chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: M
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No side effects or symptoms reported. No Additional information provided. No Additional AE/ N; HCP called to report a patient received MMR II (03/01/2025) and then received VARIVAX 7 days later  (03/07/2025) instead of the recommended 4-week interval.; This spontaneous report was received from a pharmacist and refers to a 26-year-old male patient.   The patient's medical history, current conditions and concomitant medications were not reported.   On 01-MAR-2025, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (strength, dose, anatomical route of administration, lot # and expiration date were not reported); and then on 07-MAR -2025 (reported as 7 days later) instead of the recommended 4 week-interval (inappropriate schedule of product administration), the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) 0.5 mL (lot #Y015100 who had been verified to be a valid lot number, expiration date assessed and reported as 06-SEP-2026), both vaccines were administered as prophylaxis.    No additional adverse events reported.
Sex: F
Vaccine: HEPAB, PNC21
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: The left arm injection site demonstrated  continuous bleeding; sickness feeling; the  entire upper portion with pain and a little itching; the  entire upper portion with pain and a little itching; Lethargy; The patient said that the swelling, redness, and warmth; The left arm showed redness and swelling; The left arm showed redness and swelling; This spontaneous report was received from other health professional regarding to a 64-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 21-FEB-2025, the patient started therapy with the first dose of pneumococcal 21-valent conjugate vaccine (CAPVAXIVE), lot number Y011819 (lot number Y011819 had been verified to be valid lot number for, expiration date was not provided, but upon an internal validation, established as 01-OCT-2025), and with hepatitis a vaccine inact;hepatitis b vaccine rHBsAg (yeast) (TWINRIX), lot number 4DS4N, both administered by intramuscular route in left arm, for prophylaxis.  Since 22-FEB-2025, the patient's left arm injection site demonstrated continuous bleeding in comparison to the right arm injection sites per patient. The left arm showed redness and swelling down the entire upper portion with pain and a little itching. The patient said that the swelling, redness, and warmth improved a little after the second night. Lethargy and sickness feeling reported for two days, ibuprofen (MOTRIN) and paracetamol (TYLENOL) was taken by the patient to alleviate the symptoms. The patient stated that she has never experienced any adverse reactions to her previous vaccinations and was contemplating going to the ER the prior day but did not. The reporter visually inspected the sites and redness was present but was much better as per patient. The reporter instructed the patient to take diphenhydramine if the redness or itching continued and to let us know if the areas did not continue to improve. The patient was satisfied with consult about this reaction.  On an unspecified date in 2025, the patient recovered from the events.   The causal relationship between the events and pneumococcal 21-valent conjugate vaccine (CAPVAXIVE) and hepatitis a vaccine inact;hepatitis b vaccine rHBsAg (yeast) (TWINRIX) was not provided.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-04-22 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 2827677 , Central date : 2025-04-22 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Sex: F
Vaccine: HEPAB, PNC21
Symptoms: Injection site warmth, Lethargy, Malaise
Clinical narrative: The left arm injection site demonstrated  continuous bleeding; sickness feeling; the  entire upper portion with pain and a little itching; the  entire upper portion with pain and a little itching; Lethargy; The patient said that the swelling, redness, and warmth; The left arm showed redness and swelling; The left arm showed redness and swelling; This spontaneous report was received from other health professional regarding to a 64-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 21-FEB-2025, the patient started therapy with the first dose of pneumococcal 21-valent conjugate vaccine (CAPVAXIVE), lot number Y011819 (lot number Y011819 had been verified to be valid lot number for, expiration date was not provided, but upon an internal validation, established as 01-OCT-2025), and with hepatitis a vaccine inact;hepatitis b vaccine rHBsAg (yeast) (TWINRIX), lot number 4DS4N, both administered by intramuscular route in left arm, for prophylaxis.  Since 22-FEB-2025, the patient's left arm injection site demonstrated continuous bleeding in comparison to the right arm injection sites per patient. The left arm showed redness and swelling down the entire upper portion with pain and a little itching. The patient said that the swelling, redness, and warmth improved a little after the second night. Lethargy and sickness feeling reported for two days, ibuprofen (MOTRIN) and paracetamol (TYLENOL) was taken by the patient to alleviate the symptoms. The patient stated that she has never experienced any adverse reactions to her previous vaccinations and was contemplating going to the ER the prior day but did not. The reporter visually inspected the sites and redness was present but was much better as per patient. The reporter instructed the patient to take diphenhydramine if the redness or itching continued and to let us know if the areas did not continue to improve. The patient was satisfied with consult about this reaction.  On an unspecified date in 2025, the patient recovered from the events.   The causal relationship between the events and pneumococcal 21-valent conjugate vaccine (CAPVAXIVE) and hepatitis a vaccine inact;hepatitis b vaccine rHBsAg (yeast) (TWINRIX) was not provided.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-04-22 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 2827677 , Central date : 2025-04-22 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Age: 47.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Reported by employee: Left arm painful, red and swollen.
