chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: significant malaise; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "significant malaise". Additional information: patient had experienced significant malaise from our vaccine in the past. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Mental disorder, Thought insertion
Clinical narrative: I'm being inundated and attacked by thought; caller got a vaccine, and it is affecting mental health; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2024-766694.  A patient (age and gender not provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (SPIKEVAX) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THOUGHT INSERTION (non-serious), outcome "not recovered", described as "I'm being inundated and attacked by thought"; MENTAL DISORDER (non-serious), outcome "not recovered", described as "caller got a vaccine, and it is affecting mental health".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hypoaesthesia, Neck pain, Neurological symptom, Vision blurred
Clinical narrative: 2-3 days after receiving vaccine, developed re-surgency of neurological symptoms which had previously resolved. Having headaches, numbness in arm, abdomen, blurred vision, neck pain.
Age: 16.0
Sex: M
Vaccine: DTAP
Symptoms: Vaccination error, Wrong product administered
Clinical narrative: Vaccination error. Patient was given Dtap instead of the correct vaccine.
Age: 61.0
Sex: M
Vaccine: TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient received vaccine in 2019 and 2022 no adverse reaction reported
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Limb discomfort, Limb mass, Peripheral swelling, Pruritus
Clinical narrative: Patient is complaining five days post vaccine of redness, swelling, itching, discomfort, and lump in her arm. Patient has been taking otc tylenol, advil, xyzal for symptom relief. Patient's reaction has not been severe enough to seek other medical attention.
Age: 6.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA, MMR, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: RN administered vaccines as ordered. When scanning vaccines into EMR, Priorix was flagged for being expired (expired 5/11/24). RN had checked all syringes of vaccines, the syringe that Priorix was drawn in, but the vial in the same box as syringe had a different expiration date. Provider and DoN made aware. No reaction noted while patient was waiting in clinic for required 15 minutes after administration.
Age: 5.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Incorrect dose administered
Clinical narrative: Hep A vaccine given was an adult dose instead of pediatric dose
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Feeling abnormal, Posture abnormal, Supine position, Syncope
Clinical narrative: Pt fainted about 15 mins after receiving vaccine.  She was standing in waiting room checking out and felt funny.  She then started to lie down because this has happened before.  She slumped to floor and had possibly brief jerking (few seconds per MA).  She then rapidly regained consciousness, but felt funny.  She was supine and then advanced to chair and then standing over next 1/2 hr.  She was monitored continuously after event until she was escorted to her Dad's car after full recovery.
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient received extra dose of Shingrix - no known adverse reactions, reporting due to patient not needing another dose
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, Condition aggravated, Fatigue, Vertigo, Viral load increased
Clinical narrative: developed vertigo for 6 days following the vaccine, then experienced dibilitating fatigue for 5 mos
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Decreased appetite, Malaise, Respiratory tract congestion
Clinical narrative: Cough, congestion, malaise, loss of appetite. Tested positive for covid on 4/30/24. Started on Paxlovid for 5 days and placed on isolation for 10 days
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Cough, congestion, malaise, loss of appetite. Tested positive for covid on 4/30/24. Started on Paxlovid for 5 days and placed on isolation for 10 days
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Anti-thyroid antibody increased, Blood cholesterol normal, Blood thyroid stimulating hormone normal, Blood triglycerides normal, Dysgraphia
Clinical narrative: Approximatey 7-8 days later, I got tremors in my hands, completely affecting my handwriting (could not write legibly). It stopped a few days later. In the meantime, I noticed my eyes seem bigger than usual, most evident in selfies. My wife's cousin and her husband (who both are medical doctors in another country) said my eyes look bulgy and to get my thyroid levels checked. During this period, my heart rate was unusually high and exceeded 100 bpm for several hours despite I not doing anything physically. I was also sensitive to heat and did not need any warm clothing in November and December. My lipid panel testing as a part of my annual physical showed completely normal cholesterol and associated parameters (LDL, triglycerides, etc), except for lower HDL (~35).
