chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema
Clinical narrative: Initial unsolicited report received from a physician on 07 Oct 2016. This case involves a female patient (age not reported) who as vaccinated with a dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (High dose flu) and PNEUMOCOCCAL VACCINE (manufacturer: unknown) (batch number, expiry date, route of administration: not reported for both vaccines) both in same arm at same time on unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, after vaccination, the patient went in for blood work and arm was red from injection area. Patient's laboratory data and corrective treatment was not reported. The outcome of the event was not reported. List of documents held by sender: none.
Sex: U
Vaccine: FLUX
Symptoms: Facial paralysis
Clinical narrative: Initial unsolicited report received from a pharmacist on 07 Oct 2016. This case involves a patient (age and gender not reported) who was vaccinated with a dose of flu shot (manufacture: 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, two weeks after vaccination, the patient had experienced Bell's palsy. Patient's laboratory data and corrective treatment was not reported. Outcome of the event was not reported. Upon internal review, this case was considered as serious due to important medical event: Bell's palsy. List of documents held by sender: none. Sender's Comments: Bell's palsy was suspected in this case after vaccination with INFLUENZA VACCINE of unknown manufacturer however diagnosis was not conformed. Time to onset two weeks is compatible with the role of vaccine. Additional information on investigation results ruling out a concurrent infection and exploration of alternate etiologies and patient's history of reaction after previous vaccinations are needed to further assess this case. Based on information role of vaccine cannot be assessed.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Facial paralysis
Clinical narrative: Initial unsolicited report received from a pharmacist on 10 October 2016. This case involves a female patient (age not reported) who was vaccinated with a dose of Flu vaccine (Batch number, expiry date, route and site of administration not reported) on an unspecified date couple of year ago. The patient's medical history was not reported. Concomitant medications was not reported. On an unspecified date, two weeks following the vaccination, the patient had experienced Bells Palsy. Lab data and corrective treatment were not reported. The outcome of the event was reported as unknown. Upon medical review, the case was considered as serious due to important medical event: Bell's Palsy. List of documents held by sender: none. Sender's Comments: Bell's palsy was suspected in this case after vaccination with INFLUENZA VACCINE of unknown manufacturer however diagnosis was not conformed. Time to onset two weeks is compatible with the role of vaccine. Additional information on investigation results ruling out a concurrent infection and exploration of alternate etiologies and patient's history of reaction after previous vaccinations are needed to further assess this case. Based on information role of vaccine cannot be assessed.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Urticaria, Wheezing
Clinical narrative: Developed hives on neck and face, had difficulty swallowing, wheezing.
Age: 35.0
Sex: M
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Hives on trunk, legs and arms.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Hypersensitivity, Injection site erythema, Injection site pruritus
Clinical narrative: Allergic Reaction; see previous box.
Age: 14.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Peripheral swelling
Clinical narrative: Redness/swelling at injection site 24hrs from administration. Redness and swelling dissipated and then patient developed swelling from shoulder to below elbow over next 48hrs. Swelling was treated with steroid and resolved.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness and itchiness at site of injection.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Myalgia
Clinical narrative: Muscle ache in thighs. They hurt is if I had done strenuous weight lifting.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Headache, Malaise, Pain
Clinical narrative: Chills, achy, headache, malaise, weakness.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Face injury, Syncope
Clinical narrative: Got up to go to bathroom. Had syncope event and hit his face.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Burning sensation, Disorientation, Dizziness, Hallucination
Clinical narrative: Dizziness; hallucinations; nausea; disorientation; itching; photophobia; small, dry blisters on my back which caused skin to rub off and then left it sensitive and had a burning feeling when clothes touched the area.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Hyperaesthesia, Nausea, Photophobia, Pruritus
Clinical narrative: Dizziness; hallucinations; nausea; disorientation; itching; photophobia; small, dry blisters on my back which caused skin to rub off and then left it sensitive and had a burning feeling when clothes touched the area.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Developed left arm pain after vaccination which has persisted, there is associated restriction in the shoulder range of motion.
Age: 85.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Initial unsolicited report received from a pharmacist on 11 October 2016. This case involves a 85-year-old female patient who was vaccinated with a dose FLUZONE HD via intramuscular route (batch number- UI689AA, expiry date -26 April 2017, dose in series and dose was not reported) in left arm; with a dose of PREVENAR 13 via intramuscular route in right arm (Manufacturer: Pfizer, batch number, expiry date, dose in series and dose were not reported) on 04 October 2016. The patient's medical history, ongoing illness at the time of vaccination was denied and pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as none. Concomitant medications were not reported. On 11 October 2016, 7 day following the vaccination, the patient had experienced large area of redness and soreness at injection site. The previously the patient was vaccinated with FLUZONE HD on 2015 (on an unknown date). Relevant laboratory data and corrective treatment were not reported. The outcome of event was unknown. List of documents held by sender: none.