Age: 9.0
Sex: M
Vaccine: HEP, MMR, TDAP
Symptoms: Immediate post-injection reaction, Lethargy, Vision blurred
Clinical narrative: Immediate blurred vision and lethargy, lasting up to 24 hours
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Axillary pain, Oedema peripheral, Skin discolouration, Skin lesion, Tenderness
Clinical narrative: 4/16 red mark on left arm and reporting left armpit pain, sl swollen and tender, seen in the office 4/24 no longer tender to the touch or with movement. Mark has dulled in color almost looks bruised, no longer arm pit pain.  PE dark red blanching, non tender, non palpable confluent oval lesion at longest length about 3 in
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Extra dose administered
Clinical narrative: A third dose of HPV was given that was not needed. Patient had already received two prior doses of HPV. No noted or observed adverse signs or symptoms.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Fatigue, Pain
Clinical narrative: shivering, achy in neck and lumbar and hips, temp 102.6, fatigue. No previous reaction to all other doses and booster in the past.
Age: 1.17
Sex: F
Vaccine: HEPA, PNC20
Symptoms: Vomiting
Clinical narrative: Vomiting in the car on the way home from the doctor
Age: 1.0
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: Vaccination given with Covid 6m-4yr vial that had been mixed the day before on 04/23/2025. Verified the date on the sheet with the vial was 4/23/2025, 3 doses were mixed, one was given and verified on 04/23/2025, the next dose was marked and verified as given on 04/24/2025. Nurse manager notified immediately after it was noticed, and a few hours after vaccine was administered. Provider was made aware of the incident and notified family. Protocol was updated to waste vial every night before end of shift to ensure it can't happen again in the future.
Age: 45.0
Sex: M
Vaccine: TDAP
Symptoms: Joint swelling, Muscle spasms, Peripheral swelling
Clinical narrative: Swelling of bilateral hands, wrists, lower extremities, sensation of lumbar back spasms.
Age: 56.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: No side effects, patient was just administered a pediatric dose rather than an adult dose.
Age: 0.17
Sex: F
Vaccine: DTAP, DTAPHEPBIP
Symptoms: Extra dose administered
Clinical narrative: patient was given pediarix and infarix at same date and time
Age: 2.0
Sex: F
Vaccine: UNK
Symptoms: Ear pain, Rash
Clinical narrative: since being vaccinated the pt has been complaining about her ears hurting. Her right ear seems to be hurting more than the left. She keeps putting her hand deep into her mouth like it is hurting her also. On 4/24/25 when the mother was changing the pts diaper she noticed a rash that resembled ant bites was from the waist line up to the neck line. It didn't seem to be itching or hurting her.  She was taken to her Pediatrician on 4/25/25 for to check the rash. It has since spread to the back. She was given a strep test but not given the results yet. The mother mentioned to the staff that she thought it maybe related to the vaccine that she recently was given but that was quickly dismissed by them. She was told it looked viral and not vaccine related.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine was expired when given
Age: 1.17
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at the injection site noticed on 04/24/25
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood calcium increased, Blood glucose normal, Blood magnesium increased, Brain fog, Cardiac monitoring
Clinical narrative: Saturday, 4/12/25 @ approx 10am I noticed a welping rash on my abdomen & in between my breasts when I was getting dressed.  My throat felt a little swollen & my voice was raspy sounding.  I called (redacted) & spoke to the on call operator who said I should probobly go to the nearest Urgent Care.  At approx 11am I arrived @ Urgent Care in (redacted).  The doctor observed the rash had spread to my arms, back, neck.  My face/throat was swollen.  Lips/tongue numb & tingly. Heart rate was @ 96bpm.  The doctor injested steroids & had me wait in the room for approx 15mins.  During this time the nurse/doctor came to check my vitals/swelling.  Because I drove myself to the Urgent Care, the doctor opted to not give me the Benadryl shot but instead prescribed 3 prescriptions that she instructed that I take 2 (Famotidine 20mg & Benadryl) right away after picking up at pharmacy.  The 3rd prescription (Prednisone 20mg) I was to start taking immediately the following day & continue taking all medications as directed.  If symptons worsen, to contact them.   On Monday, 4/14/25 I had a routine visit scheduled with my Endocrinoligist, I saw Dr. at Endocrinology & Assoc.  My rash was gone, but obvious swelling was still present.  My Endoc. noted my rapid heart rate (still in 90's) & decided to make a few adjustments to my routine Blood Pressure medication (Losartan/HCTZ) & to cut the morning dose to half.  She also ordered blood work,  The blood results indicated several things: My Calcium was very High @ 10.7 0n a range of 8.4-10.2mg/dl.  My Glucose was High @ 140 on a range of 70-110mg/dl.  My T. Protein was High @ 8.3 on a scale of 6.0-7.8g/dl.  Dr. requested that I repeat labs in one week. In addition, she is having me monitor & upload my BP & heart rate to her throughout the week. On Wednesday, 4/16/25 when I was getting dressed  I noticed my skin appeared "blotchy".  No itching or rash, just blotchy.  I felt a little tired feeling but never thought much more bout it.  