chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Salivary gland disorder, Throat irritation, Tinnitus, Tongue discolouration, Tongue discomfort
Clinical narrative: Woke up with intense chronic pain throughout/adjacent to digestive tract, chest, neck, abdomen, lower back, colon & groin area/penis; burning mouth/tongue/throat with canker sores and discolored lingual papillae, total salivary gland dysfunction for months to a year, esophageal inflammation w/ sphincter dysfunction for over a year, intestinal/colon inflammation for months to a year, diarrhea, indigestion, lost 50 lbs in 4 weeks, permanent increased difficulty urinating, mild peripheral neuropathy in both forearms for months, excessive orthostatic tachycardia for over a year, constant headache for months, permanent onset of tinnitus in both ears
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: Woke up with intense chronic pain throughout/adjacent to digestive tract, chest, neck, abdomen, lower back, colon & groin area/penis; burning mouth/tongue/throat with canker sores and discolored lingual papillae, total salivary gland dysfunction for months to a year, esophageal inflammation w/ sphincter dysfunction for over a year, intestinal/colon inflammation for months to a year, diarrhea, indigestion, lost 50 lbs in 4 weeks, permanent increased difficulty urinating, mild peripheral neuropathy in both forearms for months, excessive orthostatic tachycardia for over a year, constant headache for months, permanent onset of tinnitus in both ears
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Calcium ionised decreased, Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Patient complains of warm, itchy, painful, 2-3 inches in diameter red spot at the site of the injection. On 09/18/2024 patient still had painful sensation at the injection site. Patient complained of loss of range of motion in both shoulders
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Joint range of motion decreased
Clinical narrative: Patient complains of warm, itchy, painful, 2-3 inches in diameter red spot at the site of the injection. On 09/18/2024 patient still had painful sensation at the injection site. Patient complained of loss of range of motion in both shoulders
Age: 87.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient requested an RSV vaccine and was administered the vaccine without problem. The next day, it was discovered by internal clinical team that she had already received this same vaccine in November of 2023. Patient was contacted and reported that she was not experiencing any adverse effects. Patient was advised to contact us and let us know if they do experience any adverse effects going forward.
Age: 74.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient received 2 doses of Arexvy dating 11/21/23 and 12/30/24
Age: 70.0
Sex: M
Vaccine: UNK
Symptoms: Nodule, Pain in extremity
Clinical narrative: PROLONGED LUMP IN ARM CREATING ONGOING PAIN. MAY OR MAY NOT BE RELATED TO VACCINATION.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Patient has body ache, fever and headache for 24 hr after the day vaccine was given. Patient took Ibuprofen and got better.
Age: 74.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient was given 2 doses of Arexvy dating 11/21/23 and 12/30/24
Age: 81.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No side effects, adverse event is that we administered a second dose when CDC guide lines recommend one.
Age: 6.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP called to report TE on PROQUAD. HCP stated that the PROQUAD was stored in the refrigerator and administered to multiple patients. Original AE 02722046 filed on 12/13/2024. At the time of the original report (12/13/2024), patient information was n; This spontaneous report has been received from a health care professional, referring a 6-year-old patient of unknown gender. The patient's medical history, previous adverse drug reactions, drug allergy, concurrent conditions, and concomitant medication were not provided.   On 10-DEC-2024, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA) (PROQUAD) injection (strength, dose, frequency, route of administration, site of administration, and vaccination scheme were not provided; lot # Y002099 which has been verified to be a valid number, expiration date reported and validated as 09-JUL-2025) as a prophylaxis; which experienced a temperature excursion before administration (product storage error). However, no signs or symptoms were reported.; Sender's Comments:  US-009507513-2412USA006216:
Age: 6.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP called to report TE on PROQUAD. HCP stated that the PROQUAD was stored in the refrigerator and administered to multiple patients. Original AE 02722046 filed on 12/13/2024. At the time of the original report (12/13/2024), patient information was n; This spontaneous report has been received from a health care professional, referring a 6-year-old patient of unknown gender. The patient's medical history, previous adverse drug reactions, drug allergy, concurrent conditions, and concomitant medication were not provided.   On 29-AUG-2024, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA) (PROQUAD) injection (strength, dose, frequency, route of administration, site of administration, and vaccination scheme were not provided; lot # Y002099 which has been verified to be a valid number, expiration date reported and validated as 09-JUL-2025) as a prophylaxis; which experienced a temperature excursion before administration (product storage error). However, no signs or symptoms were reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2412USA006100: US-009507513-2412USA006311: US-009507513-2412USA005703: US-009507513-2412USA006214:
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs; expired PNEUMOVAX 23 vaccine was administered; This spontaneous report was received from medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 17-OCT-2024, the patient was vaccinated with expired dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, 0.5 ml, valid lot #X014729, expiration date: 22-NOV-2024, administered intermuscularly for prophylaxis (strength was not provided). No other information provided.  No additional adverse events (AEs) were reported.
