chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: The caller said he had a titer checked on an unknown date in March of 2024, and the titer was negative for antibodies.; This spontaneous report was received from a consumer and refers to a male patient of unknown age. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 14-MAR-2018, the patient was vaccinated with varicella virus vaccine live (OKA/MERCK) (VARIVAX) injection, 0.5 milliliter, administered intramuscularly for prophylaxis (strength, lot #, and expiry date were not provided).  On an unknown date in March 2024, he had a titer checked and was negative for antibodies. At the time of reporting, the outcome of the event was unknown..  Causality assessment between the event and varicella virus vaccine live (OKA/MERCK) (VARIVAX) injection was not provided.
Age: 17.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: HCP called to report that a 17 year old patient was given a dose of PROQUAD on an unspecified date.; No additional AE; This spontaneous report was received from a registered nurse and refers to a 17-year-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (OKA-MERCK) virus vaccine live (PROQUAD) injection, lot #X019553, expiration date: 19-JAN-2025 for prophylaxis (strength and route of administration were not provided) (Product administered to patient of inappropriate age). No additional adverse event was reported.
Sex: F
Vaccine: HPV9
Symptoms: Type 1 diabetes mellitus
Clinical narrative: Company Representative reported AE on behalf of HCP (nurse) who reported that their friend's daughter was diagnosed with Type I Diabetes after being administered GARDASIL 9 vaccine. Patient demographics unknown. No symptoms reported. Obtained consent to contact HCP. M; Spontaneous information has been received from a Nurse via Company Representative regarding a female patient of unknown age (reported as "friend's daughter"). No patient's pertinent medical history, concurrent conditions, drug reactions or allergies, nor concomitant therapies were reported.     On an unknown date the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, dose number, frequency, scheme, route, anatomical location, lot number and expiration date were not reported), for prophylaxis.    On an unknown date, the patient was diagnosed with Type I Diabetes after being administered hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9).  The outcome of the event was not reported as well as the causal relationship between the event and the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9).  Upon internal review Type I Diabetes was determined to be medically significant event.  Lot number is being requested and will be submitted if received.
Age: 10.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Abdominal pain upper, Chest pain, Dizziness, Dyspnoea, Fatigue
Clinical narrative: reactions all weekend including difficulty breathing, weakness in his legs, chest pain, stomach pain, and extreme fatigue.  Diffuse leg pain developed on the second day after the vaccine
Age: 10.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: reactions all weekend including difficulty breathing, weakness in his legs, chest pain, stomach pain, and extreme fatigue.  Diffuse leg pain developed on the second day after the vaccine
Age: 10.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Abdominal pain upper, Chest pain, Dyspnoea, Fatigue, Leg amputation
Clinical narrative: reactions all weekend including difficulty breathing, weakness in his legs, chest pain, stomach pain, and extreme fatigue.  Diffuse leg pain developed on the second day after the vaccine
Age: 10.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Muscular weakness
Clinical narrative: reactions all weekend including difficulty breathing, weakness in his legs, chest pain, stomach pain, and extreme fatigue.  Diffuse leg pain developed on the second day after the vaccine
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: administered expired PENTACEL to a patient with no reported adverse event.; Initial information received on 05-Apr-2024 regarding an unsolicited valid  non-serious case received from a Nurse.  This case involves a 4 months old female patient who was administered expired Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine [Pentacel (Vero)] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal Vaccine CONJ 20V (CRM197) (Prevnar 20) for Immunisation.  On 05-Apr-2024, the patient received expired 0.5 ml (dose 2) of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine (Suspension for injection) (lot UJ869AA, expiry date: 23-Mar-2024, strength: standard, frequency: once) via intramuscular route in the left leg with no reported adverse event (expired product 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: 0.17
Sex: F
Vaccine: HEPA, PNC20, RV5, VARCEL
Symptoms: Injection site pain, Injection site swelling, Product administered to patient of inappropriate age, Pyrexia, Rash
Clinical narrative: Hepatitis A and Varivax given inappropriately for the 2 month old baby on 4/9/24. Parents were informed right away of the error by phone and personally after the error was discovered. Possible side effects discussed including fever, injection site tenderness or swelling from the vaccine or rash from the vaccine 2-4 weeks after. Advised to be seen for follow up as needed.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death, Sudden death
Clinical narrative: Online report of sudden death in 56-year-old male EUA Countermeasure recipient of three known inoculations. DOSE#1 Date 04/22/21 LOT#EW0169, DOSE#2 Date 05/13/21 LOT#EW0175, DOSE#3 Date 01/19/22 LOT#022J21A. Any potential subsequent inoculations after DOSE#3 are unknown. The first two inoculations were performed by a person named according to an online copy of victim's vax card. Victim died in his sleep according to online reports.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Arthralgia, Fatigue, Feeling cold, Lethargy
Clinical narrative: Sore arm, sore elbow, fever, chills all by 7:30 pm on day of injection. Next morning body aches, fever, chills, lethargic, exhausted, nausea, stomach pain all ongoing as of 4:30 am day after injection.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pain in extremity, Pyrexia, Shift to the left
Clinical narrative: Sore arm, sore elbow, fever, chills all by 7:30 pm on day of injection. Next morning body aches, fever, chills, lethargic, exhausted, nausea, stomach pain all ongoing as of 4:30 am day after injection.
