chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: Late 2nd dose/did not receive the 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult female patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (1st dose received on 25-MAR-2025, batch number-Y5X9T and expiry date-30-SEP-2026).   On an unknown date, the patient did not receive the 2nd dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incomplete course of vaccination (Verbatim: Late 2nd dose/did not receive the 2nd dose). The outcome of the incomplete course of vaccination was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 27-MAY-2025 The patient did not come back to get the 2nd dose on the 2nd month. Till the time of reporting the patient had not received the second dose of Engerix-B, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Insomnia, Pain
Clinical narrative: unable to sleep without waking up from pain or discomfort every 15-20 minutes; unable to sleep without waking up from pain or discomfort every 15-20 minutes; unable to sleep without waking up from pain or discomfort every 15-20 minutes; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN (unable to sleep without waking up from pain or discomfort every 15-20 minutes), DISCOMFORT (unable to sleep without waking up from pain or discomfort every 15-20 minutes) and INSOMNIA (unable to sleep without waking up from pain or discomfort every 15-20 minutes) in a 74-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043837) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-May-2025, the patient received tenth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 25-May-2025, the patient experienced PAIN (unable to sleep without waking up from pain or discomfort every 15-20 minutes) and INSOMNIA (unable to sleep without waking up from pain or discomfort every 15-20 minutes). 25-May-2025, the patient experienced DISCOMFORT (unable to sleep without waking up from pain or discomfort every 15-20 minutes). At the time of the report, PAIN (unable to sleep without waking up from pain or discomfort every 15-20 minutes), DISCOMFORT (unable to sleep without waking up from pain or discomfort every 15-20 minutes) and INSOMNIA (unable to sleep without waking up from pain or discomfort every 15-20 minutes) outcome was unknown.            No concomitant medication was reported. Patient and her husband had no issues or problems until they received the 10th COVID-19 vaccines on 24-May-2025. On 25-May-2025, both of them were unable to sleep without waking up from pain or discomfort every 15-20 minutes.  The pharmacist started injecting the shots into the shoulders. Patient's husband asked him to inject the vaccine in the bicep at the widest point of the arms (into the softest padded area of the upper arm), but he said he had to inject them in the shoulder.  It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. Reporter causality was not reported.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site pruritus, Injection site reaction
Clinical narrative: Patient received DTaP-IPV in left thigh and MMRV in right thigh on 5/27/25 Mother reports pt c/o itching of left thigh at bedtime on 5/27/25 - minimal redness noted The following day pt c/o itching of right thigh - no decrease in activity or pain no fever At bedtime 5/28/25 noted to have and pain of right thigh. No fever Seen for sick visit on morning of 5/29/25 Right thigh with 18cm x 20cm area of redness - not painful Left thigh - with 3cm x 2cm area of redness - not painful No fever No restriction of activity Parents report areas of redness decreased on morning of 5/29/25 as compared to bedtime of 5/28/25
Age: 83.0
Sex: F
Vaccine: PNC20
Symptoms: Cellulitis, Erythema, Pain, Swelling
Clinical narrative: redness, swelling, pain. Cellulitis. Started on cephalexin 500mg q6hrs for 5  days.
Age: 1.33
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Product preparation error
Clinical narrative: HIB vaccine given with non-preferred diluent. Unknown sx and/or reactions from this error.
Age: 1.75
Sex: M
Vaccine: DTAPIPVHIB, PNC20
Symptoms: Differential white blood cell count, Full blood count, Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: Redness and swelling. Two small knots at injection site.
Age: 8.0
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Administered combo vaccine to an 8-year-old patient that is only indicated for ages 4-6, so she should have received DTaP and IPV as separate injections.  No adverse events or side effects reported by patient or her parents.
Age: 5.0
Sex: F
Vaccine: DTPPVHBHPB, HEPA, MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Vaxelis given to a 5 year old. It is only licensed to give the ages 6 weeks -  4 years of age. Consulted with the Immunization program and no doses need to be repeated.  No adverse events.