Age: 7.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vaccine administered on 31-MAY-2012 and 15-APR-2014; This spontaneous report has been received from lawyer and via Immunization Records from a case in litigation for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (2409USA010187), concerning a currently 20-year-old female patient. Information regarding the patient's concurrent conditions, concomitant therapies or medical history provided were captured in 2409USA010187.  On 31-MAY-2012, the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated (manufacturer unknown) (reported as Hep A, ped/adol, 2 dose) lot #1586AA and expiration date not reported upon internal review established as 08-AUG-2014 (formulation, dose, route of administration and vaccination site were not provided) administered for prophylaxis.  On 15-APR-2014, he was vaccinated with the second dose of hepatitis a vaccine, inactivated (manufacturer unknown) (reported as Hep A, ped/adol, 2 dose), lot # J005713 and expiration date not reported upon internal review established as 25-OCT-2015 (formulation, dose, route of administration and vaccination site were not provided) administered for prophylaxis (inappropriate schedule of product administration).; Sender's Comments:  US-009507513-2409USA010187: US-009507513-2412USA009782:
Age: 0.17
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vaccine administered on 07-DEC-2004, 01-MAR-2005 and 21-NOV-2005; Vaccine administered on 07-DEC-2004, 01-MAR-2005 and 21-NOV-2005; This spontaneous report has been received from lawyer and via Immunization Records from a case in litigation for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (2409USA010187), concerning a currently 20-year-old female patient. Information regarding the patient's concurrent conditions, concomitant therapies or medical history provided were captured in 2409USA010187.  On 07-DEC-2004, the patient was vaccinated with the first dose of hepatitis b vaccine (recombinant) (manufacturer unknown) (reported as Hep b, adolescent or pediatric) administered for prophylaxis (formulation, strength, lot #, expiry date, and route of administration were not provided).  On 01-MAR-2005, the patient was vaccinated with the second dose of hepatitis b vaccine (recombinant) (manufacturer unknown) (reported as Hep b, adolescent or pediatric) administered for prophylaxis (formulation, strength, lot #, expiry date, and route of administration were not provided) (inappropriate schedule of product administration).  On 21-NOV-2005, the patient was vaccinated with the third dose of hepatitis b vaccine (recombinant) (manufacturer unknown) (reported as Hep b, adolescent or pediatric) administered for prophylaxis (formulation, strength, lot #, expiry date, and route of administration were not provided) (inappropriate schedule of product administration).  This is one of the few reports concerning the same patient.; Sender's Comments:  US-009507513-2412USA009781: US-009507513-2409USA010187:
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Hypersensitivity, Pyrexia, Rash
Clinical narrative: Allergic reaction; Rash; Fever; Chills; This non-serious case was reported by a consumer via patient support programs and described the occurrence of allergic reaction in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included blood pressure abnormal (takes blood pressure medications). Concomitant products included cholesterol and calcium.   On 01-FEB-2023, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced allergic reaction (Verbatim: Allergic reaction), rash (Verbatim: Rash), fever (Verbatim: Fever) and chills (Verbatim: Chills). The outcome of the allergic reaction was unknown and the outcome of the rash, fever and chills were not reported.   It was unknown if the reporter considered the allergic reaction, rash, fever and chills to be related to Shingrix.     It was unknown if the company considered the allergic reaction, rash, fever and chills to be related to Shingrix.   Additional Information: GSK Receipt Date: 02-DEC-2024 The patient was taking blood pressure medications, cholesterol, antidepressants, calcium supplement. The patient took 1st dose of Shingrix vaccine, and got very sick from the vaccine and experienced rash, fever and chills. The patient also experienced as allergic reaction.
