chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: M
Vaccine: HEP, HEPA, HPV9, IPV, MENB, MMR, MNQ, TDAP, VARCEL
Symptoms: Pallor, Syncope
Clinical narrative: This 17 yr old child was vaccinated with 9 vaccines at 4:55 pm.  Approximately 3-5 minutes approx 5:05pm after being vaccinated with the HPV9 vaccine this child began  to experience an episode of syncope.  His face, fingers and limbs became very pale while he experienced an episode of syncope.  Client was placed on floor in supine position with legs raised towards ceiling.   Client began to immediately recover and skin color returned to normal tone.   His vitals were  BP-109/76 R-17 HR-59 Child began to immediately recover and was discharged home at 5:20pm. Interpreter was available to assist.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Immediate post-injection reaction, Loss of consciousness, Syncope, Tremor
Clinical narrative: Immediately after vaccines were administered, patient fainted and nurse caught her and brought her to the ground. Per report of family member, patient was shaking once on the ground.  She immediately regained consciousness and was sitting up talking.
Age: 11.0
Sex: F
Vaccine: DTAP
Symptoms: Wrong product administered
Clinical narrative: I looked on the Pts Chart and the order showed  Dtap but when i administered the vaccine  the provider said it was meant to be meant to be a Tdap i administered the incorrect vaccine
Age: 3.0
Sex: F
Vaccine: DTAP, FLU4, HEPA, HIBV, PNC20
Symptoms: Injection site reaction, Rash macular, Rash pruritic
Clinical narrative: Red blotchy itchy rash on anterior thighs that started 5 days after received vaccines.                                                                                               1/24/24 received vaccines.  The next day developed bumps like "balls" on the sides of her legs.  Bump where each shot was.  Kept itching it. Put desitin cream on it and redness went down.  Put cortisone on it too.  1/29/24  started to notice where shot were given the "balls" went down.  Just on legs.  Itchy.  No fever.
Age: 72.0
Sex: M
Vaccine: HEPAB
Symptoms: Injection site swelling, Skin exfoliation
Clinical narrative: Swelling at the injection site and skin peeling
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Feeling abnormal
Clinical narrative: child was given vaccine approximately 1:20 pm, at approximately 1:23 pm, she removed herself from the exam table and stated she did not feel good, we ( her father and pr vider) sat her down in a chair and laid her down on her side across two waiting room chairs, at approximately 1:27 PM she opened her eyes and stated she was feeling  better, child and father stayed in the exam room with technician, Child and father left the clinic - on foot - at approximately 1:35 pm.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site rash
Clinical narrative: Patient believed she developed an allergic reaction to vaccine due to receiving vaccine subcutaneously versus IM.  Developed a baseball size rash at site of injection, but is non itchy after her vaccine on 7/25/24.  Informed pharmacy team on 7/27/24 of the adverse event.   As of today, 8/5/2024 during a follow up call, patient has recovered from her adverse reaction and did not seek medical attention from her provider.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: A few hours after the vaccination patient developed a red rash on one leg/thigh. She said it was not painful or itchy.  She had her doctor exam it and was given a topical steroid for it.
Age: 57.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Herpes zoster, Pain, Uveitis
Clinical narrative: I had never had chickenpox. This was verified by blood test in 2008 when I had Uveitis.  Yet in July 2023 I was diagnosed with shingles. I went through 3 rounds of antivirals, and was put on gabapentin.  I still get pain in the area.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear infection, Tinnitus
Clinical narrative: bilateral tinnitus; nausea; vomiting; diarrhea; This is a spontaneous report received from a Nurse.  A 71-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, 0.3 ml single (Batch/Lot number: unknown) intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "visual impairment" (ongoing); "kidney disease" (ongoing); "allergy" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, 0.3ML SINGLE, LOT# is EL9265), administration date: 30Jan2021, when the patient was 67-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, 0.3ML SINGLE, LOT# is EN6198), administration date: 20Feb2021, when the patient was 67-year-old, for COVID-19 immunization. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "bilateral tinnitus"; NAUSEA (non-serious), outcome "unknown"; VOMITING (non-serious), outcome "unknown"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea". The event "bilateral tinnitus" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information:  The patient was having problems with hearing, the patient visited the audiologist and primary care physician, after testing patient was diagnosed with bilateral tinnitus. The patient stated at first got the common side effects of nausea, vomiting and diarrhea.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Audiogram, Diarrhoea, Nausea, Tinnitus, Vomiting
