chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Peripheral swelling, Pyrexia
Clinical narrative: I had swelling in wrists and knees that started about 11 hours after I received the injection long with headache, fever, and general malaise. Although I get headache, fever, and sometimes nausea and vomiting (with Moderna covid vaccine), what was unusual this time was the joint pain and swelling particularly in my hands, wrists, and knees. This was a new and disconcerting symptom since I do not have arthritis. This felt like that. After taking Advil, the swelling in my hands went down, but the swelling in my knees did not. It took almost 2 weeks for the swelling in my knees to get down to how they were before.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Client received high dose influenza vaccine. He should have received regular dose. Client notified. No adverse effects at the present time.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HEP, PNC20, RV5
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: No symptoms but Hepatitis B was given instead of HIB.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Hallucination, visual, Syncope
Clinical narrative: may have had reaction to the flu vaccine. States later in the evening, around dinner time, she said her head leaned back and she saw pictures fly by and she "flopped" on the floor, She has never had this response, not has she had seizures before. denies fever during this time.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Swelling
Clinical narrative: Per mother; swelling and redness
Age: 14.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Dizziness, Nausea
Clinical narrative: Patient came in with dad to get both fluzone and covid pfizer vaccines. About 2 minutes after receiving both vaccines patient stated she felt lightheaded and nauseated. I had her sit and gave her a wet damp paper towel to put on her neck and face. I also gave her some water. After about 20 minutes the patient stated she was feeling better. she sat in the lobby waiting area for another 10 minutes was feeling fine and left with dad. Dad said she has never had a reaction to vaccines before.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Frequent bowel movements, Full blood count, Irritability, Laboratory test
Clinical narrative: 2 month infant received RotaTeq vaccine on 10/17 and 3 days later had significant diarrhea  (mucous, 10+ per day, large volumes) and fussiness. No fever/blood in stool or vomiting. Her symptoms were not getting better after 3 weeks  so a stool sample provided and PCR ran on sample which was positive for Rotavirus A. She continued to have frequent diarrhea up until 11/20 where she has finally resumed more normal infant stooling patterns.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Metabolic function test, Rotavirus infection, Rotavirus test positive
Clinical narrative: 2 month infant received RotaTeq vaccine on 10/17 and 3 days later had significant diarrhea  (mucous, 10+ per day, large volumes) and fussiness. No fever/blood in stool or vomiting. Her symptoms were not getting better after 3 weeks  so a stool sample provided and PCR ran on sample which was positive for Rotavirus A. She continued to have frequent diarrhea up until 11/20 where she has finally resumed more normal infant stooling patterns.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Confusional state, Decreased appetite, Diarrhoea, Headache
Clinical narrative: Onset of myalgia, chills, HA, nausea, anorexia, diarrhea, confusion about 12 hours after vaccination
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea
Clinical narrative: Onset of myalgia, chills, HA, nausea, anorexia, diarrhea, confusion about 12 hours after vaccination
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Echocardiogram, Pyrexia, Scan myocardial perfusion
Clinical narrative: FEVER THAT NIGHT OF SHOT, 9PM , 99.8 TEMP.,GAVE TYLENOL 325MG,WENT TO BED, 7:15 AM OCT. 23 . FEVER UNABLE TO WAKE PATIENT , CALLED AMBULANCE TAKEN TO HOSPTIAL ER. THEN SENT TO HOSPITAL TO SEE CARDIOLOGIST .
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Unresponsive to stimuli, Urine analysis
Clinical narrative: FEVER THAT NIGHT OF SHOT, 9PM , 99.8 TEMP.,GAVE TYLENOL 325MG,WENT TO BED, 7:15 AM OCT. 23 . FEVER UNABLE TO WAKE PATIENT , CALLED AMBULANCE TAKEN TO HOSPTIAL ER. THEN SENT TO HOSPITAL TO SEE CARDIOLOGIST .
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Flushing, Urticaria
Clinical narrative: a half hour post injection patient reported face flushing and hives which spread from arm to face on left side.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Blood bilirubin increased, Computerised tomogram abdomen, Hepatic enzyme increased, Jaundice, Metabolic function test
Clinical narrative: jaundice, elevated liver enzymes and total bilirubin
Age: 39.0
Sex: F
Vaccine: TD
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Vaccine was given early. She received a TD in 2010, 2020, 2023 and 2024. She has not had any adverse reactions she has just received extra doses.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Fall, Head injury, Syncope
Clinical narrative: Patient fainted after received the HPV vaccine. Patient was asked before administration if she has ever felt dizzy, fainted, or lightheaded after a blood draw or vaccination and patient stated she has not. Patient was seated on the exam table while receiving the vaccine, once the vaccine was fully administered, the patient fainted and fell backward on the exam table and hit her head on the wall. Examined by provider and patient stated she was ok. Patient went home. Checked in on patient next day and she stated she was doing fine.
