chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: M
Vaccine: MNQ, TYP
Symptoms: Arthralgia, Hypoaesthesia, Muscular weakness, Pain, Paraesthesia
Clinical narrative: The member stated he first observed the symptoms on the same day the vaccination was given. At first the symptom was tingling, especially down his right arm, from the tricep down to fingertips. The week of March 17 he started feeling pain in his elbow and wrist, infrequent and mostly not bad, I'd rate it a 4 out of 10 , but could be a 8/10 in rare occasions. The pain happens when his arm or wrist is at a  different angle than normal and when it happens the pain is very fast and doesn't normally linger. That same week the feeling of being numb, especially in his ring and pinky fingers up to the right side of his upper forearm was and is happening more consistently. His grip strength and arm strength feels weaker than normal.  The treatment plan is for the member to receive bilateral upper extremity nerve conduction and an electromyography study done ASAP as of 3/25/2025.
Age: 36.0
Sex: F
Vaccine: MMR
Symptoms: Blood ethanol, Brain natriuretic peptide, Creatinine renal clearance, Fibrin D dimer, Full blood count
Clinical narrative: MMR was given and approximately 30 minutes after receiving the vaccine, employee felt 'sick'. Sat on toilet to move bowels and passed out. Brough to ER where she was treated with IVF's and monitored for other symptoms.
Age: 36.0
Sex: F
Vaccine: MMR
Symptoms: International normalised ratio, Loss of consciousness, Malaise, Metabolic function test, Prothrombin time
Clinical narrative: MMR was given and approximately 30 minutes after receiving the vaccine, employee felt 'sick'. Sat on toilet to move bowels and passed out. Brough to ER where she was treated with IVF's and monitored for other symptoms.
Age: 36.0
Sex: F
Vaccine: MMR
Symptoms: Toxicologic test, Troponin, Urine analysis
Clinical narrative: MMR was given and approximately 30 minutes after receiving the vaccine, employee felt 'sick'. Sat on toilet to move bowels and passed out. Brough to ER where she was treated with IVF's and monitored for other symptoms.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: PT CAME IN FOLLOWING DAY (3/26/25) COMPLAINING OF REDNESS AT THE INJECTION SITE.  I ENCOURAGED HER TO KEEP A COOL COMPRESS AND APPLY TOPICAL TO TREAT ITCHING
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Death, Haematological malignancy
Clinical narrative: no immediate reaction. 3 years later rare aggressive blood cancer fatal in one week.
Age: 10.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: The patient arrived to the clinic this morning for their well child check. The patient's PCP ordered a Gardasil (HPV) vaccine at the visit and this nurse went to administer at the end of the appointment. Mom chose to not wait the recommended 15 minute observation time. The patient was walking out of the clinic and experienced a syncopal event. This nurse caught her by placing this nurse hands/arms under the patient's armpits. and was lowered in to a chair to prevent a fall to the floor. The patient was still not responsive but slowly came to a few seconds later. The patient vomited x 2 and was pale and sweaty.  This nurse assessed patient's blood pressure and it was a low result. The patient rested for about 5-10 minutes and then was able to have some crackers and water. The patient's blood pressure was checked again about 15 minutes later and was then stable. The pcp came in and assessed the patient and it was determined that the patient was safe to leave the clinic.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Polymyalgia rheumatica
Clinical narrative: 4 years later diagnosed with Polymyalgia Rheumatica
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: THE EVENING AFTER RECEIVING THE VACCINE, THE PATIENT EXPERIENCED SIGNIFICANT SWELLING AND REDNESS AT THE INJECTION SITE.  SUGGESTED COOL COMPRESS OR ICE TO THE AREA AND SEE THE DOCTOR IF NO IMPROVEMENT IN 1 WEEK. SUGGESTED IBUPROFEN ALSO BUT PATIENT IS HIGHLY ALLERGIC TO NSAIDS SO WILL TAKE TYLENOL ARTHRITIS.
Age: 49.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site swelling
Clinical narrative: Patient reports "a knot" under the skin at injection sit. Patient also reports redness, itchiness and swelling to the injection site. Symptoms began approximately one day after administration and was ongoing for several days.
Age: 32.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered
Clinical narrative: Additional (extra) dose given. Pt verbalized that she had had 2 doses, 3 doses were documented.
