chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.75
Sex: F
Vaccine: MEN
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Menquadfi was given to a 9-month-old infant, which is against the prescribed age of administration which should be 2 years of age (with no reported adverse event); Initial information received on 30-Jul-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 9 months old female patient who was given Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi], which is against the prescribed age of administration which should be 2 years of age (with no reported adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; and HEPATITIS A VACCINE (HEPA [HEPATITIS A VACCINE]) for Immunisation.  On 03-Jul-2024, the patient of 9 month old received a 0.5 ml (Frequency: Once) dose of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine Solution for injection (lot U7853BA, Expiry: 31-Oct-2025, Strength: standard) via intramuscular route in the right thigh as immunization which is against the prescribed age of administration which should be 2 years of age (with no reported adverse event) (product administered to patient of inappropriate age) (Latency: same day). Treatment = N/A    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: MEN
Symptoms: No adverse event, Underdose
Clinical narrative: only able to administer half of the MENQUADFI vaccine, with no reported adverse event; Initial information received on 30-Jul-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age/gender patient who received MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] only half dose with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 30-Jul-2024, the patient received 0.25 ml of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE, Solution for injection (lot: unknown) (strength, route, expiry and administration site: unknown) (incorrect dose administered, latency same day) for immunization.  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: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Incorrect route of product administration, No adverse event
Clinical narrative: inappropriate use due to Adacel dose being administered subcutaneously rather than intramuscularly with no reported adverse event; Pregnant patient received Adacel with no reported adverse event; Initial information received on 31-Jul-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 30 years old pregnant female patient who was exposed to Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] in context of inappropriate use due to adacel dose being administered subcutaneously rather than intramuscularly with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.   The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy.   On 30-Jul-2024, the pregnant patient received a unknown dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine Suspension for injection (strength and expiry date: unknown and lot U8232AA) via subcutaneous route in the left arm as Prophylactic vaccination (immunization) and inappropriate use due to adacel dose being administered subcutaneously rather than intramuscularly with no reported adverse event (incorrect route of product administration) (maternal exposure timing unspecified) (latency: same day).  Additionally, at time of reporting, the outcome of the pregnancy is unknown.  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: 16.0
Sex: M
Vaccine: MEN
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: patient received a dose of menquadfi 6 weeks apart from that menacwy vaccine with no reported adverse event; Initial information received on 31-Jul-2024 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 16 years old male patient who received a dose of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI]  6 weeks apart from that menacwy vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 15-Jul-2024, the patient received dose 0.5 ml TOTAL  Solution for injection of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE lot U7949AA expiry-01-Mar-2026 via intramuscular route in the left deltoid for Immunisation (strength unknown) 6 weeks apart from that menacwy vaccine with no reported adverse event (inappropriate schedule of product administration) (latency same day).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 11.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: patient was injected with daptacel instead of tdap with no reported adverse event; Initial information received on 31-Jul-2024 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 11 years old female patient who was injected with DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of tdap with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 30-Jul-2024, the patient received 0.5 ml TOTAL dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE Suspension for injection  expiry- 04-NOV-2024 lot 2CA28C1 via intramuscular route in the left deltoid for Prophylactic vaccination (Immunisation) (strength unknown) instead of tdap with no reported adverse event (wrong product administered) (latency same day).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.25
Sex: M
Vaccine: PNC13
Symptoms: No adverse event, Product prescribing error
Clinical narrative: 15 old month male patient came in for 15 month  wellness visit. Standard vaccine schedule is Dtap and HIB at 15 months of age. Orders placed  by provider were Dtap and Prevar13. Orders should have been Dtap and Pedvax HIB. Administration of wrong vaccine was not found until patient turned 5 yrs of age. Patient did not have any adverse reaction post admin of the Prevnar 13 dose.
