chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: HEP, MMR, MNQ, TDAP, VARCEL
Symptoms: No adverse event
Clinical narrative: No Known Adverse Events
Age: 83.0
Sex: F
Vaccine: RSV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: pt received an inappropriate 2nd Arexvy vaccine 14 months after receiving the 1st - pt had no adverse reactions or other issues
Age: 13.0
Sex: F
Vaccine: PNC20
Symptoms: No adverse event
Clinical narrative: Patient received PCV 20 instead of the second dose of HPV she was scheduled to receive. There was no known adverse reaction but an vaccine administration error. This has been reported to the parent of the child and discussed in length with the Nurse and MA responsible for the error. The person reporting is the program Supervisor whom was not in the room when the error took place. Discussed with parent that the child will still require her second HPV to complete the series if they would like it.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pyrexia, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Pain and 5cm area of  redness and swelling to vaccination site on left upper arm, lasting about 5 days.  Low grade fever of 99.5 and feeling very tired on 2nd and 3rd day.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Patient became dizzy after receiving Fluad vaccine.
Age: 38.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: Vaccination error occurred when pediatric Hep A dose was given instead of the adult Hep B dose that was requested. Once identified, discussed with patient signs and symptoms to report. Offered to come back to clinic to give Hep B and patient declined at this time. She reported she will get vaccine next month if she is still at Works. Discussed error with administrator. No Adverse reaction occurred.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Product administered at inappropriate site
Clinical narrative: Patient called on 01/03/25 to inform us that she received this vaccination in the wrong area of her deltoid. Patient expressed her arm hurt even after it being 2 weeks and was seen by a provider for the issue.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: Death
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Injection site bruising, Injection site swelling
Clinical narrative: The patient reported swelling and bruising at the injection site.  She used over the counter pain medications and ice therapy.  She did not come back in for me to examine the site but states it was very swollen and black and blue
Age: 1.33
Sex: M
Vaccine: DTAP, FLU3, HEPA, MMR, VARCEL
Symptoms: Incorrect dose administered
Clinical narrative: The Hepatitis A vaccination given to 16 month old child was the adult dose. Called and informed health department and patients mother. 01/08/2025 at 10:45am
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Rash erythematous, Rash pruritic, Skin warm
Clinical narrative: A couple of days after I received the vaccine, I noticed a large bump (like a muscular knot) on my left arm, but it was three or four inches below the injection site.  Also, below and to the right of this bump/knot (i.e., even FURTHER away from the injections site), there was a red, rashy/itchy place on my arm that was the size of a baseball and almost perfectly round.  It was warm to the touch.  Concerned and not knowing what else to do, I did what I have often read that one should do with areas around the injection site of a normal flu shot -- I massaged the bump/knot and the red, rashy/itchy area that was the size of a baseball.  In a day or two, it was gone.  NOTE:  This was my EIGHTH COVID vaccine, and all I have been Moderna.  Although I have had some sort of fatigue with all of the COVID vaccines, this was the first time I experienced an outward manifestation of this type.
Age: 0.5
Sex: M
Vaccine: DTPPVHBHPB, FLU3, PNC20, RV5
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Pt was given dose number 2 of flucelevax too soon to first dose. No symptoms.
Age: 64.0
Sex: F
Vaccine: PNC20
Symptoms: Headache
Clinical narrative: headache which lasted for about 18 hours. no treatment needed.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV5
Symptoms: Immediate post-injection reaction, Skin lesion, Urticaria
Clinical narrative: Immediately broke out in urticaria after all injections administered. Urticaria developed on legs bilaterally first, and then developed two lesions on lower lip. Benadryl administered in office.  No respiratory complaints noted.  No vomiting noted.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Fall
Clinical narrative: Received a phone call from school nurse stating child's left arm looked slightly red on 01/07/2025. Nurse circled area and kept an eye on it until child came to school on 01/08/2025 with redness now outside of border drawn by nurse on the day before. Nurse called Pediatrician's office and had child come in to be evaluated by Pediatrician. Father states child was playing after receiving vaccines and fell on left arm. Child had no pain or complaints. Given Benadryl 25mg in office. Pediatrician advised father to give Benadryl for 3 days and to follow up in one week.
Age: 29.0
Sex: F
Vaccine: RSV, TDAP
Symptoms: Pyrexia, Tachycardia
Clinical narrative: Tachycardia x 36 hours; Fever 101.3
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient states that her arm has been hurt since the vaccine. Patient did show me location where shot was administered and it was in the appropriate location on the deltoid muscle on the left arm .
