chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: Patient received 3 Varivax doses; No adverse event; Proquad administered instead on MMR; This spontaneous report was received from a medical assistant and refers to a 5-year-old patient of an unspecified gender.  The patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  On an unspecified date, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, administered for prophylaxis (strength, exact dose, lot #, expiry date, and route of administration were not provided). On 10-AUG-2022 and on 19-APR-2024, the patient was vaccinated with other doses of varicella virus vaccine live (oka/merck) (VARIVAX) injection, administered for prophylaxis (strength, exact dose, lot #, expiry date, and route of administration were not provided). The patient reportedly received three doses of varicella virus vaccine live (oka/merck) (VARIVAX) prior to receiving PROQUAD (no additional information provided. Vaccination dates not provided) (Extra dose administered). On 29-AUG-2024, the patient was inadvertently administered the wrong vaccine. The patient reportedly should have received the "plain  Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (reported as MMR vaccine)" but instead was given the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human Albumin)(PROQUAD) injection, 1 dose, lot #X018584, expiration date was reported and confirmed as 05-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided) (Wrong product administered). Operator of device was a health professional. The office has been in contact with the patient's parents, and they reported the patient has had no fever, or any swelling. The office reported they were unaware of any adverse event and would contact the company should one be reported to them. No additional adverse events were reported. No further information provided. No product quality complaint.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: CP called to report TE for ROTATEQ.  TE filed: 02669891. Caller reports product was administered.  No symptoms reported.  Consent to correspond was granted.  No additional AE/No PQC.  Names of vaccines involved (including lot/exp) ROTATEQ 975783 10/1; No additional AE; This spontaneous report was received from an other health professional regarding to a 6-month-old patient with unknown gender.  The patient's medical history, concomitant medications, and previous drug reactions or allergies were not reported.   On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2.0ml, administered for prophylaxis, reported lot #955783 with an expiration date on 10-DIC-2024, is an invalid number for rotavirus vaccine, live, oral, pentavalent (ROTATEQ), (strength, vaccination scheme, and site of vaccination were not provided). The administered dose of the vaccines were stored at 8.6 C for 10 minutes (product storage error) with no previous temperature excursion. No additional AE. At the time of reporting. (No adverse event)
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Discomfort, Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I have shingles now; feeling uncomfortable; 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 (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and VARICELLA ZOSTER VACCINE for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix, the 1st dose of Shingrix and VARICELLA ZOSTER VACCINE. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: I have shingles now) and discomfort (Verbatim: feeling uncomfortable). The outcome of the vaccination failure and discomfort were not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and discomfort to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be related to Shingrix and Shingrix. It was unknown if the company considered the shingles and discomfort to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 04-SEP-2024 This case was reported by a patient via interactive digital media. The patient had shingles at the time of reporting. The patient had the old Shingles vaccine and the Shingrix series. The patient stated that it was very uncomfortable, but was hoping by having the vaccines, that case will be mild. 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. It was unknown if the reporter considered the vaccination failure, shingles and discomfort to be related to Varicella zoster vaccine. The follow-up could not be possible as no contact details were available.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK vaccine Shingrix.
Age: 46.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: late 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 46-year-old female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (1st dose received on an unknown date). Concomitant products included Hepatitis b vaccine rHBsAg (yeast) (Heplisav b).   On 03-SEP-2024, the patient received the 2nd dose of Twinrix. On 03-SEP-2024, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: late 2nd dose). The outcome of the drug dose administration interval too long was not reported.   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: 07-SEP-2024 Pharmacist asked about a female adult patient that received a late second dose (more than 6 months) in between the first and second dose. Pharmacist wanted to advise on the proper time/schedule for this patient to receive the third dose. Vaccine and vaccination date detail, as well as patient demographics were completed in the sections above. No further information was provided from the pharmacist end during this call. The reporter stated that patient received Heplisav vaccine (Hepatitis B) on Sep 2024. The patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccinations schedule.
