chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: M
Vaccine: FLUC4
Symptoms: Hypoaesthesia
Clinical narrative: Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Pt got covid and flu vaccine at 11am 12/29/24 then called the pharmacy at 6pm. Pt stated he was watching tv when he noticed numbness in his feet he waited an hour before calling the pharmacy to ask what he should do. I (the rph that day) told the pt if it continues or gets worse to call his doctor tomorrow., Other Vaccines:  VaccineTypeBrand: covid; Manufacturer: moderna; LotNumber: 3043836; Route: im; BodySite: left arm; Dose: 1; VaxDate: 12/29/2024
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Asthenia, Dizziness
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Weakness-Mild
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Confusional state, Fatigue, Flushing, Hyperhidrosis
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Confusion-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Systemic: Vomiting-Mild, Additional Details: Patient passed out immediately when covid vaccine was administered, assisted to lay down in bed, then immediately became awake and alert, patient a bit confused, unsure of what happened. Patient then had large amount of emesis, she was afebrile. Patient was stabilized after incident, awake, oriented, vital signs stable at 107/76, pulse oximetry 99% on room air. Mom present at time of incident., Other Vaccines:  VaccineTypeBrand: Flucelvax; Manufacturer: Seqirus; LotNumber: 388534; Route: im; BodySite: ld; Dose: unknown; VaxDate: 12/30/2024
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Injection site pain, Lethargy, Loss of consciousness, Tremor
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Confusion-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Systemic: Vomiting-Mild, Additional Details: Patient passed out immediately when covid vaccine was administered, assisted to lay down in bed, then immediately became awake and alert, patient a bit confused, unsure of what happened. Patient then had large amount of emesis, she was afebrile. Patient was stabilized after incident, awake, oriented, vital signs stable at 107/76, pulse oximetry 99% on room air. Mom present at time of incident., Other Vaccines:  VaccineTypeBrand: Flucelvax; Manufacturer: Seqirus; LotNumber: 388534; Route: im; BodySite: ld; Dose: unknown; VaxDate: 12/30/2024
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Confusion-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Systemic: Vomiting-Mild, Additional Details: Patient passed out immediately when covid vaccine was administered, assisted to lay down in bed, then immediately became awake and alert, patient a bit confused, unsure of what happened. Patient then had large amount of emesis, she was afebrile. Patient was stabilized after incident, awake, oriented, vital signs stable at 107/76, pulse oximetry 99% on room air. Mom present at time of incident., Other Vaccines:  VaccineTypeBrand: Flucelvax; Manufacturer: Seqirus; LotNumber: 388534; Route: im; BodySite: ld; Dose: unknown; VaxDate: 12/30/2024
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Abdominal pain upper, Asthenia, Fatigue, Headache, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Headache-Medium, Systemic: Weakness-Medium, Additional Details: PATIENT SAID HAVING HEADACHE, STOMACH ACHE, SORED, SWOLLEN ARM, WEAKNESS AND FELT TIRED
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Injection site swelling, Lethargy, Peripheral swelling
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Headache-Medium, Systemic: Weakness-Medium, Additional Details: PATIENT SAID HAVING HEADACHE, STOMACH ACHE, SORED, SWOLLEN ARM, WEAKNESS AND FELT TIRED
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Injection site pain, Pain in extremity
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: Patient reports left arm pain and left hand numbness after previous covid vaccine.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Systemic: Fever-Medium, Additional Details: Patient's wife reports after COVAX she and her husband became very sick, & experienced high fevers.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Infection, Injection site pruritus, Injection site swelling, Pruritus
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: infection  and itiching on whole arm after vaccine-Medium, Additional Details: patient was given  azithromycin 250mg, prednisone 20mg, ibuprofen 600mg and cetirizine 10mg on 12/31/24 by PCP, Other Vaccines:  VaccineTypeBrand: shingrix; Manufacturer: gsk; LotNumber: 445tk; Route: im; BodySite: left arm; Dose: ; VaxDate: UNKNOWN
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Systemic: Vomiting-Medium, Additional Details: Patient threw up the evening after the receiving the vaccine and the next day.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Severe, Additional Details: immediately after adminstering vaccine into patient's left arm, she felt intense pain and burning.  She stated that she could feel the vaccine go into her arm and that i pushed to hard
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Contusion, Dizziness, Fall, Seizure, Tongue biting
Clinical narrative: Systemic: Seizure-Medium, Additional Details: PATIENT REPORTS SEIZURE DURING SHOWER ON 12/25/24 (A COUPLE OF DAYS AFTER VACCINES) CAUSING HER TO FALL OUT OF THE SHOWER. BRUISED HEAD, ARM, AND LEGS, BIT TONGUE. WAS BROUGHT TO THE ER WHERE SEIZURE DIAGNOSED. STILL FEELING "WOOZY" AS OF TODAY, 01/01/25 , Other Vaccines:  VaccineTypeBrand: INACTIVATED FLU (FLUZONE HIGH-DOSE TRIVALENT 2024-25); Manufacturer: SANOFI-PASTEUR; LotNumber: U8515DA; Route: IM; BodySite: LEFT DELTOID (ARM); Dose: ; VaxDate: UNKNOWN
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Asthenia, Injection site pain, Speech disorder