Age: 11.0
Sex: M
Vaccine: MNP
Symptoms: Diarrhoea, Pyrexia, Swelling, Vomiting
Clinical narrative: Vomiting, diarrhea,  swelling, fever
Age: 65.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: pt received 2nd dose of rsv
Age: 62.0
Sex: F
Vaccine: COVID19, HEP, PNC20, VARZOS
Symptoms: Feeling abnormal, Pain, Peripheral swelling, Pyrexia
Clinical narrative: swelling of the arms--patient got 4  vaccines that day: Shingrix and Comirnaty in the left arm and Prevnar and Heplisav in the right arm.  She started having fever and body aches that same day after administration. She was still feeling bad the next day and called her PCP, who advised her to go to the ER. She went to the ER and got a muscle relaxant, Promethazine and fluids (according to the pt). She is feeling much better now, but still have swelling in the Arms.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Dyspnoea, Hypotonia, Immediate post-injection reaction, Loss of consciousness, Pallor
Clinical narrative: Patient became pale and limp immediately following the vaccine administration.  Patient moved to the floor and given ice packs. Patient in and out of consciousness.  Patient complained of trouble breathing.  911 called. Patient responded to EMS and began to improve. Patient's mother did not want patient to go to the hospital.  Patient given fluids and released to her mother's care at 2:31pm.
Age: 2.0
Sex: M
Vaccine: MMRV
Symptoms: Erythema, Induration, Injection site rash, Rash, Rash pruritic
Clinical narrative: On February 25, 2025, patient received vaccinations in his left leg. Subsequently, he developed a rash on the left leg, which began on March 11, 2025. The rash has progressively enlarged and is associated with itching. patient has been scratching the area, leading to scratch marks. The rash became noticeable with red cheeks and ears on March 17, 2025, followed by a full-body rash on March 18, 2025, which lasted until March 21, 2025, before diminishing. There is some drainage from a particular spot on the rash, and the area underneath the skin has become hard. Patient has not experienced any fevers and continues his regular activities. He is aware of the rash and finds it bothersome. There is no history of eczema or similar rashy conditions. Patient is two years post-bone marrow transplant and is not on any active oncology treatments.
Age: 2.0
Sex: M
Vaccine: MMRV
Symptoms: Skin discharge, Skin lesion, Varicella virus test positive, Varicella zoster virus infection
Clinical narrative: On February 25, 2025, patient received vaccinations in his left leg. Subsequently, he developed a rash on the left leg, which began on March 11, 2025. The rash has progressively enlarged and is associated with itching. patient has been scratching the area, leading to scratch marks. The rash became noticeable with red cheeks and ears on March 17, 2025, followed by a full-body rash on March 18, 2025, which lasted until March 21, 2025, before diminishing. There is some drainage from a particular spot on the rash, and the area underneath the skin has become hard. Patient has not experienced any fevers and continues his regular activities. He is aware of the rash and finds it bothersome. There is no history of eczema or similar rashy conditions. Patient is two years post-bone marrow transplant and is not on any active oncology treatments.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 11 year old inadvertently given 12+ COVID dose
Age: 1.0
Sex: F
Vaccine: UNK
Symptoms: Crying, Malaise, Muscle rigidity, Postictal state, Pyrexia
Clinical narrative: On thursday my daughter started to get sick and had a 102°F fever rectally. I medicated her with Tylenol and she woke up on Friday 04/25 with no fever. That afternoon she had a fever of 100.5°F rectally, I did not medicate, and she fell asleep on me. I transferred her to her crib and got in the shower. She had cried out in her sleep and my husband checked on the monitor and she was repositioning in her crib. Not even a minute later I got out of the shower and checked the monitor and she was seizing. I grabbed her out of the crib and she continued to seize in my arms. We called 911 and they were at our house within 5 minutes and my daughter was still seizing. They administered a dose of versed and she started to cry and enter a post ictal phase. She seized for probably 7-8 minutes and she had equal movements bilaterally during the seizure. Her eyes rolled up during the seizure and she was breathing. She did not vomit. Her post ictal phase lasted less than 5 minutes and she was rigid and crying. Her legs were straight out with her toes pointed inward and her arms were up towards her chest with her hands curled inward. They took her temperature in the ambulance and it was 102.7°F axillary.  The seizure only occurred once. She was day 10 post MMR vaccine and CDC website states  highest risk of febrile seizure occurs days 8-15 post MMR vaccine. And my child just happened to viruses during that window of time frame. My child has had viruses before with a 103°F over a couple of days and been fine.