Clinical narrative: bilateral tinnitus; nausea; vomiting; diarrhea; This is a spontaneous report received from a Nurse.  A 71-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, 0.3 ml single (Batch/Lot number: unknown) intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "visual impairment" (ongoing); "kidney disease" (ongoing); "allergy" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, 0.3ML SINGLE, LOT# is EL9265), administration date: 30Jan2021, when the patient was 67-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, 0.3ML SINGLE, LOT# is EN6198), administration date: 20Feb2021, when the patient was 67-year-old, for COVID-19 immunization. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "bilateral tinnitus"; NAUSEA (non-serious), outcome "unknown"; VOMITING (non-serious), outcome "unknown"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea". The event "bilateral tinnitus" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information:  The patient was having problems with hearing, the patient visited the audiologist and primary care physician, after testing patient was diagnosed with bilateral tinnitus. The patient stated at first got the common side effects of nausea, vomiting and diarrhea.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 1.25
Sex: F
Vaccine: PNC15, PNC15, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC.; HBP called to report inadvertent administration of VAXELIS and VAXNEUVANCE after a temperature excursion.; This spontaneous report was received from other reporter and refers to multiple patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant therapies, dug reactions or allergies were not reported.  On 04-JUN-2024, the patients were vaccinated with diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (V419) injection, (valid lot number U7535AA, expiration date: 23-SEP-2025), administered for prophylaxis; and pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, (valid lot number X019624, expiration date: 07-NOV-2025), administered for prophylaxis (dose, dose number, frequency, anatomical location and route of administration were not provided for both vaccines), after a temperature excursion of 34.3 degrees Fahrenheits (F), with a time frame of 0 hours 20 minutes 0 seconds. No previous temperature excursion (product storage error).   No additional adverse event (AE) reported.  This is a non-valid report due to the lack of multiple patients' identifiers.  Follow-up information has been received from a medical assistant (previously reported as "other") on 31-JUL-2024.  It was confirmed that the patient was a 15-month-old (conflicting information, also reported as 16-month-old) female patient. The patient's weight at birth was reported as 7.2 libras and had 1 bother and 1 sister.  On 10-JUN-2024 (previously reported as 04-JUN-2024), the patient was vaccinated with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE), via intramuscular at the right thigh; and diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (V419), administered at a private doctor's office/hospital. The vaccines' operator was a trained healthcare professional.  It was informed that the vaccines were labeled and stopped until approval. The patient's response was none. The current location of the vaccines was in a refrigerator for vaccines at medical office. The temperature excursion occurred as a result of a reading from a Digital Data Logger. It was stated that the refrigerator was without use for long time because they did not have enough patients. It was closed for prolonged time causing a drop in the temperature.  On 06-JUL-2024, the vaccines were resumed (strength, dose, frequency, route of administration, anatomical injection site, lot number and expiration date were not provided) and the patient's response was none.  This was a non-valid report but after follow-up information received it becomes valid.  Lot number is being requested and will be submitted if received.
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: VAQTA administered after temperature excursion.; This spontaneous report was received from a nurse and referred to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the vaccine hepatitis a vaccine, inactivated (VAQTA), lot #X025163, (expiration date: 12-MAY-2025), underwent a temperature excursion, at a temperature 57.9-degree Fahrenheit for a time frame of 2 hours 12 minutes. On 22-JUL-2024, the patient was vaccinated with the improperly stored hepatitis a vaccine, inactivated (VAQTA), administered for prophylaxis (strength, dose, and route of administration were not provided) (Product storage error). No other information provided. No product quality complaint (PQC) reported. No previous temperature excursion reported.   This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2407USA012756:
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: no other AE; an expired dose of VARIVAX was administered to a patient; This spontaneous report was received from a healthcare worker referring to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 26-JUL-2024, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, administered for prophylaxis (Lot number w021541 is an invalid lot number for varicella virus vaccine live (oka/merck) (VARIVAX). Lot number w021541 does not match any company product as confirmed by Lot verification team; expiration date was reported as 10-JUL-2024; strength, dose, and route of administration were not provided) (Expired product administered). It was confirmed that no other adverse event occurred, and the product did not have any temperature excursions prior to administration.  Lot# is being requested and will be submitted if received.
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: No additional AE; Pharmacist calling to report a 19-year-old male patient has missed his third dose of GARDASIL 9 by a month and a half, exact date of events were unspecified.; This spontaneous report was received from a pharmacist and refers to a 19-year-old male patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with the first and second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On an unspecified day in June 2024 (reported as a month and a half), the patient missed his third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (product dose omission issue). No additional information or adverse events were reported (no adverse event).  Lot # is being requested and will be submitted if received.
