chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Erythema, Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, more than 2 years after receiving Shingles vaccine and more than a year after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 22-MAR-2025 This case was reported by a patient via interactive digital media. Patient had both shingles shots back in 2019.  The year after, he/she got shingles, but it was such a mild case that he/she had to have his/her physician verify that it had truly been shingles.  It was one patch of red approximately one and one-half inches by one inch with one tiny little blister just below his/her waist on his/her left side.  Patient experienced no pain, no itching, and absolutely no discomfort.  He/she was so glad he/she had gotten the vaccine.  The reporter asked what could had been agony turned out to be no big deal.  The vaccine had worked. This case was considered as suspected vaccination failure as details regarding  laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine (1st  dose)and Shingles vaccine( 2nd dose).
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; had the shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had the shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 23-MAR-2025 This case was reported by a patient via interactive digital media. The reporter reported that get the vaccine, he/she did and had the shingles but a less severe case. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine.
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Stress, Vaccination failure
Clinical narrative: suspected vaccination failure; got the shingles; lot of stress; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: got the shingles) and stress (Verbatim: lot of stress). The outcome of the vaccination failure and stress were not reported and the outcome of the shingles was resolved.   It was unknown if the reporter considered the vaccination failure, shingles and stress to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure, shingles and stress to be unrelated to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 23-MAR-2025 This case was reported by a patient via interactive digital media. The patient received both shots of Shingles vaccine, also but after a lot of stress the patient got the shingles. The patient was thankful for the shots as the shingles were very much lighter and have not last as long. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. This is 1 of the 3 cases reported by the same reporter.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description,  time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. Herpes zoster and Stress are unlisted events which are considered unrelated to GSK Shingles vaccine. US-GSK-US2025AMR036152:Different Patient US-GSK-US2025AMR036211:Different Patient
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; come down with the shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 60-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In AUG-2024, the patient received the 2nd dose of Shingrix. In FEB-2024, the patient received the 1st dose of Shingrix. In MAR-2025, between 6 and 8 months after receiving Shingrix and between 1 and 2 years after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: come down with the shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 24-MAR-2025 The case was received from the patient via (Shingrix GSK CHATBOT) interactive digital media. The patient had both Shingrix shots and in March of 25 he/she come down with the shingles.  The patient was wondering when or if he/she should another shot. This case was considered as suspected vaccination failure as details regarding completion laboratory confirmation regarding shingles was unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (1st dose)and Shingrix(2nd dose)
Age: 10.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Engerix-B admisnitered after given an expired dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 10-year-old female patient who received HBV (Engerix B) (batch number EP274, expiry date 14-MAR-2025) for prophylaxis.   On 19-MAR-2025, the patient received Engerix B. On 19-MAR-2025, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Engerix-B admisnitered after given an expired dose). The outcome of the expired vaccine used 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: 19-MAR-2025 A registered nurse wanted to know the efficacy on Engerix-B immunization after given an expired dose to patient after the expiration date (less than 30 days), which led to expired vaccine used. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up. This case was linked with case US2025033673 reported by the same reporter, for different patient.; Sender's Comments:  US-GSK-US2025033673:Same reporter/Different patient
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: missed her 2nd dose, and is almost time for her 3rd dose of Twinrix"; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 83-year-old female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (1st dose received on 16-SEP-2024, batch number-344J3 and expiry date 12-SEP-2026).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: missed her 2nd dose, and is almost time for her 3rd dose of Twinrix"). The outcome of the incomplete course of vaccination 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: 20-MAR-2025 The patient that missed her 2nd dose, and was almost time for her 3rd dose of Twinrix. Till the time of reporting the patient had not received the second dose of Twinrix, which led to incomplete course of vaccination. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.
Age: 67.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: Incorrect Route of Administration; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a 67-year-old female patient who received MMR (Priorix) (batch number 42ZS4) for prophylaxis.   On 19-MAR-2025, the patient received Priorix (intramuscular). On 19-MAR-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: Incorrect Route of Administration). The outcome of the subcutaneous injection formulation administered by other route 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: 20-MAR-2025 Pharmacist called and reported recently received the MMR vaccine, the Priorix administered to patient at pharmacy intramuscularly instead of Subcutaneously, which led subcutaneous injection formulation administered by other route and just wondering if that dose has been studied that way or it has to be readministered. The reporter consented to follow up.
