chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Vaccine: MMR
Symptoms: Pyrexia, Rash, Rash maculo-papular, Rhinorrhoea, SARS-CoV-2 test negative
Clinical narrative: measles-like symptoms following vaccination; This spontaneous report was received from a consumer regarding a child patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.   On 23-APR-2025, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), 0.5 mL administered intramuscularly as prophylaxis (lot number reported as 4015995, which is an invalid lot number for this product, expiration date reported as 24-SEP-2026) (vaccination scheme and anatomical site of injection were not reported). The vaccine was reconstituted with sterile diluent (BAXTER STERILE DILUENT) (lot # and expiration date were not reported).  On 01-MAY-2025, the patient started to experience unusually severe measles-like symptoms (Measles) following the vaccination, such as runny nose and cough. On 04-MAY-2025, the patient experienced maculopapular rash covering most of the body. On 05-MAY-2025, the patient experienced 102 Fahrenheit degree (F) fever. On an unknown date in 2025, the patient tested negative for COVID and flu, and polymerase chain reaction (PCR) showed +. MeVa test result was pending. The outcome of measles-like symptoms was unknown.   The causal relationship between the event and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) was not reported.
Age: 13.0
Sex: M
Vaccine: HPV9, MMR, MMR
Symptoms: Dyspnoea, Urticaria
Clinical narrative: shortness of breath; hives; This spontaneous report was received from a consumer via Company representative, concerning their child as a currently 15-year-old male patient.   The patient's medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported.   On approximately 2023 (reported as "at age 13"), the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) dose number 1, 0.5 mL administered by intramuscular (IM) route (lot #, expiration date and anatomical location were not reported); and on the same date with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), 0.5 mL (dosage regimen, lot #, expiration date, anatomical location and route of administration were not reported) which was diluted with sterile diluent, 0.5 mL (expiration date, and lot # were not reported). Both vaccines were administered as prophylaxis.  On an unknown date, after receiving his first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), shortness of breath (dyspnoea) and hives (urticaria.)   The patient recovered from the events on an unspecified date.  The causal relationship between dyspnoea, urticaria and the suspect vaccines/sterile diluent was not provided.   Lot # is being requested and will be submitted if received.
Vaccine: HPV9, HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE; stated patient is scheduled to receive third dose on 5/16/2025; patient received the 2 dose of GARDASIL 9 doses outside of the schedule regimen within the Prescribing Information on 17-JAN-2025; This spontaneous report was received from a pharmacist on 16-MAY-2025 and refers to a patient of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 20-MAR-2024, the patient was vaccinated with a first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), (lot #, expiration date, dose, anatomical location and route of administration were not mentioned) for prophylaxis.  On 17-JAN-2025, the patient received the second dose of with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) outside of schedule regimen within the Prescribing Information (lot #, expiration date, dose, anatomical location and route of administration were not mentioned) for prophylaxis (Inappropriate schedule of product administration). Reporter stated patient was scheduled to receive third dose on 16-MAY-2025 (Inappropriate schedule of product administration).  No additional adverse event reported.  Lot # is being requested and will be submitted if received.
Sex: M
Vaccine: MMR
Symptoms: Morbillivirus test positive
Clinical narrative: Measles PCR+; This spontaneous report was received from an unspecified health care professional on 16-MAY-2025 and refers to a Child male patient.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 29-APR-2025, the patient was vaccinated with a first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (Batch/Lot number 4015995 is an invalid batch/lot number for Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live , expiration date reported as  24-SEP-2026), (dose, frequency, anatomical location, and route of administration were not reported) and with a first dose of sterile diluent (MERCK STERILE DILUENT), (dose, frequency, anatomical location, route of administration, lot#, expiration date and indication were not reported) for prophylaxis at Clinic.  On 10-MAY-2025, the patient presented to the emergency department with fever, rash, wheezing, and cough, and was confirmed measles Polymerase Chain Reaction (PCR) positive, on 15-MAY-2015 (Measles). They would submit the specimen for  Measles Virus Genotype A Realtime -qPCR (MeVA) testing to confirm it is vaccine strain as soon as the specimen arrived at their state lab."  At the reporting time, the outcome of Measles was unknown.   The reporter considered the event unknown to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and sterile diluent (MERCK STERILE DILUENT).  Lot # will be requested and will be submitted if received.  This is one of several reports from the same source.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Shingles; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included blood pressure high and blood cholesterol increased. Concomitant products included atenolol, losartan, simvastatin and acetylsalicylic acid (Aspirin).