chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Eyelid rash, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Patient states she developed a rash around her neck and eyes. The rash has been severely itchy since Friday afternoon (4 days) from getting the vaccination. She wasn't sure if was from the vaccination, so she went to her doctor for an appointment to get medication to relieve the itching. Patient states the eye has cleared up and not itching. The rash around neck is still present, red, and itching.
Age: 86.0
Sex: F
Vaccine: COVID19, PNC20
Symptoms: Discontinued product administered, Expired product administered
Clinical narrative: Moderna COVID 2023/2024 administered in September 2024 after approval of 2024/2025 vaccine and past vaccine BUD.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Brain fog, Electromyogram, Fatigue, Headache
Clinical narrative: Headache, Neck Pain, Fatigue, Light Sensitivity, Nervous System Issues, Widespread Chronic Pain, Brain Fog, Irritability. Treaments included fibromyalgia medications, nerve block injections, botox, physical therapy, chiropractor, nerve medications, muscle relaxants. All over the span of 3 years.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Irritability, Magnetic resonance imaging, Neck pain, Nervous system disorder, Pain
Clinical narrative: Headache, Neck Pain, Fatigue, Light Sensitivity, Nervous System Issues, Widespread Chronic Pain, Brain Fog, Irritability. Treaments included fibromyalgia medications, nerve block injections, botox, physical therapy, chiropractor, nerve medications, muscle relaxants. All over the span of 3 years.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Photophobia, Urine analysis, Visual acuity tests, X-ray
Clinical narrative: Headache, Neck Pain, Fatigue, Light Sensitivity, Nervous System Issues, Widespread Chronic Pain, Brain Fog, Irritability. Treaments included fibromyalgia medications, nerve block injections, botox, physical therapy, chiropractor, nerve medications, muscle relaxants. All over the span of 3 years.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Tachycardia
Clinical narrative: Patient called 9/16/24 and stated that he had noticed a few hours after receiving the second dose of shingrix that he developed tachycardia with a heart rate in the 120's which is out of the patient's normal heart beat range and that he just didn't feel good. He states he is feeling better now but wanted to check to see if this was a side effect of the vaccine.
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Dysphagia, Throat irritation
Clinical narrative: patient had an itchy throat and trouble swallowing
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: SYMPTOMS STARTED A COUPLE HOURS THAT NIGHT AFTER VACCINE ADMINISTRATION.  ARM WAS VERY PAINFUL AND PATIENT COULD NOT LIFT HER ARM DUE TO THE PAIN. PATIENT TOOK IBUPROFEN TO HELP WITH THE PAIN AND POTENTIAL INFLAMMATION AND TYLENOL. NEITHER SEEMED TO HELP. PATIENT ALSO USED ICE PACKS THAT DID NOT HELP EITHER. AS OF TODAY 09/17/24, THE PAIN IN THE ARM IS STILL PRESENT BUT NOT AS BAD AS ON THE FIRST DAY
Age: 16.0
Sex: F
Vaccine: UNK
Symptoms: Foaming at mouth, Headache, Lethargy, Loss of consciousness, Muscle spasms
Clinical narrative: Adverse reactions included: Passing out 1-2 mins after injection?slight Foam of the mouth upon awakening.  A rash on her chest developed 24 hours after injection. 48 hours after injection she began experiencing muscle spasms in her left arm and loss of control of her fingers. There was a tingling sensation throughout her neck and entire left arm. The muscle spasms continued 5 days later. She experienced severe headaches and lethargy up until 7 days later.
Age: 16.0
Sex: F
Vaccine: UNK
Symptoms: Musculoskeletal disorder, Paraesthesia, Rash
Clinical narrative: Adverse reactions included: Passing out 1-2 mins after injection?slight Foam of the mouth upon awakening.  A rash on her chest developed 24 hours after injection. 48 hours after injection she began experiencing muscle spasms in her left arm and loss of control of her fingers. There was a tingling sensation throughout her neck and entire left arm. The muscle spasms continued 5 days later. She experienced severe headaches and lethargy up until 7 days later.
Age: 34.0
Sex: U
Vaccine: FLU4
Symptoms: Cough, Dyspnoea, Hypertension, Nasal congestion, Sneezing
Clinical narrative: Nasal stuffiness, sneezing, coughing, shortness of breath, vomiting, tachycardia, hypertension
Age: 34.0
Sex: U
Vaccine: FLU4
Symptoms: Tachycardia, Vomiting
Clinical narrative: Nasal stuffiness, sneezing, coughing, shortness of breath, vomiting, tachycardia, hypertension
Age: 8.0
Sex: F
Vaccine: DTAPIPV, IPV, MMRV
Symptoms: Wrong product administered
Clinical narrative: TDaP was meant to be given but Kinrix was inadvertently administered.  No treatment was needed and the patient will return at a later date to receive TDaP.
