chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: FLUX
Symptoms: No adverse event, Wrong product administered
Clinical narrative: use of Tubersol instead of the intended flu vaccine with no reported adverse event; Initial information received on 24-Mar-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 18 years old female patient who experienced inappropriate use of Tubersol [Tuberculin test] instead of the intended flu vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 24-Mar-2025, the patient received an 0.5 ml dose of  tuberculin test [tubersol], Solution for injection 0.5 for Immunisation was exposed to  tubersol instead of the intended flu vaccine via intramuscular route in the left deltoid  for tuberculin skin test (tuberculin test) (wrong product administered) (latency: same day) (lot number:3CA48C1, unknown strength, expiry date:31-OCT-2031)  List concomitant or no other vaccines no other vaccines. Reportedly, Nurse at a walk-in clinic at college called regarding TUBERSOL that was incorrectly administered. Should have administered 0.1 ml intradermal and instead was delivered at 0.5 intramuscular.  Action taken  was not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. .
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient was given a tdap and covid vaccine in the left arm on 3/21/2025. Mom called 3/22/2025 and spoke to a nurse on our triage team. She reported patient had swelling in his left with redness the size of a softball and bruising size of popcorn. She stated he was complaining of area being itchy, there was no fever and no other signs of illness. Nurse routed this to provider on call and mom was notified of providers advise " if this is concerning to family, they can go to ER tonight or doctor in the morning. If they have not tried ice and NSAIDS I would advise they try this" Mom was notified of this and verbalized understanding, stated they will try ice and NSAIDS and if no improvement by next day they would go in and be seen.
Age: 8.0
Sex: F
Vaccine: HPV9, IPV, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: During a subsequent vaccine appointment the mother pointed out that the child's date of birth was incorrect, thereby deeming the child  eight years old not nine.  There were not reported adverse effects reported by mother at this time from the dose of HPV the child received on 2/24/2025.
Age: 50.0
Sex: F
Vaccine: HEP, VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever, chills, body aches 24 hours after administration.  Patient took over the counter pain medications to help with symptoms and got some rest. After 48 hours after administration, the symptoms were greatly improved
Age: 33.0
Sex: M
Vaccine: COVID19, FLU3, HEP, HEPA, HPV9, IPV, TDAP, UNK, VARCEL
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: High-Dose Flu administered to an out of age range patient
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient received 2 flu vaccines in (2024-2025) flu season
Age: 30.0
Sex: M
Vaccine: COVID19, FLU3, HEP, HEPA, HPV9, IPV, MMR, TDAP, VARCEL
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: High Dose Flu Vaccine administered to an out of age range patient.
Age: 12.0
Sex: F
Vaccine: DTAP, HPV9
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: L thigh has an area of redness and slight swelling about 2" diameter surrounding injection site - seen by myself, the school nurse, on 3/24/25. Tells me that it is painful. I call Mom and encourage her to call the doctor's office who administered the vaccine. On 3/26/25, Mom tells me via phone that she thinks the redness and swelling are abating.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired NS 0.9% diluent given with vaccine
Age: 4.0
Sex: F
Vaccine: PNC15
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site warmth
Clinical narrative: PT MOTHER STATES "REDNESS/ INFLAMMATION/ WARM AND ITCHING AT THE SITE OF INJECTION"
Age: 5.0
Sex: F
Vaccine: ADEN_4_7
Symptoms: Erythema, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: Parent called- patient received vaccine on 3/25/25. Arm swollen, red, hot to touch, tender to touch, started with symptoms on 3/26/25. Follow up visit scheduled for 3/27/25.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Dyskinesia, Loss of consciousness, Seizure like phenomena
Clinical narrative: 2 minutes after administering the vaccine, patient said she was feeling dizzy and passed out. Had loss of consciousness with bilateral upper and lower extremity jerky/seizure like movements lasted for 20 seconds and recovered without any intervention.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Erythema, Pain, Peripheral swelling
Clinical narrative: Parent calling- patient seen in ER due to reaction from Quadracel vaccine administered on 3/24/25. Right upper arm swelling, redness and pain. Follow up guidelines provided.
Age: 44.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Arthralgia
Clinical narrative: Patient reported experiencing a shoulder pain after receiving the vaccines
Age: 17.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Heplisav-B accidently given to 17year old patient. Manufacturer indications list vaccine recommended to patients 18 years and older
Age: 21.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Induration, Injection site erythema, Skin warm
Clinical narrative: Erythema noted on rt deltoid, rt axillary region and rt side of neck. Area on arm warm to touch and firm. Pt states he noticed redness the day after his injection.