Age: 31.0
Sex: M
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: stability data for Menveo (1-vial), Havrix, Boostrix, Infanrix, Engerix-B stored at 33.3F x 14.33 hours.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 31-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 42G27, expiry date 22-SEP-2026) for prophylaxis.   On 15-AUG-2024, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: stability data for Menveo (1-vial), Havrix, Boostrix, Infanrix, Engerix-B stored at 33.3F x 14.33 hours.). The outcome of the incorrect storage of drug 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: 04-SEP-2024 The other health professional requested stability data for Boostrix stored at 33.3 Fahrenheit for 14.33 hours.  No prior excursions.  The other health professional reported that excursion started on 13th August 2024 and vaccine was used in greater than 10 points since the excursion occurred which led to incorrect storage of drug. The reporter consented to follow up. This was 1 of 5 cases, reported by same reporter.; Sender's Comments:  US-GSK-US2024110258:SAME REPORTER US-GSK-US2024110235:Same reporter US-GSK-US2024110225:Same reporter
Sex: U
Vaccine: HEP, HEP
Symptoms: Underdose
Clinical narrative: administer 2 pediatric doses to adults; administer 2 pediatric doses to adults; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a patient who received HBV (Engerix B pediatric) (batch number 973K4, expiry date 07-APR-2025) for prophylaxis.   Co-suspect products included HBV (Engerix B pediatric) (batch number 973K4, expiry date 07-APR-2025) for prophylaxis.   On an unknown date, the patient received Engerix B pediatric and Engerix B pediatric. On an unknown date, an unknown time after receiving Engerix B pediatric and Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: administer 2 pediatric doses to adults) and underdose (Verbatim: administer 2 pediatric doses to adults). The outcome of the adult use of a child product and underdose were unknown.   Additional Information: GSK Receipt Date: 05-SEP-2024 Healthcare Professional reported that he/she was in a rural area so used Engerix B do the pediatric/adolescent for adults , as well as kids because the reporter did not see enough to order adult and pediatric doses that ended up wasted, they expire before the reproter used them. The reporter did not provide any specific data for patients (DOB, initials, gender) but provided 1 lot number to verify that the vaccine was pediatric dose. According to what reporter saw was a common practice to administer 2 pediatric doses to adults so it was suspected that more than one adult patient was administered 2 pediatric doses to complete the adult recommended dose which led to adult use of a child product and underdose.; Sender's Comments:  US-GSK-US2024110815:same event; same suspect product
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Product preparation issue
Clinical narrative: accidentally administered sterile water to a patient instead of the vaccine; accidentally administered sterile water to a patient instead of the vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 1-year-old female patient who received MMR (Priorix) for prophylaxis.   On 30-AUG-2024, the patient received Priorix. On 30-AUG-2024, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: accidentally administered sterile water to a patient instead of the vaccine) and inappropriate dose of vaccine administered (Verbatim: accidentally administered sterile water to a patient instead of the vaccine). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-SEP-2024 Nurse reported that clinic accidentally administered sterile water to a patient instead of the vaccine which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. Nurse's quality team would like to know if needed to do a VAERS report for this error and if there was any specific guidance your company had.? Upon calling Nurse back, confirmed that the correct reconstituted dose was administered on the same day.
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue
Clinical narrative: pharmacist give a pregnant patient Arexvy; patient younger than 50 years old receievd Arexvy; This non-serious prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 30-AUG-2024, the patient received Arexvy. On 30-AUG-2024, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: patient younger than 50 years old receievd Arexvy). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: pharmacist give a pregnant patient Arexvy). The outcome of the inappropriate age at vaccine administration and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 06-SEP-2024 A pharmacy technician called to inform that they had a pharmacist who gave a pregnant patient a vaccine, the Arexvy even though it was not indicated which led to vaccine exposure during pregnancy. Reporter confirmed that patient was younger than 50 years old which led to inappropriate age at vaccine administration.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: a patient got his first dose of Shingrix on 2022 and now wants to receive the second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received in 2022).   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: a patient got his first dose of Shingrix on 2022 and now wants to receive the second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 06-SEP-2024 The pharmacist reported that if a patient got his first dose of Shingrix on 2022 and now wanted to receive the second dose. The reporter asked if the patient had to restart the series. The patient only had 1 dose at the moment of the call. Till the time of reporting the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Product preparation issue