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Exophthalmos, Heart rate increased, High density lipoprotein decreased, Low density lipoprotein normal, Temperature intolerance
Clinical narrative: Approximatey 7-8 days later, I got tremors in my hands, completely affecting my handwriting (could not write legibly). It stopped a few days later. In the meantime, I noticed my eyes seem bigger than usual, most evident in selfies. My wife's cousin and her husband (who both are medical doctors in another country) said my eyes look bulgy and to get my thyroid levels checked. During this period, my heart rate was unusually high and exceeded 100 bpm for several hours despite I not doing anything physically. I was also sensitive to heat and did not need any warm clothing in November and December. My lipid panel testing as a part of my annual physical showed completely normal cholesterol and associated parameters (LDL, triglycerides, etc), except for lower HDL (~35).
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Thyroid stimulating immunoglobulin increased, Thyroxine increased, Tremor, Tri-iodothyronine increased
Clinical narrative: Approximatey 7-8 days later, I got tremors in my hands, completely affecting my handwriting (could not write legibly). It stopped a few days later. In the meantime, I noticed my eyes seem bigger than usual, most evident in selfies. My wife's cousin and her husband (who both are medical doctors in another country) said my eyes look bulgy and to get my thyroid levels checked. During this period, my heart rate was unusually high and exceeded 100 bpm for several hours despite I not doing anything physically. I was also sensitive to heat and did not need any warm clothing in November and December. My lipid panel testing as a part of my annual physical showed completely normal cholesterol and associated parameters (LDL, triglycerides, etc), except for lower HDL (~35).
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Malaise, Pyrexia, Respiratory tract congestion
Clinical narrative: Fever, cough, congestion, malaise. tested positive for covid on 4/30/24. Started on paxlovid for 5 days and place on isolation for 10 days.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Fever, cough, congestion, malaise. tested positive for covid on 4/30/24. Started on paxlovid for 5 days and place on isolation for 10 days.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Decreased appetite, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: Cough, congestion, loss of appetite. Tested positive for covid on 4/28/24. Resident started on Paxlovid x 5days and placed on isolation for 10 days
Age: 81.0
Sex: F
Vaccine: COVID19-2, VARZOS
Symptoms: Expired product administered
Clinical narrative: Administered the Spikevax without verifying expiration date and gave an expired dose. Dose had expired on 4.30.2024 and was administered on 5.8.2024
Age: 61.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: PATIENT RECEIVED A SECOND DOSE OF AREXVY 4 MONTHS AFTER THE FIRST DOSE. NO SIGNIFICANT ADVERSE EFFECTS REPORTED AFTER 24  HOURS.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Rash
Clinical narrative: rash ongoing celluilitis recurrent times 3 weeks
Age: 61.0
Sex: F
Vaccine: RSV, TDAP
Symptoms: Dizziness, Syncope
Clinical narrative: Patient reported dizziness and fainting 48 hours post vaccination
Age: 52.0
Sex: F
Vaccine: RSV
Symptoms: Blindness, Headache, Visual impairment
Clinical narrative: severe headache resulting in vision impairment/loss of vision within 4.5 hours of vaccine administration. resolved when awoken after going to sleep.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Blue toe syndrome, Chest pain, Dizziness, SARS-CoV-2 test
Clinical narrative: Anaphylaxis; Severely dizzy I felt like I was walking sideways; Severe chest pain for 4 to 5 hours 3 inch block of ice on my chest and ice in my mouth; Purple toes; This is a spontaneous report received from a Consumer or other non HCP.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19May2022 at 14:00 as dose 1, single (Lot number: EW0185) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANAPHYLACTIC REACTION (disability) with onset May2022, outcome "not recovered", described as "Anaphylaxis"; BLUE TOE SYNDROME (disability) with onset May2022, outcome "not recovered", described as "Purple toes"; CHEST PAIN (disability) with onset May2022, outcome "not recovered", described as "Severe chest pain for 4 to 5 hours 3 inch block of ice on my chest and ice in my mouth"; DIZZINESS (disability) with onset May2022, outcome "not recovered", described as "Severely dizzy I felt like I was walking sideways". The events "anaphylaxis", "severely dizzy i felt like i was walking sideways", "severe chest pain for 4 to 5 hours 3 inch block of ice on my chest and ice in my mouth" and "purple toes" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of anaphylactic reaction, dizziness, chest pain, blue toe syndrome included Lyrica, centrizine. Clinical courses is as follows: No other vaccine in four weeks. Severely dizzy patient felt like she was walking sideways and then just severe chest pain for 4 to 5 hours 3 inch block of ice on her chest and ice in her mouth. Patient was having anaphylaxis - anaphylaxis on and off since then and purple toes. Pain in her chest comes and goes.