Age: 15.0
Sex: M
Vaccine: IPV
Symptoms: Nausea, Pallor, Tachypnoea
Clinical narrative: Shortly after second immunization (IPV) patient developed significant nausea, tachypnea, And pale discoloration.  - No rash, blood pressure remained stable, no vomiting - Prescribed dose of Zofran and provided patient with juice. Patient was monitored for approximately 20 minutes before third injection was given. Patient tolerated the next injection well and was monitored for approximately 20 minutes after.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, HEP, MMR, VARCEL
Symptoms: Malaise, Vomiting
Clinical narrative: RN gave patient vaccines. Patient went to waiting room while his sibling was vaccinated. Within 10 minutes, patient started vomiting. Patient's mother then said patient was not feeling well and had not eaten anything all day. RN gave patient water and nutrigrain bar and continued to observe patient for several minutes. Patient then said he was feeling ok and wanted to leave.  Patient's other sibling does have chicken pox and Patient was exposed to that child as well.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Mass, Pain, Skin discolouration
Clinical narrative: So his wife came in today and stated that pt said he got a lump after his vaccine 4 weeks later, it started small and it is now the size of a golf ball has not gone down, it is painful and discolored.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Body temperature increased, Cough, Drug hypersensitivity, Rash morbilliform
Clinical narrative: Full body measles rash from head to toe for 7 days, 103 degree temperature for 4 days, cough for 7 days
Age: 34.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Dizziness, Erythema, Face oedema, Rash
Clinical narrative: WEAKNESS, LIGHT HEADED, PRURITIS RASH (ENTIRE BODY), FACIAL EDEMA, MACULAR ERYTHEMA, URTICARIAL WHEALS.  GIVEN 40MG MEDROL, 50 MG BENADRYL.
Age: 34.0
Sex: F
Vaccine: UNK
Symptoms: Rash pruritic, Urticaria
Clinical narrative: WEAKNESS, LIGHT HEADED, PRURITIS RASH (ENTIRE BODY), FACIAL EDEMA, MACULAR ERYTHEMA, URTICARIAL WHEALS.  GIVEN 40MG MEDROL, 50 MG BENADRYL.
Age: 0.83
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: Expired vaccine given - date of expiration date is 3/14/25
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: per ma at office pt presented to office with redness and swelling around injection site 1 week after faccine
Age: 40.0
Sex: M
Vaccine: MMR, TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: On March 21, 2025, the patient visited the clinic for due vaccines and presented her shot record. MMR , Hep B , Flu , Varicella and  TD  vaccines were administered and the patient was monitored for fifteen minutes without experiencing any side effects. It was brought to my attention by the provider of the week, who alerted me to the mistake that I had given the MMR vaccine too early. I did a review of this patient chart and found out that I administered another MMR vaccine, which the patient had already received 3 days prior due to an oversight. I noted the vaccine's received date as March 18, 2024, instead of the correct date, March 18, 2025, which was an oversight. i followed up with the patient on 3/24/2025 and patient denied any adverse effect and stated that he is okay. moving forward I will ensure that I am more meticulous when conducting review of patients records to prevent a reoccurrence of such.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Rash, Rash pruritic
Clinical narrative: Rash starting on right thigh at injection site 3/24/25. Enlarging for the past few days. Now, erythematous raised boarders with central clearning without crusting or scale. No warmth or tenderness. Describes rash as mildly painful and pruritic. No vesicles noted.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Allergy test positive, Allergy to plants, Arthralgia, Bursitis, Exercise tolerance decreased
Clinical narrative: After the shot, pain began developing close to my left humerus in the biceps brachii (long head) along a 3-4  zone.  It has not abated over time, and my arm becomes quite weak and sore with various exercises (I can no long do any pushups, for example).  Raising my arm upwards or exercising generates considerable pain, and the shoulder joint also seems sore.  I decided to give my condition a full six months before filing this report, hoping it would subside, but it has not.  I received the shot 10 days after receiving a yellow jacket sting in the same arm, but the injury had fully subsided before getting the Fluzone injection.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Food allergy, Inflammation, Injection site pain, Milk allergy, Muscular weakness
Clinical narrative: After the shot, pain began developing close to my left humerus in the biceps brachii (long head) along a 3-4  zone.  It has not abated over time, and my arm becomes quite weak and sore with various exercises (I can no long do any pushups, for example).  Raising my arm upwards or exercising generates considerable pain, and the shoulder joint also seems sore.  I decided to give my condition a full six months before filing this report, hoping it would subside, but it has not.  I received the shot 10 days after receiving a yellow jacket sting in the same arm, but the injury had fully subsided before getting the Fluzone injection.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Pain in extremity, Seasonal allergy
Clinical narrative: After the shot, pain began developing close to my left humerus in the biceps brachii (long head) along a 3-4  zone.  It has not abated over time, and my arm becomes quite weak and sore with various exercises (I can no long do any pushups, for example).  Raising my arm upwards or exercising generates considerable pain, and the shoulder joint also seems sore.  I decided to give my condition a full six months before filing this report, hoping it would subside, but it has not.  I received the shot 10 days after receiving a yellow jacket sting in the same arm, but the injury had fully subsided before getting the Fluzone injection.
Age: 80.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Dizziness, Nausea, Urticaria
Clinical narrative: Reports developed hives on entire body within 48 hours of receiving vaccines. Had nausea and lightheadedness the first few days. Reporting symptoms on 3/26/25 and that still has hives on chest and back. Denied and difficulty breathing.