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: ADULT PATIENT WAS GIVEN PEDIATRIC DOSE OF 0.5. Patient notified to return to clinic to recevie addditional 0.5ml today or 1 ml dose if after 3.27.25
Age: 50.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Product preparation issue
Clinical narrative: RN accidentally gave only diluent with no vaccine. Pt will need to be given the vaccine.
Age: 17.0
Sex: F
Vaccine: HIBV
Symptoms: Wrong product administered
Clinical narrative: There was not an adverse event. This is reported as a vaccine administration error. The patient was due to receive her Men-B vaccine but was administered the Hib vaccine in error.
Age: 1.25
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: expired 0.9% NS diluent used for admin
Age: 1.25
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired 0.9%  NS diluent used for admin
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Bone pain, Joint dislocation, Joint lock, Joint noise
Clinical narrative: Lying in my bed I heard a popping sound from my left arm. I have severe pain in both shoulders as well as my clavicle and wrists. I also have severe bone pain throughout. My shoulders come out of the socket when I turn them a certain way and it is excruciating and then directly after that severe weakness, whichever arm. I also have fingers that lock up this is very painful and I have to actually manually correct them. Oh good Lord
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness
Clinical narrative: Lying in my bed I heard a popping sound from my left arm. I have severe pain in both shoulders as well as my clavicle and wrists. I also have severe bone pain throughout. My shoulders come out of the socket when I turn them a certain way and it is excruciating and then directly after that severe weakness, whichever arm. I also have fingers that lock up this is very painful and I have to actually manually correct them. Oh good Lord
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Dyspnoea, Fatigue, Fibromyalgia, Neuralgia
Clinical narrative: So I can?t remember the name of the doctor who administered the vaccine. The one I listed is my doctor now who specializes in MCAS.  I had anaphylaxis. Temporary paralysis, extreme fibromyalgia, difficulty breathing, hives, heart racing, fatigue, nerve pain.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Palpitations, Paralysis, Urticaria
Clinical narrative: So I can?t remember the name of the doctor who administered the vaccine. The one I listed is my doctor now who specializes in MCAS.  I had anaphylaxis. Temporary paralysis, extreme fibromyalgia, difficulty breathing, hives, heart racing, fatigue, nerve pain.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Pain, Pain in extremity, Rash, Rash erythematous
Clinical narrative: Two weeks after vaccine administration (3/19) I began to have intense pain/burning on left hip and fanning all over anterior left quadricep area and inner thigh. Three days later (3/22) followed eruption of a few skin lesions on left hip/thigh, progressing to full red vesicular rash following L1 and L2 dermatome patterns; left sacral and buttocks, left hip, thigh. Sought care for progressing rash with lesions and intense pain on 3/25/25 and diagnosed with Shingles. Currently in treatment with Valacyclovir and lesions continue to progress as of today's date (3/27/25) all throughout the L1 and L2 dermatome map. Continuing to follow with medical care as of today; not yet in recovery phase.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Rash vesicular, Skin lesion
Clinical narrative: Two weeks after vaccine administration (3/19) I began to have intense pain/burning on left hip and fanning all over anterior left quadricep area and inner thigh. Three days later (3/22) followed eruption of a few skin lesions on left hip/thigh, progressing to full red vesicular rash following L1 and L2 dermatome patterns; left sacral and buttocks, left hip, thigh. Sought care for progressing rash with lesions and intense pain on 3/25/25 and diagnosed with Shingles. Currently in treatment with Valacyclovir and lesions continue to progress as of today's date (3/27/25) all throughout the L1 and L2 dermatome map. Continuing to follow with medical care as of today; not yet in recovery phase.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy skin abnormal, Injection site reaction, Squamous cell carcinoma
Clinical narrative: Squamous cell carcinoma at injection site.
Age: 0.5
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: expired NS 0.9% diluent used for admin
Age: 61.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Pruritus
Clinical narrative: Large localized reaction w/erythema and itching.
Age: 0.58
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired 0.9% NS diluent used for admin
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Delirium, Pyrexia
Clinical narrative: Very high fever, delirium
Age: 59.0
Sex: F
Vaccine: PNC20
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: About a minute or two   after receiving  the Prevnar 20  vaccine, the patient stated dizziness and asked if she could use the restroom.  The pharmacist recommended to remain sitting on the chair and not to get up because she was feeling dizzy.    When the pharmacist opened the consultation door  for some air,   the patient got up and started to  walk towards the restroom.  On the way the patient stopped walking.   The pharmacist  right away rushed towards the patient,  grabbed and stopped her from falling on the floor.   The pharmacist slowly put the patient on the floor and raised her feet. Then the patient came back to conscious. The patient stated she could not remember what happened to her.  The pharmacist said you fainted.   Then the patient remembered everything and said she would never get the Pneumonia vaccine again.   By then the paramedics arrived and took patient to the hospital to make sure everything is ok.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: The LPN added 1.1 ml of sodium chloride to Covid Pfizer 5y-11y single use vial. LPN administered 0.3 ml of reconstituted Covid vaccine. Infectious disease department was contacted by MD. ID states the dose is invalid and will need to be repeated if parent chooses.
