chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Ear pain, Facial pain
Clinical narrative: After the vaccine was administered, the patient started having pain in the same distribution that she had previously had shingles. Including her face and left ear. She is still experiencing this today to a decreasing degree.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Office notified on 4/14 of patient with red, hot, hard injection site to the right thigh. Spot the size of an orange Patient ultimately went to Urgent care and was diagnosed with cellulitis of the injection site. They started antibiotics to treat (keflex).
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, X-ray limb
Clinical narrative: - acute onset of shoulder pain after Shingrix vaccine 1/29/25 which has persisted x 4 weeks, with symptoms temporarily relieved by NSAIDs but still has not resolved. She believes vaccination was given in deltoid area, does not think it was done too high up in shoulder. Continues to have right shoulder pain and has gotten imaging and is now being offered steroid injections and PT.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Osteoarthritis, X-ray limb abnormal
Clinical narrative: - acute onset of shoulder pain after Shingrix vaccine 1/29/25 which has persisted x 4 weeks, with symptoms temporarily relieved by NSAIDs but still has not resolved. She believes vaccination was given in deltoid area, does not think it was done too high up in shoulder. Continues to have right shoulder pain and has gotten imaging and is now being offered steroid injections and PT.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV9, MNQ, TDAP
Symptoms: Erythema, Skin induration, Skin swelling
Clinical narrative: red swollen and induration of skin
Age: 43.0
Sex: F
Vaccine: PNC20
Symptoms: Chills, Erythema, Lethargy, Pain, Peripheral swelling
Clinical narrative: High fever x 3 days (101.5F) body aches, chills, arm swelling, redness that is increasing in size, feeling lethargic.
Age: 43.0
Sex: F
Vaccine: PNC20
Symptoms: Pyrexia
Clinical narrative: High fever x 3 days (101.5F) body aches, chills, arm swelling, redness that is increasing in size, feeling lethargic.
Age: 57.0
Sex: F
Vaccine: PNC20
Symptoms: Wrong technique in product usage process
Clinical narrative: Vaccine was administered by pinching the skin and not the recommended z-track method causing some of the vaccine to come back out of the patients arm. It is unknow the amount of vaccine the patient received. CDC was contacted and advised to re-vaccinate the patient and that patient has been informed.
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administered Heplisav to newborn . No treamtnet. No s/s at this time
Age: 63.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: patient states left arm was red and at first looked like it was going away then came back, has gotten bigger and now is swollen. Patient states seen by women's clinic 4/14/2025 and was told to use hydrocortisone cream but no relief. Patient advised to be seen by emergency department
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Tremor
Clinical narrative: Patient got Shingrix shot on 4/10/2025. He said he was chill, and his body was shaking. He was back to normal about 24 hours.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Abnormal uterine bleeding, Pyrexia, Trismus
Clinical narrative: Felt fine for the initial few days. Then 2 days later had 102 fever, jaw locking and "spasms." 2 weeks later reports abnormal uterine bleeding after no periods x 14 months
Age: 58.0
Sex: M
Vaccine: RSV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient received vaccine at age 58 instead of recommended age of 60 years old. No adverse reactions occurred.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Conjunctivitis bacterial, Injection site erythema, Injection site swelling, Injection site urticaria, Otitis media
Clinical narrative: patient developed redness and swelling around the injection site 24 hrs after injection of proquad vaccine into right thigh.  this progressed to hives, starting around the injection site and spreading across body.  the hives resolved with a dose of oral benadryl and did not return.  no breathing issues, wheezing, abdominal pain or vomiting to suggest anaphylaxis.  Of note, the patient had started taking oral amoxicillin for a middle ear infection 3-4 days prior to onset of hives.  no other generalized rash.  She also had bacterial conjunctivitis the day she got the vaccine and was started on polytrim antibiotic eye drops for this the day she got her vaccines.  Pt was given a kinrix vaccine the same day in the left thigh.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Urticaria
Clinical narrative: patient developed redness and swelling around the injection site 24 hrs after injection of proquad vaccine into right thigh.  this progressed to hives, starting around the injection site and spreading across body.  the hives resolved with a dose of oral benadryl and did not return.  no breathing issues, wheezing, abdominal pain or vomiting to suggest anaphylaxis.  Of note, the patient had started taking oral amoxicillin for a middle ear infection 3-4 days prior to onset of hives.  no other generalized rash.  She also had bacterial conjunctivitis the day she got the vaccine and was started on polytrim antibiotic eye drops for this the day she got her vaccines.  Pt was given a kinrix vaccine the same day in the left thigh.
Age: 63.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Extra dose administered
Clinical narrative: 3rd Shingrix dose given due to patient getting one at MD office that was unknown to pharmacy at the time.