Age: 72.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Skin warm, Urticaria
Clinical narrative: Was in doctor's office getting blood work done and RN noticed it was "hot to the touch with a raised welt." RN advised to follow up with pharmacy and to mark area around with marker to see if it spreads and to apply Benadryl topical to area
Age: 28.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue, Wrong product administered
Clinical narrative: Given arexxvy instead of abryvso vaccine
Age: 34.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injection site rash, Rash
Clinical narrative: RASH EXTENDING FROM ARM TO CHEST/BACK AND COVERING BREAST ON LEFT SIDE.  FOLLOWED UP WITH DERMATOLOGIST AND WAS GIVEN STEROID CREAM THAT HELPED WITH RASH.   GOT A RASH LAST YEAR BUT WAS LOCALIZED TO UPPER ARM THAT SHE RECEIVED THE VACCINES IN.
Age: 58.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Pain in extremity, Sciatica
Clinical narrative: Approximately Three weeks (on November 14) after vaccination I developed leg pain which increased in intensity and has not resolved. Diagnosed with sciatica.
Age: 28.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: Patient came into the pharmacy 11/20/24 in the late evening and asked to speak to the pharmacist on staff about his fluarix reaction. Patient states that he has been having "severe, deep muscle pain" ever since he received his vaccine.  I asked him to come over to the vaccine area and examined his arm. There is no swelling, redness, bruising, extra heat on the area or any other visible signs of issues. He was not running a fever and claimed to have no other issues other than the pain. But said that it was bad enough that it interfered with daily tasks and made them difficult.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV5, DTPPVHBHPB, PNC20, RV5
Symptoms: Biopsy lymph gland, Lymphadenitis, Staphylococcal infection, Staphylococcus test positive
Clinical narrative: bilateral inguinal MSSA lymphadenitis. No local cellulitis at injection sites. Due to unusual presentation, we are investigating a congenital immunodeficiency or chronic granulomatous disease. However, due to nature of infection, wanted to report to make sure no other similar incidents.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV5, DTPPVHBHPB, PNC20, RV5
Symptoms: Biopsy lymph gland, Blood culture, Chest X-ray, Cough, Full blood count
Clinical narrative: bilateral inguinal MSSA lymphadenitis. No local cellulitis at injection sites. Due to unusual presentation, we are investigating a congenital immunodeficiency or chronic granulomatous disease. However, due to nature of infection, wanted to report to make sure no other similar incidents.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV5, DTPPVHBHPB, PNC20, RV5
Symptoms: Incisional drainage, Lymph node abscess, Lymphadenitis, Lymphadenopathy, Lymphocyte count
Clinical narrative: bilateral inguinal MSSA lymphadenitis. No local cellulitis at injection sites. Due to unusual presentation, we are investigating a congenital immunodeficiency or chronic granulomatous disease. However, due to nature of infection, wanted to report to make sure no other similar incidents.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV5, DTPPVHBHPB, PNC20, RV5
Symptoms: Metabolic function test, Poor feeding infant, Pyrexia, Rhinorrhoea, Staphylococcal infection
Clinical narrative: bilateral inguinal MSSA lymphadenitis. No local cellulitis at injection sites. Due to unusual presentation, we are investigating a congenital immunodeficiency or chronic granulomatous disease. However, due to nature of infection, wanted to report to make sure no other similar incidents.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV5, DTPPVHBHPB, PNC20, RV5
Symptoms: Staphylococcus test, Swelling, Ultrasound liver, Ultrasound scan abnormal
Clinical narrative: bilateral inguinal MSSA lymphadenitis. No local cellulitis at injection sites. Due to unusual presentation, we are investigating a congenital immunodeficiency or chronic granulomatous disease. However, due to nature of infection, wanted to report to make sure no other similar incidents.
Age: 44.0
Sex: M
Vaccine: RSV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event to report after following up with patient. We administered this vaccine to this patient who is less than 60 years of age. Their prescriber gave them a prescription and the patient has a comorbidity of type 2 diabetes. After researching on facts and comparisons, it indicates that patients 18-59 years of age with an risk factor for RSV are eligible. Pharmacy system still flagged this and indicated that this vaccine shouldn't have been administered and now this needs to be documented.
Age: 41.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Product administered at inappropriate site, Shoulder injury related to vaccine administration
Clinical narrative: After vaccination, vaccine site was noted to be higher on arm than typical and towards the back of shoulder joint area. Day after vaccination, experienced extreme pain and loss of range of motion in left arm/shoulder. No relief from heat, ice or over-the counter pain medication minimal improvement for seven days at which point a primary care. Physician appointment was scheduled. Physician prescribed steroid dose pack in ordered orthopedic consult. The physicians impression was a likely case of SIRVA based on presentation.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: None at this time.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Pharyngeal swelling
Clinical narrative: About 10 minutes after vaccination, patient reported that she was short of breath and felt her throat swelling up.  Patient was given Benadryl and Epi Pen shot and EMS was called. EMS arrived shortly after, stayed with her for a while until the breathing got better and then helped her home.
