chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Fall, Loss of consciousness
Clinical narrative: After the shot, student felt dizzy, fell from his chair and loss consciousness for few seconds. Student woke up, alert and oriented. No shortness of breath. Denies any pain. No bumps, redness or injuries noted on head and body. Vital signs are as follows: 02:32pm: BP: 128/62, HR: 67 bpm, RR: 20. Laying down with feet up. Awake, alert, oriented, dizziness 02:35pm: BP: 128/63, HR: 61 bpm, RR:20. No changes. 02:40pmL BP: 122/67, HR 67 bpm, RR:20. No complain of dizziness 02:43pm: BP: 137/70, HR 68 bpm, RR: 20. Sitting position. No dizziness.  02:45pm: BP: 110/63, HR 79 bpm, RR: 20. No complain at this time. Water given. 02:50pm: BP: 104/49, HR: 70 bpm, RR: 20. No changes. 03:00pm: BP: 108/60, HR: 72 bpm, RR: 20. Standing. Denies feeling dizziness.  Student was discharged from the clinic with no incidence. Advise mother to seek medical care if student complains of severe dizziness, headache, respiratory problem. Parent understands the instructions. Follow-up call with mother this morning. Student is doing well. He has pain on injection site only.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: covid infection after vaccination
Age: 11.0
Sex: M
Vaccine: HPV9, TDAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: 10/30/2024 Patient came to the clinic to get the following vaccines: Tdap, HPV and Meningococcal vaccines.  On 11/01/2024 patient came back with the following symptoms: redness, edema and warm in the site of the vaccines administered( left arm)
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: covid infection after vaccination
Age: 17.0
Sex: M
Vaccine: MENB, MNQ, MNQ
Symptoms: Device connection issue, Syringe issue
Clinical narrative: The needle on the  MCV4 (Menquadfi) came loose and the vaccine leaked/squirted out of the hub area where the needle meets the syringe.    I felt the patient didn't receive enough vaccine so I drew up a new MCV4 and administered it during the same visit.  Patient's mom was present and made aware per same and agreed.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: covid infection after vaccination
Age: 52.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: Bruise at injection site and pain
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Cough, Upper respiratory tract infection
Clinical narrative: No adverse event in my opinion.  I simply developed a bad upper respiratory tract infection almost 3 weeks after COVID booster.  The same infection everyone else in Urgent Care had when I was seen for cough.  I doubt that I had an adverse reaction to vaccination.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: covid infection after vaccination
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Please contact PCP for the visit summary. Per patient, Red, hot, swollen right arm from shoulder to elbow.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Aphthous ulcer, Arthralgia
Clinical narrative: Vaccine given in am.  By that evening her knees were aching.  Woke up in the morning the next day and all of her joints were hurting and her mouth was full of canker cores.  No history of canker sores.
Age: 75.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Chest pain, Eye pain, Vision blurred
Clinical narrative: On 10/29/24 - sharp chest pain, left side, intermittent, all day.   On 10/31/24 - Blurry vision left eye and Sharp pain, left eye.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Pain in extremity, Ultrasound scan normal, X-ray limb normal
Clinical narrative: intense pain in shoulder and upper arm.   occurs when elbow/arm is not supported. ice and ndsaids provide only temporary relief
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient is 10 years old and received the adult Pfizer vaccine, for ages 12+. Incorrect vaccine was administered but she did not experience any adverse events after administration.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Abdominal pain upper, Ascites, Back pain, Burning sensation
Clinical narrative: Began with slight swelling in the hands, redness and itchy in palm of both hands in the morning then progressed to heel and bottom of feet burning pain and severe bilateral feet swelling in the evening.  Also had face redness and lip swelling.  Also got stomach and low back pain with constant nausea, vomiting.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Chest X-ray normal, Computerised tomogram normal, Erythema, Gastritis, Laboratory test normal
Clinical narrative: Began with slight swelling in the hands, redness and itchy in palm of both hands in the morning then progressed to heel and bottom of feet burning pain and severe bilateral feet swelling in the evening.  Also had face redness and lip swelling.  Also got stomach and low back pain with constant nausea, vomiting.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Lip swelling, Nausea, Peripheral swelling, Pruritus, Ultrasound scan normal
Clinical narrative: Began with slight swelling in the hands, redness and itchy in palm of both hands in the morning then progressed to heel and bottom of feet burning pain and severe bilateral feet swelling in the evening.  Also had face redness and lip swelling.  Also got stomach and low back pain with constant nausea, vomiting.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Began with slight swelling in the hands, redness and itchy in palm of both hands in the morning then progressed to heel and bottom of feet burning pain and severe bilateral feet swelling in the evening.  Also had face redness and lip swelling.  Also got stomach and low back pain with constant nausea, vomiting.