Age: 50.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site discomfort, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: The evening it was swollen and sore. The next day it was swollen, painful and had fever. 2/13/2025 i took a 9 hrs vacation trip. Pain driving due to pain in upper left arm.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial thrombosis, Cardiac operation, Coagulation test normal, Echocardiogram abnormal, Intracardiac mass
Clinical narrative: Was diagnosed with mass in the heart via echo. Was then admitted into the hospital for removal, they then discovered 2 orginizing thrombi inside of my right atrium. I then was tested post op for any blood clotting disorders and they all came back clear.
Age: 2.0
Sex: F
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: The menveo vaccine that was administered was no appropriate for her age, it is for use in individuals age 10 through 55
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site cellulitis
Clinical narrative: PT presented to clinic with cellulitis on left thigh. No other issues.  Keflex has been prescribed.
Age: 0.5
Sex: M
Vaccine: UNK, UNK
Symptoms: Inflammation, Injection site nodule
Clinical narrative: The mother of the patient noticed a nodule that appeared on the patient's left thigh 2 days after receiving the vaccines. She reports that the patient had inflammation but no swelling, redness, or fever. The patient had an appointment on 3/27/25 for a weight check, and during this visit, the mother brought up the concern about the vaccine reaction to Dr. The doctor could not feel the nodule during the exam, and the mother reported that the nodule has since gone down. However, she thinks it's slightly there.  In addition to question 20, The doctor believes the patient has recovered from the adverse event, however, patient's mother thinks it's still slightly present.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Cellulitis, Influenza, Lymphoedema, Malaise, Pyrexia
Clinical narrative: Had flu like symptoms . Around midnight, pt got very sick. Strted running a fever. Went to dr a couple of days later. Diagnosed with cellulitis and lymphadema. Took 10 days of doxycycline. Been having leg wrapped at edema clinic. Much better but still recovering.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Vaccine given at Left acromium process, experienced redness, swelling and pain radiating to clavicle several hours later. pains persists for greater than 48 hours difficult to lift arm and turn head. Over the counter Tylenol and Motrin taken and ice applied. symptoms temporarily relieved but redness, pain and swelling remain/
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient came in stating he needed to receive the first dose of shingrix. After the dose was administered, the patient continued to talk to a staff member who discovered he believed he was supposed to receive the shinrix vaccine yearly. Upon looking at state registry patient had received doses on 6/27/2021, 11/26/22, 5/8/2023 and 3/27/2025.
Age: 41.0
Sex: F
Vaccine: HPV9
Symptoms: Burning sensation, Immediate post-injection reaction, Injection site abscess, Pain in extremity
Clinical narrative: Immediate burning sensation to entire left arm. Within a week I had no range of motion. To this day I feel severe pain and limited range of motion
Age: 16.0
Sex: M
Vaccine: MENB, MNQ, VARCEL
Symptoms: Fall
Clinical narrative: patient fell after receiving vaccines, per nurse patient alert, drank juice, vital signs 128/76, pulse of 82, speech is clear, patient reported only eating cereal in the last 12 hours, patient reports he's okay and got up and left with parent
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Extra dose administered
Clinical narrative: No ASE. Client received additional injection of Merck sterile water diluent SQ left thigh.  Diluent LOT 1973313 EXP 11/10/26.
Age: 0.83
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: expired 0.9% NS diluent given with admin
Age: 0.92
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired 0.9% NS diluent used for admin
Age: 1.08
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired 0.9% NS diluent used for admin
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This vaccine was given in error.   The patient was to receive the second dose of HPV vaccine, but Menquadfi was ordered in error, and it was given to the patient.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Erythema, Induration, Peripheral swelling, Skin warm
Clinical narrative: Pt had a reaction--leg was very swollen, red, hard,  and hot to touch.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Syncope
Clinical narrative: light headed. Fainted. layed her down and she woke up. bp was stable. Given juice. She improved and went home. i spoke with parents at the end of the day and she had been fine once leaving the oiffice.