Age: 0.42
Sex: M
Vaccine: DTAPIPVHIB, FLU3, PNC20, RV5
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 5 MONTH OLD WAS ADMINISTERED FLU VACCINE PRIOR TO RECOMMENDED AGE
Age: 53.0
Sex: M
Vaccine: PNC20
Symptoms: Migraine, Nausea, Vomiting
Clinical narrative: Pt received doses of both Prevnar 20 as well as seasonal influenza in our clinic on 10/17/24. Pt is also receiving care at second clinic and got both vaccines while in their care on 11/20. Pt awoke today with migraine and nausea/vomiting today.  Confirmed with second clinic that vaccines were administered to patient 11/20/24. Confirmed that doses given at first clinic are populated in record.
Age: 62.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Tinnitus
Clinical narrative: Significant Tinitus developed by the next morning in patient who has never had any Tinitus symptoms prior
Age: 79.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Cold sweat, Disorientation, Dizziness, Loss of consciousness, Tremor
Clinical narrative: Patient was dizzy and lightheaded and passed out during the middle of the night. Clammy skin, shaking, disoriented.
Age: 1.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Urticaria
Clinical narrative: Hive rash, urticaria
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: fluzone HD given at age 61 , no other adverse outcomes at this time
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Feeling cold, Hyperhidrosis, Nausea, Pain
Clinical narrative: 12 hours after FLUZONE HD vac came down with coldness and chills, body aches, cold sweats, and a low-grade fever of 100.3. It felt like a full-blown flu and happen really fast. Also felt nausea that woke me. I also receive the COVID vac at the same time.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: 12 hours after FLUZONE HD vac came down with coldness and chills, body aches, cold sweats, and a low-grade fever of 100.3. It felt like a full-blown flu and happen really fast. Also felt nausea that woke me. I also receive the COVID vac at the same time.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse reaction noted. Duplicate FLUAD 2024-2025 given, first dose was given 08/24/24 and second dose give 10/21/24. Insurance covered both. Patient was not upset.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Diarrhoea, Dizziness, Electrocardiogram, Headache
Clinical narrative: Received vaccine 11/7/2024. 11/8/2024 developed fever and was lethargic. This was my 7th Covid vaccines. Had pretty much the same symptoms with all of the vaccines, but only for the day after and just the 1 day. I was fine 11/9 and 11/10. Went to work on 11/11. I felt fine.  I had breakfast. About 30 minutes later, I went to the bathroom and had a bowel movement. Within 10 minutes, I became diaphoretic, dizzy, blurred vision and a headache. I went to the bathroom and had massive diarrhea. Was taken to the ER. My blood pressure was 50/30. An IV was started, lab work and an EKG. Discharged after several hours with a diagnosis of syncope and diarrhea. Doctor couldn?t be certain what caused  the above. I never mentioned the vaccine at the time. Not sure if it had anything to do with the vaccine.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Lethargy, Pyrexia, Syncope, Vision blurred
Clinical narrative: Received vaccine 11/7/2024. 11/8/2024 developed fever and was lethargic. This was my 7th Covid vaccines. Had pretty much the same symptoms with all of the vaccines, but only for the day after and just the 1 day. I was fine 11/9 and 11/10. Went to work on 11/11. I felt fine.  I had breakfast. About 30 minutes later, I went to the bathroom and had a bowel movement. Within 10 minutes, I became diaphoretic, dizzy, blurred vision and a headache. I went to the bathroom and had massive diarrhea. Was taken to the ER. My blood pressure was 50/30. An IV was started, lab work and an EKG. Discharged after several hours with a diagnosis of syncope and diarrhea. Doctor couldn?t be certain what caused  the above. I never mentioned the vaccine at the time. Not sure if it had anything to do with the vaccine.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: Ended up with a sinus infection. Unknown if related. But did begin about 1 week after vaccination.
Age: 45.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Condition aggravated, Vertigo
Clinical narrative: Onset of vertigo this past Saturday
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient accidentally received a second flu vaccine 2 months after initial. no reactions reported
Age: 66.0
Sex: F
Vaccine: COVID19, FLU3, PNC20
Symptoms: Injection site rash, Rash papular
Clinical narrative: Pt had raised rashes to both right and left deltoid
Age: 35.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Underdose
Clinical narrative: Clinic nurse administered a pediatric dose of Hep A instead of the adult dose.