My husband travels with his career & was out of town this week.  The end of this day I came home never set our home alarm, never fed the dog, fully dressed shoes & all went to sleep on the living room sofa.  I am sharing this because it was about this time that I began a strange "brain fog" I cannot explain.   Friday, 4/18/25 I started experiencing my calves, ankles & feet swelling if I stood on my feet for too long.   Tuesday, 4/22/25 I went for 2nd set of blood work.  New results indicated Calcium had went down  @10.2, still high end of range but down.  My Glucose was still High @ 102 but down from the 140 week prior.  However, new week results indicated a new issue.  My Magnesium is now High @ 2.4 0n a scale of 1.6-2.3mg/dl.   I am currently having tingling & numbness in both forearms hands/fingers.  The raspy voice still there but not as bad as before.  I am still experencing the swelling in calves, ankles & feet.  Thankfully the brain fog is no longer there.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysphonia, Fatigue, Hypoaesthesia, Hypoaesthesia oral, Joint swelling
Clinical narrative: Saturday, 4/12/25 @ approx 10am I noticed a welping rash on my abdomen & in between my breasts when I was getting dressed.  My throat felt a little swollen & my voice was raspy sounding.  I called (redacted) & spoke to the on call operator who said I should probobly go to the nearest Urgent Care.  At approx 11am I arrived @ Urgent Care in (redacted).  The doctor observed the rash had spread to my arms, back, neck.  My face/throat was swollen.  Lips/tongue numb & tingly. Heart rate was @ 96bpm.  The doctor injested steroids & had me wait in the room for approx 15mins.  During this time the nurse/doctor came to check my vitals/swelling.  Because I drove myself to the Urgent Care, the doctor opted to not give me the Benadryl shot but instead prescribed 3 prescriptions that she instructed that I take 2 (Famotidine 20mg & Benadryl) right away after picking up at pharmacy.  The 3rd prescription (Prednisone 20mg) I was to start taking immediately the following day & continue taking all medications as directed.  If symptons worsen, to contact them.   On Monday, 4/14/25 I had a routine visit scheduled with my Endocrinoligist, I saw Dr. at Endocrinology & Assoc.  My rash was gone, but obvious swelling was still present.  My Endoc. noted my rapid heart rate (still in 90's) & decided to make a few adjustments to my routine Blood Pressure medication (Losartan/HCTZ) & to cut the morning dose to half.  She also ordered blood work,  The blood results indicated several things: My Calcium was very High @ 10.7 0n a range of 8.4-10.2mg/dl.  My Glucose was High @ 140 on a range of 70-110mg/dl.  My T. Protein was High @ 8.3 on a scale of 6.0-7.8g/dl.  Dr. requested that I repeat labs in one week. In addition, she is having me monitor & upload my BP & heart rate to her throughout the week. On Wednesday, 4/16/25 when I was getting dressed  I noticed my skin appeared "blotchy".  No itching or rash, just blotchy.  I felt a little tired feeling but never thought much more bout it.  My husband travels with his career & was out of town this week.  The end of this day I came home never set our home alarm, never fed the dog, fully dressed shoes & all went to sleep on the living room sofa.  I am sharing this because it was about this time that I began a strange "brain fog" I cannot explain.   Friday, 4/18/25 I started experiencing my calves, ankles & feet swelling if I stood on my feet for too long.   Tuesday, 4/22/25 I went for 2nd set of blood work.  New results indicated Calcium had went down  @10.2, still high end of range but down.  My Glucose was still High @ 102 but down from the 140 week prior.  However, new week results indicated a new issue.  My Magnesium is now High @ 2.4 0n a scale of 1.6-2.3mg/dl.   I am currently having tingling & numbness in both forearms hands/fingers.  The raspy voice still there but not as bad as before.  I am still experencing the swelling in calves, ankles & feet.  Thankfully the brain fog is no longer there.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Paraesthesia oral, Peripheral swelling, Pharyngeal swelling, Protein total increased
Clinical narrative: Saturday, 4/12/25 @ approx 10am I noticed a welping rash on my abdomen & in between my breasts when I was getting dressed.  My throat felt a little swollen & my voice was raspy sounding.  I called (redacted) & spoke to the on call operator who said I should probobly go to the nearest Urgent Care.  At approx 11am I arrived @ Urgent Care in (redacted).  The doctor observed the rash had spread to my arms, back, neck.  My face/throat was swollen.  Lips/tongue numb & tingly. Heart rate was @ 96bpm.  The doctor injested steroids & had me wait in the room for approx 15mins.  During this time the nurse/doctor came to check my vitals/swelling.  Because I drove myself to the Urgent Care, the doctor opted to not give me the Benadryl shot but instead prescribed 3 prescriptions that she instructed that I take 2 (Famotidine 20mg & Benadryl) right away after picking up at pharmacy.  The 3rd prescription (Prednisone 20mg) I was to start taking immediately the following day & continue taking all medications as directed.  If symptons worsen, to contact them.   On Monday, 4/14/25 I had a routine visit scheduled with my Endocrinoligist, I saw Dr. at Endocrinology & Assoc.  My rash was gone, but obvious swelling was still present.  My Endoc. noted my rapid heart rate (still in 90's) & decided to make a few adjustments to my routine Blood Pressure medication (Losartan/HCTZ) & to cut the morning dose to half.  