Age: 1.58
Sex: F
Vaccine: DTAP
Symptoms: Injection site swelling
Clinical narrative: Patient received DTap on 10/28/2024, mother stated the next morning around 8:00 right thigh was swollen. on 10-30-24 , mother brought child in to be seen by PCP.
Age: 39.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Culture urine, Diarrhoea, Muscle tightness, Urinary tract infection, Urine analysis
Clinical narrative: UTI, Muscle Tightness in back, diarrhea
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: 2 doses of Covid Pfizer vaccine given in error; pt received 2 doses of Covid Pfizer, rather then a High Dose Flu and Covid Pfizer per patient request
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: None reported 14 days later by mom
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Induration, Swelling
Clinical narrative: large area of swelling,  induration, and redness, however, no pain. 10x17cm area of redness.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia eye
Clinical narrative: she had numbness starting on her right eye, went up to her head, then moved down around her earlobe and then into her jawbone. This numbness lasted for about 3 days. Now it is more of a spuratic numbing sensation that comes and goes. She contacted her PCP with her symptoms and was advised not to take another covid vaccine. She didn't have any reaction from the Jansen covid vaccine in 2021, but had the same symptoms as she is having now when she took the Moderna vaccine in 2022.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV5
Symptoms: Haematochezia, Occult blood positive
Clinical narrative: Blood in stool - advised for mom to limit dairy intake
Age: 12.0
Sex: F
Vaccine: HEPA, MMR, MNQ, TDAP, VARCEL
Symptoms: Dysphagia, Pallor, Syncope, Throat tightness, Unresponsive to stimuli
Clinical narrative: After the administration of the 5th immunization , patient fainted, became pale, and initially unresponsive to name.   Physician on staff alerted immediately by myself.  Patient evaluated by physician, health history obtained from parent, VS obtained.  EMS notified as patient reported difficulty swallowing and fullness in her throat.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: 3 days post vaccine administration, a third party family member who works in clinic mentioned that pt states she has been experiencing numbness in hand since vaccine was administered. Pt was observed for 15 minutes post vaccine administration and did not state any unusual sensations or side effects at that point. Attempt to reach pt were unsuccessful as telephone was not in service.  Pt's 3rd party family member was requested to reach out to pt and advise them to immediately visit Walk In Clinic at Health Center
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Autoimmune thyroiditis, Fatigue, Injection site pain, Pain, Pain in extremity
Clinical narrative: Background?I work in LTC facilities as a CNA. I worked on Covid units from the beginning (2020). I never got COVID. My job and livelihood was threatened once the government mandate (that was later cancelled) was put in place. It was get the jab or lose everything. I had no immediate reaction to the vaccines besides pain at injection site and some fatigue. So fast forward to March 2022?I get Covid post vax for the first time ever. Severe pain from my hips down. Flu like but far worse. Treated with Remdesivir. Then in April 2022 I became extremely fatigued to the point of not being able to stay awake. Weight gain despite diet and exercise. Soreness throughout entire body. Addressed with PCP. Labs were drawn and my thyroid levels were abnormal. Testing was done and Hashimoto?s Disease was diagnosed. Treated with Synthroid. I am only reporting this because  I was tested for this disease several years prior to Covid and results were negative.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Thyroid disorder, Ultrasound thyroid, Weight increased
Clinical narrative: Background?I work in LTC facilities as a CNA. I worked on Covid units from the beginning (2020). I never got COVID. My job and livelihood was threatened once the government mandate (that was later cancelled) was put in place. It was get the jab or lose everything. I had no immediate reaction to the vaccines besides pain at injection site and some fatigue. So fast forward to March 2022?I get Covid post vax for the first time ever. Severe pain from my hips down. Flu like but far worse. Treated with Remdesivir. Then in April 2022 I became extremely fatigued to the point of not being able to stay awake. Weight gain despite diet and exercise. Soreness throughout entire body. Addressed with PCP. Labs were drawn and my thyroid levels were abnormal. Testing was done and Hashimoto?s Disease was diagnosed. Treated with Synthroid. I am only reporting this because  I was tested for this disease several years prior to Covid and results were negative.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Computerised tomogram thorax abnormal, Cough, Pericardial effusion, Scan with contrast abnormal
Clinical narrative: New onset cough and chest pressure tightness the day after.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Pruritus
Clinical narrative: Patient received the vaccine and reported itching. We monitored the patient for 20 minutes and he reported he felt fine besides his arm itching. We recommended and offered patient Benadryl and he refused.   Several hours later patient had trouble breathing and went to Emergency Room.