Age: 14.0
Sex: M
Vaccine: COVID19, FLU3, HEP, HEPA, HPV9, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Condition aggravated, Seizure
Clinical narrative: on 3/17/25 pt mother reported that pt had  a seizure following the administration of vaccines on the day of 01/02/25. Pt has history of seizures. And does not know if receiving all of these vaccines in one day contributed to an episode on 01/02/25. No further concerns at this time. Pt came from (redacted). And vaccines there as well. Going forward pt will separate vaccines to minimize episodes. Decision is based on pts family request.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Injection site very swollen, red, hard, and hot to touch
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Hypoaesthesia, Paraesthesia, Swelling, Swelling face, Urticaria
Clinical narrative: Hives, facial swelling, numbness, tingling to Right side, swelling to Right side of body
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired 0.9%NS diluent given with admin
Age: 1.33
Sex: F
Vaccine: RAB
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Incorrect vaccine was administered-Dtap but received Kinrex
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired 0.9% NS diluent given with admin
Age: 0.58
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired 0.9% NS diluent given with admin
Age: 1.33
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired 0.9% NS diluent used for admin
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Limb injury, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Patient claims to have received upper shoulder injury from the vaccine being administered too high up the arm.   Initially, patient had pain/soreness in the arm for 1 month.  Now (4 months later), she just has soreness of the arm.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Feeling hot, Induration, Swelling
Clinical narrative: Redness, swelling, heat to area that persisted and expanded to 9 cm x 11 cm with central clearing and induration on 03/27/25 when I saw him
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Colitis ulcerative, Colonoscopy, Computerised tomogram abdomen
Clinical narrative: Ulcerative collitis.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective
Clinical narrative: Covid/ Extremely tired- fever 102 degree - body aches, can't breath properly - headache/sick for 3 to 4 days each time; Covid/ Extremely tired- fever 102 degree - body aches, can't breath properly - headache/sick for 3 to 4 days each time; This is a spontaneous report received from a Consumer or other non HCP.  A 70-year-old female patient received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EN6205), in right arm and on 18Mar2021 as dose 2, single (Lot number: EP7534) at the age of 70 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Illness: Arth" (ongoing), notes: Onset date: Child; So bad in hands, hurts to write.  The patient took concomitant medications (do not remember) within 2 weeks prior to the event onset. Vaccination history included: Flu shot, for Immunization, reaction(s): "allergic", "sick/flu". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19Mar2021, outcome "recovered" (Mar2021) and all described as "Covid/ Extremely tired- fever 102 degree - body aches, can't breath properly - headache/sick for 3 to 4 days each time". Clinical course: she has had Covid-19 for 4x's. Every covid shot she received, she got covid. Extremely tired- fever 102 degree - body aches, can't breath properly - headache. Event onset reported as 19Mar2021 12hrs after shot. The patient refuse to get the flu shot & covid -vacs because she get so sick from them. The patient was so sick for 3 to 4 days each time.  This adverse event did not require a visit to the Emergency room or a visit to a Physician's office. The culture was not performed.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500017839 Same patient/Vaccine, different event, different vaccine dose;
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, Fatigue, Myalgia, Pyrexia
Clinical narrative: Covid/ Extremely tired- fever 102 degree - body aches, can't breath properly - headache/sick for 3 to 4 days each time; Covid/ Extremely tired- fever 102 degree - body aches, can't breath properly - headache/sick for 3 to 4 days each time; This is a spontaneous report received from a Consumer or other non HCP.  A 70-year-old female patient received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EN6205), in right arm and on 18Mar2021 as dose 2, single (Lot number: EP7534) at the age of 70 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Illness: Arth" (ongoing), notes: Onset date: Child; So bad in hands, hurts to write.  The patient took concomitant medications (do not remember) within 2 weeks prior to the event onset. Vaccination history included: Flu shot, for Immunization, reaction(s): "allergic", "sick/flu". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19Mar2021, outcome "recovered" (Mar2021) and all described as "Covid/ Extremely tired- fever 102 degree - body aches, can't breath properly - headache/sick for 3 to 4 days each time". Clinical course: she has had Covid-19 for 4x's. Every covid shot she received, she got covid. Extremely tired- fever 102 degree - body aches, can't breath properly - headache. Event onset reported as 19Mar2021 12hrs after shot. The patient refuse to get the flu shot & covid -vacs because she get so sick from them. The patient was so sick for 3 to 4 days each time.  This adverse event did not require a visit to the Emergency room or a visit to a Physician's office. The culture was not performed.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500017839 Same patient/Vaccine, different event, different vaccine dose;