She also ordered blood work,  The blood results indicated several things: My Calcium was very High @ 10.7 0n a range of 8.4-10.2mg/dl.  My Glucose was High @ 140 on a range of 70-110mg/dl.  My T. Protein was High @ 8.3 on a scale of 6.0-7.8g/dl.  Dr. requested that I repeat labs in one week. In addition, she is having me monitor & upload my BP & heart rate to her throughout the week. On Wednesday, 4/16/25 when I was getting dressed  I noticed my skin appeared "blotchy".  No itching or rash, just blotchy.  I felt a little tired feeling but never thought much more bout it.  My husband travels with his career & was out of town this week.  The end of this day I came home never set our home alarm, never fed the dog, fully dressed shoes & all went to sleep on the living room sofa.  I am sharing this because it was about this time that I began a strange "brain fog" I cannot explain.   Friday, 4/18/25 I started experiencing my calves, ankles & feet swelling if I stood on my feet for too long.   Tuesday, 4/22/25 I went for 2nd set of blood work.  New results indicated Calcium had went down  @10.2, still high end of range but down.  My Glucose was still High @ 102 but down from the 140 week prior.  However, new week results indicated a new issue.  My Magnesium is now High @ 2.4 0n a scale of 1.6-2.3mg/dl.   I am currently having tingling & numbness in both forearms hands/fingers.  The raspy voice still there but not as bad as before.  I am still experencing the swelling in calves, ankles & feet.  Thankfully the brain fog is no longer there.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash macular, Urticaria
Clinical narrative: Saturday, 4/12/25 @ approx 10am I noticed a welping rash on my abdomen & in between my breasts when I was getting dressed.  My throat felt a little swollen & my voice was raspy sounding.  I called (redacted) & spoke to the on call operator who said I should probobly go to the nearest Urgent Care.  At approx 11am I arrived @ Urgent Care in (redacted).  The doctor observed the rash had spread to my arms, back, neck.  My face/throat was swollen.  Lips/tongue numb & tingly. Heart rate was @ 96bpm.  The doctor injested steroids & had me wait in the room for approx 15mins.  During this time the nurse/doctor came to check my vitals/swelling.  Because I drove myself to the Urgent Care, the doctor opted to not give me the Benadryl shot but instead prescribed 3 prescriptions that she instructed that I take 2 (Famotidine 20mg & Benadryl) right away after picking up at pharmacy.  The 3rd prescription (Prednisone 20mg) I was to start taking immediately the following day & continue taking all medications as directed.  If symptons worsen, to contact them.   On Monday, 4/14/25 I had a routine visit scheduled with my Endocrinoligist, I saw Dr. at Endocrinology & Assoc.  My rash was gone, but obvious swelling was still present.  My Endoc. noted my rapid heart rate (still in 90's) & decided to make a few adjustments to my routine Blood Pressure medication (Losartan/HCTZ) & to cut the morning dose to half.  She also ordered blood work,  The blood results indicated several things: My Calcium was very High @ 10.7 0n a range of 8.4-10.2mg/dl.  My Glucose was High @ 140 on a range of 70-110mg/dl.  My T. Protein was High @ 8.3 on a scale of 6.0-7.8g/dl.  Dr. requested that I repeat labs in one week. In addition, she is having me monitor & upload my BP & heart rate to her throughout the week. On Wednesday, 4/16/25 when I was getting dressed  I noticed my skin appeared "blotchy".  No itching or rash, just blotchy.  I felt a little tired feeling but never thought much more bout it.  My husband travels with his career & was out of town this week.  The end of this day I came home never set our home alarm, never fed the dog, fully dressed shoes & all went to sleep on the living room sofa.  I am sharing this because it was about this time that I began a strange "brain fog" I cannot explain.   Friday, 4/18/25 I started experiencing my calves, ankles & feet swelling if I stood on my feet for too long.   Tuesday, 4/22/25 I went for 2nd set of blood work.  New results indicated Calcium had went down  @10.2, still high end of range but down.  My Glucose was still High @ 102 but down from the 140 week prior.  However, new week results indicated a new issue.  My Magnesium is now High @ 2.4 0n a scale of 1.6-2.3mg/dl.   I am currently having tingling & numbness in both forearms hands/fingers.  The raspy voice still there but not as bad as before.  I am still experencing the swelling in calves, ankles & feet.  Thankfully the brain fog is no longer there.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine expired when given
Age: 8.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: In error patient was suppose to receive Tdap
Age: 10.0
Sex: M
Vaccine: TYP, YF
Symptoms: Crying, Loss of consciousness, Musculoskeletal stiffness
Clinical narrative: Patient was fine with first vaccine administered (Typhim VI) but after yellow fever vaccine, patient began to cry and then went stiff. Loss of consciousness occurred. Patient began to slide off the chair but was caught before hitting the ground. Patient recovered shortly thereafter and was kept at the pharmacy for observation for several minutes. No further loss of consciousness or adverse symptoms occurred. Patient was offered a drink of cold water and then taken home by their parents. Follow up occurred 20 minutes after patient left facility and no further adverse events or symptoms were reported by patient's mother.