Age: 2.0
Sex: M
Vaccine: HEPA, MMRV, VARCEL
Symptoms: No adverse event, Wrong patient
Clinical narrative: Patient presented to the clinic with his mother to get caught up on immunizations. Patient's sister was also present to get caught up on her immunizations as well. Patient was due for a Hepatitis A, MMR and Varicella. Patient was given a Hepatitis A, Varicella and mistakenly given his sister's MMRV instead of plain MMR. Patient's mother was notified right away, the doctor who evaluated was also notified right away. She then contacted the pharmacy to ensure patient safety. No adverse reactions or symptoms occurred.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine was shipped refrigerated and then subsequently placed in the freezer for clinic storage. Per manufacturer, patient needing to be revaccinated. No adverse symptoms or outcome related to the event.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Localized reaction to right thigh progressively enlarged to 5x5 inches of redness since approximately 8:00am on 3/25/2025. He has associated swelling and tenderness to the thigh. No respiratory symptoms or fevers. Seen at provider on 3/26/2025 at 2:15 pm. Patient is clinically well appearing. Recommended Tylenol, Motrin, Benadryl for comfort.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: RIGHT DELTOID, INJECTION SITE, HOT TO TOUCH, LARGE KNOT, PAINFUL ARM WITH MOVEMENT, REDNESS. TREATMENT- ANTIHISTAMINE, ICE, ADVIL
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Agoraphobia, Anxiety, Menstruation irregular, Panic attack
Clinical narrative: I had been on Zoloft for 9 years and was told that I did not need to see a therapist or psychiatrist after college and could you receive Zoloft through my general practitioner; this is to provide context of how well mental health wise I was doing before this. Around 2 weeks after the first dose, I experienced intense anxiety seemingly randomly (still experiencing), anxiety and panic attacks (for a year after), agoraphobia (for 2-3 years after), and an irregular menstrual cycle with intense physical symptoms (for 3 years after).
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: PATIENT RECEIVED EXPIRED VACCINE, NO ADVERSE EVENT REPORTED BY FAMILY
Age: 64.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Lip pruritus, Lip swelling, Pruritus, Swelling face
Clinical narrative: approx 1-2 hours from inoculation: Swelling of lips, jaw, itching at site of swelling, lasting at least until 2 days after.  benadryl helping, told to seek medical attention if any difficulty breathing occurs or if symptoms dont improve with benadryl
Age: 1.17
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine was shipped refrigerated and then subsequently placed in the freezer for clinic storage. Per manufacturer, patient needing to be revaccinated. No adverse symptoms or outcome related to the event.
Age: 84.0
Sex: F
Vaccine: RSV
Symptoms: Fatigue, Lymphadenopathy, Myalgia, Pyrexia
Clinical narrative: Patient comes to the office 3/25/2025 accompanied by her husband.  She had the RSV vaccine on Friday.  Since then she has developed some swollen glands underneath her jaw, fever yesterday, fatigue and myalgias.  Her chronic headache is no different.  She was developing a canker sore on her right lip before she got the vaccine.  No chills, night sweats, ear pain, sore throat, shortness of breath, cough, nausea or vomiting.  No diarrhea.
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Rash pruritic
Clinical narrative: Body itch rash starting from Ears, to neck, face, back, chest, arms. No treatment except for allergy OTC stuff.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine was shipped refrigerated and then subsequently placed in the freezer for clinic storage. Per manufacturer, patient needing to be revaccinated. No adverse symptoms or outcome related to the event.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: The Varicella that was given expired on 3/12/2024. I did contact the state and Was informed to fill out this form and to repeat the varicella in 4 weeks.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine was shipped refrigerated and then subsequently placed in the freezer for clinic storage. Per manufacturer, patient needing to be revaccinated. No adverse symptoms or outcome related to the event.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1
Symptoms: Blood culture negative, Blood sodium normal, C-reactive protein increased, CSF culture negative, Conjunctivitis
Clinical narrative: Patient developed diarrhea the day after his vaccines, which persisted until he developed a fever, conjunctivitis, lethargy, and diffuse macular rash on 3/4/25. He was admitted to the hospital, and after CBC showed elevated platelets and UA showed pyuria, he was diagnosed with Kawasaki Disease.  He was treated with IVIG and Remicade and started on daily aspirin and his fever resolved within 24 hours. Echocardiogram showed no evidence of coronary vessel dilatation.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1
Symptoms: Culture urine positive, Diarrhoea, Escherichia infection, Full blood count normal, Immunoglobulin therapy