Age: 71.0
Sex: F
Vaccine: COVID19, FLUA4
Symptoms: Fatigue, Heart rate increased, Hypotension, Injection site erythema, Injection site pain
Clinical narrative: injection site reaction (pain, red, hot to the touch down to the elbow) for 6 days; nausea for  3 days and fatigue for 1 day, itchy arm for over a week,; low blood pressure, high pulse starting 2 days later for  2 days
Age: 71.0
Sex: F
Vaccine: COVID19, FLUA4
Symptoms: Injection site reaction, Injection site warmth, Nausea, Pruritus
Clinical narrative: injection site reaction (pain, red, hot to the touch down to the elbow) for 6 days; nausea for  3 days and fatigue for 1 day, itchy arm for over a week,; low blood pressure, high pulse starting 2 days later for  2 days
Age: 38.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event
Clinical narrative: N/A was no adverse effects reported
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Genital herpes
Clinical narrative: Reactivation of genital herpes that had been dormant for decades.  no treatments of this date 9/17/24
Age: 15.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Condition aggravated, Depression, Mood altered, Muscle spasms, Muscle twitching
Clinical narrative: Patient reports left arm 'tics' and twitching, weakness and pain from the constant muscle spasms; also experiencing nausea, and mood changes (worsening depressive episodes).  No redness or swelling reported.
Age: 15.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Muscular weakness, Nausea, Pain in extremity, Tic
Clinical narrative: Patient reports left arm 'tics' and twitching, weakness and pain from the constant muscle spasms; also experiencing nausea, and mood changes (worsening depressive episodes).  No redness or swelling reported.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: none
Age: 63.0
Sex: M
Vaccine: FLUC4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received annual flu shot on both 7/30/2024 and 9/16/2024. No adverse reactions noted as of yet.
Age: 6.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: There was no adverse event(s)  I called the patients mother to explain  that I gave  tdap instead of  dtap and the differences and  she stated that her son was doing fine  and she had no concerns.
Age: 4.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Diarrhoea, Fatigue, Inflammation, Pain, Pyrexia
Clinical narrative: Hive rash, inflammed raised rash across her face, both cheeks and across the nose, fever, rash, fatigue, aches, pains and diarrhea. Tylenol, Ibuphofen, brat diet, cold compress, Benadryl topical oinment, Ivenno all across the rash.
Age: 4.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Rash, Rash papular, Urticaria
Clinical narrative: Hive rash, inflammed raised rash across her face, both cheeks and across the nose, fever, rash, fatigue, aches, pains and diarrhea. Tylenol, Ibuphofen, brat diet, cold compress, Benadryl topical oinment, Ivenno all across the rash.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Computerised tomogram, X-ray
Clinical narrative: shoulder pain; pt has used acetaminophen without much relief. Pt states he has been unable to go to scheduled Dr appointments.  He did to the ER where he recieved Percocet for pain  and he got relief.
Age: 60.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Erythema nodosum, Nodule, Pain, Peripheral swelling
Clinical narrative: Redness, swelling, sharp stinging feeling developed in both lower legs within 24 hours post receiving vaccine.  It progressed without improvement. 1st doctor visit on 9/11, 6 days post receiving vaccine report adverse reaction and to ask for recommendation.  There were nodules developing, but reasonably calm.  9/12, reaction took a turn for the worse.  9/17, 2nd visit to doctor, to confirm Erythema Nodosum.  Very painful, raised bumps/nodules, swelling, redness, stinging, purple coloration in some areas. Dr. identified reaction, and prescribed steriods, ibuprofen, and baby aspirin to relieve symptomms.
Age: 60.0
Sex: F
Vaccine: RSV
Symptoms: Rash, Rash papular, Skin discolouration
Clinical narrative: Redness, swelling, sharp stinging feeling developed in both lower legs within 24 hours post receiving vaccine.  It progressed without improvement. 1st doctor visit on 9/11, 6 days post receiving vaccine report adverse reaction and to ask for recommendation.  There were nodules developing, but reasonably calm.  9/12, reaction took a turn for the worse.  9/17, 2nd visit to doctor, to confirm Erythema Nodosum.  Very painful, raised bumps/nodules, swelling, redness, stinging, purple coloration in some areas. Dr. identified reaction, and prescribed steriods, ibuprofen, and baby aspirin to relieve symptomms.
