chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: expired Havrix vaccine was administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 11-year-old male patient who received HAV (Havrix) (batch number 9R5LC, expiry date 02-NOV-2024) for prophylaxis.   On 14-JAN-2025, the patient received Havrix. On 14-JAN-2025, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: expired Havrix vaccine was administered). The outcome of the expired vaccine used was unknown.   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: 14-JAN-2025 The office manager reported that an expired Havrix vaccine was administered  to a patient which led to, expired vaccine used. At the time of reporting, a repeat dose had not been administered. The vaccine administration facility was the same as primary reporter. This case had been link with US2025004473, reported by the same reporter.; Sender's Comments:  US-GSK-US2025004473:Same reporter/Different patient
Sex: F
Vaccine: MEN
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: received menquadfi 26 months apart, she didn't receive the 2nd menquadfi after the age of sixteen both were done before the patient turned 16 with no reported adverse event; Initial information received on 27-Jan-2025 regarding an unsolicited valid non-serious case received from a Other health professional.  This case involves, the child female patient who received Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] 26 months apart, she didn't receive the 2nd menquadfi after the age of sixteen both were done before the patient turned 16 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 a dose of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine Solution for injection (unknown strength, dosage, expiry date, batch number and route) via unknown administration site for prophylactic vaccination 26 months apart, she didn't receive the 2nd menquadfi after the age of sixteen both were done before the patient turned 16 with no reported adverse event (product administered to patient of inappropriate age) (unknown latency).  Reportedly, The problem is she didn't receive the 2nd Menquadfi after the age of sixteen. Both were done before the patient turned 16 but were 26 months apart. They want to know if the patient is still immunized or do they need the booster after age of sixteen even though the patient had the 2 Menquadfi.  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.
Sex: F
Vaccine: YF
Symptoms: Product preparation issue
Clinical narrative: administered yf-vax to a patient reconstituted using a sterile diluent for an mmr vaccine instead of the diluent supplied with the yf-vax with no reported ae; administered yf-vax to a patient reconstituted using a sterile diluent for an mmr vaccine instead of the diluent supplied with the yf-vax with no reported ae; Initial information received on 27-Jan-2025 regarding an unsolicited valid non-serious case received from a physician.  This case involves an unknown age female patient who received yellow fever vaccine - US [YF-VAX] reconstituted using a sterile diluent for an MMR vaccine instead of the diluent supplied with the YF-VAX with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date, the patient received unknown dose of suspect yellow fever vaccine - US Solution for injection (Unknown strength, lot and expiry date) via unknown route in unknown administration site for Immunization, reconstituted using a sterile diluent for an MMR vaccine instead of the diluent supplied with the YF-VAX with no reported adverse event (product preparation error) (poor quality product administered) (Latency same day).  Information on the batch number was requested corresponding to the one at time of event occurrence.  Reportedly, the patient was a singer on a cruise ship. She was mandated to take a yellow fever vaccine, and since the dose was invalid, she needs to be re-vaccinated as soon as possible.   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.
Age: 1.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product storage error
Clinical narrative: PENTACEL being inadvertently administered to a patient after being exposed to a shipping temperature excursion with no reported adverse event; Initial information received on 27-Jan-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old male patient who had Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (VERO)] being inadvertently administered to a patient after being exposed to a shipping temperature excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal Vaccine Conj 20V (CRM197) (Prevnar 20) for Immunisation.  On 27-Jan-2025, the patient received a dose 1 of 0.5 ml of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine (Suspension for injection) lot UK114AA, Expiry date: 30-Sep-2025, strength was unknown via intramuscular route in the left vastus lateralis for Immunization and pentacel being inadvertently administered to a patient after being exposed to a shipping temperature excursion with no reported adverse event (poor quality product administered) (latency : same day).  Reportedly "This situation is pre-assessed as a medication error/an inappropriate use due to administration of PENTACEL after a shipping excursion."  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.