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient is 8 years old and was accidentally given the Moderna COVID vaccine meant for patients 12 and older. He experienced no adverse side effects.
Age: 21.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Dizziness, Gait disturbance
Clinical narrative: Patient felt dizzy 5min after injection and was staggering a little. She felt better after 20 minutes.
Age: 76.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Confusional state, Crying, Screaming
Clinical narrative: Patient was getting both Comirnaty as well as Fluzone HD. She was pleasant and alert throughout the vaccination process. After receiving the vaccination, while she was putting her coat, she started to cry and say, "It is so hard", "My mother came in with me", and then started screaming for her mother, stating "Mom, mom, where are you?" We were able to calm her down a little by telling her to sit and we would find her mother. She then stated that, "My mom is in heaven but sometimes she is here with me." She sat for about a minute but then insisted on going home. The pharmacist made sure she was comfortable with going on her own, asked if there was anyone we could call. She stated no and that she would be fine to go. She seemed to be back to her normal state of mind. She insisted on going home and the pharmacy clerk walked her to her car. At 2:00PM, the pharmacist called her to make sure she made it home safely. She was at home and stated that she is resting. She did indicate that she has been feeling sudden onset confusion lately.
Age: 68.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Nausea, Vomiting
Clinical narrative: Nausea, vomiting and large red area where I got injection
Age: 59.0
Sex: F
Vaccine: PNC21
Symptoms: Pruritus, Urticaria
Clinical narrative: Within 12-24 hour after inection, patient experienced widespred hives and intense itching.  Denies any fever/chills/swelling/difficulty breathing.  Took zyrtec, pepcid, and benadryl without any improvement in symptoms. On 1/8, was seen by provider for course of prednisone.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Hospitalization related to COVID 19 following completion of primary vaccine series
Age: 6.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: patient was given immunization that was not storred appropriately, no adverse reaction reported by patient
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Vomiting
Clinical narrative: Dizziness and had vomited once ,the symptoms started 4 days after getting the vaccination
Age: 40.0
Sex: F
Vaccine: VARCEL
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: After receiving Varivax, the patient complained of increased sweating and complaints of being dizzy.  Vital signs were obtained and were WNL.  Nurse encouraged the patient to go to the ER if s/s worsened.  A follow up was made to contact number listed and nurse.  Unable to reach the patient.  On 1/7/2025 the patient called the clinic and stated that the reason she was unable to be reached on 12/17/1014 evening is due to fact that she went to the ER related to worsening symptoms.  Was triaged at ER.  Vital signs WNL.   Patient left the ER without seeing a doctor/provider.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC20
Symptoms: Dysgeusia, Headache, Hypoaesthesia, Nasopharyngitis, Pain
Clinical narrative: pt says after getting the shots she started tasting the the medicine in the back of her throat and then her left index finger started itching. Her left heel started itching. These symptoms only lasted seconds. By the evening time her left arm was very swollen. Her left arm and fingers were numb and tingling. This lasted a couple of days and it would come and go.  A few days after that she had some swelling in the left  forearm, hand and fingers that caused some tingling and itching. On Dec. 30th she had some head congestion, head aches, blurred vision, sneezing, and body aches with no fever. The cold symptoms are better today but she is having more numbness and tingling in the left arm, palm of her hand and fingers. She has taken some photos of the swelling. She contacted her her PCP but is still waiting on a call back. She will also give her allergist a call to let him know if case she needs medical treatment.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC20
Symptoms: Paraesthesia, Peripheral swelling, Pruritus, Sinus congestion, Sneezing
Clinical narrative: pt says after getting the shots she started tasting the the medicine in the back of her throat and then her left index finger started itching. Her left heel started itching. These symptoms only lasted seconds. By the evening time her left arm was very swollen. Her left arm and fingers were numb and tingling. This lasted a couple of days and it would come and go.  A few days after that she had some swelling in the left  forearm, hand and fingers that caused some tingling and itching. On Dec. 30th she had some head congestion, head aches, blurred vision, sneezing, and body aches with no fever. The cold symptoms are better today but she is having more numbness and tingling in the left arm, palm of her hand and fingers. She has taken some photos of the swelling. She contacted her her PCP but is still waiting on a call back. She will also give her allergist a call to let him know if case she needs medical treatment.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC20
Symptoms: Vision blurred