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Difficlty with speach-Medium, Systemic: Joint Pain-Medium, Systemic: Weakness-Medium, Additional Details: previously reported but pt not contacted, Other Vaccines:  VaccineTypeBrand: fluzone trivalent pf syringe; Manufacturer: sanofi pasteur; LotNumber: ut8408la; Route: IM; BodySite: Left Deltoid; Dose: ; VaxDate: UNKNOWN
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Tinnitus
Clinical narrative: Systemic: Tinnitus-Severe, Additional Details: Previously reported, but pt was never contacted. patient would like to be contacted. patient reported long term tinnitus. please contact pt, Other Vaccines:  VaccineTypeBrand: shingrix; Manufacturer: GlaxoSmithKline; LotNumber: M4DY4; Route: IM; BodySite: Left Deltoid; Dose: ; VaxDate: UNKNOWN
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Patient experienced intense redness and swelling at the injection site that she and her doctor think in cellulitis and will require an antibiotic
Age: 59.0
Sex: M
Vaccine: MMR
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Mild
Age: 52.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Other Vaccines:  VaccineTypeBrand: boostrix; Manufacturer: ; LotNumber: 235132; Route: IM; BodySite: left deltoid; Dose: 1; VaxDate: 12/26/2024, VaccineTypeBrand: heplisav; Manufacturer: ; LotNumber: 945657; Route: IM; BodySite: left deltoid; Dose: 1; VaxDate: 12/26/2024
Age: 50.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Mild
Age: 64.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 64.0
Sex: M
Vaccine: RSV
Symptoms: Pain in extremity
Clinical narrative: Patient is having no signs/symptoms other than a sore arm.
Age: 47.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: injection site erythema and pain developing the same day as injection - treated with supportive care with compresses; fever reported by patient which self-resolved 2 days after vaccine
Age: 71.0
Sex: F
Vaccine: PNC20
Symptoms: Arthralgia, Injection site cellulitis, Injection site rash, Injection site warmth, Neck pain
Clinical narrative: Patient reported cellulitis at the injection site including a hot rash, soreness of neck shoulders and down her arm with a low grade 99 degree temperature. Symptoms started the next day from vaccination.  She was treated with prednisone and cephalexin.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives, itchy lower down on same arm as injection. No systemic symptoms. Used some lotion and feeling better but still has welts.
Age: 75.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received Arexvy vaccine on 1/3/25 from our pharmacy. Patient had already received this vaccine last year on 12/1/23. Currently, patient has experienced no adverse events from receiving the 2nd vaccine and requested that the patient follow up with us if he does.
Age: 9.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: Patient was given expired dose of vaccine Pneumovax 23 on 12/20/2024 vaccine expired 11/24/2024, the reason a hard stop did not happen is because employee put in wrong lot number of vaccine. I spoke with provider, Dr., she stated that titers would be done 2-3 months after vaccine was given and if no antibodies then patient would receive another dose of Pneumovax 23. Patients parent was called, and she understood, several follow up appointments have been made.
Age: 75.0
Sex: F
Vaccine: UNK
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received Arexvy on 12/27/23. Patient received another dose on 1/5/25. Patient reports no side effects.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Has rash on his trunk, neck and back. Rash started on 1/5.  Dr. diagnosed by photo of rash sent through app to the clinic.
Age: 66.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: This was the patient's second dose and it was given in error as that has not been approved yet. First dose was in September 2023
Age: 77.0
Sex: F
Vaccine: PNC21
Symptoms: Erythema, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: left arm turned dark pink over large area of arm, tender, swollen, warm to touch.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein, Chest pain, Echocardiogram normal, Electrocardiogram normal, Full blood count
Clinical narrative: Myocarditis. Patient is a 15 y.o. male who presented to Hospital on 1/5/2025 for chest pain with elevated troponins ongoing since COVID vaccine on 12/31/24. Patient was admitted to the PICU for continuous monitoring (telemetry and serial troponins) and further workup. Work up included ECHO and EKG which returned with no abnormal findings. Troponins decreased overnight and cardiology agreed with home management and outpatient follow up.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Intensive care, Liver function test, Metabolic function test, Myocarditis, Respiratory pathogen panel
Clinical narrative: Myocarditis. Patient is a 15 y.o. male who presented to Hospital on 1/5/2025 for chest pain with elevated troponins ongoing since COVID vaccine on 12/31/24. Patient was admitted to the PICU for continuous monitoring (telemetry and serial troponins) and further workup. Work up included ECHO and EKG which returned with no abnormal findings. Troponins decreased overnight and cardiology agreed with home management and outpatient follow up.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Troponin increased
Clinical narrative: Myocarditis. Patient is a 15 y.o. male who presented to Hospital on 1/5/2025 for chest pain with elevated troponins ongoing since COVID vaccine on 12/31/24. Patient was admitted to the PICU for continuous monitoring (telemetry and serial troponins) and further workup. Work up included ECHO and EKG which returned with no abnormal findings. Troponins decreased overnight and cardiology agreed with home management and outpatient follow up.
