chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: it said that administer subcutaneously, we did one intramuscularly; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a patient who received MMR (Priorix) for prophylaxis.   On an unknown date, the patient received Priorix (intramuscular). On an unknown date, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: it said that administer subcutaneously, we did one intramuscularly). The outcome of the subcutaneous injection formulation administered by other route 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: 03-APR-2025 It was reported for the MMR, Priorix vaccine, it said to administer subcutaneously, they did one intramuscularly which led to subcutaneous injection formulation administered by other route. The reporter wanted to know about the side effects or what happens, and asked If it is not effective.
Vaccine: DTAP, DTAPIPV, FLU3, HEP, MENB, TDAP
Symptoms: Product storage error
Clinical narrative: Possible administration of vaccines after temperature excursion; This non-serious case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis, HBV (Engerix B) for prophylaxis, Flu Seasonal TIV Quebec (Flulaval) for prophylaxis, DTPa (Infanrix) for prophylaxis and DTPa-IPV (Kinrix) for prophylaxis.   On an unknown date, the patient received Bexsero, Boostrix, Engerix B, Flulaval, Infanrix and Kinrix. On an unknown date, an unknown time after receiving Bexsero, Boostrix, Engerix B, Flulaval, Infanrix and Kinrix, the patient experienced incorrect storage of drug (Verbatim: Possible administration of vaccines after temperature excursion). The outcome of the incorrect storage of drug 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: 03-APR-2025 The doctor called to report Bexsero, Boostrix, Engerix-B, Flulaval, Infanrix, Kinrix experienced a temperature excursion at 24.2°F for 14 hours and after that was possible some of the vaccines were administered but did not had any more information, which led to incorrect storage of drug. The Vaccine Administration Facility was the same as Primary Reporter.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient had first dose one year ago/late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 69-year-old male patient who received Herpes zoster (Shingrix) (batch number f95ys, expiry date 31-MAR-2027) for prophylaxis.   Previously administered products included Shingrix (Patient had first dose one year ago).   On 04-APR-2025, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: patient had first dose one year ago/late second dose). The outcome of the drug dose administration interval too long was not applicable.   Additional Information: GSK Receipt Date: 04-APR-2025 Patient had 1 dose Shingrix 1 year ago and second dose on the day of reporting. Also asked how many doses does patient need of Shingrix if 2 dose given 1 year after 1st. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule.
Age: 0.5
Sex: F
Vaccine: HIBV
Symptoms: Paralysis
Clinical narrative: palsy-like" reaction at 6 months of age after receiving ACTHIB and VAXELIS; Initial information received on 08-Apr-2025 regarding an unsolicited valid serious case received from a other health professional.  This case involves a 6 months old female patient who had palsy-like" reaction at 6 months of age after receiving HIB (PRP/T) vaccine [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 22-Jul-2024, the patient received a 0.5ml dose of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection standard strength, frequency-once, (lot number, expiry date-unknown) via unknown route in unknown administration site for Immunization.  On an unknown date the patient developed a serious palsy-like" reaction at 6 months of age after receiving acthib and vaxelis (paralysis) (latency-6 months).  Reportedly- The patient continues to see a neurologist since the adverse reaction. Caller didn't have any further information about current symptoms/treatment other than the patient sees a neurologist for ongoing problems. The patient received the products at another pediatrician's office, so the details of administration are limited.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  Seriousness Criteria- This event is assessed as medically significant.; Sender's Comments: Sanofi company comment dated 11-Apr-2025: This case involves a 6 months old female patient who had palsy-like" reaction at 6 months of age after receiving HIB (PRP/T) vaccine [ACT-HIB].Further information regarding regarding allergic history, medical history, concomitant medication and tolerance,  laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: IPOL that was no longer viable was given to a patient after temperature excursion (with no reported adverse event); Initial information received on 08-Apr-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who received IPV (VERO) [IPOL] which  was no longer viable given to a patient after temperature excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown  dose of suspect IPV (VERO) lot W1C831M,expiry date :18-Nov-2025  via unknown route in unknown administration site for Immunization which was no longer  viable after temperature excursion (with no reported adverse event) (poor quality product administered) (latency: same day)  Reportedly, Caller states that one their providers called previously to report a temperature excursion and some of the vaccines were not viable. She is calling to get information if they need to re-vaccinate the patient if the vaccine that was given were not viable. She states they had MENQUADFI, ACT-HIB, IPOL, QUADRACEL, PENTACEL, and TENIVAC but only MENQUADFI, QUADRACEL and IPOL were given to a patient after the excursion.  Action taken  was not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2025SA102586: US-SA-2025SA101723:
Age: 25.0
Sex: F
Vaccine: MEN, MMR
Symptoms: No adverse event, Product preparation error
Clinical narrative: vaccine mix-up" and that the MENQUADFI was beside the diluent for MMR-II/mistakenly combined the MENQUADFI with the MMR-II/administered this mixture to patient, with no reported adverse event; vaccine mix-up" and that the MENQUADFI was beside the diluent for MMR-II/mistakenly combined the MENQUADFI with the MMR-II/administered this mixture to patient, with no reported adverse event; Initial information received on 10-Apr-2025 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case is linked to US-SA-2025SA105121 (Cluster case).  This case involves a 25 years old female patient who experienced a vaccine mix-up" and that the Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] was beside the diluent for mmr-ii/mistakenly combined the menquadfi with the mmr-ii and the patient was administered this mixture, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 10-Apr-2025, the patient received a 0.5 ml dose of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine Solution for injection (lot U7852AB , Expiry: 31-Oct-2025) (Strength: Standard) via intramuscular route in the left arm as immunization which was mistakenly mixed with Mmr ii as diluent, the menquadfi was beside the diluent for mmr-ii with no reported adverse event (product preparation error) (poor quality product administered) (Latency: same day).  Reportedly, They said that these patients did not need MENQUADFI. Pharmacist said that patients did not report any adverse events.   Action taken: not applicable.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2025SA105121:
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site erythema, Injection site swelling, Muscular weakness
Clinical narrative: Severe redness and swelling at injection site, nausea, fatigue, muscle weakness , severe HA.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: Severe redness and swelling at injection site, nausea, fatigue, muscle weakness , severe HA.
Age: 11.0
Sex: M
Vaccine: UNK
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth, Pyrexia
Clinical narrative: Left arm vaccination site 8x6 inches - warm to the touch, hard, red and inflammed. Fever experienced 4/10/25.
Age: 40.0
Sex: M
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Pediatric dose of Vaqta (0.5 ml IM) administered to an adult patient. Pt will be recalled to receive correct dose.
Age: 0.25
Sex: F
Vaccine: COVID19, FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: dose was given to soon before the right age. Patient made aware of it as soon as it happened and has not reported any adverse physical  events.
Age: 72.0
Sex: F
Vaccine: PNC20, TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Administered Prevnar 20 dose 4/7/2025 when patient had been vaccinated 11/08/2023, outside of CDC guideline.
Age: 1.42
Sex: M
Vaccine: DTAP
Symptoms: Peripheral swelling
Clinical narrative: Diffuse limb swelling. Entire thigh where vaccine was injected.
Age: 51.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Extra dose administered
Clinical narrative: Vaccine was given on March 17th, ten days past beyond use date.  Vaccine had been stored at frozen, then thawed on January 10, 2025 and stored at 2C.  Eight weeks of eligible use in the fridge ended on March 7th.  Patient did not report any adverse events related this to this vaccine administration.  Revaccination was offered to patient and he is considering it.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Malaise, Pallor
Clinical narrative: Approximately 5 min after receiving 3 vaccinations, student appeared pale in the face, leaning forward in her chair, stated feeling sick. RN vaccinated stayed with patient and called for assistance. Post-vac RN and another RN assisted student, obtained BP 98/72, oxygen level 99%, 61HR. Student vomited, small amount, while sitting on chair, able to still follow commands, oriented x3. Student rested at the station for about 5 more minutes, wheelchair was brought and student escorted to nurse station for further monitoring. School nurse contacted student's parents to notify them of situation.  No known prior reaction to vaccinations or medical conditions on record. Patient denied any chance of pregnancy, confirmed no known allergies. Student denied having any breakfast prior to receiving vaccinations.
Age: 47.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Hypoaesthesia
Clinical narrative: patient states that in March of 2025 she began feeling numbness to her feet that then went up to her legs and eventually her waist which prompted her to visit the ER, she states she was in the hospital for some time and now she is following with a neurologist she states she is unsure if it could be the vaccine but her doctors wanted to know what ones she got the day she was here.
Age: 33.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was given on March 11th, four days past beyond use date.  Vaccine had been stored at frozen, then thawed on January 10, 2025 and stored at 2C.  Eight weeks of eligible use in the fridge ended on March 7th.  Patient did not report any adverse events related this to this vaccine administration.  Revaccination was offered to patient and he is considering it.