Age: 0.67
Sex: M
Vaccine: PPV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient was due for Prevnar 20, he was given Pneumovax 23 instead. Mother reports no adverse event or side effects after vaccination.
Age: 75.0
Sex: F
Vaccine: PNC20
Symptoms: Chills, Decreased appetite, Dizziness, Headache, Pain in extremity
Clinical narrative: pt says she after getting the vaccine she had soreness in left arm and had developed a bad headache, became dizzy, chills with no fever, loss of appetite, and did not sleep well. By morning she felt some better but not well. Her arm is still tender and she is still tired.
Age: 75.0
Sex: F
Vaccine: PNC20
Symptoms: Sleep disorder
Clinical narrative: pt says she after getting the vaccine she had soreness in left arm and had developed a bad headache, became dizzy, chills with no fever, loss of appetite, and did not sleep well. By morning she felt some better but not well. Her arm is still tender and she is still tired.
Age: 53.0
Sex: F
Vaccine: HEPA
Symptoms: Burning sensation, Erythema, Influenza like illness
Clinical narrative: flu like symptoms and redness and burning
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Pain
Clinical narrative: Persistent Stinging in muscle. Pain increasing when raising arm.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: 4 y/o child was given routine vaccines on 4/22/2025 around 4:15pm. Mother called facility on 4/24/25 wanting to speak to a nurse. I talked with her. Mother states on 4/23/2025 around 8:30pm-child was taking a bath and removed the bandaid from the arm and had a big puffy ring under the bandaid. Mother states arm was swollen, red and had a hard knot under bandaid. She took him to the ER that night. She states they gave him Benadryl, a steriod, and antibiotics and said they was treating him for an allergic reaction to the vaccine and cellulitis. Mother states the area was 12cm x 11cm in size on his arm. She denies that the child was having any pain, states it was very itchy to him. I explained to her again about possible swelling, redness and knot with any vaccine. I questioned her about a possible reaction to the bandaid. It was left on the arm for over 24 hours. She denies him ever having a problem with bandaids in the past. When I spoke with mother on 4/24/2025 she was at Dr.'s office with child for a follow up. She states that the area had gotten worse since 4/23/25 night @ the ER with more swelling and the skin was even starting to crack open. I called mother today 4/25/2025 to follow up and to see how MD appt. was yesterday evening. Mother states symptoms have improved a lot since yesterday. She states the swelling has started to go down and it's not as red. She states nurse practitioner did feel like it was an allergic reaction to the vaccine but wasn't 100% sure. NP advised mother to continue giving child the medication prescribed in the ER and no new meds were prescribed. Mother asked about child getting Tdap in the future when child is 11 years of age. I advised her that she would want to discuss that with PCP at that time.  She is states she wants him to get it if he can since it will be the last Tdap he has to get for school. Advised mother that would be up to his PCP.  Mother thanked me for calling and checking on the child today.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Loss of consciousness
Clinical narrative: Patient passed out when checking out from her visit. Patient was observed for 10 minutes in the exam room post vaccine. Patient regained consciousness quickly and was assisted to a wheelchair. Patient was laid on exam table in supine position with head of bed at approximately 30 degrees and given juice to drink after sitting up further.
Age: 66.0
Sex: F
Vaccine: COVID19, MMR
Symptoms: Fine motor skill dysfunction, Hypoaesthesia, Pain, Paraesthesia
Clinical narrative: Continual paresthesia in right arm for past month since vaccination. Numbness, tingling, shooting pains, more pronounced at night. Slight difficulty with fine motor activities of right fingers.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: Wasn't given this vaccine it was allegedly administered to me by pharmacy on 10/04/2023 malicious intent to harm me and my mother
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Crying, Infant irritability
Clinical narrative: Inconsolable crying  >12 hrs. Started in the evening of the vaccine date. Continued through the night and irritability persisted then next day.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute kidney injury, Blood creatinine increased, Blood urea increased, Chronic kidney disease, Dehydration
