chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Anaphylactic reaction, Endotracheal intubation
Clinical narrative: anaphylaxis; intubated; This serious case was reported by a other health professional via call center representative and described the occurrence of anaphylaxis in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shellfish allergy. Concomitant products included lisinopril.   On 04-FEB-2025, the patient did not received the 2nd dose of Shingrix (left arm). In FEB-2025, an unknown time after receiving Shingrix, the patient experienced anaphylaxis (Verbatim: anaphylaxis) (serious criteria hospitalization, GSK medically significant, life threatening and clinically significant/intervention required) and intubation (Verbatim: intubated) (serious criteria hospitalization, life threatening and clinically significant/intervention required). The outcome of the anaphylaxis and intubation were not resolved.   It was unknown if the reporter considered the anaphylaxis and intubation to be related to Shingrix.     The company considered the anaphylaxis and intubation to be unrelated to Shingrix.   Additional Information: GSK Receipt Date:10-FEB-2025 Other Healthcare Professional reported that the patient took Shingrix vaccine and experienced anaphylaxis and intubated. The reporter did not consent to follow-up.; Sender's Comments: Anaphylactic reaction is a listed event which, due to the following criteria (concurrent shellfish allergy, insufficient information regarding medical history, completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix. Endotracheal intubation is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Malaise
Clinical narrative: Shingrix - sore arm at injection site; Patient felt sick for 24 hours after first dose; This non-serious case was reported by a physician via call center representative and described the occurrence of injection site pain 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 injection site pain (Verbatim: Shingrix - sore arm at injection site) and sickness (Verbatim: Patient felt sick for 24 hours after first dose). The outcome of the injection site pain was unknown and the outcome of the sickness was resolved (duration 24 hrs).   It was unknown if the reporter considered the injection site pain and sickness to be related to Shingrix.     It was unknown if the company considered the injection site pain and sickness to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-FEB-2025 The physician reported that a patient had extremely sore arm at injection site after first dose of Shingrix and felt sick for 24 hours.  They want to know if patient should still get the second dose of Shingrix.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: administered 2 adjuvants (1ml total) to a patient and did not put powder (antigen) component into liquid; administered 2 adjuvants (1ml total) to a patient and did not put powder (antigen) component into liquid; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number 7zm55, expiry date 15-NOV-2026) for prophylaxis.   On 11-FEB-2025, the patient received Shingrix. On 11-FEB-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: administered 2 adjuvants (1ml total) to a patient and did not put powder (antigen) component into liquid) and inappropriate dose of vaccine administered (Verbatim: administered 2 adjuvants (1ml total) to a patient and did not put powder (antigen) component into liquid). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 12-FEB-2025 The LPN (Licensed practical nurses) reported that day before reporting that the MA(Medical assistant) administered two adjuvants (1ml total) to a patient and did not put powder (antigen) component into liquid which led to, inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A 11 months old female patient received a dose of Kinrix.; 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 11-month-old female patient who received DTPa-IPV (Kinrix) (batch number 5H95B, expiry date 16-FEB-2026) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: A 11 months old female patient received a dose of Kinrix.). The outcome of the inappropriate age at vaccine administration was 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: 12-FEB-2025 The nurse reported that they administered a dose of Kinrix to a 11 months old female patient which was intended to get DTaP and IPV, which led to inappropriate age at vaccine administration. The reporter ask was there any documentation regarding this.
Sex: U
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: received the Shingrix active ingredient or just the diluent; received the Shingrix active ingredient or just the diluent; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: received the Shingrix active ingredient or just the diluent) and inappropriate dose of vaccine administered (Verbatim: received the Shingrix active ingredient or just the diluent). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 12-FEB-2025 The pharmacist contacted via chat on February 12th 2025 and mentioned that they had an incident where they do not know if a patient received the Shingrix active ingredient or just the diluent, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. Chat was suddenly interrupted before agent could ask for additional details on the case.