Age: 49.0
Sex: M
Vaccine: MNQ
Symptoms: Musculoskeletal stiffness
Clinical narrative: Stiff neck
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Fatigue, Loss of consciousness, Somnolence
Clinical narrative: May 4, 2021 he said he passed out at kitchen table. He woke back up and discovered he had tipped and spilled his soda. We attributed it to him being tired, because he normally took a nap every day.  The next morning he did not make his usual wake up call to his friend. They called him. No answer. They called 911 for a welfare check. EMTs came and had to get in through window.  He was still in bed, very drowsy. They ascertained he was ok. I do not know if they checked vitals on him.  They reported to his friend that he was ok.  She tried calling later. No answer. She went there at 4 pm and he was dead on floor.
Age: 60.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient inadvertently received duplicate Flu vaccines on 7/25/24 and 10/31/24
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient reported arm swelling, redness and warm starting with the size of an orange 1 day after vaccine administration. The size grows larger to the size of 4 inches x 7 inches migrating medially on the left arm
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Chest X-ray normal, Diarrhoea
Clinical narrative: A couple of months after being vaccinated she developed the covid virus and had to miss work. About 3 months later she had the covid virus again and missed work. About another month after that she had the covid virus again and had to miss work. She currently has the on-set of the covid virus and is not able to work. She is light headed and has had diarrhea for about 4 days. She cannot smell or taste. She is going to contact her PCP for treatment so she can return to work.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Impaired work ability, SARS-CoV-2 test negative
Clinical narrative: A couple of months after being vaccinated she developed the covid virus and had to miss work. About 3 months later she had the covid virus again and missed work. About another month after that she had the covid virus again and had to miss work. She currently has the on-set of the covid virus and is not able to work. She is light headed and has had diarrhea for about 4 days. She cannot smell or taste. She is going to contact her PCP for treatment so she can return to work.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Rash, Rash pruritic
Clinical narrative: Rash on face, arms, and chest. Lump at injection site.  Patient took benadryl at time of rash and next morning.  Rash has stopped itching but still noticeable. No symptoms of troubled breathing.
Age: 27.0
Sex: F
Vaccine: TD
Symptoms: Fatigue, Injection site nodule, Injection site pain, Pain
Clinical narrative: On September 14, 2024, the donor disclosed that following the Tetanus immunization received on September 8, 2024, the donor began to feel "fatigued and achy" that evening and the next day.  The donor also stated that the immunization site was "pretty sore" for "2 to 3 days" after the immunization and that it was still tender to the touch 6 days later with a knot in the immunization site.
Age: 15.0
Sex: M
Vaccine: HEP, HEPA, HPV9, MMR, TDAP, VARCEL
Symptoms: Dizziness
Clinical narrative: PATIENT BECAME DIZZY AFTER ma ADMINISTERED VACCINE; PATIENT RECLINED IN SUPINE POSITION; APPLIED COOL COMPRESS TO FOREHEAD; NEVER BECAME DIAPHORETIC OR LOSS OF CONSCIOUSNESS.  NO NAUSEA/VOMITING. PATIENT FELT BETTER PRIOR TO LEAVING CLINIC VSS. BP 113/67-72.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Endocrine ophthalmopathy, Facial paralysis, Headache, Laboratory test, Muscular weakness
Clinical narrative: Pt was admitted 10/17/2024 to facility / with new right facial droop  and LUE weakness x 4days and was r/o'd out for CVA (all records reviewed and  scanned to imaging)  + blurred right  vision in the setting of thyroid eye diseases - + able to fully close OD  of note she rec'd flu vaccine 10/10/2024 and is concerned that it was the cause.  She also had 4 days of right frontal headache before arrival to ED
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Vision blurred
Clinical narrative: Pt was admitted 10/17/2024 to facility / with new right facial droop  and LUE weakness x 4days and was r/o'd out for CVA (all records reviewed and  scanned to imaging)  + blurred right  vision in the setting of thyroid eye diseases - + able to fully close OD  of note she rec'd flu vaccine 10/10/2024 and is concerned that it was the cause.  She also had 4 days of right frontal headache before arrival to ED
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Blister
Clinical narrative: Patient broke out in blisters all over his body
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Autonomic nervous system imbalance, Dizziness, Gene mutation identification test, Head discomfort, Hypoaesthesia
Clinical narrative: Immediate numbness and tingling in lower legs, dizziness, vertigo. Two weeks later, I had what felt like a panic attack but with no prior history or triggering event. I later had right side body numbness and tingling in addition to hands and feet numbness and pain, as well as "saddle area" numbness and muscle aches.  Dizziness and head pressure increased. Then I developed GERD symptoms. Finally, I developed PAC, PVC and tachycardia. I had none of these symptoms before getting the vaccine. My doctor describes my symptoms as dysautonomia. We thought it might be anxiety, but a healthy lifestyle, medication, and therapy over the last 3 years have not affected these symptoms.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Laboratory test, Myalgia, Pain in extremity, Paraesthesia
Clinical narrative: Immediate numbness and tingling in lower legs, dizziness, vertigo. Two weeks later, I had what felt like a panic attack but with no prior history or triggering event. I later had right side body numbness and tingling in addition to hands and feet numbness and pain, as well as "saddle area" numbness and muscle aches.  Dizziness and head pressure increased. Then I developed GERD symptoms. Finally, I developed PAC, PVC and tachycardia. I had none of these symptoms before getting the vaccine. My doctor describes my symptoms as dysautonomia. We thought it might be anxiety, but a healthy lifestyle, medication, and therapy over the last 3 years have not affected these symptoms.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Supraventricular extrasystoles, Tachycardia, Ventricular extrasystoles, Vertigo
Clinical narrative: Immediate numbness and tingling in lower legs, dizziness, vertigo. Two weeks later, I had what felt like a panic attack but with no prior history or triggering event. I later had right side body numbness and tingling in addition to hands and feet numbness and pain, as well as "saddle area" numbness and muscle aches.  Dizziness and head pressure increased. Then I developed GERD symptoms. Finally, I developed PAC, PVC and tachycardia. I had none of these symptoms before getting the vaccine. My doctor describes my symptoms as dysautonomia. We thought it might be anxiety, but a healthy lifestyle, medication, and therapy over the last 3 years have not affected these symptoms.