Clinical narrative: pt says after getting the shots she started tasting the the medicine in the back of her throat and then her left index finger started itching. Her left heel started itching. These symptoms only lasted seconds. By the evening time her left arm was very swollen. Her left arm and fingers were numb and tingling. This lasted a couple of days and it would come and go.  A few days after that she had some swelling in the left  forearm, hand and fingers that caused some tingling and itching. On Dec. 30th she had some head congestion, head aches, blurred vision, sneezing, and body aches with no fever. The cold symptoms are better today but she is having more numbness and tingling in the left arm, palm of her hand and fingers. She has taken some photos of the swelling. She contacted her her PCP but is still waiting on a call back. She will also give her allergist a call to let him know if case she needs medical treatment.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Hospitalization related to COVID 19 following completion of primary vaccine series
Age: 1.33
Sex: M
Vaccine: MMR
Symptoms: Aphasia, Blood test normal, Crying, Decreased interest, Discomfort
Clinical narrative: On December 20th patient developed a 102 temperature and was fussy. On December 4th he started vomiting (7 times within 24 hours), then developed a 102 temperature next day. He was lethargic and had random outbursts of pain and discomfort. After 3 days of him being lethargic, not mobile, won't walk, won't talk,  has no interest in anything, and hasn't smiled, something was wrong. We took him to Urgent Care then they wanted me to take him to the ER By the time we took him there, his neck was stiff and he was curling his back and wouldn't rest.  I was worried about Meningitis but the stiff neck was really the only symptom. He was and still is irritable, won't move, and is in pain.  X-ray came back normal, no ammonia.  Sonogram came back normal Blood work came back ok.        What's interesting is that Monday night at bedtime when I was holding him upright, he suddenly thrusted his neck back and arched his back. I remember his eyes looking at me but he wasn't crying. He is a strong kid and sometimes will forcefully move when he wants out of my arms but this was different. I laid him back as I continued to feel force. I think at that time something internally was happening and the thrust gave him Torticollis. What I mentioned to the Urgent Care & Emergency Room visits is that he was given the MMR shot less than 3 weeks of all this happening. I'd like it noted and recorded in his records. that he had this adverse reaction to the vaccine.?  This was the first vaccine where he developed a high fever the next day and ever since that vaccine he has been fussier than he typically is.?  If he really had Neurovirus or a stomach flu - both highly contagious, no one else in the house got it.?  We think the vomiting, fever, neck thrusting, stiff neck, and arched back area an adverse reaction from the metals in the MMR vaccine. This was an is still very scary. We're just praying patient comes back to life and normal sometime soon.  He isn't showing interest in toys, lies/sleeps (lethargic) all day, randomly cries, isn't talking, isn't singing, no dancing or walking, and even baths are miserable.
Age: 1.33
Sex: M
Vaccine: MMR
Symptoms: Flat affect, Irritability, Lethargy, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: On December 20th patient developed a 102 temperature and was fussy. On December 4th he started vomiting (7 times within 24 hours), then developed a 102 temperature next day. He was lethargic and had random outbursts of pain and discomfort. After 3 days of him being lethargic, not mobile, won't walk, won't talk,  has no interest in anything, and hasn't smiled, something was wrong. We took him to Urgent Care then they wanted me to take him to the ER By the time we took him there, his neck was stiff and he was curling his back and wouldn't rest.  I was worried about Meningitis but the stiff neck was really the only symptom. He was and still is irritable, won't move, and is in pain.  X-ray came back normal, no ammonia.  Sonogram came back normal Blood work came back ok.        What's interesting is that Monday night at bedtime when I was holding him upright, he suddenly thrusted his neck back and arched his back. I remember his eyes looking at me but he wasn't crying. He is a strong kid and sometimes will forcefully move when he wants out of my arms but this was different. I laid him back as I continued to feel force. I think at that time something internally was happening and the thrust gave him Torticollis. What I mentioned to the Urgent Care & Emergency Room visits is that he was given the MMR shot less than 3 weeks of all this happening. I'd like it noted and recorded in his records. that he had this adverse reaction to the vaccine.?  This was the first vaccine where he developed a high fever the next day and ever since that vaccine he has been fussier than he typically is.?  If he really had Neurovirus or a stomach flu - both highly contagious, no one else in the house got it.?  We think the vomiting, fever, neck thrusting, stiff neck, and arched back area an adverse reaction from the metals in the MMR vaccine. This was an is still very scary. We're just praying patient comes back to life and normal sometime soon.  He isn't showing interest in toys, lies/sleeps (lethargic) all day, randomly cries, isn't talking, isn't singing, no dancing or walking, and even baths are miserable.