Age: 1.0
Sex: F
Vaccine: UNK
Symptoms: Seizure
Clinical narrative: On thursday my daughter started to get sick and had a 102°F fever rectally. I medicated her with Tylenol and she woke up on Friday 04/25 with no fever. That afternoon she had a fever of 100.5°F rectally, I did not medicate, and she fell asleep on me. I transferred her to her crib and got in the shower. She had cried out in her sleep and my husband checked on the monitor and she was repositioning in her crib. Not even a minute later I got out of the shower and checked the monitor and she was seizing. I grabbed her out of the crib and she continued to seize in my arms. We called 911 and they were at our house within 5 minutes and my daughter was still seizing. They administered a dose of versed and she started to cry and enter a post ictal phase. She seized for probably 7-8 minutes and she had equal movements bilaterally during the seizure. Her eyes rolled up during the seizure and she was breathing. She did not vomit. Her post ictal phase lasted less than 5 minutes and she was rigid and crying. Her legs were straight out with her toes pointed inward and her arms were up towards her chest with her hands curled inward. They took her temperature in the ambulance and it was 102.7°F axillary.  The seizure only occurred once. She was day 10 post MMR vaccine and CDC website states  highest risk of febrile seizure occurs days 8-15 post MMR vaccine. And my child just happened to viruses during that window of time frame. My child has had viruses before with a 103°F over a couple of days and been fine.
Age: 49.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Aphasia, Condition aggravated, Seizure, Tinnitus
Clinical narrative: Patient stopped speaking and went into a seizure.  After coming too, she claimed she had ringing in her ear before it happened. She use to get that same feeling when she used cocaine and her blood pressure spiked.  EMT was called.  They monitored the patient, but she refused to go to the hospital
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Mobility decreased, Ultrasound joint
Clinical narrative: On 5/28 patient received Tdap vaccine. Patient seen in clinic on 5/29/25 for worsening pain in her left shoulder. Felt ok initially, but had progressive discomfort through the day. Limited range of motion, pain 9/10. Patient very tender over area of injection, guarding. Pain with resisted RTC testing and weak with sharper pain on abduction and external rotation.  Does not tolerated impingement testing. Diagnostic ultrasound performed by provider:   Long and Short axis view of the biceps shows  no tear of the tendon without fluid in the sheath and negative subluxation. AC joint appears normal in long axis.  Pectoralis major tendon in long axis is intact. Short  and long axis view of the subscapularis shows no tear of the tendon and no subcoracoid bursitis or impingement. Short and long axis views of the supraspinatus shows tendinopathy of the tendon. With dynamic resistance testing there is no retraction of the tendon.  There is no significant subacromial bursitis.   Short and long axis views of the infraspinatus shows no tear of the tendon. With dynamic resistance testing there is no retraction of the tendon. There is no joint effusion and GH joint appears normal. Evaluation of the posterior labrum shows no tear.    Impression : Diagnostic ultrasound of the left shoulder with findings supporting accidental vaccine administration into the supraspinatus tendon as a contribution to the patients pain and dysfunction.   ASSESSMENT & PLAN   1. Shoulder injury related to vaccine administration (SIRVA)  meloxicam (MOBIC) 15 mg tablet    She has significant pain and dysfunction in her shoulder following vaccine administration yesterday. Based on location of bandage and hypoechogenic focus in the supraspinatus tendon in concert with her symptoms and physical exam,  it appears that there was inadvertent administration of the Tdap booster into the subacromial space instead of IM into the deltoid muscle belly.  Follow up in  2 weeks with me at Ortho.   We will plan for xrays at that time if needed.  May consider repeat US of shoulder.  May consider referral to PT.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Echocardiogram, Electrocardiogram, Heart rate increased
Clinical narrative: Rapid heart rate while at rest at times, shortness of breath all day, everyday, chest pain, abnormal heart rate after running
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary function test
Clinical narrative: Rapid heart rate while at rest at times, shortness of breath all day, everyday, chest pain, abnormal heart rate after running
Age: 12.0
Sex: F
Vaccine: HPV9, PNC20
Symptoms: Wrong product administered
Clinical narrative: wrong vaccine given
Age: 60.0
Sex: M
Vaccine: HEP
Symptoms: Erythema, Rash, Urticaria
Clinical narrative: VERBALIZED UTICARIA ON BACK, ASSESSED RED, AND PALPATED  5-7 MM SIZE BUMPS
Age: 36.0
Sex: M
Vaccine: TDAP
Symptoms: Extra dose administered
Clinical narrative: Received TDAP on 5/23/2025 & on 5/30/2025 in error
Age: 0.25
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product preparation issue
Clinical narrative: No s/s noted or reported.   The diluent only was given.
Age: 22.0
Sex: F
Vaccine: MENB
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Trumenba was administered today in office.  It was discovered after the patient left she had had a Bexsero dose previously on 8-19-19.  No adverse reaction or symptoms have been noticed by patient.