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: A patient received a dose of Priorix via Intramuscular instead of subcutaneous injection; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a female patient who received MMR (Priorix) (batch number 4N222, expiry date 13-SEP-2026) for prophylaxis.   On an unknown date, the patient received Priorix (intramuscular). On an unknown date, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: A patient received a dose of Priorix via Intramuscular instead of subcutaneous injection). The outcome of the subcutaneous injection formulation administered by other route 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: 21-MAR-2025 A pharmacist reported that a female patient received Priorix intramuscularly instead of subcutaneously which led to subcutaneous injection formulation administered by other route. The reporter wanted to know if it was going to be harmful for the patient.
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: there is no record of a second dose administered, so caller is not sure if the patient got the second dose at the appropriate time; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: there is no record of a second dose administered, so caller is not sure if the patient got the second dose at the appropriate time). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 28-MAR-2025 The pharmacist mentioned that a patient got their first dose of Shingrix on 2020, and patient was sure that they got their second dose, but when they went to the pharmacy, there is no record of a second dose administered,  The reporter not sure if the patient got the second dose at the appropriate time which led to incomplete course of vaccination. They thought on administering a dose now (not administered yet, at the moment of the call), but not sure in case they do it, that would be a late second dose or an extra dose. The pharmacist did not have additional details and offered to bring the patient to the line, but since it was also requested Medical Information, agent decided to start providing the Medical Information data since that is exclusively for Healthcare Providers and not for patients, but pharmacist got impatient and decided to only receive information via email and ended the call
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: she had joint pain with the "first series" of covid vaccines which was awhile; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID:.  A 47-year-old female patient received BNT162b2 (BNT162B2), in Dec2020 as dose 1, single (Batch/Lot number: unknown) at the age of 47 years for covid-19 immunisation. The patient's relevant medical history included: "little bit fat" (unspecified if ongoing), notes: no significant health conditions other than being a "little bit fat". The patient's concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "she had joint pain with the "first series" of covid vaccines which was awhile".  Additional information: She also noted that she had joint pain with the "first series" of covid vaccines which was awhile. The first and second dose in the fall of the first year it was approved for emergency use authorization. She wants to know if she should be concerned about getting another vaccine booster and if the forehead numbness could be a build up of too much of the spike proteins. Her pharmacist said not to worry about the forehead numbness as they had heard about this before.  Caller states she has no significant health conditions other than being a "little bit fat".  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-202500069769 Same patient and product; different dose and event;US-PFIZER INC-202500069770 Same patient and product; different dose and event;
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Pain in extremity, Vaccination site mass, Vaccination site pain
Clinical narrative: constant pain/the second dose was very painful/Spot where she had the 2nd one that every now and then has pain there; hand pain with cramping; hand pain with cramping; spot there is a boil or a bump at the injection site/bump started coming up 2 weeks ago; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 71-year-old 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 was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 omicron (kp.2) (dose 1), for COVID-19 immunization, reaction(s): "everything was ok". The following information was reported: VACCINATION SITE MASS (non-serious) with onset Mar2025, outcome "unknown", described as "spot there is a boil or a bump at the injection site/bump started coming up 2 weeks ago"; VACCINATION SITE PAIN (non-serious), outcome "not recovered", described as "constant pain/the second dose was very painful/Spot where she had the 2nd one that every now and then has pain there"; PAIN IN EXTREMITY (non-serious), MUSCLE SPASMS (non-serious), outcome "unknown" and all described as "hand pain with cramping". Additional information: Patient is currently taking a blood pressure medication. Patient had three of the Pfizer Covid vaccines. The first one and third one were fine. The second was very painful and took a long time before the pain went away. Spot where she had the 2nd one that every now and then has pain there that comes and goes.