Age: 66.0
Sex: M
Vaccine: FLU3, RSV
Symptoms: Anxiety, Arthralgia, Heart rate increased, Pain in extremity
Clinical narrative: The first 3 nights, patient felt moderately anxious with heart rate a little higher than normal. On the second day, patient reported his joint pain increased by a fair amount. On Friday, 1/3/25 patient reports the joint pain has finally returned to a level prior to vaccines. Patient reports left arm soreness yet today (1/6/25).
Age: 16.0
Sex: F
Vaccine: UNK, UNK, UNK, UNK
Symptoms: Anxiety, Loss of consciousness
Clinical narrative: passed out, ice pack applied and effective. Mother explained after the fact that child has anxiety.
Age: 23.0
Sex: F
Vaccine: UNK, UNK, UNK
Symptoms: Exposure during pregnancy, Foetal death, Ultrasound antenatal screen abnormal
Clinical narrative: first trimester fetal demise. P1 G0 LMP 28 Sep. Vaccinated 16 Oct. BhCG positive 16 Oct (16.37), 29 Oct hCG 6637.5.  Symptoms: MAT CARE,PR FT GRW,1TRI,N/A/UN(O365910).
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Exercise tolerance decreased, Fatigue, Gait disturbance, Illness
Clinical narrative: Initially any health impairment (cold, less sleep, extra exertion...) resulted in extreme weakness, e.g. difficulty climbing stairs, tottering while walking, feeling of exhaustion. Over several months deconditioning increased, ability to exercise decreased, debility with any illness increased. Recently (2.75 years post vaccine) exercise attempts (pull ups/pushups) are sometimes painful w/sense of tearing fibers in muscles. Weakness is chronic.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Muscle disorder, Myalgia, Nasopharyngitis, Physical deconditioning
Clinical narrative: Initially any health impairment (cold, less sleep, extra exertion...) resulted in extreme weakness, e.g. difficulty climbing stairs, tottering while walking, feeling of exhaustion. Over several months deconditioning increased, ability to exercise decreased, debility with any illness increased. Recently (2.75 years post vaccine) exercise attempts (pull ups/pushups) are sometimes painful w/sense of tearing fibers in muscles. Weakness is chronic.
Age: 73.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient came in asking for RSV vaccine without realizing patient received same vaccine on 9/11/2023. Patient received 2 doses
Age: 33.0
Sex: M
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Peripheral swelling
Clinical narrative: Patient was given Tdap boostrix vaccine IM in left deltoid, arm immediately swelled up. Patient was seen by physician and was advised to take Benadryl PRN, Aleve, and to apply cold compress to arm.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fatigue, Headache, Immediate post-injection reaction, Injection site swelling
Clinical narrative: The injection site immediately swelled after the vaccine. For the next few days, I had a mild fever, mild respiratory symptoms, and body aches. Since then, that injection site has swelled numerous times . Generally, I notice fatigue, malaise, headaches, and moderate stomach upset each time my arm has been swollen. I have not been able to correlate if there is something that happens that makes it swell and makes me sick though.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain, Pyrexia, Respiratory symptom
Clinical narrative: The injection site immediately swelled after the vaccine. For the next few days, I had a mild fever, mild respiratory symptoms, and body aches. Since then, that injection site has swelled numerous times . Generally, I notice fatigue, malaise, headaches, and moderate stomach upset each time my arm has been swollen. I have not been able to correlate if there is something that happens that makes it swell and makes me sick though.
Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Mistaken administration, given too soon.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient injected with expired vaccine due to improper storage. Patient has not reported any adverse effects.
Age: 48.0
Sex: M
Vaccine: HEPA
Symptoms: Wrong product administered
Clinical narrative: Pt requested third dose of HEP B and received HEP A vaccine instead,
Age: 33.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Diarrhoea, Exposure during pregnancy, Fatigue, Myalgia
Clinical narrative: I received the RSV vaccine at my OB appointment while I was 35 weeks and 5 days pregnant. The following day, approx 30 hours after, I experienced diarrhea, body and joint aches. These symptoms lasted all of Friday night and Saturday all day/night. Sunday and today (Monday) is just fatigue and muscle aches. Baby is moving fine and I?m trying to rehydrate from the weekend but I definitely believe I experienced the hypersensitive immune response.
