chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Vaccine: HPV4, HPV4
Symptoms: Antiphospholipid syndrome, Autonomic nervous system imbalance
Clinical narrative: Antiphospholipid antibodies/syndrome; Autonomic dysfunction; This initial spontaneous report was received from a lawyer regarding a case in litigation, concerning patient (pt) of a not reported age or gender. Patient's current conditions, medical history and concomitant therapy was not reported. On 27-MAR-2018 and 27-SEP-2018, the pt was vaccinated with the first and second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (strengths, doses, lot numbers, expiration dates, routes of administration and anatomical locations were not provided) administered for prophylaxis. On an unknown date, the pt experienced Autonomic dysfunction and Antiphospholipid antibodies/syndrome. At the reporting time, the outcome of the events was not provided. The reporter considered the events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL). It was stated that the lawyer previously filed a petition, however, the lawsuit would remain unfiled during a period while the legal statute of limitations would remain preserved.  Upon internal review, the event of Antiphospholipid antibodies/syndrome was determined to be medically significant.
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AEs; Caller reported patient received PROQUAD and VARIVAX at same office visit.; This spontaneous report was received from a physician assistant (reported as medical assistant and refers to a patient of unknown age and gender.   The patient's medical history, concurrent conditions, concomitant therapies, previous drugs and allergies were not reported.   On 06-May-2025, the patient was vaccinated with a dose of  Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA [recombinant Human albumin]) (PROQUAD) injection, 0.5 mL, administered subcutaneously as prophylaxis (Lot No. Y014436 has been verified to be a valid lot number for [measles, mumps, rubella and varicella (oka-merck) virus vaccine live], expiration date reported and upon internal validation established as 22-Feb-2026) (strength, dose number, anatomical location of administration and vaccination scheme frequency were not provided); also with a dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), Injection 0.5 mL, administered subcutaneously as prophylaxis (Lot No. Y015559 has been verified to be a valid lot number for [varicella virus vaccine live (oka-merck)], expiration date reported and upon internal validation established as 16-Sep-2026)(strength, dose number, anatomical location of administration and vaccination scheme frequency were not provided); both doses were reconstituted with sterile diluent solution for injection (BAXTER STERILE DILUENT) administered subcutaneously (Lot No., expiration date and indication were not provided). It was stated that the patient received both doses of previous mentions vaccines at the same office visit (overdose). No additional adverse events were reported (no adverse event).
Sex: M
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Received HEPLISAV-B and then ENGERIX B; Initial report received on 11-Apr-2025.  A nurse reported that a 40-year-old male received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization on 21-Feb-2025 and then received ENGERIX-B on 02-Apr-2025.  No medical history or concomitant medications were reported.  On 21-Feb-2025, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot number, expiration date, NDC number, route, and site not available)].  On 02-Apr-2025, 41 days after having been vaccinated with HEPLISAV-B, the patient received dose 2 of a hepatitis B vaccine [ENGERIX-B (lot number and expiration date not provided)]. The reporter was inquiring if another dose of HEPLISAV-B was required. No adverse reactions were reported.   No additional information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: F
Vaccine: HEP
Symptoms: Dyspnoea, Erythema, Pruritus, Urticaria
Clinical narrative: A Red Face; Shortness of Breath; Itchiness; Hives; Initial report received on 17-Apr-2025.    A reporter reported that a 19-year-old female (ethnicity not reported) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and developed hives, a red face, itchiness, and shortness of breath.   No medical history was reported.    No concomitant medications were reported.    On 16-Apr-2025, the patient received dose 2 of a hepatitis B vaccine [HEPLISAV-B (lot #945664, expiration date 31-Jan-2027, NDC # 43528-003-01)] intramuscularly in the left deltoid.    On an unknown date, after receiving dose 2 of HEPLISAV-B, the patient developed hives, a red face, itchiness, and shortness of breath. No other side effects were reported.   No other information was available.      Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Vaccine: VARZOS
Symptoms: Seizure
Clinical narrative: Had a seizure 6 days after getting the first shot; This serious case was reported by a consumer via interactive digital media and described the occurrence of seizure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 6 days after receiving Shingles vaccine, the patient experienced seizure (Verbatim: Had a seizure 6 days after getting the first shot) (serious criteria GSK medically significant). The outcome of the seizure was not reported.   It was unknown if the reporter considered the seizure to be related to Shingles vaccine.     The company considered the seizure to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 01-MAY-2025 This case was reported by a patient via interactive digital media. The patient had a seizure 6 days after getting the first shot. The patient did not get the 2nd shot. The patient would have gotten it if he/she had not had the seizure. The patient would take his/her chances.; Sender's Comments: Seizure is an unlisted event which is considered unrelated to GSK Shingles vaccine.