Age: 1.33
Sex: M
Vaccine: MMR
Symptoms: Opisthotonus, Pain, Pyrexia, Restlessness, Somnolence
Clinical narrative: On December 20th patient developed a 102 temperature and was fussy. On December 4th he started vomiting (7 times within 24 hours), then developed a 102 temperature next day. He was lethargic and had random outbursts of pain and discomfort. After 3 days of him being lethargic, not mobile, won't walk, won't talk,  has no interest in anything, and hasn't smiled, something was wrong. We took him to Urgent Care then they wanted me to take him to the ER By the time we took him there, his neck was stiff and he was curling his back and wouldn't rest.  I was worried about Meningitis but the stiff neck was really the only symptom. He was and still is irritable, won't move, and is in pain.  X-ray came back normal, no ammonia.  Sonogram came back normal Blood work came back ok.        What's interesting is that Monday night at bedtime when I was holding him upright, he suddenly thrusted his neck back and arched his back. I remember his eyes looking at me but he wasn't crying. He is a strong kid and sometimes will forcefully move when he wants out of my arms but this was different. I laid him back as I continued to feel force. I think at that time something internally was happening and the thrust gave him Torticollis. What I mentioned to the Urgent Care & Emergency Room visits is that he was given the MMR shot less than 3 weeks of all this happening. I'd like it noted and recorded in his records. that he had this adverse reaction to the vaccine.?  This was the first vaccine where he developed a high fever the next day and ever since that vaccine he has been fussier than he typically is.?  If he really had Neurovirus or a stomach flu - both highly contagious, no one else in the house got it.?  We think the vomiting, fever, neck thrusting, stiff neck, and arched back area an adverse reaction from the metals in the MMR vaccine. This was an is still very scary. We're just praying patient comes back to life and normal sometime soon.  He isn't showing interest in toys, lies/sleeps (lethargic) all day, randomly cries, isn't talking, isn't singing, no dancing or walking, and even baths are miserable.
Age: 1.33
Sex: M
Vaccine: MMR
Symptoms: Ultrasound scan normal, Vomiting, X-ray normal
Clinical narrative: On December 20th patient developed a 102 temperature and was fussy. On December 4th he started vomiting (7 times within 24 hours), then developed a 102 temperature next day. He was lethargic and had random outbursts of pain and discomfort. After 3 days of him being lethargic, not mobile, won't walk, won't talk,  has no interest in anything, and hasn't smiled, something was wrong. We took him to Urgent Care then they wanted me to take him to the ER By the time we took him there, his neck was stiff and he was curling his back and wouldn't rest.  I was worried about Meningitis but the stiff neck was really the only symptom. He was and still is irritable, won't move, and is in pain.  X-ray came back normal, no ammonia.  Sonogram came back normal Blood work came back ok.        What's interesting is that Monday night at bedtime when I was holding him upright, he suddenly thrusted his neck back and arched his back. I remember his eyes looking at me but he wasn't crying. He is a strong kid and sometimes will forcefully move when he wants out of my arms but this was different. I laid him back as I continued to feel force. I think at that time something internally was happening and the thrust gave him Torticollis. What I mentioned to the Urgent Care & Emergency Room visits is that he was given the MMR shot less than 3 weeks of all this happening. I'd like it noted and recorded in his records. that he had this adverse reaction to the vaccine.?  This was the first vaccine where he developed a high fever the next day and ever since that vaccine he has been fussier than he typically is.?  If he really had Neurovirus or a stomach flu - both highly contagious, no one else in the house got it.?  We think the vomiting, fever, neck thrusting, stiff neck, and arched back area an adverse reaction from the metals in the MMR vaccine. This was an is still very scary. We're just praying patient comes back to life and normal sometime soon.  He isn't showing interest in toys, lies/sleeps (lethargic) all day, randomly cries, isn't talking, isn't singing, no dancing or walking, and even baths are miserable.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Dementia with Lewy bodies, Loss of personal independence in daily activities, Neurological symptom
Clinical narrative: Within weeks, patient began having Guillain Barre Syndrome symptoms and then neurological symptoms. She was no longer able to do any physical work due to GBS symptoms and was diagnosed not long after with Lewy Body Dementia.
Age: 3.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Extra dose administered
Clinical narrative: Pediarix was given as dose 4 of polio vaccination. Pediarix is not authorized for dose 4 of polio vaccination.
Age: 18.0
Sex: M
Vaccine: COVID19, FLU3, HEPA, HPV9, MENB, MMR, MNQ, TDAP, VARCEL, MMR
Symptoms: Expired product administered
Clinical narrative: Patient received a dose of MMR on 01/08/2025 that had expired on 01/02/2025. I called Merck, and they stated that they have data supporting the potency of the vaccine.