Age: 28.0
Sex: F
Vaccine: HPV9, UNK
Symptoms: Feeling hot, Flushing, Pain, Rash, Rash erythematous
Clinical narrative: Pt  got rash and elevated BP
Age: 28.0
Sex: F
Vaccine: HPV9, UNK
Symptoms: Rash pruritic, Skin tightness, Skin warm
Clinical narrative: Pt  got rash and elevated BP
Age: 28.0
Sex: F
Vaccine: HPV9, UNK
Symptoms: Blood pressure increased, Rash
Clinical narrative: Pt  got rash and elevated BP
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Caller reported AE on behalf of a patient who was administered improperly stored VARIVAX on 4/29/2024. No symptoms reported.; Caller reported AE on behalf of a patient who was administered improperly stored VARIVAX on 4/29/2024. No symptoms reported.; This spontaneous report was received from a medical assistant concerning to a patient of unspecified age and gender. The patient's medical history, historical drugs, known allergies, concurrent conditions, and concomitant therapies were not reported.  On 29-APR-2024, the was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter, lot #X023323, expiration date: 20-SEP-2025, administered for prophylaxis (strength, anatomical location, and route of administration were not provided) that had gone through a temperature excursion of 18.5 degree Fahrenheit  (F)/ 14 degree F up to 46 F during 53 hours and 28 minutes (improper storage of product in use). Nevertheless, there were no symptoms reported, neither additional adverse events (AE) or product quality complaints (PQC).
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: HCP calling to report an adverse event regarding improperly stored and administered doses of VARIVAX.  HCP stated the VARIVAX doses were exposed to a temperature excursion and were inadvertently administered after the excursion occurred; They have not received any reports of the patients having any medical concerns or symptoms due to being administered the doses of VARIVAX.; This spontaneous report was received from a nurse prescriber concerning to a patient of unspecified age and gender. The patient's medical history, historical drugs, known allergies, concurrent conditions, and concomitant therapies were not reported.  On 30-APR-2024, the patient was inadvertently vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 ml / two dose series, lot #X026320, expiration date: 07-NOV-2025, administered for prophylaxis (strength, anatomical location, and route of administration were not provided) that was improperly stored as it had been exposed to a temperature excursion (Improper storage of product in use).Nevertheless, no reports of the patient having any medical concerns or symptoms due to being administered a dose of this vaccine had been received. No additional information provided.
Age: 12.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; VAQTA administered after a supported temperature excursion/date of administration 21-MAR-2024; This spontaneous report was received from a nurse and referred to a 12-year-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 14-MAR-2024, the vaccine hepatitis a vaccine, inactivated (VAQTA) lot #X023975, (expiration date: 18-APR-2025), underwent a temperature excursion, temperature reported: 34.3-degree Fahrenheit (F) for 21 minutes. After the supported temperature excursion, on 21-MAR-2024, the patient was vaccinated in a private doctor's office/hospital with public funds by a health care professional with the improperly stored hepatitis a vaccine, inactivated (VAQTA), administered intramuscularly in the left deltoid for prophylaxis (strength and dose was not provided) (Product storage error) (it was reported that the medication error occurred during storage in clinical practice). Temperature excursion was discovered on 22-MAR-2024 and was reported to the manufacturer (after the vaccine excursion was reported, manufacturer was contacted). No previous temperature excursions. No additional adverse event (AE), no product quality complaint (PQC) (No adverse event). No additional information.   This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2403USA008020: US-009507513-2405USA002625: US-009507513-2405USA001624: US-009507513-2405USA001628: US-009507513-2405USA001629: US-009507513-2405USA001626: US-009507513-2405USA001627:
Age: 14.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; VAQTA administered after a supported temperature excursion/date of administration 22-MAR-2024; This spontaneous report was received from a nurse and referred to a 14-year-old male patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 14-MAR-2024, the vaccine hepatitis a vaccine, inactivated (VAQTA) lot #X023975, (expiration date: 18-APR-2025), underwent a temperature excursion, temperature reported: 34.3-degree Fahrenheit (F) for 21 minutes. After the supported temperature excursion, on 22-MAR-2024, the patient was vaccinated in a private doctor's office/hospital with public funds by a health care professional with the improperly stored hepatitis a vaccine, inactivated (VAQTA), pre-filled syringe,  administered intramuscularly in the left deltoid for prophylaxis (strength and dose was not provided) (Product storage error) (it was reported that the medication error occurred during storage in clinical practice). Temperature excursion was discovered on 22-MAR-2024 and was reported to the manufacturer (after the vaccine excursion was reported, manufacturer was contacted). No previous temperature excursions. No additional adverse event (AE), no product quality complaint (PQC) (No adverse event). No additional information.   This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2403USA008020: US-009507513-2405USA002625: US-009507513-2405USA001625: US-009507513-2405USA001624: US-009507513-2405USA001629: US-009507513-2405USA001628: US-009507513-2405USA001627:
Age: 9.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; VAQTA administered after a supported temperature excursion/date of administration 18-MAR-2024; This spontaneous report was received from a nurse and referred to a 9-year-old female patient.  The patient's medical history and concomitant therapies were not reported. The patient's concurrent conditions included iron deficiency anaemia.   On 14-MAR-2024, according to a digital data logger, the vaccine hepatitis a vaccine, inactivated (VAQTA) lot #X023975, (expiration date: 18-APR-2025), underwent a temperature excursion, temperature reported: 34.3-degree Fahrenheit (F) for 21 minutes. After the supported temperature excursion, on 18-MAR-2024, the patient was vaccinated in a private doctor's office/hospital with public funds by a health care professional with the improperly stored hepatitis a vaccine, inactivated (VAQTA), pre-filled syringe,  administered intramuscularly in the right deltoid for prophylaxis (strength and dose was not provided) (Product storage error) (it was reported that the medication error occurred during storage in clinical practice). Temperature excursion was discovered on 22-MAR-2024 and was reported to the manufacturer (after the vaccine excursion was reported, manufacturer was contacted). No previous temperature excursions. No additional adverse event (AE), no product quality complaint (PQC) (No adverse event). No additional information.   This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2403USA008020: US-009507513-2405USA001625: US-009507513-2405USA001626: US-009507513-2405USA001624: US-009507513-2405USA001629: US-009507513-2405USA002625: US-009507513-2405USA001628:
Age: 9.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; VAQTA administered after a supported temperature excursion/date of administration 18-MAR-2024; This spontaneous report was received from a nurse and referred to a 9-year-old male patient.  The patient's medical history and concomitant therapies were not reported. The patient's concurrent conditions included constipation.   On 14-MAR-2024, according to a digital data logger, the vaccine hepatitis a vaccine, inactivated (VAQTA) lot #X023975, (expiration date: 18-APR-2025), underwent a temperature excursion, temperature reported: 34.3-degree Fahrenheit (F) for 21 minutes. After the supported temperature excursion, on 18-MAR-2024, the patient was vaccinated in a private doctor's office/hospital with public funds by a health care professional with the improperly stored hepatitis a vaccine, inactivated (VAQTA), pre-filled syringe,  administered intramuscularly in the right deltoid for prophylaxis (strength and dose was not provided) (Product storage error) (it was reported that the medication error occurred during storage in clinical practice). Temperature excursion was discovered on 22-MAR-2024 and was reported to the manufacturer (after the vaccine excursion was reported, manufacturer was contacted). No previous temperature excursions. No additional adverse event (AE), no product quality complaint (PQC) (No adverse event). No additional information.   This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2403USA008020: US-009507513-2405USA001625: US-009507513-2405USA001624: US-009507513-2405USA001626: US-009507513-2405USA001627: US-009507513-2405USA001629: US-009507513-2405USA002625:
Age: 11.0
Sex: F
Vaccine: HEPA
Symptoms: Medication error, No adverse event, Product storage error
Clinical narrative: No additional AE; VAQTA administered after a supported temperature excursion/date of administration 20-MAR-2024; This spontaneous report was received from a nurse and referred to an 11-year-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 14-MAR-2024, according to a digital data logger, the vaccine hepatitis a vaccine, inactivated (VAQTA) lot #X023975, (expiration date: 18-APR-2025), underwent a temperature excursion, temperature reported: 34.3-degree Fahrenheit (F) for 21 minutes. After the supported temperature excursion, on 20-MAR-2024, the patient was vaccinated in a private doctor's office/hospital with public funds by a health care professional with the improperly stored hepatitis a vaccine, inactivated (VAQTA), administered intramuscularly in the right deltoid for prophylaxis (strength and dose was not provided) (Product storage error) (it was reported that the medication error occurred during storage in clinical practice). Temperature excursion was discovered on 22-MAR-2024 and was reported to the manufacturer (after the vaccine excursion was reported, manufacturer was contacted). No previous temperature excursions. No additional adverse event (AE), no product quality complaint (PQC) (No adverse event). No additional information.   