Sex: M
Vaccine: HEP
Symptoms: No adverse event
Clinical narrative: Patient had no adverse reactions to this vaccine
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest pain, Chills, Electrocardiogram, Full blood count, Headache
Clinical narrative: Patient had onset of chills, headache, then left arm pain and chest pain. Was severely incapacitated for 2 days, could not get out of bed.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Metabolic function test, Mobility decreased, Pain in extremity
Clinical narrative: Patient had onset of chills, headache, then left arm pain and chest pain. Was severely incapacitated for 2 days, could not get out of bed.
Age: 73.0
Sex: M
Vaccine: RSV
Symptoms: Sudden cardiac death
Clinical narrative: Sudden Cardiac Death. No heart disease history. I do not know which manufacturor of RSV vaccine was given--please contact vaccine administrator if indicated.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Hypoaesthesia, Rash, Swelling
Clinical narrative: Numbness for 3-5 minutes in 3 fingers and shoulder on the same side as the injection along with rash and swelling
Age: 60.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Shingles rash started with a small area on left lower leg and then a very large area of rash developed on both lower legs. I contacted my allergy doctor after the rash was present almost a week and she said to take Zyrtec twice a day and use 1% cortisone cream twice a day. I have a history of unusual/rare reactions to some medications.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Pruritus, Rash, Swelling
Clinical narrative: Rash covering half the thigh. Redness, raised, itchy. Larger than an adult hand print
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 30 day refrigeration beyond use date for the Moderna 2023-2024 COVID vaccine administered was 4/7/24.  The vaccine was given on 4/8/24, one day after the beyond use date.  Patient notified 2 days later and denied any adverse effects.
Age: 1.17
Sex: M
Vaccine: FLU4, HIBV, MNQ, PNC20
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Pt given MedQuadfi outside of recommended window for vaccination.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 30 day refrigeration use by date for the COVID vaccine administered was 3/7/24.  The vaccine was given to the patient on 3/8/24, on day after the beyond use date.  Patient was notified two days after vaccine administration with no adverse outcome.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Induration, Pain
Clinical narrative: Pt indicated redness, soreness, hard area approximately 2 inches in diameter.  Pt indicated that it was gone 4 days later.
Age: 1.25
Sex: M
Vaccine: COVID19, DTAP, HIBV, PNC20
Symptoms: Decreased appetite, Fatigue, Pyrexia
Clinical narrative: Patient's mother called to say that pt has a fever that reached 104 overnight, but the fever came down with Tylenol. Patient is fatigued and not eating as much. Advised to continue to watch him and administer Tylenol as needed. Advised to monitor for s/sx of infection. Advised to call me tomorrow if his fever isn't coming down or if he's getting worse.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Covid-19 Breakthrough infection
Age: 18.0
Sex: F
Vaccine: HEP, HPV9, MENB
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products
Clinical narrative: CLIENT IN TO RECEIVE 2ND HEP B IN SERIES. NEEDED TO COMPLETE HEP B SERIES AGAIN FOR NURSING SCHOOL SINCE TITERS LOW.  SCREENING QUESTIONS ASKED IF CLIENT HAD RECEIVED ANY VACCINATIONS IN THE LAST 4 WEEKS. CLIENT MARKED YES.  CLIENT WAS ASKED WHAT VACCINES SHE RECEIVED. SHE STATED SHE RECEIVED HEP B. THAT CORRESPONED TO THE STATE RECORD. I EXPLAINED TO CLIENT THAT SHE HAS STARTED THE MEN B & HPV SERVIES AND DID SHE WANT TO FINISH THEM. CLIENT STATED YES. VACCINES GIVEN.  CLIENT LEFT CLINIC. VACCINES THEN SCANNED INTO COMPUTER SYSTEM. AT THAT TIME I REALIZED THAT CLIENT HAD BEEN SEEN IN OUR CLINIC ON APRIL 1 BY MY COWORKER AND HAD RECEIVED THE HPV AND MEN B VACCINE. EXCEPT THAT MY COWORKER HAD GIVEN HER THE TRUEMBA MEN B. AT THAT TIME SUPERVIOR NOTIFIED. CLIENT NOTIFIED VIA PHONE CALL WHAT HAPPENED, WHAT TO EXPECT,  AND THAT ANOTHER HPV VACCINE WOULD STILL NEED TO BE RECEIVED IN 6 MONTHS FOR SERIES TO BE COMPLETED.  WHILE ON PHONE WITH CLIENT ASKED WHY SHE CAME INTO CLINIC ON APRIL 1. STATED TO RECEIVE 2ND HEP B. WAS TOLD BY NURSE IT WAS TOO EARLY.  ALSO ASKED WHY SHE ONLY MENTIONED RECEIVING HEP B VACCINE WHEN QUESTIONED ABOUT RECEIVING VACCINES WITHIN THE LAST 4 WEEKS. STATED SHE DIDN'T MENTION THEM BECAUSE SHE DIDN'T REMEMBER THEIR NAMES.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Blood test, Decreased appetite, Diarrhoea, Gastrooesophageal reflux disease