Age: 18.0
Sex: M
Vaccine: COVID19, FLU3, HEPA, HPV9, MENB, MMR, MNQ, TDAP, VARCEL, MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received a dose of MMR on 01/08/2025 that had expired on 01/02/2025. I called Merck, and they stated that they have data supporting the potency of the vaccine.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Hospitalization related to COVID 19 following completion of primary vaccine series
Age: 10.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Chest discomfort, Pain in extremity, Pallor, Throat tightness
Clinical narrative: pale and stated chest felt heavy, thought throat felt tight with some left arm pain
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Feeling abnormal, Pain in extremity
Clinical narrative: felt "kind of funny," complained of lightheadedness, chest tightness/heaviness, and right arm pain.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Pain, Paraesthesia, Skin warm
Clinical narrative: After Vaccination Patient compliant of tingling  in left hand on the finger tips. And left minor elbow pain radiating down towards the hand. tingling subsided after 10 minutes. Patient also stated that left Palm of hand was warm.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Throat tightness
Clinical narrative: itchy, tightness in throat
Age: 9.0
Sex: F
Vaccine: HEPA, IPV, TDAP, VARCEL
Symptoms: Lethargy, Pallor, Palpitations
Clinical narrative: Child was very nervous prior to receiving vaccines. Tolerated vaccinations well. Nurse stepped away from the room; returned; child was standing holding chest stated, " Heart racing" Moved child to exam table; elevated her head and lower extremities. Child then appeared pale and lethargic; arousable. V/S B/P 69/40 pulse 64, 02 sat 100%. Child then appeared on the verge of unconsciousness with eyes closed; yet able to arouse.  V/S retaken 83/54 pulse 76 02 sat 100%. Within 3-4 minutes Child was alert; color good, V/S 112/66 02 sat 96% pulse 79. Stated she felt better. Nurse Practitioner assessed pt; and spoke with mother; mother stated, " She has done this before because she is very terrified of Shots" Explained to mother; this needs to be communicated with staff everywhere she goes; even for blood draws. Verbalized understanding.
Age: 70.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Arthralgia, Fatigue, Myalgia, Polymyalgia rheumatica
Clinical narrative: Pt first started experience side effects from the vaccines 4 days after the vaccines were administered.  Pt experienced exhaustion, muscle pain, joint pain, shoulder pain, and knee pain.
Age: 0.83
Sex: F
Vaccine: DTAPHEPBIP, FLU3
Symptoms: Product storage error
Clinical narrative: Vaccine deemed not stable due to temp excursion
Age: 2.0
Sex: M
Vaccine: PPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse reactions
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Fall, Pain in extremity, Photopsia, Screaming
Clinical narrative: Pt came to pharmacy to request a refill for her Amlodipine refilled and asked for a Flu shot.. Upon filling the questionnaire, pt answered all questions as (NO) which include "do you get dizzy or faint after a vaccine".. after vaccine was administered; pt was advised to wait for a bit just in case but she objected. and said "I have to leave to take care of my disabled husband".. as she was leaving the pharmacy, Pharmacy staff received a call from the front register indicating patient fell. Pharmacist, pharmacy tech and shift lead approached the patient trying to help her questioning patient; patient said "I was diabetic and my doctor just took me off Metformin.. I did not have anything to eat or drink this morning.. as was leaving the store I saw a flash of light in front of me and I fell". Patient asked team to just help her to get up as she wanted to go home, but as tech was helping her out, she was screaming of pain in her arm and could NOT bare the pain, so team had to call 911 and get her sent to hospital.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness unilateral, Electric shock sensation, Tinnitus
Clinical narrative: I and my friend both had shooting electric shock 1 sec pain that migrated around the body for about 4-6 weeks after the vaccine. They resolved in both of us. I have had this return briefly one for only a day about a year later but for the last 4 weeks has returned. Neurology has said no MS etc. never has before the vaccine. I also have had a return of tinnitus that became mostly in my left ear that resulted in hearing loss but also in the right ear. The right ear still has tinnitus. None was present before the vaccine. I begin to make multiple autoantibodies after the JnJ including new Anti-TSI, Anti scl-70, HSCrp is 6.11
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Blood glucose normal, Dizziness, Syncope
Clinical narrative: Syncope episode after injection , felt faint, was placed on exam table laying down with elevated legs, RN and staff monitored patient until she felt better- juice and water provided-pt had not had any food prior to injection. Patient was discharged in stable condition.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pt given high dose flu not within the age parameters of the high dose limits.  Pt gave wrong name and birthdate verified by both front desk and myself. I was using interpreter during the visit but when the patient could speak some of the language the interpreter stopped helping.