Age: 1.0
Sex: M
Vaccine: HIBV, MEN, MMR
Symptoms: Autism spectrum disorder
Clinical narrative: He was diagnosed with autism not long after his 3rd birthday in 2010; This serious case was reported by a consumer via interactive digital media and described the occurrence of autism in a 18-year-old male patient who received Hib (Hiberix) for prophylaxis.   Co-suspect products included MMR (Priorix) for prophylaxis and Meningococcal vaccine C conj (CRM197) (Meningitec) for prophylaxis.   Previously administered products included Infanrix hexa (received 1st dose on 02-MAR-2007 and received Prevenar 7 also on same day), Infanrix hexa (received 2nd dose on 21-MAY-2007 and received Prevenar 7 also on same day) and Infanrix hexa (received 3rd dose on 23-JUL-2007 and received Prevenar 7 also on same day).   On 01-FEB-2008, the patient received Hiberix, Priorix and Meningitec. On an unknown date, an unknown time after receiving Hiberix and Priorix, the patient experienced autism (Verbatim: He was diagnosed with autism not long after his 3rd birthday in 2010) (serious criteria GSK medically significant). The outcome of the autism was not resolved.   The reporter considered the autism to be related to Hiberix, Priorix and Priorix Pre-Filled Syringe Device.     The company considered the autism to be unrelated to Hiberix, Priorix and Priorix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 30-APR-2025 This case was reported by a patient via interactive digital media. The reporter reported that a patient received 3 doses of Infanrix hexa and Prevnar 7 vaccines in 2007(the first 6 months of his life) and in 2008 vaccinated with Hiberix, Priorix and Meningitec vaccines. The patient recently had to obtain his immunisation records for the agency.  The reporter thought what was he/she thought, did not like he/she, so many parents, unless you have a vaccine injured child, or you have been injured by Pharma, carry on blindly believing and never questioning.  He was diagnosed with autism not long after his 3rd birthday in 2010, so stopped with all injections after that. Never again.  Now reporter was worried sick as he was joining the agency and they are still mandating the messenger ribonucleic acid death shots, not to mention the other jabs that he would need to catch up on.  The reporter's general practitioner would not gave him an exemption.  Looks like would be drafting a letter of conscientious objection when it was time for his medical assessment .  The reporter did not like his chances.  All reporter could did was hope that the next intake was after September and pray that did not go back on his word. The reporter considered the autism to be related to Meningitec.; Sender's Comments: Autism spectrum disorder is an unlisted event which is considered unrelated to GSK vaccine Hiberix, Priorix and Priorix PRE-FILLED SYRINGE DEVICE.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, HEPA, PNC15
Symptoms: Cough, Rhinorrhoea
Clinical narrative: Pt had runny nose last night with cough by father reported on 5-6-25.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: TDAP administered into left deltoid on 01/08/2025. On 02/03/2025, patient notified clinic of left arm pain. Patient denied skin color changes; no fever; no itching; no redness. Patient returned to clinic on 03/03/2025 for an unrelated issues. Patient did not express and reference to the previous left arm pain. On 03/11/2025, patient sent an electronic message to the provider indicating still having left arm pain / soreness. Patient was seen for follow up on 03/20/2025. At that appointment, patient denied numbness, tingling, weakness. Physician ordered a treatment plan of NSAIDs/ice and an ultrasound of the left arm to assist with determining cause/source of pain. Received a phone call on 04/29/2025 to discuss left arm pain. Per patient, she is still experiencing left arm pain although it has markedly improved. Ultrasound was not completed.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV9, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: brief syncope with last vaccine administered (Tdap) immediately recovered when name called. mom believes he was holding breath. Laid in supine position given H20, vitals stable.