This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2403USA008020: US-009507513-2405USA001624: US-009507513-2405USA002625: US-009507513-2405USA001625: US-009507513-2405USA001628: US-009507513-2405USA001626: US-009507513-2405USA001627:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; PROQUAD was administered the same day the temperature excursion occurred, 08-MAY-2024; This spontaneous report was received from a medical assistant referring to a patient of unspecified age and gender.  The patient's concurrent conditions, medical history, previous drug reactions, drug allergies and concomitant therapies were not provided.  On 08-MAY-2024, the patient was vaccinated with the first dose of an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant Human albumin (rHa) (involved lot # was X021759, expiration date: 23-FEB-2025 [verified to be valid]); administered as prophylaxis (strength, and route of administration were not provided). On the same date, the administered dose of the vaccine experienced a temperature excursion (temperature and time frame were unknown at the reporting time). No previous temperature excursion was reported. This report was called because of a data logger. There was no adverse effect reported. No product quality complaint was involved.  This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2405USA002604: US-009507513-2405USA002603: US-009507513-2405USA002604:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; ROTATEQ was administered the same day the temperature excursion occurred 08-MAY-2024; This spontaneous report was received from a medical assistant referring to a patient of unspecified age and gender.  The patient's concurrent conditions, medical history, previous drug reactions, drug allergies and concomitant therapies were not provided.  On 08-MAY-2024, the patient was vaccinated with the third dose of an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (involved lot # was X010219, expiration date: 14-DEC-2024); administered as prophylaxis (strength, and route of administration were not provided).On the same date, the administered dose of the vaccine experienced a temperature excursion (temperature and time frame were unknown at the reporting time). No previous temperature excursion was reported. This report was called because of a data logger. There was no adverse effect reported. No product quality complaint was involved.  This is one of two reports from the same reporter.  ; Sender's Comments:  2405USA002603:
Sex: F
Vaccine: HPV9
Symptoms: Apgar score, Foetal exposure during pregnancy, Term baby
Clinical narrative: Category II fetal heart rate; Foetal exposure during pregnancy, second trimester; The information has been received from a pharmacist, regarding a foetus female patient.  The patient's concurrent conditions, medical history, and neonatal concomitant therapies were not provided. Her mother's concomitant therapies included acetylsalicylic acid (ASPIRIN), an unspecified prenatal vitamins, and salbutamol (ALBUTEROL HFA). Her mother had uncomplicated delivery on 10-SEP-2022 with a male baby. Her mother had concurrent condition asthma, had been never smoking, never used drugs, and didn't use alcohol during pregnancy.   The patient's mother got pregnant with a last menstrual period (LMP) on about 21-MAY-2023. On 13-SEP-2023, the patient's mother was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection for prophylaxis (strength, dose, lot #, expiry date, and route were not provided) (captured in MARRS# 2309USA005637). The patient was exposure via transplacental in second trimester (Foetal exposure during pregnancy). On an unknown date, category II fetal heart rate tracing was identified.  the patient was live birth full-term and delivered by vaginal. The patient's birth weight was 6lbs 3ozs, Apgar score was 8 in 1 minute, and 9 in 5 minutes (units not reported). The outcome of Foetal exposure during pregnancy was considered as recovered on the same day. The outcome of category II foetal heart rate was unknown.  The causal relationship between Category II fetal heart rate and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown.  Lot number is being requested and will be submitted if received.; Sender's Comments:  US-009507513-2309USA005637:MSD
Sex: U
Vaccine: PNC15, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Nurse called to report TE where products have been administered to patients. No Additional AE/PQC.; Nurse called to report TE where products have been administered to patients. No Additional AE/PQC.; This spontaneous report was received from a registered nurse concerning to a patient of unspecified age and gender. The patient's medical history, historical drugs, known allergies, concurrent conditions, and concomitant therapies were not reported.  On an unknown dates, the patient was vaccinated with doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 milliliter, lot #2003139, expiration date: 30-APR-2025, administered orally (strength was not provided); and  pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) 0.5 milliliter injection, lot #x019438, expiration date: 07-NOV-2025; both administered as prophylaxis (dose, anatomical location, and route of administration were not provided) that had been involved in a temperature excursion (TE) of 9.85 degree Celsius (C) for 30 minutes (Improper storage of product in use). There had not been previous temperature excursions. No additional adverse events (AE) or product quality complaints (PQC) were reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: Nurse confirmed that the patient reported no additional AEs.; Nurse reported that a dose of VAQTA was administered to a patient on 09MAY2024 after the product had experienced a temperature excursion on 07MAY2024.; This spontaneous report was received from a nurse referring to a patient of unspecified age and gender.  