chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Wound infection
Clinical narrative: The day following the shot, I started to experience pain in my lymph node / armpit area. It progressively got worse,  very red and sore, and by day 3 I could barely move my arm. That evening (3 days post vaccine), the two red areas in my arm pit were now open sores/abrasion type areas. Within the next 48 hours, it became extremely infected, which has resolved with antibiotics.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Got hives on left side of face 5 minutes after flu shot. Was given Claritin
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: non raised red circular reaction 4 inches below site of actual vaccination
Age: 64.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Endotracheal intubation, Gait inability
Clinical narrative: On 9/27/24 at ~ 8:00am,  patient began experiencing swelling left side of tongue.  Patient drove to free standing clinic.  Ambulance called as facial/throat swelling advancing.  Patient transferred to Hospital. Due to airway compromise, patient intubated by 11am and brought to ICU.  Patient's treatment resulted in no change in her condition.  Therefore, on 9/29/24 at ~ 5pm, patient med flighted to Hospital.  Patient extubated on 10/3/24. ICU course notable for BP > 200. Post-extubation. patient with full body paralysis.  Patient transferred to acute rehab on October 24, 2024.
Age: 64.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Endotracheal intubation, Intensive care, Laboratory test, Obstructive airways disorder, Pharyngeal swelling
Clinical narrative: On 9/27/24 at ~ 8:00am,  patient began experiencing swelling left side of tongue.  Patient drove to free standing clinic.  Ambulance called as facial/throat swelling advancing.  Patient transferred to Hospital. Due to airway compromise, patient intubated by 11am and brought to ICU.  Patient's treatment resulted in no change in her condition.  Therefore, on 9/29/24 at ~ 5pm, patient med flighted to Hospital.  Patient extubated on 10/3/24. ICU course notable for BP > 200. Post-extubation. patient with full body paralysis.  Patient transferred to acute rehab on October 24, 2024.
Age: 64.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Quadriplegia, Swelling face, Swollen tongue
Clinical narrative: On 9/27/24 at ~ 8:00am,  patient began experiencing swelling left side of tongue.  Patient drove to free standing clinic.  Ambulance called as facial/throat swelling advancing.  Patient transferred to Hospital. Due to airway compromise, patient intubated by 11am and brought to ICU.  Patient's treatment resulted in no change in her condition.  Therefore, on 9/29/24 at ~ 5pm, patient med flighted to Hospital.  Patient extubated on 10/3/24. ICU course notable for BP > 200. Post-extubation. patient with full body paralysis.  Patient transferred to acute rehab on October 24, 2024.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives. Lasted a week without improvement. Told to take Allegra, Benadryl, and methlyprednisolone pack which improve and slowed Hives from popping up all over my body,
Age: 29.0
Sex: M
Vaccine: FLU3
Symptoms: Ear pruritus, Ear swelling, Erythema, Eye pruritus, Lip erythema
Clinical narrative: I have been getting swelling , itching, redness and hives around my eyes, my ears and groin and nose and lips.
Age: 29.0
Sex: M
Vaccine: FLU3
Symptoms: Lip pruritus, Lip swelling, Ocular hyperaemia, Periorbital swelling, Pruritus
Clinical narrative: I have been getting swelling , itching, redness and hives around my eyes, my ears and groin and nose and lips.
Age: 29.0
Sex: M
Vaccine: FLU3
Symptoms: Swelling, Swelling face, Urticaria
Clinical narrative: I have been getting swelling , itching, redness and hives around my eyes, my ears and groin and nose and lips.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Pain and tingling in hands and feet beginning two days after the vaccine, consulted a telehealth doctor who agreed vaccine was a plausible catalyst
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Peripheral swelling, Pruritus
Clinical narrative: My arm started to  itching and the next day  swelling, redness, and warmth.
Age: 30.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Premature delivery, Premature labour, Preterm premature rupture of membranes
Clinical narrative: G2P0 at the time, 34w4d (estimated date of delivery was 11/29/24), adverse event from the RSV vaccine was pre-term labor. PPROM less than 12 hours from the time vaccine was administered and subsequent spontaneous labor without need for induction or complication. Baby birthweight was 5lbs 9oz
Age: 59.0
Sex: M
Vaccine: UNK
Symptoms: Arthralgia
Clinical narrative: Intense shoulder pain
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Injection site pain, Injection site pruritus, Injection site reaction
Clinical narrative: Redness, swelling, pain, heat, itchiness at injection site. Headache, muscle aches, nausea, light headedness., full body hives.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Injection site warmth, Myalgia, Nausea, Urticaria
Clinical narrative: Redness, swelling, pain, heat, itchiness at injection site. Headache, muscle aches, nausea, light headedness., full body hives.
Age: 5.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Abdominal pain, Decreased appetite, Headache, Vomiting
Clinical narrative: 10/27/2024 0700: complaints of tummy ache, put in bathtub for comfort. 0800: complaints of headache, offered breakfast refused, ate popsicle and sipped water, 0900: cries and vomited twice, cleaned up,  temp 100.4 temporal. 0949: complaints that head hurts ?everywhere? PO tylenol given for headache. Monitoring for changes and will contact pediatrician if fever does not decrease or vomiting continues.