Age: 4.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, Rash
Clinical narrative: Patient was given a Proquad (MMRV) and varicella vaccine at the same time. Patient developed a rash after getting the 2 vaccines.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: Patient reported Guillain-Barre to pharmacy on 8-5-2024 as diagnosed on 6-12-2024
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Crying, Pyrexia, Somnolence
Clinical narrative: Extremely difficult to wake up in the morning (3 days post injection), 103.5 degree F fever 3 days post injection, hysterically crying for 5 hours at bedtime 4 days postinjection
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pain in extremity
Clinical narrative: Patient said they had extreme arm pain and redness around area. Told patient this is normal. Patient said shot was given high on the arm. I talked with provider who saw patient post shot and the area was fine.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test normal, Computerised tomogram head normal, Diarrhoea, Dizziness, Electrocardiogram normal
Clinical narrative: He got his vaccine, on Thursday he started with dizziness, shuffling of feet, headache and now diarrhea has set in.  He has taken Naprosyn sodium for his symptoms.  He is getting ready to take some Imodium.  He has continued with the dizziness since Thursday.  He went to the ER and they did a CT scan, blood work and EKG and everything has come back within normal limits.  He was not given anything for his symptoms.  He has contacted his doctor and is waiting for a response from them.  He went to an UC as the ER had a shooting and could not go there.  His doctors advised to rule out the possibility of a stroke, which that was ruled out.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Gait disturbance, Headache
Clinical narrative: He got his vaccine, on Thursday he started with dizziness, shuffling of feet, headache and now diarrhea has set in.  He has taken Naprosyn sodium for his symptoms.  He is getting ready to take some Imodium.  He has continued with the dizziness since Thursday.  He went to the ER and they did a CT scan, blood work and EKG and everything has come back within normal limits.  He was not given anything for his symptoms.  He has contacted his doctor and is waiting for a response from them.  He went to an UC as the ER had a shooting and could not go there.  His doctors advised to rule out the possibility of a stroke, which that was ruled out.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Skin exfoliation
Clinical narrative: Client noticed a band of redness and swelling below the injection site the next morning after vaccination. Redness continues today which is one week later. Skin is pink and dry with some peeling. the band extends across anterior aspect of left arm  8 inch x 3 inch.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Underdose
Clinical narrative: During vaccine administration, the patient recoiled and his left thigh was moved away from the vaccine, resulting in a partially administered vaccine. The patient had no known adverse effects and no injuries during this incident. The event was documented in system and patient will be scheduled for a repeat vaccine after August 29, 2024 per CDC consult as this is a live vaccine.
Age: 1.25
Sex: F
Vaccine: HIBV
Symptoms: Product preparation issue
Clinical narrative: Hib vaccination requires mixing the dilutant provided with the powder vaccine.  The vaccine was given without the mixing. The patient only received the sterile dilutant.
Age: 41.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Feeling hot, Oedema, Pain, Skin reaction
Clinical narrative: Erythema, edema, streaking, calor, pain which started ~8 hours after immunization was given and progressively worsened.
Age: 3.0
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: NO ADVERSE EVENTS NOTED AT THIS TIME.
Age: 11.0
Sex: F
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: Meningococcal B was administered instead of MenQuadfi that was ordered. The Meningococcal B was not due until 8/16/2024.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Dizziness, Magnetic resonance imaging, Migraine
Clinical narrative: migraine and dizziness starting morning after pm shot.  Most severe symptoms lasted at least a year, with continual mild symptoms still, almost 3 years later!
Age: 92.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: Swollen itchy arm
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Cytogenetic analysis normal, Delivery, Foetal disorder, Laboratory test normal
Clinical narrative: I had 4 healthy pregnancies, then was forced to take the Covid vaccine in nursing school, and then I had a stillbirth and miacarriage related to anencephaly. On April 7th, 2023, we found out out son, had anecephaly and i had a high risk of heavy bleeding, due to a low laying placenta. Because of the laws, I had to deliver him. He was born. For our next pregnancy, we found out that our daughter had the same diagnosis of anencephaly on May 6th, 2024. We delivered her. Both of our children died. The covid vaccine is the only thing that is different from my previous healthy 4 pregnancies.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Placental disorder, Stillbirth, Ultrasound foetal abnormal
Clinical narrative: I had 4 healthy pregnancies, then was forced to take the Covid vaccine in nursing school, and then I had a stillbirth and miacarriage related to anencephaly. On April 7th, 2023, we found out out son, had anecephaly and i had a high risk of heavy bleeding, due to a low laying placenta. Because of the laws, I had to deliver him. He was born. For our next pregnancy, we found out that our daughter had the same diagnosis of anencephaly on May 6th, 2024. We delivered her. Both of our children died. The covid vaccine is the only thing that is different from my previous healthy 4 pregnancies.
