chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: FLU3, MNQ, TDAP
Symptoms: Dizziness, Feeling abnormal, Pallor
Clinical narrative: Pt received 3 vaccinations. Less than 5 minutes after receiving vaccinations patient begins complaining of dizziness. Pt became pale. Juice and crackers given to patient. Pt stated he was feeling worse. BP taken at 1041 was 78/52. Pt laid down and feet were elevated. Pt remained conscious entire time and was talking to this RN. MD was present at bedside d/t pt history of seizures. BP repeated at 1044 was 126/76. Pt color returned and he stated he was no longer dizzy. Pt moved to sitting position and BP repeated at 1046 107/58. Pt stated he felt fine and was no longer dizzy. Pt color returned to baseline and all vitals WNL. Pt monitored in clinic for additional 30 minutes d/t history. Interpreter present for incident.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: Out of range temperature for refrigerator. No adverse reactions
Age: 28.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: Out of range temperature for refrigerator. No adverse reactions
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: Out of range temperature for refrigerator. No adverse reactions
Age: 17.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: Out of range temperature for refrigerator. No adverse reactions
Age: 34.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Joint stiffness, Musculoskeletal stiffness, Myalgia
Clinical narrative: Muscle and Joint stiffness and pain, ibuprofen and topical muscle cream
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: Out of range temperature for refrigerator. No adverse reactions
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest injury, Dizziness, Face injury, Headache, Mobility decreased
Clinical narrative: Severe headache, Dizziness that resulted in fainting three times (which caused injuries to my face and ribcage), Nausea resulting in vomiting.  All symptoms persisted for more than 24 hours.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Syncope, Vomiting
Clinical narrative: Severe headache, Dizziness that resulted in fainting three times (which caused injuries to my face and ribcage), Nausea resulting in vomiting.  All symptoms persisted for more than 24 hours.
Age: 90.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Erythema
Clinical narrative: Developed redness that spread to elbow area.  Was diagnosed with cellulitis and given antibiotic prescription x 7 days.   1-week later redness started to subside.
Age: 44.0
Sex: F
Vaccine: FLU3, HEPAB, IPV, VARCEL
Symptoms: Loss of personal independence in daily activities, Pain, Pain in extremity, Tenderness
Clinical narrative: Patient reported experiencing bilateral arm pain after receiving vaccines in both arms. However, pain in left upper arm continued. Patient returned 1 month later for second doses and reported pain to RN. Adacel received in left deltoid on 1/21/25. Client reported bilateral arm pain due to vaccination, pain in left upper arm continued. Patient returned to clinic on 2/25/25 to report pain. Describes pain as sharp like a needlestick upon palpation, soreness with movement- hurts/makes getting dressed difficult. Upon evaluation, no obvious bruises, masses, redness, swelling present. Patient denies injury or trauma to site before or after vaccination and reports she does not sleep on that side nor does any work that strains the muscle. Describes pain as 8/10- still feels like she was recently vaccinated.
Age: 50.0
Sex: M
Vaccine: PNC13
Symptoms: Asthenia, Headache, Immediate post-injection reaction, Influenza, Nausea
Clinical narrative: Immediate flu symptoms. 101.5 fever.  Rash on inner arm for one week thus far.  Night sweats for a week and thus far.  Severe headache. Felt like I was getting better but on day 7 feeling very weak, nausea and headache is back. Still itchy rash.
Age: 50.0
Sex: M
Vaccine: PNC13
Symptoms: Night sweats, Pyrexia, Rash, Rash pruritic
Clinical narrative: Immediate flu symptoms. 101.5 fever.  Rash on inner arm for one week thus far.  Night sweats for a week and thus far.  Severe headache. Felt like I was getting better but on day 7 feeling very weak, nausea and headache is back. Still itchy rash.
Age: 7.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse reaction. Pfizer-BioNTech for age 12 years and up was administered to a 7 year old patient.