Age: 51.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Rash, Rash pruritic, Urticaria
Clinical narrative: hives/itchy rash on arms, torso, legs
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Product storage error
Clinical narrative: On January 9, 2024 the vaccines in the clinic were moved to Health Department due to a power outage. The power came back on around 9:30a.m. when I arrived to work but I was advised by my supervisor to move the vaccine still in case it took a while for the refrigerator to return to the proper temperature. Vaccines were packed with ice packs and bubble wrap and transported by CRNP. The vaccine was transported back to Health Department that afternoon. A temperature excursion was noted on the digital data logger. Once returned to clinic the data logger was found to be beside the ice packs instead of by the vaccine. The vaccine manufacturers of the affected vaccine were notified and made aware of the temperature excursion. I notified the companies that the vaccine reached a temperature of 1.8 degrees Celsius. The max temperature that the vaccine reached during transport was 12.0 degrees Celsius. Per the vaccine companies, the only vaccine that was not recommended to use was the opened vial of IPOL and the opened MDV of Fluzone. They were discarded per the vaccine companies? recommendations.  Moving forward to April 10, 2024. The vaccine was transported again to Health Department due to inclement weather that day. Vaccine was transported by my supervisor and returned on April 12, 2024. Another temperature excursion occurred when the vaccine was transported back to the clinic. The vaccine companies were again contacted for recommendations on viability of the vaccine. When contacting the vaccine companies, I was asked if any of the vaccines had undergone a previous temperature excursion. It was then when I pulled my documentation from the previous excursion that I realized I had read the temperature log incorrectly and that the vaccine had reached a temperature of negative 1.8 degrees Celsius instead of what I reported to the vaccine companies of a +1.8 Degrees Celsius. Therefore, in fact there were two 2 temp excursions one on January 9, 2024 and the other on April 12th, 2024.  A list of all patients that received vaccines between January 9-April 12th was compiled. The list was sorted through as to what patients received the affected vaccine. Patients were notified of questionable viability of vaccines and were offered and recommended to be revaccinated if desired. Notes were added into immprint for outside providers.  The process of packing vaccine during transport during emergencies had been reviewed by all staff to include packaging with conditioned water bottles instead of frozen ice packs. Patient was notified. Vaccine was repeated 09/12/2024.
Age: 17.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Bulbar palsy, CSF cell count normal, CSF glucose normal, CSF protein increased, Guillain-Barre syndrome
Clinical narrative: Guillain Barre Syndrome: presented with ascending weakness beginning in his legs, progressing to upper extremities and bulbar muscles resulting in hospitalization at PICU
Age: 17.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Intensive care, Magnetic resonance imaging spinal, Muscular weakness, Scan with contrast
Clinical narrative: Guillain Barre Syndrome: presented with ascending weakness beginning in his legs, progressing to upper extremities and bulbar muscles resulting in hospitalization at PICU
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: The patient inadvertently received age inappropriate vaccine. No abnormal reaction or symptom reported so far.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Product storage error
Clinical narrative: On January 9, 2024 the vaccines in the clinic were moved to Health Department due to a power outage. The power came back on around 9:30a.m. when I arrived to work but I was advised by my supervisor to move the vaccine still in case it took a while for the refrigerator to return to the proper temperature. Vaccines were packed with ice packs and bubble wrap and transported by CRNP. The vaccine was transported back to Health Department that afternoon. A temperature excursion was noted on the digital data logger. Once returned to clinic the data logger was found to be beside the ice packs instead of by the vaccine. The vaccine manufacturers of the affected vaccine were notified and made aware of the temperature excursion. I notified the companies that the vaccine reached a temperature of 1.8 degrees Celsius. The max temperature that the vaccine reached during transport was 12.0 degrees Celsius. Per the vaccine companies, the only vaccine that was not recommended to use was the opened vial of IPOL and the opened MDV of Fluzone. They were discarded per the vaccine companies? recommendations.  Moving forward to April 10, 2024. The vaccine was transported again to Health Department due to inclement weather that day. Vaccine was transported by my supervisor and returned on April 12, 2024. Another temperature excursion occurred when the vaccine was transported back to the clinic. The vaccine companies were again contacted for recommendations on viability of the vaccine. When contacting the vaccine companies, I was asked if any of the vaccines had undergone a previous temperature excursion. It was then when I pulled my documentation from the previous excursion that I realized I had read the temperature log incorrectly and that the vaccine had reached a temperature of negative 1.8 degrees Celsius instead of what I reported to the vaccine companies of a +1.8 Degrees Celsius. Therefore, in fact there were two 2 temp excursions one on January 9, 2024 and the other on April 12th, 2024.  A list of all patients that received vaccines between January 9-April 12th was compiled. The list was sorted through as to what patients received the affected vaccine. Patients were notified of questionable viability of vaccines and were offered and recommended to be revaccinated if desired. Notes were added into immprint for outside providers.  The process of packing vaccine during transport during emergencies had been reviewed by all staff to include packaging with conditioned water bottles instead of frozen ice packs.  04/30/2024. Phonecall to Pt's mom. Notified of need to have DTAP given on 03/07/2024 repeated due to vaccine undergoing a temperature excursion and we cannot be certain of effectiveness/viability of vaccine.Chart is flagged. Appointment was scheduled for 05/28/2024.  Patient no showed 05/28/2024 and appointment was cancelled on June 12,2024. Chart remains flagged needs repeat DTAP.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Asthenia, Back pain, Electrocardiogram, Heart rate increased