Clinical narrative: Administration of Only Liquid Component; Administration of Only Liquid Component; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMDBO208, expiry date 03-APR-2025) for prophylaxis.   On 27-AUG-2024, the patient received the 1st dose of Menveo. On 27-AUG-2024, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Administration of Only Liquid Component) and inappropriate dose of vaccine administered (Verbatim: Administration of Only Liquid Component). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 06-SEP-2024 The reporter stated that he/she was the manager of a primary care office, and was reconciling vaccines, and noticed that missed 2 diluents of Menveo vaccine, and knew that somebody received the liquid portion of the 2 dose vial which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The HCP called to report that 3 patients received only the liquid part of the Menveo (2 vial) vaccine, by this, first she said that she could not find 2 liquid portion of the vaccine, so she supposed that 2 patients only received the liquid portion. Later, she said that probably 3 patients received only the liquid portion of this vaccine and she provide the info of this patients. This was 1 of the 3 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024111420:same reporter/different patient US-GSK-US2024111373:same reporter/different patient
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: patient was administered only the adjuvant portion of Shingrix; patient was administered only the adjuvant portion of Shingrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 61-year-old male patient who received Herpes zoster (Shingrix) (batch number BT59B, expiry date 10-AUG-2026) for prophylaxis.   On 06-SEP-2024, the patient received Shingrix. On 06-SEP-2024, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: patient was administered only the adjuvant portion of Shingrix) and inappropriate dose of vaccine administered (Verbatim: patient was administered only the adjuvant portion of Shingrix). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 06-SEP-2024 Registered Nurse reported a patient was administered only the adjuvant portion of Shingrix which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: U
Vaccine: RV1
Symptoms: Poor quality product administered
Clinical narrative: photographs of the PFS with mold; This non-serious case was reported by a consumer via call center representative and described the occurrence of poor quality vaccine administered in a patient who received Rota (Rotarix liquid formulation) for prophylaxis.   On an unknown date, the patient received Rotarix liquid formulation. On an unknown date, an unknown time after receiving Rotarix liquid formulation, the patient experienced poor quality vaccine administered (Verbatim: photographs of the PFS with mold). The outcome of the poor quality vaccine administered 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: 06-SEP-2024 Immunizations manager reported that customer sent photographs of Rotarix syringes that showed mold. The reporter thought this was a multilevel case, a Quality complaint and a possible adverse event and should report as well an adverse event She said that she received an email with photographs of the PFS with mold. She was not sure if this was a suspected adverse event because of the mold present. MI agent asked if, she knew if any patient had been administered with the vaccine but she was not sure which led to poor quality vaccine administered.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Immunisation reaction, Pyrexia
Clinical narrative: experienced a strong adverse reaction; extreme fatigue; fever; This spontaneous case was reported by a patient family member or friend and describes the occurrence of IMMUNISATION REACTION (experienced a strong adverse reaction), FATIGUE (extreme fatigue) and PYREXIA (fever) in a 23-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Sep-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On 07-Sep-2024, the patient experienced IMMUNISATION REACTION (experienced a strong adverse reaction), FATIGUE (extreme fatigue) and PYREXIA (fever). At the time of the report, IMMUNISATION REACTION (experienced a strong adverse reaction), FATIGUE (extreme fatigue) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown) was unknown.   For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Suspect product dosage text was reported as unknown. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-773495 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-773495:Reporter son case
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: I was given the wrong vaccine. I made an appointment to receive the Novavax vaccine. I checked my records on Sunday Sept 15 and saw that I was given the Pfizer mRNA vaccine instead. I was never advised of this change and would have never known had I not checked.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Immunisation reaction
Clinical narrative: she experienced a strong adverse reaction with extreme fatigue; she experienced a strong adverse reaction with extreme fatigue; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (she experienced a strong adverse reaction with extreme fatigue) and FATIGUE (she experienced a strong adverse reaction with extreme fatigue) in a female patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Sep-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. In September 2024, the patient experienced IMMUNISATION REACTION (she experienced a strong adverse reaction with extreme fatigue) and FATIGUE (she experienced a strong adverse reaction with extreme fatigue). On 06-Sep-2024, IMMUNISATION REACTION (she experienced a strong adverse reaction with extreme fatigue) and FATIGUE (she experienced a strong adverse reaction with extreme fatigue) had resolved.        The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown) was unknown.   For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   Patient had an injection of Vitamin Tresa Loeve Aera BCE yesterday before the vaccine and at the time of reporting she felt better. It was reported that next or further doses up to near seven doses for Sileo. Number of the time of that may change. Patient was looking at the center of it, things seemed to be getting worse. No concomitant medication was reported. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-773500 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-773500:Patient son case