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles). The patient was treated with aciclovir sodium (Acyclovir) and bentonite, calamine, phenol, zinc oxide (Calamine). The outcome of the shingles was resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 15-MAY-2025 The reporter was the patient who received 2 doses of Shingrix last year.  2 days after each dose, she experienced a rash on her right buttock that was diagnosed as shingles.  It was the size of a silver dollar and in both instances, the rash was in the same spot.  It did not get bigger or spread.  Her doctor prescribed acyclovir 400 mg and the rash went away after 1 or 2 weeks.  She also applied calamine lotion to the rash in addition to taking acyclovir. For tolerance of 2nd dose of Shingrix, refer case US2025AMR060778.; Sender's Comments:  US-GSK-US2025AMR060778:same patient/Dose 2
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine inappropriate age administration; of 4 months old instead of the correct age vaccine and this was supposed to be the second dose in the DTaP series; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number Y49BZ, expiry date 17-MAY-2026) for prophylaxis.   On 15-MAY-2025, the patient received the 2nd dose of Kinrix. On 15-MAY-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Vaccine inappropriate age administration) and inappropriate schedule of vaccine administered (Verbatim: of 4 months old instead of the correct age vaccine and this was supposed to be the second dose in the DTaP series). The outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were not applicable.   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:15-MAY-2025 The reporter called to inform that a Kinrix vaccine dose was administered to a female patient of 4 months old instead of the correct age vaccine and this was supposed to be the second dose in the DTaP series, which led to inappropriate age at vaccine administration and inappropriate schedule of vaccine administered.  The reporter wanted to know how to proceed.  The Vaccine Administration Facility is the same as Primary Reporter. The reporter consented to follow up.
Sex: M
Vaccine: DTPPVHBHPB, PNC15, RV5
Symptoms: Incorrect route of product administration, Off label use
Clinical narrative: an inappropriate use due to VAXELIS being administered via the incorrect route/VAXELIS to a patient subcutaneous instead of intramuscular; This non-serious spontaneous safety report, with reference number 02733835 (interaction number: 02733830), was received by partner on 28-FEB-2025 and forwarded to UBC on 03-MAR-2025 from other health professional.  Off-label classification was added due to Vaxelis being administered via incorrect route.  Due to the nature of the event, the causality between the event 'an inappropriate use due to VAXELIS being administered via the incorrect route/VAXELIS to a patient subcutaneous instead of intramuscular' and Vaxelis was not applicable.  Further information is expected.  SIGNIFICANT FOLLOW-UP INFORMATION was received from a health professional on 28-MAR-2025.  Due to the nature of the event, the causality between the event 'an inappropriate use due to VAXELIS being administered via the incorrect route/VAXELIS to a patient subcutaneous instead of intramuscular' and Vaxelis was not applicable.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Needle issue, Underdose
Clinical narrative: Received less than the desired dose/needle came off of the syringe tip and some of the product was not administered; Received less than the desired dose/needle came off of the syringe tip and some of the product was not administered; Received less than the desired dose/needle came off of the syringe tip and some of the product was not administered; This non-serious spontaneous safety report, with reference number 02763066 (interaction number: 02763063), was received by partner on 03-MAR-2025 and forwarded on 04-MAR-2025 from other health professional. Additional information was received on 04-MAR-2025 by the partner and forwarded on 05-MAR-2025 from the other health professional.  Combination product classification was added as the event concerned the device part.  Due to the nature of the event, the causality between the event "6 month old female received less than the desired dose of VAXELIS. HCP states that during administration of the vaccine, the needle came off of the syringe tip and some of the product was not administered to the patient", and Vaxelis was not applicable.     Further information is expected.  Non-significant follow-up information was received by the partner on 04-MAR-2025 and forwarded on 10-MAR-2025, from other health professional. The case is maintained as non-serious.  Due to the nature of the event, the causality between the event "6 month old female received less than the desired dose of VAXELIS. HCP states that during administration of the vaccine, the needle came off of the syringe tip and some of the product was not administered to the patient", and Vaxelis was not applicable.     Further information is expected.
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Contusion, Erythema, Skin mass, Skin warm
Clinical narrative: lump under the skin; warm to the touch; lump under the skin and appears bruised.; The area became red; This non-serious spontaneous, Safety Report was received by partner, on 12-MAR-2025 and forwarded on 12-MAR-2025 from a consumer.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events; "lump under the skin" "warm to the touch"", lump under the skin and appears bruised"; and "The area became red".  Further information is expected.