Sex: M
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barre syndrome; This spontaneous report received from a patient concerned a male patient of unspecified age. Received via J and J managed social media. The patient's height and weight were not reported. Age at time of vaccination was unknown.  No past medical history, concurrent conditions or pre-existing medical conditions were reported.  The patient received janssen covid-19 vaccine (suspension for injection, intramuscular, batch number not reported) dose, frequency and therapy dates not reported, additional dosage information included: dose series 1, for covid-19 prophylaxis. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers.  No concomitant medications were reported.  On an unspecified date, the patient experienced guillain-barre syndrome. (dose series 1) Now the patient have very weak muscles and now paralyzed.  The action taken with janssen covid-19 vaccine was not applicable.  The outcome of guillain-barre syndrome was not reported.  This report was serious (other medically important condition).; Sender's Comments: V0: janssen covid-19 vaccine -Guillain-Barre syndrome. This event(s) is labeled per RA and is therefore considered potentially related.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Aortic aneurysm, Atrial fibrillation, COVID-19
Clinical narrative: he had after being vaccinated started to have weird heart issue and found out afib and aortic aneurysm; he had after being vaccinated started to have weird heart issue and found out afib and aortic aneurysm; COVID-19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ATRIAL FIBRILLATION (he had after being vaccinated started to have weird heart issue and found out afib and aortic aneurysm) in an 8-decade-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) 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 SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced ATRIAL FIBRILLATION (he had after being vaccinated started to have weird heart issue and found out afib and aortic aneurysm) (seriousness criterion medically significant), AORTIC ANEURYSM (he had after being vaccinated started to have weird heart issue and found out afib and aortic aneurysm) and COVID-19 (COVID-19). At the time of the report, ATRIAL FIBRILLATION (he had after being vaccinated started to have weird heart issue and found out afib and aortic aneurysm), AORTIC ANEURYSM (he had after being vaccinated started to have weird heart issue and found out afib and aortic aneurysm) and COVID-19 (COVID-19) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       Patient was in his 70s. No concomitant medication was reported. Patient had after being vaccinated started to have weird heart issue and found out afib and aortic aneurysm. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2025-782162, US-MODERNATX, INC.-MOD-2025-782163 (E2B Linked Report).   Reporter did not allow further contact; Reporter's Comments: Company comment: The benefit-risk relationship of product is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-782163:Patient US-MODERNATX, INC.-MOD-2025-782162:Patient's Aunt
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: lot of floaters in eyes; covid Pfizer was an allergy for her; dizzy; vertigo; throwing up; headache behind right eye; This is a spontaneous report received from a Consumer or other non HCP.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 07Jan2021 as dose 1, single (Lot number: EJ1685) at the age of 62 years for covid-19 immunisation. The patient's relevant medical history included: "hyperthyroid " (unspecified if ongoing); "Guillain-Barre" (unspecified if ongoing); "constipated person" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing); "Low blood pressure" (unspecified if ongoing); "Pott's" (unspecified if ongoing); "asthma" (unspecified if ongoing), notes: in her late 20s. The patient's family history included: "hypothyroid" (unspecified if ongoing), notes: has a sister that's been on since high school. Sister is 10 years older. Concomitant medication(s) included: SYNTHROID taken for hypothyroidism (ongoing). Past drug history included: Advair for asthma. The following information was reported: DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "dizzy"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache behind right eye"; VOMITING (non-serious) with onset 2021, outcome "unknown", described as "throwing up"; VERTIGO (non-serious) with onset 2021, outcome "not recovered"; VITREOUS FLOATERS (non-serious), outcome "not recovered", described as "lot of floaters in eyes"; ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "covid Pfizer was an allergy for her". The events "vertigo", "throwing up", "headache behind right eye" and "dizzy" required physician office visit. Clinical course: Covid vaccine is listed as an allergy. After the first vaccine, patient ended up with lot of floaters in eyes. It seemed to disappear. Patient was working at the time to where she was vaccinated, but on leave because was non-essential. Patient got all the vaccines and all of them were the Pfizer. After the first vaccine, she contacted the doctor because she started getting dizzy. They kept her longer after first vaccine because of this. She was sent home and told to contact her own physician if anything worsened. By the time she got home, she was throwing up. She had headache behind right eye and then started vertigo. The patient contacted physician and got in to see her and she suggested to see ENT and eye doctor. The vertigo went away and so just she kept an appointment with an eye doctor. The patient want to make it very clear she is not an anti-vaxxer. She believes in vaccines. If it can determine with genetic testing that there would be a problem with certain meds, as patient has, there would be no anti-vaxxers. Patient stated it needs to be researched, most doctors think Pfizer has no liability. If it could be researched so someone else doesn't have problem.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500033318 same pattient/product, different dose number/events;US-PFIZER INC-202500033305 same pattient/product, different dose number/events;