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: supervisor stated that instead of using a saline diluent to reconstitute hib, they used sterile water in a pre-filled syringe 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 1-year-old female patient and supervisor stated that instead of using a saline diluent to reconstitute HIB (PRP/T) VACCINE [ACT-HIB], they used sterile water in a pre-filled syringe 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 a 0.5 ml dose of suspect HIB (PRP/T) VACCINE HIB (PRP/T) VACCINE [ACT-HIB] of lot UJ975AB and expiry date: 06-Oct-2024 via intramuscular route in unknown administration site as immunization and supervisor stated that instead of using a saline diluent to reconstitute hib, they used sterile water in a pre-filled syringe with no reported adverse event (product preparation error) (Latency: on 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: 23.0
Sex: M
Vaccine: HEPAB, HEPAB
Symptoms: Hepatitis B surface antigen positive, Injection site urticaria
Clinical narrative: I received my first dose of Twinrix on 6/30/2024 and my second dose on 07/28/2024. After the first dose, I visited my primary care physician for routine lab work on 7/3/2024. Before reviewing my bloodwork results, I returned for my second dose. After the second injection, I developed hives on the arm where the injection was administered. There were hundreds of small bumps on my skin, some of which are still visible now.  I went back to my primary care physician on 07/29/2024. My doctor informed me that I had tested positive for Hepatitis B and that my blood was reactive to the Hepatitis B Surface Antigen (HBSAG). This result was confirmed through further testing. Just one month prior, I had tested negative for Hepatitis B and had not been exposed to the virus.
Age: 0.25
Sex: M
Vaccine: RV5
Symptoms: Infant irritability, Rash, Rash macular
Clinical narrative: Patient received hid 4-month-old dose and 6-month-old dose of ROTATEQ and was "fussy" and developed a rash after both administrations; Patient received hid 4-month-old dose and 6-month-old dose of ROTATEQ and was "fussy" and developed a rash after both administrations; Patient received hid 4-month-old dose and 6-month-old dose of ROTATEQ and was "fussy" and developed a rash after both administrations; The rash lasted about a month after the 4 month old dose; This spontaneous report was received from  a licensed practical nurse concerning to a 4-month-old male patient.  The patient's medical history, historical drugs, known allergies, concurrent conditions, and concomitant therapies were not reported.  On an unknown date in May 2024,  the patient was vaccinated with the 4-month-old dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered orally for prophylaxis (strength, exact dose, lot #, and expiry date were not provided) by a health care professional.  During this administration, the patient was fussy (Irritability). On another unspecified date in  2024 (reported as after 4-month-old dose administration), the patient developed a rash, so medical attention was sought and this rash was described as pinpoint, red, and located all over (Rash macular). This event lasted about a month, so on an unspecified date in 2024, he recovered from rash macular.     On 18-JUL-2024, the patient was vaccinated with the 6-month-old dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered orally for prophylaxis (strength, exact dose, lot #, and expiry date were not provided) by a health care professional. During this administration, the patient was fussy (Irritability).   On an unknown date in July 2024 (also reported as after the 6-month-old dose  and as after both administrations), the patient experienced another rash, so medical attention was sought and this rash was described as pinpoint, red, and located all over (Rash macular). No treatment was given for the events. At the time of this report the patient had not recovered form rash macular (onset :July 2024). The outcome of both events of irritability, was not provided.   The causal relationship between all the events and the suspect vaccine was not reported.
Age: 23.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: adult patient accidentally received a dose of Infanrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 23-year-old female patient who received DTPa (Infanrix) (batch number 7hm5j, expiry date 13-SEP-2024) for prophylaxis.   On 25-JUL-2024, the patient received Infanrix. On 25-JUL-2024, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: adult patient accidentally received a dose of Infanrix). The outcome of the inappropriate age at vaccine administration was not reported.   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: 25-JUL-2024 The HCP who stated that an adult patient accidentally received a dose of Infanrix instead of Boostrix today (on the day of reporting), which led to inappropriate age at vaccine administration.. Consented to follow up.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Blood pressure decreased, Fall, Syncope
Clinical narrative: Pt received Tdap vaccine + MenQuadfi vaccine - he sat for awhile; as MOC & he were checking out to leave he fainted & fell to floor - in the lap of an adult - POX & BP taken - POX good (100) BP was low - we sat him down, called 911, - gave him water; elevated legs & his BP improved - but went to ED for further eval - awake, alert, walking when he left
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Muscle spasms, Rash pruritic
Clinical narrative: Reported Symptoms: 10028322:MUSCLE PAIN; 10028411:MYALGIA; 10037087:PRURITUS; 10037844:RASH; Narrative: Patient complained of muscle cramps (shoulders), fatigue, and rash 2 days after getting most recent COVID-19 booster. Patient stated he got the booster (left arm) at the pharmacy on 06/26/2023 and developed the symptoms 2 days after. He was evaluated in ED at the facility on 7/4/23 and was found to have pruritic rash without anaphylactic symptoms. Symptoms resolved 1.5 months after vaccination and reaction to vaccine was not documented until medicine clinic visit in April 2024. Other Relevant HX: Patient previously received 3 doses of pfizer COVID-19 vaccine without hypersensitivity reactions Other: RASH; MUSCLE PAIN
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Reported Symptoms: 10037844:RASH; Narrative: Patient did not report rash at the time of injection, but reported 3 years later at a primary care visit. No treatment needed at time of event. Other Relevant HX: Other: RASH
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Right upper arm redness, swelling, and warmth around the vaccine site, approximately 4cm x 5cm in size. Started on the day after vaccination (7/31/24), peaked on 8/1/24, checked patient in our office on 8/6/24 and is resolving now.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Electric shock sensation, Nodule, Rash, Urticaria
Clinical narrative: hives on wrist arms and ankles, a swollen grape sized nodule near right clavicle, a severe bilateral rash warping around my stomach/torso, electrical shock feelings on my extremities (legs, arms, feet).   I did not seek treatment for several days mistaking the reaction for Multiple Sclerosis symptoms initially.  Finally received hydrocortisone ointment several days later.