Age: 61.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: Patient presented to clinic today and received a hepatitis B vaccine.  He reports that after the vaccine he felt dizzy and lightheaded and started sweating. -  He reports that he is now feeling better.  He did have some apple juice and was able to sit for a while and now feels well.  No longer having any symptoms when seen by physician.                                                                                                                                                                                         States that he has always had this happen with vaccines and blood draws.  This has been happening ever since he was a kid.  He wonders why this is the case.
Age: 52.0
Sex: F
Vaccine: PNC21
Symptoms: Burning sensation, Erythema, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: REDNESS AND SORENESS AT INJECTION SITE, FEVER, PAIN IN AREA OF KIDNEY. FELT LIKE ON FLAME AND REDNESS ON INNER THIGH.
Age: 52.0
Sex: F
Vaccine: PNC21
Symptoms: Renal pain
Clinical narrative: REDNESS AND SORENESS AT INJECTION SITE, FEVER, PAIN IN AREA OF KIDNEY. FELT LIKE ON FLAME AND REDNESS ON INNER THIGH.
Age: 8.0
Sex: M
Vaccine: TYP, YF
Symptoms: Pallor, Thirst
Clinical narrative: After about 10 minutes from receiving the vaccines, patient stated he was feeling very thirsty. Mom noticed patient looked a little pale in the face. I walked over to the patient to check vaccine injection sites for any reaction, no reaction seen. I noticed as well that he was pale. Mom and I had patient lay down on exam table. I had the provider come back into the room and we raised his feet into the air and check his vitals. Had the epi-pen available if needed. We had patient drink a little bit of water and some apple juice. Patient started feeling better and his color was coming back. We had patient wait in the exam room for an additional 15-20 Minutes before provider felt he was ok to leave.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Extra dose administered, Lower urinary tract symptoms, Pain, Pruritus
Clinical narrative: Patient was administered a 3rd dose by mistake thinking she only had one dose on 4/24. had fever chills body aches and vomiting from vaccine administration to 2 days after.  after 10 days has chills, scalp itching (also has possible UTI today)
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Urine analysis, Vomiting
Clinical narrative: Patient was administered a 3rd dose by mistake thinking she only had one dose on 4/24. had fever chills body aches and vomiting from vaccine administration to 2 days after.  after 10 days has chills, scalp itching (also has possible UTI today)
Age: 40.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Tinnitus
Clinical narrative: Ringing of the LEFT ear.
Age: 77.0
Sex: F
Vaccine: HEPAB, VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pain, Paraesthesia, Pruritus
Clinical narrative: Redness at injections site., Soar, Redness on face and itching/tingle
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Parosmia, Tinnitus
Clinical narrative: Following first shot, constant ringing in my right ear developed and experienced the smell of onions. The phantom smell dissipated after a day or two but the ringing in the right ear has been constant since 1 Apr 2021.
Age: 25.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Injection site haemorrhage, Paraesthesia, Peripheral swelling
Clinical narrative: Heplisav-B dose 2 of 2 and Varicella 2 of 2 given in clinic.  10 minutes post vaccination patient stated she began feeling a tingling sensation in her left arm where the varicella vaccine was given. She reports that it radiated from her shoulder down into her fingers. She reported to nurse that she felt her left hand was beginning to swell. Nurse observed petechiae around injection site 10 minutes post vaccination. Petechiae did not spread further then around injection site.  Clinic provider ordered 25mg PO Benadryl STAT to be given, and ice pack applied to site. Patient rested in chair and was observed in clinic for 3 hours. Symptoms began improving 20 minutes after Benadryl was given. At the end of 3-hour observation period petechiae around injection site was minimal, patient reported itching sensation went from severe to mild, and patient reported the swelling sensation in her left hand decreased. No symptoms occurred in arm that Heplisav-B was given.