Vaccine: COVID19
Symptoms: Cardiac arrest, Post-anoxic myoclonus
Clinical narrative: have a cardiac arrest and I was dead for 16 minutes; Lance Adam's syndrome; This spontaneous case was reported by a patient and describes the occurrence of CARDIAC ARREST (have a cardiac arrest and I was dead for 16 minutes) and POST-ANOXIC MYOCLONUS (Lance Adam's syndrome) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 vaccination.     The patient's past medical history included Physical therapy (for 4 years.).    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC ARREST (have a cardiac arrest and I was dead for 16 minutes) (seriousness criterion medically significant) and POST-ANOXIC MYOCLONUS (Lance Adam's syndrome) (seriousness criterion disability). The patient was treated with Physical therapy for Post-anoxic myoclonus. At the time of the report, CARDIAC ARREST (have a cardiac arrest and I was dead for 16 minutes) and POST-ANOXIC MYOCLONUS (Lance Adam's syndrome) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       No concomitant medications were reported.  The patient had own construction company for 30 years and now in physical therapy for 4 years and can barely walk. The patient can't use left hand either.   No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-Feb-2025: Live follow up received that contains no new significant information. On 20-Feb-2025: Live follow up received that contains no new significant information.; Reporter's Comments: The benefit-risk relationship of the product is not affected by this report.
Age: 13.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Wrong product administered
Clinical narrative: Patient and guardian did not consent to vaccination but doses were administered. No physical symptoms or adverse reaction occurred. 02/27/2025 Phone follow-up: Patient believes they did not consent states they did not consent to vaccine.
Age: 7.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Dtap given to 7 year old
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC20, VARCEL
Symptoms: Decreased appetite, Rash, Rash morbilliform, Rash pruritic
Clinical narrative: Rash on the back and abdomen began two days ago. Mom applied hydrocortisone twice yesterday and again this morning, but the rash remains unchanged and continues to itch. No fever, patient is drinking well, but appetite temporarily decreased after vaccination and is now improving. No known sick contacts. Rash appears measles-like, likely a reaction to the MMR vaccine, with no signs of active measles. Parents were educated that the rash is self-limiting and will resolve on its own. No medication needed at this time.
Age: 0.17
Sex: F
Vaccine: RV1
Symptoms: Haematemesis
Clinical narrative: 1 episode of frank hematemesis that the day after vaccine administration
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Box expiration date is 06/11/2025. After vaccine administered and patient left, RN realized that the BUD date was 02/08/2025 (as it was in the fridge). No adverse reactions in office.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20
Symptoms: Erythema, Induration, Peripheral swelling
Clinical narrative: Erythema and swelling of thigh, with residual induration palpable
Age: 28.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no noted adverse events
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Disorientation, Dizziness, Headache, Heart rate increased, Immediate post-injection reaction
Clinical narrative: Spoke to mother,  she explains right after he received the vaccines, he begun feeling disorientated, dizzy, HR was elevated, and stated he felt like he was going to have a seizure. I asked mother if he had a history of seizures and she stated no history of seizures. After about 2 hours, the symptoms subsided, but had a HA that lasted a couple days after. Mother feels it may have been the Menveo or Bexsero he had received that day.  I explained to mother I would report his reaction to vaers. And if any other information is needed from mother, she would ne contacted.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Seizure like phenomena
Clinical narrative: Spoke to mother,  she explains right after he received the vaccines, he begun feeling disorientated, dizzy, HR was elevated, and stated he felt like he was going to have a seizure. I asked mother if he had a history of seizures and she stated no history of seizures. After about 2 hours, the symptoms subsided, but had a HA that lasted a couple days after. Mother feels it may have been the Menveo or Bexsero he had received that day.  I explained to mother I would report his reaction to vaers. And if any other information is needed from mother, she would ne contacted.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood pressure fluctuation, Heart rate decreased
Clinical narrative: Blood pressure spikes and dives. Resting heart rate lower.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac failure congestive, Catheterisation cardiac, Computerised tomogram thorax, Echocardiogram, Electrocardiogram
Clinical narrative: Developed Acute congestive cardiac failure 4 months after 3rd vaccine.  Follow on testing indicated leaking aortic heart valve.  No family history of heart issues.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Heart valve incompetence, Scan with contrast
Clinical narrative: Developed Acute congestive cardiac failure 4 months after 3rd vaccine.  Follow on testing indicated leaking aortic heart valve.  No family history of heart issues.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Mom called yesterday afternoon 2/25 about patient's right thigh becoming swollen, painful and red the day after patient was vaccinated on 2/24.  DTAP/IPV given to patient in that thigh. Mom instructed to apply cold compresses and give Ibuprofen, and to monitor site. Mother brought patient in to the clinic today. Patient evaluated by doctor and sent home with instructions on what to monitor for and further instructions.
Age: 0.33
Sex: F
Vaccine: DTAP, RV5
Symptoms: Crying, Injection site reaction, Pyrexia, Rash erythematous
Clinical narrative: inconsolable crying for 3 days, fever, reddened site with bumps.