Age: 45.0
Sex: F
Vaccine: UNK
Symptoms: Erythema
Clinical narrative: I had an adverse event red dots on face and body after my vaccination.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Arthralgia, C-reactive protein increased, Erythema, Joint swelling, Laboratory test normal
Clinical narrative: Left knee reactive synovitis (pain/swelling and redness) later in day he received 2nd Gardasil vaccine
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Synovitis
Clinical narrative: Left knee reactive synovitis (pain/swelling and redness) later in day he received 2nd Gardasil vaccine
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Pain
Clinical narrative: Patient experienced a great deal of pain immediately after the vaccine which became almost debilitating even at the time of reporting in mid-October.  Patient has consulted her provider who stated the vaccine may have been administered too high in her shoulder.  She received two vaccines, one on each, and has no issues with the other arm.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on both arms from top of hand to inner elbow crease
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient was administered high dose when they were under 65.
Age: 32.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Heart rate increased, Palpitations, Sleep disorder
Clinical narrative: couldn't sleep and I had heart beat feeling I've never had before, my upper part of my heart started beating fast and it felt like the lower half wasn't beating i stood up straight and it felt like my heat completely stopped the starter to beat heard but normally ive never have experienced this before and i saw the report of over 56% of test have adverse and 40% did not get 2nd dose i will not be getting that 2nd dose, I've gotten all my covid flu and immunizations but this mpox needs to be reformulated im 32 this would have killed and older person, i hate to even report this but i must for safety of others I appreciate what the medical community provides and i hate that it has become so politicized i support and will always get vaccinated but this mpox is not a good shot
Age: 45.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Condition aggravated, Erythema, Headache, Migraine, Nausea
Clinical narrative: COVID VACCINE, LEFT ARM: palm-sized red welt hot to the touch, large knot in the middle, unusually severe pain - arm could not be touched my anything without the severe pain (all lasting 1.5 weeks); nausea, daily head pain/migraine and blurred vision/vision change - my normal corrective glasses/contacts do not work anymore post-covid vaccine (all starting vaccine day and currently ongoing)
Age: 45.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Nodule, Pain in extremity, Skin warm, Tenderness, Urticaria
Clinical narrative: COVID VACCINE, LEFT ARM: palm-sized red welt hot to the touch, large knot in the middle, unusually severe pain - arm could not be touched my anything without the severe pain (all lasting 1.5 weeks); nausea, daily head pain/migraine and blurred vision/vision change - my normal corrective glasses/contacts do not work anymore post-covid vaccine (all starting vaccine day and currently ongoing)
Age: 45.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Vision blurred, Visual impairment
Clinical narrative: COVID VACCINE, LEFT ARM: palm-sized red welt hot to the touch, large knot in the middle, unusually severe pain - arm could not be touched my anything without the severe pain (all lasting 1.5 weeks); nausea, daily head pain/migraine and blurred vision/vision change - my normal corrective glasses/contacts do not work anymore post-covid vaccine (all starting vaccine day and currently ongoing)
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Injection site pain, Myalgia
Clinical narrative: Fatigue, muscle aches, diarrhea and pain injection site
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Arthritis, Brain fog, Condition aggravated, Fatigue
Clinical narrative: Increased arthritis symptoms in right finger, hand and wrist. Short term memory issues/brain fog. Continues fatigue different from past vaccines and boosters
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Pruritus
Clinical narrative: 30 minutes after the vaccines, patient reports itching all over and joint pain. Reports that is resolved the next morning after a cold shower
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Patient describes injection site as : warm, red, puffy and is experiencing diarrhea. Patient describes redness as a somewhat circular area surrounding injection site and NOT radiating up or down arm.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Condition aggravated, Headache, Injection site pain, Injection site swelling