Age: 57.0
Sex: M
Vaccine: HEP, HEPA, IPV, MMR, MMRV, TDAP
Symptoms: Unevaluable event
Clinical narrative: None Known Of
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Mother reported patient "woke this morning she c/o pain to her legs and could not walk. Parent noted redness/swelling to L thigh. She called the nurse line and was advised to offer medication PRN.  Child also had a fever this morning. Parent last offered Motrin 5 hours ago and has noted improvement in pain. Child is now walking Area is still warm, tender, and swollen but improving.  No rash"  Assessment noted a "tender, indurated about 3-4 cm area surrounding injection site with mild erythema. "
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Pain, Rash, Rash macular, Rash pruritic
Clinical narrative: Small itchy rash around injection site that began blotchy and filled in. First started 4-6-2025. On 4-7-25 the rash began with hive-like bumps on my chest. It rapidly filled in on my chest and neck, from about below ears and all the way across. Very red and slightly raised. Doesn't respond to anthistimine or Benedryl creme. Slowly spreading around to my back. Not itchy. It stings.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Hypersomnia
Clinical narrative: May 7 by 7AM  had 100.6 temperature, slept entire day
Age: 82.0
Sex: F
Vaccine: PNC21, TYP
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient developed severe shooting pain in the right arm after vaccination with the yellow fever vaccine. She was seen by physical therapy the day after her travel clinic appointment. No fevers, redness, warmth. Patient reported having been vaccinated with YF vaccination 60 years prior but had no documentation.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Chills, Injection site swelling, Pain, Peripheral swelling, Pruritus
Clinical narrative: Patient reported symptoms started the next day with chills, arm swelling starting at site of injection and then involving entire left arm, rash present. Itch and pain present. symptoms continue 5/8/25
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Lymphadenopathy, Pharyngeal erythema, Pyrexia, Rash, Streptococcus test positive
Clinical narrative: She started with rash on face & trunk on 5/1/25- 2 weeks after vaccine given.  She was seen in office on 5/2/25 & rash was on face, trunk, arms, groin & thighs. She also had enlarged cervical lymph nodes, enlarged tonsils & red throat. She also had fever 3 days after MMR vaccine  (4/21/25) & was seen & tested positive for Strep throat & started on Amoxil.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Tonsillar hypertrophy
Clinical narrative: She started with rash on face & trunk on 5/1/25- 2 weeks after vaccine given.  She was seen in office on 5/2/25 & rash was on face, trunk, arms, groin & thighs. She also had enlarged cervical lymph nodes, enlarged tonsils & red throat. She also had fever 3 days after MMR vaccine  (4/21/25) & was seen & tested positive for Strep throat & started on Amoxil.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Pt reports golf ball sized red slightly raised injection site reaction. Reports it is itchy and hot.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Blood creatine phosphokinase increased, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Lumbar puncture normal
Clinical narrative: Patient began to have numbness of feet starting on 4/21/25.  this progressed to full Guillain Barré syndrome with 4 day admission to hospital and 3 rounds of IVIG with good response to treatment.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Magnetic resonance imaging spinal abnormal, Muscular weakness
Clinical narrative: Patient began to have numbness of feet starting on 4/21/25.  this progressed to full Guillain Barré syndrome with 4 day admission to hospital and 3 rounds of IVIG with good response to treatment.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Arthralgia, Dizziness, Ear pain, Headache, Injection site pain
Clinical narrative: After he got his shots he got light headed afterwards. HIs arm was very tingly. Then about 2-3 hours after that it started hurting, up above the where they put the shot in. He thought it was related to the medicine in the shot. Then the pain started migrating down his arm and up his shoulder and neck into his ear. Yesterday it started migrating into his hand. He uses his laptop to do his homework it start a throbbing pulsing pain. The headaches started two to three hours after the shot, then it turned into a very bad migraine. IT went away and he was able to sleep a few hours, he must have rolled in his sleep and the pain started up again, a pulsing pain in his arm. The headaches are mild now. He took tylenol and motrin for the headache. No nausea, no vision change. He had chills and felt hot at first. Not sure if he had a fever. No vomiting, no diarrhea, no cough, no runny nose. The issue is in the left arm.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Migraine, Neck pain, Pain, Pain in extremity, Paraesthesia
Clinical narrative: After he got his shots he got light headed afterwards. HIs arm was very tingly. Then about 2-3 hours after that it started hurting, up above the where they put the shot in. He thought it was related to the medicine in the shot. Then the pain started migrating down his arm and up his shoulder and neck into his ear. Yesterday it started migrating into his hand. He uses his laptop to do his homework it start a throbbing pulsing pain. The headaches started two to three hours after the shot, then it turned into a very bad migraine. IT went away and he was able to sleep a few hours, he must have rolled in his sleep and the pain started up again, a pulsing pain in his arm. The headaches are mild now. He took tylenol and motrin for the headache. No nausea, no vision change. He had chills and felt hot at first. Not sure if he had a fever. No vomiting, no diarrhea, no cough, no runny nose. The issue is in the left arm.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient came in for a post-partum visit 5/2/2025, patient was due for her second dose of hep b vaccine on 2/23/2025 but did not schedule appt. After collaboration with Dr. it was agreed she will receive her 2nd dose today during the appt. Upon getting the vaccine ready, I acciedntly pulled the Heb P vaccine from the state vaccine section in our vaccine refrigerator (pediatric dose 0.5 mL) and administered the hep b vaccine to patient.   I was aware that I made this misake as I was in patient chart to document vaccine and the lot number was not populating in the state nor the private vaccine section.   Asked Nursing Supervisor for assistance. She investigated and informed me that I pulled the wrong vaccine from fridge.  Patient was called and informed of this situation and has been rescheduled for a nurse visit to get the correct dose of the Heb Vaccine. Pt had no adverse reaction outside of the need to repeat dose w/the 1 mL vaccine.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Influenza like illness
Clinical narrative: Severe flu like symptoms: fatigue, headache, chills, fever, and reduced appetite lasting for longer than expected (4 days).