Age: 56.0
Sex: F
Vaccine: PNC21
Symptoms: Erythema
Clinical narrative: pt had allergic rx after 3 days its only reddness no fever or any signs of infection
Age: 1.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Vomiting
Clinical narrative: Had 3 episodes of vomiting on 2/21/2025. Starting at 6:30 AM.
Age: 1.0
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient was given a live virus too soon to the previously given live vaccine. The dosing betweeen MMR and Varicella was only 2 weeks instead of the 4 week guideline. Per vaccine guidelines, the child will not have immunity given from the varicella vaccine and will require 2 doses appropriately spaced. No other symptoms reported by parents.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Urticaria
Clinical narrative: Diffuse urticaria about 1 hour post administration. Returned to clinic-received 10 mg Zyrtec orally with some resolution. Denied SOB, wheezing, angioedema. Normal BP and normal pulse ox. No previous allergies
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diplopia, Hypoaesthesia, Laboratory test normal, Magnetic resonance imaging head abnormal, Magnetic resonance imaging spinal abnormal
Clinical narrative: I had my first Multiple Sclerosis flare in July 2021 (1.5 months after receiving vaccine). I was officially diagnosed in April 2023.
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Multiple sclerosis, Multiple sclerosis relapse
Clinical narrative: I had my first Multiple Sclerosis flare in July 2021 (1.5 months after receiving vaccine). I was officially diagnosed in April 2023.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: he has had COVID19 3 times; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (he has had COVID19 3 times) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (he has had COVID19 3 times). At the time of the report, COVID-19 (he has had COVID19 3 times) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       No concomitant medication was reported. Patient was a senior and he had every shot with Moderna vaccine for COVID and his last shot was last summer, he thought it was on 01June 2024. He had COVID19 3 times with the last case being approximately 2 months (Aug2024) after last COVID19 vaccine administration.  No treatment medication was reported.   This case was linked to MOD-2025-782574 (Patient Link).   Reporter did not allow further contact
Age: 1.0
Sex: M
Vaccine: DTPPVHBHPB, DTPPVHBHPB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: CHILD CAME IN FOR HIS 1 YEAR WELL CHILD VISIT WITH HIS MOTHER.  PATIENT WAS TO BE GIVEN HIS VARICELLA VACCINE TODAY BUT WAS ADMINISTERED VAXELLIS IN ERROR.   PROVIDER NOTICED THE ERROR WHEN REVIEWING THE PATIENTS CHART AND CALLED TO SPEAK WITH THE MOTHER IMMEDICATELY.  THE PATIENT IS NOT HAVING ANY SYMPTOMS OR SIDE EFFECTS FROM THE VAXELLIS.  MOTHER WILL MONITOR AND REPORT ANYTHING TO OUR OFFICE IF SOMETHING ARISES.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Patient was given first Covid vaccine one year prior to this one. This vaccine was the second dose for patient, but it was given without being diluted.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Erythema, Full blood count, Magnetic resonance imaging, Peripheral swelling
Clinical narrative: SHORTLY AFTER RECEIVING THE FIRST DOSE OF SHINGRIX IN MY LEFT ARM, I EXPERIENCED ADVANCED SWELLING. THE SWELLING CONTINUED AND 2 DAYS AFTER RECEIVING THE INJECTION, MY ARM WAS SWOLLEN AND EXTREMELY HOT TO THE TOUCH. THE REDNESS AND SWELLING CONTINUED AND I WENT TO THE EMERGENCY ROOM 4 DAYS POST INJECTION.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm, Ultrasound scan
Clinical narrative: SHORTLY AFTER RECEIVING THE FIRST DOSE OF SHINGRIX IN MY LEFT ARM, I EXPERIENCED ADVANCED SWELLING. THE SWELLING CONTINUED AND 2 DAYS AFTER RECEIVING THE INJECTION, MY ARM WAS SWOLLEN AND EXTREMELY HOT TO THE TOUCH. THE REDNESS AND SWELLING CONTINUED AND I WENT TO THE EMERGENCY ROOM 4 DAYS POST INJECTION.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Back pain, Balance disorder, Gait inability, Nervous system disorder, Spinal operation
Clinical narrative: 30 days after the second vaccination I had balance problems, severe back pain, and couldn't walk. This has not gone away since.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: on Feb 23, 2025, 6 y/o female was given a pfizer vaccine (5y-11month )that had passed the BUD of 1/22/2025. Father is notified the incident on Feb 26, 2025. No side effect is notified.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Computerised tomogram, Constipation, Henoch-Schonlein purpura, Laboratory test
Clinical narrative: For about two months I suffered with severe nausea, abdominal pain, rashes (painful and itching), constipation. Diagnosed w/ IgA vasculitis.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Nausea, Rash, Rash pruritic
Clinical narrative: For about two months I suffered with severe nausea, abdominal pain, rashes (painful and itching), constipation. Diagnosed w/ IgA vasculitis.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Syringe issue
Clinical narrative: While giving the patient her influenza vaccine, the vaccine fluid sprayed out of the side of the hub of the pre-filled syringe Upon noticing this occurring, the vaccine was stopped.  Patient reported not having felt any vaccine going into her arm.  Another influenza vaccine was attempted and was able to be administered without incident.  Upon closer inspection of the failed vaccine pre-filled syringe, there appears to be a small hole on the side of the hub.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: rash, swelling and itching at injection site
Age: 1.5
Sex: F
Vaccine: DTAPIPV
Symptoms: Wrong product administered
Clinical narrative: She was just due for DTaP and was given DTaP/IPV combo.