Age: 76.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Confusional state, Dizziness, Gait disturbance, Hemiparesis, Imaging procedure abnormal
Clinical narrative: Felt woozy after vaccination, presented at ED with stroke symptoms: L sided weakness, gait abnormalities, vomiting, confusion. Imaging revealed MCA ischemic stroke
Age: 76.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Ischaemic stroke, Middle cerebral artery stroke, Neurological symptom, Vomiting
Clinical narrative: Felt woozy after vaccination, presented at ED with stroke symptoms: L sided weakness, gait abnormalities, vomiting, confusion. Imaging revealed MCA ischemic stroke
Age: 17.0
Sex: M
Vaccine: HEP, IPV, MMR, TDAP, VARCEL
Symptoms: Blood glucose normal, Dyskinesia, Syncope
Clinical narrative: Patient fainted and presented upper body involuntary movement. No change of skin tone, eye roll. Vitals : Pulse 88 Resp. 25 B/P 131/75 @ 11:42AM. Pulse 104 Resp. 24 B/P 140/99@ 11:46AM. O2 Saturation : O2 99 Taken @ 11:42am
Age: 0.75
Sex: F
Vaccine: FLU4, HEP
Symptoms: Bacterial test positive, Bilirubin urine, Blood electrolytes normal, Blood gases normal, Blood lactic acid increased
Clinical narrative: Pt went to her PCPs this morning where she had a normal 9 month well child check. She has been meeting all developmental milestones and growing well. At the end of her visit around 10 am, she received a flu vaccine and Hep B booster. Pt then went home and had a normal day. Around 10:15 pm tonight, parents heard a thud from her bedroom and came in to find her standing in her crib, hitting her head against the crib because she was jerking her head. Parents have a video monitor of her crib and were able to review the video and see that she stood up and hit her head hard on the side of the crib which made the thud sound. Pt has continued to have this jerking movement to the left side ever since the initial episode. She is otherwise behaving normally and does not seen upset by the movements. Mom notes she is maybe a little more fussy but attributes this to it being the middle of the night. Dad commented that she is maybe blinking a little less than usual. Parents brought her in to the ED shortly after.  In the ED, pt has continued to intermittently have the head jerking. Parents have kept her in her carseat while sleeping in the ED to prevent her from hitting her head. She underwent a head CT and had labs done that were notable for a leukocytosis to 17.4 and a lactate of 2. Electrolytes and blood gas were grossly normal. Neurology was consulted and recommended admitting for observation and vEEG to further characterize the movements.  Of note, pt has previously tolerated all vaccines well. There is no known family history of seizures. Mom denies any recent viral illness that she is aware of. Patient has not had any cough, congestion, or fevers. Her identical twin is acting totally normal.
Age: 0.75
Sex: F
Vaccine: FLU4, HEP
Symptoms: Blood urine absent, Chromaturia, Computerised tomogram head normal, Dyskinesia, Electroencephalogram
Clinical narrative: Pt went to her PCPs this morning where she had a normal 9 month well child check. She has been meeting all developmental milestones and growing well. At the end of her visit around 10 am, she received a flu vaccine and Hep B booster. Pt then went home and had a normal day. Around 10:15 pm tonight, parents heard a thud from her bedroom and came in to find her standing in her crib, hitting her head against the crib because she was jerking her head. Parents have a video monitor of her crib and were able to review the video and see that she stood up and hit her head hard on the side of the crib which made the thud sound. Pt has continued to have this jerking movement to the left side ever since the initial episode. She is otherwise behaving normally and does not seen upset by the movements. Mom notes she is maybe a little more fussy but attributes this to it being the middle of the night. Dad commented that she is maybe blinking a little less than usual. Parents brought her in to the ED shortly after.  In the ED, pt has continued to intermittently have the head jerking. Parents have kept her in her carseat while sleeping in the ED to prevent her from hitting her head. She underwent a head CT and had labs done that were notable for a leukocytosis to 17.4 and a lactate of 2. Electrolytes and blood gas were grossly normal. Neurology was consulted and recommended admitting for observation and vEEG to further characterize the movements.  Of note, pt has previously tolerated all vaccines well. There is no known family history of seizures. Mom denies any recent viral illness that she is aware of. Patient has not had any cough, congestion, or fevers. Her identical twin is acting totally normal.
Age: 0.75
Sex: F
Vaccine: FLU4, HEP
Symptoms: Glucose urine absent, Head banging, Infant irritability, Leukocytosis, Magnetic resonance imaging head
Clinical narrative: Pt went to her PCPs this morning where she had a normal 9 month well child check. She has been meeting all developmental milestones and growing well. At the end of her visit around 10 am, she received a flu vaccine and Hep B booster. Pt then went home and had a normal day. Around 10:15 pm tonight, parents heard a thud from her bedroom and came in to find her standing in her crib, hitting her head against the crib because she was jerking her head. Parents have a video monitor of her crib and were able to review the video and see that she stood up and hit her head hard on the side of the crib which made the thud sound. Pt has continued to have this jerking movement to the left side ever since the initial episode. She is otherwise behaving normally and does not seen upset by the movements. Mom notes she is maybe a little more fussy but attributes this to it being the middle of the night. Dad commented that she is maybe blinking a little less than usual. Parents brought her in to the ED shortly after.  In the ED, pt has continued to intermittently have the head jerking. Parents have kept her in her carseat while sleeping in the ED to prevent her from hitting her head. She underwent a head CT and had labs done that were notable for a leukocytosis to 17.4 and a lactate of 2. Electrolytes and blood gas were grossly normal. Neurology was consulted and recommended admitting for observation and vEEG to further characterize the movements.  Of note, pt has previously tolerated all vaccines well. There is no known family history of seizures. Mom denies any recent viral illness that she is aware of. Patient has not had any cough, congestion, or fevers. Her identical twin is acting totally normal.