Sex: U
Vaccine: HIBV
Symptoms: Product preparation issue
Clinical narrative: inappropriate use due to only the diluent of ACT-HIB was given to a patient with no reported adverse event; Initial information received on 28-Jan-2025 regarding an unsolicited valid non-serious case received from a Other health professional.  This case involves, the inappropriate use due to only the diluent of HIB (PRP/T) Vaccine [ACT-HIB] was given to a patient 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 inappropriate use due to only the diluent of HIB (PRP/T) Vaccine Powder and solvent for solution for injection (unknown strength, dosage, expiry date, batch number and route) via unknown administration site for prophylactic vaccination was given to a patient with no reported adverse event (single component of a two-component product administered) (unknown latency).  Information on the batch number was requested corresponding to the one at time of event occurrence.  Reportedly, Supervisor did not have the patient's information at the time of the call.   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.
Age: 11.0
Sex: F
Vaccine: HIBV
Symptoms: Extra dose administered, Product administered to patient of inappropriate age
Clinical narrative: ACTHIB was administered to an 11 year old patient and child was not intended to received ACTHIB and this was considered an extra dose with no adverse event; ACTHIB was administered to an 11 year old patient and child was not intended to received ACTHIB and this was considered an extra dose with no adverse event; Initial information received on 28-Jan-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves HIB (PRP/T) VACCINE [ACT-HIB] was administered to a 11 year old female patient and child was not intended to receive ACT-HIB and this was considered an extra dose with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Influenza vaccine and HPV vaccine VLP rL1 2v (baculovirus) (Human papillomavirus (types 16, 18) vaccine, adsorbed) for Immunisation.  On 27-Jan-2025, the 11 year old patient received 0.5 ml  (dose 3) of HIB (PRP/T) VACCINE, Powder and solvent for solution for injection (lot UK092AB; Expiration Date: 31-May-2025) via intramuscular route in the left deltoid for Immunization and child was not intended to receive ACT-HIB and this was considered an extra dose with no adverse event (product administered to patient of inappropriate age) (extra dose administered) (latency: same day).  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.
Sex: F
Vaccine: PPV
Symptoms: Therapy non-responder
Clinical narrative: A 23 serotype pneumococcal antibody panel was obtained, which revealed low levels of all but two serotypes tested (types 3 and 18C). However, her last pneumococcal vaccine was 12 years prior.; Literature Report.  This literature marketed report has been received from the authors of a published literature article, titled as stated above and refers to a female patient of unknown age. Her concurrent conditions, medical history and concomitant therapies were not provided.   On an unknown date, she was vaccinated with pneumococcal 23v polysaccharide vaccine (manufacturer unknown) (dose, route of administration, lot # and expiration date were not provided), for prophylaxis. It was reported that her last pneumococcal vaccination was 12 years ago.   On an unknown date, reported as 12 years later, A 23 serotype pneumococcal antibody panel was obtained, which revealed low levels of all but two serotypes tested (types 3 and 18C). The outcome of the event was not provided.   The authors of the article considered low levels of antibodies as related to pneumococcal 23v polysaccharide vaccine (manufacturer unknown).   A copy of the published article is attached as further documentation of the patient's experience.  Lot # is being requested and will be submitted if received.
Age: 23.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired dose given; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 23-year-old male patient who received HAV (Havrix) (batch number 95DB2, expiry date 13-DEC-2024) for prophylaxis.   On 06-JAN-2025, the patient received the 1st dose of Havrix. On 06-JAN-2025, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Expired dose given). The outcome of the expired vaccine used was unknown.   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: 06-JAN-2025 The patient received his first dose of Havrix that was expired on 13th December 2024 which led to expired vaccine used. The vaccine administration facility was the same as primary reporter.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: received two doses of Shingrix on the same day back on January 8th 2025 by accident; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of accidental overdose in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number 354M3, expiry date 13-NOV-2026) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) and VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 08-JAN-2025, the patient received the 3rd dose of Shingrix. On 08-JAN-2025, an unknown time after receiving Shingrix and an unknown time after receiving SHINGRIX, the patient experienced accidental overdose (Verbatim: received two doses of Shingrix on the same day back on January 8th 2025 by accident). The outcome of the accidental overdose was unknown.   Additional Information: GSK receipt date: 09-JAN-2025 The pharmacist reported that the patient received two doses of Shingrix on the same day which led to, accidental overdose.