Age: 33.0
Sex: F
Vaccine: RSV
Symptoms: Pain
Clinical narrative: I received the RSV vaccine at my OB appointment while I was 35 weeks and 5 days pregnant. The following day, approx 30 hours after, I experienced diarrhea, body and joint aches. These symptoms lasted all of Friday night and Saturday all day/night. Sunday and today (Monday) is just fatigue and muscle aches. Baby is moving fine and I?m trying to rehydrate from the weekend but I definitely believe I experienced the hypersensitive immune response.
Age: 71.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient given same vaccine twice - on 9/18/23 and 01/04/25
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: No adverse event noted at time of administration.
Age: 60.0
Sex: M
Vaccine: TYP
Symptoms: Lymph node pain, Lymphadenopathy, Rash, Sleep disorder
Clinical narrative: 8 days after my 4th dose, I broke out in what first presented as a rash in both underarms, my chest and pubic mound. Less than a day later the rash turned in to severe swollen lymph nodes. They were so painful that after a week I sought medical advice because I was not sleeping soundly anymore due to the pain, and the Doctor basically told me I had to deal with it by taking antihistamines and NSAIDS.  The treatment did little and now its 17 days later and the lymph nodes are still extremely swollen and painful.  I just want to note that my girlfriend, who is going to be travelling with me had the same symptoms, though less severe than mine, a mere 2 days after finishing her last dose. She may report this separately though it sounds like she doesn't want to, but I feel its important that you know this.
Age: 0.25
Sex: M
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: PT developed a few hives on legs and some on face; This spontaneous report was received from nurse and refers to a 3-month-old male. The patient's medical history was not reported. The patient's concurrent conditions included milk allergy, and hydrocele. Concomitant therapies were not reported. His brother medical history included anaphylactic reactions post vaccines when he was younger  On 27-NOV-2024, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, administered for prophylaxis (dose, strength, lot #, expiry date, and route of administration were not provided).  On an unknown date in 2024, the patient experienced experienced a few hives on legs and some on face (mild). On an unknown date in 2024, the patient was treated with 3 ml of children's bonodryl once and within 20 minutes hives almost resolved. The patient was assessed another 30 minutes later and all resolved and the patient was going well On an unknown date in 2024, the patient recovered from the event. The mother of the patient was informed that the reaction could have been due to the alcohol wipes, the gloves, or event the bandaid. The patient's mother was given samples of all 3. When rash had completely resolved the mother can retry them individually to see if he reads to any of them. If so then less likely due to the vaccine/ If not will plan on referring to allergist for evaluation or guidance on future vaccines. The patient's mother was informed that the patient can continue to do vaccines one at a time if desired. The patient's mother was given the script for prednisolone in case needed over the holiday weekend. The action taken with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) regarding the event was not applicable.   The causal relationship between the event and hepatitis b vaccine (recombinant) (RECOMBIVAX HB) was not reported.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Inflammation, Mobility decreased, Pain in extremity, X-ray normal
Clinical narrative: I received the tetanus TDAP vaccine on 12/20/2024 for a routine physical prior to start of college (spring semester)- I anticipated arm soreness but after a  couple of days pain continued to intensify and localize in my left shoulder joint.  A week later I woke up and my arm was so painful I could not move it. I returned to the same office and was seen by a different doctor, and requested steroids to help with the inflammation. I completed a 5 day taper of prednisone, which helped temporarily during the day but pain would resume at night. It has now been 18 days and I am still having unresolved joint pain which has not subsided. I have used Tylenol, pain meds at night, heat, massage, and rest with no success.
Age: 62.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Dizziness, Fall, Skin warm
Clinical narrative: Patient got warm after the vaccination and stepped outside immunization room and fell on the floor because of light headness.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Syringe issue, Underdose
Clinical narrative: Unknown amount of vaccine dose leaked from the needle hub during administration, rendering an incomplete dose administered
Age: 0.25
Sex: F
Vaccine: HIBV, PNC20
Symptoms: Crying, Cyanosis, Erythema, Hypertonia, Infant irritability
Clinical narrative: Patient is a 3 m.o. female born at term via NSVD, twin gestation, to a GBS negative mother who had no pregnancy or delivery complication presenting for admission after a episode of cyanosis and hypertonia at home. She was at her baseline health without concerns for illness.  Earlier in the day she went to get her vaccinations with her twin sister. S/p vaccination, patient had was increasingly fussy. Mom fed her and her sister with minimal amount of spit up. Mom set patient down to change her diaper which baseline cries and gets upset with. She started crying and turned red, she then turned blue and started getting stiff and breathing only out. Spit then started coming out of her mouth as she was breathing outwards with her eyes open. Mom called EMS and took patient outside hoping cold air would make her gasp and take a breath in. Mom states this kept going on for 3 minute and when EMS arrived O2 was 88%. Episode did not resolve until she was given O2 by EMS.