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Myocarditis; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A 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".  Clinical course: Patient reported that The adverse affects I had to the flu shot and how I had covid once no shot because natural immunity. Friends with 4 or more Pfizer boosters got covid more times than boosters. My 2 friends sons with Myocarditis due to the covid vaccine.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500033362 Same drug, AE, different patient;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: he has a red ring that never seemed to heal that scabs over and will swell up again.; feel pain in the muscle where the injection went into; he has a red ring that never seemed to heal that scabs over and will swell up again.; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A male patient received BNT162b2 (COMIRNATY), on 24Jan2021 as dose 1, single (Lot number: EL9262), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "feel pain in the muscle where the injection went into"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 2021, outcome "unknown" and all described as "he has a red ring that never seemed to heal that scabs over and will swell up again.".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500033720 same patient, different dose and AE;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site scab, Vaccination site swelling
Clinical narrative: he has a red ring that never seemed to heal that scabs over and will swell up again.; feel pain in the muscle where the injection went into; he has a red ring that never seemed to heal that scabs over and will swell up again.; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A male patient received BNT162b2 (COMIRNATY), on 24Jan2021 as dose 1, single (Lot number: EL9262), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "feel pain in the muscle where the injection went into"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 2021, outcome "unknown" and all described as "he has a red ring that never seemed to heal that scabs over and will swell up again.".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500033720 same patient, different dose and AE;
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: feel pain in the muscle where the injection went into; he has a red ring that never seemed to heal that scabs over and will swell up again.; he has a red ring that never seemed to heal that scabs over and will swell up again.; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A male patient received BNT162b2 (COMIRNATY), on 14Feb2021 as dose 2, single (Lot number: EL9267), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: comirnaty (1st dose, lot EL9262), administration date: 24Jan2021, for covid-19 immunization, reaction(s): "vaccination site erythema", "vaccination site pain", "vaccination site swelling". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "feel pain in the muscle where the injection went into"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 2021, outcome "unknown" and all described as "he has a red ring that never seemed to heal that scabs over and will swell up again.".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500033581 same patient, different dose and AE;US-PFIZER INC-202500033721 same patient, different dose and AE;
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: he has a red ring that never seemed to heal that scabs over and will swell up again.; he has a red ring that never seemed to heal that scabs over and will swell up again.; feel pain in the muscle where the injection went into; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A male patient received BNT162b2 (COMIRNATY), as dose 3 (booster), single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: comirnaty (2nd dose, lot EL9267), administration date: 14Feb2021, for covid-19 immunization, reaction(s): "vaccination site pain", "vaccination site erythema", "vaccination site swelling"; comirnaty (1st dose, lot EL9262), administration date: 24Jan2021, for covid-19 immunization, reaction(s): "vaccination site swelling", "vaccination site swelling", "vaccination site swelling". The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious), outcome "unknown" and all described as "he has a red ring that never seemed to heal that scabs over and will swell up again."; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "feel pain in the muscle where the injection went into". The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500033720 same patient, different dose and AE;US-PFIZER INC-202500033581 same patient, different dose and AE;
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Generalised tonic-clonic seizure