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Product storage error
Clinical narrative: Incorrect storage of drug; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 19-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number NR394, expiry date JUL-2025) for prophylaxis.   On 28-AUG-2024, the patient received the 1st dose of Menveo (intramuscular, right deltoid). On an unknown date, an unknown time after receiving Menveo, the patient experienced incorrect storage of drug (Verbatim: Incorrect storage of drug). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 02-DEC-2024 The patient received Menveo vaccine after temperature excursion, which led to incorrect storage of drug. This was 1 of 15 linked report, reported by same reporter.; Sender's Comments:  US-GSK-US2024123268:Same reporter US-GSK-US2024123266:Same reporter
Age: 2.0
Sex: U
Vaccine: DTAP
Symptoms: Product storage error
Clinical narrative: Incorrect storage of drug; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 2-year-old patient who received DTPa (Infanrix) (batch number 9R2D7, expiry date MAY-2025) for prophylaxis.   Additional patient notes included (redacted).   On 19-AUG-2024, the patient received the 2nd dose of Infanrix (intramuscular, right thigh). On an unknown date, an unknown time after receiving Infanrix, the patient experienced incorrect storage of drug (Verbatim: Incorrect storage of drug). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 02-DEC-2024 The patient received Infanrix vaccine after temperature excursion, which led to incorrect storage of drug. This was 1 of 17 linked report, reported by same reporter; Sender's Comments:  US-GSK-US2024123268:Same reporter US-GSK-US2024123266:Same reporter
Age: 0.58
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Underage administration; vaccine that should have been received was Flulaval; Underdose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-month-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number CX4HL, expiry date 09-NOV-2026) for prophylaxis.   Co-suspect products included Flu Seasonal TIV Quebec (Flulaval) for prophylaxis.   Previously administered products included Pediarix (Patient received 1st dose of Pediarix in the past on unknown date.) and Pediarix (Patient received 2nd dose of Pediarix in the past on unknown date.).   On 02-DEC-2024, the patient received the 1st dose of Boostrix. On an unknown date, the patient received Flulaval. On 02-DEC-2024, an unknown time after receiving Boostrix and not applicable after receiving Flulaval, the patient experienced inappropriate age at vaccine administration (Verbatim: Underage administration), wrong vaccine administered (Verbatim: vaccine that should have been received was Flulaval) and underdose (Verbatim: Underdose). The outcome of the inappropriate age at vaccine administration, wrong vaccine administered and underdose 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: 02-DEC-2024 Other HCP reported that a 7 months old received on the day of reporting a dose of Boostrix which led to inappropriate age at vaccine administration, and underdose when the vaccine that should have been received was Flulaval which led to wrong vaccine administered. Patient received 2 Pediarix doses in the past.
Age: 83.0
Sex: F
Vaccine: RSV
Symptoms: Incorrect route of product administration
Clinical narrative: Arexvy administered via subcutaneous route; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 83-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 5J959, expiry date 25-OCT-2025) for prophylaxis.   On 04-DEC-2024, the patient received Arexvy (subcutaneous). On 04-DEC-2024, an unknown time after receiving Arexvy, the patient experienced intramuscular formulation administered by other route (Verbatim: Arexvy administered via subcutaneous route). The outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK Receipt Date: 04-DEC-2024 Pharmacist reported Arexvy administered via subcutaneous route to a patient in a nursing facility, which led to Intramuscular formulation administered by other route. The reporter consented for follow-up.
Age: 9.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: inadvertently administered adult dose of Havrix to a pediatric; administered adult dose of Havrix to a pediatric; This non-serious case was reported by a nurse via call center representative and described the occurrence of accidental overdose in a 9-year-old female patient who received HAV (Havrix 1440 adult) (batch number T9TL9, expiry date 05-DEC-2025) for prophylaxis.   On 30-SEP-2024, the patient received the 1st dose of Havrix 1440 adult. On 30-SEP-2024, an unknown time after receiving Havrix 1440 adult, the patient experienced accidental overdose (Verbatim: inadvertently administered adult dose of Havrix to a pediatric) and adult product administered to child (Verbatim: administered adult dose of Havrix to a pediatric). The outcome of the accidental overdose and adult product administered to child 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-DEC-2024 The licensed practical nurse reported that she inadvertently administered an adult dose of Havrix to a pediatric patient, which led to accidental overdose and adult product administered to child. This was the patient's first dose in the series and reported no issues.