Age: 18.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Chills, Migraine, Vomiting
Clinical narrative: chills, migraine, vomiting
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: had covid in June of this year; had covid in June of this year; This is a spontaneous report received from a Consumer or other non HCP, Program ID: .  A 35-year-old male patient received BNT162b2 (BNT162B2), on 30Apr2021 as dose 1, single (Lot number: EW0170, Expiration Date: 22Nov2021), in right arm, on 21May2021 as dose 2, single (Lot number: EW0178, Expiration Date: 22Nov2021), in right arm and as dose 3 (booster), single (Lot number: FJ8757, Expiration Date: 22Nov2021), in right arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: had it when was unvaccinated. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2024, outcome "unknown" and all described as "had covid in June of this year".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400329270 same patient, different vaccine dose/event;US-PFIZER INC-202400329386 same patient, different vaccine dose/event;
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: just tested positive for Covid this morning / I've been with Pfizer since that /  I've taken all the shots; just tested positive for Covid this morning / I've been with Pfizer since that /  I've taken all the shots; This is a spontaneous report received from a Consumer or other non HCP, Program ID: .  A 70-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary immunization series complete), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "just tested positive for Covid this morning / I've been with Pfizer since that /  I've taken all the shots". Additional information: During this inbound call for financial assistance the caller (patient) stated "...I just tested positive for Covid this morning, and my doctor ordered the prescription for me. Now I do have a prescription card from my company, but the problem is the card I downloaded expired at the end of last year." Then at the end of the call the caller stated "...I just hope this gets this thing cleared up, It's not as bad as had it in 2020 but I've been with Pfizer since that, that's for sure, I've taken all the shots, although (inaudible) Covid shots..."  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: U
Vaccine: PNC20
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Itchy red rash; Itchy red rash; This is a spontaneous report received from a Pharmacist.  An adult patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in Oct2024 as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH ERYTHEMATOUS (non-serious), RASH PRURITIC (non-serious) all with onset Oct2024, outcome "unknown" and all described as "Itchy red rash". Therapeutic measures were taken as a result of rash erythematous, rash pruritic. Additional information: pharmacy said that one of their patients back in October (2024) had gotten a itchy red rash after getting a Prevnar 20 vaccine (adult patient). The patient was given Zyrtec and a topical Benadryl. This adverse reaction that had happened in October (2024).  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Age: 33.0
Sex: F
Vaccine: RSV
Symptoms: Injection site discomfort, Injection site erythema, Injection site swelling, Lymphadenopathy
Clinical narrative: swelling, redness and discomfort (like a huge hive) at the site of injection; swelling, redness and discomfort (like a huge hive) at the site of injection; swelling, redness and discomfort (like a huge hive) at the site of injection; swelling, redness and discomfort (like a huge hive) at the site of injection; swollen lymph nodes in armpit and side of breast on the side that injection was administered; This is a spontaneous report received from an Other HCP.  A 33-year-old female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 31Dec2024 as dose 1, single (Lot number: LN5463) at the age of 33 years for maternal immunisation. The patient's relevant medical history included: "adhesive tape allergy" (unspecified if ongoing); "shellfish allergy" (unspecified if ongoing). The patient is expected to deliver a baby(s) on 13Feb2025. The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE DISCOMFORT (non-serious), VACCINATION SITE URTICARIA (non-serious), outcome "recovering" and all described as "swelling, redness and discomfort (like a huge hive) at the site of injection"; LYMPHADENOPATHY (non-serious), outcome "recovering", described as "swollen lymph nodes in armpit and side of breast on the side that injection was administered". Therapeutic measures were not taken as a result of vaccination site swelling, vaccination site erythema, vaccination site discomfort, vaccination site urticaria, lymphadenopathy. Additional information: Patient was vaccinated on the left side. The patient did not receive any other vaccines on the same date as the ABRYSVO and any other vaccines within 4 weeks PRIOR to the ABRYSVO.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Caller had covid in 27Aug2024; Caller had covid in 27Aug2024; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 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. Vaccination history included: Bnt162b2 (Primary immunization completed), for Covid-19 immunization; Bnt162b2 (Dose number unknown, Booster), for Covid-19 immunization; Bnt162b2;bnt162b2 omi ba.4-5 (Dose number unknown, Booster), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Aug2024, outcome "unknown" and all described as "Caller had covid in 27Aug2024". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chest discomfort, Hypotension