Clinical narrative: That night she did not feel well. Later that week dad tested positive for COVID but she was negative. Since then has had intermittent abdominal pain, diarrhea/loose stools, decreased appetite, reflux, and weight loss. Has tried probiotics, food elimination, and pepto. Undergoing current work up with labs pending but stool specimen positive for occult blood. Referred to GI.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, SARS-CoV-2 test negative, Stool analysis, Weight decreased
Clinical narrative: That night she did not feel well. Later that week dad tested positive for COVID but she was negative. Since then has had intermittent abdominal pain, diarrhea/loose stools, decreased appetite, reflux, and weight loss. Has tried probiotics, food elimination, and pepto. Undergoing current work up with labs pending but stool specimen positive for occult blood. Referred to GI.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Blepharospasm, Blood test normal, Computerised tomogram normal, Disorientation, Dizziness
Clinical narrative: Extreme dizziness, ringing ears, sensitivity to light, heart palpitations,  light headedness, tingling extremities, twitching eyes, headaches, disorienting feeling
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Electroencephalogram normal, Headache, Lumbar puncture normal, Magnetic resonance imaging head normal, Palpitations
Clinical narrative: Extreme dizziness, ringing ears, sensitivity to light, heart palpitations,  light headedness, tingling extremities, twitching eyes, headaches, disorienting feeling
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Photophobia, Tinnitus
Clinical narrative: Extreme dizziness, ringing ears, sensitivity to light, heart palpitations,  light headedness, tingling extremities, twitching eyes, headaches, disorienting feeling
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: GIVEN TRUMEMBA WHEN VACCINE GIVEN SHOULD HAVE BEEN BEXSERO. GIVEN BY COWORKER, NOT PERSON REPORTING EVENT.  STATE RECORD WAS CONSULTED. CLINIC THAT GAVE FIRST MEN B VACCINE RECORDED ALL FIELDS BUT THE MANUFACTOR.  MANUFACTOR WAS NOT REPORTED TO STATE DATA BASE IN THE STAND VIEWS THAT THE NURSES CONSULT. ERROR  WAS DISCOVERED ONLY WHEN DOVE DEEPER INTO STATE RECORDS AFTER APRIL 10 INCIDENT WITH CLIENT. MANUFACTOR OF MEN B WAS FOUND AFTER REVIEWING SEVERAL DIFFERENT REPORTS IN THE STATE DATA BASE THAT THE NURSES DON'T USUALLY CONSULT.
Age: 37.0
Sex: F
Vaccine: UNK
Symptoms: Exposure during pregnancy, Joint range of motion decreased, Mobility decreased
Clinical narrative: 35+6 weeks   received tdap vaccine (right deltoid) at her office visit on 4/3/2024   Approximately 3 days later-she experience extreme loss of range of motion in her arm. She states it is difficult to pick up gallon of milk or laundry   She denies redness or edema to site. She does note that it seemed like the injection was given "higher in her arm" than previous injections
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Cellulitis, Incisional drainage, Local reaction
Clinical narrative: Developed local reaction then cellulitis and abscess requiring antibiotics and I and D.
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Chills, Headache, Neck pain, Pyrexia
Clinical narrative: fever, chills, neck pain, headache
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site pain, Injection site rash, Injection site swelling, Injection site warmth, Rash erythematous
Clinical narrative: Received Kinrix vaccine on 4/9/24. This morning, parent noticed that L leg was swollen, red and splotchy, and w/pain. Left thigh with red macular rash that blanches and is warm to the touch, it is approximately 6.5 in x 5.5 in in size, no tenderness with palpation.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Rash macular
Clinical narrative: Received Kinrix vaccine on 4/9/24. This morning, parent noticed that L leg was swollen, red and splotchy, and w/pain. Left thigh with red macular rash that blanches and is warm to the touch, it is approximately 6.5 in x 5.5 in in size, no tenderness with palpation.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site pain, Injection site rash, Injection site swelling, Injection site warmth, Rash erythematous
Clinical narrative: Received Kinrix vaccine on 4/9/24. This morning, parent noticed that L leg was swollen, red/splotchy,  and w/ pain. Left upper thigh with red macular rash that blanches and is warm to touch and is approximately 6 in x 6 in in size, no tenderness with palpation .