Age: 89.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: An Arexvy vaccine was given twice; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 89-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number JP329) for prophylaxis.   Previously administered products included Arexvy (1st dose of vaccine was received on 15th November 2023).   On 10-DEC-2024, the patient received the 2nd dose of Arexvy. On 10-DEC-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: An Arexvy vaccine was given twice). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 10-DEC-2024 Report called to report that an Arexvy vaccine was given twice. 1st dose was given on 15th November 2023 and 2nd dose was given on 10th December 2024. Patient had not an actual reaction. Reporter consented to follow up. Upon callback to reporter, she stated that the patient had no signs or symptoms as of 10th December evening 2 hours or less after administration of the second dose of Arexvy.  She had not yet followed up with the patient as of 11th December 2024. Arexvy was administered 2 times for the patient, which led to Extra dose administered.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: never received a second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose in 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: never received a second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 11-DEC-2024 The pharmacist reported that a patient received the first dose of Shingrix and never received a second dose. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: hasn't received a second dose yet; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 06-JAN-2023).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: hasn't received a second dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 24-DEC-2024 The nurse calls reported that a patient received a first dose of Shingrix and had not received a second dose yet.  The patient wanted to receive the second dose and reporter asked to make clinical decision on how to proceed. The Vaccine Administration Facility was the same as Primary Reporter. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Lung neoplasm malignant, Underdose, Wrong product administered
Clinical narrative: lung cancer; Vaccine underdose; Wrong vaccine administered; This spontaneous case was reported by a patient family member or friend and describes the occurrence of LUNG NEOPLASM MALIGNANT (lung cancer) in a 73-year-old female patient who received mRNA-1273.712 (MODERNA COVID-19 VACCINE 2024-2025 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.712 (MODERNA COVID-19 VACCINE 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced LUNG NEOPLASM MALIGNANT (lung cancer) (seriousness criterion medically significant), UNDERDOSE (Vaccine underdose) and WRONG PRODUCT ADMINISTERED (Wrong vaccine administered). At the time of the report, LUNG NEOPLASM MALIGNANT (lung cancer) was resolving and UNDERDOSE (Vaccine underdose) and WRONG PRODUCT ADMINISTERED (Wrong vaccine administered) outcome was unknown.        The action taken with mRNA-1273.712 (MODERNA COVID-19 VACCINE 2024-2025 PFS) (Intramuscular use) was unknown.       Concomitant medication and treatment information were not reported.  Patient had lung cancer. She was on a high volume of liters of oxygen and was recovering. She had taken all the vaccines. She's up to date with all the vaccines. She had taken a lot of vaccines more than the usual throughout the course of COVID-19 up to now.  It was unknown if she experienced any additional symptoms/events.   This case was linked to MOD-2024-780221 (Patient Link).; Reporter's Comments: Company comment: Event of lung cancer is assessed as not related considering lack of biological plausibility for causality. The benefit-risk relationship of product is not affected by this report.