Age: 35.0
Sex: F
Vaccine: RAB
Symptoms: Rash
Clinical narrative: Rash to chest, upper back, neck and jawline.  Treated with IM benadryl with onset of symptoms, but had po benadryl prior to vaccine due to unreported/unseen rash from first dose on chest per patient.  No respiratory symptoms, no hypotension.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Nausea
Clinical narrative: Dizziness and nausea, within 15 minutes after administration
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Autoimmune disorder, Feeling cold, Influenza like illness, Malaise
Clinical narrative: Event occurred approximately 8 hours after receiving my 3rd Moderna (booster) shot.  A few hours after receiving the shot I started feeling unwell like I was coming down with the flu, then by 8:00 PM that same day I felt like I was freezing cold and sweating in bed, developed a fever of 102, every muscle in my body was tense and was rigid like I had tetanus, and the body pain was so intense that I did not sleep for 24 hours. These symptoms subsided after 48 hours, but my entire body was sore for days afterwards from the severe muscle rigidity.  I was also diagnosed with asthma and an autoimmune disorder later but I am unsure if this is a delayed side-affect of the Covid booster or not.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle rigidity, Musculoskeletal stiffness, Pain, Pyrexia, Sleep disorder
Clinical narrative: Event occurred approximately 8 hours after receiving my 3rd Moderna (booster) shot.  A few hours after receiving the shot I started feeling unwell like I was coming down with the flu, then by 8:00 PM that same day I felt like I was freezing cold and sweating in bed, developed a fever of 102, every muscle in my body was tense and was rigid like I had tetanus, and the body pain was so intense that I did not sleep for 24 hours. These symptoms subsided after 48 hours, but my entire body was sore for days afterwards from the severe muscle rigidity.  I was also diagnosed with asthma and an autoimmune disorder later but I am unsure if this is a delayed side-affect of the Covid booster or not.
Age: 82.0
Sex: F
Vaccine: RSV
Symptoms: Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: Itchy, red and raised area of injection site after 1 week
Age: 27.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Discomfort, Immediate post-injection reaction, Local reaction, Rash, Skin lesion
Clinical narrative: Pt presented on 2/24/25 stating that he has had a painful rash, MPOX lesions, to the bilateral palms of his hands. He said it started right after the first vaccine. We proceeded with 2nd vaccination on 2/24/25. He presents today 2/26/25 with a local reaction to the RUA. Given steroid shot and instructed to take antihistamines. Spoke to epidemiologist and was told it was a vaccine reaction. Lidocaine applied to lesions and he states that did help with discomfort
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Testicular pain
Clinical narrative: Acute pain in one side of testicle
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, warm, swelling to injection site.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Asthenia, Headache, Heavy menstrual bleeding, Loss of personal independence in daily activities
Clinical narrative: My menstrual cycle, which was always very regular, became completely unpredictable in the months following the Covid vaccine. It became some burdensome, that I was unable to prepare for the start and stop of it the menstruation. Additionally, I never suffered from PMS prior to the vaccine. Now, I suffer from debilitating cramps, headache, and stomach pain prior to and during menstruation. My periods are extremely heavy - which was not the case prior to the vaccine. I have never had a regular period since June of 2021. This is a direct result of the Covid Vaccine that I was forced to take. I am unable to participate in the physical activities I once enjoyed due to the pain, embarrassment, and discomfort of irregular periods, heavy periods, and constant stress of bleeding.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Menstrual discomfort, Menstruation irregular, Muscle spasms, Premenstrual dysphoric disorder, Stress
Clinical narrative: My menstrual cycle, which was always very regular, became completely unpredictable in the months following the Covid vaccine. It became some burdensome, that I was unable to prepare for the start and stop of it the menstruation. Additionally, I never suffered from PMS prior to the vaccine. Now, I suffer from debilitating cramps, headache, and stomach pain prior to and during menstruation. My periods are extremely heavy - which was not the case prior to the vaccine. I have never had a regular period since June of 2021. This is a direct result of the Covid Vaccine that I was forced to take. I am unable to participate in the physical activities I once enjoyed due to the pain, embarrassment, and discomfort of irregular periods, heavy periods, and constant stress of bleeding.