Age: 1.25
Sex: F
Vaccine: HIBV, PNC20
Symptoms: Erythema, Induration, Local reaction, Tenderness
Clinical narrative: local reaction--10cm redness, induration, tenderness. no systemic symptoms
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Feeling abnormal, Influenza like illness, Nausea, Vertigo, Vomiting
Clinical narrative: pt says when she stood up she had virtigo. The room started spinning and she vomited. She stayed nauseated and her head was spinning all day. She vomited about 30 times. She called her doctors office and recommended her to go to the ER. She went to Medical Center. After sitting in the ER for about 2 hours her symptoms seemed to get better so she left before being treated. She went home and had some broth and sodas, however she was not able to keep them down. She no longer had the virtigo. By this morning she was able to eat some toast and have some juice and keep it down.  She still feels bad like she has the flu but she does feel some better and thinks she will be okay. She will contact her PCP to follow up.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received Flublock vaccine, which is intended for patients 18 and older, not for a 6 year old patient. No significant side effects noted following this. Family reported some low grade fever, congestion following the vaccine but also acknowledged that she could have minor viral illness.
Age: 28.0
Sex: F
Vaccine: MMR
Symptoms: Contraindication to vaccination
Clinical narrative: MMR given to patient while patient on Humira
Age: 26.0
Sex: F
Vaccine: RAB
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Pt. Had Post exposure rabies vaccines- this was #2. vaccine given in morning and that evening she noticed 2 swollen lymph Glands  in clavicle area  On exam, Pt. has 2 tender swollen glands, 1 cm each. 1 is infraclavicular on the left and the other is above this approximately 4cm . Normal range of arm . No other infectious source is noted. Pt advised to use ibuprofen and hot packs. Will touch base next day. Also has follow up appointment on 2/5/2025
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Death, Electrocardiogram ST segment elevation
Clinical narrative: Sent out for ST elevation; expired on 1/12/24
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: none at time of administration
Age: 11.0
Sex: M
Vaccine: FLU3, MNQ, TDAP
Symptoms: Vaccination error
Clinical narrative: Flu vaccine was given in error. Flu vaccine was declined by parent.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, C-reactive protein increased, Chest X-ray abnormal, Chest pain, Dyspnoea
Clinical narrative: Already described earlier in the report- fever, acardia, chest pain, severe myalgia and arthralgias, shortness of breath, localized swelling in the arm, elevated white count.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram normal, Fibrin D dimer normal, Leukocytosis, Myalgia, Peripheral swelling
Clinical narrative: Already described earlier in the report- fever, acardia, chest pain, severe myalgia and arthralgias, shortness of breath, localized swelling in the arm, elevated white count.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary mass, Pyrexia, Red blood cell sedimentation rate normal, Troponin normal, Twin reversed arterial perfusion sequence malformation
Clinical narrative: Already described earlier in the report- fever, acardia, chest pain, severe myalgia and arthralgias, shortness of breath, localized swelling in the arm, elevated white count.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: White blood cell count increased
Clinical narrative: Already described earlier in the report- fever, acardia, chest pain, severe myalgia and arthralgias, shortness of breath, localized swelling in the arm, elevated white count.
Age: 56.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site pain, Injection site pruritus, Pruritus
Clinical narrative: Patient did not have reaction right away and has itching throughout her body as well as the injection site along with pain at the site
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: resident died
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: On 1/10/2025 the patient received a Moderna covid vaccine for 6 months-11 years of age instead of for 12 years of age and above.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Autoimmune thyroiditis, Laboratory test, Magnetic resonance imaging, Mast cell activation syndrome
Clinical narrative: Currently diagnosed hashimotos auto immune disease, mcas, vasovagal syncope
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Tilt table test, X-ray
Clinical narrative: Currently diagnosed hashimotos auto immune disease, mcas, vasovagal syncope
Age: 16.0
Sex: M
Vaccine: HEP, HPV9, MENB
Symptoms: Dyskinesia, Immediate post-injection reaction, Muscle spasms, Syncope
Clinical narrative: Immediately after administration of HPV vaccine in patient s Right arm, patient was syncopal with muscle spasms/jerking for <1 minute.  Patient was helped to supine position on exam table during episode. Patient s father in room with patient. Patient regained consciousness within 1 minute.  Took sequential blood pressures. Blood pressures within normal limits shortly after syncopal episode. Nurses completed orthostatic pressures, within normal for laying, sitting and standing. Also offered cool air, cool compresses to neck/axilla, juice and pretzels. Patient took 1 sip of juice and declined pretzels. Patient stated felt normal. Walked around exam room without dizziness.  Patient denies dizziness, AOx4 .  At 10:35am discharge instructions given. Dad states will stay home with patient. Patient stable
Age: 1.08
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Wheezing
Clinical narrative: After receiving vaccine, patient experienced a rash and wheezing.  Benadryl given 10 minutes after administration of vaccine. EMS notified.