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.  Follow-up (01Apr2025): This is a spontaneous follow-up report received from a Consumer or other non HCP. Updated information: reporter contact details, event Pain recoded to Vaccination site pain, Vaccination site mass verbatim updated, clinical course.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: she might have COVID too; she might have COVID too; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary Immunization series complete), for covid-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "she might have COVID too". The clinical course was reported as follows:   the patient's husband had COVID, and the reporter stated she might have COVID too. They got all those COVID-19 shots; they were all Pfizer.   The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Positive for COVID-19; Positive for COVID-19; This is a spontaneous report received from a consumer, Program ID: .  An 80-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Brought COVID-19 home from the gym ", start date: 16Feb2024 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19Feb2024, outcome "unknown" and all described as "Positive for COVID-19". The event "positive for covid-19" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Feb2024) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient's wife was to enroll the patient. A year ago, the physician prescribed nirmatrelvir/ritonavir (PAXLOVID) to patient in case they got it, but did not get it. Both the patient and wife have COVID-19, and they are currently sharing a box and the physician called in another prescription for PAXLOVID for both of them to take together. It was further reported that they got a box about a year and a half ago (2022) because they were going on vacation and then they didn't use it. And so, the patient brought COVID-19 home from the gym on Friday (16Feb2024). And so, on Saturday (17Feb2024), the patient's wife started to feel sick. Yesterday (19Feb2024), they took the test, and they were both positive so they shared the beginning of the first box and so by tomorrow night there will be like one sheet left. They were splitting the first box. By tomorrow (21Feb2024) after the morning dosage, only one of them would be able to go another day. This area was supposed to have really high COVID-19. Neither the patient nor his wife has ever gotten it. They' had all the vaccines, every single one of them.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500070647 Same reporter, product, and event; different patient;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: diagnosed with COVID-19; diagnosed with COVID-19; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A 78-year-old 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 included: "COVID-19", start date: 2022 (unspecified if ongoing), notes: He wound up in the hospital three times three years ago. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary Immunization series complete), for COVID-19 immunization; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTER)), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2025, outcome "unknown" and all described as "diagnosed with COVID-19". The clinical course was reported as follows: The patient's wife reported that her husband was recently diagnosed with COVID-19. He contracted it again, and his doctor prescribed nirmatrelvir;ritonavir (PAXLOVID) to him on the morning of 01Apr2025. He has not been sleeping well and was quite sick. The reporter mentioned that they got all those COVID-19 shots; he must have had seven of them; they were all Pfizer.   The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: have given Fluzone HD to patients younger than indicated with no adverse event; Initial information received on 27-Mar-2025 regarding an unsolicited valid  non-serious case received from a consumer/non-heathcare professional.  This case involves Adult and unknown gender patient who received influenza USP trival A-B high dose subvirion vaccine [fluzone high dose] younger than indicated with no Adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received 1ml dose (once) of suspect influenza USP trival A-B high dose subvirion vaccine, Suspension for injection in pre-filled syringe, unknown strength and expiry date, lot number not reported via intramuscular route in unknown administration site for flu vaccine (flu immunisation) earlier than indicated age with no adverse event (product administered to patient of inappropriate age) (latency same day).   There will be no information on batch number and expiration date corresponding to the one at time of event occurrence.  Action taken was not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  No follow-up is possible as Reporter cannot be contacted by Sanofi
Age: 65.0
Sex: F
Vaccine: PNC21
Symptoms: Cough, Headache, Injection site erythema, Injection site pain, Nausea
Clinical narrative: Developed cough, body aches, headache, sore throat and nausea, sore arm, redness, tenderness at injection site.  (Baseball size) Self treated with Tylenol and OTC cold medicine.  arm redness, swelling went down within 24 hours.  Declined office visit to assess.