Age: 60.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: REDNESS, ITCHING, TENDERNESS, ERYTHEMA AT INJECTION SITE; SENT TO ER - BENADRYL, PEPCID, MONITORED, RELEASED WITH RX FOR EPIPEN.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Fatigue, Gait disturbance
Clinical narrative: Fatigue and limping
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event
Clinical narrative: No adverse symptoms at this time.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Vomiting
Clinical narrative: Vomiting starting August 6 early morning was otherwise perfectly and in no contact with anyone sick  unknown if more vomiting will occur if so will see a physician at urgent care
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event
Clinical narrative: Parent states no adverse signs or symptoms at this time.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Recurrence of shingles. I had shingles at the age of 22.
Age: 76.0
Sex: M
Vaccine: PNC20
Symptoms: Hallucination, visual, Hyperhidrosis, Nightmare, Restlessness
Clinical narrative: Pt states started having hallucinations and/or nightmares. Said he was sweating and kicking in the middle of night and seeing monsters attacking him.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Patient had typical soreness in her arm. Vaccine received Saturday afternoon, then Sunday evening into Monday morning patient started having more significant discomfort in that arm. When she woke up Monday morning she had 3 painful nodules approx. 1-2 inches below injection site. They were red, not puss filled or scabbed looking. Very painful. She iced the are and applied hydrocortisone cream to it. they eventually bloomed or grew into each other and she had one large swelled area. after about a week the swelling and redness has finally gone down
Age: 61.0
Sex: F
Vaccine: RSV
Symptoms: Injection site pain
Clinical narrative: Pain at injection site-still ongoing.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute coronary syndrome, Angiocardiogram, Arterial thrombosis, Catheterisation cardiac abnormal, Coronary artery bypass
Clinical narrative: PATIENT MAY HAVE HAD COVID-19 IN 2020, THEN SUFFERED AN ACUTE MYOCARDIAL INFARCTION AND UNDERWENT PCI AND STENTING.  PFIZER #1 3/18/2021 PFIZER #2 7/27/2021 PFIZER #3 1/28/2022 AND SUFFERED MULTIPLE INTERCURRENT ACUTE CORONARY SYNDROMES UNDERWENT HEART CATHTERIZATION AND STENTING MULTIPLE VESSELS LEADING TO A TWO VESSEL CABG IN 2022.  PATIENT DESCRIBES MULTIPLE CORONARY THROMBOTIC COMPLICATIONS. DIAGNOSIS COVID-19 VACCINE ACCELERATED CORONARY ATHEROTHROMBOSIS AND MYO-PERICARDITIS WITH LV DYSFUNCTION. MANAGED ON BETA-BLOCKERS, ARB, ELIQUIS, ASPIRIN, CLOPIDOGREL PRIOR TO OFFICE VISIT.  CHANGED TO CARVEDILOL, ENTRESTO, COLCHICINE, ASPIRIN, PLAVIX, AND PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Coronary artery thrombosis, Echocardiogram, Electrocardiogram, Immunisation reaction, Laboratory test
Clinical narrative: PATIENT MAY HAVE HAD COVID-19 IN 2020, THEN SUFFERED AN ACUTE MYOCARDIAL INFARCTION AND UNDERWENT PCI AND STENTING.  PFIZER #1 3/18/2021 PFIZER #2 7/27/2021 PFIZER #3 1/28/2022 AND SUFFERED MULTIPLE INTERCURRENT ACUTE CORONARY SYNDROMES UNDERWENT HEART CATHTERIZATION AND STENTING MULTIPLE VESSELS LEADING TO A TWO VESSEL CABG IN 2022.  PATIENT DESCRIBES MULTIPLE CORONARY THROMBOTIC COMPLICATIONS. DIAGNOSIS COVID-19 VACCINE ACCELERATED CORONARY ATHEROTHROMBOSIS AND MYO-PERICARDITIS WITH LV DYSFUNCTION. MANAGED ON BETA-BLOCKERS, ARB, ELIQUIS, ASPIRIN, CLOPIDOGREL PRIOR TO OFFICE VISIT.  CHANGED TO CARVEDILOL, ENTRESTO, COLCHICINE, ASPIRIN, PLAVIX, AND PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Left ventricular dysfunction, Myopericarditis, Percutaneous coronary intervention, Therapy change, Vascular stent insertion