Clinical narrative: had funny feeling on left chest in the afternoon; hypotension (80/60mmHg); This is a spontaneous report received from a Physician from a sales representative.  A 58-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 01Oct2024 as dose 1; single (Batch/Lot number: unknown) at the age of 58 years for covid-19 immunisation. The patient's relevant medical history included: "tiredness" (unspecified if ongoing), notes: 1-yr history; "weakness" (unspecified if ongoing), notes: 1-yr history; "numbness" (unspecified if ongoing), notes: 1-yr history; "covid-19", start date: Jun2024 (not ongoing), notes: approx 4 months prior to vaccination; "anxious personality" (unspecified if ongoing); "high mercury" (unspecified if ongoing), notes: received chelation therapy. The patient's concomitant medications were not reported. The following information was reported: CHEST DISCOMFORT (non-serious) with onset 01Oct2024, outcome "recovered", described as "had funny feeling on left chest in the afternoon"; HYPOTENSION (non-serious) with onset Oct2024, outcome "recovered", described as "hypotension (80/60mmHg)". The events "had funny feeling on left chest in the afternoon" and "hypotension (80/60mmhg)" required emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chest discomfort, hypotension. Additional information: Received Comirnaty vaccine in morning, had funny feeling on left chest in the afternoon, and went to ER the following day with hypotension (80/60mmHg).  Received aspirin, and had echo & cardiologist follow-up.  Also f/u 3 months later with neurologist for 1-year history of weakness, numbness, tiredness. He was treated with aspirin. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: recently contracted COVID; recently contracted COVID; 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. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 Immunization; Bnt162b2 (DOSE 2), for COVID-19 Immunization; Bnt162b2 (DOSE 3 (BOOSTER)), for COVID-19 Immunization; Bnt162b2 (DOSE 4 (BOOSTER)), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "recently contracted COVID".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Chills, Condition aggravated, Cough, Depressed mood, Fatigue
Clinical narrative: Pneumonia/cough/fatigue; Product origin unknown; fever; chills; body aches; depressed mood; red eyes; rashthat sprouted and spreaded on the thighs, knees, feet and elbows, arms and knuckles; This spontaneous report was received from 37-year-old female patient and refers to herself via Pharmacy. The patient's medical history was not reported. The patient's concurrent conditions included rash, and asthma. Concomitant therapies were not reported. The patient's past medical history/medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.  On an unknown date in 2024 (also reported as month ago), the patient was vaccinated with HPV vaccine (HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) or Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (manufacture not reported), administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided). On 01-JAN-2024, the patient started therapy with dupilumab (DUPIXENT) solution for injection, 300 milligram, qow, administered subcutaneously for asthma (strength, lot #, and expiry date were not provided). Both products were delivered via unknown device.  After administration of dupilumab (DUPIXENT), the patient developed fever (pyrexia), chills, body aches (pain). Patient reported that she had been depressed for personal reasons (depressed mood) and think thought of hospitalization in a psychiatric facility. Also reported a rash that sprouted and spreaded on the thighs, knees, feet and elbows, arms and knuckles, these symptoms had been present before dupilumab (DUPIXENT) but now they were more pronounced while being treated with dupilumab (DUPIXENT) and HPV vaccine. On unknown date in 2024, the patient experienced red eyes (Ocular hyperemia) (unknown latency). On 08-OCT-2024, the patient experienced pneumonia (latency: 9 month 7days) and was hospitalized due to event pneumonia from 08-OCT-2024 to 15-OCT-2024, she was still recovering and continued with cough and fatigue. It was unknown if the patient experienced any additional symptoms/events. It was not reported corrective treatment for all events.   At the time of reporting, the outcome of event ocular hyperemia was reported as recovered in 2024 and the outcome of rest of events was reported as recovering. The action taken with dupilumab (DUPIXENT) was reported as no action taken (dose not changed). The action taken with the HPV vaccine was not applicable. The causal relationship between all events and all suspect products were unknown.   Upon internal review, the event Pneumonia was determined to be medically significant.