Age: 71.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: No adverse event, Wrong product administered
Clinical narrative: accidentally administered FLUZONE NP to a 71-year-old patient instead of FLUZONE HD with no reported adverse event; Initial information received on 04-Sep-2024 regarding an unsolicited valid  non-serious case received from a nurse.                                                                                                                                                          This case involves a 71 years old male patient who was accidentally administered and influenzA USP trival A-B subvirion no preservative vaccine [Fluzone] instead of vaccines influenza USP trival A-B high dose subvirion vaccine [Fluzone high dose]with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date the patient accidentally got administered with an unknown dose of influenzA USP trival A-B subvirion no preservative vaccine Suspension for injection (lot U8486BA and expiry date- 30-JUN-2025) instead of influenza USP trival A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe (with an unknown lot number and expiry date) with no reported adverse event (wrong product administered) (latency- same day).  Information on the batch number and expiry date was requested corresponding to the one at time of event occurrence  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 and Regulatory Authority Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: ADACEL exposed to Temperature excursion/ Max/low temperature reached:  negative (-) 15.3°CDuration: From 31Aug2024 until 03Sep2024 and was administered post excursion with no reported adverse event; Initial information received on 04-Sep-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves unknown age/gender patient who was administered with diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] exposed to Temperature excursion/ Max/low temperature reached:  negative (-) 15.3°CDuration: From 31Aug2024 until 03Sep2024 and was administered post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   Caller reported that diphtheria-2/tetanus/5 AC pertussis vaccine Suspension for injection with dose 0.5 ml (with an unknown strength and route of administration)  (lot U8000AA and expiry date- 10-Feb-2026) as immunization was exposed to temperature excursion/ max/low temperature reached:  negative (-) 15.3°c duration: from 31-Aug-2024 until 03-Sep2024 and was administered post excursion with no reported adverse event (poor quality product administered) (latency- same day).   Reportedly, There was no previous excursion. Human error was not involved and vaccine was administered to 1 patient post excursion. The excursion due to Refrigerator malfunction.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 2.33
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Peripheral swelling, Urticaria
Clinical narrative: Swelling, welt in arm
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchospasm, Chest discomfort, Cough, Dizziness, Injection site induration
Clinical narrative: dizziness and bronchospasm (chest tightness, cough) within 1 hour of vaccination; raised, hard, itchy red welt approximately 0.5  inch diameter at injection site within 6 hours, grew to 1 inch diameter within 18 hours. Bronchospasm recurred within about 18 hours as well.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site swelling, Injection site urticaria
Clinical narrative: dizziness and bronchospasm (chest tightness, cough) within 1 hour of vaccination; raised, hard, itchy red welt approximately 0.5  inch diameter at injection site within 6 hours, grew to 1 inch diameter within 18 hours. Bronchospasm recurred within about 18 hours as well.
Age: 79.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Audiogram abnormal, Blindness unilateral, Deafness neurosensory, Deafness unilateral, Dyspnoea
Clinical narrative: Within days my breathing became affected and I contacted my physician's office to get a refill of my inhaler, and again on 09/29/2023 when I relized my Lost of hearing in my left ear and received a referral for a hearing appointment. Otolaryngology APPOINTMENTS  10/5,6,12,20/2023 and 11/08/2023 Hearing test/Audiogram dates 10/5,6,19,2023 and 11/08/2023   diagnosed as sudden sensorineural hearing lossMedical tests and laboratory results (if applicable) I recovered a large portion of my hearing lost.   finished treatment for my left ear which had lost most of its hearing.  After receiving 4 steroid inter-ear injections, one a week, I have regained almost all of it back. Somewhere around t 2/12/2024  3:03 PM Subjective HPI patient has had hearing loss. Has seen ENT. Has had IT steroid injections. Also has visual loss on the left side. Othervise patient is doing fine.  Appointments Otolaryngology 10/5,6,12,20/2023 and 11/08/2023 H/o 4 injections steroids left ear  at 10/20/2023  9:16 AM Procedure: LEFT Transtympanic Dexamethasone Injection Indication: LEFT sided sudden sensorineural hearing loss Referral at 4/4/2024  3:39 PM H54.62 Vision loss of left eye  (primary encounter diagnosis) Comment: Patient notice at least since December 2023. Had had a series of steroid shots in the left ear prior to vision loss that she suspects contributed to vision loss in  OCT MACULA SPECIAL ORDER left eye.  OCT macula demonstrates Referred to  at 4/10/2024  9:25 AM Dr. referral EYLEA HD (AFLIBERCEPT) 8MG  INTRAVITREAL INJECTION OS (LEFT  EYE)  May 10, 2019 o Unfortunately, patients who have repeated steroid exposure are at risk for irreversible steroid glaucoma. In fact, every week of steroid use .