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Initial unsolicited report received from a consumer (sister of patient) via social media on 10 Oct 2016. This case involves a female patient (age unknown) who was vaccinated with dose of INFLUENZA VACCINE (batch number, expiry date, dose, route and site of administration were not reported) on unspecified date. Medical history and concomitant medications were not reported. On unspecified date, following the vaccination, the patient had got flu. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. The reporter assessed the events as minor. List of documents held by sender: none.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Initial unsolicited report received from consumer via social media on 13-Sep-2016. THIS CASE IS LINKED WITH 2016SA188144, 2016SA188556, 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, 2016SA188850, 2016SA188851 (same site, same vaccine). This case involves a patient (age and gender: not reported) who was vaccinated with dose of INFLUENZA VACCINE (batch number, expiry date, route, dose and site of administration: not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, post vaccination, the patient had always got flu. Lab data and corrective treatment was not reported. Outcome of the event was not reported. List of documents held by sender: none.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Initial unsolicited report received from consumer via social media (on 16-Sep-2016. This case is linked with 2016SA188144, 2016SA188556, 2016SA188803, 2016SA188804, 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, 2016SA188850, 2016SA188851. (same site, same vaccine). This case involves a patient (age and gender: not reported) who was vaccinated with dose of INFLUENZA VACCINE (batch number, expiry date, route, dose and site of administration: not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, post vaccination, the patient got flu. Lab data and corrective treatment was not reported. Outcome of the event was not reported. List of documents held by sender: none.
Sex: U
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
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, 2016SA188810, 2016SA188811, 2016SA188812, 2016SA188813, 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 reporter source, same vaccine). This case involves a patient (age and gender are not reported) who was vaccinated with a dose of Flu shot (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on unspecified date in 2010. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient experienced Guillain Barre Syndrome. The patient's laboratory data and corrective treatment was not reported. The outcome of event was not reported. Upon medical review, the case was considered as serious due to important medical event: Guillain Barre Syndrome. List of documents held by sender: none. Sender's Comments: In this case Guillain Barre syndrome was reported following INFLUENZA VACCINE, in this poorly documented social media case where manufacturer of INFLUENZA VACCINE is not provided. Further information on patient's medical history, concomitant medications, previous immunization and tolerance information are needed to complete assessment of the case.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Influenza, Pneumonia
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, 2016SA188810, 2016SA188811, 2016SA188812, 2016SA188813, 2016SA188814, 2016SA188815, 2016SA188816, 2016SA188817, 2016SA188818, 2016SA188819, 2016SA188820, 2016SA188821, 2016SA188822, 2016SA188833, 2016SA188835, 2016SA188836, 2016SA188837, 2016SA188838, 2016SA188839, 2016SA188840, 2016SA188841, 2016SA188842, 2016SA188843, 2016SA188844, 2016SA188845, 2016SA188846, 2016SA188847, 2016SA188848, 2016SA188849, 2016SA188850, 2016SA188851 (Same reporter source, same vaccine). This case involves a male patient (age not reported) who was vaccinated with a dose of Flu shot and pneumonia shot (batch number, expiry date, dose, dose in series, route and site of administration were not reported for both vaccines) on unspecified date. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient experienced flu and pneumonia. The patient's laboratory data and corrective treatment was not reported. The outcome of events was not reported. Upon medical review, the case was considered as serious due to important medical event: pneumonia. List of documents held by sender: none. Sender's Comments: This is poorly documented case as patient take flu and pneumonia shot every year and had flu and 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. As lab data and culture report are needed to further assess vaccine efficacy. Based on available information the role of vaccine cannot be assessed.