Age: 65.0
Sex: F
Vaccine: PNC21
Symptoms: Oropharyngeal pain, Pain, Pain in extremity, Swelling
Clinical narrative: Developed cough, body aches, headache, sore throat and nausea, sore arm, redness, tenderness at injection site.  (Baseball size) Self treated with Tylenol and OTC cold medicine.  arm redness, swelling went down within 24 hours.  Declined office visit to assess.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: Lump, hot, redness/swelling. Large but localized to vaccine site.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: Lump, hot to touch, red, swollen area. Large but localized to injection site.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: Lump, hot to touch, red, swollen area. Large but localized to injection site.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac failure, Cerebrovascular accident
Clinical narrative: stroke and heart failure
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: Lump, hot to touch, red, swollen area. Large but localized to injection site.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Throat tightness, Tongue disorder
Clinical narrative: pt says she began having shortness of breath and her chest became tight. She noticed her throat started closing. She took a Benadryl and  then about an hour and half later she took another Benadryl. Her throat is still tight and her tongue feels thick but she is not having any trouble breathing. She is going to reach out to the pharmacy and her allergist.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Generalised tonic-clonic seizure
Clinical narrative: The patient stated that she has been on Keppra since having a grand mal seizure 3 weeks to a month after receiving her third covid vaccination  (first booster) on 8/14/21 at pharmacy (Moderna) Lot 049E21A
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Dizziness, Hyperhidrosis, Pallor, Vision blurred
Clinical narrative: Approxametly 4 minutes post vaccination, student felt dizzy, starting looking pale when he stood up after vaccination and quickly lost his footing. RN vaccinating helped the patient lay down on the floor with support by another nurse. Student reported having blurry vision, "not feeling good," diaphoretic. BP taken laying down 90/110. Legs slightly elevated to increase blood flow, pt laid down for about 5minutes. He was able to sit up and tolerate drinking juice box, BP rechecked 100/70. Student ambulated with stand-by assist to bed-cot with RN and rested for 10min before returning to class. Parents were notified. BP rechecked 102/70 9:25. Returned to class 9:28am.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Passed away
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site mass
Clinical narrative: The patient came to the pharmacy on 4/2/25 and stated that he has a bump on his arm on the spot that he received a shingles vaccine 5 months prior on 11/8/24 and he thinks it's the adverse effect from that vaccine
Age: 28.0
Sex: F
Vaccine: IPV, MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This nurse inadvertently administered a third (not needed) dose of the MMR vaccine. It was administered as one of patient's two previously received doses was marked as invalid on patient's forecaster report.  Patient had no symptoms/signs/no outcomes or treatment needed.
Age: 77.0
Sex: M
Vaccine: PNC20
Symptoms: Extra dose administered
Clinical narrative: unneeded vax. Pt had already received 3/1/25
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received additional Quadracel and Proquad, no adverse reactions or symptoms.
Age: 45.0
Sex: F
Vaccine: UNK
Symptoms: Injection site pain, Product preparation issue
Clinical narrative: Patient was given the diluent of sterile water instead of the flu vaccine. Patient stated the injection stung and hurt but no other effects.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Behcet's syndrome, Biopsy skin abnormal, Skin lesion, Ulcer
Clinical narrative: Triggered autoimmune response. Lesions and ulcers.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: I'm not sure of the exact date and time of the shot, but my arm is still sore after a month and I can't lift it as high as I could previously. It hurts if I try to lift it, or scratch my back. My left arm has has had more flexibility since I had a double neck fusion 15+ years ago, but now I can't do as much with it.
Age: 35.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient given expired vaccine, no symptoms.  Patient informed.  Patient scheduled to come back in 2 weeks to receive vaccine.
Age: 18.0
Sex: M
Vaccine: HPV9, MENB, MNQ, TDAP
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: After administration of HPV vaccine, patient stated he "feels woozy" then lost consciousness. Patient transferred to bed and feet elevated above heart level and regain consciousness. Vitals checked: bp 109/69, hr 69, resp 20, and 02 sat 98% on ra. Mother and patient report that he did not eat breakfast and has had similar incidents at school when seeing blood. Patient given peanut butter crackers and water, and continued to rest for 10 minutes. Vitals rechecked bp 107/74, hr 85, resp 18, and O2 sats 98% on RA. Then slowly positioned to sitting position for 5 minutes then to standing. He became dizzy again, then positioned to a lying with elevated feet position again and allowed to rest for another 10 minutes. Slowly repositioned and states he was feeling better.
Age: 28.0
Sex: M
Vaccine: TDAP
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Pt received TDAP vaccine in L deltoid on 1/2/25, has been having arm pain and loss of ROM since injection.