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Severe flu like symptoms: fatigue, headache, chills, fever, and reduced appetite lasting for longer than expected (4 days).
Age: 72.0
Sex: M
Vaccine: PNC20
Symptoms: Pneumonia
Clinical narrative: Patient received 2 pneumonia doses within one year's time -- first dose administered on 8/10/2024; second dose given on 5/7/2025.   Patient has not reported any adverse effects to date.
Age: 55.0
Sex: F
Vaccine: PNC20
Symptoms: Fatigue, Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Immediate and extreme pain in the injection site. Inability to lift arm for 48 hours. Pain is decreasing now and mobility is increasing but it is still painful four days later. Redness, swelling at injection site is still present four days later. Extreme exhaustion for several days.
Age: 55.0
Sex: F
Vaccine: PNC20
Symptoms: Mobility decreased
Clinical narrative: Immediate and extreme pain in the injection site. Inability to lift arm for 48 hours. Pain is decreasing now and mobility is increasing but it is still painful four days later. Redness, swelling at injection site is still present four days later. Extreme exhaustion for several days.
Age: 2.0
Sex: M
Vaccine: PNC21
Symptoms: No adverse event, Wrong product administered
Clinical narrative: LPN, gave Pneumococcal Conjugate 21 today in place of Prevnar 20 in error; Time 5/8 at 1028am; No reaction thus far
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine give after expiration date of 4/25/26
Age: 7.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: PT was given a Dtap even though they are seven and it is indicated for ages up to 6.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Hyperlipidaemia, Muscle strength normal, Pain, Sensory level normal
Clinical narrative: Left arm pain...  Onset: november context: covid vaccine in left arm, flu in the right  Constant pain since then, sometimes radiating to fingers   states pain in the muscle than the joint   active rom is painful  pt thinks related to vaccine, shoulder injury after vaccines   limits his activity somewhat, does a lot of landscaping (rocks, wheelbarrels)  []exam today=  MUSCULOSKELETAL: no ttp over muscles, has good rom, but painful in  abduction/internal rotation/external rotation, some crepitus on articulation fo  left shoulder joint  NEURO: bilateral upper ext strength 5/5, intact prinprick sensation of left  upper extremity
Age: 2.0
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: NO REACTION, PATIENT WAS NOT OF AGE TO RECEIVE,
Age: 16.0
Sex: F
Vaccine: MENB, MNQ, MENB, MNQ
Symptoms: Body temperature increased, Headache, Injection site hypoaesthesia, Injection site pain, Ultrasound scan abnormal
Clinical narrative: Menveo and Bexsero yesterday. Numbness close to injection site and pain in rest of the arm. No redness or swelling. Tmax 100.6. Headaches, but no vomiting, diarrhea, or dizziness. ?Her arm has numbness, it hit after lunch. This happened yesterday, they took ibuprofen and it helped. Her heart rate is elevated, her blood pressure is up, she's starting to run a fever. Right arm hurts. She can lift it and move it, if she moves too fast it hurts very bad. She does have a lot of fluid in her ears, that was checked yesterday. No upset stomach, no diarrhea. She has a throbbing headache. She had a blood pressure of 132/87, HR 128 at school.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ, MENB, MNQ
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site hypoaesthesia, Injection site pain
Clinical narrative: Menveo and Bexsero yesterday. Numbness close to injection site and pain in rest of the arm. No redness or swelling. Tmax 100.6. Headaches, but no vomiting, diarrhea, or dizziness. ?Her arm has numbness, it hit after lunch. This happened yesterday, they took ibuprofen and it helped. Her heart rate is elevated, her blood pressure is up, she's starting to run a fever. Right arm hurts. She can lift it and move it, if she moves too fast it hurts very bad. She does have a lot of fluid in her ears, that was checked yesterday. No upset stomach, no diarrhea. She has a throbbing headache. She had a blood pressure of 132/87, HR 128 at school.
Age: 0.5
Sex: M
Vaccine: DTPPVHBHPB, HIBV, PNC20
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt. mother was called and informed on 5/1 that there had been a vaccine error. Pt. mother stated during phone call that pt. L thigh was red and swollen around injection site. Mother was advised to bring pt in to be seen. Upon being seen, it was noted by NP that pt. had a 3cm round area at injection site that was warm to the touch. Mother was sent home with antibiotic in the event that area on L thigh did not get better, and was advised to contact PCP NP should it get worse over the weekend.
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Pain in extremity, Skin warm
Clinical narrative: Sore arm and warm spot after 3 weeks
Age: 1.5
Sex: M
Vaccine: MMR
Symptoms: Patient isolation, Rash, Stomatitis
Clinical narrative: Rash covered body, has spots in mouth, ended up in the hospital and in isolation.