Age: 21.0
Sex: F
Vaccine: SMALLMNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was given on March 10th, three days past beyond use date.  Vaccine had been stored at frozen, then thawed on January 10, 2025 and stored at 2C.  Eight weeks of eligible use in the fridge ended on March 7th.  Patient did not report any adverse events related this to this vaccine administration.  Revaccination was offered to patient  and she was revaccinated on 3/26/2025.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Urticaria
Clinical narrative: hives located on the arm of which patient received the immunizations and spread to face
Age: 24.0
Sex: F
Vaccine: SMALLMNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was given on March 11th, four days past beyond use date.  Vaccine had been stored at frozen, then thawed on January 10, 2025 and stored at 2C.  Eight weeks of eligible use in the fridge ended on March 7th.  Patient did not report any adverse events related this to this vaccine administration.  Revaccination was offered to patient and she declined.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: PATIENT WAS GIVEN THE PEDIATRIC FORMULATION OF THE COVID VACCINE. PATIENT WAS CONTACTED TO OFFER THE CORRECT FORMULATION BUT PATIENT DENIED THE CORRECT VACCINE AT THIS TIME AND STATES THEY WILL RECEIVE IT NEXT YEAR.
Age: 39.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was given on March 10th, three days past beyond use date.  Vaccine had been stored at frozen, then thawed on January 10, 2025 and stored at 2C.  Eight weeks of eligible use in the fridge ended on March 7th.  Patient did not report any adverse events related this to this vaccine administration.  Revaccination was offered to patient and he is considering it.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC20, VARCEL
Symptoms: Culture throat negative, Influenza virus test negative, Pyrexia, Rash, Respiratory tract congestion
Clinical narrative: Fever and congestion started 3/23/25 100.5F. He had PET placed monday 3/24/25. That evening he spiked fever 102.8F, up to 104.1F Tuesday 3/25/25. He was seen in office Wednesday 3/26/25 after having a fever 102.6. He had a rapid strep that was negative, throat culture ended up resulting negative as well. Rash developed as small red dots on back of neck/upper back on Wednesday. Thursday 3/27/25 the rash spread to his face - small red dots. Persistent fever 103.5F that day. The rash spread down over chest, back, torso and he developed red watery eyes. He was very fatigued, not eating well with decreased urine output. Then on Friday 3/28/25 he had a fever 102F and returned to office.  In office rapid covid-19 and flu swabs were negative. Due to concerning timeline of rash, Measles oropharyngeal PCR and serum IgM were sent. The rash reached its peak on Saturday 3/29/25 which was his last day of fever 101F.  On Monday 3/31/25 his measles PCR resulted positive, which was sent to the state health department who ran genotype testing and determined that it was vaccine type (not wild type measles virus) and the IgM resulted negative. His rash began to improve after 3/31/25.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC20, VARCEL
Symptoms: SARS-CoV-2 test negative, Streptococcus test negative
Clinical narrative: Fever and congestion started 3/23/25 100.5F. He had PET placed monday 3/24/25. That evening he spiked fever 102.8F, up to 104.1F Tuesday 3/25/25. He was seen in office Wednesday 3/26/25 after having a fever 102.6. He had a rapid strep that was negative, throat culture ended up resulting negative as well. Rash developed as small red dots on back of neck/upper back on Wednesday. Thursday 3/27/25 the rash spread to his face - small red dots. Persistent fever 103.5F that day. The rash spread down over chest, back, torso and he developed red watery eyes. He was very fatigued, not eating well with decreased urine output. Then on Friday 3/28/25 he had a fever 102F and returned to office.  In office rapid covid-19 and flu swabs were negative. Due to concerning timeline of rash, Measles oropharyngeal PCR and serum IgM were sent. The rash reached its peak on Saturday 3/29/25 which was his last day of fever 101F.  On Monday 3/31/25 his measles PCR resulted positive, which was sent to the state health department who ran genotype testing and determined that it was vaccine type (not wild type measles virus) and the IgM resulted negative. His rash began to improve after 3/31/25.
Age: 50.0
Sex: F
Vaccine: PNC20, UNK
Symptoms: Cellulitis, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Cellulitis-like reaction in the left arm near the bicep appearing approximately 24 hours post-vaccination measuring approximately 8 inches by 4 inches in size, raised, hot to the touch, sore to the touch. Still present 48 hours after vaccination (when this report was submitted); mild fever ~12 hours post-vaccination resolving after 8 hours.