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Rash macular
Clinical narrative: Received Kinrix vaccine on 4/9/24. This morning, parent noticed that L leg was swollen, red/splotchy,  and w/ pain. Left upper thigh with red macular rash that blanches and is warm to touch and is approximately 6 in x 6 in in size, no tenderness with palpation .
Age: 72.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: expired vaccine administered
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Chills, Dizziness, Injection site erythema, Injection site warmth, Tremor
Clinical narrative: Patient was given varicella vaccine on 4/5/2024 at 3:00pm.  The vaccine was given in the back of the left upper arm.  Around 6pm on 4/5/2024, the patient noticed her left arm near the injection site  was red and hot.  She went home after her shift was over came back to work on 4/6/2024,  but noticed a big bump on her arm and her arm was swollen and hot.  She continued to observe it throughout the day.  Later that night, the bump kept getting bigger it hurt so bad she was having chills and shaking.  She couldn't lift her arm.   She called the ER and was told to outline it and keep an eye on it.  She traveled the next morning when she noticed the bump was larger, so she went to urgent care on 4/7/2024 where they stated they did not know why the vaccine was injected in the back of her arm. At urgent care, they outlined the site again and stated if the patient starts to get chest pain or it gets bigger to go to the ER.  On 4/8/2024, the patient woke up to bad chest pain and her arm was really swollen.  She was dizzy and having sweats and chills. When she got to the ER, they examined her and said the site looked infected.  They treated her with a cephalexin shot, prednisone, and diphenhydramine.  Patient was told to follow-up with her PCP.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV, JEV1
Symptoms: Injection site erythema, Skin reaction
Clinical narrative: 2 yr old boy presents after immunizations 48 hours ago, received PedvaxHib and Infanrix in right vastus lateralis. DTaP top injection and Hib bottom.  Pt brought in by parent, arrived with 5x 4 cm area of erythema to bottom injection site of right thigh.  No warmth to skin noted and pt has no complaint of pain on exam. Seen by provider, confirmed localized skin reaction and prescribed Zyrtec and hydrocortisone cream to treat.
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Oropharyngeal pain
Clinical narrative: really bad sore throat. It lasted 24 hours.
Age: 66.0
Sex: F
Vaccine: HEPAB, PNC20
Symptoms: Cellulitis, Injection site erythema, Injection site irritation, Injection site swelling, Injection site warmth
Clinical narrative: Monday at 09:00pm patient reported slight redness and irritation  at injection site. Tuesday Morning patient reported worsening of symptoms along with swelling and increased temperature at the site of inection. Thursday patient reports symptoms still present and has worsened since tuesday. Dr. on Tuesday   diagnosed patient of cellulitis (was prescribed antibiotic therapy) and will have follow-up Thursday 04/11.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Eye swelling, Irritability, Periorbital swelling, Pyrexia
Clinical narrative: Patient received the Moderna 2023-2024 vaccine on 4/9/24 at 1540. Patient got sent home from daycare on 4/10 with a temperature of 102.7. Patient also had increased fussiness and was sleepy, a stomach ache and emotional. After a nap, patient's face was swollen around his eyes, no other swelling. Today, 4/11/24, patient is afebrile and back to self with mild puffiness around his eyes.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Patient received the Moderna 2023-2024 vaccine on 4/9/24 at 1540. Patient got sent home from daycare on 4/10 with a temperature of 102.7. Patient also had increased fussiness and was sleepy, a stomach ache and emotional. After a nap, patient's face was swollen around his eyes, no other swelling. Today, 4/11/24, patient is afebrile and back to self with mild puffiness around his eyes.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was given vaccine 3 days after before use date on vaccine.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram abnormal, Ventricular extrasystoles
Clinical narrative: PVC?s multiple times a day for over a week now. EKG confirmed.
Age: 28.0
Sex: F
Vaccine: PNC13
Symptoms: Hypoaesthesia, Lip swelling
Clinical narrative: Pt notes that approximately 45 minutes after receiving the vaccine she started having numbness to the lower half of her face and swelling of her lips. Patient stopped at a pharmacy and picked up a dose of Benadryl to take. She took one dose and notes that her symptoms greatly improved and were fully resolved by the next morning.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was given vaccine after the before use date of 3/8/2024 but manufacturer expiration date was 7/31/2024
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Abdominal distension
Clinical narrative: Redness and swelling to right thigh.  Mother states that she has applied warm compresses and ice to are with no relief of symptoms and that redness only seems to be getting worse.  Mother states that she believes this happened when child received DTAP in the past.  Denies any shortness or breath or other symptoms.