Age: 39.0
Sex: M
Vaccine: COVID19, FLU3, HEP, MMR, VARCEL
Symptoms: Fatigue, Product administered to patient of inappropriate age
Clinical narrative: Patient was given a high dose flu vaccine by mistake. Patient reported more fatigue than normal a few hours after receiving their dose
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Fatigue, Flatulence, Loss of personal independence in daily activities
Clinical narrative: stomach pain, severe chills and fever of 99.9.  Exhaustion, severe digestive gas - these started on Day 4 after the vaccine (vaccine on Friday 4/10, severe side effects started 4/15).  Had a very large red and itchy rash for the first 3 days, as soon as the rash went away on day 4, the severe symptoms started. All I could do was lay in bed all day
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: stomach pain, severe chills and fever of 99.9.  Exhaustion, severe digestive gas - these started on Day 4 after the vaccine (vaccine on Friday 4/10, severe side effects started 4/15).  Had a very large red and itchy rash for the first 3 days, as soon as the rash went away on day 4, the severe symptoms started. All I could do was lay in bed all day
Age: 1.5
Sex: M
Vaccine: HIBV, IPV, MMR, VARCEL
Symptoms: Antibody test, Decreased eye contact, Pyrexia, Rash morbilliform
Clinical narrative: went to appointment smiling, talking, good eye contact, kissing hugging normal social response. Left appointment - lost eye contact developed fever 105 - measles ooking rash never went back to pre 1/31/05
Age: 37.0
Sex: F
Vaccine: DTAP
Symptoms: Arthralgia, Mobility decreased
Clinical narrative: Left shoulder pain and decreased range of motion 7 days post injection
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Syncope
Clinical narrative: Vasovagal syncope with loss of consciousness 30-60 seconds following administration
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Vasovagal syncope with loss of consciousness 30-60 seconds following administration
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Injection site swelling
Clinical narrative: Erythema and swelling at site of injection.
Age: 16.0
Sex: F
Vaccine: HEPA
Symptoms: Wrong product administered
Clinical narrative: Client should have gotten Hep B in stead, then she got the correct vaccine
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site vesicles
Clinical narrative: 1 cm X 1 cm blister to site of injection with itchiness and pain
Age: 53.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: When documenting vaccine the vaccinator noticed that it was expired on 3/28/25. The vaccinator did not inform the patient or the provider evaluating the patient. The vaccinator informed the practice manager and was advised to complete and incident report.
Age: 63.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse events reported, was administered IM instead of SQ
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Abdominal pain upper, Anaphylactic reaction, Eye movement disorder, Loss of consciousness, Screaming
Clinical narrative: 10min after receiving vaccine started screaming that stomach hurt. Vomited and eyes rolled back into head and had LOC. started developing hives over entire body. Rushed her to ER where two doses of epinepherine were administered for anaphylaxis.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Urticaria, Vomiting
Clinical narrative: 10min after receiving vaccine started screaming that stomach hurt. Vomited and eyes rolled back into head and had LOC. started developing hives over entire body. Rushed her to ER where two doses of epinepherine were administered for anaphylaxis.
Age: 1.17
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: Patient was administered and expired vaccination on 4/15/2025. Vaccination expired 04/11/2025, manufacturer was contacted and they could not provide recommendations but could send in house information and links for CDC and immunize.org for the provider to use to make a decision. Information was given to the provider and patients parent/guardian was contacted for the patient to come to the office to receive another vaccination.
Age: 50.0
Sex: F
Vaccine: MMR
Symptoms: Wrong product administered
Clinical narrative: Patient received incorrect vaccine on 3/19/2025. Patient received MMR and should have received Shingles vaccine.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Brain fog, Condition aggravated, Fatigue, Memory impairment, Pain
Clinical narrative: Patient is a Veteran of a war. Has history of chronic fatigue syndrome dating back 20+ years with negative workup. Patient claims his fatigue worsened following COVID19 vaccines. He received 3 Moderna vaccines, the latest being 01/07/2022.  Patient reports worsening in pre-existing fatigue, and now mental fog, memory impairment,  and increased chronic pain.  Pt has been evaluated by neuropsych, mental health, endocrinology, speech pathology to help with symptom management. Patient given modafinil to help with fatigue.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dry skin, Electrocardiogram normal, Flushing, Heart rate irregular
Clinical narrative: Heart stopping and starting beating repeatedly. Palpitations. Numbness tingling up spine with extreme panic attacks. Facial flushing and feeling of about to pass out. Itchy dry skin on face that did not exist previously.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Palpitations, Panic attack, Paraesthesia, Pruritus
Clinical narrative: Heart stopping and starting beating repeatedly. Palpitations. Numbness tingling up spine with extreme panic attacks. Facial flushing and feeling of about to pass out. Itchy dry skin on face that did not exist previously.
Age: 0.33
Vaccine: DTAP, HEPA, IPV, PNC20
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient was given an HEP A vaccine in error, patient was supposed to get the HEP B vaccine. Patient did not have any adverse event/
Age: 0.92
Sex: F
Vaccine: DTAPIPV, HEP, HEPA, HIBV, MMRV, MNQ
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Child was monitored for 15 minutes at the clinic, then parents were notified of the wrong vaccination given, and given instructions to go to ER if child has an adverse affect. The parent was called on 4-16-25 to ask about the child and the mom reported not adverse event. My supervisor, was notifed immediately upon the discovery of the event.