Clinical narrative: Patient developed diarrhea the day after his vaccines, which persisted until he developed a fever, conjunctivitis, lethargy, and diffuse macular rash on 3/4/25. He was admitted to the hospital, and after CBC showed elevated platelets and UA showed pyuria, he was diagnosed with Kawasaki Disease.  He was treated with IVIG and Remicade and started on daily aspirin and his fever resolved within 24 hours. Echocardiogram showed no evidence of coronary vessel dilatation.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1
Symptoms: Lethargy, Measles antibody negative, Platelet count increased, Procalcitonin increased, Pyrexia
Clinical narrative: Patient developed diarrhea the day after his vaccines, which persisted until he developed a fever, conjunctivitis, lethargy, and diffuse macular rash on 3/4/25. He was admitted to the hospital, and after CBC showed elevated platelets and UA showed pyuria, he was diagnosed with Kawasaki Disease.  He was treated with IVIG and Remicade and started on daily aspirin and his fever resolved within 24 hours. Echocardiogram showed no evidence of coronary vessel dilatation.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1
Symptoms: Pyuria, Rash macular, Red blood cell sedimentation rate increased, Respiratory viral panel, Rotavirus test positive
Clinical narrative: Patient developed diarrhea the day after his vaccines, which persisted until he developed a fever, conjunctivitis, lethargy, and diffuse macular rash on 3/4/25. He was admitted to the hospital, and after CBC showed elevated platelets and UA showed pyuria, he was diagnosed with Kawasaki Disease.  He was treated with IVIG and Remicade and started on daily aspirin and his fever resolved within 24 hours. Echocardiogram showed no evidence of coronary vessel dilatation.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1
Symptoms: Urine analysis abnormal, White blood cells urine positive
Clinical narrative: Patient developed diarrhea the day after his vaccines, which persisted until he developed a fever, conjunctivitis, lethargy, and diffuse macular rash on 3/4/25. He was admitted to the hospital, and after CBC showed elevated platelets and UA showed pyuria, he was diagnosed with Kawasaki Disease.  He was treated with IVIG and Remicade and started on daily aspirin and his fever resolved within 24 hours. Echocardiogram showed no evidence of coronary vessel dilatation.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine was shipped refrigerated and then subsequently placed in the freezer for clinic storage. Per manufacturer, patient needing to be revaccinated. No adverse symptoms or outcome related to the event.
Age: 1.0
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Blood glucose normal, Breath holding, Crying, Echocardiogram normal, Electrocardiogram normal
Clinical narrative: 7 am patient woke up as normal ate breakfast, by 7:22 she was crying, her nose turned red, she was pale and warm, threw up mucous, no fever, but not acting right. I changed her diaper, she was lethargic on the changing table. 7:39 i put her on the living room floor and she was mostly unrepsonsive and still breathing. I called 911. I rolled her to her side, she threw up. Firefighters arrived 7 mins, didnt crawl away or make a peep when they got her vitals. EMS arrived 5 mins later, still lethargic, not pulling away. Finally she started to open her eyes. Put her in the EMS van sitting in her carseat, but eyes closed and very fatigued. When they pricked her heel for blood she finally withdrew her limb. Glucose 115 Got to the ED by 8:33. Workup included an abdominal US which was negative for intussusception. She did tolerating crackers and breastfeed without issue. CBC and BMP negative.  Neuro consult, not a seizure. She was back to herself and we were discharged. We had follow ups with cardiology. Her echo and EKG were both normal. We were told there is nothing wrong with her heart and that possible it was a crying spell or a breath holding spell, but she never turned blue. We also followed up with neurology who agreed that it was NOT a seizure.
Age: 1.0
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Erythema, Feeling hot, Full blood count normal, Hyporesponsive to stimuli, Lethargy
Clinical narrative: 7 am patient woke up as normal ate breakfast, by 7:22 she was crying, her nose turned red, she was pale and warm, threw up mucous, no fever, but not acting right. I changed her diaper, she was lethargic on the changing table. 7:39 i put her on the living room floor and she was mostly unrepsonsive and still breathing. I called 911. I rolled her to her side, she threw up. Firefighters arrived 7 mins, didnt crawl away or make a peep when they got her vitals. EMS arrived 5 mins later, still lethargic, not pulling away. Finally she started to open her eyes. Put her in the EMS van sitting in her carseat, but eyes closed and very fatigued. When they pricked her heel for blood she finally withdrew her limb. Glucose 115 Got to the ED by 8:33. Workup included an abdominal US which was negative for intussusception. She did tolerating crackers and breastfeed without issue. CBC and BMP negative.  Neuro consult, not a seizure. She was back to herself and we were discharged. We had follow ups with cardiology. Her echo and EKG were both normal. We were told there is nothing wrong with her heart and that possible it was a crying spell or a breath holding spell, but she never turned blue. We also followed up with neurology who agreed that it was NOT a seizure.