Sex: M
Vaccine: FLUX
Symptoms: Death
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, 2016SA188810, 2016SA188811, 2016SA188812, 2016SA188813, 2016SA188814, 2016SA188815, 2016SA188816, 2016SA188817, 2016SA188818, 2016SA188819, 2016SA188820, 2016SA188821, 2016SA188822, 2016SA188833, 2016SA188834, 2016SA188835, 2016SA188836, 2016SA188837, 2016SA188838, 2016SA188840, 2016SA188841, 2016SA188842, 2016SA188843, 2016SA188844, 2016SA188845, 2016SA188846, 2016SA188847, 2016SA188848, 2016SA188849, 2016SA188850, 2016SA188851. (Same reporter source, same vaccine). This case involves a male patient (age not reported) who was vaccinated with a dose of Flu shot (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unknown date, 30 hours following the vaccination, the patient died. The patient's laboratory data and corrective treatment was not reported. It was unknown that Autopsy was performed. List of documents held by sender: none. Sender's Comments: This is poorly documented case of death 30 hours following influenza vaccination. Time to onset is compatible but detail medical history, any co morbidity, past vaccination history leading to any severe reaction and allergic history is needed to further assess the case. Reported Cause(s) of Death: Death NOS.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Dyskinesia
Clinical narrative: Patient woke up that morning and could barely open his mouth. Later in the afternoon he was able to open it wide enough to eat. No reaction at site of injection. By the next day he was close to fully recovered.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Saturday left deltoid was tender, red and raised. Sunday was worst day being bright red and tender. Monday skin was fading into light pink with a bluish hue.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Loss of consciousness, Pyrexia, Tremor
Clinical narrative: Shakiness, fever, loss of consciousness.
Age: 11.0
Sex: M
Vaccine: MENB
Symptoms: Computerised tomogram normal, Dizziness, Headache, Injection site erythema, Injection site pain
Clinical narrative: Patient was given TRUMENBA vaccine (#2 of series) on 10/10/16. Mom reports within an hour he developed a severe headache and nausea, dizziness. Was transported via ambulance from home to hospital. Lab, CT scan, and vitals were normal. Injection site was red, swollen and tender. Was discharged and has been fine since per mom.
Age: 11.0
Sex: M
Vaccine: MENB
Symptoms: Injection site swelling, Laboratory test normal, Nausea
Clinical narrative: Patient was given TRUMENBA vaccine (#2 of series) on 10/10/16. Mom reports within an hour he developed a severe headache and nausea, dizziness. Was transported via ambulance from home to hospital. Lab, CT scan, and vitals were normal. Injection site was red, swollen and tender. Was discharged and has been fine since per mom.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Body temperature decreased, Chills, Malaise
Clinical narrative: Pt said she had stomach upset, chills and drop in body temperature almost immediately after leaving from vaccination location.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site discolouration, Pain in extremity, Peripheral coldness
Clinical narrative: ARM FELT SORE, SKIN TURNED A DIFFERENT COLOR AT INJECTION SITE, AT TIMES HAS A COLD FEELING IN ARM.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Dizziness, Headache, Impaired work ability, Myalgia
Clinical narrative: Starting getting muscle aches and I took and ADVIL and thought I would be fine by the morning. As the evening progressed the muscle aches worsened, felt feverish, had chills and headache and could not sleep at all through the night. Got up to take another ADVIL during the night and began to feel dizzy and my heart started to race. The symptoms I felt were very severe. I missed a day of work the next day due to no sleep and still felt achy.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Palpitations, Pyrexia, Sleep disorder
Clinical narrative: Starting getting muscle aches and I took and ADVIL and thought I would be fine by the morning. As the evening progressed the muscle aches worsened, felt feverish, had chills and headache and could not sleep at all through the night. Got up to take another ADVIL during the night and began to feel dizzy and my heart started to race. The symptoms I felt were very severe. I missed a day of work the next day due to no sleep and still felt achy.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling, Injection site warmth, Irritability
Clinical narrative: Red, swollen (very hard), warm spot approx 2"x3" on thigh at site of injection, turning into a large dark bruise after 1.5 days, small increase in fussiness.
Age: 6.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema
Clinical narrative: Patient rec. DTaP on 10/12/2016 and patient later developed redness that traveled down to elbow. Mom called family doctor and was instructed to give BENADRYL and warm compresses. 10/15/2016 mom took patient to Urgent Care as redness was not getting better. Urgent Care gave Prednisone 5mg/5ml give 4 tsp once then 2tsp x 6 days and Cephalexin 1tsp BID (250mg/5ml) for 10 days. 10/17/2016 mom called with update and stated patient's arm looks much better today.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Mouth swelling, Pharyngeal oedema, Productive cough
Clinical narrative: The next day, patient experienced productive cough, throat and mouth swelling. No treatment. Symptoms have since resolved but patient wanted to make us aware.