Age: 0.75
Sex: F
Vaccine: FLU4, HEP
Symptoms: Nitrite urine absent, Protein urine absent, Red blood cells urine positive, Specific gravity urine normal, Urine abnormality
Clinical narrative: Pt went to her PCPs this morning where she had a normal 9 month well child check. She has been meeting all developmental milestones and growing well. At the end of her visit around 10 am, she received a flu vaccine and Hep B booster. Pt then went home and had a normal day. Around 10:15 pm tonight, parents heard a thud from her bedroom and came in to find her standing in her crib, hitting her head against the crib because she was jerking her head. Parents have a video monitor of her crib and were able to review the video and see that she stood up and hit her head hard on the side of the crib which made the thud sound. Pt has continued to have this jerking movement to the left side ever since the initial episode. She is otherwise behaving normally and does not seen upset by the movements. Mom notes she is maybe a little more fussy but attributes this to it being the middle of the night. Dad commented that she is maybe blinking a little less than usual. Parents brought her in to the ED shortly after.  In the ED, pt has continued to intermittently have the head jerking. Parents have kept her in her carseat while sleeping in the ED to prevent her from hitting her head. She underwent a head CT and had labs done that were notable for a leukocytosis to 17.4 and a lactate of 2. Electrolytes and blood gas were grossly normal. Neurology was consulted and recommended admitting for observation and vEEG to further characterize the movements.  Of note, pt has previously tolerated all vaccines well. There is no known family history of seizures. Mom denies any recent viral illness that she is aware of. Patient has not had any cough, congestion, or fevers. Her identical twin is acting totally normal.
Age: 0.75
Sex: F
Vaccine: FLU4, HEP
Symptoms: Urine ketone body absent, Urobilinogen urine, Vitamin C normal, White blood cell count increased, White blood cells urine positive
Clinical narrative: Pt went to her PCPs this morning where she had a normal 9 month well child check. She has been meeting all developmental milestones and growing well. At the end of her visit around 10 am, she received a flu vaccine and Hep B booster. Pt then went home and had a normal day. Around 10:15 pm tonight, parents heard a thud from her bedroom and came in to find her standing in her crib, hitting her head against the crib because she was jerking her head. Parents have a video monitor of her crib and were able to review the video and see that she stood up and hit her head hard on the side of the crib which made the thud sound. Pt has continued to have this jerking movement to the left side ever since the initial episode. She is otherwise behaving normally and does not seen upset by the movements. Mom notes she is maybe a little more fussy but attributes this to it being the middle of the night. Dad commented that she is maybe blinking a little less than usual. Parents brought her in to the ED shortly after.  In the ED, pt has continued to intermittently have the head jerking. Parents have kept her in her carseat while sleeping in the ED to prevent her from hitting her head. She underwent a head CT and had labs done that were notable for a leukocytosis to 17.4 and a lactate of 2. Electrolytes and blood gas were grossly normal. Neurology was consulted and recommended admitting for observation and vEEG to further characterize the movements.  Of note, pt has previously tolerated all vaccines well. There is no known family history of seizures. Mom denies any recent viral illness that she is aware of. Patient has not had any cough, congestion, or fevers. Her identical twin is acting totally normal.
Age: 0.75
Sex: F
Vaccine: FLU4, HEP
Symptoms: pH urine normal
Clinical narrative: Pt went to her PCPs this morning where she had a normal 9 month well child check. She has been meeting all developmental milestones and growing well. At the end of her visit around 10 am, she received a flu vaccine and Hep B booster. Pt then went home and had a normal day. Around 10:15 pm tonight, parents heard a thud from her bedroom and came in to find her standing in her crib, hitting her head against the crib because she was jerking her head. Parents have a video monitor of her crib and were able to review the video and see that she stood up and hit her head hard on the side of the crib which made the thud sound. Pt has continued to have this jerking movement to the left side ever since the initial episode. She is otherwise behaving normally and does not seen upset by the movements. Mom notes she is maybe a little more fussy but attributes this to it being the middle of the night. Dad commented that she is maybe blinking a little less than usual. Parents brought her in to the ED shortly after.  In the ED, pt has continued to intermittently have the head jerking. Parents have kept her in her carseat while sleeping in the ED to prevent her from hitting her head. She underwent a head CT and had labs done that were notable for a leukocytosis to 17.4 and a lactate of 2. Electrolytes and blood gas were grossly normal. Neurology was consulted and recommended admitting for observation and vEEG to further characterize the movements.  Of note, pt has previously tolerated all vaccines well. There is no known family history of seizures. Mom denies any recent viral illness that she is aware of. Patient has not had any cough, congestion, or fevers. Her identical twin is acting totally normal.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Vision blurred
Clinical narrative: Patient was at work and started to experience dizziness and her vision kept going blurry. Was taking to to the hospital and given meclizine for the dizziness.