The patient's concurrent conditions, medical history, previous drug reactions, drug allergies and concomitant therapies were not provided.  On 07-MAY-2024, a dose of hepatitis a vaccine, inactivated (VAQTA) (involved lot # was X023973, expiration date: 26-DEC-2024) experienced a temperature excursion of -0.4 degrees Celsius (C) for 4 hours 51 minutes 0 seconds. No previous temperature excursion was reported. On 09-MAY-2024, the improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) was administered as prophylaxis (strength, and route of administration were not provided) to the patient (1 dose). There was no adverse effect reported. No product quality complaint was involved.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: administered pentacel but did not combine the dtap ipv and acthib components/ only the acthib was mixed with sterile diluent and then administered with no reported adverse event; Initial information received on 09-May-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 6 months old male patient who was administered Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] but did not combine the dtap ipv and acthib components/ only the acthib was mixed with sterile diluent and then administered 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 Hepatitis B Vaccine (Hepatitis B Vaccine) for Immunisation and  MCV4.  On 01-May-2024, the patient received 0.5 ml total (1 X)  (dose 3) of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine Suspension for injection (lot number: UJ975AA) (Expiry date: 23-Nov-2024) (Strength: standard) (Frequency: once) via intramuscular route in the left thigh for immunization.  On 01-May-2024, the patient was administered Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] but did not combine the dtap ipv and acthib components/ only the acthib was mixed with sterile diluent and then administered with no reported adverse event (single component of a two-component product administered) (latency: same day).   Reportedly, Now calling back to request information about the vaccine. would like to know if everything needs to be readministered or if it's okay to administer the just the DTap separately. HCP (healthcare professional) states that the sterile diluent used was the sterile water diluent they receive with the MMR vaccine.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired pentacel was inadvertently administered to a patient with no reported adverse event; Initial information received on 10-May-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an unknown age and unknown gender patient to whom expired DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (Pentacel) was inadvertently administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received expired DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE, Suspension for injection (x1) via unknown route in unknown administration site for immunization (strength, dose, batch number and expiry date unknown) with no reported adverse event (expired product administered) (latency same day). Information on the batch number was requested.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: HIBV
Symptoms: Medication error, No adverse event, Product preparation error
Clinical narrative: patient received a dose of ACTHIB that was reconstituted with sterile water with no reported adverse event; Initial information received on 10-May-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves an unknown age and unknown gender patient who received a dose of Hib (Prp/T) Vaccine [Act-Hib] that was reconstituted with sterile water with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection (with an unknown strength, expiry date, lot number) via unknown route in unknown administration site for immunization.  On an unknown date, the patient received a dose of Hib (Prp/T) Vaccine that was reconstituted with sterile water with no reported adverse event (product preparation error) (latency: same day).  Reportedly, Nurse calling from a provider's office. Caller would like to know if the sterile water changes the efficacy of the dose. This situation is pre-assessed as a medication error/an inappropriate use due to the use of an alternate diluent. Nurse does not have any patient or event information at hand right now. She was informed that the office should received a questionnaire and that the patient and event details can be documented on there and sent back.   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: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Diagnosed cellulitis; swelling at injection site; redness at injection site; This non-serious case was reported by a other health professional via call center representative and described the occurrence of injection site cellulitis in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number 2YC74, expiry date 25-JAN-2026) for prophylaxis.   