Age: 1.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Injection site erythema, Pyrexia, Rash, Rash erythematous, Rash maculo-papular
Clinical narrative: Fever onset 4 pm with rash. Maculopapular erythematous rash over abdomen, back and legs, not itchy, redness at injection site also. T 103.5, tachycardia
Age: 1.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Tachycardia, Viral infection
Clinical narrative: Fever onset 4 pm with rash. Maculopapular erythematous rash over abdomen, back and legs, not itchy, redness at injection site also. T 103.5, tachycardia
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC20
Symptoms: Body temperature increased, Eye movement disorder, Fall, Hypotonia, Loss of consciousness
Clinical narrative: Vaccine given on 4/2/2024, then on 4/8/2024 around 4:45 PM patient (1 year old) was playing with blocks sitting on the floor with me (mom) and suddenly went unconscious and "fell" face forward to the ground, limp. I quickly picked her up and her eyes rolled to the back of her head and she was limp in my arms for 20-30 seconds. After that time passed she began throwing up. Her temperature was taken after the fact and it was around 101.2, I called the pediatrician who informed me to go to urgent care (it was after hours) so we did that. Her temperature at the urgent care was 99.68.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC20
Symptoms: Vomiting
Clinical narrative: Vaccine given on 4/2/2024, then on 4/8/2024 around 4:45 PM patient (1 year old) was playing with blocks sitting on the floor with me (mom) and suddenly went unconscious and "fell" face forward to the ground, limp. I quickly picked her up and her eyes rolled to the back of her head and she was limp in my arms for 20-30 seconds. After that time passed she began throwing up. Her temperature was taken after the fact and it was around 101.2, I called the pediatrician who informed me to go to urgent care (it was after hours) so we did that. Her temperature at the urgent care was 99.68.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Extra dose administered
Clinical narrative: Vaccine had already been administered. Duplicate vaccine given. Patient received Prevnar 20 on 3/8/2023.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Rotator cuff syndrome, Tendon pain
Clinical narrative: Rotator cuff tendinitis pain starting the day after injection, when there was none previously.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Administration of vaccine past expiration date. No reaction reported.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Angina pectoris, Cellulitis, Chills, Fatigue, Injection site reaction
Clinical narrative: Patient developed left sided chest pain and tingling that developed day of administration.  She also developed a welt at the site of administration the next day. She took benadryl daily for the rash however it continued to enlarge. She developed fatigue and chills. She presented to my office 4/7/25 and was found to have a cellulitis on the left arm for which she was prescribed antibiotics.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Rash, Urticaria
Clinical narrative: Patient developed left sided chest pain and tingling that developed day of administration.  She also developed a welt at the site of administration the next day. She took benadryl daily for the rash however it continued to enlarge. She developed fatigue and chills. She presented to my office 4/7/25 and was found to have a cellulitis on the left arm for which she was prescribed antibiotics.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine administered after expiration date. No adverse reaction reported.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine administered after expiration date at room temperature of 60 days receiving vaccine on 12/31/2024, no adverse reaction reported.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine administered after expiration date at room temperature of 60 days receiving vaccine on 12/31/2024, no adverse reaction reported.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine administered after expiration date at room temperature of 60 days receiving vaccine on 12/31/2024, no adverse reaction reported.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Antinuclear antibody increased, Rash
Clinical narrative: Post-Moderna vaccination (doses 1 and 2), I developed an elevated ANA and a groin area skin rash.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Diarrhoea, Fatigue, Muscle spasms, Oropharyngeal pain
Clinical narrative: I had the same symptoms with the first and second shot. With the first shot I did not know it was the vaccine until it happened again with the second shot. Flu like symptoms with sore throat, extreme muscle cramping and joint pain and swelling, slight fever, fatigue, explosive foul smelling diarrhea.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Swelling
Clinical narrative: I had the same symptoms with the first and second shot. With the first shot I did not know it was the vaccine until it happened again with the second shot. Flu like symptoms with sore throat, extreme muscle cramping and joint pain and swelling, slight fever, fatigue, explosive foul smelling diarrhea.