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness and pain at injection site; Redness and pain at injection site; This is a spontaneous report received from a Consumer or other non HCP.  An adult female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 16Dec2024 at 14:00 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 19Dec2024, outcome "recovering" and all described as "Redness and pain at injection site". Therapeutic measures were taken as a result of vaccination site erythema, vaccination site pain.  Additional information: Redness and pain at injection site and extending beyond injection site. 4in by 3in red rectangle. Nurse advised ibuprofen, ice, and Benadryl as a treatment. The patient did not receive any other vaccines on the same date as the suspect vaccine and did not receive any other vaccines within 4 weeks prior to suspect vaccine. The patient was taking any other medications (unspecified) within 2 weeks of the event starting. The patient had no known allergies No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 73.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Blood glucose, Blood glucose fluctuation, Rash pruritic
Clinical narrative: I developed itchy rash on my right and left legs. This is the first time I developed rash after Pfizer vaccine.; I noticed temporary elevation of my blood sugar; This is a spontaneous report received from a Consumer or other non HCP.  A 73-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 19Dec2024 as dose 1, single (Batch/Lot number: unknown) at the age of 73 years, in left deltoid for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 19Dec2024 as dose number unknown, single), in left arm for immunisation. The patient's relevant medical history included: "mild hypertension" (ongoing); "Allergy penicillin" (unspecified if ongoing); "Allergy raw blue fish" (unspecified if ongoing); "prediabetic" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), for Covid-19 immunization. The following information was reported: BLOOD GLUCOSE FLUCTUATION (non-serious) with onset 20Dec2024, outcome "unknown", described as "I noticed temporary elevation of my blood sugar"; RASH PRURITIC (non-serious) with onset 20Dec2024 at 04:00, outcome "not recovered", described as "I developed itchy rash on my right and left legs. This is the first time I developed rash after Pfizer vaccine.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of rash pruritic.  Additional information: The patient reported developing an itchy rash on both their right and left legs, noting that this was the first time they had experienced a rash after receiving the Pfizer vaccine, despite having received multiple previous doses of the Pfizer vaccine. They inquired about any differences in the vaccine's ingredients. Additionally, the patient mentioned noticed temporary elevation in their blood sugar levels, with the reading on the 20th increasing to 130, on the 21st reaching 117, and today decreasing to 107. The patient is prediabetic, not on medication, but maintains a healthy diet and exercises for at least two hours daily. After reviewing publications, they noted that temporary increases in blood glucose have been reported following vaccination.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Atrioventricular block, Myocardial infarction
Clinical narrative: major myocardial infarction; 99% blocked on right side of heart; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, 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: MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "major myocardial infarction"; ATRIOVENTRICULAR BLOCK (non-serious), outcome "not recovered", described as "99% blocked on right side of heart". Therapeutic measures were taken as a result of myocardial infarction. The patient experienced major myocardial infarction after covid vaccine. Currently 99% blocked on right side of heart with 5 stents in the left.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400167892 same reporter/ product, different patient/ events;
Sex: M
Vaccine: COVID19
Symptoms: Illness, Myocarditis
Clinical narrative: her son was sick and the MD thought it was myocarditis; sick; This is a spontaneous report received from a Consumer or other non HCP.  An adult male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, 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: MYOCARDITIS (medically significant), outcome "unknown", described as "her son was sick and the MD thought it was myocarditis"; ILLNESS (non-serious), outcome "unknown", described as "sick". It was unknown if therapeutic measures were taken as a result of myocarditis, illness.  Clinical Course: It was unknown if other vaccines were received from the same date, or if other vaccine received in four weeks and unknown if other medications were taken in two weeks. Patient's mother stated her son was sick and the MD thought it was myocarditis due to the Covid Pfizer vaccine. Patient had no known allergies.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Mast cell activation syndrome, Urticaria chronic
Clinical narrative: mcas; chronic urticaria; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A patient (age and gender not provided) received BNT162b2 (BNT162B2), on 24Aug2021 as dose 2, single (Lot number: fc3182) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Lot: fc3130), administration date: 02Aug2021, for Covid-19 immunization. The following information was reported: MAST CELL ACTIVATION SYNDROME (medically significant), outcome "unknown", described as "mcas"; URTICARIA CHRONIC (non-serious), outcome "unknown", described as "chronic urticaria".
Sex: F
Vaccine: PNC20
Symptoms: Malaise
Clinical narrative: got very sick; This is a spontaneous report received from an Other HCP, Program ID.  A 65-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in Jan2024 as dose number unknown, 0.5ml single (Batch/Lot number: unknown) intramuscular for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "got very sick". The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Age: 72.0
Sex: M
Vaccine: COVID19, PNC20
Symptoms: Asthenia, Sluggishness
Clinical narrative: he feels very blah, no energy; sluggish; This is a spontaneous report received from an Other HCP, Program ID.  A 72-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 as dose number unknown, 30 ug single (Batch/Lot number: unknown) at the age of 72 years intramuscular for covid-19 immunisation; pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in Sep2023 as dose number unknown, 0.3ml single (Batch/Lot number: unknown) at the age of 72 years intramuscular for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ASTHENIA (non-serious) with onset 2023, outcome "unknown", described as "he feels very blah, no energy"; SLUGGISHNESS (non-serious) with onset 2023, outcome "unknown", described as "sluggish".  Additional information: patient reports when he receives the vaccine the next day he feels very blah, no energy, and sluggish. no further information provided. lot number and expiration date are unknown.  The information on the batch/lot number for BNT162b2 omi xbb.1.5, pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: he experienced really bad joint pain; This is a spontaneous report received from an Other HCP, Program ID.  A 62-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Nov2023 as dose 1, 30 ug single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "he experienced really bad joint pain". The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.  Additional information: Patient reports after receiving the vaccine he experienced really bad joint pain a few weeks after getting the vaccine and lasts about 3 months afterwards. MD was aware.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Pain in extremity, Vaccination failure
Clinical narrative: sore arm; they had covid in Aug2024; they had covid in Aug2024; This is a spontaneous report received from an Other HCP, Program ID. The reporter is the Patient.  A 66-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, 0.3 ml single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2024, outcome "unknown" and all described as "they had covid in Aug2024"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm". The patient reported that the last time they had the covid vaccine they had a sore arm after the injection. They also reported that they had covid in Aug2024.  The information on the batch/lot number for [BNT162B2 OMI XBB.1.5] will be requested and submitted if and when received.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162b2 omi xbb.1.5 in this patient cannot be completely excluded.