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. VAXELIS was administered, no symptomatic events. Temperature: 47.5F Time frame: 0 hours 36 minutes 51 seconds; This non-serious spontaneous safety report, with reference number 02778163 (interaction number: 02777948), was received by partner on 27-MAR-2025 and forwarded on 28-MAR-2025 from other health professional.   Due to the nature of the event, the causality between the event 'HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. VAXELIS was administered, no symptomatic events. Temperature: 47.5F Time frame: 0 hours 36 minutes 51 seconds' and Vaxelis was not applicable.  This case shares the same event with the following companion cases: MCM-007744, MCM-007745, MCM-007746, MCM-007747, MCM-007748, MCM-007749, MCM-007750, MCM-007751, MCM-007752, MCM-007753, MCM-007754, MCM-007755, MCM-007757, MCM-007759, MCM-007760, MCM-007769, MCM-007770, MCM-007771.  Further information is expected.
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. HCP reported that VAXELIS and GARDASIL-9 were administered.; HCP confirmed that there were no symptomatic events; This non-serious spontaneous safety report, with reference number 02778139 (interaction number: 02777948), was received by partner on 27-MAR-2025 and forwarded on 28-MAR-2025 from other health professional.   Due to the nature of the event, the causality between the event 'HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. VAXELIS was administered, no symptomatic events. Temperature: 47.5F Time frame: 0 hours 36 minutes 51 seconds', 'HCP confirmed that there were no symptomatic events' and Vaxelis was not applicable.  This case shares the same event with the following companion cases: MCM-007744, MCM-007745, MCM-007746, MCM-007747, MCM-007748, MCM-007749, MCM-007750, MCM-007751, MCM-007752, MCM-007753, MCM-007754, MCM-007755, MCM-007756, MCM-007757, MCM-007759, MCM-007760, MCM-007769, MCM-007770.  Further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 67-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 08Apr2025 as dose 1, single (Lot number: MD3414) for covid-19 immunisation. The patient's relevant medical history included: "type 1 diabetic" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Moderna (DOSE NUMBER UNKNOWN (All of her COVID vaccines prior to Comirnaty were manufactured by Moderna)), for COVID-19 immunization.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2025, outcome "unknown" and all described as "COVID-19". It was reported on 20May2025 that the patient contracted COVID-19 the week prior. Therapeutic measures were taken as a result of vaccination failure, covid-19, which included nirmatrelvir, ritonavir (PAXLOVID).  No follow-up attempts are possible.
Vaccine: MENB
Symptoms: Product preparation error
Clinical narrative: Bexsero syringe  is not shaken immediately before use; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong technique in product usage process in a patient who received Men B NVS (Bexsero) (batch number DD72H, expiry date 30-NOV-2027) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced wrong technique in product usage process (Verbatim: Bexsero syringe  is not shaken immediately before use). The outcome of the wrong technique in product usage process was not applicable.   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: 15-MAY-2025 The medical assistant did not provided the details of the healthcare providers that prepare and administer the product. The Bexsero syringe was not shaken immediately before use which led to wrong technique in product usage.
Vaccine: VARZOS
Symptoms: Blood pressure increased
Clinical narrative: I experienced a rise with blood pressure with the first Shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of increased blood pressure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced increased blood pressure (Verbatim: I experienced a rise with blood pressure with the first Shingles). The outcome of the increased blood pressure was not reported.   It was unknown if the reporter considered the increased blood pressure to be related to Shingrix.     It was unknown if the company considered the increased blood pressure to be related to Shingrix.   Additional Information: GSK receipt date: 16-MAY-2025 Patient stated that they experienced a rise with blood pressure with the first Shingrix vaccine. Patient was hesitate to take the second shot.
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: severely red about the size of a baseball injection site; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In MAY-2025, the patient received Shingles vaccine. In MAY-2025, an unknown time after receiving Shingles vaccine, the patient experienced injection site erythema (Verbatim: severely red about the size of a baseball injection site). The outcome of the injection site erythema was not reported.   It was unknown if the reporter considered the injection site erythema to be related to Shingles vaccine.     It was unknown if the company considered the injection site erythema to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 16-MAY-2025 The case was received from the patient via (Shringrix GSK Chatbot) interactive digital media. The reporter got a shingle shot 3 days before reporting and it was red severely red about the size of a baseball injection site.