Age: 1.83
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: GAVE VACCINE TO CHILD NOT WITHIN AGE RANGE OF VACCINE-NO NONE ADVERSE EVENTS
Age: 3.0
Sex: F
Vaccine: DTAPIPV, HEP
Symptoms: Wrong product administered
Clinical narrative: Patient was given DTap + IPV (kinrix) instead of  DTap + Hep B + IPV (Pediarix ) by accident
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Injection site haemorrhage, Injection site induration, Injection site swelling
Clinical narrative: Injection site bled and a nickel sized raised bump resulted from vaccination. Bump was hard, but not painful and subsided with time (10 minutes). Patient was advised to keep an eye on the area and apply cold compression. Pharmacy will follow up in a few hours with patient.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Blood lactic acid, Differential white blood cell count, Full blood count, Gait inability
Clinical narrative: 2 days after receiving the shot I had a tingling sensation on my legs and toes and persisted for 5 days. On day 6 I woke up with both of my feet completely numb and got worse over time. I first went to Urgent Care to be checked and they sent me to hospital. After 3 hours they told me to go to Medical Center to get further evaluated by a neurologist and get an MRI because the MRI facility was down at hospital and they did not have a neurologist to evaluate me and treat me. After a couple of hours in Medical Center my symptoms worsened over time, at the point that I was not able to walk anymore and needed assistance to get up or walk. The hospital admitted me and I was there for 11 days to be treated for Acute Transverse Myelitis and they started a 5 day treatment with steroids. After 11 days I was transferred to an inpatient rehabilitation facility for 16 days to help me regain the strength on my lower body. I was released from the rehabilitation hospital 12/22/2023. On 12/27/2023 I followed up with my primary doctor. On 01/02/2024 I followed up with Dr from the Neuroscience. I went to the Rehab clinic for Ocupational therapy evaluation at Sports Medicine facility On 01/03/2024. On 01/09/2024 I went to the rehab clinic for Physical therapy evaluation. I had physical therapy from 01/11/2024 to 03/01/2024. On 01/31/2024 I followed up with Dr. On 02/22/2024 I followed up with Dr. On 02/28/2024 I went to see Dr Urology.  Specialists : On 04/01/2024 I had another MRI at Medical Center. On 06/25/2024 I followed up with Dr. I?m still being treated for Acute Transverse Myelitis with Dr.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia, International normalised ratio, Magnetic resonance imaging head, Magnetic resonance imaging spinal, Metabolic function test
Clinical narrative: 2 days after receiving the shot I had a tingling sensation on my legs and toes and persisted for 5 days. On day 6 I woke up with both of my feet completely numb and got worse over time. I first went to Urgent Care to be checked and they sent me to hospital. After 3 hours they told me to go to Medical Center to get further evaluated by a neurologist and get an MRI because the MRI facility was down at hospital and they did not have a neurologist to evaluate me and treat me. After a couple of hours in Medical Center my symptoms worsened over time, at the point that I was not able to walk anymore and needed assistance to get up or walk. The hospital admitted me and I was there for 11 days to be treated for Acute Transverse Myelitis and they started a 5 day treatment with steroids. After 11 days I was transferred to an inpatient rehabilitation facility for 16 days to help me regain the strength on my lower body. I was released from the rehabilitation hospital 12/22/2023. On 12/27/2023 I followed up with my primary doctor. On 01/02/2024 I followed up with Dr from the Neuroscience. I went to the Rehab clinic for Ocupational therapy evaluation at Sports Medicine facility On 01/03/2024. On 01/09/2024 I went to the rehab clinic for Physical therapy evaluation. I had physical therapy from 01/11/2024 to 03/01/2024. On 01/31/2024 I followed up with Dr. On 02/22/2024 I followed up with Dr. On 02/28/2024 I went to see Dr Urology.  Specialists : On 04/01/2024 I had another MRI at Medical Center. On 06/25/2024 I followed up with Dr. I?m still being treated for Acute Transverse Myelitis with Dr.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Myelitis transverse, Paraesthesia, Prothrombin time