Age: 1.0
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Metabolic function test normal, Pallor, Ultrasound abdomen normal, Vomiting
Clinical narrative: 7 am patient woke up as normal ate breakfast, by 7:22 she was crying, her nose turned red, she was pale and warm, threw up mucous, no fever, but not acting right. I changed her diaper, she was lethargic on the changing table. 7:39 i put her on the living room floor and she was mostly unrepsonsive and still breathing. I called 911. I rolled her to her side, she threw up. Firefighters arrived 7 mins, didnt crawl away or make a peep when they got her vitals. EMS arrived 5 mins later, still lethargic, not pulling away. Finally she started to open her eyes. Put her in the EMS van sitting in her carseat, but eyes closed and very fatigued. When they pricked her heel for blood she finally withdrew her limb. Glucose 115 Got to the ED by 8:33. Workup included an abdominal US which was negative for intussusception. She did tolerating crackers and breastfeed without issue. CBC and BMP negative.  Neuro consult, not a seizure. She was back to herself and we were discharged. We had follow ups with cardiology. Her echo and EKG were both normal. We were told there is nothing wrong with her heart and that possible it was a crying spell or a breath holding spell, but she never turned blue. We also followed up with neurology who agreed that it was NOT a seizure.
Age: 64.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site cellulitis
Clinical narrative: Patient developed cellulitis at the site of injection following administration. Evaluated at the clinic and received antibiotics.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Anxiety, Blood pressure increased, Hot flush, Injection site erythema, Injection site pain
Clinical narrative: Patient reported he experienced hot flashes the evening he received his first dose of Shingrix.  He felt anxious about the sudden hot flashes that lasted about 24 hours; as a result, his blood pressure increased (he currently takes nifedipine and olmesartan for BP).  Patient also reported mild redness and muscle soreness at the site of administration.  When he came to report this to the pharmacy, 4 days have elapsed, and he is feeling much better.
Age: 8.0
Sex: M
Vaccine: MMR
Symptoms: Fall, Head injury, Nausea
Clinical narrative: AT APPROX 1500, HEARD MOTHER SCREAMING PT'S NAME IN HALLWAY, RN X2 IMMEDIATELY  ASSESSED. CHILD FOUND IN FLOOR OUTSIDE WIC LAB. UNWITNESSED FALL. CHILD AWAKE,  ALERT, AND ORIENTED. STATED HE HIT HIS HEAD. SMALL RED AREA NOTED TO L FOREHEAD.  CHILD ASSISTED TO WIC LAB CHAIR. VITALS TAKEN AND STABLE. FACE, HEAD, NECK, AND  SPINE PALPATED WITH NO C/O PAIN. CHILD C/O NAUSEA BUT NO EMESIS NOTED. CHILD  MONITORED FOR 5-10 MIN. MENTATION APPROPRIATE, NEURO INTACT. ADVISED MOTHER TO  TAKE CHILD TO ER TO RULE OUT ANY INJURY S/P FALL. CHILD AMBULATORY OUT TO  VEHICLE WITHOUT DIFFICULTY.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse events - this report is being submitted because the Pfizer-BioNTech vaccine (2024 - 2025 formula, NDC: 59267-4438-02) was inadvertently administered past the product's 10 week Beyond Use Date (BUD). The products BUD as marked on the box by facility was 12/24/2024.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse events - this report is being submitted because the Pfizer-BioNTech vaccine (2024 - 2025 formula, NDC: 59267-4438-02) was inadvertently administered past the product's 10 week Beyond Use Date (BUD). The products BUD as marked on the box by facility was 12/24/2024.
Age: 65.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Underdose
Clinical narrative: MMRV given instead of MMR to an adult. No adverse reactions noted.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Mobility decreased, Pain, Sleep disorder
Clinical narrative: Office Visit Note 3/18/25 - Pain began after vaccine administration.  Pain is throbbing and affects sleep.  She has been sleeping in recliner to try and reduce pain.  She has used heat and ice.  Patiently, she has significantly reduced range of motion of the left shoulder. She has continued to work, but does not have full use of left arm. Significantly reduced range of motion of the left shoulder.  Only able to actively abduct to approximately 30 degrees.  Passive range of motion is slightly better, although patient has significant pain with this.  Can use NSAIDs, but must stop 2 weeks prior to upcoming breast surgery. Can try Flexeril at night.  Also recommend that she begin physical therapy as soon as possible. Physical Therapy Note 03/24/2025 - ASSESSMENT Patient presents to physical therapy evaluation with primary c/o L shoulder pain. The results of the objective tests and measures show decreased L shoulder ROM, decreased L shoulder strength, positive rotator cuff testing. Functional deficits include but are not limited to Reaching overhead, reaching across body, lifting. Signs and symptoms are consistent with diagnosis of Acute pain of left shoulder (M25.512). Pt and PT discussed evaluation findings, pathology, POC and HEP.  Pt voiced understanding and performs HEP correctly without reported pain. Skilled Physical Therapy is medically necessary to address the above impairments and reach functional goals.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse events - This report is being submitted due to the Pfizer-BioNTech COVID-19 vaccine (2024 - 2025 formula, NDC 59267-4438-02) being inadvertently administered past its 10 week Beyond Use Date (BUD). It's BUD as marked by facility was 12/24/2024.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Patient reports 2 weeks hospitalization after receiving Pfizer COVID-19 vaccine. No other information provided.