Age: 79.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Intra-ocular injection, Optical coherence tomography abnormal, Sudden hearing loss
Clinical narrative: Within days my breathing became affected and I contacted my physician's office to get a refill of my inhaler, and again on 09/29/2023 when I relized my Lost of hearing in my left ear and received a referral for a hearing appointment. Otolaryngology APPOINTMENTS  10/5,6,12,20/2023 and 11/08/2023 Hearing test/Audiogram dates 10/5,6,19,2023 and 11/08/2023   diagnosed as sudden sensorineural hearing lossMedical tests and laboratory results (if applicable) I recovered a large portion of my hearing lost.   finished treatment for my left ear which had lost most of its hearing.  After receiving 4 steroid inter-ear injections, one a week, I have regained almost all of it back. Somewhere around t 2/12/2024  3:03 PM Subjective HPI patient has had hearing loss. Has seen ENT. Has had IT steroid injections. Also has visual loss on the left side. Othervise patient is doing fine.  Appointments Otolaryngology 10/5,6,12,20/2023 and 11/08/2023 H/o 4 injections steroids left ear  at 10/20/2023  9:16 AM Procedure: LEFT Transtympanic Dexamethasone Injection Indication: LEFT sided sudden sensorineural hearing loss Referral at 4/4/2024  3:39 PM H54.62 Vision loss of left eye  (primary encounter diagnosis) Comment: Patient notice at least since December 2023. Had had a series of steroid shots in the left ear prior to vision loss that she suspects contributed to vision loss in  OCT MACULA SPECIAL ORDER left eye.  OCT macula demonstrates Referred to  at 4/10/2024  9:25 AM Dr. referral EYLEA HD (AFLIBERCEPT) 8MG  INTRAVITREAL INJECTION OS (LEFT  EYE)  May 10, 2019 o Unfortunately, patients who have repeated steroid exposure are at risk for irreversible steroid glaucoma. In fact, every week of steroid use .
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Body temperature increased, Chills, Palpitations, Sleep disorder
Clinical narrative: I woke up with severe chills a bit after midnight. Extra blankets. Back to sleep.    At about 4:00 AM I woke up with rapid heart beat sounding in my ears. Got out of bed about 4:20. Heart beat 98. Temp 100.9 F.  Blood pressure 153/86.  All of this passed by about 10:AM. The heartbeat only slowly returned to my normal (60-79), reaching that in the early afternoon.
Age: 2.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: PATIENT WAS GIVEN QUADRACEL TOO EARLY
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Fall, Posture abnormal, Syncope
Clinical narrative: Patient was here for vaccines. Administered 2 vaccines in the LD Men quad and TDAP, then gave HPV in the RD at 905AM.Just after administration of the HPV vaccine the patient fainted and began to slump and fall from the chair. Patient landed face down on the floor.  Patient came to quickly, within 1 minute. I did not have to use the ammonia. Patient sat in the floor for ~ 3 minutes, I applied a cool damp cloth to her face and neck area. Patient was alert and orientated times 3, and able to stand up and move herself to the chair. The patient rested in the chair for ~ 5 more minutes. Then patient was able to ambulate unassisted. No obvious injury noted. Patient denied injury. Mother and patient left ambulatory to home
Age: 0.33
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Bradykinesia, Choking, Crying, Dyspnoea, Glassy eyes
Clinical narrative: 9/14/22 7:22am: Woke up to baby with high pitched cry, picked baby up from bassinet immediately and noticed he was limp in all extremities. Took forehead temp, 99.1F. Babies' eyes were open but glazed over and not responding to  external stimuli. Baby briefly stopped crying and laid on changing table, and began to move all extremities slowly. Picked baby up and baby still did not regain all muscle tone, baby began making "gasping" breaths, but no skin color changes. Baby appear to choke on spit and gurgling noise heard, gave baby pats on the back and baby was able to cough it up and clear airway- no skin color changes note. Episode lasted about 5-10min, baby returned back to baseline. Reached out to pediatrician via message and was told to monitor and go to ER if abnormal movements occur.