Clinical narrative: 2 days after receiving the shot I had a tingling sensation on my legs and toes and persisted for 5 days. On day 6 I woke up with both of my feet completely numb and got worse over time. I first went to Urgent Care to be checked and they sent me to hospital. After 3 hours they told me to go to Medical Center to get further evaluated by a neurologist and get an MRI because the MRI facility was down at hospital and they did not have a neurologist to evaluate me and treat me. After a couple of hours in Medical Center my symptoms worsened over time, at the point that I was not able to walk anymore and needed assistance to get up or walk. The hospital admitted me and I was there for 11 days to be treated for Acute Transverse Myelitis and they started a 5 day treatment with steroids. After 11 days I was transferred to an inpatient rehabilitation facility for 16 days to help me regain the strength on my lower body. I was released from the rehabilitation hospital 12/22/2023. On 12/27/2023 I followed up with my primary doctor. On 01/02/2024 I followed up with Dr from the Neuroscience. I went to the Rehab clinic for Ocupational therapy evaluation at Sports Medicine facility On 01/03/2024. On 01/09/2024 I went to the rehab clinic for Physical therapy evaluation. I had physical therapy from 01/11/2024 to 03/01/2024. On 01/31/2024 I followed up with Dr. On 02/22/2024 I followed up with Dr. On 02/28/2024 I went to see Dr Urology.  Specialists : On 04/01/2024 I had another MRI at Medical Center. On 06/25/2024 I followed up with Dr. I?m still being treated for Acute Transverse Myelitis with Dr.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Unevaluable event
Clinical narrative: MCV4 given before age of 16 years.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The vaccine that was given was expired.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Dehydration, Dizziness, Hypoaesthesia, Loss of consciousness, Nausea
Clinical narrative: Donor states she was at her sons football game after donation and she had LOC for about a minute with nausea, numbness /tingling, and dizziness. Ambulance was called but donor refused transport to the hospital. EMT told donor the cause was dehydration.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Paraesthesia
Clinical narrative: Donor states she was at her sons football game after donation and she had LOC for about a minute with nausea, numbness /tingling, and dizziness. Ambulance was called but donor refused transport to the hospital. EMT told donor the cause was dehydration.
Age: 1.83
Sex: F
Vaccine: MMRV
Symptoms: Wrong product administered
Clinical narrative: 22 month old child, behind in their immunizations, was accidentally given ProQuad instead of separate MMR and Varicella vaccines.  Parent did not note any reaction at the injection site nor any systemic reactions of any kind after the immunization.
Age: 21.0
Sex: F
Vaccine: YF
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Yellow Fever was given wrong route intramuscularly in the left deltoid.  Patient observed for 20 minutes in clinic prior to dispo.  No adverse effects noted.  Vaccine manufacture contacted.  Confirmed no additional doses needed, no other precautions to be take.  The patient was informed of administration error via phone call by immune nurse who gave the vaccine.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary pain, Breast pain, Breast tenderness, Injected limb mobility decreased, Neck pain
Clinical narrative: On 08/02/24- Patient c/o of having soreness/warmth to right arm. On 08/03/24- Patient c/o of pain/tenderness to right axillary/breast and arm. On 08/04/24- Patient c/o of having tenderness/swelling/restricted movement to right arm. She also states she began having pain/tenderness to neck and throat. On 08/05/24- Patient states her symptoms have improved. She states she has been taking OTC Benadryl for reported symptoms.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Oropharyngeal pain, Pain in extremity, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: On 08/02/24- Patient c/o of having soreness/warmth to right arm. On 08/03/24- Patient c/o of pain/tenderness to right axillary/breast and arm. On 08/04/24- Patient c/o of having tenderness/swelling/restricted movement to right arm. She also states she began having pain/tenderness to neck and throat. On 08/05/24- Patient states her symptoms have improved. She states she has been taking OTC Benadryl for reported symptoms.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Depressed level of consciousness, Fatigue, Gait inability
Clinical narrative: 24 hours after vaccination, client experienced profound fatigue and client unable to walk.  She was barely conscious.  She went to urgent care and had comprehensive testing (blood work, urinalysis and chest x-ray) with no findings from the testing identified
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Urine analysis
Clinical narrative: 24 hours after vaccination, client experienced profound fatigue and client unable to walk.  She was barely conscious.  She went to urgent care and had comprehensive testing (blood work, urinalysis and chest x-ray) with no findings from the testing identified
Age: 1.5
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash, Rash erythematous