Age: 64.0
Sex: M
Vaccine: MMR, PNC20
Symptoms: Extra dose administered
Clinical narrative: Patient came into facility for MMR vaccine. Review of his forecast done with a fellow staff, reviewed that he could receive Zoster and was up to date on PCV. Misinterpreted the communication and thought she had said that he needed the PCV vaccine.  Patient last received the PCV vaccine in December 2024. Patient was notified. Medical director notified as well.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Injection site rash, Lymphadenopathy, Nausea
Clinical narrative: Rash from injection site to the elbow, Axillary lymph node enlargement, Nausea
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site swelling, Pain in extremity, Pyrexia
Clinical narrative: Patient complained of fever as well as a red, sore arm.  Patient states arm is swollen at injection site around the size of a lemon
Age: 62.0
Sex: F
Vaccine: COVID19, TDAP
Symptoms: Aphasia, Brain fog, Electrocardiogram normal, Fatigue
Clinical narrative: Brain fog, fatigue, speech difficulty. Assessed in the ER for stroke (stroke work-up negative)
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Skin warm
Clinical narrative: Redness to arm. Warm at touch.
Age: 90.0
Sex: M
Vaccine: MNQ
Symptoms: Mobility decreased, Muscular weakness
Clinical narrative: IBC from daughter that they no longer require the vaccines. Patient was taken off Ultomiris as he had a reaction to the medication. Patient experienced muscle weakness and had trouble getting out of bed for 6 hours after first dose. With the second dose of the medication, patient was not able to get up for 3 days. Patient is currently in rehab. Doctor has cancelled any further Ultomiris doses and said due to his age they will try something less invasive. At his age of 91, his body just cannot tolerate the medication.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Psoriasis
Clinical narrative: Patient had an outbreak of psoriasis within days after 2nd Shingrix vaccine which required medical attention
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Syringe issue, Underdose
Clinical narrative: Needle entered arm but syringe would not push.  No vaccine went in arm.  Injection site developed some slight swelling.
Age: 0.75
Sex: M
Vaccine: DTAPIPV, FLU3, HIBV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse reactions. Patient tolerated vaccine well. Nurse and supervisor met and reviewed proper ages and dosage for vaccines and supervisor provided written educational materials to the nurse to review.
Age: 61.0
Sex: M
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Priorix given intramuscularly instead of subcutaneously, no reported adverse effects from patient reported
Age: 1.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Patient recieved MMRV and Varicella so 2 doses of varicella
Age: 27.0
Sex: M
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Patient received tetanus shot in his left arm on 1/30/25 and reported the following day on 1/31 of arm pain. Patient was advised to apply warm compress, take ibuprofen, and to move arm around. Patient reported stiffness and difficulty to move arm on 2/10/25, requested physical therapy ordered by primary care provider and reported on latest PT visit on 4/8/25 that therapy has helped with left arm pain.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Brain fog, Chills, Choking sensation, Depression, Dyspnoea
Clinical narrative: I had a minor laminectomy surgery on Feb 3rd, 2021. My doctor said it was ok to take Pfiser Covid vaccine in March when it came out. After my part 2 second shot, I woke up to a massive whole body muscle spasm and fell to the floor. I could not breathe properly and was shivering. I had brain fog. Form that point forward, i got worse to where i developed tinnitus in April, and could not stand up straight for more that 5 seconds, All doctors and physical therapists were puzzled as to why I was not recovering from the surgery like others. NO ONE questioned the vaccine until three years later! My  muscles atrophied and I could not breathe properly for months.  It felt like I was choking and my muscles were also not receiving oxygen. I felt I was dying. What made it worse is NO ONE questioned the vaccine! I had to find out from Facebook groups of people with similar symptoms. I tried natural therapies to repair the muscular and vascular damage,. I am still not fully recovered and very depressed and now I am an Anti Vaxxer! My symptoms are document at various doctors and physical therapists that NEVER suspected the vaccine. Now I hear from same doctors that many of the patients are complaining of similar injuries after the vaccine.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Dysstasia, Fall, Laboratory test, Muscle atrophy, Muscle injury
Clinical narrative: I had a minor laminectomy surgery on Feb 3rd, 2021. My doctor said it was ok to take Pfiser Covid vaccine in March when it came out. After my part 2 second shot, I woke up to a massive whole body muscle spasm and fell to the floor. I could not breathe properly and was shivering. I had brain fog. Form that point forward, i got worse to where i developed tinnitus in April, and could not stand up straight for more that 5 seconds, All doctors and physical therapists were puzzled as to why I was not recovering from the surgery like others. NO ONE questioned the vaccine until three years later! My  muscles atrophied and I could not breathe properly for months.  It felt like I was choking and my muscles were also not receiving oxygen. I felt I was dying. What made it worse is NO ONE questioned the vaccine! I had to find out from Facebook groups of people with similar symptoms. I tried natural therapies to repair the muscular and vascular damage,. I am still not fully recovered and very depressed and now I am an Anti Vaxxer! My symptoms are document at various doctors and physical therapists that NEVER suspected the vaccine. Now I hear from same doctors that many of the patients are complaining of similar injuries after the vaccine.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Tinnitus, Vascular injury
Clinical narrative: I had a minor laminectomy surgery on Feb 3rd, 2021. My doctor said it was ok to take Pfiser Covid vaccine in March when it came out. After my part 2 second shot, I woke up to a massive whole body muscle spasm and fell to the floor. I could not breathe properly and was shivering. I had brain fog. Form that point forward, i got worse to where i developed tinnitus in April, and could not stand up straight for more that 5 seconds, All doctors and physical therapists were puzzled as to why I was not recovering from the surgery like others. NO ONE questioned the vaccine until three years later! My  muscles atrophied and I could not breathe properly for months.  It felt like I was choking and my muscles were also not receiving oxygen. I felt I was dying. What made it worse is NO ONE questioned the vaccine! I had to find out from Facebook groups of people with similar symptoms. I tried natural therapies to repair the muscular and vascular damage,. I am still not fully recovered and very depressed and now I am an Anti Vaxxer! My symptoms are document at various doctors and physical therapists that NEVER suspected the vaccine. Now I hear from same doctors that many of the patients are complaining of similar injuries after the vaccine.