Clinical narrative: Approximately 10 hours after receiving vaccine, pt reported sweating, decreased energy, fast heart rate (20 about resting HR. BP slightly lower than normal. pt also complained of knees, back being sore. Pt went to her family physician where EKG was done & found to be normal. Pt was directed to the ED by her family physician.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Hyperhidrosis
Clinical narrative: Approximately 10 hours after receiving vaccine, pt reported sweating, decreased energy, fast heart rate (20 about resting HR. BP slightly lower than normal. pt also complained of knees, back being sore. Pt went to her family physician where EKG was done & found to be normal. Pt was directed to the ED by her family physician.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Mobility decreased
Clinical narrative: left shoulder pain and decreased shoulder range of motion
Age: 78.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient had an inadvertent dose Respiratory syncytial virus (RSV) vaccine. He had one dose of Arexvy on 02/05/2024 and received Abrysvo today 11/21/2024 as an inadvertent dose since only 1 dose is currently recommended. Patient was notified of this today
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Injection site discomfort, Injection site mass
Clinical narrative: Large, cyst-like lump at injection site.  Larger than a 50 cent piece.  Kind of squishy.  Doesn't hurt.  Some discomfort if I push at it too much. Not warm to touch.       Listed as "Comirnaty Covid 25-25 (12y UP) PFS in treatment chart.             LOT Exp: 4/3/25.        (Had flu shot at same time : FLUZONE Trivalent 2024-25 syrg. Left deltoid / intramuscularly.... about an inch forward of COVID shot).  Pharmacist said "is Moderna" but I was just told it was Pfizer.  I've had both in the past.
Age: 19.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered
Clinical narrative: Patient received an additional Pneumococcal vaccine instead of the second dose of Meningococcal B.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Patient said a week after receiving 5th dose of pfizer covid vaccine she developed blood clots. She called to be seen by her doctor and doctor had told patient that blood clots developed after getting the vaccine.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient reports feeling sore, deltoid showed redness about 3 inches in diameter around injection site.  Patient will monitor if redness spreads and will go to urgent care if needed.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered, No adverse event
Clinical narrative: 6 month old male was administered the 3rd dose of the Pediarix vaccine series in the left thigh without technical complication. The vaccine was inadvertenly administered from an expired lot #E9Y29 with an expiration date of 10/26/24. Patient's parents were aware and advised to any vaccine reactions. The manufacturer GSK was contacted and referred to CDC recommendations which is to repeat the dose. As of 11/21/24 no reports of any vaccine reactions received.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Client received 0.5ml of COVID19 vaccine instead of 0.25 ml peds dose of COVID19 vaccine.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Crying, Pruritus, Urticaria
Clinical narrative: Extreme itching, R calf, within 15 minutes of injection administration. .. A large, weeping welt subsequently developed.  There was no prior issue such as this from any previous initial or Covid booster.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Client received 0.5ml COVID19 vaccination instead of 0.25ml Peds COVID19 vaccine.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Client received 0.5ml COVID19 vaccine instead of 0.25ml COVID19 peds vaccine
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC15, RV5
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient received Pediarix which included Hep-B and they were not due for the 3rd dose of HEP-B until 01/17/2025. The patient was due for the HIB vaccine and was given that separately once the error was identified.  This error was identified prior to patient leaving the office and provider and office manager spoke with patient's mother regarding the error. Patient was not injured and had no adverse reaction that was reported to me.
Age: 79.0
Sex: F
Vaccine: PNC21
Symptoms: Body temperature increased, Fatigue, Malaise, Peripheral swelling, Rash
Clinical narrative: pt says the next day after getting the vaccine her left arm was more swollen than the day before so she took a couple of motrin. Her temperature was going up so took more motrin. She ended up having a seizure. The last thing she remembered was making it to the couch, reaching for a blanket and laying down. She awoke about 3 or 4 hours later. She took 3 more motrin and laid back down for several more hours. She got back up, took a couple of Tylenol and went to bed. She got up the next day, took motrin every 4 hours. Her arm was swollen down to her elbow and covered with a rash. She slept mostly the entire day. She was very sick for about 3 days. By the following day she still had some a temp and was feeling some better. The swelling was a little better and temputure was coming down. She kept alternating tylenol and motrin. She felt tired and weak for over two weeks before she started feeling normal.