Age: 8.0
Sex: M
Vaccine: DTAP, IPV, VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Dtap inadvertently given instead of tdap, no symptoms, just wrong vax administered
Age: 61.0
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: 57.0
Sex: F
Vaccine: PNC21, TDAP, VARZOS, UNK, UNK, VARZOS
Symptoms: Incoherent, Syncope
Clinical narrative: After the 3rd vaccine (order was shingrix, capvaxive, adacel) patient incoherent then fainted.  I administered one dose of epinephrine 0.3mg.
Age: 38.0
Sex: F
Vaccine: TD
Symptoms: Muscular weakness, Pain in extremity, Restlessness
Clinical narrative: Arm is weak and restless. Pt denies redness or swelling at the injection site. Pt does have pain in the arm.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Pallor, Vomiting
Clinical narrative: Patient was very anxious prior to vaccination. 5 minutes after Men B vaccine patient felt dizzy and lightheaded. She ended up vomiting. She was sat in a chair. She was pale. given Juice. Vital signs stable. Patient monitored for 15 min. Discussed with Provider. Patient felt better deemed could leave office with ride. Had similar episode with 1st HPV and worse episodes with blood work. Known needle phobia.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypokinesia, Impaired work ability, Therapeutic response unexpected
Clinical narrative: almost unable to work, and was looking at a job as well as farming; she couldn't lift anything anymore and had to practically crawl to get to the barn; she was tired all the time/had constant fatigue; Therapeutic response unexpected; This spontaneous case was reported by a patient and describes the occurrence of IMPAIRED WORK ABILITY (almost unable to work, and was looking at a job as well as farming) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in November 2020.   On 03-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 31-Mar-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMPAIRED WORK ABILITY (almost unable to work, and was looking at a job as well as farming) (seriousness criterion disability), HYPOKINESIA (she couldn't lift anything anymore and had to practically crawl to get to the barn), FATIGUE (she was tired all the time/had constant fatigue) and THERAPEUTIC RESPONSE UNEXPECTED (Therapeutic response unexpected). At the time of the report, IMPAIRED WORK ABILITY (almost unable to work, and was looking at a job as well as farming), HYPOKINESIA (she couldn't lift anything anymore and had to practically crawl to get to the barn) and FATIGUE (she was tired all the time/had constant fatigue) had resolved and THERAPEUTIC RESPONSE UNEXPECTED (Therapeutic response unexpected) outcome was unknown.            No concomitant medications were reported.  The patient was a farmer, and it was hard for her to do anything after that, she couldn't lift anything anymore and had to practically crawl to get to the barn, she could previously pick up a 50-pound bale of hay or 50-pound bag of grain, but now she was tired all the time and had constant fatigue. For the whole winter the patient was almost unable to work, and was looking at a job as well as farming, so it was really, really hard for her. Almost immediately she improved and was back to almost normal.  No treatment medications were reported.; Reporter's Comments: The events were assessed as not related to the vaccine due to the absence of temporal relationship; they occurred before mRNA-1273 doses; only therapeutic response unexpected occurred after moderna vaccine. The benefit -risk relationship of product is not affected by this report.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity, Skin discolouration
Clinical narrative: PT RECEIVED AFLURIA VACCINE ON 2/17/25 AT PHARMACY. PT THEN CALLED PHARMACY ON 2/22/25 SAYING SHE WAS GOING TO THE HOSPITAL BECAUSE FER LEFT FINGER WAS IN ALOT OF PAIN AND HAD  TURNED PURPLE. HOS[PITAL DR PRESCRIBED NITRO OINTMENT AND NIFEDIPINE TO HELP WITH CIRCULATION
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Injected limb mobility decreased, Pain, Pain in extremity, Periarthritis
Clinical narrative: Left arm sore, aching.  Did not subside and worsened over time to painful deltoid area and joint, loss of ROM.  Saw , NP 12/17/24 who directed me to see Orthopedist.  Earliest appointment 01/28/2025 obtained and saw Dr .  XRays taken w/ no Bone abnormalities found.  Six weeks PT ordered and started Feb 4, 2025.  Pain now radiating into upper left arm down to elbow, sometimes to left hand or to left clavicle w/ radiation into neck.  Ortho dx:   Shoulder injury r/t vaccine administration (SIRVA) (S49.80XA, T50.Z95A),   Adhesive Capsulitis with ROM loss.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Shoulder injury related to vaccine administration, X-ray limb
Clinical narrative: Left arm sore, aching.  Did not subside and worsened over time to painful deltoid area and joint, loss of ROM.  Saw , NP 12/17/24 who directed me to see Orthopedist.  Earliest appointment 01/28/2025 obtained and saw Dr .  XRays taken w/ no Bone abnormalities found.  Six weeks PT ordered and started Feb 4, 2025.  Pain now radiating into upper left arm down to elbow, sometimes to left hand or to left clavicle w/ radiation into neck.  Ortho dx:   Shoulder injury r/t vaccine administration (SIRVA) (S49.80XA, T50.Z95A),   Adhesive Capsulitis with ROM loss.