Age: 1.0
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Kinrix was mistakenly given by the medical assistant in the clinic with MMR, Varicella and Flu. Hep A was accidently replaced with Kinrix instead of given as ordered. This is the pt. 4th dose of Dtap/IPV since birth. There was no adverse reaction as of now, just wrong vaccine given at the wrong age.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Myalgia
Clinical narrative: Patient experienced severe muscle pain in her arms and legs.  Patient couldn't get out bed for 2 days.
Age: 13.0
Sex: M
Vaccine: FLU3, HPV9
Symptoms: Refusal of vaccination
Clinical narrative: PATIENT KEPT JERKING AWAY AND REFUSED TO TAKE THE VACCINE AFTER MOTHER ACCEPTED THE IMMUNIZATION. INTAKE HAD BEEN PERFORMED AND VACCINE HAD BEEN SCANNED OUT AND PRPEPARED FOR ADMINISTRATION AND ONCE THE NURSE ENTERED THE ROOM TO ADMINISTER THE CHILD BECAME INSISTANT HE WAS NOT GOING TO TAKE THE SHOTS.
Age: 45.0
Sex: F
Vaccine: FLU3, HEPA, HEPA
Symptoms: Underdose
Clinical narrative: Patient was given a Hep A pediatric dose in error. Was noticed immediately and was given a Hep A adult dose. Client was informed of the situation. Client had no complications after or any concerns. Client had no after vaccination complications.
Age: 3.0
Sex: M
Vaccine: DTAP, UNK
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient showed signs of cellulitis on 01-29-2025 in his left thigh. The affected area was swollen, red, and warm. The pediatrician prescribed him Prednisolone and Cephalexin. After 1 day of taking the medications his leg did not appear as swollen, although it was still just as red. Today is day 3 of taking the medication and his leg appears much less swollen and red, although it is still slightly swollen and red.
Age: 7.0
Sex: M
Vaccine: DTAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse affects noted. Patient should have received TDaP, received DTaP instead.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Pain, Product administered at inappropriate site
Clinical narrative: Patient reports that the Tdap was given very close the shoulder joint and has had joint pain in that shoulder since the vaccine was administered.  States that the vaccine was given right below the shoulder joint and he developed a lot of aching into the shoulder but no aching or pain into the deltoid muscle.  He has not take anything for the pain does have pain with some shoulder movements.  Denies any swelling or discoloration.  States that symptoms will wax and wane and that 3 days ago his symptoms were more severe than they are currently. Suspect patient had the Tdap vaccine administered into the subacromial bursa given location of where the vaccine was administered.  Discussed that this should continue to resolve with supportive care and encouraged use of anti-inflammatories with ibuprofen or Aleve as well as warm compresses and topical Voltaren gel.
Age: 2.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Medication error- Vaccine was to be given to sister
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Pain, Sleep disorder, X-ray limb normal
Clinical narrative: 12/25/2024 it was reported that the patient was having a lot of trouble moving her right arm at the shoulder. She could not lift arm over her head without a lot of pain. Having a hard time sleeping due to the pain. Recommended to take ibuprofen and alternating ice and heat to the area. 1/2/2025 still experiencing same symptoms. Patient was requested to come back in for an evaluation. Patient was seen on 1/8/2025. Celecoxib 200 mg was prescribed.  Seen again in the office on 1/20/2025. Amoxicillin 500 mg, benzonatate 200mg, diclofenac sodium 75mg and lidocaine 5% patch prescribed.  Shoulder X-ray ordered and referral to PT was placed.  X-ray was unremarkable.
Age: 4.0
Sex: F
Vaccine: HEPA
Symptoms: Wrong product administered
Clinical narrative: Medication Error- Vaccine was to be given to brother
Age: 78.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered, Pain in extremity
Clinical narrative: Vaccination was duplication. Originally given 3/25/22 but did not pull up in pharmacy system or in state database so repeated on 1/30/25. Patient denied any adverse effects other than sore arm.
