day. I'm better now, except for the headache. Didn't get much sleep. I always feel sick to some extent after I get the flu shot, but this was much worse than I have experienced. It felt like the full-blown flu."
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling abnormal, Headache, Hyperhidrosis, Influenza like illness, Insomnia
Clinical narrative: Patient/Employee reported a "flu shot response" via email 10/13/2016 upon returning to work the next day. The following information has been copied from her email. "I mentioned this to person, and she said I should tell Employee Health so you can document reactions. I had a pretty severe reaction to the flu shot last night, worse than your typical immune response. Severe muscle, nerve, and joint pain all over my body, and my organs & bones actually hurt (bizarre feeling). Bad flu-like kind of headache w/dizziness, which I still have (dizziness has improved). I had a high fever I could tell (didn't take temperature because I couldn't move); was drenched in sweat but had severe chills. Very red eyes and fatigue. Nausea all day yesterday. I couldn't move my arm without significant pain all day. I'm better now, except for the headache. Didn't get much sleep. I always feel sick to some extent after I get the flu shot, but this was much worse than I have experienced. It felt like the full-blown flu."
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Myalgia, Nausea, Neuralgia, Ocular hyperaemia, Pain
Clinical narrative: Patient/Employee reported a "flu shot response" via email 10/13/2016 upon returning to work the next day. The following information has been copied from her email. "I mentioned this to person, and she said I should tell Employee Health so you can document reactions. I had a pretty severe reaction to the flu shot last night, worse than your typical immune response. Severe muscle, nerve, and joint pain all over my body, and my organs & bones actually hurt (bizarre feeling). Bad flu-like kind of headache w/dizziness, which I still have (dizziness has improved). I had a high fever I could tell (didn't take temperature because I couldn't move); was drenched in sweat but had severe chills. Very red eyes and fatigue. Nausea all day yesterday. I couldn't move my arm without significant pain all day. I'm better now, except for the headache. Didn't get much sleep. I always feel sick to some extent after I get the flu shot, but this was much worse than I have experienced. It felt like the full-blown flu."
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Patient/Employee reported a "flu shot response" via email 10/13/2016 upon returning to work the next day. The following information has been copied from her email. "I mentioned this to person, and she said I should tell Employee Health so you can document reactions. I had a pretty severe reaction to the flu shot last night, worse than your typical immune response. Severe muscle, nerve, and joint pain all over my body, and my organs & bones actually hurt (bizarre feeling). Bad flu-like kind of headache w/dizziness, which I still have (dizziness has improved). I had a high fever I could tell (didn't take temperature because I couldn't move); was drenched in sweat but had severe chills. Very red eyes and fatigue. Nausea all day yesterday. I couldn't move my arm without significant pain all day. I'm better now, except for the headache. Didn't get much sleep. I always feel sick to some extent after I get the flu shot, but this was much worse than I have experienced. It felt like the full-blown flu."
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Dysuria, Prostatitis
Clinical narrative: Difficulty urinating, diagnosed with prostatitis at physician's office. Placed on sulfa antibiotics for 2 weeks.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Endoscopy normal, Gastrointestinal examination normal, Pain, Swelling, Tuberculin test negative
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. This nurse reported similar events for 3 patients. This is the second of three reports. A 19 year-old female patient of an unspecified race and ethnicity received the first dose of TRUMENBA via an unspecified route of administration in Jul2016 at 0.5 ml single for immunisation.  Relevant medical history included abdominal pain (problem stress related) from 30Nov2012, gastrointestinal (GI) FU in Feb2013 and endoscopy on an unspecified date were within normal limit, symptoms resolved in Apr2013. Negative tuberculin test with 0 mm induration was performed on 22Jul2016.  Concomitant medications were not provided. The patient experienced swelling and pain in Aug2016 a couple of days after vaccination. The outcome of the events was unknown. Follow-up (07Oct2016): Follow-up attempts are completed. No further information is expected. Follow-up (13Oct2016): New information reported from a contactable nurse includes: reporter occupation updated from medical assistant to nurse, updated patient age, suspect vaccine administration date and dose number, medical history and relevant tests. Sender's Comments: Linked Report(s): US-PFIZER INC-2016383049 similar report from same reporter; US-PFIZER INC-2016383050 similar report from same reporter.
Age: 76.0
Sex: M
Vaccine: PNC13
Symptoms: Cellulitis
Clinical narrative: This is a spontaneous report obtained from a contactable nurse. This nurse reported similar events for two patients. This is the first of two reports. A 76-year-old male patient received, on 28Sep2016, at 11:00, PREVNAR 13, Lot, M35761, Expiration date: 30May2017) 0.5 ml, single, in the left deltoid, for immunization (prevention of Pneumonia). Relevant medical history included type 2 diabetes mellitus (ongoing), hyperlipidemia (ongoing), and hypertension (ongoing). Concomitant medications included influenza vaccine injection on 26Sep2016, for immunization; oral amlodipine 5 mg once a day, for hypertension (ongoing); atorvastatin 10 mg once a day at night, for hyperlipidemia (ongoing); oral tadalafil (CIALIS) 20 mg, as needed, for erectile dysfunction (ongoing); oral glimepiride, one tablet daily for type 2 diabetes mellitus (ongoing); losartan potassium, 100 mg once a day, for hypertension (ongoing); oral metformin, 1000 mg one tablet twice daily, for type 2 diabetes mellitus (ongoing) and oral cinnamomum verum (CINNAMON) 500 mg twice a day, for type 2 diabetes mellitus (ongoing). On an unspecified date, in 2016, after administration of pneumococcal 13-val conj vac (dipht crm197 protein), the patient experienced cellulitis. He was seen in a urgent care and was on antibiotics (unspecified) for 10 days. The patient recovered completely on an unspecified date, in 2016. There was a reasonable possibility the event was related to pneumococcal 13-val conj vac (dipht crm197 protein). Sender's Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. In particular, the following relevant information is not available: onset date of the event. This case will be reassessed when additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Hyperhidrosis, Injection site erythema, Injection site pruritus, Injection site swelling, Nausea
Clinical narrative: This is a spontaneous report from a contactable physician. A 20-year-old female patient received the second dose of TRUMENBA, via an unspecified route of administration at 0.5 ml, single on 07Oct2016 for immunisation. The patient medical history and concomitant medications were not reported. The patient previously took the first dose of Trumenba (Lot # N77282, Expiry Date 30Jun2017) on 08Jul2016 for immunisation. On 11Oct2016, the patient experienced nausea, sweatiness, injection site was a little itchy with outcome of recovered on 12Oct2016. The event inject site started to turn red on 11Oct2016 with outcome of unknown, injection site was swollen on an unspecified date with outcome of not recovered.