Age: 1.33
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, VARCEL
Symptoms: Erythema, Pruritus, Pustule
Clinical narrative: Day 4 following immunizations patient had small red pustules on left wrist, left ankle, and two on left cheek. Mom reports itching, no evidence of pain or infection. Patient is alert, pleasant, and active
Age: 22.0
Sex: F
Vaccine: MENB, MNQ, VARCEL
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: The patient reported to the clinic with a chief complaint of redness on her right arm. She reported that her arm had been bothering her and was swollen, red, itchy and warm. Upon examination her symptoms were verified. The patient was instructed to take benadryl and report back to the clinic on 2/24/25 if there was no improvement.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy
Age: 21.0
Sex: M
Vaccine: TDAP
Symptoms: Fall
Clinical narrative: Patient was fasting before vaccine. I administered the vaccine and shortly after the patient had fallen to the floor. We sat the patient back on the chair and gave him water, pretzels, and a lollipop and had him wait there until he was feeling better. We offered to call 911 but the patient declined.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Injection site warmth, Pain in extremity, Peripheral swelling
Clinical narrative: Patient presents to clinic with the complaint of warmth at the injection site, swelling, pain and redness to a large portion of her arm, concern for allergic reaction vs cellulitis
Age: 0.17
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was given a pedvax hib  a vaxelis and a rota. Patient should have received a prevnar, vaxelis and a rota. This was immediately reported to Dr and team lead nurse. An incident report was filed. Parent was notified. No adverse effects reported.
Age: 42.0
Sex: F
Vaccine: PNC20, TDAP
Symptoms: Dermatitis, Pruritus
Clinical narrative: 15 min after admin, pt had skin inflammation and itchiness on neck, forehead, and chest. Gave pt 50mg diphenhydramine. pt had her own epipen with her but she stated that she did not have difficulty breathing at the time.
Age: 52.0
Sex: F
Vaccine: FLU3, PNC21
Symptoms: Lethargy, Mobility decreased, Peripheral swelling, Rash, Skin warm
Clinical narrative: PATIENTS ARM WAS SEVERELY SWOLLEN AND BROKE OUT IN SEVERE RASH WITH HIGH FEVER IN ARM. PATIENT COMPLAINED OF NOT BEING ABLE TO LIFT ARM APPROPRIATELY, LETHARGY
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: he had COVID19 3 times; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (he had COVID19 3 times) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Jun-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. In August 2024, the patient experienced COVID-19 (he had COVID19 3 times). At the time of the report, COVID-19 (he had COVID19 3 times) outcome was unknown.            No concomitant medications were provided. Patient was senior and that in the past he had every shot with Moderna for COVID and his last shot was last summer, he thought it was 01-Jun-2024. He had COVID19, 3 times with the last case being approximately 2 months (Aug2024) after last COVID19 vaccine administration. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was provided. Reporter causality was not reported.     This case was linked to MOD-2025-782733 (Patient Link).   Reporter did not allow further contact
Age: 91.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: COVID-19
Clinical narrative: has tested positive for Covid/he caught a COVID-19 infection; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (has tested posted for Covid/he caught a COVID-19 infection) in a 91-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.    Co-suspect product included non-company product Influenza vaccine for an unknown indication.    Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (lot- 038K20A) on 08-Feb-2021, Moderna COVID-19 Vaccine (lot- 010A21A) on 08-Mar-2021 and Moderna COVID-19 Vaccine (lot- 076C21A) on 27-Oct-2021. Past adverse reactions to the above products included No adverse effect with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine. Concurrent medical conditions included Blood pressure.   In September 2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form and dose of Influenza vaccine (unknown route) 1 dosage form. On 17-Feb-2025, the patient experienced COVID-19 (has tested posted for Covid/he caught a COVID-19 infection). At the time of the report, COVID-19 (has tested posted for Covid/he caught a COVID-19 infection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Feb-2025, SARS-CoV-2 test: Positive.         The customer was prescribed several pills for blood pressure.  The patient was not able to confirm in which arm the Moderna COVID-19 vaccine was administered but he confirmed that he had the Moderna COVID-19 vaccine shot in one arm and the Flu vaccine shot in the other arm on the same date of vaccination. As of reporting, patient was not sure if the patient was still positive for Covid. The patient did not experience any additional symptoms/events. No treatment medication was reported. Reporter causality was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-Feb-2025: Live significant follow-up received: As reported term and vaccination date was updated, Current condition, historical vaccine and co-suspect added.