Age: 0.5
Sex: M
Vaccine: DTPPVHBHPB, PNC20
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse reaction was noted or seen, HD called today and informed us that they gave the patient Pentacel on 10-13-23 along with PCV13 and it was not indicated on the record when the record was printed in the office on the date of the patient's appointment on 10-24-23 when vaxellis and PCV20 was given. Mother was informed today, and an incident report was filled today as well.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: none known
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was given vaccine after before use date of 3/8/24. Manufacturer expiration date 7/31/2024
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient left upper arm is red and warm measures 140mm in length and 120m in width
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered Expired Vaccine. Dose received on 2/15/24 but expired on 02/08/24.
Age: 17.0
Sex: F
Vaccine: HEPA
Symptoms: C-reactive protein normal, Full blood count normal, Headache, Metabolic function test normal, Musculoskeletal stiffness
Clinical narrative: Severe headache and neck stiffness
Age: 17.0
Sex: F
Vaccine: HEPA
Symptoms: Red blood cell sedimentation rate normal
Clinical narrative: Severe headache and neck stiffness
Age: 1.92
Sex: M
Vaccine: DTAPIPV
Symptoms: Nausea, Vomiting, Wrong product administered
Clinical narrative: child was given the wrong vaccine. profuse vomiting began approximately 36 hours later resulting in a trip to the ER.  zofran was given to quell nausea and vomiting and we were discharged.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac function test, Cardiomyopathy, Catheterisation cardiac, Chest X-ray, Computerised tomogram
Clinical narrative: Within two weeks of vaccine I began experiencing trouble breathing and exhaustion with any and all movement.    Within 90 days I was hospitalized with cardiomyopathy and myocarditis and pneumonia.    I stayed in the hospital for 5 days and missed 3 weeks of work.   My out of pocket expenses have exceeded $10,000 and my company's self funded health plan paid out approximately $180,000.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Echocardiogram, Fatigue, Impaired work ability, Myocarditis
Clinical narrative: Within two weeks of vaccine I began experiencing trouble breathing and exhaustion with any and all movement.    Within 90 days I was hospitalized with cardiomyopathy and myocarditis and pneumonia.    I stayed in the hospital for 5 days and missed 3 weeks of work.   My out of pocket expenses have exceeded $10,000 and my company's self funded health plan paid out approximately $180,000.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia, Pulmonary function test
Clinical narrative: Within two weeks of vaccine I began experiencing trouble breathing and exhaustion with any and all movement.    Within 90 days I was hospitalized with cardiomyopathy and myocarditis and pneumonia.    I stayed in the hospital for 5 days and missed 3 weeks of work.   My out of pocket expenses have exceeded $10,000 and my company's self funded health plan paid out approximately $180,000.
Age: 11.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Bell's palsy
Clinical narrative: Developed left-sided Bell's palsy on left side the day after vaccination, no management
Age: 55.0
Sex: F
Vaccine: HEPAB, VARZOS
Symptoms: Asthenia, Pain, Pyrexia, Vomiting
Clinical narrative: Patient was receiving second shingles dose along with the third Twinrix dose (Twinrix EXP 12-30-25, LOT# 7X224). Patient reports feeling weak, feverish, and having aches about 3 hours after injections (04/09/24). Patient lives alone but thinks she was having convulsions over the period of an hour on Wednesday morning (04/10/24) paired with incidents of vomiting. Patient continues to feel weak as of today 04/11/24 but is recovering and not having any further symptoms while at home.
Age: 30.0
Sex: F
Vaccine: DF
Symptoms: Amenorrhoea
Clinical narrative: No menstruation for 6 months after dose.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pruritus, Injection site urticaria
Clinical narrative: Varicella vaccination given today on the right upper arm and within 1 minute the patient developed a hive aprox. 1 inch from the injection site, she had mild itching. The area was assessed and hydorcortisone cream and a cool compress were applied. The patient was monitored for 30 minutes and no further hives were noted. Discussed with mom the need to monitor throughout the day for spreading of hives, cough, wheezing, or swelling of the lips or eyes. If this occurs then benadryl is to be given and pt is to return to clinic immediately or taken to ER. Mom verbalized understanding.
Age: 46.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was given Gardasil 9 vaccination at age 46 - cut off age is 45 for vaccine.  No Adverse reaction noted. MD and patient notified
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Injection site red, swollen, itchy, and warm. Whole body aches also. No fever.