Age: 57.0
Sex: F
Vaccine: FLUX, TD
Symptoms: Injection site pain
Clinical narrative: PAIN FROM UPPER LEFT ARM (WHERE I GOT THE FLU SHOT) GO UP THE LEFT SHOULDER. I TOOK ADVIL BUT THE PAIN IS STILL THERE FOR ALMOST A MONTH NOW.
Age: 28.0
Sex: M
Vaccine: ANTH
Symptoms: Abdominal pain upper, Anxiety, Arthralgia, Arthritis, Balance disorder
Clinical narrative: Arthritis, stomach pain, joint pain and cramps, itching, burning sensation, spots on skin, toe fungus, unbalanced, dizzy, erectile dysfunction, major depression, anxiety.
Age: 28.0
Sex: M
Vaccine: ANTH
Symptoms: Burning sensation, Dizziness, Erectile dysfunction, Fungal skin infection, Major depression
Clinical narrative: Arthritis, stomach pain, joint pain and cramps, itching, burning sensation, spots on skin, toe fungus, unbalanced, dizzy, erectile dysfunction, major depression, anxiety.
Age: 28.0
Sex: M
Vaccine: ANTH
Symptoms: Muscle spasms, Pruritus, Rash
Clinical narrative: Arthritis, stomach pain, joint pain and cramps, itching, burning sensation, spots on skin, toe fungus, unbalanced, dizzy, erectile dysfunction, major depression, anxiety.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Dysphonia, Erythema
Clinical narrative: Pt woke up with red cheeks and hoarse throat on 10/14/2016. He contacted his primary doctor via phone and was advised to take Benadryl and go to ER if having difficulty breathing. Patient's symptoms were resolved after taking Benadryl. Phamacy was notified of ADR on 10/17/16 and all signs and symptoms resolved. Protocol doctor was notified by pharmacy of ADR on 10/17/16.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain upper, Feeding disorder, Headache, Vomiting
Clinical narrative: Throwing up. Stomach pains. Headache.Not able to consume any food.
Age: 25.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain upper, Chills, Hyperhidrosis, Influenza like illness, Pyrexia
Clinical narrative: Extreme, concentrated stomach pain--which lasted for about 1.5 hours. This stomach pain has recurred often and sporadically to present day. The next day (10/04/2011), fever, chills, sweats presented. General flu-like symptoms, which lasted for 5 days.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Skin warm, Urticaria
Clinical narrative: Localized hive that got as large as 3 inches and was warm to the touch.  Resolved within 48 hours.
Age: 72.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Arthralgia, Injection site pain
Clinical narrative: Sore at injection site then moved to elbow area that now aches.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Extensive swelling of vaccinated limb
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 56-year-old male patient who received FLUARIX QUADRIVALENT (batch number 9D325, expiry date 15th June 2017). On 3rd October 2016, the patient received FLUARIX QUADRIVALENT .5 ml. On 4th October 2016, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced extensive swelling of vaccinated limb and localized erythema. The patient was treated with BENADRYL. On an unknown date, the outcome of the extensive swelling of vaccinated limb and localized erythema were recovering/resolving. It was unknown if the reporter considered the extensive swelling of vaccinated limb and localized erythema to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: On next day of vaccination, the patient woke up with 12-inch redness and swelling from elbow to above the shoulder. The patient received BENADRYL as per primary care physician's order. Reporter spoke with the patient prior to calling GlaxoSmithKline at 2:55 pm. On 4th October 2016, the swelling had gone down a bit. The reported lot number (90325) for FLUARIX did not exist and was updated to 9D325 as per the sales database.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Fatigue, Headache, Musculoskeletal pain, Myalgia
Clinical narrative: Severe pain in shoulder for 24 hrs, myalgia, severe fatigue, and headache. All disappeared after 2 days.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Pt began having bumps appear near injection site then became pruritic then rash and itching.
Age: 14.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Asthenia, Dyskinesia, Hyperhidrosis, Pallor, Staring
Clinical narrative: 10/11/16 Child r/d Tdap on 6-20-16 @ Dr's office w/o incident. Today patient rc'd HPV - Men. Had LOC x 10 seconds with fixed stare, jerky movements of both upper extremities x 5 seconds, very pale and diaphoretic, vss. Client assisted to floor where he was awake but not feeling able to sit up x 10 minutes. Juice and crackers given. Reviewed VIS with Mom and when to contact Dr if needed. Recomended patient receive next vaccines in Dr's office vs. and off site clinic with HD.