Age: 44.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Patient noted to have a red oblong raised area on 11/01/24 at 2:30PM. Patient reports area starting to become itchy about an hour after getting vaccine.  Area measured at length of 62mm and width of 45mm. Patient reports itching mostly in area that is red, denies scratching area, reports some itchiness in other areas of arm. Area noted to be warm to touch. Patient denies any other symptoms (SOB, chest pain, nausea, emesis, fever, or hives elsewhere). Patient advised to go to her PCP.
Age: 1.0
Sex: F
Vaccine: DTAPIPV, FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was given DTAP + IVP 4-6 yrs. Nurse discovered error after patient left Well Child Check appointment. Provider followed up with parents and confirmed no side effects (nausea, vomiting, diarrhea, rash, etc) or adverse reactions from vaccine error.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Diarrhoea, Dyspnoea, Fatigue, Gastrooesophageal reflux disease
Clinical narrative: Extreme fatigue about 4 days after the event, with increasing shortness of breath and coughing. Then 11 days after developed diarrhea, nausea  with extreme reflux and vomiting
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Extreme fatigue about 4 days after the event, with increasing shortness of breath and coughing. Then 11 days after developed diarrhea, nausea  with extreme reflux and vomiting
Age: 1.0
Sex: F
Vaccine: DTAPHEPBIP, HEP, MMR, PNC20, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Infant should have received Dtap, HIB, IPV combination vaccine (pentacel), but instead was given DTAP, HepB, IPV (pedirix). Infant additionally got MMR, Varicella, Hep B, and PCV20. Giving her two Hep B vaccinations today.
Age: 1.5
Sex: F
Vaccine: FLU3, HEPA, VARCEL
Symptoms: Cellulitis
Clinical narrative: Cellulitis to L thigh. Tx with Augmentin and Mupirocin. Outcome pending, began antibiotics today.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered on 11/1/2024 expired the previous day on 10/31/2024. Patient informed of error, also documented in house on pharmacy incident reporting tool
Age: 15.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Flublok is for age 18+yrs and patient is under age 18yrs.  He has no symptoms
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Choreoathetosis
Clinical narrative: Choreoathetoid movements that began  approximately  24 hours after vaccine and continued for 48 hours intermittently
Age: 12.0
Sex: M
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient is under age 18yrs and received Flublok, which is for age 18+years.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Abdominal pain upper, Arthralgia, Back pain, Chills
Clinical narrative: 10/29 - 3:10 AM - Nausea and chills lasting 5 minutes. Both shoulder ache, stabbing pain in legs and abdomen . 5:15 AM pain in arms, back, knees, feet. No chills or fever. Stomach growling with gas.  7:11 Am Random pain in every sector of body. Shivers/Chills began and lasted until 7:45 AM. 9:13 AM had a round of dry heeves after sharp stomach pains. Took 3 tablets of Tums chewables. 10:05 AM Second round of dry heaves. 1:10 PM Took my prescription pills (not Floamx) more TUMS and a Tylenol capsule, 1:27 PM ate a banana.1:29 PM  Took 2 Advil gel tablets. 2:00 PM Ate a ham and chees sandwich with chips. Aches lasted two more days.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Flatulence, Nausea, Pain in extremity, Retching
Clinical narrative: 10/29 - 3:10 AM - Nausea and chills lasting 5 minutes. Both shoulder ache, stabbing pain in legs and abdomen . 5:15 AM pain in arms, back, knees, feet. No chills or fever. Stomach growling with gas.  7:11 Am Random pain in every sector of body. Shivers/Chills began and lasted until 7:45 AM. 9:13 AM had a round of dry heeves after sharp stomach pains. Took 3 tablets of Tums chewables. 10:05 AM Second round of dry heaves. 1:10 PM Took my prescription pills (not Floamx) more TUMS and a Tylenol capsule, 1:27 PM ate a banana.1:29 PM  Took 2 Advil gel tablets. 2:00 PM Ate a ham and chees sandwich with chips. Aches lasted two more days.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Mobility decreased, Neck pain
Clinical narrative: Vaccinee  woke up next morning unable to lift head off pillow. She states her arm was sore from injection site, up side of neck. She used ibuprofen, heat and massage and pain diminished throughout the course of 24 hours.