Age: 0.5
Sex: M
Vaccine: MNQ
Symptoms: Wrong product administered
Clinical narrative: DO asked MA to not let patient leave as pt has sickle cell anemia and needs an Menveo vaccine. MA grab already mixed Menveo vaccine and administer vaccine in left thigh. Dr and MA didnt realize that there was another type of Menveo.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray normal, Computerised tomogram thorax normal, Cough, Fatigue, Oropharyngeal pain
Clinical narrative: Chronic lung phlegm, coughing, very frequent, also bad fatigue and some other symptoms which are not as bad like sore throat, but I am in a hurry to complete this form before you close me out.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Post-acute COVID-19 syndrome, Productive cough
Clinical narrative: Chronic lung phlegm, coughing, very frequent, also bad fatigue and some other symptoms which are not as bad like sore throat, but I am in a hurry to complete this form before you close me out.
Age: 74.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Patient given Priorix intramuscularly instead of the required subcutaneous route. Patient has not reported any adverse reaction to the incorrect route.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient presents to clinic for right sided shoulder pain following Pfizer covid-19 vaccine at the clinic yesterday 4/10 at approx 2:30 pm. Patient has had Moderna and Pfizer covid vaccines in past w/o incident Patient reports that at the time of injection there was no pain. However within 1 hour a sharp aching discomfort developed at injection site. Overnight the pain worsened and patient cannot move his arm all the way. Pain at rest 0/10 Pain with movement 8/10 OTC denies no previous injuries to the right shoulder, no surgeries to right shoulder.   Patient expresses concern over "seeing the nurse drop the vaccine on the floor before giving it to me"
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Induration, Peripheral swelling
Clinical narrative: Pt returned to clinic after 48 hours with  guarantor reporting swelling and redness around arm that started the next day after administration of vaccines. Pt came home from school  the day after vaccines at 13:00 reporting swelling of arm with no pain present.  Firmness in swelling felt around deltoid muscle . Pt returned to clinic after 48 hrs for f/u  with visible swelling and redness noted in length 6 inchs x width 6 inchs  . Upper arm swelling measurements taken around entire arm were 9 inches compared to non vaccinated arm of 7 inches around. Prescribed antibiotic and Benadryl by PCP.  Mother instructed to continue to monitor and mark new changes if increased swelling or report any changes as needed  and return to clinic asap with any new concerns.  Educated on worsening S/S and to return to clinic or go to nearest ER if necessary.
Age: 5.0
Sex: F
Vaccine: TYP
Symptoms: Incorrect dose administered
Clinical narrative: Multidose vial purchased erroneously and placed in the Polio location. MA did not verified vaccine. Counseling and training done with MA.
Age: 7.0
Sex: M
Vaccine: DTAP
Symptoms: Urticaria
Clinical narrative: Widespread hives all over patient's body.
Age: 4.0
Sex: M
Vaccine: TYP
Symptoms: Incorrect dose administered
Clinical narrative: Multidose vial purchased erroneously and placed in the Polio location. MA did not verified vaccine. Counseling and training done with MA.
Age: 9.0
Sex: F
Vaccine: HEP, IPV, MMR, MMR, TDAP
Symptoms: Circumstance or information capable of leading to medication error, No adverse event
Clinical narrative: Patient pulled arm away during subcutaneous administration of MMR vaccine to left arm. Less than half of the dose appeared to have been administered. Parent was informed and consented to re-administration of the vaccine. A repeat dose of the same MMR lot number was administered subcutaneously to the right arm. No adverse symptoms were observed.