Age: 92.0
Sex: M
Vaccine: PNC20
Symptoms: Tremor
Clinical narrative: Patient reports that the day after the vaccine was administered, he began to uncontrollably shake. Patient described the shaking as violent and full body prompting him to go to the ER. Patient stated that shortly after arriving to the ER he was provided "fluids and antibiotics" and the shaking stopped. The patient reports that the hospital elected to keep him for a total of 4 days due to other concerns. He has not had any more symptom since initially arriving at the ER.
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE GIVEN ON 5/8/25. VACCINE EXPIRATION DATE 3/28/25. HEALTH DEPT AND MANUFACTURER REPRESENTATIVE  CONTACTED, INSTRUCTED THAT VACCINE WILL HAVE TO BE REDOSED AT A LATER TIME AND THAT A VAERS REPORT NEEDED TO BE SUBMITTED.
Age: 7.0
Sex: F
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: client was 7 years old
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Headache, Muscle disorder, Nausea, Seizure like phenomena
Clinical narrative: Patient reported nausea, chills, muscles HA around 1 hour later and states suspected seizure like activity overnight.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Fall, Loss of consciousness
Clinical narrative: As Patient was leaving after being checked out fell down unconscious.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia, Cardiac monitoring abnormal, Cardiac ventricular thrombosis, Catheterisation cardiac abnormal, Myocardial infarction
Clinical narrative: Abnormal heart rhythm followed by a blood clot and heart attack.
Age: 9.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site rash, Rash
Clinical narrative: She broke out on a rash around the shot site and then it spread to her cheeks, chest, and legs
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling, Rash
Clinical narrative: Patient reporting having mild rash all over his body, and injection site is worse starting 5 days after injection. Injection site is also swollen per patient.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Skin warm
Clinical narrative: Rash, hot to the touch
Age: 53.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Dysgeusia, Immediate post-injection reaction
Clinical narrative: Patient stated he tasted a metalic taste in mouth while Heplisav was being administered. Seconds later he then felt fine.  Patient was instructed to monitor for any additional side effects.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Type 1 diabetes mellitus
Clinical narrative: I was diagnosed with Type 1 Diabetes two years later
Age: 0.25
Sex: M
Vaccine: RV5
Symptoms: Urticaria
Clinical narrative: 12:20 pm  Rotavirus vaccine started,  12:22 pm hives started,  12:25 pm 2.5 ml Benadryl given po,  12:35 pm reaction was less erythematous, 12:45 pm even less erythematous and parents were ready to go home.  Patient did not develop respiratory distress during reaction and observation.   Script for prednisolone 2 ml po BID x 3 days given and is to be started if hives persist beyond 1 hour.  To ER if breathing problems develop or RTC 5/12/25 if hives persist.
Age: 42.0
Sex: F
Vaccine: HEP, VARZOS
Symptoms: Chills, Dizziness, Headache, Injection site pain, Pharyngeal swelling
Clinical narrative: In the evening of the day I received the vaccines, I first experienced chills, along with the soreness at the injection sites. This changed to several hours of fever, dizziness, and headache. I also felt tightness in the throat when swallowing. The next day, Wednesday, I experienced chills again, along with extreme dizziness and headache. Today, Thursday, I am experiencing dizziness and continuing soreness at the injection sites.
Age: 42.0
Sex: F
Vaccine: HEP, VARZOS
Symptoms: Pyrexia, Throat tightness
Clinical narrative: In the evening of the day I received the vaccines, I first experienced chills, along with the soreness at the injection sites. This changed to several hours of fever, dizziness, and headache. I also felt tightness in the throat when swallowing. The next day, Wednesday, I experienced chills again, along with extreme dizziness and headache. Today, Thursday, I am experiencing dizziness and continuing soreness at the injection sites.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Extra dose administered
Clinical narrative: Pt came in to pick up Rx. We were prompted in our que that she was due for Tdap and HPV. We offered the vaccinations and patient accepted. I pulled database and saw she was due for Tdap and HPV and printed screen. There was no report that it had been given at other location. I gave the shot after confirming multiple times that patient was about to get Tdap and HPV.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Given Proquad instead of MMR. Was given the same time as Varivax so 2 doses of Varicella vaccines.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Asthenia, Chills, Diarrhoea, Fatigue
Clinical narrative: arm tenderness at injection site; stomach pain; diarrhea; shivering; fever; weakness; extreme fatique  for 3 days; no treatment
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pyrexia
Clinical narrative: arm tenderness at injection site; stomach pain; diarrhea; shivering; fever; weakness; extreme fatique  for 3 days; no treatment
Age: 47.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient requested PPD plant for work.  Was administered with Polio 0.1 mL in error. Discussed with Dr. Immunization ok to receive at this age and may serve as a booster. Upon review, IPV is safe to be administered intradermally. Patients may obtain booster. Only received 0.1 mL vs 0.5 mL which may serve as a therapeutic dose.   Call to patient and advised of error. Advised immunization is safe via given route. She reports no immediate reaction.  Stated understanding. Patient scheduled for administration of PPD.