Age: 5.0
Sex: M
Vaccine: HEPA
Symptoms: Product label issue, Wrong product administered
Clinical narrative: WE JUST GOT ALL ARE VACCINES BACK FROM OTHER SITE. PATIENT WAS HERE TO GET HIS VACCINES AND I PULLED THE VACCINE ( HEP A ) FROM THE THE ONE THAT WAS LABLED HEP A PEDIATRIC/ADOLESCENT . AFTER GIVING THE VACCINE TO THE PATIENT WE WERE TOLD THE THE VACCINE WAS NOT FOR PEDIATRIC / ADOLESCENTS. I NOTIFICED ARE MANAGER TO LET HER KNOW THAT WE GAVE THE WRONG VACCINE TO THE PATIENT, ALSO LET THE PROVIDER KNOW THAT IT WAS THE WRONG VACCINE.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain upper, Feeling hot, Hyperhidrosis, Nausea, Pallor
Clinical narrative: Nausea/Vomiting/Stomach Pain/Warmth\Pallor/Sweating
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Vomiting
Clinical narrative: Nausea/Vomiting/Stomach Pain/Warmth\Pallor/Sweating
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Immunisation reaction, Injection site erythema, Injection site pain
Clinical narrative: Redness and soreness at her vaccination site starting yesterday, worsened today.   Dx: Adverse effect of vaccine, initial encounter  Notes: Believe the patient's rash is most likely secondary to delayed vaccine reaction. Believe reaction is local as she has no other systemic signs to include shortness of breath, rash, vomiting, or diarrhea. At this point, have a low suspicion for anaphylactic reaction. Recommended initiation of 5 mg of Zyrtec daily as well as as needed Benadryl for itching and discomfort. Instructed that likely lesion would improve on its own in the next 72 hours. However, marked the lesion as it is slightly warm to the touch on exam. Discussed return precautions to include new rash, spreading redness outside of marked lines, or the development of fever. Additionally, will go through (via nursing staff) appropriate reporting systems for delayed vaccine reaction to the Kinrix shot that she received in that arm on 4/9. Have a low suspicion for cellulitis at this time or superimposed posed bacterial infection. Recommended reporting to the emergency department if patient has any trouble breathing/develops vomiting. Grandparents expressed understanding and all question concerns were addressed.
Age: 40.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No additional AE/PQC.; a dose of PROQUAD that was inadvertently administered to a 40 year old female patient, instead of MMR-II; This spontaneous report was received from a registered nurse referring to a 40-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 12-MAR-2024, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin [rHA]) (PROQUAD) injection, 0.5 milliliter, lot #X019555, expiration date: 19-JAN-2025, administered subcutaneously for prophylaxis (strength was not provided) instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (Wrong product administered). No additional adverse event (AE) (No adverse event).
Age: 0.5
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product preparation error, Wrong product administered
Clinical narrative: Confirmed no other AE; Customer reported a does of PNEUMOVAX 23 was administered to a 6 month old patient on 3/25/2024.; Customer reported a does of PNEUMOVAX 23 was administered to a 6 month old patient on 3/25/2024.; drew up incorrect Prevnar; This spontaneous report was received from pharmacist and referred to a 6-month-old female patient.   Information about concurrent condition, concomitant medication and medical history was not provided.  25-MAR-2024, the patient was supposed to receive pneumococcal vaccine conj 7v (crm197) (PREVNAR) (lot# 47748AA, expiration date: 24-APR-2024) into left vastus lateralis for prophylaxis. The nurse incorrectly drew up the vaccine, and the patient was vaccinated a dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, lot #X014729, expiration date: 22-NOV-2024, administered into left vastus lateralis for prophylaxis (strength, exact dose, and route of administration were not provided) (Inappropriate age at vaccine administration, Wrong vaccine administered, Vaccine preparation error). Confirmed no other adverse event occurred.