Clinical narrative: Vaccine Schedule: COVID-19 Moderna 1st Dose                      24-Jan-2021      No adverse event COVID-19 Moderna 2nd Dose                     21-Feb-2021     No adverse event COVID-19 Moderna Booster Shot               31-Oct-2021     No adverse event COVID-19 Moderna Bivalent Booster 18+ 29-Apr-2023     No adverse event COVID-19 Moderna Spikevax Booster        05-Oct-2024     ADVERSE EVENT     NDC: 80777-0110-96  Very loud TINNITUS within 24 hours of booster. Typical reactions from previous COVID-19 vaccinations included: fever, chills, headache, and pain/swelling at injection site. This was expected, however, the reactions for the Spikevax were much, much worse. The swelling at the injection site was visibly prominent and the pain was similar to when I had a bone bruise on my femur as a child. I have had mild tinnitus since high school, which comes and goes and is typically only a minor annoyance, similar to a mosquito. Unfortunately, the increase in tinnitus severity was immediately apparent and so unusual I mentioned it to my wife while laying on the couch the day after vaccination, but thought it would pass. It cannot be drowned out by background noise or music. If that were loud enough to have an effect, it would likely cause hearing damage. My ears were checked by my ENT within the past 4 months; no problems or issues were observed.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Tinnitus
Clinical narrative: Vaccine Schedule: COVID-19 Moderna 1st Dose                      24-Jan-2021      No adverse event COVID-19 Moderna 2nd Dose                     21-Feb-2021     No adverse event COVID-19 Moderna Booster Shot               31-Oct-2021     No adverse event COVID-19 Moderna Bivalent Booster 18+ 29-Apr-2023     No adverse event COVID-19 Moderna Spikevax Booster        05-Oct-2024     ADVERSE EVENT     NDC: 80777-0110-96  Very loud TINNITUS within 24 hours of booster. Typical reactions from previous COVID-19 vaccinations included: fever, chills, headache, and pain/swelling at injection site. This was expected, however, the reactions for the Spikevax were much, much worse. The swelling at the injection site was visibly prominent and the pain was similar to when I had a bone bruise on my femur as a child. I have had mild tinnitus since high school, which comes and goes and is typically only a minor annoyance, similar to a mosquito. Unfortunately, the increase in tinnitus severity was immediately apparent and so unusual I mentioned it to my wife while laying on the couch the day after vaccination, but thought it would pass. It cannot be drowned out by background noise or music. If that were loud enough to have an effect, it would likely cause hearing damage. My ears were checked by my ENT within the past 4 months; no problems or issues were observed.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Eye pain, Fatigue, Headache, Neck pain
Clinical narrative: 8-9 hours after vaccine had all the usual reactions- arm pain, fatigue, headache. About an 1-2 hours later random brief stabbing pains - head, eye, neck , finger joints
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: 8-9 hours after vaccine had all the usual reactions- arm pain, fatigue, headache. About an 1-2 hours later random brief stabbing pains - head, eye, neck , finger joints
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: This patient received 2 Fluad influenza vaccines inside 90 days. The first was administered at our facility on 8/9/24 and  the second also here on 10/24/24. The patient was called and has
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Skin warm, Swelling
Clinical narrative: Red hot and swollen, color has changed to a dark color (bruising). Using ice packs but made it sting. Trying tylenol to help with pain.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pyrexia, Tremor
Clinical narrative: Fever, fatigue, nausea, shakiness started next day 10/25, continued x 3 days.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Injection site reaction, Morphoea, Pain
Clinical narrative: BURNING PAIN WITHIN 24 HOURS OF THE SHOT PERSISTED, AND THEN SHE HAD A MORPHEA RASH DEVELOP THAT IS NOW PERSISTENT WITH CONSTANT BURNING PAIN. SHE HAS A RASH  WITH MORPHEA IN BILATERAL UPPER ARMS IN AREAS OF PAST COVID-19 SHOTS.
Age: 77.0
Sex: F
Vaccine: FLU3, RSV
Symptoms: Aphonia, Decreased appetite, Fatigue, Headache, Influenza like illness
Clinical narrative: patient came to pharmacy 10/27/24, 16 days after receiving vaccines, reporting persistant and ongoing right arm tenderness, sore throat, lost voice, fatigue, malaise, headache, fever (99-100 F), loss of appetite, and flu-like symptoms. Patient has been resting, using ibuprofen and otc cold medicine, fortify drinks, and body armour drinks to recover. Patient is till experiencing symptoms but reports slight improvement 10/27/24.
Age: 77.0
Sex: F
Vaccine: FLU3, RSV
Symptoms: Malaise, Oropharyngeal pain, Tenderness
Clinical narrative: patient came to pharmacy 10/27/24, 16 days after receiving vaccines, reporting persistant and ongoing right arm tenderness, sore throat, lost voice, fatigue, malaise, headache, fever (99-100 F), loss of appetite, and flu-like symptoms. Patient has been resting, using ibuprofen and otc cold medicine, fortify drinks, and body armour drinks to recover. Patient is till experiencing symptoms but reports slight improvement 10/27/24.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Rash, Rash pruritic
Clinical narrative: My right arm around the injection site has a rash and itches like crazy; also have a rash on my neck. This happened last year also. Nothing else has changed in my skincare routine so explain a rash.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dehydration, Nausea, Vomiting
Clinical narrative: Patient experience chills and vomiting.  Patient report unable to keep food down for 3 days since vaccine.  Started experiencing side effects the evening after receiving vaccination. Patient reported having side effects consistent with dehydration. Recommended contacting physician to report symptoms and possibly get medication to help with nausea.