Clinical narrative: Patient's parent presented a photo of a diffuse rash which developed across the trunk and both arms of the patient's body two days following their first MMR vaccination. The patient spiked a fever at the same time. The parent did not report the reaction until she brought the patient in for a follow up vaccine on 7/17/2024. Rash and fever resolved, aside from a small patch of residual erythmatous rash on the patient's upper right chest. The patient's parent was advised to check in with the patient's pediatrician for guidance on continuing with the MMR series, potential concerns with other vaccines, and the small area of residual rash.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site reaction, Pallor, Rash erythematous
Clinical narrative: Per ED note, "Skin: Warm and dry. L thigh 12 cm blanching, flat erythematous rash. No induration or fluctuance. No streaking." Patient treated with oral Benadryl
Age: 62.0
Sex: M
Vaccine: PNC20
Symptoms: Arthralgia, Headache, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Redness, heat, itchiness at injection site. Headache, joint pain, aches
Age: 62.0
Sex: M
Vaccine: PNC20
Symptoms: Pain
Clinical narrative: Redness, heat, itchiness at injection site. Headache, joint pain, aches
Age: 84.0
Sex: M
Vaccine: FLUA4
Symptoms: Blood test, Muscle atrophy, Rash, Skin exfoliation, Yellow skin
Clinical narrative: hands turned yellow repeatedly, full body rash, muscle wasting, full body skin peeling
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given Tdap and Meningitis vaccine in today. After reviewing the record pt had received both vaccines last year 07/23. Pt had no adverse reaction to the vaccines given. Parent made aware and had no questions.
Age: 25.0
Sex: F
Vaccine: RAB
Symptoms: Anaphylactic reaction, Anaphylaxis treatment
Clinical narrative: Anaphylactic reaction requiring treatment in the ED
Age: 79.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient c/o pain in the left upper arm. Patient has redness wrapping around the upper arm measuring 120mm in length just below the injections site. Patient reports that she has taken Acetaminophen 500mg and iced the area 3 times. Reports current pain at a 4-5/10.  Patient verbally instructed by FNP-C to take Zyrtec or Allegra during the day and Benadryl at night. Along with Pepcid or Zantac. Advised to continue icing as needed until symptoms resolve.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Malaise, Nausea, Pallor
Clinical narrative: WITHIN 5 MINUTES OF RECEIVEING HIS IMMUNIZATIONS, THE CLIENT BECAME NAUSEATED AND PALE. HAD NOT EATEN NOR HAD ANY FLUIDS TODAY. HE HAS HAD RASHES FROM VACCINES IN THE PAST.  HIS MOTHER GAVE HIM A GATORADE TO DRINK & HE FELT BETTER WITHIN A MIUNTE. NO LOSS OF CONSCIOUSNESS. BP AT 4-5 MIN POST ILL SYMPTOMS WAS 105/64, HR 64. HE STAYED ONSITE RESTING FOR 30 MINUTES. HE LEFT FEELING MUCH BETTER AND WAS ENROUTE TO EAT BREAKFAST.
Age: 50.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: VARICELLA VACCINE GIVEN INSTEAD OF SHINGLES VACCINE. PATIENT REPORTS NO ADVERSE REACTION AS OF 8-5-24.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Cough, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Dry cough, body aches, fever
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Eye pain, Throat irritation
Clinical narrative: Scratchy throat, dizzy, pain behind eyes
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Cellulitis at injection site-Medium
Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Insomnia
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: just pain at injection site-Mild, Systemic: Unable to Sleep-Mild, Additional Details: Pt reports pain during the injection. Her right arm is still red at injection site, brused, and painful.  She denies any pain in the shoulder and is able to lift arm normally.  States the area is still red, it is NOT warm to the touch.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: very red left thigh-Medium
Age: 32.0
Sex: M
Vaccine: TDAP
Symptoms: Anxiety, Blindness transient, Dizziness, Hypotension, Visual impairment
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Temporary loss of vision reported-Mild, Systemic: Hypotension-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Patient states vaccine-related anxiety BP 104/68
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Nausea, Product administered at inappropriate site
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Fever-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Severe, Additional Details: pt states had n/v injectino site got extremely swollen x 4 days. had fever and felt worn down on trip.  had to delay arthritis treatment due to what was going on with her post vaccine. went to urgent care and they stated that the injection was given too low. according to patient it was given on back of arm half way between elbow and shoulder. either bicept or tricept.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Fever-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Severe, Additional Details: pt states had n/v injectino site got extremely swollen x 4 days. had fever and felt worn down on trip.  had to delay arthritis treatment due to what was going on with her post vaccine. went to urgent care and they stated that the injection was given too low. according to patient it was given on back of arm half way between elbow and shoulder. either bicept or tricept.