Clinical narrative: 35 grand mal seizures; fell on my face when I fell off the bed; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A 31-year-old female patient received BNT162b2 (BNT162B2), on 28Jul2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 27 years for covid-19 immunisation. The patient's relevant medical history included: "Cancer" (unspecified if ongoing), notes: years ago. The patient's concomitant medications were not reported. The following information was reported: GENERALISED TONIC-CLONIC SEIZURE (medically significant), outcome "unknown", described as "35 grand mal seizures"; FALL (non-serious), outcome "unknown", described as "fell on my face when I fell off the bed".  Clinical course: The patient had 35 grand mal seizures in the past 5 years and shared some of the photos she had from being injured from this covid vaccine. She added that it ruined her life. She had cancer years ago and it wasn't as life-threatening as this vaccine. A photo of her was attached wherein she fell on her face when she had fallen off the bed.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: After covid issues; After covid issues; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  An adult 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "After covid issues". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: allergic reaction to the covid vaccine; This is a spontaneous report received from a Consumer or other non HCP, Program ID: .  An elderly 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: ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "allergic reaction to the covid vaccine".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Asthma, COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Second time having COVID-19; Affecting her asthma; COVID-19; COVID-19 test positive; COVID-19; COVID-19 test positive; This is a spontaneous report received from a consumer, Program ID:  A 63-year-old female patient received BNT162b2 (BNT162B2), in 2020 as dose 1, single (Batch/Lot number: unknown) and in 2020 as dose 2, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma", start date: 1993 (ongoing), notes: Diagnosed 32 years ago; "Hypothyroid" (ongoing), notes: Diagnosed over 30 years ago. Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation as dose number unknown, single. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "COVID-19; COVID-19 test positive"; ASTHMA (non-serious) with onset 11Feb2025, outcome "not recovered", described as "Affecting her asthma"; DISEASE RECURRENCE (medically significant) with onset 11Feb2025, outcome "not recovered", described as "Second time having COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Feb2025) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, disease recurrence, asthma. The patient has already taken her Pfizer COVID-19 Vaccine. While in the call, she is trying to talk, but her face is covered with a mask, so it is hard to speak. The patient currently has COVID-19 and was prescribed nirmatrelvir/ritonavir (PAXLOVID); COVID-19 test positive on 11Feb2025. This is her second time having COVID-19 and said that the first time was 2 years ago (2023). She is tired and is so confused. She is worn out. According to the patient, her chest is killing her. Her symptoms started off as head congestion, runny nose, fever, chills, coughing, and now it is affecting her asthma. She has coughing and congestion in her chest. She thought it was sinus infection but was diagnosed with COVID-19. She also had her flu vaccine. She got the Pfizer COVID-19 vaccine when the shots first came out; she received 2 doses. It was the 2-part series of the COVID-19 vaccine that she received in 2020, she thinks. Further, the patient had just got off the phone with the pharmacy to get the prescription she needs, paroxetine hydrochloride (PAXIL). The patient was going outside to take her mask off as she can't breathe. And then she would go to the doctors. That's what she was going for sinuses. The patient got COVID-19, and she had her Pfizer shot. The patient got COVID-19 which she thought was a sinus infection.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500034910 Same patient and product; different dose and events;
Age: 68.0
Sex: F
Vaccine: COVID19, PNC20
Symptoms: Injection site pain, Limb operation, Pain in extremity
Clinical narrative: Patient complained of pain at injection site the evening of the vaccine, then on 2/13 her arm appeared red and still painful, she came into the pharmacy on 2/14 her arm was pink and she was still experiencing some pan
Age: 27.0
Sex: F
Vaccine: UNK
Symptoms: Exposure during pregnancy, Product use issue
Clinical narrative: Arexvy is not indicated for pregnant women at 31-32 weeks At the time patient was 31-32 weeks along.
Age: 37.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Large itchy, red area around injection site.
Age: 60.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site pain, Rash
Clinical narrative: Rash on patient's left arm around the injection site. Patient had the rash for approximately 5 days and had been seen by the urgent care provider to rule out an infection.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate increased, Paraesthesia, Syncope, Vision blurred
Clinical narrative: Blood pressure 218/132, vision trouble focusing, almost fainted, pins and needles in hands, high pulse, dizzy
Age: 84.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered
Clinical narrative: Patient received an inappropriate dose of Prevnar 20. Patient had already received two doses of Prevnar 20 in 2023 and 2024. These vaccines were not reported on registry and patient was told by her doctor that they were due to receive this vaccine. Patient did not report any adverse effects from receiving this vaccine.