Age: 73.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Soreness at sight of injection and has moved lower down the arm.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain in extremity
Clinical narrative: Per patient on 10/6 experienced redness then migrated down to different parts of arm including forearm. Painful but no itching.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Both arms itchy, red rash initially progressed to right sided facial numbness.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV, PNC13
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Shots on 10/3/16- had quarter size red area on right leg for 4 days and then it went away. On 10/11/16- developed 2 inch long red area on other injection site on right leg- grandma said is hard, red and getting warmer. No fever and child acting ok.  Grandma called doctor office 10/13/16 and they prescribed Benadryl. Grandma called agency the same day and we called state nurse consultant for immunizations. She thought should go in to doctor to check it out. Called grandma back to inform.  Called grandma on Monday- 10/17/16 for follow up and stated ended up taking baby in on 10/13/16 to have it checked and was diagnosed with cellulitis. Is on antibiotics and the area is getting smaller as of 10/17/16.
Age: 70.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Cough, Gait disturbance, Hypersomnia, Pain
Clinical narrative: Had enhanced flu shot in morning. After I went to bed, awoke with bad chills, shivering. Kept up all night. Body aches and deep cough developed. Shaky on my feet, stumbled going to bathroom. Slept most of day 10/15 and again that night. Was fine on 10/16.
Age: 70.0
Sex: M
Vaccine: FLUX
Symptoms: Sleep disorder
Clinical narrative: Had enhanced flu shot in morning. After I went to bed, awoke with bad chills, shivering. Kept up all night. Body aches and deep cough developed. Shaky on my feet, stumbled going to bathroom. Slept most of day 10/15 and again that night. Was fine on 10/16.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Altered state of consciousness, Computerised tomogram, Dizziness, Facial paralysis, Hemiparesis
Clinical narrative: Impaired hearing, tingling over head, dizziness, diaphoretic, unequal and sluggish pupils, R sided weakness and facial drooping, in and out of awareness, R leg drift.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Hyperhidrosis, Hypoacusis, Laboratory test, Muscle spasticity, Nuclear magnetic resonance imaging
Clinical narrative: Impaired hearing, tingling over head, dizziness, diaphoretic, unequal and sluggish pupils, R sided weakness and facial drooping, in and out of awareness, R leg drift.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia, Pupillary reflex impaired, Pupils unequal, Scan with contrast, Ultrasound Doppler
Clinical narrative: Impaired hearing, tingling over head, dizziness, diaphoretic, unequal and sluggish pupils, R sided weakness and facial drooping, in and out of awareness, R leg drift.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Ultrasound scan
Clinical narrative: Impaired hearing, tingling over head, dizziness, diaphoretic, unequal and sluggish pupils, R sided weakness and facial drooping, in and out of awareness, R leg drift.
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Pruritus, Rash
Clinical narrative: Palms of hands became itchy, followed by raised flesh colored bumps on trunk and legs.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site joint pain, Injection site pain, Pain
Clinical narrative: Extreme right shoulder joint pain. difficulty moving right arm. pain to move or touch.+
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test, Encephalopathy, Lumbar puncture, Nuclear magnetic resonance imaging
Clinical narrative: Encephalopathy.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Skin warm
Clinical narrative: Reddened area approx. 4x4 cm warm to touch.