Age: 61.0
Sex: F
Vaccine: PNC20
Symptoms: Fatigue, Pain in extremity, Palpitations, Pulse abnormal
Clinical narrative: MerckY019159. Conjugate PCV21. The night of the vaccine I was so tired I had to go to bed at 6pm and my arm was incredibly painful (7  out of 10). The next day, I had palpitations all day. From taking my pulse, I believe I was having AFIB episodes (even with my medicine). By Sunday, I felt better and I haven't had any issues since Saturday night.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Gait disturbance, Malaise, Pain in extremity, Pyrexia
Clinical narrative: patient receive vaccine through local pharmacy on 4/14/25. developed malaise, sore arm, and low grade fever on 4/14/25. on 4/15/25, developed severe weakness, unable to walk independently and fever greater than 100. symptoms resolved by 4/16/25.
Age: 82.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event. Elderly patient was given pediatric dose of MMRV
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: covid infection with hospitalization after vaccination
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: 0928 - pre-vaccination, pt asked about previous vagal response, denied prior history of dizziness/nausea/chills/weakness. 0930 - vaccine administered. 0931 - Patient sent to observation area for standard 15 minute post-vaccination observation. While walking to observation area, patient became dizzy and leaned against the wall. Patient assisted to sit on the ground, leaning against the wall. Patient complained of nausea, small amount of clear vomit/saliva expressed into trash can. Cold pack applied to back of neck. Patient provided with water. BP measured as 122/86, pulse 82, via automatic cuff. Patient observed until he stated he was able to stand. Patient escorted to waiting area. Patient then escorted with school nurse to school clinic.
Age: 42.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was inadvertently given an adult dose of Hep A vaccine before the minimal interval had elapsed. First dose of Hep A was given as Twinrix (Hep A/B combo). The dose was given 11 days after the first dose.
Age: 1.92
Sex: F
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Gave Menveo 1 vial when it is only indicated for patients 10 and older
Age: 69.0
Sex: F
Vaccine: TDAP
Symptoms: Rash pruritic
Clinical narrative: small bumps and rash, very itchy
Age: 52.0
Sex: F
Vaccine: RSV
Symptoms: Rash
Clinical narrative: rash all over back, chest, arms, legs
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Rash
Clinical narrative: Patient's mother called clinic in regards to patient having adverse reaction to MMRV vaccination 1 week after getting vaccine. Mother states patient broke out in rash all over body. She states it is still present today and she was seen by her pediatrician and she prescribed oral steroids for her. Pediatrician advised mother to contact health department to report reaction.
Age: 16.0
Sex: F
Vaccine: FLU3, FLU3, MENB, MNQ
Symptoms: Extra dose administered
Clinical narrative: Gave a duplicate dose of Influenza vaccine.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1
Symptoms: CSF test, Electroencephalogram, Full blood count, Seizure like phenomena, Urine analysis
Clinical narrative: seizure like activity
Age: 1.33
Sex: M
Vaccine: PNC20
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: The patient was inadvertently given a PCV-20. Patient tolerated well and left without incident. MOC was advised to call our office with any concerns but patient should not have any adverse effects.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Dizziness, Headache, Loss of consciousness, Syncope, Vision blurred
Clinical narrative: within 2-3 minutes adverse events happened. patient passed out twice, became dizzy, had blurred vision, and headache. patient had 2 episodes of becoming faint and passing out. HR minutes after 1st episode was about 45 bpm.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Haematemesis
Clinical narrative: Patient reported repeated vomiting after vaccination--this reaction did not happen after ger first dose.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site discharge, Paraesthesia
Clinical narrative: Patient stated that after a couple days the shot never healed had a clear discharge for over a month.  Then about a month ago the upper arm started tingling.  He spoke to his MD and he told him to contact the pharmacy where received.  Patient also stated that he was seeing a physical therapist for another issue and mentioned the tingling to him.  The therapist said it may be a tight muscle in the neck that could be causing the tingling  so he said he would work on that area also.
Age: 50.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: Itching, redness, swelling and pain
Age: 72.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: Pt has redness/swelling 6 days after vaccination
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cardiac ablation, Chest pain, Electrocardiogram abnormal, Supraventricular tachycardia
Clinical narrative: Within two hours of receiving vaccine, patient experienced chest pain with associated SVT and had to be seen in the local ER for medication. He then had to see another hospital within the next two weeks and was admitted for a fib and uncontrolled SVT. This resulted in having to undergo cardiac ablation. Now patient continues to have heart problems and likely will need a pacemaker.
Age: 104.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Vaccine offered per CDC recommendations to residents present in facility that are eligible, resident received as eligible on 3/28/2025 but unfortunately was not processed correctly on paperwork as administered so was re-administered on 4/9/2025 as though it was recommended to receive (duplicate spring booster administered).