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Covid 19 vaccines was administered after the do no use beyond date.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Pt said her arm was sore and swollen and had to seek medical attention
Age: 23.0
Sex: F
Vaccine: UNK
Symptoms: Abortion spontaneous, Herpes zoster, Pain, Rash
Clinical narrative: My miscarriage occurred from Nov.9.2020- February2021 malpractice and shingles June 1st 2021 that cause the left side of my body was in agonizing pain for 3 months until they discover through the sores that opened up on my face it was shingles which has cause lasting issues I'm still dealing with due to the shot. I was completely healthy now my immunity compromised now.
Age: 55.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Product storage error
Clinical narrative: Patient received Boostrix on 2/17/25 and 5/5/25. She hasn't reported any AEs but we are reporting administration outside of normal range.
Age: 11.0
Sex: F
Vaccine: HPV9, PNC15
Symptoms: Product storage error
Clinical narrative: Phn went to the refrigerator and accidentally chose Prevnar 15 instead of HPV vaccine to give to patient. Phn  realized after giving vaccine what she had done. Patient and patient's mother were informed of what happened and hpv vaccine was then given to  patient in the other arm.
Age: 53.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness at and around injection site, swollen, painful, spreading down arm below elbow after a few days.
Age: 5.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Expired product administered
Clinical narrative: Covid 19 vaccine was administered after the do not use beyond date
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abortion spontaneous, Echocardiogram, Electrocardiogram, Fibrin D dimer increased, Laboratory test
Clinical narrative: Beginning on/around August 2021, I was experiencing constant back pain in the upper left shoulder blade area. There was no relief. Lying down did not help, standing did not help, sitting did not help, Motrin did not help. After experiencing this pain for months, on/around 10/12/2021, I went to the Emergency Department at Hospital.  My bloodwork resulted in a 2 day hospital stay at hospital.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging heart, Musculoskeletal pain, Myocarditis, Troponin increased
Clinical narrative: Beginning on/around August 2021, I was experiencing constant back pain in the upper left shoulder blade area. There was no relief. Lying down did not help, standing did not help, sitting did not help, Motrin did not help. After experiencing this pain for months, on/around 10/12/2021, I went to the Emergency Department at Hospital.  My bloodwork resulted in a 2 day hospital stay at hospital.
Age: 20.0
Sex: M
Vaccine: HEP
Symptoms: Blood pressure decreased, Dizziness
Clinical narrative: The patient became dizzy and his blood pressure dropped after receiving the first dose of Engrerix B 20mcg. His blood pressure was taken twice: 85/52 and 87/53. We gave him an ice pack, he lay down with his legs elevated, we got him water, and his mother brought him a chocolate bar because he hadn't had breakfast or lunch. After 20 minutes, his color improved, he felt well, and he left. N/A
Age: 8.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: 24h after vaccination, noted to have tenderness and redness within 1 in of vaccine site. Over the next 12 hours redness spread to 6.5x6in area with fullness and some gait disruption (mild limp). No fever.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Immediate post-injection reaction, Injection site reaction, Rash, Rash erythematous, Urticaria
Clinical narrative: Immediately after administration of vaccines (less than a minute), a red rash appeared on abdomen, spreading to cheeks, hives appeared on knees, red welts appeared around injection sites, covering upper left arm. Benadryl given, rash stopped spreading after Benadryl administration.
Age: 7.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Expired product administered
Clinical narrative: Covid 19 vaccine was administered to patient after the do not use beyond date.
Age: 10.0
Sex: M
Vaccine: DTAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: There was no adverse effect reported but rather an incorrect vaccine administered to the patient based on their age.  Patients guardian brought a  list of vaccines requested by the school district. School requested DTap vaccine and Infanrix was given into the patient. The vaccine NDC: 58160-810-52(box) expiration:07/07/2026 and lot number 9KB9G.  Dtap was delivered to patient even though they were supposed to receive Tdap based on their age (10 years old). The mistake was realized on 5/8/25 and the patient will be notified via phone call that they can receive Tdap vaccine via VFC program here at our pharmacy. ISMP reported and submitted 05/08/25 at 12:38 pm.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Started in the evening felt like having an Angina in the chest. It was short and each event would last for 5-10 seconds, go away and come back again. It happened for 3 days at least 6 times a day spread out through out the day and each would last for 10 sec.