Clinical narrative: AFTER THE FIRST DOSE , MY CREATNIN WAS RISED UP TO 3.4 AND MY INR 18.0 THEY FOUND OUT I ALSO HAD 3 TEAR /HOLES ARUND MY MITRAL VALVE   AFTER 2ND SHOT, I WAS GETTNG DEHUDRATED DESPITE OF DRINKINGSO MUCH WATER .AFTER SOME DOAGNOSTIC TESTING , MY CREATNI 8.5,  I WAS TOLD I HAVE AKI OR KIDNET FAILURE.AND ENDED UP IN HOSPITAL 12 DAYS AND GETTING DIALYSISi NEVER HAD ADVERSE REATION TO ANY VACCINE TIL COVID VACCIN. SINCE THEN I HVE ADVERSE REACYTION TO FLUE VACCIN, MY KIDNEY FUNTION FALL  AN CRATNING INSCREASES ABOUT 3.4 AND M NOW I HAVE A CHRONIC KIDNEY DSEASE .  MY GFR IS LOW, MY CREATNING AND BUN ARE HIGH.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dialysis, Glomerular filtration rate decreased, Immunisation reaction, International normalised ratio increased, Mitral valve incompetence
Clinical narrative: AFTER THE FIRST DOSE , MY CREATNIN WAS RISED UP TO 3.4 AND MY INR 18.0 THEY FOUND OUT I ALSO HAD 3 TEAR /HOLES ARUND MY MITRAL VALVE   AFTER 2ND SHOT, I WAS GETTNG DEHUDRATED DESPITE OF DRINKINGSO MUCH WATER .AFTER SOME DOAGNOSTIC TESTING , MY CREATNI 8.5,  I WAS TOLD I HAVE AKI OR KIDNET FAILURE.AND ENDED UP IN HOSPITAL 12 DAYS AND GETTING DIALYSISi NEVER HAD ADVERSE REATION TO ANY VACCINE TIL COVID VACCIN. SINCE THEN I HVE ADVERSE REACYTION TO FLUE VACCIN, MY KIDNEY FUNTION FALL  AN CRATNING INSCREASES ABOUT 3.4 AND M NOW I HAVE A CHRONIC KIDNEY DSEASE .  MY GFR IS LOW, MY CREATNING AND BUN ARE HIGH.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Renal failure
Clinical narrative: AFTER THE FIRST DOSE , MY CREATNIN WAS RISED UP TO 3.4 AND MY INR 18.0 THEY FOUND OUT I ALSO HAD 3 TEAR /HOLES ARUND MY MITRAL VALVE   AFTER 2ND SHOT, I WAS GETTNG DEHUDRATED DESPITE OF DRINKINGSO MUCH WATER .AFTER SOME DOAGNOSTIC TESTING , MY CREATNI 8.5,  I WAS TOLD I HAVE AKI OR KIDNET FAILURE.AND ENDED UP IN HOSPITAL 12 DAYS AND GETTING DIALYSISi NEVER HAD ADVERSE REATION TO ANY VACCINE TIL COVID VACCIN. SINCE THEN I HVE ADVERSE REACYTION TO FLUE VACCIN, MY KIDNEY FUNTION FALL  AN CRATNING INSCREASES ABOUT 3.4 AND M NOW I HAVE A CHRONIC KIDNEY DSEASE .  MY GFR IS LOW, MY CREATNING AND BUN ARE HIGH.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient received 3 extra dose ( 5 total). reports no issues
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Magnetic resonance imaging joint, Muscle spasms, Pain, Paraesthesia
Clinical narrative: On the day of the injection (December 26, 2024), I experience soreness, deep pain, spasm and throbbing . The arm and shoulder became tingly, numb and tender to the touch. The pain wakes me from sleep.  The has not resolved over 4 months. I received the following therapies but the pain and discomfort have not resolved the issue: Ice therapy, massage, red light therapy, infrared therapy, sauna therapy, acupuncture, physical therapy, lidocaine spray, bio freeze patches and cream. I began using a prescription muscle relaxer and pain relief rub on Feb 18, 2025. I am currently receiving physical therapy.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Sleep disorder, Tenderness, X-ray limb
Clinical narrative: On the day of the injection (December 26, 2024), I experience soreness, deep pain, spasm and throbbing . The arm and shoulder became tingly, numb and tender to the touch. The pain wakes me from sleep.  The has not resolved over 4 months. I received the following therapies but the pain and discomfort have not resolved the issue: Ice therapy, massage, red light therapy, infrared therapy, sauna therapy, acupuncture, physical therapy, lidocaine spray, bio freeze patches and cream. I began using a prescription muscle relaxer and pain relief rub on Feb 18, 2025. I am currently receiving physical therapy.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dyskinesia, Loss of consciousness, Musculoskeletal stiffness, Unresponsive to stimuli
Clinical narrative: HPV, Tdap, and Meningitis given at 11:45am, 11:48am mom came in office after pulling out of parking space stating child having a seizure.  Mom explained he started to pass out, body went stiff, had a couple of jerking motions, and could not respond to her-patient evaluated by doctor, MA's, and PA at 1148am.  Child was coherent, drinking juice, no other symptoms.
Age: 10.0
Sex: F
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: On 9/23/2024. Patient received menquadfi and she was under the age of 11.
Age: 82.0
Sex: F
Vaccine: HEP
Symptoms: Chest discomfort, Pruritus, Throat tightness
Clinical narrative: Patient was given Venofer 50mg IVP at 9:20am, not her first dose tolerated well previously. Patient's second dose of Heplisav-B (Lot#:945663 EXP 1/31/27) series was given at 10:19 am with no reaction within the next 2 hours, previously her first dose was tolerated well. At 12:24 patient started complaining of itching all over her body, Benadryl 50mg PO given at 12:32 pm since there was no access available, she was done with her treatment. Within the next 2 minutes she started complaining of her throat closing up, 911 was called, her son was notified. She wanted to be taken to hospital, all her belongings went with her via ambulance. BP was stable throughout treatment, with a low reading that was due to loose cuff, BP was stable upon second reading. She complained that she had pills stuck in her chest area from this morning before she came in, PCT offered water at 12pm when the patient notified her.