Age: 58.0
Sex: F
Vaccine: YF
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Site: Swelling at Injection Site-Mild, Other Vaccines:  VaccineTypeBrand: Shingrix; Manufacturer: GlaxoSmithkline; LotNumber: 542e3; Route: im; BodySite: Right Deltoid Muscle; Dose: ; VaxDate: UNKNOWN
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Dizziness, Flushing, Hyperhidrosis, Visual impairment
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Mild, Additional Details: Patient stayed at pharmacy until symptoms resolved. Patient attributes cause to possible anxiety.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: Site: Redness at Injection Site-Medium, Additional Details: Patient was diagnosed with cellulitis by doctor on 07/31/2024 and prescribed Doxycycline 100mg bid
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Additional Details: redness and warmth at injection site with mild discomfort
Age: 15.0
Sex: F
Vaccine: HEP
Symptoms: Head injury, Syncope, Tooth fracture, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted after vaccine administration while exiting exam room. Patient head-strike to floor. Two front teeth broken. Patient taken to ED by mother.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Dizziness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Weakness-Medium, Additional Details: Mother laid patient down before she fainted. Pt did not hit head. Pt recovered on her own strength
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Mild
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Dysphagia, Hypotension, Paraesthesia, Throat tightness
Clinical narrative: Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Hypotension-Severe, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Patient received both the Trumemba and Menveo vaccines and became lightheaded about 5 minutes after administration. Her blood pressure was checked and she was found to be hypotensive (80 mmHg SBP/ 60 mmHg). She sat down in the pharmacy waiting area and drank some water, but this did not help her symptoms. She stated having tingling in her fingers and that she felt like she was having trouble swallowing. The pharmacist then administered 1 dose of epinephrine 0.3 mg and EMS was called., Other Vaccines:  VaccineTypeBrand: Menveo; Manufacturer: Glaxo Smith Kline; LotNumber: AMVA993A; Route: IM; BodySite: Left Deltoid; Dose: ; VaxDate: UNKNOWN
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Severe
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Inappropriate schedule of product administration
Clinical narrative: Patient was 24 weeks pregnant and received the vaccine 4 weeks earlier than she should have.
Age: 54.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness
Clinical narrative: Dizziness
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Pain, Rhinorrhoea
Clinical narrative: Body aches, pain, cough, runny nose
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: Patient's right arm was red, painful and warm upon checking at 15 minutes after his vaccine administration. Patient was instructed to lay down for give additional minutes for monitoring. He developed no other symptoms and redness and skin warmth decreased.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Aspiration joint, Blood pressure increased, Blood test, Echocardiogram, Electrocardiogram
Clinical narrative: She got her vaccine, and noticed swelling in all her joints, specifically her knees.  Her husband had similar findings, but his got better.  I went to see my NP and I could not get my jeans over my knees.  She injected the knees, and I had to keep going back and my BP was high.  I had not had trouble with my BP prior.  She wanted to give me a pill before I left the office it was so high.  Had her do a log of her bp and going back and forth and increasing the dose and then sent her to a cardiologist.  She does not do injections in the knees, she sent her to an orthopedist.  Orthopedics for the injections in her knees.  During the choas she went into kidney failure.  She was an RN for 23 years, and did not know what was going on.  Nobody in her family has kidney issues.  She is seeing a nephrologist now, and told him that it all started after getting his booster.  She is in 3B kidney failure at this point.  Her Nephrologist is Dr. at Kidney Specialists, and is on Farxiga 5 mg every day.  The cardiologist did not say a whole lot who is Dr. He did put her on BP medications of Diovan 300 mg every morning, Doxazosin Mesylate 2 mg every afternoon, at bedtime Amlodipine Desylate 10 mg every night. She is also on cholesterol medications Atorvastatin 10 mg every morning, and a depression medicine Wellbutrin HCL SR 150 twice a day.   She was also taking Neurontin 300 mg for her back in the morning.  She also takes Zanaflex HCL 4 mg three times a day.   She had no problems other than having a car accident and having back problems on 7/1/2020, but otherwise she was healthy before the vaccine.  She was not able to walk unless she had the shots at that time.  Her knees were doing good for about a year, and had it injected about 6 weeks ago.  The injections are helping with the joints.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Renal failure, X-ray abnormal