Age: 1.25
Sex: M
Vaccine: HEPA
Symptoms: No adverse event
Clinical narrative: parent reports no adverse reaction
Age: 60.0
Sex: F
Vaccine: PNC21
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy, stable
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Abdominal pain upper, Asthma, Dyspepsia, Injected limb mobility decreased, Injection site pain
Clinical narrative: Severe stomach pain (burning/cramping), nausea, prolonged pain at injection site as well as not being able to move left arm weeks after injection, asthma suspected.  Treatment/test for GI issues was out of state at another hospital.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Laboratory test, Nausea
Clinical narrative: Severe stomach pain (burning/cramping), nausea, prolonged pain at injection site as well as not being able to move left arm weeks after injection, asthma suspected.  Treatment/test for GI issues was out of state at another hospital.
Age: 37.0
Sex: M
Vaccine: SMALL
Symptoms: Borrelia test negative, Brain fog, Chronic sinusitis, Disorientation, Disturbance in attention
Clinical narrative: Symptom 1: Brain Fog / disorientation. Started day after vaccine and lasted for approximately 2 years. Symptoms improved immediately upon self administering white pine needle tea. Symptom 2: Vertigo / chronic sinusitis. Symptoms started day after vaccine and included extreme vertigo. Verito symptoms lessoned over the course of approximately 6 months but persisted / did not clear 100%. Initially I described it as a feeling of dizziness and pressure between the eyes that would come in waves and at its worse roll through to the back of the head inducing nausea. Conducted several tests including comprehensive metabolic panel (8/5/2021),  ENT checkup (date unknown ~8/21), MRI brain scan (1/19/2022), and Lyme disease test (1/21/2022) all of which were normal / negative.  The feeling of water in the ear has persisted and still present. Self diagnosis includes chronic sinusitis although this was not acknowledged by (or suggest to) healthcare providers at the time of investigation (21-22).  Symptoms improve with manually assisted sinus draining. Persistent symptoms include sinus pressure (forehead between eyes) and the feeling of vertigo although appears to be related to sinus pressure rather than other causes of vertigo. Symptoms started the day after the vaccine and have improved, but not 100%. Symptoms impact sleep as they worsen while laying down. Ability to focus is reduced due to distraction from sinus pressure. Treatments tried include long term additional water intake and administration of flonase (neither helped).
Age: 37.0
Sex: M
Vaccine: SMALL
Symptoms: Dizziness, Ear discomfort, Head discomfort, Magnetic resonance imaging head normal, Metabolic function test normal
Clinical narrative: Symptom 1: Brain Fog / disorientation. Started day after vaccine and lasted for approximately 2 years. Symptoms improved immediately upon self administering white pine needle tea. Symptom 2: Vertigo / chronic sinusitis. Symptoms started day after vaccine and included extreme vertigo. Verito symptoms lessoned over the course of approximately 6 months but persisted / did not clear 100%. Initially I described it as a feeling of dizziness and pressure between the eyes that would come in waves and at its worse roll through to the back of the head inducing nausea. Conducted several tests including comprehensive metabolic panel (8/5/2021),  ENT checkup (date unknown ~8/21), MRI brain scan (1/19/2022), and Lyme disease test (1/21/2022) all of which were normal / negative.  The feeling of water in the ear has persisted and still present. Self diagnosis includes chronic sinusitis although this was not acknowledged by (or suggest to) healthcare providers at the time of investigation (21-22).  Symptoms improve with manually assisted sinus draining. Persistent symptoms include sinus pressure (forehead between eyes) and the feeling of vertigo although appears to be related to sinus pressure rather than other causes of vertigo. Symptoms started the day after the vaccine and have improved, but not 100%. Symptoms impact sleep as they worsen while laying down. Ability to focus is reduced due to distraction from sinus pressure. Treatments tried include long term additional water intake and administration of flonase (neither helped).