On 03-MAY-2024, the patient received the 2nd dose of Shingrix (intramuscular, left deltoid). On 05-MAY-2024, 2 days after receiving Shingrix, the patient experienced injection site cellulitis (Verbatim: Diagnosed cellulitis), injection site swelling (Verbatim: swelling at injection site) and injection site erythema (Verbatim: redness at injection site). The outcome of the injection site cellulitis, injection site swelling and injection site erythema were unknown.   It was unknown if the reporter considered the injection site cellulitis, injection site swelling and injection site erythema to be related to Shingrix.     It was unknown if the company considered the injection site cellulitis, injection site swelling and injection site erythema to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-MAY-2024 The reporter was the Office Manager for the physician's group.   The patient received Shingrix vaccination and experienced swelling and redness at the injection site.   The patient saw the doctor on the date of reporting and was diagnosed with cellulitis.  The patient received prescription medication to treat it. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Sex: U
Vaccine: HIBV
Symptoms: Product preparation error, Single component of a two-component product administered, Underdose
Clinical narrative: several diluent only administrations; several diluent only administrations; This non-serious case was reported by a other health professional and described the occurrence of inappropriate preparation of medication in an unspecified number of patients who received Hib (Hiberix) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced inappropriate preparation of medication (Verbatim: several diluent only administrations) and inappropriate dose of vaccine administered (Verbatim: several diluent only administrations). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-MAY-2024 In the past week reporter reported that they had administrated several diluents only, following the roll out of the new Hiberix vaccine presentation with the prefilled syringe of diluent. The reporter stated teams were administering without knowledge or clear visibility of the powder.  The reporter concerned about packaging that the eyes go straight to the syringe and hides the vial and to consider repackaging differently. The reporter mentioned that as no banding was available or created for prefilled syringe diluent and powder vial and vaccine bands have been very effective in holding diluent vial and powder vial together, forcing staff to see the two part vaccine. They had post dilution confusion that there was no way to tell if a vaccine has been diluted or not and it would be ideal if the color of the vaccine changed in the event the vaccine was diluted like other companies have done.  They had expressed concerns prior to distribution or production 1 year ago. The reporter had administrated Hiberix diluent portion only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: Patient received Pfizer BionTech Covid-19 vaccine for 5-11 years old, but clinical staff diluted it with 0.9% Sodium Chloride prior to administering. Patient did not have any adverse effects that we are aware of.
Age: 49.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site induration, Injection site nodule, Injection site warmth
Clinical narrative: Large, hard, hot to the touch nodule at injection site.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1
Symptoms: Choking, Cyanosis, Gaze palsy, Pyrexia, Seizure
Clinical narrative: Patient noted while feeding breast milk from bottle to be making a noise like choking but no vomiting. At same time patient had perioral cyanosis and eyes deviated to the right. Episode occured about 1:15 PM. Similar episode recurred about 5:00PM. EMS called and patient transported to Hospital Center ER for evaluation. Patient had 2 more seizures in the ER treated with IV Medazolam then a loading dose of Keppra. Patient then transferred to another Hospital for further care. Enroute to Hospital, patient had a 4th seizure. She was noted to be febrile (38.8 C) in the 2nd ER. While inpatient, she had 2 more seizures managed with Ativan x 2 and a Phenobarbital loading dose. No more seizures
Age: 18.0
Sex: M
Vaccine: MENB, VARCEL
Symptoms: Dizziness, Pallor
Clinical narrative: patient became pale and a little lightheaded a minute or so after giving the injections. He attributed it to the conversation he and his mother were having about his sister having an adverse reaction to an injection. Patient was instructed to lie down on the exam bench which he did for approximately three minutes. He then sat up slowly and after tolerating this was able to stand and walk around the room independently. He left the office with steady gait independently.
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated.
Age: 4.0
Sex: M
Vaccine: COVID19, FLU4, HEPA, MMRV, PNC20, VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient received both ProQuad and Varicella due to mistaken vaccine.  Patient was supposed to receive ProQuad and Vaxelis.No adverse symptoms, signs. No treatment required.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated.
Age: 50.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated.