Age: 31.0
Sex: F
Vaccine: UNK
Symptoms: Injection site bruising, Injection site thrombosis
Clinical narrative: some clotting developed at injection site; Post administration of vaccine- bruising; Initial information received on 19-Dec-2024 regarding an unsolicited valid serious case received from a consumer/non-healthcare professional.  This case involves a 31 years old female patient who post administration of vaccine- bruising and some clotting developed at injection site after receiving Influenza trivalent recombinant vaccine [Flublok TIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 14-Dec-2024, the patient received 1 DF (dosage form) dose of suspect influenza trivalent recombinant vaccine Solution for injection lot number not reported via intramuscular route in unknown administration site (route, strength and expiration date: not provided) for Vaccination against flu (Influenza immunisation).  Information regarding batch number and expiration date corresponding to the one at a time of event occurrence was requested.  On 14-Dec-2024 the patient post administration of vaccine- bruising (vaccination site bruising) and some clotting developed at injection site (Injection site thrombosis) (latency- same day)  Action taken- not applicable.  No corrective treatment was received for the event (Post administration of vaccine- bruising).  It was not reported if the patient received a corrective treatment for the event (some clotting developed at injection site).  At time of reporting, the outcome was Recovering / Resolving for vaccination site bruising and unknown for Injection site thrombosis.  Seriousness criteria- Medically significant for Injection site thrombosis.; Sender's Comments: Sanofi Company Comment dated 31-Dec-2024: This case involves a 31 years old female patient who post administration of vaccine- bruising and some clotting developed at injection site after receiving Influenza trivalent recombinant vaccine [Flublok TIV]. The causal role of the company suspect vaccine cannot be assessed based on the temporal relevance. Further information regarding concurrent condition during vaccination, previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.
Sex: M
Vaccine: FLUX
Symptoms: Cough, Influenza, Oropharyngeal pain
Clinical narrative: Flu; sore throat; terrible cough; Initial information received on 29-Dec-2024 regarding an unsolicited valid Social Media non-serious case received from a patient.  This case involves Adult male patient who experienced flu after receiving Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer Solution for Injection (lot number, strength, dose and expiry not reported) via Subcutaneous route in unknown administration site as prophylactic vaccination.  On an unknown date the patient developed new strain of flu (influenza) with sore throat (oropharyngeal pain) and terrible cough (cough) (unknown latency) following the administration of Influenza Vaccine.  Reportedly, New strain comes with a terrible cough to a sore throat. Can also lead to pneumonia...be ware.      Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the event.