Age: 0.83
Sex: M
Vaccine: DTAP, FLU3, PNC13
Symptoms: Affective disorder, Attention deficit hyperactivity disorder, Autism spectrum disorder, Constipation, Cytogenetic analysis normal
Clinical narrative: The day after his 10 month shots, patient was whiny. He had diarrhea. Constipation followed, then diarrhea again a few weeks later. He wouldn't sleep at night. Over the weeks following the injections, he stopped responding to his name as well. He made less eye contact as well. He was sick with respiratory viruses for most of the year following the shots. He began toe walking and repetitive tasks, lining up toys, being fascinating by dripping water. His speech was delayed. He was diagnosed with Sensory Processing Disorder at his 4 year check up, then ADHD at 5, then a childhood mood disorder at 7. He finally received an autism disorder diagnosis at 9 which placed all of his previous disorders as symptoms of the umbrella autism diagnosis.
Age: 0.83
Sex: M
Vaccine: DTAP, FLU3, PNC13
Symptoms: Decreased eye contact, Depression, Diarrhoea, Generalised anxiety disorder, Insomnia
Clinical narrative: The day after his 10 month shots, patient was whiny. He had diarrhea. Constipation followed, then diarrhea again a few weeks later. He wouldn't sleep at night. Over the weeks following the injections, he stopped responding to his name as well. He made less eye contact as well. He was sick with respiratory viruses for most of the year following the shots. He began toe walking and repetitive tasks, lining up toys, being fascinating by dripping water. His speech was delayed. He was diagnosed with Sensory Processing Disorder at his 4 year check up, then ADHD at 5, then a childhood mood disorder at 7. He finally received an autism disorder diagnosis at 9 which placed all of his previous disorders as symptoms of the umbrella autism diagnosis.
Age: 0.83
Sex: M
Vaccine: DTAP, FLU3, PNC13
Symptoms: Irritability, Neuropsychological test, Respiratory tract infection viral, Sensory processing disorder, Speech disorder developmental
Clinical narrative: The day after his 10 month shots, patient was whiny. He had diarrhea. Constipation followed, then diarrhea again a few weeks later. He wouldn't sleep at night. Over the weeks following the injections, he stopped responding to his name as well. He made less eye contact as well. He was sick with respiratory viruses for most of the year following the shots. He began toe walking and repetitive tasks, lining up toys, being fascinating by dripping water. His speech was delayed. He was diagnosed with Sensory Processing Disorder at his 4 year check up, then ADHD at 5, then a childhood mood disorder at 7. He finally received an autism disorder diagnosis at 9 which placed all of his previous disorders as symptoms of the umbrella autism diagnosis.
Age: 0.83
Sex: M
Vaccine: DTAP, FLU3, PNC13
Symptoms: Stereotypy, Toe walking, Unresponsive to stimuli
Clinical narrative: The day after his 10 month shots, patient was whiny. He had diarrhea. Constipation followed, then diarrhea again a few weeks later. He wouldn't sleep at night. Over the weeks following the injections, he stopped responding to his name as well. He made less eye contact as well. He was sick with respiratory viruses for most of the year following the shots. He began toe walking and repetitive tasks, lining up toys, being fascinating by dripping water. His speech was delayed. He was diagnosed with Sensory Processing Disorder at his 4 year check up, then ADHD at 5, then a childhood mood disorder at 7. He finally received an autism disorder diagnosis at 9 which placed all of his previous disorders as symptoms of the umbrella autism diagnosis.
Age: 63.0
Sex: F
Vaccine: PNC20
Symptoms: Limb mass, Pain in extremity, Pruritus, Skin discolouration
Clinical narrative: Beside pain in the arm which last until the 14th, I experienced a discolored round circle extending to the sides of the arm. The arm continues to itch and I broke out in bumps along my left back shoulder and arm extended.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chronic obstructive pulmonary disease, Clear cell renal cell carcinoma, Nephrectomy, Renal cancer
Clinical narrative: I now have COPD which is not normal for a 40 year old and I had Kidney cancer twice.
Age: 80.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient has redness and swelling at injection site. Warm to the touch and was painful. Was over a week long symptoms lasted
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Erythema, Hypoaesthesia, Paraesthesia, Raynaud's phenomenon, Skin discolouration
Clinical narrative: A year and a half later I developed Raynaud?s disease where the tips of my fingers turn completely pale. It tingles and feels numb. It started out lasting only 15 minutes and worked itself up to lasting longer. It occurs at random times. My feet also get beet red. Although I have not had a diagnosis for the feet, I did go tot the doctor for my hands and fingertips. This has never occurred with me and  nobody in my family has ever had this happen.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm was "very sore"; This is a spontaneous report and received from Consumer or other non HCPs.  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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm was "very sore"". Additional information: The reporter stated that the arm of the patient was "very sore" after she received her COVID-19 vaccine.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.  Follow-up (01Feb2025): This is a spontaneous follow-up report received from a Consumer or other non HCP. Updated information included: New reporter and patient Information.  Follow-up (12Feb2025): This is a spontaneous follow-up report received from a Consumer or other non HCP. Updated information included: Primary Reporter Qualification.
