chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: SkinRash Narrative:  Patient developed hives and itching. Resolved without intervention.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site discomfort, Injection site pain
Clinical narrative: Pain/Discomfort at injection site, fatigue or tiredness  Narrative:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site discomfort, Injection site pain
Clinical narrative: Headache Pain/Discomfort at injection site Narrative:
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Fatigue, Headache, Lethargy
Clinical narrative: Confusion & Headache Narrative:  Woke up the day after with a really bad headache, took Excedrin which did not help much, severe fatigue and lethargy. States she also had a bit of confusion, got lost in her yard yesterday, could not find her door. Has a history of lupus. Headache is lingering, also has a history of migraines.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia, Palpitations
Clinical narrative: Myalgia, Palpitations, chills Narrative:
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Impaired work ability, Myalgia, Nausea, Pain
Clinical narrative: Myalgia, Fever, NauseaVomiting, Fatigue Narrative:  Covid Team nurse reported patient called last Friday and missed work that day. Reported fatigue, fever, nausea and body aches.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Myalgia, Fever, NauseaVomiting, Fatigue Narrative:  Covid Team nurse reported patient called last Friday and missed work that day. Reported fatigue, fever, nausea and body aches.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: Headache, Myalgia Fatigue NarrativeL
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site discomfort, Injection site pain
Clinical narrative: Pain/Discomfort at injection site Narrative:
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Myalgia
Clinical narrative: Myalgia pain at injection site Narrative:
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Dry mouth, Fatigue, Malaise
Clinical narrative: dry mouth/fatigue Narrative:  Approx. 2 hrs after second dose, complains of not feeling well with fatigue and dry mouth.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Vomiting
Clinical narrative: Headache, Myalgia & NauseaVomiting Narrative:
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Myalgia, Pyrexia
Clinical narrative: Myalgia, Fever, enlarged lymph node Narrative:  stayed at home for 2 days
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site discomfort, Injection site pain, Pyrexia
Clinical narrative: Fever Pain/Discomfort at injection site Narrative:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Toothache
Clinical narrative: Headache teeth pain Narrative:
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site discomfort, Injection site pain
Clinical narrative: Pain/Discomfort at injection site Narrative:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling cold, Headache, Mobility decreased
Clinical narrative: Headache, Myalgia, Fever, NauseaVomiting, fatigue, chills Narrative:  1/12 4:00 fatigue and chills, 1/13 0300 freezing, temp to 99.5, body aches, headache, fatigue, nausea. Stayed in bed all day. 1/14 symptoms started to get better about 1:00 pm. Symptoms almost completely resolved by 6:00 that night. 1/15 felt normal.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Headache, Myalgia, Fever, NauseaVomiting, fatigue, chills Narrative:  1/12 4:00 fatigue and chills, 1/13 0300 freezing, temp to 99.5, body aches, headache, fatigue, nausea. Stayed in bed all day. 1/14 symptoms started to get better about 1:00 pm. Symptoms almost completely resolved by 6:00 that night. 1/15 felt normal.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Discomfort, Fatigue, Headache, Myalgia
Clinical narrative: Local symptoms- pain-discomfort. General symptoms-chills, fever, headaches, muscle pains, fatigue. Narrative:
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Local symptoms- pain-discomfort. General symptoms-chills, fever, headaches, muscle pains, fatigue. Narrative:
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache Narrative:  patient had headache two weeks after first dose
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site discomfort, Injection site pain
Clinical narrative: Pain/Discomfort at injection site Narrative:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Cough, Wheezing
Clinical narrative: CoughWheeze Asthma attack Narrative:  Asthma attack treated with steroids, nebulizer
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site discomfort, Injection site pain
Clinical narrative: Pain/Discomfort at injection site Narrative:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site discomfort, Injection site pain
Clinical narrative: Pain/Discomfort at injection site Narrative:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: Headache, Myalgia, fatigue, injection site soreness Narrative:
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site discomfort, Injection site pain
Clinical narrative: Pain/Discomfort at injection site Narrative:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Myalgia
Clinical narrative: Myalgia, Arthralgia,  fatigue Narrative:
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: injection site tenderness Narrative:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Gaze palsy, Injection site discomfort, Injection site pain