Age: 10.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Expired product administered
Clinical narrative: Covid 19 vaccines was administered after the do not use beyond date
Age: 59.0
Sex: M
Vaccine: HEP, VARZOS
Symptoms: Abdominal pain, Chills, Computerised tomogram, Laboratory test, Magnetic resonance imaging
Clinical narrative: fever, chills, muscle weakness, neuropathy, intense abdominal pain
Age: 59.0
Sex: M
Vaccine: HEP, VARZOS
Symptoms: Metabolic function test, Muscular weakness, Neuropathy peripheral, Pyrexia
Clinical narrative: fever, chills, muscle weakness, neuropathy, intense abdominal pain
Age: 58.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Patient has large swollen rash at injection site that required follow-up with primary care MD. Started on oral prednisone and rash marked by PCP. Patient will be following up with PCP in 3 days or sooner if rash continues to spread.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site rash, Rash, Urticaria
Clinical narrative: Large local reaction at left deltoid and developing uticarial rash left axilla extending to neck and upper chest
Age: 26.0
Sex: M
Vaccine: ANTH
Symptoms: Immediate post-injection reaction, Pain, Pruritus, Urticaria
Clinical narrative: Patient received Anthrax vaccine dose #2 on 4/28/2025. Immediately after the vaccine he began feeling stinging and itching sensations on his body, however he did not report this to the Immunization staff and left the clinic. Within and hour he reported for medical evaluation after developing diffuse hives on his torso and arms, with severe itching and stinging.
Age: 16.0
Sex: M
Vaccine: MNP
Symptoms: Headache, Nausea, Pain in extremity
Clinical narrative: Arm pain, nausea, headache
Age: 27.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Vaccine given intramuscularly NOT subcutaneously. No adverse effects reported.
Age: 17.0
Sex: M
Vaccine: HEPAB, HEPAB
Symptoms: Antibody test positive, Product administered to patient of inappropriate age
Clinical narrative: TwinRix given outside of indicated age range, in addition patient had a positive titer to Hepatitis A
Age: 60.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Peripheral swelling, Pruritus, Rash
Clinical narrative: Rash on entire left arm with redness, itchiness, tenderness and swelling. Continuing for 4 days (until today and is still occurring) with decreasing severity. Self treated with an antihistamine cream with limited success.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Rash, Rash pruritic, Urticaria
Clinical narrative: Experienced a rash, hive-like break out around my shoulders, upper back, neck and chest and some itching in the areas the bumps appeared.
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Change of bowel habit, Gastrointestinal disorder, Laboratory test
Clinical narrative: 2.5 weeks later onset stomach distress, change in bowel habits. Under investigation for irritable bowel disease or colitis.
Sex: F
Vaccine: HBHEPB, HBHEPB, HBHEPB
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: the patient received a third dose of PEDVAXHIB at 6 months of age; a lump on the left thigh (2cm)/slightly irregular shaped; with redness; This spontaneous report was received from a nurse and refers to a 6-month-old female patient.   The patient had no medical history, concomitant therapies and no known drug reactions or allergies.   On unknown dates, the patient was vaccinated with 1st and 2nd dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAX HIB) suspension for injection (dose, route of administration, anatomical location, lot# and expiry date were not reported) for prophylaxis. On 27-FEB-2025, the patient was vaccinated with 3rd dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAX HIB) suspension for injection at a dose of 0.5 mL, administered intramuscularly, lot #Y005248, expiration date 17-SEP-2026, for prophylaxis (anatomical location was not reported) (Inappropriate schedule of vaccine administered). Three other unknown vaccines were given that day.  On an unspecified date in 2025, the patient experienced a 2-centimeter, slightly irregular shaped lump on the left thigh with redness. On 01-MAR-2025, the patient went to urgent care with aforementioned symptoms. The patient was not hospitalized and no treatment was rendered.  The patient's current status and the outcome of the events was unknown.  Causality assessment was not provided.  This is one of several reports received from the same reporter.  Additional information is not expected.
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no side effects or other symptoms; Medical Assistant reports MMRII expired 9/15/2024 and was administered to a patient on 4/12/2025. No previous temperature excursion, n; This spontaneous report was received from an Other health professional (medical assistatn) and refers to a female patient of unknown age.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 12-Apr-2025, the patient started therapy with an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), injection, lot #W029538 was confirmed to be valid, expiration date reported and confirmed as 15-SEP-2024, 0.5 mL (route and site of administration not provided)for prophylaxis (expired product administered); administered with sterile diluent (MERCK STERILE DILUENT) (strength dose, route and site of administration, lot # and expiration date were not reported). There were no previous temperature excursion, no side effects or other symptoms (no adverse event).