Clinical narrative: PATIENT MAY HAVE HAD COVID-19 IN 2020, THEN SUFFERED AN ACUTE MYOCARDIAL INFARCTION AND UNDERWENT PCI AND STENTING.  PFIZER #1 3/18/2021 PFIZER #2 7/27/2021 PFIZER #3 1/28/2022 AND SUFFERED MULTIPLE INTERCURRENT ACUTE CORONARY SYNDROMES UNDERWENT HEART CATHTERIZATION AND STENTING MULTIPLE VESSELS LEADING TO A TWO VESSEL CABG IN 2022.  PATIENT DESCRIBES MULTIPLE CORONARY THROMBOTIC COMPLICATIONS. DIAGNOSIS COVID-19 VACCINE ACCELERATED CORONARY ATHEROTHROMBOSIS AND MYO-PERICARDITIS WITH LV DYSFUNCTION. MANAGED ON BETA-BLOCKERS, ARB, ELIQUIS, ASPIRIN, CLOPIDOGREL PRIOR TO OFFICE VISIT.  CHANGED TO CARVEDILOL, ENTRESTO, COLCHICINE, ASPIRIN, PLAVIX, AND PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 14.0
Sex: M
Vaccine: ADEN_4_7
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient came to his Well Child Visit. Found 2 records on database and 1 record in database. When reconciling the record,  the second nurse verifier, transposed the digits on the year where the 1st MENVEO was given 1/5/2012 instead of 1/5/2021. Prompting me to give a MENVEO on 8/5/2024.  After given vaccine, documenting,  and reprinting  the shot record the ! (invalid min age/interval) made me realized that the patient had a MENVEO at age 11.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: EXPIRED VACCINE GIVEN/NO A/R
Age: 18.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Dizziness, Eye movement disorder, Pallor, Unresponsive to stimuli
Clinical narrative: AFTER RECEIVING VACCINES, PATIENT BECAME PALE AND LIGHTHEADED. WAS GIVEN COOL WATER AND FANNED. HE THEN AFTER 3 MINUTES BECAME PALE AGAIN, EYES ROLLED TO SIDE AND HE WAS NOT RESPONSIVE FOR ABOUT 10 SECONDS, THEN AWAKE, ALERT, ORIENTED X3. GIVE MORE COOL WATER AND PEANUT BUTTER CRACKERS AS HE HAD NOT EATEN OR DRANK MUCH THAT DAY. COLOR RETURNED TO NORMAL, VITAL SIGNS STABLE 95/60 BP, 66 HR, 100% O2 SAT. DID WELL AND LEFT WITH MOTHER.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: VERY LARGE REDDENED HARD AREA ON THIGH. VERY WARM TO TOUCH
Age: 60.0
Sex: F
Vaccine: TD, VARZOS
Symptoms: Arthralgia, Headache, Pain in extremity
Clinical narrative: Customer stated her hips started to hurt 24 hours after vaccination.  She stated the pain started going down her right leg.  She stated she still has a headache and arm is still tender.  Went to the emergency department.  The doctor did not think it was vaccine related.  Gave her oxycodone/apap 5/325 and dexamethasone.  Customer stated he had back surgery recently but had no problems after
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Facial pain
Clinical narrative: Left Face Pain started 3 hours after the vaccine administration.
Age: 17.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Eye movement disorder, Posture abnormal, Skin discolouration, Speech disorder
Clinical narrative: Client in clinic for 12th grade immunizations.   Spoke very little while preparing and signing information.  MCV4 administered in Left deltoid.    HPV4 administered in right deltoid.   Immediately after vaccine administered asked  client how he felt.  He mumbled .  Client color was changing.  Mom was asked to stand in front of client in the chair to keep from sliding out.  I held his head and body up to wall to keep from falling.   Pupils were rolled back into his head.   Assistance was called and Vital Signs were recorded.   Spot Vital signs 4400.  Bp 71/50 and HR not recorded.   911 called   Immediately reassessed Bp 90/59 HR 60   Opening  and closing eyes and color returning  some.   EMS arrived and assessed client.  Client becoming more responsive and color improving.  Refused EMS transport.  Bp 116/60 HR 70   Able to stand and eat nabs and drink Pepsi.   Ambulatory to car with nurse and mom.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: Gave pt adult Hep B vaccine vs peds (pt is 19 y/o)
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles outbreak reported the morning of 8/6/2024.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Brother noticed the morning after injection that there was a raised area.  Mother reports red, raised, circular shape, right below injection site, approximately 2in x 3in.  No pain or itching.   Not noticeable after 5 days.