Age: 0.5
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Erythema of eyelid, Injection site discharge, Injection site inflammation, Rash
Clinical narrative: Redness of lower eyelids, inflammation of injection site along with bruising and discomfort. Rash located on the chest and abdomen.
Age: 82.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site pruritus, Injection site rash, Skin mass
Clinical narrative: Nodule under skin and rash near vaccine site and partially down arm that lasted for a few days. Slightly itchy, but not extreme. Resolved on its own eventually.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Patient developed redness and swelling around injection site with raised edges, hot to touch, and rash that extended down arm. patient is taking tylenol, using hydrocortisone cream, and going to take benadryl. Patient said hydrocortisone seemed to help some.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: PT GIVEN LIVE VACCINE TOO CLOSE TO ANOTHER LIVE VACCINE. 25 DAYS OUT INSTEAD OF 28.  INFORMED MOTHER OF ERROR AND TOLD WHEN TO RETURN FOR THE NEXT DOSE.
Age: 1.67
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: An adult dose was given to to pediatric
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood glucose fluctuation, Fatigue, Headache, Influenza, Mobility decreased
Clinical narrative: at first she felt fine, and then it got sore in the evening. the next day she woke up she felt fatigued and extreme headache. she tried to get rid of headache with allegra, an another decongestant. at 7:00 PM she took the low dose aspirin.  she described the symptoms to having the worst flu, she went to bed most of the day. blood glucose spiked and decreased  a bunch throughout the day. up to 250 at around 12:00PM. she said she took protein to try and combat the spikes. patient also has a large warm rash
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Skin warm
Clinical narrative: at first she felt fine, and then it got sore in the evening. the next day she woke up she felt fatigued and extreme headache. she tried to get rid of headache with allegra, an another decongestant. at 7:00 PM she took the low dose aspirin.  she described the symptoms to having the worst flu, she went to bed most of the day. blood glucose spiked and decreased  a bunch throughout the day. up to 250 at around 12:00PM. she said she took protein to try and combat the spikes. patient also has a large warm rash
Age: 0.58
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Faeces discoloured
Clinical narrative: Within 45 minutes of receiving the shot, patient had a grey colored stool that had a chemical smell. 7 hours after receiving the shot, patient had another grey and white colored stool. Patient only had one stool a day for the past month in the morning and she has that prior to shot. No foods were changed and her normal schedule was followed. No fevers or any other symptoms. Just suddenly grey/white stool
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: No adverse event, Wrong patient
Clinical narrative: MCV4  U8375AB Right Deltoid IM, and Tdap U8252AA Left Deltoid IM, was inadvertently administered to patient. Instead of intended recipient. The patient was verbally  asked to state his name, which he did. I then stated the the date of birth and the patient said yes. I proceeded with the vaccine. The error was identified shortly after administration. Patient was observed for 30 Minutes, there was no adverse reaction. Patient's mother was notified immediately and provided with a full  explanation of the error. Provider was informed at 11:18AM School Nurse  was also notified.
Age: 1.08
Sex: M
Vaccine: HEPA, MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Patient received Varivax, ProQuad, and Hep A on 3/14/2025. Mother was notified regarding extra Varicella dose via Proquad product approx. an hour after administration.  A follow up call 3/17/2025 to patient was made and mother reported patient did well over the week. He was afebrile, and immunization sites with no changes.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Injection site urticaria, Rash, Urticaria
Clinical narrative: She developed hives after injections at each vaccination site, bilateral wrists, and both side of face, spread up arms and down legs. She was given oral Benadryl and monitored at the clinic office for 2 hours after injections. Hives resolved and rash had improved prior to leaving. Instructed to go to ER if hives recurred, swelling of face, trouble breathing, wheezing, or rash worsened.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site rash
Clinical narrative: Rash on thigh at injection site
Age: 78.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Extra dose administered
Clinical narrative: PATIENT RECEIVED ONE DOSE OF AREXVY ON 11/14/2023 AND THEN A SECOND DOSE OF AREXVY ON 12/21/2024
Age: 66.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Wrong product administered
Clinical narrative: Gave Prevnar 20 instead of the ordered Shingrix, called pt to inform them of what had happened. Submitted an RL. Pt came back to receive correct vaccine. Informed provider and supervisor of the incident.
Age: 4.0
Sex: F
Vaccine: TD
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient came in clinic with a form from school saying she needed the vaccine. This vaccine was not supposed to be given to a four year old. No adverse event.