Age: 18.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Fall, Immediate post-injection reaction, Loss of consciousness, Scratch
Clinical narrative: This case was reported by a consumer and described the occurrence of passed out in a 18-year-old male patient who received FLUARIX QUADRIVALENT. On 9th October 2016, the patient received the 1st dose of FLUARIX QUADRIVALENT. On 9th October 2016, immediately after receiving FLUARIX QUADRIVALENT, the patient experienced passed out (serious criteria GSK medically significant), lightheadedness, scratch and fall. On an unknown date, the outcome of the passed out, lightheadedness and fall were recovered/resolved and the outcome of the scratch was recovering/resolving. The reporter considered the passed out, lightheadedness and fall to be possibly related to FLUARIX QUADRIVALENT. The reporter considered the scratch to be unrelated to FLUARIX QUADRIVALENT. Additional details were reported as follows: The patient received FLUARIX QUADRIVALENT at local pharmacy. The patient was standing during administration of vaccine by pharmacist. The pharmacist finished administering the vaccine and placed Band-Aid at the site of vaccination. Immediately after vaccination, the patient turned away and fell against his sister and then to the ground inside the store. Within seconds, the patient was rolled onto his back and to attention and was able to speak. He did not remember falling. The head pharmacist had the in-store clinic's Nurse Practitioner to attend the patient. The nurse took a blood pressure reading while patient was lying flat and again once the patient sat up. The nurse was satisfied with the readings. The nurse remained with the patient for about 30 minutes until the patient felt stable enough to walk to the car and be driven home. The patient had sustained minor scrape marks (scratch) on face, elbow and knee when landing on store's carpeting. The patient was not admitted to the hospital. The health care professional did not consider the events to be life threatening. The health care professional did not consider the events to result in persistent or significant disability or incapacity. The events did not require surgical or medical intervention. The events did not result in a congenital anomaly or birth defect.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal pain upper, Cough, Dyspepsia, Fatigue, Headache
Clinical narrative: My husband and I both received a PNEUMOVAX shot against pneumonia and we both got sick right away. Headache, body aches and pains, fatigue, he had stomach pain and indigestion and I have a runny nose and cough. We were both very healthy prior to the shot! We both still feel sick after 9 days and plan to take some time off work.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Malaise, Pain, Rhinorrhoea
Clinical narrative: My husband and I both received a PNEUMOVAX shot against pneumonia and we both got sick right away. Headache, body aches and pains, fatigue, he had stomach pain and indigestion and I have a runny nose and cough. We were both very healthy prior to the shot! We both still feel sick after 9 days and plan to take some time off work.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Hypotension, Rash
Clinical narrative: Dizziness, skin rash and hypotension.
Age: 23.0
Sex: M
Vaccine: FLU4, HEPA, IPV, TDAP, TYP
Symptoms: Inappropriate schedule of drug administration, Rash pruritic, Urticaria
Clinical narrative: 9/19/16 client in with boyfriend for travel IZs for 3 months. Advised IZs per CDC. Immunized as charted. Recommended Japanese encephalitis and possibly rabies vaccines, client will check with insurance to see if they are covered before getting these. Client was given written information on mosquito precautions, food and water precautions, road safety, sun safety, avoiding animals, finding medical care abroad, travel medical insurance providers, and a medical packing list. A country profile with basic preventative measures was printed for client. Assessed for malaria risk -- present. Recommended doxycycline or MALARONE and explained how to take it based on risk areas visited. Highlighted water disinfection, medications abroad, finding medical care, and medical evacuations during visit. Client denies having any questions at this time. 09/22/16 client left a voicemail stating he took two pills back to back. LVM for client instructing him to continue taking the pills at the right intervals. 09/26/16 client left a voicemail over the weekend stating he had hives all over his body and would probably be ok with the three typhoid pills for partial protection. LVM to client asking him about other symptoms, when they started, if he took anything, if he took the last typhoid pill. 09/28/16 Called client again to check in. Client states he did not take the fourth pill. Explained I would ask advise from the manufacturers regarding 3 year protection from the first three pills even if the first two were taken back to back. Per client, he took pill #1 on 9/20, #2 on 9/21, #3 on 9/23. Client states he developed a rash on Friday evening in his armpit. He states the next morning the rash extended to his "back, butt, chest, neck, face." States he took 50mg of BENADRYL then went to the ER. Per client, he was prescribed steroids but has not taken them. He last took a BENADRYL on 9/27/16 at night. Client described the rash as very itchy "splotchy little welts" that came together to form a big welt. He also described it as "reactive to touch" stating he had a hair tie around his wrist and developed part of the rash where the hair tie had touched his skin. Client states today that rash has gone away and it's not bothering him anymore. Client denies any other symptoms (airway, cardiovascular).
Age: 60.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Facial pain, Pruritus, Rash, Rash erythematous, Scab
Clinical narrative: Red rash and scabbing on right lower cheek, 2 inches in length. Itching and pain in area. (Patient received flu shot the same day as ZOSTA).