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Resident received 2nd booster dose for spring 2025 from nurse error in order review that was the nurse that administered vaccine
Age: 9.0
Sex: M
Vaccine: HPV9
Symptoms: Abdominal pain, Diarrhoea, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: He received the HPV vaccination at his appointment last week, 04/07/25. He had left arm soreness for a few days after the vaccination on 4/7/25. Yesterday, his arm started hurting again. No erythema, but the site was swollen and tender. There is a knot under the skin. Yesterday, he also had abdominal pain and diarrhea. Abdominal pain is generalized. He feels nauseated, but no vomiting. Older brother is also reporting abdominal pain, but no diarrhea. He has been alternating tylenol and ibuprofen which does help.
Age: 9.0
Sex: M
Vaccine: HPV9
Symptoms: Nausea, Pain in extremity
Clinical narrative: He received the HPV vaccination at his appointment last week, 04/07/25. He had left arm soreness for a few days after the vaccination on 4/7/25. Yesterday, his arm started hurting again. No erythema, but the site was swollen and tender. There is a knot under the skin. Yesterday, he also had abdominal pain and diarrhea. Abdominal pain is generalized. He feels nauseated, but no vomiting. Older brother is also reporting abdominal pain, but no diarrhea. He has been alternating tylenol and ibuprofen which does help.
Age: 70.0
Sex: M
Vaccine: HEPAB
Symptoms: Injury associated with device, Occupational exposure to product
Clinical narrative: ACCIDENTAL NEEDLE STICK TO ASSOCIATE ADMINISTERING THE SHOT
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Varicella
Clinical narrative: Patient developed rash - NP, believes it is chicken pox.
Age: 62.0
Sex: M
Vaccine: PNC21
Symptoms: Chest X-ray normal, Culture, Oropharyngeal pain, Pharyngeal swelling
Clinical narrative: Patient stated he received the Capvaxive vaccine and then woke up with a sore, swollen throat the following day. He stated he feels find other wise and was seen by an urgent care provider, who thinks it is most likely an upper respiratory infections and not pneumonia. Cultures were sent out for testing.
Age: 1.25
Sex: F
Vaccine: HEPA, MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Pt received both MMRV (MMR with Varicella) and another vaccine of Varicella so she received 2 doses of varicella
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Feeling hot, Hyperhidrosis, Presyncope
Clinical narrative: Vasovagal episode after vaccinations, 10-15 minutes later. Sweaty, felt warm. Kept supine then sitting for 20 minutes drinking apple juice and water till felt better and B/P returned to his normal.. Observed while recovering, seen by his doctor before leaving.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, C-reactive protein, Full blood count, Joint stiffness, Metabolic function test
Clinical narrative: Diffuse joint pain and stiffness, past 4-5 days.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Red blood cell sedimentation rate
Clinical narrative: Diffuse joint pain and stiffness, past 4-5 days.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Redness at injection site
Age: 55.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Limb mass, Pruritus, Skin exfoliation, Urticaria
Clinical narrative: Per patient,  skin on her nose started to peel off 2 days after the vaccines, then bumps developed on arms and hands. Finally, welts showed up on her neck and they've caused lots of itchiness, especially at night.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Wrong product administered
Clinical narrative: Patient was given the incorrect vaccination. He was given a Meningococcal ACWY instead of the Meningococcal B vaccine that he was due for.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Hypoaesthesia, Mobility decreased, Muscular weakness
Clinical narrative: Shortly after administration of 3 vaccines (2 in right deltoid, 1 in left deltoid) as above, patient complained of numbness and weakness of the entire right arm. No other deficits on neurologic exam but patient was unable to voluntarily lift arm or maintain arm in raised position. mild withdrawal to pain noted.
Age: 55.0
Sex: F
Vaccine: PNC21
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Swollen arm for more than 5 days and severe arm pain
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered, Injection site pain
Clinical narrative: patient was given an extra dose of the MCV vaccine. Provider was made while documenting for the vaccine. Parent was called and made aware of  the error. Per provider ,parent made aware of no adverse reaction are to be expected with the extra dose of the MCV other than pain at the injection site.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Product administered at inappropriate site
Clinical narrative: Pharmacist administered vaccine to high and caused severe pain for the patient that lasted over 2 days.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Breath sounds abnormal, Eye movement disorder, Hypotonia, Loss of consciousness, Unresponsive to stimuli
Clinical narrative: 2-3 MINUTES AFTER HER HBS SHOT THE DONOR SLUMPED BACKWARDS IN THE CHAIR IN PS OFFICE #2 LOST CONSCIOUSNESS FOR 90 SECONDS, HAD NOISY BREATHING, DONOR WAS UNAROUSABLE BY LOUD VOICE, DONOR EYES ROLLED BACK INTO HER HEAD, SHE HAD ABNORMAL UPPER LIMBS POSITIONING BUT NOT RHYTHMIC JERKY MOVEMENTS, WHEN DONOR REGAINED CONSCIOUSNESS SHE WAS AWARE OF WHERE SHE WAS AND RECALLED RECENT EVENTS.