Sex: M
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Administration after a below temperature excursion of 29.9°F as the minimum reached; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 39LB7) and (batch number 2B723) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: Administration after a below temperature excursion of 29.9°F as the minimum reached). The outcome of the incorrect storage of drug was not applicable.   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: 15-MAY-2025 A registered nurse asked the recommendations after giving several vaccines that were exposed to a temperature excursion of 29.9 degree Fahrenheit as the lowest reached for Boostrix. The Vaccine Administration Facility was the same as Primary Reporter; Sender's Comments:  US-GSK-US2025061548:Same reporter,Different patient US-GSK-US2025061546:Same reporter,Different patient
Sex: F
Vaccine: TDAP
Symptoms: Incorrect dose administered
Clinical narrative: Administration after a below temperature excursion of 29.9 degree F as the minimum reached; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 39LB7) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: Administration after a below temperature excursion of 29.9 degree F as the minimum reached). The outcome of the incorrect storage of drug was not applicable.   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: 15-MAY-2025 Other HCP reported that after giving several vaccines that were exposed to a below temperature excursion of 29.9 degree F as the lowest reached for Boostrix, which led to incorrect storage of drug. This case is 1 of 3 cases reported by same reporter.; Sender's Comments:  US-GSK-US2025061548: US-GSK-US2025061546:Same reporter,Different patient
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Administration after a below temperature excursion of 29.9°F as the minimum reached; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a female patient who received Herpes zoster (Shingrix) (batch number M7G39) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: Administration after a below temperature excursion of 29.9°F as the minimum reached). The outcome of the incorrect storage of drug was not applicable.   Additional Information: GSK Receipt Date: 15-MAY-2025 A registered nurse asked the recommendations after giving several vaccines that were exposed to a temperature excursion of 29.9 degree Fahrenheit as the lowest reached for Shingrix. The Vaccine Administration Facility was the same as Primary Reporter; Sender's Comments:  US-GSK-US2025061548:same reporter,Different patient US-GSK-US2025061546:Same reporter,Different patient
Sex: F
Vaccine: MNQ
Symptoms: Product storage error
Clinical narrative: Administration after a below temperature excursion of 29.9°F as the minimum reached; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a female patient who received Men ACWY-CRM NVS (Menveo) (batch number LB93L) and (batch number AMVBO44A) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced incorrect storage of drug (Verbatim: Administration after a below temperature excursion of 29.9°F as the minimum reached). The outcome of the incorrect storage of drug was not applicable.   Additional Information: GSK Receipt Date: 15-MAY-2025 A registered nurse asked the recommendations after giving several vaccines that were exposed to a temperature excursion of 29.9 degree Fahrenheit as the lowest reached for Menveo. The Vaccine Administration Facility was the same as Primary Reporter; Sender's Comments:  US-GSK-US2025061548:Same reporter,Different patient US-GSK-US2025061546:Same reporter,Different patient US-GSK-US2025061573:SAME PATIENT SAME REPORTER, DIFFERENT SUSPECT
Age: 31.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Pathology test, Premature delivery, Premature separation of placenta, Stillbirth
Clinical narrative: Had a stillbirth at 34 weeks gestation secondary to placental abruption. Baby was born with a weight of 4lb 4oz.  Acute onset with minimal to no risk factors. Autopsy results were normal. Placental path just showed placental abruption
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: vaccine expired on 5/19/2025
Age: 11.0
Sex: F
Vaccine: HPV9, MENB, TDAP
Symptoms: Wrong product administered
Clinical narrative: Individual given three vaccines, two in the left deltoid and the other in the right deltoid.  After administration client and mother left with information on all the vaccines given.  Soon after individual left this writer noticed that MenB was given instead of MenQuadfi.  Called the mother of the client to notify her that an error was made but that it wouldn't cause any injury at 4:17 pm.  Emailed direct supervisor with the error and outcome.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Passed away while receiving hospice care.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood creatine phosphokinase, Full blood count, Metabolic function test, Muscle contractions involuntary, Muscle spasms
Clinical narrative: muscle fasciculations and cramping. began two days after vaccine. has persisted over one month. unclear if directly related to vaccine.