Age: 1.67
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event
Clinical narrative: patient did not have adverse effects
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: pain, no itching.  the swollen area is red/warm, it was tender.  it is decreasing in size and per mother is now about half the size as it was earlier in the week.  Vaccines given in that leg were Kinrix and MMRV.  likely vaccine is kinrix as it was the one given in the superior portion of the leg per the MA who administered the shot.  no systemic symptoms.  mom has been giving motrin, tylenol, benadryl, and cool compresses
Age: 40.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Anxiety, Dizziness
Clinical narrative: Pt received first injection (Heplisav B) without incident.  With second (MMR), she was cautioned that it would sting more than the first.  After receiving second, she reported feeling "anxious" and bowed her head, then reported feeling light headed.  1st BP/HR on check was 80/52, HR 62.  Continued to monitor, giving her water and ice pack, and she soon reported feeling better. BP on recheck was 109/64 and HR 64 after 5 minutes.  Supervisor notified and also assessed CG, giving her more fluids.  She continued to report improvement and was able to stand without feeling dizzy.  Last BP was 115/67, HR 67, and she was escorted back to her car about 25 minutes after injection here she had someone waiting to drive her home.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: MMRV given instead of MMR and varicella, no adverse effects noted, POC notified by provider
Age: 62.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus
Clinical narrative: Patient woke up this morning (8/6/24) with red arm, inflammation, and itchiness around the injection site. Did not feel any of this at time of vaccination.
Age: 50.0
Sex: F
Vaccine: MMR
Symptoms: Musculoskeletal stiffness
Clinical narrative: PATIENT STATES SHE HAS A STIFF NECK ON BOTH SIDES
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Single component of a two-component product administered
Clinical narrative: Pentacel was not reconstituted. Patient received only the liquid portion (Dtap/polio) of the vaccine without the powder (Hib).  CDC was contacted, Dtap and polio is still valid, patient will need to be vaccinated with separate Hib vaccine.  Parent was contacted and appointment for vaccination was made.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: MMR administered 7/29/24 had expired on 7/25/24. No adverse side effects. Repeat vaccine to be administered 4 weeks post date given.
Age: 11.0
Sex: F
Vaccine: HPV9, MMRV, MNQ, TDAP
Symptoms: Wrong product administered
Clinical narrative: Pt was given MMRV instead of varicella
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Myalgia
Clinical narrative: Chills/shivers, muscle aches, fatigue approximately 12 hours after vaccine  was administered. Most intense 12-18 hours after vaccine. Less severe, but still bothersome, symptoms Fatigue, muscle aches lasted 24 hours after vaccine
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Product administered at inappropriate site
Clinical narrative: Mom sent pictures in of red arm several days after vaccination. Appointment made with PCP for same day. Vaccine administered incorrectly into tricep per PCP. No antibiotics needed at this time, though PCP will follow closely for further reaction.
Age: 14.0
Sex: M
Vaccine: HPV9, MMRV, PNC20, VARCEL
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Provider had previously ordered Proquad for the patient. Providers MA drew up Proquad and had to leave to help a situation. Provider then asked a second MA for patient vaccines and had changed the orders to MMRII and Varivax. First MA handed off proquad to the second MA. Second MA gave patient Proquad and Varivax
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Dementia, Hyperbilirubinaemia, Hyperlipidaemia, Metabolic encephalopathy
Clinical narrative: Hospitalization for severe sepsis likely due to COVID-19 pneumonia with organ dysfunction, metabolic encephalopathy, hyperbilirubinemia, acute on chronic thrombocytopenia, Type 2 diabetes, dementia, hyperlipidemia on dates 7/13/24- 7/30/24. Treated with dexamethasone,  Remdesivir.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Multiple organ dysfunction syndrome, Sepsis, Thrombocytopenia, Type 2 diabetes mellitus
Clinical narrative: Hospitalization for severe sepsis likely due to COVID-19 pneumonia with organ dysfunction, metabolic encephalopathy, hyperbilirubinemia, acute on chronic thrombocytopenia, Type 2 diabetes, dementia, hyperlipidemia on dates 7/13/24- 7/30/24. Treated with dexamethasone,  Remdesivir.
Age: 67.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient had come into pharmacy to receive a TDap and RSV shot, but was accidentally given TDap and Shingles. The patient had previously received a shingles shot on 7/8/24. At the time of submitting this report, the patient has been reached out to but has not been able to be contacted.