Clinical narrative: She got her vaccine, and noticed swelling in all her joints, specifically her knees.  Her husband had similar findings, but his got better.  I went to see my NP and I could not get my jeans over my knees.  She injected the knees, and I had to keep going back and my BP was high.  I had not had trouble with my BP prior.  She wanted to give me a pill before I left the office it was so high.  Had her do a log of her bp and going back and forth and increasing the dose and then sent her to a cardiologist.  She does not do injections in the knees, she sent her to an orthopedist.  Orthopedics for the injections in her knees.  During the choas she went into kidney failure.  She was an RN for 23 years, and did not know what was going on.  Nobody in her family has kidney issues.  She is seeing a nephrologist now, and told him that it all started after getting his booster.  She is in 3B kidney failure at this point.  Her Nephrologist is Dr. at Kidney Specialists, and is on Farxiga 5 mg every day.  The cardiologist did not say a whole lot who is Dr. He did put her on BP medications of Diovan 300 mg every morning, Doxazosin Mesylate 2 mg every afternoon, at bedtime Amlodipine Desylate 10 mg every night. She is also on cholesterol medications Atorvastatin 10 mg every morning, and a depression medicine Wellbutrin HCL SR 150 twice a day.   She was also taking Neurontin 300 mg for her back in the morning.  She also takes Zanaflex HCL 4 mg three times a day.   She had no problems other than having a car accident and having back problems on 7/1/2020, but otherwise she was healthy before the vaccine.  She was not able to walk unless she had the shots at that time.  Her knees were doing good for about a year, and had it injected about 6 weeks ago.  The injections are helping with the joints.
Age: 65.0
Sex: F
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was adminsitered 2nd Menveo dose of series at week 4 instead of at week 8 per guidelines
Age: 44.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Dizziness, Hyperhidrosis, Injection site pain, Malaise, Pallor
Clinical narrative: After one Boostrix dose and one Gardasil-9 dose were administrated to the patient , she felt unwell and dizzy . She told us she had only had breakfast and had not eaten , she was pale and sweating and felt her hands cold. I immediately called the tech for assistance and gave alcohol swabs for smell them and keep patient seated and her feet were elevated. She was feeling better as the minutes goes by. We never leave her alone and confirmed she was well enough and all symptoms of the adverse reaction have passed to let her go home; it took about 30-40 minutes to recover from all symptoms. Finally we called her later and she had already arrived at her house and feels fine . The next day (Sunday) 08/04/2024 the patient also was contacted and she confirmed she feels well and stable, only a little soreness of injection site .
Age: 44.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Peripheral coldness
Clinical narrative: After one Boostrix dose and one Gardasil-9 dose were administrated to the patient , she felt unwell and dizzy . She told us she had only had breakfast and had not eaten , she was pale and sweating and felt her hands cold. I immediately called the tech for assistance and gave alcohol swabs for smell them and keep patient seated and her feet were elevated. She was feeling better as the minutes goes by. We never leave her alone and confirmed she was well enough and all symptoms of the adverse reaction have passed to let her go home; it took about 30-40 minutes to recover from all symptoms. Finally we called her later and she had already arrived at her house and feels fine . The next day (Sunday) 08/04/2024 the patient also was contacted and she confirmed she feels well and stable, only a little soreness of injection site .