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: Flu shots were/may have been stored below freezing overnight which may decrease efficacy of vaccine.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect product storage
Clinical narrative: Flu shots were/may have been stored below freezing overnight which may decrease efficacy of vaccine.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Severely painful arm pain - lasted all afternoon - evening. Better next day. Got at 11 AM 10/4/16. Patient unable to use arm so painful. First time getting high dose.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Bursitis, Immediate post-injection reaction, Injection site pain, Mobility decreased, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Severely painful arm pain - lasted all afternoon - evening. Better next day. Got at 11 AM 10/4/16. Patient unable to use arm so painful. First time getting high dose.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain
Clinical narrative: Severely painful arm pain - lasted all afternoon - evening. Better next day. Got at 11 AM 10/4/16. Patient unable to use arm so painful. First time getting high dose.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect product storage
Clinical narrative: Flu shots were/may have been stored below freezing overnight which may decrease efficacy of vaccine.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Diarrhoea, Fatigue, Headache, Hypersomnia
Clinical narrative: Was given FLUZONE high dose 2016-17 0.5 ml SYR at 10 in the morning. About 8 hours later I started feeling very tired and had an upset stomach. Ten hours later I developed a fever of 102, headache, and some diarrhea. I slept for about 14 hours (other than trips to the bathroom). The next day I just felt washed out but the fever, nausea and diarrhea were gone. I had been given the high dose flu vaccine last year without any side effects other than some very minor soreness at the injection site. Prior to that I had received the regular dose flu vaccine for as long as I can remember without any side effects.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pyrexia
Clinical narrative: Was given FLUZONE high dose 2016-17 0.5 ml SYR at 10 in the morning. About 8 hours later I started feeling very tired and had an upset stomach. Ten hours later I developed a fever of 102, headache, and some diarrhea. I slept for about 14 hours (other than trips to the bathroom). The next day I just felt washed out but the fever, nausea and diarrhea were gone. I had been given the high dose flu vaccine last year without any side effects other than some very minor soreness at the injection site. Prior to that I had received the regular dose flu vaccine for as long as I can remember without any side effects.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local reaction, Pruritus, Swelling
Clinical narrative: Localized reaction, erythema, mild swelling and pruritus. To be treat with diphenhydramine.
Age: 19.0
Sex: M
Vaccine: FLU3
Symptoms: Presyncope
Clinical narrative: Vasovagal response.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Contusion, Nasopharyngitis
Clinical narrative: Patient presented today with a bruise on arm that was approximately 1.5 to 2 inches in diameter. Said it is not getting better and it has been since 10-6-16. He said he had no pain from it but was concerned since it wasn't getting better. Also reported cold-like symptoms. Counseled that shot doesn't make sick and that he probably came into contact with a different virus.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 10-year-old male patient who received FLUARIX QUADRIVALENT (batch number Y495S,  expiry date June 2017). On 30th September 2016, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On an unknown date, less than a week after receiving FLUARIX QUADRIVALENT, the patient experienced injection site swelling, injection site warmth, injection site erythema and injection site inflammation. On an unknown date, the outcome of the injection site swelling, injection site warmth, injection site erythema and injection site inflammation were unknown. The reporter considered the injection site swelling, injection site warmth, injection site erythema and injection site inflammation to be probably related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient received FLUARIX QUADRIVALENT on unknown arm and his arm became swollen and inflamed. It was red and hot to the touch. After receiving the vaccine the patient was away with his father for several days. When the mother next saw him the reaction was present. The mother did not indicate if the symptoms were improving.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Fatigue, Injection site pain, Vomiting
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 55-year-old female patient who received FLUARIX QUADRIVALENT (batch number AF29T, expiry date 25th June 2017). Concomitant products included ADVIL. On 4th October 2016, the patient received the 1st dose of FLUARIX QUADRIVALENT 0.5 ml. On 4th October 2016, less than a day after FLUARIX QUADRIVALENT, the patient experienced dizziness, injection site pain, tiredness and vomiting. On an unknown date, the outcome of the dizziness, injection site pain, tiredness and vomiting were recovering/resolving. The reporter  considered the dizziness, injection site pain, tiredness and vomiting to be possibly related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was previously reported to a doctor. The patient had planned to continue follow-up with her physician on an unknown date.