Age: 75.0
Sex: M
Vaccine: FLUA4, RSV, FLUA4, RSV
Symptoms: Back pain, Chest discomfort, Dyspnoea, Groin pain, Immediate post-injection reaction
Clinical narrative: Patient reported having palpitations immediately after receiving both vaccines.  He also reported having chest pressure/discomfort with radiation to back pain and groin, in addition to dyspnea.   We had patient sit down and we were going to call EMS for an ambulance.  Patient stated he felt better, symptoms improved.  He refused medical care and left against medical advice.
Age: 75.0
Sex: M
Vaccine: FLUA4, RSV, FLUA4, RSV
Symptoms: Palpitations
Clinical narrative: Patient reported having palpitations immediately after receiving both vaccines.  He also reported having chest pressure/discomfort with radiation to back pain and groin, in addition to dyspnea.   We had patient sit down and we were going to call EMS for an ambulance.  Patient stated he felt better, symptoms improved.  He refused medical care and left against medical advice.
Sex: F
Vaccine: FLU4, HEP
Symptoms: Circumstance or information capable of leading to medication error, No adverse event
Clinical narrative: Newborn was ordered Hepatitis B (Engerix-B) vaccine to be administered shortly after birth.  RN pulled vaccine out of the refrigerator and administered. After administration, it was noted that the newborn received a dose of Trivalent Flulaval 2024-25 (the only option to select on the drop down in Quadrivalent, however the 2024-25 formulation is trivalent). After noting the error, a dose of Hepatitis B vaccine was administered appropriately. The newborn did not experience any adverse effects. The RN noted that the two pre-filled syringes look nearly identical, potentially leading to the error.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Tenderness
Clinical narrative: Patient reported redness, warmth, and tenderness lasting greater than 48 hours. She stated that area is getting worse and larger after 48 hours. She is self monitoring at home.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: After leaving the pharmacy the patient returned and stated they thought they were getting a COVID vaccine and they had received a flu vaccine the week before at their providers office.
Age: 64.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acne, Lip swelling, Pyrexia
Clinical narrative: Started to get a fever, lips became swollen, and experienced "breakout of pimples" on face
Age: 8.0
Sex: M
Vaccine: MMRV
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Pt needed just varicella vaccine but received the MMRV.  He was complete with his MMR just needed 2nd Varicella.
Age: 75.0
Sex: M
Vaccine: UNK
Symptoms: Chest X-ray, Chills, Computerised tomogram thorax, Fatigue, Headache
Clinical narrative: headache, fever, chills, tired
Age: 75.0
Sex: M
Vaccine: UNK
Symptoms: Pyrexia
Clinical narrative: headache, fever, chills, tired
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Patient came back into the store and stated they thought the were getting a COVID vaccine and they had received a FLU vaccine the week before at their providers office.  They then asked could they now receive a COVID vaccine and was given one.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: Patient's wife presented to pharmacy on 9/17/24 reporting patient had experienced significantly more adverse effects from the COVID IMZ received on 9/13/24 than any of the previouis COVID IMZ. He had  significant joint/muscle pain starting in the left arm from elbow to shoulder, then it moved to both arms the following day, then the following day to the legs around the knees as well. He has gotten some relief from otc ibuprofen but the symptoms seem to return each evening. He has not gone to his provider yet.
Age: 44.0
Sex: M
Vaccine: TYP
Symptoms: Rash, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Patient developed raised, red, itchy rash of the axilla, neck, chest and back.
Age: 59.0
Sex: F
Vaccine: FLUA4
Symptoms: Chills, Injection site erythema, Injection site swelling, Muscular weakness, Nausea
Clinical narrative: Nausea, muscle weakness, body aches and chills, redness and swelling around injection site.
Age: 59.0
Sex: F
Vaccine: FLUA4
Symptoms: Pain
Clinical narrative: Nausea, muscle weakness, body aches and chills, redness and swelling around injection site.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient presented to clinic on 9/13/2024 and received vaccinations, MMR, Kinrix, and Varicella. Patient presented back to clinic on 9/16/2024 with mother. Mother stated that on 9/15/2024 patient had been itching at left thigh and she noticed swelling off and on at stie. Mother stated that left thigh had been warm to touch and hurts patient when he touches it. MMR and Kinrix were given in left thigh. Patient was evaluated by Dr.. Diagnosis - Adverse effect of vaccine, initial encounter. Noted 9x9cm area of erythema around reaction site. Patient did not have any complaints that day. Traced around erythema to monitor. Recommended OTC chewable Claritain and use of ice packs to site.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse events reported nor recorded. Patient is 5 years old and received a COVID vaccine suitable for individuals who are 12 years and above.