Age: 32.0
Sex: F
Vaccine: ANTH
Symptoms: Pain, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Swelling around vaccination site within 12 hours of vaccination. Swelling spread to approximately 2 inches by 3 inches across shoulder as of 9:00 AM 01NOV2024. Complaint of pain when moving her arm. Reported warm to touch and itching last night at approximately 7:00 PM.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Histamine level, Lip swelling, Throat irritation, Urticaria
Clinical narrative: SHE STATED AFTER THE FLU VACCINE SHE WENT TO THE STORE AND WAS WALKING AROUND AND A FRINED WITH HER NOTICED HER LIPS WERE SWOLLEN. SHE THEN REALIZED SHE WAS DEVELOPING HIVES ON HER FACE AND HER THROAT WAS SCRATCHY. SHE WAS COUGHING WHEN SHE CALLED.
Age: 0.92
Sex: F
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site reaction, Rash erythematous
Clinical narrative: 4 small erythematous bumps and erythematous area noted over left thigh where vaccines were administered. No pain noted and no streaking.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Administration error,  Student received Fluarix on 10/25/2024 and 11/01/2024.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure increased, Chest discomfort, Condition aggravated, Hyperchlorhydria
Clinical narrative: he started feeling like he had covid. He took a covid test that was negative. This lasted for about 3 days. About a week later, his acid level goes up in his stomach which he is taking medication for but had to increase it. This is when his blood pressure started increasing. He had tightness in the chest and head.  He lowered his sodium intake, started walking, started avoiding stress and stopped lifting weights. This has helped lower is blood pressure. It has increased his anxiety. At this time the blood pressure is better but is not normal and still has to have more medication for the acid in his stomach.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, SARS-CoV-2 test negative, Tension headache
Clinical narrative: he started feeling like he had covid. He took a covid test that was negative. This lasted for about 3 days. About a week later, his acid level goes up in his stomach which he is taking medication for but had to increase it. This is when his blood pressure started increasing. He had tightness in the chest and head.  He lowered his sodium intake, started walking, started avoiding stress and stopped lifting weights. This has helped lower is blood pressure. It has increased his anxiety. At this time the blood pressure is better but is not normal and still has to have more medication for the acid in his stomach.
Age: 52.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Pt (healthcare worker) came to clinic after having nonreactive titer for measles and needing MMR vaccine. MMRV vaccine was given inadvertently to pt prior to scanning out through system. After giving the vaccine, I realized I had not scanned it out prior to giving it. This is when I saw that it was MMRV instead of MMR. No adverse reactions after giving vaccine noted at this time. Pt will not need to be revaccinated.
Age: 4.0
Sex: M
Vaccine: MMR, MMRV
Symptoms: Extra dose administered
Clinical narrative: Patient was given a priorix and a proquad.
Age: 46.0
Sex: F
Vaccine: PNC20
Symptoms: Cellulitis
Clinical narrative: SULFAMETHOXAZOLE-TRIMETHOPRIM 800-160 MG OR TABS 14 tablet Take 1 tablet by mouth 2 times daily for 7 days. Cellulitis, unspecified cellulitis site
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Headache, Induration, Skin irritation
Clinical narrative: Right arm irritated, hard, and red since 10/21/24, also reported headache that began on 10/21/24.
Age: 0.42
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received an influenza vaccine prior to 6 months of age (5 months and 20 days).
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient reported to the pharmacy on 11/1/24 at 3:45 p.m. and wanted to show us his arm.  His arm displayed a large red ring around the site that the vaccination was administered earlier in the week.  The patient then showed us a picture on his phone which displayed a bright red, larger ring, and swollen arm from the night of 10/31/24.   The patient was educated on injection site reactions and educated on treatment options including diphenhydramine and an ice pack for the swelling.  The patient disclosed no issues with breathing and no other reaction post-vaccination.  The patient then said that he did have a similar reaction after his first dose, just not quite as large of a red ring.  The patient was headed to work, so he was given a diphenhydramine 25 mg tablet to take with him for when he feels he can safely administer the dose.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: NO ASE extra dose administered
Age: 85.0
Sex: F
Vaccine: PNC20, RSV, PNC, RSV
Symptoms: Joint stiffness, Joint swelling, Mobility decreased, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Stiffness, difficulty moving left leg , and painful, joints in left leg swollen,  left knee  stiffness if trying to articulate . Still recovering.