Age: 0.33
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Hypotonia, Increased bronchial secretion, Productive cough, Unresponsive to stimuli
Clinical narrative: 9/14/22 7:22am: Woke up to baby with high pitched cry, picked baby up from bassinet immediately and noticed he was limp in all extremities. Took forehead temp, 99.1F. Babies' eyes were open but glazed over and not responding to  external stimuli. Baby briefly stopped crying and laid on changing table, and began to move all extremities slowly. Picked baby up and baby still did not regain all muscle tone, baby began making "gasping" breaths, but no skin color changes. Baby appear to choke on spit and gurgling noise heard, gave baby pats on the back and baby was able to cough it up and clear airway- no skin color changes note. Episode lasted about 5-10min, baby returned back to baseline. Reached out to pediatrician via message and was told to monitor and go to ER if abnormal movements occur.
Age: 10.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Unevaluable event
Clinical narrative: NONE
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Oral herpes, Pyrexia
Clinical narrative: Fever, weakness, cold sores
Age: 7.0
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no event
Age: 88.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling
Clinical narrative: UPPER ARM SWELLING
Age: 88.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Pyrexia, Swelling
Clinical narrative: UPPER ARM SWELLING
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Condition aggravated, Death, Dementia, SARS-CoV-2 test positive
Clinical narrative: Pt was admitted to the hospital for psych on 7/25. Pt tested positive for covid on 8/15. Pt recovered from covid but did die during hospitaliztion on 9/15 due to dementia and going to comfort care.
Age: 80.0
Sex: F
Vaccine: RSV
Symptoms: Angiogram cerebral normal, Arteriogram carotid normal, Blood cholinesterase, Computerised tomogram head normal, Eyelid ptosis
Clinical narrative: Patient received vaccine on 8/30/24.  on 9/6/24 she developed ptosis of her right eyelid.
Age: 80.0
Sex: F
Vaccine: RSV
Symptoms: Magnetic resonance imaging head normal
Clinical narrative: Patient received vaccine on 8/30/24.  on 9/6/24 she developed ptosis of her right eyelid.
Age: 1.5
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC15, VARCEL
Symptoms: No adverse event, Single component of a two-component product administered
Clinical narrative: After Patient was vaccinated with Pentacel on 8/19, it was discovered that only the diluent portion of the Pentacel was administered to the pt, the lyophilized (powder) portion was not administered. No adverse reaction was noted. Patient was contacted to return to the clinic for Hib vaccination per orders of state immunization Doctor. Patient revaccinated with ActHib on 9/3/24.