Age: 3.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD for vaccine. Outcome will be recommend to to receive the covid 19 2024-25 vaccine when available in the fall.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Patient received vaccine 9/16/24. On 9/17/24 patient could not feel both legs for about 20 minutes. Patient reports feeling is back to normal in both legs but is following up with primary provider.
Age: 7.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD for vaccine. Outcome will be recommend to to receive the covid 19 2024-25 vaccine when available in the fall.
Age: 7.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD for vaccine. Outcome will be recommend to to receive the covid 19 2024-25 vaccine when available in the fall.
Age: 6.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD for vaccine. Outcome will be recommend to to receive the covid 19 2024-25 vaccine when available in the fall.
Age: 65.0
Sex: F
Vaccine: COVID19, FLUA4
Symptoms: Pain, Peripheral swelling, Swelling
Clinical narrative: EXTREME PAIN/SWELLING ; BUMP-LIKE SWELLING ON LEFT FOREARM OCCURRED DAYS AFTER; RESOLVED WITH ICE AND OTC MEDICATIONS
Age: 11.0
Sex: M
Vaccine: COVID19-2, HPV9, MNQ, TDAP
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD for vaccine. Outcome will be recommend to to receive the covid 19 2024-25 vaccine when available in the fall.
Age: 43.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Arteriogram coronary normal, Cardiac stress test abnormal, Chest discomfort, Computerised tomogram thorax abnormal, Dizziness
Clinical narrative: Shortness of breath/light headedness/Chest tightness/Palpatations
Age: 43.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Dyspnoea, Electrocardiogram normal, Palpitations, Pulmonary mass
Clinical narrative: Shortness of breath/light headedness/Chest tightness/Palpatations
Age: 5.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD for vaccine. Outcome will be recommend to to receive the covid 19 2024-25 vaccine when available in the fall.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Intense vomiting, could not keep light food or water down
Age: 14.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD for vaccine. Outcome will be recommend to receive the covid 19 2024-25 vaccine when available in the fall.
Age: 13.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD for vaccine. Outcome will be recommend to receive the covid 19 2024-25 vaccine when available in the fall.
Age: 3.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD for vaccine. Outcome will be recommend to receive the covid 19 2024-25 vaccine when available in the fall.
Age: 7.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD for vaccine. Outcome will be recommend to receive the covid 19 2024-25 vaccine when available in the fall.
Age: 2.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD for vaccine. Outcome will be recommend to receive the covid 19 2024-25 vaccine when available in the fall.
Age: 1.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD for vaccine. Outcome will be recommend to receive the covid 19 2024-25 vaccine when available in the fall.
Age: 9.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD for vaccine. Outcome will be recommend to receive the covid 19 2024-25 vaccine when available in the fall.
Age: 0.83
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD for vaccine. Outcome will be recommend to receive the covid 19 2024-25 vaccine when available in the fall.
Age: 63.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Incorrect dose administered, Incorrect product formulation administered, No adverse event
Clinical narrative: Trivalent High Fluzone dose was given instead of Fluzone.  No adverse events reported.
Age: 8.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD for vaccine. Outcome will be recommend to receive the covid 19 2024-25 vaccine when available in the fall.
Age: 9.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD for vaccine. Outcome will be recommend to receive the covid 19 2024-25 vaccine when available in the fall.
Age: 5.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD for vaccine. Outcome will be recommend to receive the covid 19 2024-25 vaccine when available in the fall.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: 4 days of itchy rash.  Started as erythematous patches over back, left frontal neck, left side, about both axillae, over both pectoralis chest area, lower abdomen, upper inner thighs.  Used diphenhydramine or Claritin for itch. Subsided and disappeared by 5th day.
Age: 12.0
Sex: M
Vaccine: COVID19-2, HPV9, MNQ
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD for vaccine. Outcome will be recommend to receive the covid 19 2024-25 vaccine when available in the fall.
Age: 1.75
Sex: F
Vaccine: TYP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Typhim administered to patient under the age of 24 months, continue to monitor for adverse reactions.
Age: 5.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD for vaccine. Outcome will be recommend to receive the covid 19 2024-25 vaccine when available in the fall.
Age: 47.0
Sex: F
Vaccine: FLUR4
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient presented to emergency room on 9/13/24 due to welts on shoulders and torso. Was released the same day and presented back to emergency room the next day 9/14/24 due to welts spreading to arms and face. Patient was also released same day and followed up with primary care due to itchiness of arms. There was no injection site reaction reported when patient informed pharmacy.
Age: 3.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD for vaccine. Outcome will be recommend to receive the covid 19 2024-25 vaccine when available in the fall.
Age: 65.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Injection site pain, Injection site swelling, Nodule, Swelling
Clinical narrative: EXTREME PAIN AND SWELLING TO RIGHT SIDE OF INJECTION SITE OF R. ARM AND SWELLING OF BALL-LIKE KNOT ON CHEST
Age: 7.0
Sex: F
Vaccine: COVID19-2, FLU4, HEPA
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD for vaccine. Outcome will be recommend to receive the covid 19 2024-25 vaccine when available in the fall.