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine was expired when it was given with no reported adverse event; Initial information received on 25-Mar-2025 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves an unknown age and unknown gender patient who received expired poliomyelitis vaccine (inactivated) 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 in 2016, the patient received unknown dose of suspect poliomyelitis vaccine (inactivated) (Unknown strength, formulation) produced by unknown manufacturer with lot LL1597 and expiry date 2013 via oral route in unknown administration site for Immunization (expired product administered) (Latency same day).  Reportedly, Based on their records, the vaccine was expired when it was given. She cannot confirm the brand name of the vaccine. She wanted to confirm if the expiration date on the record truly matches the lot number. Nurse checking on the information if the expiration date matches the lot number Unknown brand of Polio vaccine.   Action taken was not applicable.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Pallor
Clinical narrative: soon after vaccines patient became pale and parents called nurse into room patient had notable pallor, but comfortable breathing and no respiratory distress appeared blue around lips per parents, but no cyanosis noted by nurse or physician pink coloring with laying supine, pale when held upright, O2 sats 99-100% throughout no retractions or grunting or tachypnea
Age: 66.0
Sex: F
Vaccine: HEPAB
Symptoms: Erythema, Sepsis
Clinical narrative: PT HAD RED  LINES ON HER ARM AND ACCORDING TO DAUGHTER DEVELOPED LOCAL SEPSIS
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Erythema, Mass
Clinical narrative: REDNESS AND LUMP TO AREA
Age: 12.0
Sex: M
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: When providing a school based immunization clinic, I inadvertently administered a Meningococcal B vaccine instead of a second dose of Hepatitis A vaccine for student. School notified, school interpreter notified parent.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Headache, Malaise, Myalgia
Clinical narrative: Full body chills, aches, joint pain, muscle pain, fever (102.3 - taken in ear), headache, malaise
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Pain, Pyrexia
Clinical narrative: Full body chills, aches, joint pain, muscle pain, fever (102.3 - taken in ear), headache, malaise
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient was vaccinated around 4pm. That night, she experienced, swelling, redness, tender to touch. By Wednesday, the rash seemed to have traveled down her arm to about 6 -8 inches from the injection site. She put an ice pack on and contacted her prescriber, who issued her antibiotics, pain meds, and a steroid dose pak Thursday. It doesn't seem to be as red, and painful as when she just got the vaccine on Monday per her report.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: It hurt very badly getting the vaccine by the RN (it never has hurt in my 29 years) and when I went home my boyfriend (who is a Pharmacist) noticed how high the shot was given and honestly hours later it was throbbing... not normal vaccine pain but it was throbbing non stop and it has been like this for 6 months now. Directly after receiving vaccine, my shoulder muscle area was hot to the touch and red. I went to see medical provider that next Monday and a NP in the office said this in her notes: On exam, appreciable weakness, does not have full ROM on LUE, and tenderness throughout LUE above elbow but localized to lateral proximal aspect. No c/f cellulitis, abscess at this time, ddx includes bursitis v local inflammation, sending to ortho for consideration of steroid injection (i never went to ortho because I was stubborn at the time and felt that I shouldn't have to pay for what they did but im considering it now because im in severe pain still.) My left shoulder muscle is very tender, feels weak and when I drop my arm it feels like dead weight. I have a PT for spine because I have tight upper back muscles that cause my stiff neck but I swear they are NOT related. I have had neck pain for over a year now. My shoulder pain happened after the flu shot. If the shoulder was from the back muscles it would of happened to my right shoulder in which it didn't. I cannot lift my arm above my head. (So i guess not above 90°?) I drop items because its incredibly weak.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Investigation, Joint impingement, Muscle tightness, Muscular weakness, Musculoskeletal stiffness