Age: 85.0
Sex: F
Vaccine: PNC20, RSV, PNC, RSV
Symptoms: Arthralgia, Injection site pruritus, Injection site swelling, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: Stiffness, difficulty moving left leg , and painful, joints in left leg swollen,  left knee  stiffness if trying to articulate . Still recovering.
Age: 85.0
Sex: F
Vaccine: PNC20, RSV, PNC, RSV
Symptoms: Peripheral swelling, Petechiae, Weight bearing difficulty
Clinical narrative: Stiffness, difficulty moving left leg , and painful, joints in left leg swollen,  left knee  stiffness if trying to articulate . Still recovering.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Limb discomfort, Pain
Clinical narrative: Soreness at site of injection which is left arm and radiating up to clavicle; pain rated as 4-5/10; also described as heaviness feeling in arm
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient received 2 injections in same arm for Flublok vaccine
Age: 40.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Cough, Immediate post-injection reaction, Loss of consciousness, Posture abnormal, Unresponsive to stimuli
Clinical narrative: Per technician who administered vaccines, patient received spikevax covid vaccine in left arm.  Then got flucelvax flu shot in right arm.  Immediately following flu shot he stated that he felt like he was going to pass out.  He remained seated in chair but became unresponsive for about 3 seconds.  This happened again and was "out" for a little longer (approx 6 seconds).  Then his head dropped and he started coughing.  In between each time he was able to communicate for a few seconds.  Patient stayed in waiting area for 30 minutes following vaccines and said he felt better when he got up to leave.  He has not had this experience after vaccines previously.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient received 2 doses of Fluzone PF 2024-2025, one on 8/31/2024 and one on 10/31/2024
Age: 61.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received 2 doses of Flucelvax for the 2024-2025 season. First dose was 9/12/24, second dose was 10/31/24. Patient should have only received 1 dose for the season. I spoke with the patient over the phone and she forgot getting the first dose. Insurance was billed both times and a paid claim was collected for each dose. Our system in our pharmacy software also did not flag the duplicate dose. Patient was ok and understanding of the situation.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dermatitis, Erythema, Injection site erythema, Injection site irritation, Rash
Clinical narrative: It started on 10/31/2024 and has continued at the time of observation, 11/1/2024 at 0930. Red inflamed skin on the right side of body. It started on the right arm near the injection site and spread down to his elbow, up into his shoulder, around his arm pit, and on the right half of his chest and stomach. Slightly painful to the touch. Rash was not hot during inspection. Had not take any medication or used creams as of 11/1/2024 at 0930.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Tenderness
Clinical narrative: It started on 10/31/2024 and has continued at the time of observation, 11/1/2024 at 0930. Red inflamed skin on the right side of body. It started on the right arm near the injection site and spread down to his elbow, up into his shoulder, around his arm pit, and on the right half of his chest and stomach. Slightly painful to the touch. Rash was not hot during inspection. Had not take any medication or used creams as of 11/1/2024 at 0930.
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: MA gave adult hep A, instead of Ped hep A.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient was given a previous flu shot on 10/23/24
Age: 36.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Bronchitis
Clinical narrative: I was diagnosed with bronchitis a week later and prescribed antibiotics. I had a cold prior to the vaccine, which I'm sure is what turned into bronchitis. I do not think my illness was related to the vaccine.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Fatigue, Feeling hot, Hypotonia, Limb discomfort
Clinical narrative: After administration of dose, pt got up from her seat without issue, was moving her arm as advised to help avoid excessive soreness. She told her mother and I that her arm felt heavy/tired, we assumed this was from the movement. Completed another family members' vaccine and they exited the clinical room, making their way across the pharmacy area, when mother approached the counter to let me know pt told her she felt dizzy. Pt's face had become very pale, so we carefully walked her over to the waiting area chairs and mom held her in lap. Pt confirmed she felt hot and dizzy and tired. She denied swelling, her breathing seemed slightly weakened. We provided a fan to cool her down and a cool compress. Pt was fairly limp in her mother's arms and her eyes kept closing, so we contacted front store to assist; they called paramedics and we moved Pt back into the clinical room in order to lay her down on her side with the fan, where she did very shortly start to feel better and regain her color in her face and lips. BP was taken and was normal per paramedics, as was her pulse ox. With questions, determined she may be slightly dehydrated compared to usual fluid intake per mom. They had her sit up on her own and then once comfortable she was able to stand and a standing BP showed no change (no orthostatic change). Pt confirmed she was feeling much better, store provided water for her and family was able to leave with Pt walking on her own and feeling much better though a little tired now.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Pallor, Respiration abnormal
Clinical narrative: After administration of dose, pt got up from her seat without issue, was moving her arm as advised to help avoid excessive soreness. She told her mother and I that her arm felt heavy/tired, we assumed this was from the movement. Completed another family members' vaccine and they exited the clinical room, making their way across the pharmacy area, when mother approached the counter to let me know pt told her she felt dizzy. Pt's face had become very pale, so we carefully walked her over to the waiting area chairs and mom held her in lap. Pt confirmed she felt hot and dizzy and tired. She denied swelling, her breathing seemed slightly weakened. We provided a fan to cool her down and a cool compress. Pt was fairly limp in her mother's arms and her eyes kept closing, so we contacted front store to assist; they called paramedics and we moved Pt back into the clinical room in order to lay her down on her side with the fan, where she did very shortly start to feel better and regain her color in her face and lips. BP was taken and was normal per paramedics, as was her pulse ox. With questions, determined she may be slightly dehydrated compared to usual fluid intake per mom. They had her sit up on her own and then once comfortable she was able to stand and a standing BP showed no change (no orthostatic change). Pt confirmed she was feeling much better, store provided water for her and family was able to leave with Pt walking on her own and feeling much better though a little tired now.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Patient given pediatric dose meant for ages 6 months to 11 years
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody positive, Arthralgia
Clinical narrative: Severe arthritis pain
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC20
Symptoms: Erythema, Skin warm
Clinical narrative: Patient developed increased redness on Left upper thigh with warmth to the touch the day after vaccination.