Age: 38.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Dry mouth, Dysphagia, Hypertension, Tongue dry
Clinical narrative: Received 1st dose injection of Gardasil 9 on Wednesday 5/15/24 at 6:30 pm at the pharmacy. Shot was given on left arm. I was not told to wait after the shot so I went home. Once I reached home my tongue and mouth were extremely dry and it was a bit hard to swallow. Took Zyrtec just incase and then decided to head to the urgent care to be checked out to make sure my mouth was not swollen. I had to drink alot of water because my mouth was so dry. I also felt a little dizzy for a few minutes. At the Urgent Care the Nurse practitioner did checked my lungs and heart seemed to be ok, checked my throat and tongue, didn't see signs of swelling. Also, my oxygen and pulse were checked as well and they were ok. My blood pressure was a little high. Nurse Practitioner gave me Benedryll (allergy medicine) and famotidine  (pepcid). Also was monitored for 45 minutes. My salvia started coming back in my mouth and it was becoming less dry and blood pressure went slightly down later on. I was given Benedryll to take every 4 hours for the next 24 hours.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site reaction, Injection site urticaria, Rash erythematous
Clinical narrative: Patient was given vaccines at one year old appointment. Patient received in the left thigh, Hepatitis A(im) and MMR(sc)/ and in the right thigh, PCV20(im) and varicella (sc). Within minutes after receiving vaccine in the right thigh, around the injection site of the varicella injection, patient developed a bright red rash and then a hive.  Ice was applied to affected area, benadryl was given per doctor orders. Patient was observed in the office for 30 minutes after reaction. Referral to allergy and immunology was entered, epi pen sent in
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Auscultation, Dizziness, Dyspnoea, Wheezing
Clinical narrative: PT vaccinated at 1020 am at a school vaccine clinic hosted by local health dept and school nurses.  PT was very anxious, but all 3 vaccines administered and wait time completed with no reports of problems.  At 1052, PT returned to clinic from class w/complaints of shortness of breath and dizziness.  BP taken- was 138/82, but pt reported SOB was improving.  At 1110, pt taken to school clinic- vitals taken :98/73, O2 sats 99%, HR 115, insp/expiratory wheezes noted upon auscultation.  Pt reports no hx of asthma.  Two puffs of Albuterol administered with some relief.  At 1115, vitals were 140/71, HR 110, O2 sats 99%.  At 1117, pt reports feeling better- 2 more puffs Albuterol administered, and pt sipping water.  No dizziness reported anymore.  Lungs clearing.  At 1134, lungs continue to improve- only slight inspirational wheezing.  O2 sats 99%, HR 96, BP 123/70.  At 1200, PT went home with parents.
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product administration error
Clinical narrative: Infant received Tdap in error. Provider was notified by RN. No adverse reactions noted.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV5
Symptoms: Infantile vomiting, Lethargy
Clinical narrative: Mom called at 16:23 on 5/15/2024 and reported 6 episodes of mild vomiting. Per mom, patient seemed to be "Lethargic." No fever per mom when called nurse triage after hours. No injection site redness or swelling from vaccine given in legs.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Cov-19 Breakthrough Infection
Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Extra dose administered
Clinical narrative: Inadvertent dose of flu vaccine given on 03/27/2024 but was already given this season's flu vaccine on 10/27/2023.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Wrong product administered
Clinical narrative: The patient received a Shingrix shot, but he wanted to receive a Comirnaty covid shot. Patient did not experience any adverse effects from the shot.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Inadvertent seasonal flu dose given on 03/27/2024, because patient had already received their seasonal flu dose on 10/27/2023.
Age: 40.0
Sex: F
Vaccine: MMR, MNQ
Symptoms: Diarrhoea, Fatigue, Headache, Lymph node pain, Lymphadenopathy
Clinical narrative: The day after vaccination (Tuesday) I had a terrible headache. By Tuesday night, the lymph node in my left arm pit was swollen and sore. Wednesday morning I became very nauseous and had diarrhea. I also had/have fatigue and body aches. No fever.
Age: 40.0
Sex: F
Vaccine: MMR, MNQ
Symptoms: Nausea, Pain
Clinical narrative: The day after vaccination (Tuesday) I had a terrible headache. By Tuesday night, the lymph node in my left arm pit was swollen and sore. Wednesday morning I became very nauseous and had diarrhea. I also had/have fatigue and body aches. No fever.
Age: 54.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Induration, Injection site erythema, Injection site induration, Injection site irritation
Clinical narrative: about 2 inch down from injection site, it started with small round spot that was hard. As the days progressed the spot got larger and became irriated and itchy. It spread to the middle part of my forearm. It itchy, red and swollen. Emergency room: keefle 500 mg capsle and atarvx 25mg.