Age: 93.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Gave influenza vaccine by mistake. Was suppose to give pneumonia vaccine.  Patient has not experienced any adverse symptoms from additional flu vaccine.
Age: 11.0
Sex: M
Vaccine: HPV9, MENB, TDAP
Symptoms: Wrong product administered
Clinical narrative: Patient is 11 years old and accidently received MenB vaccine instead of MenACWY vaccine. He does not have any medical indication to have it early.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Fatigue, Feeling cold, Productive cough
Clinical narrative: pt developed a cough and alot of phlegm with drainage coming down causing her to cough. She has been taking OTC meds to dry it up along with a breathing treatment and her inhaler. She is feeling cold and tired today like she needs to go back to bed, but is feeling some better.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site bruising, Injection site erythema, Injection site pruritus
Clinical narrative: Patient has red itchy area around the injection site with light bruising.
Age: 33.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Magnetic resonance imaging abnormal, Nerve stimulation test normal, Pain
Clinical narrative: Felt immediate pain from the injection point. Noted to the clinician that injection was higher than normal. Was assured it was normal. Arm was in severe pain for 48 hours, I could not move it more than a few inches. Once initial pain receded there was local pain with most movement. This went on for 2.5 months with requests to my GP for physical therapy referral in November and in December for an ortho appointment for the ongoing pain. I went to physical therapy for a month before going to the Ortho clinic where I was sent for x-rays and MRIs and nerve testing. I am scheduled for a cortisone injection end of January.
Age: 33.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: X-ray normal
Clinical narrative: Felt immediate pain from the injection point. Noted to the clinician that injection was higher than normal. Was assured it was normal. Arm was in severe pain for 48 hours, I could not move it more than a few inches. Once initial pain receded there was local pain with most movement. This went on for 2.5 months with requests to my GP for physical therapy referral in November and in December for an ortho appointment for the ongoing pain. I went to physical therapy for a month before going to the Ortho clinic where I was sent for x-rays and MRIs and nerve testing. I am scheduled for a cortisone injection end of January.
Age: 48.0
Sex: M
Vaccine: PNC20
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given Prevnar 20 outside of recommended age with no clinical indication to give it earlier than 50 years old
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site reaction, Irritability, Rash erythematous, Rash vesicular, Skin lesion
Clinical narrative: fussy with rash mostly localized to right lateral leg, dermatomal in nature, vesicular in different stages with erythematous base.  initially thought to be related to HFM outbreak at school, however no lesions on soles or palms.  5-10 mild lesions on trunk, face, right foot. >100 lesions on right lateral leg.  Supportive care initially with acetaminophen and ibuprofen and fluids.  Now adding acyclovir due to progressive worsening.
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Food poisoning, Injected limb mobility decreased, Injection site pain, Loss of personal independence in daily activities
Clinical narrative: The vaccine was administered in my right arm (not left as the record states).  I felt usual soreness at the injection site that evening and the following day.  When I woke up on the morning of 1/18 my arm was hurting and not at the injection site but higher up on my arm.  I took ibuprofen, applied ice and BioFreeze.  My range of motion was decreased and it was difficult to move my arm, put on clothing, and carry anything.  I experienced difficulty sleeping due to the pain.  This continued for several days and the pain would transfer to different areas of my upper arm and shoulder.  I made a doctor's appointment on 1/23 but I had to cancel due to food poisoning.  I continued to do the same treatment, gently massaging and the range of motion improved.  The pain lessened as well.   The severity of the pain lessened but I am still experiencing pain 17 days later and this is not a reaction I have ever had to receiving a vaccine.  I contacted the pharmacy and they advised me to report this and to follow up with my primary care physician.  I have an appointment scheduled for 2/7.