Age: 7.0
Sex: M
Vaccine: DTAPHEPBIP, HIBV
Symptoms: No adverse event, Wrong patient
Clinical narrative: Patient and parents arrived in room, I then stated the name on immunization card and parent stated it was the correct child. After verification of patient. I went through normal protocol of giving information on the vaccine and possible side effects. After patient left out of room with card, they then brought card back and stated, ?O this was for the other child.? After Further investigation I noticed that both children?s names were very similar. After noticing the error, I notified the parent of vaccines given were for a five-year-old and the child they brought to me was Seven and would have needed different. I notified the parents of possible side effects or adverse events to look out for. I monitored the patient for thirty minutes while the patient was in the waiting area. No adverse effect from vaccine occurred., During time of being monitored.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Fatigue, Injection site pain, Pain, Rash macular
Clinical narrative: The patient presented 3 days after getting the first dose of shingrix saying he had red splotches that blistered and scabbed on his hands, arms, around ankles.  The patient was tired and achy the day of the vaccine, but did not experience any fever, nausea, vomiting, or GI disturbance. The injection site was sore, but there was no redness, rash, bumps or any issues at injection site.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Scab
Clinical narrative: The patient presented 3 days after getting the first dose of shingrix saying he had red splotches that blistered and scabbed on his hands, arms, around ankles.  The patient was tired and achy the day of the vaccine, but did not experience any fever, nausea, vomiting, or GI disturbance. The injection site was sore, but there was no redness, rash, bumps or any issues at injection site.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administration Error. Minor was administered 0.3mg of pfizer for 5-11 years of age when it should have been 0.5mg. Minor is noted to be above the age of 11. Agency was contacted and made aware. Minor was administered the correct dose on 6/17/24 per DOH recommendations.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Pruritus, Rash
Clinical narrative: Mild to medium Rash on hands, wrist, abdomen, and face. Small blisters in short rows, 3 to 8 on each site, itchy and burning. Very similar to the actual shingles I had 25 years ago. One week later still finding about 5 new blisters daily on lower abdomen.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Administration Error. Minor was administered 0.3mg of Pfizer for 5-11 years of age when it should have been 0.5mg. Minor is noted to be above the age of 11. Clinic was contacted and made aware. Minor was administered the correct dosage on 6/17/24 per DOH recommendations.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Biopsy, Colitis ulcerative, Colonoscopy, Detoxification, Echocardiogram
Clinical narrative: PFIZER #1 5/7/2021 PFIZER #2 5/28/2021 PFIZER #3 1/15/2022, THEN IN 2023 DEVELOPED VACCINE INDUCED ULCERATIVE COLITIS AND SMALL FIBER NEUROPATHY.  ALSO DIAGNOSED WITH VACCINE PERICARDITIS.   TREATED WITH MESALAMINE, PREDNISONE, ORAL BUDESONIDE AND PROTOCOL
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electrocardiogram, Immunisation reaction, Laboratory test, Pericarditis, Small fibre neuropathy
Clinical narrative: PFIZER #1 5/7/2021 PFIZER #2 5/28/2021 PFIZER #3 1/15/2022, THEN IN 2023 DEVELOPED VACCINE INDUCED ULCERATIVE COLITIS AND SMALL FIBER NEUROPATHY.  ALSO DIAGNOSED WITH VACCINE PERICARDITIS.   TREATED WITH MESALAMINE, PREDNISONE, ORAL BUDESONIDE AND PROTOCOL
Age: 52.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site pruritus, Injection site reaction, Injection site swelling, Rash erythematous
Clinical narrative: patient developed red rash, swelling and itching in upper and inner arm area of right arm on Saturday after Shingrix immunization given on Thursday. Patient presented to pharmacy on 8/6/24 and stated the rash/swelling /itching seemed to be getting worse. Patient followed up with their primary care physician on 8/6/24.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; dose of PROQUAD was administered to a patient after the product was involved in a temperature excursion; This spontaneous report was received from an office manage and refers to a patient of unknown age or gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 03-JUL-2024, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 1 dose, lot #X018816, expiration date: 07-JAN-2025, administered for prophylaxis (exact dose, and route of administration were not provided). The dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was administered to the patient after the product was involved in a temperature excursion (temperature: -14 degrees Celsius (C) to -10C (-14.53C), time frame: 0 Hours 30 minutes 0 seconds; previous temperature excursion: -10C to 8C (-8.31C) for 11 hours 30 minutes 0 seconds; -14C to -10C (-13.87C) for 0 hours 45 minutes 0 seconds; -10C to 8C (-7.61C) for 15 hours 45 minutes 0 seconds; -10C to 8C (-2.91C) for 21 hours 15 minutes 0 seconds) (product storage error). No patient symptoms have been reported. No additional adverse event (AE) and no product quality complaint (PQC) was reported (no adverse event).  