Age: 64.0
Sex: M
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse event, reporting incorrect Administration (administered IM instead of SQ)
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site rash, Rash
Clinical narrative: Patient reports rash at injection site that has migrated to the back of his arm, as of today 4/16/25 he said the condition is improving.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Back pain, Immediate post-injection reaction, Injected limb mobility decreased, Joint noise
Clinical narrative: I described them. Pediatric onset Multiple Sclerosis never ever had upper shoulder pain/upper extremity and neck pain until the second dose of moderna vaccine My upper body and shoulders were completely fine until I had the second Moderna vaccine. It started in my left shoulder with swelling, pain, stiffness, difficulty lifting, and a heavy feeling. I thought it was just an initial reaction, but the symptoms persisted, then spread to my right shoulder, shortly after to my neck, and upper back. I now experience chronic pain, crunching, grinding, stiffness, myofascial pain syndrome (MPS), severe neck tightness, and spasticity. I had none of these symptoms before.  I only started getting TPI (trigger point injection) therapy in 2023, which helps relieve the pain. However, I have had this pain for four years, and it was unbearable before starting TPI treatment. I now have chronic pain in both shoulders, my upper back, and my neck.  Lot number: 017C21A  (please do not share Lot # info unless asked)- Site: Left Deltoid dosage: 0.5 NDC can be provided upon request. Vaccine time 9-11 am. All records saved. Please do not share my lot number unless specifically requested. I prefer that this information remain confidential, as I receive ongoing care and do not want it to affect me. Thank you.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Joint swelling, Limb discomfort, Mobility decreased, Multiple sclerosis, Muscle spasticity
Clinical narrative: I described them. Pediatric onset Multiple Sclerosis never ever had upper shoulder pain/upper extremity and neck pain until the second dose of moderna vaccine My upper body and shoulders were completely fine until I had the second Moderna vaccine. It started in my left shoulder with swelling, pain, stiffness, difficulty lifting, and a heavy feeling. I thought it was just an initial reaction, but the symptoms persisted, then spread to my right shoulder, shortly after to my neck, and upper back. I now experience chronic pain, crunching, grinding, stiffness, myofascial pain syndrome (MPS), severe neck tightness, and spasticity. I had none of these symptoms before.  I only started getting TPI (trigger point injection) therapy in 2023, which helps relieve the pain. However, I have had this pain for four years, and it was unbearable before starting TPI treatment. I now have chronic pain in both shoulders, my upper back, and my neck.  Lot number: 017C21A  (please do not share Lot # info unless asked)- Site: Left Deltoid dosage: 0.5 NDC can be provided upon request. Vaccine time 9-11 am. All records saved. Please do not share my lot number unless specifically requested. I prefer that this information remain confidential, as I receive ongoing care and do not want it to affect me. Thank you.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle tightness, Musculoskeletal stiffness, Myofascial pain syndrome, Neck pain, Pain
Clinical narrative: I described them. Pediatric onset Multiple Sclerosis never ever had upper shoulder pain/upper extremity and neck pain until the second dose of moderna vaccine My upper body and shoulders were completely fine until I had the second Moderna vaccine. It started in my left shoulder with swelling, pain, stiffness, difficulty lifting, and a heavy feeling. I thought it was just an initial reaction, but the symptoms persisted, then spread to my right shoulder, shortly after to my neck, and upper back. I now experience chronic pain, crunching, grinding, stiffness, myofascial pain syndrome (MPS), severe neck tightness, and spasticity. I had none of these symptoms before.  I only started getting TPI (trigger point injection) therapy in 2023, which helps relieve the pain. However, I have had this pain for four years, and it was unbearable before starting TPI treatment. I now have chronic pain in both shoulders, my upper back, and my neck.  Lot number: 017C21A  (please do not share Lot # info unless asked)- Site: Left Deltoid dosage: 0.5 NDC can be provided upon request. Vaccine time 9-11 am. All records saved. Please do not share my lot number unless specifically requested. I prefer that this information remain confidential, as I receive ongoing care and do not want it to affect me. Thank you.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Swelling