Age: 79.0
Sex: F
Vaccine: PNC21
Symptoms: Seizure, Somnolence
Clinical narrative: pt says the next day after getting the vaccine her left arm was more swollen than the day before so she took a couple of motrin. Her temperature was going up so took more motrin. She ended up having a seizure. The last thing she remembered was making it to the couch, reaching for a blanket and laying down. She awoke about 3 or 4 hours later. She took 3 more motrin and laid back down for several more hours. She got back up, took a couple of Tylenol and went to bed. She got up the next day, took motrin every 4 hours. Her arm was swollen down to her elbow and covered with a rash. She slept mostly the entire day. She was very sick for about 3 days. By the following day she still had some a temp and was feeling some better. The swelling was a little better and temputure was coming down. She kept alternating tylenol and motrin. She felt tired and weak for over two weeks before she started feeling normal.
Age: 76.0
Sex: F
Vaccine: PNC20
Symptoms: Swollen tongue
Clinical narrative: I did call and check on pt after reading the ER note. She told me that she was at the grocery store after leaving her Office visit this morning when she felt her tongue start to swell on her. She left the ER as she didn't want her insurance to be charged an ER visit. She went and bought liquid Benadryl after leaving the ER and went home. She has taken 2 "capfuls" per the patient with the last one taken about 1.5 hours ago. She tells me that the swelling has gone down for her and she is feeling better. I did explain to her that when she had come back with her swelling issues this afternoon that the ER was the best place for her to go as they have the best supplies to manage her airway if needed. She did voice understanding in this when it was explained to her. I also let her know that if her swelling comes back to please come in to be seen. We value her and would like her to be around longer. I also asked if I could call her in the morning to check on her and she said that would be fine. --- Per EMR encounter dated 11/19/24 at 1357     I did call and talk to pt this morning she did have to take more Benadryl last night she tells me. She is feeling back to normal this morning she tells me. Her left arm is sore as she did get 2 vaccines in that arm. However, she doesn't have any redness or swelling she tells me. I did let her know that she can come back to be evaluated still if the swelling comes back for her. She voiced understanding in this plan.---per EMR encounter dated 11/20/22 at 9:06 AM
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Brain fog, Gait inability, Ophthalmic migraine
Clinical narrative: Was unable to walk. Had no connection between my brain and the right side of my body. Also had numerous ocular migraines and tremendous brain fog.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Face oedema, Lip oedema, Pruritus, Respiratory disorder
Clinical narrative: Patient had itching to his face which resolved completely with one dose of diphenhydramine 25mg po. He declined to go to the ED. He denied any other symptoms (edema of the lips, mouth, face, or respiratory difficulties).
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site pain, Myalgia, Pain in jaw, Swelling face
Clinical narrative: Immediate soreness in left arm at point of vaccine lasting 24 hours. 48 hours after flu shot: toothache in lower molar, left side. 72 hours later strong dental pain on left side molars, upper and lower. Took aspirin.  96 hours after shot excruciating jaw pain, left side, upper and lower. Took Advil every 4 hours for next 48 hours. Face started swelling on left side only. 120 hours after shot muscle pain in left jaw, molar/dental pain began receding. 144 hours after shot facial swelling slowly receded, jaw muscle still painful. 168 hours after shot: Burning sensation in jaw muscle, pain in right jaw and teeth, especially upper incisor.  192 hours after shot, slight dental pain.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Toothache
Clinical narrative: Immediate soreness in left arm at point of vaccine lasting 24 hours. 48 hours after flu shot: toothache in lower molar, left side. 72 hours later strong dental pain on left side molars, upper and lower. Took aspirin.  96 hours after shot excruciating jaw pain, left side, upper and lower. Took Advil every 4 hours for next 48 hours. Face started swelling on left side only. 120 hours after shot muscle pain in left jaw, molar/dental pain began receding. 144 hours after shot facial swelling slowly receded, jaw muscle still painful. 168 hours after shot: Burning sensation in jaw muscle, pain in right jaw and teeth, especially upper incisor.  192 hours after shot, slight dental pain.
Age: 75.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Atrophic vulvovaginitis, Auditory disorder, Hypoaesthesia, Pain, Pelvic discomfort
Clinical narrative: First adverse event- strong shaking all over lasting only a minute,  achiness, low grade fever  lasting 2 days ;pelvic discomfort diagnosed by gynecologist as vaginal atrophy within  a week; left facial numbness and auditory problem in left ear still affected (appointment with otolaryngologist January), MAJOR ADVERSE EVENT happened October 14, about 7 pm nol when I experienced severe upper body pain - front and back- requiring ambulance trip to Emergency Room where I was treated with morphine to relieve pain.  ER Doctor diagnosed as lung infection, but pulmonologist reviewed records a few days later October 21, and checked me saying I definitey had no lung infection on the 14th nor currently.