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Electrocardiogram, Feeling abnormal, Illness, Malaise
Clinical narrative: That shot made him super sick and he could barely function for a week or two and made him feel really bad; That shot made him super sick and he could barely function for a week or two and made him feel really bad; Felt horrible; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 61-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 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, MANUFACTURER UNKNOWN), for COVID-19 vaccination, reaction(s): "feel bad"; Bnt162b2 (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 vaccination, reaction(s): "feel bad"; Bnt162b2 (DOSE 3, MANUFACTURER UNKNOWN), for COVID-19 vaccination, reaction(s): "feeling bad". The following information was reported: ILLNESS (non-serious), FEELING ABNORMAL (non-serious), outcome "unknown" and all described as "That shot made him super sick and he could barely function for a week or two and made him feel really bad"; MALAISE (non-serious), outcome "unknown", described as "Felt horrible". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient was calling about Pfizer bivalent spike protein covid 19 booster, when he received it this was his 4th shot which he received in Nov2022 and that was the one that was supposed to be the updated shot for the omicron. That shot made him super sick and he could barely function for a week or two and made him feel really bad. He is trying to find assistance to try to feel better and see if there is something to reverse effects of the symptoms that he has had for two years. They were done with blood work and EKG and can't find anything wrong. The patient felt horrible.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes simplex
Clinical narrative: I had a very recalcitrant HSV2 reaction; This is a spontaneous report received from a Consumer or other non HCP.  A 74-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 29Jan2025 at 10:00 as dose 1, single (Batch/Lot number: unknown) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hbp" (unspecified if ongoing); "hsv2" (unspecified if ongoing); "copd" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN. Past drug history included: Tetracycline, reaction(s): "drug allergy". The following information was reported: HERPES SIMPLEX (non-serious) with onset 30Jan2025 at 07:00, outcome "recovered" (18Feb2025), described as "I had a very recalcitrant HSV2 reaction". Therapeutic measures were taken as a result of herpes simplex. Additional information: Patient didn't receive any other vaccines on the same date as the vaccine. Patient didn't receive any other vaccines within 4 weeks prior to the vaccine. Patient had a very recalcitrant HSV2  reaction. Patient has had hsv2 for many years but this episode was very difficult to deal with. It was not responding to famciclovir. Treatment received for the adverse event included Famciclovir. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Vaccine: COVID19, FLUX
Symptoms: Vomiting
Clinical narrative: I spit out black stuff, it looked like mold; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 21Feb2025 at 11:30 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 21Feb2025 at 11:30 as dose number unknown , single) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (DOSE 1, lot number unknown), for COVID-19 immunisation; Comirnaty (DOSE 2, lot number unknown), for COVID-19 immunisation; Comirnaty (DOSE 3(BOOSTER), lot number unknown), for COVID-19 immunisation; Comirnaty (DOSE 4(BOOSTER), lot number unknown), for COVID-19 immunisation; Comirnaty (DOSE 5(BOOSTER), lot number unknown), for COVID-19 immunisation. The following information was reported: VOMITING (non-serious) with onset 22Feb2025 at 09:30, outcome "unknown", described as "I spit out black stuff, it looked like mold".  Additional information: The patient was vaccinated against Flu and Covid yesterday(21Feb2025) at the consulate around 11:30 am and today(22Feb2025) at 9:30, patient spit out black stuff, it looked like mold. Patient was worried that it's something bad. Proposed response: vomiting is listed as a commonly reported side effect, but no specific information was found on 'spitting out black stuff.'   The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Received Comirnaty; get COVID, symptomatic COVID at the beginning of this month; Received Comirnaty; get COVID, symptomatic COVID at the beginning of this month; This is a spontaneous report received from a Consumer or other non HCP.  A male 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: Comirnaty (dose number unknown; religiously got it each year), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 12Feb2025, outcome "unknown" and all described as "Received Comirnaty; get COVID, symptomatic COVID at the beginning of this month". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Feb2025) Positive. The patient received Comirnaty and religiously got it each year. Reporter have a disabled son (patient) also managed for the first time to get COVID, symptomatic COVID at the beginning of this month and put on Paxlovid. COVID positive on date 12Feb2025. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500042895 Same reporter and vaccine and event, different patients.;US-PFIZER INC-202500042913 Same reporter and vaccine and event, different patients.;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Received Comirnaty; get COVID, symptomatic COVID at the beginning of this month; Received Comirnaty; get COVID, symptomatic COVID at the beginning of this month; This is a spontaneous report received from a Consumer or other non HCP.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Received Comirnaty; get COVID, symptomatic COVID at the beginning of this month". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Feb2025) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500042863 Same reporter and vaccine and event, different patients;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: received Comirnaty/get COVID, symptomatic COVID; received Comirnaty/get COVID, symptomatic COVID; This is a spontaneous report received from a Consumer or other non HCP.  A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 04Sep2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (primary immunization series completed), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2025, outcome "unknown" and all described as "received Comirnaty/get COVID, symptomatic COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Feb2025) Positive; (20Feb2025) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient reported two adverse events that basically count as a vaccine failure and as a drug failure. There are three people (one of which is the patient). They all received Comirnaty and religiously got it each year. He has a disabled son, his wife, and him (the patient) managed for the first time to get COVID, symptomatic COVID at the beginning of this month (Feb2025) and they were put on Paxlovid and all of them have had rebound. All of them after coming off Paxlovid got even sicker. The patient became sick in 12Feb when he started taking the Paxlovid and then completed the five days course. He received the vaccine on 04Sep2024. He was positive by BinaxNOW test. When confirmed if all three to them were COVID positive on same date 12Feb2025, the patient confirmed Yes but they all differ a little bit.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500042863 same reporter/drug/event, different patient;US-PFIZER INC-202500042895 same reporter/drug/event, different patient;US-PFIZER INC-202500042863 Same reporter and vaccine and event, different patients.;
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Ultrasound scan
Clinical narrative: developed a DVT shortly after having the vaccine; This is a spontaneous report received from a Consumer or other non HCP.  A 38-year-old male patient received BNT162b2 (BNT162B2), on 15Apr2021 at 12:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 38 years, in arm (shoulder) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DEEP VEIN THROMBOSIS (medically significant) with onset 15Apr2021 at 12:00, outcome "not recovered", described as "developed a DVT shortly after having the vaccine". The patient underwent the following laboratory tests and procedures: Ultrasound scan: unknown results. Therapeutic measures were taken as a result of deep vein thrombosis and included blood thinners.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 80.0
Sex: M
Vaccine: PNC20
Symptoms: Discomfort, Malaise, Pruritus
Clinical narrative: experienced itching/feeling itchy; feeling uncomfortable and unwell/uncomfortable; feeling uncomfortable and unwell/he does not feel that well; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  An 80-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 25Feb2025 as dose 1, single (Batch/Lot number: unknown) at the age of 80 years for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRURITUS (non-serious) with onset 25Feb2025, outcome "unknown", described as "experienced itching/feeling itchy"; MALAISE (non-serious) with onset 25Feb2025, outcome "unknown", described as "feeling uncomfortable and unwell/he does not feel that well"; DISCOMFORT (non-serious) with onset 25Feb2025, outcome "unknown", described as "feeling uncomfortable and unwell/uncomfortable". Therapeutic measures were taken as a result of pruritus, discomfort, malaise.  Additional information: The patient took an antihistamine (Allegra 24 hour); has no known allergies.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Vaccine: COVID19
Symptoms: Memory impairment
Clinical narrative: lost all sense of recognition; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 65-year-old patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, 0.3ml single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "lost all sense of recognition". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500043515 same reporter/event, different patient;