Age: 0.25
Sex: M
Vaccine: RV5
Symptoms: Bradycardia, Infantile apnoea, Oxygen saturation decreased, Underdose
Clinical narrative: decreased oxygen saturation/additional oxygen support; experienced apnea; experienced bradycardia to a rate of 53; received a 2 mL dose but the chart noted a partial dose.; This spontaneous report was received from a pharmacist and refers to a 3-month male patient.   The patient's concurrent conditions included Premature Baby, NICU, and oxygen support.  Concomitant medications included Hepatitis B Vaccine (manufacturer unknown), Diphtheria vaccine toxoid;HIB vaccine conj (tet tox);Pertussis vaccine acellular 5-component;Polio vaccine inact 3v (MRC 5);Tetanus vaccine toxoid) (PENTACEL), Pneumococcal vaccine (manufacturer un known) .  On 06-APR-2025, the patient was vaccinated with a first dose of  dose of  Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), (lot #209662, expiration date: 27-MAR-2026), dose: 2 mL, but it was reported that the baby  received a 2 mL dose but the chart noted a partial dose(Underdose) , administered by Oral route for prophylaxis reported as Primary immunization.  After being administered the vaccine, on the same day, the patient experienced apnea, bradycardia to a rate of 53 (units not provided), decreased oxygen saturation. The baby did not respond to suctioning or repositioning. The baby needed additional oxygen support. The hospitalization prolonged, on an unknown day in 2025. The baby was still admitted in hospital. The patient recovered from the events on the same day (on 06-APR-2025). It was mentioned that the reporter stated that he/she was undecided if patient would get second dose  The causal relationship between the events and  Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was unknown.   The reporter considered, the events of experienced apnea bradycardia to a rate of 53 and decreased oxygen saturation/additional oxygen support to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Facial nerve neuritis
Clinical narrative: Facial nerve inflammation; This serious case was reported by a consumer via call center representative and described the occurrence of neuritis cranial in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, several months after receiving Shingrix, the patient experienced neuritis cranial (Verbatim: Facial nerve inflammation) (serious criteria GSK medically significant). The outcome of the neuritis cranial was unknown.   It was unknown if the reporter considered the neuritis cranial to be related to Shingrix.     The company considered the neuritis cranial to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 22-APR-2025 Consumer reported that  a few months after receiving Shingrix, he experienced facial nerve inflammation.; Sender's Comments: Neuritis cranial  is an unlisted event which is considered unrelated to GSK vaccine Shingrix
Sex: M
Vaccine: RSV
Symptoms: Aphonia, Cough, Fatigue
Clinical narrative: lost his voice; he developed fatigue; cough; loss of appetite; This non-serious case was reported by a consumer via call center representative and described the occurrence of loss of voice in a elderly male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included Influenza vaccine (Influenza vaccin) for prophylaxis and COVID-19 vaccine for prophylaxis.   In OCT-2024, the patient received Arexvy, Influenza vaccin and COVID-19 vaccine. In OCT-2024, an unknown time after receiving Arexvy and Influenza vaccin, the patient experienced loss of voice (Verbatim: lost his voice), fatigue (Verbatim: he developed fatigue), cough (Verbatim: cough) and appetite lost (Verbatim: loss of appetite). The outcome of the loss of voice was not resolved and the outcome of the fatigue, cough and appetite lost were resolving.   It was unknown if the reporter considered the loss of voice, fatigue, cough and appetite lost to be related to Arexvy.     It was unknown if the company considered the loss of voice, fatigue, cough and appetite lost to be related to Arexvy.   Additional Information: GSK Receipt Date : 17-APR-2025 Patient reported he received Arexvy vaccine on October of 2024.  After received the vaccine, he developed fatigue, loss of appetite, cough, and losted his voice.  Patient reported his voice had not recovered since he started experiencing the side effect. Patient reporeds that he received the Covid vaccine and a Flu vaccine the same day he received arexvy. It was unknown if the reporter considered the loss of voice, fatigue, cough and appetite lost to be related to Covid 19 vaccine and Flu vaccine.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: developed redness at the injection site; developed rash at the injection site; developed itchy at the injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11-FEB-2025, the patient received the 1st dose of Shingrix (left deltoid). On 11-FEB-2025, less than a day after receiving Shingrix, the patient experienced injection site erythema (Verbatim: developed redness at the injection site). On an unknown date, the patient experienced injection site rash (Verbatim: developed rash at the injection site) and injection site itching (Verbatim: developed itchy at the injection site). The outcome of the injection site erythema, injection site rash and injection site itching were resolved (duration 4 weeks).   It was unknown if the reporter considered the injection site erythema, injection site rash and injection site itching to be related to Shingrix.     It was unknown if the company considered the injection site erythema, injection site rash and injection site itching to be related to Shingrix.   Additional Information: GSK receipt date: 18-APR-2025 The patient reported that she experienced redness at the injection site the day she received her 1st dose of Shingrix, on 11th February 2025. The patient reported that this red area started getting bigger and bigger, and stayed itchy and red off and on for about a month (no specific date provided). The patient mentioned that she received the first dose of the Shingrix vaccine and developed a very large red, itchy rash at the injection site which lasted about 4 weeks. The patient had a doubt was it safe for her to receive the second dose. The patient received her vaccine at her local pharmacy from the pharmacist. The patient did not have the lot number and expiry information or route of administration.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient who received his first dose of SHINGRIX in 2018. His records does not indicate that he received a second dose even though he thinks he did. Unknown if he received second dose.; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose in 2018).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient who received his first dose of SHINGRIX in 2018. His records does not indicate that he received a second dose even though he thinks he did. Unknown if he received second dose.). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 23-APR-2025 The patient self-reported this case. The patient received his first dose of Shingrix in 2018 and his records did not indicate that he received a second dose even though he thought he did and was unknown if he received second dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.; Sender's Comments:  US-GSK-US2025049324:Same reporter,Different patient