Age: 75.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Pneumonia, Pyrexia, Tremor
Clinical narrative: First adverse event- strong shaking all over lasting only a minute,  achiness, low grade fever  lasting 2 days ;pelvic discomfort diagnosed by gynecologist as vaginal atrophy within  a week; left facial numbness and auditory problem in left ear still affected (appointment with otolaryngologist January), MAJOR ADVERSE EVENT happened October 14, about 7 pm nol when I experienced severe upper body pain - front and back- requiring ambulance trip to Emergency Room where I was treated with morphine to relieve pain.  ER Doctor diagnosed as lung infection, but pulmonologist reviewed records a few days later October 21, and checked me saying I definitey had no lung infection on the 14th nor currently.
Age: 28.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Syncope
Clinical narrative: PATIENT FAINTED AND EXHIBITED CLASSIC SIGNS OF SYNCOPE ABOUT 5 MINUTES AFTER VACCINATION WAS GIVEN.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Pruritus
Clinical narrative: Patient felt dizzy and itchy the hour following her flu vaccine. Over the weekend she felt palpitations. Reported to VAERS. She plans to follow up with her PCP.
Age: 67.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Product preparation error
Clinical narrative: SHINGRIX Antigen Component vial inadvertently reconstituted with BOOSTRIX  prefilled syringe and administered IM in left deltoid by vaccine certified pharmacy technician. Patient notified of error by writer and advised to monitor for rash and swelling at the injection site and any fever or headache. Clinical Pharmacist with patient's primary care provider was notified. Immunization Coordinator notified and contacted GSK and CDC for resources.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No symptoms occurred, gave 65+ vaccine to 60 year old patient
Age: 2.0
Sex: M
Vaccine: DTAP, PNC15
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient started to experience swelling in right thigh. Red bump started to appear in the side of gumball. Visible injection marks. Hot to touch.
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Chills, Headache
Clinical narrative: Severe chills/headache within 12 hours post injection. Chills abated within 8 hours, but headache persists 26 hours later.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Parent signed a consent for child to receive vaccine during a school located vaccine clinic. It was noted after the clinic the child had had an influenza vaccine on 9/12/24 also.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Patients mother submitted consent form for child to receive flu vaccine during school located vaccine clinic. Mother indicated patient had not ever had a flu shot in their lifetime and had not ever had 2 doses of flu vaccine prior to July 1 2024. Therefore, patient received 2 doses of flu vaccine this season. It was determined after the 2nd dose was administered that the child had had >2 doses of flu vaccine in their lifetime and 2nd dose was not indicated this season.
Age: 20.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Accidently gave a 20 year old a pediatric Hep A meant for 18 and under.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was administered after the expiration date. No known signs, symptoms reported by patient at this time.
Age: 60.0
Sex: F
Vaccine: COVID19, FLU3, VARZOS
Symptoms: Dizziness, Headache, Oropharyngeal discomfort
Clinical narrative: Patient comes back 5 minutes after vaccines and mentions that she is feeling very dizzy. I told patient to have a seat and I will watch her. Patient mentions that throat felt weird like it was swelling.  Watched over patient for 15 minutes and gave her water. After 15 minutes she still felt dizzy. Her husband picked her up later, since she was unable to drive. I advised them to go to urgent care. Called patient and she mentions she  had normal symptoms next day, like a headache.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Patient said he has pain down his arm for the past week. He will contact his provider in a few days if condition remains the same or worsens.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Patients mother submitted consent form for child to receive flu vaccine during school located vaccine clinic. Mother indicated patient had not ever had 2 doses of flu vaccine prior to July 1 2024 . Therefore, patient received 2 doses of flu vaccine this season. It was determined after the 2nd dose was administered that the child had had >2 doses of flu vaccine in their lifetime and 2nd dose was not indicated this season per the vaccine quality data report from system.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure decreased, Chest X-ray, Cholecystitis, Cholelithiasis
Clinical narrative: exhaustion followed by nausea which got progressively worse.  I went to urgent care after being dizzy and experiencing body aches in all my joints. I  was sent to Hospital on November 13 after CT scan showed gallbladder inflammation and gall stones.   blood pressure very low.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram abdomen abnormal, Dizziness, Nausea
Clinical narrative: exhaustion followed by nausea which got progressively worse.  I went to urgent care after being dizzy and experiencing body aches in all my joints. I  was sent to Hospital on November 13 after CT scan showed gallbladder inflammation and gall stones.   blood pressure very low.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Pain, Pain in extremity, Peripheral swelling, Skin discolouration