Age: 9.0
Sex: F
Vaccine: FLU3, PNC13, PPV
Symptoms: Body temperature increased, Chills, Gait disturbance
Clinical narrative: STUDENT BROUGHT TO NURSE AT 2;28PM 03/24/25BY TEACHER STATING SHE COULD NOT WALK ON HER LEG AND CHILLING THROUGHOUT THE DAY AFTER ARRIVING TO SCHOOL FROM HE DOCOTOR'S APPOINTMENT.  INITIALLY TEMPERATURE WAS WNL AT 98.6 TAKEN BY INFRA-RED FOREHEAD THERMOMETER.  PARENT CALLED TO PICK UP STUDENT.  ICE PALCED ON INJECTION SITE OF 3 VACCINES  IN SAME AREA.  WHILE WAITING FOR PARENT TEMPERATURE SOARED TO 103.3.  MONM ARRIVED AND HAD CALLED HER PEDIATRICIAN WHO RECOMMENDED TO NEDICATE WITH 400 MG IBUPROFEN. STUDENT MEDICATED BY MOM AND THE TRANSPORTED HOME.
Age: 67.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Duplicate vaccine - Prevnar20 was previously administered  4/2024 - patient reports no adverse reactions.
Age: 72.0
Sex: M
Vaccine: COVID19, FLU3, PNC21
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient has had pain in left arm since day after receiving vaccine.  After 2 weeks went to a physician that recommended treatment with ibuprofen.   Patient is still having pain in arm after 42  days.  Reseen by physician who is referring him to orthopedic doctor.   Patient also having difficulty with range of motion of left shoulder.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness
Clinical narrative: Patient became dizzy and felt faint 3 minutes after her vaccine. She remained seated and was given an ice pack to put behind her neck. She then stated that her legs and arms felt stiff and numb. I asked if patient has eaten and she only had a protein bar all day. I gave her some water and candy to increase her blood sugar. Patient felt better after wards and sat there for another 20 min. Her father came to help her home once she felt better.
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient received an extra Arexvy dose outside of recommendation guidlines. Received first dose  on Jan 28, 2024 and received a second dose by error on May 24, 2024
Age: 1.42
Sex: F
Vaccine: IPV
Symptoms: Lethargy, Lip swelling, Mobility decreased, Nephrotic syndrome, Oedema peripheral
Clinical narrative: Patient had zero illnesses or known viruses prior to the flu shot.  About two weeks after the flu shot, she started showing signs of swelling in her eyelids, lids, and lips.  They progressed over the next few weeks and she became increasingly swollen to the point that she couldn't see well out of her eyes.  She could barely move, was lethargic, and had edema in her arms and legs at this point.  I called the clinic and Dr. insisted that we keep her home and put her in a steam shower.  By the end of December, it was so bad that I took her to the ER against Dr.'s advice and she was hospitalized for 10 days.  She was then diagnosed with nephrotic syndrome.  Her nephrologist said that pediatric nephrotic syndrome is caused by an overreaction to a virus.  Patient had no viruses prior to the flu shot.  She was healthy, breastfed, and was not at daycare or around other children.  It was during COVID and she was primarily at home without exposure to other viruses.  The flu shot seems to be the only thing she was exposed to.
Age: 1.42
Sex: F
Vaccine: IPV
Symptoms: Swelling of eyelid, Visual impairment
Clinical narrative: Patient had zero illnesses or known viruses prior to the flu shot.  About two weeks after the flu shot, she started showing signs of swelling in her eyelids, lids, and lips.  They progressed over the next few weeks and she became increasingly swollen to the point that she couldn't see well out of her eyes.  She could barely move, was lethargic, and had edema in her arms and legs at this point.  I called the clinic and Dr. insisted that we keep her home and put her in a steam shower.  By the end of December, it was so bad that I took her to the ER against Dr.'s advice and she was hospitalized for 10 days.  She was then diagnosed with nephrotic syndrome.  Her nephrologist said that pediatric nephrotic syndrome is caused by an overreaction to a virus.  Patient had no viruses prior to the flu shot.  She was healthy, breastfed, and was not at daycare or around other children.  It was during COVID and she was primarily at home without exposure to other viruses.  The flu shot seems to be the only thing she was exposed to.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Biopsy skin normal, Blepharospasm, Brain fog
Clinical narrative: Day after the vaccine noticed eye floaters in my left eye. Those became worse and showed up in my right a few weeks after the left eye. Couple days later I noticed knee pain and generalized weakness throughout entire body. Fatigue was present. Body aches and joint pain. Twitching in both arms, legs, and eyes. A tingling sensation from feet up to face that felt like my body was attached to an electric stim machine. Cold hands and feet, with discoloration in both hands. Altered gate where felt like my legs would randomly buckle. Burning in the hands and feet. White coat on tongue. Brain fog and light headedness. Insomnia and never felt like I got enough sleep even with 10 hours of sleeping.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Chest X-ray normal, Dizziness, Electric shock sensation, Electrocardiogram normal