Age: 37.0
Sex: M
Vaccine: SMALL
Symptoms: Nausea, Paranasal sinus discomfort, Sleep disorder, Vertigo
Clinical narrative: Symptom 1: Brain Fog / disorientation. Started day after vaccine and lasted for approximately 2 years. Symptoms improved immediately upon self administering white pine needle tea. Symptom 2: Vertigo / chronic sinusitis. Symptoms started day after vaccine and included extreme vertigo. Verito symptoms lessoned over the course of approximately 6 months but persisted / did not clear 100%. Initially I described it as a feeling of dizziness and pressure between the eyes that would come in waves and at its worse roll through to the back of the head inducing nausea. Conducted several tests including comprehensive metabolic panel (8/5/2021),  ENT checkup (date unknown ~8/21), MRI brain scan (1/19/2022), and Lyme disease test (1/21/2022) all of which were normal / negative.  The feeling of water in the ear has persisted and still present. Self diagnosis includes chronic sinusitis although this was not acknowledged by (or suggest to) healthcare providers at the time of investigation (21-22).  Symptoms improve with manually assisted sinus draining. Persistent symptoms include sinus pressure (forehead between eyes) and the feeling of vertigo although appears to be related to sinus pressure rather than other causes of vertigo. Symptoms started the day after the vaccine and have improved, but not 100%. Symptoms impact sleep as they worsen while laying down. Ability to focus is reduced due to distraction from sinus pressure. Treatments tried include long term additional water intake and administration of flonase (neither helped).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Pain, Rheumatoid arthritis
Clinical narrative: After getting the vaccine i have been in constant pain and flare-up,  no medication works and I am in pain i was prescribed prednisone and that increased ICT and I needed to be on Diamox so I would go blind.
Age: 16.0
Sex: F
Vaccine: FLU3, MNP
Symptoms: Dizziness, Dyskinesia, Loss of consciousness, Memory impairment
Clinical narrative: Patient became dizzy after receiving the vaccine, made involuntary movements such as jumping, does not remember the event when it occurred, regained consciousness a few seconds later
Age: 75.0
Sex: M
Vaccine: HEP
Symptoms: Blood pressure decreased, Chest pain, Dyspnoea, Pruritus
Clinical narrative: within minutes of administration patients blood pressure dropped and pt complained of itchy palms, denies shortness of breath or chest pain. patient was given benadryl 25mg by mouth and patient reported improvement after approximately 20 minutes after benadryl administration.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV9, TDAP
Symptoms: Dizziness, Electric shock sensation, Respiratory rate decreased, Syncope
Clinical narrative: Patient experience syncope symptoms (slowed breathing, felt dizzy and light headed, almost fainted) patient was instructed to stay seated and focus on breathing. 911 called and EMS arrived and patient received full evaluation.
Age: 4.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse events reports at this time
Age: 71.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Contusion, Mobility decreased, Pain, Product administered at inappropriate site, X-ray
Clinical narrative: Patient states vaccine was given quite low. Had severe pain, bruising, and immobility.
Age: 19.0
Sex: F
Vaccine: FLU3, HEP
Symptoms: Anti-cyclic citrullinated peptide antibody positive, Antinuclear antibody positive, Arthralgia, Blood potassium increased, Eosinophil count increased
Clinical narrative: Reaction /Symptoms began around 11/29/24 with rash red splotchy rash on hands, up arm, legs with itching that felt like was beneath my skin and paresthesia. Visited Student Health Services first week of December 2024 because rash and itching did not go away. Prescribed antihistamine and steroid, Symptoms did not resolve and progressed to all over joint pain (hands, fingers, ankles, knees, wrists, elbows so returned to clinic 12/12/24 and saw Dr, Chief Medical Officer and she said it sounded like  serum like sickness  from the vaccine and to not continue series.  Referred to allergist and told to continue Aleve.  12/19/24 visit to Internal Medicine.  Symptoms had somewhat subsided. Dr wrote a waiver to not receive 2nd dose of Hepatitis B vaccine and ordered a complete blood panel and ANA Screen IFA for autoimmune disease. Eosinophils and potassium came back high , ANA panel was normal.  Beginning of January 2025 , symptoms returned and continue to this date. Wake up with swollen hands and fingers that remain that way for hours some days.  Itching, paresthesia, red splotchy rash on hands, wrists, and sometimes knees, comes and goes.  Stiff feeling in hands fingers and ankles.  Itchy eyes and flushed hot feeling and face has also occurred. Established with Dr on 1/15/25. Dr ordered complete blood panel and repeat of ANA Screen and scheduled appointment with rheumatologist on 5/9/24. ANA screen done on 2/14/25 came back abnormal.