Sex: M
Vaccine: MMRV, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Temperature excursion; This spontaneous report was received from a physician assistant and refers to a 13-year-old male patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included Hepatitis A Vaccine, Inactivated (VAQTA).  On an unknown date, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) reconstituted with sterile diluent (BAXTER STERILE DILUENT), lot #Y017511, expiration date: 15-Apr-2026, administered by subcutaneous route in the left thigh for prophylaxis. The vaccine administered experienced a temperature excursion of -9.8 degree celsius (°C) for a time frame of 2 hours and 3 minutes.   No other information provided. No additional adverse event (no adverse event) and no previous temperature excursion reported.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-04-28 , MNSC number : , CLIC number : , ESTAR number : , IRMS number :  , Central date : 2025-04-28 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AEs; PROQUAD administered after temperature excursion; This spontaneous report was received from a registered nurses and refers to a patient of unknown age and gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 28-Apr-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot #Z002989, expiration date: 14-Jul-2026), 0.5 mL administered by subcutaneous route for prophylaxis by a health professional (strength was not reported). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date not provided). The vaccine was administered after temperature excursion at 4.6 C for 137 hours (Product storage error). There was no previous temperature excursion. No additional adverse event was reported.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: innapropriate schedule of vaccine administered; no adverse event; This spontaneous report has been received from a consumer regarding a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant therapies was not reported.  On an unspecified date, the patient received the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant Suspension for injection (GARDASIL 9) for prophylaxis (strength, dose, anatomical site, route of administration, lot number and expiration date not reported). On an unknown date after 2 years of first vaccination, the patient received the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant Suspension for injection (GARDASIL 9) for prophylaxis (strength, dose, anatomical site, route of administration, lot number and expiration date not reported) (Inappropriate schedule of vaccine administered) (no adverse event).
Vaccine: VARZOS
Symptoms: Blindness
Clinical narrative: blinded; This serious case was reported by a consumer via interactive digital media and described the occurrence of blind in a 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 blind (Verbatim: blinded) (serious criteria GSK medically significant). The outcome of the blind was not reported.   The reporter considered the blind to be related to Shingles vaccine.     The company considered the blind to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 03-MAY-2025 This case was reported by a consumer via interactive digital media. The reporter stated to avoid the shingles vaccine as his/her cousin was blinded by the shingles vaccine.; Sender's Comments: Blindness is an unlisted event which is considered unrelated to GSK vaccine Shingles vaccine.
Sex: M
Vaccine: TDAP
Symptoms: Fatigue, Somnolence, Urticaria
Clinical narrative: Hives; tiredness; This non-serious case was reported by a other health professional via patient support programs and described the occurrence of hives in a 20-year-old male patient who received DTPa (Reduced antigen) (Tdap Vaccine) (batch number m77cc) for prophylaxis.   On 07-MAR-2025, the patient received Tdap Vaccine (intramuscular). On 14-MAR-2025, 7 days after receiving Tdap Vaccine, the patient experienced hives (Verbatim: Hives). In MAR-2025, the patient experienced tiredness (Verbatim: tiredness). The patient was treated with prednisone. The outcome of the hives was resolving and the outcome of the tiredness was not reported.   It was unknown if the reporter considered the hives and tiredness to be related to Tdap Vaccine.     It was unknown if the company considered the hives and tiredness to be related to Tdap Vaccine.   Additional Information: GSK Receipt Date: 28-MAR-2025 Hives lasting about an hour, then migrating to different locations for a week. Treated with prednisone and antihistamines with resolution of hives. Experiencing tiredness requiring frequent sleeping but is improving.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pustule
Clinical narrative: vesicles on her back which was diagnosed as shingles/pustules; This non-serious case was reported by a nurse via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) (batch number 47n3y, expiry date 30-MAR-2027) for prophylaxis.   On 16-APR-2025, the patient received the 1st dose of Shingrix. In APR-2025, 3 days after receiving Shingrix, the patient experienced shingles (Verbatim: vesicles on her back which was diagnosed as shingles/pustules). The outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-APR-2025 The reporter stated that a patient received her first dose of Shingrix and 3 days later, she came back with vesicles on her back which was diagnosed as shingles. Also stated that there were 10 little pustules with the area with the diameter of about 2 in in the left upper quadrant on the patient's back below the left scapula. This case is linked with case US2025051115, reported by the same reporter.; Sender's Comments:  US-GSK-US2025051115:SAME REPORTER
Age: 6.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: received Kinrix at 7 years and 5 days old; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-year-old female patient who received DTPa-IPV (Kinrix) (batch number 5H95B) for prophylaxis.   On 22-APR-2025, the patient received Kinrix. On 22-APR-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: received Kinrix at 7 years and 5 days old). The outcome of the inappropriate age at vaccine administration 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: 28-APR-2025 Health care professional reported that a child received Kinrix at 7 years and 5 days old, which led to inappropriate age at vaccine administration.