Age: 8.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD for vaccine. Outcome will be recommend to receive the covid 19 2024-25 vaccine when available in the fall.
Age: 15.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD for vaccine. Outcome will be recommend to receive the covid 19 2024-25 vaccine when available in the fall.
Age: 4.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD for vaccine. Outcome will be recommend to receive the covid 19 2024-25 vaccine when available in the fall.
Age: 6.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD for vaccine. Outcome will be recommend to receive the covid 19 2024-25 vaccine when available in the fall.
Age: 0.58
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD for vaccine. Outcome will be recommend to receive the covid 19 2024-25 vaccine when available in the fall.
Age: 2.33
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD for vaccine. Outcome will be recommend to receive the covid 19 2024-25 vaccine when available in the fall.
Age: 5.0
Sex: M
Vaccine: COVID19-2, DTAPIPV, MMRV
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD for vaccine. Outcome will be recommend to receive the covid 19 2024-25 vaccine when available in the fall.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Cheilitis, Chills, Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Per patient the day (09/12/24) of receiving the TDAP shot she experienced swelling, redness, and a lump on her right arm where she received the shot. She states that she also developed a fever, chills and that her skin where she received the shot was warm to the touch.  Per patient her fever lasted 2 days, until (09/13/24). The patient states that her fever on Friday was 100.0 degrees F.  She states that she also developed a sore on her lip. She states that the chills resolved after one day. She states that swelling and redness has not worsened or improved and she states that the hard lump has remained the same as well.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: Per patient the day (09/12/24) of receiving the TDAP shot she experienced swelling, redness, and a lump on her right arm where she received the shot. She states that she also developed a fever, chills and that her skin where she received the shot was warm to the touch.  Per patient her fever lasted 2 days, until (09/13/24). The patient states that her fever on Friday was 100.0 degrees F.  She states that she also developed a sore on her lip. She states that the chills resolved after one day. She states that swelling and redness has not worsened or improved and she states that the hard lump has remained the same as well.
Age: 8.0
Sex: M
Vaccine: COVID19-2, HEPA
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD for vaccine. Outcome will be recommend to receive the covid 19 2024-25 vaccine when available in the fall.
Age: 8.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD for vaccine. Outcome will be recommend to receive the covid 19 2024-25 vaccine when available in the fall.
Age: 1.5
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD for vaccine. Outcome will be recommend to receive the covid 19 2024-25 vaccine when available in the fall.
Age: 17.0
Sex: F
Vaccine: COVID19-2, FLU4, MENB, MNQ
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD for vaccine. Outcome will be recommend to receive the covid 19 2024-25 vaccine when available in the fall.
Age: 62.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Chills, Ear swelling, Eye swelling, Fatigue, Lip swelling
Clinical narrative: Swelling ears, lips, eyes and muscle pain, sore throat, body aches, chills, fatigue, itchiness on face and swelling in feed
Age: 62.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Myalgia, Oropharyngeal pain, Pain, Peripheral swelling, Pruritus
Clinical narrative: Swelling ears, lips, eyes and muscle pain, sore throat, body aches, chills, fatigue, itchiness on face and swelling in feed
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain, Sleep disorder, Treatment failure
Clinical narrative: PER PATIENT, SHE EXPERIENCED EXCRUCIATING SKELETAL MUSCLE ACHE FROM HEAD TO TOE WHICH BEGAN 2 HOURS AFTER THE SHOT. IT LASTED ALL NIGHT. SHE TOOK HER BREAKETHROUGH OXYCODONE BUT HAD NO RELIEF AND THE PAIN KEPT HER UP ALL NIGHT. PER PATIENT IT WAS THE WORSE PAIN, WORSE THAN KIDNEY STONE PAIN BUT HAD RELIEF ABOUT 12 HOURS LATER
Age: 15.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE details reported; 15-year-old patient who received an adult dose of VAQTA instead of a pediatric dose; This spontaneous report was received from a pharmacist and refers to a 15-year-old patient of an unknown gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 15-JUL-2024, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection (formulation pre-filled syringe), 1 milliliter/ dose, lot #X024966, expiration date: 23-MAR-2025, administered for prophylaxis (strength, anatomical location, dose number, and route of administration were not provided). It was reported that the patient received an adult dose instead of a pediatric dose (overdose). No symptoms were reported. No additional adverse event (AE) reported (no adverse event).