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Ocular hyperaemia, Pain, Pneumonia, Pyrexia, Rash
Clinical narrative: Pneumonia/cough/fatigue; Product origin unknown; fever; chills; body aches; depressed mood; red eyes; rashthat sprouted and spreaded on the thighs, knees, feet and elbows, arms and knuckles; This spontaneous report was received from 37-year-old female patient and refers to herself via Pharmacy. The patient's medical history was not reported. The patient's concurrent conditions included rash, and asthma. Concomitant therapies were not reported. The patient's past medical history/medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.  On an unknown date in 2024 (also reported as month ago), the patient was vaccinated with HPV vaccine (HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) or Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (manufacture not reported), administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided). On 01-JAN-2024, the patient started therapy with dupilumab (DUPIXENT) solution for injection, 300 milligram, qow, administered subcutaneously for asthma (strength, lot #, and expiry date were not provided). Both products were delivered via unknown device.  After administration of dupilumab (DUPIXENT), the patient developed fever (pyrexia), chills, body aches (pain). Patient reported that she had been depressed for personal reasons (depressed mood) and think thought of hospitalization in a psychiatric facility. Also reported a rash that sprouted and spreaded on the thighs, knees, feet and elbows, arms and knuckles, these symptoms had been present before dupilumab (DUPIXENT) but now they were more pronounced while being treated with dupilumab (DUPIXENT) and HPV vaccine. On unknown date in 2024, the patient experienced red eyes (Ocular hyperemia) (unknown latency). On 08-OCT-2024, the patient experienced pneumonia (latency: 9 month 7days) and was hospitalized due to event pneumonia from 08-OCT-2024 to 15-OCT-2024, she was still recovering and continued with cough and fatigue. It was unknown if the patient experienced any additional symptoms/events. It was not reported corrective treatment for all events.   At the time of reporting, the outcome of event ocular hyperemia was reported as recovered in 2024 and the outcome of rest of events was reported as recovering. The action taken with dupilumab (DUPIXENT) was reported as no action taken (dose not changed). The action taken with the HPV vaccine was not applicable. The causal relationship between all events and all suspect products were unknown.   Upon internal review, the event Pneumonia was determined to be medically significant.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; caller verified the ROTATEQ was administered after the RMPDS case was submitted.; This spontaneous report was received from a nurse referring to a patient, age and gender was not provided.   Information regarding the patient's pertinent medical history, drug allergies or reactions, or concomitant medications was not provided.  On 02-JAN-2025, the patient was vaccinated with an improperly stored dose of rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) oral liquid, 2 ml, for prophylaxis, (route of administration, vaccination scheme frequency, anatomical location was not reported, valid lot number x028576 with an expiration date on 08-OCT-2025). The administered dose of the vaccine experienced a temperature excursion 34.7 degrees Fahrenheit for 24 hours, it was not reported if the information was recorded by a data logger or not. No previous temperature excursion. There was no adverse effect reported.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product preparation error
Clinical narrative: No additional AE reported; T/E for STERILE DILUENT. HCP stated wasn't sure if on 12/16/2024 there was a T/E. HCP stated there was no T/E; This spontaneous report was received from a nurse, concerning to a 1-year-old patient of unknown gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 16-DEC-2024, a temperature excursion could happened,  involving: sterile diluent (BAXTER STERILE DILUENT), measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and/or varicella virus vaccine live (oka/merck) (VARIVAX).      On the same day, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, administered for prophylaxis (strength, dose, and route of administration were not provided; lot #X024178 has been verified to be valid for this vaccine, expiration date reported and confirmed as 14-JUL-2025); varicella virus vaccine live (oka/merck) (VARIVAX) injection, administered for prophylaxis (strength, dose, and route of administration were not provided;  lot #Y006523 has been verified to be valid for this vaccine, expiration date reported and confirmed as 25-MAR-2026); with sterile diluent (BAXTER STERILE DILUENT) solution for injection/infusion (strength, dose, route of administration, and indication were not provided; Lot # 1940390 has been verified to be valid for this product, expiration date not reported but confirmed as 05-OCT-2025). (Product storage error). No additional adverse event (no adverse event).
Sex: U
Vaccine: HPV9
Symptoms: Dizziness
Clinical narrative: felt dizzy and lightheaded; This spontaneous report was received from a medical assistant regarding an adolescent patient of unspecified age and gender.   The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (exact dose, vaccination scheme frequency, lot number, expiration date, anatomical site of injection and route of administration were not provided). Following the vaccination, the patient felt dizzy and lightheaded in the exam room (Dizziness).   At the time of the report, the outcome of the event Dizziness was not reported.   The causal relationship between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the event of Dizziness was not provided.   This is one of 3 reports from the same reporter.; Sender's Comments:  US-009507513-2501USA001092:
Sex: U
Vaccine: HPV9
Symptoms: Dizziness
Clinical narrative: felt dizzy and lightheaded; This spontaneous report was received from a medical assistant regarding an adolescent patient of unspecified age and gender.   The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (exact dose, vaccination scheme frequency, lot number, expiration date, anatomical site of injection and route of administration were not provided). Following the vaccination, the patient felt dizzy and lightheaded in the exam room (Dizziness).   At the time of the report, the outcome of the event Dizziness was not reported.   The causal relationship between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the event of Dizziness was not provided.   This is one of 3 reports from the same reporter.; Sender's Comments:  US-009507513-2501USA001092