Clinical narrative: It hurt very badly getting the vaccine by the RN (it never has hurt in my 29 years) and when I went home my boyfriend (who is a Pharmacist) noticed how high the shot was given and honestly hours later it was throbbing... not normal vaccine pain but it was throbbing non stop and it has been like this for 6 months now. Directly after receiving vaccine, my shoulder muscle area was hot to the touch and red. I went to see medical provider that next Monday and a NP in the office said this in her notes: On exam, appreciable weakness, does not have full ROM on LUE, and tenderness throughout LUE above elbow but localized to lateral proximal aspect. No c/f cellulitis, abscess at this time, ddx includes bursitis v local inflammation, sending to ortho for consideration of steroid injection (i never went to ortho because I was stubborn at the time and felt that I shouldn't have to pay for what they did but im considering it now because im in severe pain still.) My left shoulder muscle is very tender, feels weak and when I drop my arm it feels like dead weight. I have a PT for spine because I have tight upper back muscles that cause my stiff neck but I swear they are NOT related. I have had neck pain for over a year now. My shoulder pain happened after the flu shot. If the shoulder was from the back muscles it would of happened to my right shoulder in which it didn't. I cannot lift my arm above my head. (So i guess not above 90°?) I drop items because its incredibly weak.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Product administered at inappropriate site
Clinical narrative: It hurt very badly getting the vaccine by the RN (it never has hurt in my 29 years) and when I went home my boyfriend (who is a Pharmacist) noticed how high the shot was given and honestly hours later it was throbbing... not normal vaccine pain but it was throbbing non stop and it has been like this for 6 months now. Directly after receiving vaccine, my shoulder muscle area was hot to the touch and red. I went to see medical provider that next Monday and a NP in the office said this in her notes: On exam, appreciable weakness, does not have full ROM on LUE, and tenderness throughout LUE above elbow but localized to lateral proximal aspect. No c/f cellulitis, abscess at this time, ddx includes bursitis v local inflammation, sending to ortho for consideration of steroid injection (i never went to ortho because I was stubborn at the time and felt that I shouldn't have to pay for what they did but im considering it now because im in severe pain still.) My left shoulder muscle is very tender, feels weak and when I drop my arm it feels like dead weight. I have a PT for spine because I have tight upper back muscles that cause my stiff neck but I swear they are NOT related. I have had neck pain for over a year now. My shoulder pain happened after the flu shot. If the shoulder was from the back muscles it would of happened to my right shoulder in which it didn't. I cannot lift my arm above my head. (So i guess not above 90°?) I drop items because its incredibly weak.
Age: 14.0
Sex: F
Vaccine: FLU3, HEPA, HPV9, IPV, TD, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: NO ADVERSE EVENT.  Gave High Dose flu vaccine to a child.
Age: 9.0
Sex: M
Vaccine: FLU3, HEPA, MMR
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event.  Gave high dose flu vaccine to a child.
Age: 62.0
Sex: M
Vaccine: YF
Symptoms: Incorrect route of product administration
Clinical narrative: I have given the vaccine to patient via IM route instead of Subcutaneous route.
Age: 0.33
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Erythema
Clinical narrative: Immediately after his shots the lower part of his lower legs turned red. No difficulty breathing, it resolved on its own within minutes.
Age: 55.0
Sex: M
Vaccine: RAB
Symptoms: Arthralgia, Sciatica
Clinical narrative: February 2nd- Left hip pain that progressed to excruciating pain. Sciatica.. given pain meds and muscle relaxers,
Age: 0.58
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Urticaria
Clinical narrative: Hives to bilateral thighs
Age: 70.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema
Clinical narrative: Developed 13x7 cm erythematous patch oat injection site. Treated with antibiotics (cephalexin started 3-20-25). Symptoms resolved a few days later.
Age: 28.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given Flu and Covid vaccine on 3/21/25 and he had already received both of those on 10/18/24. Patient had no adverse effects from this-
Age: 62.0
Sex: F
Vaccine: PNC20
Symptoms: Discomfort, Erythema, Pyrexia, Skin warm, Swelling
Clinical narrative: Patient started noticing discomfort that evening. On Saturday patient with redness, swelling, tenderness and fever (102). Came to clinic on 3/24/25 with redness, swelling, tenderness and warm to touch. Patient was given antibiotic and treated for possible cellulitis.