Age: 80.0
Sex: M
Vaccine: COVID19, RSV, VARZOS
Symptoms: Diarrhoea, Influenza like illness, Pyrexia
Clinical narrative: fever, diarrhea, flu-like symptoms began overnight after vaccine administration. pt called 911 to go to hospital due to side effect concerns
Age: 0.5
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was expired by 3 days. Reported to Moderna and parent made aware.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Asthenia, Diarrhoea, Fatigue, Malaise, Pyrexia
Clinical narrative: WEAKNESS, TIREDNESS, VOMITING, DIARRHEA, FEVER, GENERAL MALAISE
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Vomiting
Clinical narrative: WEAKNESS, TIREDNESS, VOMITING, DIARRHEA, FEVER, GENERAL MALAISE
Age: 64.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Tenderness
Clinical narrative: Redness, Tenderness
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Aortic valve incompetence, Cardiac murmur, Cardiac operation, Cardiac valve disease, Catheterisation cardiac
Clinical narrative: Developed a deteriorated bicuspid valve that required open hear surgery
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram heart abnormal, Echocardiogram, Electrocardiogram, Fatigue
Clinical narrative: Developed a deteriorated bicuspid valve that required open hear surgery
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Blood test normal, Computerised tomogram normal, Depressed level of consciousness, Gait inability, Headache
Clinical narrative: Immediately after vaccination on Apr. 24, 2025  noticeable swelling that looked like a blister or keloid developed.  11 days later, on May 5th 2025 the patient woke from sleep around 10:30pm shrieking and screaming. His torso was very tense and then he fell limp with little to no control of his muscles. He could not walk and would not come-to after several attempts to wake him. This episode lasted for several minutes, long. We tried asking him if he was in pain to which he tried answering but he could not lift his head or arms to point but he did complain that his head hurt.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Hypotonia, Immediate post-injection reaction, Mobility decreased, Screaming, Seizure like phenomena
Clinical narrative: Immediately after vaccination on Apr. 24, 2025  noticeable swelling that looked like a blister or keloid developed.  11 days later, on May 5th 2025 the patient woke from sleep around 10:30pm shrieking and screaming. His torso was very tense and then he fell limp with little to no control of his muscles. He could not walk and would not come-to after several attempts to wake him. This episode lasted for several minutes, long. We tried asking him if he was in pain to which he tried answering but he could not lift his head or arms to point but he did complain that his head hurt.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Sleep disorder, Swelling, Tension
Clinical narrative: Immediately after vaccination on Apr. 24, 2025  noticeable swelling that looked like a blister or keloid developed.  11 days later, on May 5th 2025 the patient woke from sleep around 10:30pm shrieking and screaming. His torso was very tense and then he fell limp with little to no control of his muscles. He could not walk and would not come-to after several attempts to wake him. This episode lasted for several minutes, long. We tried asking him if he was in pain to which he tried answering but he could not lift his head or arms to point but he did complain that his head hurt.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: rash within 24 hrs of vaccine in ER
Age: 17.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Dizziness, Heart rate increased, Hypertension, Paraesthesia
Clinical narrative: Client reported dizziness at 1:00 pm. It was also stated that client may have experienced tingling of arms and mouth, conflicting information on those symptoms provided. HR and BP high. Sought emergency care. Recovered by 5:00 pm on 05/09/2025. ED doctor diagnosed allergic reaction to vaccine.   Client has history of fainting and anxiety with previous tests involving needles. Client was extremely anxious prior to recieving vaccinations at this visit.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Blood test, Joint swelling, Rash, X-ray
Clinical narrative: Rash, severe joint pain and swelling.  Joint pain never went away - only got worse over time.  Currently seeing Dr. at a Clinic.
Age: 1.5
Sex: F
Vaccine: DTAP, FLU3, HEPA
Symptoms: Cyanosis, Death, Immunisation reaction, Lethargy, Malaise
Clinical narrative: Morning after vaccination child was lethargic and blue in the lips. Rushed to the emergency room where doctor agreed she was having a reaction to vaccines. Tylenol wasz given. She was sick the rest of the week until she passed away 5/1/25
Age: 1.5
Sex: M
Vaccine: DTAP, FLU3, HEPA
Symptoms: Cyanosis, Death, Immunisation reaction, Lethargy, Malaise
Clinical narrative: Child was lethargic and blue in the lips morning after vaccination. Mom rushed him to the ER where the doctor confirmed he was having an adverse reaction to the vaccines. Tylenol was given. Child was sick the entire week as was his twin sister until they unfortunately passed away on 5/1/25.