Age: 64.0
Sex: M
Vaccine: FLUR4, VARZOS
Symptoms: Erythema, Fatigue, Headache, Oropharyngeal pain, Pain
Clinical narrative: Swelling, redness, and pain in left arm.  Headaches, body aches, sore throat, fever 101.5, tiredness for 24-36 hrs
Age: 64.0
Sex: M
Vaccine: FLUR4, VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Swelling, redness, and pain in left arm.  Headaches, body aches, sore throat, fever 101.5, tiredness for 24-36 hrs
Age: 21.0
Sex: M
Vaccine: FLUC4
Symptoms: Adenovirus test, Cardiogenic shock, Catheterisation cardiac normal, Cytomegalovirus test, Echocardiogram abnormal
Clinical narrative: Patient had fatigue and slept more than usual the day after his vaccine (9/11). On 9/12, he developed a fever and family took him to the ED where he had cardiogenic shock and diffuse ST elevation. Cardiac cath negative. Subsequent work-up concerning for myocarditis. Infectious work-up for myocarditis in process. Currently admitted to ICU for management. Note: did not receive SARS-CoV2 vaccine at his 9/10 visit
Age: 21.0
Sex: M
Vaccine: FLUC4
Symptoms: Electrocardiogram ST segment elevation, Enterovirus test negative, Epstein-Barr virus test, Fatigue, Hypersomnia
Clinical narrative: Patient had fatigue and slept more than usual the day after his vaccine (9/11). On 9/12, he developed a fever and family took him to the ED where he had cardiogenic shock and diffuse ST elevation. Cardiac cath negative. Subsequent work-up concerning for myocarditis. Infectious work-up for myocarditis in process. Currently admitted to ICU for management. Note: did not receive SARS-CoV2 vaccine at his 9/10 visit
Age: 21.0
Sex: M
Vaccine: FLUC4
Symptoms: Influenza A virus test negative, Influenza B virus test negative, Intensive care, Laboratory test, Left ventricular dysfunction
Clinical narrative: Patient had fatigue and slept more than usual the day after his vaccine (9/11). On 9/12, he developed a fever and family took him to the ED where he had cardiogenic shock and diffuse ST elevation. Cardiac cath negative. Subsequent work-up concerning for myocarditis. Infectious work-up for myocarditis in process. Currently admitted to ICU for management. Note: did not receive SARS-CoV2 vaccine at his 9/10 visit
Age: 21.0
Sex: M
Vaccine: FLUC4
Symptoms: Parvovirus B19 test, Pyrexia, Respiratory syncytial virus test negative, Respiratory viral panel, Right ventricular dysfunction
Clinical narrative: Patient had fatigue and slept more than usual the day after his vaccine (9/11). On 9/12, he developed a fever and family took him to the ED where he had cardiogenic shock and diffuse ST elevation. Cardiac cath negative. Subsequent work-up concerning for myocarditis. Infectious work-up for myocarditis in process. Currently admitted to ICU for management. Note: did not receive SARS-CoV2 vaccine at his 9/10 visit
Age: 21.0
Sex: M
Vaccine: FLUC4
Symptoms: SARS-CoV-2 test negative, Viral test negative
Clinical narrative: Patient had fatigue and slept more than usual the day after his vaccine (9/11). On 9/12, he developed a fever and family took him to the ED where he had cardiogenic shock and diffuse ST elevation. Cardiac cath negative. Subsequent work-up concerning for myocarditis. Infectious work-up for myocarditis in process. Currently admitted to ICU for management. Note: did not receive SARS-CoV2 vaccine at his 9/10 visit
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Cold sweat, Dizziness, Feeling cold
Clinical narrative: vaccines on 9/13/24 included second shingles vaccine. 9/14/24 side effects were similar to first shingles vaccine earlier this summer - body aches, chills, headache, feeling too warm. 9/15/24 woke up feeling almost 100% except for slight headache. everything was normal until at church and felt suddenly extremely cold and my vision closing in. felt extremely weak as if i was about to faint. my heartrate and breathing seemed normal. i sat down, broke out into a cold sweat. laid down briefly, my vision had become "starry" and laying down it went back to normal. i went back home and laid down for about 30 minutes to warm up. the cold sweat went away and felt much better after getting up and moving around.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Pain, Photopsia, Visual impairment
Clinical narrative: vaccines on 9/13/24 included second shingles vaccine. 9/14/24 side effects were similar to first shingles vaccine earlier this summer - body aches, chills, headache, feeling too warm. 9/15/24 woke up feeling almost 100% except for slight headache. everything was normal until at church and felt suddenly extremely cold and my vision closing in. felt extremely weak as if i was about to faint. my heartrate and breathing seemed normal. i sat down, broke out into a cold sweat. laid down briefly, my vision had become "starry" and laying down it went back to normal. i went back home and laid down for about 30 minutes to warm up. the cold sweat went away and felt much better after getting up and moving around.
Age: 72.0
Sex: F
Vaccine: FLUA4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient had already received her FLUAD vaccine on 8/18/2024 Lot #388459 in left arm. This was her second flu shot, pulled consent forms and spoke to patient on 9/16/2024 and confirmed that was her second flu vaccine, has not symptoms or signs at this time
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Injection site rash, Lethargy, Pain in extremity, Pyrexia
Clinical narrative: Initially, severe pain in arm from injection to wrist. Fever, lethargy 12 hours through 36 hours after. Rash at injection site after 24 hours.