Age: 29.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue
Clinical narrative: No adverse event was reported. Submitting report due to Arexvy given in error. 2/14/25 was date of delivery.
Age: 29.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Device use issue, Exposure during pregnancy, No adverse event
Clinical narrative: No adverse event was reported. Submitting report due to Arexvy given in error. 2/14/25 was date of delivery.
Age: 25.0
Sex: F
Vaccine: ANTH
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Nausea
Clinical narrative: fatigue, nausea, vomiting, fever, chills, sweating, and headache
Age: 25.0
Sex: F
Vaccine: ANTH
Symptoms: Pyrexia, Vomiting
Clinical narrative: fatigue, nausea, vomiting, fever, chills, sweating, and headache
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: Pain and weakness in arm, continuing daily through this submission. The pain is not 24 hours a day, but it is daily. I am due for the second dose by May and am concerned whether or not to get it
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Cardiac stress test, Chest discomfort, Echocardiogram, Electrocardiogram, Heart rate irregular
Clinical narrative: Within 24 hours of receiving the vaccine, I began having an irregular heartbeat, palpitation and chest discomfort on 12/8/24. I was evaluated by my cardiologist Dr on 12/10/24 and diagnosed with Premature Atrial Contractions.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Palpitations, Supraventricular extrasystoles
Clinical narrative: Within 24 hours of receiving the vaccine, I began having an irregular heartbeat, palpitation and chest discomfort on 12/8/24. I was evaluated by my cardiologist Dr on 12/10/24 and diagnosed with Premature Atrial Contractions.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Eczema
Clinical narrative: The patient reports that she was diagnosed with eczema after receiving her Shingles vaccine.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain, Tendonitis, X-ray
Clinical narrative: Initially I had pain in my left arm after the flu injection on 10/25/2024 around the site of the injection. Days later,  the pain got worse around the site and on the back side of my arm, It was painful to twist my arm, reach behind me or lie on it,  I saw an Orthopedic Nurse Practicioner in Janurary  2024. She diagnosed it as Rotator Cuff Tendonitis. I then started Physical Therapy in February 2025 and am getting treatment twice a week now.  The Therapist told me that I was the third patient she had that reported this problem after receiving a flu injection.
Age: 69.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered, Injection site pain
Clinical narrative: Administration error: 1st dose given 10/18/2022, 2nd dose not needed but given 2/13/2025. Pt states soreness at injection site, no other ADR.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Furuncle, Pain of skin
Clinical narrative: Patient described skin boils that were painful. She reported the need to seek urgent care and was given a course of antibiotics.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Haematochezia
Clinical narrative: Blood in stool
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: Patient started feeling dizzy, lightheaded, and sweating 1-2 minutes after receiving the vaccine.  Patient laid down and within 1-2 minutes made full recovery.