Age: 1.42
Sex: F
Vaccine: RV1
Symptoms: No adverse event
Clinical narrative: Patient didn't have adverse reaction
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthma, Decreased immune responsiveness, Hypersensitivity
Clinical narrative: Asthma, allergies, weakened immune system. Diagnosed with Eosinophilic Asthma in July of 2023
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Cardiac failure, Echocardiogram, Myocarditis
Clinical narrative: Developed Mycarditis/heart failure soon after second vaccine shot, still have condition over 4 years later
Age: 15.0
Sex: M
Vaccine: HEPA, HPV9, TDAP
Symptoms: Syncope
Clinical narrative: syncope episode, observed for 15 minutes after episode, discharged to home without any further issues
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received Covid-19 Vaccine on 5/22/2025. Vaccine had an expiration date of 5/7/2025.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: I had a heart attack  5 weeks after the shot
Age: 11.0
Sex: F
Vaccine: FLU3, HPV9, MNQ, TDAP
Symptoms: Abdominal pain upper, Dizziness, Fall, Head injury, Syncope
Clinical narrative: Client was given four vaccines (Tdap, MCV4, HPV9, and Flu). Client states she did not eat since 10:00 a.m. Client was given tang juice prior to immunizations. After vaccinations given, assessed client, asked if she was dizzy while sitting, client denied any issues. Client stood up to grab a toy (rubber duck) from drawer and experienced syncopal episode falling to the floor. Unable to catch client, she then hit her front, left side of head on floor. Client awoke within 30 seconds to one minute. Client states she felt dizzy and her stomach hurt. Paramedics were called at this time and evaluated client. Vitals taken by paramedics at 3:05 p.m. (sitting) at 95/51 and "good" HR per paramedic, 100% Sp02. BP then taken by paramedics standing, 121/63. Paramedics state it was up to parents if they wanted client to go to hospital, parents opted to monitor client at home and not take her to hospital at this time. Client observed for 20 minutes longer after paramedics left clinic and laid down on patient bed with knees above head, ice pack behind neck and then given water and crackers. Client's BP at 3:22 p.m. taken again was 110/82. Client denied any dizziness, stomach pain, head pain/headache, nausea, or other symptoms at that time and fully recovered prior to leaving.
Age: 7.0
Sex: F
Vaccine: TDAP
Symptoms: Extra dose administered
Clinical narrative: accidently gave a Tdap dose when it was not needed
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Vaccine (Daptacel) was administered in the left deltoid using aseptic technique on Tuesday (05/20/25) at approximately 9:00am will no adverse reaction noted at that time.  At approximately 9:00pm that evening dad reports noticing the vaccine site turn red, swell and feeling warm to the touch - dad states, it stayed like that since then with no changes.
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Blood pressure decreased, Hot flush, Rash, Rash pruritic
Clinical narrative: Immediately after her hepatitis B vaccination she started to get warm feeling flushed developed a rash on her neck and was itchy on the neck symptoms then spread to the entire body where she developed itching throughout the body and felt warm and flushed throughout.  She denied any breathing difficulty wheezing or difficulty swallowing.  She had no swelling of the lips or tongue.  She was given Benadryl 25 mg immediately to see if that would improve symptoms.  Vitals were monitored her blood pressure started to drop compared to initial blood pressure.  She has a history of anaphylaxis to other drug ingredients in contrast.  She also mention that she gets chronic hives intermittently and rashes when eating certain foods but has not pinpointed the specifics as she would like to see an allergist.  She also had other med allergies.  Discussed with her that she is having a mild anaphylactic reaction with the systemic itching and the rash.  Recommended epi 0.3 mg IM which was given today.  Following epinephrine administration by my nurses she immediately felt better and the itching improved.  Blood pressure was stable she had no breathing difficulty throat swelling lip swelling tongue swelling upon discharge.  Recommended Benadryl every 4-6 hours for the next 24 hours. Discussed worrisome signs and symptoms to follow up on or seek urgent medical care for.
Age: 18.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Syncope
Clinical narrative: syncope after immunizations; observed for 15 min, discharged to home without incident
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Blood pressure diastolic decreased, Chest discomfort, Hyperhidrosis, Vomiting
Clinical narrative: Initially chest tightness, then sweating, low diastolic blood pressure. Then 20 minutes later vomited.
Age: 73.0
Sex: F
Vaccine: PNC21, VARZOS
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: patients right arm swollen, light red, warm to touch. has not spread or improved the last few days. patient has used ice packs, benadryl, ibuprofen. will continue to monitor for worsening signs/symptoms and go to hospital if needed
Age: 5.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose of Hep A given too soon
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Loss of consciousness, Malaise
Clinical narrative: Patient stated she had fainted with prior vaccine but had gotten 2 at once when it happened.  We administered the vaccine, then sat and chatted for several minutes.  She then said she wasn't feeling well, pharmacist stayed with her, while the other pharmacist got her a water.  Patient took few sips of water then stated she felt like she was going out.  She passed out for a moment or 2 then came back.  Patient continued to sit with the fan on her and cool paper towels.  Offered sugar or crackers didn't want either.  Still wasn't feeling well at about 20 mins, didn't want 911 called, called her husband who is a physician, and he came to the store.  She sat for a few more moments than he left to take her to the hospital.