Age: 66.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Heart rate increased, Musculoskeletal stiffness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of stiff neck in a 66-year-old male patient who received Influenza vaccine. Co-suspect products included Pneumococcal vaccine and ANORO ELLIPTA unknown (batch number 6ZP6390, expiry date 30th April 2018) for chronic obstructive pulmonary disease. The patient's past medical history included bladder catheterization. Concomitant products included albuterol and SYMBICORT. On 6th October 2016, the patient received Influenza vaccine, Pneumococcal vaccine and ANORO ELLIPTA 1 puff(s) twice daily (2 puff(s) daily). On 6th October 2016, less than a day after receiving Influenza vaccine and Pneumococcal vaccine, less than a day after receiving Influenza vaccine and Pneumococcal vaccine and 1 hr after starting Influenza vaccine and ANORO ELLIPTA, the patient experienced stiff neck and high pulse rate. ANORO ELLIPTA was continued with no change. On 6th October 2016, the outcome of the stiff neck was recovered/resolved. In October 2016, the outcome of the high pulse rate was recovered/resolved. It was unknown if the reporter considered the stiff neck and high pulse rate to be related to Influenza vaccine, Pneumococcal vaccine and ANORO ELLIPTA. Additional details were provided as follows: The patient reported that approximately 1 hour after taking an ANORO dose in the doctor's office, he developed a stiff neck that resolved later in the day. He also experienced a high pulse rate about 8 hours after his 1st dose. His pulse usually runs about 84 and it went to 104. Then it came back to normal. The patient also received an unknown manufacturer's influenza vaccine and pneumonia injection on the same office visit. The patient had denied permission to contact their physician.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Injection site reaction. Red, sore, warm to touch.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: Flu shots were/may have been stored below freezing overnight which may decrease efficacy of vaccine.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Left arm cellulitis.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect product storage
Clinical narrative: Flu shots were/may have been stored below freezing overnight which may decrease efficacy of vaccine.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect product storage
Clinical narrative: Flu shots were/may have been stored below freezing overnight which may decrease efficacy of vaccine.
Age: 37.0
Sex: U
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Patient had FLUARIX administered on 9/21/2016. Patient called pharmacy on 9/27/16 complaining of soreness and lack of range of motion in arm.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Pallor, Peripheral swelling, Throat irritation
Clinical narrative: Red swollen arm, pale face, itchy throat.
Age: 48.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Impaired work ability, Injected limb mobility decreased, Pain in extremity, Sleep disorder
Clinical narrative: Left arm pain. Cannot lift arm. Cannot sleep due to pain. Cannot work.
Age: 48.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Mobility decreased, Pain, Pain in extremity, Ultrasound scan, Vaccination complication
Clinical narrative: Left arm pain. Cannot lift arm. Cannot sleep due to pain. Cannot work.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Abasia, Arthralgia, Chills, Malaise, Pain
Clinical narrative: 6 PM. Cold Chills/Shakes. 9:30 - 10 pm skin burning (hands/feet), sore joints (couldn't walk). Pt took some BENADRYL at 3 am, symptoms eased up around 6 am. Sore and general feeling of malaise until Monday am.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Skin burning sensation, Tremor
Clinical narrative: 6 PM. Cold Chills/Shakes. 9:30 - 10 pm skin burning (hands/feet), sore joints (couldn't walk). Pt took some BENADRYL at 3 am, symptoms eased up around 6 am. Sore and general feeling of malaise until Monday am.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Fall, Syncope
Clinical narrative: Pt was extremely worked up regarding getting the vaccine. She was crying and very upset took several minutes to get her to sit still. After receiving the vaccine was walking in store and fell down/fainted. EMS was called but she wasn't taken in.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Hypertension, Syncope, Tachycardia
Clinical narrative: About 20 min after vaccine, pt reported dizziness, faint, tachycardia. Went to urgent care, then called ambulance from there. Was treated for HTN, tachy, and released. Declined ER visit.
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Local reaction, Nodule
Clinical narrative: This is a spontaneous report obtained from a contactable pharmacist through a Pfizer sales representative. An adult female patient of an unspecified age (more than 18 year) and ethnicity received TRUMENBA (Lot: M95612; Exp.: 30Jul2017) IM 0.5 ml single dose in left arm on 19Aug2016 09:30am for immunization (Meningococcal infection prophylaxis). Relevant medical history and concomitant medications were unknown. No other vaccines were administered on the same date. No other vaccinations within 4 weeks prior the date of vaccination.  On 21Aug2016, the patient had a localized reaction, the patient experienced a small knot. Patient got redness on the arm at the site of the injection. It was not a rash, was not itchy or swollen, her mother said it was gone within 2 days. Patient did not even notice the redness. She had on shirt with no sleeves and the mom noticed the redness.  The redness was pretty extensive. No hurt and itch were reported. The event did not require an emergency room or physician visit. Clinical outcome of the events was recovered. The reporter stated that the patient did provide to him/her information regarding the reported adverse events with the use of the suspect. The reporter considered there was  a reasonable possibility that the event is related to suspect product. The reporter was willing to be contacted again by Pfizer on the reported adverse events. Follow-up attempts are completed. No further information is expected. Follow-up (11Oct2016): New information reported from a contactable pharmacist included: suspect details; reporter informed regarding the adverse events; no other vaccines administered with suspect; events onset date and outcome; course of events; reporter event causality assessment; reporter further contactability.