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Sleep disorder
Clinical narrative: The vaccine was administered in my right arm (not left as the record states).  I felt usual soreness at the injection site that evening and the following day.  When I woke up on the morning of 1/18 my arm was hurting and not at the injection site but higher up on my arm.  I took ibuprofen, applied ice and BioFreeze.  My range of motion was decreased and it was difficult to move my arm, put on clothing, and carry anything.  I experienced difficulty sleeping due to the pain.  This continued for several days and the pain would transfer to different areas of my upper arm and shoulder.  I made a doctor's appointment on 1/23 but I had to cancel due to food poisoning.  I continued to do the same treatment, gently massaging and the range of motion improved.  The pain lessened as well.   The severity of the pain lessened but I am still experiencing pain 17 days later and this is not a reaction I have ever had to receiving a vaccine.  I contacted the pharmacy and they advised me to report this and to follow up with my primary care physician.  I have an appointment scheduled for 2/7.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Hemiplegia, Mobility decreased
Clinical narrative: I got the vaccine at 3:00 p.m. and was partially paralyzed on the left side of my body by 10:00 p.m. I could not move and had to call paramedics
Age: 25.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Arthralgia, Pain, Pain in extremity
Clinical narrative: Patient had bilateral arm pain initially.  Pain improved in left arm but persisted on right arm.  Was seen in clinic and though to have normal post-vaccine pain but seen again on 1/30/25 and still having pain in arm/shoulder with movement.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Audiogram, Deafness neurosensory, Deafness unilateral, Dizziness, Ear pain
Clinical narrative: Right Ear pain, headache, dizzyness, Nausea, and loss of hearing.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Magnetic resonance imaging head, Nausea, Tympanometry, Vestibular function test abnormal
Clinical narrative: Right Ear pain, headache, dizzyness, Nausea, and loss of hearing.
Age: 43.0
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 3rd dose of the Hep B series was given too early. It is recommended to be given 8 weeks after the 2nd dose and it was given 5 weeks after the 2nd dose. This requires the patient to be re-vaccinated in 8 weeks after the last given vaccine.
Age: 78.0
Sex: F
Vaccine: RAB
Symptoms: Death
Clinical narrative: Patient was seen at our clinic on 1/28/25 for a rabies booster shot due to a raccoon bite. She was scheduled to return 1/31/25 for day 3. She only needed rabies boosters due to having had the pre-exposure series. She works at a center. On Jan 30th, 2025 patient was found deceased in her home. She was alone. Cause of death is being investigated.
Age: 1.25
Sex: F
Vaccine: DTAP, FLU3, HEPA, HIBV, PNC20
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling and warmth noted to all injection sites- worse being the injection sites on the right thigh- FLU, PCV 20 and HIB. Parents giving ibuprofen- encouraged to continue with NSAIDS and warm compresses/baths. Can consider antihistamine (Zyrtec 2.5 ml once daily). TO go to the ER with worsening redness, swelling or onset of fever.
Age: 83.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: There was no adverse event. Patient was given Arexvy on 1/26/24 and Abrysvo on 10/10/24 so received an additional RSV vaccination when not needed/recommended.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Death, Polyarteritis nodosa, Pyrexia, Refusal of treatment by patient
Clinical narrative: Patient's husband reported that patient received a dose of Fluad on 11/1/2024 and was hospitalized on 11/17/2024 at Clinic until she passed away on 12/10/2024. Patient's symptoms at time of hospitalization included fevers, skin lesions on arms/legs, and chest pain. During the course of her hospitalization, she was diagnosed with poylarteritis nodosa, a rare form of vasculitis, with renal involvement. At some point during the hospitalization, she refused intubation. According to the patient's husband, the doctor suspected that the influenza vaccination she received may have affected her immune system and eventually led to the previously described series of events.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Renal disorder, Skin lesion
Clinical narrative: Patient's husband reported that patient received a dose of Fluad on 11/1/2024 and was hospitalized on 11/17/2024 at Clinic until she passed away on 12/10/2024. Patient's symptoms at time of hospitalization included fevers, skin lesions on arms/legs, and chest pain. During the course of her hospitalization, she was diagnosed with poylarteritis nodosa, a rare form of vasculitis, with renal involvement. At some point during the hospitalization, she refused intubation. According to the patient's husband, the doctor suspected that the influenza vaccination she received may have affected her immune system and eventually led to the previously described series of events.
Age: 62.0
Sex: F
Vaccine: PNC20
Symptoms: Rash
Clinical narrative: rash
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Blood glucose normal, Pallor
Clinical narrative: Pt here today for 16 year old well child. She received menveo, bexsero, and gardasil. After vaccines were administered pt began to turn pale and closed her eyes and this medical assistant helped position pt to lie down so pt wouldn?t hurt herself. As soon as pt was lied down pt immediate asked ?what happened?? After providing verbal reassurance pt was instructed to remain lying down and her vitals were as followed: Bp100/60, 76 HR, 18 RR, 98% O2, 83 fasting blood sugar. Pt was also evaluated by aprn after vitals were obtained.After 30 minutes pt was A&Ox4 and reported feel better and wanting to go home. Pt was then discharged.