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Head injury, Syncope
Clinical narrative: Patient was given a flu vaccine and when leaving the pharmacy fainted in the aisle and hit her head
Age: 74.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Pruritus
Clinical narrative: Very itchy for two-three weeks
Age: 66.0
Sex: F
Vaccine: PNC21
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Very red and swollen arm. Redness got bigger across the entire arm
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Patient called 10/27/25 stating that on 10/26/24 about 18 hours later that she developed hives on both arms, legs, and neck.  Patient states that she did NOT have any swelling anywhere, and no itching.  Patient was counsel to monitor the rash if it gets worse to seek medical care and if there was any swelling or difficulty breathing to go immediately to ER.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Tinnitus
Clinical narrative: Severe, high-pitched tinnitus. Occurred twelve hours after dose. Also occurred  twelve hours afterModerna two years ago, but the tinnitus is doubled in volume now.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Nodule
Clinical narrative: After receiving COVID19 vaccine, patient develop a large knot of the top of her shoulder
Age: 70.0
Sex: F
Vaccine: COVID19, TDAP
Symptoms: Hypoaesthesia, Neurological symptom, Transient ischaemic attack
Clinical narrative: Patient received 2 vaccinations, Comirnaty(pfizer) covid shot and Boostrix due to patient arriving with puncture wound from a dog bite.  2 days later she was admitted to the hospital with stroke-like symptoms.   numbness down the left side.  diagnosis from hospitalist was TIA. patient was prescribed several heart medications including valsartan, clopidogrel, aspirin, and atorvastatin
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Myalgia, Pain
Clinical narrative: Severe body, joint & muscle aches, lassitude, extreme fatigue.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Hypoaesthesia, Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: Patient says when he got a vaccine on 10/10/24 it felt like a "normal" vaccine but everyday since then pain in the injection arm has gotten worse.  Pt called in to the pharmacy on 10.27 to report this adverse reaction.  He says he can not raise his arm and does not have full mobility and that there is numbness in the left arm.  He has been taking Advil daily and the pain is not going away.  He say the pain radiates all over his shoulder.  He says there is no rash. He has not yet seen a doctor but said he will make an appointment this week.
Age: 89.0
Sex: F
Vaccine: FLU3
Symptoms: Goitre
Clinical narrative: RECEIVED VACCINE ON WED 10/23, REPORTED ON 10/27 THAT SYMPTOMS BEGAN ON 10/26 - SWOLLEN THYROID ONLY - NO FEVER, SWEATING, OR DIFFICULTY BREATHING
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Nausea
Clinical narrative: Body aches, headache, nausea, chills, fatigue,loss of appetite
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Body aches, headache, nausea, chills, fatigue,loss of appetite
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis psoriasiform, Rash
Clinical narrative: Within 3 days of receiving the Spikevax vaccine patient described a reaction in which she had a psoriatic type rash all over her body.
Age: 81.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injection site erythema, Injection site rash, Injection site reaction, Injection site swelling, Skin wound
Clinical narrative: injection site reaction/ swelling / rash  - pink/red broken skin - 1/4 to 1/2 inch crescent shaped marks
Age: 12.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Arthralgia, Head injury, Headache, Joint injury, Syncope
Clinical narrative: Patient fainted and hit her head and elbows after receiving the vaccine. 911 was called. She was taken to the hospital right after. She complained her head and elbows were hurting. She was able to answer all the questions from the EMT.
Age: 35.0
Sex: F
Vaccine: HPV9
Symptoms: Heavy menstrual bleeding
Clinical narrative: first vaccine was 7/30/24 second 10/21/24 and ever since the first one I have been getting periods when I hadn't previously and this time when on my period it became heavier and longer 11 days now. I am on progesterone only birth controls which has allowed me not to have a period for months and no problem until this vaccine
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Injection site pain
Clinical narrative: the vacccine hurted so much it was a big needle and my top shoulder was left so numb fro many days. i only took this out of respect for my boss and because i had to return to work and it was my job request for this. i got three shots all together of something that is not even described in the system . my first dose was 12-11-2021
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Decreased appetite, Fatigue, Malaise, Myalgia
Clinical narrative: Severe Weakness, malaise, fatigue, loss of appetite, muscle pains, fever
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Severe Weakness, malaise, fatigue, loss of appetite, muscle pains, fever
Age: 10.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Fall, Head injury, Imaging procedure, Loss of consciousness
Clinical narrative: Patient is a 10 year old female that received both the fluarix and moderna pedicatric injection. A few minutes after receiving her vaccination the patient lost consciousness when standing, fell backwards, and hit her head on the floor.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Incontinence, Pain, Pyrexia