Age: 47.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose of Hep A was given too soon
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Gave child a tdap shot instead of the Hep A vaccine in which he was due for. Spoke with client and family after I noticed the mistake and they said it was fine and did not report any issues.
Age: 48.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Hep A #2 administered too soon
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was given Covid-19 vaccination on 5/21/2025. Vaccination had an expiration date of 5/7/2025.
Age: 71.0
Sex: M
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: upper arm redness, site reaction with swelling/warmth approx 2.5 inches in diameter
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test normal, Gene mutation identification test negative, Hepatic vascular thrombosis
Clinical narrative: A random blood clot occurred near my liver. I am healthy with no prior conditions. I had my blood checked for any illnesses, and also had a genetics testing done that found no irregularities. I have not had any issues since. The doctors never saw a case like mine in a healthy individual. My only conclusion was the COVID vaccine, since others had the same issue.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anti-thyroid antibody increased, Asthenia, Blepharospasm, Blood pressure increased, Blood test
Clinical narrative: I was sitting still on a plane and got an immediate intense head rush/vertigo, Heart rate jumped to 150 BPM, Blood pressure 160/110, sweats, body shakes and hand tremors. These were the first occurrences of these adrenaline dumps.  Other symptoms included swollen armpit lymph nodes, rib cage discomfort, spinal pain, muscle pains and spasms, left eye twitches. From January 24, 2025 until May 13, 2025, these event became worse and worse as nutrients became more and more depleted from my body. Dry skin occurred, body weakness, and other low nutrient signs. One key note, walking seemed to short term assist in the issue but as soon as the body stops working out, the body begins to have these episodes again to cause adrenaline dumps once again. Episodes are 4-5 rushes every 20-30 minutes as adrenal glands fill up enough then begin dumping again.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac stress test, Chest discomfort, Computerised tomogram, Dry skin, Echocardiogram
Clinical narrative: I was sitting still on a plane and got an immediate intense head rush/vertigo, Heart rate jumped to 150 BPM, Blood pressure 160/110, sweats, body shakes and hand tremors. These were the first occurrences of these adrenaline dumps.  Other symptoms included swollen armpit lymph nodes, rib cage discomfort, spinal pain, muscle pains and spasms, left eye twitches. From January 24, 2025 until May 13, 2025, these event became worse and worse as nutrients became more and more depleted from my body. Dry skin occurred, body weakness, and other low nutrient signs. One key note, walking seemed to short term assist in the issue but as soon as the body stops working out, the body begins to have these episodes again to cause adrenaline dumps once again. Episodes are 4-5 rushes every 20-30 minutes as adrenal glands fill up enough then begin dumping again.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Heart rate increased, Hyperhidrosis, Immunology test normal, Inflammatory marker test, Laboratory test normal
Clinical narrative: I was sitting still on a plane and got an immediate intense head rush/vertigo, Heart rate jumped to 150 BPM, Blood pressure 160/110, sweats, body shakes and hand tremors. These were the first occurrences of these adrenaline dumps.  Other symptoms included swollen armpit lymph nodes, rib cage discomfort, spinal pain, muscle pains and spasms, left eye twitches. From January 24, 2025 until May 13, 2025, these event became worse and worse as nutrients became more and more depleted from my body. Dry skin occurred, body weakness, and other low nutrient signs. One key note, walking seemed to short term assist in the issue but as soon as the body stops working out, the body begins to have these episodes again to cause adrenaline dumps once again. Episodes are 4-5 rushes every 20-30 minutes as adrenal glands fill up enough then begin dumping again.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lymphadenopathy, Muscle spasms, Myalgia, Scan with contrast, Spinal pain
Clinical narrative: I was sitting still on a plane and got an immediate intense head rush/vertigo, Heart rate jumped to 150 BPM, Blood pressure 160/110, sweats, body shakes and hand tremors. These were the first occurrences of these adrenaline dumps.  Other symptoms included swollen armpit lymph nodes, rib cage discomfort, spinal pain, muscle pains and spasms, left eye twitches. From January 24, 2025 until May 13, 2025, these event became worse and worse as nutrients became more and more depleted from my body. Dry skin occurred, body weakness, and other low nutrient signs. One key note, walking seemed to short term assist in the issue but as soon as the body stops working out, the body begins to have these episodes again to cause adrenaline dumps once again. Episodes are 4-5 rushes every 20-30 minutes as adrenal glands fill up enough then begin dumping again.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Thyroid hormones test, Tremor, Vertigo