Age: 62.0
Sex: F
Vaccine: PNC20
Symptoms: Tenderness
Clinical narrative: Patient started noticing discomfort that evening. On Saturday patient with redness, swelling, tenderness and fever (102). Came to clinic on 3/24/25 with redness, swelling, tenderness and warm to touch. Patient was given antibiotic and treated for possible cellulitis.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Influenza like illness, Pain, Vaccine positive rechallenge
Clinical narrative: flu like symptoms; aches and pains; first dose of shingrix in 2022 and second dose of shingrix on 8 March 2025.; This non-serious case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included SHINGRIX with an associated reaction of influenza like illness (1st dose received in 2022 with aches and pains and pain at the injection site). Concomitant products included lisinopril, rosuvastatin calcium (Crestor), pantoprazole, prednisone, levothyroxine, ipratropium bromide, salbutamol sulfate (Duoneb), sodium chloride, fluticasone propionate;salmeterol xinafoate and tiotropium bromide monohydrate (Spiriva).   On 08-MAR-2025, the patient received the 2nd dose of Shingrix .5 ml. On 08-MAR-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: first dose of shingrix in 2022 and second dose of shingrix on 8 March 2025.). On 09-MAR-2025, the patient experienced influenza-like symptoms (Verbatim: flu like symptoms) and pain (Verbatim: aches and pains). Rechallenge with Shingrix was positive. On 10-MAR-2025, the outcome of the influenza-like symptoms and pain were resolved (duration 1 day). The outcome of the drug dose administration interval too long was not applicable.   It was unknown if the reporter considered the influenza-like symptoms and pain to be related to Shingrix.     It was unknown if the company considered the influenza-like symptoms and pain to be related to Shingrix.   Linked case(s) involving the same patient:  US2025029169   Additional Information: GSK Receipt Date: 10-MAR-2025 I had Shingrix dose in 2022 and again 08-March-2025, the patient did not go back for the second vaccine within the recommended schedule time, which led to lengthening of vaccination schedule. The reporter asked was a third dose recommended due to the time lag in between doses. Recently her physician notified her that to start Nucala she would have to receive the second dose of Shingrix. The patient has not started Nucala yet.  The patient had her second dose of Shingrix. After the second dose of Shingrix the patient did have the same flu-like symptoms with aches and pains one day after the resolved the next day. Medications listed in this report were medication that patient was taking in 2025 during second dose of suspect vaccine.; Sender's Comments:  US-GSK-US2025029169:
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC15, RV5, DTAPIPVHIB, HEP, PNC15, RV5
Symptoms: Crying, Erythema, Infant irritability, Joint swelling, Rash
Clinical narrative: the patient was diagnosed with urticaria; Infant irritability; Crying; This case was downloaded from Vaccine Adverse Event Reporting System (VAERS) (agency#: 2822244) on 25-MAR-2025.  This spontaneous report was referring to an infant female patient (reported as 0.17 years).  The patient's medical history was not reported. On 01-Jan-2025 (on Wednesday), the patient had low grade fever (99.6 F).  THE patient was given infant tylenol every 4 hours for 3 doses until there is was no more fever (also reported as 30 three doses). On 02-Jan-2025 (on Thursday), the patient was doing better.  On 03-Jan-2025 (on Friday), the patient was taken to the primary provider to get vaccines. On that day, she was vaccinated with the first dose of Pneumococcal 15-valent Conjugate Vaccine (VAXNEUVANCE) administered intramuscularly (IM) in the right leg (RL) (lot #Y002963, expiration date: 04-Oct-2026); with the first dose of Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq) administered orally (lot #Y005907, expiration date: 16-Nov-2025); with the second dose of Engerix b (Hepatitis b vaccine rHBsAg (yeast)) administered via "SYR" route in the RL (lot #4D333); and with the first dose of Pentacel (Diphtheria vaccine toxoid;HIB vaccine conj (tet tox);Pertussis vaccine acellular 5-component;Polio vaccine inact 3v (MRC 5);Tetanus vaccine toxoid) administered IM in the left leg (LL) (lot #UK109AA) (exact dosages were not provided). All vaccines were administered for prophylaxis.  On 04-Jan-2025 (on Saturday), the patient became very fussy and cried a lot, however, she was consolable. On 05-Jan-2025 (on Sunday), in the morning the patient was still fussy, but now had a rash on her. It was on both elbows, left pinkie and middle finger, right ring finger and left foot and knee were red, hot and swollen. The parents took the patient to the emergency room (ER) for further evaluation. The patient had shots a couple of days ago. In the ER the patient was diagnosed with urticaria and was prescribed prenisolone 15mg/5ml solution - in a step-down regimen for 6 days. The Moc was advised to follow-up with patient's primary provider. When she went the patient was referred to an allergist for further evaluation. The patient recovered on an unknown date.  The causal relationship between the suspected vaccines and the adverse events was not reported.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-03-26 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 2822244-1 , Central date : 2025-03-26 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC15, RV5, DTAPIPVHIB, HEP, PNC15, RV5
Symptoms: Skin warm, Urticaria