Age: 1.0
Sex: F
Vaccine: HIBV, MMRV
Symptoms: Urticaria, Vomiting
Clinical narrative: the patient experienced hives all over their body as well as vomiting several times; the patient experienced hives all over their body as well as vomiting several times; This spontaneous report was received from a nurse and referred to a 1-year-old female patient.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 25-MAR-2024, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant Human albumin (rHA) injection) administered subcutaneously (SQ)(lot number X022919 has been verified to be a valid lot number for measles, mumps, rubella and varicella [oka-merck] virus vaccine live [PROQUAD], expiration date reported and validated as 12-MAR-2025) (strength, dose, vaccination scheme, and anatomical location were not provided), with its sterile diluent for injection/infusion, administered as prophylaxis (strength, dose, lot #, expiration date, and route of administration were not provided). On the same date, he was vaccinated with HIB vaccine, administered intramuscularly (lot number U5996AA, expiration date 31-MAR-2025) (strength, dose, vaccination scheme, and anatomical location were not provided).   On the same date, the patient experienced hives all over their body (Urticaria) as well as vomiting several times. No drug was administered as treatment for the event. On an unspecified date in 2024, the patient recovered from the events.  The causal relationship between measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), its sterile diluent and HIB vaccine regarding urticaria and vomiting was unknown.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: HCP calling to report an AE regarding the GARDASIL 9 vaccine. HCP reported that the patient received her 1st dose of GARDASIL 9 on 12/2016 and her second dose of the GARDASIL 9 vaccine on 02/05/2024. HCP stated that she does not know the reason for t; No adverse event; This spontaneous report was received from a nurse refers to a female patient of unknown age.  The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On an unknown exact day in December 2016, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), formulation: injection (lot #, expiration date, exact dose, route of administration and anatomical location were not provided) for prophylaxis.  On 05-FEB-2024, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), formulation: injection (lot #, expiration date, exact dose, route of administration and anatomical location were not provided) for prophylaxis (Inappropriate schedule of product administration). The reason for the long dosing interval between the first and second dose was unknown. No additional adverse events reported (No adverse event).
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Blood test normal, Febrile convulsion, Immunisation reaction, Pyrexia, Somnolence
Clinical narrative: fever of 107 degrees; fever of 107 degrees and seizure; groggy; This spontaneous report was received from the patient's mother and refers to a male patient who was 30 years old at the time of reporting.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date in 1994 (at the age of 1 year), the patient was vaccinated with a first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  At 6th day post administration, the patient developed a fever of 107 degrees (unit not specified) and went to the hospital where he was admitted. He was treated with ibuprofen (MOTRIN), acetaminophen as well as ice water on his head and a cooling mat. After the patient's temperature came down it did not rise again. The hospital kept him a few days doing blood testing to determine a cause for the fever. Testing came back negative for everything. He was released with no diagnosis.   The patient had a second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) at 4 years of age in 1997. The same thing happened. Exactly 6 days post administration, he developed a fever of 107 degrees (unit not specified) and had seizure. Mother took him to his physician's office. The doctor gave him intramuscular valium (that was what she recalled them calling it) and called the ambulance. The emergency medical technicians took him to hospital but he was not admitted. Several hours were spent for tests and there was a mix up at first as the paperwork did not note he had the valium at the doctor's office, once they knew that explained why he was so groggy. Bloodwork was done and he was again released with no diagnosis or answers. His doctor ultimately diagnosed the events as reactions to the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II).  The outcome of fever, febrile convulsion and grogginess was reported as recovered (dates were not provided).  The reporter considered fever, febrile convulsion and grogginess to be related to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II).  This is one of several reports received from the same reporter.  Lot # is being requested and will be submitted if received.; Sender's Comments:  US-009507513-2404USA006442:
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: B-cell type acute leukaemia, CSF test normal, Disseminated varicella zoster virus infection, Neutropenia, Pyrexia
Clinical narrative: Disseminated VZV; neutropenia; B-cell acute lymphoblastic leukaemia; This spontaneous report has been received from a physician, referring to a 2-year-old female patient. The patient's concomitant therapies included sulfamethoxazole (+) trimethoprim (BACTRIM). The patient's concurrent conditions or medical history were not reported. She had never had chickenpox and did not have any prior history of herpes zoster.  On 25-APR-2022, the patient was vaccinated with the first dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), at a dose of 0.5 milliliter (route of administration, anatomical location, lot# and expiry date were not provided) for prophylaxis.  