Age: 2.0
Sex: F
Vaccine: TYP
Symptoms: Wrong product administered
Clinical narrative: Multidose vial purchased erroneously and placed in the Polio location. MA did not verified vaccine. Counseling and training done with MA.
Age: 19.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Patient complains of swelling, redness at site as well as rash at site of injection
Age: 71.0
Sex: F
Vaccine: PNC21, PNC21
Symptoms: Hypoaesthesia, Influenza like illness, Injection site pain, Nausea
Clinical narrative: She experienced flu-like symptoms the night of the vaccine. She states extremely painful arm at injection site.  Arm is still sore and mild numbness over a week later. States she slept for 24 hours after vaccine and was extremely nauseous.
Age: 71.0
Sex: F
Vaccine: PNC21, PNC21
Symptoms: Chills, Headache, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: She experienced flu-like symptoms the night of the vaccine. She states extremely painful arm at injection site.  Arm is still sore and mild numbness over a week later. States she slept for 24 hours after vaccine and was extremely nauseous.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster oticus
Clinical narrative: Ramsey Hunt Syndrome.  See Medical history
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site reaction
Clinical narrative: Moderate to severe injection site reaction over anterior R thigh, 10 - 12 cm in greatest dimension. Developed in first 24 hours. No systemic sx noted.  Advised cool compresses, Tylenol / Motrin PRN, and OTC topical 1% HC for itching PRN. Discussed signs of anaphylaxis, reasons to seek emergency care.
Vaccine: VARZOS
Symptoms: Hepatic enzyme increased
Clinical narrative: post-hepatic transplant so elevated liver labs/transient elevation in liver labs; liver transplant; This serious case was reported by a physician via sales rep and described the occurrence of elevated liver enzymes in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced elevated liver enzymes (Verbatim: post-hepatic transplant so elevated liver labs/transient elevation in liver labs) (serious criteria life threatening) and liver transplant (Verbatim: liver transplant) (serious criteria clinically significant/intervention required). The outcome of the elevated liver enzymes was resolved and the outcome of the liver transplant was not reported.   The reporter considered the elevated liver enzymes to be related to Shingrix. It was unknown if the reporter considered the liver transplant to be related to Shingrix.     The company considered the elevated liver enzymes and liver transplant to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 08-APR-2025 The reporter stated that the patient was post-hepatic transplant so elevated liver labs were serious, even if the elevated labs were transient.; Sender's Comments: Hepatic enzyme increased and Liver transplant are unlisted events which are considered unrelated to GSK vaccine Shingrix.
Age: 46.0
Sex: F
Vaccine: HEPAB
Symptoms: Dizziness, Dyspnoea, Nausea, Nervousness, Paraesthesia
Clinical narrative: After receiving  TwinRix vaccine, patient felt nervous, dizzy, light headed and nauseous, tingling in her hands and had shortness of breath. I called 911. Pt had some gatorade to drink.  She started feeling better later on.   Emt took her to hospital for further evaluation.
Age: 54.0
Sex: M
Vaccine: HEP
Symptoms: Rash
Clinical narrative: Patient reports rash all over body. Patient states rash subsided over a few days.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Pt presented with swollen, red, warm arm. Pt also had chills overnight. Pt c/o pain in the arm, pt reports pain when laying over affected arm or even when she lifts up her arm. Clinic provider will assess pt further and treat symptoms.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Pt presented with swollen, red, warm arm. Pt also had chills overnight. Pt c/o pain in the arm, pt reports pain when laying over affected arm or even when she lifts up her arm. Clinic provider will assess pt further and treat symptoms.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: 4/11/25 Pt reports being pregnant after administration of Varivax subcutaneously in the L upper arm for employment. No immediate side effects LMP 3/6/25, estimated due date per LMP 12/16/25. First OB appointment scheduled for 5/16/25.