Age: 0.25
Sex: F
Vaccine: HIBV, PNC20
Symptoms: Infantile spitting up, Musculoskeletal stiffness, Respiration abnormal
Clinical narrative: Patient is a 3 m.o. female born at term via NSVD, twin gestation, to a GBS negative mother who had no pregnancy or delivery complication presenting for admission after a episode of cyanosis and hypertonia at home. She was at her baseline health without concerns for illness.  Earlier in the day she went to get her vaccinations with her twin sister. S/p vaccination, patient had was increasingly fussy. Mom fed her and her sister with minimal amount of spit up. Mom set patient down to change her diaper which baseline cries and gets upset with. She started crying and turned red, she then turned blue and started getting stiff and breathing only out. Spit then started coming out of her mouth as she was breathing outwards with her eyes open. Mom called EMS and took patient outside hoping cold air would make her gasp and take a breath in. Mom states this kept going on for 3 minute and when EMS arrived O2 was 88%. Episode did not resolve until she was given O2 by EMS.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Underdose, Wrong product administered
Clinical narrative: Nurse gave wrong vaccine dose, Flu vaccine regular dose administered to this 74 year old female rather than the high-dose which is indicated for patients 65 years and older.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Laboratory test, Muscular weakness
Clinical narrative: We have been working up patient over the last couple years for progressive LE weakness and generalized fatigue. Patient has had extensive work-up without definitive diagnosis. Upon continued evaluation concern was this possible could be related to adverse reaction to a COVID vaccination.
Age: 35.0
Sex: F
Vaccine: UNK
Symptoms: Urticaria
Clinical narrative: HIVES
Age: 53.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Skin warm
Clinical narrative: Redness noticed to right arm 1-5-25 Expanding redness-2-3 inches. 1/6/25, redness and warmth expanding to 3"x4". Assisted with appointment for evaluation
Age: 55.0
Sex: M
Vaccine: HEP
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Diffuse pruritic erythematous rash over arms, chest, abdomen, back and some involvement of lower extremities presented on 12/25/2024. Patient denies anything else new that may have contributed to onset of rash. Worse under arms but no reaction at injection site.  Seen for symptoms on 1/3/2025 and treated with Prednisone, Zyrtec, Benadryl and topical triamcinolone cream.
Age: 54.0
Sex: M
Vaccine: MMR
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: 54 y/o male presented to PCP requesting MMR vaccine for entry into school. Vaccine was administered despite the contraindication for live vaccines while the patient is taking teriflunomide to treat his chronic MS.  Patient was contacted and monitored via phone calls. No symptoms or adverse effect was noted.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arachnoiditis, Blood test, Diplegia, Embolism, Fall
Clinical narrative: Tripping, falling, legs paralyzed.  Two embolisms, spinal surgery (fissures) in 2022.  Spinal cord stimulator implanted in 2024.  Use walker to ambulate.  Symptoms/treatments occurred/occurring over the last three plus years.  No further treatment known; will continue to deteriorate with arachnoiditis now.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Gait disturbance, General physical health deterioration, Intervertebral disc annular tear, Magnetic resonance imaging, Spinal nerve stimulator implantation
Clinical narrative: Tripping, falling, legs paralyzed.  Two embolisms, spinal surgery (fissures) in 2022.  Spinal cord stimulator implanted in 2024.  Use walker to ambulate.  Symptoms/treatments occurred/occurring over the last three plus years.  No further treatment known; will continue to deteriorate with arachnoiditis now.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Spinal operation, Walking aid user, X-ray
Clinical narrative: Tripping, falling, legs paralyzed.  Two embolisms, spinal surgery (fissures) in 2022.  Spinal cord stimulator implanted in 2024.  Use walker to ambulate.  Symptoms/treatments occurred/occurring over the last three plus years.  No further treatment known; will continue to deteriorate with arachnoiditis now.
Age: 22.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue
Clinical narrative: Pregnant patient (36 weeks) received Arexvy, should?ve gotten Abrysvo.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 11 y/o male brought to Clinic for well child visit was administered the COVID vaccine (Spikevax) which is indicated for patients 12 years of age and older.