Clinical narrative: Day after the vaccine noticed eye floaters in my left eye. Those became worse and showed up in my right a few weeks after the left eye. Couple days later I noticed knee pain and generalized weakness throughout entire body. Fatigue was present. Body aches and joint pain. Twitching in both arms, legs, and eyes. A tingling sensation from feet up to face that felt like my body was attached to an electric stim machine. Cold hands and feet, with discoloration in both hands. Altered gate where felt like my legs would randomly buckle. Burning in the hands and feet. White coat on tongue. Brain fog and light headedness. Insomnia and never felt like I got enough sleep even with 10 hours of sleeping.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Electromyogram normal, Fatigue, Gait disturbance, Insomnia, Magnetic resonance imaging head normal
Clinical narrative: Day after the vaccine noticed eye floaters in my left eye. Those became worse and showed up in my right a few weeks after the left eye. Couple days later I noticed knee pain and generalized weakness throughout entire body. Fatigue was present. Body aches and joint pain. Twitching in both arms, legs, and eyes. A tingling sensation from feet up to face that felt like my body was attached to an electric stim machine. Cold hands and feet, with discoloration in both hands. Altered gate where felt like my legs would randomly buckle. Burning in the hands and feet. White coat on tongue. Brain fog and light headedness. Insomnia and never felt like I got enough sleep even with 10 hours of sleeping.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging spinal normal, Muscle twitching, Muscular weakness, Nerve conduction studies normal, Pain
Clinical narrative: Day after the vaccine noticed eye floaters in my left eye. Those became worse and showed up in my right a few weeks after the left eye. Couple days later I noticed knee pain and generalized weakness throughout entire body. Fatigue was present. Body aches and joint pain. Twitching in both arms, legs, and eyes. A tingling sensation from feet up to face that felt like my body was attached to an electric stim machine. Cold hands and feet, with discoloration in both hands. Altered gate where felt like my legs would randomly buckle. Burning in the hands and feet. White coat on tongue. Brain fog and light headedness. Insomnia and never felt like I got enough sleep even with 10 hours of sleeping.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Peripheral coldness, Skin discolouration, Somnolence, Tongue coated
Clinical narrative: Day after the vaccine noticed eye floaters in my left eye. Those became worse and showed up in my right a few weeks after the left eye. Couple days later I noticed knee pain and generalized weakness throughout entire body. Fatigue was present. Body aches and joint pain. Twitching in both arms, legs, and eyes. A tingling sensation from feet up to face that felt like my body was attached to an electric stim machine. Cold hands and feet, with discoloration in both hands. Altered gate where felt like my legs would randomly buckle. Burning in the hands and feet. White coat on tongue. Brain fog and light headedness. Insomnia and never felt like I got enough sleep even with 10 hours of sleeping.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Vitreous floaters, X-ray limb normal, X-ray normal
Clinical narrative: Day after the vaccine noticed eye floaters in my left eye. Those became worse and showed up in my right a few weeks after the left eye. Couple days later I noticed knee pain and generalized weakness throughout entire body. Fatigue was present. Body aches and joint pain. Twitching in both arms, legs, and eyes. A tingling sensation from feet up to face that felt like my body was attached to an electric stim machine. Cold hands and feet, with discoloration in both hands. Altered gate where felt like my legs would randomly buckle. Burning in the hands and feet. White coat on tongue. Brain fog and light headedness. Insomnia and never felt like I got enough sleep even with 10 hours of sleeping.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: died weeks after her one dose and that dose is listed as her cause of death on her death certificate; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "died weeks after her one dose and that dose is listed as her cause of death on her death certificate". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Reported Cause(s) of Death: Unknown cause of death
Vaccine: PNC21, PNC21
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Caller confirmed no side effects/symptoms reported at this time; Caller is a nurse who reports they had a patient that received a dose of CAPVAXIVE on 2/13/2025 and an additional dose on 3/14/2025.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 13-FEB-2025 and on 14-MAR-2024, the patient was vaccinated with the first and second dose respectively of pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE), lot #Y011819, which has been verified to be valid lot number for pneumococcal 21-valent Conjugate Vaccine, expiration date reported and upon internal validation establish as 01-OCT-2025 (strength, exact quantity volume, route and anatomical site of administration were not reported), administered for prophylaxis (Inappropriate schedule of product administration). The reported confirmed no side effects or symptoms at this time (No adverse event).