Clinical narrative: patient reported fever of 100.5F, cold body chills and body aches lasting 64 hours , incontinence 6 times.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood thyroid stimulating hormone, Dizziness, Electrocardiogram, Full blood count
Clinical narrative: Palpitations daily starting on 9-6> went to urgent care and diagnosed as PVCs. (no previous history of palpitations or arrhythmias). Confirmed as PVCs at subsequent cardiology visit. Followed on 9-10 by vertigo daily and intermittently until 9-18. Intermittent light headedness for and additional 6 weeks.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test, Palpitations, Ventricular extrasystoles, Vertigo
Clinical narrative: Palpitations daily starting on 9-6> went to urgent care and diagnosed as PVCs. (no previous history of palpitations or arrhythmias). Confirmed as PVCs at subsequent cardiology visit. Followed on 9-10 by vertigo daily and intermittently until 9-18. Intermittent light headedness for and additional 6 weeks.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Nasal congestion, Pruritus, Sinus congestion
Clinical narrative: PATIENT REPORTS GENERALIZED ITCHING 15 MINUTES AFTER RECIEVING THE INJECTION ALONG WITH SINUS AND NASAL CONGESTION
Age: 65.0
Sex: F
Vaccine: DF
Symptoms: Chest pain, Choking, Computerised tomogram, Drooling, Dysarthria
Clinical narrative: onset initially chest pain ,joint stiffness , then progression after several weeks into slurred speech, after booster shot in august rapid decline with choking facial -left face weakness, slurred speech , tongue weakness, drooling and difficulty swallowing
Age: 65.0
Sex: F
Vaccine: DF
Symptoms: Dysphagia, Facial paresis, Guillain-Barre syndrome, Joint stiffness, Magnetic resonance imaging
Clinical narrative: onset initially chest pain ,joint stiffness , then progression after several weeks into slurred speech, after booster shot in august rapid decline with choking facial -left face weakness, slurred speech , tongue weakness, drooling and difficulty swallowing
Age: 65.0
Sex: F
Vaccine: DF
Symptoms: Tongue movement disturbance
Clinical narrative: onset initially chest pain ,joint stiffness , then progression after several weeks into slurred speech, after booster shot in august rapid decline with choking facial -left face weakness, slurred speech , tongue weakness, drooling and difficulty swallowing
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Discomfort, Erythema, Headache, Musculoskeletal stiffness
Clinical narrative: Severe headache and nausea. Mild muscle aches; resolving after 72 hours with Tylenol and Advil PRN. Significant joint pain in hips, shoulders, spine, toes, balls of feet, fingers with mild swelling, erythema, tenderness to touch, and stiffness. Joint pain and discomfort still not resolved after 72 hours and seems to be getting worse.  Plan on contacting PCP for follow-up.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Nausea, Spinal pain, Swelling, Tenderness
Clinical narrative: Severe headache and nausea. Mild muscle aches; resolving after 72 hours with Tylenol and Advil PRN. Significant joint pain in hips, shoulders, spine, toes, balls of feet, fingers with mild swelling, erythema, tenderness to touch, and stiffness. Joint pain and discomfort still not resolved after 72 hours and seems to be getting worse.  Plan on contacting PCP for follow-up.
Age: 42.0
Sex: M
Vaccine: COVID19, FLU3, HEPAB
Symptoms: Anaphylactic reaction, Feeling abnormal, Heart rate irregular, Respiration abnormal
Clinical narrative: anaphylaxis Reaction? feel very bad about 1 week got  respiratory and hearth irregular  , fewer
Age: 13.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Loss of consciousness, Syncope
Clinical narrative: PT RECEIVED PFIZER COVID VACCINE AND FLUARIX FLU SHOT IN LEFT ARM. PT WAS ALERT AND WAS OK RIGHT AFTER GIVEN THE VACCINES. PT WAS WAITING FOR MOTHER TO FINISH GETTING HER VACCINES AND THE PT FAINTED FOR A SPLIT SECOND THEN CAME TO CONSCIOUS AGAIN. I OFFERED MEDICAL ASSISTANT BUT THE MOTHER REFUSED. PT WAS OBSERVED IN THE WAITING ROOM FOR 20 MINUTES. PT WAS ALERT, MOBILE AND OK TO LEAVE THE PHARMACY AFTER 2O MINUTES.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Development of Shingles on right flank. Previously had earlier version of shingles vaccine.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Oropharyngeal pain
Clinical narrative: Muscle aches, fatigue, headache, mild sore throat, low grade fever of 99.7. Tylenol and Motrin taken. Felt better after 2 days
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Cough, Influenza like illness, Malaise, Pertussis, Pleurisy
Clinical narrative: Got sick about a week later with what felt like the flu then had a persistent cough for 2 months. I got pleurisy from coughing so hard for so long. (Whooping cough)
Age: 34.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Arthralgia, Back pain, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: L deltoid site reaction- Noted within a few hours of injection, red, warm, raised and extremely tender to touch.  Maximum size so far 1"x 1.5";  Joint pains - small joints of hand, wrists, hips, lower back; treatment- NSAIDs x 24 hours and decreased activity; Malaise- started next day, treated with decreasede activity, improved within 48 hours.
Age: 34.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injection site warmth, Malaise
Clinical narrative: L deltoid site reaction- Noted within a few hours of injection, red, warm, raised and extremely tender to touch.  Maximum size so far 1"x 1.5";  Joint pains - small joints of hand, wrists, hips, lower back; treatment- NSAIDs x 24 hours and decreased activity; Malaise- started next day, treated with decreasede activity, improved within 48 hours.