Age: 3.0
Sex: F
Vaccine: HEPA, IPV, PNC20, VARCEL
Symptoms: Pyrexia, Rash macular, Urticaria
Clinical narrative: Hives or red splotchy areas on face,  shoulder and back. Less so on legs, lasted  6 days. Had little fever on day one, no vomiting or other complaints. Gave Benadryl on the next day, did not see another provider as advised.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Blood thyroid stimulating hormone decreased, C-reactive protein, Cardioversion, Full blood count normal
Clinical narrative: On 12/21/24 I experienced an episode of Rapid A-fib (rate 150-240 BPM) with RVR which required Emergency care. Adenosine was given x 2. Cardioversion with 200 joules was done and converted me back to a normal sinus rhythm. I have not previously experienced any arrhythmias. Needed to be started on Eliquis 5 mg PO BID
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Thyroxine normal, Tri-iodothyronine normal
Clinical narrative: On 12/21/24 I experienced an episode of Rapid A-fib (rate 150-240 BPM) with RVR which required Emergency care. Adenosine was given x 2. Cardioversion with 200 joules was done and converted me back to a normal sinus rhythm. I have not previously experienced any arrhythmias. Needed to be started on Eliquis 5 mg PO BID
Age: 18.0
Sex: F
Vaccine: DTAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient received infanrix when boostrix indicated. No adverse reaction had by patient
Age: 38.0
Sex: U
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue
Clinical narrative: Ob patient got Arexvy instead of Abrysvo
Age: 42.0
Sex: M
Vaccine: RSV
Symptoms: Off label use
Clinical narrative: RSV was administered per primary care provider's instruction due to Pt's active diagnoses'. Pt tolerated administration well and left clinic without incident.
Age: 12.0
Sex: M
Vaccine: FLU3, HPV9
Symptoms: Confusional state, Immediate post-injection reaction, Loss of consciousness, Pallor, Posture abnormal
Clinical narrative: Child was given second vaccine. He immediately started turning pale, passed out, then slumped down in the chair. Patient was unresponsive for about 4 seconds then opened his eyes confused about what had occurred. Vitals signs as following: FSBS-113, Pulse 94, O2 saturation-99% on room air, and bp-108/64 in his right arm. Patient was given 4 ounces of apple juice and 4 ounces of water. After sitting in clinic for 20 minutes, patient ambulated out of facility accompanied by his mother and sister.
Age: 12.0
Sex: M
Vaccine: FLU3, HPV9
Symptoms: Unresponsive to stimuli
Clinical narrative: Child was given second vaccine. He immediately started turning pale, passed out, then slumped down in the chair. Patient was unresponsive for about 4 seconds then opened his eyes confused about what had occurred. Vitals signs as following: FSBS-113, Pulse 94, O2 saturation-99% on room air, and bp-108/64 in his right arm. Patient was given 4 ounces of apple juice and 4 ounces of water. After sitting in clinic for 20 minutes, patient ambulated out of facility accompanied by his mother and sister.
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional adverse event; Voicemail received in voice mailbox on 30DEC2024 at 4:35 PM ET with the following: "My name is (redacted), I'm a physician assistant with One Medical. My call back number is XXX-XXX-XXX. The best time to call me back is Tuesday, December 31st at 1; Inappropriate age at vaccine administration; This spontaneous report was received from other health professional and refers to an 11-day-old male.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 24-DEC-2024, the patient was vaccinated with rxpired dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, unk, expiration date: 13-DEC-2024, administered for prophylaxis (strength, lot #, and route of administration were not provided) (Expired product administered and product administered to patient of inappropriate age). No additional adverse event was reported.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This season?s COVID vaccine was ineffective. I showed symptoms of COVID-19 on Dec 26, less than 3 months after vaccination. Discontinue vaccine administration, or update your vaccines appropriately.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given Comirnaty 30 mcg but does not meet age requirement for dosage.
Age: 11.0
Sex: F
Vaccine: COVID19, FLU3, HPV9, MNQ, TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Given Covid-19 dose for ages 12 and up
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient received 2 doses of arexvy vaccine. she has not reported any adverse effects.
Age: 11.0
Sex: M
Vaccine: MMR
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was given MMR in his left deltoid intramuscular mistakenly instead of the MCV4 that was needed. Patient tolerated it well on 1/3/2025 about 11:00 a.m. No adverse reaction to this vaccine given.
Age: 0.08
Sex: F
Vaccine: DTAPIPVHIB, PNC15, RV5, DTAPIPVHIB, PNC15, RV5, DTAPIPVHIB
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient received vaccines too early. No adverse effects noted.