Age: 1.08
Sex: F
Vaccine: VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: 3/15 Patient arrived with parent and received Varicella vaccine by RN  Patient was given MMR 10 days prior. Dose not valid 5/29 Parent notified by physician, patient doing well and will receive Varicella dose at 2 year visit
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Rash
Clinical narrative: 1 day later developed rash on buttocks, pubic area, bilateral legs and antecubital fossae. Rash resolved with Hibilcens wash, oral clindamycin, and topical mupirocin.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles to underside of right breast with pain to the area noted on 4/25-25 2246.  COVID19 vaccine given on 4/21 between 1100-1300.  Treated with Valtrex 500 mg TID until 5/3/25
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Bursitis, Pain, Periarthritis, X-ray limb
Clinical narrative: Frozen shoulder -adhesive bursitis,  shoulder pain, physical therapy,  stable but still painful on certain movements
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Extra dose administered
Clinical narrative: Patient was seen at his doctors on 5/28/25 and received a Tdap vaccine. Patient came to school vaccine clinic and grandfather consented to patient getting Tdap - did not state that patient had received it on 5/28/25. Tdap was administered, again, on 5/30/25.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram head, Dizziness, Headache, Hypoaesthesia, Laboratory test
Clinical narrative: Dizziness/lightheadedness, Numbness to the face/head, Severe muscle weakness, POTS, Tachycardia/Palpitations, Headaches.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging head, Magnetic resonance imaging neck, Magnetic resonance imaging spinal, Muscular weakness, Palpitations
Clinical narrative: Dizziness/lightheadedness, Numbness to the face/head, Severe muscle weakness, POTS, Tachycardia/Palpitations, Headaches.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Postural orthostatic tachycardia syndrome, Tachycardia
Clinical narrative: Dizziness/lightheadedness, Numbness to the face/head, Severe muscle weakness, POTS, Tachycardia/Palpitations, Headaches.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropathy, Bedridden, Cardiac disorder, Headache, Hypoaesthesia
Clinical narrative: Site injection started to swell up and then got sore per usual for a vaccine.  Immediately was sick that evening with headache, horrific BODY ACHES , numbness and tingling in my extremities.  Rash all over but suffered through it.  I knew that whatever that vaccine contained was NOT  SUPPOSED  to go into a human body!! Refused any other vaccines and quit my job. Became unemployed after that day of taking that poison.  I?ve now suffered with heart issues inflammation all over my body. They don?t know what?s wrong with me, but they know somethings wrong. I?ve been to every specialist under the sun multiple times. And all my joints are wasting away. I also have a bad heart now.  I was healthy and working. I am bed fast now and disabled. I am in severe pain on a daily basis.   I have to have both of my knees replaced and I?m 46 years old.  I?ve had rashes uncontrollably all over my face, leaving scars on my arms and legs with white stringy things that come out of them.  I would love to know what it is, but I do know that it?s some form of their site.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Injection site pain, Injection site swelling, Laboratory test, Muscle atrophy
Clinical narrative: Site injection started to swell up and then got sore per usual for a vaccine.  Immediately was sick that evening with headache, horrific BODY ACHES , numbness and tingling in my extremities.  Rash all over but suffered through it.  I knew that whatever that vaccine contained was NOT  SUPPOSED  to go into a human body!! Refused any other vaccines and quit my job. Became unemployed after that day of taking that poison.  I?ve now suffered with heart issues inflammation all over my body. They don?t know what?s wrong with me, but they know somethings wrong. I?ve been to every specialist under the sun multiple times. And all my joints are wasting away. I also have a bad heart now.  I was healthy and working. I am bed fast now and disabled. I am in severe pain on a daily basis.   I have to have both of my knees replaced and I?m 46 years old.  I?ve had rashes uncontrollably all over my face, leaving scars on my arms and legs with white stringy things that come out of them.  I would love to know what it is, but I do know that it?s some form of their site.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Paraesthesia, Rash, Scar
Clinical narrative: Site injection started to swell up and then got sore per usual for a vaccine.  Immediately was sick that evening with headache, horrific BODY ACHES , numbness and tingling in my extremities.  Rash all over but suffered through it.  I knew that whatever that vaccine contained was NOT  SUPPOSED  to go into a human body!! Refused any other vaccines and quit my job. Became unemployed after that day of taking that poison.  I?ve now suffered with heart issues inflammation all over my body. They don?t know what?s wrong with me, but they know somethings wrong. I?ve been to every specialist under the sun multiple times. And all my joints are wasting away. I also have a bad heart now.  I was healthy and working. I am bed fast now and disabled. I am in severe pain on a daily basis.   I have to have both of my knees replaced and I?m 46 years old.  I?ve had rashes uncontrollably all over my face, leaving scars on my arms and legs with white stringy things that come out of them.  I would love to know what it is, but I do know that it?s some form of their site.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness
Clinical narrative: lingering stiffness in right arm/deltoid
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dry throat, Fatigue
Clinical narrative: Experienced fatigue for the first 3-4 days, dry throat, and chronic cough - still coughing (over 1 week).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dry throat, Fatigue
Clinical narrative: Experienced fatigue for the first 3-4 days, dry throat, and chronic cough - still coughing (over 1 week).
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Unevaluable event
Clinical narrative: no tx needed
Age: 37.0
Sex: F
Vaccine: MMR
Symptoms: Product preparation issue
Clinical narrative: Priorix antigen was not reconstituted with diluent, so only diluent was administered to patient.