Age: 5.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: inappropriate use/medication error because ADACEL was given to a 5-year-old patient instead of DAPTACEL with no reported adverse event; Initial information received on 20-Dec-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 5 years old female patient who had inappropriate use of Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel] was given to patient instead of Diphtheria-15/Tetanus/5 AC Pertussis Vaccine [Daptacel] 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 a vaccine inact (Hep a in vac) for Immunisation.  On an unknown date, the patient received a 0.5 ml dose of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine suspension for injection (strength; standard, lot number: U7898AA and expiry date: 19-Sep-2025)  via intramuscular route in the right thigh as immunization instead of daptacel with no reported adverse event (wrong product administered) (same day latency).   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: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Temperature reached (max/low): 8.7 degrees Celsius(max), 4.5 degrees Celsius (min) with no reported adverse event; IPOL was administered post excursion, no reported adverse event; Initial information received on 26-Dec-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who received IPV (VERO) [IPOL] post excursion, no reported adverse event and temperature reached (max/low): 8.7 degrees celsius(max), 4.5 degrees celsius (min) with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Punctured IPV (VERO) (15-Dec-2024),temperature reached (max/low): 8.7 degrees celsius(max), 4.5 degrees celsius (min) with no reported adverse event (product storage error).    On an unknown date, the patient received a dose of suspect IPV (VERO), suspension for injection (lot X1C891M and expiry 31-Oct-2026) (strength and dose: unknown) post excursion, no reported adverse event (poor quality product administered) (latency same day)  via unknown route in unknown administration site for prophylactic vaccination.  Reportedly:- Pharmacist was conducting inventory and the door maybe open for a little too long\"Human error: Yes.The stability of punctured MDVs and or prepared IPOL outside the recommended storage conditions has not been evaluated. She then asked whether it is viable. Reiterated the information to her and added that it will be their clinical decision to use it or not. She concurred and said whether they should call the patient to ask if they are going to get another dose or not. Informed her that that will be their clinical decision. She concurred.This is reported as AE as the stability of punctured Ipol MDV has not been evaluated and the product was administered after the temperature excursion.   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: 13.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 13-year-old patient received a dose of FLUZONE HD, with no reported adverse event; Initial information received on 27-Dec-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 13 years old female patient who had received a dose of Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s),concomitant medications and family history were not provided.   On 26-Dec-2024, the patient received a  dose of 0.7 ml of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine (Suspension for injection in pre-filled syringe) lot U8519BA, Expiry date: 01-Jun-2025, strength was unknown via intramuscular route in the right arm for Immunization and 13-year-old patient received a dose of fluzone hd, with no reported adverse event (product administered to patient of inappropriate age) (latency : same day).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: gave a diluent of the Pentacel shot, and did not mix it with the powder with no reported adverse event; Initial information received on 27-Dec-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 1 years old female patient who got a diluent of the diphtheria/tetanus/5 hybrid ac pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] shot, and did not mix it with the powder 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 Varicella zoster vaccine (Varicella vaccine) and measles vaccine, mumps vaccine, rubella vaccine (MMR) for Immunisation.  On 20-Dec-2024, the patient received 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine Suspension for injection (strength- standard) once (lot- UK046AA and expiry- 31-Aug-2025) via intramuscular route in the left vastus lateralis for Immunisation and patient got a diluent of the pentacel shot, and did not mix it with the powder with no reported adverse event (single component of a two-component product administered) (latency- same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Dysstasia, Head injury, Loss of consciousness, Presyncope
Clinical narrative: Patient attempted to stand about 5 minutes after vaccine administration. Claims he "got dizzy and passed out". He struck the back of his head on both a table and the floor.  Pt was negative for s/sx of anaphylaxis. He regained consciousness almost immediately. EMS was called to further assess and clear patient. It was determined it was most likely related to a vasovagal response to the vaccination. Pt denied previous history of vaccine reaction. EMS cleared pt and instructed him to report for further evaluation if any new symptoms presented.
Age: 82.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no se. AE- gave pt second dose when CDC recommends only one
Age: 22.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy
Clinical narrative: medication given to pregnant
Age: 79.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: The patient received the vaccine 01/29/2024 and then requested the same vaccine 12/19/24. And received the vaccine again. No ill adverse events reported by patient.
Age: 40.0
Sex: F
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient given MMRV an d Varicella  today, patient notified, no symptoms or signs.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Mobility decreased, Pain
Clinical narrative: I expected soreness and stiffness since I?ve gotten this vaccine before. However, while lessened from what it originally was, I am still experiencing pain and limited mobility. I was using multiple Motrin per day as well as cold compresses for two weeks before I saw minimal improvement.
Age: 61.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Extra dose administered
Clinical narrative: Administration error. Patient received two flu shots two months apart.
Age: 23.0
Sex: F
Vaccine: MMR
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was given this live vaccine when last live vaccine was only 14 days previous. Live vaccines should be given 28 days apart