Age: 5.0
Sex: F
Vaccine: HPV9
Symptoms: Diarrhoea, Product administered to patient of inappropriate age
Clinical narrative: the patient experienced diarrhea; 5-year-old female received a single intramuscular dose of GARDASIL 9 (HPV9), which is outside the indicated age range; This spontaneous report was received, from a scientific leader/healthcare professional via company representative and agency, regarding to a 5-year-old female patient.   The patient's medical history, concurrent conditions, concomitant therapies and drug allergies or reactions were not reported.  In approximately July 2024, the patient was vaccinated with a single dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, at a dose of 0.5 milliliter, administered intramuscularly for prophylaxis (strength, scheme, lot number, and expiration date were not provided), which is was outside the indicated age range (Product administered to a patient of inappropriate age).  In approximately August 2024 (reported as approximately two weeks after vaccination and about a month ago), the patient experienced diarrhea (Diarrhoea). It was unknown if the patient received treatment for the adverse event, if laboratory diagnostics or studies were performed, or if the patient sought medical attention.  The outcome for the event of diarrhea, and the causal relationship between the event of diarrhea and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) were not provided..
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: CP called to report TE for GARDASIL 9. Caller reports product was administered.; No additional AE; This spontaneous report was received from a nurse and refers to a currently 10-year-old patient of unknown gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with an improperly dose of HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, lot #1965046, expiration date: 22-JAN-2026, administered for prophylaxis (strength, and route of administration were not provided) (Product storage error). Temperature excursion was at 8.6C for 10 minutes. No previous temperature excursion occurred. No symptoms reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2409USA004203:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: CP called to report TE for GARDASIL 9.  TE filed: 02669891. Caller reports product was administered.  No symptoms reported.  Consent to correspond was granted. This case is related to AE cases: 02669899, 02669968, 02669980, 02669985 and 02669992. No; No symptoms reported.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was provided.  On an unknown date the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # 1965046 and expiration date 22-JAN-2026, 0.5 milliliter for prophylaxis (dose number, route and site of administration were not provided). The temperature excursion lasted for 10 minutes in temperature of 8.6 Celsius degrees (product storage error). No additional adverse events and product quality complaints was provided (no adverse event). ; Sender's Comments:  US-009507513-2409USA004145: US-009507513-2409USA003916: US-009507513-2409USA003853: US-009507513-2409USA004119: US-009507513-2409USA004156:
Age: 1.5
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE. No PQC.; HBP calling to report patient received VAQTA 5 days early; This spontaneous report has been received from a health business professional (Other) regarding to a child patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.  On 30-JUL-2020, (at 18 months-old) the patient was vaccinated with the first dose of Hepatitis A Vaccine, Inactivated, inactivated (VAQTA) intramuscular injection (strength, dose, vaccination scheme, route of administration, anatomical site of injection, lot number and expiration date were not reported). Then on 25-JAN-2021, instead of being vaccinated on 30-JAN-2021, the patient received the second dose (5 days early)(Inappropriate schedule of product administration) of Hepatitis A Vaccine, Inactivated (VAQTA) intramuscular injection, lot number (#) T014835 which has been verified to be valid, expiration date reported and established as 17-JUL-2021, both doses as prophylaxis (strength, dose, vaccination scheme, route of administration, and anatomical site of injection were not reported).  No additional adverse events were reported in the patient.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Constipation, Fatigue, Feeling cold, Headache
Clinical narrative: headache; constipation; shilling sensations; cancel my shift; to fill very tired; a little sensation of cold; fever; This non-serious case was reported by a consumer via call center representative and described the occurrence of tiredness in a 69-year-old patient who received Herpes zoster (Shingrix) (batch number NJ374) for prophylaxis.   On 03-SEP-2024 14:00, the patient received Shingrix. On 03-SEP-2024 18:00, less than a day after receiving Shingrix, the patient experienced tiredness (Verbatim: to fill very tired) and feeling cold (Verbatim: a little sensation of cold). On 04-SEP-2024, the patient experienced headache (Verbatim: headache), constipation (Verbatim: constipation), feeling abnormal (Verbatim: shilling sensations) and inability to work (Verbatim: cancel my shift). In SEP-2024, the patient experienced fever (Verbatim: fever). The patient was treated with paracetamol (Tylenol). The outcome of the tiredness, feeling cold, fever, headache, constipation, feeling abnormal and inability to work were not reported.   It was unknown if the reporter considered the tiredness, feeling cold, fever, headache, constipation, feeling abnormal and inability to work to be related to Shingrix.     It was unknown if the company considered the tiredness, feeling cold, fever, headache, constipation, feeling abnormal and inability to work to be related to Shingrix.   Additional Information: GSK receipt date: 04-SEP-2024 The patient date of year was 1955 The patient got that vaccine yesterday (day before reporting) and body reacted. begun to fill very tired with a little sensation of cold so went to bed.  The patient waked up at 2am with fever, and took 2 Tylenol and at at 5AM waked up again to cancel the shift. The patient's pocket was very sad for that because everybody needed to work. At 8am the patient decided to sleep again and waked up at 2pm with a little headache and shilling sensations and some constipation.  The patient was only taking water now (at the time of reporting). For no reason the patient would apply the second doses in 6 months.