Age: 70.0
Sex: F
Vaccine: FLUA4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This was second flu shot received by patient. Patient has no adverse symptoms or reactions.
Age: 13.0
Sex: F
Vaccine: HPV9, MENB, TDAP
Symptoms: Wrong product administered
Clinical narrative: Patient given MenB (Bexsero) instead of meningococcal groups A,C,Y and W (MEnQuadfi)
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter
Clinical narrative: Patient has had Pfizer and Moderna in the past. She received Pfizer and called me the next day and told me she felt flutters that night after her shot. She took her regular meds that help control her A Fib and monitored it that night and said she felt better before going to bed. The next day she was not having the flutters.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Fall, Syncope
Clinical narrative: brief syncope after standing up, client fell to floor. Woke, was unhurt. RN had him lie on floor for a few minutes, then sit in chair with feet up. Client accepted and drank apple juice. Stable and comfortable when left office.
Age: 83.0
Sex: F
Vaccine: FLUA4, FLUA4
Symptoms: Extra dose administered, Limb discomfort
Clinical narrative: Patient was administered a second dose of FLUAD.  Patient reported "heavier arm" for the day following the second dose, but states she feels great now.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC20, RV5
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Pentacel ordered but Pediarix administered to patient.  Vaxelis administered on 6/13/2024.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Patient says it hurt when she got the shot and now she has pain radiating from shoulder to hand.
Age: 30.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Chest pain, Fatigue, Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Large, red itchy rash at injection site that persisted for at least 5 days (it's still happening). Soreness in arm. Very tired the day after the vaccine, a little chest pain over the weekend, but the tiredness and little chest pain was expected. The large, red itchy rash was the main thing I wanted to report. It matches the description of "COVID arm." I wanted to report it somewhere so there is more data on how many people have had this reaction! I honestly thought I had an infection until I learned about "COVID arm." The rash looks better this morning so I think I'm getting better.
Age: 30.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Pain in extremity
Clinical narrative: Large, red itchy rash at injection site that persisted for at least 5 days (it's still happening). Soreness in arm. Very tired the day after the vaccine, a little chest pain over the weekend, but the tiredness and little chest pain was expected. The large, red itchy rash was the main thing I wanted to report. It matches the description of "COVID arm." I wanted to report it somewhere so there is more data on how many people have had this reaction! I honestly thought I had an infection until I learned about "COVID arm." The rash looks better this morning so I think I'm getting better.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Neck pain
Clinical narrative: Patient reports severe neck and back pain the day after the Corminarty 12+ vaccination, wanted to mention to pharmacy staff of the pain after the shot. Patient did not experience other side effects such as fever, chillls, or shortness of breath
Age: 58.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Musculoskeletal stiffness, Pain in jaw
Clinical narrative: Patient received both flu and shingles vaccine in her left arm at approximately 12pm 9/15.  Patient contacted me on 9/16 stating she had a stiff neck and a sore jaw.  She has had flu vaccines before without issue, but believes this is from the Shingles vaccine.  She noted that her upper arm is also red and swollen from where the vaccines were given more so than a usual vaccine in her experience.  Advised patient on at home care and to contact her doctor if condition did not improve or symptoms worsened today.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20
Symptoms: Injection site reaction, Pyrexia, Urticaria
Clinical narrative: Pt's parent reached out via online source stating hives had developed on thigh <2 hrs after shots given. Our office was closed so we reached out in morning. Dr. advised Zyrtec 2.5mL to help with hives. Hives spread to face and developed 102.4 fever 9/5. Zyrtec given. Hives cleared up 9/6.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Anxiety, Breath holding, Bruxism, Hypotonia, Lip discolouration
Clinical narrative: About 5 minutes after vaccine administration, patient reported feeling very anxious. She became unresponsive and limp and was holding her breath. RN held patient head and neck for support and called for help/assistance. Patients arms and legs became stiff while sitting in chair. Patients face became very pale, and her lips appeared to be white. Her jaws were clinched at this time. 2nd RN assisted by maneuvering patients jaw to maintain open airway. 3rd RN assisted with checking vitals and calling 911. Pt began to take breaths on her own and began to respond to staff and was able to answer questions and follow commands. All assisting staff remained with patient until Ambulance arrived for transport and monitoring.