Age: 17.0
Sex: F
Vaccine: FLUX, MENB
Symptoms: Mobility decreased, Pain in extremity, Rash, Rash erythematous, Skin warm
Clinical narrative: This is a spontaneous report from a contactable physician, reporting for her daughter. This 17 year-old female patient of an unspecified race and ethnicity received a single dose of TRUMENBA intramuscular in the left upper arm on 12Oct2016 for immunisation.  The patient medical history and concomitant medications were not reported. On an unspecified date in Oct2016 the patient developed a large (approximately 10 cm) rash on upper arm, rash was not itchy but it was red and warm, and she had severe pain that limited arm movement. The patient received ADVIL as treatment but pain only partially responded to it. The patient was recovering.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site paraesthesia, Paraesthesia
Clinical narrative: Tingling from injection site and radiating down arm.
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Anal incontinence, Gait disturbance, Hypoaesthesia, Laboratory test, Paraesthesia
Clinical narrative: NUMBNESS, TINGLING IN EXT. PROGRESSIVELY GETTING WORSE, DECREASED SENSATION, INCONTIENCE OF BOWEL AND BLADDER. AS SX PROGRESSED DIFFICULTY AMBULATING.
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Scan, Sensory disturbance, Urinary incontinence
Clinical narrative: NUMBNESS, TINGLING IN EXT. PROGRESSIVELY GETTING WORSE, DECREASED SENSATION, INCONTIENCE OF BOWEL AND BLADDER. AS SX PROGRESSED DIFFICULTY AMBULATING.
Age: 1.42
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, VARCEL
Symptoms: Rash generalised, Rash vesicular, Scab, Skin lesion
Clinical narrative: DEVELOPED A FLUID FILLED RASH STARTING ON TRUNK AND MOVING TO THE REST OF HIS BODY FROM HEAD TO LEGS. BETWEEN 250-499 LESIONS. BEGAN TWO DAYS FOLLOWING VACCINATION. RASH WAS COMPLETELY SCABBED OVER BY 10/18/2016. NO REPORT OF FEVER OR OTHER SIGNS OF ILLNESS.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema
Clinical narrative: Area of redness surrounding the site of administration approx. 40mm x 20mm.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Joint range of motion decreased, Pain in extremity
Clinical narrative: Immediate arm pain, loss of range of motion due to pain continuously and ongoing. Per Employee Health physician, heat pad, prescription for physical therapy. First appointment one week from now.
Age: 75.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, Redness, fever in arm, painful, redness extending down arm from injection site. Pt saw dr on 10/17 upon recommendation from pharmacist and was diagnosed with cellulitis and edema, treated with BACTRIM DS and cephalexin 500mg.
Age: 75.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Oedema
Clinical narrative: Swelling, Redness, fever in arm, painful, redness extending down arm from injection site. Pt saw dr on 10/17 upon recommendation from pharmacist and was diagnosed with cellulitis and edema, treated with BACTRIM DS and cephalexin 500mg.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site inflammation, Pain
Clinical narrative: Patient called to notify us of a quarter-size round inflamed reaction at the injection site that she discovered this morning. She said she has had soreness since the injection as well.
Age: 29.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Infertility male, Malaise, Skin disorder
Clinical narrative: Became extremely ill after every anthrax vaccination. To this day I have skin conditions no one can explain. I found out in 2012 that I could not have children.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Back pain, Gait disturbance, Myalgia, Paraesthesia
Clinical narrative: 9/27/16 Received phone message that she was itching and had hives. Stated her DR. thought reaction to Flu shot. 9/28/16 Received another message stating she was getting worse and having difficulty walking. 10/10/16 Left message for patient to call us so we can follow up. 10/10/16 Weakness, pain in muscles, tingling hands and feet. Pain in back.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Urticaria, Vaccination complication
Clinical narrative: 9/27/16 Received phone message that she was itching and had hives. Stated her DR. thought reaction to Flu shot. 9/28/16 Received another message stating she was getting worse and having difficulty walking. 10/10/16 Left message for patient to call us so we can follow up. 10/10/16 Weakness, pain in muscles, tingling hands and feet. Pain in back.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Rash
Clinical narrative: Numbness around her mouth, specifically on the "corner of her right mouth and extending down into her right chin". It feels "kind of like when NOVOCAINE is wearing off". BP 125 systolic by report which is "high for (her)". HR 105. No dizziness or nausea. Reported rash that resolved. Seeking medical attention from PMD for evaluation 10/18/16.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse reactions, patient given High dose FLUZONE at age 61.  No problems when talked with patient.