Clinical narrative: Headache, Myalgia, Pain/Discomfort at injection site, chills, fatigue or tiredness Narrative:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Headache, Myalgia, Pain/Discomfort at injection site, chills, fatigue or tiredness Narrative:
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pain in extremity
Clinical narrative: Myalgia Sore arm 2nd day after vaccine, fatigue during 2nd week after first dose Narrative:  Sore arm 2nd day after vaccine, fatigue during 2nd week after first dose
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Vaccination site reaction
Clinical narrative: two vesicles 1-2 inches from vaccine site. Narrative:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain in extremity
Clinical narrative: Headache & Myalgia Narrative:  Moderate to severe arm soreness, muscle aches and headache lasted about 36 hours.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia
Clinical narrative: Headache, Myalgia, chills Narrative:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site discomfort, Injection site pain, Myalgia
Clinical narrative: Myalgia Pain/Discomfort at injection site, fatigue or tiredness Narrative:
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Lacrimation increased, Pain in extremity, Peripheral coldness
Clinical narrative: chills, achy legs, watery eyes, coldness to hands Narrative:
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Fatigue, Insomnia
Clinical narrative: fatigue, sleep difficulty, epistaxis Narrative:
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations, Pyrexia
Clinical narrative: Fever & Palpitations Narrative:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Rash
Clinical narrative: Myalgia, SkinRash, chills Narrative:
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pruritus, Rash
Clinical narrative: Headache & Rash Narrative:  chills, fatigue, itching
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain in extremity
Clinical narrative: Headache & Myalgia Narrative:  sore arm 2nd day, headache first and second day
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Erythema, Injection site erythema, Injection site pain, Nausea
Clinical narrative: Diarrhea, NauseaVomiting,  redness/soreness, nausea, vomit, diarrhea Narrative:  Day 1 - redness to inj site; Day 2 and 3 - red/sore to inj site, nausea, vomiting, diarrhea; Day 4 - sore to inj site, nausea and diarrhea; Day 5 - some soreness to inj site; no further symptoms
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Vomiting
Clinical narrative: Diarrhea, NauseaVomiting,  redness/soreness, nausea, vomit, diarrhea Narrative:  Day 1 - redness to inj site; Day 2 and 3 - red/sore to inj site, nausea, vomiting, diarrhea; Day 4 - sore to inj site, nausea and diarrhea; Day 5 - some soreness to inj site; no further symptoms
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Peripheral swelling
Clinical narrative: Arthralgia swelling hand and feet Narrative:
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cold sweat, Confusional state, Disturbance in attention, Dizziness
Clinical narrative: Confusion, Dizziness, Arthralgia, Local tenderness. presyncope including clammy torso Narrative:  Floating, airy, light head, can't keep thoughts on track. Can't concentrate. Also, clammy, esp upper torso. Aches in neck & finger joints arthralgia. Pre-syncopal. Local tenderness. Axillary tenderness
Sex: F
Vaccine: COVID19
Symptoms: Presyncope, Tenderness
Clinical narrative: Confusion, Dizziness, Arthralgia, Local tenderness. presyncope including clammy torso Narrative:  Floating, airy, light head, can't keep thoughts on track. Can't concentrate. Also, clammy, esp upper torso. Aches in neck & finger joints arthralgia. Pre-syncopal. Local tenderness. Axillary tenderness
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Myalgia, Neck pain
Clinical narrative: Headache, Myalgia, Arthralgia, Neck pain, chills Narrative:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blister rupture, Blood blister, Headache, Injection site vesicles
Clinical narrative: Headache, Myalgia, Arthralgia, Fever, blister at injection site Narrative: Employee stated she developed a fever, headaches, joint pain and muscle aches and a blister at the injection site. Stated blister popped and clear fluid drained. Events happened on friday, employee stated yesterday, blister returned and now had blood blister and tenderness to left arm. Examined by Occ Health provider.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Tenderness
Clinical narrative: Headache, Myalgia, Arthralgia, Fever, blister at injection site Narrative: Employee stated she developed a fever, headaches, joint pain and muscle aches and a blister at the injection site. Stated blister popped and clear fluid drained. Events happened on friday, employee stated yesterday, blister returned and now had blood blister and tenderness to left arm. Examined by Occ Health provider.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Myalgia, Pyrexia
Clinical narrative: Headache, Myalgia, Fever, WEAKNESS Narrative:
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Myalgia, Nausea
Clinical narrative: Myalgia, Arthralgia, Diarrhea, NauseaVomiting, CHILLS Narrative:
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Myalgia, Arthralgia, Diarrhea, NauseaVomiting, CHILLS Narrative:
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain, Myalgia, Vertigo positional
Clinical narrative: Headache, Myalgia, Pain at site, fatigue and tiredness and benigh paroxysmal positional vertigo Narrative: Symptoms lasted 12 hours and resolved without medical interventions.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chills, Feeling cold, Headache
Clinical narrative: Myalgia, Arthralgia, cold chills, fever, lower back pain, achy knee joints, headaches Narrative:
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Myalgia, Arthralgia, cold chills, fever, lower back pain, achy knee joints, headaches Narrative:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hallucination
Clinical narrative: Dizziness & Hallucinations Narrative:
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Headache FATIGUE Narrative:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Narrative: Myalgia & Fever
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dizziness, Headache, Myalgia, Pruritus
Clinical narrative: Dizziness, Headache, Myalgia, Fever, SkinRash, CoughWheeze, Rash & UrticariaPruritus & Narrative:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Urticaria, Wheezing
Clinical narrative: Dizziness, Headache, Myalgia, Fever, SkinRash, CoughWheeze, Rash & UrticariaPruritus & Narrative:
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Device connection issue, Needle issue, Syringe issue, Underdose
Clinical narrative: when inj was administered the connection between the syringe and needle was not secure. A few drops of the vaccine leaked from the connection. Only a partial dose was administered. When attempting to remove the needle, the syringe came completely off Narrative: when inj was administered the connection between the syringe and needle was not secure. A few drops of the vaccine leaked from the connection. Only a partial dose was administered. When attempting to remove the needle, the syringe came completely off the needle. The needle had to be separately removed from the arm.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus
Clinical narrative: ITCHING AT INJECTION SITE Narrative:
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: Headache & Myalgia Narrative:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema multiforme, Injection site erythema, Pain
Clinical narrative: ErythemaMultiform Narrative: 11 days-red spot continued to inj set, intermittent soreness; rec PCP f/u if s/s progress to infection. Similar reaction to flu vax couple of years ago; reports cellulitis 2/2 last injection of anthrax series 2003
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pain
Clinical narrative: Myalgia body ache, pain, fatigue x 24 hrs. Narrative:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Myalgia
Clinical narrative: Dizziness, HEADACHE, Myalgia, CHILLS/FATIGUE Narrative:
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Myalgia, Pain in extremity
Clinical narrative: Headache, Myalgia, Sore Arm, fogginess to head for 1 day Narrative:
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: Headache, Myalgia, FATIGUE Narrative:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Injection site pain, Myalgia, Nausea, Neck pain
Clinical narrative: Myalgia, NauseaVomiting, SORENESS AT INJECTION SITE/NECK PAIN /WEAKNESS/NAUSEA Narrative:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Myalgia, NauseaVomiting, SORENESS AT INJECTION SITE/NECK PAIN /WEAKNESS/NAUSEA Narrative:
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Depression, Fatigue, Myalgia, Respiratory disorder
Clinical narrative: Myalgia, RespDepression, CoughWheeze, fatigue Narrative:
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: Myalgia, RespDepression, CoughWheeze, fatigue Narrative:
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Musculoskeletal chest pain, Nausea, Pyrexia, Vomiting
Clinical narrative: Headache, Fever, NauseaVomiting RIB PAIN Narrative:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Myalgia & Fever Narrative:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, SARS-CoV-2 test negative
Clinical narrative: Headache & Myalgia Narrative: Headache, myalgia; 12/31/2020 & 1/15/21 Covid test (-)
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Headache Sore throat, runny nose Narrative:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Headache, Myalgia, Fever, FATIGUE Narrative:
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Nausea, Pyrexia
Clinical narrative: Myalgia, Fever, NauseaVomiting, CHILL/FATIGUE./BODY SHAKING Narrative:
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor, Vomiting
Clinical narrative: Myalgia, Fever, NauseaVomiting, CHILL/FATIGUE./BODY SHAKING Narrative:
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue
Clinical narrative: Arthralgia fatigue Narrative: Arthralgia, fatigue; self resolved 48 hours
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Rhinorrhoea, Sneezing
Clinical narrative: Headache, fatigue, rhinorrhea, sneezing Narrative: Extreme fatigue, headache, rhinorrhea, sneezing within
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache Narrative: Headache; has hx of migraines; self resolved in 48 hours.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Respiratory tract congestion
Clinical narrative: Headache Chills, congestion Narrative:
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Myalgia, Nausea, Vomiting