Age: 0.08
Sex: F
Vaccine: DTAPIPVHIB, PNC15, RV5, DTAPIPVHIB, PNC15, RV5, DTAPIPVHIB
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong patient
Clinical narrative: Patient received vaccines too early. No adverse effects noted.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Extra dose administered
Clinical narrative: Set of twins were given DTAP, PIV and MMRV on 12/24/2024 by LPN. As per nurse, parent denied children getting vaccines elsewhere. State System was not verified before administration. Staff received a call from NP from Pts' school to advise me that these vaccines were already administered by her on 12/04/2024, as per State System. Provider  Dr. advised. Provider stated no harm done and vaccines will be invalid. Nurse unable to contact parent at this current time.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional Ae reported; HCP called to report T/E. T/E occurred on 12/21/2024.; This spontaneous report has been received from a physician regarding a 12-month-old female patient. The patient's medical history, concurrent conditions, concomitant therapies, and previous drug reactions or allergies were not reported.  On 23-DEC-2024, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, administered as a first dose for prophylaxis (lot number reported as X026319, which has been verified as valid, expiration date reported and validated as 07-NOV-2025) (strength, dose, route of administration, and anatomical site of injection were not provided).  The administered dose was exposed to a temperature excursion of 20.0 Fahrenheit degree (F) for 3 hours and 42 minutes (Product storage error). There was no previous temperature excursion. No additional adverse events were reported in the patient.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse event; Caller reported VARIVAX administered after temperature excursions.; This spontaneous report was received from a technician referring to a patient, age and gender was not reported.   Information regarding the patient's pertinent medical history, drug allergies/reactions, or concomitant medications was not provided.  On 19-DEC-2024, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, for prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location were not reported, valid lot number Y011015 and expiration date on 18-JUN-2026). The administered dose of the vaccine experienced a temperature excursion 01 degrees Celsius for 14 hours and 22minutes, it was not reported if the information was recorded by a data logger or not. There was no adverse effect reported.
Sex: U
Vaccine: PNC15
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; The healthcare worker is reporting that a patient received improperly stored vaccine.  No additional AEs were reported, no further information provided.  Names of vaccines involved (including lot/exp) VAXNEUVANCE (y002643   10/4/2026) Temperature:  4; This spontaneous report was received from a healthcare worker referring to a patient with unknown age and gender. The patient's pertinent medical history and drug reactions/ allergies and concomitant medication were not reported.   On 31-DEC-2024, the patient received 1 dose of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, 1 dose, lot #y002643, expiration date: 04-OCT-2026, administered for prophylaxis (strength, and route of administration were not provided) after experiencing a temperature excursion (Temperature: 46.6F; Time frame: 1 hour 55 minutes) (product storage error). No additional adverse event (AE) information was reported (no adverse event). No additional information/clarification. No previous temperature excursion.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; Caller reported VARIVAX administered after temperature excursions.; This spontaneous report was received from a pharmacy technician and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 29-DEC-2024, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #Y011015, expiration date: 18-JUN-2026, administered for prophylaxis (exact dose, dose number, route of administration and anatomical location were not provided). The aforementioned dose of varicella virus vaccine live (oka/merck) (VARIVAX) underwent a temperature excursion of 1 degree Celsius for 14 hours and 22 minutes (Product storage error). There was no previous temperature excursion. No additional adverse events were reported.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Insomnia, Pain, Pyrexia
Clinical narrative: All over body pain; Fever; Chills; not sleeping; This non-serious case was reported by a consumer and described the occurrence of general body pain in a 57-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Varicella zoster vaccine with an associated reaction of adverse drug reaction (1st dose of Shingles vaccine received on an unknown date). Concomitant products included evolocumab (Repatha).   On 06-DEC-2024, the patient received the 2nd dose of Shingles vaccine. On 06-DEC-2024, less than a day after receiving Shingles vaccine, the patient experienced general body pain (Verbatim: All over body pain), fever (Verbatim: Fever), chills (Verbatim: Chills) and insomnia (Verbatim: not sleeping). The outcome of the general body pain, fever, chills and insomnia were not resolved.   It was unknown if the reporter considered the general body pain, fever, chills and insomnia to be related to Shingles vaccine.     It was unknown if the company considered the general body pain, fever, chills and insomnia to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 07-DEC-2024 The patient self-reported this case for himself. Patient reported that he took second shot, and the side effects were as bad as the first shot. Days of feeling flu like symptoms was reported as all over body pain, fever, chills and not sleeping. The symptoms were treated.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Provider mistakenly gave Pediarix to newborn infant instead of HepB; This non-serious case was reported by a nurse via sales rep and described the occurrence of wrong vaccine administered in a infant patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Pediarix. On an unknown date, an unknown time after receiving Pediarix, the patient experienced wrong vaccine administered (Verbatim: Provider mistakenly gave Pediarix to newborn infant instead of HepB). The outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 07-DEC-2024 The nurse reported that a provider mistakenly gave Pediarix to newborn infant instead of HepB, which led to wrong vaccine administered. Provider stated this happened recently but did not gave exact date also stated that baby did not have any adverse reactions following error.