Clinical narrative: the patient was diagnosed with urticaria; Infant irritability; Crying; This case was downloaded from Vaccine Adverse Event Reporting System (VAERS) (agency#: 2822244) on 25-MAR-2025.  This spontaneous report was referring to an infant female patient (reported as 0.17 years).  The patient's medical history was not reported. On 01-Jan-2025 (on Wednesday), the patient had low grade fever (99.6 F).  THE patient was given infant tylenol every 4 hours for 3 doses until there is was no more fever (also reported as 30 three doses). On 02-Jan-2025 (on Thursday), the patient was doing better.  On 03-Jan-2025 (on Friday), the patient was taken to the primary provider to get vaccines. On that day, she was vaccinated with the first dose of Pneumococcal 15-valent Conjugate Vaccine (VAXNEUVANCE) administered intramuscularly (IM) in the right leg (RL) (lot #Y002963, expiration date: 04-Oct-2026); with the first dose of Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq) administered orally (lot #Y005907, expiration date: 16-Nov-2025); with the second dose of Engerix b (Hepatitis b vaccine rHBsAg (yeast)) administered via "SYR" route in the RL (lot #4D333); and with the first dose of Pentacel (Diphtheria vaccine toxoid;HIB vaccine conj (tet tox);Pertussis vaccine acellular 5-component;Polio vaccine inact 3v (MRC 5);Tetanus vaccine toxoid) administered IM in the left leg (LL) (lot #UK109AA) (exact dosages were not provided). All vaccines were administered for prophylaxis.  On 04-Jan-2025 (on Saturday), the patient became very fussy and cried a lot, however, she was consolable. On 05-Jan-2025 (on Sunday), in the morning the patient was still fussy, but now had a rash on her. It was on both elbows, left pinkie and middle finger, right ring finger and left foot and knee were red, hot and swollen. The parents took the patient to the emergency room (ER) for further evaluation. The patient had shots a couple of days ago. In the ER the patient was diagnosed with urticaria and was prescribed prenisolone 15mg/5ml solution - in a step-down regimen for 6 days. The Moc was advised to follow-up with patient's primary provider. When she went the patient was referred to an allergist for further evaluation. The patient recovered on an unknown date.  The causal relationship between the suspected vaccines and the adverse events was not reported.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-03-26 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 2822244-1 , Central date : 2025-03-26 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC15, RV5, DTAPIPVHIB, HEP, PNC15, RV5
Symptoms: Crying, Infant irritability, Rash, Urticaria
Clinical narrative: the patient was diagnosed with urticaria; Infant irritability; Crying; This case was downloaded from Vaccine Adverse Event Reporting System (VAERS) (agency#: 2822244) on 25-MAR-2025.  This spontaneous report was referring to an infant female patient (reported as 0.17 years).  The patient's medical history was not reported. On 01-Jan-2025 (on Wednesday), the patient had low grade fever (99.6 F).  THE patient was given infant tylenol every 4 hours for 3 doses until there is was no more fever (also reported as 30 three doses). On 02-Jan-2025 (on Thursday), the patient was doing better.  On 03-Jan-2025 (on Friday), the patient was taken to the primary provider to get vaccines. On that day, she was vaccinated with the first dose of Pneumococcal 15-valent Conjugate Vaccine (VAXNEUVANCE) administered intramuscularly (IM) in the right leg (RL) (lot #Y002963, expiration date: 04-Oct-2026); with the first dose of Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq) administered orally (lot #Y005907, expiration date: 16-Nov-2025); with the second dose of Engerix b (Hepatitis b vaccine rHBsAg (yeast)) administered via "SYR" route in the RL (lot #4D333); and with the first dose of Pentacel (Diphtheria vaccine toxoid;HIB vaccine conj (tet tox);Pertussis vaccine acellular 5-component;Polio vaccine inact 3v (MRC 5);Tetanus vaccine toxoid) administered IM in the left leg (LL) (lot #UK109AA) (exact dosages were not provided). All vaccines were administered for prophylaxis.  On 04-Jan-2025 (on Saturday), the patient became very fussy and cried a lot, however, she was consolable. On 05-Jan-2025 (on Sunday), in the morning the patient was still fussy, but now had a rash on her. It was on both elbows, left pinkie and middle finger, right ring finger and left foot and knee were red, hot and swollen. The parents took the patient to the emergency room (ER) for further evaluation. The patient had shots a couple of days ago. In the ER the patient was diagnosed with urticaria and was prescribed prenisolone 15mg/5ml solution - in a step-down regimen for 6 days. The Moc was advised to follow-up with patient's primary provider. When she went the patient was referred to an allergist for further evaluation. The patient recovered on an unknown date.  The causal relationship between the suspected vaccines and the adverse events was not reported.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-03-26 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 2822244-1 , Central date : 2025-03-26 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; PRODUCT was administered after a temperature excursion; This spontaneous report was received from a medical assistant and referred to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.   On 17-Mar-2025, the patient was vaccinated with Hepatitis A Vaccine, Inactivated (VAQTA) (frequency once; lot # Y012227, expiration date: 12-Nov-2025; strength, dose and route were not reported) for prophylaxis by a health professional, which was administered after a temperature excursion (Product storage error). The excursion temperature was 52.5 Fahrenheit with time frame of 1 hour. There was no previous temperature excursion. No additional adverse event (AE) was reported (No adverse event).   This is one of four reports received from the same reporter.