Clinical narrative: I described them. Pediatric onset Multiple Sclerosis never ever had upper shoulder pain/upper extremity and neck pain until the second dose of moderna vaccine My upper body and shoulders were completely fine until I had the second Moderna vaccine. It started in my left shoulder with swelling, pain, stiffness, difficulty lifting, and a heavy feeling. I thought it was just an initial reaction, but the symptoms persisted, then spread to my right shoulder, shortly after to my neck, and upper back. I now experience chronic pain, crunching, grinding, stiffness, myofascial pain syndrome (MPS), severe neck tightness, and spasticity. I had none of these symptoms before.  I only started getting TPI (trigger point injection) therapy in 2023, which helps relieve the pain. However, I have had this pain for four years, and it was unbearable before starting TPI treatment. I now have chronic pain in both shoulders, my upper back, and my neck.  Lot number: 017C21A  (please do not share Lot # info unless asked)- Site: Left Deltoid dosage: 0.5 NDC can be provided upon request. Vaccine time 9-11 am. All records saved. Please do not share my lot number unless specifically requested. I prefer that this information remain confidential, as I receive ongoing care and do not want it to affect me. Thank you.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Abdominal pain, Abdominal pain upper, Blood bilirubin increased, Cholecystectomy, Cholecystitis
Clinical narrative: Gardasil doses were administered on 7/10/2008, 09/12/2008, and 01/30/2009. Following the initial dose, severe abdominal pain began resulting in a visit to the Emergency room on 7/15/2008. I was admitted for observation overnight where lab work was drawn. I was discharged the morning of 7/16/2008 and my parents were contacted by the doctor that same evening that my doctor that we needed to return to the hospital due to elevated bilirubin levels and suspected inflamed gallbladder. I was readmitted to the hospital on 7/16/2008 for further testing as well as continued abdominal pain. Imaging was done that evening which showed my gallbladder was full of gallstones. I was scheduled for gallbalder removal on 7/17/2008. Following the removal of my gallbladder, I continued having extreme stomach pain and devloped bowel issues. Over the course of the next few months I recieved a Crohn's disease, IBS, and eventually colonic inertia. Up until 7/10/2008 I had no bowel issues, now pain or stomach problems or other autoimmune issues.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Cholelithiasis, Crohn's disease, Gastrointestinal disorder, Gastrointestinal motility disorder, Imaging procedure abnormal
Clinical narrative: Gardasil doses were administered on 7/10/2008, 09/12/2008, and 01/30/2009. Following the initial dose, severe abdominal pain began resulting in a visit to the Emergency room on 7/15/2008. I was admitted for observation overnight where lab work was drawn. I was discharged the morning of 7/16/2008 and my parents were contacted by the doctor that same evening that my doctor that we needed to return to the hospital due to elevated bilirubin levels and suspected inflamed gallbladder. I was readmitted to the hospital on 7/16/2008 for further testing as well as continued abdominal pain. Imaging was done that evening which showed my gallbladder was full of gallstones. I was scheduled for gallbalder removal on 7/17/2008. Following the removal of my gallbladder, I continued having extreme stomach pain and devloped bowel issues. Over the course of the next few months I recieved a Crohn's disease, IBS, and eventually colonic inertia. Up until 7/10/2008 I had no bowel issues, now pain or stomach problems or other autoimmune issues.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Irritable bowel syndrome
Clinical narrative: Gardasil doses were administered on 7/10/2008, 09/12/2008, and 01/30/2009. Following the initial dose, severe abdominal pain began resulting in a visit to the Emergency room on 7/15/2008. I was admitted for observation overnight where lab work was drawn. I was discharged the morning of 7/16/2008 and my parents were contacted by the doctor that same evening that my doctor that we needed to return to the hospital due to elevated bilirubin levels and suspected inflamed gallbladder. I was readmitted to the hospital on 7/16/2008 for further testing as well as continued abdominal pain. Imaging was done that evening which showed my gallbladder was full of gallstones. I was scheduled for gallbalder removal on 7/17/2008. Following the removal of my gallbladder, I continued having extreme stomach pain and devloped bowel issues. Over the course of the next few months I recieved a Crohn's disease, IBS, and eventually colonic inertia. Up until 7/10/2008 I had no bowel issues, now pain or stomach problems or other autoimmune issues.