Vaccine: HPV9
Symptoms: No adverse event, Syringe issue
Clinical narrative: No adverse event; reported on behalf of HCP that a GARDASIL 9 syringe broke while a nurse in the practice was administering to a patient.  Unkown at time of report if patient actually received the dose.  Filing this precautionary AE.  No additional information pro; Poor quality device used; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.   The patient's medical history, concurrent conditions, and concomitant therapies were not reported.   On 22-APR-2025, the patient was vaccinated with human papillomavirus 9-valent vaccine, recombinant (GARDASIL 9) administered by intramuscular route as prophylaxis (dose, anatomical location, lot # and expiration date were not reported). On that same day, the reporter informed that the syringe broke while a nurse in the practice was administering to a patient (however it was unknown if patient actually received the dose). On that same day, another nurse was injured in the practice while administering product (captured in case #2282098) No additional adverse events reported. Lot # is being requested and will be submitted if received.  This is non-valid report due to lack of patients' identifiers.  This is one of several reports received from the same reporter.
Age: 52.0
Sex: M
Vaccine: VARCEL
Symptoms: Wrong product administered
Clinical narrative: HCP confirmed that patient did not have any symptomatic events; HCP reported that a patient who initially was looking to receive SHINGRIX was accidently administered VARIVAX; This spontaneous report was received from a Register Nurse and refers to a 52-year-old male patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 02-MAY-2025, the patient was accidentally vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), Injection (lot #, dose, strength, route of administration and anatomical location of vaccine and expiration date were not reported) diluted with sterile diluent (MERCK STERILE DILUENT); instead of a dose of Varicella zoster vaccine rgE (CHO) (SHINGRIX) (Wrong vaccine administered) for prophylaxis. It was confirmed that the patient did not have any symptomatic events.   Lot # is being requested and will be submitted if reported.
Vaccine: MMR
Symptoms: No adverse event, Underdose
Clinical narrative: no adverse event; some of the vaccine spilled out  resulting in a lower than recommended dose; some of the vaccine spilled out; that this was a user error; This spontaneous report was received from a medical assistant and refers to a 9-month-old patient of unknown gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 12-May-2025, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (lot #X028353 was verified to be a valid number, expiration date: 11-Dec-2025) (dose, scheme, injection site, formulation and route of administration was not reported), reconstituted with sterile diluent (BAXTER Sterile Diluent) (dose, formulation, expiration date and lot # were not reported) for prophylaxis; while administering some of the vaccine spilled out (product leakage) resulting in a lower than recommended dose (underdose). The Medical Assistant reports that this was a user error (wrong technique in product usage process) and not related to any product quality issue with the vaccine or syringe. No additional adverse event was reported.
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: confirmed that patient had no symptomatic events; patient had accidently received PROQUAD and VARIVAX; This spontaneous report was received from a nurse 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 19-MAY-2025, the patient was accidently vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX  REFRIGERATOR STABLE), Injection (lot # and expiration date were not reported) with sterile diluent (MERCK STERILE DILUENT), Solution for injection (lot # and expiration date were not reported) and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), Injection (lot # and expiration date were not reported) with sterile diluent (MERCK STERILE DILUENT) for prophylaxis (Accidental overdose). The patient had no symptomatic events (No adverse event). Lot # is being requested and will be submitted if received.
Vaccine: PNC15
Symptoms: No adverse event, Syringe issue
Clinical narrative: no injury to patient, No additional AE; a broken finger flange for VAXNEUVANCE during administration on 05/20/2025, "near the barrel at the end of the plunger" for the broken finger flange; a broken finger flange for VAXNEUVANCE during administration on 05/20/2025, "near the barrel at the end of the plunger" for the broken finger flange; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 20-May-2025, the patient was vaccinated with Pneumococcal 15-valent Conjugate Vaccine (VAXNEUVANCE) (lot #Y019380, expiration date reported as and upon internal validation confirmed to be 28-May-2027) (dose, route of administration and vaccination site were not reported) administered for prophylaxis. The nurse reported a broken finger flange for with Pneumococcal 15-valent Conjugate Vaccine (VAXNEUVANCE) during administration (poor quality device used). The location was described as "near the barrel at the end of the plunger" for the broken finger flange (syringe issue). Defective unit has been set aside for return and photos were provided. No injury to patient was confirmed (no adverse event). No other information was available. No additional adverse event (AE) and no additional product quality complaint (PQC) was noted.; Sender's Comments: Priority : 5 , Is case serious : No , number : , number : , number : , number : 500UW00000bQFPWYA4|28052025230010|6658 , Central date : 2025-05-29 , Classification :, Attachment description : Call , Safety case number : , case number : , interaction number : , Integration log UniqueID : 500UW00000bQFPWYA4|28052025230010|6658 , Service cloud CaseID : 500UW00000bQFPWYA4
Vaccine: VARCEL, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No Side effects or symptoms reported.; HCP called to report one patient received VARIVAX after a temperature excursion.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 20-May-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX  REFRIGERATOR STABLE) injection (lot #Y003892, expiration date: 06-Feb-2026) 0.5 mL as prophylaxis, the vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported) which experienced a temperature excursion (Improper storage of product in use) at 14.2F for 1 hour 3 minutes 0 seconds. No previous excursions. No Side effects or symptoms reported (No adverse event).