On an unknown date, the patient was diagnosed with B-cell acute lymphoblastic leukemia (ALL). Treatment included consolidation therapy: mercaptopurine, paracetamol (+) tramadol hydrochloride (ARAC), cyclophosphamide (CYTOXAN) and methotrexate sodium (METOTREXATE). On 18-MAR-2024 (conflicting information, reported also as 15-MAR-2024), the patient experienced disseminated varicella zoster virus (VZV) infection and neutropenia. That day, she was admitted to hospital due to fever with a maximum body temperature of 103.3 (units not reported) and neutropenia, and then developed a rash with fever. The rash was papular, with about 15 lesions distributed on head, neck, torso and legs. On the same day, cerebrospinal fluid (CSF) test was performed from a recent collection as a part of ALL treatment, and the result was negative for VZV. On 19-MAR-2024, the patient was discharged from hospital and returned later that day to the hospital due to fever. On 20-MAR-2024, lesion swab was VZV positive. The patient was first treated with intravenous acyclovir, then transitioned to oral acyclovir prior to being discharged from hospital. On 21-MAR-2024, an unspecified blood test was VZV low positive. The patient remained hospitalized until 26-MAR-2024; that day, she was discharged. The patient was stable throughout hospitalization and did not deem their diagnosis as life-threatening.   At the time of reporting, the patient was recovering from disseminated varicella zoster virus infection; it has been reported that she was still recovering from lesions (conflicting information, it was also reported that she made a full recovery from rash and fever). The outcome of B-cell acute lymphoblastic leukemia and neutropenia was not reported.  The causality assessment was not provided.  Upon internal review, all the events were determined to be medically significant.  Lot # is being requested and will be submitted if received.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Rash papular, Skin lesion, Varicella virus test positive
Clinical narrative: Disseminated VZV; neutropenia; B-cell acute lymphoblastic leukaemia; This spontaneous report has been received from a physician, referring to a 2-year-old female patient. The patient's concomitant therapies included sulfamethoxazole (+) trimethoprim (BACTRIM). The patient's concurrent conditions or medical history were not reported. She had never had chickenpox and did not have any prior history of herpes zoster.  On 25-APR-2022, the patient was vaccinated with the first dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), at a dose of 0.5 milliliter (route of administration, anatomical location, lot# and expiry date were not provided) for prophylaxis.  On an unknown date, the patient was diagnosed with B-cell acute lymphoblastic leukemia (ALL). Treatment included consolidation therapy: mercaptopurine, paracetamol (+) tramadol hydrochloride (ARAC), cyclophosphamide (CYTOXAN) and methotrexate sodium (METOTREXATE). On 18-MAR-2024 (conflicting information, reported also as 15-MAR-2024), the patient experienced disseminated varicella zoster virus (VZV) infection and neutropenia. That day, she was admitted to hospital due to fever with a maximum body temperature of 103.3 (units not reported) and neutropenia, and then developed a rash with fever. The rash was papular, with about 15 lesions distributed on head, neck, torso and legs. On the same day, cerebrospinal fluid (CSF) test was performed from a recent collection as a part of ALL treatment, and the result was negative for VZV. On 19-MAR-2024, the patient was discharged from hospital and returned later that day to the hospital due to fever. On 20-MAR-2024, lesion swab was VZV positive. The patient was first treated with intravenous acyclovir, then transitioned to oral acyclovir prior to being discharged from hospital. On 21-MAR-2024, an unspecified blood test was VZV low positive. The patient remained hospitalized until 26-MAR-2024; that day, she was discharged. The patient was stable throughout hospitalization and did not deem their diagnosis as life-threatening.   At the time of reporting, the patient was recovering from disseminated varicella zoster virus infection; it has been reported that she was still recovering from lesions (conflicting information, it was also reported that she made a full recovery from rash and fever). The outcome of B-cell acute lymphoblastic leukemia and neutropenia was not reported.  The causality assessment was not provided.  Upon internal review, all the events were determined to be medically significant.  Lot # is being requested and will be submitted if received.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No Adverse Event; HCP calling to report T/E. HCP stated it was administered during T/E. T/E was supported. No additional AE reported. No PQC reported.   Names of vaccines involved (including lot/expiration): VARIVAX, X017484, 6/25/2025 Temperature:  -13C Time frame:; This spontaneous report was received from a medical assistant refers to a 12-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 14-MAR-2024, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX), formulation: injection, lot # X017484, expiration date: 25-JUN-2025 (exact dose, route of administration and anatomical location were not provided) for prophylaxis.  Administered dose of vaccine was exposed to the temperature excursion of -13 degrees Celsius (C) for 28 minutes. The previous temperature excursions had occurred ( -14.8 C for 30 minutes and -13C for 45 minutes) (Product Storage Error). There were no additional adverse events reported (no adverse event).
Age: 32.0
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Received An Expired Dose; Initial report received on 30-Jan-2024  A pharmacist reported that a 32-year-old male (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization that had expired.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 29-Jan-2024, the patient received the first dose of HEPLISAV-B (lot # 937338, expiration date 30-Aug-2024, and NDC #43528-003-05) intramuscularly in the left deltoid from a pharmacist. The dose was noted as being expired.  The patient was being vaccinated for immigration processing.   Concomitant vaccines administered included MMR (measles, mumps, and rubella), Boostrix (Tdap), Covid-19, and influenza (lot # and route not specified).  Three concomitant vaccines were administered in the right arm and two were administered in the left arm (location was not specified by vaccine type).     The reporter indicated that it was discovered when they scanned the vaccination information in the system and noted the expiration date.  The patient was going to be called and notified of the expired dosing.  The patient has not called to report any adverse effects.    No additional information was reported.   Company Comment The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.