Clinical narrative: Pain in left big toe joint. Dark red discoloration in big toe that spread up the foot to the calf. Associated with constant throbbing 2/10 pain and 5/10 pain when walking or touching the joint. Ibuprofen 600 mg QID helped with pain. Toe and foot swollen for 10 days.  Returned again 4 weeks later and is currently repeating the same progression again. This swelling and pain prevents me from walking, putting on a shoe, and even a sheet touching the toe is enough to cause pain. I tried icing the foot, massage, exercises, bending the toe, elevating the toe, heat and resting it. Nothing seemed to provide better relief than any other treatment.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: Pain in left big toe joint. Dark red discoloration in big toe that spread up the foot to the calf. Associated with constant throbbing 2/10 pain and 5/10 pain when walking or touching the joint. Ibuprofen 600 mg QID helped with pain. Toe and foot swollen for 10 days.  Returned again 4 weeks later and is currently repeating the same progression again. This swelling and pain prevents me from walking, putting on a shoe, and even a sheet touching the toe is enough to cause pain. I tried icing the foot, massage, exercises, bending the toe, elevating the toe, heat and resting it. Nothing seemed to provide better relief than any other treatment.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Patients mother submitted consent form for child to receive flu vaccine during school located vaccine clinic. Mother indicated patient had not ever had 2 doses of flu vaccine prior to July 1 2024 . Therefore, patient received 2 doses of flu vaccine this season. It was determined after the 2nd dose was administered that the child had had >2 doses of flu vaccine in their lifetime and 2nd dose was not indicated this season per the vaccine quality data report from system.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash, Injection site swelling, Rash erythematous
Clinical narrative: Red Rash developed on arm of injection going from shoulder to elbow and wrapping around to axilla. Slight swelling and redness.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Patients mother submitted consent form for child to receive flu vaccine during school located vaccine clinic. Mother indicated patient had not ever had 2 doses of flu vaccine prior to July 1 2024 . Therefore, patient received 2 doses of flu vaccine this season. It was determined after the 2nd dose was administered that the child had had >2 doses of flu vaccine in their lifetime and 2nd dose was not indicated this season per the vaccine quality data report from system.
Age: 82.0
Sex: F
Vaccine: FLU3, PNC20
Symptoms: Urticaria
Clinical narrative: HIVES STARTED EVENING OF IMMUNIZATION. PATIENT TOOK BENADRYL AT BEDTIME WHICH IMPROVED SYMPTOMS. HIVES RETURNED THE AFTERNOON THE NEXT DAY.  PT INSTRUCTED TO CONTINUE BENADRYL AND CONTACT PHYSICIAN.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Patients mother submitted consent form for child to receive flu vaccine during school located vaccine clinic. Mother indicated patient had not ever had 2 doses of flu vaccine prior to July 1 2024 . Therefore, patient received 2 doses of flu vaccine this season. It was determined after the 2nd dose was administered that the child had had >2 doses of flu vaccine in their lifetime and 2nd dose was not indicated this season per the vaccine quality data report from record.
Age: 73.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Joint range of motion decreased
Clinical narrative: The patient reports severe shoulder pain and mobility issues with the shoulder joint.
Age: 78.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Balance disorder, Confusional state, Dizziness, Fall, Somnolence
Clinical narrative: Patient complained of confusion, drowsiness, and dizziness beginning at 3:00pm and continuing until she fell asleep at 6:30pm.  During that time, she felt unsteady when she tried to get up and fell on the couch.  She stated that she was not injured.  When she woke up the next morning between 6:30am and 7:00am.  Patient did not seek care because the symptoms resolved.
Age: 25.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE/no PQC; HCP called regarding GARDASIL 9. HCP has a patient who received first dose of GARDASIL 9 four years ago and would like to continue the series. AE filed as outside of P/missed dosesI. No reported signs/symptoms of adverse effects from missed doses/mis; This spontaneous report was received from pharmacist and refers to a patent of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date in 2020 (reported as '4 years ago'), the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, (1st dose- discrepancy - also reported as '2nd dose', lot #, expiration date, route of administration and anatomical location were not provided) for prophylaxis (Inappropriate schedule of product administration). The patient would like to continue the series. No reported signs/symptoms of adverse effects (No adverse event). Limited information available. No additional AE/no PQC.  Lot # is being requested and will be submitted if received.  Follow-up information has been received from the pharmacist on 18-NOV-2024. It was confirmed that the 29-years-old female patient received her first dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection on an unknown date  in 2020. On 16-OCT-2024, the patient received her second dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (strength, dose, frequency, scheme, and route were not reported), in her right deltoid, Lot #X026926, expiration date 10-APR-2026. The patient also received a flu shot (manufacturer unknown) on the same day in the left deltoid. No vaccines were given in the four weeks prior to 16-OCT-2024. The patient has no significant past medical history. No side effects were reported.  No further information is available.  This report was previously considered as non-valid, but due to the information reported on 18-NOV.2024, the case now is valid.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: no adverse event; A physician called to report that a pregnant patient received a dose of GARDASIL 9. The physician said no adverse effects were noted and was calling to alert Merck in case there was a pregnancy registry for GARDASIL 9. The caller provided the patient; This spontaneous report was received from a physician and refers to a pregnant female patient of unknown age.  The patient's medical history and concomitant therapies were not reported. The patient's concurrent conditions included pregnancy.  On an unknown date (assessed as in 2024), the pregnant patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (Exposure during pregnancy). The physician said no adverse effects were noted (no adverse event).  Lot # is being requested and will be submitted if received.