Age: 1.5
Sex: F
Vaccine: DTAP, HEPA, HIBV, PNC20
Symptoms: Blood culture, Computerised tomogram head, Culture urine, Electroencephalogram, Febrile convulsion
Clinical narrative: Complex febrile seizures requiring admit to hospital and multiple IV medications
Age: 1.5
Sex: F
Vaccine: DTAP, HEPA, HIBV, PNC20
Symptoms: Full blood count, Lumbar puncture, Metabolic function test
Clinical narrative: Complex febrile seizures requiring admit to hospital and multiple IV medications
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Febrile convulsion
Clinical narrative: Diagnosed with Febrile seizure in ER on 10/20/2024. Had another episdose on 10/24/2024. Due to see Pediatric Neurologist on 10/31/2024 for further evaluation
Age: 70.0
Sex: M
Vaccine: FLU3, UNK
Symptoms: Asthenia, Back pain, Chest discomfort, Dizziness, Dyspnoea
Clinical narrative: Trouble breathing; Back pain; Burning up/ Burning feeling; Chest was pounding and feeling heavy; This spontaneous case initially received on 09-Oct-2024, was reported by a non health professional and concerns elderly male patient.  Past medical history included High blood pressure. Drug history included Avelox (Reaction: Allergy).  Concomitant medication: Blood pressure medication.  Administration of company suspect drug(s): On 09-Oct-2024, the patient received Fluad (TIV) for Influenza prophylaxix, Influenza prophylaxis, Dose regimen: 0.5 ml, Route of administration: Intramuscular Left Deltoid, Lot number: 388492.  No additional suspect drugs.  Adverse reactions/events and outcomes: On 09-Oct-2024, the patient experienced Trouble breathing (outcome: Recovered / Resolved, stop date: 09-Oct-2024), Back pain (outcome: Recovered / Resolved, stop date: 09-Oct-2024), Burning up/ Burning feeling (outcome: Recovered / Resolved, stop date: 09-Oct-2024), Chest was pounding and feeling heavy (outcome: Recovered / Resolved, stop date: 09-Oct-2024).  The patient reported that he received his FLUAD vaccine today around 5:45 PM EST at his doctor's office. Patient stated that shortly after receiving his vaccination, he left his doctor's office, got into the car, and started to go out of the driveway of the office. Patient reported that as he was pulling out of the driveway of the doctor's office and turning right onto the main road to go home, he started to experience issues with breathing. He got about 200 yards down the main road and did a U-turn back to the doctor's office. Patient stated that he was having trouble breathing and his chest was pounding and feeling heavy. Additionally, the patient stated that he felt like he was burning up and he was experiencing back pain. Patient states that when he got back to the doctors office, they put him on oxygen and called an emergency squad, who monitored his blood pressure. Patient states that no medication was given to treat the event. Patient states that the difficulty breathing, burning feeling, and pounding and heaviness in the chest went away after 15 minutes and the back pain subsided later. Patient states that the event had resolved. Patient reports that his doctor stated that he would be contacting Seqirus separately to report the event. No additional information is provided.  Fluad (TIV) action taken: Not Applicable Treatment medication: Oxygen  Reporter's assessment: The reporter assessed all events as non-serious and the causality for all events was not provided.; Reporter's Comments: Company considered all the events as related.
Age: 70.0
Sex: M
Vaccine: FLU3, UNK
Symptoms: Fatigue
Clinical narrative: Trouble breathing; Back pain; Burning up/ Burning feeling; Chest was pounding and feeling heavy; This spontaneous case initially received on 09-Oct-2024, was reported by a non health professional and concerns elderly male patient.  Past medical history included High blood pressure. Drug history included Avelox (Reaction: Allergy).  Concomitant medication: Blood pressure medication.  Administration of company suspect drug(s): On 09-Oct-2024, the patient received Fluad (TIV) for Influenza prophylaxix, Influenza prophylaxis, Dose regimen: 0.5 ml, Route of administration: Intramuscular Left Deltoid, Lot number: 388492.  No additional suspect drugs.  Adverse reactions/events and outcomes: On 09-Oct-2024, the patient experienced Trouble breathing (outcome: Recovered / Resolved, stop date: 09-Oct-2024), Back pain (outcome: Recovered / Resolved, stop date: 09-Oct-2024), Burning up/ Burning feeling (outcome: Recovered / Resolved, stop date: 09-Oct-2024), Chest was pounding and feeling heavy (outcome: Recovered / Resolved, stop date: 09-Oct-2024).  The patient reported that he received his FLUAD vaccine today around 5:45 PM EST at his doctor's office. Patient stated that shortly after receiving his vaccination, he left his doctor's office, got into the car, and started to go out of the driveway of the office. Patient reported that as he was pulling out of the driveway of the doctor's office and turning right onto the main road to go home, he started to experience issues with breathing. He got about 200 yards down the main road and did a U-turn back to the doctor's office. Patient stated that he was having trouble breathing and his chest was pounding and feeling heavy. Additionally, the patient stated that he felt like he was burning up and he was experiencing back pain. Patient states that when he got back to the doctors office, they put him on oxygen and called an emergency squad, who monitored his blood pressure. Patient states that no medication was given to treat the event. Patient states that the difficulty breathing, burning feeling, and pounding and heaviness in the chest went away after 15 minutes and the back pain subsided later. Patient states that the event had resolved. Patient reports that his doctor stated that he would be contacting Seqirus separately to report the event. No additional information is provided.  Fluad (TIV) action taken: Not Applicable Treatment medication: Oxygen  Reporter's assessment: The reporter assessed all events as non-serious and the causality for all events was not provided.; Reporter's Comments: Company considered all the events as related.