Age: 1.0
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; MMR II was administered after a temperature excursion; This spontaneous report was received from a nurse and refers to a 13-month-old patient of unknown gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 27-Aug-2024 at 09:56 AM, the patient was vaccinated with an improperly storage dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), lot #X0114411, expiration date expiration date was not reported, however upon internal validation determined as 19-Apr-2024 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not provided).   Administered dose of vaccine was exposed to the temperature excursion of 12.3 degrees Celsius for 6 hours and 23 minutes (product storage error). No previous temperature excursion occurred. There were no additional adverse events reported (no adverse event).   This is one of several reports received from the same reporter.  Follow-up information has been received from the reporting Nurse on 21-MAR-2025. The Nurse stated the following: "The Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) was currently and had previously always been stored in a FREEZER (unknown temperature) throughout the out-of-range temperature times (previously reported) and not in a refrigerator." Additionally, the patient had no adverse effects. No more medical information has been reported.; Reporter's Comments:
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptomatic events reported; T/E for VARIVAX; This spontaneous report was received from a healthcare business professional and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 18-MAR-2025, the patient was administered Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), 0.5 ml, lot #Y011712, expiration date: 02-JUL-2026 (route of administration was not provided) for prophylaxis. The suspect vaccine was stored at 14.65 Fahrenheit (F) for 13 hours 15 minutes (product storage error). No adverse events were reported (no adverse event).
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC.; HCP called and reported inadvertent administration of GARDASIL 9 after a temperature excursion that occurred on 18MAR2025. GARDASIL 9 was administered on 19MAR2025 to a patient. Limited demographics provided. No additional AE/PQC. No additional infor; This spontaneous report was received from a nurse and refers to a 17-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 19-MAR-2025, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) suspension for injection, 0.5 mL per dose (valid lot number Y010656, expiration date 29-NOV-2026) (dose number, vaccination scheme, frequency, anatomical location, route of administration was not provided) for prophylaxis, after a temperature excursion of -0.6 degrees Celsius, with a time frame of 25 hours 0 minutes 0 seconds that occurred on 18-MAR-2025. No previous temperature excursion.  No additional adverse event (AE) reported.
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Vaccination failure, Varicella
Clinical narrative: Lack of efficacy 15-month old child developed a mild case of chicken pox; rash started around Friday 3/21.; Lack of efficacy; This spontaneous report was received from a consumer regarding a 15-month-old male patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with the first dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), administered as prophylaxis (strength, dose, route of administration, anatomical site of injection, lot number, and expiration date were not reported). The vaccine was reconstituted with sterile diluent (BAXTER STERILE DILUENT) (lot number and expiration date were not reported).  On 21-MAR-2025, the patient experienced lack of efficacy as he developed a mild case of chicken pox (Varicella, Vaccination failure). The patient was in a daycare setting and his brother was also vaccinated. The outcome of varicella was not reported.   The reporter considered the event of vaccination failure to be related to Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX). The causal relationship between the event varicella and Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) was not reported.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; still got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still got shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 23-MAR-2025 This case was reported by a patient via interactive digital media. The patient had the shot and still got shingles three times. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: "Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Dyspnoea, Injection site pain, Pyrexia, Rash, Rash pruritic
Clinical narrative: AT AROUND MIDNIGHT POST-VACCINATION PT DEVELOPED A FEVER, ITCHY RASHES IN THE ABDOMINAL AREA, UNDER THE ARMS AND BREAST. PT STATED SHE HAD SOB, "ROLLING IN MY CHEST." PT THEN DRANK WATER TOTALING 4 GLASSES THAT MORNING AND 2 TBSP OF SUGAR "FOLK MEDICINE." PT ALSO DRANK (3) 250MG OF NAPROXEN FOR PAIN RELIEF AT INJECTION SITE. AFTER SHE WAS ABLE TO SLEEP THAT NIGHT.  WHEN SHE WOKE UP SHE HAD NO PAIN, FEVER, SOB, BUT RASHES PERSISTED FOR THE NEXT 3 DAYS. PT TOOK MANY COLD SHOWERS TO RELIEVE THE PAIN. PT IS BETTER NOW.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Disturbance in social behaviour, Emotional distress, Fatigue, Injury, Laboratory test
Clinical narrative: Developed new OCD complex motor tics-compelled to push up off the ground and jump up in the air, kicking buttocks. Occurs multiple times an hour. Compelled to sniff objects and lick objects. Makes it difficult to engage in activities and creates social difficulties. Causes injury, exhaustion and distress. Symptoms are getting progressively worse and becoming disabling. Consulted with a tic doctor at Hospital.  Receiving therapy with therapist specializes in tic disorder: combination of CBIT and ERP. Starting medication.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Obsessive-compulsive disorder, Tic
Clinical narrative: Developed new OCD complex motor tics-compelled to push up off the ground and jump up in the air, kicking buttocks. Occurs multiple times an hour. Compelled to sniff objects and lick objects. Makes it difficult to engage in activities and creates social difficulties. Causes injury, exhaustion and distress. Symptoms are getting progressively worse and becoming disabling. Consulted with a tic doctor at Hospital.  Receiving therapy with therapist specializes in tic disorder: combination of CBIT and ERP. Starting medication.