Age: 50.0
Sex: F
Vaccine: PNC21, PNC20
Symptoms: Headache, Swelling face, Urticaria
Clinical narrative: hives and swelling of the face, headache
Age: 50.0
Sex: F
Vaccine: PNC21, PNC20
Symptoms: Urticaria
Clinical narrative: hives and swelling of the face, headache
Age: 2.75
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was due to receive a Varicella vaccine but unintentionally received a MMR-Varicella vaccine, no reaction to vaccine. This was the patient's 2nd MMR vaccine and 1st Varicella vaccine.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Cellulitis
Clinical narrative: Cellulitis of R leg / thigh after administration of MMRV + Quadracel.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 74-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EK9231), in arm, as dose 2, single (Lot number: EN6201), in arm and as dose 3 (booster), single (Lot number: FF2587), in arm for covid-19 immunisation. The patient's relevant medical history included: "Pernicious anemia", start date: 1954 (ongoing), notes: congenital verification test 1996, Extreme fatigue.; "Pernicious anemia", start date: 1996 (ongoing); "Osteoarthritis" (ongoing), notes: Joint pain, bone loss, physical therapy 2018, 2021; "Osteoporosis", start date: 2021 (ongoing); "Herpes simplex", start date: 1983 (ongoing), notes: valacyclovir as needed 2021; "Occipital neuralgia", start date: 2020 (ongoing), notes: test conducted; "Mitral valve prolapse", start date: 2021 (ongoing); "HBP" (ongoing); "Blood thinner" (unspecified if ongoing); "Allergies" (unspecified if ongoing). Concomitant medication(s) included: ATENOLOL oral taken for hypertension, start date: 2015 (ongoing); VITAMIN D3 taken for pernicious anaemia, start date: 1996 (ongoing); VITAMIN B12 [CYANOCOBALAMIN] taken for pernicious anaemia, start date: 1996 (ongoing); ASPIRIN [ACETYLSALICYLIC ACID] taken for blood disorder, start date: 1996, stop date: 2023; BENADRYL taken for multiple allergies, start date: 2020, stop date: 2021; CALCIUM taken for pernicious anaemia, start date: 1996 (ongoing); BUPROPION. The patient also took other concomitant therapy. Vaccination history included: Flu vaccine, for Immunization, reaction(s): "failure". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06Feb2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Feb2022) Positive.  Clinical course: 03Jan2020: illness began following contact with others. No smell, no taste, slight fever, cough recovered in 14 days. 21Jan2020: symptoms recovered in 5 days physician contacted. 28Jan2020: physician diagnosed flu vaccine failure. No covid test available yet. Jun2020: antibodies tested (illegible) negative after 6 month of illness onset trouble breathing at night. Elevated head. Jun2020: hospitalized for extreme dizziness chest pain inability to (illegible). HR 43 BP extremely low diagnosis occipital neuralgia BP meds discontinued discharged to conjugate (illegible) recovery 2 weeks. Jan2021: Relocated to new retirement facility contacted new physician full vaccine completed 23Jan2021. 03Feb2022: Exposure to COVID- at residential facility not monitored by board of health (death rate not monitored either). 06Feb2022: Positive COVID diagnosis by air bio lab. 17Feb2022: COVID to presented contained clinic RN. (no physician available). No treatment recommended except 5-7 days rest after 2 vaccines, recovery in 7 days, bit cough and ear infection lingered one month referred to ENT physician.
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Dizziness, Dysstasia, Gait inability
Clinical narrative: the patient did receive a RSV (Arexvy) in 09/06/2023. However, after a week, the patient developed a dizziness and couldn't walk. She needed her spouse to stand her up and hold her in order for her to walk. Now, her symptom is improved, but she still has a dizziness every day.
Vaccine: VARCEL, VARCEL, HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: PEDVAX HIB was administered after a temperature excursion; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 28-Mar-2025, the patient was vaccinated with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB), (lot #X022981, expiration date: 21-May-2026), 0.5 mL administered by intramuscular route for prophylaxis. The vaccine was administered after a temperature excursion at 54.19 F for 2 hours 45 minutes (Product storage error). There was no previous temperature excursion. No other information was provided.  This is one of several reports received from the same reporter.
Vaccine: VARCEL, VARCEL, HIBV
Symptoms: Product storage error
Clinical narrative: PEDVAX HIB was administered after a temperature excursion; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 28-Mar-2025, the patient was vaccinated with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB), (lot #X022981, expiration date: 21-May-2026), 0.5 mL administered by intramuscular route for prophylaxis. The vaccine was administered after a temperature excursion at 54.19 F for 2 hours 45 minutes (Product storage error). There was no previous temperature excursion. No other information was provided.  This is one of several reports received from the same reporter.
Sex: M
Vaccine: PNC21
Symptoms: Antibody test abnormal, Staphylococcus test
Clinical narrative: Blood work was done to address serotype findings. These were not at the level that the patient was expecting based on review of clinical data.; This spontaneous report was received from a male patient of unknown age reporting on himself via company representative.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine Solution for injection (CAPVAXIVE) (lot #Y011819, expiration date: 01-Oct-2025) administered by unknown route as prophylaxis.  Post administration of the vaccine, on 04-Feb-2025, blood work was done to address serotype findings. These were not at the level that the patient was expecting based on review of clinical data (antibody test abnormal). On this date, S Pneumoniae IgG serotype 1 was 30 ug/mL, S Pneumoniae IgG serotype 33F was 1.6 ug/mL, S Pneumoniae IgG serotype 9V was 0.3 ug/mL, S Pneumoniae IgG serotype 19A was unable to perfor due to a reagent issue, S Pneumoniae IgG serotype 18C was 0.5 ug/, S Pneumoniae IgG serotype 15B was 1.1 ug/mL, S Pneumoniae IgG serotype 7F was 3.7 ug/mL, S Pneumoniae IgG serotype 11A was 1.1 ug/mL, S Pneumoniae IgG serotype 10A was 0.2 ug/mL, S Pneumoniae IgG serotype 6B was 1 ug/mL, S Pneumoniae IgG serotype 23F was 0.1 ug/mL, S Pneumoniae IgG serotype 22F was 0.6 ug/mL, S Pneumoniae IgG serotype 20 was 0.5 ug/mL, S Pneumoniae IgG serotype 19F was 0.3 ug/mL, S Pneumoniae IgG serotype 17F was 3.6 ug/mL, S Pneumoniae IgG serotype 14 was 3.9 ug/mL, S Pneumoniae IgG serotype 12F was 0.2 ug/mL, S Pneumoniae IgG serotype 8 was 3.6 ug/mL, S Pneumoniae IgG serotype 4 was 0.1 ug/mL, S Pneumoniae IgG serotype 3 was 0.1 ug/mL, S Pneumoniae IgG serotype 2 was 2.2 ug/mL, S Pneumoniae IgG serotype 5 was less than 0.1 ug/mL, S Pneumoniae IgG serotype 9N was 37.1 ug/mL. At the reporting time, the outcome of this event was unknown.   The causal relationship between the event and the suspect vaccine was not provided.