Clinical narrative: Headache, Myalgia, Diarrhea & NauseaVomiting Narrative:
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain, Pain in extremity
Clinical narrative: Headache, Myalgia, sore arm Narrative: Headache, body aches, sore arm
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia
Clinical narrative: Narrative: Chills/Fatigue Myalgia
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever CHILLS Narrative:
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: left axillary lymph swelling Narrative:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Pain in extremity, Vomiting
Clinical narrative: Headache, Myalgia, NauseaVomiting, SORE ARM Narrative:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site hypoaesthesia, Injection site pain, Injection site warmth
Clinical narrative: NUMBNESS/REDNESS/TENDERNESS WARM & PAIN AT INJECTION SITE Narrative:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: Myalgia, Fever, CHILLS/FATIGUE Narrative:
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Facial pain, Headache, Hypoaesthesia, Myalgia, Neck pain
Clinical narrative: Headache, Myalgia, Fever, Has muscle pain right side of face and neck, has mild numbness on right side of face, no drooping. Narrative:
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Headache, Myalgia, Fever, Has muscle pain right side of face and neck, has mild numbness on right side of face, no drooping. Narrative:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: Headache, Myalgia & Fever Narrative:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pain, Myalgia, Pain
Clinical narrative: Headache, Myalgia, Fever, chills and all over body, in addition to injection site pain. Headache continued to linger Narrative: Noted that symptoms persisted for >24 hours, but have mostly resolved. Mild headache still reported greater that 5 days post vaccine
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Headache, Myalgia, Fever, chills and all over body, in addition to injection site pain. Headache continued to linger Narrative: Noted that symptoms persisted for >24 hours, but have mostly resolved. Mild headache still reported greater that 5 days post vaccine
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Blood sodium, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: Headache, Myalgia, Diarrhea, NauseaVomiting, SORE AT INJECTION SITE/CHILLS/FATIGUE Narrative:
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Myalgia, Vomiting
Clinical narrative: Headache, Myalgia, Diarrhea, NauseaVomiting, SORE AT INJECTION SITE/CHILLS/FATIGUE Narrative:
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Pyrexia
Clinical narrative: Fever CHILLS/ABDOMINAL CRAMPS Narrative:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Myalgia, Pyrexia
Clinical narrative: Myalgia, Fever, FATIGUE/WEAKNESS Narrative:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Headache, Myalgia, Fever, TIRED/CHILLS Narrative:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Neck pain, Pain, Pyrexia
Clinical narrative: Headache, Fever, Arm pain, severe neck and wrisk and body ache, Fever 103 Narrative:
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Malaise, Nausea, Respiratory depression, Vomiting
Clinical narrative: RespDepression, NauseaVomiting, Malaise and weakness also reported. Narrative:
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nasal congestion, Oropharyngeal pain, Pyrexia
Clinical narrative: Headache, Fever, SORE THROAT/STUFFY NOSE Narrative:
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: Aches & chills lasting approx. 5 hours Narrative:
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Headache, Myalgia, Fever, CHILLS/FATIGUE Narrative:
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Headache, Myalgia, Fever, CHILLS/FATIGUE Narrative:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Headache, Myalgia, Fever, NauseaVomiting, Fatigue Narrative:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Headache, Myalgia, Fever, NauseaVomiting, Fatigue Narrative:
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Myalgia, Nausea, Tremor
Clinical narrative: Dizziness, Myalgia, NauseaVomiting, FATIGUE/SHAKY LEGS Narrative:
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Dizziness, Myalgia, NauseaVomiting, FATIGUE/SHAKY LEGS Narrative:
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Malaise, Pyrexia
Clinical narrative: low grade fever, chills, malaise x 2 days Narrative:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Pain, Throat tightness
Clinical narrative: Headache TIGHT THROAT/SWOLLEN LYMPH NODES/BILATERAL LEGS & LWR ABD THROBBING/SWOLLEN UNDER ARM & BREAST Narrative:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: FEELING DRAINED Narrative:
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Pyrexia
Clinical narrative: Myalgia, Arthralgia & Fever Narrative:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia
Clinical narrative: Headache, Myalgia, Fatigue, Chills Narrative:
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash Narrative:
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling of body temperature change, Myalgia
Clinical narrative: Myalgia Afebrile but feeling hot and then cold Narrative:
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Hypoaesthesia
Clinical narrative: Dizziness NUMBNESS ON LEFT SIDE OF BODY,JOINTS/KNEES, FATIGUE Narrative:
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache Narrative:
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Myalgia, Fever, chills Narrative: Myalgia, fever, chills; recovered in 24 hours
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Pain in extremity, Pyrexia
Clinical narrative: Fever SORE ARM/LETHARGY Narrative:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Nausea, Pain
Clinical narrative: Headache, Myalgia, NauseaVomiting, wheezing, slight nausea, fatigue, body ache Narrative:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting, Wheezing
Clinical narrative: Headache, Myalgia, NauseaVomiting, wheezing, slight nausea, fatigue, body ache Narrative:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dizziness postural, Immediate post-injection reaction, Nausea, Paraesthesia oral
Clinical narrative: Dizziness Narrative: Immediately after 2nd dose, developed 8/10 dizziness, lip tingling; VS 144/82,hr 68-71, O2 sats 96-100%. 16-24 oz po H20 and g. crackers provided. 20 min later dizziness, lip tingling down to 3-5/10 but nausea 3/10 began. Stood up from sitting position with continued 2/10 dizziness noted. VS 125/87 , hr 71-73, O2 sats 97-100%. 30 min later all sx resolved 0/10 w/vs feet with no rebound sx. Closely monitored throughout episode. Provided contract numbers if any worrisome sx may reoccur.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Myalgia Narrative:
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: Headache, Fever, Fatigue Narrative:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue
Clinical narrative: Arthralgia Severe fatigue and chills Narrative:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Nausea, Vomiting
Clinical narrative: Headache, Arthralgia, NauseaVomiting, Intermittent Narrative:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: Headache, Myalgia, Fatigue Narrative:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pyrexia
Clinical narrative: Myalgia, Fever, FATIGUE Narrative:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Malaise, Myalgia
Clinical narrative: Headache, Myalgia, Fever, BRAIN FOG/CHILLS/RIGORS/GENERAL MALAISE Narrative:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Headache, Myalgia, Fever, BRAIN FOG/CHILLS/RIGORS/GENERAL MALAISE Narrative:
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: Headache, Myalgia, Fatigue Narrative:
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Vomiting
Clinical narrative: Headache, Myalgia & NauseaVomiting Narrative:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pain
Clinical narrative: Myalgia SORENESS/FATIGUE Narrative:
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Headache, Myalgia, Fever, CHILLS Narrative:
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Lethargy, Pain in extremity
Clinical narrative: Narrative: Dizziness, Sore Arm/Fatigue/Left Argic
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Narrative: NauseaVomiting
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Myalgia, Pain, Pain in extremity
Clinical narrative: Narrative: Dizziness, Myalgia, Pain, Tingling in fingers, Joint pain in shoulder and arm
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Narrative: Dizziness, Myalgia, Pain, Tingling in fingers, Joint pain in shoulder and arm
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal sensation in eye, Euphoric mood, Somnolence
Clinical narrative: Narrative: Felt high/groggy with funny eyes
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Malaise, Pyrexia
Clinical narrative: Fever CHILLS/MALAISE Narrative:
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: Headache, Myalgia & Fever Narrative:
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dizziness, Headache, Pyrexia, Wheezing
Clinical narrative: Headache, Fever, CoughWheeze, LIGHT HEADED Narrative:
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea Narrative:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Myalgia Soreness and pain to RT Arm, pt is going to Urgent Care this morning for assessment. Narrative:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Asthenia, Headache, Nasopharyngitis, Paranasal sinus discomfort
Clinical narrative: Headache Narrative: States worst headache, "debilitating." States took ADA and s/s resolved, but returned that evening around 1800. Took ASA, Tylenol, and a muscle relaxer; again symptoms resolved. States she awoke this morning with headache which was again relieved with OTC meds. 1/19 Headache gone; now beginning with cold s/s rhinorrhea, sinus pressure.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: Headache Narrative: States worst headache, "debilitating." States took ADA and s/s resolved, but returned that evening around 1800. Took ASA, Tylenol, and a muscle relaxer; again symptoms resolved. States she awoke this morning with headache which was again relieved with OTC meds. 1/19 Headache gone; now beginning with cold s/s rhinorrhea, sinus pressure.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: Headache, Myalgia & Fever Narrative:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Jaw disorder, Tenderness
Clinical narrative: Narrative: Headache, Jaw and Face tenderness x 2 days
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: Fever FATIGUE Narrative:
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Pruritus, Urticaria