This is one of few reports received from the same reporter.; Sender's Comments:  US-009507513-2407USA003825: US-009507513-2407USA003806:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; a dose of ROTATEQ was administered to a patient after the product was involved in a temperature excursion; This spontaneous report was received from office manager and refers to a unknown patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 27-MAY-2024, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 1 dose, lot #1975783, expiration date: 12-OCT-2024, administered orally for prophylaxis (strength was not provided). This vaccine underwent temperature excursion in 8.94 degree Celsius for 30 minutes (Product storage error). No additional adverse event was reported.; Sender's Comments:  US-009507513-2407USA003825: US-009507513-2407USA003806:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; dose of ROTATEQ was administered to a patient after the product was involved in a temperature excursion; This spontaneous report was received from the Office Manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 14-MAY-2024, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 1 dosage form, lot #1975783, expiration date: 12-OCT-2024, administered for prophylaxis (strength, and route of administration were not provided) after a temperature excursion as follows: temperature: 8.94 C, time frame: 0 hours 30 minutes 0 seconds. No previous temperature excursion. Caller stated no patient symptoms were reported.  This is one of the several cases received from the same reporter.; Sender's Comments:  US-009507513-2407USA003806: US-009507513-2407USA003825:
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Extra dose administered, No adverse event
Clinical narrative: NO AE; pediatric patient who was inadvertently given 3 doses of VAQTA; This spontaneous report was received from a other Health Professional and refers to a 2-year-old female patient. The patient's medical history included lymph nodes enlarged. The patient's concurrent conditions included anaemia, egg allergy and milk allergy. Concomitant therapies were not reported. On about 17-JUL-2023, the patient received the first dose of hepatitis a vaccine, inactivated (VAQTA), on 17-JUN-2024, the patient received the second dose of hepatitis a vaccine, inactivated (VAQTA).  On 18-JUL-2024, the patient was inadvertently received the third dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection lot #X025908, expiration date: 24-APR-2025, administered intramuscularly at left thigh for prophylaxis (strength, and dose were not provided) (Extra dose administered). No adverse event occurred (no adverse event).
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: received a varicella vaccine that wore off,; This spontaneous report was received from the female patient and referred to herself (age was not reported). Pertinent medical history, concomitant medications and drug reactions/allergies were not reported.  On an unknown date, the patient received the dose of varicella virus vaccine live (oka/merck) (manufacture unknow) administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided).  On an unknown date, the patient experienced antibody test negative (the vaccine wore off). At the time of reporting, the outcome of the event was not known.    The causal relationship between the event and varicella virus vaccine live (oka/merck) (manufacture unknown) was unknown.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Device leakage
Clinical narrative: No injuries reported. No additional AE/PQC reported.; needle in patient GARDASIL 9 squirted all out of the side of the Luer lock attachment; needle in patient GARDASIL 9 squirted all out of the side of the Luer lock attachment; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 18-JUL-2024, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (lot#: X019196, expiration date: 25-APR-2025; strength, dose, and route of administration were not reported) by a medical assistant for prophylaxis. The syringe tray was intact and undamaged on receipt, cellophane covering was intact and completely sealed. The syringe carton was not damaged prior to use. The syringe looked fine, no cracks or breakage was not leaking prior to attempted administration. During the administration, the needle squirted out (syringe issue and poor quality device used). All medication came out from the side of the Luer lock attachment. No crack, broken parts, tip of the syringe or Luer lock adaptor loose, difficulty attaching the Syringe Needle to the Syringe were noticed or seen. The needle was not supplied by company. The syringe tip cap attached properly prior to use. It was redosed with another syringe later. The patient did not miss any doses. The product was available for retrieval and the needle was not supplied by the company. No injuries reported. No additional adverse events (AE) were reported.  Follow-up information was received on 01-AUG-2024. The case referred to a 12-year-old male patient. The patient use needle: 25g x 1 (medical hypodermic needle-pro). The sample has been retrieved.  The patient's identifiers were missing in prior version.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other AE.; The caller said the patient received an expired dose on 7/31/2024.; This spontaneous report was received from a medical assistant and a physician regarding to a patient of unspecified age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not provided.  On 31-JUL-2024, the patient was vaccinated with human papilloma virus (HPV) rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, lot number U007652 (lot number U007652 had been verified to be valid lot number for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine [yeast] [GARDASIL 9]), expiration date 14-APR-2023 (strength, dose, frequency, route of administration and anatomical injection site were not provided) for prophylaxis (expired product administered).  The reporter confirmed no other adverse event (AE) occurred, and the product did not have any temperature excursions prior to administration. AE letter sent to prescriber. No other AE. No product quality complaint (PQC).