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV1
Symptoms: Dyskinesia, Electroencephalogram normal, Muscle spasms, Respiratory viral panel, Rotavirus test positive
Clinical narrative: On 1/18 patient was noted to have several episodes of abnormal movements that appeared like spasms including brief flexion of her head and upper extremities which lasted few seconds and repeated for few minutes, after which she returned to baseline.  Patient was evaluated at Hospital ED and admitted for EEG and neurological evaluation. Patient has not had any additional episodes of abnormal movement. EEG was normal and neurological evaluation was normal.  After discussion with neurology team, it was concluded that the abnormal movement episode was and isolated event and likely not related to immunizations received the day prior.  Patient has been well since the hospitalization.
Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: Arthralgia, Injection site pain, Musculoskeletal pain
Clinical narrative: Patient reports pain in her left shoulder where her injection site of the pneumonia vaccine was given on 1/24/25. She stated that the pain had gotten worse and then was in her left shoulder blade area 1-2 days later. She reports that her shoulder blade pain has subsided but her injection site, deltoid area that extends to her "shoulder joint" area is still hurting.  She states that there is no bruising but "it feels like it is bruised.
Sex: U
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received Arexvy vaccine on 1/28/25.  Unbeknownst to staff, the patient had already received Abrysvo vaccine on 1/4/24.  We asked patient if she had received an RSV vaccine in the past and she said no.  Our system did not catch the duplicate immunizations at verification and record.  No adverse events reported, we are just filing report since the 2 rsv shots in 2 consecutive years is currently outside guidelines.
Age: 75.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient received Arexvy vaccine on 1/28/25.  Unbeknownst to staff, the patient had already received Abrysvo vaccine on 1/4/24.  We asked patient if she had received an RSV vaccine in the past and she said no.  Our system did not catch the duplicate immunizations at verification and record.  No adverse events reported, we are just filing report since the 2 rsv shots in 2 consecutive years is currently outside guidelines.
Age: 1.58
Sex: M
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Urticaria
Clinical narrative: a patient experienced hives 2 days after being administered VAQTA (first dose in series) concomitantly with PENTACEL.; This spontaneous report was received from Physician and refers to a 19-month-old male patient. The patient's medical history was not reported. The patient's concurrent conditions included  prophylaxis. Concomitant therapies were not reported.  On 07-JAN-2025, the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, unk, lot #Y007585, expiration date reported as 12-MAR-2025, but upon internal validations was established as  31-OCT-2025 (strength, and route of administration were not provided) in his right leg; and  diphtheria vaccine toxoid, hib vaccine conj (tet tox) and with the third dose of pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL), (strength, formulation, lot #, expiry date, and route of administration were not provided).  On 09-JAN-2025 after 2 days of vaccination, the patient experienced  a boke out in hive all over his body and scalp. At the time of reporting, the patient was recovering from the event.   The reporter considered event to be related to hepatitis a vaccine, inactivated (VAQTA).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: The HCP reports that PROQUAD was inadvertently administered after suffering from a Temperature Excursion. No symptomatic adverse events were reported.; The HCP reports that PROQUAD was inadvertently administered after suffering from a Temperature Excursion. No symptomatic adverse events were reported.; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. Concomitant medication included sterile diluent (MERCK STERILE DILUENT) (used to reconstitute the vaccine lot# and expiration date unknown).   On 13-DEC-2024, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin [rHA]) (PROQUAD) injection, 0.5ml/ series, lot #Y013574 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as: 03-FEB-2026, administered for prophylaxis (strength, and route of administration were not provided). Operator of device was health professional. The diluent used to reconstitute the vaccine lot# and expiration date unknown.  The HCP reported that measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) was inadvertently administered after suffering from a temperature excursion (Product storage error). The current information available was that the product reached 11.6c and was out of range for 3 hours 5 minutes 0 seconds, but previous excursions could not be confirmed. Previous excursions could not be confirmed. No symptomatic adverse events were reported (No adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2501USA008885: US-009507513-2501USA008877:
Age: 18.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AEs were reported.; Healthcare worker reported that a 18 years old patient received VARIVAX and PROQUAD together on the same day on 1/22/2025.; Healthcare worker reported that a 18 years old patient received PROQUAD; This spontaneous report was received from other health professional and refers to 18-year-old patient of unknown gender.   The patient's pertinent medical history, concurrent conditions, concomitant medications and previous drugs reactions or allergies were not reported.  On 22-JAN-2025, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, dose description reported as 1 dose), administered as prophylaxis (Lot No. y013347 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 02-AUG-2026) (strength, dose number, route of administration, anatomical location of administration and vaccination scheme frequency were not provided); together with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA[recombinant human albumin]) (PROQUAD) injection dose description reported as 1 dose, administered as prophylaxis (Lot No. Y013582 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 03-FEB-2026) (strength, dose number, route of administration, anatomical location of administration and vaccination scheme frequency were not provided) (overdose)(product administered to patient of inappropriate age)   No additional adverse event was reported (no adverse event)
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Customer calling to report that an expired dose of GARDASIL 9 was administered. Dose administered 1/28/2025, dose expired 1/2/2025. Vaccine did not experience temperature excursion. No additional AE, no PQC. No additional information.; This spontaneous report was received from and administrator and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 28-JAN-2025, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #X004375, expiration date: 02-JAN-2025 (Expired product administered), administered for prophylaxis (dose, route of administration and anatomical location were not provided).Vaccine did not experience temperature excursion. No additional AE, noPQC. No additional information.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional adverse event was reported; expired vaccine administered to a patient; This spontaneous report was received from physician and refers to a 5-year-old.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included sterile diluent (STERILE DILUENT) (manufacturer unknown).   On 29-JAN-2025, the patient was vaccinated with expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, unk, lot #X019302, expiration date: 14-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered). No additional adverse event was reported.
Sex: U
Vaccine: HEP, HEP
Symptoms: Injection site erythema, Injection site induration, Nausea, Pyrexia
Clinical narrative: Patient had fever; nausea; localized erythmea at injection site that was very red and hard; localized erythmea at injection site that was very red and hard; Child was administered RECOMBIVAX HB on 1/31/2023 and 8/08/2023; This spontaneous report has been received from a nurse regarding a child of unknown age and gender. Historical vaccines included hepatitis b vaccine rhbsag (yeast) (ENGERIX). Information regarding medical history, concurrent conditions and concomitant therapies was not reported.  On 31-JAN-2023, the patient was vaccinated with second dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB), intramuscular injection, 5 per 0.5 micrograms per milliliter for prophylaxis, lot number  W008704 which has been verified to be valid, expiration date not reported but upon internal review established as 18-NOV-2024 (dose, route of administration and anatomical site not provided). Subsequently, on 08-AUG-2023 the patient was vaccinated with the third dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB), intramuscular injection, 5 per 0.5 micrograms per milliliter for prophylaxis, lot number  W022795 which has been verified to be valid, expiration date not reported but upon internal review established as 19-MAY-2025 (dose, route of administration and anatomical site not provided). (Inappropriate schedule of vaccine administered)  On an unspecified date, the patient experienced fever, nausea, localized erythema at injection site that was very red and hard (vaccination site erythema) (vaccination site induration). The reporter stated that it took 3 weeks to go away. However, the reporter did not confirm if the adverse event occurred at both of administered dates and refused to provide any additional information. The outcome of the events was unknown.  The causal relationship between the suspect vaccines and the events was unknown.
Sex: F
Vaccine: HPV9
Symptoms: Incomplete course of vaccination
Clinical narrative: Consumer called to report they received their first dose of GARDASIL 9 on 03/22/2024 and did not return for their second dose until today, 01/29/2025.; No additional AE; This spontaneous report was received from a female patient of unknown age. Patient's concurrent conditions, pertinent medical history and concomitant therapies were not provided.  On 22-MAR-2024, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose, frequency, lot #, expiry date, and route of administration were not provided) and came out on 29-JAN-2025, for their second dose, however the health care professional was unsure if the vaccine schedule needed to be repeated entirely or to continue and administer the second dose.  No side effects or symptoms reported.