Clinical narrative: UrticariaPrurius, lightheadedness and flushing Narrative:
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain in extremity, Vomiting
Clinical narrative: Headache, NauseaVomiting, fatigue, arm pain Narrative:
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Myalgia, Fever, SORENESS AT INJECTION SITE/CHILLS Narrative:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Fatigue, Headache, Nausea, Vomiting
Clinical narrative: Headache, NauseaVomiting, FATIGUE/CHEST PAIN, CHEST PAIN RESOLVED AFTER VOMITING Narrative:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: SkinRash Rash appeared on right Beast on 1/12, 1/13 and was gone on 1/14. Narrative:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain, Pyrexia
Clinical narrative: Headache, Fever, sorethroat Narrative:
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Malaise
Clinical narrative: FATIGUE/FEELING 'UNWELL' Narrative:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pain in extremity
Clinical narrative: Myalgia SORE ARM/CHILLS Narrative:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain
Clinical narrative: Fatigue, chills and body ache Narrative:
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Myalgia
Clinical narrative: Myalgia "ALL MY INTERNAL ORGANS WERE BURNING" Narrative:
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache
Clinical narrative: Headache CHILLS/FATIGUE Narrative:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site hypoaesthesia
Clinical narrative: NUMBNESS IN RIGHT ARM Narrative:
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Tachycardia
Clinical narrative: Rash & Tachycardia Narrative: TOOK OTC BENADRYL FOR ITCHING. NO OTHER MEDICEAL INTERVENTION NOTED.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: SkinRash Rash to Back Narrative:
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Wheezing
Clinical narrative: CoughWheeze, CHILLS Narrative:
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: Headache & Myalgia Narrative;
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Sedation, Sleep disorder
Clinical narrative: Confusion, Dizziness & Sedation Narrative: S/S started about 30 minutes after injection, employee had already been discharged from observation but was in his car preparing to go home; even though he was dizzy and confused he decided to drive himself home. Upon arrival he "ate and healthy meal and fell asleep." He reports this was a deep sleep that he awoke around 2100 and then was unable to go back to sleep during the night. Stated s/s are better now, but may not return to work tonight.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: ITCHING Narrative:
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Myalgia
Clinical narrative: Headache, Myalgia, Diarrhea, FATIGUE/CHILLS/BODYACHES/DIARRHEA/HEADACHE/SCRATCHY THROAT/PHLEGN Narrative:
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Productive cough, Throat irritation
Clinical narrative: Headache, Myalgia, Diarrhea, FATIGUE/CHILLS/BODYACHES/DIARRHEA/HEADACHE/SCRATCHY THROAT/PHLEGN Narrative:
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site cellulitis
Clinical narrative: DEVELOPED CELLULITIS AT INJECTION SITE 8 DAYS AFTER ADMINISTRATION Narrative:
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: Headache, Chills, and body ache Narrative:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Injection site warmth, Neck pain, Pain
Clinical narrative: PAIN AT INJECTION SITE WITH HEAT TRAVELING TO NECK/CHILLS Narrative:
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Narrative: Dizziness, Headache, Myalgia, Fever, SkinRash, Rash & NauseaVomiting
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vomiting
Clinical narrative: Narrative: Dizziness, Headache, Myalgia, Fever, SkinRash, Rash & NauseaVomiting
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Myalgia & Fever Narrative:
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Myalgia, Pyrexia
Clinical narrative: Myalgia, Fever, CHILLS Narrative:
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Fatigue, Nausea, Pain
Clinical narrative: Arthralgia, NauseaVomiting, Fatigue Narrative: Nausea, diarrhea, fatigue, jaw pain on opening and closing; encouraged to COVID test, negative:
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in jaw, SARS-CoV-2 test negative, Vomiting
Clinical narrative: Arthralgia, NauseaVomiting, Fatigue Narrative: Nausea, diarrhea, fatigue, jaw pain on opening and closing; encouraged to COVID test, negative:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Injection site mass, Injection site reaction, Rash erythematous
Clinical narrative: LUMP AT INJECTION SITE Narrative: PAIN IN ARMPIT AND 3-4 RED SPOTS AT INJECTION SITE WITH LUMP AT INJECTION SITE. THESE LASTED 48HR
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Headache, Injection site pain, Lymphadenopathy
Clinical narrative: Headache SWOLLEN LYMPH NODES/FLUSHING/INJECITON SITE SORENESS Narrative:
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Injection site swelling
Clinical narrative: Headache PAIN AND SWELLING AT INJECTIONS SITE Narrative:
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Nausea, Paraesthesia, Vomiting
Clinical narrative: Arthralgia, NauseaVomiting, numbness, tingling Narrative: Nausea, joint pain; numbers & tingling of arms & legs on third day. Resolved in 72 hours.