Age: 15.0
Sex: F
Vaccine: HEP, IPV, MMR, TD, VARCEL
Symptoms: Dyskinesia, Loss of consciousness, Syncope
Clinical narrative: Hep B, Varicella  and Td administered in left deltoid. Following the 3rd vaccine the patient fainted and moved arms and legs involuntarily for less than 5 seconds. She regained consciousness in 1-2 minutes. She reports the same thing happened after the HPV vaccine when she got immunizations in 10/2024
Age: 25.0
Sex: M
Vaccine: HEPAB, HPV9, TDAP
Symptoms: Seizure
Clinical narrative: Patient received 3 vaccinations.  About 5 minutes after administration he proceeded to have a seizure for approx 1 min before losing consciousnous for approx 2 min.  Upon awakening he threw up.  EMS was called to the scene.  Pt began feeling much better afterwards.  EMS took vitals and Blood Sugar reading.  Pt was allowed to go home.  No history of seizures or prior adverse reactions were reported or claimed.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Mobility decreased, Rash, Secretion discharge
Clinical narrative: Spikevax administered on 3/22/25 @ 11:27 am.  PT reported that about an hour after vaccination, he started to get pain at the injection site.  The next morning pt felt that he could not move his arm and thought he was having a stroke.  Pt then noticed he was getting small raised bumps and eventually excesive mucus.  Pt took atarax on his own(has on hand for another condition) and called his PCP and infectious disease dr.  Pt was seen by both, who as per patient, agreed to monitor pt's condition.  At this time, while pt feels he has not fully recovered, he is improving and feels he will be recovered soon.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Laboratory test normal, Muscle spasms, Pollakiuria
Clinical narrative: Have had chest pains, trouble breathing pain in arms muscle spasm feel like throat is constantly closing can't eat or drink without it feeling like my throat is closing now can't stop using bathroom (peeing) and constipated
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Have had chest pains, trouble breathing pain in arms muscle spasm feel like throat is constantly closing can't eat or drink without it feeling like my throat is closing now can't stop using bathroom (peeing) and constipated
Age: 1.0
Sex: M
Vaccine: DTAPIPVHIB, HEPA, PNC15
Symptoms: Febrile convulsion, Influenza A virus test negative, Influenza B virus test negative, Respiratory syncytial virus test negative, SARS-CoV-2 test negative
Clinical narrative: Pt taken to ER with possible febrile seizure. Parent reported he was shaking and had foam near his mouth, lasted approx 10 mins per mom.  Mom gave 3.75mL Tylenol given at 2200. Parents state fever was 101.4 at home.
Age: 1.0
Sex: M
Vaccine: DTAPIPVHIB, HEPA, PNC15
Symptoms: Tremor
Clinical narrative: Pt taken to ER with possible febrile seizure. Parent reported he was shaking and had foam near his mouth, lasted approx 10 mins per mom.  Mom gave 3.75mL Tylenol given at 2200. Parents state fever was 101.4 at home.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC20
Symptoms: Crying, Dyspnoea, Hypotonic-hyporesponsive episode, Infant irritability, Pallor
Clinical narrative: Medical Assistant administered vaccines. Per her and father's report, patient's face started to turn white about 5 minutes after though was responsive, active, and smiling. Medical assistant informed provider and was advised to watch and wait in the room. About 5 minutes later medical assistant informed provider color was not returning. Provider went into the room. Patient had significant pallor, face was cold to touch, however was responsive, active, smiling. Continued to stay in the room to monitor. About 5 more minutes passed, patient started to get more color return to his face. Shortly after started to become irritable and started to cry intermittently, breaths appeared shallow, counted to be 42 breaths per minute, then became tired and seemed to have difficulty keeping his eyes open. Was responsive to stimuli however very drowsy. Would slightly respond when father tried to wake him. Concern for Hypotonic-hyporesponsive episode. EMS called. EMS arrived to exam room. Patient care summary printed with vaccines administered while EMS was present for them to take to the ER. Note completed after they were on their way to ER.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC20
Symptoms: Peripheral coldness, Somnolence
Clinical narrative: Medical Assistant administered vaccines. Per her and father's report, patient's face started to turn white about 5 minutes after though was responsive, active, and smiling. Medical assistant informed provider and was advised to watch and wait in the room. About 5 minutes later medical assistant informed provider color was not returning. Provider went into the room. Patient had significant pallor, face was cold to touch, however was responsive, active, smiling. Continued to stay in the room to monitor. About 5 more minutes passed, patient started to get more color return to his face. Shortly after started to become irritable and started to cry intermittently, breaths appeared shallow, counted to be 42 breaths per minute, then became tired and seemed to have difficulty keeping his eyes open. Was responsive to stimuli however very drowsy. Would slightly respond when father tried to wake him. Concern for Hypotonic-hyporesponsive episode. EMS called. EMS arrived to exam room. Patient care summary printed with vaccines administered while EMS was present for them to take to the ER. Note completed after they were on their way to ER.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Computerised tomogram normal, Electroencephalogram abnormal, Magnetic resonance imaging normal, Scan with contrast normal, Seizure
Clinical narrative: Beginning in April 2024, my daughter began reporting a recurring sensation described as a "leg fizzle" in her left leg. Over the following weeks, these sensations progressed into observable physical seizure activity, which began in May 2024. An EEG was performed in May, confirming seizure activity. Both MRI and CT scans were conducted and returned normal findings.  Despite these normal imaging results, the seizure activity has continued to progress. She was officially diagnosed with a seizure disorder in mid-2024 and began treatment shortly thereafter. She is currently taking Aptiom (eslicarbazepine acetate) and lacosamide as prescribed anticonvulsant medications. However, she continues to experience nightly seizures, indicating that the condition is not fully controlled by current treatment.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Sensory disturbance
Clinical narrative: Beginning in April 2024, my daughter began reporting a recurring sensation described as a "leg fizzle" in her left leg. Over the following weeks, these sensations progressed into observable physical seizure activity, which began in May 2024. An EEG was performed in May, confirming seizure activity. Both MRI and CT scans were conducted and returned normal findings.  Despite these normal imaging results, the seizure activity has continued to progress. She was officially diagnosed with a seizure disorder in mid-2024 and began treatment shortly thereafter. She is currently taking Aptiom (eslicarbazepine acetate) and lacosamide as prescribed anticonvulsant medications. However, she continues to experience nightly seizures, indicating that the condition is not fully controlled by current treatment.