Clinical narrative: I was sitting still on a plane and got an immediate intense head rush/vertigo, Heart rate jumped to 150 BPM, Blood pressure 160/110, sweats, body shakes and hand tremors. These were the first occurrences of these adrenaline dumps.  Other symptoms included swollen armpit lymph nodes, rib cage discomfort, spinal pain, muscle pains and spasms, left eye twitches. From January 24, 2025 until May 13, 2025, these event became worse and worse as nutrients became more and more depleted from my body. Dry skin occurred, body weakness, and other low nutrient signs. One key note, walking seemed to short term assist in the issue but as soon as the body stops working out, the body begins to have these episodes again to cause adrenaline dumps once again. Episodes are 4-5 rushes every 20-30 minutes as adrenal glands fill up enough then begin dumping again.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Wrong product administered
Clinical narrative: Administered Kinrix to patient for 3rd Dose instead of 5th.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Dtap dose given not needed since he had received 4 doses and one of them was at age 4; plus 5th dose was administered 2 months after his last dose
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: No adverse event, Vaccination error
Clinical narrative: Dose given in error.  Patient is asymptomatic. No c/o SOB, discomfort or pain, no N/V, gait steady, auditory and vision intact. Speech clear, no c/o dizziness
Age: 1.58
Sex: M
Vaccine: HIBV
Symptoms: Product preparation error, Rash, Rash macular, Rash papular, Rash pruritic
Clinical narrative: Last seen in the office 3/26 for 19mos HME -at that visit was given Hep A vaccine (right thigh) and HIB vaccine (left thigh) -the next days later, it was discovered that the HIB vaccine was inadvertently mixed with sterile water rather than the accompanying 0.4% saline diluent 4/4/2025 parent report patient developed a rash - bumpy, rough dry mildly itchy back legs and chest. Per physical exam significant for a cluster of erythematous papules on right thigh and lower back.
Age: 1.0
Sex: M
Vaccine: MNQ
Symptoms: Wrong product administered
Clinical narrative: Patient was injadverte4nly given menveo single dose vaccine instead of menveo two vial presentaion
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB, PNC20
Symptoms: Pyrexia, Urticaria
Clinical narrative: patient developed full body hives following vaccination, around 20-24 hours later. also had fever on the same day as the vaccine that started around 12 hours after vaccination. no signs or symptoms of anaphylaxis reported by parents, seen in the ED and PCP office without any other symptoms beyond skin findings.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, Injection site pain
Clinical narrative: Notified pt that her 3rd HPV given was too soon and she will need to get another vaccine on 5/25/2024 or later. Pt states she is feeling fine, has a sore arm where vaccine was placed. Pt states that is the same way she felt after her previous HPV vaccines.  Pt voices understanding she needs to get another dose of HPV on 5/25/24 or later.
Age: 76.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: Gave 1 dose pediatric dose of Hep A vaccine in error instead of adult dose. Had patient come back in for 2nd pediatric dose in same day to equal an adult dose. He tolerated the vaccines well. Each were given in separate arms. No symptoms or adverse events noted or reported by patient.
Age: 5.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Mother of patient called back and was notified that pt received his Hep A vaccine too soon. He will need to come back 12/1/2023 or later to complete series. Mother voices understanding and states child has done well with his vaccines, no fever or illness.
Age: 70.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site pain, Lethargy, Somnolence
Clinical narrative: Patient has soreness at injection site, is lethargic, and very sleepy.
Age: 16.0
Sex: F
Vaccine: HEP, HEPA, MMR, MNQ, TDAP
Symptoms: Hyperhidrosis, Nausea, Pallor, Syncope
Clinical narrative: Pallor, diaphoresis, nausea, and syncope. Pt assisted to supine position on table and monitored. Pt rested for approximately 5 minutes -10 minutes and stated she "felt okay".  Upon standing pt experienced the same symptoms again, assisted to sitting position in chair. Pt experienced syncopial episode. Pt monitored, VS stable, pt responsive after syncopial episode. Symptoms resolved after 15-20 minutes of rest and juice with cracker.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Pt fainted approximately 15 minutes after receiving vaccines; Pt became alert within 30 seconds or less of fainting; Vital signs were stable; No interventions needed.
Age: 41.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Cardiac disorder, Catheterisation cardiac, Computerised tomogram, Condition aggravated, Echocardiogram
Clinical narrative: Heart problems have worsened. Headaches,  I have growths in my neck and stomach that I didn't have before.
Age: 41.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Electrocardiogram, Gastric neoplasm, Headache, Neoplasm, Ultrasound scan
Clinical narrative: Heart problems have worsened. Headaches,  I have growths in my neck and stomach that I didn't have before.