Sex: F
Vaccine: RSV
Symptoms: Injection site pain, Oral pain
Clinical narrative: Injection site pain; Sore muscles; This non-serious case was reported by a consumer via patient support programs and described the occurrence of injection site pain in a 69-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On 15-NOV-2024, an unknown time after receiving Arexvy, the patient experienced injection site pain (Verbatim: Injection site pain) and muscle soreness (Verbatim: Sore muscles). The outcome of the injection site pain and muscle soreness were unknown.   It was unknown if the reporter considered the injection site pain and muscle soreness to be related to Arexvy.     It was unknown if the company considered the injection site pain and muscle soreness to be related to Arexvy.   Additional Information: GSK Receipt Date: 11-DEC-2024 The reporter reported that the patient had received a  dose of Arexvy vaccine and had experienced injection site pain and muscle soreness.
Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: Amnesia, Confusional state, Deafness, Dizziness, Malaise
Clinical narrative: some weird unexplainable rashes; hearing loss; Extreme dizziness, after 7 months after vaccination symptoms got worse; had confusion; memory loss; blurry vision; floaters; horrible body aches; malaise feeling all the time; This serious case was reported by a consumer and described the occurrence of hearing loss in a 41-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 58160-0842-52) for prophylaxis.   On 03-JUL-2023, the patient received Boostrix .5 ml. On 01-SEP-2023, 60 days after receiving Boostrix, the patient experienced hearing loss (Verbatim: hearing loss) (serious criteria GSK medically significant), dizziness (Verbatim: Extreme dizziness, after 7 months after vaccination symptoms got worse), confusion (Verbatim: had confusion), memory loss (Verbatim: memory loss), blurred vision (Verbatim: blurry vision), floaters (Verbatim: floaters), general body pain (Verbatim: horrible body aches) and malaise (Verbatim: malaise feeling all the time). On an unknown date, the patient experienced rash (Verbatim: some weird unexplainable rashes). The outcome of the hearing loss, dizziness, confusion, memory loss, blurred vision, floaters, general body pain and malaise were not resolved and the outcome of the rash was not reported.   It was unknown if the reporter considered the hearing loss, dizziness, confusion, memory loss, blurred vision, floaters, general body pain, malaise and rash to be related to Boostrix and Boostrix Pre-Filled Syringe Device.     The company considered the hearing loss to be unrelated to Boostrix and Boostrix Pre-Filled Syringe Device. It was unknown if the company considered the dizziness, confusion, memory loss, blurred vision, floaters, general body pain, malaise and rash to be related to Boostrix and Boostrix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-DEC-2024 The patient reported that all started with a little dizziness progressed to extreme dizziness after 4 to 5 months after seven months he had extreme, horrible malaise, feeling bodyaches, confusion, memory loss, blurred vision, and hearing loss and some weird unexplainable rashes. Reporter did not provided consent to contact.; Sender's Comments: Deafness is an unlisted event which is considered unrelated to GSK vaccine Boostrix and Boostrix PRE-FILLED SYRINGE DEVICE.
Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: Pain, Rash, Vision blurred, Vitreous floaters
Clinical narrative: some weird unexplainable rashes; hearing loss; Extreme dizziness, after 7 months after vaccination symptoms got worse; had confusion; memory loss; blurry vision; floaters; horrible body aches; malaise feeling all the time; This serious case was reported by a consumer and described the occurrence of hearing loss in a 41-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 58160-0842-52) for prophylaxis.   On 03-JUL-2023, the patient received Boostrix .5 ml. On 01-SEP-2023, 60 days after receiving Boostrix, the patient experienced hearing loss (Verbatim: hearing loss) (serious criteria GSK medically significant), dizziness (Verbatim: Extreme dizziness, after 7 months after vaccination symptoms got worse), confusion (Verbatim: had confusion), memory loss (Verbatim: memory loss), blurred vision (Verbatim: blurry vision), floaters (Verbatim: floaters), general body pain (Verbatim: horrible body aches) and malaise (Verbatim: malaise feeling all the time). On an unknown date, the patient experienced rash (Verbatim: some weird unexplainable rashes). The outcome of the hearing loss, dizziness, confusion, memory loss, blurred vision, floaters, general body pain and malaise were not resolved and the outcome of the rash was not reported.   It was unknown if the reporter considered the hearing loss, dizziness, confusion, memory loss, blurred vision, floaters, general body pain, malaise and rash to be related to Boostrix and Boostrix Pre-Filled Syringe Device.     The company considered the hearing loss to be unrelated to Boostrix and Boostrix Pre-Filled Syringe Device. It was unknown if the company considered the dizziness, confusion, memory loss, blurred vision, floaters, general body pain, malaise and rash to be related to Boostrix and Boostrix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-DEC-2024 The patient reported that all started with a little dizziness progressed to extreme dizziness after 4 to 5 months after seven months he had extreme, horrible malaise, feeling bodyaches, confusion, memory loss, blurred vision, and hearing loss and some weird unexplainable rashes. Reporter did not provided consent to contact.; Sender's Comments: Deafness is an unlisted event which is considered unrelated to GSK vaccine Boostrix and Boostrix PRE-FILLED SYRINGE DEVICE.