Age: 14.0
Sex: F
Vaccine: MMR
Symptoms: Asthenia, Fall, Lethargy, Loss of consciousness, Musculoskeletal stiffness
Clinical narrative: Within fifteen minutes of receiving the MMR vaccine, my daughter stiffened and and drained of color. She then closed her eyes and fell over with her body stiffened. I was able to catch her as she fell.  She remained unconscious while we yelled for the nurse to come back out to the reception. Within a couple minutes she began to relax and come to. She was given some fruit juice and crackers and they took her blood pressure. She felt strong enough to return to the car within about twenty minutes.  For the remainder of the day she felt very weak and was lethargic.
Age: 14.0
Sex: F
Vaccine: MMR
Symptoms: Pallor
Clinical narrative: Within fifteen minutes of receiving the MMR vaccine, my daughter stiffened and and drained of color. She then closed her eyes and fell over with her body stiffened. I was able to catch her as she fell.  She remained unconscious while we yelled for the nurse to come back out to the reception. Within a couple minutes she began to relax and come to. She was given some fruit juice and crackers and they took her blood pressure. She felt strong enough to return to the car within about twenty minutes.  For the remainder of the day she felt very weak and was lethargic.
Age: 20.0
Sex: F
Vaccine: FLU3, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: This Tuberculin Derivation Expires 11/2027. It as opened on 3/4/2025 with BUD date 4/2/2025. It had not been disposed of on 4/2/2025 and was used on 4/4/2025 for TB skin testing. The patient was seen on 4/7/2025 for TB Read (before this was realized) without any averse reactions.
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Caller had a question about RECOMBIVAX HB. Pharmacist stated that he has an employee that had received 3 doses of RECOMBIVAX HB in the past and the titer showed below threshold. Consent was obtained to follow up with the HCP.  No additional AE/PQC.; This spontaneous report was received from a pharmacist and refers to a 24-year-old female patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with the first, second and third dose of with Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB), solution for injection (lot # and expiration date were not reported) for Prophylaxis.  On an unknown date, the Pharmacist stated that he had an employee that had received 3 doses of the vaccine, and the titer showed below threshold. At the reporting time, the outcome of the event was not reported.   The causal relationship between the event and Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) was unknown.
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event, Wrong product administered
Clinical narrative: administer an MMR vaccine with the VARIVAX, but instead administered PROQUAD and VARIVAX to a patient in the same visit; administered PROQUAD and VARIVAX to a patient in the same visit; No additional adverse events were reported.; This spontaneous report was received from a Nurse Practitioner and refers to a 1-year-old patient of unknown gender.   The patient's medical history, concurrent condition, concomitant therapies and drug reactions/allergies were not reported.   On an unknown date, the nurse was supposed to administered Measles, Mumps and Rubella vaccine with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), but instead, the patient  was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), 1 dosage form (dosage regimen, anatomical location, route of administration, lot # and expiration date were not reported) and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), 1 dosage form (dosage regimen, anatomical location, route of administration, lot # and expiration date were not reported) (wrong product administered) (overdose), which were diluted with sterile diluent (expiration date and lot # were not reported) and administered as prophylaxis in the same visit.  No additional information was provided. No additional adverse events were reported (no adverse event.)  Lot # is being requested and will be submitted if received.