Sex: F
Vaccine: RSV
Symptoms: Device breakage, Device leakage
Clinical narrative: It broke/malfunction; Some of the diluent leaked out; This is a spontaneous report received from a Pharmacist, Program ID: .  A 90-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose 1, 0.5 ml single (Lot number: KC7884, Expiration Date: Sep2025) for immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "It broke/malfunction"; DEVICE LEAKAGE (non-serious), outcome "unknown", described as "Some of the diluent leaked out".  Additional information: The pharmacist reported that they were trying to reconstitute the Abrysvo vaccine, however they had a Abrysvo vaccine malfunction, it broke. The reporter was not able to administer it, because some of the diluent leaked out, so she/he was not sure like how the concentration would be have been right. The patient did not receive the vaccine.  Causality for "it broke/malfunction" and "some of the diluent leaked out" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Nausea
Clinical narrative: little dizzy; fatigued; nauseous; This is a spontaneous report received from a Consumer or other non HCP.  An adult patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: comirnaty (DOSE 2, SINGLE), administration date: 17Feb2022, for COVID-19 immunisation, reaction(s): "Inappropriate schedule of vaccine administered"; Comirnaty (DOSE 1, SINGLE), administration date: Jan2021, for COVID-19 immunisation. The following information was reported: FATIGUE (non-serious) with onset Oct2023, 1 day after the suspect product(s) administration, outcome "unknown", described as "fatigued"; DIZZINESS (non-serious) with onset Oct2023, 1 day after the suspect product(s) administration, outcome "unknown", described as "little dizzy"; NAUSEA (non-serious) with onset Oct2023, 1 day after the suspect product(s) administration, outcome "unknown", described as "nauseous".  Additional information: Patient got every vaccine available from the time the first one became available and then last year in Oct2023, patient got 2023's vaccination and then again this year (2024). Patient had the same reaction in 2023 as patient did this year and the reaction not the day she/he received the vaccination but the next day had some other reactions that pretty much made her/him feel that could not stay awake to be functional. Patient felt little dizzy, very fatigued, even a little nauseous and that was exactly the same kind of feeling patient had the day after the vaccination in 2023. So, two years in a row same reaction but not until the next day.  Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400290454 same reporter/patient/product, different dose/event.;US-PFIZER INC-202400290514 same reporter/patient/product, different dose/event.;
Sex: F
Vaccine: COVID19
Symptoms: Pericarditis
Clinical narrative: Pericarditis 8 hours after her second shot; This is a spontaneous report received from a Consumer or other non HCP.  A female patient received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, Manufacturer: Unknown), for COVID-19 immunization. The following information was reported: PERICARDITIS (medically significant), 8 hrs after the suspect product(s) administration, outcome "not recovered", described as "Pericarditis 8 hours after her second shot". The event "pericarditis 8 hours after her second shot" required physician office visit. Clinical course: Patient have to see a cardiologist, 'as a measurement' she is under the care of cardiologist it has not gone away it comes and goes. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: U
Vaccine: UNK
Symptoms: Syringe issue, Underdose
Clinical narrative: Partial dose administered; the syringe was leaking halfway through the shot; This spontaneous case  initially received on 15-Oct-2024, was reported by a health professional (pharmacist) and concerns an patient of unknown age/gender.  Administration of company suspect drug: On an unknown date, the patient received Flucelvax Quadrivalent for an unknown Indication, Dosing regimen: Not reported, Route of administration: Not reported, Anatomical location: Unknown, Lot number: Not reported and would be requested upon follow-up.  No additional suspect drugs.  Adverse reactions/events and outcomes: On an unknown date, by patient, Partial dose administered (outcome: Not Reported), The syringe was leaking halfway through the shot (outcome: Not Reported).  On an unknown date, the pharmacist reported that patient did not receive full dose of Flucelvax. He realized the syringe was leaking halfway through the shot. He enquired if the patient should be revaccinated or not. There was one defective unit. This defect was discovered during use.   Flucelvax Quadrivalent action taken: Not Applicable  Reporter's assessment: The reporter did not provide seriousness and causality for all the events.; Reporter's Comments: The event Partial dose administered assessed as unelated while The syringe was leaking halfway through the shot assessed as related to the Flucelvax Quadrivalent.