Age: 70.0
Sex: M
Vaccine: FLU3, UNK
Symptoms: Back pain, Chest discomfort, Dyspnoea, Feeling hot, Palpitations
Clinical narrative: Trouble breathing; Back pain; Burning up/ Burning feeling; Chest was pounding and feeling heavy; This spontaneous case initially received on 09-Oct-2024, was reported by a non health professional and concerns elderly male patient.  Past medical history included High blood pressure. Drug history included Avelox (Reaction: Allergy).  Concomitant medication: Blood pressure medication.  Administration of company suspect drug(s): On 09-Oct-2024, the patient received Fluad (TIV) for Influenza prophylaxix, Influenza prophylaxis, Dose regimen: 0.5 ml, Route of administration: Intramuscular Left Deltoid, Lot number: 388492.  No additional suspect drugs.  Adverse reactions/events and outcomes: On 09-Oct-2024, the patient experienced Trouble breathing (outcome: Recovered / Resolved, stop date: 09-Oct-2024), Back pain (outcome: Recovered / Resolved, stop date: 09-Oct-2024), Burning up/ Burning feeling (outcome: Recovered / Resolved, stop date: 09-Oct-2024), Chest was pounding and feeling heavy (outcome: Recovered / Resolved, stop date: 09-Oct-2024).  The patient reported that he received his FLUAD vaccine today around 5:45 PM EST at his doctor's office. Patient stated that shortly after receiving his vaccination, he left his doctor's office, got into the car, and started to go out of the driveway of the office. Patient reported that as he was pulling out of the driveway of the doctor's office and turning right onto the main road to go home, he started to experience issues with breathing. He got about 200 yards down the main road and did a U-turn back to the doctor's office. Patient stated that he was having trouble breathing and his chest was pounding and feeling heavy. Additionally, the patient stated that he felt like he was burning up and he was experiencing back pain. Patient states that when he got back to the doctors office, they put him on oxygen and called an emergency squad, who monitored his blood pressure. Patient states that no medication was given to treat the event. Patient states that the difficulty breathing, burning feeling, and pounding and heaviness in the chest went away after 15 minutes and the back pain subsided later. Patient states that the event had resolved. Patient reports that his doctor stated that he would be contacting Seqirus separately to report the event. No additional information is provided.  Fluad (TIV) action taken: Not Applicable Treatment medication: Oxygen  Reporter's assessment: The reporter assessed all events as non-serious and the causality for all events was not provided.; Reporter's Comments: Company considered all the events as related.
Age: 63.0
Sex: M
Vaccine: UNK, FLUC4
Symptoms: Abdominal distension, Erythema, Pain in extremity, Peripheral swelling, Rash
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Joint Pain-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium
Age: 63.0
Sex: M
Vaccine: UNK, FLUC4
Symptoms: Arthralgia, Dermatitis allergic, Hypoaesthesia, Paraesthesia, Pruritus
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Joint Pain-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium
Age: 63.0
Sex: M
Vaccine: UNK, FLUC4
Symptoms: Rash
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Joint Pain-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium
Age: 75.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Chills, Diarrhoea, Erythema, Gastrointestinal disorder, Limb mass
Clinical narrative: Vaccination site mass; chills; Diarrhoea; Gastrointestinal disorder; Vaccination site discolouration; Vaccination site erythema; Information was received from the Regulatory Authority (AU-TGA-0000820268) on 22-OCT-2024. This spontaneous report was received from a Health professional via seqirus referring to a 75-years-old-female patient. Information regarding the patient's concurrent conditions, pertinent medical history and concomitant medication was not provided.  On 05-JUN-2018, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine(PNEUMOVAX23) (dosage, route of administration, lot number and expiration date were not provided) for prophylaxis. Other suspect vaccines included influenza vaccine (INFLUENZA VIRUS VACCINE). On the same day of the vaccination, the patient experienced redness (vaccination site erythema) and lump (vaccination site mass), expanding to lower arm. On an unknown date, the patient experienced chills, vaccination site discolouration, gastrointestinal disorder and diarrhea. The patient stated that she was in bed for 36 hours, she had previous reaction to pneumococcal 23v polysaccharide vaccine(PNEUMOVAX23) before. On unspecified date, the patient was admitted to hospital due to vaccination site mass.  The outcome of vaccination site mass, vaccination site erythema, gastrointestinal disorder, diarrhoea and chills was unknown. The outcome of vaccination site discolouration was reported as not recovered/not resolved (reported as "the arm injection site was still orange").  The reporter considered chills, vaccination site mass, vaccination site erythema, vaccination site discolouration, gastrointestinal disorder and diarrhoea to be related to pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23).