Age: 68.0
Sex: M
Vaccine: FLUA4, PPV
Symptoms: Chills, Dyskinesia, Pain in extremity
Clinical narrative: Uncontrollable jerking; Extreme arm soreness; Chills; This spontaneous case was retrieved on 23-Dec-2020 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 890354-1), reported by other health professional and concerned a 68-year-old, male patient.  The patient's concurrent condition included diabetes mellitus type 2. The patient had no allergies. The patient's concomitant medications were not reported.    On 13-Oct-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59; anatomical location: right arm, route of administration: intramuscular, dose and indication: not reported). The batch number reported was 279820.  On the same day, the patient was vaccinated with non-company co-suspect Pneumovax (pneumococcal vaccine polysacch 23v; route of administration: intramuscular, anatomical location: left arm, dose and indication: not reported). The batch number reported was T021485.   On 14-Oct-2020, one day after receiving Fluad Quadrivalent and co-suspect Pneumovax, the patient experienced chills. Chills were causing uncontrollable jerking. Also, the patient experienced extreme arm soreness, but it was controlled by over-the-counter (OTC) pain reliever.   On an unspecified date in Oct-2020, the patient recovered from events.   The reporter did not provide causality assessment.    The case was assessed as non-serious.  Company comment:The patient developed all events one day after vaccination with the suspect product, Fluad Quadrivalent. Chronology is plausible. Causality may have been confounded by treatment with co-suspect vaccine Pneumovax. Considering all above mentioned, causal relationship for all events is assessed as possibly related (defaults to ''related'' in the safety database for reporting purposes).; Sender's Comments: The patient developed all events one day after vaccination with the suspect product, Fluad Quadrivalent. Chronology is plausible. Causality may have been confounded by treatment with co-suspect vaccine Pneumovax. Considering all above mentioned, causal relationship for all events is assessed as possibly related (defaults to ''related'' in the safety database for reporting purposes).
Age: 67.0
Sex: F
Vaccine: FLUA4
Symptoms: Mouth swelling
Clinical narrative: Swelling in the corner of the mouth; This spontaneous case was retrieved on 24-Dec-2020 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 891875-1) reported by other health professional and concerned a 67-year-old, female patient.  The patient's concurrent condition included atrial fibrillation, rheumatoid arthritis, acid reflux and aspartame, codeine, intravenous pyelogram (IVP)dye and tape adhesive band aids allergy.The patient's concomitant medications included clecoxib, hydroxychloroquine, hydrochlorothiazide/ irbesartan, levothyroxine, metoprolol artrate, flecainide, Pradaxa (dabigatran etexilate mesilate), spironolactone, sulfasalazine EC, Nexium (esomeprazole sodium), multivitamin, vitamin D and calcium, all used for unreported indications.  On 18-Oct-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose reported as one, route of administration: intramuscular; anatomical location: left arm; indication: not repored). The batch number reported was 279819.  On 19-Oct-2020, one day after receiving Fluad Quadrivalent, the patient came through the drive thru stated they had just gone out for ice cream and had swelling in the corner of the mouth and only thing different was flu shot. Patient did not have difficulty breathing or swelling. Patient contacted medicinae doctor (MD) and was instructed to take a Benadryl (diphenhydramine).  On the same day, the patient recovered from event, since it was reported that swelling resolved and she felt good.  The reporter did not provide a causality assessment.  The case was assessed as non-serious  Company comment: A 67-year-old, female patient developed mouth swelling one day after vaccination with the suspect product, Fluad Quadrivalent. The patient contacted medicine doctor, nevertheless information regarding the related diagnostic findings have not been provided. Due to plausible time relationship, causality of the suspect product cannot be totally excluded and is assessed as possibly related.; Sender's Comments: A 67-year-old, female patient developed mouth swelling one day after vaccination with the suspect product, Fluad Quadrivalent. The patient contacted medicine doctor, nevertheless information regarding the related diagnostic findings have not been provided. Due to plausible time relationship, causality of the suspect product cannot be totally excluded and is assessed as possibly related.
Age: 67.0
Sex: M
Vaccine: FLUA4
Symptoms: Mouth swelling
Clinical narrative: Swelling in corner of mouth; This spontaneous case was retrieved on 24-Dec-2020 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 891876-1), reported by other health professional and concerned a 67-year-old male patient.  The patient's concurrent conditions included high cholesterol and hypertension. The patient's concomitant medications included Bisoprolol /HCTZ (bisoprolol fumarate, hydrochlorothiazide), atorvastatin and metformin, all used for unreported indications.  On 18-Oct-2020, the patient was vaccinated with Fluad Quadrivalent vaccine (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose reported as one, route of administration: intramuscular, anatomical location: left arm and indication: not reported). The batch number reported was 279819.  On the same day, after receiving Fluad Quadrivalent, the patient came through the drive-thru stating they had just gone for ice cream and had swelling in corner of the mouth. The patient had no difficulty breathing or swallowing. She contacted Doctor of Medicine (MD) and they instructed her to take Benadryl (diphenhydramine hydrochloride).  On 19-Oct-2020, the patient recovered from the event, she was followed up and stated she was feeling good.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment:The patient developed mouth swelling on the same day after vaccination with the suspect product, Fluad Quadrivalent. Chronology is suggestive. The patient's concomitant medications included bisoprolol fumarate/ hydrochlorothiazide, atorvastatin and metformin, which may have contributed to development of the event. Considering all above mentioned, causal relationship is assessed as possibly related (defaults to ''related'' in the safety database for reporting purposes).; Sender's Comments: The patient developed mouth swelling on the same day after vaccination with the suspect product, Fluad Quadrivalent. Chronology is suggestive. The patient's concomitant medications included bisoprolol fumarate/ hydrochlorothiazide, atorvastatin and metformin, which may have contributed to development of the event. Considering all above mentioned, causal relationship is assessed as possibly related (defaults to ''related'' in the safety database for reporting purposes).