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Arthralgia, Fatigue, Immediate post-injection reaction, Injection site erythema, Injection site pain
Clinical narrative: Received trumenba vaccine on 7/22 in left deltoid and as soon as she got vaccine had instant pain.  That evening pain continued and then got low grade fevers and felt very fatigued.  These symptoms lasted about 3 -4 days.   Erythematous skin with some swelling noticed around site and spread down anterior portion of upper arm.  This lasted for a week.  First two days low key but then after that started feeling better.  Symptoms had started to improve and then  started feeling better for about a week then two days ago started with some left shoulder pain that has worsening. Hadn't been to gym or done any known positions which caused pain in shoulder.    Then yesterday was driving and started having pain in left hand and left wrist.    Shoulder 6/7 out of 10 pain  Achy wrist 3 out of 10 pain   No ice heat or Advil. No obvious edema
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site swelling, Pain in extremity, Pyrexia
Clinical narrative: Received trumenba vaccine on 7/22 in left deltoid and as soon as she got vaccine had instant pain.  That evening pain continued and then got low grade fevers and felt very fatigued.  These symptoms lasted about 3 -4 days.   Erythematous skin with some swelling noticed around site and spread down anterior portion of upper arm.  This lasted for a week.  First two days low key but then after that started feeling better.  Symptoms had started to improve and then  started feeling better for about a week then two days ago started with some left shoulder pain that has worsening. Hadn't been to gym or done any known positions which caused pain in shoulder.    Then yesterday was driving and started having pain in left hand and left wrist.    Shoulder 6/7 out of 10 pain  Achy wrist 3 out of 10 pain   No ice heat or Advil. No obvious edema
Age: 19.0
Sex: F
Vaccine: PNC20
Symptoms: Syncope
Clinical narrative: Syncope post vaccination. Patient recovered quickly.
Age: 49.0
Sex: M
Vaccine: HEPAB
Symptoms: Aphonia, Dysphonia
Clinical narrative: Hoarseness, unable to speak (within 2 hours)
Sex: U
Vaccine: HIBV
Symptoms: Exposure via skin contact, Occupational exposure to product, Product complaint, Syringe issue
Clinical narrative: adjuvant syringes leaked adjuvant all over (hands); adjuvant syringes leaked adjuvant all over (hands); adjuvant syringes leaked adjuvant all over (hands); Pharmaceutical product complaint; This non-serious case was reported by a other health professional via call center representative and described the occurrence of exposure via skin contact in a patient who received Hib (Hiberix) (batch number HE243, expiry date 14-MAR-2026) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced exposure via skin contact (Verbatim: adjuvant syringes leaked adjuvant all over (hands)), occupational exposure while preparing product for administration (Verbatim: adjuvant syringes leaked adjuvant all over (hands)), syringe leak (Verbatim: adjuvant syringes leaked adjuvant all over (hands)) and pharmaceutical product complaint (Verbatim: Pharmaceutical product complaint). The outcome of the exposure via skin contact, occupational exposure while preparing product for administration, syringe leak and pharmaceutical product complaint were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-JUL-2024 Healthcare professional reporting more information on PQC 02063487/ QE-016926 that was filed day before reporting on 25 July 2024. She stated one of the 4 Hiberix PQC was the adjuvant syringes leaked adjuvant all over (hands) HCP that was preparing the vaccine which led to exposure via skin contact, occupational exposure while preparing product for administration, syringe leak and pharmaceutical product complaint. Syringe was discarded and that dose was not administered.
Age: 0.17
Sex: F
Vaccine: RV1
Symptoms: Oral administration complication, Underdose, Vomiting
Clinical narrative: patient threw up almost all of Rotarix; patient threw up almost all of Rotarix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of regurgitation of medication in a 2-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number 5F7L2, expiry date 08-MAY-2026) for prophylaxis.   On 26-JUL-2024, the patient received the 1st dose of Rotarix lyophilized formulation. On 26-JUL-2024, 2 min after receiving Rotarix lyophilized formulation, the patient experienced regurgitation of medication (Verbatim: patient threw up almost all of Rotarix) and accidental underdose (Verbatim: patient threw up almost all of Rotarix). The outcome of the regurgitation of medication and accidental underdose were unknown.   It was unknown if the reporter considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Pre-Filled Unspecified Oral Administration Device.     It was unknown if the company considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Pre-Filled Unspecified Oral Administration Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-JUL-2024 Medical assistant reported that a 2 month old patient threw up almost all of Rotarix after 2 minutes of administration which led to regurgitation of medication and accidental underdose. The medical assistant will call GlaxoSmithKline and refused to provide any additional information. No additional AEs were reported. No further information provided. No PQC.