Sex: F
Vaccine: HEPA
Symptoms: Crying, Decreased appetite, Fontanelle depressed, Pyrexia
Clinical narrative: not eating very well; potential dehydration.; meant to receive VAXELIS but received VAQTA; Inconsolable the night after the administration; HCP called to report a 2-month-old patient was administered a VAQTA vaccine and experienced a fever and was inconsolable the night after the administration. HCP states the patient was meant to receive VAXELIS but received VAQTA instead and is now pre; Fever; Slightly sunken fontanelle; This spontaneous report was received from a physician and refers to a 2-month-old female patient.   The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications were not reported.  On 28-May-2025, the patient was vaccinated with Hepatitis A Vaccine, Inactivated (VAQTA) at a dose of 0.5 mL, administered intramuscularly for vaccination (lot number and expiration date were not reported), instead of Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Protein Conjugate], and Hepatitis B [Recombinant] Vaccine (VAXELIS) (dose, indication, lot number, and expiration date were not reported). (Wrong product administered, Product administered to patient of inappropriate age).  On 28-May-2025, the patient experienced fever (pyrexia) and was inconsolable the night after the administration (emotional distress). On 29-May-2025 (reported as a day later), the patient went to the emergency room, afebrile (conflicting information, fever was also reported as not recovered), not eating very well (decreased appetite), and with a slightly sunken fontanelle (fontanelle depressed) that indicated potential dehydration. At the time of the report, the patient had not recovered from the events.   The causal relationship between the events and Hepatitis A Vaccine, Inactivated was not provided.; Reporter's Comments
Vaccine: FLUN3
Symptoms: Influenza like illness
Clinical narrative: Patient has flu-like symptoms and feels like she got the flu from FluMist; A spontaneous report has been received from a other health professional. The report concerns a female patient (age 62 years).  The patient's past and current medical history included fainting (dates not reported).  No concomitant products were reported.  The patient received Flumist (batch number(s) WF2582), via nasal use on 30-OCT-2024. The patient received 1 dose(s).   It is unknown who administered Flumist to the patient.  On an unknown date, the patient experienced patient has flu-like symptoms and feels like she got the flu from flumist (preferred term: Influenza).      Action taken with suspect is not applicable.  The outcome of the event(s) of patient has flu-like symptoms and feels like she got the flu from flumist was unknown.      The event was considered non-serious.      Device Information:  Combination Product Report: Yes  Product As Reported: Flumist Brand Name: FLUENZ TETRA, FLUENZ TETRA, FLUMIST Product Role:Suspect Manufacturer Name:ASTRAZENECA Labeled for single use:No; Sender's Comments: This case does not meet the criteria for company clinical comment
Vaccine: FLUN4
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: On 15Dec2024 patient received dose of FluMist that expired on 09Dec2024; C: Nurse at HCP office administered expired dose of FluMist; A spontaneous report has been received from a other health professional. The report concerns a female patient born in 1990.  No medical history was reported.   No concomitant products were reported.  The patient received Flumist, Influenza Virus Vaccine Polyvalent, Q/Laiv (batch number(s) Unknown) (expiration date(s) 09-DEC-2024), via unspecified route, on 15-DEC-2024. The patient received 1 dose(s).    On an unknown date, the patient experienced on 15dec2024 patient received dose of flumist that expired on 09dec2024 (preferred term: Expired product administered) and c: nurse at hcp office administered expired dose of flumist (preferred term: Wrong technique in product usage process).      At the time of reporting, the event c: nurse at hcp office administered expired dose of flumist was ongoing. The outcome of the event(s) of on 15dec2024 patient received dose of flumist that expired on 09dec2024 was unknown.      The events were considered non-serious.      This case was marked as suppressed due to Misuse/Product use issues with no associated AE.  Device Information:  Combination Product Report: Yes  Product As Reported: Flumist, Influenza Virus Vaccine Polyvalent, Q/Laiv Brand Name: FLUMIST, INFLUENZA VIRUS VACCINE POLYVALENT, Q/LAIV Product Role:Suspect Manufacturer Name:ASTRAZENECA Labeled for single use:No  Corrected report the event inappropriate schedule of drug administration deleted as it was already coded in the event expired product administered and Flumist was re coded correctly. Narrative was updated., case suppressed  due to Misuse/Product use issues with no associated AE. Case corrected in response to data correction request DCR-011041-A