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient had previously received the vaccine on 12/17/2023, so this was an extra unnecessary dose.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, Injection site pain
Clinical narrative: Patient had previously received the vaccine on 12/17/2023, so this was an extra unnecessary dose. Patient has experience no other symptoms except for normal injection site reactions (soreness)
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Exposure during pregnancy, Immediate post-injection reaction, Limb discomfort, Loss of personal independence in daily activities
Clinical narrative: Patient received a TDAP vaccine last week as part of routine 28 week prenatal care, which caused significant pain and discomfort in her right arm and shoulder. The pain was immediate and has persisted for eight days, making it difficult to sleep. It is described as throbbing and deep, not typical muscle soreness. Patient is concerned that the vaccine was administered too high, possibly affecting the rotator cuff. There are no visible signs of redness, warmth, or rash on the arm. No numbness or tingling in the fingers, but the pain is severe enough to interfere with daily activities. She is also concerned about the potential impact of the vaccine on her baby. Planning for RT shoulder ultrasound. treating with cyclobenzaprine and tylenol.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal discomfort, Pain, Pain in extremity, Sleep disorder
Clinical narrative: Patient received a TDAP vaccine last week as part of routine 28 week prenatal care, which caused significant pain and discomfort in her right arm and shoulder. The pain was immediate and has persisted for eight days, making it difficult to sleep. It is described as throbbing and deep, not typical muscle soreness. Patient is concerned that the vaccine was administered too high, possibly affecting the rotator cuff. There are no visible signs of redness, warmth, or rash on the arm. No numbness or tingling in the fingers, but the pain is severe enough to interfere with daily activities. She is also concerned about the potential impact of the vaccine on her baby. Planning for RT shoulder ultrasound. treating with cyclobenzaprine and tylenol.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pain, Pyrexia
Clinical narrative: pt reported pain, fever and redness in arm.  pt stopped by pharmacy on 02/15/25 to have redness checked.  about a 2 inch diameter of redness was around injection side.  no visible swelling observed. rph advised pt to place a cool pack on it to help with redness.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood pressure increased, Dizziness, Head discomfort, Headache
Clinical narrative: 3 days after vaccination I experienced severe Lightheadedness, rise of blood pressure, bad headache and pressure inside my head. Those symptoms were coming back about 10 days after vaccination.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Mentioned getting rash and itchiness on area got vaccine. Said been getting better since getting vaccine a week ago, but reporting for precaution
Age: 37.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Sapovirus test positive, Urinary tract infection
Clinical narrative: Tested positive for sapovirus and a UTI
Age: 86.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient received a Arexvy vaccination on 1/23/24. She did not require a revaccination.  Another dose was administered on 2/13/25.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: On 2-15-25-PATIENT REPORTED A SEVERE REACTION TO FLUAD INJECTION, IN BED FOR 2.5 DAYS (FEVER, CHILLS, ACHES). SHE STATED SHE ALSO HAD A SEVERE REACTION TO SHINGRIX IN PAST. I RECOMMENDED REPORTING TO HER FAMILY DOCTOR (NOT ABLE TO TOLERATE ADJUVANTS) SHE STATED SHE DID NOT HAVE ISSUES IN THE PAST WITH FLU SHOTS.
Age: 65.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, Pain in extremity
Clinical narrative: Patient received a prior RSV (Arexvy) on 10/29/2023 and was revaccinated on 2/15/2025. Pharmacist spoke to patient and he had a sore arm for a few hours which has since resolved. Patient feels well.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Pruritus, Pyrexia, Rash morbilliform, Swelling
Clinical narrative: Fever, measles like rash all over body, itching and swelling
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Acoustic stimulation tests abnormal, Ear inflammation, Ear injury, Hypoacusis, Sinus congestion
Clinical narrative: After receiving seasonal flu vaccine, approximately 13 hours later, awoke in the night with ringing in left ear and sinus congestion. Treated with OTC decongestant medication,  allertec nose spray.  No change to ringing in ear, after weeks  of otc treatment.  Sought medical advice/treatment .
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Sleep disorder, Tinnitus
Clinical narrative: After receiving seasonal flu vaccine, approximately 13 hours later, awoke in the night with ringing in left ear and sinus congestion. Treated with OTC decongestant medication,  allertec nose spray.  No change to ringing in ear, after weeks  of otc treatment.  Sought medical advice/treatment .
Age: 64.0
Sex: F
Vaccine: RSV
Symptoms: Blood blister, Injection site bruising, Injection site pain, Injection site reaction, Injection site scab
Clinical narrative: patient experienced a bruise/ blood blister at injection site that eventually scabbed over and is about the size of a quarter about 10 days after vaccination. patient went to physician 2/15/25 because area is now warm, painful and scab is not healing.
Age: 64.0
Sex: F
Vaccine: RSV
Symptoms: Injection site warmth
Clinical narrative: patient experienced a bruise/ blood blister at injection site that eventually scabbed over and is about the size of a quarter about 10 days after vaccination. patient went to physician 2/15/25 because area is now warm, painful and scab is not healing.