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; The nurse 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) PROQUAD (y014436   2/22/2026) Temperature: 14.92F Time frame:; This spontaneous report was received from Certified Nursing Assistant (CNA) and refers to a patient of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 28-Mar-2025, the patient was vaccinated with and improperly storage dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD)(rHA), (lot #Y014436, expiration date: 22-Feb-2026), the vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (Dose, route, and anatomical location were not reported) for prophylaxis  It was reported that the vaccines had a temperature excursion of 14.92F during a time frame of 1 hour and 40 minutes. There were not previous temperature excursions. No additional adverse events were reported, no further information provided.
Sex: M
Vaccine: UNK
Symptoms: Antibody test negative
Clinical narrative: Antibody test negative; This literature marketed report has been received from the authors of a published literature article, and refers to a 33-year-old male patient  The patient's medical history included 2 episodes of immune thrombocytopenia (ITP). The patient's concurrent conditions and concomitant therapies were not reported.   On an unknown date, the patient started therapy with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23), Solution for injection (indication, expiration date, and lot # were not reported).  On an unknown date, the patient experienced Antibody test negative. Immunoglobulin (Ig) gG was 249 mg/dL, IgA was 22 mg/dL, IgM was 25 mg/dL. The was referred to immunology and was found to have a poor pneumococcal vaccine response (only 4 of 23 serotypes became positive).  At the reporting time, the outcome of Antibody test negative was unknown.   The authors considered the event of Antibody test negative to be related to Pneumococcal Vaccine, Polyvalent (23-valent).
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: No symptoms; pediatric dose of RECOMBIVAX HB was administered to an adult patient in error; This spontaneous report was received from a licensed practical nurse (LPN) concerning an adult patient of unspecified gender.   The patient's medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported.   On 04-Apr-2025, the patient was vaccinated in error by a healthcare professional with a pediatric dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) 5 mcg/0.5 mL pre-filled syringe, lot #X021478, expiration date reported as 29-Nov-2025 but upon internal verification established as 18-May-2026, 1 dosage form (dosage regimen, anatomical location and route of administration were not provided) administered as prophylaxis (accidental underdose). It was reported that patient was intending to get Hepatitis b vaccine rHBsAg (yeast) (HEPLISAV B) vaccine. There were no symptoms (no adverse event.)
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; medical assistant who reports temperature excursion products PROQUAD and VARIVAX were administered to patients. Diluent not involved in excursion.; This spontaneous report was received from a physician assistant and refers to unknown patients of unknown age and gender.   The patients' medical history and concurrent conditions were not reported. Concomitant medication included sterile diluent (MERCK STERILE DILUENT).  On an unknown date, the patients were vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (lot # and expiration date were not reported) as prophylaxis which experienced temperature excursion (Product storage error). The vaccines were reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported) which was not involved in excursion. No additional adverse event (AE) reported (No adverse event).   Follow-up information has been received from reporter on 01-APR-2025. On 03-Mar-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (lot # Y015101, expiration date 06-Sep-2026). The temperature excursion was 5.7 degree Fahrenheit for 12 hours.   This previous invalid report become valid since patient information was reported.  This is one of several reports received from the same reporter.
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; medical assistant who reports temperature excursion products PROQUAD and VARIVAX were administered to patients. Diluent not involved in excursion.; This spontaneous report was received from a physician assistant and refers to unknown patients of unknown age and gender.   The patients' medical history and concurrent conditions were not reported. Concomitant medication included sterile diluent (MERCK STERILE DILUENT).  On an unknown date, the patients were vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (lot # and expiration date were not reported) as prophylaxis which experienced temperature excursion (Product storage error). The vaccines were reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported) which was not involved in excursion. No additional adverse event (AE) reported (No adverse event).   Follow-up information has been received from reporter on 01-APR-2025. On 05-Mar-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (lot # Y015101, expiration date 06-Sep-2026). The temperature excursion was 5.7 degree Fahrenheit for 30 hours 30 minutes.   This previous invalid report become valid since patient information was reported.  This is one of several reports received from the same reporter.