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient received the second dose of Shingrix on 22 May 2025; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number AHACIMBM51LI) for prophylaxis.   Previously administered products included Shingrix (patient received the first dose of Shingrix on 20 January 2020).   On 22-MAY-2025, the patient received the 2nd dose of Shingrix. On 22-MAY-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: The patient received the second dose of Shingrix on 22 May 2025). The outcome of the drug dose administration interval too long was not applicable.   Additional Information: GSK receipt date: 26-MAY-2025 The reporter was the patient. Patient asked what information do we currently have regarding Shingrix effectiveness when the two doses are widely separated, in my instance by more than five years? The patient received the first dose of Shingrix on 20th January 2020. The patient received the second dose of Shingrix on 22th May 2025, which led to drug dose administration interval too long
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Reporting because the vaccine was expired by 8 days; This non-serious case was reported by a nurse via sales rep and described the occurrence of expired vaccine used in a 21-year-old female patient who received HBV (Engerix B adult) (expiry date MAY-2025) for prophylaxis.   On 28-MAY-2025, the patient received Engerix B adult. On 28-MAY-2025, an unknown time after receiving Engerix B adult, the patient experienced expired vaccine used (Verbatim: Reporting because the vaccine was expired by 8 days). The outcome of the expired vaccine used was not applicable.   Additional Information: GSK Receipt Date: 28-MAY-2025 The nurse reported because the vaccine was expired by 8 days and which was administered by patient, which led to expired vaccine used.
Vaccine: RVX
Symptoms: Cough, Respiratory syncytial virus infection, Vaccination failure
Clinical narrative: Suspected vaccination failure; Respiratory syncytial virus infection; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   In OCT-2023, the patient received RSV vaccine. On 08-APR-2025, between 1 and 2 years after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: Respiratory syncytial virus infection). The outcome of the vaccination failure and respiratory syncytial virus infection were not reported.   It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection to be related to RSV vaccine.     The company considered the vaccination failure to be unrelated to RSV vaccine. It was unknown if the company considered the respiratory syncytial virus infection to be related to RSV vaccine.   Additional Information: GSK Receipt Date:08-MAY-2025 This case was reported by a consumer via interactive digital media. The patient got the RSV vaccine and immunity only lasted 2 years. The reporter stated that you could only get it once. The patient got RSV, and it was horrible and now he/she had a constant chronic cough. Pulmonologist said this cough might last for months. This case was considered as suspected vaccination failure as details regarding laboratory test confirming respiratory syncytial virus infection was unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about  laboratory confirmation of disease) is considered unrelated to GSK vaccine RSV vaccine
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; friend of mine got the two shot and ended up with Shingles a year later.; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, more than a year after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: friend of mine got the two shot and ended up with Shingles a year later.). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 25-MAY-2025 This case was reported by a patient via interactive digital media. A friend of a reporter got the two shot and ended up with Shingles. It wasn't too bad but still you can get Shingles no matter what. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding exact time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 and Dose 2).
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash
Clinical narrative: I have a friend that wishes she never got the shots as they only suppressed the rash; only suppressed the rash, not the pain and it will keep coming back for the rest of her life; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of rash in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced rash (Verbatim: I have a friend that wishes she never got the shots as they only suppressed the rash) and pain (Verbatim: only suppressed the rash, not the pain and it will keep coming back for the rest of her life). The outcome of the rash was resolving and the outcome of the pain was not reported.   It was unknown if the reporter considered the rash and pain to be related to Shingles vaccine.     It was unknown if the company considered the rash and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 24-MAY-2025 This case was reported by a consumer via interactive digital media. They advised not to get the shots, and instead to see a physician on the first day of the rash, as it usually cleared up quickly for most people. They mentioned having a friend who wished she had never received the shots, as they had only  suppressed the rash but not the pain, and the condition kept recurring for the rest of her life.