Age: 79.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received inappropriate dose of Prevnar 20. Patient had already received Prevnar 20 in 2023 but was not recorded on state system. Patient reports no adverse effects from having additional dose.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Ventricular extrasystoles
Clinical narrative: Lightheaded than developed pvcs
Age: 33.0
Sex: F
Vaccine: RSV
Symptoms: Blood pressure increased, Delivery, Exposure during pregnancy, Induced labour, Pre-eclampsia
Clinical narrative: I was given the vaccine at 34 weeks pregnant. Prior to that my blood pressure had been very good (113/80). Two weeks later my blood pressure was in the 140's. The following week (37 weeks pregnant; December 23rd) my blood pressure was 164/109. I was sent to labor and delivery. There my blood pressure was 173. I was diagnosed with pre-eclampsia and induced. Baby was born 10:36 am December XX, 2024, weighing 7lbs 10oz.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Amniocentesis abnormal, Exposure during pregnancy, Foetal growth abnormality, Stillbirth, Trisomy 18
Clinical narrative: First child, diagnosed with trisomy 18. Fetal growth issue. Still born at 32 months pregnant
Age: 67.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site mass, Injection site warmth, Pain in extremity
Clinical narrative: Large very red area at injection site. Sore arm.  Large lump in left arm at injection site.  This continued to be red and hot to the touch.  The lump. erythema and pain were still evident 2 weeks post injection which warranted my phone call to my PCP and visit to him the next day.   On 4/28/24 I still had a lump in my left arm from the injection.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac failure congestive, Dyspnoea
Clinical narrative: sudden breathing difficulty, 02sat rate at 77.  Admitted to hospital with congestive heart failure.  Never had any history of cardiac ailments.   Now it is permanent.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anal abscess, Anal fissure, Anal fistula, Exercise tolerance decreased, Gait inability
Clinical narrative: After getting the 2nd shot, 7 months later my body had developed a perianal fistula, 2 abscesses, an external fissure and a hemmroid.  I was not able to sit, walk, run, exercise, etc for over 2 years. Specialty docs wanted to give me another colostomy bag as they said that s the only cure. I refused. I found Dr through a social media support group for fistulas. I went to out of the country twice to get fixed in 2023 & 2024 and still am healing from it.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Haemorrhoids, Surgery
Clinical narrative: After getting the 2nd shot, 7 months later my body had developed a perianal fistula, 2 abscesses, an external fissure and a hemmroid.  I was not able to sit, walk, run, exercise, etc for over 2 years. Specialty docs wanted to give me another colostomy bag as they said that s the only cure. I refused. I found Dr through a social media support group for fistulas. I went to out of the country twice to get fixed in 2023 & 2024 and still am healing from it.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Blepharospasm, Hyperhidrosis, Otolithiasis, Tremor, Vertigo
Clinical narrative: Shaking sweats disabling
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Vestibular disorder, Vision blurred
Clinical narrative: Shaking sweats disabling
Age: 61.0
Sex: M
Vaccine: UNK
Symptoms: Bell's palsy, Cardiac failure congestive, Laboratory test
Clinical narrative: Bell's palsey and Congestive heart failure
Age: 48.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Chest pain, Computerised tomogram, Gastric dilatation, Magnetic resonance imaging, Portal shunt procedure
Clinical narrative: Blown up stomach felt like heart attack dx portal vein. Thrombosis
Age: 48.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Portal vein thrombosis, Ultrasound abdomen
Clinical narrative: Blown up stomach felt like heart attack dx portal vein. Thrombosis
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Rash erythematous, Rash pruritic, Swelling face
Clinical narrative: I received my first Shingrix shingles shot on 2/8/25.  The following Wednesday (2/12) 4 days after my vaccination, I noticed a red swollen itchy patch next to my left eye.  Thursday (2/13) the red patch had spread to the top left of my forehead and in my scalp back toward the center/top of my head. I saw a provider at my local urgent care today (2/16/25) and she diagnosed me with shingles.  I have never been diagnosed or shown symptoms of shingles.
Age: 0.42
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Rash
Clinical narrative: Rash within an hour  and red spots also we had told the doctor we did not want that vaccine and he was given it anyway because the doctor said they were on auto pilot.