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Oropharyngeal discomfort, Pharyngeal hypoaesthesia, Productive cough, Throat tightness
Clinical narrative: Felt a thickness in her throat; Phlegm inducing; Numbness; This spontaneous case from the  was retrieved on 24-Dec-2020 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 892086-1), reported by other health professional and concerned a 66-year-old female patient.  The patient had no relevant medical history and was not taking any concomitant medications.  On 09-Oct-2020, the patient was vaccinated with Afluria Quadrivalent vaccine (influenza vaccine, route of administration: intramuscular, anatomical location: left arm, dose and indication: not reported). The batch number reported was P100230204.  On the same day, about two hours after receiving Afluria Quadrivalent, the patient felt a thickness in her throat, phlegm inducing and numbness. She took Benadryl (diphenhydramine hydrochloride), went to bed and symptoms resolved.  On an unspecified date in Oct-2020, the patient recovered from the events.  The reporter did not provide causality assessment.  The case was assessed as non-serious.  Company comment: A 66-year-old female patient developed oropharyngeal discomfort, productive cough and hypoaesthesia about two hours after vaccination with the suspect product, Afluria Quadrivalent. As reported, the patient had no relevant medical history and was not taking any concomitant medications. Advanced age may have played a role in the development of the events. Due to plausible time relationship, causality is assessed as possibly related for all events. Due to limited information, Brighton Collaboration criteria for anaphylaxis could not be assessed.; Sender's Comments: A 66-year-old female patient developed oropharyngeal discomfort, productive cough and hypoaesthesia about two hours after vaccination with the suspect product, Afluria Quadrivalent. As reported, the patient had no relevant medical history and was not taking any concomitant medications. Advanced age may have played a role in the development of the events. Due to plausible time relationship, causality is assessed as possibly related for all events. Due to limited information, Brighton Collaboration criteria for anaphylaxis could not be assessed.
Sex: F
Vaccine: FLUA4
Symptoms: Chest X-ray, Electrocardiogram, Feeling abnormal, Full blood count, Headache
Clinical narrative: High white blood cell (WBC) 18,000; Hand shaking uncontrollable; Inside felt like jelly; Headache; Weakness legs heavy; This spontaneous case from the was retrieved on 24-Dec-2020 from Vaccine Adverse Event Reporting System (VAERS) (reference number 892918-1), reported by other health professional and concerned a female patient of an unspecified age.  The patient's concurrent conditions included high blood pressure (BP), hyper cholesterol and hypertension. The patient's concomitant medications included lisinopril, atenolol, Norvasc (amlodipine besilate) and fish oil, all for unreported indications.  On 07-Oct-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59; route of administration: intramuscular, anatomical location: right arm, dose reported as 'one', indication: not reported). The batch number reported was 279782.  On 10-Oct-2020, three days after receiving Fluad Quadrivalent, the patient experienced severe headache, severe weakness legs heavy and hand shaking uncontrollable. The patient felt like jelly inside.  On 11-Oct-2020, four days after receiving Fluad Quadrivalent, the patient went to urgent care and then was sent to emergency room (ER). Labs, imaging and additional tests were completed. Chest x-ray, complete blood count (CBC) and electrocardiogram (EKG) were performed but with no results provided. Covid test revealed negative results. White blood cell count revealed high results of 18,000.  On 15-Oct-2020, the patient recovered from the events of headache, 'lower extremities weakness of' and 'shaking of hands'.  On an unspecified date in Oct-2020, the patient recovered from the events of 'feeling abnormal' and 'white blood cell count high'.  The reporter did not provide causality assessment.   The case was assessed as non-serious.  Company comment: A female patient experienced muscular weakness, white blood cell count increased, tremor, feeling abnormal and headache in the days after administration of Fluad Quadrivalent. In the end, the patient recovered from all events. Covid test revealed negative results. Causality is assessed as possibly related for all events, but also confounded with reported concomitant drugs.; Sender's Comments: A female patient experienced muscular weakness, white blood cell count increased, tremor, feeling abnormal and headache in the days after administration of Fluad Quadrivalent. In the end, the patient recovered from all events. Covid test revealed negative results. Causality is assessed as possibly related for all events, but also confounded with reported concomitant drugs.