Sex: F
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: In current year she found out she was allergic to steroids and cortisone/Product Information "hydrocortisone" was used in current year's Fluad; This spontaneous case  initially received on 15-Oct-2024, was reported by a health professional and concerns an female patient.  Drug history included hydrocortisone (Reaction: allergy).  Administration of company suspect drug(s): On an unknown date, the patient received Fluad (TIV) for Influenza Immunization., Dose regimen: 0.5 ml, Route of administration: Not reported, Lot number: Lot number not reported; will be requested upon follow-up.  No additional suspect drugs.  Adverse reactions/events and outcomes: On an unknown date, the patient experienced In current year she found out she was allergic to steroids and cortisone/Product Information "hydrocortisone" was used in current year's Fluad (outcome: Not Reported).  HCP inquires: HCP has a patient that had the Fluad last year and she did just fine with it, but in current year she found out she was allergic to steroids and cortisone. HCP saw in the Product Information "hydrocortisone" was used in current year's Fluad. HCP asked to confirm if it was present in last year's formula too.  Fluad (TIV) action taken: Not Applicable  Reporter's assessment: Seriousness and causality assessment was not provided by the reporter.; Reporter's Comments: The event was considered as related.
Age: 30.0
Sex: F
Vaccine: UNK
Symptoms: Device connection issue, Injury associated with device
Clinical narrative: The one Incident was after she administered It; Accidental needle stick with one vaccine; This spontaneous case, initially received on 17-Oct-2024 (including additional information received 23-Oct-2024), was reported by a health professional and concerns an adult female patient.  Administration of company suspect drug: On 17-Oct-2024, the patient received Flucelvax (TIV) for Flu Immunization, Dose regimen: 0.5 ml, Route of administration:Not reported, Lot number: 391258.  No additional suspect drugs. No relevant medical history and concomitant medications were reported  Adverse reactions/events and outcomes: On 17-Oct-2024, the patient experienced Accidental needle stick with one vaccine (outcome: Unknown, stop date: 17-Oct-2024).  On unknown date, the patient experienced  The one Incident was after she administered It (outcome: not reported).  Reporter informed that she had an accidental needle stick with one vaccine. She had two incidences, but only been stuck once. The one Incident was after she administered It. She went to go secure the needle with the safety lock, and it popped off and stuck her. That's when that happened. The clear hub broke off, and then the needle came back and hit her. The second one. it was not a dirty needle. It still had the cap and all on it. She went to go secure it, holding the hub, screwed it on, and she went to go make sure it was locked. The whole thing spun off the ampule, and so It's not allowing the needle to be properly secured.  It was reported 2 defective units. The first defect discovered after use, and the second one prior to use. The full dose administered was not administered. Unknown if there is complaint sample available, if there is a picture of the complaint sample available, how / when was the damaged syringe first noticed. where is the syringe damaged, Unknown if there are any signs of leakage. Unknown how was the product stored.   Complaint Investigational Summary Assessment:   No reportable device malfunction based on the following: There was no device malfunction/issue cause or contribute to death. There was no device malfunction/issue cause or contribute to serious injury. There was no malfunction/issue were to recur, would it be likely to cause or contribute to death or serious injury. The reportable device malfunction was associated with the needle only therefore does not need to be entered into the Safety Database was not applicable.  Flucelvax (TIV) action taken: Not Applicable  Reporter's assessment:  The reporter did not provide seriousness and causality for the events.; Reporter's Comments: The special situation is not related to Flucelvax (TIV)
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: Menveo plus unapproved diluent; Menveo plus unapproved diluent; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA987A, expiry date 31-OCT-2024) for prophylaxis.   On 02-OCT-2024, the patient received Menveo. On 02-OCT-2024, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Menveo plus unapproved diluent) and inappropriate dose of vaccine administered (Verbatim: Menveo plus unapproved diluent). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 21-OCT-2024 It was reported that sterile water was used to reconstitute the lyophilized portion of Menveo and administered to a patient which led to Wrong solution used in drug reconstitution and Inappropriate dose of vaccine administered.