Age: 75.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Vaccination site discolouration
Clinical narrative: Vaccination site mass; chills; Diarrhoea; Gastrointestinal disorder; Vaccination site discolouration; Vaccination site erythema; Information was received from the Regulatory Authority (AU-TGA-0000820268) on 22-OCT-2024. This spontaneous report was received from a Health professional via seqirus referring to a 75-years-old-female patient. Information regarding the patient's concurrent conditions, pertinent medical history and concomitant medication was not provided.  On 05-JUN-2018, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine(PNEUMOVAX23) (dosage, route of administration, lot number and expiration date were not provided) for prophylaxis. Other suspect vaccines included influenza vaccine (INFLUENZA VIRUS VACCINE). On the same day of the vaccination, the patient experienced redness (vaccination site erythema) and lump (vaccination site mass), expanding to lower arm. On an unknown date, the patient experienced chills, vaccination site discolouration, gastrointestinal disorder and diarrhea. The patient stated that she was in bed for 36 hours, she had previous reaction to pneumococcal 23v polysaccharide vaccine(PNEUMOVAX23) before. On unspecified date, the patient was admitted to hospital due to vaccination site mass.  The outcome of vaccination site mass, vaccination site erythema, gastrointestinal disorder, diarrhoea and chills was unknown. The outcome of vaccination site discolouration was reported as not recovered/not resolved (reported as "the arm injection site was still orange").  The reporter considered chills, vaccination site mass, vaccination site erythema, vaccination site discolouration, gastrointestinal disorder and diarrhoea to be related to pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23).
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No side Effects; Patient received one additional dose of PROQUAD outside if PI recommendation; This spontaneous report was received from Consumer concerning a 5-year-old female patient.   Information regarding the patient's pertinetn medical history, concurrent conditions and concomitant therapies was not provided.  On 07-OCT-2024, the patient was vaccinated with an additional dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5 milliliter, lot #X022920, expiration date: 12-MAR-2025. (Albumin status was not reported, however upon internal validation was confirmed as rHA) administered for prophylaxis (strength, and route of administration were not provided).  No side effects or symptoms were reported.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No side effects reported; HCP calling to report expired MMRII was inadvertently administered after its labelled expiry date of 10/16/2024. HCP reports the vaccine has no previous temperature excursions. No side effects reported. Additional AE filed, refer to case #02694349. N; This spontaneous report was received from a registered nurse and refers to a 12-month-old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent (MERCK STERILE DILUENT).   On 22-OCT-2024, the patient was inadvertently vaccinated with and expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin [rHA]) (M-M-R II) injection, 0.5 milliliter, lot #W031980 which had been verified to be a valid lot number, expiration date reported and conformed as 06-OCT-2024, administered for prophylaxis (strength, route of administration, and anatomical location were not provided) (expired product administered).   It was confirmed that the vaccine had no previous temperature excursions. No side effects reported (no adverse event). No additional information provided.  This is one of the two reports received from the same reporter.; Sender's Comments:  US-009507513-2410USA010479:
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 16 Year Old Received A Dose of HEPLISAV-B; Initial report received on 19-Sep-2024.  A nurse reported that a 16-year-old male (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization as a first dose.  Medical history and concomitant medications at the time of vaccination were not reported. The patient had no known drug allergies.  On 19-Sep-2024, the patient received the first dose of HEPLISAV-B (lot # 944914 expiration date 05-Sep-2026, and NDC # and route not reported) in the deltoid from a pharmacist. The patient was under 18-years-old. No adverse reactions were reported by the reporter.  No additional information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: F
Vaccine: HEP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: 15 Weeks Pregnant; Initial report received on 23-Sep-2024.  The report was initially received from the HEPLISAV-B Pregnancy Registry.  A nurse reported that a 39-year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization while 15 weeks pregnant.  Medical history and concomitant medications were not reported.   The patient was 15 weeks pregnant.  The patient's last menstrual period date, pregnancy history, and pregnancy risk factors were not reported.   On 23-Sep-2024, the patient received the first dose of HEPLISAV-B (lot # 944919, expiration date 28-Nov-2026, and NDC # 43528-003-01) intramuscularly in the right arm.  The patient was 15 weeks pregnant at the time of vaccination.  The incident was discovered after the injection was given.  No adverse side effects were reported.   No additional information was available.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: Soreness in arm; flu like symptoms; This non-serious case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: Soreness in arm) and influenza-like symptoms (Verbatim: flu like symptoms). The outcome of the pain in arm and influenza-like symptoms were resolved.   The reporter considered the pain in arm and influenza-like symptoms to be related to Shingrix.     The company considered the pain in arm and influenza-like symptoms to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-OCT-2024 The physician reported that the patient received Shingrix and experienced soreness in arm and flu like symptoms. The reporter did not know the dose number of vaccine.